Suitability of Instruments (Risk Mitigation and Measurement Quality Assurance)

“Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.”(21 CFR 820.72).While this quote is intended for Medical Device manufacturers, the concept behind it gets to the root of good manufacturing practices for any industry with an interest in minimizing rework, scrap, recall, and/or safety problems in order to maximize profits. And everyone likes more cash. . . well, except her (as Jimmy Fallon states in the Capital One commercial). The problem is some companies don’t make the connection that the instruments that are selected and used to quantify decisions about a process or about their product may be driving one or more of the root causes of these profit pilfering penalties. We will cover different aspects of determining the suitability of instruments, including parameter, range, resolution, accuracy, process tolerances, Process Accuracy Ratio (PAR), Process Uncertainty Ratio (PUR), operator influence, storage/handling and other categories. You should expect to be able to formulate your own definition of Instrument Suitability so that you can compare it to your organization’s current definition or to help your organization develop a definition if it does not currently have one in place.