Today’s increasingly complex food and beverage manufacturing environment (not to mention the global supply chain) harbors innumerable opportunities for contamination, adulteration, and other potential food safety breaches. Manufacturers need a systematic analysis and response strategy to mitigate these risks effectively and protect public health.
Hazard Analysis and Risk-Based Preventive Controls (HARPC) programs provide a valuable framework for addressing a wide array of food safety issues, but there’s still potential for mistakes during hazard analysis and implementation to put products at risk. Knowing the common pitfalls to avoid during HARPC drafting and implementation can prevent many issues from occurring.
What is HARPC?
HARPC stands for Hazard Analysis and Risk-Based Preventive Controls, mandated by the FDA’s Food Safety Modernization Act (FSMA). HARPC is a regulated food safety system in the U.S. that helps food and beverage manufacturers identify and prevent hazards that could affect food safety.
A company’s HARPC program will encompass identifying and evaluating a wide variety of potential biological, chemical, and physical hazards present in their particular production process, then establishing Preventive Controls (PCs) to mitigate the food safety risks inherent in these identified hazards. HARPC extends beyond the traditional biological, chemical, and physical hazards required for consideration in HACCP programs and also includes radiological hazards and economically motivated adulteration.
Because HARPC programs are so all-encompassing and comprehensive, they’re time consuming and labor intensive to develop and implement, leaving significant room for potential gaps. HARPC plan stakeholders should take extra care to avoid the following issues:
Implementing a HARPC plan effectively requires advanced knowledge of food safety practices, as well as the ability to carefully follow processes for identifying and documenting hazards. Amid high turnover rates and the overall labor shortage, many manufacturers may find it difficult to assign the right people to their HARPC team, creating an additional layer of risk.
Solution: Company leaders should carefully vet potential HARPC team candidates to ensure they have the necessary level of expertise, experience, and confidence to perform their duties. Allocating time and resources to properly train employees to understand and execute HARPC plans is critical to helping team members meet standards and stay abreast of best practices.
The FDA trains their investigators to follow Appendix 1 of their HARPC Draft Guidance when assessing manufacturers’ HARPC plans, which outlines all known hazards of every individual ingredient. If the manufacturer’s HARPC team doesn’t follow Appendix 1 when conducting their own hazard analysis while formulating their plan, they are likely to overlook hazards and fail to implement effective PCs into their food safety system, resulting in serious compliance breaches.
Solution: Company stakeholders should be familiar with what the FDA has identified as hazards in Appendix 1 and provide necessary documents to their HARPC team to ensure they develop a plan that accounts for all known hazards.
In addition to failing to identify all known hazards in their operation, HARPC teams may miss the relevant sanitation-related preventive controls they need to include in their plan, resulting in 117.135 (c) (3) citations if caught during an FDA inspection. Failure to maintain adequate sanitation conditions for their operation can also result in a foodborne illness outbreak, a recall due to allergen cross-contact, or issuance of FDA Form 483.
Solution: Leaders should invest in the necessary education to ensure their HARPC team members are familiar with all regulatory-compliant sanitation PCs for allergen change over protocols. They also need to understand the importance of and best practices for employee hygiene and the control of environmental pathogens.
HARPC team members are required to outline the monitoring schedule for their preventive controls in the HARPC plan, and then monitor PCs accordingly. Failure of qualified individuals to monitor all PCs according to the defined planned frequency, means that all products run during the monitoring gap may be at risk of contamination. This may result in costly rework activities or the destruction of the at-risk products. Companies are also required to have a qualified team member, other than the one who conducted the monitoring activity, verify all PC monitoring records within seven working days of the monitoring activity first occurring to be compliant with 117.165.
Solution: To prevent compliance breaches, leaders should pre-assign alternates to cover PC monitoring and record verification activities in case of employee absence or sudden departure. Stakeholders should schedule regular reviews of their HARPC plan documentation to ensure all hazards and preventive controls are up to date and accurately reflect current product formulations and processes.
HARPC compliance is critical to protect the public from potential supply chain, ingredient, and manufacturing food safety risks. It takes the proper personnel, necessary training and education, and diligent adherence to FDA regulations to avoid compliance breaches and costly recalls. With new guidance in the pipeline, stakeholders need to refresh their training regularly.
AIB International has educated frontline food safety workers on standards and best practices for over a century. The PCQI Online course provides a comprehensive overview of current HARPC guidelines, ensuring students are up to date on standards, as well as how to develop and follow food safety protocols that comply.