• Journal of Pharmaceutical Investigation
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• 제37권6호
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• 한국가스학회지
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• 제21권5호
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• pp.95-103
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• 2017

제조산업 현장에서는 수많은 유해위험물질이 사용, 처리 및 생산되고 있으며, 암모니아를 취급하는 시설에서 많은 누출, 화재 폭발사고가 보고되고 있다. 유해위험시설에서의 위험관리 및 사고예방을 위하여 공정안전관리(PSM), 가스안전관리(SMS), 장외영향평가(ORA) 제도 등 다양한 안전환경관리 프로그램이 국내 산업현장에 적용되고 있고 학계에서도 위험성평가 관련 연구가 활발하게 진행되고 있다. 본 연구에서는 암모니아 입하 및 저장 시설을 대상으로 정량적 위험성평가가 수행되었는데 사고 시나리오에 대한 피해영향범위 산정에는 장외영향평가용 KORA 프로그램, 사고 빈도 분석에는 LOPA PFD 활용 방식을 적용하였다. 평가 결과 추정된 위험도를 완화하고 지속적인 위험을 관리하는 방안으로 누출 감지 및 비상 차단, 물 분무 및 증기 희석 설비, 방류벽 및 트렌치, 누출 비산 방호 등 공정 안전설계 하드웨어 개선부분과 위험관리기준 효과적 적용, LOPA 보완적용, 보조 피해영향범위 산정 프로그램 활용, 위험도기반 공정안전관리제도 적용, 공정위험성 재평가 및 이행성 관리 등 프로그램 및 제도 운용 측면에서의 방안이 제시되었다.

• 산업경영시스템학회지
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• 제41권3호
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• pp.72-82
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• 2018

In this paper, we identify risk factors that are likely to occur during the lifecycle of a new product development (NPD) project from the literatures, and identify the three objectives or three constraints that will ultimately be achieved for project success in the ICT industry : performance (scope/quality), schedule (time), and cost. Firstly, we interviewed the project experts to classify the risk factors according that the final project objectives are changeable based on scope/quality, time and cost budget constraints. Secondly, the survey for pairwise comparisons between the risk factors was asked to the project managers and members who had ever actually participated in the NPD projects of ICT industry to determine the priority ranks on relative importance using AHP (Analytic Hierarchy Process). The risk factors negatively affecting the goals of projects were analyzed by using the AHP respectively in four project stages during the life cycle of the project. The comparison of risk factors within each stage is a different approach unlike the literatures which have covered project's overall risk assessment. There is an advantage that risk management can be effectively performed with priorities according to each stage from the start to the end of the project. In other words, it is necessary to identify what risk factors will occur in each stage, and to have ideas at each stage with the priorities so that they can be mitigated and eliminated before actual occurrence. As a result, risks on scope & quality changes were found to be the most important considerations for initiative stage of NPD projects in the ICT industry, whereas in the final stage, risks on schedule (time) changes were the most important priorities. Among the ICT industry product categories, 'communication and broadcasting devices' and 'IT and communication based devices' generally have a high priority in terms of risks on scope & quality changes when initiating the project. At the closing stage of the project, however, considering that schedule (time) changeable risk is getting higher, these products tend to target at B2B market rather than B2C because the new products must be delivered and launched in time as customer firm required.

• Journal of Dairy Science and Biotechnology
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• 제29권2호
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• pp.69-73
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• 2011

Food borne pathogens are a growing concern for human health and food safety throughout the world. Milk and dairy products are commonly associated with spoilage or contamination from a wide variety of physical, microbial, and chemical hazardous. Microbiological risk analysis consists of three components: risk assessment, risk management, and risk communication, and overall objective of this process is ultimately public health protection. The microbiological risk assessment is useful tool to evaluate food safety as it is based on a scientific approach. In addition risk assessment process includes quantitative estimation of the probability of occurrence of microbial hazards to evaluate more accurate human exposure. The aim of this study is to review the microbiological risk assessment on the prevalence of bacterial foodborne pathogens in milk and dairy products.

• Asia Marketing Journal
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• 제14권1호
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• pp.159-174
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• 2012

This study investigate the role of consumer's perception of quality in new technology adoption process in China which is given little attention in the field of Information System and Communication Technology. Here, we developed a simple model in the level of consumer perception by exploring the antecedent of perceived quality. Three factors are introduced as determinants of perceived quality: perceived usefulness, perceived risk and trialability. An empirical study is conducted with analysis of the adoption mechanism of a new innovative product. Data analysis results support some of our proposed hypotheses. It indicates that perceived quality is positively related to the adoption intention and fully mediates the relationship between triablility and purchase intention. And we conclude that a product's perceived quality plays an important role in adoption intention. And what makes Chinese customers perceive product's quality good is a trialability of a product. This suggests that when market managers plan to launch products in China, they need to craft an effective strategy based on the market system of the consumer especially understanding the consumers' critical factor for adopting a new product. Chinese are more interested to purchase a product with free trial and free experiential period, therefore, suggesting an advertisement highlighting the trialability of a product is possible in China.

• 대한조선학회논문집
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• 제55권3호
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• pp.215-221
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• 2018

The structural design of offshore installations against explosions has been required to protect vital areas (e.g. control room, worker's area etc.) and minimize the damage from explosion accidents. Because the explosion accident will not only result in significant casualties and economic losses, but also cause serious pollution and damage to surrounding environment and coastal marine ecosystems. Over the past two decades, an incredible efforts was made to develop reliable methods to reduce and manage the explosion risk. Among the methods Quantitative Risk Assessment and Management (QRA&M) is the one of cutting-edge technologies. The explosion risk can be quantitatively assessed by the product of explosion frequency based on probability calculation and consequence analyzed using computer simulations, namely Computational Fluid Dynamics (CFD) and Finite Element Analysis (FEA). However to obtain reliable consequence analysis results by CFD and FEA, uncertainties associate with modeling and simulation are needed to be identified and validated by comparison with experimental data. Therefore, large-scaled explosion test procedure is developed in this study. And developed test procedure can be helpful to obtain precious test data for the validation of consequence analysis using computer simulations, and subsequently allow better assessment and management of explosion risks.

• 한국지반공학회논문집
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• 제20권1호
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• pp.49-59
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• 2004

본 논문에서는 도심지에서의 터널 시공에 따른 지반거동을 평가하고 이에 따른 인접 건물 혹은 매설관의 위험도를 평가하는 GIS기반의 위험도 관리 시스템(GIS-TURIMS) 개발에 대한 내용을 다루었다. 본 시스템은 상용 GIS 소프트웨어인 ArcView 8.1을 기반으로 개발되었고, VB(Visual Basic)와 VBA(Visual Basic Application)를 사용하여 터널시공으로 인한 지반거동과 건물 손상정도의 공학적 연산을 수행할 수 있도록 하였다. 개발된 시스템은 GIS기술의 장점을 최대한 활용하여 터널 시공으로 인한 지반거동, 건물/매설관 손상평가의 강력한 해석을 수행할 수 있도록 하였다. 본 논문에서는 GIS-TURIMS의 개요와 개발과정에 대하여 상세히 다루었다.

• Clinical and Experimental Pediatrics
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• 제50권10호
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• pp.948-953
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• 2007

Acute renal failure is the generic term for an abrupt and sustained decrease in renal function resulting in retention of nitrogenous and non nitrogenous waste product. This may results in life threatening consequences including volume overload, hyperkalemia, and metabolic acidosis. Acute renal failure is both common and carries high mortality rate, but as it is often preventable, identification of patients at risk and and appropriate management are crucial. This review summarized the most recent information on definition, epidemiology, clinical causes and management of acute renal failure in pediatric patients.

• 한국경영과학회:학술대회논문집
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• 한국경영과학회 2004년도 추계학술대회 및 정기총회
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• pp.587-590
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• 2004

The present business environment has been incurred much competition by oversupply so that customers have been to have more opportunities in selection of firms to produce required product. Under this circumstance, companies have to provide attractive proposal (for example, low price and on time delivery) to customers as considering their capacity and risk for their survival. Therefore this paper proposes a method to select customer and to propose price and due date for maximum profit in the restricted situation.

• 한국화재소방학회:학술대회논문집
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• 한국화재소방학회 1997년도 International Symposium on Fire Science and Technology
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• pp.244-251
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• 1997

Since 1970s, The Petrochemical Industry in Korea has grown rapidly by the successful economic growth. While the process became larger and more complex, hazardous chemicals have been used in large quantity, Therefore, the risk of a major accident such as fire, explosion and toxic material release has been increased. Korea has been ranked the fifth in petrochemical product capacity worldwide, also required to meet international standards on process safety management. Fire Protection System integral part of safely management in Petrochemical Plants, will be reviewed.