C
Chance
I agree with you Mark. Some auditors might issue a CAR for that because they did not see anything else. Better safe than sorry for me.
J
JustADude
Jim, why measure anything if you don't have valid results? And how can you call the measurement valid if the measuremnet device may be bad/defective. And how can you say that the measurememt device is not bad/defective if it isn't calibrated or verified?
If I'm measuring something with a linear scale, and the results produced are valid (i.e., there's no evidence that lack of calibration has ever resulted in anything bad happening), it's wasteful to do calibration and it's not required by the standard.
How can you call the measurement valid if a calibrated device is out of tolerance and no one knows it? The act of calibration, in and of itself, doesn't ensure valid results.
See above. When something measured is found to be perilously close to a specification limit, no one should assume that the measurement is accurate, regardless of the calibration status of the device, and I mean even if the thing was calibrated an hour ago. The verification process should include verifying the device, (or use of another device of known accuracy) or the method or the operator, or all three.And how can you say that the measurememt device is not bad/defective if it isn't calibrated or verified?
J
JustADude
Sounds like you are thinking that everything is valid unless it is proven otherwise. I think you will have trouble selling that idea to a lot of auditors.
I've had a few discussions
, but the thing to remember is that if there is no evidence of nonconformity and no evidence that the standard or internal requirements have been violated (and you can provide positive evidence to the contrary) the burden of proof is on the auditor, not the auditee.
M
Mark Cost
Okay, but I don't understand why anyone would NOT calibrate/verify any measuring device/instrument/tool. It seems to me even the short-term financial burden is worth the long-term benefit. You may be able to sell some auditors, but others may have an issue. Again, I don't believe this should be the "hill on which you die".I've had a few discussions
The discussion is (I thought) about what's required by the standard and not about what might be prudent. We should all do what makes sense for the application, but not allow the tail to wag the dog. Nonetheless, we all have to choose our battles carefully. I've been in situations where there was extensive use of linear scales (measuring for cutting fabric and sheet vinyl) where the tolerance was so liberal (and nonconformities never happened) that it simply made no sense to calibrate--it served no useful purpose.
M
Mark Cost
I am with you on that and agree the requirement is the question. But, coming from where the OP is currently not too long ago, I would've wanted - along with the requirement - an opinion based on practicality. I'd rather commit myself to alleviating any possibility of unwarranted scrutiny.
I understand.
The problem is that we find ourselves in this position--having to justify compliance with the standard--because too many people allow auditors to more or less arbitrarily decide what's necessary to ensure valid results and just calibrating everything in sight to avoid trouble. Much calibration is done not to avoid trouble with the product, but to avoid trouble with myopic auditors.
T
treesei
Jim's observation goes beyond calibration, being true with almost evry QMS aspect. Because the standards are purposedly made vague to allow their use in various situations, auditors have enough room to subjectively (somehow) interpret the standards. Modifying a QMS to satisfy every auditor's demands will in no doubt mess up the system. We should go back to and start from the bottom line: What the requirements are.
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