Corrective and/or Preventive Action Procedure

Do you work in a regulated industry where the concept of CAPA is a common expectation? If not, one procedure for Corrective Action and Preventive Action is, in my experience totally inappropriate. There is woefully bad understanding of both - particularly when it comes to taking actions which seem preventive in nature, but in response to a problem which has occurred, so to have pushed the 2 into one document causes this confusion to be reinforced, in my mind. I'd strongly suggest separating them out before looking into specific techniques. Actually, when you do, you'll see that they demand different approaches which cannot be commonized in one procedure. If you ARE in a regulated industry - good luck!

 

I agree with Andy.

We can, especially from here on out, rightfully call Corrective Action problem solving (well, we always could...) and Preventive Action risk management (again, we could have always called it that). The methods and tools have been in place for a long time. In the old days we called them the Seven Management Tools but since we've added to the list. The only one true criteria for selecting a tool is What Is Effective For Your Organization.

 

To me, the CAPA procedure(s) scope was to capture the flow of the CAPA activities (from initiator to resolver to analyzer and so on). The idea of using it to detail the methods of corrective or preventing something seems non-value-added to me. The form(s) can identify the sections where suitable methods are to be applied. Training can detail the methods applicable to the appropriate situation(s). The procedure was, in my opinion, used to address responsibilities and flow of information.