CAPA Corrective Action/Preventive Action

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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.