Re-Assessing FSVP
Keeping Your FSVP Alive
Many importers treat the Foreign Supplier Verification Program (FSVP) as a document to complete, file, and forget. In reality, FDA expects FSVP to function as a living system, one that evolves as suppliers, products, and risks change.
When Should an Importer Re-Evaluate Its FSVP?
FSVP must be re-evaluated whenever there is a material change that could affect food safety or compliance. Common triggers include:
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Supplier changes: New foreign suppliers, changes in ownership, manufacturing location, or food safety controls.
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Product or process changes: New formulations, ingredients, processing steps, or packaging that introduce new hazards.
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New or newly identified hazards: Emerging biological, chemical, or physical risks, or updated scientific understanding of existing hazards.
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Regulatory updates: Changes to FDA regulations, guidance, enforcement priorities, or country-specific import alerts.
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Performance signals: Failed verification activities, adverse inspection findings, complaints, or test failures.
Even absent a triggering event, FDA expects periodic re-evaluation every 3 years to confirm that supplier verification activities remain appropriate and effective.
Using Process Standards to Drive Continuous Improvement
This is where process standards transform FSVP from a static plan into a dynamic, functional system.
Process standards introduce discipline by defining:
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Key Performance Indicators (KPIs) – e.g., on-time supplier document reviews, audit completion rates, deviation frequency, corrective action closure times.
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Monitoring mechanisms – routine review of supplier performance, test results, audit outcomes, and trend data.
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Corrective feedback loops – structured responses when performance falls outside acceptable limits, including root cause analysis and documented corrective actions.
Rather than reacting only when something goes wrong, importers can proactively identify an emerging risk.
Embedding “Process Standard” Thinking into FSVP
To make FSVP dynamic rather than static, importers should:
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Define review intervals (e.g., annual or semi-annual FSVP effectiveness reviews).
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Standardize re-evaluation triggers so staff know when reassessment is required.
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Document decision logic—why certain verification activities are sufficient and when escalation is necessary.
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Link FSVP to broader quality systems, such as supplier approval programs, internal audits, and management review processes.
When FSVP is built on process standards, re-evaluation becomes routine, measurable, and defensible, rather than reactive and disruptive.
Documenting
The FSVP re-evaluation must be documented. The responsible party must also document any changes that have occurred. This part and parcel of the FSVP law. According to FDA, if not documented the re-evaluation did not occur.
The Bottom Line
An effective FSVP is not a binder on a shelf. It is a continuously improving system that adapts to change, monitors performance, and closes gaps before they become compliance failures. By embedding process standards into FSVP design, importers not only meet FDA expectations, but also strengthen supplier oversight, reduce risk, and improve operational resilience.
For more information about the FSVP re-evaluation, please contact us:
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