CAPA Risk Audit
Can this CAPA decision be reconstructed?
Every CAPA closes with a decision. Months later, an FDA investigator may have to reconstruct and defend that decision using only what's in the record.
The person who made the decision may no longer be there. An auditor or an incoming reviewer may have nothing but the documents. This audit tests whether one specific CAPA decision survives that — it does not ask whether your CAPA procedures exist. The unit of analysis is the decision, not the system.
Identifies documentation gaps before an investigator does.
The decision under audit
Choose one recently closed CAPA. By the end of this audit you will know whether another reviewer could independently reconstruct and defend that decision from the record alone.
Identify the specific CAPA decision being tested. This is a decision-level reconstruction test, not a system assessment.
Complete at least the CAPA ID and decision type to begin.
Reconstruction domains
For each criterion, answer the prompt using your decision record, then score whether the decision can be understood on that dimension. Scoring is yours — this is a guided self-audit, not an automated document review.
Result
This is a guided self-audit. Scoring is user-selected based on targeted prompts — it is not an automated document review. It does not determine FDA compliance and does not constitute regulatory or legal advice. FDA consent decrees and warning letters are cited as illustrative precedent, not as the criteria themselves. The criteria are derived from the reconstruction methodology.
Need help documenting this decision?
If this audit identified reasoning gaps, the Inspection Response Record documents the reasoning already behind the decision.
