CAPA stands for Corrective and Preventive Action. It is a critical concept in quality management systems, especially in pharmaceutical, manufacturing, and healthcare industries, to ensure product and process quality.
🔍 Definition:
Corrective Action: Action taken to eliminate the cause of a detected nonconformity or other undesirable situation to prevent its recurrence.
Preventive Action: Action taken to eliminate the cause of a potential nonconformity or situation to prevent it from occurring.
🧩 Purpose of CAPA:
Improve product and process quality.
Prevent future deviations or failures.
Ensure regulatory compliance (e.g., FDA, ISO 9001, WHO-GMP).
📊 CAPA Process (Steps):
1. Identification – Detect a deviation, failure, or risk.
2. Evaluation – Assess the impact and urgency.
3. Investigation (Root Cause Analysis) – Use tools like 5 Whys, Fishbone (Ishikawa) diagram.
4. Action Plan – Develop a plan for corrective and/or preventive actions.
5. Implementation – Apply the actions.
6. Effectiveness Check – Verify if the actions resolved the issue.
7. Documentation – Record all steps for audit and future reference.
✅ Example:
Problem: A batch of tablets failed dissolution testing.
Corrective Action: Investigate and fix the issue in granulation process.
Preventive Action: Revise SOP and train staff to avoid similar issues in future batches.
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