Medical device manufacturers must have a documented Corrective Action and Preventive Actions procedure. This procedure provides the authoritative definition the CAPA subsystem of the company’s overall quality system. The CAPA procedure may reference additional procedures that further define it.
For manufacturers in the United States, when FDA audits your CAPA procedure they will:
- Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
- Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
- Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
- Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.
- Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.
- Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.
- Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.
- Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.
- Verify that corrective and preventive actions for product and quality problems were implemented and documented.
- Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.
More information on how the FDA will inspect your CAPA process is available from the FDA.
Additional information on FDA inspection protocol is available here.