• KIPS Transactions on Software and Data Engineering
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• v.6 no.12
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• pp.543-548
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• 2017

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.

• Journal of Technology Innovation
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• v.24 no.4
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• pp.159-191
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• 2016

In order to deal with uncertainty and conflicting interests in technological risk policy-making, various participatory decision-making models have been practiced. This participatory approach is an alterative to the traditional process of science and technology policy-making where scientific experts provide evidence and government officials make decisions. However, there still remain different opinions on who should play what kind of role in decision-making process. Therefore this paper examines the division of labour in the public deliberations for radioactive waste management policy carried out in the UK and Korea. It discusses the ways in which various actors are defined, and the rationales are employed for allocating actors to certain roles and participatory methods. In so doing, this paper unfolds the ways in which the participatory decision-making process for risk governance is delivered in real policy context. Similarities and differences revealed in the division of labour of two cases contribute to development of radioactive waste management policy and the policy instruments for risk governance.

• Journal of the Korean Society of Safety
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• v.27 no.5
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• pp.64-69
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• 2012

The concept of SIL is applied in the most of all standards relating to functional system safety. However there are problems for the people to apply SIL to their plants. as these standards don't include sufficient informations. In this regards, this paper will suggest the direction of SIL application and concept based on IEC 61508 and IEC 61511. A Safety Integrity Level(SIL) is the discrete level(one out of possible fours), corresponding to a range of the probability of an E/E/PE (Electric/Electrical/Programmable Electrical) safety-related system satisfactorily performing the specific safety functions under all the stated conditions within a stated period of time. SIL can be divided into the target SIL(or required SIL) and the result SIL. The target SIL is determined by the risk analysis at the analysis phase of safety lifecycle and the result SIL is calculated during SIL verification at the realization phase of safety lifecycle. The target SIL is determined by the risk analysis like LOPA(Layer Of Protection Analysis), Risk Graph, Risk Matrix and the result SIL is calculated by HFT(Hardware Fault Tolerance), SFF(Safe Failure Fraction) and PFDavg(average Probability of dangerous Failure on Demand). SIL is applied to various areas such as process safety, machinery(road vehicles, railway application, rotating equipment, etc), nuclear sector which functional safety is applied. The functional safety is the part of the overall safety relating to the EUC and the EUC control system that depends on the correct functioning of the E/E/PE safety-related systems and other risk reduction measures. SIL is applied only to the functional safety of SIS(Safety Instrumented System) in safety. EUC is the abbreviation of Equipment Under Control and is the equipment, machinery, apparatus or plant used for manufacturing, process, transportation, medical or other activities.

• Journal of the Korean Society of Safety
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• v.33 no.5
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• pp.141-149
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• 2018

In a PCB factory, there is a corrosive chemical substance supply system that can causes major leakage accidents. These accidents can give rise to shut down the factory and do residents damage that cause enormous loss of properties. To mitigate these risks, it is necessary to provide a chemical disaster prevention system. Moreover, after considering the situation and environment of the production site, it is of great importance to build an optimal chemical accident prevention system by reflecting risk reduction measures from the point of process design and by assessing quantitative risk based on reliability data. However, because there was no established database of the reliability about facilities and equipment that can be used in the domestic, the business site and consulting organization had being used the reliability data such as USA CCPS(Center for Chemical Process Safety). In these days, Korean institutes are studying on reliability data utilization method of quantitative risk assessment for preventing chemical accidents and domestic utilization algorithms and storage bed of reliability data. This study presents samples of reliability database about the chemical substance supply system that constructed from the history data such as failure, maintenance for 10 years at a PCB factory. Also, this work proposes the safety design criteria for supply facilities of corrosive chemical substance by assessing quantitative risk on the basis of the reliability data.

• Journal of the Microelectronics and Packaging Society
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• v.27 no.3
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• pp.35-39
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• 2020

Nonwet (Head in Pillow) defect is one of the defects in SMT (surface mount technology) process, the defect is caused by several factors, such as solder paste misalignment, reflow condition, package warpage and package ball size. This paper focused on ① reflow condition ② package ball & solder paste misalignment ③ package ball size for nonwet experiment. The first, on the case of reflow condition, there would be high risk of nonwet defect when the soldering time was increased, but N₂ was adopted to reflow process, there could be no or low risk of nonwet defect because of oxidation barrier control. And when the contact depth between Solder ball and solder paste was below 20 ㎛, there could be high risk of nonwet defect. Also smaller package ball would have low risk of nonwet defect.

• Korean Journal of Construction Engineering and Management
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• v.22 no.6
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• pp.131-137
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• 2021

Since many resources are put into the work of changing the railway operation within limited time, it is important to have a specific work plan and safety management. For this reason, the work schedule is shared in advance, and parallel work is being carried out simultaneously by rail system, such as tracks, trolly wires, and signals. However, due to the nature of the transfer work, the work is carried out at night when the railway operation is finished, and many resources are put into the limited area of the operating line, so the risk of safety accidents and failure to change the operating line is recognized as high. Nevertheless, there is still not enough research done in korea regarding the operation line change construction. Therefore, this study is conducted a survey on the track exchange work of railroad for working people, and analyzed the results of the survey. Finally, a standard work process was suggested to reduce the risk of track exchange work.

• Journal of the Korean Society of Safety
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• v.17 no.1
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• pp.68-71
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• 2002

A research on accident loss calculation for polyol process without safety management activities, and safety cost estimation using process risk assessment has been implemented. In order to estimate a magnitude of loss, accident scenarios were made by combining result made from HAZOP Study method with accident possibility analysis results implemented with FTA. Also effect assessment was implement for accident consequence of each scenario. And minimum possible loss cost has been calculated when safety investment do or not. Result from cost-benefit analysis was shown as approximately \335 billion(=USS44,000 billion), as cost after subtracting safety management cost from minimum possible loss cost.

• International conference on construction engineering and project management
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• 2015.10a
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• pp.15-18
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• 2015

Front end planning is arguably the most impactful process in the successful delivery of capital projects. Organizations expend substantial effort in this planning process, intending to minimize risk and promote project success. This process has been well documented, including critical technical components, as well as the importance of team collaborative components. As organizations continue to pursue large projects with multi-national participation from sponsors, designers, contractors and suppliers, the importance of collaboration on a global scale during front end planning becomes more important, not less. This paper will outline research performed over the past two decades giving the basic components of the process and the value of global collaboration. It will provide guidance to project participants in pursuing successful planning.

• Journal of Information Management
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• v.37 no.1
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• pp.131-148
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• 2006

This paper is to probe foreign cases about risk management and to develop a method for the risk management of the digital resources, This is under the perception that the risk management is necessary for digital archiving implementation. OCLC and Cornell University Library are the leading institutions in the area of risk management. They are the best examples because they make a decision about the risk management through the testing and experimentation. Based on case studies, identification of element of risk management process in our environment, the foundation of national center for risk management, and testing file format and migration program as practical plan of risk management for digital resources are suggested.

• Proceedings of the Korean Institute of Building Construction Conference
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• 2002.11a
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• pp.117-121
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• 2002

The purpose of this study was to Identification the Risk of construction method to protect and reduce the risk of construction period. For this study we are using the pre and during construction period Inspection list. The inspection list was used by construction company for check a flaw of Construction field. So we rearrange the individual item of inspection list to match the Risk factor. This inspection list usually has the difference of importance because this list is not made by Method which is not focused on Method. Therefore, To find the difference of these importance, We surveyed this matter by doing interview of specialist group. To find the application of field and the possibility of measurement of Risk status, We tested Risk occurring frequency and it's strength by checking the level of Risk. The results of this study were as follows; Each Method Check List made out through the rearrangement of Construction Inspection list which used in construction company. To solve and compensate the matter which happened by changing the each Method Check List to each General Inspection List, we added the each Method Check List by checking the importance of check list of each process. By doing this, The Check List for finding Risk level of Method was created by using the check list of each Method.