Implementing a new risk management culture in a forensic genetics laboratory: first steps

IF 1 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-12-05 DOI:10.1007/s00769-024-01627-5
Isadora Cooke Silva, Ígor Giraldi de Oliveira, Renato Teodoro Ferreira de Paranaiba, Levy Heleno Fassio, Ronaldo Carneiro da Silva Junior, Bruno Rodrigues Trindade
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Abstract

The risk management approach has become crucial in quality management systems, to the extent that its importance has been reflected in the new version of ISO/IEC 17025:2017. In 2014, the Brazilian Federal Police’s Forensic Genetics Expertise Service (SEPGEF/PF) implemented a quality management system based on NBR ISO/IEC 17025:2005. This article outlines the initial steps taken to embed a risk management culture within the laboratory to align it with the new NBR ISO/IEC 17025:2017 version. The main focus was to analyze SEPGEF’s nonconformity records between august 2014 and april 2024 and, based on this, to develop methods for mapping, assessing and treating the risks associated with these events. Additionally, the main risks that threaten the integrity of DNA samples were discussed. We also presented future prospects for the unit in order to promote more effective management of the risks that affect its objectives.

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在法医遗传学实验室实施新的风险管理文化:第一步
风险管理方法在质量管理体系中已变得至关重要,其重要性已反映在新版ISO/IEC 17025:2017中。2014年,巴西联邦警察法医遗传学专业服务(SEPGEF/PF)实施了基于NBR ISO/IEC 17025:2005的质量管理体系。本文概述了在实验室内嵌入风险管理文化以使其与新的NBR ISO/IEC 17025:2017版本保持一致所采取的初步步骤。主要重点是分析2014年8月至2024年4月期间SEPGEF的不合格记录,并在此基础上制定与这些事件相关的风险映射、评估和处理方法。此外,还讨论了威胁DNA样本完整性的主要风险。我们还介绍了该单位的未来前景,以便促进对影响其目标的风险进行更有效的管理。
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来源期刊
Accreditation and Quality Assurance
Accreditation and Quality Assurance 工程技术-分析化学
CiteScore
1.80
自引率
22.20%
发文量
39
审稿时长
6-12 weeks
期刊介绍: Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.
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