• Journal of the Korea Safety Management & Science
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• v.15 no.3
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• pp.61-69
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• 2013

According to ISO 26262 (the international standard on functional safety for automotive industry), the functional safety should be considered during the whole automotive systems life cycle from the design phase throughout the production phase. In order to satisfy the standard, the automotive and related industry needs to take appropriate actions while carrying out a variety of development activities. This paper presents an approach to coping with the standard. Analyzing the standard indicates that the safety issues of the automotive systems should be handled with a system's view whereas the conventional approach to solving the issues has been practiced with focus on the component's level. The aforementioned system's view implies that the functional safety shall be incorporated in the system design from both the system's life-cycle view and the hierarchical view for the structure. In light of this, the systems engineering framework can be quite appropriate in the functional safety development and thus has been taken in this paper as a problem solving approach. Of various design issues, the analysis and verification of the safety requirements for functional safety is a key study subject of the paper. Note, in particular, that the conventional FMEA (failure mode effects analysis) and FTA (fault tree analysis) methods seem to be partly relying on the insufficient experience and knowledge of the engineers. To improve this, a systematic method is studied here and the result is applied in the design of an ABS braking system as a case study.

• Journal of Hydrogen and New Energy
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• v.31 no.1
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• pp.73-81
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• 2020

For the fault tree analysis (FTA) analysis of the packaged hydrogen filling station, the composition of the charging station was analyzed and the fault tree (FT) diagram was prepared. FT diagrams were created by dividing the causes of events into external factors and internal factors with the hydrogen event as the top event. The external factors include the effects of major disasters caused by natural disasters and external factors as OR gates. Internal factors are divided into tube tailer, compressor & storage tank, and dispenser, which are composed of mistakes in operation process and causes of accidents caused by parts leakage. In this study, the purpose was to improve the hydrogen station. The subjects of this study were domestic packaged hydrogen stations and FTA study was conducted based on the previous studies, failure mode & effect analysis (FMEA) and hazard & operability study (HAZOP). Top event as a hydrogen leaking event and constructed the flow of events based on the previous study. Refer to "Off shore and onshore reliability data 6th edition", "European Industry Reliability Data Bank", technique for human error rate prediction (THERP) for reliability data. We hope that this study will help to improve the safety and activation of the hydrogen station.

• Journal of the Korean Society of Radiology
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• v.11 no.7
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• pp.627-635
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• 2017

Brachytherapy is generally performed in conjunction with external radiation therapy, and the treatment course is very complicated, which can lead to radiation accidents. In order to solve this problem, we designed the process map by applying the failure mode and effects analysis (FMEA) method to the Brachytherapy and scored the risk priority number (RPN) for each treatment course based on this process map. The process map consisted of five steps, Patient consulting", "Brachytherapy simulation", "CT simulation", "Brachytherapy treatment planning" and "Treatment". In order to calculate the RPN, doctor, medical physicist, dose planners, therapist, and nurse participated in the study and evaluated occurrence, severity, and lack of detectability at each detail step. Overall, the process map is preceded by a patient identification procedure at each treatment stage, which can be mistaken for another patient, and a different treatment plan may be established to cause a radiation accident. As a result of evaluating the RPN for the detailed steps based on the process map, overall "Patient consulting" and "Brachytherapy treatment planning" step were evaluated as high risk. The nurses showed a tendency to be different from each other, and the nurses had a risk of 55 points or more for all the procedures except "Treatment", and the "Brachytherapy simulation" step was the highest with 88.8 points. Since the treatment stage differs somewhat for each medical institution performing radiotherapy, it is thought that the risk management should be performed intensively by preparing the process map for each institution and calculating the risk RPN.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.13 no.10
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• pp.4762-4767
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• 2012

The AF track circuit that detecting train position and transmitting various train control data for DTG to the train on-board is composed of single operation system. If a failure occurs on this system, the driver should be operate the train by manually until the system is restored, because the system cannot control switch machines and signals by automatically. In this process the human error affects to the train delay, collision, derailment and critical safety accident. Therefore, this document has analyzed the effects that each failure mode influences on system and train, and quantified the failure valuation point and class. Basis on this quantified analysis result, MTBF increased and MTTR decreased and failure number also decreased by adopting the independent installation of power supply, the replacement of defected capacitors, the installation of resister cooling system and the improvement of maintenance methods. And the failure factors of AF track circuits were decreased by conducting the preventive maintenance which is a quantitative way of maintenance system by experience.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of the Society of Naval Architects of Korea
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• v.49 no.3
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• pp.254-263
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• 2012

The survivability of warship is assessed by susceptibility, vulnerability and recoverability. Essentially, a vulnerability assessment is a measure of the effectiveness of a warship to resist hostile weapon effects. Considering the shot line and its penetration effect on the warship, present study introduces the procedural aspects of vulnerability assessments of warship. Present study also considers the prediction of penetration damage to a target caused by the impact of projectiles. It reflects the interaction between the weapon and the target from a perspective of vulnerable area method and COVART model. The shotline and tracing calculation have been directly integrated into the vulnerability assessment method based on the penetration equation empirically obtained. A simplified geometric description of the desired target and specification of a threat type is incorporated with the penetration effect. This study describes how to expand the vulnerable area assessment method to the penetration effect. Finally, an example shows that the proposed method can provide the vulnerability parameters of the warship or its component under threat being hit through tracing the shotline path thereby enabling the vulnerability calculation. In addition, the proposed procedure enabling the calculation of the component's multi-hit vulnerability introduces a propulsion system in dealing with redundant Non-overlapping components.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.42 no.4
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• pp.31-38
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• 2019

The purpose of this study is to provide the priority of the front-loading factors in the design stage of the automotive parts development process in order to efficiently and effectively respond to the demands of the car maker (customer). Front-loading is defined as a strategy in order to improve development performance by shifting the identification and solving of design problems to earlier phases of a product development process. Two approaches of the front-loading are project-to-project knowledge transfer and rapid problem solving. For the study, a survey was conducted on the R&D department in the automobile parts company and analyzed by AHP (Analytic Hierarchy Process) method. The result of the survey shows the cost savings is the highest weight in terms of front-loading effect and in terms of front-loading factors, it gives priorities as "the problems of past project" first, "Design Review" second, "CAE (Computer Aided Engineering)" third, "FMEA (Failure Mode and Effects Analysis)" fourth, "benchmarking" and SR (Sourcing of Requirements). The results of the study will be helpful to provide practical value for improving product design of component development.