Medical Device Link.

Originally Published MX November/December 2001

GOVERNMENTAL & LEGAL AFFAIRS

The 411 on CAPA

A good CAPA management system should be able to pull together a great deal of information from a variety of areas. Potential sources of data about product-quality issues include the following.³

• Acceptance activity records relating to component, in-process, and finished-device testing.
• Complaints.
• Medical device reports (MDRs) and vigilance reports.
• FDA 483s and warning letters.
• Reports of system, process, or product nonconformities.
• Process-monitoring data such as statistical control charts, trends, and run charts.
• Calibration and maintenance records.
• Scrap, rework, and "use-as-is" records.
• Clinical adverse events.
• Internal, external, supplier, and third-party audits.
• Returned-product analysis.
• Installation and repair reports.
• Spare parts usage.
• Customer and technical service requests.
• Field service and warranty reports.
• Customer feedback.
• Historical records from previous corrections.
• Previous corrective and preventive actions.
• Lawsuits and other legal actions.
• Published literature.
• Reports from employees.

3. M Allen, M Armstrong, and N Singer, "Points to Consider When Preparing for an FDA Inspection Under the QSIT Corrective and Preventive Actions Subsystem" (Washington, DC: AdvaMed, 2001).

Copyright ©2001 MX