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A generic framework for qualifications of digital twins in maintenance
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作者 Jie Liu Xingheng Liu +1 位作者 Jørn Vatn Shen Yin 《Journal of Automation and Intelligence》 2023年第4期196-203,共8页
Digital twins have emerged as a promising technology for maintenance applications,enabling organizations to simulate and monitor physical assets to improve their performance.In Operation and Maintenance(O&M),digit... Digital twins have emerged as a promising technology for maintenance applications,enabling organizations to simulate and monitor physical assets to improve their performance.In Operation and Maintenance(O&M),digital twin facilitates the diagnosis and prognosis of critical assets,forming the basis for smart maintenance planning and reducing downtime.However,there is a lack of standardized approaches for the qualifications of digital twins in maintenance,leading to low trustworthiness and limiting its application.This paper proposes a novel framework for the qualifications of digital twins in maintenance based on five pillars,namely fidelity,smartness,timeliness,integration,and standard compliance.We demonstrate the effectiveness of the framework through two case studies,showing how it can be implemented on digital twins for preventive maintenance and condition-based maintenance.Our proposed framework can help organizations across different industrial domains develop and implement digital twins in maintenance more effectively and efficiently,leading to significant benefits in terms of cost reduction,performance improvement,and sustainability. 展开更多
关键词 Digital twin QUALIFICATION Standardized approach Maintenance applications Maintenance models
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THE TANGENT CONES ON CONSTRAINT QUALIFICATIONS IN OPTIMIZATION PROBLEMS 被引量:3
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作者 黄龙光 《Acta Mathematica Scientia》 SCIE CSCD 2008年第4期843-850,共8页
This article proposes a few tangent cones,which are relative to the constraint qualifications of optimization problems.With the upper and lower directional derivatives of an objective function,the characteristics of c... This article proposes a few tangent cones,which are relative to the constraint qualifications of optimization problems.With the upper and lower directional derivatives of an objective function,the characteristics of cones on the constraint qualifications are presented.The interrelations among the constraint qualifications,a few cones involved, and level sets of upper and lower directional derivatives are derived. 展开更多
关键词 Constraint qualifications upper directional derivatives lower directional derivatives strongly directional differentiable concave functions
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Publication behaviour and(dis)qualification of chief editors in Turkish national Social Sciences journals
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作者 Lokman Tutuncu 《Journal of Data and Information Science》 CSCD 2024年第3期181-212,共32页
Purpose:This study investigated the publication behaviour of 573 chief editors managing 432 Social Sciences journals in Turkey.Direct inquiries into editorial qualifications are rare,and this research aims to shed lig... Purpose:This study investigated the publication behaviour of 573 chief editors managing 432 Social Sciences journals in Turkey.Direct inquiries into editorial qualifications are rare,and this research aims to shed light on editors’scientific leadership capabilities.Design/methodology/approach:This study contrasts insider publication behaviour in national journals with international articles in journals indexed by the Web of Science(WOS)and Scopus.It argues that editors demonstrating a consistent ability to publish in competitive WOS and Scopus indexed journals signal high qualifications,while editors with persistent insider behaviour and strong local orientation signal low qualification.Scientific leadership capability is measured by first-authored publications.Correlation and various regression tests are conducted to identify significant determinants of publication behaviour.Findings:International publications are rare and concentrated on a few individuals,while insider publications are endemic and constitute nearly 40%of all national articles.Editors publish 3.2 insider papers and 8.1 national papers for every SSCI article.62%(58%)of the editors have no SSCI(Scopus)article,53%(63%)do not have a single lead-authored WOS(Scopus)article,and 89%publish at least one insider paper.Only a minority consistently publish in international journals;a fifth of the editors have three or more SSCI publications,and a quarter have three or more Scopus articles.Editors with foreign Ph.D.degrees are the most qualified and internationally oriented,whereas non-mobile editors are the most underqualified and underperform other editors by every measure.Illustrating the overall lack of qualification,nearly half of the professor editors and the majority of the WOS and Scopus indexed journal editors have no record of SSCI or Scopus publications.Research limitations:This research relies on local settings that encourage national publications at the expense of international journals.Findings should be evaluated in light of this setting and bearing in mind that narrow localities are more prone to peer favouritism.Practical implications:Incompetent and nepotistic editors pose an imminent threat to Turkish national literature.A lasting solution would likely include the dismissal and replacement of unqualified editors,as well as delisting and closure of dozens of journals that operate in questionable ways and serve little scientific purpose.Originality/value:To my knowledge,this is the first study to document the publication behaviour of national journal chief editors. 展开更多
关键词 Academic qualification Editorial bias Favouritism Insider bias Higher education Publication behaviour and(dis)qualification of chief editors in Turkish national Social Sciences journals
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Clinical-DNA Correlates of Anxiety in Patients with Ehlers-Danlos Syndrome
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作者 Golder N. Wilson Vijay S. Tonk 《Open Journal of Psychiatry》 2024年第4期319-333,共15页
Introduction: Anxiety disorders have a lifetime prevalence of 34% with a similar level of heritability (31%) yet lack objective markers that could differentiate patients with underlying conditions. Up to 60%-70% of pa... Introduction: Anxiety disorders have a lifetime prevalence of 34% with a similar level of heritability (31%) yet lack objective markers that could differentiate patients with underlying conditions. Up to 60%-70% of patients with Ehlers-Danlos syndrome have anxiety that meets criteria of generalized anxiety disorder, their clinical-DNA findings worth examining as biomarkers for patients with generalized anxiety. Method: Of the 1899 patients diagnosed with Ehlers-Danlos syndrome, 1261 were systematically evaluated for 80 history and 40 physical findings and separated into 826 who reported anxiety and 435 who did not. The most consistently reported or management-directing 60 of these clinical findings were, along with variations in genes relevant to these disorders, examined for association with anxiety. Results: Among the 30 anxiety- associated findings judged most predictive of Ehlers-Danlos syndrome in patients with anxiety were expected ones of adrenergic stimulation (difficulty concentrating-87% frequency and 1.26 anxiety/no anxiety ratio;chronic fatigue-84%, 1.17;sleep issues 69%, 1.52 that are criteria for generalized anxiety disorder) or of cholinergic suppression (e.g., frequent nausea 64%, 1.26). Less associated but more discriminating for underlying disease were those reflective of neuromuscular impact (e.g., chronic daily headaches 76%, 1.12);hypermobility (e.g., awareness of flexibility 72%, 1.03), or skin changes (e.g., elasticity around jaw 71%, 1.06). Anxiety-associated DNA variants included 54 of 88 in collagen type I/V/VII/IX genes, 14 of 16 in sodium channel SCN9A/10A/ 11A genes, 59 of 85 in POLG/MT-DNA genes, and 21 of 28 in profilaggrin- FLG genes that respectively impacted tissue laxity, sensory neural, autonomic-mitochondrial, and autonomic-inflammatory functions. Conclusion: Analysis of pathogenetic mechanisms in Ehlers-Danlos syndrome selected some 50 clinical-DNA findings useful for its diagnosis in those with generalized anxiety disorders. 展开更多
关键词 ANXIETY Generalized Anxiety Disorder Ehlers-Danlos Syndrome Long COVID19 Joint Hypermobility DYSAUTONOMIA DNA Testing Whole Exome Sequencing DNA Variant Qualification
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Higher Vocational and Professional Higher Education Qualifications in the European Level 5 Area——A basis for more international cooperation
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作者 Hans Daale 《中国高等教育评论》 2017年第2期15-25,共11页
The'European Level 5 Area'(EL5A)is a relatively new concept for Europe,giving an excellent opportunity to link the sectors for Vocational Education and Training(VET)and Higher Education(HE)to each other.Then i... The'European Level 5 Area'(EL5A)is a relatively new concept for Europe,giving an excellent opportunity to link the sectors for Vocational Education and Training(VET)and Higher Education(HE)to each other.Then it is about looking at qualifications at level 5 of the European Qualifications Framework(EQF)for Lifelong Learning and using them 展开更多
关键词 HIGHER Vocational and PROFESSIONAL HIGHER Education qualifications in the EUROPEAN LEVEL 5 Area VET
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Women Prove Theil Mayoral Qualifications
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作者 XIAO MING CHEN SHANSHAN 《Women of China》 1995年第10期24-26,共3页
OF the 517 large and small cities in the country, more than 300 have women mayors and vice mayors. These women play an important role in the construction and development of their cities. Ordinary Chinese people like t... OF the 517 large and small cities in the country, more than 300 have women mayors and vice mayors. These women play an important role in the construction and development of their cities. Ordinary Chinese people like to call their local officials "father-and- mother officials," but these 展开更多
关键词 Women Prove Theil Mayoral qualifications
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On Basic Constraint Qualifications for Infinite System of Convex Inequalities in Banach Spaces
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作者 Xin Tao YE Chong LI 《Acta Mathematica Sinica,English Series》 SCIE CSCD 2007年第1期65-76,共12页
The BCQ and the Abadie CQ for infinite systems of convex inequalities in Banach spaces are characterized in terms of the upper semi-continuity of the convex cones generated by the subdifferentials of active convex fun... The BCQ and the Abadie CQ for infinite systems of convex inequalities in Banach spaces are characterized in terms of the upper semi-continuity of the convex cones generated by the subdifferentials of active convex functions. Some relationships with other constraint qualifications such as the CPLV and the Slate condition are also studied. Applications in best approximation theory are provided. 展开更多
关键词 system of convex inequalities basic constraint qualification Abadie constraint qualification best approximation
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英、澳、美中高职衔接课程体系的构建及对我国的借鉴 被引量:2
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作者 谭文培 《科教文汇》 2014年第21期104-105,共2页
英国通过资格与学分框架(QCF)实现了中高职课程体系衔接,澳大利亚通过TAFE课程的开发实现中高职课程体系的衔接,美国通过职业生涯与技术教育课程实现中高职课程体系衔接。他们在中高职衔接的课程开发制度、科学的课程开发依据和系统的... 英国通过资格与学分框架(QCF)实现了中高职课程体系衔接,澳大利亚通过TAFE课程的开发实现中高职课程体系的衔接,美国通过职业生涯与技术教育课程实现中高职课程体系衔接。他们在中高职衔接的课程开发制度、科学的课程开发依据和系统的课程开发流程、注重职业教育课程的职业导向性以及强调文化课与专业课衔接、教育和劳动力市场需求衔接的诸多做法值得我国借鉴。 展开更多
关键词 中高职衔接课程体系 资格与学分框架 TAFE课程 职业生涯与技术教育 借鉴 qualifications and CREDIT Framework(QCF)
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采用反吹、微流控技术分析原油中的轻烃组分 被引量:4
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作者 朱翠山 赵红 +2 位作者 王培荣 张敏 徐冠军 《色谱》 CAS CSCD 北大核心 2007年第3期449-450,共2页
利用程序升温蒸发进样器、反吹技术和微流控装置分析原油中的C5-C13轻烃组分,用一根HPPONA色谱柱分离,同时得到保留时间相同的火焰离子化检测信号和质谱检测信号,为原油中轻烃组分的色谱定性提供了新的有力工具。该方法中所用的色谱... 利用程序升温蒸发进样器、反吹技术和微流控装置分析原油中的C5-C13轻烃组分,用一根HPPONA色谱柱分离,同时得到保留时间相同的火焰离子化检测信号和质谱检测信号,为原油中轻烃组分的色谱定性提供了新的有力工具。该方法中所用的色谱柱使用寿命长,分离效果好,对平湖4井油样中C5~C13馏分的分离得到了可用质谱定性的峰约290个(尚有不少混合峰存在),较难分离的物质对t-1,2-二甲基环戊烷与2-乙基戊烷得到了较好的分离,2-乙基戊烷峰得到非常好的质谱图,是目前研究原油中轻烃组分分析的有效手段。同时应用微流控装置后可在质谱仪不停机的条件下更换色谱柱。 展开更多
关键词 程序升温蒸发进样器(programmed temperature VAPORIZER injector) 反吹技术(backflushing technique) 微流控装置(micro—fluidic splitter) 气相色谱(GC) 气相色谱-质谱(GC—MS) 轻烃组分(light hydrocarbons) 定性(qualification) 原油(crude oil)
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A Note on the Guignard Constraint Qualification and the Guignard Regularity Condition in Vector Optimization
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作者 Giorgio Giorgi 《Applied Mathematics》 2013年第4期734-740,共7页
Some remarks are made on the use of the Abadie constraint qualification, the Guignard constraint qualifications and the Guignard regularity condition in obtaining weak and strong Kuhn-Tucker type optimality conditions... Some remarks are made on the use of the Abadie constraint qualification, the Guignard constraint qualifications and the Guignard regularity condition in obtaining weak and strong Kuhn-Tucker type optimality conditions in differentiable vector optimization problems. 展开更多
关键词 Constraint qualifications REGULARITY CONDITIONS OPTIMALITY CONDITIONS Vector Optimization Problems
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On the Second Order Optimality Conditions for Optimization Problems with Inequality Constraints
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作者 Mourad Naffouti 《Open Journal of Optimization》 2013年第4期109-115,共7页
A nonlinear optimization problem (P) with inequality constraints can be converted into a new optimization problem (PE) with equality constraints only. This is a Valentine method for finite dimensional optimization. We... A nonlinear optimization problem (P) with inequality constraints can be converted into a new optimization problem (PE) with equality constraints only. This is a Valentine method for finite dimensional optimization. We review second order optimality conditions for (PE) in connection with those of (P). A strictly complementary slackness condition can be made to get the property that sufficient optimality conditions for (P) imply the same property for (PE). We give some new results (see Theorems 3.1, 3.2 and 3.3) .Without any assumption, a counterexample is given to show that these conditions are not equivalent. 展开更多
关键词 OPTIMALITY CONDITIONS CONSTRAINT qualifications Copositivity
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对应框架:欧洲与中国资格的一一对应(英文)
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作者 Ciarán O'LEARY 《计算机教育》 2010年第9期24-27,共4页
Both Ireland and the European Union use a framework of qualifications as a means of charting and describing the level of ability demonstrated by individuals in specific domains.Europe's frameworks are outcome base... Both Ireland and the European Union use a framework of qualifications as a means of charting and describing the level of ability demonstrated by individuals in specific domains.Europe's frameworks are outcome based,identifying individuals by the level of ability they have demonstrated to assessors,and as such provide a useful means of mapping pathways through education for students,across a whole career or lifetime.Additionally,the framework serves as a communication tool,whereby institutions,students,employers or indeed countries can use a common vocabulary to discuss the achievements and abilities of individuals.We describe in brief the qualifications frameworks used in both China and Europe,and ask whether the European Qualifications Framework could serve as a communication tool between China and Europe. 展开更多
关键词 educational quality assurance qualifications frameworks transnational agreement
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The Importance of Mentoring in Nursing Academia
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作者 Susan Wynn Cheryl Holden +1 位作者 Sonia Romero Paula Julian 《Open Journal of Nursing》 2021年第4期241-248,共8页
Mentoring in academia promotes the retention of students and future faculty. Presently, it is general knowledge that we have a shortage of nurses in our profession. However, we also have a shortage of experientially q... Mentoring in academia promotes the retention of students and future faculty. Presently, it is general knowledge that we have a shortage of nurses in our profession. However, we also have a shortage of experientially qualified educators and mentors. In general, the problem is there is a lack of mentors in healthcare as a whole that have the ability or willingness to mentor future generations of faculty. Mentors are needed to pass on knowledge and promote retention of students and faculty in academia. The example we present to the students in healthcare professions will also impact the retention of healthcare faculty as a whole. It is logical to think that if we retain our students in academia, we also retain future experientially qualified faculty in academia. How we mentor one another as a novice and seasoned faculty can impact what students see and learn as well from us. A literature review of 46 articles was completed and 19 of the articles were used as references in this article, along with a few more relevant references. The articles from the literature review showed evidence of positive mentoring experiences lead to the retention of students, future mentees, and mentors in nursing academia. 展开更多
关键词 MENTORING FACULTY ACADEMIA Benefits of Mentoring Retention and Mentoring Academic Coaching Developing Nurses Challenges of Mentoring qualifications of a Mentor Characteristics of a Mentor Mentoring in Nursing and Healthcare
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Guignard’s Constraint Qualification (GCQ) and Multiobjective Optimisation Problems
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作者 H. S. Faruque Alam Ganesh Chandra Ray 《Journal of Applied Mathematics and Physics》 2022年第7期2356-2367,共12页
Investigation of optimality conditions has been one of the most interesting topics in the theory of multiobjective optimisation problems (MOP). To derive necessary optimality conditions of MOP, we consider assumptions... Investigation of optimality conditions has been one of the most interesting topics in the theory of multiobjective optimisation problems (MOP). To derive necessary optimality conditions of MOP, we consider assumptions called constraints qualifications. It is recognised that Guignard Constraint Qualification (GCQ) is the most efficient and general assumption for scalar objective optimisation problems;however, GCQ does not ensure Karush-Kuhn Tucker (KKT) necessary conditions for multiobjective optimisation problems. In this paper, we investigate the reasons behind that GCQ are not allowed to derive KKT conditions in multiobjective optimisation problems. Furthermore, we propose additional assumptions that allow one to use GCQ to derive necessary conditions for multiobjective optimisation problems. Finally, we also include sufficient conditions for multiobjective optimisation problems. 展开更多
关键词 Constraint qualifications Multiobjective Optimization Karush Kuhn-Tucker Conditions Constraint Optimization
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Main Steps for Radiopharmaceuticals Hot Cells Validation in Accordance with GMP Requirements:Methodology and Practical Guide
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作者 Fábio Eduardo de Campos Efrain Araujo Perini +2 位作者 Carlos Leonel Zapparoli Júnior Wilson Aparecido ParejoCalvo Valeriia Niowaveinc Starovoitova 《Journal of Environmental Science and Engineering(A)》 2018年第3期132-139,共8页
关键词 Injectable radiopharma ceuticals GMP qualifications regulations
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Growth and form of Quercus robur and Fraxinus excelsior respond distinctly different to initial growing space: results from 24-year-old Nelder experiments 被引量:6
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作者 Christian Kuehne Patrick Pyttel +1 位作者 Edgar Kublin Jürgen Bauhus 《Journal of Forestry Research》 SCIE CAS CSCD 2013年第1期1-14,共14页
Initial growing space is of critical importance to growth and quality development of individual trees. We investigated how mortality, growth (diameter at breast height, total height), natural pruning (height to fir... Initial growing space is of critical importance to growth and quality development of individual trees. We investigated how mortality, growth (diameter at breast height, total height), natural pruning (height to first dead and first live branch and branchiness) and stem and crown form of 24-year-old pedunculate oak (Quercus robur [L.]) and European ash (Fraxinus excelsior [L.]) were affected by initial spacing. Data were recorded from two replicate single-species Nelder wheels located in southern Germany with eight initial stocking regimes varying from 1,020 to 30,780 seedlings·ha?1. Mortality substantially decreased with increasing initial growing space but significantly differed among the two species, averaging 59% and 15% for oak and ash plots, respectively. In contrast to oak, the low self-thinning rate found in the ash plots over the investigated study period resulted in a high number of smaller intermediate or suppressed trees, eventually retarding individual tree as well as overall stand development. As a result, oak gained greater stem dimensions throughout all initial spacing regimes and the average height of ash significantly increased with initial growing space. The survival of lower crown class ashes also appeared to accelerate self-pruning dynamics. In comparison to oak, we observed less dead and live primary branches as well as a smaller number of epicormic shoots along the first 6 m of the lower stem of dominant and co-dominant ashes in all spacing regimes. Whereas stem form of both species was hardly affected by initial growing space, the percentage of brushy crowns significantly increased with initial spacing in oak and ash. Our findings suggest that initial stockings of ca. 12,000 seedlings per hectare in oak and 2,500 seedlings per hectare in ash will guarantee a sufficient number of at least 300 potential crop trees per hectare in pure oak and ash plantations at the end of the self-thinning phase, respectively. If the problem of epicormic shoots and inadequate self-pruning can be controlled with trainer species, the initial stocking may be reduced significantly in oak. 展开更多
关键词 spacing trial STOCKING SELF-THINNING intraspecific competition qualification spatially explicit modelling generalized additive model
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BAYESIAN DEMONSTRATION TEST METHOD WITH MIXED BETA DISTRIBUTION 被引量:5
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作者 MING Zhimao TAO Junyong +1 位作者 CHEN Xun ZHANG Yun'an 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2008年第3期116-119,共4页
A complex mechatronics system Bayesian plan of demonstration test is studied based on the mixed beta distribution. During product design and improvement various information is appropriately considered by introducing i... A complex mechatronics system Bayesian plan of demonstration test is studied based on the mixed beta distribution. During product design and improvement various information is appropriately considered by introducing inheritance factor, moreover, the inheritance factor is thought as a random variable, and the Bayesian decision of the qualification test plan is obtained, and the correctness of a Bayesian model presented is verified. The results show that the quantity of the test is too conservative according to classical methods under small binomial samples. Although traditional Bayesian analysis can consider test information of related or similar products, it ignores differences between such products. The method has solved the above problem, furthermore, considering the requirement in many practical projects, the differences among this method, the classical method and Bayesian with beta distribution are compared according to the plan of reliability acceptance test. 展开更多
关键词 Reliability qualification test Inheritance factor Bayesian analysis Binomial distribution Maximum posterior risk
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Dynamic grey model of verification cycle and lifecycle of measuring instrument and its application 被引量:4
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作者 苏海涛 杨世元 +1 位作者 董华 沈毛虎 《Journal of Central South University》 SCIE EI CAS 2005年第S2期86-89,共4页
Two dynamic grey models DGM (1, 1) for the verification cycle and the lifecycle of measuring instrument based on time sequence and frequency sequence were set up, according to the statistical feature of examination da... Two dynamic grey models DGM (1, 1) for the verification cycle and the lifecycle of measuring instrument based on time sequence and frequency sequence were set up, according to the statistical feature of examination data and weighting method. By a specific case, i.e. vernier caliper, it is proved that the fit precision and forecast precision of the models are much higher, the cycles are obviously different under different working conditions, and the forecast result of the frequency sequence model is better than that of the time sequence model. Combining dynamic grey model and auto-manufacturing case the controlling and information subsystems of verification cycle and the lifecycle based on information integration, multi-sensor controlling and management controlling were given. The models can be used in production process to help enterprise reduce error, cost and flaw. 展开更多
关键词 measuring equipment VERIFICATION CYCLE LIFECYCLE dynamic GREY model QUALIFICATION RATE information s
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A welding document management software package based on a Client/Server structure 被引量:4
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作者 魏艳红 杨春利 王敏 《China Welding》 EI CAS 2003年第1期72-77,共6页
According to specifications for Welding Procedure Qualification of ASME IX Section and Chinese code, JB 4708 2000, a software package for managing welding documents has been rebuilt. Consequently, the new software pa... According to specifications for Welding Procedure Qualification of ASME IX Section and Chinese code, JB 4708 2000, a software package for managing welding documents has been rebuilt. Consequently, the new software package can be used in a Limited Area Network (LAN) with 4 different levels of authorities for different users. Therefore, the welding documents, including DWPS (Design for Welding Procedure Specifications), PQRs (Procedure Qualification Records) and WPS (Welding Procedure Specifications) can be shared within a company. At the same time, the system provides users various functions such as browsing, copying, editing, searching and printing records, and helps users to make decision of whether a new PQR test is necessary or not according to the codes above as well. Furthermore, super users can also browse the history of record modification and retrieve the records when needed. 展开更多
关键词 C/S structure welding procedure qualification DATABASE LAN
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Development of a rapid GC-FID method to simultaneously determine triethylamine, diisopropylamine, and 1,1,3,3-tetramethylguanidine residues in an active pharmaceutical ingredient 被引量:2
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作者 Minshan Shou Haixiao Qiu 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2021年第2期251-256,共6页
A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical i... A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and reproducibility.The final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix interference.Key parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites. 展开更多
关键词 GC-FID AMINES API Method development Method qualification
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