1. Purpose:
To establish a systematic and effective process for identifying, implementing, and monitoring corrective and preventive actions (CAPA) within the organization, ensuring the continuous improvement of processes and products.
2. Scope:
This SOP for Corrective Action and Preventive Action (CAPA) applies to all departments and functions within the organization where CAPA processes are necessary to address non-conformances, deviations, and potential issues.
3. Definitions Involved in CAPA:
- Corrective Action: An action taken to address and eliminate the root cause of an identified non-conformance, preventing its recurrence.
- Preventive Action: Proactive measures taken to identify and mitigate potential issues before they occur, thereby preventing non-conformances.
4. Responsibilities:
4.1 Identification and Reporting:
- Employees shall promptly report any non-conformances, deviations, or potential issues to their respective department heads or designated personnel.
- Department heads or designated personnel shall assess the reported issue and determine whether it requires corrective or preventive action.
4.2 Root Cause Analysis:
- The Quality Assurance (QA) department shall lead the investigation into the root cause of identified non-conformances.
- Cross-functional teams may be formed to conduct a thorough analysis and identify underlying causes.
4.3 CAPA Plan Development:
- Based on the root cause analysis, the QA department, in collaboration with relevant departments, shall develop a comprehensive CAPA plan.
- The plan shall outline specific corrective or preventive actions, responsible individuals, timelines, and expected outcomes.
4.4 Implementation:
- Responsible individuals shall execute the CAPA plan according to the established timeline.
- Necessary resources and support shall be provided to ensure the successful implementation of actions.
4.5 Verification and Effectiveness:
- The QA department shall verify the completion of CAPA actions and assess their effectiveness.
- If the implemented actions are found to be effective, the CAPA process for the specific issue is considered closed.
4.6 Documentation and Records:
- All CAPA activities, including investigations, plans, actions, and outcomes, shall be thoroughly documented and maintained.
5. Review and Continuous Improvement:
- CAPA processes shall be periodically reviewed by the QA department to ensure their effectiveness and relevance.
- Lessons learned from completed CAPA processes shall be utilized to enhance future preventive measures.
6. Communication:
- Regular communication and updates on CAPA status shall be provided to relevant stakeholders, ensuring transparency and accountability.
7. Training and Awareness:
- Employees shall receive training on the CAPA process, their roles, and the importance of timely reporting and action.
8. Non-compliance:
- Failure to adhere to the CAPA process or provide accurate and timely information may result in appropriate corrective actions.
9. Approval:
- This SOP for Corrective Action and Preventive Action (CAPA) has been reviewed and approved by [Name], [Title], on [Date].
10. Effective Date:
- This SOP for Corrective Action and Preventive Action (CAPA) shall become effective on [Date].
11. References:
- List any relevant policies, regulations, or guidelines that are referenced in this SOP for Corrective Action and Preventive Action (CAPA).
12. Attachments:
- List any attachments or supporting documents related to this SOPcorrective and preventive actions (CAPA).
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