Quality Systems: Simple or Complex

A quality assurance (QA) system can be simple or complex. However, the industry seems to be moving toward complex as evidenced by FSMA. A simple QA system consists of a few basic aspects that, when present, establish a foundation on which to build the quality system. Complex systems can create some good-looking programs in a conference room but can be so complex that they lead to poor product produced in the plant. What is a practical solution for this dilemma? You should assure that you have an effective yet simple QA system, usually found within a complex system. Following are six aspects needed for quality and food safety in almost any food plant operation.
 

1. Guiding Principles. Usually found in a company’s mission statement, guiding principles should not consist of the word quality itself. The word quality means different things to different people at different times. Better understood words might be highly nutritious, market leader, perfection, or exceed customer expectations; and they should be principles that can be objectively measured. Guiding principles must be found in the plant and within employees. If you don’t live this belief every minute of every shift, product quality will suffer. Good guiding principles are those originating from the company owner(s) and instilled in employees by example. Poor guiding principles are those found on a visitor waiting room wall without company employees knowing they exist or understanding them.

2. Production Methods. Ranging from raw materials to product packaging, production methods begin with the selection of raw materials and suppliers, with selection based on requirements, specifications, and measurement techniques. One part of the production methods is having key checkpoints designed into the process by which production employees can measure conformance. You cannot inspect quality into a product; you must build quality into the product. Another important part of production methods is a HACCP program, assuring that hazards do not occur. Using quality control techniques that compare conformance to standards should be measured by production personnel throughout the process. Product packaging controls are another part of the production methods aspect with specific measurement techniques utilized by production personnel and, where appropriate, lab employees.

3. Sanitation Practices and Beliefs. This aspect includes sanitary design, plant and equipment clean-up, refuse removal, pest management, and Good Manufacturing Practices (GMPs). Unannounced inspections should be routine with announced audits periodic. Both have their advantages, and both should be followed with management and employee training. Quality products can be made only in quality environments. If an environment is not in compliance, production must cease until it is.
 

4. Laboratory Methods. A plant laboratory should provide meaningful, timely, precise, and accurate data following recognized procedures at a level to withstand a good laboratory-procedure audit and/or regulatory investigation. Most plant labs will be set up for basics such as package guarantees, key product attributes, production method confirmations, and ingredient conformance to specification. Most plants will require the use of an outside laboratory to confirm plant laboratory accuracy and testing beyond the basics such as microbial.

5. Policies and Procedures. Any QA system must inform and communicate requirements. Policies typically originate from company headquarters and, where appropriate, include a procedure model to be customized by each plant. Policies and procedures are written to make employees aware of these six aspects, with regulatory requirements (GMPs) providing the direction a company must follow to achieve standardization of products.

6. Monitoring of the Previous Aspects. For example, quality assurance must be started before product production begins, then continue both during and after product production. Another aspect is the measuring of retail product quality, assuring compliance to key attributes at the point of purchase. A large part of it is customer satisfaction, measured by a formal process that asks customers, “How are we doing?” Meeting requirements and exceeding customer expectations is a fundamental principle. When performed correctly, continuous improvement of product and service will result.

Through FSMA, the government is requiring sweeping reform of food safety laws, which is leading us away from core principles and into complexity. I once heard it said that an effective quality system cannot be put on one page. But, this one-page quality system was my first and remains the core of my QA system work today. The system is as effective now as it was more than 30 years ago.

Let’s keep things simple.