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Run: Deviation and Incident Investigation Procedure (GMP) SOP

Use this GMP deviation and incident investigation SOP to log events, contain affected material, classify severity, and drive root cause analysis through CAPA...

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Steps

The reporter enters the deviation or incident into the quality system immediately after discovery. The reporter records the date, time, location, product or process affected, and a factual description of what occurred.
The operator isolates affected product, equipment, or records to prevent unintended use or release. The operator applies hold status or quarantine controls according to site procedure.
The quality reviewer evaluates the event against the site classification matrix and determines whether the event is minor, major, or critical. The reviewer records the rationale for the preliminary classification.
The quality reviewer notifies the required escalation chain and documents who was informed, when they were informed, and what immediate actions were requested.
The investigator defines the boundaries of the investigation, including the affected batch, equipment, shift, process step, and any related records or personnel interviews needed to reconstruct the event.
The investigator gathers objective evidence, including batch documentation, equipment logs, environmental data, calibration status, maintenance records, and witness statements. The investigator records only factual observations and avoids speculation.
The investigator analyzes the evidence to determine the root cause, contributing factors, and any systemic weaknesses. The investigator uses an approved method such as 5 Whys or fishbone analysis and records the logic used to reach the conclusion.
The investigator and quality reviewer define corrective actions to address the immediate issue and preventive actions to reduce recurrence. The team assigns each action an owner, due date, and acceptance criteria.
The CAPA owner updates the tracking system as actions progress. The owner documents evidence of completion and flags overdue actions for escalation.
The quality reviewer verifies that the CAPA actions were completed, the root cause was addressed, and the event did not recur within the defined monitoring period. The reviewer then approves closure of the deviation or incident record.

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