Risk calculations for conformity assessment in practice

Abstract

In 2012, the Joint Committee for Guides in Metrology (JCGM) published novel guidance on the consideration of measurement uncertainty for decision-making in conformity assessment (JCGM 106:2012). The two situations of making a wrong decision are considered: the risk of accepting a non-conforming item, denoted as the customer risk, and the risk of rejecting a conforming item, denoted as the producer risk. In 2017, the revision of ISO 17025 obliged calibration and testing laboratories to “document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule” in the context of the decision made about the conformity of an item. However, JCGM 106:2012 can in some cases be perceived as quite difficult to apply for non-statisticians as it mainly relies on calculations involving probability distributions. In order to facilitate uptake of the methodology of JCGM 106:2012, EURAMET is funding the project EMPIR 17SIP05 “CASoft” (2018 – 2020), involving the National Measurement Institutes from France, Sweden and the UK. The objective is to make the methodology accessible to organisations involved in decision-making in conformity assessment: calibration and testing laboratories, industrialists and regulation authorities. Where the customer or producer are concerned, there are two kinds of risks arising from measurement uncertainty: specific risk which concerns the risk of an incorrect decision for a particular item and global risk which is the risk of an incorrect decision for any item chosen at random. Both kinds of risk may involve prior information, taken into account through a so-called prior probability distribution, introducing the concept of a Bayesian evaluation of the risks. If a calibration and testing laboratory performing the measurement has difficulty accessing prior information, it is likely that the industrialist in control of production processes will have some idea of the quality of the items produced. In this paper, the two problems of estimating the specific and global risks are addressed. The consideration of prior information is also discussed through a practical example as well as the use of software implementing the methodology, which will be made publically available at the end of the project.