Hello good people of the world! Today’s post is about Corrective Action / Preventive Action, typically referred to as CAPA. CAPA is an integral part of any Quality System, and certainly one of the first things an agency will look at in any audit.
There is a ton of good information out there already on CAPA, including FDA’s own guidance from 2014.
The key points of the CAPA program are:
- Issue identification, i.e. ensuring the issue is truly understood and well documented
- Root cause analysis, i.e. identifying the root cause of the issue
- effectiveness check, i.e. verifying actions have actually resolved the issue
What tips have you learned from your CAPA program? Comment below.