Don’t Flood the CAPA System!
You don’t want to flood the CAPA system with every problem that arises. Only “systemic issues” should be entered.
‘Systemic Issue’ Defined
So, what is a systemic issue? It’s one that, if not addressed, will continue to occur. Systemic issues can be found in the quality system (missing procedures), product (repeated failures), manufacturing (repeated out-of-tolerance results), process (missing actions or actions not occurring), and so on.