Producing Valid Results(Risk Mitigation and Measurement Assurance)

Abstract

Quality measurements are not produced by accident. They are not the result of a single action, occurrence, or event. They are a collection of activities that are planned, interrelated and cohesive; they should be considered alongside the development of manufacturing processes and not an afterthought. Measurement activities are inextricably linked to product quality and manufacturing systems. These activities collectively are referred to as Measurement Quality Assurance (MQA). MQA is good for product quality and good for business, and can even be legislated. The Unites States Code of Federal regulations, Title 21- Food and Drugs states, “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)A comprehensive Measurement Quality Assurance program designed to mitigate risk has many components. It starts with the product design and identification of the required measurements and the process tolerances required to efficiently build a quality process or service. Once the process tolerances have been defined, test equipment must be selected to take these measurements. The test equipment selected must be suitable and appropriate for the measurement tasks and it must also be capable of producing valid results. Even the proper instrument can produce in-valid results if not handled, maintained, used and stored properly. Even if these events happen, but are not documented by objective evidence, the intent of the MQA program, mitigating risk, can be derailed.