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Hazard Analysis and Risk-Based Preventive Controls (HARPC) food safety plans have been a requirement in most food and beverage facilities since the Food Safety Modernization Act (FSMA) went into effect in 2011. This type of plan is designed to address gaps in the Hazard Analysis and Critical Control Points (HACCP) by adopting a broader definition of “hazards.”
HARPC is a critical food safety program to get right, not just for compliance, but to protect the public from the full breadth of food safety threats. With that said, implementing and managing a HARPC program can be complex — unless you know the pitfalls to avoid.
What is HARPC?
HARPC is an FDA-mandated food safety program that requires food facilities to proactively identify and assess potential hazards that could affect the safety of their products. Unlike HACCP, which primarily addresses biological, chemical, and physical hazards, HARPC encompasses all of these hazards as well as additional risks like economically motivated adulteration and radiation.
Of the two hazard analysis-based food safety systems, HARPC now has the broadest application in the U.S., while HACCP is more common globally and specifically required for manufacturers and processors working with seafood, meat, poultry, and juice.
The Requirements of a HARPC Plan
HARPC-mandated facilities must develop a food safety plan that includes:
- Written hazard analysis, in English, that includes identification of hazards, evaluations of the likelihood of the hazard, consideration of naturally occurring or introduced hazards, and the factors like supply chain and personnel that contribute to hazards
- Preventive controls for identified significant hazards like sanitation, allergen control, personnel procedures, and custom methods or processes to reduce or eliminate the hazards identified in the first step
- Monitoring procedures to help ensure preventive controls are continuously implemented and effective in controlling identified hazards
- Corrective actions that must be taken when preventive controls are not functioning as intended
- Verification activities used to confirm that the controls outlined in the HARPC plan are effectively controlling the hazards
4 Tips for Building a Better HARPC Plan
Though HARPC is designed to fill gaps left by HACCP, the broad application of this protocol can make development, implementation, and management of the plan unusually difficult. Keep these points in mind as you draft your own HARPC plan:
1. Be proactive about supply chain disruption
Supply chain disruptions are becoming a normal part of business in every industry. In the food and beverage sector, they can lead to a shortage of critical ingredients and packaging materials, forcing manufacturers to pivot to un-vetted suppliers and other risky adaptations.
It’s important to maintain relationships with multiple suppliers for key ingredients to minimize the impact of a disruption with any single supplier.
Conduct regular supplier audits to ensure they comply with food safety standards equivalent to your own, especially when partnering with new suppliers. Review their food safety plan and incorporate any possible hazards into your evaluation and mitigation process. Consider implementing a regulated supply chain program.
If possible, consider keeping a reserve stock of essential ingredients to buffer against short-term disruptions.
2. Account for maintenance hazards
The FDA requires that all known or reasonably foreseeable hazards be considered, and that includes equipment issues. The equipment in question can involve any aspect of production, like machines or production processes that formulate, move, package, process, or handle food in any way. Even the sanitation equipment cleaning food-processing machines is subject to this oversight.
If equipment is poorly maintained, malfunctions or breaks down unexpectedly, it could expose products to industrial lubricants or shards of plastic, metal, and other contaminants.
To avoid this, implement a regular maintenance schedule for all equipment to ensure they are operating correctly and safely. Additionally, mandate thorough equipment checks after technicians complete their work to ensure no food safety issues were created during maintenance.
3. Prioritize elimination of intentional adulteration
Economically motivated food adulteration (EMA) and other intentional acts of sabotage tend to increase during times of disruption and uncertainty. Not only does this put consumer health at risk, but it can also trigger food safety recalls and tarnish your brand reputation.
As part of your initial HARPC development, conduct a thorough operations assessment to identify potential points in your process where EMA might occur.
Train employees to recognize signs of tampering or suspicious behavior and establish clear protocols for reporting potential violations. Regular product testing can help identify and eliminate EMA as well.
4. Don’t forget water quality
Water is often used for cleaning, as part of overall food processing operations, or as an ingredient in products — making it a significant hazard if contaminants and pathogens are present in the water supply.
To avoid potential issues, implement a schedule for regular water source testing to ensure it’s free and clear of contaminants. Invest in proper water treatment systems and filters to remove any materials that might undermine food safety standards.
Enhance HARPC Compliance With AIB International
Improving compliance with FSMA’s HARPC mandate is critical to protecting public health and complying with FDA regulations. How effectively your company adheres to these standards ultimately comes down to the training and dedication of your employees.
AIB International has over a century of experience educating frontline workers and food safety leaders alike on the latest food safety systems and best practices. Want to ensure your team conforms to standards? Learn more about our Food Safety and Sanitation Online - HARPC Module.