FDA Inspection Decision Scenario

Supplier Qualification: Who Authorized This Decision?

“Who made the qualification decision for this supplier, and what was the basis for that determination?”

21 CFR Parts 210 and 211 · 21 CFR 211.84 · 21 CFR 820.50

Why this becomes difficult to defend

The decision exists. The basis for it may not be retrievable as one record.

The investigator is reviewing your approved supplier list and supply-chain controls. Site audits and quality records exist. The investigator asks who made the formal supplier qualification decision.

The supplier file contains audit reports, quality agreements, and other supplier-management records. It does not contain a record of who evaluated the totality of evidence and made the qualification authorization decision.

What must be retrievable

The reviewer needs more than the final outcome.

  • Named individual accountable for the supplier qualification authorization
  • Evidence reviewed at the moment of the qualification decision
  • Risk assessments and supplier-quality evidence considered before approval
  • Regulatory standard applied to the supplier evaluation
  • Authorization timestamp for the qualification event
  • Reasoning for why the supplier met the qualification threshold

Relevant proof

See how the record connects evidence, judgment, risk, and authorization.

A completed ComplianceWorxs record shows the reasoning layer that is usually hardest to reconstruct after the decision has been made.

EvidenceWhat was known JudgmentHow it was evaluated RiskWhat was weighed AuthorizationWho decided and why

When this is your active decision

Preserve the reasoning before the context disappears.

Use the completed proof first. When the decision is consequential enough to preserve, create an Inspection Response Record for the actual decision.