Verifying Your Supply Chain Without On-site Audits

Gone are the days when you only had to worry about what was happening in the four walls of your operation. Prior to the passage of the Food Safety Modernization Act (FSMA), many companies had supplier approval programs and many focused on financial and supply chain security. At that time, the emphasis on food safety requirements for suppliers varied between buyers, although third-party audits were commonly used to gain market access. Still, in some cases, buyers relied on a third-party audit of their supplier as a means to protect the purchasing company.

Both the Foreign Supplier Verification Programs (FSVP) and Preventive Controls rules explicitly require companies to ensure the safety of the food and ingredients they source. The rules recognize audits as a key tool to verify suppliers, but what if audits can’t be conducted — as the industry faced with COVID-19?

With respect to food safety audits and regulatory requirements, the inability to travel as a result of the pandemic clearly jeopardized the ability to conduct on-site food safety audits. Audit organizations responded, with the Global Food Safety Initiative (GFSI) providing guidance to allow for the extension of certificates by the Certified Program Owners. Similarly, FDA noted that it would postpone most domestic and foreign audits, limiting them to specific for-cause reasons (e.g., related to outbreaks or recalls) and even then, only if it were safe for inspectors to do so. In the absence of audits, how could food safety be assured?

First, we must remember that audits do not, or at least should not, drive food safety practices and procedures. Audits are intended to verify that a company has appropriately identified food safety risks and is actively managing those risks. There are many examples of outbreaks where the supplying firm was audited.

So, despite the continued reliance on audits, the better question is, “How can I feel confident that my supplier’s food is safe?” Then when audits as a tool are unavailable, the industry must look for other tools in the toolbox. The question becomes, are there other ways that food safety can be verified?

The answer is yes. FDA suggests that if the hazard to be controlled by a supplier meets the “serious adverse health consequence or death for humans or animals” standard (SAHCODHA), an annual on-site audit is the default verification tool. But, as FSVP lead instructors, the authors of this column have both had the opportunity to brainstorm approaches that can be used to assess the safety of food/ingredients being sourced. For example, a class participant once asked about alternatives, explaining that some suppliers were located in war zones where it was unsafe to conduct audits. There are other verification tools that can be used. Within the FSVP rule and related guidance, the review of food safety-related records (not the plans or SOPs, but actual records of implementation), as well as testing, can be elements of a program. So these, or other verification mechanisms identified by the importer, can be leaned upon more heavily in those circumstances where conducting an on-site audit is not possible.

When deciding how to construct a verification program in lieu of an audit, it is critical to articulate the food safety concerns that you’re trying to address. This should already have been done, as it is based on the hazard analysis for that food, considered in light of your evaluation of the supplier. For instance, if the product is ready-to-eat and the facility is older and/or has equipment commonly associated with Listeria harborages, such that Listeria is a main concern, it could be appropriate to ask to see results of the environmental monitoring program, as well as the details of the plan, to verify its likelihood to detect a potential issue. If the food is thermally processed, reviewing records of the time-temperature treatment could be useful. Finished product test results have their limitations, but in some instances, they could be used as long as the sampling plan, method, etc. are conveyed so the result can be interpreted properly.

Shortly after travel restrictions were enacted, limiting the ability for audits to be conducted, the Consumer Brands Association, working with its members, compiled suggestions for alternative food safety verification measures and some hypothetical scenarios.

One example of this is that of a receiving facility that obtains roasted pecans from a supplier when there is a delay in the annual on-site audit due to an emergency situation. The receiving facility could select the following combination of verification measures:

1. Conduct enhanced sampling and testing for Salmonella for all lots during the period of time that the annual on-site audit is delayed; and
2. Using a virtual platform, review the suppliers’ food safety records and document this review (e.g., records demonstrating the roasting of pecans occurred at a specified temperature and time period, supplier’s environmental monitoring records, and sanitation records for the post-lethality area).

Audits have become the default for the food industry, but if a company truly understands the types of hazards and degree of risk associated with the products they are purchasing, they may find that there are many additional verification tools in their food safety toolbox.