Do you have a written procedure that explains how due dates are determined?
Scubabiker03
Registered
We do, but looking into it during this new quality system investigation, it didn't have a responsible person or time that it should be completed other than at the start of a new asset. We've changed this for our new quality system but now quality is requiring this justification for our change. My first responses was there is no a requirement for a justification, but was then informed by leadership it's an internal requirement. My next question was then so what was the justification 4 years ago when you went to the current requirements? They didn't have this requirement back then so there wasn't one.
Sorry, no disrespect intended about your experience.
But whether it is an internal requirement or an external requirement, it doesn't matter. The auditor still has the responsibility to clearly state the requirement. What is it, where does it come from? Maybe it is something like "Section 3.2 of ABC Company Procedure 7.1 "Calibration" states that blah blah blah....".
If it is an undocumented requirement, well, maybe that's part of the problem.
Hello Scubabiker03!
Question.... what industry are you in? Saying, is there an industry pattern or practice that would lead the internal auditor to believe end of month practice is not OK?
So if I understand, you have a procedure in place that specifies establishing an interval for each instrument enrolled into the system (e.g. six months). And in your procedure you also state that calibrations are due at end of month. So for an instrument calibrated in March and September, the calibration is past due on April 1. But the internal auditor is stating that won't muster on its own and requires some kind of justification?
Off-topic.... some of the most time consuming/ non-value added process activities I've seen implemented and abandoned not too long afterwards, were due to internal audit findings with no questioning, no citations, and a "just do it" approach.
Question.... what industry are you in? Saying, is there an industry pattern or practice that would lead the internal auditor to believe end of month practice is not OK?
So if I understand, you have a procedure in place that specifies establishing an interval for each instrument enrolled into the system (e.g. six months). And in your procedure you also state that calibrations are due at end of month. So for an instrument calibrated in March and September, the calibration is past due on April 1. But the internal auditor is stating that won't muster on its own and requires some kind of justification?
Off-topic.... some of the most time consuming/ non-value added process activities I've seen implemented and abandoned not too long afterwards, were due to internal audit findings with no questioning, no citations, and a "just do it" approach.
If I understand this correctly, the thing that started this was a perception on the part of an auditor that the existing requirements weren't adequate? There's nothing wrong with auditors bringing things like this to light. It's not right to characterize it as a nonconformity unless there's a documented requirement that hasn't been met, but auditors should question things that don't smell right to them. Is it a fact that a new procedure was written, and it was the new procedure that is being questioned as to month-end due dates?
It seems like the thing to do at this point is to provide the decision-maker(s) with a written explanation of the rationale behind your strategy, including the fact that there is no written requirement anywhere that proscribes the determination of due dates that you're proposing.
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