Calibration Requirements for Production Equipment

#1
My company has been formally registered to IS9001 for 25+years. We are reviewing our maintenance departments calibration program and have found many inconsistencies with their interpretation of the standard. I would appreciate feedback on the following: when is calibration or verification required for machine process settings? For instance, if we have a coating machine that has line speed and oven temperatures that are used to produce Product A and we know these are critical characteristics, do we need to perform verification or calibration on these machine settings? We do end product testing on Product A to ensure that it is made correctly and meets the end customer's specs of thickness and hardness and calibrate the test equipment (ex: micrometer), so is it necessary to perform calibration on the machine's line speed and oven temp or is it up to us based on our risk analysis.
 
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Ninja

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#2
For production line...it is up to your risk analysis.
For measurements of "does this meet spec?", calibration is required...typically by the customer if nothing else...

I use micrometers for controlling coating thickness in the production line, and I do not calibrate the mic heads...it would be pointless.
I choose to calibrate the line speed...I choose not to calibrate the heaters or the air flow meter.
That said, the gages I use to verify final (dry, cured, ready to ship) coating thickness and other properties are calibrated without question.
 

ScottK

Not out of the crisis
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#3
Hi NatanyaD - welcome to the Cove.
Since you are basing acceptance of product on testing you can make a risk based argument that you don't need to calibrate your line speed and temp indicators.
You should consider how much product is tested in that risk analysis... if I was a customer I would want to see a decent sample size throughout the run tested.
I worked in a place where we did dipped powder coating. Parts were essentially 100% checked coming off the line and QC sampled per a c=0 plan with a tight AQL. We did calibrate the temperature controllers for our own needs as there was a fine line between melting and burning. We did not calibrate the line speed or dwell timers. We did get that questioned by our ISO auditors on occasion but defended it successfully.
 

Ninja

Looking for Reality
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#4
FWIW...I had a real gem as an internal auditor (hated him...but he did a great job and I appreciated it...or appreciated the results, anyway)...
We wrote directly into the procedure document what did and did not require calibration just to shut him up...not required, but easier than fighting with him...once we did that, we were never questioned again by ISO, IATF or customer audits...so it was worthwhile.
 
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