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In 4.11 under Calibration Services states three ways of doing calibration



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).]


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.


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.

barb butrym

Quite Involved in Discussions
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.


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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