What To Know (CAPA)
Corrective Action/Preventive Action is a US FDA requirement for medical device manufacturers. It is a central process defined as part of your overall quality management system. CAPA ensures that your company is adequately managing risks along the projected product lifecycle. CAPA is also a framework by which to find the root cause of product nonconformity and the methods to be deployed to address the situation.
A "Corrective" action includes a root cause analysis and corrective measures. A "Preventive" action ensures the failure doesn't occur again. The CAPA framework includes detailed reporting, verification and validation of remedial and preventive measures and approvals .
CAPA differs from a "NCR" (nonconformance report). A nonconformance report documents the details of a failure identified in a quality audit or other process review. A NCR is a less stringent method to track specific product nonconformities.
How We Can Help
Our consultants can carry out comprehensive CAPA support, including:
- Initiate CAPAs for product complaints
- Approve and implement product design drawings
- Investigate and analyze field-returned products
- Manage complaints and customer support
- Implement corrective actions
- Evaluate and complete NCRs, product complaints, CAPAs, and field actions
- Assess if a defect warrants escalation to a CAPA
- Guide product development activities per design control procedures
- Develop quality plans
- Oversee other project deliverables like Design and Development Plans (DDP), Verification and Validation plans and reports
- Lead CAPA activities using the DMAIC process to address internal audit findings
- Work with internal and external auditors to find root-cause failures
We look forward to answering your questions and supporting your medical device initiatives.