Yes. The company's internal procedures should define exactly what is to be filled in on any form. Note that it can happen that a customer specific requirement could affect what is required in the company's procedure and form, and certain standards may have specific requirement(s).
I agree, and not having the "due date" specified is against the procedure. I have issued a minor NC.
If a requirement wasn't fulfilled, it is an NC.
You might also suggest that the requirements be reviewed.
What requirement would be cited as having not been fulfilled? No need for an NC if there is no explicit requirement. It would be a good idea, however, to suggest that the requirements be reviewed.
Ah, yes thank you for correcting me! I definitely misspoke haha
If you are asking about an internally driven requirement that ALL fields in ALL forms have to filled out or N/A'ed, I guess very few organizations would have a requirement such as this. But, I repeat myself: the internal auditor is NOT auditing the form completion activity, he is auditing the CA process. Data capture, timelines, etc. are important for the PROCESS to function effectively. The overarching requirements from the QMS standard should have been made granular in the process definition of the company. I have no idea what the granular requirements for this organization are. But auditing the tree while the forest is on fire, does not add value.
Excellent points Sidney. Yes the whole CAPA process was audited and reviewed for proper Root Cause identified and implemented. Also looked at preventive actions identified and follow up actions. All were good, some minor discussion points. The blank fields were observations on some of the forms and we are addressing with a NC since the due dates were missing.
This assumes that a strict dichotomy exists. In other words, it assumes that there's a choice between doing one or the other, but not both, either concurrently or serially.