Application of the Failure Mode and Effects Analysis Tool in Testing Laboratory for a Risk Analysis

Abstract

The new version of the GOST ISO/IEC 17025-2019 standard requires the laboratories to plan and carry out actions to eliminate risks and opportunities. Several management tools can be used to identify risks, such as Failure Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), Ishikawa diagram, risk matrix, brainstorming, and etc. The result of risk identification in the laboratory is a risk register containing all potential risks that may arise during laboratory activities. FMEA is one of the such registries. The purpose of this study was to demonstrate the possibility of using the FMEA tool for risk assessment in a testing laboratory, taking into account the requirements of GOST ISO/IEC 17025-2019. Two processes were selected and used for FMEA analysis - review of requests, applications and internal laboratory control. As part of the analysis, point estimates (on a ten-point scale) of the Severity of Effect S, the Probability of Occurrence O, and the Likelihood of Detection D. Based on the scores, the risk priority number RPN is calculated. For nonconformities with the RPN value exceeded 100, corrective measures were developed that made it possible to reduce the RPN values to an acceptable laboratory level. It is recommended to analyze the processes using the FMEA method in order to identify the causes of nonconformities and prevent their recurrence periodically. Risk analysis and management are necessary to achieve the intended results in the activities of testing laboratories, maintain and improve the quality management system.