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![]() ISO 9001/4:2000
![]() Calibration 4.11 2c
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| Author | Topic: Calibration 4.11 2c |
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Wendell Goodson Lurker (<10 Posts) Posts: 6 |
Question? Our Third party registrar LRQA has stated that we (my company) must define 4.11.2 Control procedures We use an outside certified laboratory to perform our calibrations on items How are other companies doing this? I've never had to do this with DnV or ABS, is this just a LRQA requirement? I've always used a certified laboratory and placed their internal procedure on the purchase order, and Regards Wendell Goodson LRQA's Response: I have not seen any paperwork from a visit to know the specifics but I can give 1. You must define the acceptance criteria for the devices. We have seen 2. If you accept a calibration lab's procedure and tolerances, you should have 3. When found to be out of your defined tolerance, a documented assessment of I hope this helps a bit. I can not give consultancy but you will have my email
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Marc Smith Cheech Wizard Posts: 4119 |
This level of detail expected is another pass-over from QS-9000. UL started pushing this a few of years back. Not so long ago the 'standard' was "...Is your equipment calibrated?" This served well for many if not most companies. However, failure investigations showed that this was insufficient for many companies. I fell to the old notion and at first, in fact, resisted this new 'level of understanding' as most of my clients had an internal person who understood measurement systems analysis. Many companies, however, did not have anyone who actually understands the entire concept. QS9000 addressed the issue with their requirements. Registrars have been increasingly enforcing, if you will, the requirement details. QS registrars, back when QS came out, were only interested in whether you had a solid calibration program but pretty much limited their questioning to "...Is your equipment calibrated?" As time passed UL was first to really 'put the screws' to companies doing the QS dance to comply with the higher requirement of, well, having a good understanding of all the details involved. As I said, I first resisted this tightening of the requirement, so to speak. This evolution could be followed in Greg Gogates wonderful list-serve as more and more suppliers of calibration services were bombarded with 'requirements' from their customers (particularly QS customers). Discussions included all the extra work involved. Some discussions centered about costing and the neccessity to increase fees as more and more customers asked for copies of calibration procedures. In addition, a chorus was heard from cal services suppliers wherein they charged that many customers were, in fact, quite ignorant of the overall process including their specific needs. The 1998 revision of QS caused a real commotion and, as many here found, they could not even find a supplier of cal services who were compliant to guide 25 or whatever. In all this what we see is an evolution of the requirement to calibrate M&TE to a requirement that someone in a company understand the whole of the situation. In all this is needed, I now admit. Enforcement has evolved as well. This might in part be due to the lack of understanding of measurement systems analysis by the auditors themselves. But this goes into an often observed ignorance of so many auditors of what they are auditing - which I won't pontificate on right now. It appears you are complying to LRQA's response #1. Response 2 is pretty self explainatory and it appears you comply with response 3. Now - did the auditor say you are not in compliance? If so, what specifically? IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
For those of you not following Greg's List serve: To: [email protected] In a message dated 6/26/00 2:06:16 PM Pacific Daylight Time, [email protected] writes: << My Question is: How can a company like GTM Plastics specify a standard to Or, if you prefer, you can ask that it be measured in accordance with ISO 10360-2. Ralph C. Veale Phone: 407-654-8660 IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
And: Date: Mon, 26 Jun 2000 14:45:44 -0400 Response to > >However, we use an outside calibration service to conduct the calibration on ANSI/ASME B89.4.1 - 1997 is the standard you are looking for. >We see the There are quite a few labs that will share their procedures. Many of IP: Logged |
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