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From: Ed Cosper
Sent: Thursday, January 23, 1997 4:18 PM
To: [log in to unmask]
Subject: ISO and calibration
Having recently passed the ISO lead auditor course and having the opportunity to perform several audits, I do have an opinion on calibration.
Basically, in instances where you have specified a parameter such as temperature, amperage, or pressure as a critical process control element, then I would expect the gages used to monitor those elements to be calibrated. If you do not calibrate a devise that measures/monitors a specified critical element of a process, then I would have to conclude that the absence of calibration could have an adverse affect on the quality of the parts produced.
Remember, an ISO auditor is only concerned with items, controls, and practices that can have an adverse effect on the quality of the product. I have addressed this concern in our facility by stating in the individual procedures for each process what is and is not critical. We only calibrate what we feel is critical for us. For instance, the digital temperature indicators on our developers, strippers, and etchers are not calibrated. However, to satisfy the process control requirements, I have stated in the procedure that bath temps shall be checked using a calibrated hand held thermometer and that the digital indicators are for reference only. This allows you to calibrate only one piece of equipment verses several digital displays. This saves money in calibration services and satisfies the calibration requirements.
In addition, in our calibration procedure, I have stated that only items used for the final acceptance of product and items used to monitor critical process parameters shall be calibrated. As long as the procedure is followed, I have not had a problem. Remember, an ISO auditor can not tell you how to run your business nor can an auditor establish what is or is not critical in your process. He / She can only evaluate how well you manage your quality system based on adherence to
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