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No clinical research is free of quality issues; in many cases quality issues are unavoidable. It is vitally important to address all quality issues promptly and properly.
Corrective action and preventive action (CAPA) is the process which investigates and solves identified issues by identifying the causes and taking corrective actions, which prevents a recurrence of the root causes and avoids any potential noncompliance.
CAPA should be an integral part of the Issues Management segment of a risk-based Clinical Quality Management System. According to ICH Q10, CAPA methodology should result in product and process improvements, and enhanced product and process understanding.
2. Effective CAPA
3. When does CAPA start?
4. Define the issue and scope
5. Take immediate action
6. Perform root cause analysis
6.1 The 5-Why approach
6.2 Fishbone diagram
6.3 Listening during root cause analysis
7. Plan the corrective action(s)
8. Implement the corrective action(s)
9. Verify that the plan works
10. Preventive action
11. Don’t forget!