I'm finding it more and more absurd that I've been made QM with no previous quality experience and I'm learning to climb a stupendously steep learning curve very quickly... The previous QM wrote a CAPA for almost everything, yet I have seen hints (mostly on here) that that need not be so. So what are the criteria for NOT writing a CAPA and pushing back? Maybe there are published guidelines somewhere? So far I have one item on my list, but am not even sure how right that is: Non-systemic issues, one-offs etc. What others might there be?