Correction is an action to eliminate a detected nonconformity; Corrective action is an action to eliminate the root cause. I get that. I think
Is there a "mini corrective action" situation?
example (of a frequent occurrence):
A customer required a CAPA for a part that was found non-conforming. Let's say a screw in the assembly was missing (no risk to a patient, no safety issues etc.). We would do a containment (check warehouse, WIP etc...), get the part back and install the missing screw (correction) , we would also investigate the possible cause (maybe there wasn't a checklist to verify the count of screws to install), for the purpose of this example, the corrective action would be to "create a checklist to verify the count of screws etc." and of course the customer would expect verification of effectiveness. All "elements of corrective actions" are there, But - this corrective action is limited to a specific product and not really looking at possible similar issues in other products (and also the root cause efforts are minimal).
Customers typically are OK with that approach, but I had an auditor commenting about the "narrow" approach.
I do understand that other products may benefit from the same action etc., but it will be an extreme effort to think and implement this line of thinking (even though it sounds good).
In situations where a risk is identified or compliance risk is identified, the corrective action needs to be broad, that is a valid expectation.
Do any of you have experience addressing that? a "mini CA"...or "local CA"... it kind of not aligned with the essence of a CA, but very useful, considering risk vs. efforts. Would something be different in the documentation for it? like a "corrective action" with different levels and added requirements for the "BIG CA"?
Happy to hear other thoughts,