Do Process gauges need to be in Calibration control system?

J

J. Kay

#1
My company is preparing to upgrade our ISO system to QS-9000. There is difference of opinion as to whether process gauges (i.e. pressure, temperature, rpm, etc.) are to be included in the gauge control system (calibration / verification). We are a raw material compounder and all product is accepted or rejected in a laboratory. Has anyone experienced problems with registration to QS-9000 where process gauges were not in the gauge control system?
 
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#2
I believe that if the gauges are used as an indication of the process and not to qualify the product then they do not need to be calibrated.
If you are performing SPC on the process and using these gauges then they ned to be calibrated.
What does the machinery book say about these gauges?
 
#3
I fought this battle many times; and lost every time.
The standard reply from an auditor is "If you don't need the gauges, then why do you have them in the process?"
If the gauge is not part of the machine and you really don't need it, then remove it.
If the gauges are part of the machine,i.e., extrusion presses, then the mfg put them there for a purpose;to controll the process.
Rule of thumb:
Any item that is used to verify, validate or otherwise used to indicate the quality of the product/process is required to be controlled.
 
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