IMPLEMENTATION OF THE FAILURE MODES AND EFFECTS ANALYSIS METHOD TO MANAGE RISKS AND CAPABILITIES OF THE TESTING LABORATORY

Implementation of risk-oriented approach in the activities of a testing laboratory (TL) is nowadays one of the mandatory criteria for assessing its competence. As practice shows, the method of failure modes and effects analysis (FMEA) most successfully allows solving the issues of risk management of various objects. The article considers the possibility of using this methodology to analyze and comparatively assess the risks of functioning of a particular testing laboratory. In order to simplify the procedure of risk assessment, the TL processes were defined, as well as their objectives. Based on the analysis of internal documents of the laboratory, the data on the types of identified nonconformities were systematized and presented. Most of them (about 80%) fall on the process “Records Management”. FMEA table of the process “Records Management” with the addition of columns that describe the relative percentage of control and preventive measures to detect nonconformities of the process, shows that the laboratory has chosen the right tactics for risk detection with an emphasis on prevention rather than control. The assessment of criticality of risks allowed to find out that in the zone of unacceptable risk are such nonconformities as: lack of records required by the quality management; lack of part of the necessary information in the records and others. Opportunity management using SWOT analysis is also considered within the scope of the article. An extended matrix of SWOT analysis of TL is presented. TL opportunities are identified, assessed, and response strategies and activities to realize the opportunities are presented.