What is CAPA for medical devices?

June 15, 2011 - PRLog -- CAPA is an acronym for Corrective Action/Preventive Action. This is a part of Quality Management System QMS and a concept of good manufacturing practices. For the purposes of medical devices manufacturers, CAPA focuses on

• Corrective action by investigating the discrepancies, failures or deviations in the performance of the device so that it can be corrected and prevented in future. This action is taken based on the data obtained from real time performance of the device.

• Preventive action by setting up a proactive methodology to determine potential discrepancies or areas that could lead to failure, deviation in performance or compromise performance. This is the preventive aspect that is included in the system even before the real-time performance data of the device is available. Integrating an effective CAPA system helps in optimizing quality standards which in turn helps the company achieve compliance and regulatory requirements.

Here is how the CAPA process works
1. Collecting data from different sources: Data is collected from different sources like complaints, management review data, returned product information, audits data, product service information, non-conforming product data, supplier performance data, process monitoring data, inspection data and any other data related to the medical device.
2. Check if the data meets threshold. (threshold is the predefined acceptable values for each data item)
3. For the data that does not meet the threshold, more data is collected and investigation is conducted into how often the deviation is encountered, where and when the deviation occurs and the extent of deviation. All these details are tabulated and analyzed to understand the risk involved in such deviations or failures. Based on this the cause of deviation or failure is determined.
4. Once the investigation results are available, action plan is initiated to correct the problem. Here the different risks are assessed and prioritized and an action plan is defined which focuses on minimizing the risks.
5. This plan is then verified and validated for consistency and accuracy.
6. After the verification process the action plan is implemented.
7. Post implementation of action plan, effectiveness checks is conducted.
8. If there are persistent discrepancies then the CAPA starts all over again until the results are satisfactory and effectiveness check indicate positive results.

Documentation
Documentation is an important feature of any quality management system component. If it is not documented, it is considered non-existent. Effective documentation of the process, the threshold definitions, action plan details and verification and validation processes as well as effectiveness check, enable the medical devices manufacturer to understand the loopholes or problem area and take corrective and preventive actions. Also during a compliance visit, the documentation is the only proof of the existence of a CAPA system.

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