It seems to be handled differently everywhere I go. One thing I can comment on that's very consistent is the way FDA investigators go about analyzing a CAPA system.
It seems that almost every organization I've been in has always been concerned with reports showing how many issues were opened, closed, are overdue, etc. but few seem interested in the actual performance indicators of the system.
I tend to try to shift the thinking and approach it from the Field Investigator's perspective. I don't see anything wrong (at least on the surface) with a large quantity of open items, or items that take a "long time" to resolve.
I'd rather see some of the detail. I think charts that illustrate
Source of issue
Type of issue (general category)
Quality System element
Specific processes
Cause (general category)
Then, set expectations based on the organization, its size, culture, quality awareness, stage of development, etc. In other words, I'd expect to see more issues related to employees not following procedures issued into the CAPA system in large quantities and in large blocks at most start-up companies. Many incorporate the nonconforming materials and/or complaint handling procedures in the same document. I typically find that the majority of the items relate to nonconforming material consistently through time, but quality system issues are raised primarily during internal audits. As an auditor, it tells me that I can most likely expect to find many instances of employees not following procedures, because they don't pay attention to them until they're audited.
If on the other hand, I see consistent entries in the CAPA system for quality system issues, it tells me that the organization is consistently monitoring their processes.
If I see very few CAPA entries, it tells me that the CAPA system is probably not effective, or the entire quality system is ineffective.
Whenever I've hosted FDA or other agency inspection, the investigators have always looked at quantity relative to the organization. They look at the same criteria I mentioned above. It gives them a bird's eye view of the entire business, and they're able to identify areas of concern very quickly.
In my opinion, the only true measure of the performance of a CAPA system is to measure
what (and how) it's doing, rather than "how many."
(that was just too much for two pennies)
Chris Ford