Creating an Effective Corrective and Preventive Action (CAPA) Plan

Effective CAPA plans are essential for addressing and preventing issues in various processes. This guide outlines the differences between CAP and CAPA, steps for developing a CAPA plan, implementing corrective and preventive actions, and encouraging continuous improvement through thorough documentation and evaluation.

• CAPA plan
• Corrective action
• Preventive action
• Root cause analysis
• Continuous improvement

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Uploaded on Jul 11, 2024 | 0 Views

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1. How To Write a Simple and Effective CAPA Plan

2. CAPA PLAN What is the difference between CAP and CAPA? CAP=Corrective Action Plan CAPA=Corrective Action and Preventive Action Plan

3. If you personally make a mistake more than once If you identify a pattern of errors If a procedure consistently fails Retraining is not working Your study participants are constantly non- complaint

4. 1. Identify an issue 2. Define the root cause of the issue 3. Correct the issue 4. Develop a plan to prevent the issue from reoccurring 5. Implement the plan to prevent the issue 6. Follow-up on and evaluate the plan implemented 7. Repeat as necessary 8. Document closure

5. Objective: address and correct current issue and prevent future similar issues from occurring Identify the W s and one H Who What When Where How

6. Corrective Action What is the issue Why is there an issue How will the issue be corrected When was the correction made Who was involved in the correction Document resolution

7. Preventive Action What is the issue Why is there an issue What is the plan to prevent the issue in the future When and How will the plan be implemented When and How will the plan be evaluated Documented resolution

8. Implementing a CAPA Plan Corrective Action 1. Communicate 2. Educate 3. Correct 4. Document Preventive Action 1. Communicate 2. Educate 3. Implement 4. Evaluate 5. Document

9. Do not be afraid to use a CAPA plan Revisit your CAPA Plan Own your improvement process