Deviation and Incident Investigation Procedure (GMP) SOP

Standard operating procedure for detecting, classifying, investigating, documenting, and closing GMP deviations and incidents, including root cause analysis and CAPA implementation.

Steps

• Log the deviation or incident
  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.
• Contain the affected material or process
  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.
• Classify the event severity
  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.
• Escalate the critical event
  The quality reviewer notifies the required escalation chain and documents who was informed, when they were informed, and what immediate actions were requested.
• Define the investigation scope
  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.
• Collect objective evidence
  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.
• Perform root cause analysis
  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.
• Define corrective and preventive actions
  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.
• Implement and track CAPA actions
  The CAPA owner updates the tracking system as actions progress. The owner documents evidence of completion and flags overdue actions for escalation.
• Verify effectiveness and close the record
  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.