Measurement Assurance for End-Item Users

The goal of a Quality Management System (QMS) as specified in ISO 9001 and AS9100 is to assure the end product meets specifications and customer requirements. Measuring devices, often called measuring and test equipments (MTE), provide the evidence of product conformity to the prescribed requirements. Therefore the processes which employ MTE can become a weak link to the overall QMS if proper attention is not given to development and execution of these processes. Traditionally, calibration of MTE is given more focus in industry standards and process control efforts than the equally important proper usage of the same equipment. It is a common complaint of calibration laboratory personnel that MTE users are only interested in "a sticker." If the QMS requires the MTE "to demonstrate conformity of the product," then the quality of the measurement process must be adequate for the task. This leads to an ad hoc definition; measurement assurance is a discipline that assures that all processes, activities, environments, standards, and procedures involved in making a measurement produce a result that can be rigorously evaluated for validity and accuracy. To evaluate that the existing measurement processes are providing an adequate level of quality to support the decisions based upon this measurement data, an understanding of measurement assurance basics is essential. This topic is complimentary to the calibration standard, ANSI/NCSL Z540.3-2006, which targets the calibration of MTE at the organizational level. This paper will discuss general measurement assurance when MTE is used to provide evidence of product conformity, therefore the target audience of this paper is end item users of MTE. A central focus of the paper will be the verification of tolerances and the associated risks, so calibration professionals may find the paper useful in communication with their customers, MTE users.