• 한국식품위생안전성학회지
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• 제32권3호
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• pp.179-186
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• 2017

수입식품 안전관리 확보와 효율성 제고를 위한 목적으로 국가식품안전관리체계 평가도구를 활용하여 수출국의 국가식품안전관리체계 현황을 평가하고 이를 자국의 수입식품안전관리에 활용하는 방안에 대한 논의가 미국을 중심으로 진행되고 있다. 본 연구는 미국의 평가도구와 도구를 활용한 평가사례를 비교조사하고, 관계 전문가의 의견을 검토하여 시사점을 도출하였다. 미국 FDA가 개발한 식품안전관리체계 평가도구는 외국의 식품안전 전문성을 이용하여 수입식품 안전성을 확보하기 위하여 마련되었으며, 평가도구는 10개 기준으로 구성되어 외국의 전반적인 식품안전관리 수준을 판단할 수 있도록 고안되어 있다. FDA는 평가도구를 활용하여 뉴질랜드와 캐나다를 대상으로 평가를 실시하였으며 두나라 모두 미국의 식품안전관리체계와 동등한 것으로 인정하였다. 전문가 인터뷰에서는 국가식품안전관리체계 평가를 통해 수입 전 위생평가와 수입식품의 국경검사 빈도관리에 활용함으로써 수입식품 안전관리에 있어 국가예산의 효율적인 배분과 대국민 신뢰도 향상에 기여할 것이며, 향후 국가식품안전관리체계 평가에 대한 활용도 제고를 위해서는 국제적인 조화와 전문가 예산의 확보도 중요하다는 의견을 제시하였다. 미국의 평가도구 조사 분석과 전문가 인터뷰를 토대로 도출한 시사점으로는 국가식품안전관리체계 평가 논의의 국제적 흐름에 능동적으로 대응할 필요가 있으며, 국가식품안전관리체계 평가도구를 활용하여 국내 식품안전관리체계를 검토하는 것이 가능할 것이다. 아울러 식품안전관리체계 평가결과는 수출입 안전관리에도 활용할 수 있을 것으로 보이며, 이러한 국제흐름에 따라 향후에는 우리나라 자체 국가식품안전관리체계 평가도구를 개발하는 방안도 고려할 필요가 있다.

• 한국환경농학회:학술대회논문집
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• 한국환경농학회 2009년도 정기총회 및 국제심포지엄
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• pp.3-18
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• 2009

It is difficult for consumers to satisfy high safety request with post-management method such as inspection and surveillance, as various changes in-and-out of the country associated with food safety. In terms of food safety problems related to foods, it is crucial to recognize public health and consumer protection and construct pre-preventive Food Control System. A joint committee, FAO/WHO made the following consultations to the National Food Safety System. ${\circ}$ Approach entirely from farm to table ${\circ}$ Get ready for Risk Analysis System ${\circ}$ Secure transparency ${\circ}$ Establish the optimal policy by evaluating the effect of regulation When it comes to summarizing the consultation, it would be accumulated as two key words; "Efficiency" and "Credibility". Whereas the problem of efficiency focuses on precaution rather than post-management, it requires policy option to maximize consumer's benefit by evaluating the cost for the Food Safety Management and its benefit. Also, analyzing risk's character and amount, demanding an optimal means, and introducing scientific analysis system put much value on the stakeholder's communications are procedure's security which can satisfy both "Efficiency" and "Credibility" simultaneously. Especially, it is emphasized here that Risk Assessment need to be separated from Risk Management. This action is a valid means of credibility security throughout improving transparency. A number of nations and organizations have reformed the method of food management passing through reflection and examination of the prior National Food Safety Management since BSE occurred in Britain, 1996. FSA; Food Standard Agency, AFFSA, EFSA, BfR, and FSC are Risk Assessment Organization functionally separated from Risk Management Organization, JECFA, JMCFA, JMPR, JEMRA in Codex charge Risk Assessment internationally. In case of advanced countries excluding several those such as The U.S. and so forth, though these Risk Assessment Organizations are either separated functionally within Risk Management Organization or operated as apart organ, common factors are in which it has independence as Science Base. While securing independence of Risk Assessment Function, it is a tendency Risk Management should be functionally unified into efficiency as well. Though Germany constructs integral Risk Management System of diverse ways according to social and political conditions of each country such as GFOCP, DVFA, SNFA, CFIS and AQIS, there is a key word in the center, "Securing efficiency of Food Safety Management". However our nation has a representative plural；diversified system with The U.S., we took a step forward for unification as empowering policy's generalization；adjustment and Risk Assessment Function by means of enacting the "Food Safety Fundamental Law" in 2008 and establishing the "Food Safety Policy Commission" with private and governmental sectors in the Prime Minister's office. Even though the unification of Risk Management hereby increased, there is the lack of strengthening function of Risk Assessment and securing independence. It needs to be required for the professional committee in Food Safety Policy Commission to develop as a exclusive office of Risk Assessment by separating from a policy decision. Administrative Branches should reinforce feeble functions such as fundamental investigation；research for carrying out Risk Assessment with securing efficiency throughout reassessment of prior Risk Management Means.

• Food Science and Biotechnology
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• 제18권2호
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• pp.279-293
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• 2009

Quantitative risk assessments are related to implementing hazard analysis and critical control points (HACCP) by its potential involvement in identifying critical control points (CCPs), validating critical limits at a CCP, enabling rational designs of new processes, and products to meet required level of safety, and evaluating processing operations for verification procedures. The quantitative risk assessment is becoming a standard research tool which provides useful predictions and analyses on microbial risks and, thus, a valuable aid in implementing a HACCP system. This paper provides a review of microbial modeling in quantitative risk assessments, which can be applied to HACCP systems.

• 대한지역사회영양학회지
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• 제12권3호
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• pp.310-321
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• 2007

Effective and systematic sanitation management programs are necessary to prevent foodborne disease outbreaks in school foodservice operations. The purpose of this study was to identify the elements to improve in order to ensure the safety of school food service by evaluating sanitation management practices implemented under HACCP-based programs. The survey was designed to assess the level of hygiene practices of school food service by using an inspection checklist of food hygiene and safety. Fifty-four school foodservice establishments considered as poor sanitation practice groups from two year inspections by Seoul Metropolitan Office of Education were surveyed from September to December in 2005. Inspection checklists consisted of seven categories with 50 checkpoints; facilities and equipment management, personal hygiene, ingredient control, process control, environmental sanitation management, HACCP system and safety management. Surveyed schools scored $68.0{\pm}12.42$ points out of 100 on average. The average score (% of compliance) of each field was 10.7/20 (53.3%) for facilities and equipment management, 7.4/11 (67.2%) for personal hygiene, 7.4/11 (74.1%) for ingredient control, 22.4/32 (69.8%) for process control, 8.9/12 (73.8%) for environmental sanitation management, 4.2/7 (59.7%) for HACCP systems management, and 7.2/8 (89.7%) for safety management, respectively. The field to be improved first was the sanitation control of facilities and equipment. The elements to improve this category were unprofessional consultation for kitchen layout, improper compartment of the kitchen area, lacks of pest control, inadequate water supply, poor ventilation system, and insufficient hand-washing facilities. To elevate the overall performance level of sanitation management, prerequisite programs prior to HACCP plan implementation should be stressed on the school officials, specifically principals, for the integration of the system.

• 대한수의학회지
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• 제61권3호
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• pp.20.1-20.9
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• 2021

This study is to develop a new scoring system for rating Hazard analysis and critical control points prerequisite evaluation items for meat shops to provide a more objective and accurate evaluation of food safety compliance. The importance of each item was measured by looking at the hazard severity level and the rate of non-compliance associated with it. It was found that the new scoring system is more stringent and gives a clearer picture of compliance with the most critical safety standards, and therefore is expected to have a positive effect on the hygiene and safety of livestock products.

• 한국수산과학회지
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• 제51권5호
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• pp.524-534
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• 2018

This study assessed the biological and physicochemical hazards involved in establishing a hazard analysis critical control point (HACCP) for canned seasoned Broughton's ribbed ark Scapharca broughtonii and examined the critical control points (CCPs) in the field. Following the basic principles of the HACCP system, the hazard-evaluation procedures were enacted during the production of canned seasoned Broughton's ribbed ark after field investigation of a seafood product company in Korea. CCPs were determined using canned seasoned Broughton's ribbed ark with the corresponding control measures. The HACCP system was applied to each step in processing the product. The results indicated that inspection of raw materials, filling, sterilization, and alien substance detection were the most important CCPs. These results can be used to prevent and control food safety problems in the production of canned seasoned Broughton's ribbed ark.

• 한국식품위생안전성학회지
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• 제16권2호
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• pp.103-110
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• 2001

예측식품미생물학(PFM)은 1980년대 후반 이후 식품미생물학 분야에서 새롭게 발생한 신학문 분야이다. PFM은 특별한 환경적 요인에 따른 미생물 특히, 병원성미생물의 반응(사멸과 생존)을 예측하기 위하여 수학적인 모델을 이용한 것이다. 현재까지 개발된 PFM모델중 완전한 것은 없지만, 어떤 특정 조건하에서는 신속하고 객관적으로 미생물의 반응을 예측하는데 이용될 수 있다는 장점 때문에, HACCP시스템, Risk Assessment 등에서 응용 가능성이 커지고 있다. 본 연구는 PFM 모델중 PMPwin5.1을 이용하여, 우유 저장에 대한 HACCP시스템 중 미생물학적 위해요소 분석, CCP 및 CL설정에 대한 방법론적 예를 제시하였다. 모델에 대한 초기조건으로 우유와 동일한 물리화학적 조건인 pH 6.7, Aw 0.993, NaCl 1.3%을 고정변수로 하고, 저장온도(4~15$^{\circ}C$)를 변이변수로 선정하여, 온도에 따른 주요 병원성미생물의 generation time, lag phase duration, infective dose에 도달하는데 걸리는 시간을 산출하였다. 이 결과를 바탕으로 온도의 변화에 따른 각 병원성미생물의 성장을 안전정도에 따라 “안전온도범위(Safe temperature zone)”, “주의온도범위(Caution temperature zone)”, “위험온도범위(Danger temperatue zone)”로 분류하였으며, 이들 분류는 우유의 유통기간인 5일을 기준으로 각 병원성미생물의 lag phase duration, infective dose에 도달하는 시간에 따라 결정하였다. 이러한 결과는 우유의 HACCP시스템에 있어, 위해요인 분석시 위해요인의 분류 및 위해요소간의 위해 정도의 우선순위 부여에 보조적인 수단으로 이용될 수 있다. 또한 유통.저장단계에서 병원성미생물의 상징에 대한 온도수준을 나타내므로, 이 단계를 CCP로 설정할 수 있고, CCP에 대한 CL은 주위온도범위내에서 설정할 수 있다. 그리고 허용수준에 대한 온도의 범위를 제시하므로 모니터링이나 검증에서도 이용할 수 있다.

• 농촌의학ㆍ지역보건
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• 제31권1호
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• pp.63-79
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• 2006

Korea's self-sufficient food ratio on a quantity basis remained a low 27.6 per cent for cereals in year 2004. Even the public auction of imported rice from the United States kicked off a couple of days ago to allow foreign rice to be sold directly to consumers on the Korea market for the first time. Therefore the safety of imported food must be a great concern of Korean consumers. All imported agricultural products are supposed to be quarantined for controlling the insect and inspected for the potent risk like residual pesticides, aflatoxin, sulfur dioxide and genetically modified. agricultural products. The 12 percent of agricultural products contained the insects detected by National Plant Quarantine was fumigated with methyl bromide or aluminum phosphide and entered the custom. The most large portion of violated agricultural products (24 cases in 2004) inspected by Korea Food and Drug Administration was dried herbal medicinal foods contaminated by sulfur dioxide which must be treated when they were dried in China. The second factor made the imported agricultural products to be criminals (19 cases in 2004) was residual pesticides. Genetically modified agricultural products like soybean and corn are under control by labelling in Korea. Genetically modified soybean and corn have been used for oil expression mostly. It is the time to set up realistic risk assessment system for our consumer with the pouring imported agricultural products.

• 한국환경보건학회지
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• 제50권2호
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• pp.125-137
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• 2024

Background: The Korea Risk Information Surveillance System (K-RISS) was developed to enable the early detection of food and drug safety-related issues. Its goal is to deliver real-time risk indicators generated from ongoing food and drug risk monitoring. However, the existing K-RISS system suffers under several limitations. Objectives: This study aims to augment K-RISS with more detailed indicators and establish a severity standard that takes into account structural changes in the daily time series of K-RISS values. Methods: First, a Delphi survey was conducted to derive the required weights. Second, a control chart, commonly used in statistical process controls, was utilized to detect outliers and establish caution, attention, and serious levels for K-RISS values. Furthermore, Bai and Perron's method was employed to determine structural changes in K-RISS time series. Results: The study incorporated 'closeness to life' and 'sustainability' indicators into K-RISS. It obtained the necessary weights through a survey of experts for integrating variables, combining indicators by data source, and aggregating sub K-RISS values. We defined caution, attention, and serious levels for both average and maximum values of daily K-RISS. Furthermore, when structural changes were detected, leading to significant variations in daily K-RISS values according to different periods, the study systematically verified these changes and derived respective severity levels for each period. Conclusions: This study enhances the existing K-RISS system and introduces more advanced indicators. K-RISS is now more comprehensively equipped to serve as a risk warning index. The study has paved the way for an objective determination of whether the food safety risk index surpasses predefined thresholds through the application of severity levels.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.363-376
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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.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.