Accreditation and Quality Assurance最新文献

{"title":"A comprehensive intra-laboratory ranking method for multi-component proficiency testing combining Z-score grouping and polygon area","authors":"Tao Song,&nbsp;Jin Shi,&nbsp;Qiuyan Lu,&nbsp;Jian Lin,&nbsp;Wusheng Fu,&nbsp;Hongjing Chen","doi":"10.1007/s00769-026-01700-1","DOIUrl":"10.1007/s00769-026-01700-1","url":null,"abstract":"<div><p>To establish an evaluation method for multi-component proficiency testing results. The proposed approach will utilize multi-element proficiency testing as an example. The data presented herein were derived from the 2023 proficiency testing results for nine elements in soybean meal. The methodological approach is outlined as follows: first, the 78 laboratories were then classified into three tiers based on the results of the z-score analysis. In order to determine the ranking of elements within each group, the standard deviation of each element’s test results must first be calculated. This calculation should be performed for Class I, Class II and Class III. The element ranking within each group is then determined based on the ascending order of standard deviation. Subsequently, a polygon radar chart should be constructed of the absolute values of Z-scores for all nine elements within each group. The polygon’s area should then be calculated precisely using the ‘sf’ package in R. The area value should then be defined as a comprehensive indicator for evaluating laboratory capability. Finally, the polygons should be ranked by area within each group from smallest to largest in order to determine the final laboratory rankings. The present study establishes a comprehensive intra-group laboratory ranking method combining Z-score grouping and polygon area analysis, thereby supplementing and enhancing the evaluation approach outlined in ISO 13528:2022.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"169 - 175"},"PeriodicalIF":1.0,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571172","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":"Impact of customer satisfaction on the implementation of ISO 9001:2015 in a chemical laboratory using the SERVQUAL model","authors":"Susan Montes-Bujaico,&nbsp;Oliver Taype-Landeo,&nbsp;Richerson Piscoche-Chinchay,&nbsp;Lucia Pantoja-Tirado","doi":"10.1007/s00769-026-01699-5","DOIUrl":"10.1007/s00769-026-01699-5","url":null,"abstract":"<div><p>Service quality is a determining factor in the competitiveness of analytical laboratories. The objective of this study was to evaluate the impact of the progressive implementation of a quality management system (QMS) in accordance with ISO 9001:2015 on customer satisfaction in a chemical analysis laboratory in Lima. A pre-experimental longitudinal design was used. Customer satisfaction was measured monthly using a questionnaire adapted from the SERVQUAL model. The analysis included descriptive statistics, Student’s t-test for related samples, and Poisson regression for complaints. The results showed statistically significant and meaningful improvements across all SERVQUAL dimensions, with the greatest increases in credibility (50% to 85%) and service personalization (45% to 80%). Overall satisfaction increased from 46 to 97%. Documentary compliance rose from 33 to 98%, and monthly complaints decreased markedly during the study period. These findings indicate that systematic measurement of customer satisfaction, integrated with quality management requirements, effectively enhances perceived service quality in chemical laboratories.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"159 - 168"},"PeriodicalIF":1.0,"publicationDate":"2026-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571174","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":"Development and validation of RP-HPLC method for simultaneous determination of brimonidine and timolol with impurity profiling and forced degradation: application of green tools—AES, AGREE, MoGAPI, RAPI, and BAGI","authors":"Harmeet Kaur Kohli,&nbsp;Satish K. Ghumare,&nbsp;Vijay A. Bagul","doi":"10.1007/s00769-026-01697-7","DOIUrl":"10.1007/s00769-026-01697-7","url":null,"abstract":"<p>Organic impurity tests are primarily employed for identification and accurate quantification, serving as critical indicators for assessing the quality of medicines and detecting potential substandard or adulterated products. In the given research work, we endorse a sensitive RP-HPLC technique for simultaneous impurities quantification of brimonidine tartrate and timolol maleate present in available drug product. A simultaneous chromatographic separation was performed on Waters X select CSH Phenyl Hexyl, 150 mm × 4.6 mm, 3.5 µm column while using gradient flowing phase comprised of octane-1-sulfonic acid sodium salt buffer pH 3.0, methanol and acetonitrile. With the photodiode array, detection was set at 248 nm for brimonidine tartrate, 295 nm for timolol maleate and their related impurities. In this developed method, injection repeatability for organic impurity analysis was 3.0 % for brimonidine and 0.7 % for timolol, demonstrating reliable precision. A resolution greater than 3.0 was achieved between both the drugs and their related impurities. Linearity was established over 0.2–3.0 μg/mL for brimonidine and 0.5–7.5 μg/mL for timolol, with correlation coefficients of <i>r</i>² = 0.9997. Resembling linearity was marked for their impurities. The LOD and LOQ for brimonidine with impurities were 0.07 and 0.20 μg/mL, respectively. In case of timolol, timolol impurity B and impurity G, the LOD/LOQ values were 0.17/0.50, 0.19/0.50 and 0.09/0.27 μg/mL, respectively. Precision (∆ ≤ 5 %) and accuracy (90–110 % recovery) demonstrated the suitability of the method for related substances analysis. The stability-indicating capability of the method was demonstrated through stress testing under hydrolytic, thermal, photolytic, acid–base, and oxidative conditions, with pronounced degradation observed under photolytic, basic, and oxidative stresses. Method suitability, efficiency, and environmental impact were assessed using established green-metric tools aligned with green analytical chemistry principles, including the Analytical Eco-Scale (AES), AGREE, and the Modified Green Analytical Procedure Index (MoGAPI). Complementary Red–Green–Blue (RGB) model tools—namely the Red Analytical Performance Index (RAPI) and the Blue Applicability Grade Index (BAGI)—were also applied to provide a comprehensive evaluation of method performance and applicability. Such stability-indicating methods are essential for impurity profiling, drug stability assessment, quality control, and regulatory submissions.</p>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"119 - 146"},"PeriodicalIF":1.0,"publicationDate":"2026-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571169","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":"An adaptive Monte Carlo method for evaluating uncertainty in confidence level of non-targeted principal component analysis classification","authors":"Ting Huang,&nbsp;Wei Li,&nbsp;Wei Zhang,&nbsp;Huan Yao","doi":"10.1007/s00769-026-01698-6","DOIUrl":"10.1007/s00769-026-01698-6","url":null,"abstract":"<div><p>In non-targeted chemical analysis, quantifying the uncertainty associated with classification confidence remains challenging. Guided by metrological standards, this study introduces an adaptive Monte Carlo method to evaluate the uncertainty in principal component analysis (PCA) and <i>K</i>-means clustering. This approach addresses the limitations of traditional methods in handling uncertainty propagation through high-dimensional data reduction and complex classification algorithms. Using proton nuclear magnetic resonance spectra of natural and artificial cream samples, eight confidence-level calculation methods were implemented and compared. The results identified the SIMCA (Soft Independent Modeling of Class Analogy) weighted averaging method as the optimal approach, followed by the Mahalanobis distance method. To ensure computational stability during extensive Monte Carlo simulations (over 10000 iterations), three novel techniques were introduced: standardization of PCA direction, standardization of cluster numbering (the “minimum-index sorting” method), and a method for handling and reporting the misclassification rate. The relationship between computational precision (defined by the significant figures of standard deviation) and efficiency was investigated, providing practical guidance for balancing accuracy and computational cost. This optimal ranking was further validated across different sample matrices (cream and oil) and classification complexities (2- and 3-cluster), confirming the general robustness of the framework. This work establishes a robust framework for uncertainty evaluation in non-targeted chemical classification, offering a new tool for chemical metrology.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"147 - 158"},"PeriodicalIF":1.0,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571175","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":"Efficient production of GMO certified reference materials in compliance with ISO 17034 requirements","authors":"Stefanie Trapmann,&nbsp;Mohamed Khaled Gijón,&nbsp;Thomas P. J. Linsinger","doi":"10.1007/s00769-025-01694-2","DOIUrl":"10.1007/s00769-025-01694-2","url":null,"abstract":"<div><p>Certified reference materials (CRMs) play a crucial role in ensuring the quality of analytical measurements. Their regular use is therefore essential for ISO/IEC 17025 accredited laboratories. CRMs can also be essential for implementation of EU legislation. The EU labelling legislation on genetically modified organisms (GMOs) in food and feed products relies on having a validated quantitative and event-specific method and GMO CRMs available. GMO CRMs and validated method together form the EU reference system for the quantification of GMO events in food and feed products. Together, they ensure that a common GMO labelling threshold for in the EU authorized GMOs is implemented. The Joint Research Centre (JRC) of the European Commission produced GMO CRMs under ISO 17034 accreditation on request of biotech companies. These GMO CRMs play a crucial role in the EU authorization process. This article summarizes the measures taken to improve the efficiency of the production of GMO CRM, while ensuring the requirements of ISO 17034. An outlook is given on how GMO CRM production could, based on JRC’s experience, be further streamlined. This information may be useful for reference material producers (RMPs) in general and more specifically if they produce CRMs according to ISO 17034. It may help them to make CRMs available in a timely manner.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"91 - 100"},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-025-01694-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571170","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":"Proficiency tests for the detection of Cronobacter spp. and Salmonella spp. in milk powder","authors":"Colin Howell,&nbsp;Romain Le Neve,&nbsp;Anne Tirard,&nbsp;Sandrine Nguyen,&nbsp;Abdelkader Boubetra","doi":"10.1007/s00769-025-01695-1","DOIUrl":"10.1007/s00769-025-01695-1","url":null,"abstract":"<div><p>The contamination of milk powder by pathogens such as <i>Cronobacter</i> spp. and <i>Salmonella</i> spp. represents a major public health risk, particularly as the primary consumers of milk powder, infants, have heightened vulnerability to bacterial infection. In the face of this danger, analytical laboratories should implement and practice suitable methods for the detection of these microorganisms with high specificity and sensitivity. For this reason, BIPEA (Bureau Interprofessionnel d’Études Analytiques) launched a new proficiency testing program for the detection of <i>Cronobacter</i> spp. in samples of milk powder in 2019, and detection of <i>Salmonella</i> spp. in the same samples was added to these tests in 2023. This paper presents the design and implementation of the program, as well as a detailed analysis of laboratory results and systems for the evaluation of qualitative proficiency testing performances. Results from these tests are encouraging, as the majority of laboratories are able to correctly identify both contaminated and uncontaminated samples. Participation in proficiency testing programs is an important quality control tool for analytical laboratories to assess and demonstrate their competence to carry out these microbiological analyses, which are critical for public health, and one of the ways to monitor their performance as per the requirements of the ISO/IEC 17025:2017 standard.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"111 - 118"},"PeriodicalIF":1.0,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571171","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":"Calibration slope-governed uncertainty framework resolves method conflicts in pharmacopeial copper compliance testing of paeoniae radix alba","authors":"Yingjuan Gao","doi":"10.1007/s00769-025-01692-4","DOIUrl":"10.1007/s00769-025-01692-4","url":null,"abstract":"<div><p>Despite having achieved a consensus on the copper PDE (10 µg/day) for oral preparations, major pharmacopeias (ChP, USP, EP, JP) lack uniformity in their recommended analytical protocols. For instance, a conflict exists between USP &lt; 233 &gt; , which designates ICP-based methods as primary, and EP Chapter 2.4.20, which accepts both AAS and ICP techniques. This lack of a unified standard thereby constitutes a key source of inter-laboratory discrepancies, particularly for concentrations near the critical 10 mg/kg compliance threshold. Pharmacopeial copper quantification near regulatory thresholds (e.g., 10 mg/kg) is challenged by method conflicts: high-sensitivity techniques (e.g., ICP-MS) amplify calibration uncertainties, while traditional methods risk false compliance. This study establishes a Linearity-Sensitivity-Uncertainty (LSU) framework to quantify slope-modulated error propagation and resolve these conflicts. Copper was quantified in <i>Paeoniae Radix Alba</i> certified reference material (CRM 9.60 ± 0.62 mg/kg) using microwave, wet, and dry digestion coupled with flame atomic absorption spectrometry (FAAS) or inductively coupled plasma mass spectrometry (ICP-MS). Method performance (accuracy, precision, LOD, LOQ) and measurement uncertainty (following GUM/EURACHEM) were evaluated. The LSU framework introduced the error amplification factor (<span>(K=frac{1}{b})</span>) to quantify slope-modulated uncertainty. Microwave digestion FAAS achieved optimal accuracy at 10 mg/kg (bias: -0.03 mg/kg; expanded uncertainty <span>(U=0.35)</span> mg/kg, <span>(k=2)</span>). ICP-MS, despite 1000-fold lower LOD (0.0005 mg/kg), exhibited 1.93-fold higher error amplification (<span>({K}_{ICP-MS}=13.49)</span> vs.<span>({K}_{FAAS}=7.00)</span>) due to its lower slope (<span>({b}_{ICP-MS}=0.0741)</span> vs.<span>({b}_{FAAS}=0.14288)</span>), elevating U to 3.70 mg/kg. Linearity-derived uncertainty dominated (&gt; 98 %) the uncertainty budget. Dry ashing degraded slope integrity (<span>(b)</span>↓5.5 %, RSD = 3.7 %), increasing U by 29 % and causing false-positive exceedance (10.05 &gt; 10.00 mg/kg). Conclusion: The LSU framework reconciles sensitivity-reliability conflicts by quantifying slope-governed uncertainty propagation (<span>(Upropto =frac{1}{b})</span>). It mandates slope-centric calibration, method-concentration zoning (FAAS for limits, ICP-MS for traces levels &lt; 0.5 mg/kg), and slope stability criteria. This mechanistic approach reduced false-positive risk by 29 % (<i>p</i> &lt; <i>0.01</i>) compared to traditional methods, advancing pharmacopeial compliance testing standards.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 2","pages":"101 - 109"},"PeriodicalIF":1.0,"publicationDate":"2026-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147571173","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":"Correction: Validation of an adjusted Evelyn–Malloy method for spectrophotometric assay of methemoglobin and preparation of quality control standards","authors":"F. Z. Saadi,&nbsp;S. Bouazza,&nbsp;H. Rezk-kallah","doi":"10.1007/s00769-025-01693-3","DOIUrl":"10.1007/s00769-025-01693-3","url":null,"abstract":"","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 1","pages":"55 - 55"},"PeriodicalIF":1.0,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147337029","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":"Proficiency testing of temperature and relative humidity in clean environments: evaluation of inspection and testing organizations in china","authors":"Lin Tian,&nbsp;Langui Xie,&nbsp;Yanjun Zhao,&nbsp;Xia Zhao,&nbsp;Huimin Sun","doi":"10.1007/s00769-025-01689-z","DOIUrl":"10.1007/s00769-025-01689-z","url":null,"abstract":"<div><p>Objective: To design and implement a proficiency testing (PT) scheme for evaluating the competence of inspection agencies in measuring temperature and relative humidity (RH) in clean environments. The study assesses laboratories’ mastery of testing standards and their operational proficiency with thermohygrometers. Methods: The PT combined a written examination (evaluating theoretical knowledge of standards) and a field assessment (assessing instrument operation and field testing accuracy). Homogeneity of temperature and RH samples was verified using relative standard deviation (RSD). Participant performance was scored using weighted criteria: the written examination (40 points) and field test (<i>z</i>-score evaluation, 60 points). Results: Sample homogeneity met PT requirements. All 54 participating laboratories achieved satisfactory results (100% satisfaction rate). Field test <i>z</i>-scores indicated high consistency: 98.1% of temperature results (|<i>z</i>|≤ 2) and 94.4% of RH results (|<i>z</i>|≤ 2) fell within satisfactory ranges. Conclusion: Laboratories demonstrated robust testing capabilities, though improvements are recommended in standard interpretation and instrument calibration practices. This PT framework establishes a novel quality assessment method for pharmaceutical clean environments and serves as a reference for similar evaluations.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 1","pages":"27 - 35"},"PeriodicalIF":1.0,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-025-01689-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147342645","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":"Evaluation of measurement uncertainties in quantifying urinary aripiprazole and dehydroaripiprazole via isotope dilution–LC–MS/MS","authors":"Yeong Eun Sim,&nbsp;Jeong Eun Kim,&nbsp;Ji Woo Kim,&nbsp;Jin Young Kim","doi":"10.1007/s00769-025-01690-6","DOIUrl":"10.1007/s00769-025-01690-6","url":null,"abstract":"<div><p>The monitoring of medication compliance is essential in managing probationers with mental disorders. With the increasing prescription of aripiprazole (APZ), which is a third-generation atypical antipsychotic, a rapid, reliable analytical method for verifying its presence in urine is critically necessary. This study established a comprehensive uncertainty budget for quantifying APZ and its metabolite, dehydroaripiprazole (DAPZ), in urine using isotope dilution–liquid chromatography-tandem mass spectrometry (ID<b>–</b>LC<b>–</b>MS/MS). After a straightforward dilute-and-shoot sample preparation, urinary APZ and DAPZ concentrations were quantified using weighted (1/<i>x</i>²) linear regression calibration with deuterated internal standards. In accordance with the Guide to the Expression of Uncertainty in Measurement (GUM), a bottom-up approach was used to systematically evaluate the significant sources of uncertainty. Method precision and calibration curve were identified as the main contributors to overall uncertainty, whereas contributions from standard solution preparation and volumetric sample handling were relatively minor. The final relative expanded uncertainties (<i>k</i> = 2, 95% confidence level) for the quantification of APZ and DAPZ in real urine were 19.8% and 22.9%, respectively. This thorough, GUM-compliant characterization confirms that the developed method delivers reliable quantitative results with a clearly defined confidence interval, making it suitable for monitoring medication compliance and supporting informed decision-making regarding treatment adherence among probationers.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"31 1","pages":"75 - 82"},"PeriodicalIF":1.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147338782","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}