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A critical view at the ISO 13528 and IUPAC's harmonized protocol approach for proficiency testing for homogeneity assessment for quantitative variables.
Analyst ( IF 3.6 ) Pub Date : 2020-09-14 , DOI: 10.1039/d0an01607a Wim Coucke 1 , Mohamed Rida Soumali
Analyst ( IF 3.6 ) Pub Date : 2020-09-14 , DOI: 10.1039/d0an01607a Wim Coucke 1 , Mohamed Rida Soumali
Affiliation
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To ensure a correct interpretation of Proficiency Testing (PT) or External Quality Assessment (EQA) results, sample batches need to be homogeneous. The importance of homogeneity testing has been underlined by ISO 13528 and the IUPAC harmonized protocol for proficiency testing. They require that the batch heterogeneity should be smaller than 0.3σpt, with σpt the standard deviation for proficiency assessment according to ISO/IEC 17043:2010 and provide procedures for assessing the batch heterogeneity. In this study, a critical appraisal of these procedures is given. Firstly, an assessment is made of the influence of the criterion of 0.3σpt on laboratory evaluation. Secondly, the assessment procedure of the batch heterogeneity is evaluated, with an emphasis on the calculation and the evaluation of the measured batch standard deviation. It was found that the 0.3σpt criterion may be loosened without a detrimental effect on laboratory evaluation. In addition, it was shown that a flaw in the calculation procedure forces the batch standard deviation to be 0 with a probability of 21.4% for batch standard deviations of 0.3σpt and repeatability of 0.5σpt. The hypothesis test for accepting a batch exhibits a high probability of accepting the batch, even for batch standard deviations that are a multiple of 0.3σpt. To conclude, this study shows that the criteria for homogeneity check of PT items by ISO 13528 and the IUPAC protocol do not assure batch homogeneity. They may be a combination of a criterion that is too strict and a permissive assessment. Alternative assessment procedures should be followed.
中文翻译：
ISO 13528和IUPAC的统一协议方法对定量变量的同质性评估进行能力测试的批评观点。
为了确保正确解释能力验证（PT）或外部质量评估（EQA）结果，样品批次必须是同质的。ISO 13528和能力验证的IUPAC协调协议已强调了同质性测试的重要性。他们要求该批次的异质性应小于0.3 σ磅，与σ PT根据ISO / IEC 17043标准偏差能力评估：2010和评估批次的异质性提供程序。在这项研究中，对这些程序进行了严格的评估。首先，做出评估0.3的标准的影响的σ角在实验室评估中。其次，对批次异质性的评估程序进行了评估，重点是所测批次标准偏差的计算和评估。结果发现，0.3 σ PT标准，而不在实验室评估产生不利的影响松开。此外，已显示的是，在计算过程的力的缺陷批次的标准偏差与21.4％0.3的批次的标准偏差的概率是0 σ PT和0.5的重复性σ角。用于接受批量假设检验表现出接受批次的高概率，即使对于是0.3的倍数批次的标准偏差σ角。总而言之，这项研究表明，ISO 13528和IUPAC协议对PT项目进行同质性检查的标准不能确保批次的同质性。它们可能是过于严格的标准和宽松的评估的结合。应遵循替代评估程序。
更新日期：2020-09-20
中文翻译：
ISO 13528和IUPAC的统一协议方法对定量变量的同质性评估进行能力测试的批评观点。
为了确保正确解释能力验证（PT）或外部质量评估（EQA）结果，样品批次必须是同质的。ISO 13528和能力验证的IUPAC协调协议已强调了同质性测试的重要性。他们要求该批次的异质性应小于0.3 σ磅，与σ PT根据ISO / IEC 17043标准偏差能力评估：2010和评估批次的异质性提供程序。在这项研究中，对这些程序进行了严格的评估。首先，做出评估0.3的标准的影响的σ角在实验室评估中。其次，对批次异质性的评估程序进行了评估，重点是所测批次标准偏差的计算和评估。结果发现，0.3 σ PT标准，而不在实验室评估产生不利的影响松开。此外，已显示的是，在计算过程的力的缺陷批次的标准偏差与21.4％0.3的批次的标准偏差的概率是0 σ PT和0.5的重复性σ角。用于接受批量假设检验表现出接受批次的高概率，即使对于是0.3的倍数批次的标准偏差σ角。总而言之，这项研究表明，ISO 13528和IUPAC协议对PT项目进行同质性检查的标准不能确保批次的同质性。它们可能是过于严格的标准和宽松的评估的结合。应遵循替代评估程序。
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