适用性能力验证评价标准方法比较

IF 1 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-04-09 DOI:10.1007/s00769-024-01590-1
Kelly Black, Polona Carson, Emmie Jenkins
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摘要

能力测试(PT)在评估实验室的能力和绩效方面起着至关重要的作用,它使实验室之间进行比较。本文的重点是评估和比较的方法,确定标准偏差的能力评估(\(\text{SDPA or}\; {\sigma }_{{\text{PT}}}\))用于建立PT方案的绩效标准。它探讨了ISO 13528:2022中提供的选项,这些选项利用实验室方法精度,以前的PT轮信息,法规或专家设置的验收标准,基于可重复性或可再现性一般模型的标准,以及来自同一轮PT的数据来设置评估标准。每个选项的优点和缺点都将在其应用的实际示例中进行检查。本文提供的对建立SDPA的各种策略的见解旨在帮助实验室和PT供应商选择符合其特定需求和目标的适当标准,并确保符合目的的绩效评估,增强实验室之间的可比性,并促进PT计划的持续质量改进。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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A comparison of proficiency testing evaluation criteria approaches for fitness-for-purpose

Proficiency testing (PT) plays a crucial role in assessing the competence and performance of laboratories by subjecting them to interlaboratory comparisons. This paper focuses on evaluation and comparison of approaches for determining the standard deviation for proficiency assessment (\(\text{SDPA or}\; {\sigma }_{{\text{PT}}}\)) used for establishing performance criteria in PT schemes. It explores options provided in ISO 13528:2022 that utilize laboratory method precision, information from previous PT rounds, regulatory or expert set acceptance criteria, criteria based on a general model for repeatability or reproducibility, and data from the same round of PT for setting evaluation criteria. The advantages and disadvantages of each option are examined alongside practical examples of their application. The insights into the various strategies to establish SDPA provided in this paper are aimed to help laboratories, and PT providers with the selection of appropriate criteria that align with their specific needs and objectives and ensure a fit-for-purpose performance assessment that enhances comparability among laboratories, and promotes continual quality improvement in PT programs.

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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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