Inspection Readiness
Decision Trail Assessment
20 questions. Three inspection scenarios. Find out if your CAPA, deviation, and batch release decisions can survive direct FDA questioning.
This is an inspection simulation — not a generic compliance checklist. Work through each question against your most recently closed CAPA, your last deviation investigation, and your last batch release with an exception.
Real records from your facility. Not hypotheticals. Answer YES only if a document exists right now that would satisfy an investigator asking directly.
YES — document exists, would satisfy investigator
PARTIAL — exists but incomplete
NO — answer lives in memory, not a record
Section A — Deviation Decisions
Is there a document that identifies — by name and role — who made the decision that the identified root cause was the correct conclusion?
Does that document capture what specific evidence that person reviewed at the moment they reached the root cause conclusion?
Is there a record of what alternative root causes were considered and why they were rejected?
If the deviation was classified as minor — is there a document showing who made that classification and against what written criteria?
Is there a documented product impact assessment — separate from the deviation record — showing who concluded product quality was not adversely affected and on what basis?
Section B — CAPA Decisions
Is there a document identifying who authorized the CAPA closure decision — specifically who concluded the corrective action was effective and the root cause controlled?
Does the effectiveness record capture the specific data reviewed — not a conclusion, but the actual data at the effectiveness check date?
Was the effectiveness determination made by someone independent of the department that implemented the corrective action? Is that independence documented?
If the effectiveness check was performed later than your procedure required — is there a documented authorization for that extension?
Does the CAPA closure record show a direct documented link between the effectiveness data and the closure authorization — demonstrating the authorizer reviewed the evidence?
Section C — Batch Release Decisions
Is there a document — separate from the batch record and the QP signature — that captures who authorized the release decision and what evidence they reviewed?
Does that document identify the regulatory standard that governed the release decision — not the specification, but the decision standard applied to the exception?
Does the record capture what alternative interpretations of the exception result were considered before the release decision was made?
Is the release authorization timestamped at the moment the decision was made — or was it documented after the fact?
Section D — Systemic Infrastructure
Does your written deviation procedure require a separate authorization record — not just a signature — for root cause conclusions and closure decisions?
Does your written CAPA procedure require documentation of who authorized the effectiveness conclusion and what evidence they reviewed?
Does your batch release procedure require an authorization record for exception decisions — separate from the batch record signature?
If a key decision-maker left your organization today — could the authorization logic behind their decisions be reconstructed from records? Or does it leave with them?
In your last internal audit — did the audit assess whether authorization records exist for key decisions? Or only whether decisions were made and documented?
If an FDA investigator walked in tomorrow and asked who authorized a specific decision — for any of the three scenarios above — could you produce that record in five minutes?
Answer all 20 questions to see your score