FDA Inspection Decision Scenario

Who Authorized the Root Cause Determination?

“Who made the decision that this was the root cause, and what evidence was used to reach that conclusion?”

21 CFR 211.192 · 21 CFR 820.100

Why this becomes difficult to defend

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

The investigator is reviewing a closed investigation. A root cause is documented. The investigator asks who authorized the root cause determination — not who documented it.

The investigation record shows a root cause was identified. It does not show who made the formal authorization that the identified cause was sufficient — or that the evidence justified closing further investigation.

What must be retrievable

The reviewer needs more than the final outcome.

  • Named individual accountable for the root cause authorization
  • Evidence reviewed before the root cause was accepted
  • Regulatory standard applied to the causal determination
  • Authorization timestamp for the root cause acceptance
  • Reasoning for why alternative causes were ruled out

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.