Application to Risk Management as Part of the Transition of the Quality Management System from ISO 17025 v2005 to ISO 17025 v2017: Case of MULTILAB Laboratory in Tunisia

Abstract

Background: Accreditation ensures a very high level of control of the risks that laboratories may face during their cycle regardless of a systemic situation, internal or external change or even in a state of crisis. MULTILAB, which is an Agri-Food and Environmental analysis laboratory, decided in 2018 to start the project accreditation for the microbiological analysis unit according to the new version of the ISO / CEI 17025: 2017 standard. This study evaluates 3 processes at MULTILAB to identify, evaluate, and control all the risks related to each process using a risk management process. The aim of this study is to reduce the identified risks of the 3 chosen processes in MULTILAB to ensure a complete identification of probable risks to enable then the laboratory to succeed the transition and accreditation project. Methods: This study was performed from March to May 2018 in MULTILAB. The samples chosen for the study were 3 processes of MULTILAB; Monitoring and Measurement as a management process, Request Review as realization process and Provision of Skills as a support process. The internal process sheets which include all the data relating to the processes were used to collect data. The risks are defined according to the 5M method and the risk process used comprised 3 phases; identification, assessment and action phase. To evaluate the risks, different rating benchmarks were used for each process. After the definition of the risk’s likelihood and severity, the criticality was calculated and then the priority number was defined for all risks. For the action phase, different actions were defined according to the priority level of each risk in each process to reduce or eliminate risks. Results: The total number of identified risks was 85 in MULTILAB; Skills Provisioning process had the majority of identified risks (37 risks), Monitoring and Measurement process represented 25 risks and Request Review process had the lowest number of risks (23 risks). Regarding the 5M method, in a total of 3 processes, the highest number of identified risks belongs to the Methods (30 risks) and there are no risks that belong to Machines within MULTILAB. Regarding the treatment priorities, the majority of the identified risks for the three processes were moderate risks. Conclusion: A risk management approach is necessary to succeed not just in the accreditation project according to the new version of the ISO17025: 2017 standard but also to succeed in all next projects and to ensure the credibility of the tests carried out. Most of the risks identified do not require immediate action, but permanent control and monitoring can mitigate and even eliminate them completely.