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 OOS investigation. Phase I and Phase II investigations are documented. The investigator asks who authorized the final conclusion.
The OOS record documents the investigation steps. It does not document who made the formal determination that the result was assignable — or that the conclusion was an authorization event at all.
What must be retrievable
The reviewer needs more than the final outcome.
- Named decision owner for the OOS conclusion authorization
- Evidence reviewed before the final determination was made
- Regulatory standard applied to the assignable cause determination
- Authorization timestamp for the conclusion decision
- Reasoning linking the investigation findings to the final disposition
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.
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.