Accreditation and Quality Assurance最新文献

{"title":"Points to consider when establishing an equipment calibration programme in a conventional food microbiology laboratory for ISO/IEC 17025:2017 accreditation purpose","authors":"Han-Min Ohn","doi":"10.1007/s00769-024-01606-w","DOIUrl":"10.1007/s00769-024-01606-w","url":null,"abstract":"<div><p>For a laboratory following the ISO/IEC 17025:2017 standard, establishing a calibration programme is a requirement as per Clause 6.4.7. Clause 6.4.6. of the ISO/IEC 17025:2017 standard states that measuring equipment shall be calibrated when its measurement accuracy or measurement uncertainty affects the validity of the test results and/or when establishment of the metrological traceability of the test results is required. Equipment commonly used in a conventional food microbiology laboratory include biosafety cabinets or laminar flow cabinets, balances, diluters, homogenizers or blenders or mixers, pH meters, autoclaves, incubators, refrigerators, freezers, deep freezers, thermostatically controlled water baths, sterilizing ovens, temperature-monitoring devices such as thermometers, micropipettes, dispensers, vortex mixers, centrifuges, hot plates, and stop watches. The standard ISO 7218:2007/Amd 1:2013 provides guidance on which equipment requires calibration but sometimes, the accreditation body establishes more stringent guidelines which the conformity assessment body needs to follow. So, equipment that requires calibration may differ between conventional food microbiology laboratories accredited by different accreditation bodies. In this practitioner’s report, the author discusses the points a conventional food microbiology laboratory needs to consider when establishing a calibration programme.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"319 - 325"},"PeriodicalIF":0.8,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141337405","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}

{"title":"Approaches for the production of reference materials with qualitative properties—The new International Standard ISO 33406","authors":"Stefanie Trapmann,&nbsp;Stephen L. R. Ellison,&nbsp;W. Clay Davis,&nbsp;Antonio Possolo,&nbsp;Jiang Zheng,&nbsp;Angelique Botha","doi":"10.1007/s00769-024-01602-0","DOIUrl":"10.1007/s00769-024-01602-0","url":null,"abstract":"<div><p>The number of reference materials (RMs), including certified reference materials (CRMs) characterized for qualitative properties, has steadily increased in recent years. In response, the Technical Committee for Reference Materials of the International Organization for Standardization, ISO/TC 334, developed ISO 33406 to provide guidance to reference material producers (RMPs) on producing qualitative RMs. ISO 33406 builds on the general requirements in ISO 17034:2016 for RMP competence and offers specific guidance on value assignment, assessment of homogeneity and stability, statement of metrological traceability, and measurement uncertainty evaluation for RMs with qualitative property values.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"269 - 276"},"PeriodicalIF":0.8,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01602-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141345892","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}

{"title":"Application of ISO 16140-3:2021 standard to verify compact dry BC method in a single food microbiology laboratory","authors":"Han-Min Ohn,&nbsp;Zon-Zin-Wai-Hlaing Thwin,&nbsp;Aye-Hsu Lae,&nbsp;Khin-Mar Win,&nbsp;Moe-Moe Aye,&nbsp;Moh-Moh Lwin,&nbsp;Tin-Tin Nwe,&nbsp;Nyein-Nyein Chaw,&nbsp;Thazin Khet,&nbsp;Myat-Mon Khaing,&nbsp;San-San Nwe,&nbsp;Hla-Hla Htay,&nbsp;Yan Aye,&nbsp;Shwe-Sin Hlaing,&nbsp;Theingi Zin,&nbsp;Khin Zaw","doi":"10.1007/s00769-024-01604-y","DOIUrl":"10.1007/s00769-024-01604-y","url":null,"abstract":"<div><p>According to clause 7.2.1.5, it is essential that a laboratory that follows the ISO/IEC 17025:2017 standard verifies standard methods or validated alternative methods before it starts using them. In 2021, the International Standard Organization published the ISO 16140-3:2021 standard. This standard provides guidelines for verification of reference methods and validated alternative methods in a single food microbiology laboratory. By using the guidelines provided in the standard, we performed the method verification of Compact Dry BC, a ready-to-use media for quantification of <i>Bacillus cereus</i> in foods or raw materials. This Compact Dry BC method was validated by MicroVal according to the ISO 16140-2:2016 standard and revealed to be at least equivalent to the reference method “ISO 7932: 2004—Microbiology of food and animal feeding stuffs—Horizontal method for the enumeration of presumptive <i>Bacillus cereus</i>—Colony count technique at 30 °C”. For implementation verification, the laboratory selected dried infant formula samples, while for food item verification, the laboratory chose dried infant formula, canned fish, breakfast cereal, sliced meat and pie samples. Intralaboratory reproducibility standard deviation (<i>S</i>_IR) obtained by the laboratory was 0.055 log₁₀ CFU, while the acceptable <i>S</i>_IR is ≤ 0.341 log₁₀ CFU. Estimated bias (eBias) for dried infant formula, canned fish, breakfast cereal, sliced meat and pie samples were also found to be ≤ 0.5 log₁₀ CFU for low, medium, and high inoculum levels. Therefore, as per the criteria set by the ISO 16140-3:2021 standard, the Compact Dry BC method is suitable to use in our laboratory for enumeration of presumptive <i>B. cereus</i> in a broad range of food.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"311 - 317"},"PeriodicalIF":0.8,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141355056","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}

{"title":"The issue of reporting the measurement uncertainty in accredited tests","authors":"Ricardo J. N. Bettencourt da Silva","doi":"10.1007/s00769-024-01603-z","DOIUrl":"10.1007/s00769-024-01603-z","url":null,"abstract":"<div><p>The globalisation of trade and environmental and health requirements, supported by the physical–chemical characterisation of relevant items, have promoted relevant evolutions on how test laboratories report results from their analysis. The relevance of reporting measurement results from the characterisation of these items with the measurement uncertainty is unquestionable to guarantee determinations are adequately uncertain and the objective interpretation of analytical information. The latest edition of the ISO/IEC 17025 standard, which supports the International Accreditation of test laboratories, even mentions the need to manage the impact of measurement uncertainty in the risk of false conformity assessments. Some accreditation bodies have considered this novelty and the reiteration that measurement results should be reported with the measurement uncertainty to make reporting the measurement uncertainty mandatory. This correct interpretation of the accreditation standard and society's expectations regarding the role of laboratories in the management of the most relevant interests of the community should be generalised.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"329 - 330"},"PeriodicalIF":0.8,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141382570","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}

{"title":"Carbon monoxide proficiency testing scheme with metrological traceability","authors":"Florencia Almirón,&nbsp;Simone Fajardo,&nbsp;Victoria Gelabert,&nbsp;Elizabeth Ferreira,&nbsp;Michela Sega,&nbsp;Mariela Medina","doi":"10.1007/s00769-024-01600-2","DOIUrl":"10.1007/s00769-024-01600-2","url":null,"abstract":"<div><p>This paper details the activities carried out by the Chemical Metrology Department of LATU in the development of a national proficiency testing (PT) scheme aimed at assessing the competence of laboratories in air quality parameters analysis. In this PT scheme, environmental monitoring laboratories were required to determine the concentration of elements in quartz-grade microfiber filters and impinger solutions, as well as to determine the amount fraction of a carbon monoxide in nitrogen gas mixture, within the range of (800 to 1700) µmol/mol. The focus of the present paper is mainly devoted to the second phase of the test, which addresses the preparation of the gas cylinder distributed to each participant for measurement. A detailed description of this stage is provided, along with the evaluation of the results reported by participating laboratories. This test provided an effective tool for participating laboratories to assess their national technical competence, using their preferred analysis methods.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"305 - 309"},"PeriodicalIF":0.8,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141118865","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}

{"title":"Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development","authors":"Kiranmayi Sathuluri,&nbsp;RamyaSri Bakam,&nbsp;Riya Jain,&nbsp;Aishwarya Dande,&nbsp;Rahul Gajbhiye,&nbsp;V. Ravichandiran,&nbsp;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}

{"title":"Certification of the total element mass fractions in UME EnvCRM 03 soil sample via a joint research project","authors":"Alper Isleyen,&nbsp;Suleyman Z. Can,&nbsp;Oktay Cankur,&nbsp;Betul Ari Engin,&nbsp;Jochen Vogl,&nbsp;Maren Koenig,&nbsp;Milena Horvat,&nbsp;Radojko Jacimovic,&nbsp;Tea Zuliani,&nbsp;Vesna Fajon,&nbsp;Aida Jotanovic,&nbsp;Luka Gaževic,&nbsp;Milena Milosevic,&nbsp;Maria Ochsenkuehn–Petropoulou,&nbsp;Fotis Tsopelas,&nbsp;Theopisti Lymberopoulou,&nbsp;Lamprini-Areti Tsakanika,&nbsp;Olga Serifi,&nbsp;Klaus M. Ochsenkuehn,&nbsp;Ewa Bulska,&nbsp;Anna Tomiak,&nbsp;Eliza Kurek,&nbsp;Zehra Cakılbahçe,&nbsp;Gokhan Aktas,&nbsp;Hatice Altuntas,&nbsp;Elif Basaran,&nbsp;Barıs Kısacık,&nbsp;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}

{"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}

{"title":"Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches","authors":"Shalini Tewari,&nbsp;Niharika Trivedi,&nbsp;Sanchi Goel,&nbsp;Rashmi Shrivastava,&nbsp;Sudha V. Gopinath,&nbsp;Ayushi Khurana,&nbsp;Anupkumar R. Anvikar","doi":"10.1007/s00769-024-01589-8","DOIUrl":"10.1007/s00769-024-01589-8","url":null,"abstract":"<div><p>The challenges in estimating measurement uncertainty in the complex matrix of biological systems, while doing compliance testing by National Control Laboratories and its importance in meeting ISO/IEC 17025 requirements are emphasised. Two primary approaches for MU, the bottom-up and top-down approaches, are discussed. Highlighting the significance of accurate estimations in NCLs, it advocates the use of a top-down approach by leveraging available quality control data and control charts for precision and bias assessment and balancing regulatory compliance to ensure the product quality and its timely release into the market, while complying with accreditation standards.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"253 - 261"},"PeriodicalIF":0.8,"publicationDate":"2024-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140705168","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}

{"title":"The role of measurement uncertainty in the validation of a measurement procedure","authors":"Fernando C. Raposo,&nbsp;Michael H. Ramsey","doi":"10.1007/s00769-024-01593-y","DOIUrl":"10.1007/s00769-024-01593-y","url":null,"abstract":"","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"267 - 267"},"PeriodicalIF":0.8,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140707951","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}