• Title/Summary/Keyword: approval procedure

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Process Development of a Standard Operating Procedure (SOP) for the Manufacturing of Standardized Distribution Boards (규격화된 분전반 제작을 위한 표준작업절차(SOP)의 공정 개발)

  • Ko, Wan-Su;Lee, Byung-Seol;Choi, Chung-Seog
    • Journal of the Korean Society of Safety
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    • v.33 no.5
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    • pp.21-27
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    • 2018
  • The purpose of this study is to develop a SOP (Standard Operating Procedure) for a distribution board that can monitor the leakage current of a load distribution line in real time. The developed distribution board was fabricated by applying IEC 61439-1. It consists of the distribution board and an alarm device. The work process for making the distribution board was compliant with the KEMC (Korea Electrical Manufacturers Cooperative) regulations. And the AC distribution board range is 1,000 V. In addition, the voltage in DC is less than 1500 V. The distribution board receives a 3-phases and 4-wires power supply system and can supply power to the load of a maximum of 32 single or three phase distribution circuits. Also, leakage current measured on the power distribution board was used by sensors installed. The SOP of the developed distribution board consists of the installation standards for the short circuit alarm device and sensor, the surge protection device, switches and indication lamps, and other devices. The operation procedure was prepared so that each manufacturing step of the distribution board must be confirmed by the persons in charge of preparation, production, quality control and approval before moving forward to the next step.

항공기용 타이어의 기술표준품 형식승인에 대한 연구

  • Park, Guen-Young;Lee, Kang-Yi;Jin, Young-Kwon
    • Aerospace Engineering and Technology
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    • v.4 no.2
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    • pp.236-243
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    • 2005
  • Civil aircraft tires require a certification according to the Technical Standard Order Authorization(TSOA) procedure. TSO-C62d contains minimum performance standards for aircraft tires. The TSOA covers design and manufacturing of the tire only. To install a TSO article on aircraft requires an installation approval. In this paper, TSOA procedure and the certification requirements for aircraft tires will be presented.

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A Study on Derivation of Railway Software Safety Management Procedure (철도소프트웨어 안전성 관리체계 계시방안 연구)

  • Joung, Eui-Jin;Shin, Kyung-Ho
    • Proceedings of the KIEE Conference
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    • 2006.10d
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    • pp.244-246
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    • 2006
  • Softwares in railway system are being used in the area of railway control system, directly associated to safety. Because the instinct characteristic of Software is uncertainty, Software development without safety insurance is very hazardous situation. In order to derive safety certification process in the railway system, certification and approval processes in the nuclear, aviation, and military area are studied. Software quality should be improved by two aspects : one is product aspect, another is process aspect. GS(Good Software) and ES(Excellent Software) certification can be exemplified in a product aspect approach. In those process certification, CMMI (Capability Maturity Model Integration) or SPICE (Software Process Improvement and Capability dEtermination : ISO/IEC15504) is being used as models for assessing process maturity of organization. Following the studies, safety management procedure in the railway system is suggested.

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Dynamometer Test Procedure of Metal Brake Pad for Part 25 Aircraft (수송류 항공기용 금속계 제동패드의 다이나모시험 절차)

  • Min-ji Kim;Kyung-il Kim;Kyung-taek Kim
    • Journal of Advanced Navigation Technology
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    • v.27 no.6
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    • pp.821-827
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    • 2023
  • In this study, the aircraft technical standards of the Korea and the United States were analyzed to derive the dynamometer test procedure required to prove the compatibility for flight test certification of the metal brake pad for transport aircraft. Since the design modification of the brake systems is classified as a major change, the STC(Supplemental Type Certificate) and the PMA(Parts Manufacturer Approval) are required. In accordance with the TSO-C135a, the technical standard order for brake system in the United States, the design landing-stop test, accelerate-stop test, and most severe landing stop test were selected among the test items for flight test. The conditions for the dynamometer test are determined according to the specifications provided by aircraft manufacturer, and the brake pad condition, deceleration, and the number of test are defined according to the TSO-C135a.

Suggestion about Modernized Classification of Herbal Medicinal Preparations in Dual Medical Systems (이원화 체계 하에서의 현대적 한약제제 분류 방안 고찰)

  • Kim, Ji-Hoon;Cho, Sun-Young;Han, Sang-Yong;Park, Sun-Dong;Kim, Yun-Kyung
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.61-74
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    • 2015
  • Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of 'Crude drugs' does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term 'Crude drug preparations', and we should use term 'Herbal medicinal preparations' in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.

Review of Consultation Requirements Under Military Air Base Law (군용 항공기지법상의 협의제도에 대한 법적고찰)

  • Lee, Kwan-Hyoung
    • The Korean Journal of Air & Space Law and Policy
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    • v.18
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    • pp.385-444
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    • 2003
  • Current Military Airbase Law, in an effort to promote safety of military aircraft and security of military airbase, requires an administrative agency or its empowered branch to consult with the Secretary of Defense or the commander of the airbase before they issue a certain administrative approval or decision related to the installation. Although this consultation process purports itself in simplifying what can be an protracted administrative procedure, and in unifying objectives of the military and the administrative services, such procedural requirement is vulnerable inevitability of various legal problems whenever there is a conflict of interests among civil, military, government services. Nor is there sufficient studies done by academian in the area of bureaucratic issues of administrative resolution, and certainly not in the area of the military consultation procedure. This article, with such reality in mind attempts to constructively examine 1) when a consultation application is submitted, whether the discretionary power of the commander of the affected airbase is acknowledged at the outset; 2) if the content of the consultation is deemed unlawful, whether a civilian can institute an administrative lawsuit against it; 3) problems about the subject matters of the consultation requirement within the framework of military airbase law; 4) whether the issuing administrative agency must abide by and issue approval or decision in accordance with the opinion proposed by the said commander; 5) the legal problems of the remedial measure such as an order of removal, appellate review, notion to challenge authority, and etc. in cases such as administrative agency ignoring the commanders proposal or issuing final approval or decision that is inconsistent with what was consulted and agreed upon between both parties.

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A Study on Developing Database System for Management of WPS/PQR in Shipyard (조선소 WPS/PQR 관리 DB시스템 개발에 관한 연구)

  • Park, Ju-Yong;Kong, Ji-Hye;Park, Se-Jin;Nam, Sung-Gil
    • Journal of Welding and Joining
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    • v.34 no.1
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    • pp.47-53
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    • 2016
  • WPS/PQR is the essential documents for shipbuilding welding. WPS is the document containing the information related to welding procedure and PQR is the record of approval for welding procedure. Both documents should be approved by the ship owners and the classification societies. It is very important to manage these documents because the welding procedure using these documents could not be carried out before they are approved. Database is an useful tool to manage these documents. It can manage a number of documents and show the processing status of WPS/PQR documents. In this study, all documents related to WPS/PQR documents were investigated and analyzed in the viewpoint of DB. An appropriate DB system was designed for WPS/PQR and the related documents on the basis of CBD methodology. The DB system could make WPS/PQR documents easily and shortly. The grasp of the processing status of WPS/ PQR could help the good management of fabrication schedule in shipbuilding.

Endometrial fluid associated with Essure implants placed before in vitro fertilization: Considerations for patient counseling and surgical management

  • Sills, E Scott;Walsh, David J;Jones, Christopher A;Wood, Samuel H
    • Clinical and Experimental Reproductive Medicine
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    • v.42 no.3
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    • pp.126-129
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    • 2015
  • Essure (Bayer) received approval from the U.S. Food and Drugs Administration as a permanent non-hormonal contraceptive implant in November 2002. While the use of Essure in the management of hydrosalpinx prior to in vitro fertilization (IVF) remains off-label, it has been used specifically for this purpose since at least 2007. Although most published reports on Essure placement before IVF have been reassuring, clinical experience remains limited, and no randomized studies have demonstrated the safety or efficacy of Essure in this context. In fact, no published guidelines deal with patient selection or counseling regarding the Essure procedure specifically in the context of IVF. Although Essure is an irreversible birth control option, some patients request the surgical removal of the implants for various reasons. While these patients could eventually undergo hysterectomy, at present no standardized technique exists for simple Essure removal with conservation of the uterus. This article emphasizes new aspects of the Essure procedure, as we describe the first known association between the placement of Essure implants and the subsequent development of fluid within the uterine cavity, which resolved after the surgical removal of both devices.

A Study on improvement of Korean aircraft system modification certification procedure (우리나라 항공기 시스템 개조 인증 절차 개선 연구)

  • Yoo, Beong-Seon;Lim, In-Kyu
    • Journal of Advanced Navigation Technology
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    • v.25 no.3
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    • pp.185-193
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    • 2021
  • The system needs to be modified to improve the performance of the aircraft in operation or to satisfy the requirements of related laws. Appropriate standards are required for the technical skills for remodeling the aircraft system, design verification for airworthiness of the aircraft, and supplemental type certification (STC) certification procedures for type certification. This study analyzes the current status and demand of domestic aircraft remodeling, examines the current supplementary type certification procedure, and diagnoses the problem. In addition, as a result of researching measures to improve remodeling technology and certification capabilities to extend the life of the aircraft, improvements in the education system were derived to improve the domestic additional type certification process, such as approval of remodeling agencies and appointment of qualifications for each professional technician.

Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore

  • Tun, Tin;Sim, Xander
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.1
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    • pp.68-80
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    • 2021
  • An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors' facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.