Under the Hazard Analysis and Risk-Based Preventive Controls (HARPC) proposed rule in the Food Safety Modernization Act (FSMA), every food processing facility is required to have an individual qualified to develop, implement, and maintain the food safety program. Let’s call this qualified individual the “program champion.” But, will you need to create a new position to meet FSMA requirements? In most cases, the answer is no. You likely have people who oversee the food safety plan, such as a food safety committee chairperson, a HACCP or food defense coordinator, etc. The key will be ensuring that the designated person is qualified to meet the responsibilities detailed in FSMA.
1. Prepare the Food Safety Plan. The first duty listed in the proposed rule is that the qualified individual is responsible for preparing the Food Safety Plan. This sounds very similar to a HACCP coordinator. In addition to developing the hazard analysis, it includes formalizing the preventive controls. This can be a very large task for an individual. The support and involvement of a product safety team is valuable and necessary to obtain input on components and maintenance of these programs and policies. The program champion should coordinate the team effort of putting the Food Safety Plan together, including educating employees on any modifications to existing policy.
2. Validate Preventive Controls. Another responsibility is coordinating validation of the preventive controls in the Food Safety Plan to determine if they effectively control any identified hazards in the products manufactured. A file that contains all validation activities performed by the team members should be maintained. These activities may include thermal processing challenge studies, trend analyses, visual observation of monitoring, etc. All validation activities must be documented and reviewed. These activities should be signed off by the program champion and the HARPC team.
3. Review Preventive Controls Record. Documentation review is another listed responsibility. This can be a tedious task for one person, and mistakes can be easily made. It is recommended that several individuals be responsible, and the program champion oversee the task, making adjustments when necessary, such as switching or retraining people and modifying forms. The proof of preventive control effectiveness is a must if any issues arise that jeopardize the integrity of the HARPC Program.
4. Reanalyze the Food Safety Plan. The final responsibility is reanalyzing the HARPC Program on a set frequency. In the food industry, an annual basis is a standard frequency for internal auditing and evaluation of programs and policies. However, the frequency is determined by the criteria you are following. All components of the programs must be assessed to determine effectiveness. This can be completed by a review of customer complaints, held product trends, deviations to the plan, returned product, etc. These factors should be used to modify, improve, and set new standards to the HARPC Program.
According to the HARPC proposed rule, “To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum (under discussion in the proposed rules) or be otherwise qualified through job experience to develop and apply a food safety system.” This means your existing designated program champion must have documentation of training to a standardized curriculum or can show that they are qualified through experience. Don’t wait until the final rule is published to ensure that your program champion is qualified, there are a wide variety of training options available to prepare your company’s qualified individual.
The author is Food Safety Education Training Director, AIB