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Author Topic:   Calibration Services
ovidiomolina
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From:Monterrey, Nuevo Le—n, Mˇxico
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posted 17 April 1999 03:34 PM     Click Here to See the Profile for ovidiomolina   Click Here to Email ovidiomolina     Edit/Delete Message   Reply w/Quote
In 4.11 under Calibration Services states three ways of doing calibration of equipment:
a) In-House "Qualified Laboratory"
b) External (commercial) Acredited Laboratory
c) By governmental agency.

Question: Does a) imply that we have to establish a formal calibration laboratory ?. Besides, it has to be "qualified according to 4.10.6". Is that true ? Or I'm seeing this too straight ?

[This message has been edited by ovidiomolina (edited 04-18-99).]

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Batman
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From:Kane, PA 16735
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posted 18 April 1999 01:16 PM     Click Here to See the Profile for Batman   Click Here to Email Batman     Edit/Delete Message   Reply w/Quote
Hi ovidiomolina!
4.10.6 is for any area considered a "lab" in your organization. If you calibrate micrometers, for instance, it is a "lab" under 4.10.6. If you fulfill the requirements of 4.10.6 - scope, procedures, material identification, storage and disposal - through your auditor's review, you then have a "qualified lab." You may then calibrate your micrometers in this lab.

The intent of 4.10.6 is more broad in scope than this example, mostly for product / materials testing.

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ovidiomolina
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posted 20 April 1999 10:54 AM     Click Here to See the Profile for ovidiomolina   Click Here to Email ovidiomolina     Edit/Delete Message   Reply w/Quote
Ok. But that is the problem. We have at least three maintenance areas responsible for preventive, corrective and predictive maintenance and the do the calibration of some instruments, but we do not considere these areas as "Calibration Labs"; besides some of the production areas do the calibration of their instruments and we do not considere these areas as "labs" either.
In the other hand, we have laboratories where chemical and mechanical determinations are made. Obviously the purpouse of these laboratories is the certification of product properties not the instrument calibration.

How can I accompish the issues stated in 4.11.2.b.1 without doing useless paperwork.

How can I counter argument an auditor who is expecting to see a "Formal Qualified Calibration Laboratory" for every single instrument used in the shop floor.

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barb butrym
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posted 20 April 1999 11:55 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
Find out if your registrar will be looking for that? If he is, then perhaps you have the wrong registrar. An auditor worth his salt won't be looking with that in mind.

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Batman
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posted 21 April 1999 01:54 PM     Click Here to See the Profile for Batman   Click Here to Email Batman     Edit/Delete Message   Reply w/Quote
Yes, I agree with Barb. Check to see what your auditor is going to look at.

Our maintenance department does the same thing. Our auditor looked for fulfillment of the preventive maintenance schedule. I would think these areas are not covered under 4.10.6.

Off-line material and chemical testing areas I think are covered in 4.10.6.

If you back up to 4.11.2.b, it refers to "identify all inspection, testing, and measuring equipment that affect product quality, and calibrate and adjust..."

In general, if you are using pressure gages to control equipment, for example, or based on certain pressure readings, making adjustments to the process, I think these gages then fall under this requirement. If however you are using a caliper to measure product features, then the pressure gage is just used for a process "setting," it goes outside this requirement, and into preventive maintenance. The calipers then come under this requirement, and they will likely be calibrated in a "lab."

This is how we are handling it in some areas.

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