Re: can I use the cmm after calibration expires?
If an Auditor is choosing to be that picky, they need to re-evaluate their techniques. We are talking a couple of days, still within the same month of calibration due date.
I would challenge any Auditor that would write this up as an NC.
I've seen it too many times for it to even be funny. Not only does the auditor comment on it, the organization overreacts and paints them self in a corner.
If I were the auditor, I would look at other instances where devices exceed the stated calibration due date (systemic issue). If this is indeed the case, I would write an NC.
Now, having said that, if you allow deviations from an established requirement, even if it's only one device, where does one "draw the line?"
What do you think?
Stijloor.
Again, I agree with you here. That's why I would be interested to determine what the recall procedure states, what industry, any regulatory pressures, etc.
One of the things I enjoy here on the Cove are what I term two views on things. One is of the frequenters here who are quality professionals and know the Best Practice approach (Coury and Stijloor just in this thread). I learn a lot here.
The other is like our friend who posted the question. They are at the receiving end of many audits by many auditors; and from what I have seen, many of them (the auditors) need to spend some more time around the Cove. Many of the practices/ approaches of auditors here, while I may not necessarily agree with, are far more logical and useful in nature than a lot of the so-called audit findings out there. I see so many burdensome, borderline ridiculous systems which were initiated from audit observations that should have been challenged or discarded altogether.
Functionally and procedurally it is just fine to go a couple of weeks past a due date. But you should have it documented; where good auditors move on to something else, and a not-so-good auditor wastes valuable time arguing about something that does not matter.