One of the key aspects of ISO 17025 Quality Management System (QMS) is the Corrective and Preventive Action process (CAPA). The standard requires that we have a policy (which is part of our Quality Manual) and standard operating procedure (SOP) for handling CAPAs. In addition, a clear designation of the authority for monitoring and implementing CAPAs has to be identified.
In general, any employee can create a CAPA. An important aspect of recording CAPAs is to clearly and concisely describe the issue that has occurred (corrective) or potential issue (preventive). For Management it is critical to nurture a company culture that is oriented to not only point out issues but also come up with constructive and timely solutions. Team work between Management, QA and lab personnel is integral to successful handling of CAPA. Determining root cause of the issue and outlining clear actions is definitely more successful with a team approach. However, usually QA personnel take leadership role in moving CAPA process forward.
The key for a successful CAPA system and the best way to resolve CAPA is having Management support and consistent follow up (and follow up, follow up…) so that issues don’t slip trough the cracks. QA team plays main role providing guidance to both Management team and personnel working on CAPA. Never give up!