Supervising the Quality Function

April 2003

Supervising anything can be difficult, but the quality function is an area of shifting priorities and demands. How an organization defines the function of quality will determine the nature of the conflicts and challenges it encounters. John Ostrin, manager, quality assurance and government contracts, Oregon Freeze Dry, Inc., Albany, OR, separates quality control (QC) from quality assurance (QA), confining QC to the actual manufacturing process, and QA acting as the bigger umbrella that covers everything from raw materials and good manufacturing practices (GMP) verification through finished-product release. This would include microbiological testing of finished product. For Ostrin, HACCP is part of QA.

Know the role
There are many QA policies that are for hanging on the wall, written to impress stockholders and customers; they were never intended to be followed in the plant. The quality area fulfills various roles in different companies: from the extremes of an in-house testing lab to full integration into all aspects of production. Unless the company is just starting up, the personality and energy of each succeeding supervisor, to some extent, modifies the role of quality. The supervisor must understand this role’s definition — whether clearly stated or just understood — as the function’s entire organization depends upon it.

However, the quality policy will not offer help if it was only written for public consumption. If the policy is written for public-relations purposes and not as a guide, it will not aid the QA manager in carrying out his mission. Knowing who actually reports what and the levels of approval that person has can shed some light on this.

Support and safety
It’s critical for top management to buy into what you are going to do, according to Joe Fry, vice president technical services and quality optimization, ConAgra Grocery Foods Group, Irvine, CA. The QA manager must report to the CEO or someone directly linked to him. Anything less indicates less than total commitment by upper management.

Sometimes, this may go further than the local division manager. For example, I worked for a newly acquired division of a multinational company and, after some culture conflicts between the parent company and the division, the CEO of the parent company sent me a letter saying I was to report any local interference with corporate quality standards directly to him. He even gave me his personal telephone numbers and sent a copy of the letter to the division president: that is total support. Corporate support does not always make one popular with local managers — they may see QC as impedance to their efficiency bonuses. But it is critical for maintaining high quality standards.

At times, a conflict exists between optimum quality and food safety. Food safety generally falls under the quality function, but manufacturers must recognize that many processes that ensure food safety do not enhance product quality. Any time a process change is undertaken to improve quality, the product safety requires reverification. Larger companies may make this a separate function, but in many smaller companies this responsibility falls to QA. By a similar token, food-safety processes are sometimes started without proper planning, which results in an unnecessary reduction in product quality. One should strive for a maximum reduction in consumer risk with a minimum alteration of final product quality. At times, if you are willing to do the work, you can “have your cake and eat it, too.”

You’ve gotta have heart
According to Fry, it takes the right talent to do the job. This means finding a person with the basic educational knowledge and the heart to do the job. If a person has the desire to perform the job, that person can be taught how to do it.

“The job is relentless and does not go away over the weekend. The quality manager must address the issues as they arise,” says Dean Tjornehoj, director of quality assurance, Land O’Lakes, Inc., western region, Tulare, CA. “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.”

What is quality?
Some define quality as the ability to make the same thing the same way, over and over again — what the customer buys today is the same as what they bought last week or will buy next month. The product must meet the customer’s expectations 100% of the time. This is where quality programs begin. Marketing has defined the customer expectations, product development has created a product that meets those expectations and 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. It sounds simple, but it’s not.

Statistically based process
The difficulty in creating a well-designed control system is obvious to the people who have been in QA for some time, says Ostrin: “You cannot inspect quality in. The process must be able to meet the specifications or there will be a lot of rework.”

This is why Fry makes note that “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 is where multifunctional teams come into play. 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? These reasons illustrate why the development team should include the QA manager. Someone needs to challenge the assumptions about the specifications. Are they necessary, or just copied from another specification?

Understanding and organizing
It is one thing to determine the desires of a retail population, it is another to understand the needs of an industrial customer. “The product must be defined in terms that the customer understands,” says Ostrin. “Make sure that the customer knows what he wants.”

Tjornehoj goes even further, advising manufacturers to discover how the customer uses the product. “Talk to the customer,” he says. “If they will let you, learn what process they are going to be using. Monitor customer feedback — suggestions and complaints — to better understand what they really want and need from the product. Then find the person in the plant that can make the change to the product that the customer is looking for.” This could be something as small as the location of the product code on the shipping container.

Install the plan
How the manager organizes the department, and the amount and quality of training provided to the QA personnel, will directly affect the quality of the product on the market. The level of automation in the process will determine the type and quantity of analyses that are needed. This is also true of the difference between the statistical process parameters and final product specifications. This difference will change over time, depending on the level of maintenance and quality of the original equipment that was installed.

Managers don’t need to have their hands in every last quality process, but they should know that the line employee doing the job has been trained and verify that the job is being done correctly. This is as simple as verifying that the check weigher was calibrated correctly or that trained personnel are actually working that day. The other part is to have the in-process laboratory test completed accurately and promptly. This includes the maintenance and calibration of the lab equipment, as well as initial training and, later, verification of the accuracy of each technician.

Make sure the product is evaluated for flavor and texture every day. If it is an ingredient that cannot be tasted as is, develop a procedure to determine if the flavor is acceptable.

Letting it go
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.

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.

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.

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.

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.

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.

Sell the program
Although no one wants to get hurt, companies must constantly promote worker-safety programs. Likewise, everyone wants to buy quality products, but making quality products also requires constant promotion.

“Remember that you are the voice of the customer in the plant,” concludes Tjornehoj. “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 our products. Get out of the office and ask the people what is going on.”