PHARMACEUTICAL CAPA MANAGEMENT CHECKLIST

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--- DEVIATION IDENTIFICATION & REPORTING ---
[ ] Deviation Date
[ ] Deviation Time
[ ] Deviation Description
[ ] Deviation Severity (Minor, Moderate, Major, Critical)
[ ] Deviation Category (Manufacturing, Quality Control, Equipment, Personnel, Other)
[ ] Batch/Lot Number (if applicable)
[ ] Location of Deviation
[ ] Supporting Documentation (e.g., photos, records)

--- ROOT CAUSE INVESTIGATION ---
[ ] Detailed Description of Deviation
[ ] Potential Root Causes (Select All That Apply) (Equipment Failure, Human Error, Process Variation, Raw Material Issue, Documentation Error, Training Deficiencies, Other (Specify))
[ ] Specify 'Other' Root Cause (if selected)
[ ] Number of Times Similar Issue Occurred Previously (if applicable)
[ ] Date of Initial Observation/Event
[ ] Supporting Data/Analysis (e.g., statistical analysis, trend charts)
[ ] Attach Supporting Documents (e.g., lab reports, equipment logs)

--- CORRECTIVE ACTION DEVELOPMENT ---
[ ] Detailed Description of Corrective Action(s)
[ ] Estimated Cost of Corrective Action (USD)
[ ] Action Responsibility (Primary Owner) (Quality Assurance, Manufacturing, Engineering, Validation, Other)
[ ] Target Completion Date
[ ] Affected Departments/Functions (Manufacturing, Quality Control, Engineering, Supply Chain, Regulatory Affairs)
[ ] Action Owner Signature

--- PREVENTIVE ACTION IMPLEMENTATION ---
[ ] Detailed Description of Preventive Action
[ ] Estimated Cost of Implementation
[ ] Planned Implementation Start Date
[ ] Planned Implementation Completion Date
[ ] Departments Responsible (Manufacturing, Quality Assurance, Engineering, Validation)
[ ] Supporting Documentation (e.g., SOP Updates, Engineering Drawings)
[ ] Risk Mitigation Strategy

--- CAPA EFFECTIVENESS VERIFICATION ---
[ ] Verification Start Date
[ ] Verification End Date
[ ] Number of Deviations Reopened (Post CAPA)
[ ] Number of New Deviations Related to Root Cause (Post CAPA)
[ ] Overall Effectiveness Rating (Based on Data) (Highly Effective, Moderately Effective, Slightly Effective, Not Effective)
[ ] Summary of Data Analyzed & Findings
[ ] Was the original Root Cause Effectively Addressed? (Yes, No, Partially)
[ ] Additional Comments or Observations

--- CAPA DOCUMENTATION & RECORD KEEPING ---
[ ] CAPA Origination Date
[ ] Detailed Description of Deviation & Initial Assessment
[ ] CAPA Number/ID
[ ] Summary of Root Cause Investigation Findings
[ ] Supporting Documentation (e.g., lab reports, investigation files)
[ ] Detailed Description of Corrective & Preventive Actions
[ ] Corrective Action Completion Date
[ ] CAPA Owner Signature

--- CAPA TRAINING & COMMUNICATION ---
[ ] Number of Employees Trained
[ ] Training Completion Date
[ ] Training Format (e.g., Online, Classroom) (Online, Classroom, Hybrid)
[ ] Brief Summary of Training Content
[ ] Topics Covered in Training (Select all that apply) (Deviation Management, Root Cause Analysis, Corrective Actions, Risk Assessment, Documentation Requirements)
[ ] Trainer Signature
[ ] Training Material Version

--- CAPA CLOSURE & REVIEW ---
[ ] Date of CAPA Closure
[ ] Summary of CAPA Resolution and Effectiveness
[ ] Number of Recurrences Post-Closure (if any)
[ ] CAPA Closure Status (Closed, Pending Further Action, Reopened)
[ ] Signature of Reviewer
[ ] Reviewer Name
[ ] Reviewer Title

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