In late 2019, the FDA announced that it would soon be moving from education to enforcement where its Food Safety Modernization Act (FSMA) was concerned. Then 2020 happened. The FDA became understandably concerned with other things, and inspections of the nation’s food supply chain dropped from an average of 900 a month to just 8 in April 2020. With vaccinations currently on the rise, however, food and beverage manufacturers should probably consider their grace period to be almost up.
With all but the smallest animal food facilities now covered by FSMA, manufacturers should take a moment to understand whether they’re adhering to current good manufacturing practices. Some non-binding controls have gradually become mandatory over the last few years, whereas others have relaxed and become recommendations.
What is definitely mandatory, however, is the implementation of hazard analysis and risk-based preventative controls, better known as HARPC. This method, along with foreign supplier verification programs (FSVPs) that apply to food importers, requires F&B manufacturers to interrogate their entire supply chain as part of a food safety plan. So, what should you be doing—and what should your supplier be doing—now that FMSA enforcement is coming back to the fore?
1. Know that HACCP and HARPC Aren’t the Same
Many F&B manufacturers were taken off guard by the FDA because they thought that their existing HACCP programs would satisfy HARPC requirements. HARPC is a broader protocol, however. HACCP stands for Hazard Analysis and Critical Control Point, which means that it looks at spaces where the manufacturer has direct control over its material and can apply food safety controls on its own.
HARPC, on the other hand, looks at preventative controls. This means that manufacturers need to focus on areas where they can ensure the safety and quality of food before it reaches their premises. This means looking at your entire supply chain—and it’s not optional.
2. Take a Second Look at Your PRPs
HARPC includes taking a look at two elements of the food production process—prerequisite programs (PRPs) and operational prerequisite programs (OPRPs). Again, these sound like the same thing, but they have critical and important distinctions.
A PRP is a performance indicator within the food production environment that might not be able to be measured using traditional metrics. Some examples of this include pest control, sanitation, and allergen control. You can hope that your pest control efforts keep pests from coming back to your facility, but it’s hard to measure “percentage of pests deterred. In traditional manufacturing efforts, the lack of an ability to effectively measure PRPs has meant they’ve gone by the wayside.
Under the HARPC methodology, F&B companies need to track PRPs both for themselves and for their suppliers as well. This means documenting how these programs are managed, collecting documentation from your suppliers, taking corrective actions if your suppliers aren’t doing enough, collecting more documentation describing how they fixed the problem, and then reevaluating on a periodic basis.
3. Likewise, Revisit Your OPRPs
Operational prerequisite programs control significant hazards, but they aren’t critical control points (CCP). In other words, the manufacturer isn’t in full control of them. Nonetheless, OPRPs should be treated like CCPs. Because you aren’t in full control of your suppliers – but they can definitely impact your production process – your risk assessment program might identify a number of potential OPRPs in your supply chain.
Again, OPRPs should be dealt with the in same manner as CCPs—identify the potential risks, monitor the situation, verify that the mitigation program is working, take corrective action if it isn’t, and record everything. The difference here is that F&B manufacturers don’t need to define critical limits for OPRPs. In addition, corrective actions can target OPRPs indirectly, but you should document the actions you’re taking and how they limit the risk of exposure to hazards.
4. Work with Suppliers to Design and Validate their Controls
FSMA, HAACP, and HARPC are confusing for US manufacturers—so imagine being a supplier in the same situation. Our experience from ETQ has shown that suppliers appreciate rigor when it comes to setting down requirements. In other words, suppliers want to do the right thing, and they want their clients to know that they’re doing the right thing.
One way to accomplish this is via instrumentation. The IIoT has come a long way in the last few years, so it’s become much easier to validate suppliers, pest control, sanitization, temperature control, and more. Some examples might include instrumented bait stations that alert facility mangers when pest activity occurs, or smart ID badges that record when employees comply with a hand-washing policy. Suppliers should be able to share information and telemetry directly with their customers in order to demonstrate that they’re complying with FSMA and its related HARPC requirements.
Here at ETQ, we’re making it easy for F&B manufacturers to integrate data directly from suppliers in a safe, convenient, and comprehensive manner. Our supplier quality applications already make it easy for manufacturers to inspect, correct, and rate suppliers based on their overall level of compliance, and future updates to Reliance will improve data sharing even more. In addition, our existing HAACP module makes it easy to build a complementary HARPC program, allowing you to eliminate gaps and maintain full compliance with FSMA as the FDA begins to resume its inspection program.
For more information on ETQ and what we can do to improve the quality of your products, request a demo today!