• Title/Summary/Keyword: Self Declaration of Conformity

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Risk Assessment of Industrial Machines and Devices and Appropriateness of Their Safety Certification and Self-Declaration of Conformity (위험기계, 기구의 위험성 평가 및 안전인증 또는 자율안전확인의 적정성)

  • Choi, Gi Heung;Loh, Byoung Gook
    • Journal of the Korean Society of Safety
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    • v.31 no.1
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    • pp.1-6
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    • 2016
  • Severity and frequency of industrial accidents are typically used to assess the "absolute" risk associated with the industrial machines and devices ("items") which are subject to safety certification or self-declaration of conformity. However, the "relative" risk associated with a particular item can further be assessed based on unit severity and unit frequency where the total number of item in use is taken into account. This study first attempts to estimate the total number of each item in use which was recently selected for safety certification or self-declaration of conformity. The appropriateness of such selection is recapitulated based on the relative risk involved. Analysis results indicate that depending on items, the relative risk is differentiated from the absolute risk. Recent selection of items for safety certification or self-declaration of conformity is then revisited for its validity. The relative risk based on unit severity and unit frequency of industrial accidents, together with the absolute risk, may be used to further categorize items for safety certification or self-declaration of conformity in the future.

Effectiveness of Direct Safety Regulations on Manufacturers and Users of Industrial Machines: Its Implications on Industrial Safety Policies in Republic of Korea

  • Choi, Gi Heung
    • Safety and Health at Work
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    • v.8 no.1
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    • pp.59-66
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    • 2017
  • Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

Evaluation of Severity Measures of Accidents Associated with Industrial Machines and Devices (산업용 기계 및 기구 관련 재해강도 지표의 평가)

  • Choi, Gi Heung
    • Journal of the Korean Society of Safety
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    • v.34 no.2
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    • pp.1-6
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    • 2019
  • This study focuses on the evaluation of severity measures used for accidents associated with industrial machines and devices. In particular, duration of medical treatment, duration of work loss, number of deaths in an individual accident associated with industrial machines and devices are evaluated in various ways to assess the severity of the accident. The number of accidents with work loss of longer than 1 year as the severity measure and the number of accidents as the frequency measure appeared to be the most discriminating information and allow risk assessment based on these frequency and severity measures for grouping of industrial machines and devices. Results of such risk assessment further confirmed the re-classification of industrial machines and devices that are currently subject to safety certification (SC) and self-declaration of conformity (SDC) or selection of those machines and devices that are newly subject to SC and SDC.

The Study on the Improvement Policy of the Pre and Post Regulation System of Radio Station (무선국 관리 사전규제 개선과 사후관리 효율화 방안에 대한 연구)

  • Kim, Ho-Yeong
    • The Journal of the Korea institute of electronic communication sciences
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    • v.17 no.5
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    • pp.745-758
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    • 2022
  • As the unlimited natural source of a country, radio waves are widely being used in the daily life toward knowledge based information society. Therefore it is necessary to provide a long term policy of radio waves management policies based on market situation to cope with rapidly changing wireless technology and effective use of radio resources. Literary survey and analysis were accomplished for the rules and regulations in the radio station approval system and post-approval policies for mobile communication service. In conclusion, this study propose an blanket radio approval policy as well as self declaration of conformity(SDoC) of radio waves technical regulation and advanced radio inspection procedure. This study has significance in providing reference for introducing deregulation policy in the radio communication imdustry.

The Proposal on the Rational Reorganization of the Radio stations Management : Focusing on the Introduction of SDoC for Radio Inspection for Telco (무선국 관리의 합리적 개선방안에 관한 제안 - 무선국의 자기적합성선언 제도 도입 검토를 중심으로 -)

  • Ho-Yeong Kim;Won-Il Roh;Seong-Jhin Choi
    • The Journal of the Korea institute of electronic communication sciences
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    • v.18 no.5
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    • pp.737-746
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    • 2023
  • As the core infrastructure to lead technical innovation for the fourth industrial revolution, economic value and utilizations of radiowaves are increased rapidly. The objectives of this study are to recognize the growing trend of radio stations that transmit information using radiowaves, a limited resource of the country, and to propose developed plans for the radio stations operation system in line with the changing radio technology and use environment. To be specific, the detailed implementation procedures and methods of the system were derived in accordance with the government's plan to convert the complete inspection of radio stations into a SDoC(Self Declaration of Conformity) by the telco. SDoC is a policy that grants autonomy and responsibility for radio waves interference management to existing telecom operator recognized as having radio stations operating capabilities. It has significance in that the function of radio stations inspection, which is a representative technical regulation, is efficiently distributed to the government and the private sector. This study has significance in providing reference for expediting deregulation in the radiowaves management policy.

Safety Policies on Prevention of Industrial Accidents Associated with Industrial Machines and Devices (산업용 위험기계 및 기구관련 산재예방 정책 연구)

  • Choi, Gi Heung
    • Journal of the Korean Society of Safety
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    • v.30 no.6
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    • pp.26-33
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    • 2015
  • This study suggests systematic procedures to improve safety policies on prevention of industrial accidents associated with industrial machines and devices. Specifically, new method of cause analysis of industrial accidents associated with industrial machines and devices is suggested and the related accident data are re-analyzed. Effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, safety device regulation and safety inspection of industrial machines and devices are also analyzed. Based on those analysis results, transition from the current user-oriented safety device regulation to more balanced direct regulations on both manufacturer and user is suggested. Together with severity and frequency of industrial accidents, unit severity and unit frequency need to be taken into account to further assess the risk associated with a particular industrial machine or device. Balance between safety regulations will be realized by proper adjustment of lists of safety certification and inspection, and certification and inspection standards. This will also guarantee the maximum benefit over cost in such safety regulations.

A Classification Model for Customs Clearance Inspection Results of Imported Aquatic Products Using Machine Learning Techniques (머신러닝 기법을 활용한 수입 수산물 통관검사결과 분류 모델)

  • Ji Seong Eom;Lee Kyung Hee;Wan-Sup Cho
    • The Journal of Bigdata
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    • v.8 no.1
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    • pp.157-165
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    • 2023
  • Seafood is a major source of protein in many countries and its consumption is increasing. In Korea, consumption of seafood is increasing, but self-sufficiency rate is decreasing, and the importance of safety management is increasing as the amount of imported seafood increases. There are hundreds of species of aquatic products imported into Korea from over 110 countries, and there is a limit to relying only on the experience of inspectors for safety management of imported aquatic products. Based on the data, a model that can predict the customs inspection results of imported aquatic products is developed, and a machine learning classification model that determines the non-conformity of aquatic products when an import declaration is submitted is created. As a result of customs inspection of imported marine products, the nonconformity rate is less than 1%, which is very low imbalanced data. Therefore, a sampling method that can complement these characteristics was comparatively studied, and a preprocessing method that can interpret the classification result was applied. Among various machine learning-based classification models, Random Forest and XGBoost showed good performance. The model that predicts both compliance and non-conformance well as a result of the clearance inspection is the basic random forest model to which ADASYN and one-hot encoding are applied, and has an accuracy of 99.88%, precision of 99.87%, recall of 99.89%, and AUC of 99.88%. XGBoost is the most stable model with all indicators exceeding 90% regardless of oversampling and encoding type.

Regulations on Wheelchair Power Assist Add-ons in Korea, Europe and United States (한국, 미국, 유럽의 휠체어동력보조장치 규제 현황)

  • Ki-Won Choi;Suk-Min Lee;Inhyuk Moon;Sangsoo Park
    • The Journal of the Convergence on Culture Technology
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    • v.9 no.2
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    • pp.525-531
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    • 2023
  • In Korea, which is entering a super-aged society, the number of elderly patients who have difficulty walking independently is expected to increase rapidly, and it is necessary to develop wheelchair products with various functions to improve the quality of life of people with walking disabilities. Recently, wheelchair power assist devices that provide propulsion power by being attached to a manual wheelchair has been developed and is entering the domestic and global markets. In this study, we compared and analyzed the process of obtaining medical device certification for wheelchair power assist devices in Korea, the United States, and Europe. In Korea, a Class 2 medical device certification process was developed in 2021, and in the US FDA, it corresponds to Class 2 like the existing electric wheelchair and must pass the 510k certification process. In the case of Europe, it is uniquely regulated as Class I, and the CE mark can be attached through a relatively easy self-declaration of conformity. The Korean medical device industry, which is struggling with MDR certification, a new European medical device regulation, should pay attention to the relatively easy entry into the global market for wheelchair power assist products.