C
Jim,
Although I agree with you in theory, I would disagree with using it as a calling card for your argument with an auditor. The statement "Where necessary to ensure valid results" is the real sticker here. It's vague. In my experience (especially when being audited by a customer), the idea of having any measurement equipment near product that is not calibrated sends up red flags. I guess the question is, "Is it better to have a procedure that allows for these non-calibrated/non-validated tools or to have all measurement equipment calibrated/validated?" I would go with the latter for two reasons: It eliminates the question "How do you ensure these items are not used to verify product?" and; Auditors see it as good practice.
Thanks,
Mark
Although I agree with you in theory, I would disagree with using it as a calling card for your argument with an auditor. The statement "Where necessary to ensure valid results" is the real sticker here. It's vague. In my experience (especially when being audited by a customer), the idea of having any measurement equipment near product that is not calibrated sends up red flags. I guess the question is, "Is it better to have a procedure that allows for these non-calibrated/non-validated tools or to have all measurement equipment calibrated/validated?" I would go with the latter for two reasons: It eliminates the question "How do you ensure these items are not used to verify product?" and; Auditors see it as good practice.
Thanks,
Mark
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.