Accreditation and Quality Assurance最新文献

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A comparison of proficiency testing evaluation criteria approaches for fitness-for-purpose 适用性能力验证评价标准方法比较
IF 1 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-04-09 DOI: 10.1007/s00769-024-01590-1
Kelly Black, Polona Carson, Emmie Jenkins
{"title":"A comparison of proficiency testing evaluation criteria approaches for fitness-for-purpose","authors":"Kelly Black,&nbsp;Polona Carson,&nbsp;Emmie Jenkins","doi":"10.1007/s00769-024-01590-1","DOIUrl":"10.1007/s00769-024-01590-1","url":null,"abstract":"<div><p>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 (<span>(text{SDPA or}; {sigma }_{{text{PT}}})</span>) 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.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"375 - 379"},"PeriodicalIF":1.0,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140727695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
(K)ILO project: proficiency tests for students (K)国际劳工组织项目:学生能力测试
IF 1 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-04-07 DOI: 10.1007/s00769-024-01581-2
Kees van Putten, Esther Peters-Grutters, Martijn Heuven
{"title":"(K)ILO project: proficiency tests for students","authors":"Kees van Putten,&nbsp;Esther Peters-Grutters,&nbsp;Martijn Heuven","doi":"10.1007/s00769-024-01581-2","DOIUrl":"10.1007/s00769-024-01581-2","url":null,"abstract":"<div><p>The (K)ILO school project (Quality in Laboratory Education) is a yearly collection of proficiency tests (PT). Students in the (K)ILO project are required to devise their own measurement plan, covering all aspects of sample preparation and analysis and to report and defend their results before an external jury. This paper reports on the 2023 year’s project where mass fractions (g/kg levels) of copper, iron, magnesium and zinc in a feed premix material (BPT-MIN2022-KILO) were determined by the participants. The students’ PT results clearly show a big difference in overall performance, <i>z</i> scores and number of outliers, when the statistical approach depends on the assigned value (AV), derived from formulation or from consensus) and the standard deviation for proficiency testing (<i>σ</i><sub>pt</sub>) fixed or derived from algorithm A. As an example, the overall performance of the four parameters with the consensus method that was assessed as satisfactory is between the range 72 to 100 % and that satisfactory performance was only 27 to 36 % when benchmarked against predetermined AVs indicating that there are underlying analytical measurement issues (most probable arising from the trace metal from sample extraction step and no information about the minimal sample intake). Of course, the students’ results and their deviations and dissemination must be seen in perspective compared to commercial laboratories with all their experience. The (K)ILO project is a valuable instrument of knowledge for future laboratory staff for understanding laboratory activities and their impact on PT results. Perhaps an international (K)ILO project could create more awareness among (future) laboratory staff of the importance of PT and quality.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"369 - 373"},"PeriodicalIF":1.0,"publicationDate":"2024-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140733755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality control charts for short or long runs without a training phase. Part 1. Performances in state of control and in the presence of outliers 无训练阶段短跑或长跑的质量控制图。第 1 部分。控制状态下和出现异常值时的性能
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-27 DOI: 10.1007/s00769-024-01584-z
Manuel Alvarez-Prieto, Ricardo S. Páez-Montero
{"title":"Quality control charts for short or long runs without a training phase. Part 1. Performances in state of control and in the presence of outliers","authors":"Manuel Alvarez-Prieto,&nbsp;Ricardo S. Páez-Montero","doi":"10.1007/s00769-024-01584-z","DOIUrl":"10.1007/s00769-024-01584-z","url":null,"abstract":"<div><p>Sometimes analytical laboratories receive requests with a small number of determinations and/or a small number of samples, or outside the typical scope of analytical services. As a result, they may not have historical data on the performance of analytical processes and/or appropriate reference materials. Under these conditions it is difficult or uneconomical to use traditional or classic quality control charts. This is the so-called start-up problem of these charts. The Q charts seem appropriate charts under these conditions because they do not need any prior training or study phase. The fundamentals and the algebraic expressions of Q charts for the mean (four cases) and for the variance (two cases) are offered. This experimental study of Q charts for individual measurements was done with data from quality control for the evaluation of mass fraction of Ni and Al<sub>2</sub>O<sub>3</sub> in a laterite CRM by ICP-OES. The performance of these Q charts is discussed where the analytical process is in the state of statistical control and in the presence of outliers at the start-up. In the first situation performance of Q charts are quite satisfactory and they behave properly. When outliers are collected at the beginning, the deformation of some charts is evident or the charts become useless. Severe outliers will corrupt the parameter estimates and the subsequent plotted points, or the charts will become insensitive and useless. The practitioner should take extreme care to assure that the initial values are obtained in the state of statistical control to have adequate sensitivity to detect parameter shifts.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"231 - 242"},"PeriodicalIF":0.8,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140374927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Improved coverage factors for expanded measurement uncertainty calculated from two estimated variance components 根据两个估计方差分量计算的扩大测量不确定性的改进覆盖因子
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-27 DOI: 10.1007/s00769-024-01579-w
Peter D. Rostron, Tom Fearn, Michael H. Ramsey
{"title":"Improved coverage factors for expanded measurement uncertainty calculated from two estimated variance components","authors":"Peter D. Rostron,&nbsp;Tom Fearn,&nbsp;Michael H. Ramsey","doi":"10.1007/s00769-024-01579-w","DOIUrl":"10.1007/s00769-024-01579-w","url":null,"abstract":"<div><p>Measurement uncertainty (MU) arising at different stages of a measurement process can be estimated using analysis of variance (ANOVA) on replicated measurements. It is common practice to derive an expanded MU by multiplying the resulting standard deviation by a coverage factor <i>k.</i> This coverage factor then defines an interval around a measurement value within which the value of the measurand, or true value, is asserted to lie for a desired confidence level (e.g. 95 %). A value of <i>k</i> = 2 is often used to obtain approximate 95 % coverage, although <i>k</i> = 2 will be an underestimate when the standard deviation is estimated from a limited amount of data. An alternative is to use Student’s <i>t-</i>distribution to provide a value for <i>k</i>, but this requires an exact or approximate degrees of freedom (df). This paper explores two different methods of deriving an appropriate <i>k</i> in the case when two variances from an ANOVA (classical or robust) need to be combined to estimate the measurement variance. Simulations show that both methods using the modified coverage factor generally produce a confidence interval much closer to the desired level (e.g. 95 %) when the data are approximately normally distributed. When these confidence intervals do deviate from 95 %, they are consistently conservative (i.e. reported coverage is higher than the nominal 95 %). When outlying values are included at the level of the larger variance component, in some cases the method used for robust ANOVA produces confidence intervals that are very conservative.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"225 - 230"},"PeriodicalIF":0.8,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01579-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140377570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Information combination and transformation: a paradox and its resolution 信息组合与转换:一个悖论及其解决方案
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-23 DOI: 10.1007/s00769-024-01578-x
Hening Huang
{"title":"Information combination and transformation: a paradox and its resolution","authors":"Hening Huang","doi":"10.1007/s00769-024-01578-x","DOIUrl":"10.1007/s00769-024-01578-x","url":null,"abstract":"<div><p>In his recent paper (https://doi.org/10.1016/j.measen.2022.100416), Willink showed two contradictory theoretical solutions to the problem of combining and transforming two sets of information about the same quantity. Each set of information is represented by a probability density function (PDF), and the transformation function is nonlinear. We refer to Willink’s contradictory result as “Willink paradox”. Two operations: (a) information combination and (b) information transformation are both mathematically valid according to probability theory. Therefore, the two contradictory solutions are both theoretically correct. In practice such as measurement uncertainty analysis, however, we cannot use both solutions; we must choose one or the other. We propose an entropy metric that can be used to provide a practical solution to the Willink paradox. Three examples are presented to illustrate the Willink paradox and the proposed entropy metric.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"183 - 187"},"PeriodicalIF":0.8,"publicationDate":"2024-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140210973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Paradox? What paradox? 悖论?什么悖论?
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-23 DOI: 10.1007/s00769-024-01577-y
R. Willink
{"title":"Paradox? What paradox?","authors":"R. Willink","doi":"10.1007/s00769-024-01577-y","DOIUrl":"10.1007/s00769-024-01577-y","url":null,"abstract":"<div><p>This article is a response to the preceding paper by Huang, who considers a recent result of Willink (Measurement: Sensors, 24:100416, 2022) and who describes the result as a paradox. The result implied that a set of information or a “state of knowledge” about a measurand cannot be identified with a unique probability distribution for the measurand, contrary to what seems suggested in the literature surrounding the revision of the <i>Guide to the Expression of Uncertainty in Measurement</i>. The result is restated and viewed in the context of CIPM Recommendation INC-1, which was foundational in the original development of the <i>Guide</i>. It is argued that the result is a proof, not a paradox, and that it will only appear paradoxical to those who have adopted an incorrect premise about probability. The idea of having “information” about the true value of a measurand is discussed and contrasted with the idea of having “belief” about it. The material supports the view that the analysis of measurement uncertainty is to be based on classical statistical principles.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"189 - 192"},"PeriodicalIF":0.8,"publicationDate":"2024-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01577-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140211250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A practical two-step procedure for taking into account all available information (prior and current) about influence quantities in measurement uncertainty analysis 在测量不确定性分析中考虑有关影响量的所有可用信息(先验信息和当前信息)的实用两步程序
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-23 DOI: 10.1007/s00769-024-01583-0
Hening Huang
{"title":"A practical two-step procedure for taking into account all available information (prior and current) about influence quantities in measurement uncertainty analysis","authors":"Hening Huang","doi":"10.1007/s00769-024-01583-0","DOIUrl":"10.1007/s00769-024-01583-0","url":null,"abstract":"<div><p>This paper considers the problem of computing the combined standard uncertainty of an indirect measurement, in which the measurand is related to multiple influence quantities through a measurement model. In practice, there may be prior information or current information, or both, about the influence quantities. We propose a practical two-step procedure for taking into account all available information (prior and current) about influence quantities in measurement uncertainty analysis. The first step is to combine prior and current information to form the merged information for each influence quantity based on the weighted average method or the law of combination of distributions. The second step deals with the propagation of the merged information to calculate the combined standard uncertainty using the law of propagation of uncertainty or the principle of propagation of distributions. The proposed two-step procedure is based entirely on frequentist statistics. A case study on the calibration of a test weight (mass calibration) is presented to demonstrate the effectiveness of the proposed two-step procedure and compare it with a subjective Bayesian approach.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"215 - 223"},"PeriodicalIF":0.8,"publicationDate":"2024-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140210816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparisons of real versus synthetic proficiency testing items 真实与合成能力验证项目的比较
IF 1 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-22 DOI: 10.1007/s00769-024-01582-1
Finlay MacKenzie, Rachel Marrington
{"title":"Comparisons of real versus synthetic proficiency testing items","authors":"Finlay MacKenzie,&nbsp;Rachel Marrington","doi":"10.1007/s00769-024-01582-1","DOIUrl":"10.1007/s00769-024-01582-1","url":null,"abstract":"<div><p>Both real and synthetic materials are regularly used by providers of external quality assessment and proficiency testing schemes, and there are, in most cases, justifiable reasons for the choice made. This article focusses on the field of clinical biochemistry and discusses the different properties of a material and the benefits and limitations of using real or synthetic material. However, the overarching principles should be able to be applied to all sectors within the laboratory. Whilst genuine/real material would appear to be the preferred matrix, this is not always practicable, and synthetic material may be a suitable alternative. Synthetic material covers a wide range of material, be it that the material is 100% artificial to real material being used as a ‘base’ item, which is manipulated either by the addition of further real material from a different source or by the addition of exogenous analyte. A number of real-life cases are presented to demonstrate the impact of material matrix, storage conditions, volume, and interferences.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"333 - 343"},"PeriodicalIF":1.0,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01582-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140215041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Target uncertainty: a critical review 目标的不确定性:严格审查
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-19 DOI: 10.1007/s00769-024-01585-y
Fernando C. Raposo, Michael H. Ramsey
{"title":"Target uncertainty: a critical review","authors":"Fernando C. Raposo,&nbsp;Michael H. Ramsey","doi":"10.1007/s00769-024-01585-y","DOIUrl":"10.1007/s00769-024-01585-y","url":null,"abstract":"","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"327 - 328"},"PeriodicalIF":0.8,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140230703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The comparison of flow rate calibration methods for high-performance liquid chromatography (HPLC) pump 高效液相色谱泵流速校准方法的比较
IF 0.8 4区 工程技术
Accreditation and Quality Assurance Pub Date : 2024-03-15 DOI: 10.1007/s00769-024-01580-3
Prangtip Uthaiwat, Theera Leeudomwong, Tassanai Sanponpute
{"title":"The comparison of flow rate calibration methods for high-performance liquid chromatography (HPLC) pump","authors":"Prangtip Uthaiwat,&nbsp;Theera Leeudomwong,&nbsp;Tassanai Sanponpute","doi":"10.1007/s00769-024-01580-3","DOIUrl":"10.1007/s00769-024-01580-3","url":null,"abstract":"<div><p>High-performance liquid chromatography (HPLC) pump has a main function to deliver a mobile phase which needs accuracy and stable flow rate. Recently, the reference of General European OMCL Network 2005: Qualification of Equipment Annex 1 qualification of liquid chromatography equipment presents three flow rate calibration methods that have been used to calibrate the HPLC pump performance such as using standard flow meter, gravimetric method, and volumetric method. In this reference, the calibration methods have not been clearly described. Therefore, this study aimed to investigate and compare the flow rate calibration by the using standard flow meter, gravimetric method, and volumetric method. The flow rate was calibrated at 0.5 and 5 mL/min with three replications. The stability between days of each method was observed for three days. The calibration procedure, traceability chart, and uncertainty budget of each method had been described. The flow rate results were analyzed by using the <i>E</i><sub><i>n</i></sub> ratio. The results showed that the stability of all methods had no statistically significant difference between days when compared to the first day itself. The average measurement flow rates by using standard flow meter, gravimetric method, and volumetric method at 0.5 mL/min were 0.4908, 0.4992, and 0.5012 mL/min, respectively, and at 5 mL/min, they were 4.8346, 4.8272, and 4.8394 mL/min, respectively. These flow rates showed consistent results between each other as confirmed with the <i>E</i><sub><i>n</i></sub> ratio ≤ 1. The precision of the three methods was 0.01 to 0.08 %RSD. This study concluded that the flow rate results of three calibration methods had been consistent with each other. All methods had a good stability and precision for the flow rate calibration of the HPLC pump.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"205 - 214"},"PeriodicalIF":0.8,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140240497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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