Accreditation and Quality Assurance最新文献

{"title":"AQbD enabled method development and quantification of asiaticoside in foam-based formulations","authors":"Mohit Kumar,&nbsp;Anjali Pant,&nbsp;Shruti Chopra,&nbsp;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_mix {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}

{"title":"Proficiency tests for analysis of pesticide residues in kimchi cabbage and ginseng in South Korea from 2008 to 2020","authors":"Seonghee Ahn,&nbsp;Byungjoo Kim","doi":"10.1007/s00769-024-01605-x","DOIUrl":"10.1007/s00769-024-01605-x","url":null,"abstract":"<div><p>From 2008 to 2020, the Ministry of Food and Drug Safety (MFDS) and the Korea Research Institute of Standards and Science (KRISS) jointly conducted a proficiency testing (PT) program for the analysis of pesticide residues in kimchi cabbage and ginseng powder. This collaborative effort marked a significant milestone in South Korea, being the first instance of employing metrologically traceable assigned values, determined via isotope dilution mass spectrometry (IDMS), in PT programs. The focus was on a selective range of pesticides, including diazinon, chlorpyrifos, <i>p,p’</i>-DDE, <i>γ</i>-HCH (lindane), <i>α</i>-endosulfan, and <i>β</i>-endosulfan. Each biennial PT program centered on two of these pesticides with participating laboratories reporting their mass fractions in provided samples. PT samples were prepared meticulously prepared in powder form by KRISS, ensuring homogeneity and stability, integral for the accuracy of the testing. The paper elaborates on the intricate processes involved in PT sample preparation and the rigorous assignment of values. To evaluate laboratory proficiency, the Horwitz equation was utilized as a general mode to set for standard deviations in proficiency assessment. An in-depth review of seven PT programs conducted over this period demonstrates the significant role these programs played in advancing the measurement competencies of laboratories, underscoring the novelty and impact of this long-term collaborative effort.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 4","pages":"277 - 283"},"PeriodicalIF":0.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142412200","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":"Collusion or falsification of results in PT: why does it happen and how can it be prevented?","authors":"Matthew Whetton","doi":"10.1007/s00769-024-01601-1","DOIUrl":"10.1007/s00769-024-01601-1","url":null,"abstract":"<div><p>Proficiency testing is an essential tool, which laboratories may use to demonstrate their competence, enabling them to evaluate their performance for specific measurements, tests or calibrations by comparison with results of other laboratories. The pressure therefore to consistently perform ‘well’ in proficiency tests may lead participants to consider colluding with other labs or falsifying data, in order to ensure a high standard of performance. The requirements for the accreditation of proficiency testing schemes to the ISO/IEC 17043 standard place a responsibility on the providers of proficiency testing to consider the possibility of collusion within their schemes and to take measures to discourage or prevent it. A survey of proficiency testing providers has been performed to gather a range of opinions on the ‘state’ of collusion within their schemes. The options available to providers for prevention of collusion and the difficulties of detection are also discussed.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"419 - 424"},"PeriodicalIF":1.0,"publicationDate":"2024-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141335784","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":"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":"Risk analysis approach for PT participation","authors":"Ian Mann","doi":"10.1007/s00769-024-01596-9","DOIUrl":"10.1007/s00769-024-01596-9","url":null,"abstract":"<div><p>The standards ISO/IEC 17025 [1] and ISO 15189 [2] both require laboratories to monitor their performance by comparison with results of other laboratories. But to what extent do laboratories have to participate. At what level and which frequency should a laboratory participate in PT schemes? To facilitate this question, a risk analysis approach should be applied by the laboratory. The EA (European co-operation for Accreditation) advisory document EA-4/18 (Guidance on the level and frequency of proficiency testing participation) [3] first published in June 2010 was revised in 2021 to include as one of the objectives, the concept of the risk analysis approach for PT participation. Risk analysis can be a nebulous concept so how can it be applied to PT participation? What criteria are important to take into consideration, can it be standardized, how do you train assessors to assess the suitability of a participation in PT strategy based on a risk analysis approach? To obtain feedback to such questions above, a survey was prepared and sent out to the EA accreditation bodies (Abs) to understand how this risk analysis approach is being implemented in their jurisdictions. In this survey, the following questions were posed:</p><ul>\u0000 <li>\u0000 <p>Are common risk-based principles used?</p>\u0000 </li>\u0000 <li>\u0000 <p>What training is given to the assessors to ensure harmonization?</p>\u0000 </li>\u0000 <li>\u0000 <p>What are the mains risks that are considered?</p>\u0000 </li>\u0000 <li>\u0000 <p>At what frequency is the suitability of the laboratory’s risk-based approach (strategy) assessed?</p>\u0000 </li>\u0000 </ul></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"415 - 417"},"PeriodicalIF":1.0,"publicationDate":"2024-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141116639","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":"Indonesian experience in providing accuracy-based proficiency testing scheme using metrologically traceable reference values for elements mass fraction in drinking water","authors":"Christine Elishian,&nbsp;Eka Mardika Handayani,&nbsp;Isna Komalasari,&nbsp;Elsha Rahmalifia Ayudianty,&nbsp;Marlina Oktaviadong Siahaan","doi":"10.1007/s00769-024-01599-6","DOIUrl":"10.1007/s00769-024-01599-6","url":null,"abstract":"<div><p>Proficiency testing (PT) scheme for the mass fraction of arsenic (As), cadmium (Cd), copper (Cu), nickel (Ni) and zinc (Zn) in bottled drinking water matrices was conducted based on ISO/IEC 17043. The aim of the PT scheme was to evaluate laboratory capability in measuring minerals and contaminants in drinking water to comply with the implementation of Indonesian National Standard SNI 3553:2015 and the Regulation of Indonesia Minister of Health No. 492/2010. The PT material was a candidate of reference material, the homogeneity and stability testing on the material was performed and evaluated according to ISO 13528 and ISO Guide 35, and the material found sufficiently homogenous and stable during the transportation condition and PT period. Metrologically traceable reference values were used as the PT assigned values which were obtained using a high accuracy method, isotope dilution inductively coupled plasma mass spectrometry (ID ICP-MS) and gravimetric standard addition (GSA) with internal standard ICP-MS. The performance of the participants was evaluated mainly against the reference value based on z-scores and <i>ζ</i>-scores which is meaningful for assessing participants’ ability in measurement capabilities and measurement uncertainty evaluation. The PT results according to z-scores showed that more than 80 % of total 22 participants obtained satisfactory performance for Cu, Ni and Zn, while only 47 % and 58 % for As and Cd. The differences between the reference values and the robust mean of participants for As (21 %) and Cd (68 %) were found significant in the scheme which shown a big variability of measurement capability of Indonesian testing laboratories in this fields. Unsatisfactory performance of laboratories within their claimed uncertainty based on <i>ζ</i>-scores evaluation means that the laboratories may not assess accurately their measurement uncertainty. Therefore, re-assessment of their uncertainty estimation is needed, and the laboratories are encouraged to improve their capability in the measurement uncertainty for further enhancement.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 5-6","pages":"405 - 414"},"PeriodicalIF":1.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141119559","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}