To be a CAPA or not be a CAPA that is the question.
The CAPA system is the heart of the Quality Management System (QMS) and indicates how effective and compliant your Quality Management System is. Therefore, it is always audited by the notified bodies and should be audited in a supplier audit.
Despite this high importance of this process the CAPA process is still one of the most “vulnerable” processes during a third-party audit and leads to critical deviations. It is still such a big issue for medical device companies that is a key issue indicated in FDA warning letters and observations.
It is very important that companies have it all together and understand how to deal with their CAPA System. In this series we want to drop some light in the darkest chapter of an audit.
We will discuss very deeply the definition and the need of a CAPA and show you your way to an effective and efficient CAPA System.
As you are probably running a CAPA System in your company already we want to present you in this first part of this series a comprehensive checklist which can help you identify your gaps before the auditor does.
- Verify that CAPA System procedure(s) address the requirements of the quality system regulation are defined, documented and uptodate.
- Determine appropriate sources of product and quality problems as input in the CAPA System
- Confirm that data from these sources are analysed to identify existing product and quality problems that may require corrective action.
- Challenge the quality data information system. Verify that the data received by the CAPA System are complete, accurate and timely.
- Define a process of reviewing and analysing the data with appropriate documentation.
Orginal Content was published in avumed.com