• Title/Summary/Keyword: Management Monitoring Standards

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A Study on a Product Safety Management Program Based on Risk Management Standards (리스크 관리규격에 기초한 제품안전 경영 프로그램에 대한 연구)

  • Lee, Dhong-Ha;Na, Yoon-Gyun;Kim, Myung-Soo
    • IE interfaces
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    • v.16 no.1
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    • pp.94-102
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    • 2003
  • This study proposed a method to apply risk management standards to a product safety management program and reviewed cases where a risk management cycle is applied to the product safety management program. Comparing the four product safety management programs suggested by several authors yielded common features of the risk management cycle: (1) organization for product safety, (2) risk identification, (3) risk evaluation, (4) risk treatment, (5) monitoring/communication, and (6) documentation. A Japan company(Ricoh)'s case showed that the risk management cycle to treat product liability risks can be used as a successful product safety management program.

Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators (인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안)

  • Ji-Yong Chung;You Rim Kim;Wonseuk Jang
    • Journal of Biomedical Engineering Research
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    • v.44 no.2
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    • pp.99-108
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

Assessment of Groundwater Quality on a Watershed Scale by Using Groundwater Quality Monitoring Data (지하수수질측정망 자료를 이용한 유역단위 지하수 수질등급 평가)

  • Kim, Jeong Jik;Hyun, Yunjung
    • Journal of Soil and Groundwater Environment
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    • v.26 no.6
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    • pp.186-195
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    • 2021
  • In Korea, groundwater quality is monitored through National Groundwater Quality Monitoring Network (NGQMN) administered by Ministry of Environment. For a given contaminant, compliance to groundwater quality standards is assessed on a annual basis by monitoring the number of incidents that concentration exceeds the regulatory limit. However, this approach provides only a fractional information about groundwater quality degradation, and more crucial information such as location and severity of the contamination cannot be obtained. For better groundwater quality management on a watershed, a more spatially informative and intuitive method is required. This study presents two statistical methods to convert point-wise monitoring data into information on groundwater quality status of a watershed by using a proposed grading scale. The proposed grading system is based on readily available reference standards that classify the water quality into 4 grades. The methods were evaluated with NO3-, Cl-, and total coliform data in Geum River basin. The analyses revealed that groundwater in most watersheds of Geum River basin is good for domestic or/and drinking with no treatment. But, there was notable quality degradation in Bunam seawall and So-oak downstream standard watersheds contaminated by NO3- and Cl-, respectively.

Development of Hazardous Materials Management Standard for Decoction Type of Personalized Herbal Medicine

  • Jeong, Hye-In;Kim, Kyeong-Han;Won, Jae-Hee;Sung, Gi-Un;Kim, Ji-Won;Han, Ji-eun;Sung, Angela Dong-Min;Park, Eun-Jung;Sung, Soo-Hyun
    • Journal of Pharmacopuncture
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    • v.23 no.2
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    • pp.71-78
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    • 2020
  • Objectives: This study was conducted to development of hazardous materials management standards for the decoction type of personalized herbal medicines (PHMs). Methods: This study was conducted in two stages. We searched documents about criteria to use words such as 'Herb', 'Herbal medicine', and 'Botanical Drug' and summarized the results. We organized the committee consisted of seven experts, and held two meetings to reach an agreement on hazardous management standards of the decoction type of PHMs. Results: The seven documents were presented in the literature review and six items related to hazardous management standards of decoction were identified. The second expert meeting brought that a total of six items, including heavy metal, pesticide residues, sulfur dioxide, benzopyrene, mycotoxin, and micro-organism limits, were selected for safety management of decoction type of PHMs. Also, the criteria and test methods for each standard were suggested for monitoring the decoction type of PHMs. Conclusion: The study suggested hazardous material management standards and criteria for the decoction types of PHMs. In the future, it would be necessary to conduct a pilot test to ensure the validity and credibility of the safety management standard and criteria. Furthermore, the government level safety management system should be introduced to verify the safety of decoction medicines.

A Study on Model of the State's Aviation Safety Management System (국가 통합항공안전관리시스템 모형 구축에 관한 연구)

  • Park, Min-Kyu
    • Journal of the Korea Safety Management & Science
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    • v.13 no.2
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    • pp.1-8
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    • 2011
  • The Chicago Convention in 1944 made important contributions to aviation safety improvement, building an aviation safety monitoring system for its signatory countries. As ICAO is now on the verge of changing its supervision system from self-reporting to preventive Continuous Monitoring Approach(CMA) in 2013, we also expect our own safety system to make a progress accordingly. The government is pushing ahead with plans to build an integrated safety management system at government level that satisfies international standards and reflects domestic features. To this end, this report proposes the most effective system-building model, by analyzing the current status of the system that is in use and meets the requirements of international aviation agencies.

APPLICATION OF MONITORING, DIAGNOSIS, AND PROGNOSIS IN THERMAL PERFORMANCE ANALYSIS FOR NUCLEAR POWER PLANTS

  • Kim, Hyeonmin;Na, Man Gyun;Heo, Gyunyoung
    • Nuclear Engineering and Technology
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    • v.46 no.6
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    • pp.737-752
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    • 2014
  • As condition-based maintenance (CBM) has risen as a new trend, there has been an active movement to apply information technology for effective implementation of CBM in power plants. This motivation is widespread in operations and maintenance, including monitoring, diagnosis, prognosis, and decision-making on asset management. Thermal efficiency analysis in nuclear power plants (NPPs) is a longstanding concern being updated with new methodologies in an advanced IT environment. It is also a prominent way to differentiate competitiveness in terms of operations and maintenance costs. Although thermal performance tests implemented using industrial codes and standards can provide officially trustworthy results, they are essentially resource-consuming and maybe even a hind-sighted technique rather than a foresighted one, considering their periodicity. Therefore, if more accurate performance monitoring can be achieved using advanced data analysis techniques, we can expect more optimized operations and maintenance. This paper proposes a framework and describes associated methodologies for in-situ thermal performance analysis, which differs from conventional performance monitoring. The methodologies are effective for monitoring, diagnosis, and prognosis in pursuit of CBM. Our enabling techniques cover the intelligent removal of random and systematic errors, deviation detection between a best condition and a currently measured condition, degradation diagnosis using a structured knowledge base, and prognosis for decision-making about maintenance tasks. We also discuss how our new methods can be incorporated with existing performance tests. We provide guidance and directions for developers and end-users interested in in-situ thermal performance management, particularly in NPPs with large steam turbines.

Design and Implementation of PC based RMON Agent System for LAN Segment Management (LAN 세그먼트 관리를 위한 PC 기반 RMON 에이전트의 설계 및 구현)

  • Park Jin-Ho
    • Journal of Digital Contents Society
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    • v.2 no.1
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    • pp.31-40
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    • 2001
  • Currently there are many standards of network management. They are: SNMP(Simple Network Management Protocol - for Internet management), CMIP(Common Management Information Protocol - standardized by ITU-T and ISO), RMON(Remote network MONitoring - for distributed management of the LAN segment), and so on. Especially RMON has created the many concerns in order to manage subnetworks of a large network, but it has negative aspects. For instance, routers or hubs with RMON capability are expensive to a network manager because of adding heavy management cost. Moreover it imposes a heavier burden on network manager, because it must use a network management tool which will be additionally needed with RMON device. This paper proposes a model of PC based RMON Agent system. The RMON Agent system monitors the traffic on LAN segment through the use of a Virtual Device Driver(VxD), based on PC. In term of cost this model will replace the expensive RMON device, and eventually enable a network manager to manage LAN segment more efficiently, due to reduced cost.

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Reliability Management of Mechanical Ventilator in Intensive Care Unit Using FMEA Based on ISO14971 (ISO14971 기반 FMEA를 이용한 중환자실내 인공호흡기 신뢰성 관리)

  • Hyun Joon, Kim;Won Kyu, Kim;Tae Jong, Kim;Gee Young, Suh
    • Journal of Biomedical Engineering Research
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    • v.44 no.1
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    • pp.19-24
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    • 2023
  • Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

A Study on Stability Evaluation and Numerical Analysis for Installing of Real-Time Monitoring System on Risky Road Cut Slope (위험절토사면의 안정성평가 및 상시계측시스템 설치를 위한 수치해석적 연구)

  • Choi, Ji-Yong;Lee, Jong-Hyun;Lee, Yeob-Jung
    • Proceedings of the Korean Geotechical Society Conference
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    • 2009.03a
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    • pp.1139-1146
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    • 2009
  • Collapse of cut slope includes many uncertainties in view of the reason and time. So, in the past, risky cut slopes have been dealt after they've been collapsed through post-management measures. But recently, advanced disaster prevention system is required, and as a part of that RTMS(Real-Time Monitoring System) was developed. In this study, stability of risky cut slope was evaluated by site investigation. To grasp deformation behavior characteristics of slope, numerical analysis based on FEM was performed and using results of that, specific standards for installation of Real-Time Monitoring System were suggested.

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A Study on Water Quality Standard for the Protection of Human Health and Aquatic Life (인체의 위해성과 수생태계를 고려한 수질환경기준 설정에 관한 연구)

  • Lee, Jae-Hyun;Kim, Yoon-Shin
    • Journal of Korean Society on Water Environment
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    • v.23 no.6
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    • pp.985-992
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    • 2007
  • There are about 40,000 chemicals used in Korea and 300 new types of chemicals are added to the list every year, influencing quality of air, soil and water. Water quality standards that serve as the basis for water quality management have been proved inefficient and insufficient compared to those of advanced countries. This study aims to improve the existing water quality standards. Most importantly, the water quality standards need to take into account not only protection of human health but also aquatic resources. To that end, water quality criteria need to be set by monitoring each watershed every year and conducting risk assessment. Criteria for human health are set at $10^{-6}$ cancer risk level, and for aquatic life at conservative level, adopting the methodology of the U.S. and Australia, respectively. After carrying out technical and economic feasibility studies, more conservative criteria will be used to decide final water quality standards. The development of this system to establish integrated water quality standards for both human health and aquatic resources protection is urgently needed.