1. Quality Assurance

2. 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

3. Quality Assurance Written definition or policy Reporting pathways Authority Product standards

4. 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

5. 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

6. 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.,

7. 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

8. 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.

9. 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.

10. 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?

11. 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

12. 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

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.