Capa A Five Step Action Plan
16 likes10,684 views
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.
Capa A Five Step Action Plan
- 1. 5 Steps to Successful CAPA Process Business Intelligence Solutions | 1.800.782.0580 | www.busintellsol.com 0 13
- 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 9
- 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.
- 9. • Five Step Approach 10
- 10. Where Companies Have Difficulty
- 11. Why? Incorrect Root Cause Identified! 13
- 12. CAPA Subsystems More than 50% of the Warning Letters and Form 483s issued by the FDA are for CAPA violations!
- 13. Business Intelligence Solutions | 1.800.782.0580 | www.busintellsol.com 0 13