CFB 30302

Quality Management
System in Food Industry
1

Topic 3
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Quality assurance
 2 LEARNING OUTCOMES

 At the end of this chapter student should be able

 Differentiate the functions of Quality Assurance (QA) department and Quality Control
(QC) Department
 Discuss the Organization of QA& QC programs.
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 Explain the QA documentation system

 Compare the traditional and new concept of Quality Control
 3 3.1 Theories, Function and Application
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 Traditional Quality Control
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 Widespread use of statistical quality control (SQC), in which

inferences are made about the quality of the population of
manufactured parts and products based on a sample
 Two principal sampling methods in SQC
 Control charts
 Graphical technique used to track measured variable of
interest over time
 Acceptance sampling
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 If the sample passes, the batch is accepted

 5 Traditional Quality Control
Typical management principles and practices:
 Customers are external to the organization
 The sales and marketing department are responsible for customers
 Company is organized by functional departments
 Inspection department is responsible for quality
 Inspection follows production
 Knowledge of SQC techniques resides only in the minds of the QC experts in
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the organization
 Quality Control Systems
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in the Production System
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 7 Modern View of Quality Control
High quality is achieved by a combination of:
 Good management – three objectives of “total quality management”:
1. Achieving customer satisfaction
2. Continuous improvement
3. Encouraging involvement of entire work force
 Good technology – traditional statistical tools combined with modern
measurement and inspection technologies.
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 8 Quality assurance & Quality control

 The terms “quality assurance” and “quality control” are often used
interchangeably to refer to ways of ensuring the quality of a service
or product. The terms, however, have different meanings.
 Assurance: The act of giving confidence, the state of being certain or the act of
making certain.
Quality Assurance: The planned and systematic activities implemented in a
quality system so that quality requirements for a product or service will be
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fulfilled.
 Control: An evaluation to indicate needed corrective responses; the act of guiding
a process in which variability is attributable to a constant system of chance causes.
Quality Control: The observation techniques and activities used to fulfill
requirements for quality.
 WHAT IS QA and QC??
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 QA is a strategic management function that:
 establishes policies, adapts programs to meet established goals, and provides
confidence that these measures are being effectively applied.

 QC, on the other hand, is “the operational

techniques and activities that are used to fulfill
requirements for quality”
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 10 More about QA….
 Quality assurance (QA) describes and manages
 the activities of control, evaluation, audits, and
regulatory aspects of a food processing system.

 A QA program consists of
 an in-house consulting organization;
 it evaluates the quality program and gives advice,
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suggestions, and instructions for its improvement.

 QA functions:
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 involve establishing and managing the company’s
quality organizations, designing operating
procedures, discussing the quality direction with
top management.

 to provide confidence for management and the

consumer — the person a company must satisfy
and who actually establishes the level of quality
of the products a company manufactures.
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 QA responsibilities
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 1. Line inspection and control of:

a. Supplies, ingredient materials, and raw products
b. Operating procedures
c. Finished products

 2. Physical evaluation and qualification of raw and

processed products, and ingredients
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 3. Chemical evaluation of raw and processed products, and

ingredients

 4. Microbiological evaluation of raw and processed

products, and Ingredients
 Cont..
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 5. Warehousing conditions for shelf-life time, temperature
control and handling procedures

 6. Sanitation control of products, processes, and storage

 7. Waste disposal control

 8. Compliance with Federal, State, and Municipal

requirements and Standards
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 9. Specification compliance during marketing and

distribution for consumer confidence and assurance of the
integrity of the product and company
 QC responsibilities
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1. Managing processing records

2. Conducting Tests and following up on any possible

problem areas

3. Testing regular commercial products

(periodic sampling, monitoring perishables)
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4. Monitoring new products

(overall quality, shelf life, ingredient safety, etc.)
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5. Investigating of retail product claims

(when a claim is received, steps are taken
immediately to discover the root of the problem
and the best solution)

6. Regular factory sanitation inspections

(hygienic condition checks, testing food
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processing equipment for cleanliness tests)

 16 3.2 Organization of QA& QC programs
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 17 Organization of QA& QC programs
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 18 Structure of Quality Assurance
 Top management must understand into what QA is doing
 QA manager must report to CEO or direct link
 Corporate support does not always make one popular
with local managers but is critical for maintaining high
quality standards
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 19 Function Quality program

 Quality Assurance
 Covers everything from raw materials and GMP verification through finished-product release
 HACCP is part of QA
 Quality Control
 Actual manufacturing process
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 20 What are the functions of a QA department?

 QA functions involve establishing and managing the company’s

quality organizations, designing operating procedures, discussing
the quality direction with top management, introducing them to the
fundamentals of quality, and making certain there is consistency in
management pronouncements.
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 21 Government regulatory compliance

 QA department will programs and verifying and auditing their implementation as

a means of regulatory compliance.
 Selection and application of QA programs can vary depending on the step in the
food production chain, size of the food business, type of product produced, etc.,
and may include:
 Good Manufacturing Practices (GMPs),
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 Good Agri-cultural Practices (GAPs),

 Good Laboratory Practices (GLPs),
 HACCP systems, and HACCP-based systems.
 22 Quality Assurance Organization
 Summary of important aspects in QA organization:
 Written definition or policy
 Clear reporting pathways
 Authority
 Product standards
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 23 The most significant aspect of a QA
program:
 upper management is able to monitor, at all times and through all stages of manufacturing,
the level of quality of its product, as well as keeping in line with industry trends.
 For example:
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 Two Aspects of Quality in
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Design and Manufacturing
1. Product features 2. Freedom from Deficiencies
 Characteristics that result  Product does what it is
from design supposed to do
 Functional and aesthetic  Product is absent of defects
features that appeal to the and out-of-tolerance
customer conditions
 “Grade”
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 Aspects of Quality:
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Product Features
 Design configuration, size, weight
 Function and performance
 Distinguishing features of the model
 Aesthetic appeal
 Ease of use
 Availability of options
 Reliability and dependability
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 Durability and long service life

 Serviceability
 Reputation of product and producer
 Aspects of Quality:
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Freedom from Deficiencies
 Absence of defects
 Conformance to specifications
 Components within tolerance
 No missing parts
 No early failures
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 Quality Responsibilities
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 Product features are the aspect of quality for which the design department is
responsible
 Product features determine to a large degree the price that a company can charge for
its products

 Freedom from deficiencies is the quality aspect for which the manufacturing
departments are responsible
 The ability to minimize these deficiencies has an important influence on the cost of
the product
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 In general:
 The responsibility for high quality extends well beyond the design and
manufacturing departments, staff and suppliers.
 28 Again.. What is Quality
 In short:
 The ability to make the same thing the same way, over
and over again
 Customer buys today is same as what they bought last
week or will buy next week
 Product meets customer’s expectations 100% of the time
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 29 Dimension of quality
 Design. This determines the market segment. It is not only an engineering
decision, but involves customers, manufacturing, and other stakeholders.
 Conformance: eight dimensions of quality to link customer requirements to
engineering design.
 Performance.
 Features.
 Reliability.
 Conformance.
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 Durability.
 Serviceability.
 Aesthetics.
 Perceived quality.
 In order to achieve that, need to do:
 30 Statistically based process
 You cannot inspect quality by applying statistical process without properly put
the programs in place.
 The process must be able to meet the specifications or there will be a lot of
rework.
 Programs have to be statistically based.
 There must be integration between R&D, engineering and marketing to define a
product that can be made 99% of the time.
 The program that is designed to control the process must then make sense.
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 31 Integration process
 Integration of product development, engineering, marketing as part of
quality assurance program:
 Will the raw materials available, combined with the normal variation
in the process, produce the product desired?
 How does one describe what is actually needed in statistical terms that
can verify the processes?
 Does the normal variation lie within the specification, or is some type
of sorting required to meet the specification?
 Does anyone know what the cost of tight specifications is?
 How will the QA manager design and implement the control program
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required to assure that the final product going out the door meets
customers’ needs, given the restrictions imposed by the raw materials,
regulatory concerns and the process design?
 32 Understand use of product

 Retail population
 Industrial customer
 Make sure that the customer knows what he wants
 Learn what process they are going to be using
 Monitor customer feedback — suggestions and complaints
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 Develop product that the customer is looking for

 3.3 Quality Assurance Personnel and
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Audits
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 Relationship between Quality Assurance and Auditing Objectives

and Functions of QA personnel and auditors are the same.
 Both QA personnel and auditors are concerned with the existence of
information system standards, compliance with these standards, and
timely, corrective actions when deviations from standard occur.
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 35

 Organizational Considerations Staffing the QA function

QA personnel must be well trained and competent, and
their skills must be kept up to date.
 Auditors should evaluate whether QA personnel have
adequate knowledge of information systems development,
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implementation and operations procedures

 36 3.4 QA documentation systems
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 37 Installation of QA plan
 Organization of department
 Make use of supervisors
 Amount and quality of training affects finished product
quality
 Every line employee should be trained
 Verify job is being done correctly
 Automation of process changes types and quantities of
analyses needed
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 Speed of testing
 What level of accuracy is necessary
 Maintenance and calibration of lab equipment
 Training of technicians
 Verification of accuracy and variation of technicians
 38 Specific major functions of the QA
department, to monitor:
 Compliance with specifications.
 Test procedures.
 Sampling procedures and schedules.
 Record-keeping and reporting procedures.
 Troubleshooting.
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 Special problems.
 39 QA/GMP Documentation
 SSOP written for a food processing plant should be a comprehensive document and must
include the following areas for monitoring:
 Hygiene and personnel practices.
 Sanitation principles and food handling practices.
 Manufacturing controls of operations.
 Communicable diseases/injuries.
 Handwashing.
 Personal cleanliness and conduct.
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 Traffic control/controlled access.

 Outside surroundings.
 Buildings and facilities.
 Building construction.
 Overhead structures and lighting.
 40 Continue..
 Heating, ventilation, air conditioning.
 Drainage and sewage systems.
 Waste facilities.
 General protection from contamination.
 Flow-through pathways.
 Washrooms, lunchrooms, changing rooms.
 Water quality program.
 Raw material receiving.
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 Temperature and humidity control.

 Returned foods.
 Nonfood chemicals.
 General cleanliness and housekeeping.
 Equipment construction and maintenance.
 41 QA operation
 Reviewing the daily lab and production reports is a part of the QA
responsibilities. This is to determine that the procedures are being followed
and the tests are being made.
 QA can spot trends by conducting consistent record reviews. If record reviews
don’t stay current, no one will get timely feedback before a real problem crops
up.
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 42 QA operation
 If certain tests take several days to complete, the
department must create a record review, and a well-
coordinated release procedure must be developed so that
product is not shipped prior to the completion of all the
tests.
 Electronic, as well as actual, inventory-control procedures
are necessary, and fall under the supervision of QA.
 This is where a great deal of pressure is brought to bear on
the QA function. The company has orders to fill and
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customers to keep happy, but the test results are not

available. As the industry develops new, rapid procedures
for microbiological testing, this time lag will decrease
dramatically.
 43 QA operation
 The question is easier to answer with food-safety issues
than with quality deviations.
 With food safety, if you don’t know or there is doubt, you don’t
ship anything.
 However, with quality deviations, the manager must ask how bad
the out-of-specification condition is.
 Previous customer complaints about a problem can be reported along
with the test data.
 One recommendation might entail a quality review committee
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established by upper management that will make these decisions

based on the data furnished by QA.
 This should occur at a management level that understands the total
ramifications of a decision to ship or not ship the product. Usually,
these are the people that established and approved the original product
specifications.
 44 QA operation
 Raw-material deviations are easier to deal with.
 Is the product safe to use? If the answer is no, then it is rejected.
 Can the company make a good, quality finished product from the
out-of-specification raw material?
 If yes, then it is accepted and a deviation report is sent to the supplier.

 Can the supplier replace the raw material in time to maintain the
production schedule?
 If not, then how badly does the company need the final product it
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contains?
 If it is critical, then can manufacturing make a processing change to
accommodate the raw-material deviation?
 If not, then it is still rejected.

 Purchasing and production must receive notification immediately of

all raw-material problems.
 45 QA operation
 Production and purchasing should get feedback regarding
raw-material and finished-product compliance, both the
good, as well as the bad.
 These departments need advance notice of any negative
trends that have been detected before they become out-of-
specification problems.
 Recommendations on how to improve the process are
always helpful, especially if someone has been observing
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the causes and effects of the various process inputs on the

final product.
 46 QA operation
 Only install new procedures that are based on verified
cause-and-effect analysis.
 Companies must avoid overly restrictive specifications that
are not directly linked to product safety, government
regulations or product quality, since these only raise the
cost of the operation.
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 47 QA operation
 QA is the voice of the customer in the plant
 Establish the expectation that the products that are to be
made will meet the specifications of the customer.
 Go to the people on the line and explain what the customer
expects from the products.
 Get out of the office and ask the worker what is going on,
i.e to find a root cause of the problem.
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 End of TOPIC 3
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