Moving from a product control strategy (product inspection to guarantee quality) to a process control strategy is a major paradigm shift for a food processing company. To make this shift, the food processor must incorporate the concepts of process control into the quality strategy. Process control focuses on the following issues:

• Designing quality and safety into the product and manufacturing process rather than inspecting the product for either quality or safety attributes.
• Using process control techniques (statistical process control or automated process control to monitor process performance) to monitor and control the process to ensure that product is produced which meets intended quality and safety requirements. The process monitoring responsibilities are typically done by production.

This strategy then changes the role of the quality function from quality control to quality assurance. Typically, quality assurance will continue to monitor and measure product parameters, however, these data are used to provide verification that the process is operating in a correct manner. In addition, food processing companies will conduct other testing such as environmental and product microbial testing.

To achieve the goal of process control, a systematic process must be used to accomplish the following:

• Study the process.
• Understand the sources of process and product variation.
• Take effective actions to eliminate, reduce or control the sources of variation.

Process control is based on the premise that if a process is operating in a stable manner (no special causes of variation), the process will consistently produce product with a predictable amount of variation.

The quality system has five major components:

1. Monitoring is the heart of the quality system. Traditionally, monitoring was the responsibility of quality control. In process control, the most effective monitoring is conducted by the person responsible for performing the job. Therefore, in a manufacturing environment, process testing and data analysis should be conducted by the personnel on the processing line. The monitoring system should be developed so that the individual 1) knows the process requirements, 2) has the tools to measure performance against the requirements, and 3) has the ability to adjust the process. The most effective process control system is to measure process parameters rather than product parameters.
2. Verification is necessary to meet the requirements of both internal and external customers. As part of the latter responsibilities, QA may be the point of contact with external customers with regard to product quality issues. Verification activities include document review, product or process testing, and data analysis and reporting. Verification is primarily a function of quality assurance, however, verification activities may also be conducted by production personnel. There are several objectives of verification: 1) Assure that the processes are operating properly, 2) Assure that the products meet requirements, and 3) Identify opportunities to improve process performance and product quality.
3. Validation is required to ensure that the system is capable of meeting the internal and external specifications. As a company makes the transition from QC to QA, validation becomes a role of manufacturing, quality assurance and research and development. In addition to initial validation, there should be revalidation of the system. This can be done on a periodic basis when the process has changed, when new technologies can improve the processes, or when a change has been made to the process.
4. Continuous improvement is central to the modern quality system. Data gathered during the monitoring and verification phases should be reviewed to identify areas for improvement so that increased efficiencies and effectiveness can be realized.
5. Management review of the quality system should be conducted on a periodic basis to ensure that the quality system is effectively operating. Reviews should include assessment of the effectiveness of the quality process and can include assessment of the monitoring, verification, validation, and continuous improvement processes. These reviews need to be done at the corporate level as well as the plant level.

The actual structure of the system and reporting will be inherent to the actual culture of the company. I personally feel that there needs to be a decrease in the role of the quality assurance as a "police force." Whenever a "police force activity" is used, there should be a review to determine why the activity was necessary and to identify improvements to the quality system to reduce the necessity of using "excessive force."

One model that can be used to describe this paradigm change is a road construction project, where an expressway is widened and traffic continues to flow on the highway. There needs to be an orderly transition in moving from product control to process control. During this transition, it may be necessary to operate two systems at the same time to ensure that production can be maintained (this latter fact can cause confusion among the employees). Therefore, in addition to the technical aspects of this transition (training, installation of software and hardware), communications must be addressed. All associates need to know where they are going, need to understand what their roles and responsibilities are, and need to be kept informed if a detour must be made in the journey.

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