• Title/Summary/Keyword: Quality assurance structure

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Good manufacturing practice of radiopharmaceuticals in Korea

  • Oh, Seung Jun
    • Journal of Radiopharmaceuticals and Molecular Probes
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    • v.1 no.2
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    • pp.98-103
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    • 2015
  • Good manufacturing Practice (GMP) regulation for diagnostic and therapeutic radiopharmaceuticals was prepared at 2014. The mandatory GMP regulation becomes effective on $1^{st}$, July 2015,with two years of grace periods. Korean radiopharmaceuticals GMP regulation was consisted of quality management, personnel, premise and facility, documentation, production, quality control and self-audit and they have a very similar structure to European Union and PIC/S GMP regulation. Here, we describe detailed description of GMP regulation each part and application to radiopharmaceuticals production. And we also compare Korea, Japan and USA radiopharmaceuticals GMP regulation. GMP is a method to maintain quality of radiopharmaceuticals in daily production and it must be embedded on the manufacturing operation and management.

Basic Study on Quality Assurance of Concrete Structure by using Odor Sensor (후각센서 사용에 의한 콘크리트 구조물의 품질평가에 관한 기초적 연구)

  • Shirokado, Yoshitsugu;Kagaya, Makoto;Lee, Sang-Hun
    • 한국방재학회:학술대회논문집
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    • 2010.02a
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    • pp.42-42
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    • 2010
  • In order to assure the quality of concrete structure in construction process, the odor strength measured by using odor sensor was used to evaluate curing effect. Then, the compressive strength and odor strength in ordinary concrete N were shown in water curing(=standard curing), indoor and outdoor atmospheric curing condition. The difference between odor strength in the standard curing and that in each curing condition was defined as the difference in the odor strength. And the difference in odor strength in slag powder concrete BP cured in water curing(=standard curing) for different period before exposing in outdoor atmosphere in winter season were evaluated at the age of 14 days. A necessity to prolong the moisture curing for the slag powder concrete BP compared with the ordinary concrete N to obtain a required curing effect was shown by measuring the odor strength and long term compressive strength.

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Application of SE Management Techniques for space Launch System Development (우주발사체 시스템 개발에 있어서의 SE관리기법 적용)

  • Jo, Mi-Ok;Jo, Byeong-Gyu;O, Beom-Seok;Park, Jeong-Ju;Jo, Gwang-Rae
    • 시스템엔지니어링워크숍
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    • s.4
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    • pp.90-94
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    • 2004
  • System engineering(SE) management techniques applied for space launch system development are introduced to assess the current status and address the effwctiveness of these techniques. Management plans and guides are prepared for the work breakdown structure , data, comfiguration, interface control, Quality assurance, procurement, reliability, risk and verification/validation . Further improvement is required for the system engineering management plan(SEMP) to merge the international cooperation into current engineering managment system.

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A study on the Aluminium Beam Methods for Building a Stone Finished Envelope (석재 외피 시공을 위한 알루미늄 빔 지지공법 연구)

  • Kim, Jang-Ook;Lee, Young-Lae;Hong, Seong-Wook;Doh, Sun-Boong;Lee, Han-Seung
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2012.05a
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    • pp.235-242
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    • 2012
  • In recently constructed building, It has become fashionable again that the heavy external skin system such as a Stone Finished Envelope. There are Squared Steel Pipe Methods, C-Shaped Steel Pipe Methods, and Aluminum Beam Methods in the structure of a heavy external skin system. The Aluminum Beam Methods is often misunderstood as a Plane Truss Structure, but this method is not appropriate to be called to a truss structure but a beam methods. The Aluminum Beam Methods is the most Eco-friendly methods in terms of Quality assurance, Efficiency, Safety, Construction period, Durability, and Recyclability. And this Methods is also very appropriate in considering the point of Energy conservation, Waste reduction, Long-life architecture, Replacement parts, Environmental protection, Public efficiency, and Building demolition.

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Difference of Prescription Services between the Health Center and the Private Clinic (일부 보건소와 일반의원에서의 투약서비스 비교연구)

  • 이선희;조공민;손명세;김한중
    • Health Policy and Management
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    • v.2 no.2
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    • pp.131-151
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    • 1992
  • The contents of prescription service were comparatively analysed between health centers(HC) and private clinics(PC). Medical chart review was done for 330 otu-patients diagnosed with upper respiratory tract infection(UR) of 120 adults and 90 children, and gastritis or duodenitis of 120 adults. Emphasis on comparison was the prime cost of medication which used in prescription service. The results were as follows; 1. The prime costs fro the medication per visit of HC group were significantly higher than PC group in all three diseases, and the out of pocket payments of patients per visit were significantly lower in the HC group than PC group. 2. The reason for high prime costs of medication per visit of HC in adult case of URI were due to the idverse use of medication and long prescription period per visit. And high medication costs in children cases of URI in HC group were due to the longer prescription day. In cases of gastritis, the prime cost of medication was also higher because of longer prescription period and the higher prime cost of medication. The proportions of medications for injection in the HC and PC groups showed similar features. 3. In depth analysis of the prescription services showed the differences of the contents of medication. In adults cases of URI, the averaged cost of oral medication was significantly lower in HC group, but that of medication for injection was higher in HC group. In children cases of URI, the averaged cost of oral medication and medication for injection was lower in HC group than in PC group. But in the cases of gastritis it was was higher in HC group than in PC group. The prescription periods were longer in HC group than in PC group in all three diseases. As a conclusion prime medication cost and quality of prescription services of HC group were higher than PC group. In terms of health care the cost containment and quality assurance in physician visit for common disease, public sector utilization is good option for those perspectives. But it should not be generalized unless future study about structure and outcome research for quality assurance.

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A Study on the Dimension of Quality Metrics for Information Systems Development and Success : An Application of Information Processing Theory

  • An, Joon M.
    • The Journal of Information Technology and Database
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    • v.3 no.2
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    • pp.97-118
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    • 1996
  • Information systems quality engineering is one of the most problematic areas in practice and research, and needs cooperative efforts between practice and theory [Glass, 1996]. A model for evaluating the quality of system development process and ensuing success is proposed based on information processing theory of project unit design. A nomological net among a set of quality variables is identified from prior research in the areas of organization science, software engineering, and management information systems. More specifically, system development success was modelled as a function of project complexity, system development modelling environment, user participation, project unit structure, resource availability, and the level of iterative nature of development methodology. Based on the model developed from the information processing theory of project unit design in organization science. appropriate quality metrics for each variable in the proposed model are matched. In this way, a framework of relevant systems development and success quality metrics for controlling systems development processes and ensuing success is proposed. The causal relationships among the constructs in the proposed model are proposed as future empirical research for academicians and as managerial tools for quality managers. The framework and propositions help quality manager to select more parsimonious quality metrics for controlling information systems development processes and project success in an integrated way. Also this model can be utilized for evaluating software quality assurance programmes, which are developed and marketed by many vendors.

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The Structure and Job Analysis of Apparel Buying Office in Korea

  • Chun, Jong-Suk;Yi, Yoo-Jin
    • The International Journal of Costume Culture
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    • v.12 no.2
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    • pp.141-152
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    • 2009
  • In this study, the business structure and characteristics of buying offices used by buyers for apparel productions through global sourcing were analyzed in specifics. Data were acquired through in-depth interviews of twelve merchandisers at representative apparel buying offices. The results of this study can be summarized as following. The business structure of a buying office varied depending on the functions, the item characteristics of products to be manufactured or the characteristics of the major buyers who were the customers. Overall, teams were formed by brands or organizations were formed by functions. Functional teams were divided within each brand team when business teams were divided by brands and personnel was divided by brands occasionally within each functional team when business teams were divided by functions. Business teams were composed of MR which managed the overall business about orders such as factory sourcing, price decision and production management and teams with various specialized skills. The teams with specialized skills were composed of Technical team, Fabric Development team, Colorist team, Quality Assurance (QA) or Quality Control (QC) team, Logistics team, Factory Audit team, and etc. For the future directions on the improvements, ways to increase international competitiveness of buying offices need to be researched and many expressed the opinion that it would be effective to move the offices to countries close to buyers or manufacturing locations as most buyers demand lower prices and shorter lead time than before and it is increasing trend for buyers and factories to do business directly without buying offices in the middle.

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A multitype sensor placement method for the modal estimation of structure

  • Pei, Xue-Yang;Yi, Ting-Hua;Li, Hong-Nan
    • Smart Structures and Systems
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    • v.21 no.4
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    • pp.407-420
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    • 2018
  • In structural health monitoring, it is meaningful to comprehensively utilize accelerometers and strain gauges to obtain the modal information of a structure. In this paper, a modal estimation theory is proposed, in which the displacement modes of the locations without accelerometers can be estimated by the strain modes of selected strain gauge measurements. A two-stage sensor placement method, in which strain gauges are placed together with triaxial accelerometers to obtain more structural displacement mode information, is proposed. In stage one, the initial accelerometer locations are determined through the combined use of the modal assurance criterion and the redundancy information. Due to various practical factors, however, accelerometers cannot be placed at some of the initial accelerometer locations; the displacement mode information of these locations are still in need and the locations without accelerometers are defined as estimated locations. In stage two, the displacement modes of the estimated locations are estimated based on the strain modes of the strain gauge locations, and the quality of the estimation is seen as a criterion to guide the selection of the strain gauge locations. Instead of simply placing a strain gauge at the midpoint of each beam element, the influence of different candidate strain gauge positions on the estimation of displacement modes is also studied. Finally, the modal assurance criterion is utilized to evaluate the performance of the obtained multitype sensor placement. A bridge benchmark structure is used for a numerical investigation to demonstrate the effectiveness of the proposed multitype sensor placement method.

Quantification for Collapsion Probability of Building Structures( I ) (건축구조물 붕괴위험도 정량화에 관한 연구( I ))

  • 손기상
    • Journal of the Korean Society of Safety
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    • v.9 no.1
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    • pp.110-120
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    • 1994
  • The Quantitative analysis for collapsion probability of each construcion work has not been developed, despite of that the one for safety management itself has been reported, up to now. It is concluded that showing critical check points against structure collapsion due to each work at construction site, and Quantifying those could be useful Quality-assuring tool, not to prevent Quality failure. Risk classes of each work at construction site, classified by German Builders Mutual-Aid Association (GEBMAS), and by special instruction rates of Korea Insurance Development Institute, are introduced to compare with the results of this study. As of a study method, total 2,002 sheets of questionwares are distributed directly to new city development areas, which are called, Ilsan 110 points : Pundang 79points and Chungdong 38points, including additional Changwon 125sheets and pusan 60sheets, by four(4) people, for contact with actual site engineers. Total responses of 1,056 sheets, are collected. Interrelationship diagram between experience years of Engrs., and risk rate of responses are also classified, with the criteria of four(4) years. Domestic journals with relation to construction have reported that main building Structure collapsions are mainly shown on apartment buildings and office ones. These two(2) building structures are again classified as five(5) kinds of works. This study takes use of an approach on haying the risk rates for each construction work on the above individual construction work. Additionally, site investigations have been performed to find out any possible unreasonable check items, due to construction method ; Reinforced Concret structure, Pre cast Concrete structure, and Steel structure building. Developed Quality Assurance Analysis Form with the Quantitative danger class, resulted from this study, are verified as it is able to be a good efficiency tool against collapsion of building structures.

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Structural damage detection based on MAC flexibility and frequency using moth-flame algorithm

  • Ghannadi, Parsa;Kourehli, Seyed Sina
    • Structural Engineering and Mechanics
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    • v.70 no.6
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    • pp.649-659
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    • 2019
  • Vibration-based structural damage detection through optimization algorithms and minimization of objective function has recently become an interesting research topic. Application of various objective functions as well as optimization algorithms may affect damage diagnosis quality. This paper proposes a new damage identification method using Moth-Flame Optimization (MFO). MFO is a nature-inspired algorithm based on moth's ability to navigate in dark. Objective function consists of a term with modal assurance criterion flexibility and natural frequency. To show the performance of the said method, two numerical examples including truss and shear frame have been studied. Furthermore, Los Alamos National Laboratory test structure was used for validation purposes. Finite element model for both experimental and numerical examples was created by MATLAB software to extract modal properties of the structure. Mode shapes and natural frequencies were contaminated with noise in above mentioned numerical examples. In the meantime, one of the classical optimization algorithms called particle swarm optimization was compared with MFO. In short, results obtained from numerical and experimental examples showed that the presented method is efficient in damage identification.