Part 5 of a 5-part series:
The first in our 5-part series of blog posts was all about the different kinds of audits you can expect to encounter in the food processing industry. Since then, we have covered Internal Audits, Second Party Audits, and Third Party Audits. It’s time to discuss the big dog – the Regulatory Audit. Those three audits are about quality and safety pertaining mostly to the supplier/customer relationship. Regulatory Audits are performed to make sure any business in the food processing industry is compliant with regulatory requirements.
Some would say that the food industry is arguably the most highly regulated industry in the United States. Being prepared for a Regulatory Audit takes time and knowledge. So, we spoke to our resident expert and Board Certified Entomologist, Hope Bowman, to talk all about the process.
Q: Hope, thanks yet again for talking to us about this important topic. Let’s start with the basics: what is a Regulatory Audit?
A: A Regulatory Audit is one that is performed by a government body, such as US FDA (Food and Drug Administration) or USDA (US Department of Agriculture), or by a subcontractor hired by the government body. Any warehouse, plant, distribution warehouse, and pharmaceutical company will be regulated by the FDA. Those businesses dealing with meat, cheese, or eggs are regulated by the USDA, and some facilities will even have a USDA inspector onsite. A Regulatory Audit may occur on a routine basis or may be initiated based on a complaint.
Q: Thanks for those details. Second question: is there any way a food industry business can actually be prepared for a Regulatory Audit?
A: The best way for a food industry business to be prepared for a Regulatory Audit is to always be prepared. Unlike the other audits we have discussed, which in general are announced, Regulatory Audits could occur at any time. Everything each one of your employees does on a daily basis prepares you for this type of audit, from every time hands are washed to each time a door is repaired to the following of sanitation procedures. Having well organized and consistent documentation will help the process go smoothly.
Q: Last one! We are a little afraid of the answer, but we have to ask it. What happens if a Regulatory Audit is failed?
A: The worst-case scenario is that the food industry business is shut down by the governing body. This would happen if there are issues that cannot be resolved without shutting down production to address them. Another tough scenario is a recall where a certain product or lot is pulled from the store shelves. It’s also possible that the regulatory agency finds some corrective actions that need to be made. If that is the case, the changes should be made as quickly as possible and communicated clearly back to the agency.
This information is not only great to know, it’s important to know. There are consequences of any of the audits we have discussed, but some are worse than others. They range from lost time to lost revenue to loss of certification. Being prepared and therefore being “always audit ready” is one way a business in the food processing industry can breathe easy.