Evidence
Event facts, investigation records, testing, interviews, process data, and supporting records.
Deviation Investigation
Can a reviewer understand why the deviation was considered adequately resolved?
A completed investigation can contain the event description, root-cause conclusion, actions, and closure signature while still leaving the reasoning behind disposition difficult to reconstruct later.
The investigation distinction
A root-cause field does not explain the closure decision.
A deviation investigation should establish what happened, define the scope, evaluate plausible causes, assess product and process impact, and support an appropriate disposition. The consequential decision comes when Quality accepts that investigation as sufficient for closure or continued action.
A later reviewer should not need to infer that reasoning from disconnected investigation notes, risk assessments, CAPA references, and signatures.
The closure record
The decision trail behind deviation closure.
Judgment
Why the investigation supported the selected root-cause, impact, and disposition conclusions.
Risk
Product impact, recurrence uncertainty, alternative explanations, and residual exposure.
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Authorization
Who accepted the investigation and closure decision, and under what authority.
What a reviewer should be able to reconstruct
Closure should answer the questions the investigation created.
What happened?
The event, scope, affected materials or processes, and known facts are clear.
Why did it happen?
The root-cause conclusion is supported by evidence and competing explanations were considered where relevant.
What did it mean?
Quality and product impact, recurrence exposure, and residual uncertainty were evaluated.
Why was closure acceptable?
The selected disposition, follow-up, and accountable closure authority are visible in the record.
From authority page to proof
See the completed decision record before applying the test to your own deviation.
The Case File demonstrates the structure of a reviewer-ready deviation-closure decision. If the issue is an actual completed consequential decision that may need a durable record, the IRR is the live-decision path.
Related authority pages