In House Laboratories - Do we have to create an entire quality system for the lab?

J

JVerde

#1
We are a small Steel Processing facility attempting QS9K certification. The problem we are having at this point is interpreting what is specificly required for an in-house calibration lab. In basic terms, our Plant Manager calibrates our Micrometers, Calipers and Master Tape measure in his office. He uses a Calibration software system to record the information and creates records. The question is, do we have to create an entire quality system for this activity ie lab scope, procedures, work instruction, measurement uncertainty/error (still can't figure instrument error out)? I need to know the simplest method available to get us through this.
 
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Jerry Eldred

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#2
The simplest method, in a nutshell, is don't over document the requirements. If you are only calibrating calipers, the scope of the lab should be quite simple. I would guess that you may perhaps even be able to write one spec to cover the entire process if indeed the lab scope is that small.

If you are calibrating in house, and the calipers have an impact on product quality, reliability, etc., then you will need to document. In situations such as that, I have seen some companies make the decision to go to an outside contractor just to avoid the details they need to cover for compliance. I am not suggesting that, as there are certain added risks which will most certainly ensue. When you go to a subcontractor, you automatically lose a degree of confidence and control over the quality of those calibrations. But that is a decision that must be locally decided. I don't want to be construed as recommending which course of action will be better in your circumstance. Simply that you'll need to weigh out the risks versus the cost and confidence level, etc.

To do it in house, you'll need an adequate written procedure for how to calibrate the calipers, the right standards, the right environmental controls, appropriate training, and the other details, and have the system documented.

After that mouth full, it must certainly be added to reiterate above, that you don't need to make it any more complicated that necessary.

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D

Daniel J. Rupright

#3
How does A2LA fall into place when calibrating in-house?

Under QS9000 don't you have to be A2LA?
 
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