The CAPA process involves several key steps to effectively address and manage issues while striving for continuous improvement:
- Identify and Document the Issue: Whenever an issue, non-conformity, or potential risk is identified, it should be documented in detail. This includes capturing the problem’s scope, potential impact, and any available evidence related to the occurrence.
- Root Cause Analysis (RCA): Conduct a thorough investigation to determine the root cause of the problem. RCA techniques such as the “5 Whys” method or fishbone diagrams can help identify the underlying reasons contributing to the issue.
- Develop and Implement Corrective Actions: Once the root cause is identified, develop and implement appropriate corrective actions to address the immediate problem. These actions should be effective, feasible, and focused on preventing recurrence.
- Implement Preventive Actions: In parallel with corrective actions, develop and implement preventive actions to avoid similar issues in the future. Proactive measures are essential for risk mitigation and continuous improvement.
- Monitor and Verify Effectiveness: After implementing the corrective and preventive actions, closely monitor the results. Verify the effectiveness of the actions taken to ensure that the problem is resolved and that preventive measures are successful.
- Documentation and Review: Throughout the CAPA process, maintain detailed documentation of each step taken. Regularly review the effectiveness of the CAPA process itself and make necessary improvements to enhance its efficiency.
- Training and Communication: Ensure that all relevant stakeholders are aware of the CAPA process and their roles within it. Provide adequate training to employees involved in CAPA execution to enhance their understanding and efficiency.
MEDVACON and our team of Quality Experts has conducted several CAPA investigation and closeout projects, some of which involved teams exceeding forty resources and others with just a few. MEDVACON can scale to investigate and close out your CAPA backlog and revise the CAPA process to be streamlined and avoid future backlogs.