Introduction to FSSC 22000

6/13/2013

INTRODUCTION TO FSSC 22000

COURSE CONTENT
SECTION 1: BACKGROUND OF FSSC 22000 SECTION 2: BACKGROUND OF ISO 22000 SECTION 3: TERMS & DEFINITIONS SECTION 4: ISO 22000 REQUIREMENTS

FOOD SAFETY MANAGEMENT SYSTEM

By Jacqueline Toon SQC Management Sdn Bhd

FOODBORNE INCIDENTS
According to the Centers for Disease Control and Prevention, Atlanta, foodborne illness affects an estimated 48 million people in the United States every year. Of those, 128,000 are hospitalized and around 3,000 die.
Source: http://www.foodsafetymagazine.com/fsm-edigest/foodsafety-focus-on-packaging/ , June 4, 2013

SECTION 1:
BACKGROUND OF FSSC 22000

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Key Food Safety Issues

Existing Issues Being addressed
Hygiene of eating establishment Residue of veterinary drugs Pesticides Abuse and overuse of food additives Mycotoxin inorganic contaminants

Key Food Safety Issues

New Issues beginning to be addressed
Migration of chemicals substances from packaging materials and other materials in contact with food Persistent Organic Environmental Pollutants (dioxin, PCBs, PAH) Chemical substances formed during cooking/processing Hypersensitivity, intolerance and allergic reactions Antibiotic resistant microorganism

Effort already taking place to reduce the contravention and risk to consumers.

Food Packaging Safety Quotes

If you supply a food company, you are no longer just the packaging industry, you are a part of the food industry We treat food packaging with the same food safety rigor as food ingredients.
(Ms. Wade-Kudla senior manager of packaging at General Mills I nc., Minneapolis)

What is FSSC 22000

A set of requirements for a Food Safety Management System (FSMS) It was developed to fill the need for a worldwide Food Safety Standard

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WHY FSSC 22000?

There have been an abundance of food safety standards in use, the problem was that they were not equivalent. It was hard to know what each certification really meant.

If your customers want to see a GFSI recognized certification

you will need to use FSSC 22000, ISO 22000 is not recognized.

GFSI determine that the prerequisite programs requirements in ISO 22000 were not specific enough!!

Global Food Safety Initiative (GFSI)

A food retail initiative created in May 2000 by the Global Food Business Forum (CIES) A network of 175 retailers and 175 suppliers in over 150 countries, representing 65 percent of global food retail revenue.

How the GFSI requirements are covered in the key global food safety standards:

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SCOPE OF FSSC 22000

Applies to Food manufacturers or food packaging manufacturers Uses ISO 22000 for the food safety management system requirements Uses an additional document for prerequisite requirements
Food Manufacturers/Processors - ISO/TS 22002-1 (supersedes PAS 220: 2008) Food Packaging Manufacturers - PAS 223

THE ORIGINS OF A GLOBAL STANDARD

WHY FSSC 22000 WORKS?

Integrates food safety management easily with other management systems, such as quality, env ironmental and safety management systems; Fully incorporates ISO 22000:2005, PAS 220:2008 Pre-requisite Programmes (PRPs), HACCP, and the application steps of CODEX; Is fully recognised by the Global Food Safety Initiativ e (GFSI); Controls/reduces food safety hazards and promotes continuous improv ement on Food Safety Aspects; Fosters legal compliance; Increases transparency throughout the food supply chain; and Allows small and/or less dev eloped organisations to implement an externally dev eloped system.

SECTION 2:
BACKGROUND OF ISO 22000

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ISO 22000 throughout the food chain

What is ISO 22000?

Food Safety Management Systems Requirements for any organization in the food chain. ISO Technical Committee 34 Working Group 8 (ISO TC 34/ WG 8) Also members: Global Food Safety Initiative (CIES) Codex Alimentarius CIAA

Why ISO 22000?

Problems in food supply chains Needs for harmonization Integration Food Safety in management systems (ISO 9001, ISO 14001 etc)

Characteristics of ISO 22000

Food Safety Management System standard Apply to all suppliers within the food supply chain Requirements for internal & external communications Food safety hazards: controlled by CCPs & Operational PRPs Reference: List of specific code of practices

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TERMS AND DEFINITIONS

Food Safety Concept that food will not cause harm to Food Safety Biological, chemical or physical agent in food, or condition of food, with the Hazard Control Measure
potential to cause an adverse health effect <Food safety> action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level the consumer when it is prepared and/or eaten according to its intended use

SECTION 3:
TERMS & DEFINITIONS

TERMS AND DEFINITIONS

Operational PRP
PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment <Food safety> step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

TERMS AND DEFINITIONS

Critical Limit Criterion which separates acceptability
from unacceptability

Monitoring

Critical Control Point (CCP)

Correction Corrective Action

Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended Action to eliminate a detected nonconformity
Action to eliminate the cause of a detected nonconformity or other undesirable situation

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Regulatory authorities

Feed producers Primary food producers Food processors

Producers of ingredients

TERMS AND DEFINITIONS

Validation
<Food safety> obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

Producers of equipment

Producers of cleaning agents Producers of packaging materials

Transport and storage operators

Verification

Distributors Retailers Consumer

Figure 1 : Communication along the food chain

Services providers

Others

Components of Food Safety Management System

Outline of ISO 22000?

Sections 4 - 8 Contain the requirements ISO 22000 Standard Section 1: Scope Section 2: Normative Reference Section 3: Terms & Definitions Section 4: General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning & Realization of Safe Products Section 8: Validation, Verification & Improvement

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4.1 General
Establish an effective Food Safety Management System (FSMS) Keep it current Identify outsourced processes

SECTION 4:
ISO 22000 REQUIREMENTS

4.2 Documentation Requirements

Document your system Control your documents

4.2 Records
Maintain required records Control your records

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5.1 Management Commitment

Management must be involved in and committed to the FSMS.
Objectives support safety Everyone knows the importance of meeting the requirements

5.2 Food Safety Policy

Management creates for Food Safety Policy Management is responsible for communicating the policy Management is responsible for ensuring that the policy is implemented

5.3 FSMS Planning

As top management, take an active role in planning the system
Be involved in the design and implementation Make sure the integrity is maintained as changes are made

5.4 Responsibility and Authority

Define responsibilities and authority Communicate them Everyone is responsible for reporting problems with the FSMS - make sure they know that

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5.5 Food Safety Team Leader

Appointed by top management Reports to top management on the status of the FSMS

5.6 Communication
Establish a system for external communication
Suppliers, contractors, customers, SR&R authorities, external expert

Establish a system for internal communication

Food safety team meeting

5.7 Emergency Preparedness

Be prepared to respond to emergency situations Prepare an emergency plan to address potential situations:
Fire Flood Accidents Contamination Others...

5.8 Management Review

Key step in a Management Systems Approach Management meets to evaluate the performance of the FSMS

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6 Resource Management
Top management is responsible for providing the resources required Human resources Infrastructure Pre-requisite Programme Work Environment

7 Planning & Realization of Safe Product

Your organization will need to plan all of the processes that go into making your product in order to ensure a safe end product
PRP OPRP HACCP

7.2 Prerequisite Program

Basic Conditions and activities that are necessary to maintain a hygienic environment throughout the food chain
The Food safety Team establishes PRPs For FSSC 22000 you will also include prerequisite programs to meet the requirements of PAS 223

7.3 Preliminary Steps

The Food Safety Team
Identifies product characteristics Describe intended use Prepare flow diagrams Describe process steps and control measures

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7 core principle steps of HACCP

The HACCP system is implemented as described above which includes five preparatory steps and seven principle steps.
Hazard Analysis Critical control point Critical Limits M onitoringand sampling Corrective Action Verification Documentation

7.4 Hazard Analysis

The Food Safety Team
Verifies the accuracy of the flow diagrams Conducts hazard analysis to identify potential food safety hazards Selects control measures to prevent or eliminate those hazards

FOOD SAFETY HAZARDS & CONTROL

Types of Hazards Biological Physical Chemical

BIOLOGICAL HAZARD
Bacillus cereus Campylobact er jejuni Clost ridium bot ulinum Clost ridium perfringens Escherichia coli List eria Monocyt ogenes Salmonella species Shigella dysent eriae St aphylococcus aureus Vibrio cholerae Yersinia ent e

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FACTORS AFFECTING MICROBIAL GROWTH

Food Acidity)

PHYSICAL HAZARDS
Hair, feather Pest & their droppings metal fragment , glass Sand, wood, stone peeled off paint jewelry, buttons cigarette butts band aid, pen caps rubber band, plastic pieces

Preservative Temperature

Moisture

Oxygen

Time

CHEMICAL HAZARDS
Naturally occurred mushroom, some fish species, some tapioca species, allergen Commercially added pesticides, herbicides, colouring, additives Unintentionally added cleaning agents, sanitizers, lubricants

Food Hazard Assessment

Risk is to be calculated for each hazard and a risk rating sheet can be dev eloped as described below :

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Food Safety Risk Matrix

CCP Decision Tree

Value of 15 25 (red area): High Risk, control measure is essential, determined by Decision Tree Value of1 12 (green area): Low Risk, Up to the HACCP team to decide whether it makes sense to hav e the control measures

RAW MATERIAL CCP DECISION TREE

Q1 Is there a hazard with this raw material?
NO YES

PROCESS STEP CCP DECISION TREE

Q1 Are there preventive measure(s) for the identified hazard?
NO YES YES

Modify step, process or product)

Not a CCP

Is control necessary at this step for safety?

NO

Go to next raw material

Q2

Are you or the customer going to process this hazard out of the product?
NO

Q2 Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level?
NO

Not a CCP (Ctrl by OPRP)

YES

Next process step

CCP
YES

Q3

Is there a cross contamination risk to the facility or to other products whic h will not be controlled?
YES

Not a CCP
NO

Q3 Could contamination occur at unacceptable level(s) or increase to an unacceptable level? Not a CCP NO (Ctrl by OPRP) YES Q4 Will a subsequent process step eliminate or reduce the hazard to an acceptable level?

Next process step

NO

CCP

Go to next raw material

YES

CCP
Next process step

Not a CCP (Ctrl by OPRP)

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7.5 Establish Operational PRPs

Similar to a Critical Control Point, an Operational Prerequisite Program is a control point where biological, physical, or chemical hazards identified in hazard analysis can be controlled. Your food safety team will determine if the control point is a CCP or oPRP using the decision criteria in Section 7 of the standard. The Food Safety Team establishes Operational PRPs

7.6 Establish the HACCP Plan

Documents the HACCP plan

7.7 Updating
Updates any preliminary information that may have changed during or as a result of the hazard analysis

7.8 Verification Planning

Identify what verification activities are required including verification of PRPs, the HACCP Plan and other procedures. Verification will include internal audits, any food safety or GMP audits, verification of cleaning records and HACCP records and other activities that you identify for your system.

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7.9 Traceability
A traceability system ensures that the identification of product is maintained from raw material to delivery.
Establish the traceability of product From supplier to distribution

7.10 Control of Nonconformity

When a control limit is exceeded or an OPRP is found to be out of control affected product must be controlled.
Corrections Corrective actions Handling of potentially unsafe product

7.10.4 Withdrawal
To have complete & timely withdrawal of lots of end products

8.2 Validation, & 8.3 Control of Measuring & Monitoring

All measuring equipment must be capable of the required measurements and show calibration to national or international standards. Calibrate and control measuring equipment to ensure that measurements are valid

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8.4 Verification
Establish and document an internal audit process The Food Safety Team evaluates and analyzes verification results The Food Safety Team takes any necessary action

8.5 Improvement
Continually improve the FSMS through the use of:
Management review Internal audits Corrective actions Verification results Validation results

8.5 Updating the FSMS

Top management is responsible for seeing that the FSMS is continually updated The Food Safety Management Team evaluates the FSMS at planned intervals

THANK YOU FOR YOUR ATTENTION

QUESTIONS ?
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