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Supply-Chain Program & Supplier Approval Verification Checklist
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Verify the risk-based supply-chain program: hazard identification, approved supplier lists, and supplier verification activities.
FSMA21 CFR 117 Subpart G
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Program Foundation
- Is a written supply-chain program established for hazards controlled by the supplier? *
- Are supply-chain-applied controls identified from the hazard analysis? *
- Are approval and verification responsibilities documented and assigned? *
Supplier Approval
- Is an approved supplier list maintained and used for purchasing decisions? *
- Are suppliers approved before use based on documented evaluation? *
- Are temporary/unapproved-supplier procedures defined for limited use? *
Verification Activities
- Is an appropriate verification activity selected based on the hazard's risk (onsite audit, testing, records review)? *
- For a SAHCODHA hazard controlled by the supplier, is an annual onsite audit conducted (or documented alternative)? *
- Are supplier verification records reviewed and retained? *
- Date of most recent supplier verification for the highest-risk supplier
Receiving & Documentation
- Are incoming materials checked against specifications and COAs at receipt? *
- Are Certificates of Analysis verified where used as a verification activity? *
- Is supplier nonconformance tracked with corrective action and re-evaluation? *
- Are third-party audit certificates current for certified suppliers? *
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