Risk management: ten years of experience in the organization of the proficiency testing AQUA

Abstract

Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe) organizes qualitative and quantitative proficiency testing (PT) schemes—in the frame of the AQUA project—in different fields of technical competence. AQUA schemes for Salmonella, rabies, and avian influenza are performed by the national and international reference centres hosted by IZSVe. These PT are accredited according to ISO/IEC 17043:2010, since 2012. This manuscript aims to illustrate the methodology used in mapping the AQUA activities, identifying risks, and evaluating the risk management strategies implemented over the past decade. The goal is to provide a practical example of our experience in effective risk management. The mitigation actions put in place demonstrated the ability of IZSVe to minimize identified risks or at least keep them under control. In order to revise the quality management system in accordance the ISO/IEC 17043:2023 standard within the planned three-year transition period, the Institute has completed the first step of the transition processes: conducting a gap analysis and definition of the transition plan. A significant enhancement in the new edition of the standard is the increased emphasis on risk analysis. The organization believes that the methodology outlined in this document is applicable to the new regulatory context; however, it will be necessary to re-evaluate the risks associated with to each process in light of the new requirements.