Download Quality Assurance

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
Quality Assurance
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Written definition or policy
Reporting pathways
Authority
Product standards
Support
• Top management must buy 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
Safety
• Conflicts may exist between optimum quality
and food safety
• Manufacturers must recognize that many
processes that ensure food safety do not
enhance product quality
• Any time a process change occurs to improve
quality, product safety requires reverification
• Responsibility may fall to QA
Supervision
• Person with basic educational knowledge
• Desire to do the job
– “The job is relentless and does not go away over the
weekend. The quality manager must address the
issues as they arise. If one leaves an issue on Friday
without making a decision, then on Monday, one is
already two days behind. The consensus is that the
good supervisors have a fire in their belly that keeps
them on top of things and does not allow them to
become complacent. One cannot ride along hoping
that things will get better without some type of
intervention.” Dean Tjornehoj, director of quality
assurance, Land O’Lakes, Inc.,
What is Quality
• 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
Customer expectations
• This is where quality programs begin.
– Marketing has defined the customer expectations.
– Product development has created a product that
meets those expectations.
– Engineering has designed a process to make the
desired product.
– Now, all QA must do is design a control system that
verifies that everything is working as designed.
Statistically based process
• You cannot inspect quality in.
• 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.
Integration process
• Integration of product development, engineering,
marketing.
– 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?
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
– Develop product that the customer is looking for
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
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.
QA operation
• If certain tests take several days to complete, the
department must create a record review, and a wellcoordinated 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
• 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.
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.
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
• 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.
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 people what is
going on.