L1 - Quality Assurance Quality Control
L1 - Quality Assurance Quality Control
L1 - Quality Assurance Quality Control
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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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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• 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
STRUCTURE OF QUALITY
ASSURANCE
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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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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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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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.
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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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.