The document outlines a 5-step process for successful Corrective and Preventive Action (CAPA): 1) Identify issues and nonconformances, 2) Implement corrective or preventive actions, 3) Verify that the actions addressed the issues, 4) Review the process for additional improvements, 5) Analyze data for trends. CAPA is important for compliance with Good Manufacturing Practices and focuses on both correcting past issues and preventing future discrepancies.

1. 5 Steps to Successful CAPA Process
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2. • Corrective and Preventive Action
5 Steps to Successful CAPA Process

3. Agenda
 What is Corrective and Preventive Action
 Five Steps to a Successful CAPA Process
 Identify
 Implement
 Verify
 Review
 Analyze
 Conclusion
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4. What is CAPA
• Corrective and Preventive Action
• A concept found with Good Manufacturing Practice (GMP),
Corrective and Preventive Actions is comprised of two important
sub-systems.
• Corrective Action addresses a nonconformance issue that has
happened in the past in order to prevent its recurrence.
• Preventive Action however, focuses on preventing a discrepancy
from occurring in the future.

5. CAPA Process Map

6. CAPA Process Map

7. CAPA Process Map

8. CAPA Process Map

9. • Five Step Approach
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10. Where Companies Have Difficulty

11. Why? Incorrect Root Cause Identified!
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12. CAPA Subsystems
More than 50% of the
Warning Letters and
Form 483s issued by
the FDA are for CAPA
violations!

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