https://eauditor.app/
Manufacturing CAPA Audit Checklist
Section 1: Corrective Action Process
1. Is there a documented procedure for corrective actions?
Yes
No
2. Are corrective actions initiated for all identified non-conformities?
Yes
No
3. Is there a designated team responsible for implementing corrective actions?
Yes
No
4. Are corrective actions documented in a tracking system?
Yes
No
5. Is there a timeline established for completing corrective actions?
Yes
No
6. Are root cause analyses performed for significant non-conformities?
Yes
No
7. Is there a process for verifying the effectiveness of corrective actions?
Yes
No
8. Are corrective actions reviewed during management meetings?
Yes
No
9. Is there a training program for staff on corrective action procedures?
Yes
No
10. Are there metrics in place to measure the success of corrective actions?
Yes
No
Section 2: Corrective Action (CAPA) Audit Checklist
1. Is there a process for prioritizing corrective actions based on risk assessment?
Yes
No
2. Are corrective actions communicated to all relevant stakeholders?
Yes
No
3. Is there a follow-up procedure to ensure corrective actions are implemented?
Yes
No
4. Are corrective actions assessed for potential unintended consequences?
Yes
No
5. Is there a process for documenting lessons learned from corrective actions?
Yes
No
6. Are corrective actions aligned with organizational goals and objectives?
Yes
No
7. Is there a review process for the effectiveness of corrective actions after implementation?
Yes
No
8. Are employees encouraged to report potential non-conformities?
Yes
No
9. Is there a mechanism for tracking the status of corrective actions?
Yes
No
10. Are corrective actions reviewed for compliance with regulatory requirements?
Yes
No
11. Is there a designated person responsible for overseeing the CAPA process?
Yes
No
12. Are corrective actions integrated into the continuous improvement process?
Yes
No
13. Is there a formal review of corrective actions at regular intervals?
Yes
No
14. Are external audits conducted to assess the CAPA process?
Yes
No
15. Is there a feedback mechanism for employees regarding the CAPA process?
Yes
No