How should "Set-up" Parameters be Addressed in Control Plans?

D

dknox4

#1
I have a process that is affected by many variables (humidity, outside temp, pressure, many other small variables). We have set-up parameters defined (actually the last settings used when the specific product was run) that we use to set the intial run. Depending upon what the product looks like as it exits the process, these initial parameters are then tweaked to dial in the product characteristics. The product inspections are in the PCP as are the "key" process char's along with the "set-up" parameters. The set-up parameters are not in the PCP as on-going (after set-up) checks but there is a feedback loop from product inspection downstream - if the product char's move then the process char's can be adjusted. We DO NOT adjust the process based on many parameters if the product char's are running good. My question (finally) has to do with calibrations of some of the process parameter setting mechanisms. Most of these offer crude measurements (just to get the process "close" and then are dialed in per above process), are maintained through PM processes and any affect upon the final product is verifed with calibrated tools in product inspection. Does anyone see a reason for calibration of these of these process measurements?
 
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BradM

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#2
If the process parameter instruments are used as adjustment devices and they are adjusted accordingly depending on final product quality, I would say they would not need to be calibrated. However, I did not pick up if you have any regulatory requirements for calibrating the instruments, or how your QMS would address them.

However.... there is value gained with having instruments calibrated. One of the values you might gain is by having the instruments calibrated and their variance minimized, the process (and subsequent end-product) variance is minimized.

It's not much fun (and frankly, sometimes costly) to have to sit and take hours to finally produce good product. If you calibrate the instruments and begin to baseline the setup parameters, material characteristics, etc., you may can minimize set-up time and save time and money.
 
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