Accreditation and Quality Assurance最新文献_第8页

Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development ICHQ14 分析程序开发指南中的设计分析质量（AQbD）

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-05-13 DOI: 10.1007/s00769-024-01587-w

Kiranmayi Sathuluri, RamyaSri Bakam, Riya Jain, Aishwarya Dande, Rahul Gajbhiye, V. Ravichandiran, Ramalingam Peraman

{"title":"Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development","authors":"Kiranmayi Sathuluri, RamyaSri Bakam, Riya Jain, Aishwarya Dande, Rahul Gajbhiye, V. Ravichandiran, Ramalingam Peraman","doi":"10.1007/s00769-024-01587-w","DOIUrl":"10.1007/s00769-024-01587-w","url":null,"abstract":"<div><p>Analytical quality by design (AQbD) is one of the risk-based approach used to develop robust analytical method in compliance with regulatory requirements. The concept of AQbD was recently established in the literature and has proven advantages in the pharma industries. Despite the differential view on AQbD, the International Council for Harmonization (ICH) has released the ICHQ14 document for analytical procedure development. Notably, the enhanced approach of the ICHQ14 document mimics AQbD workflows in analytical procedure development. Among ICHQ14 recommendations, the need for knowledge assessment, multivariate models for proven acceptable range (PARs) as method operable region, sample suitability assessment in robustness, and real-time release testing with product critical quality attribute specifications as the challenging components for pharmaceutical industries. In addition, the integration of ICHQ14 with other ICH documents like ICH Q6A/6B, ICHQ8, ICHQ9, ICHQ10, ICHQ11, and ICHQ12 are well defined in the document. Thus, the revised ICHQ2 (R2) guideline has defined the validation procedure with integration to ICHQ14 documents.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 1","pages":"1 - 14"},"PeriodicalIF":0.8,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140983641","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

Concept for evaluating results close to the participants’ limits of quantification in proficiency tests for elements in food 在食品元素能力验证中对接近参与者定量限的结果进行评估的概念

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-05-08 DOI: 10.1007/s00769-024-01594-x

Timo Kapp, Rudolf Hackenberg

{"title":"Concept for evaluating results close to the participants’ limits of quantification in proficiency tests for elements in food","authors":"Timo Kapp, Rudolf Hackenberg","doi":"10.1007/s00769-024-01594-x","DOIUrl":"10.1007/s00769-024-01594-x","url":null,"abstract":"<div><p>Proficiency testing (PT) in chemical analysis ideally provides participants with feedback on all aspects of laboratory performance. In the field of analysis of elements in food, analyte levels in test items are often close to the legal limits. Performance criteria such as those in Commission Regulation (EC) No. 333/2007 also refer to maximum values for limits of detection (LOD) and limits of quantification (LOQ), as well as to selectivity and control of contamination. Therefore, PTs with analyte levels in the range of LOD and LOQ are also very beneficial, as at these low levels, insufficient selectivity or contamination during sample preparation are more likely to affect the analytical results.</p><p>Since 2017, our unit has provided 7 PTs, each with at least one parameter (e.g. an element prone to contamination such as arsenic or mercury) with very low mass fractions. In these cases, the datasets showed a significant proportion of results reported as “< LOQ”, together with quantitative results as well.</p><p>If the “< LOQ”-values are predominant, calculation according to ISO 13528 is not feasible. Due to the wide range of the individual LOQs, the numerical use of the LOQs or a percentage of them is not appropriate. Therefore, we decided to sort the quantitative results and the “< LOQ” results numerically. We then determined the median and evaluated all quantitative results above the median as “false positive”, while all other results were evaluated as “true statement”. In this way, laboratories affected by contamination, for example, received appropriate feedback.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"397 - 403"},"PeriodicalIF":1.0,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01594-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140998619","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

New statistical framework for interlaboratory evaluation of anti-doping testing results by WADA 世界反兴奋剂机构对反兴奋剂检测结果进行实验室间评估的新统计框架

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-05-08 DOI: 10.1007/s00769-024-01595-w

Juris Meija, Antonio Possolo, Bruno Carius Garrido, Sanjana Kisoona, Osquel Barroso

引用次数: 0

A new proficiency testing scheme for occupational hygiene laboratories undertaking the analysis of diesel engine particulate emissions 职业卫生实验室分析柴油发动机微粒排放的新能力验证计划

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-05-07 DOI: 10.1007/s00769-024-01598-7

Owen Butler, James Forder

{"title":"A new proficiency testing scheme for occupational hygiene laboratories undertaking the analysis of diesel engine particulate emissions","authors":"Owen Butler, James Forder","doi":"10.1007/s00769-024-01598-7","DOIUrl":"10.1007/s00769-024-01598-7","url":null,"abstract":"<div><p>We report details of a proficiency testing (PT) scheme for laboratories undertaking the analysis of diesel engine particulates (DEP) collected on workplace air filter samples. Within this occupational hygiene setting, the established approach is to measure the elemental carbon (EC) content within DEP as a specific marker of workers’ exposure to engine emissions. Measuring EC is undertaken in laboratories using combustion-based analysers. To date six, PT rounds have been completed with participation ranging between thirteen and twenty-three laboratories. In each round participants received four quartz fibre filter samples (plus blank filters) loaded with DEP with indicative EC mass loadings in the range 9–204 µg/filter. Round assigned values and standard deviation for performance assessment values were calculated by consensus from returned participant data following outlier removal. On this basis, it was determined that on average 81 % of the returned data was deemed satisfactory, i.e. returning a <i>z</i> (or <i>z</i>’) score ≤ 2. The use of two operationally defined analytical protocols, namely NIOSH 5040 and EN 16909, now dominate but they give different EC values so the preparation of reference air filter samples with preordained EC values determined using both protocols for use in future interlaboratory comparisons is therefore recommended.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"391 - 395"},"PeriodicalIF":1.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01598-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002001","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

Certification of the total element mass fractions in UME EnvCRM 03 soil sample via a joint research project 通过联合研究项目认证 UME EnvCRM 03 土壤样本中的总元素质量分数

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-23 DOI: 10.1007/s00769-024-01597-8

Alper Isleyen, Suleyman Z. Can, Oktay Cankur, Betul Ari Engin, Jochen Vogl, Maren Koenig, Milena Horvat, Radojko Jacimovic, Tea Zuliani, Vesna Fajon, Aida Jotanovic, Luka Gaževic, Milena Milosevic, Maria Ochsenkuehn–Petropoulou, Fotis Tsopelas, Theopisti Lymberopoulou, Lamprini-Areti Tsakanika, Olga Serifi, Klaus M. Ochsenkuehn, Ewa Bulska, Anna Tomiak, Eliza Kurek, Zehra Cakılbahçe, Gokhan Aktas, Hatice Altuntas, Elif Basaran, Barıs Kısacık, Zeynep Gumus

{"title":"Certification of the total element mass fractions in UME EnvCRM 03 soil sample via a joint research project","authors":"Alper Isleyen, Suleyman Z. Can, Oktay Cankur, Betul Ari Engin, Jochen Vogl, Maren Koenig, Milena Horvat, Radojko Jacimovic, Tea Zuliani, Vesna Fajon, Aida Jotanovic, Luka Gaževic, Milena Milosevic, Maria Ochsenkuehn–Petropoulou, Fotis Tsopelas, Theopisti Lymberopoulou, Lamprini-Areti Tsakanika, Olga Serifi, Klaus M. Ochsenkuehn, Ewa Bulska, Anna Tomiak, Eliza Kurek, Zehra Cakılbahçe, Gokhan Aktas, Hatice Altuntas, Elif Basaran, Barıs Kısacık, Zeynep Gumus","doi":"10.1007/s00769-024-01597-8","DOIUrl":"10.1007/s00769-024-01597-8","url":null,"abstract":"<div><p>Soil certified reference material (CRM), UME EnvCRM 03 was produced by a collaborative approach among national metrology institutes, designated institutes and university research laboratories within the scope of the EMPIR project: Matrix Reference Materials for Environmental Analysis. This paper presents the sampling and processing methodology, homogeneity, stability, characterization campaign, the assignment of property values and their associated uncertainties in compliance with ISO 17034:2016. The material processing methodology involves blending a natural soil sample with a contaminated soil sample obtained by spiking elemental solutions for 8 elements (Cd, Co, Cu, Hg, Ni, Pb, Sb and Zn) to reach the level of warning risk monitoring values specified for metals and metalloids of soils in Europe. Comparative homogeneity and stability test data were obtained by two different institutes, ensuring the reliability and back up of the data. The certified values and associated expanded uncertainties for the total mass fractions of thirteen elements (As, Cd, Co, Cr, Cu, Fe, Hg, Mn, Ni, Pb, Sb, V and Zn) are established. The developed CRM can be used for the development and validation of measurement procedures for the determination of the total mass fractions of elements in soil and also for quality control/assurance purposes. The developed CRM is the first example of a soil material originating from Türkiye.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"293 - 301"},"PeriodicalIF":0.8,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140670292","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

Internal audit techniques for testing laboratories: ISO/IEC 17025:2017 perspective 检测实验室的内部审核技术：ISO/IEC 17025:2017观点

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-16 DOI: 10.1007/s00769-024-01592-z

Han-Min Ohn

{"title":"Internal audit techniques for testing laboratories: ISO/IEC 17025:2017 perspective","authors":"Han-Min Ohn","doi":"10.1007/s00769-024-01592-z","DOIUrl":"10.1007/s00769-024-01592-z","url":null,"abstract":"<div><p>Internal auditing is an important part of the ISO/IEC 17025:2017 standard. Clause 8.8 of the ISO/IEC 17025:2017 standard describes the requirements that the testing and calibration laboratories need to follow in the area of internal auditing. However, the standard does not describe which technique to use when conducting internal audits and the ISO 19011:2018 standard (Guidelines for Auditing Management Systems) only mentions the audit methods that can be used by an auditor, lacking practical aspects. Based on the internal auditing technique used, non-conformities that are present may or may not be detected. For example, technical competency of an analyst cannot be completely ascertained by just thoroughly reviewing the related documents such as training records. Therefore, it is important that internal auditors utilize appropriate techniques during an internal audit for it to be an effective one. Different internal auditors use different techniques during the audit. The commonest way internal auditors use is to develop a checklist (usually the one used by the accreditation body to which the laboratory is affiliated) for auditing the compliance to the ISO/IEC 17025:2017 management system and witnessing the technical competence of the technical staff. The aim of this article is to share the techniques utilized by the author during the internal auditing of ISO/IEC 17025:2017 accredited testing laboratories.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"263 - 266"},"PeriodicalIF":0.8,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140697184","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

Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches ISO/IEC 17025 国家控制实验室生物制品检测中的测量不确定性：实用方法

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-14 DOI: 10.1007/s00769-024-01589-8

Shalini Tewari, Niharika Trivedi, Sanchi Goel, Rashmi Shrivastava, Sudha V. Gopinath, Ayushi Khurana, Anupkumar R. Anvikar

引用次数: 0

The role of measurement uncertainty in the validation of a measurement procedure 测量不确定性在验证测量程序中的作用

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-13 DOI: 10.1007/s00769-024-01593-y

Fernando C. Raposo, Michael H. Ramsey

引用次数: 0

Proficiency testing in analytical chemistry, microbiology and laboratory medicine: discussions on current practice and future directions 分析化学、微生物学和检验医学中的能力测试：关于当前实践和未来方向的讨论

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-12 DOI: 10.1007/s00769-024-01588-9

Brian Brookman, Csilla Bélavári, Owen Butler, Raquel Múrtula Corbí, Monika Horsky, Heather Jordan, Caroline Laurent, Marina Patriarca, Ulla Tiikkainen, Kees van Putten, Piotr Robouch, Erika Sárkány, Angela Sorbo

{"title":"Proficiency testing in analytical chemistry, microbiology and laboratory medicine: discussions on current practice and future directions","authors":"Brian Brookman, Csilla Bélavári, Owen Butler, Raquel Múrtula Corbí, Monika Horsky, Heather Jordan, Caroline Laurent, Marina Patriarca, Ulla Tiikkainen, Kees van Putten, Piotr Robouch, Erika Sárkány, Angela Sorbo","doi":"10.1007/s00769-024-01588-9","DOIUrl":"10.1007/s00769-024-01588-9","url":null,"abstract":"<div><p>A summary of the working group discussions on proficiency testing (PT) and external quality assessment (EQA) held at the Eurachem proficiency testing Workshop, Windsor, during September 2023 is provided. The working groups covered a range of issues concerned with current practice and future directions: the revision of ISO/IEC 17043; guidance on different methods for setting the standard deviation for proficiency assessment; collusion or falsification of results in PT/EQA; comparison of synthetic versus real PT items; performance assessment in non-quantitative PT/EQA; and risk analysis approach for PT/EQA participation. The discussions at the working groups were aided by a keynote lecture given on each of the topics on the same day. Delegates from forty-five countries attended the workshop and this diversity of backgrounds was represented on each of the working groups, capturing a range of views and experience from around the world and from a number of different analytical measurement sectors. Most of the working group participants were PT/EQA providers, participants in PT/EQA schemes and representatives of national accreditation bodies, including technical assessors. In addition, delegates from academia, PT/EQA software developers and test kit manufacturers were also present.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"381 - 389"},"PeriodicalIF":1.0,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140711757","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

Comparison of continuous flow analysis and ion chromatography for determinations of nitrate, nitrite and phosphate ions in seawater and development of related seawater certified reference materials 比较连续流动分析法和离子色谱法测定海水中的硝酸盐、亚硝酸盐和磷酸盐离子，并开发相关的海水认证参考材料

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-04-10 DOI: 10.1007/s00769-024-01586-x

Chikako Cheong, Toshihiro Suzuki, Tsutomu Miura, Akiharu Hioki

引用次数: 0