QIC Guru

Quality management system standards uniformly have requirements for controlling the devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. Everyone seems to miss something. It’s almost inevitable. Perhaps it’s because this process is generally referred to as “calibration” and the mental image it conjures up is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more elaborate, addressing appropriate consideration for gages, thermostats, software, jigs, timers, known-good-samples – a multiple of devices for measuring product or process. Controlling monitoring and measuring devices must, therefore, include multiple factors.

 When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. If results from monitoring and measuring devices are fed into a computer and the program mathematically processes the results to provide an end result (for example using Microsoft Excel), the program should be “validated”. Typically, validation is done by comparing the results of the program with the results calculated manually. If the results do not match then it implies a fault in the software program (assuming the manual calculation is correct). Software validation should be carried out before the system is put into use. If the calculation algorithm of the program is modified then the validation exercise should be repeated.