Seven Elements of a Successful Foreign Supplier Verification Program

Seven Components of a Successful FSVP

Denis Storey
June 16, 2021

On-Demand Webinar: “Staying Compliant with the Temporary FSVP Policy”

Watch the Recording

On-Demand Webinar: “Staying Compliant with the Temporary FSVP Policy”

Join FSVP Lead Instructor James Chu for expert advice on how to comply with temporary FSVP policy updates so you can take the necessary steps to protect your customers and your brand.

Watch the Recording

Today’s global marketplace – and increasingly complex supply chain – has driven more companies to look abroad for suppliers. And while sourcing internationally comes with a host of challenges, few create as much confusion as FSMA's Foreign Supplier Verification Program (FSVP).

The FSVP rule shifts responsibility for ensuring the safety of imported food products from the government to companies. Simply put, the FDA hold importers accountable for ensuring the food entering the United States is up to the agencys standards. We've outlined seven recommendations that help businesses subject to the FSVP rule succeed.

What are the seven components of a successful FSVP program?

  1. Review supplier compliance status. The FSVP rule expects U.S. importers to review foreign supplierscurrent compliance status and history to pinpoint potential risk areas. This assessment should include any "FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act)."

  2. Conduct a hazard analysis. Importers must investigate any hazards associated with everything they import, including the likelihood and severity of each hazard if it were to occur. Frequently, foreign suppliers have already performed a hazard analysis. But it's vital not to take this at face value. U.S. importers must scrutinize this documentation and compare it with in-house hazard analysis to ensure its sufficient. If a supplier hasn't performed a hazard analysis, the importer must shoulder the responsibility of examining the foreign supplier's operations and identifying any hazards that require control. If the review fails to uncover any risks, product verification isn't necessary. However, the U.S. importer should keep a record of the hazard analysis on file.

  3. Verify suppliers. Importers must provide sufficient assurances through verification activities that potential risks are actively identified, controlled, and monitored. Verification activities can include onsite audits, periodic sampling, and a review of foreign supplier documentation. Importers can conduct onsite audits themselves or contract a third-party auditor to examine a foreign supplier's operations. Onsite audits aren't required unless there's a good chance a hazard could cause serious adverse health consequences or death, according to the Code of Federal Regulations (CFR) Title 21. If the importer relies on product testing and sampling for verification, they must maintain detailed records on each test's process and outcome.

  4. Take corrective actions as needed. Any complaint an importer receives about the food they import needs an investigation to uncover the cause and the appropriate corrective action. Further verification activities might determine a supplier isn't storing products at the required temperature, or there aren't bathroom facilities for field workers, for example. Each instance requires a unique and appropriate corrective action to demonstrate that remedies are specific to each situation, supplier, and product.

  5. Periodic reassessment of FSVP. Every three years, importers must reassess their FSVPs. The exception is if the importer is aware of new information about potential hazards. In which case, the reassessment needs to occur sooner in response to the discovery. If the review finds an imported product doesn't meet FSVP requirements, the importer must take corrective action. Steps might include not working with the supplier until they address the identified hazards or electing to update their FSVP plan to ensure they vet suppliers more thoroughly in the future.

  6. Importer identification at entry. The FSVP rule requires importers to provide a legal business name, electronic mailing address, and unique facility identifier (UFI) for all food products entering the U.S. The Data Universal Numbering System (DUNS) number, which is assigned and maintained by Dun & Bradstreet, is free of charge and currently the only UFI approved by the FDA.

  7. Recordkeeping. The FDA is taking more steps to increase the number of records kept. Under this rule, the FDA requires importers to maintain records related to compliance status, foreign supplier verification activities, hazard analyses, investigations, corrective actions, and FSVP reassessments, find a complete listing here. What's different about the FSVP rule is that the FDA insists the importer keeps a certain amount of records the agency can access easilyImporters must retain original copies of their records, photocopies, or digital records for at least two years unless otherwise specified. Also, the documents must be available upon request.

Although the FDA hasn’t requested it for other rules, there are clear indications it prefers digital records for FSVP compliance. This preference is evident in two ways:

  • Electronic access to records: The importer must provide electronic access to records immediately upon review. Typically, if the FDA is requesting documents, they’ll visit a facility and make or receive copies. However, it seems if you're importing products from another country, the FDA doesn’t want to wait.

  •  Records can't deteriorate: Companies must maintain all records in a way that's not subject to deterioration, which is easy to interpret as digital.

Check out our on-demand webinar, where James Chu, FSVP Lead Instructor, and Supplier Quality Manager at John B. Sanfilippo & Son Inc., offers insight on how to comply with temporary FSVP policy updates. You can watch it here