What Is CAPA?
A CAPA is an action taken to correct and protect the quality management system, product, or system involving a medical device product.
What Is Corrective Action?
A corrective action is fixing a current process that creates an issue or a nonconforming product.
What Is Preventive Action?
Preventive action is correcting the process that could cause a nonconformance or issue with the medical device process.
Common Misconceptions Around CAPA
CAPAS are only for Corrective actions
CAPAS are solely for compliance
CAPAS are only for major issues
CAPAS are a one time activity
CAPAS are primarily the quality department’s responsibility
CAPAS must always result in change
1. Treating CAPA as A One-Time Event
CAPAs should be viewed as a continuous process rather than a one-time activity. Implementing a CAPA does not signify the end of the issue; it requires ongoing monitoring and verification to ensure sustained effectiveness. Additionally, CAPAs should be reviewed periodically to assess their efficacy and make necessary adjustments.
2. Neglecting Preventive Actions
CAPAS are meant to be done frequently to find preventive actions.
CAPA Reports
CAPA Reports are intended to show that the project of analysis and investigation has been implemented and complete.
What is included in a CAPA Report?
- Affected Product
- Cause for initiation
- Failure investigation and risk analysis results
- Correction, root cause, and proposed solution
- Implementation description
- Verification of implementation
- Effectiveness assignment
- Verification of effectiveness
Identify what’s causing the issue
- Customer complaints
- Internal audits
- Process deviations
- Root Cause Analysis
- Fishbone Diagrams
- 5 Whys
- Pareto Analysis
- Fault Tree Analysis
- Customer satisfaction
- Data Analysis
- Stakeholder Input
- Regulatory Compliance
- Previous CAPA Review
Corrective actions to be taken
- Process Modification
- Training and Education
- Equipment replacement
- Quality Control measurements
- Supplier corrective actions
- Documentation and Recordkeeping Improvements
- Risk Mitigation Strategies
Results of actions
- Problem resolution
- Prevention of recurrence
- Improved quality
- Enhanced compliance
- Cost reduction
- Enhanced reputation
- Risk mitigation
- Increased efficiency
How Rook can help with CAPA Reporting
Rook can help with internal audits that expose reasons for CAPAS. Rook can also help with a gap analysis which could trigger a CAPA creation. Rook can also create CAPAS and complete it for CAPA support for your medical device company. We have years of experience we can support and give recommendations when handling CAPAS for your quality management system.