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QUALITY ASSURANCE
& QUALITY CONTROL
CFD20002 : Quality Assurance and Quality Control in Food Industries
Lecture 1
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WHAT IS QUALITY??
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• 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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TWO ASPECTS OF QUALITY IN


DESIGN AND
MANUFACTURING
1. Product features 2. Freedom from
• Characteristics that Deficiencies
result from design • Product does what it is
• Functional and supposed to do
aesthetic features that • Product is absent of
appeal to the defects and out-of-
customer tolerance conditions
• “Grade”
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
• In general:
• The responsibility for high quality extends well beyond the
design and manufacturing departments, staff and
suppliers.
ASPECTS OF QUALITY:7

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
• Durability and long service life
• Serviceability
• Reputation of product and producer
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ASPECTS OF QUALITY:
FREEDOM FROM DEFICIENCIES
• Absence of defects
• Conformance to specifications
• Components within tolerance
• No missing parts
• No early failures
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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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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 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?
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UNDERSTAND USE OF
PRODUCT
• Retail population
• Industrial customer
• Make sure that the customer needs
• Learn what process they are going to be using
• Monitor customer feedback — suggestions and
complaints
• Develop product that the customer is looking for
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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 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?? 13

• 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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QUALITY CONTROL SYSTEMS


IN THE PRODUCTION SYSTEM
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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, suggestions, and instructions for its
improvement.
QA FUNCTIONS: 16

• 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.
QA RESPONSIBILITIES 17

• 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

• 3. Chemical evaluation of raw and processed


products, and ingredients

• 4. Microbiological evaluation of raw and


processed products, and Ingredients
CONT.. 18

• 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

• 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)

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
processing equipment for cleanliness
tests)
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TRADITIONAL AND MODERN CONCEPTS OF


QUALITY
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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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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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ORGANIZATION OF QA&
QC PROGRAMS
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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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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),
• Good Agri-cultural Practices (GAPs),
• Good Laboratory Practices (GLPs),
• HACCP systems, and HACCP-based systems.
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QUALITY ASSURANCE
ORGANIZATION
• Summary of important aspects in QA organization:
• Written definition or policy
• Clear reporting pathways
• Authority
• Product standards
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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.
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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
• 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
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SPECIFIC MAJOR
FUNCTIONS OF THE QA
DEPARTMENT, TO MONITOR:
• Compliance with specifications.
• Test procedures.
• Sampling procedures and schedules.
• Record-keeping and reporting procedures.
• Troubleshooting.
• Special problems.
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QA/GMP
DOCUMENTATION
• Standard Operation Procedure (SOP) 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.
• Traffic control/controlled access.
• Outside surroundings.
• Buildings and facilities.
• Building construction.
• Overhead structures and lighting.
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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.
• Temperature and humidity control.
• Returned foods.
• Nonfood chemicals.
• General cleanliness and housekeeping.
• Equipment construction and maintenance.
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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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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 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.
QA OPERATION
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• 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 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.
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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 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.
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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 the causes and effects of the various
process inputs on the final product.
QA OPERATION
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• 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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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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