safety-CAPA-management

CAPA Management

Overview

Management of corrective and preventive actions (CAPA) tracking including generation from incident findings or audit results, assignment, due date monitoring, effectiveness verification, and closure. Primary agent: Incident Investigation Specialist.

Triggers

• Root cause analysis completed with corrective action recommendations
• Audit findings generated requiring corrective action
• Inspection findings requiring corrective action
• Management review identifying improvement opportunities
• Regulatory finding requiring corrective action

Prerequisites

• Root cause or finding documented
• Corrective actions identified and prioritised
• Responsible persons and timeline defined
• Resources allocated for implementation

Steps

Step 1: CAPA Registration

• Assign unique CAPA ID
• Record source (incident, audit, inspection, management review)
• Classify corrective vs preventive action
• Assign severity/priority
• Record due date and responsible person

Step 2: CAPA Assignment

• Assign to responsible person or department
• Communicate CAPA requirements and timeline
• Ensure resource availability
• Confirm acceptance of assignment

Step 3: CAPA Implementation Tracking

• Monitor progress against implementation plan
• Track milestone completion
• Record status updates
• Flag at-risk items (approaching due date, resource constraints)
• Escalate overdue items

Step 4: Effectiveness Verification

• Verify corrective action has been implemented as planned
• Assess effectiveness in addressing root cause
• Collect evidence of sustained improvement
• Document verification results
• Identify any need for additional actions

Step 5: CAPA Closure

• Verify all evidence collected and documented
• Confirm root cause addressed
• Update source record (incident, audit) with CAPA closure
• Record lessons learned
• Share improvements with relevant stakeholders

Success Criteria

• All CAPAs assigned with clear responsibility and due dates
• Implementation tracked with regular status updates
• Effectiveness verified before closure
• All CAPAs closed within required timeframes

Common Pitfalls

1. Vague corrective actions → Actions not specific enough to address root cause
2. Unrealistic timeframes → Due dates set without resource confirmation
3. Missing effectiveness verification → Actions completed but root cause still present
4. No escalation → Overdue CAPAs not escalated to management

Cross-References

• safety-RCA-analysis/SKILL.md — Root cause analysis source
• safety-incident-tracking/SKILL.md — Incident closure verification