Accreditation and Quality Assurance最新文献_第2页

Sampling in the context of conformity assessment 合格评定中的抽样

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-06-18 DOI: 10.1007/s00769-023-01542-1

Fernando Cordeiro, Michael H. Ramsey

引用次数: 0

Identifying risk management challenges in laboratories 识别实验室风险管理挑战

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-05-12 DOI: 10.1007/s00769-023-01540-3

Evdoxia Tziakou, Argyro G. Fragkaki, Agapios Ν. Platis

{"title":"Identifying risk management challenges in laboratories","authors":"Evdoxia Tziakou, Argyro G. Fragkaki, Agapios Ν. Platis","doi":"10.1007/s00769-023-01540-3","DOIUrl":"10.1007/s00769-023-01540-3","url":null,"abstract":"<div><p>Over the years, risk management gains significant importance in laboratories of every kind. The safety of workers, the accuracy and reliability of laboratory results, issues of financial sustainability as well as the protection of the environment play an important role in decision-making in both industry and services. In order a laboratory to be considered as reliable, safe, and therefore competitive, it is recommended to comply with the requirements of international standards and other regulatory documents as well as to use tools and risk management procedures. In this paper, information is summarized concerning the terms “risk” and “risk management” which are then approached through the latest ISO 9001, ISO/IEC 17025, and ISO 14001 standards. The process of risk management based on the ISO 31000 standard is described, the options for treatment and the techniques that can be applied in the risk management process based on the latest ISO 31010 standard are grouped and indicated. Additionally, information from the literature is referred to the reasons that led the laboratories to integrate in their quality system risk management techniques, the most common mistakes that occur in the various phases of laboratory tests, their causes, their consequences as well as the proposed treatments. The aim of this work is to highlight significant challenges concerning the need to implement management procedures in the daily routine, to warn, raise awareness and inform about existing ways of risk management that can be implemented, methodologically and technically, to laboratories, under internationally recognized and updated standards.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"28 4","pages":"167 - 179"},"PeriodicalIF":0.9,"publicationDate":"2023-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-023-01540-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4508915","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

The conception and initial years of a quality management system based on ISO/IEC 17025: an action research 基于ISO/IEC 17025的质量管理体系的概念和最初几年:行动研究

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-05-11 DOI: 10.1007/s00769-023-01539-w

Laura Neves de Jesus, Ricardo Batista Penteado, Fernando Costa Malheiros, Lucio Abimael Medrano Castillo, Luís Fernando Magnanini de Almeida

{"title":"The conception and initial years of a quality management system based on ISO/IEC 17025: an action research","authors":"Laura Neves de Jesus, Ricardo Batista Penteado, Fernando Costa Malheiros, Lucio Abimael Medrano Castillo, Luís Fernando Magnanini de Almeida","doi":"10.1007/s00769-023-01539-w","DOIUrl":"10.1007/s00769-023-01539-w","url":null,"abstract":"<div><p>This work presents research focused on obtaining and maintaining the ISO/IEC 17025 recognition in a Brazilian environmental analysis laboratory that acts as an environmental consultancy, providing services for the biological treatment of effluents. Three research cycles were conducted, covering the recognition preparation, surveillance period, and first reassessment preparation. The importance of considering both the technical and managerial aspects of this process is highlighted. In addition, it is fundamental to involve all employees in the process and reinforce the value of audits as an instrument for evaluating and improving the entire system. Despite the importance of the consultancy contracted to assist in the design of the management system, only with its effective use was it possible to improve the laboratory’s needs. Thus, the contribution of all collaborators to this process is fundamental. Despite the importance of “metrological networks” for encouraging a quality culture and accreditation in Brazil, greater rigor may be needed regarding the demand for systematic evidence of sustainable compliance and maturity of the management system. The recognition and accreditation challenges are the first, as the need to review and improve the Quality Management System is recurrent, whether due to the greater maturity of the laboratory or the identification of new opportunities.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"28 4","pages":"147 - 157"},"PeriodicalIF":0.9,"publicationDate":"2023-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4474009","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

From VIM3 toward the next edition of the International Vocabulary of Metrology 从VIM3到下一版的国际计量词汇

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-04-19 DOI: 10.1007/s00769-023-01538-x

Franco Pavese

引用次数: 0

Design and implementation of electronic reference material document system 电子参考资料文档系统的设计与实现

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-04-17 DOI: 10.1007/s00769-023-01537-y

Wang Bin, Ma Liandi, Lu Xiaohua

{"title":"Design and implementation of electronic reference material document system","authors":"Wang Bin, Ma Liandi, Lu Xiaohua","doi":"10.1007/s00769-023-01537-y","DOIUrl":"10.1007/s00769-023-01537-y","url":null,"abstract":"<div><p>Reference material (RM) documents are indispensable for proper use of reference materials, playing an important role in guiding users to store and use reference materials correctly. However, limitations have been found in paper documents of reference materials, such as waiting long for their preparation, high risk of loss, and lack of security measures. This paper describes the design and implementation of an information system for electronic reference material documents. Based on the varieties and batches of reference materials, the coding rules for two-dimensional codes of reference materials are formulated and employed to uniquely manage each unit of reference materials. A complete process of document template making, review and release has been designed as part of the manufacturing process for reference materials. Using the interface development function of major social media platforms, the method of generating and previewing documents by scanning the QR code on the label of a reference material with a mobile phone is designed. Users may view and download all electronic documents generated by their scanning through the special document management website page. The system has been implemented and is currently in use. Compared with paper documents, electronic documents have obvious advantages in uniqueness, security and convenience.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"28 4","pages":"139 - 146"},"PeriodicalIF":0.9,"publicationDate":"2023-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-023-01537-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4963687","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

Evaluation of the 1R6F certified reference cigarette for proficiency testing of mainstream smoke parameters 评估1R6F认证的参考卷烟对主流烟雾参数的能力测试

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-03-13 DOI: 10.1007/s00769-023-01534-1

Stacey Slone, C. Ruth McNees, Matt Craft, Huihua Ji, Andrew Shearer, Brent Shelton, Ling Yuan, Orlando Chambers

{"title":"Evaluation of the 1R6F certified reference cigarette for proficiency testing of mainstream smoke parameters","authors":"Stacey Slone, C. Ruth McNees, Matt Craft, Huihua Ji, Andrew Shearer, Brent Shelton, Ling Yuan, Orlando Chambers","doi":"10.1007/s00769-023-01534-1","DOIUrl":"10.1007/s00769-023-01534-1","url":null,"abstract":"<div><p>A goal of the cooperative agreement between the U.S. Food and Drug Administration and the Center for Tobacco Reference Products (CTRP) at the University of Kentucky was to produce a standard reference cigarette for researchers to further tobacco science. The 1R6F certified reference cigarette for analytical testing was developed to be typical of an American blend cigarette. The cigarettes have been used in proficiency testing (PT) schemes under the supervision of the CTRP since 2016 for a variety of parameters. Data were compared from 8 rounds of PT schemes submitted by participating laboratories, which include various international stakeholders comprised of academic institutions, federal research/regulatory laboratories, tobacco product manufacturers, and independent contract testing laboratories. Evaluation of the datasets for harmful and potentially harmful constituents (HPHCs) within the mainstream smoke of the 1R6F certified reference cigarette included tobacco-specific nitrosamines (TSNA), tar, nicotine, and carbon monoxide (TNCO), and Benzo[<i>α</i>]pyrene (B<i>α</i>P). Of the datasets evaluated, less than 5 % resulted in either a warning or alert, and less than 2 % resulted in an alert. Comparisons across multiple PT rounds revealed no significant differences in the consensus means of the tested parameters. Evaluation of data submitted by participating laboratories for multiple proficiency test rounds shows that the 1R6F certified reference cigarette is an acceptable material as a control reference for the analysis of HPHCs which is imperative since some stakeholders may be required to participate in, and receive satisfactory results, from PT for accreditation purposes.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"28 2","pages":"69 - 76"},"PeriodicalIF":0.9,"publicationDate":"2023-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-023-01534-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4549308","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

Correction to: Improving performance evaluation via the provision of proficiency testing programmes in Asia–Pacific with metrologically traceable reference values for inorganic elements 更正:通过在亚太地区提供具有计量可追溯的无机元素参考值的能力测试计划，改善绩效评估

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-03-07 DOI: 10.1007/s00769-023-01536-z

Yiu-Tung Wong, Alvin Wai-Hong Fung, Yiu‑Chung Yip, Della Wai-Mei Sin

引用次数: 0

Paul De Bievre down under: practical metrology in chemistry and its principles 保罗·德·比夫尔:化学中的实用计量学及其原理

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-03-04 DOI: 10.1007/s00769-023-01535-0

Gary Price

引用次数: 0

On the optimal use of silver–silver chloride reference electrodes 银-氯化银参比电极的最佳使用

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-02-07 DOI: 10.1007/s00769-023-01533-2

Igor Maksimov, Toshiaki Asakai, Masaki Ohata

引用次数: 0

Laboratory glassware cleaning validation in pharmaceutical industry: a case study 制药行业实验室玻璃器皿清洁验证:案例研究

IF 0.9 4区工程技术

Accreditation and Quality Assurance Pub Date : 2023-02-06 DOI: 10.1007/s00769-023-01531-4

Linda Belgacem, Redouane Amine Cherif

{"title":"Laboratory glassware cleaning validation in pharmaceutical industry: a case study","authors":"Linda Belgacem, Redouane Amine Cherif","doi":"10.1007/s00769-023-01531-4","DOIUrl":"10.1007/s00769-023-01531-4","url":null,"abstract":"<div><p>Glassware cleaning is an essential part of pharmaceutical industry’s quality process, although, to date, no precise methodology is recommended by the pharmaceutical regulations. This study focuses on developing a detailed validation procedure for laboratory glassware cleaning and applying it routinely in quality control labs. The first step was the determination of the worst-case among raw materials controlled on a pharmaceutical site by using the failure mode effects analysis (FMEA) approach based on water solubility (WS), flask volume (FV), concentration (C), detectability (D) according to the absorptivity, and the probability (P) of the occurrence of the risk based on raw material analysis frequency. The adopted manual cleaning method was validated on three series of six flasks. Absorbances at <i>λ</i><sub>max</sub> of cleaned and worst-case flasks were compared to the limit of detection (LOD). Methylparaben was found to be the worst-case. Cleaning validation was carried out on 50 mL flasks containing aqueous solutions at 0.11 g/L after a contact time of 20 min under stirring. A prewash with tap water, a proper wash with a 95-V/5-V water/detergent solution (quaternary ammonium), and a final wash with purified water were carried out. The absorbances of all the cleaned flasks were lower than those of the worst-case LOD (< 0.0112). The selected cleaning procedure has been successfully validated. The proposed approach precisely describes the steps to be followed and can be adapted by other pharmaceutical industries as part of their laboratory glassware cleaning validation methodology.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"28 2","pages":"59 - 64"},"PeriodicalIF":0.9,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4248768","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: 2