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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 ‡ ‡ ‡ ‡ 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 .

product safety requires reverification ‡ Responsibility may fall to QA .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.

. 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 is already two days behind. One cannot ride along hoping that things will get better without some type of intervention.Supervision ‡ Person with basic educational knowledge ‡ Desire to do the job ± ³The job is relentless and does not go away over the weekend. . If one leaves an issue on Friday without making a decision. director of quality assurance. Land O¶Lakes.´ Dean Tjornehoj. The quality manager must address the issues as they arise. then on Monday. Inc.

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 .What is Quality ‡ The ability to make the same thing the same way.

. ± Product development has created a product that meets those expectations.Customer expectations ‡ This is where quality programs begin. ± Now. ± Marketing has defined the customer expectations. all QA must do is design a control system that verifies that everything is working as designed. ± Engineering has designed a process to make the desired product.

‡ The process must be able to meet the specifications or there will be a lot of rework. ‡ 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.Statistically based process ‡ You cannot inspect quality in. ‡ Programs have to be statistically based.

given the restrictions imposed by the raw materials. marketing. regulatory concerns and the process design? . combined with the normal variation in the process.Integration process ‡ Integration of product development. ± Will the raw materials available. 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. engineering. 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.

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 ² 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 ± ± ± ± ± 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. no one will get timely feedback before a real problem crops up. If record reviews don¶t stay current. . 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.

as well as actual. . As the industry develops new. and a wellcoordinated release procedure must be developed so that product is not shipped prior to the completion of all the tests. ‡ This is where a great deal of pressure is brought to bear on the QA function. inventory-control procedures are necessary. but the test results are not available. and fall under the supervision of QA. The company has orders to fill and customers to keep happy.QA operation ‡ If certain tests take several days to complete. the department must create a record review. this time lag will decrease dramatically. ‡ Electronic. rapid procedures for microbiological testing.

these are the people that established and approved the original product specifications. Usually. ± However. .QA operation ‡ The question is easier to answer with food-safety issues than with quality deviations. with quality deviations. you don¶t ship anything. 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. if you don¶t know or there is doubt. ± With food safety.

.QA operation ‡ Raw-material deviations are easier to deal with. then it is rejected. then can manufacturing make a processing change to accommodate the raw-material deviation? ‡ If not. ± Can the supplier replace the raw material in time to maintain the production schedule? ‡ If not. ± Purchasing and production must receive notification immediately of all raw-material problems. then it is still rejected. ± Is the product safe to use? If the answer is no. quality finished product from the out-of-specification raw material? ‡ If yes. then how badly does the company need the final product it contains? ‡ If it is critical. then it is accepted and a deviation report is sent to the supplier. ± Can the company make a good.

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

‡ Companies must avoid overly restrictive specifications that are not directly linked to product safety. since these only raise the cost of the operation. government regulations or product quality.QA operation ‡ Only install new procedures that are based on verified cause-and-effect analysis. .

‡ Get out of the office and ask the people what is going on.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. .