Food Safety Tool Kit

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Toolkit
Food Safety
IFC, a member of the World Bank Group, creates opportunity for people to escape poverty and improve their lives. We foster
sustainable economic growth in developing countries by supporting private sector development, mobilizing private capital, and
providing advisory and risk mitigation services to businesses and governments.
IFC Food Safety Toolkit has been produced by IFC through its Global Food Safety Advisory Program.
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views of, IFC or its Board of Directors, or the World Bank or its Executive Directors, the Austrian Ministry of Finance or the
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1
Content
MODULE 1 MODULE 3
Introduction and Overview Food Safety Legislation 2

Basic Facts About IFC ........................................................6 Introduction ........................................................................32
Developing Agribusiness ..................................................6 Main Food Safety Regulations:
List of Regulations, Summary of Scope,
About IFC Global Food Safety Program ...................6
Links with Codex Alimentarius, EU and US ........... 33
Donor partners ..................................................................... 7
Requirements for FBOs .................................................37
Foreword .................................................................................8
Import/Export..................................................................... 50
The IFC Food Safety Toolkit ...........................................9
Regulatory Authority ......................................................52
Other Relevant Regulations .........................................54
3
The Eurasian Economic Union (EEU) ......................59
MODULE 2 MODULE 4
Food Safety Standards and Food Safety Tools

Schemes
Introduction ..........................................................................12
and Techniques
Introduction ....................................................................... 68
4
British Retail Consortium (BRC) ..................................13 FSTK PRP Workbook ..................................................... 68
International Featured Standard (IFS) Food ..........15 FSTK PRP Workbook Instruction Guide ................ 68
Food Safety System Certification (FSSC) 22000 ... 16 An overview of PRPs. ...................................................... 69
PrimusGFS............................................................................. 19 Planning and Development of PRPs .........................71
Global Red Meat Standard (GRMS) ...........................21 FSTK PRP Wprkbook: Examples & Instructions
CanadaG.A.P. ......................................................................22
Global G.A.P. ........................................................................24
(WS1- WS6) ..........................................................................73
PRP 6: Utilities, supply of air, water and
5
energy ...............................................................74
Global Aquaculture Alliance (GAA) Seafood PRP 9: Management of Purchased Material....84
Processing Standard ........................................................26 PRP 11: Cleaning and Sanitizing ............................ 94
Safe Quality Food (SQF) .................................................27 PRP 12: Pest Control ............................................... 106
China HACCP .....................................................................28 PRP 13: Employee Hygiene and Employee
Facilities...........................................................116
GMP + Feed Certifcation Scheme ..............................29
6
PRP 14: Rework ......................................................... 128
FSTK HACCP/O-PRP Plan Workbook ................... 138
History of HACCP ........................................................... 139
Preliminary Steps in Developing a HACCP Plan ...141
HACCP Document Templates for Whole Milk ...144
Overview&Guid of the HACCP Worksheets ......144
7
1
4
MODULE 5 MODULE 6
FSMS Procedures Food Safety Training

and Documentation Introduction ..................................................................... 292
Documentation Overview ...........................................170 Choosing Food Safety Trainers

or Training Course ......................................................... 292
2 Process of Approval, Issue and Control of Food

Safety management System Documents ........... 176
Electronic or Hard Copy Records? .......................... 177
Training Effectiveness and Evaluation .................294
Outcomes Used in Evaluating
Training Programs .......................................................... 295
Food Safety Management System
Documentation Templates ........................................ 178 Training and Development Procedure
Control of Documents ............................................. 179 Template ............................................................................. 298
Control of Records ....................................................189 Responsibility Matrix, Training Needs Analysis

Complaint Management ........................................194 and Training Plan [Partial Sample] ..........................306
3
Control of Nonconforming Product ................ 200 Food Safety Training Matrix .....................................308
Calibration....................................................................206 Food Safety T&D Matrix .............................................309
Corrective and Preventive Action ......................220
Internal Auditing ....................................................... 226
Traceability ....................................................................235
Product Recall and Withdrawal .........................246 MODULE 7
Mock Recall ..................................................................253
Food Defence Plan .................................................... 261 Information for Company
Management
4
Allergen Control .........................................................273
Hygiene Procedure ....................................................277 Introduction ....................................................................... 312
Identification and Evaluation of
Food Safety Policy ........................................................... 312
Compliance ..................................................................284
Management Commitment ....................................... 314
Recourses ............................................................................ 315
Management Review procedure Template ..........317
Example of Management Review Meeting
materials ............................................................................. 324
5
Annexes
Useful links ....................................................................333
Terms and definitions ............................................ 336
7
Introduction
and Overview
MODULE 1
6 MODULE 1 INTRODUCTION AND OVERVIEW
Basic Facts About IFC

We work with the private sector in developing countries to help create opportunity for all.
IFC, a member of the World Bank Group, is the largest global development institution focused exclusively on
the private sector in developing countries.
We utilize and leverage our products and services — as well as products and services of other institutions in
the World Bank Group — to provide development solutions customized to meet clients’ needs. We apply our
financial resources, technical expertise, global experience, and innovative thinking to help our partners over-
come financial, operational, and political challenges.
Clients view IFC as a provider and mobilizer of scarce capital, knowledge, and long-term partnerships that
can help address critical constraints in areas such as finance, infrastructure, employee skills, and the regulatory
environment.
IFC is also a leading mobilizer of third-party resources for its projects. Our willingness to engage in diffi-
cult environments and our leadership in crowding — in private finance enable us to extend our footprint
and have a development impact well beyond our direct resources. For more information, visit www.ifc.org.
Developing Agribusiness
IFC has made agribusiness a priority because of its potential for broad development impact and especially
strong role in poverty reduction. We combine investments and advisory services to help the sector address
higher demand and escalating food prices in an environmentally sustainable and socially inclusive way.
In the fiscal year ended in June 2015, we invested $3.2 billion across the agribusiness supply chain — from farm
to retail — to help boost production, increase liquidity, improve logistics and distribution, and expand access
to credit for small farmers. At the end of the fiscal year, IFC’s committed portfolio for our own account stood
at $3.4 billion.
About IFC Global Food Safety Program

IFC’s activities comprise advisory support to companies that promote good agricultural practices that benefit
small-scale farmers, and value chain solutions involving small and medium size enterprises. IFC has launched
an advisory platform (the Program) to help agribusiness companies build capacity in food safety globally. The
goal of the Program is to reduce food safety risk for IFC clients in agribusiness while contributing to industry
sector capacity in select markets. Within the scope of this project, IFC will be working with agribusiness and
retail clients (“the Clients”) in all food industry sectors on efforts to increase their competitiveness. Specifically,
IFC will be providing advisory services that will facilitate the upgrading of food safety management systems in
keeping with changing global requirements that will lead to improvement of their performance and efficiency
and ultimately to sales increase, costs and risk profile reduction.
Contact: Sarah Ockman, Program Lead, sockam@ifc.org

Donor partners 7
Donor partners
Austrian Ministry of Finance (MOF)

External Economic Program
MOF’s external economic program supports the development and transition process in Southeast and East
Europe. The program aims at promoting sustainable investments to support economic growth, create jobs
and improve the business environment. Supporting local and foreign investments helps to improve the liveli-
hood of people and the progress towards a stable and prospering region. Our goal is to contribute to private
sector growth through capacity building, SME support, facilitation of investments, and building business part-
nerships between Austrian and local investors.
The Norwegian Ministry of Foreign Affairs

The Royal Norwegian Ministry of Foreign Affairs (MFA) has the overall responsibility for foreign policy, trade
policy and aid-related relations between Norway and developing countries and between Norway and inter-
national organizations.
The main goal of Norwegian development cooperation is to contribute towards lasting improvements in eco-
nomic, social and political conditions for the populations of developing countries. The Norwegian government
aid policy aims at strengthening developing countries’ ability to solve their poverty problems and promote
economically and environmentally sustainable development.
The scope for the assistance to the countries in Southeast Europe is to support the government’s decision of
integration with European and North Atlantic structures. Euro-Atlantic integration to promote stability and
democratization in the countries of the region and in the region as a whole are central to Norway’s efforts in
the Western Balkans. High priority is being given to the implementation of the EU Stabilization and Associa-
tion process which has given the Western Balkan countries the prospect not only of closer cooperation with
the EU, but also of possible future membership.
The priorities are to strengthen the democratic institutions, support economic and political reforms, support
business development, enhance respect of the human rights, fight against corruption and crime and improve
the regional cooperation.
Japan’s Ministry of Finance

Japan is committed to contributing to global development with a particular focus on Africa. To further deepen
partnerships with developing countries and contribute to international stability, Japan provides official de-
velopment assistance both bilaterally and through multilateral institutions such as IFC. Japan’s Ministry of
Finance has been a major donor to the Japan Comprehensive Trust Fund (CJTF), which has been an important
vehicle for supporting IFC Advisory globally since 1995. In 2014, Japan added a dedicated Tokyo International
Conference on African Development (TICAD) window under CJTF to support projects in Sub-Saharan Africa
and North Africa.
Foreword
The latest estimates predict a global population of nine billion by the year 2050. This substantial increase in
the number of people will require a sustainable and safe food supply, which unfortunately has not yet been
secured. Investments in food safety management systems are a key prerequisite in assuring a reliable and
constant supply of safe food as well as increased cross border trade.
The agribusiness industry is a vital engine in the economies of many counties around the globe. However, in-
adequate food safety standards and poor food safety practices inhibit agribusiness growth potential and shut
domestic companies out of global value chains.
The corporate world recognizes the risks: according to a 2015 survey by KPMG of senior executives from global
manufacturing and retail, food and product safety ranks as the top priority for sustainability and corporate
responsibility, and the top priority for investment.
Internationally recognized standards have a proven track record of delivering results that include better risk
management, increased access to new markets and major retailers, better operational efficiency (due to re-
duced costs and higher productivity) and enhanced reputations. Therefore, addressing food safety in a system-
ic and sustainable way will contribute toward increasing sales, exports and profits, reducing costs, minimizing
risks and attracting investors.
IFC, a global leader in providing the private sector with a full range of investment and advisory services to
boost sustainable development in emerging markets, has developed a unique product calibrated to help food
producers to access and implement an effective food safety management system.
Designed to be a self-guided instructional manual, the Food Safety Toolkit is ideal for businesses that have not
yet developed their own system or wish to improve their existing one. The Toolkit has already been success-
fully tested with food companies in Europe and Central Asia as well as in selected countries of Asia and Africa.
Companies which have already improved their food safety systems with the help of the Toolkit have entered
new markets, increased profitability, and improved customer trust and confidence.
We are convinced that the IFC Food Safety Toolkit will help companies implement better food safety systems
improve their competitiveness and facilitate entry into global value chains.
Tania Lozansky
Head of Advisory, IFC Manufacturing, Agribusiness and Services
Foreword 9
The Food Safety Toolkit

The IFC Food Safety Toolkit is designed to enable companies in developing markets reduce a key risk in grow-
ing a sustainable food business: meeting the ever-increasing demands, needs, expectations and trust of cus-
tomers, wholesalers, retailers, government food safety regulators, and ultimately, consumers.
The Toolkit was developed by IFC with food industry help and expertise. It is based on HACCP principles of
foodstuff hygiene (European Union food hygiene legislation: Regulations (EC) No 852/2004, 853/2004 and
854/2004), and best industry practices and standards.
The Toolkit provides companies with the know-how to develop, implement and maintain a modern food
safety management system based on the principles of the Hazard Analysis Critical Control Points system
(HACCP). HACCP is a systematic approach to identifying and controlling hazards (whether microbiological,
chemical or physical) which pose potential hazards in the preparation of safe food. HACCP aims to proactively
identify and prevent potential problems that could put food safety at risk. In simple terms, that means control-
ling the safety of ingredients and supplies coming into a food business and correctly handling them thereafter.
The Toolkit helps companies to identify gaps in their existing practices and develop more efficient food safety
system. Specifically companies can:
 Apply the Toolkit in any process regardless of production facility size, location and food safety
sophistication;
 Develop systemic science-based approaches to food safety management;
 Benchmark their own food safety system against the best international practices;
 Use the Toolkit as simple and practical self-service tool, replicating it to all production lines as necessary;
 Tailor the templates in accordance with their needs.
The Toolkit consists of seven modules. It serves as a ‘roadmap’ to help companies manage their food safety
systems in a clear, informative manner. The following summarizes the purpose of each module:
Module 1 introduces the Food Safety Toolkit and provides an overview of the contents. It identifies the target
audience and describes the benefits of using it. This section also references an awareness presen-
tation for companies planning to launch a food safety management system to more effectively
engage employees and stakeholders. Associated with Module 1 are two executive management
tools: (i) a document highlighting the benefits, challenges and lessons to be learned from other
FBOs that have adopted a FSMS using the IFC FSTK; and (ii) a self-assessment tool that enables the
FBO executive management team to quickly establish the maturity of their FSMS compared to the
preferred GFSI or other food safety Scheme. See Module 7 – Executive Management Module and
specifically the resource section for additional details.
Module 2 consists of an overview of GFSI and other FSMS schemes and standards that a producer may
choose in managing food safety. The schemes and standards selected are based on international
best practices.
Module 3 provides an overview of the primary food safety legislation now in place, including the role and
responsibilities of the various enforcement agencies; the role and responsibility of the company;
recommended sources of food safety legislation; a process through which a company can demon-
strate its legal compliance with these food safety requirements; and useful links to enable the FBO
become aware of new of amendments in food safety regulations, GFSI and other FSMS schemes.
Module 4 consists of two elements:

(1) An overview of Pre-Requisite Programs [PRPs] based on the requirements of ISO/TS 22002-1. Six
examples of PRPs associated with Milk Processing based upon ISO/TS 22002-1 is included in the
IFC FSTK version 3.0 with a PRP document template that may be used by FBOs when developing
their PRPs. Also included is general information on planning and development of PRPs;
(2) General information about HACCP, including its history, underlying principles, benefits, and the
preliminary steps in developing a HACCP system. IFC has also developed a comprehensive cost-
benefit analysis tool to enable the FBO establish the benefits of adopting HACCP or a FSMS (see
Module 7 of the IFC FSTK). Included in the IFC FSTK Version 3 is a partial example of a milk pro-
cessing HACCP plan. In the partial milk processing example, two Critical Control Points [CCPs]
and one O-PRP example are provided.
A HACCP plan document template is provided and it may be used by the FBO when developing its
HACCP plan[s]. The IFC FSTK also contains a CD with a MS Word document version of the PRP and
the HACCP plan document template.
Module 5 provides details on establishing and developing FSMS procedures and documentation. Specifically,
this module provides an overview of the typical documentation structure or hierarchy in a FSMS;
an explanation of the purpose and benefits of a documented FSMS; a description of the different
documents in a FSMS [namely policy, objectives, procedures, work instructions, food safety plans,
specifications, forms and records]; and the control of FSMS documents and general information
on record management and retention. Finally, this module provides completed examples of the
primary documented procedures an FBO is likely to need as defined by the various GFSI and other
FSMS schemes. Also included is a basic example of a food defense plan enabling the FBO meet its
food security requirements.
Module 6 consists of general information on training and development and provides sample documents,
including a training and development procedure, an example of a FSMS responsibility, a training
needs analysis and training plan, an FSMS training and development matrix, a new section on
evaluation of training effectiveness, and methods of evaluating training. The FBO may adapt these
documents to include in its FSMS.
Module 7 provides an overview on how to establish and develop a food safety policy, describes the need for
top management commitment, and explains what resources are required to establish, develop,
implement and maintain and effective FSMS. This module also includes an example of a FSMS man-
agement review procedure and a MS PowerPoint document template that the FBO may consider
when documenting and recording the actions and decisions arising from a FSMS management
review, including evaluation of related follow-up activities.
Food Safety Standards
and Schemes
MODULE 2
12 MODULE 2 FOOD SAFETY STANDARDS AND SCHEMES
Introduction
This module provides an overview of primary and voluntary food safety schemes, and the standards applicable
for Food Business Operators (FBOs). The module includes the International Food Safety Management System
Standard FSSC 22000 and a variety of private label and Government managed FSMS Schemes or standards
known collectively as the Global Food Safety Initiative (GFSI) standards plus GMP+.
In fact, the knowledge food businesses have about these different schemes and standards is limited. Partly
that is due to the number of FSMS schemes and standards already existing in the market. In this module, we
offer overview-level detail on the FSMS Schemes and Standard as an aid in helping FBOs consider which FSMS
Scheme(s) may be most relevant to them, their customers and consumers.
No opinion is offered or given on which FSMS Scheme or standard a particular FBO should select.
British Retail Consortium 13
British Retail Consortium (BRC)

What is the British Retail Consortium?
BRC Global Standards is a leading safety and quality certification program, used by over 23,000 certificated
suppliers in 123 countries, with certification issued through a worldwide network of accredited certification
bodies.
Which standards does the BRC operate?
The BRC Global Standards consists of a list of standards, namely:
GFSI GFSI
BRC Global Standard
Scheme Scope
BRC Global Standard for Food Safety Issue 7 Yes D, EI, EII, EIII, EIV
BRC Global Standard for Packaging and Packaging Materials Issue 4 Yes M
BRC Global Standard for Storage and Distribution Issue 2 Yes J
BRC Global Standard for Consumer Products Issue 3 No
BRC Global Standard for Agents and Brokers issue 1 No
BRC Global Standard for Food Safety (Issue Seven)

The BRC Global Standard for Food Safety (Issue Seven) is a standard developed by the British Retail Consor-
tium for companies providing retailer-branded food products. The BRC Global Standard for Food Safety Issue
7 was published in January 2015.
This standard covers food safety and product quality management and operational criteria in a food manu-
facturing organization to fulfil obligations with regard to legal compliance and protection of the consumer.
The standard is owned by the BRC (United Kingdom) and written and managed with input from an interna-
tional multi-stakeholder group made up of food manufacturers, retailers, and food service and certification
body representatives.
BRC/IoP Global Standard for Packaging and Packaging Materials (Issue Five)
This is one of the main global standards for the manufacture and conversion of packaging materials for both
food and non-food use. The BRC Global Standard for Packaging and Packaging Materials Issue 5 was pub-
lished in July 2015.
The standard covers the hygienic production of packaging materials and the management of quality and func-
tional properties of the packaging to provide assurance to customers. The standard includes optional modules
to cover logistics operations such as wholesale, contract packing, product inspection and waste recovery.
Certification to this standard requires strict control of comprehensive technical and sanitary characteristics of
production in order to assess the possibility of the supplier to produce and deliver consistently safe products
for consumers in accordance with its specifications.
The standard is operated by the BRC in conjunction with the Packaging Society and an advisory committee
of stakeholders.
Background
In 1998 the British Retail Consortium generated its first BRC food technical standard in order to address the
growing demand to ensure safe and quality food production within the industry. After its initial success, it
evolved into a global standard used, not just to assess retail suppliers, but as the foundation upon which com-
panies have based their supplier assessment programs.
On April 24, 2014, the BRC Global Standard for Food Safety (Issue 6) and BRC/IoP Global Standard for Packaging and
Packaging Materials (Issue 4) were successfully benchmarked by the Global Food Safety Initiative and have achieved
recognition in the GFSI Guidance Document Sixth Edition.
Who is it relevant to?
The BRC Global Standards [GFSI approved schemes] are relevant to food and ingredient manufacturers,
wholesalers and distributors. The BRC Global Standard deals with food, packaging, storage and distribution.
Fundamental Standard Requirements:

 Top management and continual Improvement
 The Food Safety Plan [HACCP]
 Food Safety and Quality Management System
 Site standards
 Product control
 Process control
 Personnel
For additional details see: www.brc.org.uk.

IFS 15
International Featured Standard (IFS) Food

What is IFS Food?
IFS Food is a standard for auditing food safety and the quality of food manufacturers’ processes and products.
First introduced in 2003, it is now operating in its sixth version. In 2011, it issued more than 11,000 certificates
in 90 different countries.
IFS Management has five regional offices worldwide, tasked with coordinating technical working groups in
different languages (German, French, North American, Spanish and Italian) for various stakeholders, including
retailers, industry players, certification bodies and food services entities. It relies on a continuous improvement
process regarding IFS standards, database and integrity program among other aspects of its mandate.
Which standards does the IFS operate?
The IFS operates the following standards:
IFS Standard GFSI Scheme GFSI Scope

IFS Food, version 6 Yes C, D, EI, EII, EIII, EIV, L, J
IFS Logistics, version 2.1 Yes J
IFS Broker No
IFC HPC No
IFC Cash & Carry No
IFS PACsecure, version 1 Yes M
IFS Food Store No
Background
IFS Food Standard (version 6) was developed with the full and active involvement of certification bodies, re-
tailers, industry and food service companies from all over the world.
On September 21, 2012 it was successfully re-benchmarked by GFSI and has achieved recognition against the GFSI Guid-
ance Document Sixth Edition.
The standard is owned by IFS Management GmbH, Germany.
The IFS Standards (GFSI approved schemes) are relevant to food and ingredient manufacturers, wholesalers
and distributors. The IFS Standards deals with food, packaging, storage and distribution.

 Top management responsibility
 A quality food safety management system
 Resource management
 Planning and production process
 Measurement, analysis, improvements
 Food defense
For additional details see: www.ifs-certification.com.

Food Safety System Certification (FSSC) 22000

What is FSSC 22000
The Food Safety System Certification 22000 (FSSC 22000) is a robust, ISO-based, internationally accepted
certification scheme for the assessment and certification of food safety management systems throughout the
entire supply chain.
The FSSC 22000 certification scheme is supported by the European Food and Drink Association (CIAA) and the
American Groceries Manufacturing Association (GMA). The certification is accredited under ISO guide 17021.
Background
The FSSC 22000 certification scheme complies with ISO 22000 and the technical specifications for PRPs.
These requirements are based on the ISO Standard developed by the International Organization for Stan-
dardization (ISO) and Publicly Available Specification (PAS) prepared by the British Standards Institution (BSI).
On February 22, 2013, FSSC 22000, version 3 (October 2011 issue) was successfully re-benchmarked by GFSI and has
achieved recognition against the GFSI Guidance Document Sixth Edition.
FSSC 22000 has been recognized against the following scopes:
C Animal Conversion;
D Pre Processing Handling of Plant Products;
EI Processing of Animal Perishable Products;
EII Processing of Plant Perishable Products;
EIII Processing of Animal and Plant Perishable Products (Mixed Products);
EIV Processing of Ambient Stable Products;
L Production of (Bio) Chemicals;
M Production of Food Packaging.
Which standards does FSSC 22000 operate?
The version 3 of FSSC 22000 was published on April 10, 2013.
FSSC 22000 = ISO 22000 + ISO/TS 22002-1 + additional requirements (applicable to food manufacturing)
Two of the previous additional FSSC requirements remain unchanged:

1. Specifications for services
2. Supervision of personnel in application of food safety principles
One of the previous additional FSSC requirements was modified:

3. Specific regulatory requirements
Organizations seeking certification shall assure that specifications for ingredients and materials take account
of any applicable regulatory requirements [e.g. control of prohibited substances]. The requirement for Inven-
tory of applicable regulations is still required under Part 1 Section 3 point 4 (on page 7 of 14). This additional
requirement is specific to ingredients and materials and is aimed at ensuring that specifications detail specific
legislative standards such as mycotoxin levels, prohibited colors, or pesticides.
FSSC 22000 17
Two additional FSSC requirements were added:
There are now five additional requirements that need to be complied with and audited (compared to three in
the previous FSSC 22000 version 3). The two new requirements are:
4. Announced, but unscheduled audits of certified organizations
The Certification Body will participate in a risk based program of office audits and announced, but unscheduled,
audits of certified organizations. In July 2014 Walt Mart asked all GFSI schemes to introduce unannounced audits
by June 2015 as a condition of doing business with them. Today all GFSI schemes have introduced unannounced
audits into their schemes. The goal of the unannounced audits is to assure day-to-day compliance of the FBO’s
products and FSMS and to ensure the FBO is ‘audit ready’. What does an unannounced audit mean? Generally its
means there will be no prior notification for any unannounced audit conducted. That said most Certification Bodies
[CBs] do announce the start of the unannounced audit to the client, e.g. the unannounced audit will occur anytime
following the beginning of Q3 2016. The CB also requires the FBO to provide access to details of their operations or
processing schedule to enable the CB audit team plan the unannounced audit. Turning up from an unannounced
GFSI audit where the FBO operations is not operating adds no value to any interested party. GFSI has yet to an-
nounce the frequency of unannounced audits. The most likely option being considered is one unannounced audit
every three years. Unannounced audits differ significantly from surveillance audits. Unannounced audits are much
shorter and tend to focus on the FBO product and preventive controls. Surveillance audits are focused on the
FSMS. Finally the introduction of the unannounced audit does impact the cost of the conformity assessment pro-
cedure, and the FBO needs to budget for the additional costs associated with the unannounced audit.
5. Management of inputs
The organization shall implement a system to assure that analysis of inputs critical to the confirmation of
product safety is undertaken. The analyses shall be performed to standards equivalent to those described in
ISO 17025.
Inputs are referring to analyses of incoming raw and packaging materials that are used to produce the finished
product.
FSSC 22000 is used to audit and certify the food safety systems of food chain organizations which process or
manufacture:
 Perishable animal products (such as meat, poultry, eggs, dairy and fish products);
 Perishable vegetable products (such as fresh fruits and fresh juices, preserved fruits, fresh vegetables,
and preserved vegetables);
 Products with a long shelf life at an ambient temperature (such as canned products, biscuits, snacks, oil,
drinking water, beverages, pasta, flour, sugar, and salt);
 (Bio)chemical manufacturers (of food ingredients such as vitamins, additives and bio-cultures), although
excluding technical and technological aids;
 Food packaging (with both direct and indirect contact with the food).
FSSC 22000 includes transportation and on-site storage if the latter is part of the operation (for example, with
cheese ripening). It is applicable to all organizations in the food chain, regardless of size and complexity, profit
making or not, public or private.

FSSC 22000 uses the existing standards ISO 22000, plus technical specifications for sector PRPs. It is owned
by FSSC 22000 in the Netherlands.
The ISO 22000 international standard specifies the requirements for a food safety management system, in-
cluding the following four elements:
 Interactive communication
 System management
 Prerequisite programs
 HACCP principles
ISO 22000 integrates HACCP system principles with the application steps developed by the Codex Alimenta-
rius Commission. Using auditable requirements, it combines the HACCP plan with PRPs. Hazard analysis is the
key to an effective FSMS, since conducting a hazard analysis assists in organizing the knowledge required to
establish an effective combination of control measures.
ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including
hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus
it provides the means to determine and document why certain identified hazards need to be controlled by a
particular organization and others do not.
During hazard analysis, the organization determines the strategy to be used to realize hazard control by
combining the prerequisite programs with the HACCP plan. The standard contains the specific requirements
needing to be addressed by the FSMS.
Generally, the ISO 22000 requirements are:

 Having an overall food safety policy for a particular organization developed by top management;
 Setting objectives to drive that company’s efforts to conform with this policy;
 Planning, designing and documenting a management system;
 Maintaining records of the system’s performance;
 Establishing a group of qualified individuals to make up a food safety team;
 Defining procedures needed to ensure effective communication with important contacts outside the com-
pany (such as regulators, customers, suppliers, and others) as well as effective internal communication;
 Having an emergency plan;
 Holding management review meetings to evaluate FSMS performance;
 Providing adequate resources for effective FSMS operation including appropriately trained and qualified
personnel, sufficient infrastructure and an appropriate work environment to ensure food safety;
 Following HACCP principles;
 Establishing a traceability system for product identification;
 Establishing a corrective action system and control of nonconforming product;
 Maintaining a documented procedure for handling product withdrawal;
 Controlling monitoring and measuring devices;
 Establishing and maintaining an internal audit program;
 Continual improvement and updating the FSMS.
FSCC 22000 contains Standard ISO/TS 22002-1:2009 Part 1: Food manufacturing which serves as a technical
specification for prerequisite programs for food manufacturers.
This technical specification does not duplicate the requirements cited in ISO 22000:2005. It is intended to be
used in conjunction with ISO 22000:2005.
ISO/TS 22002-4:2013 is intended to be used by food packaging manufacturing organizations that wish to
implement PRPs in such a way as to address the requirements specified in ISO 22000:2005.
ISO/TS 22003:2007 defines the rules applicable for the audit and certification of an FSMS complying with the
requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements). It provides the necessary
information, and so bolsters customer confidence around the way their suppliers’ certification has been granted.
For further details see www.fssc22000.com.

PrimusGFS 19
PrimusGFS
What is PrimusGFS?
PrimusGFS is a GFSI recognized audit scheme for the certification of produce sector products — from growing
operations to minimally-processed (fresh-cut) produce products.
Depending on the operation being audited, PrimusGFS audits include Food Safety Management Systems
(FSMS), Good Agricultural Practices (GAPs), Good Manufacturing Practices (GMPs) and Hazard Analysis Criti-
cal Control Points (HACCP).
Which standards does the PrimusGFS operate?
The PrimusGFS operates the following standards:
PrimusGFS Standard GFSI Scheme GFSI Scope

Primus GFS, version 2.1 Yes BI, BII, D, EII, EIII, EIV
Background
The GFSI, managed by CIES (the food business forum), was set up in 2000 to pursue continuous improvement
in food safety management systems, cost efficiency in the supply chain and safe food for consumers world-
wide. In February 2010 the Global Food Safety Initiative (GFSI) announced full recognition of the PrimusGFS
scheme.
PrimusGFS is a Global Food Safety Initiative (GFSI) benchmarked and fully recognized audit scheme cover-
ing both Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) scopes, as well as Food
Safety Management Systems (FSMS).
PrimusGFS is focused on food safety of agricultural products designated for human consumption, both fresh or
minimumly processed. PrimusGFS establishes a series of requirements for managing the production, handling,
processing and storage operations which should be met fo consumer safety.
On February 20th the PrimusGFS Standard (v2.1 – December 2011) has been successfully re-benchmarked by
GFSI and has achieved recognition against the GFSI Guidance Document Sixth Edition.

PrimusGFS audits are composed of several modules and their applicability depends on the type of operation
being audited:
Module 1 FSMS Applicable to all operations types

Applicable to growing areas (fields, ranches, greenhouses); harvest crew section
Module 2 GAP
is optional
Module 2 GMP Applicable to facilities (coolers, packinghouses, processors and storage)
Module 3 HACCP Applicable to all facilities; not applicable to growing areas/harvest crews
Module 1 Food Safety Management System:

1.1 Management System
1.2 Control of Documents and Records
1.3 Procedures and Corrective Actions
1.4 Internal and External Inspections
1.5 Rejection and Release of Product
1.6 Supplier Control
1.7 Traceability and Recall
1.8 Food Defense
Module 2 GAP and GMP Options:

2.1 General GAP
2.2 Site Identification
2.3 Ground History
2.4 Adjacent Land Use
2.5 Pest and Foreign Material Controls – Applicable for greenhouses only
2.6 Growing Media (Substrate) Use – Applicable for greenhouses only
2.7 Fertilizer/Crop Nutrition
2.8 Irrigation / Water Use
2.9 Crop Protection
2.10 Field Worker Hygiene (Applies to on-the-farm workers not the harvesting workers)
2.11 Harvesting Inspections, Policies and Training
2.12 Harvesting Worker Activities & Sanitary Facilities (Applies to harvesting workers)
2.13 Harvest Practices
2.14 Transportation and Tracking
2.15 On-site Storage
2.16 General GMP
2.17 Pest Control
2.18 Storage Areas & Packaging Materials
2.19 Operational Practices
2.20 Worker Practices
2.21 Equipment
2.22 Equipment Cleaning
2.23 General Cleaning
2.24 Buildings and Grounds
2.25 Chemicals Files
2.26 Pest Control Documentation
2.27 Operation Monitoring Records
2.28 Maintenance & Sanitation Files
2.29 Worker Documentation
2.30 Testing/ Analysis Records
2.31 Temperature Controlled Storage & Distribution Logs
2.32 Allergen Control
Module 3 HACCP:
3.1 Preliminary Steps
3.2 Development of the Written HACCP Plan
3.3 Execution of the HACCP Plan on the Plant Floor
GRMS 21
Global red Meat Standard (GRMS)

What is the GRMS?
The Global Red Meat Standard (GRMS) is a scheme specifically developed for the red meat industry. The GRMS
sets out the requirements for all processes relating to the production of meat and meat products and focuses
on areas critical to achieving the highest safety and quality standards. It was launched in 2006.
Which standards does the GRMS operate?
The GRMS operates the following standards:
GRMS Standard GFSI Scheme GFSI Scope

GRMS, version 2.1 Yes C, EI, EIII
Background
The GRMS is a standard specifically developed for the processes of slaughtering, cutting, deboning and sales
of red meat and meat products. It encompasses the entire production chain and is, therefore, applicable to
all aspects of the transport, lairage, stunning, slaughtering, deboning, cutting and handling of meat and meat
products.
On February 7, 2013, the GRMS (fourth edition version 4.1) was re-benchmarked and recognized by the Global Food Safety
Initiative (GFSI) against its revised Guidance Document Sixth Edition.
The Global Red Meat Standard Scheme is owned by the Danish Agricultural & Food Council, Denmark.
The standard sets out the requirements for all processes related to the production of meat and meat products.
Process: Transport, lairage, slaughtering, evisceration, chilling, cutting, deboning, curing, marinating, mincing,
mixing, fermentation, smoking, cooking, packing, chilling, freezing, and storage.
Product: Fresh meat, meat products, meat preparations, mixed products and edible by-products.

 Audit protocol;
 Requirements with respect to audit qualification, training and experience;
 Good Manufacturing Practice (GMP);
 HACCP system;
 Quality Management System;
 Non-conformance procedures;
 Traceability.
For additional details see: www.grms.org.

CanadaGAP
What is CanadaGAP?
CanadaGAP® is a food safety program for companies that produce and handle fruits and vegetables. It is de-
signed to help implement and maintain effective food safety procedures within fresh produce operations.
Which standards does the CanadaGAP operate?
The CanadaGAP operates the following standards:
CanadaGAP Standard GFSI Scheme GFSI Scope

GLOBALG.A.P. Integrated Farm Assurance, version 4 Yes AII, BI, D
Background
The CanadaGAP® certification program was launched by the Canadian Horticulture Council (CHC), covering
eight crop groupings.
The standards program was developed by the Canadian Horticultural Council (CHC), the national industry as-
sociation for fruit and vegetable producers in Canada, as a means of standardizing and updating on-farm food
safety programs, and covers the safe production, storage and packing of fresh produce. The CHC participates
in the federal On-Farm Food Safety Recognition Program, which involves comprehensive reviews by federal
and provincial governments to ensure the technical soundness of the CanadaGAP standard.
On April 24 2013, CanadaGAP was re-benchmarked and recognized by the Global Food Safety Initiative (GFSI) against its
revised Guidance Document Sixth Edition.
The owner of the Scheme is CanAgPlus, Canada.
CanadaGAP (Good Agricultural Practices) is an on-farm food safety program for companies that grow, pack
and store fresh produce.

Two manuals, one specific to Greenhouse operations, the second for other fruit and vegetable operations,
have been developed by the horticultural industry and reviewed for technical soundness by Canadian govern-
ment officials. The manuals are designed for companies implementing Good Agricultural Practices (GAPs) in
their production, packing and storage operations, and for re-packers and wholesalers implementing Good
Manufacturing Practices (GMPs) and HACCP programs. The program is also designed for fresh produce bro-
kers implementing best practices in supplier management and product traceability.
CanadaGAP 23
Fruit and Vegetables and Greenhouse Manuals:

 Commodity Starter Products
 Premises
 Commercial Fertilizers, Pulp Sludge and Soil Amendments
 Manure, Compost/Compost Tea and other Products
 Mulch and Row Cover Materials
 Agriculture Chemicals
 Agriculture Water
 Equipment
 Cleaning and Maintenance Materials
 Waste Management
 Personnel Hygiene Facilities
 Employee Training
 Visitor Policy
 Pest Program for Buildings
 Water (for Fluming and Cleaning)
 Ice
 Packaging Materials
 Growing and Harvesting
 Sorting, Grading, Packing, Repacking, Storing and Brokerage
 Storage of Product
 Transportation
 Identification and Traceability
 Deviations and Crisis Management
 HACCP Plan and Food Safety Program Maintenance and Review
The manuals are based on a rigorous hazard analysis applying the seven principles of the internationally-
recognized HACCP (Hazard Analysis and Critical Control Point) approach.
For additional details: see www.canadagap.ca.

GLOBALG.A.P.
What is GLOBALG.A.P.?
GlobalG.A.P. is a private sector body that sets voluntary standards for agricultural product certification around
the world. The GLOBALG.A.P. standard is designed to reassure consumers about how their food is produced on
the farm. Focal points include minimizing detrimental environmental impacts of farming operations, reducing
the use of chemical inputs and ensuring a responsible approach to worker health and safety as well as animal
welfare.
The organization aims to establish one standard for Good Agricultural Practice (G.A.P.), with varied product
applications capable of interfacing seamlessly with the whole pattern of global agriculture.
Which standards does the GLOBALG.A.P. operate?
The GLOBALG.A.P. operates the following standards:
GLOBALG.A.P. Standard GFSI Scheme GFSI Scope

GLOBALG.A.P. Integrated Farm Assurance, version 4 Yes BI, D
Background
GLOBALG.A.P. was formerly known as EurepG.A.P. This organization was launched in 1997 as a retailers’ initia-
tive rooted in the Euro-Retailer Produce Working Group (EUREP). Its starting point was an effort to develop
standards and procedures for the development of Good Agricultural Practice (G.A.P.) in conventional agricul-
ture, specifically in highlighting the importance of integrated crop management and a responsible approach
to worker welfare.
On April 24 2013, GLOBALG.A.P. was re-benchmarked and recognized by the Global Food Safety Initiative (GFSI) against
its revised Guidance Document Sixth Edition.
The owner of GLOBALG.A.P. is c/o FoodPLUS GmbH, Germany.
Global G.A.P. is a pre-farm gate standard. The certificate covers the process of taking certified product from
farm inputs, like feed or seedlings, and all the farming activities until the product leaves the farm.
The Standard Documents
Global G.A.P. is a single integrated standard with modular applications for different product groups (see be-
low), ranging from plant and livestock production to plant propagation materials and compound feed manu-
facturing.
GLOBALG.A.P. 25

The requirements for each standard can be found in a document called Controlled Points and Compliance Criteria.
Integrated Farm Assurance Standard
For additional details: see www.globalgap.org.
Plant Propagation Material
CB FV Fruit&Vegetables
GlobalG.A.P. risk assesment on social practice (GRASP)
CC Combinable Crops
CO Green Cofee
Crops Base
TE Tea
AF
Chaine of Custody
FO Flowers&Ornamentals
LB RB DY Dairy
All farm base
CS Carttle&Sheep
Ruminant Base
Transport
CYB Calf/Young Beef
Livestock Base
PG Pigs
PY Poultry
TY Turkey
AB Aquacultural module
Compaund feed manufacturing

Global Aquaculture Alliance (GAA) Seafood Standard

What is the GAA Seafood Processing Standard?
The Global Aquaculture Alliance (GAA) is an international, non-profit trade association dedicated to advancing
environmentally and socially responsible aquaculture. The Alliance develops Best Aquaculture Practices (BAP)
certification standards. These cover aquaculture facilities (hatchery and feed mill to farm and processing plant)
producing shrimp, salmon, tilapia, channel catfish and pangasius. A specific standard is available for each facil-
ity type and category. Additional standards have recently been developed.
Which standards does the GAA operate?
The GAA operates the following standards:
GAA Standard GFSI Scheme GFSI Scope

BAP Seafood Processing Standard, Issue 3, Rev 1, 2014 Yes EI
Background
The Alliance was established in 1997 and consisted of 59 members from America, Europe and Asia. That has
grown to 1,100 members from 70 countries today, making it the highest profile industrial organization in the
global aquaculture business.
The guiding principles underlying Best Aquaculture Practices aim to assure the environmental, economic and
social sustainability of aquaculture operations by minimizing the environmental effects, promoting the ratio-
nal use of fresh water, avoiding disease outbreaks and minimizing risks related to the introduction of exotic
species, for the benefit of local economies and communities.
On May 16, 2013, GAA was re-benchmarked and recognized by the Global Food Safety Initiative (GFSI) against its revised
Guidance Document Sixth Edition.
The BAP Seafood Processing Standard is owned by Global Aquaculture Alliance (GAA), in the United States.
A full range of aquaculture facilities (from farms to processing plants).

 Regulatory management
 A Quality Management System
 Personnel management
 Environment and waste management
 Food Safety Management
 Verification
 Traceability
For additional details see: www.gaalliance.org.

Safe Quality Food Institute (SQF) 27
Safe Quality Food Institute (SQF)

What is the Safe Quality Food Institute?
The SQF Code (seventh edition level two) was redesigned for use by all sectors of the food industry, from
primary production to transport and distribution. Edition seven applies to all industry sectors and replaces the
SQF 2000 Code (edition six) and the SQF 1000 Code (edition five).
The SQF Code is a process and product certification standard. It is an HACCP-based food safety and Quality
Management System that utilizes the National Advisory Committee on Microbiological Criteria for Food and
the Codex Alimentarius Commission HACCP principles and guidelines.
The SQF Code is intended to support industry-or company-branded products and offers benefits to suppliers
and their customers. With consistent application of the SQF program by certification bodies that have been
accredited according to ISO/IEC guide 65: 1996, products produced and manufactured under SQF Code certi-
fication have a high degree of acceptance in global markets.
Which standards does the SQF operate?
The SQF operates the following standards:
SQF Standard GFSI Scheme GFSI Scope

SQF Code, 7th Edition, Level 2 Yes AI, BI, C, D, EI, EII, EIII, EIV, F, L, M
Safe Feed/Safe Food No
Ethical Sourcing, 2nd Edition No
Background
The code was developed and pilot programs implemented in 1994 to ensure its applicability to the food in-
dustry. On October 15, 2012 the SQF Code (seventh edition level two) was successfully re-benchmarked by GFSI and has
achieved recognition against the GFSI Guidance Document Sixth Edition.
The scheme is owned by the Safe Quality Food Institute, United States.
The SQF 2000 code is relevant for the manufacturing, processing and distribution sectors.

 Food Safety Management System and Quality Management System
 Document controls and records
 Specification and product development
 Food safety attained
 Verification
 Product identification, trace, withdrawal and recall
 Site security
 Identity of preserved foods
For further details see www.sqfi.com.

China HACCP
What is the China HACCP?
In addition to the benchmarking and recognition of private schemes, GFSI introduced a

new category for government-owned schemes entitled Technical Equivalence.
Taking into account the differently structure of government-owned schemes, this new category acknowl-
edges their equivalence to the relevant technical requirements of the GFSI Guidance Document. Technical
Equivalence is distinguished from GFSI recognition of private schemes the scheme’s governance and opera-
tional management components.
The China HACCP scheme has been assessed within this Technical Equivalence category and is acknowl-
edged as equivalent to the GFSI technical requirements.
For details of the China HACCP Scheme contact:
China HACCP
9 Madian East Road, Tower B
Haidian District, Beijing 100088
P.R.China
Tel: 86-10-82262765
Email: chinahaccp@cnca.gov.cn
www.cnca.gov.cn/bmzz/zcglb/
GMP+ Feed Certifciation Scheme 29
GMP+ Feed Certifciation Scheme

What is GMP+?
GMP stands for Good Manufacturing Practices. In 1992 the current GMP+ Feed Certification scheme start-
ed out with these, but later developed into a full-fledged certification scheme by integrating ISO Quality
Management requirements, HACCP and other elements.
The ‘+’ stands for the integration of Hazards Analysis and Critical Control Points (HAACP). The foundation of the
GMP+ systematic is partly determined by continuous improvement according to the principle of the Deming
cycle Plan, Do, Check, Act: write down what I’m doing, do what I’ve written down and provide proof that I effectively did it.
The GMP+ Feed Certification scheme defines conditions relating to production facilities of feed, storage,
transport, staff, procedures, documentation and more. With its partners, GMP+ International transparently
defines conditions to guarantee feed safety and sustainability so that certification bodies can conduct inde-
pendent audits.
With over 14,600 participating companies in more than 70 countries, GMP+ International is a leading global
player in the market of feed safety assurance certification. A GMP+ certificate provides an additional qualita-
tive guarantee for every entrepreneur dealing with the international feed industry.
Which standards does GMP+ operate?
The GMP+ Feed Certification scheme originated from a feed safety perspective, and in 2013 the first feed re-
sponsibility standard was published. It includes two modules: GMP+ Feed Safety Assurance, focusing on feed
safety, and GMP+ Feed Responsibility Assurance focusing on responsible feed.
GMP+ Feed Safety Assurance is a complete module to ensure feed safety in all links of the feed chain. De-
monstrable assurance of feed safety is a ‘license to sell’ in many countries and markets. Based on needs in
practice, multiple components have been integrated into the GMP+ FSA module such as requirements for the
Quality Management System (ISO 9001), HACCP, Product Standards, Traceability, Monitoring, Pre-Requisites
Programs, Chain approach and the Early Warning System.
The documents within the GMP+ Feed Certification scheme are subdivided into a number of series. The
next schematic representation shows the content of the GMP+ Feed Certification scheme.
GMP+ Feed Certification Scheme
A – documents
General requirements for participation in the CMP+ FC scheme
B – documents
Normative documents, appendices and country notes
Feed Safety Feed Responsibility
Assurance Assurance
C – documents
Certification requirements of the GMP+ FC scheme
D – documents
Guidelines to help companies with the implementation of the GMP+ requirements
Background
The GMP+ Feed Safety Assurance Scheme is currently not a GFSI-approved FSMS Scheme.
The GMP+ Feed Safety Assurance scheme (GMP+ FSA) was developed in 1992 managed by the Product Board
Animal Feed in The Hague until 2009. Since 2010, it has been managed by GMP+ International.
The GMP+ Feed Safety Assurance scheme (GMP+ FSA) is a scheme for assuring feed safety in all the links in
the feed chain. It is also an international scheme applied globally.
Food Safety
Legislation
MODULE 3
32 MODULE 3 FOOD SAFETY LEGISLATION
Introduction
The issue of food safety has been addressed by different international institutions. One of the most important
is the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary (SPS)
Measures, commonly referred to as the “SPS Agreement.”
WTO members are encouraged to base their SPS measures on international standards, guidelines and recom-
mendations where these exist. WTO rules are also applicable to non-members who are trading with WTO
member countries. The standard specifically mentioned in the SPS for food safety is the Codex Alimentarius
Commission (CAC).
The CAC implements the Joint Food Agriculture Organization (FAO) / World Health Organization (WHO)
Food Standards Program. The Codex Alimentarius is a collection of internationally-adopted food standards
presented in a uniform manner. Their joint purpose is:
 To protect the health of consumers;
 To ensure fair practices in food trade;
 To promote the harmonization of standards.
This section provides an overview of food safety legislation for food business operators. Complementing provi-
sions of CAC, it addresses relevant legislation from the European Union and the United States. This legislation
was selected for review because of the global importance of these two markets for FBOs. Additionally, the
European Union and the United States are leaders in developing food product regulations that ensure both a
high level of safety and consumer confidence.
This module also provides information on production and marketing of food products in the Eurasian Eco-
nomic Union (EEU). Information was drawn from Comparative Analysis of EEU and EC by The Investment Cli-
mate for Agribusiness Project In Ukraine.
Main Food Safety Regulations 33
Main Food Safety Regulations:

List of Regulations, Summary of Scope,
Links with Codex Alimentarius, EU and US
Codex Alimentarius
The Codex Alimentarius is a collection of international food standards adopted by the Codex Alimentarius
Commission (CAC). Along with standards for separate types of products, the Codex contains general stan-
dards for regulating issues of labeling, food hygiene, food additives, contaminants, pesticide residues, food
safety research procedures and biotechnology. The CAC enables countries to develop their food safety regula-
tions in line with international standards.
European Union (EU) Regulations

The European Union joined the Codex Alimentarius in 2003 and accepted the obligations established under
the Codex statutes. The main EU food safety directives and regulations refer to CAC as the basis for their re-
quirements.
Below is a list of important EU food legislation:
Regulation (EC) No 178/20021 – the General Food Law – establishes the general principles and requirements
of food law, the general concepts of food legislation within the EU, and ensures a consistent approach to the
development of national food law in EU countries. It sets out the general principles of EU food law for member
states to follow. The main objective is to ensure the free circulation of safe food and feed in the EU, for the
health and well-being of its citizens.
In addition to Regulation (EC) No 178/2002, a “Hygiene Package” group of regulations was adopted to deliver
consistency in the food chain. These include:
 Regulation (EC) No 852/2004 on the hygiene of foodstuffs (general hygiene requirements for food
production);
 Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin (basic hygiene
principles for businesses at all stages of the food chain of animal products);
 Regulation (EC) No 854/2004 laying down specific rules for the organization of official controls on
products of animal origin intended for human consumption;
 Regulation (EC) No 882/2004 on official controls to be invoked in verifying compliance with feed and
food law, animal health and animal welfare rules, thereby establishing control principles for EU and
third-countries.
1
Full latest consolidated text of all mentioned EU legislation is available at: http://eur-lex.europa.eu.
Additionally, there are number of supportive regulations that deal with specific food safety topics:
 Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs;2
 Regulation (EC) No 1881/2006 on maximum permitted levels for certain contaminants in foodstuffs;
 Regulation (EC) No 2074/2005 laying down implementing measures for certain products under
Regulations.
(EC) No 853/2004 for conducting official control according to Regulations (EC) No 854/2004, 882/2004 and
partially cancelling measures requirements of Regulation (EC) No 852/2004 [addressing the registration and
approval of facilities producing food of animal origin] and supplementing Regulations (EC) No 853/2004 [ad-
dressing the requirements for approval of facilities producing food of animal origin and feed], 854/2004;
 Regulation (EC) No 1162/2009 laying down transitional measures for the implementation of Regulations
(EC) No 853/2004, 854/2004 and 882/2004.
The General Food Law

Food safety general principles, rules,
definitions Harmonization of EU legislation
Food hygiene Control system
Regulation (EC) Regulation (EC) Regulation (EC) Regulation (EC)

EU regulation
№ 852/2004 № 853/2004 № 882/2004 № 854/2004
Specific rules for the orga-

General rules about Specific rules on the hy-
Basis for national nization of official controls
Aims food hygiene, FBO giene of food of animal
monitoring and control on products of animal
responsibility origin
origin
Applies to raw and pro- Only applies in respect

All stages of produc- All stages of produc-
cessed foods of animal to activities and persons
Scope tion, processing, mar- tion, processing, and
origin; does not apply to to which Regulation (EC)
keting and export sale
retailers № 853/2004 applies
Specific requirements
Mandatory official
Responsibility of FBOs; for companies to Cooperation with
control;
transparency of the marketing products of regulatory authorities; risk
General regularity and propor-
food chain; animal origin; analysis; specific periods of
principles tionality of inspections;
flexibility; special guarantees for control depending on the
inspections as precau-
introduction of HACCP certain types of meat type of product
tions, not punishment
products
2
The latest consolidated text of this regulation is available at: http://eur-lex.europa.eu.
United States Regulations 35
United States Regulations

As the U.S. has been a member of CAC since 1963; legislators and responsible agencies there tend to harmo-
nize US food safety laws and regulations with Codex requirements. The United States Food Regulatory Sys-
tem consists of numerous statutes, rules and regulations. This overview focuses on federal regulation of food
safety. However, state regulatory agencies also play an important role, especially in enforcement. In particular,
state regulatory agencies are primarily responsible for food sanitation and safe food handling by food retailers,
foodservice providers, and food-vending operations.
The main U.S. food safety statutes are:

 Food Safety Modernization Act (FSMA)3 of January 4, 2011: empowers the Food and Drug Administration
(FDA) to implement a science-based system to address food safety hazards, shifting the focus from re-
sponding to contamination to preventing it. The act covers FDA-regulated foods, including all domestic
and imported food products except for meat, poultry, and egg products, which are regulated by the U.S.
Department of Agriculture (USDA);
 Federal Food, Drug, and Cosmetic Act of 1938 with amendments (FDCA)4 is a set of laws giving authority to
the FDA to oversee the safety and efficacy of FDA-regulated food, drugs, and cosmetics;
 Federal Meat Inspection Act of 1906 with amendments5 passed to prevent adulterated or misbranded
meat and meat products from being sold as food. It also ensures that meat and meat products are
slaughtered and processed under sanitary conditions. This bedrock legislation also regulates inspec-
tions of imported meat products to ensure that they meet U.S. food safety standards;
 Poultry Products Inspection Act of 1957, as amended6 regulates the processing and distribution of poultry
products and requires certain sanitary standards and practices, as well as labeling and container stan-
dards, to prevent the sale of adulterated or misbranded poultry products. The USDA is also responsible
for the enforcement of this act. It provides inspection for all poultry products sold in interstate com-
merce, and re-inspects imported products;
 Egg Products Inspection Act of 1970, as amended.7 The FDA shares responsibility for egg safety with the
USDA. The latter is responsible for the safety of liquid, frozen, and dried egg products, domestic and
imported, and for the safe use or disposition of damaged and dirty eggs under this act;
 Federal Insecticide, Fungicide, and Rodenticide Act of 1947, as amended8 provides for federal regulation of
pesticide distribution, sale, and use. All pesticides distributed or sold in the U.S. must be registered (li-
censed) by the U.S. Environmental Protection Agency;
 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires
registration of food facilities, the establishment and maintenance of records, and prior notice of im-
portation of food. The Bioterrorism Act also grants FDA additional enforcement authority. To enforce
the statutes related to food safety, regulatory authorities (USDA, FDA, and others) enact rules and
regulations which are referred to as administrative law (as an example, the Poultry Products Inspection
Regulations.)9 The Code of Federal Regulations (CFR) is the codification of the general and permanent
rules and regulations published in the Federal Register by the executive departments and agencies of
the Government of the United States of America.
3
Available at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm.
4
Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.
htm.
5
Available at: http://www.fsis.usda.gov/regulations/federal_meat_inspection_act/index.asp.
6
Available at: http://www.fsis.usda.gov/regulations/Poultry_Products_Inspection_Act/index.asp.
7
Available at: http://www.fsis.usda.gov/regulations/Egg_Products_Inspection_Act/index.asp.
8
Available at: http://www.epa.gov/oecaagct/lfra.html.
9
Available at: http://www.gpo.gov/fdsys/pkg/CFR-2010-title9-vol2/pdf/CFR-2010-title9-vol2-part381.pdf.
Additionally, regulatory authorities publish guidance documents and recommendations for both the food in-
dustry and consumers. They do not create or confer any rights for or on any person and do not operate to
bind the FDA or the public, but reflect the vision of the FDA on certain issues. For instance, the FDA publishes
the Food Code,10 a model set of guidelines and procedures that assists food control jurisdictions by providing a
technical and legal basis for regulating the retail and food service industries, including restaurants and grocery
stores.
Importantly, case law is also one of the sources of the U.S. food safety law system. Precedents are rules estab-
lished in previous legal cases that are either binding on, or persuasive for, a court when deciding subsequent
cases with similar issues or facts. The National Agricultural Law Center has made a compilation of reported
and unreported federal and state court decisions involving food safety decided on or after January 1, 1995.11
10
Available at http://www.fda.gov/food/foodsafety/retailfoodprotection/foodcode/default.htm.
11
A compilation of decisions available at: http://www.nationalaglawcenter.org.
Requirements for FBOs 37
Requirements for FBOs
1. General Principles Including FBO Responsibilities
Codex Alimentarius
To protect consumers from unsafe food and ensure that consumer health is protected throughout the food life
cycle, Codex Alimentarius developed the General Principles of Food Hygiene (CAC/RCP 1-1969, Rev.4-2003).12
The document follows the food chain from primary production to final consumption, highlighting the key
hygiene controls at each stage and offering recommendations regarding establishments, personal hygiene,
transportation and application of the HACCP-based approach.
European Union
А. General principles of EU food legislation
The common basis for European food legislation is an integrated “farm-to-fork” approach combined with risk
analysis in relation to food, precautionary principles, protection of consumer interests, principles of transpar-
ency, and the primary legal responsibility of the food business operator to ensure food safety:13
 The “farm to fork” approach is the general principle driving European food safety legislation. It aims
to cover all potential hazards along the food chain, whether from primary production, processing, and
transportation/distribution; or retail, catering, food service and home use of food.14
 The “equivalency” principle states that food and feed imported into EU markets from third countries
must have food safety characteristics equivalent to food produced in EU member states. Or, in cases
where there may be a specific agreement between a third country and an EU member state, that food
must comply with provisions stated in that agreement.
 Risk analysis assumes that all measures relating to food safety will be underpinned by strong science.
 The “precautionary” principle is relevant in circumstances where health risks are at an unacceptable
level, yet supporting data and information is too sparse to make comprehensive risk assessment pos-
sible. In such situations, measures necessary to ensure high standards of health protection, as chosen
by the community, may be adopted pending further scientific information for a more comprehensive
risk assessment.
 The “early warning” principle states that food operators must immediately withdraw unsafe food
from the market and inform the authorities and consumers.
 Implementation of a protection of consumers’ interest principle means creating a status quo in which
consumers will be able to make informed choices in relation to the foods they consume.
 EU food business operators at all stages of production, processing and distribution bear the prime re-
sponsibility for ensuring that the food under their control satisfies food law requirements.
12
Full text of CAC/RCP 1-1969 is available at: http://www.codexalimentarius.org/standards/list-of-standards/en/.
13
General Principles of European food legislation came into force in 2002 with adoption of EU Food Law (Regulation (EC)
No 178/2002 of the European Parliament and of the Council of January 28, 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of
food safety).
14
More about from “farm to fork” approach can be found in “From farm to fork: Safe food for Europe’s consumers”, available
at: http://ec.europa.eu/dgs/health_consumer/information_sources/docs/from_farm_to_fork_2004_en.pdf.
B. General principles introducing general rules for FBOs on hygienic foodstuffs
In addition to general principles adopted in EU Food Law,15 a list of principles amplifying the general rules for
food business operators regarding hygienic foodstuffs have been developed. These are:
 Food that cannot be stored safely at ambient temperatures, particularly frozen food, should be held in
an unbroken cold chain;
 The general implementation of procedures based on HACCP principles and the application of good
hygienic practice should reinforce FBO responsibility;
 Guides to best practices are valuable instruments for aiding FBOs at all levels of the food chain to com-
ply with food hygiene rules and apply HACCP principles;
 Microbiological criteria and temperature control requirements should be established based on scientific
risk assessment;
 Imported foods should be at held to the same hygienic standards as food produced in the community.
United States
The U.S. food safety system is based on strong, flexible, and science-based federal and state laws and industry’s
legal responsibility to produce safe foods.
The system is guided by the following principles:

1. Only safe and wholesome foods may be marketed;
2. Regulatory decision-making in food safety is science-based;
3. The government has enforcement responsibility;
4. Manufacturers, distributors, importers and others are expected to comply and are liable if they do not;
and
5. The regulatory process is transparent and accessible to the public.16
Science and risk analysis are fundamental to U.S. food safety policymaking. Regulatory decisions regarding
food safety standards and requirements rely on risk analysis performed by competent authorities qualified
to make scientifically-sound decisions. U.S. food safety statutes, regulations, and policies have precautionary
approaches embedded in them. One example is the pre-market approval requirements established for food
additives, animal drugs, and pesticides. These products are not allowed on the market unless, and until, they
are shown by producers to be safe.
2. Hazard Analysis and Critical Control Points (HACCP) & Traceability

Requirement
HACCP
HACCP is a globally-recognized Food Safety Management System built on a risk-based approach with poten-
tial hazards analysis and prevention established throughout the production process.
HACCP can be applied throughout the food chain, from primary production to final consumption. However,
beyond enhancing food safety, HACCP implementation provides other significant benefits. Practice has shown
that Food Safety Management System based on HACCP open up new international markets for high value-
added food products. They also increase the efficiency of domestic markets. Most private standards, includ-
ing IFS, BRC, ISO 22 000, developed and recognized by big retailers, are based on HACCP. Compliance with
15
EU Regulation 852/2002 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.
16
FDA, USDA. A description of the U.S. Food Safety System is available at: http://www.fsis.usda.gov/oa/codex/system.htm.
HACCP principles has become obligatory for food business operators who work, or plan to work, with large
global or regional retailers.
Codex Alimentarius
The recommendation to implement an HACCP-based approach wherever possible in enhancing food safety
is fixed in the General Principles of Food Hygiene (CAC/RCP 1-1969, Rev.4-2003).17 Codex defines HACCP as
“a system which identifies, evaluates, and controls hazards which are significant for food safety” and says that
“food business operators should control food hazards through the use of systems such as HACCP.”
The annex to CAC/RCP 1-1969 (Rev. 4 - 2003) consists of seven HACCP principles with general guidance in
applying the system. The principles are:
1. Conduct a hazard analysis (identifying all hazards – and their degree of severity – that can occur, and consider
the control measures best applied to each hazard);
2. Determine the Critical Control Points. CCPs are the steps through which controls can be applied and
are essential in preventing or eliminating a food safety hazard, or at minimum, reducing these to an
acceptable level;
3. Establish critical limits. Critical limits are the boundaries of safety for each CCP and may be set accord-
ing to specific preventive measures such as temperature, time, physical dimensions, water activity (aw),
pH, and available chlorine;
4. Establish a system to monitor CCP control. Monitoring is the measurement or observation of a CCP
relative to its critical limit; this helps detect loss of control at the CCP;
5. Establish the corrective action to be taken; such monitoring indicates that a particular CCP is not under
control. These actions must ensure that the CCP has been brought under control, and include proper
disposition of the affected product;
6. Establish verification procedures to confirm that the HACCP system is working effectively. Such proce-
dures may include random sampling and analysis, often performed on behalf of the business by external
experts;
7. Establish documentation concerning all procedures and records relevant to these principles and their
application. Documentation examples include: hazard analysis, CCP determination, and critical limit
determination, among others.
17
In the situation described above, the document FAO/WHO guidance to governments on the application of HACCP in small and/or
less-developed food businesses could be relevant. Available at http://www.who.int/foodsafety/publications/food-businesses/
en/.
General guidance is offered recognizing that there are limitations in fully applying HACCP principles at the
primary production level. Where HACCP cannot be implemented at the farm level, for instance, fastidious hy-
gienic, agricultural and veterinary practices, good agricultural practices and good veterinary practices should
be followed.
Following CAC/RCP 1-1969 (Rev. 4 - 2003), a number of industry-specific codes of practices in line with the
peculiarities of implementing a HACCP-based approach have been developed and recommended by Codex.
They are:
 Code of Practice for Fish and Fishery Products (CAC/ RCP 52-2003);
 Code of Hygienic Practice for Milk and Milk Products (CAC/RCP 52-2003);
 Code of Hygienic Practice for Meat (CAC/RCP 58- 2005).
Useful to know: often, small and/or less-developed businesses face problems in developing and implement-
ing an effective HACCP plan because they lack on-site expertise. In such situations Codex recommends
using expert advice from trade and industry associations, independent experts and regulatory authorities.
Even when using expertly developed HACCP guidance, substantial attention needs to be paid to the spe-
cifics of the foods and/or processes under consideration.18
European Union
EU Regulation 852/2002 requires FBOs to establish and maintain a permanent procedure or procedures based
on HACCP principles. This requirement does not apply to primary production, however.
FBOs must be able to provide the competent authority with evidence of their compliance with the official
norms regarding this obligatory HACCP implementation.
The regulation provides the possibility of so-called “flexible” or simplified HACCP implementation, particularly
in the case of small food businesses. This approach enables HACCP application in all circumstances, regardless
of the size and type of activities undertaken by a specific food business.
Useful to know: in another effort to clarify all aspects of HACCP Principles Implementation, DG-SANCO19
has developed Guidance Document on the Implementation of Procedures Based on the HACCP Principles, and Fa-
cilitation of the Implementation of the HACCP Principles in Certain Food Businesses.20
United States
In the United States, HACCP adherence is mandatory for manufacturers of:

 Meat and poultry;21
 Seafood,22 and
 Juice products.23
18
Ibid.
19
Health and Consumer Protection Directorate General of the European Commission: http://ec.europa.eu/dgs/
health_food-safety/index_en.htm.
20
Full text available at: http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf.
21
9 CFR Parts 304, et al., http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf.
22
21 CFR Part 123, http://www.gpo.gov/fdsys/pkg/CFR-2010-title21-vol2/pdf/CFR-2010-title21-vol2-part123-subpartA.pdf.
23
21 CFR part 120, http://www.gpo.gov/fdsys/pkg/CFR-2010-title21-vol2/pdf/CFR-2010-title21-vol2-part120-subpartA.pdf.
Meat and poultry HACCP is regulated by the U.S. Department of Agriculture, while seafood and juice HACCP is
covered by the U.S. Food and Drug Administration. These agencies publish guidance documents explaining the
HACCP system in specific areas along with support documents for HACCP implementation and information
on HACCP training activity. The use of HACCP in other food industries is not mandatory. However, accord-
ing to the FSMA, food plants must have a written preventive controls plan implemented if they do not use
the HACCP system voluntarily. The federal agencies responsible for food safety encourage the food industry
across-the-board to implement the HACCP system, even if this is not required.
For instance, the FDA’s website includes the Manual for Voluntary Use of HACCP Principles for Operators of Food
Service and Retail Establishments24 and Dairy Grade A Voluntary HACCP guidance and forms.25
Under FSMA, certain qualified facilities26 are exempt from the preventive control/HACCP provisions. However,
they must either identify potential hazards and implement preventive controls to address them or demon-
strate to the FDA that they are in compliance with state or local food safety laws.
Traceability
Food traceability is a record-keeping instrument that follows food through all processes, from business to
business/consumers. It has become a legal requirement in some parts of the world. Food traceability does not
improve food safety by itself, but contributes considerably to food safety management system efficiency when
combined with food safety measures such as those implicit in the HACCP-based approach.
Codex Alimentarius
Principles for Traceability/Product Tracing as a Tool Within a Food Inspection and Certification System (CAC/GL 60
-2006) declare traceability a tool that “should be able to identify at any specified stage of the food chain (from
production to distribution) from where the food came (one step back) and to where the food went (one step
forward), as appropriate to the objectives of the food inspection and certification system.”
There are also numbers of Codex documents which consider traceability a requirement for the food business:
 Codex Code on Prevention and Reduction of Aflatoxin Contamination in Tree Nuts (CAC-RCP 59-2005);
 Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts (CAC/RCP 55-2004);
 Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM) (CAC/GL 63-2007).
24
HACCP Principles for Operators of Food Service and Retail Establishments, available at: http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControl-
PointsHACCP/RetailFoodServiceHACCP/default.htm.
25
Dairy Grade A Voluntary HACCP guidance and forms, available at: http://www.fda.gov/Food/FoodSafety/Product-Specific Information/MilkSafety/
DairyGradeAVoluntaryHACCP/default.htm.
26
These are either (1) a “very small business” as defined by FDA rules; or (2) the average annual monetary value of all food sold by the facility during
the previous three year period was less than $500,000; but only so long as the majority of food sold by that facility was sold directly to consumers,
restaurants, or grocery stores (as opposed to third party food brokers), and were in the same state where the facility sold the food, or within 275
miles of the facility.
European Union
EU food law defines traceability as “the ability to trace and follow a food, feed, food-producing animal or sub-
stance intended to be, or expected to be incorporated into a food or feed, through all stages of production,
processing and distribution.”
Thus, an implemented traceability system should be constructed so that it ensures the ability to identify any
person supplying food, business operators with a product, as well as identify other businesses similarly sup-
plied. It follows, therefore, that labeling/identification of products through relevant documentation is an inte-
gral component of the traceability system. In additional to EU food law, specific traceability norms are cited in
legislation as they apply to certain categories of food (beef, fish, GMO):
 Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establish-
ing a system for the identification and registration of bovine animals and regarding the labelling of beef
and beef products and repealing Council Regulation (EC) No 820/97;
 Regulation (EC) No 2065/2001 of 22 October 2001 laying down detailed rules for the application of
Council Regulation (EC) No 104/2000 as regards to informing consumers about fishery and aquaculture
products;
 Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the trace-
ability and labeling of genetically modified organisms and the traceability of food and feed products
produced from genetically modified organisms and amending Directive 20018/18/EC.
Useful to know: in order to clarify issues on traceability and ease of implementation, the EU has published
Guidelines on the Implementation of Traceability. These guidelines provide details on scope of the trace-
ability requirement and its implementations.27
United States
In the U.S., many producers, manufacturers and retailers have product tracing systems in place, although cur-
rently such systems are not required by law.
The FSMA has directed the FDA to build a system that will enhance its ability to track and trace both domes-
tic and imported foods. In particular, the FDA, along with the USDA and state agencies, has been directed to
establish pilot projects to explore and evaluate methods to identify recipients of food as a means of prevent-
ing or controlling a food-borne illness outbreak. The FSMA also requires the FDA to establish record-keeping
requirements for high-risk foods delivered to FBOs as an aid in tracing products.
Where this concerns a USDA-regulated area, USDA has issued a proposed rule to establish general regulations
for improving traceability when animal diseases occur.
Species covered in the proposed rule include cattle and bison, sheep and goats, swine, horses and other
equines, captive cervids (for example, deer and elk), and poultry. Covered animals moved interstate, unless
otherwise exempt, will have to be officially identified and accompanied by an interstate certificate of veteri-
nary inspection (ICVI) or another valid movement document.28
27
Full version of the guidance is available at: http://ec.europa.eu/food/food/foodlaw/guidance/docs/guidance_rev_8_en.pdf.
28
USDA. Animal Disease Traceability, available at: http://www.aphis.usda.gov/traceability/.
3. Food Labeling
Food labelling is the primary means of communication linking the producer and seller of food on one hand,
and the purchaser and consumer on the other. The most important rule of labelling is that the consumer
should not be misled.
Codex Alimentarius
The Codex Alimentarius standards and guidelines on food labelling enable their wide use and understanding
by governments, regulatory authorities, food industries and retailers, and consumers.
The Codex Alimentarius Commission has developed different standards and guidelines related to food labeling
(specifically, on labeling of prepackaged food, food additives, and food for special dietary uses; and guidelines
on claims, nutrition labeling, and the like).29
The core standard is the General Standard for the Labeling of Prepackaged Food,30 which applies to the label-
ling of all prepackaged foods to be offered as such to the consumer, or for catering purposes, and to certain
aspects related to its presentation. It sets out mandatory information which must appear on the label of pre-
packaged food, such as the name of the food, list of ingredients, net contents and drained weight, name and
address, country of origin, lot identification, date marking and storage instructions, and instructions for use.
There may be additional requirements for quantitative ingredient declarations and irradiated food.
Codex Alimentarius has also developed guidelines for dealing with, among other things, the labelling aspects
of organically produced food31 and separate guidelines for labeling genetically modified food.32
European Union
EU labeling legislation requires that the following appear on the label:33

 Name under which the product is sold;
 List of ingredients;
 Quantity of certain ingredients;
 Net quantity;
 Date of minimum durability;
 Any special storage instructions or conditions of use;
 Name or business name and address of the manufacturer/packager/ a seller within the European Union;
 Place of origin of the foodstuff if its absence might mislead the consumer to a material degree;
 Instructions for use where necessary;
 Beverages with more than 1.2 percent alcohol by volume must declare their actual alcoholic strength.
29
Codex Alimentarius labeling standards, available at: www.fao.org/docrep/010/a1390e/a1390e00.htm.
30
General Standard for the Labeling of Prepackaged Food available at: www.codexalimentarius.org/input/download/stan-
dards/32/CXS_001e.pdf.
31
Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced Food, available at:
www.codexalimentarius.net/input/download/standards/360/cxg_032e.pdf.
32
Compilation of Codex Texts Relevant to Labeling of Foods Derived from Modern Biotechnology, available at: www.codexalimen-
tarius.net/input/download/report/765/REP11_FLe.pdf.
33
Directive 2000/13/ EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws
of member states relating to labeling, presentation and advertising of foodstuffs.
Useful to know: As of December 13, 2014, EU Regulation (EU) 1169/201134 replaced Directive 2000/13/ EC.
Beside these general labeling requirements, there are special requirements for different products. For in-
stance, specific legislation has been set down with regard to the labeling of beef products.35
Regulation (EC) No 1760/2000 requires that the beef label shall contain:
 A reference number or reference code ensuring the link between the meat and the animal or animals;
 The approval number of the slaughterhouse at which the animal or group of animals was slaughtered,
and the member state or third country in which the slaughterhouse is established;
 The approval number of the cutting hall which performed the cutting operation on the carcass or group
of carcasses and the member state or other country in which the hall is established Regulation (EC) No
1829/200336 sets out specific labeling requirements for foods which are to be delivered as such to the
final consumer or mass caterers; and which
a) contain or consist of GMOs; or
b) are produced from or contain ingredients produced from GMOs.
United States
Under the FDCA, food labeling is required for most prepared food. The act specifies that food labels must in-
clude five types of information:
1. The name of the food;
2. The name and place of business of the manufacturer;
3. A statement of ingredients;
4. The net quantity of the contents;37 and
5. Nutritional content.
Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary.
The Food Allergen Labeling and Consumer Protection Act of 200438 also requires food labels to indicate the presence
of eight major food allergens, such as: milk, eggs, fish (for example, bass, flounder, or cod), crustacean shellfish
(for example, crab, lobster, or shrimp), tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts,
and soybeans.
34
Regulation (EU) 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food in-
formation to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament
and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive
1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and
2008/5/EC and Commission Regulation (EC) No 608/2004, available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:L:2011:304:0018:0063:EN:PDF.
35
Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for
the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing
Council Regulation (EC) No 820/97, available at: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!C
ELEXnumdoc&lg=EN&numdoc=32000R1760&model=guichett.
36
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modi-
fied food and feed, available at: http://ec.europa.eu/food/food/animalnutrition/labelling/Reg_1829_2003_en.pdf.
37
Weight is expressed in pounds, with any remainder in terms of ounces or common or decimal fractions of the pound; or
in the case of liquid measure, in the largest whole unit (quarts, quarts and pints, or pints, as appropriate).
38
The Food Allergen Labeling and Consumer Protection Act, available at: http://www.fda.gov/Food/LabelingNutrition/
FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm.
To assist food producers, the FDA has developed Guidance for Industry: A Food Labeling Guide which contains
non-binding recommendations on labeling food products.39
Labeling of bio-engineered foods: The FDA also requires labeling of GE foods if the food has a significantly differ-
ent nutritional property; if a new food includes an allergen that consumers would not expect to be present
(for example, a peanut protein in a soybean product); or if a food contains a toxin beyond acceptable limits.40
Country of Origin Labeling (COOL) requires retailers to notify their customers regarding the source of certain
foods (namely, muscle cut and ground meats: beef, veal, pork, lamb, goat, and chicken; wild and farm-raised
fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng).41
However, WTO ruled that COOL is a technical barrier to free trade and violates trade agreements the United
States has with other countries.42
4. Withdrawal/Recall
The withdrawal or recall of food is one of the core responsibilities of FBOs aiming to protect customers from
unsafe food. There is a slight difference between recall and withdrawal, but mostly these terms are used in one
context as they serve the same goal, namely to protect the public from unsafe food.
Along with the obligation to withdraw or recall unsafe food, the FBO is also responsible for cooperating with
the relevant regulatory authorities.
Codex Alimentarius
Provisions on food recall can be found in the Recommended International Code of Practice General Principles of
Food Hygiene.43 paragraph 5.8 of Section 5 “Control of Operation” cites requirements for recall procedures that
require having effective measures in place to assure the complete, rapid recall of any implicated lot of the
finished food from the market.
In addition, where a product has been withdrawn because of an immediate health hazard, other products pro-
duced under similar conditions, and which may present a similar hazard to public health, should be evaluated
for safety and may ultimately need to be withdrawn.
These principles also state the requirement to notify the public regarding existing hazards. Finally, recalled
products should be held under supervision until they are destroyed, used for purposes other than human con-
sumption, determined to be safe for human consumption, or reprocessed in a manner to ensure their safety.
39
Available at: http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodLabelingNutrition/FoodLabeling-Guide/UCM265446.pdf.
40
See Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bio-engineering /
Draft Guidance, available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodLabelingNutrition/ucm059098.htm.
41
For more information, please see: http://www.ams.usda.gov/AMSv1.0/cool.
42
On August 21, 2012, the United States informed the WTO that it intended to implement these recommendations on
removal of this barrier. See details of this case at http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds384_e.htm.
43
Codex Alimentarius Recommended International Code of Practice General Principles of Food Hygiene, available at: www.fao.org/
docrep/012/a1552e/a1552e00.htm.
European Union
Withdrawal and recall provisions in EU food safety legislation are set out in the EU Food Safety Law.44 The
obligation to withdraw the food from the market applies when the following two cumulative criteria are met:
 The food in question is considered not in compliance with the food safety requirements by the operator;
 The food is in the market and has left the immediate control of the initial food business.
Withdrawal means removing the food from the market that has gone to market but has not yet reached the
public; whereas recall must be implemented when the product has reached the customers and other mea-
sures undertaken have not been sufficient to achieve a high level of health protection.45
Withdrawal/recall procedures are to be buttressed by informing the relevant regulatory authorities and col-
laborating with them.46
United States
Before the FSMA, FDA-regulated food recalls were voluntary for the industry (except for infant formula). With
the FSMA, FDA was authorized to issue mandatory recalls of any FDA-regulated food (including all domestic
and imported food products except meat, poultry, and egg products). Nevertheless, the FDA has to follow a
three-step process prior to ordering such recalls (again, apart from infant formula):
1. Determining that there is evidence of a threat that meets a certain “standard of proof;”
2. Offering the company the opportunity to voluntarily recall the product before a mandatory recall is
ordered;
3. Providing the company with the opportunity to challenge a recall decision.
In 2003, FDA issued recall guidance to companies – Guidance for Industry: Product Recalls, Including Removals and
Corrections47 that addresses both voluntary and mandatory recalls. In summary, recall procedure consists of the
following steps: recall submission to FDA, public notification, and evaluation of the recall.
Meat and poultry recalls are voluntary and they are initiated by the manufacturer or distributor, sometimes at
the request of FSIS. If a company refuses to recall its products; however, FSIS has the legal authority to detain
and seize those products that are on the market.
When FSIS learns that a potentially unsafe or mislabeled meat or poultry product is in commerce (through
inspections, sampling programs, and/or other activity), it investigates the need for a recall. In case of an actual
recall, FSIS notifies the public. The recall information is issued to media outlets in the areas where the product
has been distributed and this information is likewise posted on the FSIS website.48
44
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures
in matters of food safety, available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:031:0001:0024:
EN:PDF.
45
More detailed information on the practical application of relevant provisions on withdrawal and recall can be found in the
EU guidance document on the implementation of particular articles of Regulation (EC) No 178/2002. available at: http://
ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_7_en.pdf.
46
Article 19 of the Regulation (EC) No 178/2002 deals with withdrawal/recall of unsafe food and Article 20 sets out relevant
obligations of the FBO’s in respect of Feed.
47
Guidance for Industry: Product Recalls, Including Removals and Corrections, available at: http://www.fda.gov/Safety/Recalls/
IndustryGuidance/ucm129259.htm.
48
FSIS food recalls, see at http://www.fsis.usda.gov/Fact_Sheets/FSIS_Food_Recalls/index.asp.
Useful to know: Unlike food recalls, market withdrawals occur when a product reveals a minor violation
that would not be subject to FDA or FSIS legal action (for example, when a product is removed from the
market due to tampering, but without evidence of manufacturing or distribution problems, such a case
would be considered a market withdrawal).
5. Microbiological Criteria for Food and Residues Control
Microbiological Criteria
Microbiological criteria play an important role in the validation and verification of HACCP procedures and
other hygiene control measures. This is why it is necessary to set microbiological criteria to define the accept-
ability of processes, along with food safety microbiological criteria to establish the limits above which a food-
stuff should be considered unacceptably contaminated by the microorganisms for which the criteria are set.
Codex Alimentarius
Codex Alimentarius has addressed the issue of microbiological criteria for food in a few of its publications. Ac-
cording to these, the microbiological criteria for food define the acceptability of a product or a food lot, based
on the absence or presence, or number of microorganisms including parasites, and/or quantity of their toxins/
metabolites, per unit(s) of mass, volume, area, or lot.
In general, microbiological criteria may be used to define the distinction between acceptable and unaccept-
able raw materials, ingredients, products, lots, by regulatory authorities and/or food business operators. Codex
Alimentarius also emphasizes importance of microbiological criteria for verification and/or validation of the
efficacy of the HACCP plan.
European Union
Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs establishes the food
safety criteria for certain important foodborne bacteria, including their toxins and metabolites. These include
Salmonella, Listeria monocytogenes, Enterobacter sakazakii, Staphylococcal enterotoxins and Histamine in
specific foodstuffs. These microbiological criteria have been developed in accordance with Codex Alimentarius.
The FBO is required to ensure that foodstuffs comply with the relevant microbiological criteria set out in An-
nex I of the Regulation.
The Regulation requires the FBO to perform tests as appropriate against these microbiological criteria when
validating or verifying whether their procedures are functioning correctly based on HACCP principles and best
hygienic practices.
United States
By contrast with the EU, there is no uniform microbiological standard in the U.S. food safety system. Such a
standard has not been adopted because of a wide variation in products and processing procedures that are
constantly changing. Instead, FDA and FSIS simply state microbiological criteria for certain foods that are in use.
For instance, within FSIS microbiological testing programs, the agency conducts microbiological tests for Sal-
monella, E. coli O157:H7, and Listeria monocytogenes.
FSIS also has performance standards for Salmonella, and a pathogen reduction regulation that requires some
plants to conduct E. coli generic testing.49 Furthermore, on June 4, 2012, FSIS began verification testing for
non- O157 Shiga toxin-producing E.coli (STEC)50 in domestic and imported beef manufacturing trimmings from
cattle slaughtered on or after June 4, 2012.51
FDA has developed Compliance Policy Guides52 that describe its policy on compliance matters, setting forth
specific criteria that must be met by producers. Contaminants covered by these guides include foodborne
pathogens, bacterial toxins, mycotoxins, and bacterial indicators (for example E. coli). Some states also have
their own microbiological standards for foods.
Residues Control
Residues control aims to protect public safety by setting maximum residue levels in accordance with generally
recognized principles of safety assessment, taking into account any other scientific assessment of the safety of
the substances concerned which may have been undertaken by international organizations, and in particular
the Codex Alimentarius.
Codex Alimentarius
CAC has addressed the residues control issue through work done by its relevant committees – the Committee
of Pesticides Residues (CCPR) and the Committee on Residues of Veterinary Drugs in Food (CCRVDF).
CCPR is responsible for establishing MRLs for pesticide in specific food items or in groups of food; CCRVDF
determines priorities for the consideration of residues of veterinary drugs in foods, and recommends MRLs
for veterinary drugs. Limits of MRLs for pesticides and veterinary drugs are constantly being developed and
updated.53
European Union
Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and ani-
mal origin54 sets out MRLs for the 315 fresh products listed. However, these MRLs also apply to the same prod-
ucts after processing, albeit adjusted to take account of dilution or concentration as a result of the process.
49
Codex Alimentarius relevant texts: Principles for Establishment and Application of Microbiological Criteria for Foods, Principles and
Guidelines for the Conduct of Microbiological Risk Assessment and Principles and Guidelines for the Conduct of Microbiological Risk
Management, available at: www.fao.org/docrep/012/a1552e/a1552e00.htm.
50 These six non-O157 STECs are O26, O45, O103, O111, O121, and O145.
51 For more information, see: http://www.fsis.usda.gov/science/Ground_Beef_E.Coli_Testing_Results/index.asp#14.
52
For more information, see: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/
ucm119194.htm.
53
List of MRLs for pesticides and veterinary drugs is available at: http://www.codexalimentarius.org/standards/pesticide-
mrls/en/ and at: http://www.codexalimentarius. org/standards/veterinary-drugs-mrls/en/.
54
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue
levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC, available
at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32005R0396:EN:NOT.
Regulation (EC) No 396/2005 covers pesticides now or previously used in agriculture in or outside the EU (to-
taling around 1,100). According to the Regulation, no pesticide shall be authorized without an established MRL.
As for the MRLs for food of animal origin, Commission Regulation (EU) No 37/2010 on pharmacologically ac-
tive substances and their classification regarding maximum residue limits in foodstuffs of animal origin55 (and
its subsequent amendments56) established MRLs of pharmacologically active substances relevant to different
species of animals. Provisions requiring assurances from the FBO that some prohibitive substances have not
been used, and that the MRLs fixed have been complied with, can be also found in the Council Directive 96/23/
EC on measures to monitor certain substances and residues thereof in live animals and animal products.57
United States
The Environmental Protection Agency (EPA)58 sets maximum residue limits (MRLs) on how much of a pesticide
residue can remain on food and feed products, or commodities.
These pesticide residue limits are known as “tolerances” in the U.S. USDA enforces the tolerances established for
meat, poultry and some egg products, while the FDA enforces tolerances established for other foods. FDA and
USDA inspectors monitor food in interstate commerce to ensure that these limits are not exceeded.
These tolerances are listed in the:

 Federal Register, which publishes new tolerances and changes to tolerances;
 Code of Federal Regulations (CFR).
Importantly, the names of agricultural food and feed products, and commodities, are being standardized. The
tolerance information provided in the CFR and Federal Register uses these standardized commodity names.
Standardized commodity names are found in the Food and Feed Commodity Vocabulary.
These commodity terms are the only terms accepted in establishing pesticide tolerances.
55
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their clas-
sification regarding maximum residue limits in foodstuffs of animal origin, available at: http://ec.europa.eu/health/files/
eudralex/vol-5/reg_2010_37/reg_2010_37_en.pdf.
56
Updates to the Commission Regulation (EU) No 37/2010 can be found at: http://ec.europa.eu/health/veterinary-use/
maximum-residue-limits/regulations_en.htm.
57
Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals
and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC,
available at: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996L0023:EN:HTML.
58
The EPA website contains detailed instruction on how to use Electronic Code of Federal Regulations (e-CFR) recourses to
find tolerances on a specific food or commodities. See at:http://www.epa.gov/pesticides/food/viewtols.htm.
Import/Export
Each country has its own body of import/export legislation, which must be followed by both domestic and
foreign FBOs. As a result, common principles for import/export trade which provide the possibility of both
developing an efficient system of state control while avoiding deceptive marketing practices have been devel-
oped by the world food community.
Codex Alimentarius
Recognizing that quality and safety can be assured through the application of well-designed food control
systems (for exports and imports), principles for food import and export inspection and certification have been
developed by the Codex Committee on Food Import and Export Inspection and Certification Systems.59
European Union
The main rule for food products slated as EU imports is that they should meet the same hygiene and safety
standards as food produced in EU. However, the import system for food of animal origin differs from what is
required for food of non-animal origin, or for food containing both animal-and plant-origin ingredients.
Food of Animal Origin and Live Animals:

1. Can be imported to the EU only from third countries included in the list compiled by the community,
and only from establishments approved by the community;60
2. Will be subject to compulsory veterinary border control at veterinary border inspection posts (BIPs).
BIPs are under the authority of official veterinarians, who are responsible for the health checks required
on incoming consignments.
3. Consignments with food of animal origin:
 Are subject to official veterinary checks in the border inspection. Official border control is conducted
on fee basis. Minimum rates were adopted by EU Regulation 882/2004 although these may vary in
each member state;
 Prior notification of consignment arrival is required;
 Should be accompanied by required documents (certificate issued by competent authority of third
country);
 Special import conditions might be imposed on the consignment if imported products are listed in
List of Special Import Conditions. This list shows which product from which county is to be checked
as well as any control actions that may be taken.61
Only after these checks prove successful, and after receiving all necessary information cited in the Common
Entry Veterinary Document (CEVD), will the consignment be allowed to enter the EU.
Consignments which are found not to be compliant with EU legislation will either be destroyed or, under cer-
tain conditions, re-dispatched within 60 days. If any one of the checks indicates that a consignment of animals
or products is likely to constitute a danger to animal or human health; however, the consignment in question
will immediately be seized and destroyed by the competent authorities.
59
The latest compilation of Codex documents related to import/export control is available at: ftp://ftp.fao.org/codex/
Publications/Booklets/Inspection/CCFICS_2012_EN.pdf.
60
Updated Third Country Establishments List is available at: http://ec.europa.eu/food/international/trade/third_en.htm.
61
Updated List of special import conditions is available at: http://ec.europa.eu/food/animal/bips/special_imports_en.htm.
Import/Export 51
Food of Non-Animal Origin:

1. Can be imported from any third country (no special approval of the country or establishment in third
country is required);
2. Import controls of food of non-animal origin take place in accordance with national law in the different
member states. This may be at the point of entry, the point of release for free circulation, the importer’s
premises, and retail outlets. Certain food of non-animal origin is to be imported to EU through a des-
ignated point of entry;
3. Is not subjected to a pre-notification procedure on arrival, except for certain foods of non-animal origin;
4. Can enter the EU without certification by the competent authorities of the third country of dispatch.
Only certain plants and plant products must be accompanied by a phytosanitary certificate, issued by
the National Plant Protection Organization of the exporting country. Upon entry into the community,
the phytosanitary certificate may be replaced by a plant passport.62
United States
Food imported to the U.S. must meet the same legal standards as food produced domestically. To assure this,
the FSMA contains significant requirements for importers. In particular, importers must verify the safety of the
food offered for import using the new Foreign Supplier Verification Program (FSVP). This program requires import-
ers to conduct risk-based verification activities to assure that imported food is not adulterated or misbranded
and is produced in compliance with the FDA’s preventive controls requirements and produce safety standards.
Verification activities may include monitoring records for shipments, lot-by-lot certification compliance, and
annual on-site inspections, checking the hazard analysis and risk-based preventative control plan of the for-
eign supplier and periodically testing and sampling shipments.63
The FSVP program is mandatory, unlike the Voluntary Qualified Importer Program (VQIP),64 which is entirely
voluntary and gives importers a green light for imported foods from trusted suppliers. Non-compliance with
the FSVP is a basis for refusal of an imported article. The FSMA authorizes the FDA to require that high-risk
imported foods, based on health consequences, be accompanied by a credible third-party certification or
other assurance of compliance as a condition of entry into the U.S.
Before importing products to the U.S., FDA also requires that:

 Food facilities (both domestic and foreign) are registered with the FDA; and that
 The FDA be given advance notice on shipments of imported food.
Foreign facilities that manufacture/process, pack, or hold food are required to register with the FDA unless
food from that facility undergoes further processing (including packaging) by another foreign facility before
the food is exported to the U.S. Food facilities may be registered and prior notice may be submitted online.
Food facilities are required to renew this registration every two years.
Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. The FDA
may detain shipments of products offered for import if the shipments are found not to be in compliance with
U.S. requirements.
Unlike the FDA, for which inspection requirements are company-specific, FSIS coordinates with the govern-
ment of the country-in-question before accepting meat, poultry or egg products for sale in the U.S. In particu-
lar, to import meat, poultry or eggs into the U.S., these products must originate from certified countries and
establishments eligible to export to the United States.
Remarkably, Canada is currently the only country eligible to export egg products to the U.S.
62
Mentioned plants and plant documents are listed in Part B of Annex V to Directive 2000/29/EC available at: http://eur-lex.
europa.eu.
63
However, importers are not required to conduct verification activity pertaining to products from foreign suppliers which
are subject to low-acid canned food regulations, and seafood or juice HACCP.
64
Available at http://www.access.fda.gov/.
Regulatory Authority
The issue of food safety regulation is one of the most important both in terms of assuring customer health and
effective FBO operations.
In fact, the ability to produce safe food and be trusted by potential customers is crucial for food producers aim-
ing to integrate their businesses into the international food trade – meaning that Food Safety Management
Systems are a key issue for the private sector. At the same time, however, food safety regulations can also
impose a heavy administrative burden on businesses.
Codex Alimentarius
CAC has addressed issues related to food safety regulation in several of its texts. For example, Principles for
Food Import and Export Inspection and Certification sets out the basic principles that inspection and certification
systems should meet. It also emphasizes the importance of having adequate means to perform such inspec-
tion and certification procedures.65
Furthermore, the Guidelines for Food Import Control Systems provide a framework for the development and
operation of an import control system aiming to protect consumers and facilitate fair practices in food trade.
Finally, the Guidelines for the Validation of Food Safety Control Measures provides practical guidance for industry
and governments on the validation of individual control measures, a limited combination of control measures,
or sets of control measure combinations forming a food safety control system (for example HACCP, GHP).66
European Union
The European Food Safety Authority is an independent European agency funded by the EU budget that oper-
ates separately from the European Commission, European Parliament and EU member states. EFSA’s role is to
assess and communicate all risks associated with the food chain.
Through its risk communication activities, EFSA seeks to raise awareness and further explain the implications
of its scientific work. EFSA aims to provide appropriate, consistent, accurate and timely communications on
food safety issues to all stakeholders and the public at large, based on the authority’s risk assessments and
scientific expertise.67
In the EU, the Member State Regulatory Authority has national responsibility for coordinating the enforce-
ment of food safety legislation in a member state.68
65
Codex Alimentarius Principles for Food Import and Export Inspection and Certification, available at: http://www.fao.org/do-
crep/009/y6396e/y6396e00.htm.
66
Codex Alimentarius Guidelines for the Validation of Food Safety Control Measures, available at: www.codexalimentarius.org/
input/download/standards/.../cxg_069e.pdf.
67
More information on EFSA can be found in Regulation (EC) 178/2002 of the European Parliament and of the Council of
28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety, available at: http://europa.eu/legislation_summaries/
consumers/consumer_information/f80501_en.htm.
68
References to web-pages of member states regulatory authorities can be found below in Useful Links Table.
Regulatory Authority 53
Finally, the Rapid Alert System for Food and Feed (RASSF) needs to be mentioned. This body was put in place
to provide food and feed control authorities with an effective tool to exchange information about measures
taken in response to serious risks detected in relation to food or feed. This information exchange helps mem-
ber states act more rapidly, and in a coordinated manner, in response to a health threat rooted in food or
feed. When a RASFF member has any information about a serious health risk linked to food or feed, it must
immediately notify the European Commission using RASFF.69
United States
Numerous federal, state and local agencies regulate the American Food Safety Management System. At the federal
level, 15 agencies collectively administer at least 30 laws related to food safety.70 Two federal agencies, the U.S. De-
partment of Agriculture (USDA) and the Food and Drug Administration (FDA) are primarily responsible for safety of
the U.S. food system.
The USDA71 is responsible for the regulation of meat, poultry, and processed egg products. Within the USDA,
the Food Safety and Inspection Service (FSIS)72 inspects and regulates meat, poultry and processed egg prod-
ucts produced in federally inspected plants. FSIS is responsible for ensuring that these products are safe,
wholesome, correctly labeled, and packaged.
The FDA73 is responsible for regulation of virtually all other foods. In particular, the Center for Food Safety and Ap-
plied Nutrition (CFSAN) works to assure that the food supply is safe, sanitary, wholesome, and honestly labeled.
Other agencies responsible for food system-related issues include:

 The US Department of Homeland Security (DHS),74 which is responsible for coordinating agencies’ food
security activities, including at U.S. borders;
 The National Marine Fisheries Service (NMFS)75 in the U.S. Department of Commerce, which conducts vol-
untary, fee-for-service inspections of seafood safety and quality;
 The Environmental Protection Agency (EPA),76 which regulates the use of pesticides and maximum allow-
able residue levels on food commodities and in animal feed;
 The Centers for Disease Control and Prevention (CDC)77 under the U.S. Department of Health and Human
Services.
Tracking single cases of foodborne illness and investigating outbreaks are some of the public health functions
that closely involve CDC.
At the state level, food safety regulatory functions may be carried out by departments of health, agriculture, or
environment, or some combination of these. State-level agencies perform a wide range of food safety functions
addressing both prevention and response to food safety problems, including outbreak response and recalls,
laboratory testing, retail, food service, processing and farm inspection, among many others. At the local level,
public health departments normally carry out restaurant inspections and other local food safety activities.78
69
More information on RASSF can be found in Regulation (EC) 178/2002 of the European Parliament and of the Council
laying down the general principles and requirements of food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety, available at: http://europa. eu/legislation_summaries/consumers/con-
sumer_information/f80501_en.htm and at: http://ec.europa.eu/food/food/rapidalert/index_en.htm.
70
GAO Federal Oversight of Food Safety, 2007, http://www.gao.gov/new.items/d07449t.pdf.
71
http://usda.gov/wps/portal/usda/usdahome.
72
http://www.fsis.usda.gov.
73
http://www.fda.gov.
74
http://www.dhs.gov/.
75
http://www.nmfs.noaa.gov/.
76
http://www.epa.gov/.
77
http://www.cdc.gov/.
78
The Essential Role of State and Local Agencies in Food Safety and Food Safety Reform, by Stephanie David etc., available
Other Relevant Regulations

European Union
The new EU Regulation 1169/2011 on the provision of food information to consumers introduced significant
changes to existing legislation on food labelling. This regulation came into force on December 13, 2014, oblig-
ing the FBO to provide nutrition information to consumers.
Regulation (EU) No 872/2012 provides a new and widened list of flavoring substances acceptable for use in
food.79 This regulation came into force April 22, 2013.
United States
The main significant changes in U.S. food safety legislation are related to the FSMA.
The Food Safety and Modernization Act (FSMA) was passed by Congress in 2011. It was the first major reform
by the FDA in over 70 years. FSMA expands the regulation of produce from farm to sale and other FDA-
regulated foods from processing to sale and introduces additional food safety requirements. Key changes are:
1. A shift of focus from reaction to prevention, including preventing intentional contamination;
2. More authority to inspect and assure compliance with inspection frequencies based on risk;
3. Mandatory recall authority;
4. Authorities to strengthen import safety to assure that U.S. food safety standards are met; and
5. Stronger partnerships with other government agencies and private entities.
Preventive Controls:
FSMA requires preventive controls for food consumed by humans. The rule is now final; compliance dates for
some businesses begin in September 2016.
Key Requirements:
 Requires FBO facilities to have a written food safety plan that includes a hazard analysis and preventive
controls;
 Hazard analysis, which must consider known or reasonably foreseeable biological, chemical and physi-
cal hazards. These include hazards that occur naturally, are intentionally introduced, or are intentionally
introduced for economic gain (if they affect food safety);
 Preventive controls required to ensure that hazards will be minimized or prevented, including process,
food allergen and sanitation controls, as well as supply chain controls and a recall plan. Oversight and
management of preventive controls include:
• Monitoring: procedures ensuring that preventive controls are consistently performed. Monitoring is
conducted as appropriate to the preventive control;
• Corrective actions and corrections taken to identify and correct a minor, isolated problem that oc-
curs during food production. These include actions to identify a problem with preventive control
implementation; reduce the likelihood the problem will recur; and evaluate affected food for safety
and prevent it from entering commerce. Corrective actions must be documented;
• Verification is required to ensure that preventive controls are consistently implemented and effec-
tive. This includes validating with scientific evidence that a preventive control is capable of effec-
tively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and
verification of instruments such as thermometers and reviewing records to verify that monitoring
and corrective actions (if necessary) are being conducted.
at http://www.thefsrc.org/State_Local/StateLocal_June17_background.pdf.
79
The list of permitted flavoring substances (Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012),
available on http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:267:0001:0161:EN:PDF.
Other Relevant Regulations 55
 Supply chain is more flexible, with separate compliance dates:

• The rule mandates that a manufacturing/processing facility has a risk-based supply chain program
for raw materials and other ingredients for which it has identified a hazard requiring a supply chain
applied control;
• Manufacturing/processing facilities that control a hazard using preventive controls, or that follow
requirements applicable when relying on a customer to control hazards, do not need to have a sup-
ply chain program for that hazard;
• Covered food facilities are responsible for ensuring that these foods are received only from approved
suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verifi-
cation activities before being accepted for use.
 Current Good Manufacturing Practices (CGMPs) are updated and clarified:
• Education and training are not binding;
• FBO management is required to ensure that all employees who manufacture, process, pack or hold
food are qualified to perform their assigned duties;
• FBO employees must have the necessary combination of education, training, and/or experience
necessary to manufacture, process, pack or hold clean and safe food;
• FBO employees must receive training in the principles of food hygiene and food safety, including the
importance of employee health and hygiene.
Foreign Supplier Verification Programs (FSVP)
FSMA requires that importers of food for humans and animals be subject to Foreign Supplier Verification Pro-
grams (FSVP). The final rule requires that importers perform certain risk-based activities to verify that food
imported into the United States has been produced in a manner that meets applicable U.S. safety standards:
 Importers covered by the rule must have a system in place to verify that their foreign suppliers are
producing food in a manner that provides the same level of public health protection as the preventive
controls or produce safety regulations, as appropriate to ensure that the supplier’s food is not adulter-
ated and is not misbranded with respect to allergen labelling;
 Importers are responsible for actions that include:
• Determining known or reasonably foreseeable hazards with each food;
• Evaluating the risk posed by a food, based on the hazard analysis, and for foreign supplier’s food
safety performance, e.g. complaints, withdrawals, or recalls;
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to ap-
prove suppliers and determine appropriate supplier verification activities;
• Conducting supplier verification activities;
• Conducting corrective actions.
Third Party Certification
This rule establishes a voluntary program for the accreditation of third party certification bodies, also known
as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans
and animals they produce. These requirements cover legal authority, competency, capacity, conflict of interest
safeguards, quality assurance and record procedures. Certificates can be used for two purposes:
 For importers to establish eligibility for participation in the Voluntary Qualified Importer Program
(VQIP), which offers expedited review and entry of food;
 To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific
circumstances that a food offered for import be accompanied by a certification from an accredited third
party certification body.
Produce Safety
This rule establishes for the first time, science-based minimum standards for the safe growing, harvesting,
packing, and holding of fruits and vegetables grown for human consumption.
Key Requirements:
 Water quality: no detectable generic E. Coli are allowed for certain uses of agricultural water in which
it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce
through direct or indirect contact. The second set of criteria of numerical criteria is for agricultural
water that is directly applied to growing produce (other than sprouts). The criteria are based on two
values, the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less
CFU [colony forming unit] of generic E. Coli per 100 mL of water and the STV of samples is 410 CFU or
less of generic E. coli in 100 mL of water;
 Testing: required for untreated water used for certain purposes, based on testing frequency on the type
of water source (i.e. surface or ground water);
 Biological soil amendments (materials intentionally added to soil to improve its chemical or physical
condition for growing plants or to improve its capacity to hold water):
• Untreated biological soil amendments of animal origin, such as raw manure, must be applied in a
manner that does not contact covered produce during application and minimizes the potential for
contact with covered produce after application;
• FDA does not object to farmers complying with the USDA’s National Organic Program standards,
which calls for a 120-day interval between the application of raw manure for crops in contact with
the soil and 90 days for crops not in contact with the soil.
 Standardized compost: microbial standards that set limits on detectable amounts of bacteria (including
Listeria Monocytogenes, Salmonella spp., fecal coliforms, and E. Coli 0157:H7) have been established for
processes used to treat biological soil amendments, including manure.
Sprouts: new requirements help prevent the contamination of sprouts, which have been frequently associated
with foodborne illness outbreaks. Sprouts are especially vulnerable to dangerous microbes because of the
warm, moist and nutrient rich conditions needed to grow them.
Food Defense
Food defense is the effort to protect the food supply against intentional contamination due to sabotage, ter-
rorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biologi-
cal, chemical and radiological hazards that are generally not found in foods or their production environment.
FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable pro-
cesses in their operations to prevent acts on the food supply intended to cause large-scale public harm. The
proposed rule, which is required by FSMA, would require the largest food businesses to have a written food
defense plan that addresses significant vulnerabilities in a food operation.
Sanitary Transportation of Human and Animal Food
This proposed rule establishes requirements for vehicles and transportation equipment, transportation opera-
tions, training, and recordkeeping. Operators of motor vehicles, railcars, and other equipment used in food
transportation would be required to establish written procedures, subject to record keeping requirements, for
cleaning their vehicles and transportation equipment.
Other Relevant Regulations 57
Administrative Detention
FSMA enhances FDA’s administrative detention authority by authorizing FDA to administratively detain ar-
ticles of food that FDA has a reason to believe may adulterated or misbranded.80
USA Fruit and Vegetable Regulations
The primary regulation relating to the importation of fruit and vegetables in the USA is 7 CFR 19.56-3. All fruits
and vegetables that are imported, must be:
 Free from plant litter or debris and free of any portions of plants that are specifically prohibited in the
regulations;
 Imported under permit issued by APHIS [Animal and Plant Health and Inspection Service], whether
commercial or noncommercial.
Port of Entry
 Fruits and vegetables must be imported into specific ports if so required or they may be imported into
any port listed in 19 CFR 101.3(b)1. Fruits and vegetables that are to be cold treated at ports in the United
States may only be imported into specific ports.
Inspection, Treatment and other Requirements

 All imported fruits or vegetables are subject to inspection, and disinfection at the port of first arrival
as may be required by a Border Control Protection [BCP] inspector, and are subject to re-inspection at
other locations at the option of an inspector. If an inspector finds plants or portions of plants, or a plant
pest or noxious weed, or evidence of a plant pest or noxious weed on or in any fruit or vegetable or its
container, or finds that the fruit or vegetable may have been associated with other articles infested with
plant pests or noxious weeds, the owner or agent of the owner of the fruit or vegetable must clean or
treat the fruit or vegetable and its container as required by an inspector, and the fruit or vegetable is also
subject to re-inspection, cleaning, and treatment at the option of an inspector at any time and place
until all applicable requirements of this subpart have been accomplished.
 Notice of arrival; assembly for inspection. Any person importing fruits and vegetables into the United States
must offer those agricultural products for inspection and entry at the port of first arrival. The owner or
agent must assemble the fruits and vegetables for inspection at the port of first arrival, or at any other place
designated by an inspector, and in a manner designated by the inspector. All fruits and vegetables must
be accurately disclosed and made available to an inspector for examination. The owner or the agent must
provide an inspector with the name and address of the consignee and must make full disclosure of the type,
quantity, and country and locality of origin of all fruits and vegetables in the consignment, either orally for
noncommercial consignments or on an invoice or similar document for commercial consignments.
 Refusal of entry. If an inspector finds that an imported fruit or vegetable is prohibited, or is not ac-
companied by required documentation, or is so infested with a plant pest or noxious weed that, in the
judgment of the inspector, it cannot be cleaned or treated, or contains soil or other prohibited contami-
nants, the entire lot or consignment may be refused entry into the United States.
80
Bibliography
Food and Drug Administration, FSMA Final Rule for Preventive Controls for Human Food
Food and Drug Administration, FSMA Final Rule on Foreign Supplier Verifications Programs (FSVP) for Importers of
Food for Humans and Animals
Food and Drug Administration, FSMA Final Rule on Accredited Third Party Certification
Food and Drug Administration, FSMA Final Rule on Produce Safety
Food and Drug Administration, FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against
Intentional Adulteration
Food and Drug Administration, FSMA Frequently Asked Questions
 Release for movement. No person may move a fruit or vegetable from the port of first arrival unless an
inspector has either:
(i) Released it;
(ii) Ordered treatment at the port of first arrival and, after treatment, released the fruit or vegetable;
(iii) Authorized movement of the fruit or vegetable to another location for treatment, further inspec-
tion, or destruction; or
(iv) Ordered the fruit or vegetable to be re-exported.
 Notice to owner of actions ordered by inspector. If an inspector orders any disinfection, cleaning, treat-
ment, re-exportation, recall, destruction, or other action with regard to imported fruits or vegetables
while the consignment is in foreign commerce, the inspector will issue an emergency action notifica-
tion (PPQ Form 523) to the owner of the fruits or vegetables or to the owner’s agent. The owner must,
within the time and in the manner specified in the PPQ Form 523, destroy the fruits and vegetables, ship
them to a point outside the United States, move them to an authorized site, and/or apply treatments
or other safeguards to the fruits and vegetables as prescribed to prevent the introduction of plant pests
or noxious weeds into the United States.
 Costs and charges. APHIS will be responsible only for the costs of providing the services of an inspector
during regularly assigned hours of duty and at the usual places of duty. The owner of imported fruits
or vegetables is responsible for all additional costs of inspection, treatment, movement, storage, de-
struction, or other measures ordered by an inspector under this subpart, including any labor, chemicals,
packing materials, or other supplies required. APHIS will not be responsible for any costs or charges,
other than those identified in this section.
The Eurasian Economic Union (EEU) 59
The Eurasian Economic Union (EEU)

This section provides information on production and marketing of food products in the Eurasian Economic
Union (EEU). The section is based on Comparative Analysis of Certain Requirements of Food Legislation in the Euro-
pean Union and the Customs Union of Russia, Belarus, and Kazakhstan.81
The Eurasian Economic Union is an international organization for regional economic integration; it has inter-
national legal personality and is established by the Treaty on the Eurasian Economic Union (EEU) dated May
29, 2014. The EEU ensures free circulation of goods, services, capital and labor force as well as coordinated,
coherent or unified policy in the economy sectors. The member states of the EEU are the Republic of Armenia,
the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation.82
The EEU has been established for comprehensive modernization, cooperation, and competitiveness improve-
ment of the national economies and to create environment for sustainable development to the benefit of
improving the living standards of the citizens of the member states.
Legal Instruments
The EEU system of normative regulation consists of number of general and product-specific technical regula-
tions that provide a framework for food control within the EEU; the common framework is then supported by
member states national laws, regulations, and standards.
Within the EEU the main legal instruments used are technical regulations. There are also voluntary standards.
However, products must comply with the technical regulatory act in the field of standardization, such as state
standards:
 National/regional;
 Standards (e.g., GOST, GOST-R),) or technical regulations (TR) that have been applied by a manufac-
turer.. The regulations and standars are directly applicable within the member states (activities in the
area of technical regulation and conformity assessment), but with some exceptions, they do not incor-
porate implementation mechanisms – these can only be found in the EEU member-states’ national
laws and regulations. Technical regulations, while directly applicable, focus mostly on technical aspects
of products and establish specifications, not policies.
For food categories where product-specific technical regulations have not been developed, the national law
of the EEU member states applies.
81
http://documents.worldbank.org/curated/en/2015/07/24794014/comparative-analysis-certain-requirements-food-legis-
lation-european-union-customs-union-russia-belarus-kazakhstan.
82
http://www.eaeunion.org/#about.
Figure 1 provides a graphical representation of the EEU food-related legal instruments:
Figure 1 Organization of Customs Union Technical Regulations
Decisions of the Commission Framework Agreements of the CU

on Procedural aspects (e.g., on common principles
(e.g., border control, joint checks in third countries) of technical regulation)
FOOD NON-FOOD
Sanitary, Epidemiology
Technical Regulations
and Hygiene Requirements
Chapter II, section 1: Safety requirements CU TR 021/2011 “On food safety”

and nutritional value of food (all food categories)
Chapter II, section 9: Requirements CU TR 005/2011 “On the safety of packaging”

for drinking water packed in containers
CU TR 022/2011 “On food products
Chapter II, section 15: Requirements in terms of their labeling”
for pesticides
CU TR 029/2012 “Requirements for the safety
Chapter II, section 16: Requirements of food additives, flavorings
for food contact materials and technological aids”
Chapter II, section 21: Requirements CU TR 033/2013 “On milk and dairy products”
for mineral water
CU TR 034/2013 “On meat and
Chapter II, section 22: Requirements meat products”
for food additives and flavorings
CU TR 023/2011 “On fruit and vegetable
Chapter II, section 23: Requirements Juice products ”
for processing aids
CU TR 024/2011 “On oils and fats”
Uniform veterinary requirements (non-food as well)
Uniform phyto-sanitary requirements CU TR 015/2011 “On the safety of grain”
Standards (national/regional CU TR 027/2012 “On safety of certain types

standards (e.g., GOST, GOST-R), of specialized food products, including foods
international: for dietary treatment and dietary preventive
- As voluntary option of compliance nutrition”
with TRs
- Mandatory sampling and testing methods Each TR establishes:
- items and processes regulated
- safety requirements
- rules of identification
- forms and procedures of assessment (confirmation) of conformity
In case of several TRs, when they entered into force, relevant sections of the uniform sanitary,
epidemiology and hygiene requirements stopped being effective with regard to the objects
of regulation covered by the TRs
Both EEU technical regulations and the laws and standards of the member states must be considered to be
compliant with the EEU. Furthermore, the EEU system does not address enforcement, fines, penalties, incident
management, recalls and withdrawals, and authorization/approval of new substances (for example, pesticides
or veterinary medicines). These issues are addressed within the framework of the national legislation of mem-
ber states. This increases the complexity of the regulatory environment and compliance for industry wishing
to export to the EEU and for governments wishing to model or harmonize with the EEU.
Organizational Arrangements
The legal framework of the EEU combines horizontal and vertical legal acts. Horizontal regulations include
technical regulations on general food safety, labeling, packaging, food additives and flavorings that cover
cross-cutting aspects for all food products (note that technical regulations on packaging also cover packaging
for non-food items). Currently, there is a technical regulation being drafted for materials contacting food that
also as a horizontal nature. There are also vertical technical regulations specific to certain product groups, in
particular grain, oils and fats, fruit and vegetable juices, meat and meat products, milk and dairy products. Ad-
ditional vertical technical regulations are being drafted for alcohol products, poultry and poultry products, fish
and fish products, bottled potable water and mineral waters.
The EEU technical regulations include a number of requirements that relate to their
circulation on the market. The most important requirement is that food must pass
conformity assessment procedures and bear a special EEU mark as a proof of con-
formity.
A single mark of circulation proves that products have passed all evaluation (conformity) procedures stipulated
in technical regulations and that they comply with the requirements of all technical regulations. Furthermore,
since the EEU is based on conformity assessments, many food products have to meet compositional stan-
dards, as well as requirements for chemical and physical properties, nutritional properties, organoleptic (ap-
pearance, taste, odor) and, in some cases, size.
Food Control System
In the EEU the food control system incorporates two levels: food control through all-Union conformity as-
sessment and individual member state controls (supervision) of sanitary, veterinary, phytosanitary aspects.
The EEU institutional framework and the scope of the official food control system are represented in Figure 2:
Enforcement is carried out by national bodies designated as competent authorities for specific areas of state
control (supervision), and in technical regulation. Conformity assessments are carried out by authorized cer-
tification (conformity assessment) bodies. Testing needed for the purposes of enforcement is carried out by
authorized testing laboratories.
Specially designated state bodies are responsible for assessing or confirming conformity for several groups of
products (e.g., specialized products, GMOs). As previously mentioned, foodstuffs are subject to conformity as-
sessment within the EEU. Evaluation (proof) of food conformity is conducted in the following forms:
1. Confirmation (declaration) of compliance of food products;
2. State registration of specialized food products;
3. State registration of new types of food products;
4. Veterinary-sanitary expertise.
In addition to conformity assessment, food products are subject to state control (supervision).83 This combines
border controls (people, vehicles, goods) and internal controls within the member states.
83
State sanitary control (supervision) is carried out against requirements to products and processes outlined in the Uniform
Sanitary, Epidemiological and Hygiene Requirements over Products Subject to State Control (Supervision); State veteri-
nary control is carried out according to Uniform Veterinary (Veterinary and Sanitary) Requirements for Goods Subject to
Veterinary Inspection (Supervision).
Figure 2 Food Control System of the Customs Union
Competent authorities in the area Approved certification Bodies on registration

of technical regulation (conformity assessment) of novel food
bodies
Competent authorities
Approved testing Bodies on registration
in the area of state sanitary control
laboratories of specialized food
(supervision)
Competent authorities Bodies on state registration

in the area of state veterinary control of establishments
(supervision)
engaged in producing and processing
of raw material of animal origin –
meat, poultry, eggs, fish
Competent authorities in the area
of state phytosanitary control
(supervision) Registers of:
Approved certification bodies
Uniform Lists: Approved testing laboratories
Products subject to mandatory assessment Specialized products
(confirmation ) of conformity Novel food
Goods subject to sanitary and epidemiological Establishments not subject to state registration
surveillance (control)
Establishments subject to state registration
Goods subject to veterinary control (engaged in producing and processing of raw material
Goods subject to quarantine and phytosanitary of animal origin – meat, poultry, eggs, fish)
control (surveillance) Establishments not subject to state registration
Registered declarations of conformity
Registered establishments in third countries
(veterinary control)
Food products are divided into three groups that subject to respectively sanitary (epidemiological, hygiene),
veterinary, and phytosanitary control (supervision). The purpose of, for instance, state sanitary (epidemiologi-
cal, hygiene) control (supervision) is to prevent the introduction and spread of, and to ensure the elimination of
infectious and massive poisonings that are hazardous to human health. Moreover, the objects of state control
are prevention of emergencies acts of terrorism with the use of biological agents, chemical and radioactive
substances.84
All food with ingredients of animal origin are subject to veterinary checks.85
Certain products, when first imported or produced in the EEU, are subject to state registration including: min-
eral, therapeutic, and bottled water; beverages such as tonics and beer; food for special purposes, including
food for babies and older children, food for pregnant and nursing women; food additives, foodstuffs derived
84
Based on item 2-1 of Decision of the Customs Union Commission No. 299 of May 28, 2010 (with amendments to item
2-1 introduced by Decision No. 101 of the Eurasian Economic Council of July 7, 2014, the food products and items that are
covered by the scope of certain technical regulations are exempt from the scope of Uniform Sanitary, Epidemiological
and Hygiene Requirements. These include, for example, materials and articles produced of polymer and other materials
intended for contact with food and food media, labeling requirements, food additives and flavorings, and technological
aids, as well as meat and meat products, and milk and dairy products.
85
The Common List of Goods Subject to Veterinary Control (Supervision). Approved by the Decision of the Customs Union
Commission No. 317 dated June 18, 2010.
from genetically engineered or modified (transgenic) organisms, and some food contact materials.86 Registra-
tion of these products is verified through state supervision.
Certain production and processing facilities also require registration. This requirement extends to facilities
engaged in production and processing products containing meat, dairy, poultry and fish. State registration
of production/processing facilities is conducted by the agencies authorized for this purpose by EEU member
states. This procedure begins with the application by the processor and is followed by an inspection of the
facility to determine its conformity to the requirements on processes (production, processing, storage, trans-
portation, sale, disposal) established by relevant technical regulations.
Details of the procedure are established by the legislation of the EEU member states.
Upon satisfactory completion of the inspection and review of the findings, the designated agency assigns an
identification number to the facility and adds it to the Registry of Food Facilities Subject to State Registration.
The state registration of a production/processing facility has no expiration date; however, it can be suspended
or cancelled in case of serious breach of the requirements of technical regulations.
Table 1 below provides a summary of the state control (supervision) framework within the EEU.
Regulation of Food Quality issues
Specifics of EEU quality are usually included in minimum composition requirements in product definitions.
These requirements can be found in under product-specific technical regulations (e.g., Article 5, “Safety re-
quirements for fruit and/or vegetable juice products” of CU TR 023/2011 On Fruit and Vegetable Juice Products),
and in annexes on microbiology, physical and chemical properties and organoleptic characteristics. The intent
is to ensure that products entering the market conform to the specific technical regulations in all attributes.
Quality characteristics outlined in the technical regulations are used to ensure uniformity of food products
offered to consumers, satisfy the needs of vulnerable groups of consumers, and for the purposes of product
identification to establish whether they are subject to conformity assessment under the relevant technical
regulation.
A general rule applies to compliance with EEU technical regulations: a manufacturer may choose whether to
comply with the technical regulation itself, or with a set of regional standards (GOSTs), a list of which sup-
ports each technical regulation. Compliance with these standards is voluntary but meets the requirements for
compliance with the technical regulation. Furthermore, in cases where norms are absent in the EEU technical
regulations, national norms of the member states apply.
Food Labeling
In the EEU labeling requirements are focused on consumer and transport packaging. An information carrier
must be attached, affixed or enclosed to the product packaging. The EEU established that packaged food
product labeling may include additional information.
Importantly, in the EEU, labeling is one of the requirements that comprise a set of specifications for mandatory
conformity assessment (in the form of declaration of conformity). Non-compliance may result in no access to
the EEU market.
86
The goods from the list, manufactured for the first time on the EAEU customs territory, as well as imported for the
first time to EAEU customs territory, are subject to state registration (Part II, Single List of Goods Subject to Sanitary-
and-Epidemiologic Supervision (control) at the Customs Border and on the Customs Territory of EAEU, as amended by
Decision of the Customs Union Commission No 341 of 17.08.2010).
Table 1 General Framework of the State Control (Supervision) in the Customs Union
State Control (Supervision)87

Sanitary Veterinary Phytosanitary
Customs Union Agreement on Agreement of the Customs Customs Union Agreement on
Key legal act Sanitary Measures88 Union on Veterinary and Plant Quarantine90
Sanitary Measures89
Competent
Competent authorities in the area of state sanitary control (supervision) in member states
authority
Common list of goods subject Common list of goods subject List of goods subject to
to sanitary and epidemiological to veterinary control quarantine and phytosanitary
control (supervision) control (supervision)
 Foodstuffs (products in nat-  Live animals  Vegetables, fresh or chilled
ural or processed form used  All food of animal origin,  Dried leguminous vegetables;
for human food) including fresh and processed  Fruits, fresh, dried
those derived from geneti-
 Food that has ingredients of  Nuts, fresh or dried, whether
Scope cally engineered or modified
animal origin or not shelled or peeled
(transgenic) organisms
 Yeasts, enzymes, starter  Coffee, not roasted, whether
 Materials, products and
cultures or not decaffeinated
equipment contacting with
foodstuffs  Grains and other plant  Cocoa beans
origin items when they are
 Pesticides and  Grains
intended for manufacture
agrochemicals  Cereal flours
of feed
 Seeds, whether or nor broken
Point of control At the border and within the customs territory of the Customs Union
Documents Uniform sanitary, epidemiology Uniform veterinary
that establish and hygiene requirements for requirements for goods
—
compliance goods subject to veterinary subject to veterinary control
criteria control (supervision) (supervision)
Procedure of state sanitary Procedure of carrying out vet- List of Quarantine Products
and epidemiological control erinary control at the customs subject to quarantine and
(supervision) over persons border and on the customs phytosanitary control
crossing the CU customs territory of the CU (supervision) while being
border, goods subject to control Procedure of carrying out joint imported to the common
that are being moved through inspections and sampling of customs territory of the CU
the customs border and goods (products) subject to vet- Procedure of carrying out the
Procedural customs territory of the CU erinary control (supervision) on quarantine and phytosanitary
documents the territory of the CU member control (supervision) at the
Common templates of product states and third countries external border of the CU
(goods) safety documentation Consolidated list of highly dan- Procedure of carrying out the
gerous and quarantine diseases quarantine and phytosanitary
of animals control in respect of quarantine
Common templates of veteri- products that are moved within
nary certificates (movement, the common customs territory of
import) the CU
Common register of state Register of food production
Registers registration certificates for objects (facilities) that are subject —
87888990
certain products to state registration
87
English translations as well as links to the specific documents referenced in the table can be found at http://ec.europa.eu/
food/international/trade/sps_requirements_en.print.htm .
88
Decision No. 28 of 11 December 2009 of the Customs Union Commission, Decision No. 299 of 28 May 2010 of the Customs
Union Commission.
89
Customs Union Agreement on veterinary and sanitary measures, Decision No. 317 of 18 June 2010 of the Customs Union
Commission, as amended by Decision No. 342 of 17 August 2010, No. 455 of 18 November 2010, No. 569 and No. 570 of 2
March 2011, No. 623 of 7 April 2011, No. 724 of 22 June 2011 and No. 726 of 15 July 2011.
90
Decision of the Interstate Council of the Eurasian Economic Community No. 30 of 11 December 2009.
Food and Food-related Articles and Materials that Require Special Authorization
The EEU has established that there are types of food and classes of substances and/or materials, that, when
either added to or come into contact with food, require special authorization before they can enter the mar-
ket. These must meet special requirements to ensure food safety. They include novel food, food supplements,
food additives and packaging and articles and materials in contact with food.
These are broad groups of substances, materials and articles that require authorizations; each group has its
own laws and technical regulations, scopes of the regulations, definitions, authorization procedures, and spe-
cific requirements. This makes each area unique and requires a separate discussion for each general topic.91
Materials and Items Contacting Food
Currently, in the EEU, only packing and bottling materials have to be regulated as materials and items contact-
ing food (CU TR 005/2011). Work is underway to draft technical regulation on the safety of materials contact-
ing food; however, at the time of this analysis, drafting was not finalized and introduced for public discussion.92
The EEU approach to conformity assessment based on testing to define the safety of packaging and bot-
tling materials is efficient; however, this approach assumes that before releasing the product on the market,
technical requirements on this product shall have been set. This means that the EEU regulatory framework on
the subject basically comprises technical specifications to the existing and approved packaging and bottling
materials.
91
Details on each of groups of substances, materials and articles that require authorizations could be find in Chapter Food
and Food-related Articles and Materials that Require Special Authorization of the Comparative Analysis of Certain Requirements
of Food Legislation in the European Union and the Customs Union of Russia, Belarus, and Kazakhstan. See http://docu-
ments.worldbank.org/curated/en/2015/07/24794014/comparative-analysis-certain-requirements-food-legislation-euro-
pean-union-customs-union-russia-belarus-kazakhstan.
92
The Technical Regulations of the Customs Union 005/2011 On Safety of Packaging, which sets requirements for packag-
ing and bottling materials both for food and non-food products. The Common Sanitary-Epidemiological and Hygienic
Requirements to goods subject to sanitary-epidemiological supervision (control), Chapter II, Section 16 Requirements to
materials and items made of polymer and other materials designed for contacting food and food manufacturing environments. The
Uniform Sanitary, Epidemiology and Hygiene Requirements to Products Subject to Sanitary Epidemiology Supervision
(Control) apply a different approach to defining the scope of the materials contacting food and that are subject to these
requirements. The EAEU TARIC codes are applied to describe these materials. These codes are based on two criteria: the
type of material, and the type of equipment. In most cases, the code specifies the type of material used to manufacture
items, and within the limits of a certain category, there is classification of specific products (for example, name of equip-
ment or utensils).
Microbiological Criteria for Food Safety
The EEU has a combination of vertical and horizontal legal acts that are used for establishing microbiological
requirements to foodstuffs: they combine general requirements set for all foodstuffs in a horizontal CU TR
021/2011 On Food Safety with additional requirements established in vertical product-specific technical regula-
tions for certain types of food. In a combined form, they can be found in the Uniform Sanitary, Epidemiology
and Hygiene Requirements for Products Subject to State Control (Supervision).93 As a general rule, when a
product-specific technical regulation is adopted, the relevant section(s) of the Uniform Sanitary, Epidemiology
and Hygiene Requirements loses its validity for products covered by the scope of the new technical regulation.
Microbiological requirements of the EEU focus on a combination of pathogens as well as indicative and spoil-
age microorganisms in finished products. This is due to the intent and regulatory framework of the EEU based
on the finished product conformity assessment as a mechanism to control food safety and quality as well as
food identification.
Approaches to Laboratory Control, Sampling and Testing
Within the EEU testing, sampling and laboratories are a part of the overall conformity assessment process
whose end-product is ensuring food safety through documents establishing conformity to the technical regu-
lations, i.e. to the safety regulations.
Within the legal framework of the EEU, sampling is a part of the conformity assessment process.
Sampling ensures the product meets the requisite technical regulations. As such, samples are used to validate
a variety of parameters including pathogens, residues of pesticides, veterinary medicines, heavy metals, radio-
nuclides, and mycotoxins.
Within the EEU, test methods and specific requirements to testing are codified in the approved lists to sup-
port each technical regulation and are established in GOST standards (or other national standards that are
approved regionally within the EEU). This establishes a certain degree of uniformity.
93
Customs Union Technical Regulation 021/2011 On Food Safety; Customs Union Technical Regulation 005/2011 On Fat and
Oil Products; Customs Union Technical Regulation 023/2011 On Fruit and Vegetable Juice Products; Customs Union Technical
Regulation 027/2012 On Safety of Certain Types of Specialized Food Products Including Therapeutic and Preventive Dietary Food;
Customs Union Technical Regulation TR CU 033/2013 “On Safety of Milk and Dairy Products;” Customs Union Technical
Regulation TR CU 034/2013 On Safety of Meat and Meat Products. Importantly, microbiological criteria are also set by the
Uniform Sanitary and Epidemiological and Hygienic Requirements for Products Subject to Sanitary and Epidemiological
Supervision (Control), Chapter II, Part 1, Requirements for Safety and Nutrition Value of Food Products. Per the Explanatory Note
to the Technical Regulation CU TR 021/2011, the requirements, including those on microbiological safety, are based on
national laws of the EAEU member states and on international requirements.
Food Safety Tools
and Techniques
MODULE 4
68 MODULE 4 FOOD SAFETY TOOLS AND TECHNIQUES
Introduction
This section consists of two workbooks (Microsoft Excel files can be found on the enclosed CD). Their purpose
is to advise and assist the implementation, development, and maintenance of a food safety management
system.
The first workbook provides food business operators with tools to establish, develop, implement and maintain
a prerequisites program (PRP) based on the Codex Alimentarius and ISO 22002-1 requirements.
The second workbook enables the FBO to do the same pertaining to an HACCP Plan, including an O-PRP Plan,
based upon the Codex Alimentarius HACCP Principles and Steps and ISO 22000 requirements.
Both workbooks include detailed instructions.
FSTK PRP Workbook

The first workbook cites all prerequisites program details the FBO needs based on Codex Alimentarius and
IS/TS 22002-1 requirements. It comprises six worksheets which should be completed by the FBO Food Safety
team.
 PRP Scope Worksheet [WS 1] defines and documents the scope of the PRP study, including the rel-
evant study history along with that of the members of the food safety team conducting the study.
 PRP Management Worksheet [WS 2] defines and documents these relevant hazards and proposes
measures for controlling them.
 PRP Verification Action Plan Worksheet [WS 3] defines a verification plan for a particular PRP.
 PRP Meeting Summary Worksheet [WS 4] defines and documents all Food Safety Team meetings
linked to the corresponding PRP.
 PRP Gap Registration and Resolution Worksheet [WS 5] defines and documents the gaps within the
FBO’s PRP program and advances a plan outline to address this gap.
 PRP Hazardous Agents Worksheet (reference only) [WS 6] defines and documents a list of hazards
relevant to food products and the hazard classification acronyms used in this workbook.
FSTK PRP Workbook Instruction Guide

Step-by-step guidance in completing the FSTK PRP Workbook
An Overview of PRPs 69
An Overview of PRPs
The World Health Organization defines a prerequisite program as the “practices and conditions needed prior
to and during the implementation of HACCP and which are essential for food safety.” Prerequisite programs
provide a foundation for an effective HACCP system. They are often facility-wide programs rather than pro-
cess or product-specific, and aim to prevent or reduce the likelihood of food safety hazards. Prerequisite pro-
grams are outside the HACCP plan but still within the HACCP system.
ISO 22000 defines a PRP as the basic conditions and activities that are necessary to maintain a hygienic en-
vironment throughout the food chain suitable for the production, handling and provision of safe end products
and safe food for human consumption.
FBOs can meet their food safety responsibilities by implementing food safety management systems along
the food production chain. The initial set of controls to be established by the FBO are called prerequisite pro-
grams (PRPs). PRPs needed by an FBO depend on the segment of the production food chain in which the or-
ganization operates and the types of organization. Examples include: Good Agricultural Practice (GAP), Good
Veterinarian Practice (GVP), Good Warehouse Practices (GWP), Good Manufacturing Practice (GMP), Good
Hygienic Practice (GHP), Good Production Practice (GPP), Good Distribution Practice (GDP) and Good Trading
Practice (GTP).
ISO, the world’s largest publisher of international standards, and which most GFSI Private standards are
benchmarked against, has published the following PRP Standards. The PRP Standards and specific guidelines
to be used together with ISO 22000 ISO/TS 22002 are:
Prerequisite programs on food safety:

Part 1: Food manufacturing (2009)
Part 2: Catering (2013)
Part 3: Farming (2011)
Part 4: Food packaging manufacturing (2013)
Small-scale producers and traders in developing countries need support in planning and implementing food
safety management programs in line with international requirements and in line with Codex guidelines and
recommendations.
As ISO/TS 22002 specific guideline standards are aligned with the Codex, we provide a high-level overview
of the PRP programs and requirements in the following sections. We specifically focus on the ISO/TS 22002-1
Food Manufacturing Specification Standard.
ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining PRPs to assist in
controlling food safety hazards.
ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in
the manufacturing step of the food chain and wish to implement PRPs in such a way as to address the re-
quirements specified in ISO 22000:2005, Clause 7.
ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all requirements specified in ISO/TS 22002-
1:2009 apply to an individual establishment or process.
Exclusions or alternative measures implemented need to be justified and documented in a hazard analysis as
described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability
of the FBO to comply with these requirements. Examples of such exclusions include the following aspects of
technical specifications relevant to manufacturing operations:
1. Rework;
2. Product recall procedures;
3. Warehousing;
4. Product information and consumer awareness;
5. Food defense, bio-vigilance and bioterrorism.
This technical specification details requirements to be considered in relation to ISO 22000:2005, 7.2.3:
a) Construction and layout of buildings and associated utilities;
b) Layout of premises, including workspace and employee facilities;
c) Supplies of air, water, energy and other utilities;
d) Supporting services, including waste and sewage disposal;
e) Suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance;
f) Management of purchased materials;
g) Measures for the prevention of cross-contamination;
h) Cleaning and sanitizing;
i) Pest control;
j) Personnel hygiene.
Included in this FSTK are six examples of PRPs based on ISO/TS 22002-1:2009 for raw milk processing, namely:
 Utilities, supply of air, water and energy;
 Management of purchased materials;
 Rework;
 Pest control;
 Equipment suitability, cleaning and maintenance;
 Product recall.
All PRP examples are for illustrative purposes only; variations may exist from one dairy plant to another. In
some countries, for example, a dairy plant may own and control the dairy farms where the raw milk is col-
lected, hence the relevant PRPs need to reflect the specific dairy plant supply chain activities.
Planning and Development of PRPs 71
Planning and Development of PRPs
Prerequisite Programs Support the HACCP Plan

Prerequisite programs deal with the “good housekeeping” concerns of the establishment, whereas HACCP
manages specific process hazards. The FBO must provide all documentation, including the written program,
records and results for all prerequisite programs which support its HACCP system. For example, an estab-
lishment may conclude that E. coli O157:H7 is a hazard not reasonably likely to occur in the establishment’s
processing because the establishment has a prerequisite program with purchase specifications addressing E.
coli O157:H7.
The information regarding this prerequisite program is supporting documentation which must be maintained.
Without this documentation, the GFSI auditor would question the adequacy of the establishment’s HACCP
system and hazard analysis. GFSI auditors expect supporting documentation concerning prerequisite pro-
grams to include the program’s procedures and operational controls in writing. In addition, GFSI auditors
expect documentation to include records that show the program is effective and that E. coli O157:H7 is not
reasonably likely to occur. Generally, the FBO’s own food safety inspectors are required to review testing and
prerequisite program records at least once per week.
How a CCP in the HACCP Plan Differs from a Prerequisite Program

Prerequisite programs are not part of the HACCP plan but lie within the overall HACCP system. The FBO au-
ditor cannot apply the same criteria to PRPs as they would to verify regulatory requirements of the HACCP
plan. Inspection program personnel evaluating PRPs will determine if they support the decisions in the hazard
analysis. What exactly is the difference between a CCP in the establishment’s HACCP plan and a prerequisite
program? A CCP is designed to control a food safety hazard that has been determined to be reasonably likely
to occur. A PRP is designed to prevent a food safety hazard from occurring.
PRPs set the stage for a HACCP system and provide on-going support for the FBO’s food safety management
system. They keep potential hazards from becoming serious enough to adversely impact the safety of foods
produced. If an establishment fails to follow their prerequisite program related to the production of E. coli
O157:H7, there is a significant food safety concern.
Role of Pre-Requisite Programs

FBOs should revise their prerequisite programs as necessary to ensure their effectiveness and take appropriate
corrective actions when they determine that their PRPs have failed to prevent contamination and/or adultera-
tion of product.
Suppose, for example, that an establishment addresses E. coli O157:H7 in its prerequisite program but not in
its HACCP plan. If it produces a product that is E. coli O157H:7-positive, this would be considered a “deviation
not covered by a specific corrective action” or an “unforeseen hazard.” Therefore, the establishment would be
required to take the corrective actions, including reassessment. The prerequisite program was not effective in
reducing the likely risk in the processing environment.
Records Generated by Pre-requisite Programs Should be Reviewed

Prerequisite programs must be implemented and include documentation to verify implementation if refer-
enced in the hazard analysis, HACCP plan, or SSOP. Records associated with monitoring and testing may in-
clude instances of less-than-perfect control without resulting in a threat to food or product safety. However,
records generated from these programs must continue to support the decisions made in the establishment’s
hazard analysis. When GFSI auditors are reviewing PRP records, they should review the records, results, and
supporting documentation for the FBO’s HACCP plan. Hence, if the FBO is reviewing results and records on a
weekly basis, it could identify trends or missing records that negate the decisions made in the hazard analysis,
resulting in noncompliance.
Planning and Developing Prerequisite Programs

When choosing and developing prerequisite programs it is essential to consider information from the follow-
ing sources:
 Statutory and regulatory requirements;
 Industry standards and codes of practices;
 Codex Alimentarius Commission principles and codes of practices;
 International food safety standards e.g. FSSC 22000, BRC, SQF, GLOBALG.A.P.;
 Customer requirements;
 Historic data such as audit reports, customer/consumer complaints, non-conforming product data,
process data etc.
All prerequisite programs should be documented, regularly audited, periodically reviewed and modified when
necessary. As a general rule, prerequisite programs are managed separately from HACCP plans; however,
there may be certain parts of prerequisite programs that are integrated into a HACCP plan.
FSTK PRP Workbook Examples and Instructions (WS1- WS6) 73
FSTK PRP Workbook:

Examples and Instructions (WS1- WS6)
Examples of PRPs based on ISO/TS 22002-1 for raw milk processing
Prerequisite Program
PRP 6: Utilities, Supply of Air, Water and Energy
PRP 9: Management of Purchased Material
PRP 11: Cleaning and Sanitizing
PRP 12: Pest Control
PRP 13: Employee Hygiene and Employee Facilities
PRP 14: Rework
Prerequisite Programs
PRP 6: Utilities, supply of air, water and energy
[WS 1] PRP Scope Worksheet

This worksheet defines the scope of the FBO PRP. The information needs to be clear, especially in detailing the
product(s), including production lines for which the study was conducted. It should also provide information
about the individuals making up the study team along with any revision history of the PRP programs.
The PRP scope worksheet has five sections with instructions for their completion as outlined below. These are
followed by a sample completed worksheet.
A blank [WS 1] PRP scope worksheet blank can be found on the enclosed CD.
Instructions:
PRP Study Scope Provide PRP title from

standard/ scheme (e.g. “Pest
Facility Joe Bloggs Dairy Plant Start Date: 20th April 2015 Control”) and standard/scheme
chapter number (e.g.“6- Utili-
Product Grade A IMS registered whole milk Status: Draft ties, supply of air, water and
category energy”).
Processes HSTS pasteurizer, aseptic filling, retort End date: Ongoing Provide the facility name,
product category, prod-
Products Grade “A” asceptically processed and uct, processes, PRP status,
packaged milk document status (e.g. draft,
approved), PRP start and end
dates.
PRP Review History
Tick as Notes/reason for unscheduled Dates of last 3 This section records informa-
PRP type
appropriate review reviews tion about history of PRP
revisions, with explanation
New PRP  Current PRPs underwent a of reason why this update is
Study comprehensive review for done: ‘according to plan’ or
compliance to ISO/TS 22002-1 and ‘unscheduled.’ For unsched-
Scheduled 20th March ISO 22000:2005 starting in April of uled revisions, explain why this
Review 2016 2015 and completed 20th April 2015. revision is unscheduled (what
These management sheets describe reason?)
Unscheduled
each PRP in place at the dairy plant
Review
facility.
PRP Team Members
Name Position Department Responsibility/Role

For every PRP study, the or-
G Moran Food Safety Manager Food Safety Food Safety/QA ganization needs to establish
an HACCP team with spe-
O Brown Hygienist/Microbiologist Food Safety Hygienist/Microbiologist cific responsibilities and roles.
Include names within the
M Rodrigues Milk Processing Manager Milk Processing Milk Processing
company, department name,
B Jackson Laboratory Manager QA Laboratory and responsibilities. The core
area of competence of each
D Smith Warehouse Manager Warehousing Warehousing team member should also be
documented in this section
O Murphy Engineering Manager Engineering Engineering
C Flack Factory Manager Management Management

FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 6: Utilities, supply of air, water and energy 75
Specialist Input To establish PRP studies,

companies may need advice
Name Location/Job Title Input/Specialist Advice from an outsourced expert.
(Consultant/ Subject matter
Angela Yard Consultant PRP Team Facilitator
expert). Explanation of expert’s
role should be explained in this
section: Input/Specialist advice
Authorization Team members must indicate

their approval of the document
Food Safety Team Leader/Quality Assurance Signature: Date by providing their names, posi-
Manager G Moran 20th April 2015 tions, and responsibilities held,
signature. The authorized team
Signature: Date member should provide his/her
Management Team Member:
C Flack 20th April 2015 signature and the date signed.
[WS 2] PRP Management Worksheet

This worksheet identifies hazards and the PRP necessary to manage them. It also identifies corrective actions
to be taken should hazard levels rise above acceptable limits. The worksheet identifies records that FBOs
should keep and the verification procedures required for each PRP.
Hazards
Prerequisite
program (go Presence,
step by step Growth,
Survival, Origin, Cause, What is Monitored and
through ISO/ Control Measures
Agent(s) Increase, Source, Vector, When
TS 22002-1) 6
Utilities - Air, Re (Con- Condition
Water, Energy tamina-
tion)
6.1 General Re- B, C, P [See Contami- Contamination by Utilities specifications, e.g. air, Audits/inspection, hygiene,
quirements below] nation pathogens. water, gas etc. cleaning, sanitization, seg-
Hygienic design of the dairy regation/physical breaks
plant between circuits contain-
Pathogen monitoring proce- ing cleaning solutions;
dure temperature and patho-
gen monitoring program.
Supplier management pro-
cedure Each batch, daily, weekly
Product inspection procedure
Cleaning/sanitizing aware-
ness/training
Audits/inspections.
6.2 Water Supply B Contami- Contamination by Water supply specification Audits/inspections,
nation pathogens may be Supplier CoA Temperature and patho-
introduced from the Supplier management pro- gen monitoring
supplier of water gram Each batch
[ground, surface].
Incoming, in-process and
waste water treatment labo-
ratory testing.
C Contami- Cleaning and Maintain proper separation or Audits/inspection, segre-
nation sanitizing solution physical break between circuits gation or physical break
residues, i.e. without containing cleaning solutions, between circuits contain-
proper separation containers and pipelines used ing cleaning solutions and
between cleaning to contain product. Particular containers and pipelines
and sanitizing solu- attention is needed to ensure used to contain product.
tions, the product that the required separation Solution temperature, con-
could become remains in place during partial/ centration, duration of ap-
contaminated. short/inter washes completed plication, cleaning sequence,
during an operating day. flow rates etc. Daily
P None None Not applicable Not applicable
6.3 Boiler B None None Not applicable Not applicable
Chemicals
C Contami- Boiler additives. Boiler additives specification Boiler water additives
nation Some boiler water Supplier management pro- Daily/weekly
compounds used in gram
the production of
steam to be used in
contact with food
or food contact sur-
faces may contain
toxic substances.
P None None Not applicable Not applicable
6.4 Air Quality B Contami- Contamination by Hygienic dairy plant design Environment pathogen
and Ventilation nation pathogens may be incorporating HVAC sys- monitoring
introduced into the tem [creation of positive air Air filtration
air supply and may pressure zones], air ducts, Air quality
come in contact air filtration, exhaust stacks,
Air turns
with the product or intake ducts
food contact surface Cleaning of air ducts
Cleaning of air ducts
if a negative air Daily/weekly
Air filtration
pressure in the dairy
Environmental pathogen
plant is allowed to
monitoring
occur.
Air testing [past the filtration].
C None Not applicable Not applicable Not applicable
P None Not applicable Not applicable Not applicable
A blank [WS 2] PRP management worksheet is available on the enclosed CD.
Correction / Cor- Verification

Who is Responsible Records Reference Documents
rective Action Activities
Dairy plant QA/ labora- Awareness/Train- Product inspec- Product [Water Dairy plant Layout of Premise and Work-
tory ing, tion Supply] Inspec- space PRP
Dairy plant engineering Ongoing product Audits tion Dairy plant Waste Disposal PRP
Dairy plant maintenance inspection GHP inspections Supplier Product Inspection Procedure
Dairy plant hygienist/hy- Product disposal, Pathogen moni- Management Dairy plant Audit Procedure
giene Team where relevant toring Program
Dairy plant GHP Inspection Procedure
Cleaning/sanitization Awareness/ Pathogen
Dairy plant Awareness/Training Proce-
operatives training Monitoring
dure
Waste water Chemical Resi-
Dairy plant Waste Water Treatment
treatment due
Monitoring Procedure
Product spoilage/ Product Spoil-
Dairy plant Pathogen Monitoring Pro-
disposal age/Disposal
cedure
Dairy plant QA/Labora- Re-sterilization of Audits Water supply Dairy Plant Cleaning and Sanitizing PRP
tory piping, equipment GHP inspections inspection Dairy Plant Product Inspection Procedure
and containers Awareness/ Product disposal Dairy Plant Pathogen Monitoring Pro-
training cedure
Pathogen moni-
toring
Dairy plant Hygienist/Hy- Awareness/Train- Audits Product inspec- Dairy Plant Cleaning and Sanitizing PRP
giene Team ing, GHP inspections tion Dairy Plant Waste Disposal PRP
Cleaning/Sanitization Product disposal, Awareness/ Product disposal Dairy Plant Awareness/Training Proce-
Operatives where relevant training dure
Product spoilage/
disposal
Not applicable Not applicable Not applicable Not applicable Not applicable
QA Return product not Incoming prod- Incoming Management of Purchased Material PRP
to specification to uct product Dairy Plant Product Inspection Procedure
supplier Supplier Dairy Plant Supplier Management Pro-
management cedure
program
Dairy plant QA/Labo- Product Hold/with- Environment Environment Dairy plant Layout of Premise and Work-
ratory [Environment drawal/ recall pathogen moni- Pathogen space PRP
Pathogen Monitoring/Air Testing of all pro- toring Monitoring Dairy plant Cleaning and Sanitizing PRP
Testing] duction lots HVAC design/ Dairy plant Environment Pathogen
Dairy plant Engineer- Implementation of drawings Monitoring Program
ing [Dairy plant Hygienic intensive cleaning/ Air Testing Dairy plant Product Inspection Procedure
Design HVAC System] sanitization Preventive Main-
Dairy plant Maintenance Review/revisions of tenance [Filter/
[Preventive Maintenance process controls Cleaning]
of Filters/Cleaning or Air
Ducts etc.]
Hazards
Prerequisite
Survival, Origin, Cause, What is Monitored and
through ISO/ Control Measures
Agent(s) Increase, Source, Vector, When
TS 22002-1) 6
Utilities - Air, Re (Con- Condition
Water, Energy tamina-
tion)
6.5 Compressed B Contami- Contamination by Specification for the supply of Environment pathogen
Air and Gases nation pathogens may be compressed air. Air is drawn monitoring
introduced into the from a clean area, if filtered Daily/weekly
air supply and may at the intake as needed, and
come in contact is provided to the point of use
with the product oil free and with free of excess
or food contact moisture. A final filter is
surface. provided as near as possible to
the point of use to verify.
C Contami- Toxic substances, Specification for the supply of Environment pathogen
nation i.e. air compressor compressor lubricants [food monitoring
lubricants may be grade]. Air is drawn from a clean Daily/weekly
carried over into area; if filtered, at the intake as
the air and may be needed, and is provided to the
toxic. point of use oil-free and free of
excess moisture. A final filter is
provided as near as possible to
the point of use to verify.
P None Not applicable Not applicable Not applicable
6.6 Lighting B Contami- Poor or inadequate Hygienic design of the dairy Hygienic design, light
nation lighting [intensity] plant. intensity, dirt, spills, pest
may contribute to Throughout the dairy plant Daily/weekly
personnel apply- storage, preparation, process-
ing poor hygienic ing areas are provided with
standards, and as natural or artificial lighting (or
a result material, both). A minimum light inten-
product or equip- sity of 200 lux is recommend-
ment may become ed. Reference the relevant
contaminated. national lighting standard
for recommended lighting
standards. All lights are fitted
with light diffusers/ covers or
shatterproof tubes to facilitate
cleaning and to prevent con-
tamination of food.
C None Not applicable Not applicable Not applicable
P Contami- Poor or inadequate Hygienic design of the dairy Hygienic design, breakages
nation lighting [intensity] plant, e.g. all lights are fitted and dirt
may contribute to with light diffusers/ covers or Daily/weekly
personnel applying shatterproof tubes to facilitate
poor hygienic stan- cleaning and to prevent
dards and as a result contamination of food and
material, product or the premises should breakage
equipment may be- occur.
come contaminated, Hygiene inspections to detect
e.g. breakages and breakages and/or dirt.
or dirt.
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, cause, Control Measure What is monitored and
Program Agent presence, source, vector, con- Describes the control measures when
Describes the Describes growth, dition the FBO has in place to control Describes the hazard mea-
ISO/TS 22002-1 the hazard survival, Describes the cause, relevant hazards. surement parameters and
requirement. agent, e.g. increase, origin, condition or the frequency of monitoring
biological, re(con- source of a hazard. required.
chemical, tamination)
physical or Describes
combination how the
thereof. hazard
manifests
as a threat,
i.e. presence,
growth or
survival.
Correction / Cor- Verification

rective Action Activities
Dairy QA Laboratory Replace com- Environment Environment Dairy Plant Environment Suitability,
pressed air/filter pathogen moni- pathogen Cleaning and Maintenance PRP
toring monitoring Dairy Plant Pathogen Monitoring Pro-
Preventive main- gram
tenance [filter]
Dairy QA Laboratory Replace com- Environment Environment Dairy Plant Environment Suitability,
pressed Air/filter pathogen moni- pathogen Cleaning and Maintenance PRP
toring monitoring Dairy Plant Environment Pathogen
Preventive main- Monitoring Program
tenance [filter] Dairy Plant Preventive Maintenance
Procedure
Dairy plant Engineering/ CapEx projects CapEx projects Cleaning/sani- Dairy Plant Design and Construction of
Food Safety [Dairy plant [hygiene related] Preventive main- tizing Buildings PRP
Hygienic design] Preventive mainte- tenance GHP inspections Dairy Plant Site Location and Standards
Dairy plant Maintenance nance Cleaning Audits PRP
[Lighting Maintenance, Cleaning/sanitiza- GHP inspection Dairy Plant Layout of Premises and
Cleaning/Sanitization tion Program Workspace PRP
Program including Spills] Dairy Plant Internal Structure PRP
Dairy plant Hygienist and Dairy Plant Environment Suitability,
Hygiene Team Cleaning and Maintenance PRP
Preventive Maintenance Procedure
Hygiene Procedures
Cleaning/Sanitization Procedures
Dairy plant Engineering/ CapEX projects CapEx projects Cleaning/sani- Dairy Plant Design and Construction of
Food Safety [Dairy plant [hygiene related] Preventive main- tizing Buildings PRP
Hygienic design] Preventive mainte- tenance GHP Inspections Dairy Plant Site Location and Standards
Dairy plant Maintenance nance Cleaning/sani- Audits PRP
[Lighting Maintenance] Cleaning/sanitiza- tizing Dairy Plant Layout of Premises and
Dairy plant Hygienist and tion program GHP inspection Workspace PRP
Hygiene Team Dairy Plant Environment Suitability,
Cleaning and Maintenance PRP
Dairy Plant Internal Structure PRP
Preventive Maintenance Procedure
Hygiene Procedures
Cleaning/Sanitization Procedures
G H I J K
Who is responsible Correction / Correc- Records Verification Reference Documents

Describes the job role or tive action Indicates the activities Describes the FBO documents and, where
title of the department/ Describes the correc- monitoring and Describes the necessary, the relevant external documents,
function within the FBO tion and corrective hazard measure- verification ac- e.g. statutory and regulatory requirements.
responsible for monitoring action aimed at pre- ment param- tivities necessary
the relevant hazard mea- venting reoccurrence eter records to be to confirm the
surement parameters. of exceeding the al- maintained. accuracy of the
lowable or permitted monitoring and
hazard measurement hazard measure-
parameters. ment param-
eters.
[WS 3] PRP Verification Action Plan Worksheet

This worksheet aids in planning PRP verification.
Verification is confirmation, supported by objective evidence, specifying that requirements have been fulfilled.
Original prerequisite program verification is carried out after the program has been implemented and de-
veloped. Further planned verifications should take place at least once a year. Unscheduled verifications are
required when PRP changes take place.
The FBO should also have a verification plan. Verification may only be carried out by an authorized person. The
FBO must document all verification activities for each PRP.
A blank [WS 3] PRP verification action plan worksheet is available on the enclosed CD.
Prerequisite Program Verification Action
Team #6 Utilities Reviewed by Utilities RPP Team
Review of referenced documents, e.g. PRPS, related procedures and utility specifications
Review of pathogen monitoring records
Review of product inspection records
Review of cleaning/sanitizing records
Review of preventive m,aintenance records
Review of product spoilage/disposal records
Review of rework records
Review of awareness/training records
Review of consumer complaints
Food Safety Management System audits
Internal cGMP audits / GHP inspections
Requency and criticality review
A B
Instructions:
Prerequisite program Verification Action

Organization to provide details Organization to provide details of PRP verification actions associated with the PRP and who is
of PRP Team Number and PRP responsible for the review of the verification action
Title. We suggest the PRP Team #
should match the relevant chapter
in the relevant FSMS Scheme
Standard, e.g. ISO/TS 22002-1
Chapter 6 - Utilities, supply of air,
water and energy
[WS 4] PRP Meeting Summary Worksheet

This worksheet is used to document PRP meetings and any resulting decisions.
A blank [WS 4] PRP meeting summary worksheet is available on the enclosed CD.
Outcome (deci-
Date Partcipants Purpose Responsibility Deadline Performed
sions/actions)
20-Apr-15 G Moran Iniital review of Update PRP man- G Moran to com- 15-May-15 15-May-15
O Brown PRP agement worksheet plete verification
review related PRPs sheet
M Rodrigues
B Jackson
D Smith
O Murphy
C Flack
28/4/2015 G Moran Complete GAP Completed and ap- G Moran to update 15-May-15 15-May-15
O Brown sheet proved PRP worksheets
M Rodrigues Review PRP Reviewed and ap-
management proved
B Jackson worksheet
D Smith
O Murphy
C Flack
12-Oct-15 G Moran Review and Complete update PRP team to com- 17-Dec-15 17-Dec-15
O Brown update utility of water supply plete
specifications specification
M Rodrigues
B Jackson
D Smith
O Murphy
C Flack
A B C D E F G
Instructions:
Date Participants Purpose Outcome(decisions/ Responsibility Deadline Performed

List meet- List attendees, Provide the reason action) Identify those re- Record Provide ac-
ing dates including both for the meeting Record decisions sponsible to execute deadlines tion dates
team members made and next steps decisions
and invitees
[WS 5] PRP GAP Registration and Resolution Worksheet

This worksheet defines and eliminates gaps between PRP requirements of a certain standard (s), for example,
ISO/TS 22002-1, and other documents that must comply with FSMS.
When completing this worksheet, the FBO may use different standards and / or documents to fulfill PRP re-
quirements, for example, for an ISO / TS 22002-1 requirement. These should correspond to the FSMS of that
particular FBO.
A blank [WS 5] PRP GAP registration and resolution worksheet is available on the enclosed CD.
Fill in only if gaps have been identified
Gap
Action Plan
Description [of the Associat- Resolution
ISO/TS Specific re- [Including
requirement of ed Dairy Gap [Actions Comments
22002-1 quirement timescales for
the Standard] Policy Completed
completion]
and Date]
6.3 Boiler The provision and distri- Boiler chem- Dairy PRP man- All documents All docu- None
Chemicals bution routes for utilities icals, if used, Plant agement to be reviewed mented rev-
to and around processing shall be ap- Food worksheet and updated eiwed and
and storage areas shall be proved food Safety incomplete, prior to next updated, see
designed to minimize the additives Policy related PRP team PRP team
risk of product contamina- which meet PRPs and meeting 28- meeting.
tion. Quality of utilities shall relevant ad- procedures Apr-2015.
be monitored to minimize ditive speci- to be re-
product contamination risk. fications. viewed and
updated.
6.4 Air The organization shall Specification Dairy Utilitiy Create pres- Air specifi- None
quality and establish requirements for for pressur- Plant specifica- surized air cation com-
ventilation filtration, humidity (RH%) ized air. Food tions to be specification pleted, see
and microbiology of air Safety created. 12-Oct-2015. PRP team
used as an ingredient or for Policy meeting.
direct product contact.
A B C D E F G H
Instructions:
Standard/ Description [of the require- Specific re- Associat- Gap Action Plan Gap Resolu- Comments
Scheme ment of the Standard] quirement ed Policy Describe the [Including tion [Actions Add any
name, PRP Provide a description of the Provide a Detail the gap. timescales for Completed additional
name and requirement arising from the short de- relevant completion] and Date] relevant
clause FSMS scheme where the gap scription of FSMS Provide details Provide comments,
number exists. the specific Policy. of the action details of the if required.
Provide a requirement to be taken to actions taken
description where the address the to address
of the FSMS gap exists specific require- the gap and
Scheme Re- within the ment identified the date of
quirement. FBO. as not having completion.
been fulfilled.
[WS 6] Hazard Agent Worksheet

The PRP Hazardous Agents Worksheet provides a standard classification system for recording hazardous
agents in the FSTK PRP workbook. The hazardous agents classification system is based on the food and bever-
age industry hazardous agent classification system.
The hazardous agent worksheet is for reference or guidance purpose only; no template is provided.
Hazardous Agents Hazard Class Abbreviation
Microbiological (vegetative or spores, depending on circumstances) B
Chemical (such as cleaning chemicals, non-food grade lubricants, oils and greases, and C
chemical residues)
Physical (such as various types of foreign material including metal, wood, plastic, or other P
foreign bodies)
Allergens (milk, soy, wheat, egg, fish, shellfish, tree nut, peanut) A
A B
Instructions:
Hazardous agent Hazard Class

Classify food safety hazard agents, e.g. biological, chemical, or physical. Indicate the food safety hazard
agent code, e.g. biological – B;
chemical – C; physical – P;
allergen – A
PRP 9: Management of Purchased Material

Instructions:

chapter number (e.g.” 9 –
Product cat- Grade A IMS registered whole milk Status: Draft Management of purchased
egory materials”).
Proessess HSTS pasteurizer, aseptic filling, retort End date: Ongoing Provide the facility name,
Products Grade A asceptically processed and
uct, processes, PRP status,
packaged milk
document status (e.g. draft,
dates.
PRP Review History
PRP type
New PRP  Current PRPs underwent a of reason why this update is
Scheduled 20th March ISO 22000:2005 starting in April of uled revision explain why this
Review 2016 2015 and completed 20th April 2015. revision is unscheduled ( what
Unscheduled
each PRP in place at the Dairy Plant
Review
facility.
PRP Team Members

For every PRP study, the
G Moran Food Safety Manager Food Safety Food Safety/QA organization needs to es-
tablish an HACCP team with
O Brown Hygienist/Microbiologist Food Safety Hygienist/Microbiologist
specific responsibilities and
roles. Include names within the

FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 9: Management of Purchased Material 85
Specialist Input To establish PRP studies, com-

panies may need advice from an
Name Location/Job Title Input/Specialist Advice outsourced expert (Consultant/
Subject matter expert). Expla-
nation of expert’s role should be
explained in this section: Input/
Specialist advice.


Hazards
Prerequisite
step by step Growth, What is Monitored
through ISO/ Survival, Origin, Cause, Source, Vec- Control Measures
Agent(s) and When
TS 22002-1) 6 Increase, Re tor, Condition
Utilities - Air, (Contami-
Water, Energy nation)
9.1 General Re- B, C, P [See Presence, Supplier Management, Supplier management Audits/inspection,
quirements below] Contamina- Hygiene, Cleaning, Sanitiza- program/ procedure hygiene, cleaning,
tion tion and Incoming Material Audits/inspection, sanitization and raw
Inspection in place as well as hygiene, cleaning, material monitored
pathogen, environmental and sanitization and raw Pathogen, myco-
extraneous material moni- material monitored toxin and extraneous
toring Pathogen, mycotoxin material monitoring
and extraneous materi- program in place
al monitoring program
in place
9.2 Selection and B, C, P [See Presence, Supplier Management, Supplier management Audits/inspection,
Management of below] Contamina- Hygiene, Cleaning, Sanitiza- program/ procedures hygiene, cleaning,
Suppliers tion tion and Incoming Material Audits/inspection, sanitization and raw
Inspection in place as well as hygiene, cleaning, material monitored
pathogen, environmental and sanitization and raw Pathogen, myco-
extraneous material moni- material monitored toxin and extraneous
toring Pathogen, mycotoxin material monitoring
and extraneous materi- program in place
al monitoring program
in place
9.3 Incoming B Presence Based upon scientific studies Supplier management Incoming product
Material Re- vegetative pathogens [Bru- program Tank Trucks Cleaning
quirements cella abortus;Campylobacter Minimize the incoming and Sanitizing Records
jejuni;Campylobacter bacterial load by pur- Milk Temperature
coli;Coxiella chasing Grade A listed Records
burnetii;Pathogenic Esch- raw milk and testing Each Batch
erichia coli (0157:H7); Listeria incoming product
monocytogenes; Mycobac- Verify the tank trucks
terium tuberculosis; Myco- were cleaned and sani-
bacterium bovis; Salmonella tized prior to picking up
enterica serotypes; Strepto- the milk being unloaded
coccus pyogenes; andYersinia Milk temperature
enterocolitica] may be pres- records from the dairy
ent in raw milk. farm to the dairy plant
C Presence Presence of therapeutic Supplier management Therauetic drugs/
drugs. program [antibiotics] and other
Screen all tankers for residues
animal drug residues Each batch
In addition, the dairy
plant should also
screen for other resi-
dues
C Presence of Based upon historical data, Supplier management AFM1 [Aflotoxin
Mycotoxins mold growth in animal feed program hydroxymetabolites],
can contaminate milk with Supplier supplied cer- daily analysis
aflatoxin M1. This is de- tificates of analysis
pendent upon geographic Periodic QA/laboratory
location, growing season testing by the dairy
conditions, etc. plant [ELISA screening]
Correction / Verification
Corrective Action Activities
Dairy plant [see below Awareness/train- Various, see be- Supplier Dairy Plant Supplier Management Procedure
for details] ing, cleaning of area low for details management Dairy Plant Audit Procedure
where deviation was program Dairy Plant Awareness/Training Procedure
found Tank truck Dairy Plant GHP Inspection Procedure
Raw material is sent cleaning and Dairy Plant Mycotixin Analysis Testing
back to supplier or sanitization Dairy Plant Raw Material Handling Proce-
discarded if not records dure
compliant Raw milk Dairy Plant Tank Truck Cleaning and Sanitiz-
temperature ing Procedure
records Dairy Plant Record Control Procedure
Raw milk in- [Manifest]
take records Dairy Plant Product Inspection Procedure
Dairy plant [see below Awareness/train- Supplier inpec- Supplier Dairy Plant Supplier Management Procedure
for details] ing, cleaning of area tions/audits, management Dairy Plant Audit Procedure
where deviation was CoA requir- program Dairy Plant Awareness/Training Procedure
found ments Tank truck Dairy Plant GHP Inspection Procedure
Raw material is sent On-site [dairy cleaning and Dairy Plant Mycotixin Analysis Testing
back to supplier farm] incoming sanitization Dairy Plant Raw Material Handling Proce-
or discarded if not product specifi- records dure
compliant cation Raw milk Dairy Plant Record Control Procedure
temperature [Manifest]
records Dairy Plant Product Inspection Procedure
Raw milk in-
take records
Dairy plant QA/labora- Pasteurization/ Wash tags Supplier Dairy Plant Dairy Plant Environment Suit-
tory Sterilization Plant cleaning management ability, Cleaning and Maintenance PRP
Dairy plant truck driver Investigation Manifest program Dairy Plant Supplier Management Procedure
[cleaning/sanitization/ QA/ labora- Tank truck Dairy Plant Raw Material Handling Proce-
milk temperature] tory incoming cleaning and dure
product sanitization Dairy Plant Tank Truck Cleaning and Sanitiz-
records ing Procedure
Raw milk Dairy Plant Record Control Procedure
temperature [Manifest]
records Dairy Plant Product Inspection Procedure
Raw milk in- Dairy Farm Hygiene Inspection/Audit Pro-
take records cedure
Dairy plant QA/labora- Awareness/training, Delvo test Milk samples at Dairy Plant Supplier Management Procedure
tory return raw milk to QA/ labora- the dairy farm Dairy Plant Awareness/Training Procedure
Dairy plant truck driver dairy farm or envi- tory incoming Laboratory Dairy Plant Raw Mlik Sample Procedure
[raw milk samples at ronmental disposal/ product incoming prod- Dairy Plant Raw Material Handling Proce-
the dairy farm] investigation at dairy uct records dure
farm Dairy Plant Record Control Procedure
[Manifest]
Dairy Plant Product Inspection Procedure
Dairy plant QA/labora- Awaress/training, ELISA [Enzyme- Screening Dairy Plant Mycotixin Analysis Testing
tory product withdrawal Linked Im- records Dairy Plant Product Inspection Procedure
by dairy farm/ munoSorbent
Suspend delivery of Assay]/ HPLC
raw milk from dairy [High-Perfor-
farm mance Liquid
Chromatogra-
phy] screening
Hazards
Prerequisite
step by step Growth, What is Monitored
through ISO/ Survival, Origin, Cause, Source, Vec- Control Measures
Agent(s) and When
TS 22002-1) 6 Increase, Re tor, Condition
Utilities - Air, (Contami-
C Presence Milk protein is considered an Labelling verification Statutory and regula-

allergen. procedure tory requirements
regarding labelling, as
changes occur
P Contamina- If dairy cattle are not kept Dairy farm hygiene Dairy farm hygiene
tion clean or if milk is drawn in practices practices, as per sup-
an unclean environment and Supplier management plier management
is not properly protected, program program
pyhsical objects from the Dairy farm inspection Dairy farm inspections,
dairy farm environmenta may during milk collection daily
become incorproated into the
raw milk.
B Presence Based upon scientific studies Supplier management Incoming product,
vegetative pathogens may be program, e.g. supplier Each batch
present in ingredients. CoAs and dairy plant
periodic QA/laboratory
testing
C Contamina- Based upon historical data Approved packaging Product packaging

tion adulteration with toxic or suppliers specification confor-
carcinogenic chemicals may Supplier CoA's mity
contaminate raw milk. Supplier management Supplier CoA [Certifi-
program cate of Analysis]
Period QA/laboratory
packaging testing
Each batch
P Contamina- Based upon historical data Approved packaging Product packaging
tion foreign materials may consti- suppliers specification confor-
tute food safety hazards. Supplier CoAs mity
Supplier management Supplier CoA [Certifi-
program cate of Analysis]
Period QA/laboratory
packaging testing
Each batch
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, cause, source, Control Measure What is monitored and
Program Agent presence, vector, condition Describes the control when
Describes the Describes growth, Describes the cause, origin, measures the FBO has in Describes the hazard
ISO/TS 22002-1 the hazard survival, condition or source of a hazard. place to control relevant measurement param-
requirement. agent, e.g. increase, hazards. eters and the frequency
biological, re(con- of monitoring required.
chemical, tamination)
physical or Describes
combination how the haz-
thereof. ard manifests
as a threat,
i.e. presence,
growth or
survival.
Dairy plant marketing, Product hold/ with- Evaluation of Document/ Dairy Plant Evaluation of Compliance Pro-
QA, food safety drawal compliance record review cedure
Product rework Labelling QA Dairy Plant Labelling Verification Procedure
Investigation verification
Consumer alert
Dairy farm Consumer aware- Manifest Document/ Dairy Farm Hygiene Inspection/Audit Pro-
Dairy plant QA/food ness, refusal to QA/ labora- record review cedure
safety accept product at tory incoming Dairy Plant Supplier Management Procedure
source product Dairy Plant Raw Material Handling Proce-
Supplier manage- Supplier hygiene dure
ment program inspection/audit
Dairy farm Refusal to accept Manifest Document/ Dairy Plant GHP Inspection Procedure
Audit plant QA/food product at source QA/ labora- record review Dairy Plant Audit Procedure
safety Supplier manage- tory incoming Dairy Plant Supplier Management Procedure
ment program product
Supplier GHP
inspections
audit reports
Dairy plant QA/food Awareness/training, QA/ labora- Document/ Dairy Plant Product Inspection Procedure
safety product hold/return tory incoming record review Dairy Plant Awareness/Training Procedure
material to supplier product Dairy Plant Supplier Management Procedure
Supplier manage- Supplier CoA
ment program Supplier inspec-
tion/audit
Dairy plant QA/food Awareness/training, QA/ labora- Document/ Dairy Plant Product Specifications
safety product hold/return tory incoming record review Dairy Plant Product Inspection Procedure
material to supplier product Dairy Plant Supplier Management Procedure
Supplier manage- Dairy farm CoAs
ment program Dairy farm/sup-
plier audit
G H I J K

Describes the job role tive action Indicates the activities Describes the FBO documents and, where nec-
or title of the depart- Describes the cor- monitoring and Describes the essary, the relevant external documents, e.g.
ment/function within rection and correc- hazard measure- verification statutory and regulatory requirements.
the FBO responsible for tive action aimed at ment parameter activities neces-
monitoring the relevant preventing reoccur- records to be sary to confirm
hazard measurement rence of exceeding the maintained. the accuracy of
parameters. allowable or permitted the monitor-
hazard measurement ing and hazard
parameters. measurement
parameters.

Team #9 Review by management of purchased materials by PRP Team

Management of purchased
materials Review of tank truck cleaning and sanitizing records
Review of raw mlik temperature records
Review of manifest records
Review of ELISA/HPLC records
Review of labelling verification records
Review of product inspection records
Review of supplier performance records
Review of awareness/training records
Review of consumer complaints
Internal GMP audits / GHP inspections
Frequency and criticality review
A B
Instructions:

of PRP Team Number and PRP responsible for the review of the verification action.
Chapter 9 - Management
of purchased materials.

Outcome
Date Partcipants Purpose (decisions/ Responsibility Deadline Performed
actions)
20-Apr-15 G Moran Iniital review of Update PRP G Moran to com- 15-May-15 15-May-15
O Brown PRP Management plete verification
M Rodrigues Worksheet Review- Sheet
B Jackson related PRPs
D Smith
O Murphy
C Flack
B Jackson management proved
D Smith worksheet
O Murphy
C Flack
12-Oct-15 G Moran Review and Complete update of PRP team to com- 17-Dec-15 17-Dec-15
O Brown update verifica- labeling verification plete
M Rodrigues tion of labeling procedure;
B Jackson procedure and Introduce man-
D Smith introduce management of inputs
O Murphy agement of inputs based upon risk
C Flack [periodic testing of raw material/
of raw mate- ingredients/ pack-
rial/ingredients/ aging.
packaging]
A B C D E F G
Instructions:

ing dates. including both for the meeting. Record decisions sponsible to execute deadlines. tion dates.
team members made and next steps. decisions.
and invitees.

particular FBO.
Gap
Action Plan
completion]
and Date]
9.1 In- Materials shall be inspected, Manage- Food Reliance Introduce Critical raw Closed
coming tested or covered by COA ment of Safety 100% of management materials,
Material to verify conformity with Inputs/ Policy Supplier of Inputs by Q4 ingredients
Require- specified requirements prior verifica- CoA 2015 and packag-
ments to acceptance or use. The tion of raw ing verified
method of verification shall materials, as conform-
be documented ingredients ing to Dairy
and packag- Plan Product
ing Specifica-
tions by Q4
2015
A B C D E F G H
Instructions:
been fulfilled.

Chemical (such as cleaning chemicals, non-food grade lubricants, oils and greases, and
C
chemical residues)
Physical (such as various types of foreign material including metal, wood, plastic, or other
P
foreign bodies)
A B
Instructions:

allergen – A.
PRP 11: Cleaning and Sanitizing

Instructions:

chapter number (e.g. “11-
Product cat- Grade A IMS Registered Whole Milk Status: Draft Cleaning and Sanitizing”).
egory
Provide the facility name,
Proessess HSTS Pasteurizer, Aseptic Filling, Retort End date: Ongoing product category, prod-
Products Grade A Asceptically processed and
packaged Milk
dates.
PRP Review History
PRP type
New PRP  Current PRP’s underwent a of reason why this update is
Review 2016 2015 and completed 20th April 2015 revision is unscheduled (what
Unscheduled
Review
facility.
PRP Team Members

For every PRP study, the orga-
G Moran Food Safety Manager Food Safety Food Safety/QA nization needs to establish an
HACCP team, with specific re-
sponsibilities and roles. Names
within the company, depart-
ment name, and responsibili-
B Jackson Laboratory Manager QA Laboratory ties. The core area of compe-
tence of each team member
D Smith Warehouse Manager Warehousing Warehousing should also be documented in
this section.

FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 11: Cleaning and Sanitizing 95

Name Location/Job Title Input/Specialist Advice outsourced expert. (Consultant/
Specialist advice


Hazards
Prerequisite
step by step Growth, What is
through ISO/ Origin, Cause, Control Measures Monitored
Survival,
TS 22002-1) 6 Agent(s) Source, Vector, and When
Increase, Re
Utilities - Air, Condition
(Contami-
11.1 General B, C, P [See Presence Contamination Hygiene, cleaning, sanitization Pathogen

Requirements below] Contamina- by pathogens Seperation between cleaning and sanitiz- monitoring,
tion Cleaning/sani- ing solution daily
tizing solution Master cleaning/sanitizing schedule Separation,
residues Temperature weekly
Temperature,
daily/weekly [7
days]
11.2 Cleaning B Presence Contamination Clean water Pathogen

and Sanitiz- Contamina- by vegetative Restricted use of condencing water from monitoring,
ing Agents and tion pathogens milk evaporators and water reclaimed daily
Tools from milk or milk products
Training of cleaning/sanitizing operators
Hygenic design/suitability of tools e.g.
brushes used for manual washing is non
absorbent, nylon or plastic bristled type
and designed not to retain soil, quick to dry
Utensils manually cleaned using a two
compartment wash and rinse sink
Color coding of tools
5S program including tools being protected
once cleaned, e.g. stored off the contact
floor, protected from splashes following
cleaning, etc.
C Presence Without proper MSDS sheets for [chemicals] chlorine/ Toxic residues
Contamina- seperation be- acids used Alkaline de-
tion tween cleaning Approved chemicals tergents/acid
and sanitizing Chemical storage cleaner, not
solutions and Maintain proper seperation or physical mixed
product there break between circuits containing clean- Daily/each
could be prod- ing solution and vessels and lines used to batch
uct contamina- contain product
tion Manual sanitizing with chemicals to be
acomplished using a third treatment vat,
unless heat is used for sanitizing
P None
QA/laboratory Re-clean, sanitize GHP inspec- Record review Dairy Plant Environment Suitability, Clean-
cleaning/sanitizing Review/update tions Inspection ing and Maintenance PRP
operators master cleaning/ Audit Audit Dairy Plant Management of Purchased
sanitizing schedule Master clean- Materials PRP
or program ing/sanitizing Dairy Plant Personal Hygiene and Employee
Revalidate the ef- Temperature Facilities PRP
fectiveness of the Utilities PRP
cleaning/sanitizing Dairy Plant Master Cleaning/Sanitizing
schedule/program Program/Schedule
Dairy Plant Cleaning/Sanitizing Procedures
Dairy Plant Awareness and Training Pro-
cedure
Dairy Plant Product Traceability Procedure
Dairy Plant Environmental and Pathogen
monitoring Procedure
QA/laboratory Replacement tools GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Clean-
cleaning/sanitizing Re-training, if tions tions ing and Maintenance PRP
operators required Audits Audit Management of Purchased Materials PRP
Re-clean/re-sanitize Milk tank truck Document/re- Utilities PRP
wash tags or cord review Master Cleaning/Sanitizing Program/
log book Schedule
Manual clean- Ceaning/Sanitizing Procedures
ing log book Dairy Plant Awareness and Training Pro-
cedure
QA/laboratory Monitoring fre- GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Clean-
cleaning/sanitizing quency review tions tions ing and Maintenance PRP
operators Re-training, if Audits Audit Dairy Plant Management of Purchased
required cleaning/sani- Document/re- Materials PRP
Re-clean, re-sanitize tizing cord review Dairy Plant Utilities PRP
Master Cleaning/Sanitizing Program/
Schedule
cedure
Hazards
Prerequisite
Survival,
Increase, Re
(Contami-
11.3 Cleaning B Presence Contamination Master cleaning/sanitizing program Pathogen

and Sanitizing Contamina- by vegetative Master cleaning/sanitizing schedule monitoring,
Programs tion pathogens Validated cleaning/sanitizing program/ daily
schedule [including re-validation] Temperature,
daily/weekly [7
days] for milk
storage tanks
C Presence Without proper Master cleaning/sanitizing program Toxic residues

Contamina- seperation be- Master cleaning/sanitizing schedule Alkaline de-
tion tween cleaning Validated cleaning/sanitizing program/ tergents/acid
and sanitizing schedule [including re-validation] cleaner, not
solutions and mixed
product there Daily/each
could be prod- batch
uct contamina-
tion
P None
11.4 Cleaning B Presence Contamination CIP parameters, e.g. temperature Temperature
in Llace [CIP] Contamina- by pathogens CIP venting door device associated with Pathogen
Systems tion larger tanks and silos monitoring
Water charecteristics with water hard-
ness exceed 100ppm hardness
C Presence Without proper CIP parameters, e.g. temperature, type, Chemical type,
Contamina- seperation be- concentration, concentration time etc. concentration,
tion tween cleaning CIP venting door device associated with contact time
and sanitizing larger tanks and silos and tempera-
solutions and Water charecteristics with water hard- ture
product there ness exceed 100ppm hardness
could be prod-
uct contamina-
tion
P None
11.5 Monitoring B Presence Contamination Master cleaning/sanitizing schedule Pathogen
Sanitation Ef- Contamina- by pathogens GHP inspection monitoring
fectiveness tion Audit frequency
Pathogen monitoring daily/weekly
Hygienist Review/update GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Clean-
Cleaning/sanitization master cleaning/ tions tions ing and Maintenance PRP
sanitizing schedule Audits Audit Dairy Plant Master Cleaning/Sanitizing
or program Master clean- Document/re- Program/Schedule
Revalidate the ef- ing/sanitizing cord review Dairy Plant Cleaning/Sanitizing Procedures
fectiveness of the validation/ Dairy Plant Awareness and Training Pro-
cleaning/sanitizing re-validation cedure
schedule/program study Dairy Plant Product Traceability Procedure
Hygienist Review/update GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Clean-
Cleaning/sanitization master cleaning/ tions tions ing and Maintenance PRP
sanitizing schedule Audits Audit Dairy Plant Master Cleaning/Sanitizing
or program Master clean- Document/re- Program/Schedule
Revalidate the ef- ing/sanitizing cord review Dairy Plant Cleaning/Sanitizing Procedures
fectiveness of the validation/ Dairy Plant Awareness and Training Pro-
cleaning/sanitizing re-validation cedure
schedule/program study Dairy Plant Product Traceability Procedure
QA laboratory Re-clean CIP Charts for GHP inspec- Dairy Plant Environment Suitability, Clean-
Cleaning operator all dairy plant tions ing and Maintenance PRP
processing Audit Dairy Plant Master Cleaning/Sanitizing
equipment Document/re- Program/Schedule
cord review Dairy Plant Cleaning/Sanitizing Procedures
cedure
QA laboratory Re-clean CIP Charts for GHP inspec- Dairy Plant Environment Suitability, Clean-
Cleaning operator all dairy plant tions ing and Maintenance PRP
processing Audit Dairy Plant Master Cleaning/Sanitizing
equipment Document/re- Program/Schedule
cord review Dairy Plant Cleaning/Sanitizing Procedures
cedure
Cleaning/sanitizing Review/update Cleaning/sani- GHP inspec- Dairy Plant Environment Suitability, Clean-
supervisor master cleaning/ tizing tions ing and Maintenance PRP
QA/laboratory sanitizing schedule GHP inspec- Audit Dairy Plant Master Cleaning/Sanitizing
or program; revali- tions Document/re- Program/Schedule
date the effective- Audits cord review Dairy Plant Cleaning/Sanitizing Procedures
ness of the cleaning/ Cleaning/ Dairy Plant Awareness and Training Pro-
sanitizing schedule/ sanitizing cedure
program validation/re- Dairy Plant Product Traceability Procedure
validation Dairy Plant Environmental and Pathogen
Hazards
Prerequisite
Survival,
Increase, Re
(Contami-
C Presence Without proper Master cleaning/sanitizing schedule Chemical type,

Contamina- seperation be- GHP inspection concentration,
tion tween cleaning Audit contact time
and sanitizing Pathogen monitoring and tempera-
solutions and ture
product there
could be prod-
uct contamina-
tion
P None
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, Control Measure What is
Program Agent presence, cause, source, Describes the control measures the FBO has monitored and
Describes the Describes growth, vector, condi- in place to control relevant hazards. when
ISO/TS 22002-1 the hazard survival, tion Describes
requirement. agent, e.g. increase, Describes the the hazard
biological, re(con- cause, origin, measurement
chemical, tamination) condition or parameters and
physical or Describes source of a the frequency
combi- how the haz- hazard. of monitoring
nation ard manifests required.
thereof. as a threat,
i.e. presence,
growth or
survival.
Cleaning/sanitizing Review/update Cleaning/sani- GHP inspec- Dairy Plant Environment Suitability, Clean-
supervisor master cleaning/ tizing tions ing and Maintenance PRP
QA/laboratory sanitizing schedule GHP inspec- Audit Dairy Plant Master Cleaning/Sanitizing
or program; revali- tions Document/re- Program/Schedule
date the effective- Audits cord review Dairy Plant Cleaning/Sanitizing Procedures
ness of the cleaning/ Cleaning/ Dairy Plant Awareness and Training Pro-
sanitizing schedule/ sanitizing cedure
program validation/re- Dairy Plant Product Traceability Procedure
validation Dairy Plant Environmental and Pathogen
G H I J K

Describes the job role tive action Indicates the activities Describes the FBO documents and, where
or title of the depart- Describes the correc- monitoring Describes the necessary, the relevant external documents,
ment/function within tion and corrective and hazard verification ac- e.g. statutory and regulatory requirements.
the FBO responsible for action aimed at pre- measurement tivities neces-
monitoring the relevant venting reoccurrence parameter sary to confirm
hazard measurement of exceeding the al- records to be the accuracy of
parameters. lowable or permitted maintained. the monitor-
parameters.

Team #11 Reviewed by hygienist and cleaning and sanitizinglPRP team

Cleaning and Sanitizing
Review of environment, pathogen and foreign objects monitoring
Review of GHP inspections
Internal GMP / hygiene audits
Review of chemicals/MSDS and chemical storage
Review of cleaning/sanitizing validation/re-validation study
Review of traceability
Review of training
Frequency & criticality review
A B
Instructions:

Chapter 11 – Cleaning and
Sanitizing.

Outcome
actions)
M Rodrigues review-related sheet
B Jackson PRPs
D Smith
O Murphy
C Flack
B Jackson mangement proved
D Smith worksheet Appointed desig-
O Murphy Review cleaning/ nated person
C Flack sanitization re-
validation study
12-Oct-15 G Moran Review of clean- Reviewed/up- PRP team to com- 17-Dec-15 17-Dec-15
O Brown ing tool program dated Training and plete
M Rodrigues awareness, e.g. 5S improvements
B Jackson program, storage, shown following
D Smith replacement improved coaching
O Murphy and supervising by
C Flack supervisors
A B C D E F G
Instructions:

and invitees.

particular FBO.
Action Plan Gap Resolu-

Description [of the Associat-
ISO/TS Specific re- [Including tion [Actions
requirement of ed Dairy Gap Comments
22002-1 quirement timescales for Completed
the Standard] Policy
completion] and Date]
11.2 Clean- Tools and equipment shall Review Food Enhance Update aware- Reviewed/ Need to
ing and be of hygienic design and effective- safety awareness ness/training updated continue
Sanitizing maintained in a condition ness of policy of 5S, stor- and monitoring awareness to monitor
Agents and which does not present a awareness age, tool effectiveness awareness/ for next six
Tools potential source of extrane- of the ISO/ protection via greater training ef- months to
ous matter TS 22002-1 procedures supervision of fectiveness, sustain im-
requirement FBO supervi- see PRP Team provements
sors Meeting shown to
28-April-2015 date
11.3 Clean- Cleaning and sanitizing Re-validate Food Previous Re-validation Review/ Need to
ing and programmes shall be es- cleaning/ safety validation study review/ approved continue to
Sanitizing tablished and validated by sanitizing policy study in- approved re-validation monitor for
Programs the organization validation complete/ study, see next twelve
study inadequate PRP Team months
Meeting 12-
Oct-2015
A B C D E F G H
Instructions:
Scheme ment of the Standard] quirement ed Policy Describe [Including tion [Actions Add any
name, PRP Provide a description of the Provide a Detail the the gap. timescales for Completed additional
been fulfilled.

chemical residues)
foreign bodies)
A B
Instructions:

allergen – A.
PRP 12: Pest Control

Instructions:
chapter number (e.g., “12- Pest
Product cat- Grade A IMS Registered Whole Milk Status: Draft Control”).
egory
packaged Milk
dates.
PRP Review History
PRP type
Unscheduled
Review
facility.
PRP Team Members


FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 12: Pest control 107

Specialist advice


Hazards
Prerequisite
Origin, Cause, What is Moni-
through ISO/ Survival, Control Measures
Agent(s) Source, Vector, tored and When
TS 22002-1) 6 Increase, Re
(Contami-
12.1 General B Contamina- Pests Hygiene, cleaning and incoming Hygiene, cleaning
Requirements tion material inspection in place as well as and raw mate-
pathogen and environmental moni- rial monitored
toring procedures through GHP
Inspections and
audits monthly
Pathogen moni-
toring program in
place weekly
12.2 Pest Control B,C Contamina- Pests, chemicals Pest control program in place, out- Pest activ-
Program tion used sourced to an external company ity, infestation,
Dairy plant designated site contact is pest activity is
the sanitizing supervisor. frequently moni-
Contact person is the dairy plant tored accord-
sanitizing supervisor ing to the pest
Documents and records are with the management
dairy plant sanitizing supervisor program
List of approved pesticide chemicals
used is available on a USB stick that is
with the Pest Management Program
folder/manual.
The food safety manager approves all
dairy plant chemical pesticides
12.3. Preventing B,C Contamina- Holes, cracks, Building maintenance in place Pest activ-
Access tion open doors, ven- Pest access points are sealed ity, infestation,
tillation openings All doors to the outside have closures, pest activity is
windows can't be opened,ventilation frequently moni-
openings are designed to minimize tored accord-
the potential entry of pests ing to the pest
Dairy plant approved pesticides management
maintained program
Material Safety Data Sheets for dairy
plant spproved pesticides maintained
12.4. Har- B Contamina- Raw material, bad cGMP and good housekeeping in Pest activ-
bourage and tion housekeeping, place throughout the Dairy Plant ity, infestation,
infestations pallets, etc Material found to be infested is sepa- pest activity is
reted or discarded frequently moni-
Outside space is not used for storage tored according
to the pest man-
agement pro-
gram, monthly
PRP audit
Dairy Plant QA Labo- Training, cleaning of GHP inspection Pest control Dairy Plant Design and Construction of
ratory area where devia- Audit Reports records no Buildings PRP
Dairy Plant Sanitiza- tion was found Pathogen pest activity Dairy Plant Site Location and Standards
tion Raw Material is sent Monitoring PRP
Dairy Plant Food back to supplier Raw Material Dairy Plant layout of Premises and Work-
Safety or discarded, if not monitoring space PRP
compliant Dairy Plant Internal Structure PRP
Dairy Plant Environment Suitability, Clean-
ing and Maintenance PRP
Raw Material Handling Procedure
Dairy Plant Cleaning and Sanitizing Proce-
dures
cedure
Dairy Plant Enrivornmental and Pathogen
Pest Control Folder/Manual [External Pest
Control Company]
Dairy Plant QA Labo- Containment during Pest manage- Pest control Dairy Plant Pest Control Program
ratory construction ment service records no Dairy Plant Pest Control Map
Dairy Plant Sanitiza- Eliminate source of report [external pest activity Pest Control Folder/Manual [External Pest
tion pest entry provider] Control Company]
Dairy Plant Food
Safety
Dairy Plant QA Close entry point of Pest manage- Pest control Dairy Plant Design and Construction of
Dairy Plant Mainte- pests ment service records no Buildings PRP
nance report [external pest activity Dairy Plant Site Location and Standards
Dairy Plant Sanitiza- provider] PRP
tion Dairy Plant layout of Premises and Work-
space PRP
Dairy Plant Sanitation Cleaning of invested Inspection/au- Pest control Dairy Plant Raw marterial handling proce-
area, dit report records no dure
Route cause analysis Training, pest activity, Dairy Plant Product Inspection procedure
Training Non-conform- Audit
ing product
Destruction of
non-conform-
ing product
Hazards
Prerequisite
(Contami-
12.5. Monitoring B Contamina- Pests Pest control program in place, out- Pest activ-
and Detection tion sourced to an external company ity, infestation,
Pest control map of detectors and pest activity is
traps included in the Pest Control frequently moni-
Folder/Manual tored accord-
Detectors and traps are according to ing to the pest
ISO/TS 22002-1 management
Dectors and traps are frequently program
inspected according to pest manage-
ment program
12.6. Eradication B, C Contamina- Pests Eradication measures shown in Pest Pest activ-
tion Management Service Report ity, infestation,
Only authorized and trained dairy pest activity is
plant personnel handles pesticides frequently moni-
Records of dairy plant approved tored accord-
pesticides are maintained in the Pest ing to the pest
Control Service Report management
program
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, Control Measure What is moni-
Program Agent presence, cause, source, Describes the control measures the FBO tored and when
Describes the Describes growth, vector, condition has in place to control relevant hazards. Describes the
ISO/TS 22002-1 the hazard survival, Describes the hazard measure-
requirement. agent, e.g. increase, cause, origin, con- ment parameters
biological, re(condition or source of and the frequency
chemical, tamination) a hazard. of monitoring
physical or Describes required.
combi- how the haz-
nation ard manifests
i.e. presence,
growth or
survival.
Dairy Plant Sanitiza- Review pest man- Pest control Pest control Dairy Plant Pest Control Folder/Manual
tion agement program records records [External Pest Control Company]
No pest activity No pest activ- Dairy Plant Enrivornmental and Pathogen
ity Monitoring Procedure
Audit Dairy Plant GHP Inspection Procedure
Dairy Plant Awareness/Training Procedure
Dairy Plant Sanitiza- Review pest man- Pest manage- Pest control Dairy Plant Pest Control Folder/Manual
tion agement program ment service records [External Pest Control Company]
Dairy Plant Food report No pest activ- Dairy Plant Awareness and Training Pro-
Safety ity cedure
G H I J K

parameters.

Team #12 Reviewed by Laboratory Manager and Pest Control RPP team
Pest Control
Review of Pest Sighting Log
Review of pest management service reports
Review of approved chemical pesticide
Review of Material Safety Data Sheets [MSDS]
Review of training
Internal GMP audits / GHP inspections
A B
Instructions:

Chapter 12 – Pest Control.

Outcome
actions)
M Rodrigues review-related Sheet
B Jackson PRPs
D Smith
O Murphy
C Flack
B Jackson mangement proved
O Murphy Appoint designated person
C Flack nated person
12-Oct-15 G Moran Review and pes- Reviewed/approved PRP team to com- 17-Dec-15 17-Dec-15
O Brown ticide chemicals pestcide chemical plete
M Rodrigues and material specification
B Jackson safety data sheets Updated MSDS
D Smith [MSDS] Folder
O Murphy
C Flack
A B C D E F G
Instructions:

and invitees.

particular FBO.

12.2 Pest The establishment shall Nominated Food No clear Agree nomi- Nominated Dairy Plant
control have a nominated person person to Safety designated person person ap- Sanitizing
programs to manage pest control manage Policy nigated by next PRP pointed, see Supervisor
activities and/or deal with pest control person team meeting PRP team appointed
appointed expert contrac- activities meeting designated
tors 28-April-2015 person
A B C D E F G H
Instructions:
clause FSMS scheme where the gap scription of FSMS Provide details Provide details comments,
number exists. the specific Policy. of the action of the actions if required.
Provide a requirement to be taken to taken to ad-
description where the address the dress the gap
of the FSMS gap exists specific require- and the date
Scheme Re- within the ment identified of completion.
quirement. FBO. as not having
been fulfilled.

chemical residues)
foreign bodies)
A B
Instructions:

allergen – A.
PRP 13: Employee Hygiene and Employee Facilities

Instructions:

chapter number (e.g. “13- Em-
Product cat- Grade A IMS Registered Whole Milk Status: Draft ployee Hygiene and Employee
egory Facilities”).
Proessess HSTS Pasteurizer, Aseptic Filling, Retort End date: Ongoing Provide the facility name,
packaged Milk
dates.
PRP Review History
PRP type
Unscheduled
Review
facility.
PRP Team Members


FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 13: Employee Hygiene and Employee Facilities 117

Specialist advice.


Hazards
Prerequisite
Survival,
Increase, Re
(Contami-
13.1 General B, C, P [See Presence Contamination Dairy plan hygiene policy Pathogen
Requirements below] Contamina- by pathogens Dairy plant hygiene awareness and monitoring,
tion Contamina- training daily
tion by cleaning GHP, weekly
and sanitizing
residues
Contamination
by extraneous
material
13.2 Personal B Presence Contamination Provision of personnel hygiene facilities Pathogen
Hygiene Facili- Contamina- by vegetative Hygenic design of personnel hygiene monitoring,
ties and Toilets tion pathogens facilities daily
Location and cleaning/maintenance of Cleaning/sani-
personnel hygiene facilities tizing, daily
Temperature of
water
Maintenance,
Weekly
Supply of soap
and/or sani-
tizer
C Presence Cleaning and MSDS sheets for cleaning and/or sanitiz- Toxic residues
Contamina- sanitizing solu- ing chemicals Daily/weekly
tion tion residues Approved cleaning and sanitizing chemi-
cals
Chemical storage
P Presence Entraneous ma- Preventive maintenance Maintenance

Contamina- terial arising from Cleaning log Cleaning
tion poor personnel Daily/weekly
facilitiy main-
tenance and/
or cleaning, e.g.
paint
All personnel Pathogen monitor- Personnel GHP inspec- Dairy Plant Measures for Prevention of
Hygienist ing hygiene tions Cross Contamination PRP
QA/laboratory Re-training, if GHP inspec- Audit Dairy Plant Hygiene Policy
required tions Document/re- Dairy Plant Cleaning/Sanitizing Procedures
Disciplinary action, if Audits cord review Dairy Plant Awareness and Training Pro-
required Pathogen cedure
monitoring Dairy Plant Environmental and Pathogen
Facilities manage- Preventive mainte- GHP inspec- GHP inspec- Dairy Plant Measures for Prevention of
ment nance tions tions Cross Contamination PRP
Hygienist Re-training, if Audits Audit Dairy Plant Construction and layout of
QA/laboratory required Personnel hy- Document/re- Building PRP
Cleaning operators/ Re-clean/re-sanitize giene facilities cord review Dairy Plant Environment Suitability, Clean-
service providers cleaning log ing and Maintenance PRP
Maintenance book Dairy Plant Management of Purchased
Materials PRP
Dairy Plant Utilities PRP
cedure
QA/laboratory Environmental GHP inspec- GHP inspec- Dairy Plant Measures for Prevention of
Sanitizing operators monitoring fre- tions tions Cross Contamination PRP
Cleaning service quency review Audits Audit Dairy Plant Construction and layout of
providers Re-training, if Cleaning/sani- Document/re- Building PRP
required tizing cord review Dairy Plant Environment Suitability, Clean-
Re-clean/re-sanitize ing and Maintenance PRP
Dairy Plant Management of Purchased
Materials PRP
cedure
Maintenance Re-training, if GHP inspec- GHP inspec- Dairy Plant Construction and layout of
Cleaning service required tions tions Building PRP
provider Re-clean/re-sanitize Audits Audit Dairy Plant Environment Suitability, Clean-
Cleaning/sani- Document/re- ing and Maintenance PRP
tizing cord review Dairy Plant Management of Purchased
Maintenance Materials PRP
cedure
Hazards
Prerequisite
Survival,
Increase, Re
(Contami-
13.3 Staff B Presence Contamination Hygienic storage of prepared food Cleaning/sani-

Canteens and Contamina- by vegetative Cooking and holding temperatures tizing, daily
Designed Eating tion pathogens Pathogen
Areas monitoring,
daily
Temperature
and time limi-
tations, daily
C Presence Cleaning and MSDS sheets for cleaning and/or sanitiz- Toxic residues
Contamina- sanitizing solu- ing chemicals Daily/weekly
tion tion residues Approved cleaning and sanitizing chemi-
cals
Chemical storage
P Presence Entraneous ma- Preventive maintenance Maintenance

Contamina- terial arising from Cleaning log Cleaning
tion poor personnel Daily/weekly
facilitiy main-
tenance and/or
cleaning, e.g. paint
13.4 Workwear B Presence Contamination Personal hygiene policy [hair, dirt, per- Temperature
and Protective Contamina- by pathogens sonnel perspiration, etc] Pathogen
Clothing tion Glove use, where Hair restraints/beard snoods monitoring
specified Dedicated dairy plant footwear/properly
Inproper foot- maintained food foamers
wear Specification for laundry of uniforms/lab
coats
Adequate supply of laundered unfiroms/
lab coats
Locker provided for uniform storage
Clean uniforms to be worn
C None
P Presence Entraneous Personal hygiene policy [jewelery, GHP
Contamina- material arising fingernails, pens/biro’s etc] Daily
tion from person-
nel jewellery,
false fingernails,
fingernail polish,
buttons, pens etc.
13.5 Health B Presence Contamination Dairy plant personal hygiene policy Personnel
Status Contamina- by pathogens Dairy plant hygiene awareness and health status
tion due to personnel training Pathogen
ill health, minor Supervisor notification monitoring
cuts or infectious Glove use after minor cuts and hand Frequency
disease washing Daily/weekly
Personnel prohibition to work handling
food products
C None
P None Contamination Use of adhesive bandage reported to Use of adhe-
from adhesive management sive bandage, if
bandage/plaster allowed
Hygienist Cleaning/sanitizing GHP inspections GHP inspec- Dairy Plant Environment Suitability, Clean-
Canteen staff schedule/program Audits tions ing and Maintenance PRP
Ingredient/product Environmental Audit Dairy Plant Cleaning/Sanitizing Procedures
disposal and pathogen Document/re- Dairy Plant Awareness and Training Pro-
monitoring cord review cedure
Cleaning/ sani- Dairy Plant Environmental and Pathogen
tizing Monitoring Procedure
Cooking and
holding tem-
perature
Waste disposal
QA/laboratory Environmental GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Cleaning
Sanitizing operators monitoring fre- tions tions and Maintenance PRP
Cleaning service quency review Audits Audit Dairy Plant Cleaning/Sanitizing Procedures
providers Re-training, if Cleaning/sani- Document/re- Dairy Plant Awareness and Training Procedure
required tizing cord review Dairy Plant Environmental Monitoring Pro-
Re-clean/re-sanitize cedure
Maintenance Re-training, if GHP inspec- GHP inspec- Dairy Plant Environment Suitability, Clean-
Cleaning service required tions tions ing and Maintenance PRP
provider Re-clean/re-sanitize Audits Audit Dairy Plant Cleaning/Sanitizing Procedures
Cleaning/sani- Document/re- Dairy Plant Awareness and Training Pro-
tizing cord review cedure
Maintenance
QA/laboratory Re-clean CIP charts for GHP inspec- Dairy Plant Measures for Prevention of
Cleaning operator all dairy plant tions Cross Contamination PRP
processing Audit PRP Dairy Plant Construction and Layout of
equipment Document/re- Building PRP
cord review Dairy Plant Environment Suitability, Clean-
Dairy Plant Management of Purchased
Materials PRP
Dairy Plant Personal Hygiene Policy
cedure
All personnel includ- Re-training, if GHP inspec- GHP inspec- Dairy Plant Personal Hygiene Policy
ing visitors and required tions tions Dairy Plant Awareness and Training Pro-
contractors Disciplinary action, if Audits Audit cedure
required Cleaning/sani- Document/re-
tizing cord review
Maintenance
All personnel Personnel prohibi- Personnel hy- GHP inspec- Dairy Plant Measures for Prevention of
Hygienist tion to work han- giene /health tions Cross Contamination PRP
Medical health nurse, dling food products GHP inspec- Audit Dairy Plant Personal Hygiene Policy
if available tions Document/re- Dairy Plant Cleaning/Sanitizing Procedures
Audits cord review Dairy Plant Awareness and Training Pro-
Pathogen cedure
monitoring Dairy Plan Product Traceability Procedure
Food safety manager Use of gloves Adhesive ban- GHP inspec- Dairy Plant Personal Hygiene Policy
dage use tions Dairy Plant Awareness and Training Pro-
Audit cedure
Document/re-
cord review
Hazards
Prerequisite
Survival,
Increase, Re
(Contami-
13.6 Illness and B Presence Contamination Dairy plant personal hygiene policy Personnel
Injuries Contamina- by pathogens Dairy plant hygiene awareness and health status
tion due to personnel training Pathogen
injury on hands Supervisor notification monitoring
and lower por- Glove use after minor cuts and hand Frequency
tions of the arms washing Daily/weekly
Personnel prohibition to work handling
food products
C None
P None Contamination Use of adhesive bandage reported to Use of adhe-
from adhesive management sive bandage, if
bandage/plaster allowed
13.7 Personnel B Presence Contamination Dairy plant personal hygiene policy Pathogen
Cleanliness Contamina- by pathogens Dairy plant hygiene awareness and monitoring
tion due to lack training frequency
of personnel Gloves, where required GHP inspec-
hygiene by per- tions/observa-
sonnel tions
Daily/weekly
C None
P None
13.8 Personal B Presence Contamination Dairy plant personal hygiene policy Pathogen
Behaviour Contamina- by pathogens Dairy plant hygiene awareness and monitoring
tion training frequency
Gloves, where required Daily/weekly
P None
P Presence Entraneous Dairy plant personal hygiene policy GHP, weekly
Contamina- material arising Dairy plant smoking policy
tion from person- Dairy plant hygiene awareness and training
nel behaviour, Designed areas for storing smoking mate-
e.g. smoking, rials, medicines
chewing gum, Maintenance of personal lockers [cleanli-
jewelery, pens ness and kept free of soiled clothing, stor-
exposed, fales age of religious/cultural imperatives etc.]; in
nails, eyelashes, summary, personal affects
medicines, etc. Hand washing signs
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, Control Measure What is
Program Agent presence, cause, source, Describes the control measures the FBO monitored and
Describes the Describes growth, vector, condition has in place to control relevant hazards. when
ISO/TS 22002-1 the hazard survival, Describes the Describes
requirement. agent, e.g. increase, cause, origin, con- the hazard
biological, re(condition or source of measurement
chemical, tamination) a hazard. parameters and
physical or Describes the frequency
combi- how the haz- of monitoring
nation ard manifests required.
i.e. presence,
growth or
survival.
All personnel Personnel prohibi- Personnel hy- GHP inspec- Dairy Plant Measures for Prevention of
Hygienist tion to work han- giene /health tions Cross Contamination PRP
Medical health nurse, dling food products GHP inspec- Audit Dairy Plant Personal Hygiene Policy
if available tions Document/re- Dairy Plant Awareness and Training Pro-
Audits cord review cedure
Pathogen Dairy Plant Environmental and Pathogen
monitoring Monitoring Procedure
Food safety manager Use of gloves Band Aid use GHP inspec- Dairy Plant Personal Hygiene Policy
tions Dairy Plant Awareness and Training Pro-
Audit cedure
Document/re-
cord review
Hygienist ing hygiene tions Cross Contamination PRP
QA/laboratory Re-training, if GHP inspec- Audit Dairy Plant Personal Hygiene Policy
required tions Document/re- Dairy Plant Awareness and Training Pro-
Disciplinary action, if Audits cord review cedure
required Pathogen Dairy Plant Environmental and Pathogen
Cleaning/sanitizing Pathogen monitor- Personnel GHP inspec- Dairy Plant Measures for Prevention of
supervisor ing hygiene tions Cross Contamination PRP
QA/laboratory Re-training, if GHP inspec- Audit Dairy Plant Personal Hygiene Policy
required tions Document/re- Dairy Plant Awareness and Training Pro-
Disciplinary action, if Audits cord review cedure
required Pathogen Dairy Plant Environmental and Pathogen
Hygienist ing hygiene tions Cross Contamination PRP Dairy Plant Envi-
QA/laboratory Re-training, if GHP inspec- Audit ronment Suitability, Cleaning and Mainte-
required tions Document/re- nance PRP
Disciplinary action, if Audits cord review Dairy Plant Personal Hygiene Policy
required Pathogen Dairy Plant Smoking Policy
monitoring Dairy Plant Awareness and Training Pro-
cedure
G H I J K

parameters.

Team #13 Reviewed by hygienist and cleaning and sanitizinglPRP team

Employee Hygiene and
Employee Facilities Review of environment, pathogen and foreign objects monitoring
Review of GHP inspections
Review of chemicals/MSDS and chemical storage
Review of cleaning/sanitizing validation/re-validation study
Review of training
A B
Instructions:

Chapter 13 – Employee Hygiene
and Employee Facilities

Outcome
actions)
B Jackson PRPs
D Smith
O Murphy
C Flack
O Brown Sheet proved PRP worksheets
B Jackson Mangement proved
D Smith Worksheet Appointed desig-
O Murphy Review Health nated person
C Flack Screening Policy
12-Oct-15 G Moran Review of stor- Reviewed/updated PRP team to 17-Dec-15 17-Dec-15

O Brown age of product policy and commu- continue to moni-
M Rodrigues contact tools and nication of prohibi- tor as part of GHP
B Jackson equipment in tion of storage of inspections
D Smith personal lockers product contact
O Murphy tools and equip-
C Flack ment in personal
lockers
A B C D E F G
Instructions:

and invitees.

particular FBO.

13.5 Health Medical examinations, Health Food Health Review/update Review/ap- Need to
Status where permitted, shall be screening of safety screening health screen proved policy continue
carried out at intervals de- personnel policy policy not policy and and re-en- to monitor
fined by the organization in compli- communicate forced policy/ for next
ance with effectively practice with tweleve
country within the FBO relevant months
regulatons as soon as personnel
nd not practical personnel,
effectively see PRP team
commu- meeting 12-
nicated to Oct-2015
personnel
13.8 Per- Prohibition of storage of Product Food Practice Re-enforce Review/ Need to
sonnel product contact tools and contact safety does not policy/practice approved continue
Behaviour equipment in personal tools and policy match re- and include in new health to monitor
lockers equipment quirmeent GHP inspec- screning for next six
to be stored of the tions policy and months to
in FBO- Standard communi- sustain im-
supplied cated to all provements
toolbox personnel, shown to
see PRP team date
meeting
28-April-2015
A B C D E F G H
Instructions:
been fulfilled.

chemical residues)
foreign bodies)
A B
Instructions:

allergen – A.
PRP 14: Rework

Instructions:

chapter number (e.g. “14 –
Product cat- Grade A IMS Registered Whole Milk Status: Draft Rework”).
egory
packaged Milk
dates.
PRP Review History
PRP type
Unscheduled
Review
facility.
PRP Team Members


FSTK PRP Workbook Examples and Instructions (WS1- WS6) Prerequisite Program. PRP 14: Rework 129

Specialist advice.


Hazards
Prerequisite
(Contami-
14.1 General B, C, P Contamina- Microbiological, Hygiene, cleaning, product inspection, Hygiene, clean-
requirements tion chemical or extra- pathogen, environmental monitoring, storage
neous matter ing, extraneous material procedures, monitored
contamination traceability through GHP
inspections and
audits monthly
Pathogen moni-
toring program in
place weekly
14.2 Storage, B Contamina- Reclaimed or Product that has not been continu- Environmental
Identification tion reworked product ously in control of the dairy plant to and pathogen
and Traceability may have been be reclaimed or reworked; is assumed monitoring
handled, stored or to contain pathogens. When product Good warehous-
used in a way to is no longer under the control of the ing practices
subject it to con- dairy plant, if can be not be assumed [GWP]
tamination with to have been held to preclude tem- Product segrega-
pathogens perature abuse of adulteration. Only tion
product that has not left the control Product protec-
of the dairy plant should be used, tion [tempera-
kept segregated, handled, protected ture]
and cooled as appropriate foe the Daily/weekly
product with the exeption fo product
approved by the Regulatory Agency.
Reworking is done in a clean area and
in a manner that will not contami-
nate the product being salvaged
C Contamina- Allergens being Foods containing undeclared al- Reworked prod-
tion mixed with prod- lergens may cause life threathening uct segregration
ucts that are not reactions in sensitive individuals Product labelling
labeled as con-
taining allergens
Dairy plant ware- Training GHP Inspection GHP inspec- Dairy Plant Design and Construction of
housing Product rework Audit Reports tions Audits Buildings PRP
Dairy plant QA labo- Product disposal Pathogen Product In- Dairy Plant Site Location and Standards
ratory Monitoring spection PRP
Dairy plant food Product In- Environmen- Dairy Plant layout of Premises and Work-
safety spection tal/ Pathogen space PRP
Traceability monitoring Dairy Plant Internal Structure PRP
Warehousing PRP
Rework Procedure
cedure
Pest Control Folder/Manual [External Pest
Control Company]
Dairy plant ware- Training GHP/GWP GHP/GWP Dairy Plant Design and Construction of
housing Product rework inspection Inspections Buildings PRP
Dairy plant milk pro- Product disposal Audit reports Audits Dairy Plant Site Location and Standards
cessing Rework [clas- Environmen- PRP
Dairy plant QA labo- sification] tal/ Pathogen Dairy Plant Layout of Premises and Work-
ratory Pathogen monitoring space PRP
Dairy plant food monitoring Dairy Plant Internal Structure PRP
safety Product in- Warehousing PRP
spection Rework Procedure
Traceability Product Traceability Procedure
cedure
housing Product rework inspection Inspections Buildings PRP
Dairy plant milk pro- Product disposal Audit reports Audits Dairy Plant Site Location and Standards
cessing Rework [clas- Environmental PRP
Dairy plant food sification] monitoring Dairy Plant Layout of Premises and Work-
safety Traceability space PRP
Warehousing PRP
Measures of Prevention of Cross Contami-
nation PRP
Rework Procedure
Allergen Management Procedure
cedure
Hazards
Prerequisite
(Contami-
P Contamina- Extraneous cate- Opening of products is conducted Foreign objects

tion rial may result in in a manner that will minimize the contamination
choking or other opportunity for bits or packaging, Each batch
physical harm to cutting tools, etc. from entering the
consumers product. Verification that, at some
point in the process ingredient or the
milk product to which the ingredient
is added, will pass through a filter,
screen, small orifice
14.3. Rework B,C,P Contamina- Microbiological, Rework Procedure and additional Hygiene, cleaning
Usage tion chemical or ex- docuemntation specifying the condi- Foreign object
traneous matter tions of rework, process step, ac- contamination,
contamination ceptable quantity, type, conditions of each batch
rework, any pre-processing steps etc. GHP inspections
Opening of products is conducted Audits
in a manner that will minimise the Environment and
opportunity for bits or packaging, pathogen moni-
cutting tools, etc. from entering the toring program in
product. Verification that, at some place weekly
point in the process ingredient or the
milk product to which the ingredient
is added, will pass through a filter,
screeen, small orifice
A B C D E F
Instructions:
Prerequisite Hazard Hazard Hazard origin, Control Measure What is moni-
Program Agent presence, cause, source, Describes the control measures the FBO tored and when
Describes the Describes growth, vector, condition has in place to control relevant hazards. Describes the
ISO/TS 22002-1 the hazard survival, Describes the hazard measure-
requirement. agent, e.g. increase, cause, origin, con- ment parameters
biological, re(condition or source of and the frequency
chemical, tamination) a hazard. of monitoring
physical or Describes required.
combi- how the haz-
nation ard manifests
i.e. presence,
growth or
survival.
housing Product rework inspection inspections Buildings PRP
Dairy plant milk pro- Product disposal Audit report audits Dairy Plant Site Location and Standards
cessing Rework [clas- Foreign ob- PRP
Dairy plant QA sification] jects monitor- Dairy Plant Layout of Premises and Work-
Dairy plant food Foreign objects ing space PRP
safety monitoring Dairy Plant Internal Structure PRP
Product in- Warehousing PRP
spection Rework Procedure
Traceability Dairy Plant Product Inspection Procedure
cedure
Dairy plant QA Training GHP inspection GHP/GWP Dairy Plant Design and Construction of
Dairy plant mainte- Product rework Audit report inspections Buildings PRP
nance Product disposal Rework [clas- audits Dairy Plant Site Location and Standards
Dairy plant sanitiza- sification] Environment, PRP
tion Environment, pathogen and Dairy Plant layout of Premises and Work-
pathogen and foreign objects space PRP
foreign objects monitoring Dairy Plant Internal Structure PRP
monitoring Product in- Dairy Plant Environment Suitability, Clean-
Product inspection ing and Maintenance PRP
spection Warehousing PRP
Traceability Rework Procedure
Waste disposal Dairy Plant Product Inspection Procedure
cedure
G H I J K

parameters.

Team #14 Reviewed by laboratory manager and pest control RPP team
Rework
Review of environment, pathogen and monitoring of foreign objects
Review of GHP/GWP inspections
Review of product inspection
Review of product disposal
Review of training
A B
Instructions:

Chapter 14 – Rework

Outcome
actions)
B Jackson PRPs
D Smith
O Murphy
C Flack
B Jackson management proved
O Murphy Appoint designated person
C Flack nated person
12-Oct-15 G Moran Review of rework Reviewed/updated PRP team to com- 17-Dec-15 17-Dec-15
O Brown classification re- procedure plete
M Rodrigues cords, e.g. product
B Jackson name,
D Smith production date,
O Murphy shift, line of origin,
C Flack shelf-life
A B C D E F G
Instructions:

and invitees.

particular FBO.
Gap
Action Plan
completion]
and Date]
14.2 Stor- The rework classifica- Recording of Food Rework Review/update Rework Need to
age, Iden- tion or the reason for rework clas- safety procedure rework proce- procedure completed
tification rework designation shall sification policy does not dure updated, see training and
and Trace- be recorded (e.g. product fully meet PRP team verify effec-
ability name,production date, shift, require- meeting 12- tiveness of
line of origin, shelf-life) ments of Oct-2015 implemen-
ISO/TS tation
22002-1
A B C D E F G H
Instructions:
been fulfilled.

chemical residues)
foreign bodies)
A B
Instructions:

allergen – A.
FSTK HACCP/O-PRP Plan Workbook

The second workbook details the FBO’s HACCP/O-PRP Plan based upon Codex Alimentarius and ISO 22000
requirements.
It consists of 13 worksheets to be filled in by the designated HACCP team. Within these are ten main work-
sheets, WS 1 to WS 10. There are three supplementary worksheets, WS A, WS B and WS C: see the FSTK
HACCP/ O-PRP Plan Workbook Overview.
The FSTK HACCP and O-PRP Plan Workbook (Excel files) can be found on the enclosed CD.
The FSTK HACCP/O-PRP Plan workbook is recommended for use in conjunction with ISO 22000:2005.
Each section of this workbook includes a worksheet stating:

 A brief description of the worksheet’s specific purpose;
 Instructions for the detail to be inserted in each field;
 An example of a completed worksheet.
Main Worksheets:
 HACCP Scope Worksheet [WS 1]: defines and documents the scope of the HACCP study along with its
revision history. It also lists the HACCP team members conducting the study.
 Product/Ingredient Description Worksheet [WS 2]: defines and documents the product character-
istics associated with the product or product category.
 Flow Diagram Worksheet [WS 3]: defines and documents all production steps concerning the product
and /or a group of similar products.
 Hazard Identification and Description Worksheet [WS 4]: defines and documents hazards noted in
the food production process, as identified by the HACCP team. These are described and assessed.
 Control Measures Selection and Categorization Worksheet [WS 5]: defines and documents the
selection and categorization of control measures related to identified hazards [WS B].
 Validation of Control Measures Worksheet [WS 6]: defines and documents FBO validation of the
control measures identified in worksheet [WS 5] above.
 HACCP Plan including O-PRP Worksheet [WS 7]: defines and documents the details of all CCPs and
O-PRPs, indicating control measures, critical limits, corrective actions taken, plus the verification events
detailed in worksheet [ WS 8].
 Verification Plan Worksheet [WS 8]: defines and documents verification activities intended to sub-
stantiate HACCP effectiveness in a particular case.
 Modification and Follow-Up Worksheet [WS 9]: defines and documents all plan modifications and
follow-up steps resulting from these modifications.
 Meeting Summery Worksheet [WS 10]: defines and documents meetings held by the HACCP team.
Supplementary worksheets
 Hazardous Agent Codes and Classification Worksheet [WS A]: defines the guideline for Food Safety/
HACCP team for assessing hazards controlled by HACCP system.
 Hazard Assessment Table [WS B]: defines and documents the hazard assessment/risk assessment.
 HACCP List of Supporting Documents Worksheet [WS C]: cites details of the list of reference docu-
ments (procedures/work instructions) associated with the FBO HACCP Plan and O-PRP.
FSTK HACCP/O-PRP Plan Workbook 139
History of HACCP
In the 1960s, the Pillsbury Corporation developed the HACCP control system with NASA to ensure food safety
for the first manned space missions. The HACCP system and guidelines for its application were defined by the
Codex Alimentarius Commission. This Commission implements the joint Food Standards Program of the Food
and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO).
Following an outbreak of E. coli 0157 in Scotland in 1996, the Pennington Report recommended that HACCP be
adopted by all food businesses to ensure food safety. All Global Food Safety Initiative Scheme standards, BRC,
SQF, FSSC 22000 etc. have specific requirements for the incorporation of HACCP into an FBO’s food safety
management system.
Effective HACCP is invaluable in supporting any due diligence defense, and will enhance good manufacturing
practice.
What is HACCP?
The word HACCP (Hazard Analysis & Critical Control Point) confuses many people. Simply put, it refers to
a system that must be put in place to ensure that produced food is safe. This system is called a Food Safety
Management System (FSMS) and must be based on the principles of HACCP.
A FSMS based on the principles of HACCP is a systematic approach to identifying and controlling hazards,
whether microbiological, chemical or physical, that could pose a threat to the production of safe food – in
simple terms, it involves identifying what could go wrong in a food system and planning how to prevent it.
The FBO’s FSMS should allow the FBO to identify and control any hazards that could pose a danger to the
preparation of safe food. It involves identifying what can go wrong, planning to prevent it and making sure the
plan is being implemented. HACCP is a legal requirement but also benefits businesses.
Principles of HACCP
A Food Safety Management System based on the principles of HACCP enables the FBO to identify and control
hazards before they threaten the safety of food to its consumers.
There are seven principles of HACCP:
1. Identify the hazards

This step requires the FBO to look at each step (e.g. purchasing, delivery, storage, preparation, cooking, chill-
ing etc.) in its operation and identify what can go wrong e.g. salmonella in a cooked chicken product due to
cross contamination with raw meat (biological hazard), contamination of uncovered food with detergent
(chemical hazard) or a piece of broken glass fallen into an uncovered food (physical hazard).
2. Determine the critical control points (CCPs)

During this step the FBO needs to identify the points in its operation that ensures control of the hazards e.g.
cooking raw meat thoroughly will kill pathogens such as E. coli O157.
3. Establish critical limit(s)

During this step the FBO sets limits to enable them to identify when a CCP is out of control, for example,
when cooking beef burgers, the center of the burger must reach a minimum temperature of 75°C (or an
equivalent time temperature combination, e.g. 70°C for two minutes) to ensure pathogens are destroyed.
4. Establish a system to monitor control of the CCP

During this step when identifying CCPs and critical limits it is important to have a way to monitor and record
what is happening at each CCP. Typically, monitoring will involve measuring parameters such as tempera-
ture and time. However, how you monitor and how often will depend on the size and nature of your busi-
ness. Monitoring should in all cases be simple, clear and easy to do. For example, measure the temperature
of refrigerated food to ensure that it is being maintained below 5°C.
5. Establish the corrective action to be taken when a particular CCP is not under control
When FBO monitoring indicates that a CCP is not under control, corrective action must be taken. For ex-
ample, when the temperature of the food in a refrigerator rises to 10°C due to a technical fault, discard the
food and repair the refrigerator using the manufacturer’s instructions to ensure the correct temperature of
5°C is achieved.
6. Establish procedures for verification to confirm the HACCP system is working effectively
The FBO should review and correct the FSMS periodically and any time they make changes to its operations.
For example, when replacing an oven, verify that the time/temperature settings in the new oven achieve the
minimum safe cooking temperature for a particular dish by measuring the temperature of the food.
7. Establish documentation concerning all procedures and records appropriate to these principles and
their application
For the successful implementation of the FSMS based upon HACCP, appropriate documentation and records
must be kept and be readily available. It is unrealistic to operate HACCP or to demonstrate compliance with
current legislation without providing evidence such as written records. As with the FSMS itself, the complex-
ity of record keeping depends on the nature and complexity of the business. The aim should be to ensure
control is maintained without generating excessive paperwork.
Preliminary Steps in Developing a HACCP Plan 141
Preliminary Steps in Developing a HACCP Plan
Introduction
To develop a HACCP plan, the FBO needs to plan and develop the processes necessary for producing safe food
products. The first step is to collect important information in a fact-finding process called Preliminary Steps. ISO
22000:2005 requires all relevant information needed to conduct the hazard analysis to be collected, main-
tained, updated and documented.
The Purpose of the Preliminary Steps:

A HACCP system and/or a FSMS is a systematic, preventive approach to ensure the safe production of food
products.
Prior to the application of HACCP, the FBO should operate according to the Codex General Principles of Food
Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. The FBO needs to
understand the food sector requirements that applies to its food products and processes.
The FBO is obliged to implement, operate and ensure the effectiveness of the planned activities and any
changes to those activities.
The Five Preliminary Steps

The internationally-recognized Codex Alimentarius Commission outlines five preliminary steps that must be
completed before developing a HACCP plan. The development of the plan is a logical step-by-step process.
The preliminary steps necessary before implementing a HACCP plan include the following, which must be ad-
dressed in sequence:
1. Assemble the HACCP team;
2. Describe the food and its distribution;
3. Describe the intended use and consumers of the food;
4. Develop a flow diagram that describes the process;
5. Verify the flow diagram.
Preliminary Step #1 – Assemble the HACCP Team

To ensure that all likely hazards and critical control points (CCPs) are identified, a multidisciplinary team of
people must be assembled to develop, implement and maintain the HACCP system.
The HACCP team should include people with operational experience, product specific knowledge and a good
understanding of the production process. The HACCP team should include the following types of employees:
quality assurance (QA), technical staff, production managers and supervisors, laboratory personnel, engineer-
ing and sanitation staff.
If the FBO is small, the HACCP Team may be supported by an external FSMS consultant. In such cases, there
should be a written agreement or contract in place between the FBO and the FSMS Consultant clearly defin-
ing their role and responsibilities. The FBO has a duty of care to ensure the FSMS consultant is qualified and
competent and can perform his or her role given the risk level of the product or commodity being processed.
A HACCP team leader should be designated to oversee the development, implementation and maintenance
of the HACCP system. He or she must have a good understanding of HACCP and a working knowledge of
the product and its production process. It is desirable that the HACCP team leader has proven competence in
training design and delivery, i.e. attendance at a recognized Train-the-Trainer course is recommended.
Preliminary Step #2 – Describe the Food and its Distribution

A full description of the product must be prepared to provide a profile of the product and help determine
food safety hazards associated with its production. A key element is the collection of food safety hazards and
acceptable limits. The HACCP team needs to collect food safety hazards identification data and acceptance
levels as defined and documented by:
Statutory and regulatory agencies:

 The Codex Alimentarius Commission;
 Customers;
 Scientific studies.
Product Descriptions must describe relevant food safety information, such as:
 Available water;
 Process parameters, e.g. pH, heavy metals;
 End product characteristics, e.g. shape, size, color, texture, odor;
 Method of preservation;
 Packaging;
 Storage conditions;
 Shelf life;
 Special labelling information;
 Customer preparation;
 Method of distribution.
Preliminary Step #3 – Describe the Intended Use and Consumers of the Food
It is important to identify the expected use of a product by the end user or consumer (for example, is the
product cooked before consumption or ready to eat without cooking) because the intended use of a product
will affect hazard analysis decisions.
Intended use information also needs to state whether the end user will be the general public or a specific con-
sumer group, particularly vulnerable groups of the population such as infants, the elderly, pregnant women, ill
people, immuno-compromised persons or cancer patients.
Preliminary Step #4 – Develop a Flow Diagram that Describes the Process

The HACCP Team must create a flow diagram that provides a clear, simple outline of all inputs, steps and
outputs in the food production process. The all steps in the process must be set out, including any rework or
recycling of materials.
The flow diagram will provide the basis for carrying out a systematic hazard analysis.
Preliminary Steps in Developing a HACCP Plan 143
Preliminary Step #5 – Verify the Flow Diagram On-Site

An on-site verification of the flow diagram must be carried out to confirm that it accurately reflects the food
production process. The HACCP team should follow the production process on-site and check that the flow
diagram includes all steps that are carried out.
When verifying the accuracy of the flow diagram, consider different shifts and hours of operation, different
batch sizes, optional ingredients and non-routine steps such as equipment maintenance.
After the five preliminary steps to developing a HACCP plan have been completed, a solid foundation will be
in place to successfully apply to the seven principles of HACCP.
Benefits of HACCP
HACCP provides businesses with a cost-effective system for controlling food safety at every stage of the food
production process, including production, storage, distribution, and sale to the final consumer. The preventive
approach of HACCP improves food safety management and complements other quality management sys-
tems. The main benefits of HACCP are:
 Saves your business money in the long run;
 Avoids you poisoning your customers;
 Food safety standards increase;
 Ensures you are compliant with the law;
 Food quality standards increase;
 Organizes your process to produce safe food;
 Organizes your staff promoting teamwork and efficiency;
 Due diligence defense in court.
IFC has developed a comprehensive cost-benefit analysis tool that enables the FBO to establish the benefits
of adopting HACCP or a FSMS. See Module 7 of the IFC FSTK.
Included in this FSTK is a partial example of a milk processing HACCP plan. In the partial milk processing ex-
ample, two CCPs and one O-PRP example are provided.
HACCP Document Templates for Whole Milk
Overview & Guide Of The HACCP Worksheets
Main Worksheets
Supplementary Worksheets Comments
[WS1-WS10] [WSA- WSC]
WS 1
Registration and approval of the HACCP Study
HACCP Scope
WS 2
Product and process description, including raw
PRODUCT/INGREDIENT
material and end product characteristics
DESCRIPTIONS
WS 3 Simplified process flow diagram with OPRP and

FLOW DIAGRAM CCP location
WS A
Guidance for Food Safety/ HACCP team for as-
HAZARDOUS AGENT CODES
sessing hazards controlled by HACCP system
AND CLASSIFICATION
WS 4 Each potential hazard is listed and significance

HAZARD IDENTIFICATION AND is determined with help of severity of health
DESCRIPTION effect and likelihood of appearance
Coding and classifying of the potentially hazard-

WS B
ous agents that need to be considered during
HAZARD ASSESSMENT TABLE
the study
WS 5 With help of the decision tree the control

CONTROL MEASURE SELECTION measures are categorized to CCP, OPRP or
AND CATEGORIZATION Modification
WS 6
Evidence that the control measure can achieve
VALIDATION OF CONTROL
the targeted limits
MEASURES
List and overview of all identified CCPs and

WS 7
OPRPs with control measures, limits, corrective
HACCP PLAN INCLUDING OPRPs
actions and responsibilities
Overview of verification activities that shows

WS 8
that the CCP's and OPRPs have been imple-
VERIFICATION PLAN
mented properly
WS 9
MODIFICATION(S) AND FOLLOW- List of modifications with all details
UP
WS 10 Recording meetings, attendances and decisions

MEETING ACTIVITY LOG made by the team
WS C (Optional)
LIST OF SUPPORTING Recording and filing supporting information
DOCUMENTS
FSTK HACCP/O-PRP Plan Workbook HACCP Document Templates for Whole Milk 145
[WS1] HACCP Scope Worksheet

This worksheet defines the extent of the scope of the FBO HACCP and demonstrates its effectiveness. The
worksheet is composed of two parts: the first should be completed before the start of the HACCP study and
the second section after the completion of HACCP study.
The worksheet consists of eight sections. Completion instructions are outlined below. A blank [WS1] HACCP
Scope Worksheet is included on the enclosed CD.
Complete the first section (below) at the start of the HACCP study Instructions:
HACCP Study N°: Version N°:
#122015 V1.0
HACCP Study
HACCP study details Tick as appropriate
Provide information includ-
New HACCP study  ing the HACCP study number,
version number HACCP study
Scheduled review 20-12-2015 details, and HACCP study start
date.
Unscheduled review
Study started Date: 01-02-2015
HACCP Study Scope
Factory Job Bloggs LLC
Plant/line 2211 HACCP Study Scope

Complete HACCP study scope,
Brand Bloggs including factory name, plant/
line, brand, product name,
Product name Whole Milk product code, FSMS reference.
Product code IMS #1
FSMS reference ISO 22000
Description of scope of study (e.g. module (start and end point) or products Description of Scope of Study
included) Provide a short descrip-
tion about the processes and
Grade “A” Asceptically processed and packaged Milk product.
Scheduled or unscheduled review: Main changes / reasons / causes Scheduled or Unscheduled

Review:
ISO 22000/FSSC 22000 Review Provide the HACCP review
history, including type
(scheduled or (unscheduled).
For unscheduled reviews,
indicate the reason.
HACCP Team Members
Name Responsibility / Role / Expertise Department /

Company
G Moran Food Safety Manager Food Safety/QA
O Brown Hygienist/Microbiologist Hygienist

HACCP Team Members
M Rodrigues Milk Processing Manager Milk Processing
Provide details on HACCP team
B Jackson Laboratory Manager Laboratory members.
D Smith Warehouse Manager Warehousing
O Murphy Engineering Manager Engineering
C Flack Factory Manager Management
N Williams Veterinary Food Safety/QA

Instructions:
Authorisation for new HACCP study or update to new version Authorization of HACCP
Study
Factory Manager C Flack Date: 15-02-2015 Indicate name and positions of
authorized persons and date of
authorization.
Complete the section below on completion of the HACCP study
Planned Modification(s) according to HACCP study
Modification N° Provisional Control Measure(s) for im- Dead-line

mediate application
Date: Planned Modifi cation

Identify HACCP study issue,
Date:
next review date, modification
Date: number, provisional control
measures and deadlines.
HACCP study review HACCP study issue date
Next scheduled 20-12-2015 Study issued Date: 15-02-2015

review - Date:
Authorisation of finished study
Food Safety Team G Moran Date: 12-02-2015 Authorization of Completed

Leader Study
Hygieniest/Micro- O Brown Date: 12-02-2015 Authorized persons should sign
biologist and date the study.
Factory Manager C Flack Date: 12-02-2015

[WS2] Product/Ingredient Description Worksheet

The product description worksheet provides details of products and processes, including raw material and
end-product characteristics. Each product (or a group of similar products) shall be fully specified and docu-
mented, including sensitivity to and potential for safety risks. The description of product safety encompasses
the food chain, ranging from raw materials used to the distribution of the finished products. The traceability
of the raw materials up to and including final supply shall be described. An extensive specification of the end
products is required to ensure a comprehensive assessment of the food safety procedures.
End-products specified on the worksheet must clearly reflect the following product details:
 Product name
 Type
 General product specifications, such as appearance and weight
 Specific requirements such as relevant legislation and/or customer requirements
 Raw materials and ingredients used (composition)
 Safety indicators (chemical, microbiological and physical, allergens)
 Product packaging
 Main steps and processing conditions (production method)
 Shelf life and storage conditions
 Safety-related product labeling
 Intended use by consumers / proper use
 Transportation conditions and distribution methods
 Potential for mishandling/misuse of the product
 Target consumer groups
 Other characteristics having an impact on food safety
The description of raw and auxiliary materials which have contact with the food should concisely indicate the
following:
 Names of these raw materials, ingredients and auxiliary materials
 Composition
 High-risk ingredients
 Safety indicators (chemical, microbiological and physical, allergens)
 Origin or supplier
 Main stages and processing conditions (production method)
 Methods of packaging and transportation
 Storage conditions and shelf life
 Preparation or processing before use/reprocessing
 Acceptance criteria related to food safety
The column “Source of Information” refers to relevant legislative, regulatory, technological or other documents
regulating the requirements specified here. All indicators in this form are provided solely for illustrative pur-
poses. When designing its own specifications, the FBO should give consideration to all indicators relative to
existing legislation and regulations and customer requirements, as well as cited features.
A blank [WS2] Product/ Ingredient Description Worksheet is included on the enclosed CD.
End- product Characteristics

Instructions:
Name (product(s), Grade ‘A’ Asceptically Processed and Packaged Milk

product group(s), line)
Composition Cow Milk
Type (e.g. raw, Ready to Eat

cooked, ready to eat)
Key physical, Chemical Parameters:

biological and Heavy metals:
chemical Lead, mg / kg, not more than 0.1
characteristics Arsenic, mg / kg, not more than 0.05
Cadmium, mg / kg, not more than 0.03
Mercury,mg/kg,notmorethan0.005
Antibiotics:
Chloramphenicol is not allowed
Tetracycline group is not allowed End-product characteristics
Streptomycin is not allowed Complete details of product
Penicillin is not allowed or product family name, type,
Inhibitory substances are not allowed physical and chemical charac-
Melamines are not allowed teristics, key processing steps
Radionuclides: and other characteristics. In-
Cs-137 Bq / kg, not more than 100 dicate details of raw materials,
Sr-90, Bq / kg, not more than 37 high risk ingredients, packaging
materials, rework, and other
Biologocal Parameters: characteristics.
• Mesophilic aerobic and facultative anaerobic microorganisms -
no more than -100,000 cfu / g
• (coliforms) in 0.1 - are not allowed
• Pathogens including Salmonella spp 25.0 g - not allowed
• Staphylococcus aureus in 1.0g - not allowed
• Listeria in 25.0 g - not allowed
Phisical Parameters:
Group purity - not less than 1
Particles of mechanical impurities are not allowed
Key processing steps

Storage, Clarifier/Seperator, Normalization, Pasteurization, Filler,
(e.g. drying, heat
Storage, Distribution/Logistics
treatments, freezing)
Other
Specifications and Regulatory requirements (food safety related) Specifi cations and regulatory
requirements
Product specifications JB-0346-7654-A (food safety related)
Indicate details of product
Product specific regu- specifications and regulatory
latory requirements PMO 2005
requirements.
Filling and Packing

Filling and packaging
Packaging description High density polyethylene gallon container with a polypropylene
(e.g. size) snap-on screw tamper evident cap Complete details of packaging
and packaging system require-
Packaging system (e.g. ments.
Aseptic packaging
modified atmosphere)
Claims and Label Information
Instruction for use by

Keep refrigerated, Grade ‘A’ pasteurized, homogenized, vitamin A
consumers (incl. use or
and D added, 30% less fat than regular milk
storage after opening) Claims and label information
Statements for safe Complete details of product
use (e.g. allergen info, claims and label information.
Shelf life - 7 days; storage temperature not to exceed +6 degrees
special instructionfor C - 24 hours
safe handling)
Other Date of manufacture

Distribution / Storage / Description
Distribution instruc-
Product is cased in standard milk cases - four units per case, us-
tions (e.g. ambient,
ing refrigerated trucks from 0 degrees C to + 20 degrees C
chilled, frozen) Distribution/storage/de-
scription
Storage instructions Distributed using refrigerated trucks from 0 degrees C to + 20
Complete details of distribution,
(e.g. ambient, chilled, degrees C in a vehicle fitted out tor the shipment of food for the
storage, shelf-life and other
frozen) wholesale and retail trade
conditions.
Storage conditions at temperature from 0 degrees C to + 20
Shelf life conditions
degrees C. Shelf life - 7 days
Other Not applicable
Use by Consumers
Ready to serve product. May also be used as an ingredient in

Intended use
preparing meals
Use by consumers
Target group of users
Supply details of intended use,
and special consumer special consumer groups, and
Consumers of all ages consume this product
considerations (e.g. reasonably expected mishan-
infants, elderly) dling and misuse.
Reasonably expected
mishandling and Not stored under proper refrigeration
misuse
Incoming Material Characteristics

Name all raw materials,
Name of raw materi-
Cow milk ingredients, food and contact
als, ingredients
materials.
Composition
Composition Cow milk Specify ingredients, including

food additives and processing
aids.
High-risk ingredients (e.g., al-

lergens, microbiological or dan-
gerous raw materials, sources
of foreign bodies)
Provide a list of high-risk
ingredients: allergens (celery,
corn, eggs, citrus, pumpkin,
legumes, peanuts, soybeans,
Cow’s milk - a hospitable environment for the development of milk, seafood, sesame, tree nuts,
High-risk ingredients microorganisms (lactic acid bacteria, streptococci, coliforms, wheat); microbiological hazards
putrefaction bacteria, Salmonella spp among others) (Salmonella spp.; Clostridium
botulinum; Staphylococcus
aurеus; Yersinia enterocolitica;
Listeria monocytogenes; Vibrio
spp.; Escherichia coli O157:H7;
Clostridium perfringens; Bacillus
cereus; Campylobacter spp.;
Shigella spp.); sources of foreign
bodies: packaging, material,
transport, product type.
Instructions:
Chemical Parameters:
Toxic elements:
• Lead, mg / kg, not more than 0.1
• Arsenic, mg / kg, not more than 0.05
• Cadmium, mg / kg, not more than 0.03
• Mercury, mg / kg, not more than 0,005
Pesticides:
• Hexachloran α, β, γ isomers), mg / kg,
not more than 1.25 (in terms of fat)
• DDT and its metabolites, mg/ kg, not
more than 1.0 (in terms of fat)
Radionuclides: Key physical, biological and
• Сs-137, Bq / kg, not more than 100 chemical characteristics
• Sr-90, Bq / kg, not more than 3.7
• Inhibiting substances are not allowed Properties or characteristics of
Antibiotics: the product are important in
Key physical, biological
and chemical charac- • Chloramphenicol is not allowed determining its safety. These
teristics • Tetracycline group is not allowed can be physical (particle size,
• Streptomycin is not allowed porosity, weight, etc.), chemi-
• Penicillin is not allowed cal (pH, water activity, acidity,
etc.) or microbiological (con-
Biologocal Parameters:
Number of somatic cells, thousand/cm3, tent CFU/g) characteristics.
• Mesophilic aerobic and facultative anaerobic microorgan-
isms - no more than -100,000 cfu / g (coliforms) in 0.1 - are not
allowed
• Pathogens including Salmonella spp 25.0 g - not allowed
• Staphylococcus aureus in 1.0g - not allowed
• Listeria in 25.0 g - not allowed
Phisical Parameters:
Density, kg/m3, at least 1028
Group of purity - not less than 1
Particle mechanical impurities not allowed
Supplier
Supplier Dairy Farm World of Milk
Specify raw material supplier.
Main stages and conditions

(method of production) such
Processing main steps as drying, heat treatment,
Obtained during the mechanical milking of cattle, followed by and freezing
and conditions (pro-
cooling to +6 ° C
duction method) Specify processes to block the
occurrence, reproduction or
survival of microorganisms.
Packaging materials in con-

Packing and transpor- Closed tightly-sealed transportation containers (stainless steel tact with food
tation containers tanks); food rubber gaskets used in sealing the lids Specify the type of material in
contact with food.
Storage conditions and shelf

life
Storage conditions and
Storage temperature not to exceed +6 ° C. 24 hours Specify shelf life and appropri-
shelf life
ate storage conditions for raw
materials.
Preparation and/or process-

ing before use
Preparation and/ or Specify stages of preparation
Filtering, cooling
processing before use or processing of raw materials
prior to use to minimize food
hazards.
Temperature when accepted of not more +10 ° C Acceptance criteria related

Availability of veterinary certificate to safety
Acceptance criteria Test for the absence of antibiotics (chloramphenicol, tetracycline
related to safety group, streptomycin, penicillin) Specify safety criteria of raw
Group of purity- not less than 1 materials checked by the
Particles of mechanical impurities are not allowed company at acceptance.
Other (e.g preserva- Other

tives, processing aids, Not applicable Specify other relevant infor-
sevices) mation, if any.
[WS 3] Flow Diagram Worksheet

This worksheet illustrates the product production process within an HACCP system.
The flow diagram should be constructed by the HACCP team and should cover all operational steps pertain-
ing to a specific product. The same flow diagram may be used for any number of products manufactured by
similar processing.
Prepare flow diagrams for the products or process categories covered by the HACCP system. Flow diagrams
should provide a basis for evaluating the possibility of an occurrence, increase or introduction of food safety
hazards.
The flow diagrams need to take into account the relevant process steps, their sequence and how they relate
to each other. If work is subcontracted or outsourced, it should be indicated in the flow diagram.
The flow diagram should detail the introduction of raw materials or ingredients. If rework is an option in the
process or recycling, these steps need to be included. Finally, waste, by-products, intermediate and end-prod-
ucts should be included in the flow diagram. The accuracy of the flow diagrams and layout shall be verified by
the HACCP/Food Safety Team. This verification shall be repeated periodically (at least annually) to identify and
document modifications to process installation and layout. The FBO needs to make diagram for all process
steps, including all control steps (CCP), with specific parameters. In parallel with the flow diagram, the docu-
ment and person responsible should be identified for most flow diagram steps. It is important to include steps
such as waste treatment, CIP systems, re-processing in the flow diagram:
1: Construct a flow diagram of the process
2: Number each step in the process
3: Indicate CCP when HACCP system study is finished
4: Indicate OPRP when HACCP system study is finished
5: Record on-site verification of flow-diagram
To complete this Worksheet, information can be found in following system documents:

 Codex Alimentarius Standard Commission
 CAC/RCP 1-1969, Rev.4-2003 General principles of Food Hygiene
 Food Safety System based on ISO 22000
# Production Process Step Step Discription

CCP1 Input control of raw and auxiliary materials is carried out in
the enterprise laboratory in accordance with the guidelines
on technochemical and microbiological control at dairy
1
1 industry companies; these are duly approved, and consis-
Raw milk receiving tent with the standards of research methods specified in
O-PRP 1 the technical specifications for this product.
Milk selected based on safety indicators is purified by me-
chanical filters, then immediately cooled to (4 ± 2) ° C and
2 2 fed to the intermediate storage tanks. The duration of raw
Raw milk cleaning/filtration and storge milk storage at a temperature up to 4 ° C is 12 hours; and 6
hours at up to 6 ° C.
3.1 3 3.2 Part of the milk is separated in cream separators in order to

3 Raw milk Storage Separation of milk Raw cream storage select the cream.
The milk is normalized in mass fractions of fat and protein

in such a way that these shares of the normalized mass
fractions correspond to milk fat and protein shares in the
end-product.
As for fat, milk is normalized as follows:
• Cream is added to a whole milk
4.1 • As for protein, the milk can be normalized by mixing milk
Vitamin receiving batches with content of varying protein weight percentages.
4.3
• Vitamins should be stored in a dry, dark place with limited
4 Vitamin dosage
4 access at a temperature not higher than + 25 ° C; Can be
Normalization stored in a sealed package without air and light 1 year.
and fortification
• For dosage of vitamins, the responsible person must be
4.2 weight the required number of vitamin and prepare a solu-
Vitamin storage
tion as recommended by the technological instruction in
O-PRP 2 compliance with the safety requirements.
• The required amount of the complex need to take, trying
not to raise dust, wearing protective gloves and goggles to
avoid contact with skin and eyes.
• After using of the vitamin the package must be tightly closed.
5
5 Homogenization Milk is homogenized at a pressure of 12-18 bar.
CCP2
The milk is pasteurized at a temperature not less than 85°
6 C and pesterization timenot less than 20 sec (this time is
6 Pasterization conditioned by constructive features of the equipment) and
cooled to 4 ± 2 ° C.
7 Pasteurized refrigerated milk enters the tank for intermedi-
7 Pasterization ate storage before further processing. The maximum shelf
storage life of pasteurized milk to sterilization is 24 hours.
8.1 8.4 Pasterized milk bottling is carried out under hygienic conditions.
Conteiner receiving Waste from The packaging material is clening with pasterized or
packaging 8 treated water before bottling.
8 Filling Packaging material is supplied only from approved supplier.
8.3
Conteiner cleaning The certificate of analysis and/or compliance is provided.
8.2
Conteiner storage with pasterized/ Laboratory is providing incoming inspection according to
treated water company requirements.
Packets put in shrink film or cardboard trays are stacked
on pallets for foodstuff transportation and fed to the dry
9 clean chamber at a temperature of 0 ° C to +20 ° C. Here
9 Cold storage the pasterized milk is cooled to a temperature of +20 °
C or less, in less than 24 hours, after which the process is
O-PRP 3 considered complete.
Product in storage must be protected from direct sunlight.
The shelf life of pasterized milk with a fat content of 5.0%
10 in a pack of composite material with a nominal volume
10 Distribution/
logistics
of 1 litre is four months from the date of manufacture at a
temperature ranging from 0 ° C to +20 ° C.
Authorization
Name Position / responsibilities in Signature Date The document should be approved on-site
the team after the flow diagram check is completed
G Moran Food Safety Manager, HACCP Signature 02.01.2015 This document should be verified on-site
Team Leader after the flow diagram check is completed
[WS 4] Hazard Identification and Description Worksheet

The hazard identification and description worksheet identifies each potential hazard and determines its signif-
icance by the severity of the potential health effect and likelihood of occurrence. Whenever the FBO changes
in a manner that could adversely affect food safety, all relevant steps of the hazard analysis should be updated.
Hazard Identification
The FBO (HACCP/Food Safety Team) shall identify and document all potential biological, chemical and physi-
cal hazards that can have an adverse effect on product safety. The identification shall include all aspects of
operations within the scope of the HACCP/FSMS system.
The hazard identification shall include:

 Raw materials and ingredients: specifications, process control at suppliers;
 Characteristics of interim and end products: intrinsic product specifications;
 Characteristics of used processes, including subcontracted services;
 Prerequisite program (PRP), including aspects including:
• Layout of the facility, production lines, installations and equipment;
• Location of rooms, routing, storage and separation of raw materials, interim products, end products,
ventilation;
• Production processes such as purchasing, cleaning and disinfection, packaging, maintenance, pest
control, and waste management;
• Personnel (including arrangements for visitors and external service providers, e.g. mechanics): hy-
giene, knowledge with regard to food hygiene and food safety, requirements to provide notification
of diseases and infections.
Hazard Analysis (Risk)
The FBO (HACCP/Food Safety Team) shall conduct a hazard analysis to identify hazards that should be elimi-
nated or reduced and controlled to ensure the safe production of food. The hazard analysis should include the
probability of hazard occurrence and severity of adverse health effects.
A blank [WS 4] Hazard Identification and Description Worksheet is included in the enclosed CD.
Location of potential
Hazard Description
hazard
Indicate the step (e.g.

raw mtrl, processing or
Describe clearly and specifically the hazards that are reasonably expected to occur at each step:
distribution) at which
class (M, P, C or A), agent, size, origin, nature, etc.
the hazard may be intro-
duced.
Nature of the hazard

Origin or source
(e.g. presense, ability
of the hazard (e.g.
to grow, survive,
Step where and how it
Step No: H# Hazard Class formation of toxins
(description) can be introduced
or toxic chemicals,
into the product or
migration of
its environment)
chemicals)
Therapeutic
Raw Milk Primary milk produc-
1 C drugs C1 Presence
Receiving tion [farm]
(antibiotics)
Raw Milk Toxic elements Primary milk produc-

1 C C3 Presence, introduction
Receiving (heavy metals) tion [farm]
Salmonella,
Staphylococ-
Primary milk produc-
Raw Milk cus aureus,
1 B B1 tion [farm], transpor- Presence, introduction
Receiving L mono-
tation
cytogenes,
Listeria,Shigella
Extraneous Primary milk produc-

Raw Milk
1 P material (stone, P1 tion [farm], transpor- Presence
Receiving
glass e.g.) tation

Raw Milk
1 A Allergen A1 tion [farm], transpor- Presence
Receiving
tation
Pathogenic mi-
croorganisms
tion [farm], person-
B salmonella, S B1 Survival
nel, work environ-
Aurus, L mono-
ment
6 Pasteurization cytogenes
C Absence __ _____ __
P Absence __ _____ __
A B C D E F G
Instructions:
Step # Step Descrip- Hazard class Hazardous agent Hazard # Origin or source of the Nature of the hazard
Defines tion Defines the description Defines the hazard Defines particular hazard
sequential Defines the title hazard agent Defines the haz- hazard agent Defines where and how threats (e.g., availability,
number or description of class: ard controlled by code: B1; C1, P the product or environ- capacity for growth, sur-
for each the process step B - biological the measure ment can be contami- vival, allocation of toxins
process C - chemical nated or toxic chemicals, migra-
step P – physical tion of chemicals)
A – allergen
Justification
Hazard Assessment
for Selection of Hazards and Assesment
Q1: Based on the hazard description, likelihood of oc- Provide supporting data/references on
currence (before applying the control measure) and likelihood of occurrence, information on
severity of health effects, does this hazard needs to severity of health effects and acceptabel
be controlled, i.e. is it a significant hazard? level in end product.
For each hazard, document why it is or

why it is not likely to occur or causing
Significant hazard?
adverse health effects. For non significant
(Yes/No)
hazards document if it is manged e.g. by
Severity For significant
Acceptable level Likelihood of a PRP, through a specification or Major
of adverse hazard, select and
in end product occurrence Allergen Declaration (MAD)
health effect categorize control
Make sure that all hazards likely to occur
measure(s) on
are considered
WS 5
Justify why a certain hazard has been
disregarded
Can cause Hazard likelyhood is frequent, antibiotics

Absence Frequent [4] Significant [20]
fatality [5] used to treat animals.
Lead, mg / kg,
not more than 0.1 Last two years there were not indentified
Arsenic, mg / kg, heavy metals in incoming milk. This hazard is
Could occur Can cause ill-
not more than Insignificant [6] controlled by the prerequisites programs for
[2] ness [3]
0.05 Cadmium, the analysis of incoming raw materials and
mg / kg, not more finished products.
than 0.03
Can lead to
Hazard is controlled by PRP [Incoming raw
Absence Rare [1] serious illness Insignificant [4]
material] and finished product].
[4]
Taking into account a moderate level of

Could occur Can cause hygiene in primary milk production on the
Absence Insignificant [6]
[2] illness 3] farm, there is a remote probability of en-
countering foreign objects in milk.
This hazard is controlled by the prerequisites

Can lead to programs - allergen control procedure and
Always presence Rare [1] serious illness Insignificant [4] mention in the label as cow’s milk.. This haz-
[4] ard is not insignificant for a consumer who
may suffer from the allergy.
Can lead to Pasterization can be violated by the survival

Could occur
Absence serious illness Significant [8] probability of microorganisms in the milk,
[2]
[4] creating a severe health hazard.
_____ __ _____ __ _____
_____ __ _____ __ _____
H I G K L
Acceptable level in Likelihood of Severity of Significant hazard Justification of hazard selection and assess-
end product occurrence adverse health Defines whether the ment
Defines acceptable Defines the like- effect hazard is significant Defines why it is or is not likely to occur, and
level of hazard as lihood of hazard Defines the or not. For significant cause, or not cause, adverse health effects
required by law or occurrence severity of any hazards, select and
customer specifica- adverse health categorize control
tions effect arising measure(s) on HACCP
from the hazard Hazard Assessment
Worksheet
[WS 5] Control Measure Selection and Categorization

The control measures selection and categorization worksheet categorizes the control measures and states
whether they should be managed through operational PRPs or by the HACCP plan.
The HACCP/Food Safety Team shall identify and document the control measures to be applied or imple-
mented when the hazard identification and hazard analysis concludes that the risk of an identified hazard is
significant and needs to be eliminated or reduced and controlled at an acceptable level.
The HACCP/Food Safety Team shall conduct an assessment of every step in the process using a decision tree.
The assessment shall be based on the differing expertise within the team and shall utilize external and internal
information.
For each step, including all products, processes and parts of the PRP, the assessed aspects shall be identified.
The reasons for deciding whether it is a CCP (critical control point) or not shall be documented and traceable.
Step and Hazard Control Measures
Select and describe a control measure or combi-

nation of control measures capable of prevent-
ing, eliminating or reducing the hazard to an
Transfer hazards considered significant in the hazard assessment in acceptable level.
WS 4 to this worksheet (WS 5). Document the rationale for the selection, e.g.
effectiveness of applied control measures alone
or in combination against identified hazard
(refer to documents if possible)?
Step
Step # H# Hazard Description of control measures
description”
1 Raw Milk Re- C1 Therapeutic Drugs (antibiot- Control of raw milk to assure the absence of anti-
ceiving ics: chloramphenicol, tetra- biotics using express method (Delvotest)
cycline family, streptomycin,
penicillin)
2 Raw Milk Filtra- P1 Extraneous Foreign Mate- PRP [Incoming Raw Material] -Filtering and purity
tion rial- glass control of raw milk
— — — — —
6 Pasterization B1 Pathogenic Micro Organisms Pasterization
— — — — —
8.3 Container clean- B1 E.coli There are no control measures
ing with paster-
ized/treated
water
A B C D E
Instructions:
Step # Step description Hazard # Hazardous agent description Description of control measures
Defines Defines the title or Defines Defines the hazard controlled by Describes the control measure / combination of con-
sequential description of the the hazard the measure trol measures taken to prevent hazards, eliminate or
number for process step agent reduce them to an acceptable level
each pro- code: B1;
cess step C1, P,
More than one control measure may be required to control a hazard, and more than one hazard may be con-
trolled by a control measure.
Classification of control measures:

a) Prerequisites Programs (PRP)
b) Operational Prerequisites Programs (O-PRP)
c) HACCP plan
Each field in this worksheet contains instructions/guides as to the information or rating to be entered in the
relevant fields.
The worksheet also contains a number of questions with answer options, where the significance of selecting
each answer is explained.
A blank [WS 5] Control Measure Selection and Categorization Worksheet can be found on the enclosed CD.
Categorization of Control Measures in OPRPs and CCPs - answer questions Q1 to Q5 as necessary

Q1: Based on the likelihood of occurrence (before applying the control measure) and the severity of adverse health effects (WS
4), is this hazard significant (needs to be controlled)?
YES: This is a significant hazard. Go to Q2. NO: This is not a significant hazard.
Q2: Will a subsequent processing step, including expected use by consumer, guarantee the removal of this significant
hazard, or its reduction to an acceptable level?
YES: Identify and name subsequent step. NO: Go to Q3.
Q3: Are control measures or practices in place at this step, and do they exclude, reduce or maintain this signifi-
cant hazard to/at an acceptable level?
YES: Go to Q4. NO: Modify the process or product and go to Q1.
Q4: Is it possible to establish critical limits for the control measure at this step?
YES: Go to Q5. NO: This hazard is managed by an OPRP.
Q5: Is it possible to monitor the control measure in such a way that corrective actions can be
taken immediately when there is a loss of control?
YES: This hazard is managed by the HACCP-plan (CCP). NO: This hazard is managed by an OPRP.
Justification Provide supporting evidence that that slelected
Q1 Q2 Q3 Q4 Q5 CCP / OPRP / MOD control measure(s) and target/critical limits will adequately
control the hazard.
Express method allows testing for each batch of raw materials
and detection of antibotics in dairy raw materials
Yes No Yes Yes Yes CCP 1
Filteration of milk by filter with a cell diameter of 0.01mm en-

Yes No Yes Yes No O-PRP 1
ables prevention of impurities in milk
— — — — — — —
Pasterization destroys some pathogenic micro organisms in milk,
Yes No Yes Yes Yes CCP 2 or at a minimum reduces their number to an acceptable level -
absence in 25 mg
— — — — — — —
Process change needed; use pasteurized or additionally purified
Process water
Yes No No — —
modification
F G H
Categorization of control measures CCP/O-PRP/process Decision justification

in OPRPs and CCPs. Answer ques- modification Notes the rationale behind the choice of a measure / combination of
tions Q1 to Q5 as necessary Identifies the category control measures
Provides questions the HACCP team of control measure
should answer, giving a range of pos- selected
sible responses
[WS 6] Validation of Control Measures Worksheet

The purpose of the validation of control measures worksheet is to provide the evidence that the control mea-
sure can achieve the targeted limits. It questions the organization as to the effectiveness of the controls that
has in place to address each hazardous agent.
Each field in this worksheet contains instructions/guides as to the information or rating to be entered in the
relevant fields.
The worksheet contains a number of questions that prompt for the type of information required.
A blank [WS 6] Validation of Control Measures Worksheet can be found on the enclosed CD.
CCP N° Justification for the Selection of

Step Hazardous agent Control measure
OPRP N° Control Measures
CCP 1 1 Therapeutic Drugs: anti- Control of raw milk Rapid test allows quick determina-
biotics: tetracycline group, for the absence of tion of the presence of antibiotics in
penicillin, streptomycin, antibotics using the raw materials. This methodology is
chloramphenicol Delvo test approved and ensures test accuracy
and reliability
O-PRP 1 2 Extraneous foreign material Filtration and purity Filtration of milk on a filter cell with
control of raw milk a diameter of 0.01 mm enables the
prevention of impurities in the fin-
ished product
CCP 2 6 Pathogenic microorganisms, Pasteurization Pasteurization destroys some

including Salmonella S. au- pathogenic microorganisms in the
reus, L. monocytogenes milk or reduces their numbers to an
acceptble level
A B c D E
Instructions:
CCP N° Step # Hazardous agent description Control measure Justification for the selection of
OPRP N° Defines Defines the hazard controlled Defines the control control measures
Defines CCP sequential by the measure measures selected for Defines whether the control measure
and O-PRP number for this hazard functions in practice
numbers each process
step
The HACCP team has to provide, or ask for, evidence that selected control measures are capable of achieving
the intended control for identified hazards.
The HACCP Team Leader shall provide answers to the following questions:
 Have potential hazards been correctly identified as significant or not?
 Are applied control measures capable of reducing the significant hazards to an acceptable level?
 Are critical limits correct and appropriate?
 Will the corrections restore product’s safety control?
Justification for the

Checking Control Measure Critical Limits (for CCP
Selection of Critical Corrections
Effectiveness only)
Limits
Monthly check using ELISA or Absence Legislation for raw milk Return to supplier or disposal
HPLC method of milk
Determination of purity ac- Not applicable Not applicable Not applicable

cording to the standard
Monthy microbiological Pasteurization temperature Technological Flow divert and re-pasteuriza-

analysis of the product not less than 85 ° C, time- instruction of pasteur- tion
not less than 20 sec ized milk
F G H I
Checking control measure Critical limits (for CCP only) Justification for the se- Corrections
effectiveness Defines the critical limits lection of critical limits Defines the actions necessary
Defines the extent to which the determined for this CCP Defines the basis for to prevent a negative effect on
control measure is effective determining the relevant food safety when critical limit is
critical limits exceeded
[WS 7] HACCP Plan Including O-PRPs Worksheet

The HACCP Plan (including the OPRP worksheet) provides an overview of all identified CCPs and OPRPs with
control measures, limits, corrective actions and identifies the people responsible.
A blank [WS 7] HACCP Plan, including the O-PRPs worksheet, is included on the enclosed CD.
Step Critical Limits /

CCP N°
H# Step # descrip- Hazard description Control measure(s) Targets (or Limits if
OPRP N°
tion applicable)
CCP 1 C 1 Raw milk Therapeutic drugs - Control of raw milk 100% absence
receiving antibiotics: chloram- for the absence of
phenicol, tetracycline antibiotics using
family, streptomycin, the express method
penicillin (Delvotest)
O-PRP 1 P 2 Raw milk Extraneous foreign Raw milk filtering Not applicable
filtration material - glass and purity control
CCP 2 B 6 Pasteuriza- Pathogenic microor- Control of tempera- Pasterization tem-

tion ganisms, including S. ture and pasteriza- perature not less than
Aureus, L. monocy- tion timing 85° C , time not less
togenes than 20 sec
A B C D E F G
Instructions:
CCP N° Hazard Step # Step de- Hazardous agent Control measure Critical limits
OPRP N° class Defines scription description Defines the control Defines the critical limits
Defines Defines the se- Defines the Defines the hazard measures selected for determined for this CCP
CCP and hazard agent quential title or de- controlled by the this hazard
O-PRP class: number scription of measure
numbers B - biological for each the process
C – chemical process step
P – physical step
A – allergen
Monitoring Corrections, Corrective actions Verification

Records
How, frequency, who? Responsibilities Responsibilities (details in WS 8)
Delvotest, each batch, Return of milk to sup- Inform dairy farm and Raw milk Control by IFA methods
by quality specialist plier or environmental veterinary service pro- receiving monthly from each sup-
disposal of product/ vider, identifying reasons log plier, laboratory technician
procurement manager for therapeutic drugs use/
quality manager
Determination of purity Repeated filtering by Unannounced audit of Filtering Checking of cooling log by
according to standard, quality specialist supplier co-ordinated by and cooling laboratory manager
each batch, quality the quality manager log
specialist
Automatic registra- Stopping milk supply Checking technical condi- Pasteriza- Parameter control of
tion of pasterization for filling, backflow tion of the device; checking tion log, reference thermometer
temperature and time, and re-pasterization of monitoring and metering thermo- hourly by shift foreman
visual inspection of milk by pasteurization the instrument; pasteuri- gram and control of thermome-
temperature indicator, operator zation training for operator ter every shift by microbi-
continuously, by the / mechanical engineer, HR ologist
pasteurization operator manager
H I J K L
Monitoring how, fre- Corrections, responsi- Corrective actions respon- Records Verification (details in
quency, who? bilities sibilities Defines the WS 8)
Defines the monitoring Defines the actions nec- Defines actions necessary to records to be Defines the verification of
method, its frequency and essary to prevent a nega- eliminate reasons for exceed- maintained conducted actions
the person responsible tive effect on food safety ing critical limits to prevent
when critical limit is their repeated occurrence
exceeded; also identifies
the person responsible
[WS 8] Verification Plan Worksheet

The verification plan worksheet provides an overview of verification activities showing that the CCPs and
OPRPs have been implemented properly.
The FBO must establish, document and implement procedures for verification of the HACCP system. The
main purpose of verification is to determine compliance with the specifications of the HACCP system and to
confirm that the system is working effectively through the application of (auditing) methods, procedures, tests
(including random sampling and analysis) and other evaluations, in addition to monitoring.
Verification procedures should be established, documented, and should include as a minimum:

 Purpose;
 Methods, standard operating procedures or tests applied;
 Tasks and responsibilities;
 Frequency;
 Records.
These procedures shall address, as a minimum, the following topics:

 Review of the HACCP system and its corresponding records;
 Analysis of any product recalls and product dispositions;
 Assessment of all general control measures, nonconformities and corrective actions taken to confirm
effective control of CCPs;
 Assessment of all general control measures to seek confirmation of implementation and to demon-
strate effective control of associated hazards;
 Conformity of the actual flow diagrams and layout with the documented situation;
 Conformity of O-PRP and CCP documents with the operational situation;
 Analysis of customer and consumer complaints related to hygiene and food safety;
 Review of analytical outcome of random sampling and analysis of products;
 Evaluation of compliance in the context of applicable legislation and regulations (as well as with fore-
seeable changes in legislation and regulations), and identification of changes in legislation and regula-
tions concerning food safety;
 Review of gaps between current and target levels of knowledge, awareness and staff training with
respect to hygiene and food safety, and the results in terms of effective (on the job) training sessions;
 Consistency of the current documentation.
A blank [WS 8] verification plan worksheet is included on the enclosed CD.

Verification
Procedure
(e.g. methods or
Verification Activity procedures to Frequency Responsible Records
CCP No:
(e.g of CCP monitoring use, observations (how often is (who is (which records
or O-PRP
or OPRP functioning, to be made or the task to be responsible should be
No:
corrective actions) measurements to performed) for the task) used)
be taken, actions if
there is a deviation
or follow-up)
CCP 1 Verify the input and Selective periodic Monthly for each FS Manager Register of
efficiency control of raw monitoring and con- supplier and weekly input control
milk in the absence of trol of records Laboratory Laboratory
therapeutic drugs Manager technician
workbook
O-PRP 1 Monitor implementa- Periodic control of Weekly Laboratory Cleaning and

tion of the raw material cleaning process and Manager cooling Register
filtration procedure and records for cleaning
its effectiveness and cooling
CCP 2 Verifying milk pasteriza- Periodic control of Control of reference Shift Supervi- Milk pasteriza-
tion, its effectiveness pasterization tem- thermometer param- sor tion register
and efficiency perature and time eters - hourly Micrrobiolo- Thermogram
Periodic control of Control of thermo- gist Peroxidaze milk
thermograms; grams - every shift Quality Spe- test register
Peroxidaze test Peroxidaze test - cialist
every shift
A B C D E F
Instructions:
CCP N° Verification activity Verification proce- Frequency Responsible Records

OPRP N° Defines the purpose of dure Defines the frequency Defines in- Defines the
Defines the verification Defines the methods with which verification dividual and/ records to be
CCP and or procedures to use, should be conducted or depart- maintained
O-PRP observations to be ment/function
numbers made or measure- responsible
ments and actions for conducting
taken if there is a de- verification
viation or follow-up
[WS 9] Modifications and Follow-Up Worksheet

The modification and follow-up worksheet details any modifications to the plan and outlines/tracks any fol-
low-up that may be required.
This worksheet references details regarding process steps and hazards.
A blank [WS 9] modifications and follow-up worksheet blank is included in the enclosed CD.
Production Process Provisional Control

Hazard Description Modification
Steps Measure(s)
Step # Step De- Hazard Hazard- Modifi- Recommended Modi- Limit Immediate measures
scription # ous Agent cation fication and Confir- date to be applied while
Descrip- N° mation of Transfer for modifications are not
tion Action yet implemented
8 Filling P1 Foreign 2 Implement control 20-2- None

Body of the packaged milk 2015
with x-ray dector to
reveal foreign bodies
8,3 Handling B1 E. Coli 1 Used for rinsing con- 20-2- Increased to weekly
contain- tainers pasteurized or 2015 the frequency of mi-
ers with additionally purified crobiological control of
water water water used
A B C D E F G H
Instructions:
Step # Step de- Hazard Hazard- Modifi- Recommended modi- Limit Provisional control
Defines scription # ous agent cation fication and confirma- date measure(s)
se- Defines Defines descrip- # tion of transfer to for Defines Defines the immediate
quential the title or the tion Defines action the provisional (contain-
number descrip- hazard Defines the Defines the recommend- planned ment) control measure
for each tion of the agent the hazard modi- ed modification and date for to be applied when
process process code: controlled fication confirmation of informa- cor- modifications are not
step step B1; C1, by the number tion to be transferred to rective yet implemented
P, A measure relevant department/ action
group for action
[WS 10] Meeting Summary Worksheet

The meeting activity log worksheet records meetings, attendances and decisions made by the team.
Meetings of HACCP/Food Safety Team enable the the entire team to be informed about implementation and
effectiveness of their food safety system. They are an important means of information transfer.
Every HACCP/Food Safety Team should have regularly scheduled meetings. In the case of unpredicted events,
the HACCP/Food Safety Team may have unscheduled meetings.
A blank [WS 10] meeting summary worksheet is included in the enclosed CD.
Outcome (deci-
Date Partcipants Purpose Responsibility Performed
sions/actions)
1-Feb-15 G Moran Review/update Updated the G Moran 5-Feb-15

O Brown the product de- product descrip-
M Rodrigues scription tion
B Jackson
D Smith
O Murphy
C Flack
N Williams
12-Dec-15 G Moran Verify the flow- No action re- G Moran 20-Dec-15

O Brown diagram, compare quired
M Rodrigues document versus
B Jackson practice
D Smith
O Murphy
C Flack
N Williams
A B C D E F
Instructions:
Date Participants Purpose Outcome Responsibilities Performed

Shows meeting Lists those HACCP Details the reasons Details decisions Identifies the indi- Shows actual
dates team members for the meetings made at the meet- viduals responsible completion dates
(and invitees) ating (for example, for executing deci-
tending next steps) sions
[WS A] Hazard Agent Codes and Classification Worksheet

Hazard agents codes and classification worksheets enable coding and classification of potentially hazardous
agents.
This is an optional activity in the implementation of the HACCP toolkit.
Ingredient or Process H# Hazard Class Hazardous Agent Description
Raw milk B1 Biological Presence of vegetative pathogens (Salmonella, Staphylococcus aureus,

L monocytogenes, Listeria, Shigella)
C1 Chemical Presence of therapeutic drugs - antibiotics: chloramphenicol, tetracy-

cline family, streptomycin, penicillin
C2 Chemical Presence of mycotoxins
C3 Chemical Presence of toxic elements (heavy metals)
P1 Physical Extraneous material (not less then 2mm- glass, stone…)
A1 Allergen Allergy to cow milk protein
Pasteurized milk B1 Biology Presence of vegetative pathogens
B2 Biology Contamination of vegatative pathogens
Other ingredients/ B1 Biological Presence of vegetative pathogens

packaging materials
C1 Chemical Presence of toxic or carcinogenic substances
P1 Physical Extraneous material
Water B1 Biological E.coli
A B C D
Instructions:
Ingredient or process H# Hazard class Hazardous agent description

Details of the ingredient Defines This column Defines the hazard controlled by the measure
or process the defines the
hazard hazard agent
agent class:
code: B – biological
B1; C1, P, C – chemical
P – physical
A – allergen
[WS B] Hazard Assessment Table

The guidance table for worksheets provides guidance for the FBO HACCP/Food Safety Team when assigning
risk associated with each hazard type. The risk table is based on ISO 31000:2009 and ISO 2000:2005.
Severity of Health
Effect
Can cause
5
fatality
Significant
(controlled by OPRPs or CCPs)
Can lead to
4
serious illness
Can cause
3
illness
Can cause
2
inconvenience
Insignificant
(controlled by PRPs)
Almost no
1
significance
Score 1 2 3 4 5
Rare Could occur Likely Frequent Very frequent
(1 year) (1 / 6 month) (1 / month) (1 / week) (1 / day)
Likelihood of Occurrence
The Hazard Assessment Table helps to separate significant from non-significant hazards and to document
the decision:
[WS C] List of Supporting Documents Worksheet

This worksheet records and files supporting information relevant to the HACCP system.
Registration must include the list of current foreign and local legal and regulatory requirements for food safety,
including those relating to raw materials, services and products, and applicable codes of practice, along with
customer requirements (and any additional requirements) related to food safety products.
Document Title and Status and Issue of Document

No. Filing Location
Designation the Document Developer
1 ISO 22000–2005 Valid from 01.09.2005, ISO Standardization and

first edition Certification Office
2 Enterprise standard IMS 008 Valid from 01.01.2011, Head of Pro- Standardization and
“Purchases of Raw and Auxiliary first edition curement and Certification Office
Materials” Logistics
3 Sanitary norms, rules and Valid from 09.06.2009 Ministry of Standardization and
hygienic standards “Hygienic Health Certification Office
Requirements for Quality and
Safety of Food Raw Materials
and Food Products,” approved
by the Ministry of Health dated
of 09.06.09 No. 63
A B C D E
Instructions:
Sequential number Document title and designation Status and issue of Document Filing location
Provides the sequen- Indicates the document number document developer Records the location of
tial number assigned and title Indicates the date pub- Identifies the the document
to each document in lished and, if needed, document au-
the register the document issue. thor or publisher
FSMS Procedures
and Documentation
MODULE 5
170 MODULE 5 FSMS PROCEDURES AND DOCUMENTATION
Documentation Overview
Introduction
The seventh and final principle of HACCP is to establish effective record-keeping procedures that document
the food safety management system. Maintaining complete and accurate records is essential to ensure ef-
fective monitoring of the Food Safety Management System and demonstrate compliance with food safety
requirements.
The structure of the documentation used in the Food Safety Management System is hierarchical, which facili-
tates the distribution, maintenance and understanding of the documentation.
Figure 1 illustrates a typical hierarchy of HACCP documentation. The development of a hierarchy depends on
the circumstances of the organization.
Figure 1
Food Safety Policy
Food Safety Management
and Objectives
System Documentation Level 4
Hierarchy
HACCP
Level 3 Plans
Standard Operating
Level 2 Procedures and PRPs
Other Documentation/
Level 1
Records
The extent of the Food Safety Management System documentation can differ from one organization to an-
other due to the:
a) size of the organization and type of activities;
b) complexity of processes and their interactions; and
c) competence of personnel.
HACCP documentation may be in any type of media, such as hard copy or electronic media.
Documentation Overview 171
Purpose and Benefits

The purposes and benefits of having Food Safety Management System documentation for an organization
include, but are not limited to, the following:
a) Describing the Food Safety Management System of the organization;
b) Providing information for cross-functional groups so that they may better understand interrelationships;
c) Communicating management’s commitment to food safety to employees;
d) Helping employees understand their role within the organization, thus giving them an increased sense
of the importance and purpose of their work;
e) Building mutual understanding between employees and management;
f) Providing a basis for expectations of work performance;
g) Stating how things are to be done in order to achieve specified requirements;
h) Providing objective evidence that specified requirements have been achieved;
i) Providing a clear, efficient framework of operation;
j) Providing a basis for training new employees and periodic re-training of current employees;
k) Providing a basis for order and balance within the organization;
l) Providing consistency in operations based on documented processes;
m) Providing a basis for continual improvement;
n) Providing customer confidence based on documented systems;
o) Demonstrating the capabilities within the organization to interested parties;
p) Providing a clear framework of requirements for suppliers;
q) Providing a basis for auditing the Food Safety Management System;
r) Providing a basis for evaluating the effectiveness and continuing suitability of the Food Safety
Management System.
Food Safety Policy and its Objectives

The Food Safety policy and its objectives should be documented either as an independent document or in-
cluded in the food safety management system. The Food Safety Policy should contain the relevant defined
requirements specified by the GFSI Food Safety Scheme.
Food Safety Objectives should be SMART, i.e. Specific, Measurable, Attainable, Realistic and Time bound. Food
Safety Objectives should be consistent with the Food Safety Policy and should be consistent with the primary
aim of the GFSI Food Safety Scheme, i.e. eliminate or reduce relevant food safety hazards.
Documented procedures
Structure and format
The structure and format of documented procedures (hard copy or electronic media) should be defined by the
organization in the following ways: text, flow charts, tables, a combination of the above, or any other suitable
method in accordance with the needs of the organization. The documented procedures should contain the
necessary information and should contain a unique identification.
Documented procedures may make reference to work instructions that define how an activity is performed.
Documented procedures generally describe activities that cross different functions, while work instructions
generally apply to tasks within one function.
Contents
Title
The title should clearly identify the documented procedure.
Purpose
The purpose of the documented procedure should be stated.
Scope
The scope of the documented procedure, including areas to be included or not included, should be described.
Responsibility and authority
The responsibility and authority of people and/or organizational functions, as well as their interrelations as-
sociated with the processes and activities described in the procedure, should be identified. These may be de-
scribed in the procedure in the form of flow charts and descriptive text as appropriate for clarity.
Description of activities
The level of detail may vary depending on the complexity of the activities, the methods used, and the levels of
skills and training of people that is necessary in order for them to accomplish the activities. Irrespective of the
level of detail, the following aspects should be considered as applicable:
a) Defining the needs of the organization, its customers and suppliers;
b) Describing the process steps in terms of text and/or flow charts related to the required activities;
c) Establishing what is to be done, by whom or by which organizational function: why, when, where and
how;
d) Describing process controls and controls of the identified activities;
e) Defining the necessary resources for the accomplishment of the activities (in terms of personnel, train-
ing, equipment and materials);
f) Defining the appropriate documentation related to required activities;
g) Defining the input and output, associated with each process step;
h) Defining the measurements to be taken.
The organization may decide that some of the above information is more appropriate in a work instruction.
Records
The records related to the activities in the documented procedure should be defined in this section of the
documented procedure or in other related section(s). The forms to be used for these records should be identi-
fied as applicable. The method required to complete, file and keep the records should be stated.
Appendices
Appendices containing information supportive to the documented procedure may be included, such as tables,
graphs, flow charts and forms.
Review, approval and revision
Evidence of review and approval, status and date of revision of the documented procedure should be indicated.
Identification of changes
Where practicable, the nature of the change should be identified either in the document or the appropriate
attachments.
Work instructions
Structure and format
Work instructions should be developed and maintained to describe the performance of all work that would be
adversely affected by lack of such instructions. There are many ways of preparing and presenting instructions.
Work instructions should contain the title and a unique identification. The structure, format and level of detail
used in the work instructions should be tailored to the needs of the organization’s personnel and depends on
the complexity of the work, the methods used, training undertaken, and the skills and qualifications of such
personnel.
The structure of the work instructions may vary from that of documented procedures.
The work instructions may be included in the documented procedures or referenced in them.
Contents
Work instructions should describe critical activities. Details which do not give more control of the activity
should be avoided. Training can reduce the need for detailed instructions, provided the persons concerned
have the information necessary to do their jobs correctly.
Types of work instructions
Although there is no required structure or format for work instructions, they generally should convey the pur-
pose and scope of the work and the objectives, and make reference to the pertinent documented procedures.
Whichever format or combination is chosen, the work instructions should be in the order or sequence of the
operations, accurately reflecting the requirements and relevant activities. To reduce confusion and uncertainty,
a consistent format or structure should be established and maintained.
Review, approval and revision
The organization should provide clear evidence of review and approval of work instructions and their revision
level and date of revision.
Records
Where applicable, the records specified in the work instruction should be defined in this section or in other
related section(s). The minimum food safety records required are identified in the relevant GFSI food scheme.
The method required to complete, file and keep the records should be stated. The forms to be used for these
records should be identified as applicable.
Identification of changes
Where practicable, the nature of the change should be identified either in the document or the appropriate
attachments.
Food Safety Plans

A food safety plan, also often referred to as a HACCP Plan (Hazard Analysis Critical Control Point) is a set of
written procedures that will help eliminate, prevent or reduce food safety hazards that may cause your cus-
tomer to become ill or injured. The contents of the Food Safety Plan are defined by Codex and the details can
be found in detail in Module 4 of the IFC Food Safety Toolkit.
Specifications
Raw Material, Ingredient and Product-contact Materials [Packaging] Specification Contents
All raw materials, ingredients and product-contact materials shall be described in documents to the extent
needed to conduct the hazard analysis, including the following, as appropriate:
a) Biological, chemical and physical characteristics;
b) Composition of formulated ingredients, including additives and processing aids;
c) Origin;
d) Method of production;
e) Packaging and delivery methods;
f) Storage conditions and shelf life;
g) Preparation and/or handling before use or processing;
h) Food safety-related acceptance criteria or specifications of purchased materials and ingredients ap-
propriate to their intended uses.
The organization shall identify statutory and regulatory food safety requirements, or the organization’s food
safety requirements that are more strict then statutory and regulatory food safety requirements related to the
above. The descriptions shall be kept up-to-date.
Finished Product Specification Contents
The characteristics of end products shall be described in documents to the extent needed to conduct the haz-
ard analysis, including information on the following, as appropriate:
a) Product name or similar identification;
b) Composition;
c) Biological, chemical and physical characteristics relevant to food safety;
d) Intended shelf life and storage conditions;
e) Packaging;
f) Labelling relating to food safety and/or instructions for handling, preparation and usage;
g) Method(s) of distribution.
The organization shall identify statutory and regulatory food safety requirements related to the above.
The descriptions shall be kept up-to-date.

Forms
Forms are developed and maintained to record the data demonstrating compliance to the requirements of the
Food Safety Management System.
Forms should contain a title, identification number, revision level and date of revision. Forms should be refer-
enced in, or attached to, the quality manual, documented procedures and/or work instructions.
Records
Food Safety Management System records state results achieved or provide evidence that the activities indi-
cated in the documented procedures and work instructions are performed. The records should indicate the
compliance with the requirements of the Food Safety Management System and the specified requirements
for food safety. The responsibilities for preparation of records should be addressed in the Food Safety Manage-
ment System documentation.
Records are the only references available to trace the production history of a finished product.
Records can be used as a tool to alert the operator to potential problems before they lead to the violation of
a critical limit.
Records can serve as evidence that proper procedures are being followed.
NOTE: Records are not generally under revision control as records are not subject to change.
Process of Approval, Issue and Control of Food Safety Management

System Documents
Review and approval
Prior to issue, the documents should be reviewed by authorized individuals to ensure clarity, accuracy, ad-
equacy and proper structure. The intended users should also have the opportunity to assess and comment on
the usability of the documents and on whether the documents reflect actual practices. Release of documents
should be approved by the management responsible for their implementation. Each copy should have evi-
dence of this release authorization. Evidence of approval of documents should be retained.
Distribution
The method of distribution of the documents by authorized personnel should ensure that pertinent issues of
appropriate documents are available to all personnel who will need the information included in the docu-
ments.
Proper distribution and control may be aided, for example, by using serial numbers of individual copies of the
documents for recipients. Distribution of documents such as the HACCP Manual may include external parties
(e.g. customers, certification bodies and regulatory authorities).
Incorporation of changes
A process for the initiation, development, review, control and incorporation of changes to the documents
should be provided. The same review and approval process used in developing the original documents should
apply when processing changes.
Issue and change control
Document issue and change control are essential to ensure that the contents of the documents are properly
approved by the authorized personnel and that the approval is readily identifiable. Various methods may be
considered for facilitating the physical process of making changes.
A process should be established to ensure that only the appropriate documents are in use. Under certain cir-
cumstances, the appropriate document to be used may not be the latest revision of the document. Revised
documents should be replaced by the latest revision. A document master list with revision level may be used
to assure the users that they have the correct issue of authorized documents.
The organization should consider recording the history of changes to the documents for legal and/or knowl-
edge preservation purposes.
Uncontrolled copies
For the purpose of tenders, customer off-site usage and other special distribution of documents where change
control is not intended, such distributed documents should be clearly identified as uncontrolled copies.
NOTE Failure to provide assurance of this process can cause unintended usage of obsolete documents.
Record Retention
Storing records
Records can be stored as case files, log books, softcopy databases, etc. FBOs should take reasonable steps to
ensure training records are stored in a secure location and are not available to others who are not authorized
to have access. FBOs also need to have a policy on backing up soft-copy data, access rights and security. Pre-
cautions should be made to protect soft copy records from electronic viruses or technical failure, and written
records from damage due to fire, water, rodents or insects (e.g. termites).
Protecting records
FBOs should develop their own confidentiality policy to protect their training written and electronic records
and other sensitive information, and the obligations of all employees to abide by them. FBOs should seek to
balance an individual’s right to confidentiality with their right to services and protection.
Access to records
When providing auditors with access to their training records, FBOs should take steps to protect the confi-
dentiality of employees and other individuals identified or discussed in such records. Both auditor requests
and the rationale for withholding records should be documented in the client’s files. Sensitive and confidential
information must be released only to authorized parties with employee consent, wherever applicable.
Record Maintenance and Destruction

Update of records
FBOs should develop their own internal policy on time frames for update of records.
FBOs should store training records for at least six years, where practical, as this is a general GFSI scheme re-
quirement. FBOs need to ensure that their record-keeping practices comply with all contractual, regulatory
or legal requirements. The transferring or disposing of FBO training records should be conducted in a manner
that protects employee confidentiality.
Electronic or Hard Copy Records?

Electronic records
Keeping training records in soft copies allows for easy access, transfer and saves storage. However, keeping re-
cords via an electronic tool such as the Personal Digital Assistant (PDA) whilst conducting intake assessments
of new clients, for example, may seem impersonal and inappropriate. If documentation and records are stored
electronically, it is important for the FBO to develop its policies and procedures for information management
and technology, including system maintenance, monitoring access and staff training.
Written records
Written records are common and more personable to employees and auditors. However, they are at times
difficult to read due to varying and unique handwriting. In addition, duplicate copies have to be made for
transmission to other parties or agencies.
FBOs could consider all factors and choose a system that meets their needs, to ultimately benefit the FBO,
employees and auditors served.
Why review records?
It is good practice to review records so that improvements in training design and delivery can be made. Hence,
records should be reviewed periodically to establish whether:
 Assessments conducted were thorough, complete and timely;
 Clients were actively involved in making informed choices regarding services received;
 Clients were given appropriate services to achieve client outcomes;
 The achievement of client outcomes could be improved upon.
Samples of Food Safety Management System Procedures
1. Control of Documents
2. Control of Records
3. Complaint Management
4. Control of Nonconforming Product
5. Calibration
6. Corrective and Preventive Action
7. Internal Auditing
8. Traceability
9. Product Recall and Withdrawal
10. Mock Recall
11. Food Defence
12. Allergen Control
13. Hygiene Procedure
14. Identification and Evaluation of Compliance
The standard operating procedures [SOPs] included here are for illustrative purposes only. The
IFC accepts no liability for the content contained within these SOPs. The FBO may use these
SOP’s as a starting point or baseline for developing their own SOPs. It is expected the FBO will
amend the contents of any SOP’s contained within the FSTK will be amended to fit the unique
needs of the FBO’s organization.
FBO Procedure Control of Documents 179
Control of Documents
FBO Procedure
Document # SOP-001
Created 20-04-2015
Updated 24-04-2015
Controller Document Controller
Owner Food Safety Manager
Information in this document must be kept confidential as per its classification be-
Confidentiality Statement
low and the rules of disclosure.
All documents within FBO are classified in the following way: PUBLIC documents are intended for anyone; COM-
MERCIAL IN CONFIDENCE documents are to be kept confidential between restricted individuals within the FBO
and partner organizations; COMPANY CONFIDENTIAL documents are to be kept confidential within the FBO and
used for normal business activities by the general office population; HIGHLY CONFIDENTIAL documents are to be
kept confidential to restricted individuals within the FBO.
© Copyright FBO. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in
any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the written permission of FBO.
Classification Company Confidential
Revision History
Date Version Author Comments (including Review History)
20-04-2015 Draft 01 Joe Bloggs Initial document for review and discussion.
24-04-2015 V1.0 Joe Bloggs Approved and released by process owner.
Contents
1 Summary..........................................................................180 6 Procedure Notes ......................................................... 185
2 Related Documents ...................................................180 7 The Document Management System ................187
3 Definitions ....................................................................... 181 7.1 General .......................................................................187
7.2 Access Rights ..........................................................187
4 Introduction ................................................................... 181
7.3 Documentation Review.....................................187
4.1 General....................................................................... 181
7.4 Obsolete Documents .........................................187
4.2 Document Control Policy ................................ 182
7.5 Documentation Disposal ..................................187
4.3 Content of Documents ..................................... 182
7.6 Documentation Archival ...................................187
4.4 Documents of External Origin .......................183
7.7 Documentation Numbering ........................... 188
5 Procedure Flow Chart ............................................... 184
8 Records ............................................................................ 188
5.1 Document Control ............................................... 184
Classification Company Confidential Control of Documents

Doc ID SOP-001 Printed Controller Document Controller
Page 1 of 10
Created 20-04-2015 Updated 24-04-2015 Owner Food Safety Manager
1 Summary
Purpose The purpose of this procedure is to describe the:

 Methodology in place to control all documentation relevant to the Food Safety
Management System.
Scope This procedure applies to:
 The creation, review, approval, obsolescence, archival, disposal/ destruction of
Food Safety Management System documentation.
 The control of documents of external original determined to be necessary for
the planning and operation of the Food Safety Management System.
 The control of the company portal, website and marketing materials.
Functional The functional responsibility for this procedure lies with the Food Safety Manager.
Responsibility They are responsible for the effective implementation and maintenance of this pro-
cedure.
2 Related documents
Policies Food Safety Policy, POL-001

Processes N/A
Procedures Control of Records, SOP-002
Work Instructions N/A
Document Request Form
Forms
Disposal/Archival Request Form
Other N/A

Page 2 of 10
3 Definitions
Term or Acronym Description

FBO Food Business Organization
FSM/MR Food Safety Manager/Management Representative
FSMS Food Safety Management System
Hazard Analysis Critical Control Point – a system that identifies, evaluates,
HACCP
and controls hazards which are significant for food safety
A document prepared in accordance with the principles of HACCP to ensure
HACCP Plan control of hazards which are significant for food safety in the segment of the
food chain under consideration
Information and the media on which it is contained (clause 3.7.2 of ISO
Document
9000:2005)
Document Controller The person responsible for the control of documentation
DMS Document Management System
Document Template The template used to create documentation.
4 Introduction
4.1 General
Documentation is used by an organization to ensure communication and consistency of action. The effec-
tive use of documentation enables:
 Achievement of conformity to customer requirements and quality improvement;
 Provision of appropriate training;
 Repeatability and traceability;
 Provision of objective evidence; and
 Evaluation of the effectiveness and continuing suitability of the FSMS.
In a Food Safety Management System the following documentation may typically occur:
 Documents that provide consistent information, both internally and externally, about the organiza-
tion’s management system; referred to as Management System Manuals (e.g. Food Safety/Food
Safety Management System Manual);
 Documents that describe how the Food Safety Management System is applied to a specific product;
referred to as PRPs, O-PRPs, HACCP Plans, etc.;
 Documents stating requirements; referred to as specifications;
 Documents stating recommendations or suggestions; referred to as guidelines;

Page 3 of 10
 Documents that provide information about how to perform activities and processes consistently;
referred to as documented procedures, work instructions and drawings, forms, document tem-
plates and other documentation;
 Documents that provide objective evidence of activities performed or results achieved; referred to
as records.
4.2. Document Control Policy

An electronic document management system has been implemented to control all documents falling under
the scope of the Food Safety Management System. This system allows documentation, in electronic format,
to be available, accessible and controlled.
The controlled master documents are held in the DMS. Any printed copies are valid only on the day of print-
ing and are deemed ‘uncontrolled’ thereafter.
Employees are not permitted to hold any versions of Food Safety Management System documentation on
their personal hard drives and to review/obtain all copies of required documents from the DMS.
Records are a special type of document and are controlled as per procedure SOP-002 Control of Records.
4.3 Content of Documents

As part of the standardisation process, all Food Safety Management System documentation will follow the
same format. In general, all company documentation must:
 Clearly display the company logo in the header;
 Identify the number and total number of pages in the footer;
 Control number;
 Name;
 Revision number.
For procedures and work instructions, the following numbering and sections are required:
1. Summary, including purpose, scope and functional responsibility;
2. Related documents table, including policies, processes, procedures, work instructions, forms and
others;
3. Definitions table;
4. Introduction to the procedure;
5. Procedure flowchart;
6. Procedure notes;
7. Records table.
Sub sections may be added as necessary and the layout of this procedure (document control) used as the
example to follow.
The format of the header and footer in this procedure (document control) must be used and edited ap-
propriately for all other procedures.

Page 4 of 10
4.4 Documents of External Origin

Where deemed necessary for the planning and operation of its processes and activities, the organization
may obtain documents from external sources. These documents may be in any medium, e.g. DVD, CD.
These documents must be controlled if a library is maintained within the FBO. Most Food Safety Schemes
require access to such documents and not necessarily a physical or electronic storage of documents of
external origin.
Examples of external documents include:

 Equipment manuals in hardcopy of CD/DVD;
 Building drawings;
 Customer specifications;
 Other legislative or regulatory requirements;
 International standards (e.g. ISO 22000:2005).
On receipt of or notification of an external document of relevance, the relevant department must inform
the document controller so that the document can be recorded in and controlled via the DMS.
This control, through the DMS, will extend to:

 Assigning a control number (where one does not already exist);
 Assigning a receipt date (receipt by the company of the document);
 Assigning a revision number (where one does not already exist);
 Recording the distribution of the document within the company.
Documents of external origin requiring a control number and a revision number will adhere to the follow-
ing format:
EXT xxx yyy Name of Document Revision zzz
Where:
 EXT = identifies the document as external in origin;
 xxx = identifies the applicable company department e.g. compliance;
 yyy = next control number available;
 zzz = revision control number.
The document controller will be responsible for the naming and numbering of all documents of external
origin. The receipt date will be noted in the DMS as a note to the document.
Where a document of external origin of relevance is referenced in the DMS and not stored the linkage to
the online location should be recorded and maintained by the Document Controller.
Any updates to documents of external origin will be reviewed by the relevant department, an assessment
of applicability made and the appropriate actions taken. The newer version of the external document will
be controlled as outlined above and the previous version obsoleted.

Page 5 of 10
5. Procedure Flow Chart

5.1 Document Control
Responsibility PROCESS Record(s)
Start
1.
Need for
Employee document
identfied
2.
Declined
Need
Manager End
reviewed
Agreed
3. Role Appointees
Document Controller Roles assigned
4.
Draft Document
Author Draft document
created
5.
Draft Document
Document
Author
classified
6. Draft Document
Author Draft sent for
approval
7а. No 7. Draft Document

Amendments Approved?
Author/ Approver(s)
made Approved
Document
8а. 8.
HR/Document Postpone release Yes
Training Training Plan
Controller until training Need?
completed
No
9.
Yes Obsolete version
9а. Previous
Document Controller
Make obsolete Version?
No
9b. 9c. 10. Released

Disposal Archival Document Document
Document Controller
process process released Archived
Document
Disposal
Authorisation
End

Page 6 of 10
6 Procedure Notes
Step 1
The potential need for a new document can be raised by any employee.
Step 2
This need must be reviewed by the Process Owner [or Head of Department] to ensure that it is a valid
requirement and that no other document already exists that covers the identified need, or that could be
amended to meet the need. Where the need is declined, the process ends at this point.
Step 3
Once the need has been accepted, the relevant documentation players are appointed, namely the docu-
ment:
 Sponsor – the person who determined that the need was valid. Can also be the process owner;
 Manager – the person with responsibility and authority for the flawless implementation and man-
agement of the procedure;
 Approver(s) – those with review and approval responsibility and authority related to the document;
 Author – the person who creates/writes the document utilizing the approved document template;
 User – the person with the responsibility for conforming to the procedure and advising of any chang-
es if required.
Step 4
The author will create the document, either within the DMS or external to the DMS, utilizing the approved
document template. The following also need to be defined at this stage:
 The effective date of the procedure;
 The review period, e.g. 12 months or sooner;
 Any verification [testing] associated with the procedure, e.g. quiz;
 Identifying the relevant interested parties;
 Identifying other documents impacted by this procedure and notifying the relevant process owners.
This is also the point in the document control process where the control of changes to existing documents
begins.

Page 7 of 10
Step 5
The author, in association with the sponsor and owner, will classify the document in accordance with its
proposed usage and circulation. Classifications include the following:
 PUBLIC documents are intended for anyone;
 COMMERCIAL IN CONFIDENCE documents are to be kept confidential between restricted individu-
als within FBO and partner organizations;
 COMPANY CONFIDENTIAL documents are to be kept confidential within the FBO, and used for
normal business activities by the general population;
 HIGHLY CONFIDENTIAL documents are to be kept confidential to restricted individuals within the
FBO.
Step 6 & 7
Once the author is satisfied with the level of detail in the procedure, he or she will verify the procedure
matches current operational practices, relevant statutory and regulatory and conformity requirements prior
to submitting for approval. This can be achieved through discussions with the relevant departments.
The document is then sent for approval via the DMS (or manually) to each of the specified approvers. All
approvers are required to read and evaluate the document and signify their approval or disapproval of the
content. Where approved the document moves to the next stage of the process; however, if one or more
approvers reject the document, it returns to the author for the appropriate amendments to be made. It will
then be re-submitted for approval.
This approvals loop may go through several iterations.
Step 8 & 8a
Once the document is approved, the impact of the document will be assessed and any training needs iden-
tified. The effective date of this procedure will be postponed until any required training has been success-
fully completed. The DMS has the ability to test persons on their understanding of a process or procedure
via a quiz.
Step 9
The DMS will automatically remove obsoleted versions of a document.
Step 9a, 9b & 9c
The DMS will automatically archive / dispose of obsoleted documents.
Step 10
The approved document is released on the DMS and the relevant personnel are informed as to its release.

Page 8 of 10
7. The Document Management System

7.1 General
A DMS has been implemented within the company to ensure the necessary control of all documentation
that falls under the scope of the FSMS. This DMS covers and provides evidence of the control of documen-
tation in line with the flow chart outlined in Section 5 of this procedure and the notes outlined in Section
6 of this procedure.
7.2 Access Rights

Access rights to the DMS have been assigned as follows:
 Full access:
• The Food Safety Manager
• The Document Controller
 Edit / Amendments:
• Document owners
• Document approvers
• Document authors
 Read Only:
• Authorized employees
Only the Document Controller and the Food Safety Manager may release a document in the DMS, subject
to a successful approvals process being completed.
7.3 Documentation Review

When placing a document within the DMS structure a review timescale is required to be defined. The
Document Controller will monitor and ensure these timescales are being adhered to.
7.4 Obsolete Documents

The DMS will automatically remove obsolete documents from view. Where hard copy obsolete documents
held for legal, knowledge retention or other purposes will be clearly marked as “obsolete” to prevent their
unintended use. Obsolete documentation held on the DMS may only be accessed by the Document Con-
troller and the Food Safety Manager.
7.5 Documentation Disposal

Authorisation via the DMS, must be granted for disposal of a document. Documents may be disposed of
through deletion from the DMS or shredding of physical documents.
7.6. Documentation Archival

The archival of documents is managed automatically within the DMS.

Page 9 of 10
7.7 Documentation Numbering

All documents within the scope of the management system shall follow the naming structure outlined
below:
Document type Numbering structure Example

POL FSMS 001 Food Safety Policy
Policy POL. xxx yyy Name Revision number
Rev 01
PRD QMS 001 Document Control
Procedure PRD xxx yyy Name Revision number
Rev 01
WI QMS 001 Writing a job descrip-
Work instruction WI xxx yyy Name Revision number
tion Rev 01
Specification SPEC xxx yyy Name Revision number SPEC QMS 001 Specification Rev 01
Form/Document FRM QMS 001 Master Document
FRM xxx yyy Name Revision number
Template Register
Where:
xxx = Department identification
yyy = Document number
Document numbers will be assigned by the document controller based on the documentation master list.
Only document controller is authorised to change this naming structure.
External document naming criteria are outlined in Section 4.4 of this procedure.
8 Records
Document Location Duration of Record Responsibility

Documentation Master List DMS Indefinitely Document Controller
Documentation Review Report DMS Indefinitely Document Controller
Disposal/Archival Request Form DMS Indefinitely Document Controller

Page 10 of 10
FBO Procedure Control of Records 189
Control of Records
FBO Procedure
Document # SOP-002
Created 20-04-2015
Updated 24-04-2015
and partner organizations; COMPANY CONFIDENTIAL documents are to be kept confidential within FBO and
used for normal business activities by the general office population; HIGHLY CONFIDENTIAL documents are to
be kept confidential to restricted individuals within FBO.
Revision History
24-04-2015 V1.0 Joe Bloggs Approved for release by process owner.
Contents
1 Summary..........................................................................190
2 Related Documents ...................................................190
3 Definitions ......................................................................190
4 Introduction ................................................................... 191
4.1 General....................................................................... 191
5 Procedure Flow Chart ................................................ 191
6 Procedure Notes ......................................................... 192
7 Records .............................................................................193
Classification Company Confidential Control of Records

Page 1 of 5
Control of Records
1 Summary
This procedure describes the methodology employed to control records

Purpose
developed as part of the food safety management system.
This procedure applies to the distribution, storage, preservation, legibility,
Scope
retention, disposition, access to and retrieval of records.
The functional responsibility for this procedure lies with the Food Safety
Manager, who is responsible for the effective implementation and main-
Functional Responsibility tenance of this procedure.
Departmental managers are responsible for ensuring records under their
control are managed in accordance with this documented procedure.
2 Related documents

Procedures Control of Documents, SOP-001
Work Instructions Not Applicable
Forms Master Document Register
Other Document Management System
3 Definitions

FSM/MR Food Safety Manager

Page 2 of 5
Control of Records
4 Introduction
4.1 General
Records are documents stating results achieved or providing evidence of activities performed. Records
can be either hard copy or soft copy (paper or electronic) and must be managed. Management of re-
cords is a critical factor in the Food Safety Management System as without the availability of records,
the company is unable to verify that required activities have taken place or that results have been
achieved.
1. Master Records List

Process Owner/ Records generated from
Department Manager [DMS]
output of processes
2.
Process Owner/ Records filed in defined and Master Records List
Department Manager locations and maintained [DMS]
for retention purposes
4.
Yes Master Records List
Retention
Process Owner/ [DMS]
period
Department Manager reached
No
4.
Master Records List
Ongoing legibility,
Process Owner/ 3a. 3b. [DMS]
identification and
Food Safety Manager Archival Disposal
retrieveability reviewed
through internal auditing Disposal List
Disposal
Authoritization
5.
Process Owner/ Records and associated Certificate of
Food Safety Manager/ 3c. data reviewed prior to
End Distruction
Internal Auditors Warehousing and presented at
management review

Page 3 of 5
Control of Records
6 Procedure Notes
Step 1 & 2
Through daily activities, quality records are generated that provide evidence of the completion of activities
and the achievement of results. These records are held in accordance with defined retention times and to
ensure preservation of their content, their identification and legibility. Storage of records will ensure that
they are corrupted. These requirements are listed on the Records Master List.
Step 3
Once the retention period for the records has been reached, the Process Owner and the Food Safety Man-
ager must decide what to do with these records. The Compliance Department will be queried to determine
if any compliance issues related to the specific records exist and need to be met.
Step 3a & 3b
Where a decision to archive the records is made, these records must be suitable boxed to preserve their
integrity. The box must be labelled clearly as to its contents (date, type of record, origin of records, etc.). An
email is then sent by the process owner or their delegate to the warehouse informing the warehouse team
to expect the delivery of the boxes. The Process Owner or their delegate will arrange for the delivery of the
boxes to the warehouse.
Step 3c
Where the decision is to dispose of the records, the Process Owner and Food Safety Manager must autho-
rize this disposal. A list of all documents to be disposed of must be created and signed off by the above to
signify their approval to dispose of the records. It is the responsibility of the process owner to create the
disposal list and obtain the necessary approvals to dispose. Where such records are held in the warehouse,
a written instruction must be sent, following authorization, to the warehouse instructing them to dispose
of the records. Records must be disposed of in a fully traceable and confidential manner using an approved
disposals company. Shredding is the preferred manner for disposal of records. It is the responsibility of the
Food Safety Manager to obtain a certificate of destruction from the disposal company. The certificate of
destruction must be attached to the disposal list and maintained by the Food Safety Manager.
Step 4
Where the retention times are not reached, the control of records is monitored as part of the internal audit-
ing process, the FSMS internal auditing.
Step 5
The management and control of records will be reviewed as part of the management review process, under
the agenda heading of documentation.

Page 4 of 5
Control of Records
7. Records
Duration
Document Location Responsibility
of Record
Records Master List Food Safety Manager Office Indefinitely Food Safety Manager
Disposal List Food Safety Manager Office Six years Food Safety Manager
Disposal Authorisation Food Safety Manager Office Six years Food Safety Manager
Certificate of Destruction Food Safety Manager Office Six years Food Safety Manager
Warehouse Storage Location List Warehouse Manager Indefinitely Warehouse Manager

Page 5 of 5
Complaint Management
FBO Procedure
Document # SOP-015
Created 20-04-2015
Updated 24-04-2015
Revision History
20-04-2015 Draft 01 Joe Bloggs Initial draft for review and discussion.
24-04-2015 V1.0 Joe Bloggs Technical Review and update of correction and correc-
tive action procedure notes.
Contents
1 Summary................................................................................ 195 6.2 Recording of Complaint ......................................... 197
2 Related Documents ......................................................... 195 6.3 Logging of Complaint .............................................. 198
3 Definitions ............................................................................ 195 6.4 Review of Complaint - Validity........................... 198
4 Introduction ........................................................................ 196 6.5 Investigation of Complaint.................................... 198
4.1 Complaint Management ........................................ 196 6.6 Correction, Corrective Action .............................. 198
5 Procedure Flow Chart ..................................................... 196 6.7 Closure of Complaint ............................................... 198
6 Procedure Notes ............................................................... 197 7 Records .................................................................................. 199
6.1 Receipt of Complaint................................................ 197
Classification Company Confidential Complaint Management

Page 1 of 6
FBO Procedure Complaint Management 195
1 Summary
This procedure describes the methodology used by the organization to

Purpose manage complaints and maintain customer (retail and commercial) and
consumer satisfaction and trust.
This procedure applies to the receipt, review, investigation and resolu-
Scope
tion of complaints.
Functional Responsibility
Manager.
2 Related documents

Processes Food Safety, PRO-001
Procedures Control of Nonconforming Product, SOP-003
Management Review, SOP-021
Corrective Action & Preventive Action, SOP-009
Forms Complaint Form
Other Not Applicable
3 Definitions

CRO Complaint Resolution Officer
CAPA Corrective Action & Preventive Action
Company FBO
A cause that once removed from the problem fault sequence, prevents the
Root Cause
final undesirable event from recurring
A method of problem solving that tries to identify the root cause of faults or
Root Cause Analysis
problems

Page 2 of 6
4 Introduction
4.1 Complaint Management
The FBO has implemented a set of flow chart steps for recording customer/consumer complaints, review-
ing these complaints, conducting investigations, determining root cause and taking actions to resolve these
complaints with a a view to preventing recurrence of the complaint.
A customer/consumer complaint can be defined as any expression of dissatisfaction made by the Com-
pany’s Customer or Consumer regarding any products or services provided by the Company. This policy
covers all written complaints, serious or unresolved telephone complaints, complaints raised in a face to
face meeting or by a third party acting for that customer such as an intermediary, legal representative or
Food Safety Regulatory Body.
5 Procedure Flow Chart
1. Communication
Customer/Consumer Records
Customer/Consumer
Feedback received
2. Complaint Register
Any FBO Employee Complaint Recorded
3. No
Complaint Complaint Register
Food Safety Manager
Valid?
Yes
Food Safety Manager/ 4. Complaint Form

Department Managers Complaint Investigation
Food Safety Manager/ 5. Complaint Form

Management Team Decisions & Actions
6. Communication
Food Safety Manager Complaint Records
Communication
7. Improvement Record
Food Safety Manager Monitor and
Measure

Page 3 of 6
6 Procedure Notes
6.1 Receipt of Complaint
A complaint can be made by a customer/consumer face to face, over the phone, by email or other method.
Where relevant food safety regulations also apply these must be completed in conjunction with this proce-
dure. If food safety regulations contain requirements that are more proscriptive or demanding they should
be adhered to.
When you receive a client complaint:

1. Listen to the client when the complaint is being given verbally, i.e. face-to-face;
2. Establish what the complaint is and record it on a complaint form;
3. Clarify with the client that you have understood the complaint correctly;
4. As a matter of good practice, apologize for the occurrence of the issue they have experienced;
5. Explain to the client that the company has a complaints policy and that the complaint will be inves-
tigated and a formal response will be issued. Also explain that this may take some time;
6. Correctly establish their contact details.
Retain copies of any documentation provided by the client and keep them with the complaint form.
6.2 Recording of Complaint

Formally complete the complaint form.
1. Date;
2. Reference number;
3. Customer name;
4. Customer contact number;
5. CPR number;
6. Customer complaint - description;
7. Action taken;
8. Final status.
Attached all documentation relating to the complaint. Forward the complaint details to the Food Safety
Manager.
The Food Safety Manager formally completes the complaint register. The client should be contacted by
phone/mail to advise that their complaint is being considered within 48 hours maximum. The complaint is
forwarded to the Food Safety Manager. A deputy may also carry out this work on behalf of the Food Safety
Manager.

Page 4 of 6
6.3 Review of Complaint - Validity

The CRO carries out an initial assessment on whether the complaint is valid or not. If it is, the complaint
goes to Step 5. If not, a formal response outlining the reasons is given as per Step 7. The complaint is for-
warded to the relevant Department Manager for investigation.
6.4 Investigation of Complaint

The Department Manager carries out a detailed investigation using the staff resources available, the Branch
Manager, the member of staff who took the initial complaint, and other members of staff as required. The
Department Manager uses the corrective action procedure to investigate the root cause, determine initial
containment actions, and corrective actions.
6.5 Action and Decision

Appropriate actions and decisions are taken following the complaint investigation and documented as a
correction and corrective action, referencing the corrective action procedure. The corrective actions are
verified for effectiveness as per the corrective action procedure. The time needed to verify effectiveness of
any corrective actions may take longer.
6.6 Closure of Complaint

The Department Manager drafts a response for the complainant. This is agreed with the Food Safety
Manager if required by the circumstances and then released to the customer/consumer. The Food Safety
Manager retains a copy of the formal response with the complaint form. Complaints are filed by reference
number and date. This should occur within 20 working days of receiving the complaint. Where required,
the complaint response is communicated to the relevant food safety regulatory body.
6.7 Monitoring and Measure

The Food Safety Manager maintains the complaint files and Complaint Register for review. The Food
Safety Manager carries out analysis of complaints (specifically recurrences) and carries out trending and
analysis of the effectiveness of the complaints system. The Food Safety Manager prepares trending data
for the Management Review process to demonstrate that the complaints are being effectively managed
to the satisfaction of the company and the client. The complaints and summaries trending are inputs into
the management review procedure. All complaints are to be completed and auditable under the internal
audit procedure. Finally, the Food Safety Manager will continue to monitor and measure the effectiveness
of actions and decisions to ensure the effectiveness and to verify if the same problem and cause occurs in
the future.

Page 5 of 6
7 Records

Complaint Form Food Safety Office 7 years Food Safety Manager
Complaint Register Food Safety Office 7 years Food Safety Manager
Complaint Investigation
Food Safety Office 7 years Food Safety Manager
Notes and Formal Responses
Trend Analysis Food Safety Office Indefinitely Food Safety Manager

Page 6 of 6
Control of Nonconforming Product
FBO Procedure
Document # SOP-003
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary.............................................................................. 201 6.1/6.2 Identification and Recording
2 Related Documents ....................................................... 201 of Non-Conformance ....................................204
3 Definitions .......................................................................... 201 6.3 Complete Investigation ....................................... 204
4 Introduction ......................................................................202 6.4 Actual Non-conformance .................................. 204
4.1 Nonconforming Product .......................................202 6.5 Correction ..........................................................................
5 Procedure Flow Chart ...................................................203 6.6 Root Cause Analysis ............................................. 204
5.1 Control of Nonconforming Product 6.7 Corrective Action .....................................................205
or Service .......................................................................203 6.8 Verification of Effectiveness ...............................205
6 Procedure Notes ............................................................ 204 6.9 Closure .........................................................................205
7 Records ................................................................................205
Classification Company Confidential Control of Nonconforming Product

Page 1 of 6
FBO Procedure Control of Nonconforming Product 201
1 Summary
This procedure describes the methodology used by the FBO to control instances
Purpose
where expected outputs have not met requirements.
This procedure applies to product delivery, i.e. ingredients, raw material, intermediate
Scope
or finished product at all levels in the organization.
Functional The functional responsibility for this procedure lies with the Food Safety Manager. They
Responsibility are responsible for the effective implementation and maintenance of this procedure.
2 Related documents
Food Safety Policy, POL-001

Policies
Customer/Consumer Complaints Policy, POL-002
Processes Departmental Process Descriptions
Procedures Corrective and Preventive Action, SOP-009
Forms Non Conformance Log (DMS)
3 Definitions

Risk Effect of uncertainty on an expected result
Nonconformity Non-fulfilment of a requirement
Corrective action Action to eliminate the cause of a nonconformity and to prevent recurrence
Correction Action to eliminate a detected nonconformity
Person or organization that could or does not receive a product or a service
Customer
is intended for or required by this person or organizations
Statutory requirement Obligatory requirement specified by a legislative body
Regulatory Obligatory requirement specified by an authority mandated by a legislative
requirement body

Page 2 of 6

Defect Nonconformity related to an intended or specified use
Output that is a result of activities where none of them necessarily is per-
formed at the interface between the provider and the customer. For the
Product
FBO this can be an ingredient, raw material, intermediate product or finished
product supplied to a customer or consumer
Intangible output that is the result of at least one activity necessarily
Service
performed at the interface between the provider and the customer
Opinions, comments and expressions of interest in a product, a service or a
Feedback
complaints-handling process
Customer’s perception of the degree to which the his or her expectations
Customer satisfaction
have been fulfilled
Expression of dissatisfaction made to an organization related to its product
Complaint or service, or the complaints-handling process itself where a response or
resolution is explicitly or implicitly expected
Permission to release a product or a service that does not conform to
Concession
specified requirements
Characteristic Distinguishing feature, inherent or assigned, qualitative or quantitative
A cause that once removed from the problem fault sequence prevents the
Root cause
A method of problem solving that tries to identify the root cause of the fault
Root cause analysis
or problem.
4 Introduction
4.1 Nonconforming Product
Nonconforming product results from a defined requirement not being met. Examples of nonconforming
product include, but are not limited to:
 Breech of statutory or regulatory compliance;
 Failure to implement and maintain a requirement of FSSC 22000/BRC/SQF;
 Failure to meet a customer requirement, both specified or implied;
 Failure to deliver a required process output.
Customer complaints are handled in accordance with POL-002 Customer/Consumer Complaints Policy.
All instances of nonconforming service must be identified, investigated and resolved to ensure continual
improvement of the FSMS and the service provided by the organization.

Page 3 of 6

5.1 Control of Nonconforming Product or Service
1. Communication
Potential Records
Employee Non-Conformance
Identified Audit Finding
2.
Relevant Department Record Non Non-Conformance
Conformance Log
3.
Relevant Department Investigation Report
Complete Investigation
Relevant Department/ 4. No Record Non Conformance

Food Safety Actual NC? Justification Log
Yes
5. Non Conformance
Relevant Department Log
Correction Taken
6. Non Conformance
Complete Root Cause Log
Relevant Department
Analysis & Determine
Impacts Root Cause Analysis
7. Non Conformance
Relevant Department
Corrective Action(s) Log
No Evidence of
Relevant Department/ 8.
Effective? Test/Verification
Food Safety
Yes
Relevant Department/ 9. Non Conformance

Food Safety Close Out Log
Non-Conformance

Page 4 of 6
6 Procedure Notes
6.1/6.2 Identification and Recording of Non-Conformance
Any employee can identify a potential non-conformity in relation to the provision of our service or the
company can be notified from an external source. Once received, the potential non-conformity must be
documented in the FSMS.
6.3 Complete Investigation

An investigation will be conducted by the appropriate department to determine the validity of the potential
non-conformity. This investigation will be in proportion to the potential risks that may arise based on the
potential non-conformity. Where there is a risk to compliance, the FSM/MR will be notified immediately
and their direction and assistance sought. The results of the investigation will be documented and for-
warded to the Food Safety Department for review.
6.4 Actual Non-conformance

A decision will be made based on the outcome of the investigation as to whether or not an actual non-
conformity exists. Where all parties agree (Food Safety and the relevant affected department) that no non-
conformity exists, then the justification for this decision will be documented and the matter closed.
6.5 Correction
Where, based on the outcome of the investigation, it is found that a non-conformity does exist, the required
correction will be taken to immediately resolve the issue.
6.6 Root Cause Analysis

A full and thorough root cause analysis will be conducted to identify the root cause of the issue. This root
cause analysis will be based on a recognized methodology (e.g. 5 Whys, Cause & Effect Diagram [Fishbone],
8D, etc.) and documented. Assistance may be sought from external parties where required. The root cause
arrived at cannot be simply stated as “human error;” if this occurs, the root cause analysis must be re-done.
Where the root cause analysis identifies other potential risks, then the appropriate preventive action must
be identified, documented and implemented.
See the Corrective and Preventive Action procedure, document ID SOP-009.

Page 5 of 6
6.7 Corrective Action

Based on the root cause identified in the previous step, the required corrective actions will be identified,
documented and implemented. Responsibilities and timelines will be established and documented for these
corrective actions. Where corrective action is planned to occur over a long time period, appropriate moni-
toring and/or measurement must be put in place to track the progress and effectiveness of the corrective
actions.
6.8 Verification of Effectiveness

After a suitable period of time has elapsed following the implementation of corrective action, the effective-
ness of the corrective action must be determined. The corrective action is aimed at eliminating the cause
of the non-conformity and also preventing recurrence, hence the verification of effectiveness must test the
possibility of the non-conformity recurring. The test performed or the data reviewed as part of this process
must be documented. Assistance from external sources may be utilized for the review of effectiveness.
Where the test shows that the corrective action has not been effective, then the root cause analysis must
be re-visited to ensure the correct cause was identified and the process repeated.
6.9 Closure
Where the verification of effectiveness of the corrective action taken is successful in determining that the
non-conformity has been rectified, then the matter is closed out and recorded as closed.
7 Records

Non-conformance log DMS Indefinitely FSM/MR
Relevant Process Owner/Department
Root cause analysis Indefinitely
department Manager
Relevant Process Owner/Department
Investigation report Indefinitely
department Manager
Evidence of the verification Relevant Process Owner/Department
Indefinitely
of effectiveness department Manager

Page 6 of 6
Calibration
FBO Procedure
Document # SOP-022
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary............................................................................................. 207
2 Related Documents ......................................................................208
3 Definitions .........................................................................................208
4 Introduction .....................................................................................209
4.1 General.........................................................................................209
5 Procedure Flow Chart ..................................................................209
6 Procedure Notes ............................................................................. 210
7 Records .................................................................................................219
Classification Company Confidential Calibration

Page 1 of 14
FBO Procedure Calibration 207
Calibration
1 Summary
This procedure describes the calibration program requirements for mea-

Purpose
surement and test equipment (MTE).
This procedure applies to measurement and test equipment, which are
devices used to test, measure, evaluate, inspect, or otherwise examine
materials, supplies, equipment, and systems, or to determine compliance
with specifications.
This also includes process control devices with the potential to impact
food safety.
This procedure shall provide instructions for the management of calibra-

tions performed on measurement and test instruments by service orga-
Scope nizations, original equipment manufacturers, contractors, or laboratories
(herein referred to as Contractors) and to ensure traceability to National
or International Standards.
This procedure states the documentation requirements for equipment

calibrated by in-house personnel.
All measurement and test equipment is to be enrolled in the Calibration

Program and/or the Preventative Maintenance Program. Enrollment shall
include measurement and test equipment designated “Reference Only”
and “No Calibration Required”.
Manager. They are responsible for the effective implementation and
Functional Responsibility maintenance of this procedure.

control are managed in accordance with this documented procedure.

Page 2 of 14
Calibration
2 Related Documents

Control of Documents, SOP-001
Procedures Non-Conformity Product, SOP-003
Corrective and Preventive Action, SOP-009
Test Equipment Installation Qualification
Forms
Measurement Instrument Status Change
Other TEM Manuals
3 Definitions

Accuracy The relative agreement of a measured value with an accepted standard
Verification of a measurement instrument’s performance against a traceable
Calibration
standard
Calibration Interval The duration of time between calibrations
The calibration of measurement instruments “as installed” in a total system and
Loop Calibration
represents calibration of the instruments “as used”
Any instrument which monitors or controls a critical parameter of a
Measurement
manufacturing process, controlled environment or used to measure a product
Equipment
or component specification
A reference tool utilized by an internationally recognized standards laboratory
National Standard
representing the country which operates that laboratory
Also known as repeatability and is the variation in readings obtained when
Precision
repeating the exact same measurement(s)
A measure of the ability of a measuring instrument to give the same readings
Reproducibility
when used by a different operator

Page 3 of 14
Calibration

The power of discrimination of an instrument. For analogue instruments, it is
Resolution
limited to 1/2 of a minor scale graduation
Range The breadth or span of an instruments capability of measurement
Standard A defined reference tool with traceability to a national standard
Traceability Documented reference of calibration results to a recognized standard.
4 Introduction
4.1 General
Calibration defines the accuracy and quality of measurements recorded using a piece of equipment. Over
time there is a tendency for results and accuracy to drift, particularly when using particular technologies or
measuring particular parameters such as temperature and humidity. To be confident in the results being
measured there is an ongoing need to service and maintain the calibration of equipment throughout its
lifetime for reliable, accurate and repeatable measurements.
The goal of calibration is to minimize any measurement uncertainty by ensuring the accuracy of test equip-
ment. Calibration quantifies and controls errors or uncertainties within measurement processes to an accept-
able level.
For example, if you know that a particular food product, e.g. batch, vat milk needs to be kept above 63°C or
161°F [USA PMO Standard] and the instrument system you are using displays a figure of 63°C, then provided
the system is calibrated to be accurate within 0.5°C at 63°C you can be confident the food is safe; if the sys-
tem has an accuracy of 1°C, however, then you cannot be certain that the food’s temperature has been cor-
rectly controlled. Food is, of course, only one example of why it is essential to have a confirmed calibrated
level of accuracy. Manufacturing processes that require specific controlled pasteurization temperatures are
another. In fact, the list goes on.
The equivalent pasteurization temperature for batch, vat milk in the EU is >62°C [EU] or > 65°C [East African
Standard].
In summary, calibration is vitally important wherever measurements are important, it enables users and
businesses to have confidence in the results that they monitor record and subsequently control.

Not applicable.

Page 4 of 14
Calibration
6 Procedure Notes
6.1 Enrolment of Equipment in the Calibration Program
6.1.1 The Requester will notify the Calibration Department of new equipment by completing and return-
ing the Test Equipment Installation Qualification Form to the Calibration Department.
6.1.2 The Requester shall deliver the following to the Calibration Department:
6.1.2.1 Measuring equipment (if portable);
6.1.2.2 Test Equipment Installation Qualification Form;
6.1.2.3 The Test Equipment Installation Qualification Form shall detail the measurement instrument’s
suitability for its intended use prior to enrolment. Suitability must consider accuracy, test ac-
curacy ratio, precision, range, resolution and conditions of use (including environmental condi-
tions). A Test Accuracy Ratio (TAR) of at least 4:1 is required; rationale for exceptions must be
documented and approved;
6.1.2.4 A Test Accuracy Ratio (TAR) of at least 10:1 shall be required for standards used for in-house
calibration; rationale for exceptions must be documented and approved;
6.1.2.5 A copy of the equipment specifications (if available from manual/catalogue), otherwise cali-
bration requirements will be listed in the special instructions section;
6.1.2.6 Operation and/or service manual(s) for equipment that is to be, or can potentially be, cali-
brated in-house (in some occasions where an equipment manual is missing, the FBO must be
able to demonstrate suitable controls, e.g. SOP’s etc.);
6.1.2.7 Calibration certificate(s);
6.1.2.8 Certificates for new measurement and test equipment require at a minimum a statement of
traceability to national, or international, or consensus standards and conformance to pub-
lished specifications.
6.1.3 Active measurement and test equipment that is not calibrated over the entire measurement range
or capabilities shall be identified with a “Limited” label, or equivalent. Limitations of use shall be af-
fixed on or near the measurement and test equipment. Limitations shall be listed in the “Special
Instructions” section of Test Equipment Installation Qualification Form.
6.2 Calibration Intervals

6.2.1 Interval assignment – should be established as recommended below in descending order of prefer-
ence:
 Calibration history of the equipment under evaluation, and the intended use;
 Similar measurement and test equipment enrolled in the calibration system;
 Documented engineering rationale based on usage;
 Manufacturer’s Recommendation.
In the event none of the above information is available the initial interval shall not be greater than
six months.

Page 5 of 14
Calibration
6.2.2 Interval changes – may be requested by the owning department by completing the Interval Change
Form. Rationale must be documented on the form. Approvals should consider the risk of using
out-of-tolerance measurement and test equipment in the production or inspection process(s).
Records of the risk assessment must be maintained by the FBO.
6.2.2.1 Interval increases – greater than half (1/2) of the current calibration cycle require justification
based on recommendations in section 6.2.1.
6.2.2.2 Initial introduction of new Measurement Instruments that have not been used since initial cal-
ibration performed by the OEM (Original Equipment Manufacturer), may be extended another
full cycle, where permitted by the OEM as documented on the OEM Calibration Certificate.
6.2.3 Calibration intervals – shall be evaluated and documented on an annual basis by the Calibration
Coordinator.
6.3 Change of Equipment Status

6.3.1 The Equipment Owner will request changes of equipment/calibration status using the measure-
ment Instrument Status Change Form. Equipment/calibration status categories include, but are
not limited to, the following:
6.3.1.1 Active – measurement and test equipment that is calibrated over the entire measurement
range or capabilities. This equipment shall be labelled with a “Calibrated” label;
6.3.1.2 Inactive – measurement or test equipment that is currently not in use and consequently should
not be an active part of the calibration program. This equipment shall be labelled with a “Do
Not Use-Out of Service” label and made non-operational if possible;
6.3.1.3 Discontinued – measurement and test equipment that has been discontinued or destroyed;
6.3.1.4 Reference Only – measurement and test equipment that has a measurement capability but is
currently not used for ANY measurement or test activities for determining conformance to any
equipment, product, process, design verification/validation, or environmental specifications.
This equipment shall be labelled with a “Not Calibrated – For Reference Only” label;
6.3.1.5 No Calibration Required – measurement and test equipment which by nature or application does
not require periodic calibration. Equipment in this category includes intrinsic standards, and equip-
ment used in specific applications whose output values are verified by other calibrated measure-
ment and test Equipment. This equipment shall be labelled with a “No Calibration Required” label;
6.3.1.6 Lost – Equipment that cannot be located by the owning department.
6.3.2 Discontinued / Disposed Equipment

6.3.2.1 The department owning the equipment to be disposed/discontinued will complete the Mea-
surement Instrument Status Change Form.
6.3.2.2 The Calibration ID label will be removed from the equipment by the Owning Department and
affixed to the Measurement Instrument Status Change Form.
6.3.2.3 The equipment shall be appropriately identified for disposal/destruction by the Owning Depart-
ment .
6.3.2.4 The Owning Department will obtain approval for disposal of asset.
6.3.2.5 The completed Measurement Instrument Status Change Form will be forwarded to the Cali-
bration Department.

Page 6 of 14
Calibration
6.3.3 Equipment Transfers – measurement and test equipment whose primary use/ownership is being
permanently transferred between departments or divisions. The original owning department is re-
sponsible for completing the Measurement Instrument Status Change Form for any Measurement
and Test Equipment that is being transferred to another department or division, and obtaining the
signature of the new owning department.
6.4 Calibration Database and Reporting

6.4.1 QA / Engineering / Document Control shall maintain a system for tracking and controlling mea-
surement and test equipment which will prevent the use of expired or unfit measurement and test
equipment.
6.4.2 The calibration database shall outline the calibration method in the comments section of the
equipment history record. For example:
6.4.2.1 Sub-contract on-site calibration (performed on-site by approved supplier);
6.4.2.2 Sub-contractor (typically measuring and test equipment sent out to an approved supplier).
6.4.3 The calibration database shall distinguish company-owned standards from measurement instru-
ments.
6.4.4 The Calibration Department will issue a calibration status report once every month to the Product
Department Supervisors, Department Calibration Representatives, the Food Safety Manager and
the Production Manager.
6.4.5 Monthly calibration status report shall consist of:

6.4.5.1 Equipment DUE for calibration in the next 30 days;
6.4.5.2 Equipment OVERDUE;
6.4.5.3 Equipment on-hand;
6.4.5.4 Remedial/Corrective Action Form status.
6.4.6 Calibration manager has two main sets of records which store all pertinent information: Equip-
ment Master and Equipment History. Records are entered in these two corresponding screens by
the Calibration Coordinator(s). The Equipment Master stores general information, such as ID de-
scription and scheduling information (called events) for each piece of equipment. The Equipment
History maintains historical information for specific pieces of equipment. Events can be calibra-
tions, repairs, operations, etc. Each time an event is performed, the result of the event, including
any measurement information, is entered as a history record by the Calibration Coordinator(s).
6.4.7 All data is entered by the Calibration Coordinator(s) and Administrator; other users such as the
Calibration Representatives have ’User’ or ‘Read Only’ status. All information, whether deleted or
entered, is mapped through an audit trail in the database.

Page 7 of 14
Calibration
6.5 Remedial/Corrective Action Process

6.5.1 The Calibration Department will issue a Remedial/Corrective Action Form to the equipment’s own-
ing department Supervisor when measurement and test equipment is returned from being cali-
brated with an identified out-of-tolerance condition before calibration. A description of the specific
out-of-tolerance parameters will be included or attached to the form.
6.5.2 Any equipment with out-of-tolerance occurrences “before calibration” will be issued a “Do Not Use
– Out of Service” label, or quarantined in the calibration area, pending completion of the Remedial/
Corrective Action Form by the Owning Department.
6.5.3 All Remedial/Corrective Action Forms will address:

6.5.3.1 The impact of the out of tolerance condition on the product(s)/process(s). A concise and de-
tailed explanation for this decision shall be documented. The following should be addressed in
the Remedial response:
6.5.3.1.1 How important the affected feature is to the end user;
6.5.3.1.2 How the out-of-tolerance condition relates to the product specification(s);
6.5.3.1.3 Any potential product impact;
6.5.3.1.4 If product impact has been identified, the product Failure Mode Effect Analysis [F]MEA and/
or a Risk Analysis report shall be used to define potential patient and or user safety impact;
6.5.3.1.5 This may include ancillary documents such as handwritten notes, calculations, graphs,
tables, sketches, or photographs.
6.5.4 Remedials should also address measurement and test equipment disposition:
6.5.4.1 The fitness of the equipment for continued use;
6.5.4.2 The calibration interval of the equipment if a change to the interval is being made as a result
of the evaluation;
6.5.4.3 Other changes to prevent the recurrence including: the appropriateness of the equipment for
the measurement/test function and operator handling of the equipment.
6.5.5 Any open remedial/corrective actions open more than four (4) weeks will be reported to the Food
Safety Manager and Department Supervisor by the Calibration Coordinator.
6.6 Labelling, Identification and Storage

6.6.1 A Calibration label must be attached to, or be posted within visual range of, the measurement and
test equipment.
6.6.2 Calibrated measurement and test equipment shall be marked with a label to display:
6.6.2.1 The date of the most recent calibration;
6.6.2.2 The date when the next calibration is scheduled;
6.6.2.3 (Note, the aforementioned dates shall be of the format type requirements of SOP-xxx, e.g.,
Jan/5/2015 or 5/Jan/15 so as to avoid confusion between calibrations performed in the United
States and Europe);
6.6.2.4 The initials of personnel or sub-contractor who performed the calibration or the name of the
sub-contractor.

Page 8 of 14
Calibration
6.6.3 If the item is too small for this type of marking, a color code or smaller identifying mark shall be employed
and cross-referenced on the Test Equipment Installation Qualification Form for that specific item.
6.6.4 Calibration Seals shall be affixed to measurement and test equipment where a possibility of altera-
tion to calibrated settings could occur. A tamperproof seal is affixed to the setting adjustment area
and or access screw; this acts to safeguard against any internal and or external adjustments that
could invalidate the calibration settings. Acceptable methods of sealing are:
6.6.4.1 Tamperproof labels;
6.6.4.2 Inspector’s lacquer;
6.6.4.3 Low-strength tread-loc.
6.6.5 Measurement instruments and standards, where applicable, i.e., Vernier callipers, shall be stored in
suitable packaging when not in use to avoid damage.
6.6.6 Spare/backup measurement and test equipment (portable) shall be stored in locked cabinets.
6.6.7 These cabinets are identified as “Calibrated Test Equipment” that contain standards and measure-
ment equipment that are currently suitable for use and “Test Equipment not Calibrated” that con-
tains items due for calibration and inactive measurement and test equipment.
6.6.8 Only the Calibration Coordinator(s) and Administrator shall have access to these storage cabinets.
6.7 Battery Replacement

6.7.1 Measurement and test equipment that requires battery replacement shall be performed by the
Calibration Coordinator using appropriate Electro Static Devices [ESD] practices and subsequent
replacement of any tamperproof seals/labels.
6.8 Calibration Procedures

6.8.1 Calibration procedures must be application specific and prescribe step-by-step instructions for cali-
bration of measurement and test equipment or categories thereof. These shall be prepared inter-
nally, by another agency, the manufacturer or a composite of any of these. Internal calibration pro-
cedure part number and current revision shall be referenced on the related Calibration Record/Form.
6.8.2 Calibration procedures must state: the acceptable limits of accuracy and precision; standards
required; and sufficient information to enable qualified personnel to perform the calibration.
6.8.3 Equipment used for calibration(s) shall have a Test Accuracy Ratio (TAR) of at least 10:1, i.e. calibration
equipment uncertainty will be 10 times greater than the uncertainty of the measurement and test
equipment being calibrated; rationale for exceptions must be documented and approved. Rational
may include an increase to the calibration frequency to compensate for this lack of compliance.
6.8.4 Calibration procedures and internal calibration records must state: “Calibration performed by
trained personnel only.”

Page 9 of 14
Calibration
6.9 Calibration – Internal

6.9.1 Requirements for calibrations performed by company personnel:
6.9.1.1 Calibration standards used to perform internal calibration shall be traceable to a National or
International Standard(s);
6.9.1.2 Calibrations are to be performed per application-specific written procedures, at the most cur-
rent revision level, describing the step-by-step method of calibrating specific instruments or
categories of instruments;
6.9.1.3 For company manufactured equipment, calibrations will be performed at the revision level
applicable to the equipment;
6.9.1.4 Calibrations performed by company personnel require a cross-check to be performed prior to
commencing to ensure proper documentation / procedure(s) is/are used;
6.9.1.5 Company personnel performing calibrations must be trained to the proper procedure and revi-
sion level as evidenced in the individuals training record;
6.9.1.6 Calibration procedures shall clearly state the ranges of acceptable tolerances or limits;
6.9.1.7 Recorded calibration data shall be recorded to the significant digit expressed in the limits;
6.9.1.8 Environmental conditions for test and measurement equipment calibration such as lighting,
vibration, etc., i.e. other than temperature and humidity except where defined by the manu-
facturer’s specification or user manual, shall comply with the manufacturer’s published speci-
fication;
6.9.1.9 Environmental conditions shall be monitored by calibration personnel to ensure requirements
are met when performing calibration in-house;
6.9.1.10 Upon completion of calibrating an item, personnel performing the calibration will indicate en-
vironmental compliance by checking off the appropriate section on the company Calibration
Report.
6.9.1.11 If temperature or humidity exceed the specified limits for a particular calibration type, work for
that type will be suspended and a supervisor notified to assess the impact.
6.9.2 Documentation of calibration shall consist of the following:

6.9.2.1 Completed Internal Calibration Report, including:
6.9.2.1.1 Equipment I.D. number;
6.9.2.1.2 Description of equipment;
6.9.2.1.3 Part number and/or manufacturer of the equipment;
6.9.2.1.4 Revision of the equipment (if applicable);
6.9.2.1.5 Calibration/test procedure/drawing numbers used;
6.9.2.1.6 Revision of the procedure used;
6.9.2.1.7 Indication of cross-check performed (if applicable);
6.9.2.1.8 Identification of person performing calibration/test;
6.9.2.1.9 Calibration standard(s) and/or equipment used;
6.9.2.1.10 Due date(s) of the standard(s) used;
6.9.2.1.11 Date the calibration was completed;

Page 10 of 14
Calibration
6.9.2.1.12 Next calibration due date;
6.9.2.1.13 Indication of equipment condition (pre- and post-calibration).
6.9.3 Personnel training for performing calibrations must also include:

6.9.3.1 Their trainer signature in the section labelled “Approved by” indicating verification of:
6.9.3.1.1 Training to, and use of, correct procedure;
6.9.3.1.2 Cross-check (if applicable);
6.9.3.1.3 Acceptability of data.
6.9.4 Calibration data (pre and post) including acceptable tolerances/limits. These may be recorded on
the Internal Calibration Report or on a data sheet specific to the equipment’s calibration proce-
dure. Completed data sheet will be attached to Internal Calibration Report.
6.9.5 The Calibration Department will perform a cursory review of the completed Internal Calibration
Report Form and applicable Data Sheets to:
6.9.5.1 Review for completeness.
6.9.5.2 Review for out of tolerance conditions:
6.9.5.2.1 If the results indicate that the pre-calibration condition was out-of-tolerance, issue a
Remedial/Corrective Action Form.
6.9.5.3 If the equipment is not fully calibrated to the manufacturer’s or procedural specifications, the
equipment may be used in a “Limited” status. In these circumstances:
6.9.5.3.1 Equipment will be identified using the “Limited Calibration” label;
6.9.5.3.2 Limitations of use will be clearly identified on or near the equipment.
6.9.6 If the calibration is found to be acceptable, the Calibration Department shall:

6.9.6.1 Sign or stamp and date the Calibration Report as evidence of completion in the section la-
belled “Reviewed by;”
6.9.6.2 Apply, or issue, an updated calibration label;
6.9.6.3 Note: if changing the equipment status, the equipment owner must complete a Measurement
Instrument Status Change Form;
6.9.6.4 The Calibration Department shall file the Calibration Report and relevant data sheets in the
equipment’s history folder.
6.10 Calibration – External

6.10.1 Calibration Method
6.10.1.1 Calibration performed by Contractors shall be conducted by approved Suppliers (registered on
the Approved Supplier List, ASL);
6.10.1.2 The methods and criteria used to perform calibration of Measurement and Test Equipment
shall comply with the manufacturers specification and shall be traceable, through certifica-
tion, to a National or International Standard, e.g., NIST, UKAS or equivalent;
6.10.1.3 Method of Calibration for linear Measurement Instruments such as External Micrometers,
Vernier Callipers and Dial Gauges may use the methodology outlined in the British Standards
in Engineering Metrology, e.g., BS 870, BS 887, BS 907, etc.;

Page 11 of 14
Calibration
6.10.1.4 Special instructions for calibration shall be detailed in the Test Equipment Installation Quali-
fication Form, where applicable.
6.10.2 Documentation Requirements. All documentation provided by the Contractor shall include at a mini-
mum:
6.10.2.1 Measurement instrument identifier;
6.10.2.2 The date of calibration;
6.10.2.3 Tolerances or specified accuracy;
6.10.2.4 Pre-calibration data;
6.10.2.5 Post-calibration data (if adjusted);
6.10.2.6 Identity of standards used;
6.10.2.7 Calibration due-date of standards;
6.10.2.8 Ancillary measurement documentation (graphs, tables, photos, etc.), if applicable;
6.10.2.9 Statement of acceptability (pass/fail):
6.10.2.9.1 Signature or stamp of person performing the Calibration, or Contractor’s name and
address.
6.10.3 Repairs. For equipment identified as requiring repairs by the Contractor, the Calibration Department
will:
6.10.3.1 Request the Contractor to provide a quote for the cost of the repair and provide an estimated
time for completion of repair;
6.10.3.2 Notify the owning department of the need for equipment repair and request approval for
repairs.
6.10.3.3 Approval of repairs:
6.10.3.3.1 The owning department will provide a signed and dated purchase request for the cost
of repair;
6.10.3.3.2 The Calibration Department will inform the Contractor to proceed with repairs and
provide an account number or purchase order number.
6.10.3.4 Disapproval of repairs:
6.10.3.4.1 Inform the Contractor to return the equipment, un-repaired, if offsite.
6.10.4 Receiving Equipment. Upon receipt of the equipment from the Contractor, the Calibration De-
partment will:
6.10.4.1 Physically examine the measurement and test equipment for any damage;
6.10.4.2 Review all calibration documentation for required information by checking off blocks on the
Calibration Return Checklist as conformance to requirements is verified;
6.10.4.3 Measurement and test equipment with documentation missing or insufficient information
shall be detained in the Calibration Storage Cabinet (“Test Equipment not Calibrated”), or
label “Do Not Use-Out of Service;”

Page 12 of 14
Calibration
6.10.4.4 Measurement and test equipment with documentation missing or insufficient information
shall require approval of Calibration Department personnel prior to releasing equipment for
use. Calibration Department personnel will print name, sign or stamp, and date the Discrep-
ancy Approval section of the Calibration Documentation Return Checklist upon acceptance
or approval of documentation, as well as document rationale in the ‘Remarks’ section for any
deficient Certificates accepted.
6.10.4.5 If Calibration Department personnel approval is denied, contact the Sub-Contractor, re-
questing the deficient information. Repeat section 6.10.4.4;
6.10.4.6 Compare specific values (data) to acceptance criteria (tolerances/accuracy specifications), or
review statement of acceptability for out of tolerance conditions;
6.10.4.7 Owing departments of equipment having a pre-calibration condition of being out-of- toler-
ance shall be issued a Remedial/Corrective Action Form;
6.10.4.8 If the Calibration Certificate indicates that the equipment is not calibrated over the entire range
of measurement or the “post-calibration” condition was out-of-tolerance, the equipment may
be:
6.10.4.8.1 Discontinued;
6.10.4.8.2 Placed in “Not in Use” or “Inactive” status;
6.10.4.8.3 Used as “Reference Only;”
6.10.4.8.4 Used in a “Limited” status. In these circumstances equipment will be identified using
a “Limited Calibration” or “Special Calibration” label. Limitations of use will be clearly
identified on or near the equipment.
6.10.4.9 Verify dates on the Calibration Label and Calibration Certificate concur as well as comparing
the due date to the calibration interval.
6.10.4.10 Check for calibration seals in place, where appropriate.
6.10.5 Finalizing
6.10.5.1 Print name, sign or stamp, and date the form, return checklist as evidence of review and avail-
ability for use. The form will be placed with equipment calibration certificate records in the
designated cabinet;
6.10.5.2 Update the calibration database to include all newly received information, such as next cali-
bration due date and status, etc.;
6.10.5.3 File the Certificate of Calibration and relevant documents as part of the equipment’s calibra-
tion history records;
6.10.5.4 Place the equipment in the calibrated equipment storage cabinet if not required for immedi-
ate use;
6.10.5.5 Notify the owning department if applicable.
6.10.6 External calibration company supplier survey/audits

6.10.6.1 Accreditation by a recognized body may be accepted by in lieu of an audit, e.g., International
Laboratory Accreditation Co-Operation [ILAC]. If an audit is not deemed necessary, a copy of
the current certificate of accreditation will be maintained in the supplier audit file.

Page 13 of 14
Calibration
7 Records

Equipment Master and
Calibration Department Indefinitely Calibration Co-Ordinator
History List
Calibration Program/
Calibration Department Six years Calibration Co-Ordinator
Schedule
Equipment calibration
Calibration Department Six years Calibration Co-Ordinator
Report
Equipment Calibration
Calibration Department Indefinitely Calibration Co-Ordinator
Certificate

Page 14 of 14
Corrective and Preventive Action
FBO Procedure
Document # SOP-009
Created 20-04-2015
Updated 24-04-2015
Revision History
24-04-2015 V1.0 Mary Cahill Original issue & update after technical review.
Contents
1 Summary.................................................................................221 6.3 Step 3 Corrective Action Plan Drafted .............224
2 Related Documents ..........................................................221 6.4 Step 4 Corrective Action Plan Reviewed........224
3 Definitions ............................................................................222 6.5 Step 5 Implement the Corrective Action ........225
4 Introduction ........................................................................222 6.6 Step 6 Monitor Implementation ........................225
5 Procedure Flow Chart .....................................................223 6.7 Step 7 Verify Implementation ..............................225
6 Procedure Notes ...............................................................224 6.8 Step 8 Review for Closure .....................................225
6.1 Step 1 Problem Definition/Record Creation ...224 6.9 Step 9 Close CAPA ....................................................225
6.2 Step 2 Root Cause Analysis...................................224 7 Records ..................................................................................225
Classification Company Confidential Corrective and Preventive Action

Page 1 of 6
FBO Procedure Corrective and Preventive Action 221
1 Summary
This procedure describes the methodology used within the organization

Purpose
to manage the corrective and preventive action process.
This procedure applies to the generation of corrective and preventive ac-
Scope tions, associated root cause analysis and the effective closure of correc-
tive and preventive actions.
Manager/Management Representative.
2 Related documents

Processes Compliance, PRO-004
Complaint Management, SOP-014
Procedures Management Review, SOP-021
Strategic Planning, SOP-029
Forms CAPA Form
Other N/A

Page 2 of 6
3 Definitions

CA Corrective Action
PA Preventive Action
RCA Root Cause Analysis
Correction Action taken to eliminate a detected nonconformity
Action taken to eliminate the cause of a nonconformity and prevent
Corrective action
recurrence
Preventive action Action taken to prevent the occurrence of nonconformity
A method of problem solving that tries to identify the root cause of faults or
Root cause analysis
problems
4 Introduction
The identification of issues affecting the FSMS and the implementation of corrective and preventive actions
are a core requirement in the continual improvement process within a management system. In order for
such corrective actions to be effective, a rigorous root cause analysis process must be followed to ensure
the actual cause of the issue is identified, eliminated and recurrence prevented.
This procedure outlines the process implemented within the organization to ensure this is achieved.

Page 3 of 6
1. Complaint
Issue Identified, Audit Finding
Employee/Auditor/ Documented and
Customer Correction Taken CAPA Log
2.
Relevant Department Root Cause Analysis Root Cause Analysis
Completed
3.
Corrective Action
Relevant Department Corrective Action Plan
Plan
Drafted
4.
FSM/MR/ Rejected Corrective Action
Action Plan
Relevant Department/ Auditor Reviewed Plan
Accepted
5. Corrective Action
Relevant Department Plan
CA Plan Implemented
FSM/MR/ 6. Corrective Action

Relevant Department/ Auditor Monitor Plan
Implementation
7. Corrective Action Plan

Verify
Relevant Department
Implementation Verification Evidence
8.
FSM/MR/Auditor Review for Verification Evidence
Closure
9.
CAPA Log
FSM/MR/ Close Issue and
Relevant Department/ Auditor Document as Closed

Page 4 of 6
6 Procedure Notes
6.1 Step 1 Problem Definition/Record Creation
An issue can be identified from several sources including auditing (both internal and external), customer
complaints or legal/regulatory issues. Once identified, immediate correction must be taken to resolve the
issue and the issue must be documented within the DMS software. The appropriate resources will then be
put in place to manage the investigation of the issue in line with the above flowchart.
6.2 Step 2 Root Cause Analysis

It is mandatory that all issues raised are investigated thoroughly utilizing a recognized root cause
analysis methodology, e.g. 5 Whys, 8D, Go See Think Do, etc. Only when the root cause has been identi-
fied can corrective action and/or preventive action be identified. Root cause analysis may only be under-
taken by trained personnel. Under no circumstances can ‘human error’ or a ‘restatement of the issue’ be
described as the root cause. In the event of this being the case, the root cause must be rejected and redone.
Root cause analysis must be completed by the department in which the issue arose. Where necessary,
preventive actions may also be identified during the root cause analysis. Where this is the case, they must
be documented as part of the corrective action plan.
6.3 Step 3 Corrective Action Plan Drafted

A corrective action plan will be created as follows:
Issue Corrective Preventive Assigned Expected completion

Root Cause
Description Action(s) Action(s) to date
The corrective action plan will be created by the relevant department where the issue arose. It is fully their
responsibility to generate this plan and submit it for review and approval.
6.4 Step 4 Corrective Action Plan Reviewed

The corrective action plan must be submitted to the FSM/MR/Auditor for review and approval. Where the
FSM/MR/Auditor decide that the corrective action plan is not sufficient or acceptable, they will return it for
rework. Corrective actions plans may be rejected on the grounds of a badly completed root cause analysis,
unrealistic timeframes or no assignment of responsibilities or other grounds as deemed appropriate by the
review team.
Where the corrective action plan is deemed to be approved, the review team will notify the department to
proceed with the plan.

Page 5 of 6
6.5 Step 5 Implement the Corrective Action

The relevant department will implement the corrective action plan as documented.
6.6 Step 6 Monitor Implementation

Implementation will be monitored in accordance with the documented plan on regular basis to ensure
timely corrective action is taken and that any issues arising are dealt with.
6.7 Step 7 Verify Implementation

When the implementing department are satisfied that the corrective action taken has been completed,
a test to determine the effectiveness of the corrective action must be undertaken and relevant evidence
recorded. Where results show that the expected outcome has not been achieved, i.e. the elimination of the
root cause, the department must redo the root cause analysis. Only when this evidence objectively shows
that the root cause of the issue has been eliminated, the department may request that the issue be closed
out.
6.8 Step 8 Review for Closure

The FSM/MR/Auditor, and other interested parties as necessary, will review the objective evidence related
to the effectiveness of the corrective action taken. Only when they are satisfied that the root cause has
been eliminated will they allow the issue to be closed. Where any doubt exists, the review team may re-
quest extra verification activities to be undertaken and results submitted again or they may request a com-
plete re-submittance of the corrective action plan.
6.9 Step 9 Close CAPA

Where the review team is satisfied that the root cause has been eliminated, they will authorize the closure
of the issue on the CAPA system.
7, Records

Compliant Food Safety Office Indefinitely FSM/MR
Audit finding Food Safety Office 6 years FSM/MR
Corrective action plan Food Safety Office 6 years FSM/MR
Verification evidence Food Safety Office 6 years FSM/MR

Page 6 of 6
Internal Auditing
FBO Procedure
Document # SOP-006
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary.............................................................................................. 227
2 Related Documents ....................................................................... 227
3 Definitions ..........................................................................................228
4 Introduction ......................................................................................229
4.1 Internal Auditing.......................................................................229
5 Procedure Flow Chart .................................................................. 230
6 Procedure Notes ..............................................................................231
7 Audit Records.................................................................................... 233
8 Records ................................................................................................234
Classification Company Confidential Internal Auditing

Page 1 of 9
FBO Procedure Internal Auditing 227
Internal Auditing
1 Summary
The purpose of this procedure is to describe the:

 Internal audit methodology employed to ensure that the Food
Safety Management System remains suitable, adequate and effec-
Purpose
tive in meeting business, customer, and compliance requirements,
the requirements of FSSC 22000 and ensure that the FSMS is ef-
fectively implemented and maintained.
This procedure applies to:
 Audit program planning, performance and follow-up, including ini-
tiating of audit, audit preparation, conducting the audit, preparing
Scope
and distributing the audit report, completing the audit and audit
follow-up if required;
 Compliance and conformance auditing.
Functional Responsibility Manager, who is responsible for the effective implementation and main-
tenance of this procedure.
2 Related documents

Processes Departmental process descriptions
Procedures
Forms FSMS Audit Checklist
Statutory and Regulatory Requirements
Other
FSSC 22000:2010

Page 2 of 9
Internal Auditing
3 Definitions

Audit plan Description of the activities and arrangements for an audit
The outcome of the audit provided by the audit team after consideration of all
Audit conclusion
the audit findings and audit objectives
Set of policies, documented information or requirements used as a reference
Audit criteria
against which audit evidence is compared
Audit finding Results of the evaluation of the audit evidence against the audit criteria
Set of one or more audits planned for a specific timeframe and directed towards
Audit programme
a specific purpose
Audit scope The extent and boundaries of the audit
Person with the demonstrated personal attributes and competence to conduct an
Auditor
audit
Compliance auditing Determination of compliance with defined statutory and regulatory requirements
Conformance Determination of conformance to defined International Standards e.g. FSSC
auditing 22000:2010
Correction Action taken to eliminate a detected nonconformity
Corrective action Action taken to eliminate the cause of a nonconformity and prevent recurrence
High risk finding Significant weakness in the system or process – need rectification immediately
Systematic and independent process for obtaining audit evidence and evaluat-
Internal audit
ing it objectively to determine the extent to which audit criteria are fulfilled
A general weakness in the system or process which if rectified immediately
Low risk finding
could improve efficiency
A total breakdown or absence of objective evidence to satisfy one or more
Quality Management System requirements, or a situation which would, on the
Major finding
basis of available objective evidence, raise significant doubt as to the quality of
the product that the organization is supplying
A potentially significant weakness in the system or process – if not rectified im-
Medium risk finding
mediately may lead to high risk
Where there is defined and documented system which generally satisfies one
or more Food Safety Management System requirements, or a situation which
Minor finding would, on the basis of available objective evidence, raise a concern as to the po-
tential quality of what the organization is supplying, e.g. the system and/or one
or more processes have not reached an acceptable maturity level

Page 3 of 9
Internal Auditing

Nonconformity The non-fulfilment of a requirement
Objective/audit Records, statements of fact or other information which are relevant to the audit
evidence criteria and verifiable
Opportunity for An issue, identified by the auditor that warrants investigation by the auditee to
improvement affect improvement
Root cause Analysis A method of problem solving that tries to identify the root cause of faults or problems
A SWOT analysis is a section of the audit report where the audit team catego-
SWOT analysis
rises the audit findings into Strengths, Weaknesses, Opportunities and Threats.
4 Introduction
4.1 Internal Auditing
Internal auditing is completed to monitor and measure the company’s level of compliance against its statu-
tory and regulatory requirements and its level of conformance with the requirements of the Food Safety
Management System.
Internal audits will be scheduled on a planned basis, conducted by trained internal auditors and their find-
ings reported to management for review and action. Where audit findings are raised, the auditee will be
required to give a commitment to addressing and resolving these issues. The internal auditor will seek
evidence of the effective implementation of these actions. The results of internal audits and the overall ef-
fectiveness of the internal audit programme will be reported at the management review meeting.

Page 4 of 9
Internal Auditing
1. Internal Audit
Food Safety Manager/
Initiating the Audit Program
Top Management
Audit Plan(s)
2. Audit Trail
Auditors Preparing the Audit
Activities Audit Checklist
Audit Plan(s)
3. Audit Trail
Auditors Conducting the Audit
Audit Checklist
Audit Findings(s)
4.
Preparing the
Auditors Distribution of Audit Report
the Audit Report
5. Audit Report
Food Safety Manager Completing the Audit
6.
Audit Findings
Auditor/Auditee Conducting Audit
Followup
7.
End

Page 5 of 9
Internal Auditing
6 Procedure Notes
Step 1
The Food Safety Manager has the responsibility to create and management the internal audit process. This
involves establishing initial contact with the auditee(s) and agreeing the following:
 Audit objectives, scope and criteria;
 Agree the date for the audit to take place;
 Resources to complete the audit, including access to the required people, processes, activities and
documentation;
 Statutory and regulatory requirements to be assessed during the audit;
 The need for any observers and/or guides; and
 Determine any specific areas of concern for the auditee.
The output from this phase is the development of an audit programme outlining the audits to be completed
over a defined period of time. It also may identify the Internal Auditor assigned to the audit. Once com-
pleted, the programme will be published and communicated across the company.
Step 2
Each individual internal auditor is responsible to create an:

 Audit plan, including audit objectives, scope and criteria;
 Audit checklist or audit trail.
Audit plans and checklist/trails will be template based to ensure consistency. Once documented by the
Internal Auditor, the audit plan will be communicated to the relevant auditee(s).
It should be noted that some audits will be conducted on an unannounced basis as directed by the Food
Safety Manager. Where this is the case, no audit plan may be produced; however, the Food Safety Manager
will fully brief the Internal Auditor as to the objectives, scope and criteria of the audit.

Page 6 of 9
Internal Auditing
Step 3
The Internal Auditor will conduct the audit in accordance with the plan. Audit checklists or audit trails will
be used by the auditor to record audit evidence. Audits will be conducted using interview, observation, re-
view of records and documents, and analysis of data. Trend analysis and tests may also be utilized to gather
evidence as required. Details to be recorded on the checklist or audit trails include the requirement being
checked, the evidence gathered, the conformance indication and identification of the auditee.
In the event of an Internal Auditor identifying a non-conformity, based on objective evidence, the Internal
Auditor will inform the Process Owner/Head of Department of the issue and explain what the non-con-
formity is, why it is a non-conformity and the requirement that has not been fulfilled. The internal auditor
will document the non-conformity in their checklist or audit trail and get the auditee to sign it signifying
the auditee’s acceptance of the issue and their commitment to rectify the issue. The Internal Auditor will
classify the audit finding as major, minor or an opportunity for improvement based upon risk. The Internal
Auditor should not downgrade an audit finding to an opportunity for improvement where there is evidence
of a non-conformity.
It is solely the responsibility of the Process Owner/Head of Department, where audit findings are raised, to
rectify these findings. Correction must be taken, a root cause analysis using a recognised root cause analysis
methodology, e.g. 5 Whys, Fishbone Diagram, etc. must be completed and corrective action identified and
implemented. A response plan must be submitted to the Internal Auditor by the auditee within 10 days of
the audit outlining the above correction, root cause analysis and corrective action(s). The Internal Auditor
will review the response plan and approve or reject it [i.e. if there is no root cause analysis, the root cause
analysis is inadequate, etc.]. If rejected, the Auditee must correct the response plan and re-submit for ap-
proval. All audit findings should be closed out within 12 weeks of the finding being made, exceptions to this
may be granted subject to approval of the Internal Auditor and the FSM/MR.
The outputs from this phase is that the audit objective has been achieved, audit plan met, completed
checklists/audit trails and, where applicable, identified audit findings and a response plan received from the
Process Owner/Head of Department.
Step 4
The Internal Auditor will prepare an audit report outlining the audit conclusion. This conclusion is based on
a comparison of all the audit findings against the audit objective. The report will be detailed and cover the
following points at a minimum:
 Identification of the audit objective, scope and criteria;
 Identification of the Auditor and Process Owner(s)/Head of Department;
 The audit conclusion;
 Executive summary;
 SWOT analysis;
 Description of the process, critical process parameters and process performance;
 The number of audit findings and their classification;

Page 7 of 9
Internal Auditing
 The audit findings in detail;

 Sample/confidentiality statement;
 Audit follow up;
 Audit checklist and/or audit trail (as an attachment).
The audit report will then be released to the Food Safety Manager and the Process Owner/Head of Depart-
ment.
Step 5
The audit is completed when all planned audit activities have been completed or otherwise agreed with the
Process Owner, e.g. there may have been an unexpected event that prevented the audit plan from being
completed.
The Food Safety Manager will technically review the audit report to ensure that all aspects of the audit
plan have been covered, the evidence gathered is objective and related to the audit criteria, and the audit
conclusion reached is correct. He or she will also manage any appeals raised by the Process Manager/Head
of Department in relation to an audit finding, and where agreement cannot be reached between the Food
Safety Manager and the Process Owner/Head of Department, the Food Safety Manager will elevate the
issue to the Executive Management Team for resolution.
Step 6
Based on the response plan submitted by the Process Owner and the agreed closure timescales, the in-
ternal auditor will follow up to ensure that all audit findings have been effectively closed out. This will be
achieved through the verification of the effectiveness of the corrective action(s) taken by the auditee. A test
or review of evidence will be conducted by the auditor to determine if the audit finding has been closed out.
Where satisfied, the internal auditor will close the audit finding.
Where the Internal Auditor does not agree to close the audit finding, agreement on the actions to be taken
will be determined between the Internal Auditor and the Auditee.
7 Audit Records
The following documentation will be maintained as evidence of audits being performed:
 Audit Plan;
 Audit Checklist/Audit Trail;
 Audit Report;
 Root Cause Analysis Data/Response Plan.

Page 8 of 9
Internal Auditing
8 Records

Internal Audit Program Food Safety Office Six years Food Safety Manager
Internal Audit Plan Food Safety Office Indefinitely Food Safety Manager
Audit Checklist / Audit Trail Food Safety Office Indefinitely Food Safety Manager
Audit Report Food Safety Office Indefinitely Food Safety Manager
Response Plan Food Safety Office Indefinitely Food Safety Manager

Page 9 of 9
FBO Procedure Traceability 235
Traceability
FBO Procedure
Document # SOP-012
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary............................................................................... 236 6.2 Identify and Record Flows or Critical
2 Related Documents ........................................................ 236 Tracking Events, [CTEs] .........................................240
3 Definitions ........................................................................... 237 6.3 Place a Standard, Human Readable
Lot ID on FBO Products [Lot ID] ........................242
4 Introduction ....................................................................... 238
6.4 Product Labelling...................................................... 242
4.1 Traceability ................................................................... 238
6.5 Testing of the Traceability System .................... 243
5 Procedure Flow Chart .................................................... 239
6.6 Traceability System Testing Frequency ..........245
6 Procedure Notes .............................................................. 239
6.7 Dairy Milk Traceability Records ..........................245
6.1 Identify and Record Lot IDs or Key Data
Elements [KDEs]......................................................... 239 6.8 Post Review Actions ...............................................245
7 Records .................................................................................245
Classification Company Confidential Traceability

Page 1 of 11
Traceability
1 Summary
To describe the process being able to trace each ingredient back to its
Purpose source and being able to track dairy product after they leave the dairy
plant.
This instruction covers all products manufactured or distributed by the
Scope FBO.
Note: Local regulations and laws prevail over this guideline.
Functional Responsibility Manager and Traceability/Recall PRP Team. They are responsible for the
effective implementation and maintenance of this procedure.
2 Related documents

Policies
Control of Non-Conforming Product, SOP-003
Recall and Withdrawal, SOP-023
Procedures Communications, SOP-020
Crisis Management, SOP-029
Recall/Withdrawal Log
Forms Communication Log
Root Cause Analysis/Corrective Action

Page 2 of 11
Traceability
3 Definitions

Expression of dissatisfaction made to an organization related to its product or
Complaint service, or the complaints-handling process itself where a response or resolu-
tion is explicitly or implicitly expected
Critical Tracking Events that identify those core business processes where traceability data cap-
Events [CTEs] ture is vital to a successful traceability process
The ability to separate the products that may have a large amount of the con-
Dilution
taminant, and those that may only have possible traces
Exclusion is the ability to EXCLUDE the products that do not contain any con-
Exclusion
taminant
Inclusion is the ability to INCLUDE any product(s) that could contain any trace
Inclusion
of a possible contaminant.
Key Data Elements
The data captured during a CTE to support a successful traceability process
[KDEs]
Output that is a result of activities where none of them necessarily is per-
formed at the interface between the provider and the customer. For the FBO
Product
this can be an ingredient, raw material, intermediate product or finished prod-
uct supplied to a customer or consumer
Recall is the process by which a product is removed from the external supply
chain/distribution and where consumers are publicly advised to take specific
Recall actions with the product (e.g. “do not consume the product,” or “return the
product to the shop or manufacturer”). This includes the FDA class I and class
II recalls
Regulatory Obligatory requirement specified by an authority mandated by a legislative
requirement body
A cause that once removed from the problem fault sequence, prevents the
Root Cause
A method of problem solving that tries to identify the root cause of faults or prob-
Root Cause Analysis
lems

Page 3 of 11
Traceability

Statutory require-
Obligatory requirement specified by a legislative body
ment
Traceability is the ability to track a food through all stages of production,
processing and distribution (including importation and at retail). Traceability
Traceability
should mean that movements can be traced one step backwards and one step
forward at any point in the supply chain
The capability to identify the origin and characteristics of a product based on
Tracing
criteria determined at each point of the supply chain
The capability to locate a product based on specific criteria wherever it is
Tracking
within the supply chain.
4 Introduction
4.1 Traceability
Traceability systems are designed to trace and track products and their components through the supply
chain. Although traceability must be an end-to-end process, it is accomplished in a supply chain consisting
of independent firms with different stand-alone information systems. To ensure continuity in the flow of
traceability information, each partner in the food chain must pass on information about the identified lot or
product group to the next partner in the food chain [traceability information chain should not be broken].
Thus, to accomplish end-to-end traceability, supply chain partners must undertake three key activities:
1. Data collection: The system must be able to capture the required data. Although this may be ac-
complished using paper-based methods, more effective technologies like bar code scanners, radio
frequency identification, handheld computers and specially engineered input devices are simplifying
data collection and allowing more data to be captured.
2. Data storage: Once collected, the data must be organized and stored in a database which allows
different options for retrieval and search.
3. Data transmission and sharing: The system is only effective if data can be exchanged between
supply chain intermediaries. Thus, traceability systems must have systems integration capabilities,
connecting hardware and software, which allows diverse corporate systems to communicate.
In dairy processing, traceability requires collecting, filing and sharing information about:
 Product ingredients;
 Processing;
 Packaging;
 Labelling;
 Storage;
 Distribution.

Page 4 of 11
Traceability

Not applicable.
6 Procedure Notes
6.1 Identify and Record Lot IDs or Key Data Elements [KDEs]
Identify the places in the FBO facility where bulk products, ingredients, or packaging materials are added to
make your final product and identify key points in the physical process where product is transformed or lots
can be discretely separated (Critical Product Flows):
a) Create a method of recording the Lot ID’s for each of these places;
b) Decide on which identifying mark will be used for the Lot ID on the various materials;
c) Train FBO employees to be consistent and accurate when recording Lot IDs;
d) Keep FBO records in a way that makes the Lot IDs easy to find. Identify and record flows (Critical
Tracking Events, CTEs).
The following specific areas are common in the dairy foods industry and should be considered when listing
KDEs - Lot Entry Points:
Raw Milk Receiving − When receiving raw milk, the receiving facility should consider each farm on a truck
as a lot of product received. The facility should have, or have access to, the farm name and address of the
farmer. Model the receiving bay as a Lot Entry Point, and record each farm received and the silo that it was
received into. This can be accomplished in three ways:
1. The receiver records the load information only, and turns the dairy farm tickets into the office where
the individual tickets are correlated with the load information. This would be used when multiple
dairy farms pickups are accumulated on a single delivered load;
2. Only the route information is recorded by the receiver because the load is co-mingled [mixed by a
cooperative]. In this case, the cooperative would need to have the dairy farm information for each
load, and would be involved in the tracking if a recall were required;
3. The receiver records the individual dairy farm tickets that are received with the load information.
Milk Hauler/Driver Responsibility − The records of the Milk Hauler/Driver performing the dairy farm pickups
are paramount to making a recall work and are the first step in creating a successful traceability program.
Accurate identification of the dairy farm, quantity, CIP records, and sample of milk is essential, reference the
manifest or e-manifest

Page 5 of 11
Traceability
Using Dairy Farm ID − The Dairy Farm ID is often used as the identifier for the dairy farm load. This can be
helpful to trace the loads, since this number is issued by a country Department of Agriculture and is used
in inspections and other records. However, many cooperatives and other dairy businesses assign their own
dairy farm ID as well. It is important that your haulers’/drivers’ and receivers’ records are consistent and
accurate.
Raw Milk Pooling − When milk is picked up from the dairy farm, loaded into silos or tanks and reshipped to
dairy foods plants, it is the responsibility of the milk pooling facility to keep the records of the dairy farm
loads as they relate to the tankers shipped. This facility will be modeled as any other facility.
Rework − Rework is common but complicates traceability. Consider and model rework as you would for any
other ingredient or product. Rework is best handled in the following manner:
 List the points [steps in the process] where rework could be collected in the process. Identify and
label the rework as a final product;
 If the rework is not a final product, create a Lot Identifying Mark on the rework. If it is a bulk rework
situation, create a Lot Identifying Mark and mark or tag the tank with this identifier;
 If the rework is a final product, use that Lot Identifying Mark;
 List the points [steps in the process] where the rework is added back into the process. Record the Lot
Identifying Marks as you would with any other ingredient. (KDE – Lot Entry Point);
 Take note of the Rework narrative in the following section, Critical Tracking Event;
 To reduce the co-mingling of lots, limit rework from one day added into another as much as possible.
Packaging Materials − Any packaging materials that come in contact with the product should be recorded.
Common Lot Entry Points Missed − CO2 addition, or other gases:

 Bags and liners for product packaging;
 Vitamins and small quantity additives.
Disposed Ingredients or Products − Records should be maintained for ingredients, products, and packaging
materials that are disposed. The quantity disposed, and the Lot Identifying Mark should be recorded as any
final product.
6.2 Identify and Record Flows or Critical Tracking Events [CTEs]

Identify the main flow paths in the Dairy Plant that product pass through from the beginning to end:
a. Create a method of recording each of these flows;
b. Train FBO employees to be consistent and accurate when recording these flows;
c. Keep GBO records in a way that makes it easy to relate the above recorded Lot IDs with the flows.
d. Track FBO flows between the facilities within your corporation or cooperative. Keeping good records
of FBO interplant transfers or a system that can link the traceability of FBO products between facili-
ties will reduce your time to identify products or exclude the FBO from a recall.

Page 6 of 11
Traceability
There are a few areas of special consideration for modeling the Critical Tracking Events in a dairy foods
facility:
 Storage that does not get CIP’d on a frequent basis. Oils, sugars, and other bulk ingredients are stored for
long periods of time without being completely emptied or CIP’d. This is common and safe, but breaks
a granular model of traceability.
 Reset the trace for this vessel on a calculated first-in, first-out method. For example, 3,000 kg of oil were
delivered, so the first 3,000 kg used exhausts that lot. On a reoccurring basis (possibly monthly) re-
verify the calculated inventory to actual inventory.
 Reset the trace based on a recurring time period. This is a common practice for city water, since there
never is really an interruption. For government-supplied water, many reset the trace every 24 hours.
 Continuous processes. Some processes run for longer periods of time than is practical for consideration
as one lot of finished product. Spray dryers, powder silos or other processes may run for several days
without stopping for a CIP. Yet the flows through these processes need to be documented either
manually or automatically to provide good traceability.
 Reset the Critical Tracking Event whenever a source or destination changes. For instance, on a dryer,
create a new flow record when the powder bin selection changes. In the case of an evaporator,
change the flow record whenever the silo feeding the evaporator changes. If these two are com-
bined, the quantity of product under one Critical Tracking Event becomes much smaller, reducing the
size of the Lot that will be considered for a recall.
When the Critical Tracking Event is reset as described, the following traceability can be accomplished:
Inclusion – Depending on the risk of the contaminant, the entire list of final product Lot Identifying Marks
can be held, recalled, or tested during the CIP to CIP run of the dryer.
Exclusion – Depending again on the risk of the contaminant, the final products that are within the nar-
rowest scope of a single silo crossing to a single powder bin can be isolated. This may be the highest risk
product.
Dilution – Depending once again on the risk of the contaminant, final product that contains items such
as a common silo, powder bin, a common rework Lot Identifying Mark, can now be isolated to find those
product lots with trace amounts of the contaminant.
This method can be used to find the source of the contaminant, especially in an automatically collected
traceability solution.
Adding rework into the process. Rework addition should be handled as any other ingredient additions. How-
ever, where creation of rework is possible, the points in the process should be modeled as a Critical Tracking
Event, with a final Lot Identifying Mark so when it is added it can be traced.

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Traceability
6.3 Place a Standard, Human Readable Lot ID on FBO Products [Lot ID]
Label the FBO final products with a simple, human-readable Lot ID so everyone using your products in their
manufacturing can also maintain consistent and accurate records:
a. Use this Lot ID in FBO records as either a primary identity, or at least a searchable field in FBO elec-
tronic or ERP system;
b. Use this Lot ID in every record, both manual and electronic (ERP);
c. Add “LOT” or “Lot ID” near the human-readable Lot ID so the operators in the FBO’s customers’ facili-
ties can easily record the correct identity.
6.4 Product Labelling

A simple, readable LOT ID should be accurately recorded is the key element in a successful traceability sys-
tem.
To allow efficient and expedient traceability, the Lot Identifying Mark should:
 Be easily readable for your customers that use manual lot tracking records;
 Stand out on the package, pallet label, and bill of lading so that customers can clearly determine the
Lot Identifying Mark they should use in their traceability records.
If you are incorporating a bar code into your records that is used by all customers, ensure that both distribu-
tors and the final customers are bar code scanning the Lot Identifying Mark, and integrating it into their
traceability records.
The Lot Identity Mark should be obvious on every package, container, pallet and bill of lading that leaves
the FBO.
If the product is meant for use by another manufacturer or processor, the text “LOT” or “Lot ID” should be
printed boldly and visibly next to the Lot Identifying Mark.
Alternatively, for a small manufacturer, the number should be applied in human readable form. Again the
text “LOT” or “Lot ID” should appear near the code.
If a customer requests or accepted more extensive Lot Identifying Marks, this is also acceptable; simply
make sure the mark is clear. The Lot Identifying Marks should be used in all correspondence.
The recommended lot identifying mark content should consist of:

 The dairy plant number, the date and a process identifier. The plant numbers are typically 4-6 digits;
 The date should be in a plain format. For example, July 26, 2012 could be shown in YYYYMMDD for-
mat as 20120726, or alternatively, in YYYYDDMM format as 20122607;
 An additional identifier for the product created in a specific day. This identifier is a line identity.

Page 8 of 11
Traceability
6.5 Dairy Milk Traceability Records

General Information
 Any final product, bulk or packaged, should have a listing of the Lot Numbers that it contains.
 The Lot Numbers that these records contain should match the Lot Numbers in the warehouse
records.
If the FBO traceability system is stored in a database, the Lot Identifying Marks should link or associate all
the records.
Traceability records should enable the FBO to find a Lot Identifying Mark and any contributing Lot Identify-
ing Marks quickly and accurately. The traceability records need to only contain the information to accom-
plish this.
For internal records, it is recommended to have the basic traceability information linked with the full record
of the process and the quality assurance records.
The following is the contents of the basic record content set.
KDEs - Lot Entry Points. An up-to-date listing of the KDEs - Lot Entry Points for your facility or process area.
This shows that you can track where other Lot Identifying Marks enter your process. It will also correlate to
the daily records you keep, either manually or electronically, of the Lot Identifying Marks that you incorpo-
rate into your final products. These records can be either textual or flow charts.
Critical Tracking Events. An up-to-date listing of the physical flows in the process, or Critical Tracking Events.
This will correlate to the daily records of the flows in your facility and will be used to find the path of the Lot
Identifying Marks through the process. These records can be either textual or flow charts.
Lot Identifying Mark. This record is only a short written description of how your Lot Identifying Mark is struc-
tured and what the digits represent. The following are the minimum records to be maintained by the FBO.
Farm Milk Records should minimally contain:

 Farm number;
 Carrier/hauler identification;
 Driver identification;
 List of farm identification in load;
 Time load was received;
 Therapeutic drug [antibiotic] test result;
 Receiver/tester;
 Milk temperature;
 Silo destination for load.

Page 9 of 11
Traceability
Bulk Receipt Records should minimally contain:

 Bill of lading number;
 Carrier information;
 Lot identifying mark from supplier;
 Time received.
Ingredient Addition Records should minimally contain:

 Lot identifying mark from supplier;
 Carrier information;
 Manufacturer name (if manual system; if electronic, this can be joined in the database from the Lot
Identifying Mark);
 Ingredient name (if manual system; if electronic, this can be joined in the database from the Lot
Identifying Mark);
 Time of addition;
 Operator.
Final Product records should minimally contain:

 Lot Identifying Mark;
 Product name;
 Time of product run start;
 Time of product run end.
Peripheral Areas (Warehouse, Distribution Centers, Shipping)
Outside the physical processing environment (within the supply chain) traceability becomes discrete,
meaning each product that can be contaminated is contained in one package. If an easily identifiable Lot
Identifying Mark is contained in the Bill of Lading, Shipping Records, Receiving Records, Warehouse system,
etc., once the suspect product(s) are traced and identified each can be quickly held, tested, removed from
the food chain or destroyed.
Record Retention, Security, and Backup
Traceability records are retained for the same duration as other regulatory records, such as CIP and pas-
teurization records. Until regulatory documents list traceability record retention, assume the same length
of time as the PMO (Pasteurized Milk Ordinance) specifies for HTST record retention.
It is important that these records are not lost, or edited. Note the following:
 If the records are manual, they should be stored in files that are either in an office that is locked when
it isn’t staffed or after business hours, OR are locked in a file cabinet;
 If the records are electronic, they should be backed up once every 24 hours and stored in a database
or data archival system in a Write Once, Read Many (WORM) format.

Page 10 of 11
Traceability
6.6 Testing and Validation of the Traceability System

The testing and validation of the FBO traceability system should at a minimum cover two scenarios via the
FBO product recall procedure:
1. Get one or more final product KDEs – Lot Identification Mark(s) and identifying the contributing
bulks, dairy farms, ingredients, additives or packaging materials that the product contains;
2. Getting a suspect or possible adulterated alert of a bulk, dairy farm, ingredient, additive, or packaging
material and needing to find the final products(s) that contains the possible containment.
The results of the traceability system testing and validation should be confirmed via QA/Laboratory results.
6.7 Traceability System Testing and Validation Frequency

The FBO policy states that testing frequency and validation of the traceability system should be at least
annual or following a serious food incident/event or a significant change to the FBO or food chain partner
traceability system.
6.8 Post Review Actions

A post review action review must be conducted when the mock recall is over and potential improvements
implemented. Any actions arising should be monitored and tracked via the FBO corrective and preventive
action procedure.
As a minimum, an analysis of the involved quantities of materials must be made (produced, sold, returned,
destroyed, authorized for release and not accounted for or consumed).
The simple goal of the Mock Recall is ideally 100 percent product [bulk, dairy farm, ingredient, additive, in-
termediate product or finished product] is accounted for within two hours or less.
7 Records

Dairy Plant Records [Various] Food Safety Office Indefinitely Food Safety Manager
Mock Recall Log Food Safety Office Indefinitely Food Safety Manager
Communication Records Food Safety Office Indefinitely Food Safety Manager
Root Cause Analysis Food Safety Office Indefinitely Food Safety Manager
Mock Recall Report Food Safety Office Indefinitely Food Safety Manager
Post Review Minutes Food Safety Office Indefinitely Food Safety Manager

Page 11 of 11
Product Recall and Withdrawal
FBO Procedure
Document # SOP-023
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary.............................................................................. 247 6.3 Decision to Recall or Withdraw........................250
2 Related Documents ....................................................... 247 6.4 Actions in the FBO Factory ................................250
3 Definitions ..........................................................................248 6.5 Actions in the FBO Distribution/Logistics ..... 251
4 Introduction ......................................................................249 6.6 Actions in Trade ........................................................ 251
4.1 Product Recall and Withdrawal ........................249 6.7 Return Transport ...................................................... 251
5 Procedure Flow Chart ...................................................249 6.8 Handling of Returned Product .......................... 252
6 Procedure Notes .............................................................249 6.9 Post Review Actions .............................................. 252
6.1 Data Collection and Management...................249 6.10 Post Review Actions ............................................ 252
6.2 Decision to Recall or Withdraw........................250 7 Records ................................................................................ 252
Classification Company Confidential Product Recall and Withdrawal

Page 1 of 7
FBO Procedure Product Recall and Withdrawal 247
1 Summary
To describe the process for effectively removing a product from the exter-
Purpose
nal supply chain/distribution.
Scope FBO.
2 Related documents

Policies
Mock Recall, SOP-008

Page 2 of 7
3 Definitions

Complaint service, or the complaints-handling process itself where a response or resolution
is explicitly or implicitly expected
Output that is a result of activities where none of them necessarily is performed
at the interface between the provider and the customer. For the FBO this can
Product
be an ingredient, raw material, intermediate product or finished product supplied
to a customer or consumer
Recall actions with the product (e.g. “do not consume the product”, or “return the
product to the shop or manufacturer”). This includes the FDA class I and class II
recalls
Regulatory
Obligatory requirement specified by an authority mandated by a legislative body
requirement
A cause that once removed from the problem fault sequence, prevents the final
Root Cause
undesirable event from recurring
Root Cause A method of problem solving that tries to identify the root cause of faults or
Analysis problems
Statutory
requirement
Withdrawal is the process by which a product is removed from the external
Withdrawal supply chain/distribution, but which does not require any action from the
consumer.

Page 3 of 7
4 Introduction
4.1 Product Recall and Withdrawal
Even within the best managed food business, an issue involving the safety and suitability of a food may oc-
cur. This may be the result, for example, of a packaging defect, a product formulation error, a manufacturing
or storage problem, a problem with the food ingredients. It is important that food business operators are
aware that food safety issues can arise with their products and therefore, recognize that there is a need to
plan ahead.
European Union (EU) food law requires all food business operators to be able to trace the food they receive
back to the immediate supplier of that food. Then, following food handling, preparation or processing, food
business operators must be able to track the distribution of food, forward from their own business to their
immediate customer.
In addition, food business operators are required to withdraw unsafe food from the market where it has
left their immediate control and, if it has reached the consumer, inform consumers of the reason for the
food being removed from the market and if necessary, recall the affected food from them. Therefore, food
business operators should develop documented food traceability and food recall/withdrawal systems and
integrate them into their Food Safety Management Systems.

Not applicable.
6 Procedure Notes
6.1 Data Collection and Management
The Food Safety Team:
 Gathers all necessary information, facts and data to enable a conscious decision to confirm the valid-
ity of the claim and proceed to a withdrawal or recall;
 Informs regulatory authorities according to crisis management rules and local regulations;
 Defines the communication with the employees, sales force, customers or consumers and other
stakeholders;
 Decides the destiny of the products removed;
 Considers all other elements which might impact the FBO.

Page 4 of 7
6.2 Decision to Recall or Withdraw

The decision to withdraw or recall is taken by the Food Safety Manager.
The decision-making process follows the Crisis Management procedures and especially takes into account:
 The situation and actions to take in markets where the same material is commercialized (inter-
market supply);
 Foreign markets, which must be consulted when taking decisions or to approve the decisions.
Specific guidelines may apply.
6.3 Decision to Recall or Withdraw

Communications are critical for the success of a recall as well as for the image of our brands. Communica-
tions are based on:
 The position statement prepared by the Food Safety Team and FBO PR/Legal Advisor recalling a
product;
 Questions and answers to be used by Consumer Services.
The media used for communications must be adequate to reach the potential consumers of the product
to be recalled.
Communication must be simple and factual:

 Why do we recall?
 What do we recall?
 What do we do as a FBO to eliminate the defect and put the product back on the market?
 What is our refund policy?
The same principles must be applied for communications to other stakeholders (employees, customers,
authorities, etc.).
6.4 Actions in the FBO Factory

The factory provides the traceability data necessary to define the material and quantities to be removed
from the entire supply chain/distribution. All affected batches must be restricted in the FBO computer sys-
tem.
The accuracy of the traceability system must be considered and a “safety margin” on either side of the con-
cerned batch added if necessary.
The incident must be investigated, root case analysis and corrective actions taken.

Page 5 of 7
6.5 Actions in the FBO Distribution/Logistics

Upon receiving instructions to block a particular product quantity, the warehouse staff must immediately
remove it from assembled loads in the warehouse. The blocked stock must be physically marked and seg-
regated.
If advised by the Food Safety Team, distribution will co-ordinate urgent material pickup from identified
warehouses and stores if necessary.
The material received back must be registered in the FBO computer system with the status “blocked” as for
all returned material.
On request, warehouse personnel can check and sort the suspected stock. The Food Safety Manager pro-
vides instructions as to how to examine product and adequate resources (training, specialists, etc.).
A detailed report must be prepared on the fate of the recalled batches. Other goods must be included when
relevant (e.g. “non-recalled” goods, other FBO products or even competitors’ products).
6.6 Actions in Trade

The Food Safety Team establishes clear instructions for shops and retailers on how to proceed with the
affected material.
Materials in the warehouses must be blocked, physically marked and a pickup schedule agreed with FBO
Distribution.
Materials already in shops (supermarkets shelves or back room storage) must be removed from shelves,
blocked, physically marked and placed in the back room storage awaiting pickup or destruction (as agreed
between the FBO and the retailer). Sales or merchandising staff may be called to assist as needed.
Retailer will communicate actual quantities to be picked up to facilitate transport. The material must be
returned as soon as possible to FBO or dedicated warehouses.
Disposal at customer sites is possible if mutually agreed on what to dispose. Method of disposal must be
defined and properly documented.
6.7 Return Transport

The return transport of affected material needs special attention and a good organization. It must be done
without delay.

Page 6 of 7
6.8 Handling of Returned Product

The returned product must be controlled, registered, marked and segregated from normal stocks.
Precise inventories must be kept. Regulatory authorities might have additional requirements on records and
information.
Returned product must be handled as non-conforming product; the rules for responsible destruction or
disposal must be followed.
In line with the FBO accounting procedure, all costs related to recalls and withdrawals must be charged to
Production-Related Overheads and not to Bad Products.

Post review action review must be conducted when the incident is over and potential improvements imple-
mented.
destroyed and not accounted for or consumed).

Recalls and withdrawals must be practiced. An annual mock recall exercise is mandatory (see Mock Recall
Procedure). A post review action of a real case cannot replace a Mock Recall. An actual recall is not the time
to test the FBO recall/traceability system.
7 Records

Recall/Withdrawal Log Food Safety Office Indefinitely Food Safety Manager
Recall/Withdrawal Report Food Safety Office Indefinitely Food Safety Manager

Page 7 of 7
FBO Procedure Mock Recall 253
Mock Recall
FBO Procedure
Document # SOP-008
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary...............................................................................254 6.3 Decision to Recall or Withdraw.........................258
2 Related Documents ........................................................254 6.4 Actions in the FBO Factory .................................259
3 Definitions ...........................................................................255 6.5 Actions in the FBO Distribution/Logistics .....259
4 Introduction .......................................................................256 6.6 Actions in Trade ........................................................259
4.1 Product Recall and Withdrawal .........................256 6.7 Return Transport .....................................................260
5 Procedure Flow Chart ....................................................256 6.8 Handling of Returned Product ..........................260
6 Procedure Notes ..............................................................256 6.9 Post Review Actions ..............................................260
6.1 Data Collection and Management....................256 6.10 Post Review Actions ............................................260
6.2 Decision to Recall or Withdraw.........................257 7 Records ................................................................................260
Classification Company Confidential Mock Recall

Page 1 of 8
Mock Recall
1 Summary
To describe the process for effectively removing a product from the exter-
Purpose
nal supply chain/distribution.
Scope FBO.
2 Related documents

Policies
Recall and Withdrawal, SOP-023

Page 2 of 8
Mock Recall
3 Definitions

Complaint service, or the complaints-handling process itself where a response or resolution
is explicitly or implicitly expected
Output that is a result of activities where none of them necessarily is performed
at the interface between the provider and the customer. For the FBO this can
Product
be an ingredient, raw material, intermediate product or finished product supplied
to a customer or consumer
Recall actions with the product. (e.g. “do not consume the product”, or “return the
product to the shop or manufacturer”). This includes the FDA class I and class II
recalls
Regulatory
Obligatory requirement specified by an authority mandated by a legislative body
requirement
A cause that once removed from the problem fault sequence, prevents the final
Root Cause
undesirable event from recurring
Root Cause Is a method of problem solving that tries to identify the root cause of faults or
Analysis problems
Statutory
requirement
Traceability is the ability to track a food through all stages of production,
processing and distribution (including importation and at retail). Traceability
Traceability
should mean that movements can be traced one step backwards and one step
forward at any point in the supply chain.

Page 3 of 8
Mock Recall
4 Introduction
4.1 Mock Recall
The Food Industry Recall Protocol (Protocol) provides information on recalling food in and guidance for
food businesses on developing a written food recall plan. A food recall is action taken to remove from
distribution, sale and consumption, food which is unsafe. This means food that may cause illness or other
physical harm to a person consuming the food.
The three primary objectives of a food recall are to:

 Stop the distribution and sale of the product as soon as possible;
 Inform the government, the food businesses that have received the recalled food and the public
(consumer level recalls only) of the problem;
 Effectively and efficiently remove unsafe product from the market.
This protocol provides guidance only and is not legally binding; however it outlines legal requirements
relating to mock recalls that are enforceable by the National or Federal and territory governments, where
applicable. Where legal obligations are not applicable, customer or Food Safety Scheme Standards require-
ments should be followed.
Recall systems should be tailored to the individual needs of the FBO. A business may seek independent
advice (including legal advice) about the system it develops for food mock recalls.

Not applicable.
6 Procedure Notes
6.1 Data Collection and Management
A food business may be informed of a problem with any of its food products, raw material, ingredient, in-
termediate product or finished product by:
 In-house testing indicating there may be a potential problem with a particular food product or batch;
 Customer/consumer complaints/feedback (e.g. phone call or email from a customer or wholesaler
informing the business about a potential problem);
 A supplier of a raw material that is used by the company in making its food products informing the
business that there is a problem with an ingredient;
 Government bodies, such as health departments, local councils, or the police, indicating that there
may be a problem with a particular food product.

Page 4 of 8
Mock Recall
Such problems may include:

 The presence of pathogenic bacteria (e.g. Salmonella);
 Chemical contamination (e.g. chemical sanitiser);
 Foreign matter contamination (e.g. pieces of glass, metal or plastic), which could cause physical harm
to a person consuming the food;
 Labelling errors (e.g. incorrect/insufficient cooking instructions);
 Undeclared allergens (e.g. allergens such as peanut, milk or soy products not being declared on the
label);
 Packaging defects (e.g. where the integrity of the package is compromised and a piece of the pack-
aging results in a choking hazard);
 Under-processing resulting in potentially unsafe food;
 It is important that all necessary information about the nature of the problem/hazard is obtained so
that an assessment can be made to establish whether the food product is unsafe and recall action is
required. In assessing the risk the sponsor needs to:
• Identify the hazard associated with the food, for example, is it microbiological, physical, chemical
or allergen related;
• Determine if the identified hazard poses a potential food safety risk, for example the food may
contain harmful levels of pathogenic bacteria;
• What action needs to be taken to manage the food safety risk.
The Food Safety Team

 Gathers all necessary information, facts and data to enable a conscious decision in order to proceed
with a mock recall. It is important to have a clearly defined goal and objective for the mock recall
being conducted, as these exercises can be done to validate specific processes and confirm suspected
weaknesses;
 Defines the communication with the employees, sales force, customers or consumers and other
stakeholders;
 Decides the destiny of the products removed;
 Considers all other elements which might impact the FBO.
6.2 Decision to Conduct a Mock Recall

The decision to conduct a mock recall is taken by the Food Safety Manager. The frequency of a product
mock recall should be twice per annum and more frequently if requested by the primary stakeholders.
The decision-making process follows the crisis management procedures and especially takes into account:
 The situation and actions to take in markets where the same material is commercialized (inter-
market supply);
 Foreign markets must be consulted when taking decisions or to approve the decisions. Specific
guidelines may apply.

Page 5 of 8
Mock Recall
Where a food safety issue has been identified for the mock recall, the Food Safety Manager should also
consider the possibility of the same problem occurring in:
 Different package sizes of the same line;
 Different flavors or varieties of the product;
 Food products with a different batch number or date marking;
 A different food product processed on the same line or in the same plant;
 The same or similar food products packaged under a generic label.
If the food safety issue is present in other foods, batches, sizes or brands, all of these foods will need to be
considered for inclusion in the mock recall.
The Food Safety Manager should also consider whether there are other products on the market or in the
food supply chain that may have been affected by the same hazard as the food subjected to the mock re-
call. This is referred to as trace-back. For example, if the problem is found to be linked to one or more raw
materials supplied to the FBO, then the FBO needs to notify the supplier of the raw materials to enable this
supplier to potentially notify other customers of the raw materials. This may then result in additional mock
recalls being initiated for more food products by other food businesses.
6.3 Decision to Mock Recall

Communications are critical for the success of a mock recall as well as for the image of our brands. Com-
munications are based on:
 The position statement prepared by the Food Safety Team/Recall Team and mock recall of a
product(s);
 The sensible and workable recall plan;
 Test procedures and plans with mock recalls;
 Identification of the Risks and Problem Areas;
 Statutory and Regulatory requirements related to mock recall communication, if relevant;
 Questions and answers to be used by Consumer Services.
The media used for communications must be adequate to reach the potential consumers of the product
to be recalled.
Communication must be simple and factual:

 Why do we mock recall?
 What do we mock recall?
 What do we do as a FBO to eliminate the defect and put the product back on the market?
The same principles must be applied for communications to other stakeholders (employees, customers,
authorities, etc.).
This protocol provides guidance only and is not legally binding; however it outlines legal requirements
relating to product recalls/withdrawals that are enforceable by the National or Federal and territory gov-
ernments, where applicable. Where legal obligations are not applicable, customer or Food Safety Scheme
Standards requirements should be followed.

Page 6 of 8
Mock Recall
6.4 Actions in the FBO Factory

The factory provides the traceability data necessary to define the material and quantities to be removed
from the entire supply chain/distribution. All affected batches must be restricted in the FBO computer sys-
tem.
The accuracy of the traceability system must be considered and a “safety margin” on either side of the con-
cerned batch added if necessary.
6.5 Actions in the FBO Distribution/Logistics

Upon receiving instructions to block a particular product quantity, the warehouse staff must immediately
remove it from assembled loads in the warehouse. The blocked stock must be physically marked and seg-
regated.
If advised by the Food Safety/Recall Team, Distribution will co-ordinate urgent material pickup from identi-
fied warehouses and stores, if necessary.
The material received back must be registered in the FBO computer system with the status “blocked” as for
all returned material.
On request, warehouse personnel can check and sort the suspected stock or hold the affected product until
the product is authorized as released. The Food Safety Manager provides instructions as to how to examine
product and adequate resources (training, specialists, etc.).
A detailed report must be prepared on the fate of the mock recalled batches. Other goods must be included
when relevant (e.g. “non-recalled” goods, other FBO products or even competitors’ products).
6.6 Actions in Trade

The Food Safety/Recall Team establishes clear instructions for shops and retailers on how to proceed with
the affected material.
Materials in the warehouses must be blocked, physically marked and traceability performed, and if required,
a pickup schedule agreed with the FBO Distribution.
Materials in shops (supermarkets shelves or back room storage) must be fully traced and where required
removed from the shelf, blocked, physically marked and placed in the back room storage awaiting pickup
or destruction or authorized release (as agreed between the FBO and the retailer). Sales or merchandising
staff may be called to assist as needed.
Retailer will communicate actual quantities to be picked up to facilitate transport, if required. The material
must be returned as soon as possible to FBO or dedicated warehouses.

Page 7 of 8
Mock Recall
6.7 Return Transport

The return transport of affected material needs special attention and good organization. It must be done
without delay.
6.8 Handling of Returned Product

The returned product must be controlled, registered, marked and segregated from normal stocks. At a
minimum, product should be obtained for laboratory analysis.
Precise inventories must be kept. Regulatory Authorities might have additional requirements on records
and information.
Returned product must be handled as non-conforming product; the rules for responsible destruction or
disposal must be followed.
In line with the FBO accounting procedure, all costs related to mock recalls must be charged to Production-
Related Overheads and not to bad products.

Post review action review must be conducted when the mock recall is over and potential improvements
implemented.
destroyed, authorized for release and not accounted for or consumed).
The simple goal of the mock recall is ideally 100 percent product [raw material, ingredient, intermediate of
finished product] is accounted for within two hours or less.
6.10 Mock Recall Frequency

Mock recalls must be practiced. To annual mock recall exercises are mandatory. A post-review action of
a real case cannot replace a mock recall. An actual recall is not the time to test the FBO recall/traceability
system.
7 Records

Mock Recall Log Food Safety Office Indefinitely Food Safety Manager
Mock Recall Report Food Safety Office Indefinitely Food Safety Manager

Page 8 of 8
FBO Procedure Food Defence Plan 261
Food Defence Plan
A FBO Plan
Document # PLAN-001
Created 20-04-2015
Updated 24-04-2015
Revision History
20-04-2015 V1.0 Joe Bloggs Original Draft.
24-04-2015 V1.0 Joe Bloggs Approved for release by Process Owner.
Contents
1 Summary...................................................................................................................................... 262
2 Related Documents ............................................................................................................... 262
3 Definitions .................................................................................................................................. 263
4 Introduction .............................................................................................................................. 264
4.1 General.................................................................................................................................. 264
5 Procedure Flow Chart ........................................................................................................... 265
6 Procedure Notes ..................................................................................................................... 265
7 Records .........................................................................................................................................272
Classification Company Confidential Food Defence Plan

Doc ID PLAN-001 Printed Controller Document Controller
Page 1 of 12
Food Defence Plan
1 Summary
To document the measures taken by the FBO to protect food and the
Purpose
food production processes from intentional harm.
This procedure is applicable to products, process and storage and produc-
Scope tion environments and suppliers across the food chain of the FBO and
address the risks to the FBO’s people, products, assets and the brand.
Functional Responsibility Manager. They are responsible for the effective implementation and
maintenance of this procedure.
2 Related documents

Procedures
Traceability, SOP-012

Page 2 of 12
Food Defence Plan
3 Definitions

Procedures used to protect electronic systems from sources of threat, such as
Electronic Security malware and hackers, intent on misusing them, corrupting them or putting them
out of use
Security of food and drink and their supply chains from all forms of malicious
Food Defence attack including ideologically motivated attack leading to contamination or
supply failure
Any and all elements of what is commonly called the food supply chain, net or
Food Supply
web with the inclusion of drink and supporting and allied services
Procedures used to confirm an individual’s identity, qualifications, experience and
Personal Security
right to work, and to monitor conduct as an employee or contractor
Techniques used to make food products resistant to contamination or misuse
Product Security
including tamper-evident closures and lot marking
Protective All the measures related to physical, electronic and personnel security which any
Security organization takes to minimize the threat of malicious attack.

Page 3 of 12
Food Defence Plan
4 Introduction
4.1 General
Multinational organizations are driving the need for their suppliers globally to have robust food defence
programs, thereby minimizing the risk of intentional contamination and tampering. If you work with, or
want to work with, a multinational company you will probably be required to have a Food Defence Plan.
The Food Defence Plan will build on your existing food safety, HACCP and crisis management plans, as well
as incorporate audits of the security of premises, shipping/receiving and personnel, in order to help ensure
safe and secure food supply.
Risks can originate from various sources: internal (employees, temporary workers, cleaning staff, etc.) or ex-
ternal (visitors, delivery personnel, suppliers, terrorist groups, activists, etc.). Malicious acts may come from
outside, but the scope of identifying risks must be understood in a broader sense. Internal risks should not
be overlooked: 70 to 80 percent come from the staff itself – disgruntled employees, for example. These can
take many forms: fraud, damage, sabotage, terrorist acts, theft, blackmail, and more. The probability is more
or less proven. Furthermore, these occurrences have a relatively strong impact on business.
The scope of Food Defence can be represented thus:
Raw materials
Ingredients Employees
Packaging material Layers of Food Defence Visitors
Water
tra
ns
po
rta Perimeter
tio
n
Plant
traceability
Process
tra traceability
ns
Prevent authorized po
rta
entry tio
n
Prevent unauthorized
Plan contractors/services entry
Pest control
Cleaning and sanitation Finished product
Maintence
Construction workers

Page 4 of 12
Food Defence Plan

Not applicable.
6 Procedure Notes
This food defence plan is organized in four sections: (1) Outside Security Measures; (2) Inside Security Mea-
sures; (3) Personal Security Measures; and (4) Incident Response Security Measures.
1. Outside Security Measures (examples: door locks, lighting, monitoring loading/unloading)
GOAL: To prevent unauthorized access by people of unapproved materials to the facility.
The FBO has in place at least one of the following measures for outside security.
1.1 Physical Security

a. Plant boundaries are clear and secured to prevent unauthorized entry (for example, fences installed,
no trespassing signs posted)
b. Entrances are secured (for example, locks and/or alarms installed and operating)
c. Plant perimeter is periodically monitored for suspicious activity
d. Outside lighting is present to deter unauthorized activities
e. Other access points such as windows and vents are secured
f. Outside storage on the premises is protected from unauthorized access
g. Other________________________________________________________________
1.2 Shipping/Receiving Security

a. Incoming shipments are examined for potential tampering
b. Incoming and outgoing vehicles are examined for suspicious activity
c. Loading and unloading are scheduled and monitored
d. Loading dock access is controlled (for example, monitored or locked)
e. Incoming shipments are secured with locks or seals
f. Outgoing shipments are locked or sealed
g. Other________________________________________________________________
1.3 Mail Handling Security

a. Mail is handled away from food including ingredients and packaged food product
b. Employees who handle mail are aware of proper handling of suspicious mail and U.S. Postal Service
guidelines
c. Other________________________________________________________________

Page 5 of 12
Food Defence Plan
2. Inside Security Measures (examples: Signs, observations, restricted access)
GOAL: To protect product from intentional contamination throughout the production process.
The FBO has in place at least one of the following measures for inside security.
2.1 General Inside Security

a. Suspicious packages are reported to appropriate personnel
b. Restricted areas of the establishment are clearly identified
c. Previously unattached materials are checked before used
d. Unexpected changes in inventory (product or equipment) are reported to appropriate personnel
e. Emergency lighting is in place
f. An emergency alert system is identifiable, tested, and reviewed with emergency contacts (for ex-
ample, police or fire personnel)
g. Other__________________________________________________________________
2.2 Processing Area Security

a. Access to ingredients, and packaged product is restricted
b. Access to process control equipment such as ovens and mixers is restricted
c. Ingredients are examined for possible tampering
d. Records ensure traceability for one step backward, one step forward, or both
e. Other__________________________________________________________________
2.3 Storage Security

a. Access to storage areas is restricted
b. Stock rotation (First In, First Out) is practiced
c. Labels and packaging materials are controlled to prevent theft and misuse
d. Periodic examinations for tampering of materials in storage are preformed
e. Other__________________________________________________________________
2.4 Ingredients/Water/Ice Security

a. Restricted access to storage tanks for potable water and to water reuse system
b. Access to lines that transfer water or ingredients are examined and restricted
c. Access to plant ice-making equipment is controlled
d. Restricted ingredients (for examples, nitrates) are controlled
e. Supplier food safety/security information is requested
f. Other__________________________________________________________________

Page 6 of 12
Food Defence Plan
2.5 Chemical/Hazardous Material Control Security

a. Chemicals/hazardous materials, including pesticides, cleaning or laboratory materials, and sanitizers,
are in a restricted area or secured by a lock
b. Maintain an up-to-date inventory of hazardous materials and chemicals, and investigate discrepancies
c. Potential hazardous waste (biological or chemical) is controlled and disposed of properly
d. Other__________________________________________________________________
2.6 Information Security

a. Access to sensitive information such as site plans and processing details in controlled
b. Access to computer systems is protected through firewalls and/or passwords
c. Other__________________________________________________________________
3. Personnel Security Measures (Examples: Check references, use visitor log or sign-in, or check IDs)
GOAL: To ensure that only authorized personal are in the facility at any time
The FBO has in place at least one of the following measures for personnel security.
3.1 Employee Security

a. A method to recognize or identify employees in the facility
b. Background or reference checks are conducted for new hires
c. Employees have restrictions on what they can bring in or take from the facility (for example, cameras)
d. Other________________________________________________________________

Page 7 of 12
Food Defence Plan
3.2 Non-employee Security (example: visitors, contractors, guests, customers, truck drivers)
a. A log of non-employees and persons working for and on behalf of the FBO entering the establish-
ment is maintained
b. A method to recognize or identify non-employees and persons working for and on behalf of the FBO
in the establishment is in place
c. Non-employees and persons working for and on behalf of the FBO are chaperoned on-site
d. Non-employees and persons working for and on behalf of the FBO are restricted to appropriate
areas
e. Non-employees and persons working for and on behalf of the FBO have restrictions on what they
can bring in or take from the facility
f. Other________________________________________________________________
3.3 Security Training

a. Awareness training on security measures is provides to new employees and persons working for and
on behalf of the FBO
b. Refresher awareness training on security measures is offered to employees and persons working for
or on behalf of the FBO on a periodic basis
c. Employees or persons working for or on behalf of the FBO are trained to report suspicious activities
or unusual observations
d. Other________________________________________________________________
4. Incident Response Security Measures (examples: reference your emergency plan, security plan, or
other)
GOAL: To respond quickly to a product contamination threat or event using planned measures
The FBO has in place at least one of the following measures for incident response security.
4.1 Investigating Security Concern

a. Have procedures to ensure that adulterated or potentially harmful products are held
b. Customer/Consumer comments are investigated
c. Reporting unusual activities is encouragement
d. Information is available to employees on how to respond to phone or other threats
e. Employees have the ability to stop activities to minimize a potential food defense incident
f. Reported security breaches (for example, alarms, suspicion of tampering) are investigated
g. Other___________________________________________________________________
4.2 Emergency Contact Security

a. Plant personnel contact information is kept up to date
b. Emergency contact information is kept up to date
c. Other___________________________________________________________________

Page 8 of 12
Food Defence Plan
4.3 Other Plan Security

a. A product recall plan is maintained and periodically reviewed
b. Key personnel are trained in product recall/withdraw procedures
c. Other___________________________________________________________________
This attachment provides a list of tools or additional security measures. These are provided to assist in tai-
loring the plan to meet the FBO’s specific needs.
1. Outside Security Tools
Physical Security Tools

 Ensure proper lighting to monitor the establishment outdoors at night and early morning;
 Install self-locking doors and/or alarms on emergency exits;
 Ensure the following are secured with locks, seals, or sensors when unattended (after hour/week-
ends) to prevent unauthorized entry:
• Outside doors and gates • Tanker truck hatches
• Windows • Railcars
• Roof openings • Bulk storage tanks/silos
• Vent opening • Loading ports
• Trailer (truck) bodies • Hose/Pump stations
 Regularly conduct and document security inspections of storage facilities, including temporary stor-
age vehicles;
 Restrict outdoor access to water wells/sources.
Shipping/Receiving Security
 Closely monitor loading and unloading of vehicle transporting raw materials, finished products, or
other materials used in food processing;
 Inspect tanker trucks and/or railcars to detect the presences of any material, solid or liquid, in tanks
prior to loading liquid products. Load only when appropriate. Report/record results;
 Control access to loading docks to avoid unverified or unauthorized deliveries;
 Require advance notification from suppliers for all deliveries;
 Immediately investigate suspicious changes in shipping documents;
 Check all deliveries outside establishment premises pending verification;
 If off-hour delivery is accepted, require prior notice of the delivery and an authorized person to be
present to verify and receive the delivery;
 Check less-than-truckload (LTL) or partial load shipments for content and condition;
 Require incoming shipment of raw product, ingredients, and finished products to be sealed with
tamper-evident or numbered, documented seals and verify the seals prior to entry. Reject if seal is
broken or missing;

Page 9 of 12
Food Defence Plan
 Select transportation companies and suppliers with consideration of security measures that they use;
 Examine returned good at a separate location for evidence of tampering before salvage or use in
rework;
 Maintain records of disposition of returned good;
 Require drivers or delivery personnel to provide identification, preferably with a photo ID, record
names;
 Minimize the time a truck is unlocked during loading or delivery.
2. Inside Security Tools
General Inside Security

 Install and monitor security cameras;
 Increase visibility within the establishment (for example, improve lighting, openness, increase super-
vision, add cameras);
 Regularly take inventory of keys to secured/sensitive areas of the establishment;
 Restrict access to controls (by locked door/gate or limiting access to designated employees) for the
following systems:
• Heating, ventilation, and air conditioning (HVAC);
• Propane, natural gas, water, electricity;
• Disinfection systems;
• Clean-in-place (CIP) systems or other centralized chemical systems.
Processing Area Security

 Maintain records to allow efficient trace backward or forward of materials and finish product;
 Reduce the time an area is left unmonitored;
 Reduce access to product containers or processing equipment;
 Do not allow unnecessary personal items within the production area.
Storage Security
 Maintain an access log for product and ingredient storage areas;
 Regularly check the inventory of finished products for unexplained additions and withdrawals from
existing stock;
 Restrict access to external storage facilities to designated employees only.
Ingredients/Water/Ice Security
 Examine packages of ingredients before use for evidence of tampering;
 Restrict access to product, ingredient, and packaging storage areas to designated employees only
(for example, by lock or gate);
 Water is from a municipally or local authority controlled source;
 Inspect water lines for possible tampering (perform visual inspection for integrity of infrastructure,
proper connections);

Page 10 of 12
Food Defence Plan
 Make arrangements with local health officials to ensure immediate notification to the establishment
if the potability if the public water supply is compromised.
Chemical/ Hazardous Material Control

 Restrict access to the in-plant laboratory;
 Have procedures in place to control receipt of samples;
 Have a procedure to place to receive, securely store, and dispose of reagents.
Information Security
 Track customer and consumer complaints/comments for trends;
 Keep details of food defense procedures confidential as necessary;
 Have up-to-date establishment layout/blueprint/drawings for local law enforcement, including the
fire department if needed.
3. Personnel Security Tools

 Authorize appropriate employees and persons working for or on behalf of the FBO to stop a process
for significant concerns;
 Control access by employees, non-employees and persons working for or on behalf of the FBO en-
tering the FBO establishment during working and non-working hours (use coded doors, receptionist
on duty, swipe cards);
 Restrict temporary employees, non-employees and persons working for or on behalf of the FBO to
areas relevant to their work;
 Implement systems to identify personnel with their specific functions, assignments or departments
(for example, corresponding colored uniforms or hair covers);
 Prohibit employees from removing company-provided uniforms or protective gear from the premises;
 Maintain an updated shift roster for each shift.
4. Incident Response Tool

 Establish evacuation procedures and include in food defense plan;
 Establish procedures for responding to threats as well as actual product contamination events;
 Pre-establish communication with local, state, and federal incident response personnel for a more
efficient response.

Page 11 of 12
Food Defence Plan
FBO
Food Defence Plan Review Form
Complete this form to document your annual review of this Food Defence Plan
Not all measures are required or need to be reviewed each time this form is completed
Person Who Conducted

Date of Annual Was the Food Defence Plan Tested?*
Annual Review
Review (Yes/No)
(Name and Title)
*Testing can be done using simple measures, such as checking locked doors or making unannounced perimeter checks.
7 Records

Food Defence Plan Review
Food Safety Office Indefinitely Food Safety Manager
Record

Page 12 of 12
FBO Procedure Allergen Control 273
Allergen Control
A FBO Procedure
Document # SOP-007
Created 20-04-2015
Updated 28-04-2015
Revision History
Contents
1 Summary...................................................................................................................................... 274
3 Definitions .................................................................................................................................. 274
4 Introduction ...............................................................................................................................275
4.1 General...................................................................................................................................275
5 Procedure Flow Chart ............................................................................................................275
6 Procedure Notes ..................................................................................................................... 276
7 Records ........................................................................................................................................ 276
Classification Company Confidential Allergen Control

Page 1 of 4
Allergen Control
1 Summary
To ensure the effective use, storage and labelling of allergens and food
Purpose
allergen management at the FBO.
This procedure is applicable to products, process and storage and produc-
Scope
tion environments and suppliers of raw materials in the FBO.
2 Related documents

Procedures
Traceability, SOP-012
3 Definitions

Immunological-based reaction to chemical substances, usually proteins or
protein fragments, by individuals who have previously been sensitized to the
same substance and have formed antibodies. Allergic reactions can be initiated
Food allergy
by small quantities of allergens. Reactions are usually mild and transitory, but in
a small percentage of the population, reactions can be severe and may in some
cases lead to death
Major food
Milk, soy, and gluten allergens.
allergens at FBOs

Page 2 of 4
FBO Procedure Allergen Control 275
Allergen Control
4 Introduction
4.1 General
Under Article 9 (1)(c) of EU FIC, all FBOs should declare the presence – whether for use as an ingredient or
a processing aid – of any of the 14 major allergens listed in Annex II to the Regulation. It should be noted
that in accordance with Articles 12 and 13 of EU FIC, the mandatory information should be easily accessible,
in a conspicuous place, easily visible and clearly legible. Information should be indelible (permanent) where
appropriate, for example, on food labels where it needs to withstand handling. The information should not
be hidden, obscured, detracted from or interrupted by other written or pictorial matter or any other inter-
vening material.
The 14 allergens listed in Annex II (as amended by Commission Delegated Regulation No. 78/2014) are rec-
ognized across Europe as the most common ingredients or processing aids causing food allergies and in-
tolerances. If there is a food product which contains or uses an ingredient or processing aid (such as wheat
flour used to roll out dough made from rye flour) derived from one of the substances or products listed in
the Annex II, it must be declared, by the FBO to the consumer.
The information supplied in this procedure is not exhaustive and does not cover other labelling require-
ments (such as other general labelling (e.g. country of origin, lactose, quantities, additives, nutrition, etc.).

Not applicable.

Page 3 of 4
Allergen Control
6 Procedure Notes
1) Storage of allergen-containing raw materials
 Allergen-containing raw materials should be stored separately from the non-allergen materials;
 Allergen-containing raw materials should not be stored over non-allergen materials;
 Milk allergen pallets should not be stored over soy allergen pallets or vice versa.
Please see Raw Material Management Procedure, SOP-010 for details.
2) Labelling
All allergen containing raw materials are initially received with orange labels from factories. Then milk and
soy allergens are labelled with purple and green labels, respectively. All finished products are labelled as
“Contains Allergens.”
3) External panel/consumer screening
External panellists and consumers who participate in product tasting are screened for sensitivity to major
allergens. Only panellists who are not allergic to foods are permitted to participate in consumer tests.
4) Internal panel screening
Internal panellists are alerted that samples consumed at the FBO may contain any one of the known al-
lergens indicated in definition section of this document.
5) Preventing allergenic cross contamination

 Use dedicated scoop for each raw material when transferred;
 Wipe down all affected surfaces after weighing out an allergen;
 Change gloves or wash hands after an allergen is handled;
 Keep all containers with allergens sealed;
 Whenever possible, store allergens on the lower section of the storage racks.
7 Records

Allergen File Food Safety Office Indefinitely Food Safety Manager

Page 4 of 4
FBO Procedure Hygiene Procedure 277
Hygiene Procedure
A FBO Procedure
Document # SOP-005
Created 20-04-2015
Updated 24-04-2015
Revision History
24-04-2015 V1.0 Joe Bloggs Reviewed and approved by Process Owner.
Contents
1 Summary...................................................................................................................................... 278
3 Definitions .................................................................................................................................. 279
4 Introduction .............................................................................................................................. 279
4.1 Hygiene ................................................................................................................................. 279
5 Procedure Flow Chart ...........................................................................................................280
6 Procedure Notes .....................................................................................................................280
7 Records .........................................................................................................................................283
Classification Company Confidential Hygiene Procedure

Page 1 of 7
Hygiene Procedure
1 Summary
To comply with legal requirements, all workers in direct contact with food
Purpose and processing lines must maintain a high standard of personal hygiene
and routines, which are outlined in this procedure.
This procedure is valid for the FBO and applies to all staff working in the
Scope FBO and the visitors/contractors/ part time and temporary workers pres-
ent on the premises.
Manager.
2 Related documents

Visitor Control, SOP-004
Contractor Control, SOP-007
Procedures Change Management, SOP-011
Internal Audit, SOP-006
Corrective Action & Preventive Action, SOP-009
Forms Not Applicable

Page 2 of 7
Hygiene Procedure
3 Definitions

Basic hygiene area is defined as the areas of food tasting and handling for
Basic hygiene area research and development purposes. A basic hygiene area at the FBO includes
the development and sensory labs
CAPA Corrective Action & Preventive Action
Company FBO
A critical hygienic area within the plant where products and ingredients
High hygiene area vulnerable to contamination and/or microbial growth are processed, treated,
handled or stored
Medium hygiene area is defined as the areas of food handling, i.e. where food is
Medium hygiene
produced, processed, stored and packaged. A medium hygiene area at the FBO
area
includes the production plant only.
4 Introduction
4.1 Hygiene
The great majority of people will experience a food or water borne disease at some point in their lives. This
highlights the importance of making sure the food we eat is not contaminated with potentially harmful
bacteria, parasites, viruses, toxins and chemicals.
Over the past half century, the process by which food gets from the farm to the plate has changed drasti-
cally. Food contamination that occurs in one place may affect the health of consumers living on the other
side of the planet. This means that everyone along the production chain, from producer to consumer, must
observe safe food handling practices.
Good food hygiene is essential for the FBO to make or sell food that is safe to eat. It is very important for
the FBO and staff to understand what good food hygiene is. Good food hygiene helps the FBO to:
 Obey the law;
 Reduce the risk of food poisoning among your consumers;
 Protect your business’s reputation.

Page 3 of 7
Hygiene Procedure

Not applicable.
6 Procedure Notes
Hygiene Rules
1) Personal Hygiene Rules
 Nails must be clean, neatly trimmed, without nail polish or artificial nails;
 No strong perfumes or strongly scented personal care products /heavy make-up are to be worn (i.e.
false eyelashes);
 Cuts and lesions must be fully covered with approved (blue), waterproof, metal-detectable adhesive
bandages, which can be obtained from first aid kits. Any lost dressing must be reported to the su-
pervisor immediately;
 All unhygienic practices such as spitting, coughing or sneezing over food, or using food dropped on
the floor for consumption, is unacceptable;
 Wash hands before entering work and after handling something dirty (e.g. waste, floor, shoes, mon-
ey, etc.);
 Gloves should be only worn when aesthetic appeal of products is endangered or for personal safety
reasons. They never replace hand washing;
 The white lab coats must be removed before entering toilet cubicles and should not be replaced until
hands have been washed;
 The FBO site is a non-smoking site and smoking is only allowed in defined areas;
 Personal safety gear must be worn when necessary;
 Personal items, such as smoking materials and medicines are allowed in designated areas only;
 Personal lockers should be maintained clean and tidy so that they are kept free from rubbish and
soiled clothing.
2) Basic Hygiene Area (Development and Sensory Labs)

 Maintain a high level of personal hygiene listed under Personal Hygiene Rules above;
 Wear lab coats and hairnets while handling products that will be tasted;
 For bench tasting, only wearing a lab coat is a minimum requirement. Further hygiene rules are up
to the tasting organizer to define if necessary;
 Employee’s private foods [food brought to the Dairy by the FBO Employee and consumed during an
official break, e.g. lunch] should be stored separately and the private foods should not be handled and
consumed where the products are handled and tasted;
 Clean and sanitize after handling private foods.

Page 4 of 7
Hygiene Procedure
3) Medium Hygiene Area (Processing Plant)

 Maintain a high level of personal hygiene listed under Personal Hygiene Rules above;
 Workwear should be changed daily;
 Wear clean garment, hairnet, and safety shoes while working;
 Wash hands before entering work;
 Eating, drinking or chewing is forbidden in the medium hygiene area;
 Remove all jewellery before entering work except solid band, plain wedding rings;
 Carrying of writing implements behind the ears is prohibited;
 Product contact tools and equipment should not be stored in personal lockers;
 Fully enclosed shoes must be worn when entering and working in the processing plant.
4) High Hygiene Area (Processing Area – Filing)

 Access only with clean protective clothing, hair covered, hand-washing (and if necessary disinfecting)
upon each entry, boot dips (if necessary);
 Stringent controls of cleaning, frequent cleaning, disinfection prior to start of new process;
 Access only for specially trained personnel required for process;
 No wooden pallets, cardboard or other unhygienic material;
 Air flow out of area (i.e. higher pressure inside zone).
5) Visitors and Contractors

 It is the responsibility of FBO employees to ensure that all visitors and contractors understand the
hygiene and safety rules and to check that they are following them when on site;
 When visitors and contractors arrive, the visitor control form will be given by the contact person to
let them read carefully and understand it and then sign on the bottom of the form;
 The contact person should keep the signed form and has responsibility to ensure the visitors and
contractors follow the stated rules in the form;
 White coats for visitors and contractors are available and they will be given by the contact person.
Cleaning and House Keeping

1) All Hygiene Areas
 Keep your working area clean and tidy at all times;
 Apply a CLEAN AS YOU GO approach of cleaning and inspect for absence of residues.

Page 5 of 7
Hygiene Procedure
2) Medium/High Hygiene Areas

 Follow the cleaning procedure and schedule in the Processing Plant Master Plans. Always remember
to clean equipment when you have finished using it to prevent hygiene issues as pest infestation and
microbiological contaminations.
Cleaning Equipment in Medium/High Hygiene Area

 The sign below is actually posted and applied in the medium hygiene area and a colour coding indi-
cates where tools have to be used:
White – Used on Food Contact Surfaces ONLY
Yellow – Used on Outside of Food Equipment and/or Packaging

(i.e. Drums, Boxes, Bags, etc.) Surfaces ONLY
RED – Used in Warehouse and Maintenance Shop ONLY
Black – Used on Floor, Wall, Pipe and Ceiling Surfaces ONLY
Black OVAL– Used on Drain Surfaces ONLY
Different coloured tools must be stored separately from each other.
Hygienic Maintenance in Medium/High Hygiene Area

 Equipment sent for maintenance should be cleaned before its re-installation in the processing plant.
Particular attention should be given to food contact surfaces that need thorough cleaning and
sanitation;
 Working tools must be stored in assigned containers and must not be placed onto food contact
surfaces or above them. The tools should be removed from the processing plant immediately after
work;
 The use of food grade lubricants is mandatory unless technological reasons prevent their use. All
exceptions should be approved by the manager. Lubricants should be applied in appropriate quantity
to avoid excess lubricant falling into products;
 Material which could taint any food product or ingredient (such as paint, glue, etc.) must not be
brought on to the site (contractors need to have written permission from the FBO Food Safety
Department to use such materials);
 Obsolete or unused equipment should be removed on a regular basis;
 Apply the change management procedure for any equipment change.

Page 6 of 7
Hygiene Procedure
Waste in Medium/High Hygiene Area
Food contact wastes and the other garbage should be placed separately:
Orange bags: food scrap or animal feed
Hygiene Training
 New personnel will receive an initial hygiene induction training session;
 Once a year, all staff working in hygiene areas need to be retrained by the Food Safety Department;
 What about contractor staff working in medium hygiene area for a period of time or regular basis
for a period of time?
Reporting of Illness and Injuries

When an employee or a member of his/her household has suffered from one of the following conditions,
the employee must report it immediately when returning to work to his/her line manager. It is the man-
ager’s responsibility to discuss the symptoms with the employee:
 Jaundice;
 Diarrhoea;
 Vomiting;
 Fever;
 Sore throat with fever;
 Visibly infected skins (boils, cuts, acne, pusts);
 Discharge from ear, eye and nose.
No person with such a disease shall be permitted to work in the Medium Hygiene Areas. The advice is to
avoid food handling for at least 48 hours after the last either vomiting or diarrhoea episode has occurred in
order to prevent contamination of the food produced at the FBO.
If the employee contracted a disease while travelling abroad (either for business or personal reasons), it is
the employee’s responsibility to contact a doctor on return to get information and advice on the disease
they have suffered from, and report the illness to his/her line manager on first day back to work.
How does this information get fed to the Food Safety Manager (confidential) and what about considering
and activating the non-conforming procedure and corrective and preventative action procedure?
7 Records

Signed Training Participant
Food Safety Office 7 years Food Safety Manager
Lists (hard copies)
Visitor Control Form Food Safety Office 7 Years Food Safety Manager

Page 7 of 7
Identification and Evaluation of Compliance
A FBO Procedure
Document # SOP-013
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary...................................................................................................................................... 285
3 Definitions .................................................................................................................................. 286
4 Introduction .............................................................................................................................. 286
4.1 General.................................................................................................................................. 286
5 Procedure Flow Chart ........................................................................................................... 287
6 Procedure Notes ..................................................................................................................... 288
7 Records ........................................................................................................................................ 289
Classification Company Confidential Identification and Evaluation of Compliance

Page 1 of 6
FBO Procedure Identification and Evaluation of Compliance 285
1 Summary
To outline how identification and evaluation of compliance to statutory

Purpose and regulatory and other requirements (hereafter referred to as compli-
ance) is managed within the FBO.
The procedure starts with the identification of a new or changed com-
pliance requirement; recording; information collected; relevance impact
Scope assessed; degree of compliance established; gaps, if any identified and
resolved; compliance register updated/improved and ongoing monitoring
and evaluation of compliance.
Manager. They are responsible for the effective implementation and
Functional Responsibility maintenance of this procedure.

control are managed in accordance with this documented procedure
2 Related documents

Non-Conforming Product, SOP-003
Corrective and Preventative Action, SOP-009
Procedures Internal Audit, SOP-006
Product Recall and Withdrawal, SOP-023
Food Safety Legal Register, REG-001

Page 2 of 6
3 Definitions

Compliance Statutory and regulatory including other legal obligation requirements
Compliance
Food Safety Legal Register
Register
Any person or organization with statutorily delegated or vested authority,
Enforcement
capacity, or power to perform a designated function or any agency which
Agency
enforces the law, e.g. FSA, FDA
External person or group (e.g. external FBO unit, consumers, regulatory agencies)
Interested Party
having an interest in the performance or success of the organization.
4 Introduction
4.1 General
A corporate vision for food safety compliance is a defined and documented strategy for mapping out the
business’s objectives for meeting its compliance obligations now and in the future. It is focused on future-
proofing the business’s need to meet a dynamic compliance framework, maintain a high level of consumer
protection and support business development objectives.
This procedure outlines the procedure for the identification and evaluation of a FBO’s legal obligations,
primarily statutory and regulatory, and to the customer.

Page 3 of 6
1. Subscription
Identify
Interested Party
New/Changes
2. Compliance Register/
Food Safety Manager Recording Meeting Minutes
3. Compliance Register
Food Safety Manager Information Collected
Food Safety Manager Assess
Relevance/Impact
5. Compliance Report
Internal Auditors Evaluate Compliance
Food Safety Manager/ 6. Change Management

Management Team Gap Resolution Plan Form
Food Safety Manager/ 7. Change Management

Management Team Implement Resolution Form
8. DMS
Update/Improve,
Management Team
if required
Food Safety Manager Monitor and
Measure

Page 4 of 6
6 Procedure Notes
Step 1
Any new or changes in compliance requirements are identified via a combination of the FBO business; en-
forcement agency; industry representative; and a legal register subscription communication/update service.
Step 2
The Food Safety Manager shall record the information including updating of the Compliance Register (Food
Safety Legal register), as required.
Step 3
The Food Safety Manager shall collect additional information on the new or changed compliance require-
ment where necessary for the purposes of better understanding and evaluation. The relevant legal register
shall be updated and maintained, as required.
Step 4
Once the necessary information and data has been collected, the relevance and impact of the new and/or
changed compliance requirement shall be identified. The relevant legal register shall be updated and main-
tained, if required. The Food Safety Manager shall communicate the information to the relevant internal
parties via a combination of email, report or meeting. The management review meeting shall review all new
or changed compliance requirements, reference the management review procedure.
Step 5
Based upon the information collected, the Food Safety Manager shall determine the best strategy for evalu-
ating the degree of compliance, e.g. document review, monitoring and measurement data, audit or a com-
bination of one of more etc., referencing the relevant legal register and updating it if required.
Step 6
Where the periodic evaluation results show there is a gap, a gap resolution plan shall be defined and docu-
mented. This may include a corrective and preventative action plan, if required. Reference the Non Confor-
mity Product Procedure and Corrective and Preventative Action Procedure.

Page 5 of 6
Step 7
The gap analysis plan shall be implemented in a timely manner to ensure full compliance.
Step 8
The relevant compliance register including FSMS documented system shall be reviewed and updated as
required.
7 Records

Food Safety Legal Register Food Safety Office Indefinitely Food Safety Manager
Internal Audit File Food Safety Office Three years Food Safety Manager
Management Review Package Food Safety Office Three years Food Safety Manager

Page 6 of 6
Food Safety
Training
MODULE 6
292 MODULE 6 FOOD SAFETY TRAINING
Introduction
If you have a food business, or work in the food industry, you are legally required to undertake food safety
training and/or be supervised in line with the level of activity you are involved in. So, for example, managers
will need different training from those serving food.
If you are responsible for the development and maintenance of your business’s food safety management sys-
tem, then you must undertake adequate training in the application of HACCP Principles and the Food Safety
Management System.
Choosing Food Safety Trainers or Training Course

In most countries there is no national accreditation body for trainers or training courses; therefore, if you de-
cide to take a course or employ a trainer, bear in mind the points below. Remember, it is advisable to contact
a number of training providers to find the one that suits your needs, as there is no single training course that
meets the needs of everyone.
Do the trainers have appropriate food safety qualifications?

 Trainers must have a background in food safety;
 They must have relevant experience in the food industry;
 They must have knowledge of how people learn and training skills.
Can they provide follow-up support?
Post-training follow-up is beneficial as it can help when putting the training theory into practice in the work-
place and can help clarify issues that may have arisen since the training took place.
Is management participation encouraged?
Management involvement is crucial to the success of the training. It is important that the trainer and manage-
ment work together to ensure that all food safety aspects relating to the business are addressed in the course.
What do some of their previous clients say about them?
Talking to previous clients will help determine the quality of the training provided. However, the success of the
service depends on the input of the training provider and the food business.
Are the training providers interested in identifying your specific needs?
Are they willing to spend time with you, listen to you and explain the best method of meeting your require-
ments?
Are they willing to show you some of their training aids or previous work?
This will give you an indication of the quality of training you can expect to receive and assess whether the
training is generic or tailored to suit your needs.
Introduction 293
How often does food hygiene training have to be done?
There is no frequency set out in legislation for training. It is up to food businesses to decide when the staff
require refresher training.
Where can I find a list of trainers or training courses?
As there is no accreditation body for trainers there is no centralized list. It is simply a matter of checking your
local or searching online for courses or trainers in your area.
IFC has developed two FSMS training courses that you should consider, namely:
 IFC Food Safety Foundation Course. This is an entry-level, three-day, on-site course aimed at the FBO
processing, catering and retail sectors. This course is recommended as a pre-requisite to attendance of
the IFC Food Safety Toolkit Training Course. The course covers the basics of Food Safety Management
and focuses on the prerequisites prior to establishing a HACCP based FSMS. The course can also be
tailored to an industry sector.
 IFC Food Safety Toolkit Training Course. This is a self-learning based training course aimed at providing
the FBO with knowledge and skills, including access to best practice HACCP tools and techniques, and
useful links that enable the FBO establish and develop a HACCP based FSMS based upon the HACCP
requirements of most GFSI FSMS schemes, including some other FSMS schemes.
For more information on the above courses, please contact:

Sarah Ockman at sockman@ifc.org
What does the auditor (e.g. external or internal auditor) look for when assessing food safety training?
The auditor will not necessarily want to see a certificate from a particular training course; rather, he or she will
observe hygiene practices and verify the food safety knowledge of staff. The officer may ask to see food safety
records or ask about the food safety training that has been provided.
Training Effectiveness and Evaluation

Key Terms
 Training effectiveness refers to the benefits that the FBO and learners receive from training
 Training outcomes or criteria refer to measures that the trainer and the FBO use to evaluate training
programs
 Training evaluation refers to the process of collecting the outcomes needed to determine the effective-
ness of training
 Evaluation design refers to how, from whom, what, and when information needed for determining the
effectiveness of the training program will be collected
Reasons to Evaluate Training Programs

 FBOs need to make optimal use of the significant resources invested in training programs to gain the
maximum competitive advantage
 Learning creates knowledge which differentiates between successful and unsuccessful FBOs and
employees
 Evaluations help identify the strengths and weaknesses of training programs
 To determine whether content, organization, and administration of the program contribute to learning
and the use of training content on the job
 To identify which learners benefited most or least from the training program
 To gather data to assist in marketing training programs
 Enables comparisons of costs and benefits of different training programs
 Enables comparisons of costs and benefits of different training programs, and of training versus non-
training investments
Training Program Evaluation Process
Conduct a Needs Analysis
Develop Measurable Learning Outcomes and Analyze

Transfer of Training
Develop Outcome Measures
Choose an Evaluation Strategy
Plan and Execute the Evaluation

Outcomes Used in Evaluating Training Programs 295
Outcomes Used in Evaluating Training Programs

Cognitive Outcomes
 Determine the degree to which learners are familiar with the principles, facts, techniques, procedures,
or processes emphasized in the training program
 Measure what knowledge participants learned in the program
Skill-Based Outcomes
 Assess the level of technical or motor skills
 Include acquisition or learning of skills and use of skills on the job
Affective Outcomes
 Include attitudes and motivation
 Learners’ perceptions of the program including the facilities, trainers, and content
Results
 Determine the training program’s payoff for the FBO
Return on Investment (ROI)

 Comparing the training program’s monetary benefits with the cost of the training
• Direct costs
• Indirect costs
• Benefits
Training Program Objectives and Their Implications for Evaluation
Did learners like the program?

Ratings by peers or managers
Reactions: Skill-Based:
based on observation of behavior
Did the environment help learning?
Trainees’ motivation
Cognitive: Pencil-and-paper tests Affective:
or job attitudes
Did company benefit through

sales, quality, productivity, re-
Skill-Based: Performance on a work sample Results: duced accidents, and complaints?
Performance on work equipment

What Determines Good Outcomes of Training Programs?

Good training outcomes need to be:
 Relevant
 Reliable
 Discriminative
 Practical
Good Outcomes Depend On…

 Criteria relevance – the extent to which training programs are related to learned capabilities empha-
sized in the training program
 Criterion contamination – extent that training outcomes measure inappropriate capabilities or are
affected by extraneous conditions
 Criterion deficiency – failure to measure training outcomes that were emphasized in the training
objectives
 Reliability – degree to which outcomes can be measured consistently over time
 Discrimination – degree to which Learner’s performances on the outcome actually reflect true differ-
ences in performance
 Practicality – refers to the ease with which the outcomes measures can be collected
Industry Training Evaluation Practices
79%
38%
15%
9%
Reaction Cognitive Behavior Results

Outcomes Used in Evaluating Training Programs 297
Training Outcome: Kirkpatrick’s Four-Level Framework of Evaluation Criteria
Level Criteria Focus
1 Reactions Learner satisfaction

2 Learning Acquisition of knowledge, skills, attitudes, behavior
3 Behavior Improvement of behavior on the job
4 Results Business results achieved by trainees
Types of Evaluation Design

 Pre-evaluation – to quantify the FBO and learner training program needs or problems and identify
specific competencies required to close gaps in FBO and learner performance
 Continuous assessment –training outcomes measured during training program delivery
 Post-evaluation –training outcomes measured after training program delivery
Pre-evaluation and post-evaluation can also be time based, i.e. a comparison of learner performance before
and after the delivery of the training program.
Training and Development Procedure Template
Training and Development
FBO Procedure
Document # SOP-014
Created 20-04-2015
Updated 24-04-2015
Owner HR Manager
Revision History
20-04-2015 Draft 01 Joe Bloggs Initial document for review and discussion
24-04-2015 V1.0 Mary Cahill Format changes and reviewing and approval by process
owner
Contents
1 Summary..............................................................................299 7.1.1 Internal Trainers .................................................303
2 Related documents ........................................................299 7.1.2 External Trainers ................................................303
3 Definitions ..........................................................................299 7.2 Training Course Evaluation .................................303
4 Introduction .....................................................................300 7.3 Trainee Evaluation .................................................. 304
4.1 Training and Development Policy ....................300 7.4 Training Materials................................................... 304
5 Procedure Flow Chart ................................................... 301 7.5 Training Course Attendance ...............................305
6 Procedure Notes. ............................................................302 7.6 Poor Performance / Unsuccessful
7 Management of Training and Development ......302 Completion of Training ......................................... 305
7.1 Selection, Approval and Evaluation 8 Records ...................................................................................305
of Trainers ....................................................................303
Classification Company Confidential Training and Development

Page 1 of 8
Created 20-04-2015 Updated 24-04-2015 Owner HR Manager
FBO Procedure Training and Development 299
1 Summary
The purpose of this procedure is to describe the methodology used by

the company to enable individuals, business units and the company over-
Purpose
all fulfil performance requirements through the provision of training and
development.
This procedure applies to the training and development of all employees
from initial onboarding to the identification of training and development
Scope
needs following a performance evaluation or mandatory corporate train-
ing, and ending with the evaluation and/or confirmation of performance.
The functional responsibility for this procedure lies with the Human Resourc-
Functional Responsibility es department, specifically the Human Resources Manager. They are respon-
sible for the effective implementation and maintenance of this procedure.
2 Related documents

Processes Human Resources Process Description, PRO-002
Recruitment & Selection Procedure, SOP-025
Performance Appraisal Procedure, SOP-026
Procedures
Disciplinary Procedure, SOP-027
Purchasing Procedure (for provision of external training), SOP-028
Job descriptions
Training attendance form
Forms
Training request
Logging data from LMS
Other ‘Train the trainer’ training course
3 Definitions

Job Description A formal account of an employee’s responsibilities
HRMS Human Resource Management System
LMS Learning Management System

Page 2 of 8
4 Introduction
4.1 Training and Development Policy
The overall objective of training and development is to develop a trained workforce that can deliver supe-
rior customer service using the latest technology and expert domain knowledge. To achieve this goal, we
provide several types of training, including new joiner onboarding, domain training, food safety compliance
training and on-the-job training.
New joiner onboarding (induction) training helps new employees to integrate quickly and effectively into
their new working environment.
Domain training refers to the industry specific knowledge training that is required by an individual to be
successful in the role that he/she holds.
Food safety compliance training is mandatory and plays an important role in the process of educating
employees on industry laws, regulations and company food safety policies and procedures. Every new em-
ployee must go through this training immediately after joining, and every employee must complete food
safety compliance training on a yearly basis.

Page 3 of 8
Training & Development

Start
1. Training Needs
Identification of Analysis Report
HR Department
T&D requirements
2. Provisional
HR Department Compile and Training Plan
analyse requirements
3. HR Budget
HR Department Prioritise and
Senior Management obtain budget Approved Training
Plan
4. Training Plan
HR Department Develop and
publish T&D plan HRMS
5. Training Plan
HR Department Implement T&D
plan HRMS
6. HRMS
HR Department Monitor
implementation Records of
training
7. HRMS
HR Department Verification of
effectiveness Performance
Appraisal Records
8.
HR Department Publish and share
results
End

Doc ID SOP-014 Printed Document Controller
Page 4 of 8
Created 20-04-2015 Updated 24-04-2015 HR Manager
6 Procedure Notes.
Step 1 T&D Requirements

The Human Resources department will identify the training and development needs across the company.
This will be achieved through a review of corporate mandatory training requirements, training require-
ments identified through the recruitment and selection process and/or the outcomes of performance ap-
praisals. Each department will be consulted during this process.
Step 2 T&D Analysis

Based on the needs identified in step one, Human Resources will compile and analyze these requirements
resulting in a provisional training plan.
Step 3 T&D Prioritization/Budget

The provisional training plan, including prioritization requirements, will be submitted to top management for
approval. Once approved, the necessary resources will be provided as part of the Human Resources budget.
Step 4 T&D Plan

Once budget approval has been received, the Human Resource department will develop and publish the
approved training and development plan via the HRMS. This plan will outline what training and develop-
ment will be provided for the coming period both mandatory and/or optional.
Step 5 & 6 T+D Plan Implementation and Monitoring

Human Resources, in association with applicable departments, will implement the training and develop-
ment plan. The Human Resources department will continuously monitor the implementation of the training
plan, using the HRMS and the LMS, to ensure that it is flawlessly executed. The HRMS and LMS systems will
show what training has been completed on a ‘per employee’ basis. Training attendance sheets and training
evaluation records will also be maintained. Where it becomes evident that the training and development
plan is not being adhered to, Human Resources will take the necessary actions, including review with senior
management, to bring the plan back on track or take other measures to ensure training is completed.
Step 7 T&D Effectiveness Verification

Human Resources will determine the effectiveness and impact of training and development courses pro-
vided on individual, business unit or company performance. Where analysis shows that training and devel-
opment is not having the desired effect, a review of the training and development plan and its implementa-
tion will be held and the necessary actions identified, taken and recorded. The outputs of the performance
appraisal process will be a direct input to the determination of the overall effectiveness of training and
development and drive the creation of the next training and development plan.
Step 8 T&D Publish Results

Human Resources will publish and share the results achieved through the implementation of the training
and development plan with all interested parties to ensure decisions related to ongoing training and devel-
opment are based on factual information.

Page 5 of 8
7 Management of Training and Development

7.1 Selection, Approval and Evaluation of Trainers
7.1.1 Internal Trainers
All employees selected to act as company trainers are required to meet the following minimum criteria:
 Be working in the area covered by the training for a significant period, two to three years minimum;
 Be a subject matter expert in the required subject/area;
 Have successfully completed a ‘Train the Trainer’ training course;
 Have successfully presented the training course to their peers and Human Resources.
7.1.2 External Trainers
Where it is necessary to employ the services of an external trainer to provide training, they shall be selected
in accordance with a defined process. Human Resources shall ensure that this trainer is competent to com-
plete the task. All external trainers shall meet the following criteria:
 Be a subject matter expert in the required subject/area;
 Have successfully completed a ‘Train the Trainer’ training course;
 Hold the necessary educational qualifications related to the training course;
 Have several years work experience related to the training course, ideally be still working in a related area;
 Provide written references and approvals with respect to the provision of training;
 Where required, hold the necessary certifications from recognized certification bodies or work on
behalf of a certified/accredited training organization.
Documented evidence of meeting the above criteria must be maintained on file by Human Resources for
all external training organizations and related trainers.
In the event of an approved external trainer not being able to attend scheduled training and a substitute
external trainer being recommended by the supplier, the substitute external trainer must also meet the
above requirements.
A panel of approved trainers and training organizations will be maintained by Human Resources.
7.2 Training Course Evaluation

All training course material and trainers will be subject to evaluation. This is required to ensure that the
level of course materials and course delivery does not deteriorate, remains relevant and that the trainee is
receiving a high standard of training.
Evaluations will take the form of:

 Training course evaluation forms – completed at the end of the course by the trainee, outlining their
rating of course delivery, course material, trainer and other relevant criteria;
 Internal trainer presentation review – witnessed and documented evaluation of the internal trainer’s
presentation completed by Human Resources on a defined basis.

Page 6 of 8
Human Resources will review the output from these evaluations and ensure that where the standards are
not being met, the appropriate actions are taken to ensure no negative impact on the trainee or the com-
pany as a whole.
7.3 Trainee Evaluation

Depending on the type of training delivered, the trainee will be evaluated to ensure that they have both
received and understood the information being delivered and can implement the training in their day-to-
day role. This evaluation and/or assessment can take several forms including, but may not be limited to:
 Written examination on the subject matter;
 Documented continuous assessment throughout course delivery;
 Trainer assessment of trainee through role play or similar exercises;
 On the job mentoring and review;
 Performance appraisal.
Trainee evaluation must be documented and maintained on file.
7.4 Training Materials

Where training material (e.g. PowerPoint presentations, training manuals, exams, or tests) are developed
in-house, it is important to assess it for quality and technical content prior to use and following any updates.
Human Resources will review the material from a quality perspective to ensure that:
 It is in a form and manner and language that is likely to be understood;
 Is grammatically correct;
 Is clear, concise and visually acceptable;
 Meets the company requirements regarding templates (e.g. for power point presentations, or notes);
 Does not contain any unauthorized language or material;
 Is revision-controlled.
The tutor, or subject matter expert, will review the material from a technical perspective to ensure that:
 The training course content is technically correct, accurate and up to date;
 The information and examples presented are compliant with all necessary rules and regulations.
Where possible, training materials provided by external providers will be reviewed prior to course delivery.
Human Resources will be responsible for the maintenance of internal course materials; however, it is the
responsibility of the subject matter expert to ensure that the course is updated as necessary and in line with
any changes to food safety compliance and/or regulatory requirements or other significant changes affect-
ing the course content.
All internal training materials will be held by Human Resources and issued to the trainers as required.

Page 7 of 8
7.5 Training Course Attendance

Once a training course has been scheduled, it the responsibility of management to release their staff to at-
tend the training and it is required that all trainees attend the full duration of the course. If for any reason
the trainee has to leave the course, then they must re-sit the entire course again. Human Resources may
amend this requirement on a case-by-case basis.
7.6 Poor Performance / Unsuccessful Completion of Training

A training matrix will be maintained by the Human Resources department identifying the both mandatory
and optional training courses available. This may be used by departments and the management team to
identify potential training solutions available where an employee is found not to be performing to expected
levels.
In the event of an employee not successfully completing a mandatory training course, they may be offered
the option to re-sit the course or course assessment. Where an employee has not successfully completed
mandatory training course after numerous attempts or their performance in the job role does not improve,
then both Human Resources and the departmental manager will meet to determine the best course of ac-
tion to be taken with regard to that employee. A decision will be made and communicated to the employee.
This decision will be documented and monitored by Human Resources.
8 Records

Human Resources
Induction Pack Forms Human Resources Office Indefinitely
Manager
Human Resources
Training Needs Analysis Human Resources Office Six years then archive
Manager
Human Resources
Training Plan Human Resources Office Six years then archive
Manager
Human Resources
Training attendance sheet Human Resources Office Six years then archive
Manager
Human Resources
Record of training Human Resources Office Six years then archive
Manager
Human Resources
Education records Human Resources Office Indefinitely
Manager
Human Resources
LMS login record LMS Indefinitely
Manager
LMS evaluation results LMS Indefinitely Human Resources

Page 8 of 8
Responsibility Matrix, Training Needs Analysis and Training Plan

[Partial Sample]
Identify responsibilities of individuals for food safety pre-requisites and the food safety management system, and of in-
dividuals performing tasks that have a potential to cause a significant food safety impact, determine their competency,
identify training needs, and plan for training.
Role / Position Title/ Qualifications/

Name Responsibilities
Position no. competency
Managing Director Mike Murphy  Participate in FSMS Management review Senior Business Admin-
 Setting policy istrator
 Reviewing objective & targets
 Resource allocation
Food Safety Manager Joe Bloggs  Establish, develop, implement, maintain and BSc Food Science Cer-
(management represen- improve the FSMS including food defence tificate of Attainment in
tative)  Training the FSMS team members Food Safety Manage-
ment Systems (FSSC
 Implementing programs for achieving set objec-
22000)
tives & targets
 Monitoring and measurement of FSMS perfor-
mance including reporting to top management
 Awareness of FSMS compliance within the FBO
 Liaison with external audit/inspection
organizations
Internal Auditor Mary Cahill  Developing internal audit program in liaison with Certified (IRCA) FSSC
Food Safety Manager 22000 Internal Auditor
 Conducting internal audits as per schedule
 Training other internal auditors
FSMS team members A. Sullivan  Awareness on Policy & FSMS FSMS including HACCP
 Implementing program for achieving set objec- principles and practices
J. Wright
tives & targets
M. Brown  PRP, HACCP Plan and O-PRP implementation,
verification and validation
K. Wriggly  Helping in monitoring and measurement
 Training respective staff in implementing FSMS
policies and procedures
Department managers All  Context of organization planning, leadership, Planning, Operations

performance evaluation, improvement of the Management
FSMS
Laboratory technician R. Harley  Conducting analytical tests, laboratory equip- Laboratory Manage-
ment maintenance and calibration, p-test, ment [Chemistry/Biol-
laboratory training ogy]
Associate All  Awareness on policy & FSMS N/A
Transport driver(s) All  Awareness on policy & FSMS Drivers licence

Responsibility Matrix, Training Needs Analysis and Training Plan [Partial Sample] 307
Training
Training needs Planned dates Remarks
details
FSMS orientation (in house) 24.04.15 FSMS-1 Training completed 24.04.15

Mandatory FSMS training, reference the training March – Oct 2016 Various Training to be completed by
matrix (internal) October 2016
Emergency preparedness and response/crisis June 2016 FSMS-4 Training to be completed by
management (external) June 2016
FSMS orientation (in house) 24.04-15 FSMS-1 Training completed 24.04.15

FSSC 22000 lead Auditor training (external) March – April 201 FSMS-5 Training confirmed
Mandatory FSMS training, reference the training March – Oct 2016 Various Training to be completed by
Emergency preparedness and response/crisis June 2016 FSMS-4 Training to be completed by
management (external) June 2016

FSSC 22000 internal Auditing course March - April FSMS-6 Training confirmed

Mandatory FSMS training, reference the training March – October 2016 Various Training to be completed by
June 2016
Emergency preparedness and response/crisis
FSMS-4 Training to be completed by
management (external)
June 2016

Emergency preparedness and response/crisis FSMS-5 Training to be completed by
management (in-house) June 2016

Analytical policies and procedures 30.09.15 LAB-1 Training completed 30.09.15
Mandatory FSMS training, reference the training March- October 2016 Various Training to be completed by


Tank cleaning/ sanitizing 24.05.15 FSMS-10 Training completed 24.04.15
Dairy farm raw milk handling/testing 24.05.15 FSMS-11 Training completed 24.04.15
Food Safety Training Maxtrix
Emergency Preparedness? Crisis Management
Consumar complaint Management

HACCP Verification and Validation
Analytical Policies and Procedures
FSMS Policies and Procedures
FSMS Management Review

Job Title
Food Safety Orientation
Pest and Waste Control
Allergen Management
Document Control
Personal Hygiene
Communications
Internal Auditing
Food Processing
Record Control
HACCP Level 2
HACCP Level 1
Food Defense
Food Delivery
Food Storage
Maintenance
Calibration
Cleaning
Managing Director M M M M M M M M M M N/A N/A M M M M M M M M M N/A M
Food Safety Manager M M M M M M M M M M N/A M M O M M M M M M M M M
Hygienist/Microbiologist M M M M M M M M M M N/A N/A M O M M M M M M M M M
Milk Processing Manager M M M M M M M M M M N/A N/A M M M M M M M M M N/A M
Laboratory Manager M M M M M M M M M M M M M N/A M M M M M M M M M
Warehousing Manager M M M M M M M M M M N/A M M N/A M M M M M O M O M
Engineering Manager M M M M M M M M M M O M M N/A M M M M M O M N/A M
Maintenance Manager M M M M M M M M M M M M M N/A O M M M M O M N/A M
Logistics Manager M M M M M M M M M M M O M N/A O M M M M M M O M
Laboratory Technician M M M M M M M M M M M M M M O M M M O O O O N/A
Food Handler M M M M M M M M M M M N/A M N/A N/A M M M O O O O N/A
Transport Driver M M M M M M M M M M M O M N/A N/A M M M M O O O N/A
M = Mandatory
O = Optional
N/A = Not applicable
Planned
Job Title
Overdue
Completed
Food Handler
Transport Driver
Logistics Manager
Managing Director
Laboratory Manager
Food Safety Manager
Engineering Manager
Laboratory Technician
Maintenance Manager
Warehousing Manager
Hygienist/Microbiologist
Milk Processing Manager

Food Safety Induction
Personal Hygiene
Pest and Waste Control
Cleaning
Food Safety T&D Maxtrix
Allergen Management
Food Delivery
Food Processing
Food Storage
HACCP Level 1
HACCP Level 2
N/A
N/A
N/A
N/A
N/A
FSMS Policies and Procedures
Analytical Policies and Procedures
N/A
N/A
N/A
N/A
N/A
N/A
HACCP Verification and Validation
N/A N/A
N/A N/A
N/A
N/A N/A
Document Control
Record Control
Emergency Preparedness/Crisis Management
Food Defense
Consumer Complaint Management
Communications
Internal Auditing
Food Safety T&D Maxtrix
N/A
N/A
N/A
N/A
FSMS Management Review

N/A N/A
N/A
N/A
309
Information for Company
Management
MODULE 7
312 MODULE 7 INFORMATION FOR COMPANY MANAGEMENT
Introduction
This module provides an overview of the FBO executive management team’s responsibilities and covers topics
such as food safety policy, management commitment and resources, management review including, actions,
decisions and follow up required to maintain an effective FSMS and improve it.
The information is also provided on two important IFC-developed management resources:
(1) An IFC publication, italicize Wisely in Food Safety: How to Maximize the Benefits and Reduce Costs, which out-
lines the benefits, challenges and lessons learned by CEOs. This is a good resource for executive management
considering the adoption of a food safety management system;1 and
(2) IFC Food Safety Self-Assessment Tool that enables the FBO executive management team to assess the
maturity of their existing FSMS system within 30 minutes and use the output when identifying the gaps within
the GFSI or other food safety management schemes being considered.
This resource should be reviewed by any FBO executive management team considering the adoption of a
FSMS. Both executive management resources are included in the CD provided by the IFC. Training on their
application is provided during the IFC Foundation and IFC FSTK training courses referenced in Module 6.
Food Safety Policy

A policy is a statement of intent and is implemented as a procedure or protocol with an FBO. The FBO’s food
safety policy is generally established and adopted by top management typically on the recommendation of
the food safety manager.
All international food safety management system schemes require an organization to establish, and flawlessly
implement their food safety policy.
Before we look at the contents of a food safety policy we will examine some key principles food safety schemes
that food safety auditors would look to when examining a FBO’s food safety policy:
 The policy should be established and adopted by top management;
 It should clearly set out top management’s aspirations and expectations in relation to food safety;
 It should address and meet the defined requirements of the relevant food safety Scheme adopted by
the FBO;
 It should be consistent with the FBO’s food safety objectives, the FBO’s regulatory and other legal
obligations.
http://www.ifc.org/wps/wcm/connect/41c7d0004c915a0faa8dabd4c83f5107/ECAAGRIInvest+Wisely+ENGApr
1
il2016+%281%29.pdf?MOD=AJPERES
Food Safety Policy Contents 313
Food Safety Policy Contents

The following is an example of what a food safety policy should consist of according to ISO 22000:
 Top management shall define, document and communicate its food safety policy;
 Top management shall ensure that the food safety policy:
a) is appropriate to the role of the organization in the food chain;
b) conforms with both statutory and regulatory requirements and with mutually-agreed food safety
requirements of customers;
c) is communicated, implemented and maintained at all levels of the organization;
d) is reviewed for continued suitability;
e) adequately addresses communication; and
f) is supported by measurable objectives.
Top management means the top manager of the FBO and his or her direct reports.
Appropriate means that the policy is based on the scope of the FBO’s food safety management system prod-
ucts, food chain activities and markets.
Suitability means the policy is ‘fit for purpose.’ Sometimes changes within the FBO makes the food safety policy
not fully ‘fit for purpose.’ This could happen, for example, if: (i) the FBO introduces new products with new
food safety hazards; (ii) the FBO markets and sells products in new markets; (iii) the FBO introduces significant
changes in technology, process or equipment.
The final requirement states that the food safety policy needs to be supported by measurable objectives.
Measurable means Specific, Measurable, Attainable, Realistic and Time Bound. In summary, SMART.
In keeping with the spirit of all food safety schemes, for example, BRC, SQF, or FSSC 2000, the primary ob-
jective is safe food; hence, all food safety objectives should be aimed at reducing or eliminating food safety
hazards in the FBO product. The following example illustrates how to draft a food safety objective based on
SMART:
By December 2015 reduce 1.14g salt per 100g in all FBO brown and white bread products, a reduction of
10 percent compared to 2015.
To organize and train all the milk processing operators with GMP by conducting two trainings per month and
thereby decreasing the Out of Specification [OOS] products by 20% by the end of the year 2016.
The above food safety objective is in keeping with the WHO recommended daily intake of salt by adults to
6gm per day.
Management Commitment
Every management system, including a food safety management system, requires management commitment.
What does this actually mean?
All levels of management – particularly the highest – are responsible for creating and fostering an environ-
ment that promotes food safety.
Top management should be aware of how the success of the organization depends largely on the ability to
monitor and continuously improve the effectiveness of risk control measures with respect to the safety of the
FBO’s products across the food chain in a continuously changing internal and external environment.
If top management does not express informed, sustained commitment to food safety as one of its primary
business objectives, the commitment to food safety in the food chain can easily shift towards other, some-
times conflicting, business objectives, particularly in less mature organizations.
Management commitment implies the direct participation by the highest level management in all specific and
important safety aspect or programs of an organization.
The following examples demonstrate how management commitment can be delivered in practice within an
FSMS:
 Showing passion for and interest in food safety;
 Formulating and establishing safety policies and objectives;
 Setting targets to improve or maintain food safety;
 Providing resources and training;
 Ensuring that all staff – including top management – are sufficiently trained and competent in their
food safety responsibilities;
 Ensuring operational control at all levels of the organization, i.e. PRPs, HACCP plans, O-PRP plans;
 Receiving regularly information about food safety, e.g. performance data (consumer complaints, waste),
and evaluating and reviewing the FSMS in light of results achieved;
 Being aware of what is happening on the ground; what audits or assessments are undertaken; receiv-
ing results related to the activities carried out internally or by contractors and other persons working
for or on behalf of the FBO;
 Ensuring appropriate top management-level review of the FSMS;
 Ensuring that all levels of the organization, including top management, receives relevant food safety
information regarding evaluation of compliance and other legal obligations;
 Being confident that persons working for or on behalf of the FBO are properly communicated to and
consulted on food safety matters, and that their concerns are reaching the appropriate level;
 Ensuring that your organization’s risks are assessed and that appropriate control measures are estab-
lished and maintained;
 Creating an environment conducive to continuous improvement;
 Bringing to the attention of top management the changes in working arrangements that may have
significant implications for food safety;
 Promoting a food safety culture throughout the FBO.
Strong and active leadership is reinforced by visible, active commitment from the top:
 Establishing effective ‘downward’ and ‘upward’ communication systems;
 Establishing effective management structures;
 Integrating food safety management with business decisions.
Resources 315
Resources
Resources is a term within an FSMS that refers to the four generic resources with a FBO; namely finance, hu-
man resources, infrastructure, and work environment within the scope of the FBO’s FSMS. Resources within
an FBO are typically controlled and managed by top management. In this chapter we will examine two of
these resources, namely financial and human.
IFC has developed a useful executive management resource entitled: Investing Wisely in Food Safety: Lessons
learned from IFC Clients. This resource was developed to assist the FBO CEO and the management team
consider the adoption of an FSMS based on HACCP to understand the benefits and challenges. The resource
also contains five key lessons covering the following topics:
 Planning;
 Financing;
 Changing Behaviour;
 Outsourcing Wisely;
 Typical Mistakes and How to Avoid Them.
It is strongly recommended that this resource be reviewed by any FBO executive management team consider-
ing the adoption of a FSMS based upon a GFSI or other relevant food safety scheme as a valuable input prior
to a formal decision being made. This executive management resource is available on the IFC-supplied CD.
The second executive management resource is a self-assessment tool that enables the FBO executive man-
agement team to assess the maturity of its existing FSMS system within 30 minutes and to use the output
when identifying the gaps within the GFSI or other food safety management schemes being considered.
Both executive management resources should be reviewed by any FBO executive management team con-
sidering the adoption of an FSMS. Both executive management resources are included in the CD provided
by IFC and training on their application is provided during the IFC Foundation and IFC FSTK training courses
referenced in Module 6.
Finance
Clearly finance is a key input or requirement for any organization. As top management controls finances
within the FBO, it is responsible for ensuring that the FBO has sufficient financial resources to fulfil its food
safety policy and objectives. Food safety throughout the food chain should not be endangered because of
financial issues.
Typically, a food safety auditor would look for the following:

 CapEx investment in preventing and/or improving food safety risk across the FBO food chain;
 Financial investment in food safety training of persons working for or on behalf of the FBO.
Note that risk assessment finance is not a factor in ensuring food safety across the food chain.
Human Resources
The most difficult challenge facing most FBOs is engaging employees in the FSMS so that employees to take
personal responsibility for their food safety actions and performance.
A good place to start is for top management to communicate its belief to all employees and persons working
for, and on behalf of, the FBO that they are responsible for contributing to the success of their FSMS. It is top
management’s responsibility to provide incentives, encourage and empower people to bring forward ideas
that can improve the FBO efforts and take action when they see operational problems that could compromise
food safety.
Secondly, top management should strive to ensure that every employee is provided the relevant food safety
training necessary to understand the FBO’s food safety policies and practices and their role in food safety.
The FBO’s managers have additional responsibilities:

 Line managers are required to respond to employees’ food safety concerns in a timely manner and to
listen to ideas for improving our food safety management system;
 Line managers at all levels are responsible for helping create a culture of food safety across the FBO;
 Top management provides line managers with the resources required to maintain a robust FSMS and
to comply fully with food safety regulations, standards and expectations set by the FBO, regulators and
customers.
For most food safety auditors, the focus is training and its effectiveness. From a FBO perspective both the rel-
evant food safety regulations and standards set out what is required and provide practical advice to the FBO.
Let us first examine the food safety regulatory perspective on food safety training. Most food safety regula-
tory agencies require the FBO to legally undertake food safety training and/or be supervised in line with the
level of activity the FBO is involved in. For example, line managers in an FBO will need different training than
employees processing or serving food.
To illustrate, the Irish Food Authority of Ireland [FSAI has produced guides for the FBO to assist with the train-
ing of FBO employees in the workplace:
 Guide to Food Safety Training Level 1 provides information on basic food safety skills that staff should be
able to demonstrate within the first month of employment;
 Guide to Food Safety Training Level 2 provides information on the additional food safety skills that staff
should be able to demonstrate within 3-12 months of commencing employment in your food business;
 Guide to Food Safety Training Level 3 provides information on the food safety skills that should be demon-
strated by managers and supervisors in food operations.
For additional information on the FSAI guides see: https://www.fsai.ie/food_businesses/training_guides.html

FBO Procedure Management Review 317
Management Review Procedures Templates
Management Review
FBO Procedure
Document # SOP-021
Created 20-04-2015
Updated 24-04-2015
Revision History
Contents
1 Summary...............................................................................318 7.1 Attendees ..................................................................... 322
2 Related documents .........................................................318 7.2 Agenda.......................................................................... 322
3 Definitions ...........................................................................318 7.3 Review Output ..........................................................323
4 Introduction .......................................................................319 7.4 Management Review Minutes...........................323
4.1 Management Review Policy ................................319 7.5 Approval of the Management Review
5 Procedure Flow Chart ...................................................320 Minutes .........................................................................323
5.1 Management Review .............................................320 7.6 Communication of the Output from
Management Review .............................................323
6 Procedure Notes .............................................................. 321
8 Records .................................................................................323
7 The Management Review Meeting ........................ 322
Classification Company Confidential Management Review

Page 1 of 7
Management Review
1 Summary
The purpose of this procedure is to describe:

 The methodology employed by senior management to ensure that
Purpose
the Food Safety Management System [FSMS] remains suitable, ad-
equate and effective.
This procedure applies to:
 The planning, data gathering and trending, presentation to the se-
Scope
nior management team and the follow-up of any identified action
items, including the updating of the FSMS.
Functional Responsibility Team Leader. They are responsible for the effective implementation and
maintenance of this procedure.
2 Related documents

Strategic Planning, SOP-029
Procedures
Risk Management, SOP-030
Internal Auditing, SOP-006
Management review meeting minutes document template
Forms
Management review meeting presentation template
Other Data reviewed as part of the management review meeting
3 Definitions

Person or group of people who directs and controls and organization
Executive Management Team
at the highest level.

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Management Review
4 Introduction
4.1 Management Review Policy
In line with good business practice and the requirements of FSSC 22000:2010, clause 5.8, top management
of the company will review the Food Safety Management System [FSMS], at least annually (fixed date), to
ensure it remains suitable, adequate and effective. This review will be a structured process and identify out-
puts and actions related to continual improvement opportunities, the need for changes to the Food Safety
Management System and resource needs.
This review will be held at least annually and must be attended by the General Manager, the Heads of
Department, the Food Safety Team Leader. A quorum of at least the General Manager, all Heads of Depart-
ment and the Food Safety Manager is required for the meeting to proceed. Minutes must be taken, includ-
ing action items arising from the meeting and held on file.

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Management Review

5.1 Management Review
Start
1.
Head of Department Data gathering
2.
Identification of trends Presentation Data
Head of Department
and issues
3. Meeting Presentation
Food Safety Manager Create meeting Slides
presentation
Meeting Presentation
Top Management/ Slides
Heads of Department/ 4.
Food Safety Manager Conduct meeting Meeting Agenda
Meeting Minutes
5.
Top Management
Identify actions items
6. Meeting Minutes
Top Management Assign responsibilities
and timelines
Meeting Minutes
7.
Food Safety Manager Meeting Presentation
Draft Meeting Minutes
Slides
8.
Food Safety Manager Publish and share results
meeting minutes
End

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Management Review
6 Procedure Notes
Step 1 & 2
In advance of the scheduled management review meeting, the Heads of Department will gather together
data in relation to the performance of their department’s processes and activities. This data will then be
reviewed by them to identify trends, either positive or negative. These trends will then be presented to the
management team during the review.
Step 3
Based on the data received from the Heads of Department, the Food Safety Manager will create the overall
management review presentation slides, where necessary/required.
Step 4, 5 & 6
The General Manager will chair the meeting, supported by the Food Safety Manager. They will assign a
person to take the minutes of the meeting on a rotational basis. The Food Safety Manager may invite other
process owners to present specific agenda items of the meeting. Each attendee will be allowed to ask any
questions in relation to the data to allow for a full and open discussion to take place. Where decisions are
taken and/or action items identified, these must be agreed by the management team and recorded in the
minutes in accordance with section 7.4 of this procedure. Where an action is agreed, the specific action,
person responsible and timescale should be recorded.
Step 7 & 8
The minutes will be taken during the meeting and the:

 Food Safety Manager must review and approve the minutes prior to issuing to the General Manager;
 The General Manager or their deputy must sign and date the minutes of the meeting to signify ap-
proval of the minutes and a commitment to ensure completion and implementation of any identified
decisions and/or actions.
Once approved, the minutes can be circulated to the organisation. A copy of the minutes must be held on
file for record purposes.
Minutes of the meeting should be published within 5 days of completion of the meeting.

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Management Review
7 The Management Review Meeting

7.1 Attendees
The following persons are required to attend the meeting:
 General Managers;
 Heads of Department;
 Food Safety Manager;
 Any other roles as required.
Where a deputy attends and represents a person, they are assumed to have the full authority of that person
in relation to making decisions and accepting responsibility to carry out any decisions or actions agreed at
the meeting. Deputies should only be used as an exception.
7.2 Agenda
The agenda for the management review meeting must include the following points at a minimum:
 The status of actions from the previous management reviews;
 Changes in external and internal issues [significant] that are relevant to the Food Safety Management
System including its strategic direction;
 Information on the food safety performance, including trends and indicators for:
• Nonconformities and corrective actions;
• Analysis of results of verification activities;
• Audit results;
• Emergency situations, accidents and withdrawals;
• Issues concerning external providers and other relevant interested parties;
• Adequacy of resources required for maintaining an effective Food Safety Management System;
• Reviewing results of system-updating activities;
• Review of communication activities, including customer/consumer feedback.
 New or revised statutory and regulatory requirements;
 The effectiveness of actions taken to address risks and opportunities;
 New potential opportunities for continual improvement;
 Food Safety policy;
 Documentation;
 Any other business.

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Management Review
7.3 Review Output

The output from the management review meeting shall include decisions and actions based on factual data
presented during the review and related to:
 Assurance of Food Safety;
 Improvement of the effectiveness of the FSMS;
 Resource needs;
 Any need for changes to the Food Safety Management System, including revisions to the food safety
policy and objectives.
The overall output from the meeting is a decision as to whether or not the Food Safety Management Sys-
tem remains suitable, adequate and effective.
7.4 Management Review Minutes

Minutes must be produced following every meeting and be created using the approved template. The min-
utes must be detailed and accurate, giving a clear description of the topics covered. Where any decisions
and/or action(s) are identified as a result of the meeting they must:
 Clearly describe the decision made including potential implications;
 Clearly describe the required action(s) to be taken;
 Identify the role responsible for the completion of the action;
 Identify the timescale assigned for completion of the action.
Management Review records will be maintained for six years.
7.5 Approval of the Management Review Minutes

The minutes are approved as outlined in steps 7 & 8 of the above flowchart.
7.6 Communication of the Output from Management Review

An abridged version of the minutes will be communicated to the company, via the Heads of Department.
8 Records

Management review Food Safety
Food Safety Office Indefinitely
presentation slides (where used) Manager
Management review meeting Food Safety
Food Safety Office Indefinitely
minutes Manager

Page 7 of 7
Example of Management Review Meeting materials
Agenda
ϭ. Previous Management Review Meeting Minutes
2. Policy and FSMS Documentation
3. Product and Process Monitoring and Measurement Data
a. Factory Objectives
b. Process KPIs
c. Raw Material, PRP, HACCP, Withdrawals/Recall
d. Inspections/Audits
e. Vendor / Contractor Data
f. Interested Party Feedback
g. Corrective and Preventative Actions
4. Changes affecting FSMS
6. FSMS Improvements/Preventative Actions
7. Resources Review [Resources, Infrastructure/Work Environment]
8. Updates Management Review Program
9. Miscellaneous
1. Previous Management Review Meeting

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2. Policy and FSMS Documentation

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3. Product and Process Monitoring and

Measurement Data
a. Factory Objectives 2015
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Useful Links 333
Annexes
1. Useful Links
State institution Internet address
Asia Pacific Food Industry http://www.apfoodonline.com/
Austrian Federal Ministry of Agriculture,

Forestry, Environment and Water Management http://www.lebensministerium.at/lebensmittel.html
– Food
Austrian Federal Office of Food Safety http://www.ages.at/ages/en/federal-office-of-foodsafety/
Belgian Federal Public Service for Health, Food

http://www.health.belgium.be/eportal/foodsafety/index.htm
Chain Safety and Environment – Food Safety
Belgian Federal Agency for the Safety of the

http://www.favv-afsca.fgov.be/home-en/
Food Chain (FASFC)
BRC Global Standards http://www.brcglobalstandards.com
Bulgarian Food Safety Agency http://www.babh.government.bg/en/
Danish Ministry of Food, Agriculture and

http://www.fvm.dk/english.aspx?id=14541
Fisheries
CanadaGap http://www.canadagap.ca
CHINA HACCP http://www.cnca.cn/bmzz/zgclb/
Croatian Food Agency http://www.hah.hr/english/eng_index.php
Cyprus Ministry of Agriculture, Natural http://www.moa.gov.cy/moa/agriculture.nsf/All/9638239B67CB5B93C22578

Resources and Environment A200307D00?OpenDocument
Cyprus Ministry of Health http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en?OpenDocument
http://www.moh.gov.cy/moh/sgl/sgl.nsf/DMLindex_en/DMLindex_
Cyprus State General Laboratory
en?OpenDocument#
Czech Republic Ministry of Agriculture http://eagri.cz/public/web/en/mze/food/
Danish National Food Institute http://www.dfvf.dk/Default.aspx?ID=21023
Danish Veterinary and Food Administration –

http://www.foedevarestyrelsen.dk/english/Food/Pages/default.aspx
Food
Estonian Ministry of Agriculture http://www.agri.ee/food-safety/
European Commission – basic food hygiene

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guide_en.htm
legislation page
European Commission Directorate General for

http://ec.europa.eu/dgs/health_consumer/index_en.htm
Health and Consumers (DG SANCO) – Food
European Commission Health EU Portal – Food

http://ec.europa.eu/health-eu/my_environment/food_safety/index_en.htm
Safety
European Food Information Council (EUFIC) –

http://www.eufic.org/article/en/expid/basics-foodsafety/
Food Safety
European Food Safety Authority (EFSA) http://www.efsa.europa.eu/
EUR-Lex - Direct free access to European

http://eur-lex.europa.eu/en/index.htm
Union Law with full search facility
EUROPA Summaries of EU legislation – Food

http://europa.eu/legislation_summaries/food_safety/index_en.htm
Safety
Food Engineering http://www.foodengineeringmag.com/
Food and Drink Technology http://www.foodanddrinktechnology.com/
Finnish Ministry of Agriculture and Forestry –

http://www.mmm.fi/en/index/frontpage/food_safety.html
Food Safety and Consumer Information
334 ANNEXES
Finnish Food Safety Authority (EVIRA) http://www.evira.fi/portal/en/food/
French Agency for Food, Environment, and

http://www.anses.fr/
Occupational Health and Safety
French Ministry of Agriculture, Food, Fisheries,

http://agriculture.gouv.fr/
Rural and Regional Development
Food Processing http://www.foodprocessing.com
Food Risk http://foodrisk.org/rm/guidelines-and-standards/
Food and Agriculture Organisation (FAO) of the

http://www.fao.org/food/food-safety-quality/en/
United Nations –
FSSC 22000 http://www.fssc2200.com
Food Safety and Quality http://www.bfr.bund.de/en/food_safety-737.html
German Federal Institute for Risk Assessment

http://www.bmelv.de/EN/Food/food_node.html
(BFR)
German Federal Ministry of Food, Agriculture

http://www.ble.de/EN/00_Home/homepage_node.html
and Consumer Protection – Food & Safety
German Federal Office for Agriculture and Food www.foodsafetyforum.org
Global Aquaculture Alliance http://www.gaalliance.com
Global Food Safety Initiative http://www.mygfsi.com/
Global Forums - policy makers in the field of

http://www.minagric.gr/en/index.html
food safety
GlobalG.A.P. http://www.globalgap.com
Global Red Meat Standard http://www.grms.com
GMP+ International http://www.gmpplus.org/
Hellenic Ministry of Agriculture and Food http://www.efet.gr/
Hellenic Food Safety Authority h ttp://www.nebih.gov.hu/en/
Hungarian National Food Safety Chain Office http://www.agriculture.gov.ie/
IFS http://www.ifsc-certification.com
Irish Department of Agriculture, Food & the

www.ipfsaph.org
Marine
International Portal on Food Safety and Animal

http://www.mast.is/index.aspx?GroupId=1281
and Plant Health
The Icelandic Food and Veterinary Authority http://www.fsai.ie/links.html
ISO, the International Organization for

http://www.iso.org
Standardization
Italian Istituto Superiore di Sanit (ISS) http://www.iss.it/chis/?lang=2
Latvian Food and Veterinary Service http://www.pvd.gov.lv/eng/left_menu/food_surveillance/
Lithuanian State Food and Veterinary Service http://vmvt.lt/en/
Luxembourg Ministry of Health http://www.ms.public.lu/fr/
Malta Competition and Consumer Affairs

http://www.mccaa.org.mt/en/smi
Authority
Maltese Environment and Planning Authority http://www.mepa.org.mt/topics
Maltese Health, the Elderly and Community http://ehealth.gov.mt/HealthPortal/others/foodsafety_week/food_safety_

Care Ministry week.aspx
Netherlands Ministry of Economic Affairs, Agri-

http://www.government.nl/issues/food-and-foodsafety
culture and Innovation – Food and Food Safety
Useful Links 335
Netherlands Food and Consumer Product

http://www.vwa.nl/english
Safety Authority
Norwegian Ministry of Agriculture and Food http://www.regjeringen.no/en/dep/lmd.html?id=627
http://www.regjeringen.no/en/dep/hod/About-the-Ministry/Subordinate-
Norwegian Food Safety Authority
institutions/Norwegian-Food-Safety-Authority.html?id=279765
Polish Chief Sanitary Inspectorate http://www.gis.gov.pl/?lang=en&go=content&id=10
Portuguese Economy and Food Safety

http://www.asae.pt/
Authority
PrimusGFS http://www.primusgfs.com
Swedish Ministry of Rural Affairs – Foodstuffs http://www.sweden.gov.se/sb/d/11310
Romanian National Sanitary Veterinary and

http://www.ansvsa.ro/
Food Safety Authority
Slovak Republic Ministry of Agriculture and

http://www.mpsr.sk/en/index.php?navID=1
Rural Development
Slovenian Ministry of Agriculture, Forestry and

http://www.arhiv.mkgp.gov.si/en/areas_of_work/food_safety/
Food
Spanish Agency on Food Safety and Nutrition http://www.aesan.msc.es/en/AESAN/web/home.shtml#
Standards and Trade Development Facility

http://www.slv.se/en-gb/
(STDF)
SQF http://www.sqfi.com
Swedish National Food Agency http://www.bag.admin.ch/index.html?lang=en
Swiss Federal Office of Public Health http://www.defra.gov.uk/
UK Department for Environment Food, and

http://www.food.gov.uk/
Rural Affairs
UK Food Standards Agency http://www.who.int/foodsafety/codex/en/
World Health Organization (WHO) – Codex

http://www.who.int/foodsafety/en/
Alimentarius
World Health Organization (WHO) – Food

www.wto.int
Safety
World Trade Organization (WTO) http://www.standardsfacility.org/en/index.htm
U.S. Department of Agriculture - Food Safety http://www.usda.gov/wps/portal/usda/usdahome?navid=FOOD_SAFETY
U.S. Department of Agriculture - Food Safety http://fsrio.nal.usda.gov/sanitation-and-qualitystandards/legislation-and-

Legislation regulations
U.S. Department of Agriculture - Food Safety

http://www.fsis.usda.gov/
and Inspection Service
U.S. Food and Drug Administration – Animal &

http://www.fda.gov/AnimalVeterinary/default.htm
Veterinary
U.S. Food and Drug Administration – Food http://www.fda.gov/Food/default.htm
U.S. Food and Drug Administration – Food

http://www.fda.gov/Food/FoodSafety/default.htm
Safety
U.S. Environmental Protection Agency – Food

http://www.epa.gov/agriculture/tfsy.html
Safety
http://www.fsis.usda.gov/science/hazard_analysis_&_pathogen_reduction/
U.S. Meat and Poultry HACCP
index.asp
http://www.fda.gov/Food/FoodSafety/
U.S. Seafood HACCP
HazardAnalysisCriticalControlPointsHACCP/SeafoodHACCP/default.htm
http://www.fda.gov/Food/FoodSafety/
U.S. Juice HACCP
HazardAnalysisCriticalControlPointsHACCP/JuiceHACCP/default.htm.
336 ANNEXES
2. Terms and definitions
Term Definition Term Definition
The independent evaluation of the Commission Committee on Residues of

CCRVDF
Training Provider or Training Provider Veterinary Drugs in Food
Product against recognised standards to
Accreditation Center for Disease Control and
ensure the organization’s management CDC
system, product and competence meets Prevention
defined standards
Centre for Disease Control and
CDC
A medical condition that causes Prevention
someone to become sick after eating,
Allergy A Certification Body or Registrar is
touching, or breathing something that is
an organization accredited by an
harmless to most people
authorizing body to undertake third
Certification
ASL Approved Supplier List party assessment of management
Body/
systems or management system uditor
Registrar
The Association for Talent Development training, and to award and withdraw
ATD
(ATD, formerly ASTD) certificates in accordance with
international or national standards
Set of policies, procedures or
requirements used as a reference CEVD Common Entry Veterinary Document
Audit criteria
against which audit evidence is
compared CEVD Common Entry Veterinary Document
Person with the competence to perform CFR Code of Federal Regulations

Auditor
an audit
CFR Code of Federal Regulations
Audit scope The extent and boundary of the audit
Center for Food Safety and Applied
CFSAN
BAP Best Aquaculture Practice Nutrition
BIS Border Inspection Post Centre for Food Safety and Applied
CFSAN
Nutrition
BIS Corder Inspection Service
CFU Colony forming Unit
BPC Border Protection Control
cGMP Current Good Manufacture Practice
Global standard for packaging and
BRC/IoP packaging materials from the British The China HACCP Government Owned
China HACCP
Retail Consortium Scheme
BRC British Retail Consortium CIAA European Food and Drink Association
CAC Codex Alimentarius Commission CoA Certificate of Analysis
CAC Codex Alimentarius Commission The Food and Agriculture Organization

Codex of the United Nations that published the
Operation that, under specified Alimentarious Codex Standards, Guidelines and Codes
conditions, in a first step, establishes a of Practice of ‘Food Code’
relation between the quantity values
with measurement uncertainties A demonstrated ability to apply
provided by measurement standards knowledge and/or skills and, where
and corresponding indications with Competence relevant, demonstrated personal
Calibration attributes, as defined in the certification
associated measurement (IAS/CL/013
October 30, 2013, revised October 1, scheme
2014, page 1 of 7 “uncertainties and, in
Any person or organization with
a second step, uses this information Competent
statutorily delegated or vested
to establish a relation for obtaining a Authority/
authority, capacity, or power to perform
measurement result from an indication”) Enforcement
a designated function or any agency
Agency
On-farm food safety program of the which enforces the law
CanadaGAP
Canadian Horticulture Council
Fulfilment of a statutory or regulatory
CAPA Corrective Action and Preventive Action Compliance requirement including other legal
obligations
Commission Committee of Pesticides
CCPR Conformity Fulfilment of a requirement
Residues
Commission Committee on Residues of Contract Binding agreement

CCRVDF
Veterinary Drugs in Food
337
A controlled document is a FSMS Product that will undergo no further

Controlled document which, through the course of End Product processing or transformation by the
Document its lifecycle, may be reviewed, modified organization
and distributed several times
Any officer, agent, or employee of a
[food safety] action or activity that can National/Federal/State, unit of local
Control be used to prevent or eliminate a food government, authorized by law or by
Enforcement
Measure safety hazard (3.3) or reduce it to an a government agency to engage in or
Officer
acceptable level supervise the prevention, detection, or
investigation of any violation of food
COOL Country of Origin Labeling law
Action to eliminate a detected Also known as Public Health Inspectors,
Correction
nonconformity Environmental Health officer [EHOs]
are responsible for carrying out
Action to eliminate the cause of a
Corrective Environmental measures for protecting public health,
detected nonconformity or other
Action Health Officer including administering and enforcing
undesirable situation
food hygiene legislation related to
Criteria Requirement public health and providing support to
minimize health and safety hazards
Criterion which separates acceptability
Critial Limit EPA Environmental Protection Agency
from unacceptability
[food safety] step at which control can EU European Union

Critical
be applied and is essential to prevent or
Control Point EUREP Euro-Retailer Produce Working Group
eliminate a food safety hazard or reduce
[CCP]
it to an acceptable level FAO Food and Agriculture Organization
CRO Compilance Resolution Officer Food Business Organization. Natural or
legal persons, controlling production,
Person or organization that could or
processing, distribution, storage and
does receive a product or a service that
Customer FBO handling of food, and responsible for
is intended for or required by this person
ensuring that food law requirements
or organization
are met within the food business under
Nonconformity related to an intended their control
Defect
or specified use
FDA Food and Drug Administration
A shipment of food product from the
Delivery FDCA Federal Food, Drug, and Cosmetic Act
seller to the buyer
FMEA Failure Mode Effect Analysis
DHS Department of Homeland Security
Sequence of the stages and operations
involved in the production, processing,
Information and its supporting medium. Food Chain distribution, storage and handling of a
It must be stressed that documents may food and its ingredients, from primary
Document be in any form or type of medium, for production to consumption
example: paper; magnetic; electronic or
A food defense plan is a written
optical computer disc or photograph
document that records the practices
Food Defense
EC European Commission implemented to control/minimize the
Plan
risk of an intentional contamination
Electronic Document Management incident
EDMS
System
Security of food and drink and their
Experimental Training and Development supply chains from all forms of malicious
EDTA
Alliance Food Defense attack including ideologically motivated
attack leading to contamination or
Education is the process of facilitating supply failure
learning, or the acquisition of
Education knowledge, skills, values, beliefs, The set of basic principles employed by
and habits especially delivered by or the food associates at all stages of food
Food Hygiene
recognised by a college or university handling to ensure that food is safe to
consume and is of good keeping quality
EFSA European Food Safety Authority
Concept that food will not cause harm
Enzyme-Linked Immunosorbent Assey to the consumer when it is prepared
ELISA Method Food Safety
method for testing for Aflotoxins and/or eaten according to its intended
use
338 ANNEXES
FBO intentions and direction of an An allergen, or a biological, chemical or

Food Safety organization related to food safety physical agent in, or condition of, food
Hazard
Policy as formally expressed by its top with the potential to cause an adverse
management health effect
A recognised International [ISO A systematic process to identify any

22000] or Private Label Food Safety hazardous biological, chemical, or
Food Scheme Management System Standard Hazard physical property in raw materials and
or Government Owned Scheme Analysis processing steps, and to assess their
[recognised by the GFSI] likeliness of occurrence and potential to
render food unsafe for consumption
A document used to record data
Form required by the FSMS. A form becomes High Performance Liquid
a record when data are entered HPLC Chromatography, a test analysis
method to seperate aflotoxins in food
FSAI Food Safety Authority of Ireland
HRMS Human Resource Management System
FSIS Food Safety and Inspection Service
Heating, Ventilation, and Air
FSMA Food Safety Moderization Act Conditioning. HVAS Systems are used
HVAC
in FBO presmises to ensure positive air
pressure flows and maintain ventilation
FSSC 22000 Food Safety Certification Scheme 22000
IFA Indirect Fluorescent Antibody Test
FSTK Food Safety Toolkit
IFC International Finance Corporation
FSVP Foreign Supplier Verification Program
International Featured Standard for
IFS Food
G.A.P. Good Acgriculture Practice Food
Global Aquaculture Alliance Seafood FBO system of facilities, equipment and

GAA Infrastructure services needed for the operation of an
Processing Standard
organization
GFSI Global Food Safety Initiative
An organized examination or formal
GFSI recognised sector and sub-sector evaluation exercise to confirm food
GFSI Scope of Inspection
scopes for recognition against the GFSI products are safe, wholesome, and
Regognition
Guidance Document Sixth Edition correctly labeled and packaged
GHP Good Hygiene Practice External person or group (e.g. external

FBO unit, consumers, regulatory
Standards for the certification of Interested
GlobalG.A.P. agencies) having an interest in
agriculture products Party
the performance or success of the
organization
American Groceries Manufacturing
GMA
Association Partly finished goods, used as inputs in
Intermediate
the production of other goods including
GMO Genetically Modified Organism Product
final goods
GMP Good Manufacturing Practice
Internal audits, sometimes called
GRMS Global red Meat Standard first party audits, conducted by the
organization itself, or on its behalf, for
Internal Audit
GWP Good Warehouse Practice management review and other internal
purposes, e.g. confirm the conformity
Hazard Analysis Critical Control Point. and compliance of the FSMS
A systematic approach taken to
identify and control hazards (whether International Register of Certificated
HACCP IRCA
microbiological, chemical or physical) Auditors
that pose a potential hazard in the
preparation of safe food ISO standatd on prerequisite programs
ISO/TS 22002-1
associated with food products
A document prepared in accordance
with HACCP principles to ensure control International Organization for
ISO
HACCP Plan of significant food safety hazards in Standardization
the segment of the food chain under
A detailed written account, agreed
consideration
Job between management and employee,
Food permissible according to Islamic Description of all the duties and responsibilities
Halal which together make up a particular job
law
KPI Key Performance Indicator
339
Legal The obligation or duty that is enforced Output of an organization that can
Requirements by a court of law be produced without any transaction
Product
taking place between the organization
LMS Learning Management System and the customer
Direct participation by the highest level in the segment of the food chain under
Management executives in a specific and critically PRP
consideration
Commitment important aspect or program of an
organization Person or entity that is a recipient of
a good or service provided by a seller
Top management-led evaluation of the Purchaser
under a purchase order or contract of
Management overall performance of an organization’s sale
Review food safety management system and to
identify improvement opportunities RASFF Rapid Alert System for Food and Feed
Mock recalls are routine exercises A collective term that describes a

conducted by manufacturers, RCA- Root wide range of approaches, tools, and
processors, distributors and other Cause Analysis techniques used to uncover causes of
Mock recall
various trading partners in the supply problems
chain to assess their recall procedures
and responsiveness A food safety program that requires
the FBO to recall food from the market
MRL Maximum Residues Level where unsafe food may have reached
Recall
the final consumer or where the
Mycotoxins are toxins produced by FBO determines other measures are
some species of mold or fungal infection insufficient to protect consumer health
that affects crops and may cause
Mycotoxins fatality. A most common type is AFM1, Document that provides objective
an aflotoxin can can contaminate evidence of activities performed,
Record
maize, red chilli, black pepper or dry events occurred, results achieved, or
ginger and may result in fatality statements made
National Institute of Standards and Obligatory requirement specified by

NIST Regulatory
Technology an authority mandated by a legislative
Requirement
body
NMFS National Marine Fisheries Service
Rule or Standard adopted by a
Non- Non fulfilment of a statutory and Regulatory Competent Authority/Enforcement
compliance regulatory requirement Agency
Non- Need or expectation that is stated,
Non fulfilment of a requirement Requirement
conformity generally implied or obligatory
O-PRP Operational Pre-Requisitive Program Resources include people, money,
information, knowledge, skill, energy,
OEM Original Equipment Manufacturer Resources
facilities, machines, tools, equipment,
OOS Out of Specification technologies, and techniques
PPI Process Performance Indicator Risk assessment is the scientific

evaluation of known or potential
Risk Analysis
Preventive adverse health effects resulting from
Preventive Action
Action human exposure to foodborne hazards
The growing, raising, cultivating, picking, A factor that caused a nonconformance

harvesting, collecting or catching Root Cause and should be permanently eliminated
food, including the transporting or through process improvement
delivering food on, from or between the
Primary SAAS Software as a Service
premises on which it was grown, raised,
Production
cultivated, picked, harvested, collected
Acroynm denoting Specific, Measurable,
or caught; and the storing food in a SMART
Attainable, Realistic, Time bound
silo that is not connected with a food
processing operation SOP Standard Operating Procedure
Specified way to carry out an activity or Document stating requirements related
Procedure
a process to raw materials, ingredients, product
Specification
contact materials (packaging) and end-
Set of interrelated or interacting
products
Process activities that use inputs to deliver an
intended result SPS Sanitary and Phytosaniatry
340 ANNEXES
SQF Safe Quality Food Institute A document describing the

organization’s training programs for
A Law set by a Competent National/ Training Plan a measurement time period based on
Statutory
Federal Government the assessment of the organization’s
training needs analysis
Statutory Obligatory requirement specified by a
Requirement legislative body A training orianization or instructor
Training who receives training and becomes
Organization that provides a product or
Supplier Provider approved to deliver an accredited or
a service
non-accredited training program
Strengths, Weaknesses, Opportunities
SWOT analysis UKAS United Kingdom Accreditation Service
and Threats Analysis
The training provider or training
Set of interrelated or interacting
System provider’s product has not been
elements Unaccredited
independently assessed in relation to
TAR Test Accuracy Ratio defined standards
Determination according to USA PMO USA Pasteurized Milk Ordinance

Test requirements for a specific intended use Standard Standard
or application
USA United States of America
Therapeutic
Drugs provided in animal production A small external flash drive that can be
Drug
USB used with any computer that has a USB
A risk management tool to enable port
the FBO, competent authority or
United States Department of
enforcement agenct the ability to USDA
Agriculture
Traceability track any food, feed, food-producing
animal or substance that will be used Confirmation, through the provision
for consumption, through all stages of of objective evidence, that the
production, processing and distribution Validation
requirements for a specific intended use
or application have been fulfilled
Training device such as a chart, flash
cards, diagram, notes, etc., intended to Confirmation, through the provision
Training Aid
enhance learning and retention by a Verification of objective evidence, that specified
learner or trainee requirements have been fulfilled
Training WHO World Health Organization
Methods for evaluation of the
Effectiveness
effectiveness of training
Methods A food safety program that requires
the FBO to withdraw food from the
Training Process for evaluating the effectiveness market where it considers or has
Evaluation of training reason to believe that a food which
it has imported, produced, processed,
A training/competency matrix is a tool Withdrawal
manufactured or distributed does
used to document and compare the
Training not comply with the food safety
required competencies for a position
Matrix requirements, and the food has left the
with the current skill level of the
immediate control of the initial food
employees performing the roles
business
Analysis for identification of the training
Training Needs Work Set of conditions under which work is
needs of the organization from a
Analysis Environment performed
business and employee perspective
Work Detailed descriptions of how to perform
Organized activity aimed at imparting
Instructions and record tasks
information and/or instructions to
Training improve the recipient’s performance or WTO World Trade Organization
to help him or her attain a required level
of knowledge or skill.

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Copyright © 2016 International Finance Corporation

Introduction and Overview Food Safety Legislation 2

Food Safety Standards and Food Safety Tools

FSMS Procedures Food Safety Training

Documentation Overview ...........................................170 Choosing Food Safety Trainers

2 Process of Approval, Issue and Control of Food

Control of Records ....................................................189 Responsibility Matrix, Training Needs Analysis

Basic Facts About IFC

About IFC Global Food Safety Program

Contact: Sarah Ockman, Program Lead, sockam@ifc.org

Austrian Ministry of Finance (MOF)

The Norwegian Ministry of Foreign Affairs

Japan’s Ministry of Finance

The Food Safety Toolkit

Module 4 consists of two elements:

British Retail Consortium (BRC)

Which standards does the BRC operate?

The BRC Global Standards consists of a list of standards, namely:

BRC Global Standard for Food Safety (Issue Seven)

Who is it relevant to?

Fundamental Standard Requirements:

For additional details see: www.brc.org.uk.

International Featured Standard (IFS) Food

Which standards does the IFS operate?

The IFS operates the following standards:

IFS Standard GFSI Scheme GFSI Scope

The standard is owned by IFS Management GmbH, Germany.

Who is it relevant to?

Fundamental Standard Requirements:

For additional details see: www.ifs-certiﬁcation.com.

Food Safety System Certiﬁcation (FSSC) 22000

FSSC 22000 has been recognized against the following scopes:

Which standards does FSSC 22000 operate?

The version 3 of FSSC 22000 was published on April 10, 2013.

Two of the previous additional FSSC requirements remain unchanged:

One of the previous additional FSSC requirements was modiﬁed:

Two additional FSSC requirements were added:

Who is it relevant to?

Fundamental Standard Requirements:

Generally, the ISO 22000 requirements are:

For further details see www.fssc22000.com.

Which standards does the PrimusGFS operate?

The PrimusGFS operates the following standards:

PrimusGFS Standard GFSI Scheme GFSI Scope

Who is it relevant to?

Fundamental Standard Requirements:

Module 1 FSMS Applicable to all operations types

Module 1 Food Safety Management System:

Module 2 GAP and GMP Options:

Global red Meat Standard (GRMS)

Which standards does the GRMS operate?

The GRMS operates the following standards:

GRMS Standard GFSI Scheme GFSI Scope

Who is it relevant to?

Fundamental Standard Requirements:

For additional details see: www.grms.org.

Which standards does the CanadaGAP operate?

The CanadaGAP operates the following standards:

CanadaGAP Standard GFSI Scheme GFSI Scope