Inspection Prep Checklist — OOS Investigation

"Who determined the OOS result was attributable to laboratory error — and what is the record of that authorization?"

• If assignable cause was identified in Phase I, a document exists identifying who authorized the invalidity conclusion — not just who investigated it
• The specific evidence supporting the assignable cause conclusion is documented — not summarized as "analyst error confirmed"
• The evidentiary standard applied to conclude assignable cause was established — what threshold of evidence was required before Phase I could support invalidity
• If Phase I did not establish assignable cause, the decision to proceed to Phase II is documented as a formal authorization — not an implicit next step

"Who authorized the decision to invalidate this result or to retest — and what evidentiary standard supported that decision?"

• Invalidity decisions are authorized by a qualified individual independent of the analyst — with the authorization documented separately from the investigation record
• If retesting was authorized, the record documents who made the retesting decision — what basis supported retesting rather than rejection, and what protocol governed the number of retests
• The pre-specified acceptance criteria for retest results are documented in the authorization record — not determined after the retest results are known
• The authorization record for invalidity can be distinguished from the investigation record — it is clear which document captures the decision versus the investigation findings

"Who made the final product disposition decision — release, reject, or retest — and where is the authorization for that decision?"

• The disposition decision has its own authorization record — separate from the investigation conclusion and the invalidity determination
• The authorizing individual for the disposition decision is identified with their name, title, date, and the specific basis for the disposition conclusion
• If the product was released following an OOS result, the authorization record demonstrates that all investigation activities were complete prior to the release authorization
• The regulatory standard governing the disposition decision is cited — not just the specification, but the decision standard under 21 CFR 211.192

"If root cause was not identified, who authorized the conclusion that the investigation was complete — and what supported that determination?"

• Inconclusive closures have a more complete authorization record, not a less complete one — documenting all investigation activities performed, why root cause was not identifiable, and who authorized the inconclusive determination
• The specific investigation activities performed are documented — not summarized as "investigation conducted" — with results that support the inconclusive conclusion
• The authorization record documents why additional investigation activities were not warranted — what alternatives were considered and why they were not pursued