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The 411 on CAPA
November 1, 2001
1 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "The 411 on CAPA")
Originally Published MX November/December 2001
GOVERNMENTAL & LEGAL AFFAIRS
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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
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