• Title/Summary/Keyword: Risk Processes

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Policies to Manage Drug Shortages in Selected Countries: A Review and Implications (주요국의 수급불안정 의약품 관리제도에 관한 고찰과 한국에의 시사점)

  • Inmyung Song;Sang Jun Jung;Eunja Park;Sang-Eun Choi;Eun-A Lim;Sanghyun Kim;Dongsook Kim
    • Health Policy and Management
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    • v.34 no.2
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    • pp.106-119
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    • 2024
  • Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

Assessment of the impact of climate variability on runoff change of middle-sized watersheds in Korea using Budyko hypothesis-based equation (Budyko 가설 기반 기후 탄력성을 고려한 기후변동이 우리나라 중권역 유출량 변화에 미치는 영향 평가)

  • Oh, Mi Ju;Hong, Dahee;Lim, Kyung Jin;Kwon, Hyun-Han;Kim, Tae-Woong
    • Journal of Korea Water Resources Association
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    • v.57 no.4
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    • pp.237-248
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    • 2024
  • Watershed runoff that is an important component of the hydrological processes has been significantly altered by climate variability and human activities in many watersheds around the world. It is important to investigate the impacts of climate variability and human activities on watershed runoff change for water resource management. In this study, using watershed runoff data for 109 middle-sized watersheds in Korea, the impacts of climate variability and human activities on watershed runoff change were quantitatively evaluated. Using the Pittitt test, the analysis period was divided into two sub-periods, and the impacts of climate variability and human activities on the watershed runoff change were quantified using the Budyko hypothesis-based climate elasticity method. The overall results indicated that the relative contribution of climate variability and human activities to the watershed runoff change varied by middle-sized watersheds, and the dominant factors on the watershed runoff change were identified for each watershed among climate variability and human activities. The results of this study enable us to predict the watershed runoff change considering climate variability and watershed development plans, which provides useful information for establishing a water resource management plan to reduce the risk of hydrological disasters such as drought or flood.

Selection of Evaluation Metrics for Grading Autonomous Driving Car Judgment Abilities Based on Driving Simulator (드라이빙 시뮬레이터 기반 자율주행차 판단능력 등급화를 위한 평가지표 선정)

  • Oh, Min Jong;Jin, Eun Ju;Han, Mi Seon;Park, Je Jin
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.44 no.1
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    • pp.63-73
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    • 2024
  • Autonomous vehicles at Levels 3 to 5, currently under global research and development, seek to replace the driver's perception, judgment, and control processes with various sensors integrated into the vehicle. This integration enables artificial intelligence to autonomously perform the majority of driving tasks. However, autonomous vehicles currently obtain temporary driving permits, allowing them to operate on roads if they meet minimum criteria for autonomous judgment abilities set by individual countries. When autonomous vehicles become more widespread in the future, it is anticipated that buyers may not have high confidence in the ability of these vehicles to avoid hazardous situations due to the limitations of temporary driving permits. In this study, we propose a method for grading the judgment abilities of autonomous vehicles based on a driving simulator experiment comparing and evaluating drivers' abilities to avoid hazardous situations. The goal is to derive evaluation criteria that allow for grading based on specific scenarios and to propose a framework for grading autonomous vehicles. Thirty adults (25 males and 5 females) participated in the driving simulator experiment. The analysis of the experimental results involved K-means cluster analysis and independent sample t-tests, confirming the possibility of classifying the judgment abilities of autonomous vehicles and the statistical significance of such classifications. Enhancing confidence in the risk-avoidance capabilities of autonomous vehicles in future hazardous situations could be a significant contribution of this research.

Technology to Remove Trace Pollutants in Sewage Treatment Water Using Jellyfish Characteristics (해파리의 특성을 활용한 하수처리장 처리수 내 미량오염물질 제거 기술)

  • Hyeok Jin Park;Eun Jin Kim;Kyung Sil Choo;Joo Eun Shim;Min-Kyeong Yeo
    • Applied Chemistry for Engineering
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    • v.35 no.1
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    • pp.54-60
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    • 2024
  • The present study was aimed to evaluate the removal of the trace pollutants (heavy metals and microplastics) in the sewage treatment plant by using the jellyfish Extract at Immunity reaction (JEI) of Aurelia coerulea. The experiment was conducted on two different scales: the lab scale using a Jar-tester and the Pilot system scale equipped with two newly developed devices in the laboratory, the active tube connection mixed system and the concentration integrated separation device. Compared to anionic polymers currently used in the field, JEI showed similar or higher efficiency to remove the trace pollutants. When JEI was added to the effluent through the Pilot system, the combination of JEI and the trace pollutants was maximized through two mixing processes, and as a result, the removal rate of the trace pollutants was greatly improved. Based on these results, we propose the present technology as an alternative to removing trace pollutants that can reduce ecosystem risk and minimize the generation of inorganic waste, away from the existing method.

Proposal for Ignition Source and Flammable Material Safety Management through 3D Modeling of Hazardous Area: Focus on Indoor Mixing Processes (폭발위험장소 구분도의 3D Modeling을 통한 점화원 및 가연물 안전관리 방안 제안: 실내 혼합공정을 중심으로)

  • Hak-Jae Kim;Duk-Han Kim;Young-Woo Chon
    • Journal of the Society of Disaster Information
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    • v.20 no.1
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    • pp.47-59
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    • 2024
  • Purpose: This study aims to propose measures for the prevention of fire and explosion accidents within manufacturing facilities by improving the existing classification criteria for hazardous locations based on the leakage patterns of flammable liquids. The objective is to suggest ways to safely manage ignition sources and combustible materials. Method: The hazardous locations were calculated using "KS C IEC 60079-10-1," and the calculated explosion hazard distances were visualized in 3D. Additionally, the formula for the atmospheric dispersion of flammable vapors, as outlined in "P-91-2023," was utilized to calculate the dispersion rates within the hazardous locations represented in 3D. Result: Visualization of hazardous locations in 3D enabled the identification of blind spots in the floor plan, facilitating immediate recognition of ignition sources within these areas. Furthermore, when calculating the time taken for the Lower Explosive Limit (LEL) to reach within the volumetric space of the hazardous locations represented in 3D, it was found that the risk level did not correspond identically with the explosion hazard distances. Conclusion: Considering the atmospheric dispersion of flammable liquids, it was concluded that safety management should be conducted. Therefore, a method for calculating the concentration values requiring detection and alert based on realistically achievable ventilation rates within the facility is proposed.

A Study on the Development of integrated Process Safety Management System based on Artificial Intelligence (AI) (인공지능(AI) 기반 통합 공정안전관리 시스템 개발에 관한 연구)

  • KyungHyun Lee;RackJune Baek;WooSu Kim;HeeJeong Choi
    • The Journal of the Convergence on Culture Technology
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    • v.10 no.1
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    • pp.403-409
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    • 2024
  • In this paper, the guidelines for the design of an Artificial Intelligence(AI) based Integrated Process Safety Management(PSM) system to enhance workplace safety using data from process safety reports submitted by hazardous and risky facility operators in accordance with the Occupational Safety and Health Act is proposed. The system composed of the proposed guidelines is to be implemented separately by individual facility operators and specialized process safety management agencies for single or multiple workplaces. It is structured with key components and stages, including data collection and preprocessing, expansion and segmentation, labeling, and the construction of training datasets. It enables the collection of process operation data and change approval data from various processes, allowing potential fault prediction and maintenance planning through the analysis of all data generated in workplace operations, thereby supporting decision-making during process operation. Moreover, it offers utility and effectiveness in time and cost savings, detection and prediction of various risk factors, including human errors, and continuous model improvement through the use of accurate and reliable training data and specialized datasets. Through this approach, it becomes possible to enhance workplace safety and prevent accidents.

Draft List and Relative Importance of Principal Processes in the Geosphere to be Considered for the Radiological Safety Assessment of the Domestic Geological Disposal Facility through Analyzing FEPs for KBS-3 Type Disposal Repository of High-level Radioactive Waste(HLW) (KBS-3 방식 고준위방폐물 심층처분장 FEP 분석을 통한 국내 사용후핵연료 심층처분시설 방사선학적 안전성 평가용 지권영역 주요 프로세스 항목 및 상대적 중요도 도출)

  • Sukhoon Kim;Donghyun Lee;Dong-Keuk Park
    • Journal of Radiation Industry
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    • v.17 no.1
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    • pp.33-44
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    • 2023
  • The deep geological repository of high-level radioactive waste shall be designed to meet the safety objective set in the form of radiation dose or corresponding risk to protect human and the environment from radiation exposure. Engineering feasibility and conformity with the safety objective of the facility conceptual design can be demonstrated by comparing the assessment result using the computational model for scenario(s) describing the radionuclide release and transport from repository to biosphere system. In this study, as the preliminary study for developing the high-level radioactive waste disposal facility in Korea, we reviewed and analyzed the entire list of FEPs and how to handle each FEP from a general point of view, which are selected for the geosphere region in the radiological safety assessment performed for the license application of the KBS-3 type deep geological repository in Finland and Sweden. In Finland, five FEPs (i.e., stress redistribution, creep, stress redistribution, erosion and sedimentation in fractures, methane hydrate formation, and salt exclusion) were excluded or ignored in the radionuclide release and transport assessment. And, in Sweden, six FEPs (i.e., creep, surface weathering and erosion, erosion/sedimentation in fractures, methane hydrate formation, radiation effects (rock and grout), and earth current) were not considered for all time frames and earthquake out of a total of 25 FEPs for the geosphere. Based on these results, an FEP list (draft) for the geosphere was derived, and the relative importance of each item was evaluated for conducting the radiological safety assessment of the domestic deep geological disposal facility. Since most of information on the disposal facility in Korea has not been determined as of now, it is judged that all FEP items presented in Table 3 should be considered for the radiological safety assessment, and the relative importance derived from this study can be used in determining whether to apply each item in the future.

Real-Time AT-PCR for Quantitative Detection of Bovine Parainfluenza Virus Type 3 during the Manufacture of Biologics (생물의약품 제조공정에서 Bovine Parainfluenza Virus Type 3 정량 검출을 위한 Real-Time RT-PCR)

  • Lee, Dong-Hyuck;Kim, Chan-Kyong;Kim, Tae-Eun;Kim, In-Seop
    • KSBB Journal
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    • v.23 no.4
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    • pp.303-310
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    • 2008
  • Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biologics such as biopharmaceuticals, tissue-engineered products, and cell therapy. Manufacturing processes for the biologics have the risk of viral contamination. Therefore viral validation is essential in ensuring the safety of the products. Bovine parainfluenza virus type 3 (BPIV3) is one of the common bovine pathogens and has widely been known as a contaminant of biologics. In order to establish the validation system for the BPIV3 safety of biologics, a real-time RT-PCR method was developed for quantitative detection of BPIV3 contamination in raw materials, manufacturing processes, and final products. Specific primers for amplification of BPIV3 RNA was selected, and BPIV3 RNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be 2.8 $TCID_{50}/mL$. The real-time RT-PCR method was validated to be reproducible and very specific to BPIV3. The established real-time RT-PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BPIV3. BPIV3 RNA could be quantified in CHO cell as well as culture supernatant. Also the real-time RT-PCR assay could detect 7.8 $TCID_{50}/mL$ of BPIV3 artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BPIV3 contamination during the manufacture of biologics.

Study on economic effects of outsourcing of food materials on the hotel kitchen - Focus on cooking Western food in the first class hotel - (식재료 아웃소싱이 경제적 주방에 미치는 영향에 관한 연구 - 특1급호텔 양식조리를 중심으로 -)

  • 성태종
    • Journal of Applied Tourism Food and Beverage Management and Research
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    • v.13 no.2
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    • pp.45-69
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    • 2002
  • This study is designed to examine feasibility and limitation of outsourcing in cooking Western food in a hotel, to interpret importance of outsourcing(eg. outside order, outside procurement, outside supply) in a broad sense in order to reinforce the core capacity in the cooking department, and to know whether the cooking human power is efficiently used and how much the chefs recognize outsourcing of food materials. As many companies conduct restructuring to cut down its size, the reduction of human power led the Western food cooking in the hotel to lower core capacities, lower quality, and lower efficiency. In addition, the sagging morale of chefs undermined creativity. To change from the traditional kitchen to an economic kitchen needs to look into importance of outsourcing, cognitive attitude of chefs, relation with outside suppliers. Here suggests performance of positive changes in the structure The study examined feasibility and limitation of outsourcing in the hotel kitchen as well as chefs' cognitive attitude toward outsourcing of food materials to reinforce core capabilities of the hotel kitchen. 1. Companies of outsourcing are selected according to variability of price conditions, flexibility of contract conditions, popularity of the outsourcing company, and reputation of the outsourcing company. 2. The importance of outsourcing in the Western food cooking is divided into 4 factors such as standard of selecting outsourcing companies, policies of cooking manu, quality of cooking, and quantity of cooking. 3. The most feasible section in outsourcing of food materials is a process of kneading flour for bread, which shows that many Western-food chefs expect to put higher possibility of outsourcing on the kneading. In other words, when it comes to confectionery and bakery, there are many outside expert processing companies supplying high quality products. In the order of outsourcing feasibility, sauce is followed by processed vegetable, garnish of main dish, and soup. The least feasible section in outsourcing of food materials is appetize. Appetize includes a concept of a improvised dish and needs speed. Due to its color, freshness, and sensibility of taste, the appetize plays a key role in the Western food cooking. 4. When outsourcing is taken in place, the highest risk is to lower the inner cooking skills. Therefore chefs in charge of the Western food sequently recognize both internal problems including storage of cooking skills, unstability of layoffs, and loss of cooperation between departments, and external problems including inferior goods, difficulty of differentiating manu, delay of delivery, and expiration date. It shows that most of the Western food chefs consider risks of the internal problems at first. 5. A effective outsourcing needs appropriate selection of outsourcing companies, maintenance of credibility, active communication, check and management of hygiene. However regardless of their position or career, chefs in charge of the Western food have the same cognitive attitude toward selecting successful outsourcing companies after the outsourcing system is enforced. The core of cooking, or a final stage in the full process of so-called artistic cooking, should be treated with insourcing. Reduction of several cooking processes resulted in shortened cooking time, increased efficiency, faster cooking, cutting the waiting-lines, and finally more room for customers. The outsourcing system can reduce or eliminate the following processes in cooking: buying various food materials, checking, storing, preparing, and processing. Especially in the Western food cooking department of a hotel, the outsourcing system should be enforced to make an economic kitchen and to efficiently manage it. Wow it's time to change from the traditional kitchen to an economic kitchen in the hotel cooking department. For that, the cooking department should become a small but strong organization by outsourcing except its core work.

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Real-Time PCR for Quantitative Detection of Bovine Herpesvirus Type 1 (Bovine Herpesvirus Type 1 정량 검출을 위한 Real-Time PCR)

  • Lee, Dong-Hyuck;Jeong, Hyo-Sun;Lee, Jung-Hee;Kim, Tae-Eun;Lee, Jung-Suk;Kim, In-Seop
    • Korean Journal of Microbiology
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    • v.44 no.1
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    • pp.14-21
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    • 2008
  • Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biopharmaceuticals, tissue engineered products, and cell therapy. Manufacturing processes for the biologicals using bovine materials have the risk of viral contamination. Therefore viral validation is, essential in ensuring the safety of the products. Bovine herpesvirus type 1 (BHV-1) is the most common bovine pathogen found in bovine blood, cell, tissue, and organ. In order to establish the validation system for the BHV-1 safety of the products, a real-time PCR method was developed for quantitative detection of BHV-1 in raw materials, manufacturing processes, and final products as well as BHV-1 clearance validation. Specific primers for amplification of BHV-1 DNA was selected, and BHV-1 DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $2\;TCID_{50}/ml$. The real-time PCR method was validated to be reproducible and very specific to BHV-1. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BHV-1. BHV-1 DNA could be quantified in CHO cell as well as culture supernatant. Also the real-time PCR assay could detect $10\;TCID_{50}/ml$ of BHV-1 artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BHV-1 contamination during the manufacture of biologics.