Accreditation and Quality Assurance最新文献_第5页

Value assignment and uncertainty evaluation for certified reference gas mixtures 经认证的标准气体混合物的值赋值和不确定度评定

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-09-09 DOI: 10.1007/s00769-024-01614-w

Christina E. Cecelski, Jennifer Carney, Antonio Possolo

{"title":"Value assignment and uncertainty evaluation for certified reference gas mixtures","authors":"Christina E. Cecelski, Jennifer Carney, Antonio Possolo","doi":"10.1007/s00769-024-01614-w","DOIUrl":"10.1007/s00769-024-01614-w","url":null,"abstract":"<div><p>The procedures used to assign values to certified reference gas mixtures and to evaluate their associated uncertainties, which are described in ISO 6143, and that were variously improved by Guenther and Possolo (Anal Bioanal Chem 399:489–500, 2011. 10.1007/s00216-010-4379-z), are further enhanced by the following developments: (i) evaluating and propagating uncertainty contributions derived from comparisons with historical reference gas mixtures of similar nominal composition; (ii) recognizing and quantifying mutual inconsistency (dark uncertainty) between primary standard gas mixtures used for calibration; (iii) employing Bayesian procedures for calibration, value assignment, and uncertainty evaluations; and (iv) employing state-of-the-art methods of meta-analysis to combine cylinder-specific measurement results. These developments are illustrated in examples of certification of two gas mixture Standard Reference Materials developed by the National Institute of Standards and Technology (NIST, USA). These examples serve only to demonstrate the methods described in this contribution and do not replace any official measurement results delivered in the certificates of any reference materials developed by NIST.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 1","pages":"15 - 34"},"PeriodicalIF":0.8,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01614-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142994579","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

Quality control charts for short or long runs without a training phase. Part 2. Performances in the presence of a persistent systematic error and simultaneous small shifts in the mean and the variance 没有训练阶段的短跑或长跑的质量控制图。第2部分。存在持续的系统误差和同时存在均值和方差的小位移时的表现

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-09-04 DOI: 10.1007/s00769-024-01616-8

Manuel Alvarez-Prieto, Ricardo Páez-Montero

{"title":"Quality control charts for short or long runs without a training phase. Part 2. Performances in the presence of a persistent systematic error and simultaneous small shifts in the mean and the variance","authors":"Manuel Alvarez-Prieto, Ricardo Páez-Montero","doi":"10.1007/s00769-024-01616-8","DOIUrl":"10.1007/s00769-024-01616-8","url":null,"abstract":"<div><p>Sometimes, analytical laboratories receive requests with a small number of determinations and/or samples or outside the typical scope of analytical services. As a result, they may not have historical data on the performance of the required analytical procedures and/or appropriate reference materials. Under these conditions, it is difficult or uneconomical to use traditional quality control charts. This is the so-called start-up problem of these charts. Quesenberry’s Q charts are appropriate in these situations because they do not require a prior training phase. In the first part of this series of publications, the fundamentals and the algebraic expressions of the Q charts were presented for the individual measurements for the mean (four cases) and for the variance (two cases). This experimental study was carried out with data from quality control of mass fractions of Co in a serpentinite CRM and SiO<sub>2</sub> in a laterite CRM, by ICP-OES. The performance of Q charts is discussed in two situations: when the analytical process showed a clear systematic error from the beginning and when small shifts in mean and variance occurred simultaneously. In the first situation, performances of Q charts for the mean depended on the case: two of them were very sensitive even in the short run and the other two were insensitive and useless. In the second situation, the Q charts showed delayed alarms, but with a comparable behavior to the chart for individual measurements and the moving range of two. EWMA charts associated to Q charts were an excellent complement.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 1","pages":"35 - 44"},"PeriodicalIF":0.8,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142994435","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

A fit-for-purpose nongaseous impurity assay procedure for potential inorganic primary reference materials by inductively coupled plasma mass spectrometry 适用于电感耦合等离子体质谱法测定潜在无机一级参比物质的非杂质分析程序

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-09-02 DOI: 10.1007/s00769-024-01617-7

Jong Wha Lee, Hyung Sik Min, Jinil Kim, Kyoung-Seok Lee

{"title":"A fit-for-purpose nongaseous impurity assay procedure for potential inorganic primary reference materials by inductively coupled plasma mass spectrometry","authors":"Jong Wha Lee, Hyung Sik Min, Jinil Kim, Kyoung-Seok Lee","doi":"10.1007/s00769-024-01617-7","DOIUrl":"10.1007/s00769-024-01617-7","url":null,"abstract":"<div><p>Purity-evaluated inorganic materials, which are potential primary reference materials (PRMs) in chemistry, are crucial to the production of inorganic calibration solutions with metrological traceability to the International System of Units (SI). Purity evaluation is typically performed by individually assaying all possible impurities (gaseous and nongaseous) in a material, but technical challenges and the lack of resources are creating bottlenecks in developing effective purity assay procedures. This study describes a nongaseous impurity assay procedure developed and used at Korea Research Institute of Standards and Science (KRISS) to evaluate the purities of inorganic PRMs. Inductively coupled plasma mass spectrometry (ICP-MS) is used to assay more than 60 impurity elements in a single day, and external glow discharge mass spectrometry (GDMS) data are used to complement ICP-MS data. All aspects of the impurity assay procedure, including sample preparation, instrument operation, and data treatment, are described in detail. It is shown that the procedure is applicable to high-purity Al, As, Cu, NaCl, Se, Si, and Zn, and that a target relative uncertainty of 0.005 % for purity values can be satisfied even if individual impurity data are quite uncertain. Particular emphasis is on clearly specifying the measurand and target uncertainty for developing a fit-for-purpose assay procedure, as they determine the acceptable level of assay quality and help preventing misinterpretation of assay results.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 2","pages":"117 - 128"},"PeriodicalIF":0.8,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-024-01617-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143602187","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

Unlocking the secret to reliable leather test results: the importance of proficiency testing in establishing metrological traceability 揭开获得可靠皮革检测结果的秘密：能力验证对建立计量溯源的重要性

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-08-10 DOI: 10.1007/s00769-024-01612-y

Tabitha Orwa Ahuya

{"title":"Unlocking the secret to reliable leather test results: the importance of proficiency testing in establishing metrological traceability","authors":"Tabitha Orwa Ahuya","doi":"10.1007/s00769-024-01612-y","DOIUrl":"10.1007/s00769-024-01612-y","url":null,"abstract":"<div><p>Leather is a versatile and widely used material, employed in various products such as fashion, footwear, furniture and automotive industries. The quality of leather products is critical in ensuring their safety, durability and aesthetic value verified through reliable and accurate testing. However, obtaining reliable leather test results can be challenging due to the complexity of the material and the test methods involved. Metrological traceability is a significant aspect of quality assurance, for ensuring results are comparable, consistent and accurate over time and across different laboratories. This paper will look at how the Polymer Laboratory of Kenya Bureau of Standards’ Testing Services Department demonstrates metrological traceability of leather tear tests results.</p><p>The Laboratory identified ISO 3377-1:2011 [IULTCS/IUP 40 Leather—physical and mechanical tests—determination of tear load. International Organization for Standardization, Geneva, Switzerland] as the appropriate reference measurement procedure for determination of tear load. Leather fibre material obtained from cowhide was tested for single-edge tear, result obtained was 6.6 ± 0.7 N. This result was then compared to assigned value for tear (8.1 ± 0.64 N) obtained through consensus of results from participating laboratories all using reference measurement procedure ISO 3377-1:2011|IULTCS/IUP 40 [8]. This comparison allowed the Laboratory to establish a traceability chain that connects its measurement result and any associated uncertainties to the SI unit of force, i.e. newton (N) through calibrated equipment.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"441 - 444"},"PeriodicalIF":1.0,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141921066","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

Risk management: ten years of experience in the organization of the proficiency testing AQUA 风险管理：有十年组织测试AQUA的熟练经验

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-08-06 DOI: 10.1007/s00769-024-01613-x

Paola Carnieletto, Paola Perini, Silvia Benato, Riccardo Muliari, Cristina Silvestrin, Maria Grimaldi, Francesca Lega, Marzia Mancin

{"title":"Risk management: ten years of experience in the organization of the proficiency testing AQUA","authors":"Paola Carnieletto, Paola Perini, Silvia Benato, Riccardo Muliari, Cristina Silvestrin, Maria Grimaldi, Francesca Lega, Marzia Mancin","doi":"10.1007/s00769-024-01613-x","DOIUrl":"10.1007/s00769-024-01613-x","url":null,"abstract":"<div><p>Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe) organizes qualitative and quantitative proficiency testing (PT) schemes—in the frame of the AQUA project—in different fields of technical competence. AQUA schemes for <i>Salmonella</i>, rabies, and avian influenza are performed by the national and international reference centres hosted by IZSVe. These PT are accredited according to ISO/IEC 17043:2010, since 2012. This manuscript aims to illustrate the methodology used in mapping the AQUA activities, identifying risks, and evaluating the risk management strategies implemented over the past decade. The goal is to provide a practical example of our experience in effective risk management. The mitigation actions put in place demonstrated the ability of IZSVe to minimize identified risks or at least keep them under control. In order to revise the quality management system in accordance the ISO/IEC 17043:2023 standard within the planned three-year transition period, the Institute has completed the first step of the transition processes: conducting a gap analysis and definition of the transition plan. A significant enhancement in the new edition of the standard is the increased emphasis on risk analysis. The organization believes that the methodology outlined in this document is applicable to the new regulatory context; however, it will be necessary to re-evaluate the risks associated with to each process in light of the new requirements.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"433 - 439"},"PeriodicalIF":1.0,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145121557","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

Correction: Certification of the total element mass fractions in UME EnvCRM 03 soil sample via a joint research project 更正：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 : 2024-07-09 DOI: 10.1007/s00769-024-01611-z

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

引用次数: 0

The optimization approach for uncertainty assessment of the heating value of aviation fuel 航空燃料热值不确定性评估的优化方法

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-07-03 DOI: 10.1007/s00769-024-01610-0

Zhaoming Zhou, Shangchun Wei, Zijun Song, Jiayang Li

引用次数: 0

Appropriate statistical techniques when using consensus statistics to evaluate performance 在使用共识统计来评估绩效时使用适当的统计技术

IF 1 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-06-24 DOI: 10.1007/s00769-024-01607-9

Daniel Tholen, Piotr Robouch

{"title":"Appropriate statistical techniques when using consensus statistics to evaluate performance","authors":"Daniel Tholen, Piotr Robouch","doi":"10.1007/s00769-024-01607-9","DOIUrl":"10.1007/s00769-024-01607-9","url":null,"abstract":"<div><p>A large variety of statistical methods can be used for proficiency testing (PT) programs in various areas of laboratory testing. Statistical methods described in ISO 13528 and other international standards address PT in a wide variety of applications. The most significant difference in statistical techniques is whether performance evaluations are determined from the participant results using consensus statistics from the current round, or whether the performance criteria are determined independently. For schemes evaluated by consensus, the next most significant factor is the experience of both the scheme and its participants. This is evidenced in the proportion of results reported by participants who lack competence, are newly enrolled, or do not understand the instructions provided. For example, statistical techniques that are necessary for novel schemes (e.g. run for the first time) may not be appropriate for a similar scheme after several rounds with the same participants. Similarly, different techniques may apply for closed schemes that have regular technical review of a limited group of experienced laboratories. Techniques that make allowances for high levels of “contamination” from incompetent or inexperienced participants, such as the <i>z’</i> score with consensus assigned values, should not be used in experienced schemes using consensus statistics. Other techniques that are more sensitive to small systematic errors should be employed for closer monitoring of experienced laboratories, including statistical techniques that consider the measurement uncertainty of the results. Mature PT schemes and closed schemes for special purposes should evaluate the measurement uncertainty of participant results in any PT scheme used by laboratories that make decisions on conformity assessment, or where improvement of participant agreement is an objective for the scheme. Oversight bodies that require compliance with ISO/IEC 17043 should consider these recommendations, to better ensure global compatibility of measurements.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"425 - 431"},"PeriodicalIF":1.0,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145122321","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

Association between blood lead levels and socio-demographic factors among outpatient children in Ningbo, China 中国宁波门诊儿童血铅水平与社会人口因素的关系

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-06-24 DOI: 10.1007/s00769-024-01609-7

Chengbo Zhou, Wenbo Lu, Haiyan Qiu, Lihua Zhu, Jishan Zheng, Wenyuan Liu

{"title":"Association between blood lead levels and socio-demographic factors among outpatient children in Ningbo, China","authors":"Chengbo Zhou, Wenbo Lu, Haiyan Qiu, Lihua Zhu, Jishan Zheng, Wenyuan Liu","doi":"10.1007/s00769-024-01609-7","DOIUrl":"10.1007/s00769-024-01609-7","url":null,"abstract":"<div><p>Lead exposure is a well-known health concern, affecting children worldwide. We aim to assess children’s blood lead levels (BLLs), and the association of risk factors with elevated BLL in children since the phase-out of leaded gasoline. We enrolled 8085 outpatient children to assess their blood lead levels, and the associations with social-demographic factors. Social-demographic information was obtained by using questionnaires. Multivariable linear and logistic regression models were performed to explore the associations between social-demographic factors and elevated BLLs. The geometric mean BLL was 15.96 μg/L. The prevalence rates of elevated BLLs (≧ 100 μg/L and ≧ 50 μg/L) were 2.0 % and 10.9 %, respectively. BLLs in boys were higher than that in girls (<i>P</i> < 0.001). Girls had a lower risk of BLLs above 50 μg/L than boys (OR = 0.83, 95 % CI 0.71–0.96). Father’s occupation as a skilled laborer or professional worker and living in the suburbs significantly contributed to the elevated BLLs ( ≧ 50 μg/L), with the ORs of 1.39 (1.06–1.81), 1.33 (1.01–1.75) and 1.24 (1.02–1.50), respectively. Our results suggested that children who lived in suburbs and whose fathers were skilled laborers and professional workers were more likely to have BLLs above 50 μg/L.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"285 - 291"},"PeriodicalIF":0.8,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142413510","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

AQbD enabled method development and quantification of asiaticoside in foam-based formulations AQbD使泡沫配方中积雪草苷的方法开发和定量成为可能

IF 0.8 4区工程技术

Accreditation and Quality Assurance Pub Date : 2024-06-24 DOI: 10.1007/s00769-024-01608-8

Mohit Kumar, Anjali Pant, Shruti Chopra, Amit Bhatia

{"title":"AQbD enabled method development and quantification of asiaticoside in foam-based formulations","authors":"Mohit Kumar, Anjali Pant, Shruti Chopra, Amit Bhatia","doi":"10.1007/s00769-024-01608-8","DOIUrl":"10.1007/s00769-024-01608-8","url":null,"abstract":"<div><p>The purpose of this study was to develop a rapid, sensitive, and precise RP-HPLC (Reverse-Phase High-Performance Liquid Chromatography) method for the estimation of asiaticoside (AC) using the analytical quality by design (AQbD) approach. Initially, important AQbD prerequisites like analytical target profile (ATP) and critical analytical attributes (CAAs), such as theoretical plates and tailing factor, were defined. The final chromatographic conditions for the analysis of AC consist of stationary phase {A COSMOSIL 5C18-MS-II packed column (250 mm × 4.6 mm i.d, 5 µm)}, mobile phase was S<sub>mix</sub> {Methanol and Acetonitrile (40:25)}, and Orthophosphoric acid buffer (0.025 % OPA) in the ratio of 65:35 v/v at a flow rate of 1.0 mL/min and detection wavelength was 205 nm. The diversity in CAAs with different inputs was explained using the Ishikawa fishbone diagram. Taguchi design was selected as the first screening design to choose the critical material attributes (CMAs) that influence the method development. Subsequently, for more systematic optimization of the chromatographic technique and evaluation of CAAs, central composite design (CCD) was employed. In conclusion, the findings of the present study validated the utility of AQbD in the systemic design of a liquid chromatographic method with fine sensitivity for AC estimation in pharmaceutical products.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 1","pages":"67 - 82"},"PeriodicalIF":0.8,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142995584","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