A Guide to FSVP Audit

The Foreign Supplier Verification Program (FSVP) is encompassed by the FDA’s Food Safety Modernization Act (FSMA). Under the rule, any U.S. company that imports food is held responsible for FSVP compliance and may therefore be required to undergo FSVP audits performed by the FDA or another approved third-party auditing body. Because compliance deadlines have passed (May 30, 2017 for large companies, and March 19, 2018 for small businesses), affected companies must ensure they have the proper means in place to be audit ready.

What is FSVP?

FSVP requires any U.S. company that imports food to take a preventive approach in foreign supplier management. The overarching objective is to proactively limit food safety risks through hazard analysis and supplier verifications.

How Can You Prepare for an FSVP Audit?

• Supplier Management Activities

Importers are responsible for assessing known or reasonably foreseeable hazards presented by each type of imported food. They should therefore perform an in-depth risk analysis, use the analysis results to determine appropriate vendor management activities (which could include facility audits), perform those activities, and carry out corrective actions as needed.

Additionally, purchasing companies should perform thorough approval and onboarding activities, and maintain seamless ongoing communication with their foreign suppliers to ensure all parties are aligned with safety practices and program requirements.

• Strong Record Keeping Practices

Under the FSVP, the FDA reserves the right to request records which could date as far back as two years and must be produced within 24 hours. Digitizing your records should therefore become a critical priority if your facility falls under FSVP. Hazard analysis protocol and supplier verification procedures must be thoroughly documented, but it is also essential to ensure that vendor performance is tracked on an ongoing basis. Documentation should be well-organized and readily accessible prior to FDA inspections. Auditors may request to see records on hazard analysis, approved foreign suppliers, vendor score carding, supplier approval practices, verification activities, corrective actions, and ongoing improvement through periodic reassessments.