• Title/Summary/Keyword: product safety assurance

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A Defect Prevention Model based on SW-FMEA (SW-FMEA 기반의 결함 예방 모델)

  • Kim Hyo-Young;Han Hyuk-Soo
    • Journal of KIISE:Software and Applications
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    • v.33 no.7
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    • pp.605-614
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    • 2006
  • The success of a software development project can be determined by the use of QCD. And as a software's size and complexity increase, the importance of early quality assurance rises. Therefore, more effort should be given to prevention, as opposed to correction. In order to provide a framework for the prevention of defects, defect detection activities such as peer review and testing, along with analysis of previous defects, is required. This entails a systematization and use of quality data from previous development efforts. FMEA, which is utilized for system safety assurance, can be applied as a means of software defect prevention. SW-FMEA (Software Failure Mode Effect Analysis) attempts to prevent defects by predicting likely defects. Presently, it has been applied to requirement analysis and design. SW-FMEA utilizes measured data from development activities, and can be used for defect prevention on both the development and management sides, for example, in planning, analysis, design, peer reviews, testing, risk management, and so forth. This research discusses about related methodology and proposes defect prevention model based on SW-FMEA. Proposed model is extended SW-FMEA that focuses on system analysis and design. The model not only supports verification and validation effectively, but is useful for reducing defect detection.

CIA-Level Driven Secure SDLC Framework for Integrating Security into SDLC Process (CIA-Level 기반 보안내재화 개발 프레임워크)

  • Kang, Sooyoung;Kim, Seungjoo
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.30 no.5
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    • pp.909-928
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    • 2020
  • From the early 1970s, the US government began to recognize that penetration testing could not assure the security quality of products. Results of penetration testing such as identified vulnerabilities and faults can be varied depending on the capabilities of the team. In other words none of penetration team can assure that "vulnerabilities are not found" is not equal to "product does not have any vulnerabilities". So the U.S. government realized that in order to improve the security quality of products, the development process itself should be managed systematically and strictly. Therefore, the US government began to publish various standards related to the development methodology and evaluation procurement system embedding "security-by-design" concept from the 1980s. Security-by-design means reducing product's complexity by considering security from the initial phase of development lifecycle such as the product requirements analysis and design phase to achieve trustworthiness of product ultimately. Since then, the security-by-design concept has been spread to the private sector since 2002 in the name of Secure SDLC by Microsoft and IBM, and is currently being used in various fields such as automotive and advanced weapon systems. However, the problem is that it is not easy to implement in the actual field because the standard or guidelines related to Secure SDLC contain only abstract and declarative contents. Therefore, in this paper, we present the new framework in order to specify the level of Secure SDLC desired by enterprises. Our proposed CIA (functional Correctness, safety Integrity, security Assurance)-level-based security-by-design framework combines the evidence-based security approach with the existing Secure SDLC. Using our methodology, first we can quantitatively show gap of Secure SDLC process level between competitor and the company. Second, it is very useful when you want to build Secure SDLC in the actual field because you can easily derive detailed activities and documents to build the desired level of Secure SDLC.

SAL 10-6 and Cytotoxicity of Sanitary Aid Products Utilizing Gamma Sterilization Technology (감마선 멸균기술을 이용한 의약외품의 무균보증수준(SAL 10-6) 확보 및 세포독성 평가)

  • Kim, Kwang Hoon;Eom, Yong Woon;Lee, Hoo Chul;Park, Sung Hyun;Kim, Soo Jin;Kim, Kwan Soo;Park, Soon Youn;Jeong, Ill Yun
    • Journal of Radiation Industry
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    • v.8 no.2
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    • pp.133-140
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    • 2014
  • The sterilization of health care products is widely used to choose conventional Ethylene Oxide gas sterilization in South Korea. But the method has brought serious issues because of the toxic residual gas and global warming of $CO_2$ evacuation after the sterilization process. This study is carried out to confirm the application possibility of gamma sterilization instead of Ethylene Oxide in sanitary aid products. Four kinds of products (gauze, menstrual pad, bandage, menstrual tampon) were treated with gamma irradiation of 15 kGy, then analyzed the achievement of the sterility assurance level (SAL) $10^{-6}$ through BI test. The cytotoxicity of accelerated samples of 6 months elapse evaluated by means of colony forming rate at various concentration of the extracts. pH and UV measurements at extract concentrations were tested according to the MFDS (Ministry of food & drug safety) guideline to verify a stability & safety of product sterilized. The results revealed that the extracts did not show any significant changes in cytoxicity assay as well as pH and UV values by gamma sterilization. All extract concentration was observed high cell viability, pH and UV values were calculated within the acceptable range prescribed by the guideline. It indicates that gamma sterilization could effectively substitute for conventional sterilization such as Ethylene Oxide sterilization in the sanitary aid products.

Development of Assessment Evaluation Check Sheet to Identify Problems in SME Field and to Develop Creative Improvement Plan (중소기업 현장 문제점 발굴과 개선방안을 모색을 위한 평가진단 체크시트 개발)

  • Lee, Deok Soo;Park, Roh Gook
    • Journal of Korea Society of Industrial Information Systems
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    • v.22 no.6
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    • pp.95-105
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    • 2017
  • The Purpose of This Study is to Develop a Checklist Model of Evaluation Diagnosis to Increase the Competitiveness of SMEs in Local Governments. The Evaluation Diagnostic Check Sheet Development Procedure Proceeded in the Order of Preliminary Investigation (Major Company Survey, Analysis of Characteristics of the Industry, Selection of Core Functions, etc.), Research and Development (Development of Core Function Check Sheet, Development of Core Function Improvement Tools). The Evaluation Model is divided into Five Categories (Vision and Strategy System, Quality Assurance and Product Safety, Field Management Level, Statistical Process Control, Improvement Activities), and 1) Recognition, 2) System, 3) Operation, 4) Review and Supplement. This Evaluation Model is expected to Contribute to the Selection of the Mainstream SMEs among the Companies Scattered within the Local Autonomous Entities, thereby Enhancing the Competitiveness of SMEs.

Establishment of National Quality Control System for Analytical Laboratory of Pesticide Products by Proficiency Testing (농약 이화학시험 분석기관의 숙련도시험을 통한 정도관리체계 확립 연구)

  • Chang, Hee-Ra;Park, Hyo-Kyung;Lim, Youngjoo;Kim, Kwang-Ho;Kim, Chan Sub;Kim, Kyun
    • The Korean Journal of Pesticide Science
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    • v.16 no.4
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    • pp.350-356
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    • 2012
  • Performance of proficiency testing and the validation of analytical method was included a scheme of quality assurance in analytical chemistry laboratory to monitor a laboratory's performance abilities and produce consistently reliable data. This study was assessed the applicability of proficiency testing scheme proposed for analytical laboratories of pesticide product in domestic. The validation of analytical methods, stability and homogeneity for formulated pesticide products (emulsifiable concentrate) of emamectin benzoate and lufenuron was confirmed for the proficiency testing. The z-score of 33 participation laboratories for emamectin benzoate were that the numbers of outlier were 2 laboratories (6.0%), z-score outside the range from -3 to 3 designated "unaccptable" were 2 laboratories and z-score in the ranges -2 to -3 and 2 to 3 designated "questionable" were 3 laboratories (9.0%). Three laboratories (9.0%) showed the z-score designated "questionable" for lufenuron. The additional proficiency testing for various product types will be needed to establish the scheme of quality control.

토양 및 지하수 Investigation 과 Remediation에 대한 현장적용

  • Wallner, Heinz
    • Proceedings of the Korean Society of Soil and Groundwater Environment Conference
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    • 2000.11a
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    • pp.44-63
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    • 2000
  • Situated close to Heathrow Airport, and adjacent to the M4 and M25 Motorways, the site at Axis Park is considered a prime location for business in the UK. In consequnce two of the UK's major property development companies, MEPC and Redrew Homes sought the expertise of Intergeo to remediate the contaminated former industrial site prior to its development. Industrial use of the twenty-six hectare site, started in 1936, when Hawker Aircraft commence aircraft manufacture. In 1963 the Firestone Tyre and Rubber Company purchased part of the site. Ford commenced vehicle production at the site in the mid-1970's and production was continued by Iveco Ford from 1986 to the plant's decommissioning in 1997. Geologically the site is underlain by sand and gravel, deposited in prehistory by the River Thames, with London Clay at around 6m depth. The level of groundwater fluctuates seasonally at around 2.5m depth, moving slowly southwest towards local streams and watercourses. A phased investigation of the site was undertaken, which culminated in the extensive site investigation undertaken by Intergeo in 1998. In total 50 boreholes, 90 probeholes and 60 trial pits were used to investigate the site and around 4000 solid and 1300 liquid samples were tested in the laboratory for chemical substances. The investigations identified total petroleum hydrocarbons in the soil up to 25, 000mg/kg. Diesel oil, with some lubricating oil were the main components. Volatile organic compounds were identified in the groundwater in excess of 10mg/l. Specific substances included trichloromethane, trichloromethane and tetrachloroethene. Both the oil and volatile compounds were widely spread across the site, The specific substances identified could be traced back to industrial processes used at one or other dates in the sites history Slightly elevated levels of toxic metals and polycyclic aromatic hydrocarbons were also identified locally. Prior to remediation of the site and throughout its progress, extensive liaison with the regulatory authorities and the client's professional representatives was required. In addition to meetings, numerous technical documents detailing methods and health and safety issues were required in order to comply with UK environmental and safety legislation. After initially considering a range of options to undertake remediation, the following three main techniques were selected: ex-situ bioremediation of hydrocarbon contaminated soils, skimming of free floating hydrocarbon product from the water surface at wells and excavations and air stripping of volatile organic compounds from groundwater recovered from wells. The achievements were as follows: 1) 350, 000m3 of soil was excavated and 112, 000m3 of sand and gravel was processed to remove gravel and cobble sized particles; 2) 53, 000m3 of hydrocarbon contaminated soil was bioremediated in windrows ; 3) 7000m3 of groundwater was processed by skimming to remove free floating Product; 4) 196, 000m3 of groundwater was Processed by air stripping to remove volatile organic compounds. Only 1000m3 of soil left the site for disposal in licensed waste facilities Given the costs of disposal in the UK, the selected methods represented a considerable cost saving to the Clients. All other soil was engineered back into the ground to a precise geotechnical specification. The following objective levels were achieved across the site 1) By a Risk Based Corrective Action (RBCA) methodology it was demonstrated that soil with less that 1000mg/kg total petroleum hydrocarbons did not pose a hazard to health or water resources and therefore, could remain insitu; 2) Soils destined for the residential areas of the site were remediated to 250mg/kg total petroleum hydrocarbons; in the industrial areas 500mg/kg was proven acceptable. 3) Hydrocarbons in groundwater were remediated to below the Dutch Intervegtion Level of 0.6mg/1; 4) Volatile organic compounds/BTEX group substances were reduced to below the Dutch Intervention Levels; 5) Polycyclic aromatic hydrocarbons and metals were below Inter-departmental Committee for the Redevelopment of Contaminated Land guideline levels for intended enduse. In order to verify the qualify of the work 1500 chemical test results were submitted for the purpose of validation. Quality assurance checks were undertaken by independent consultants and at an independent laboratory selected by Intergeo. Long term monitoring of water quality was undertaken for a period of one year after remediation work had been completed. Both the regulatory authorities and Clients representatives endorsed the quality of remediation now completed at the site. Subsequent to completion of the remediation work Redrew Homes constructed a prestige housing development. The properties at "Belvedere Place" retailed at premium prices. On the MEPC site the Post Office, amongst others, has located a major sorting office for the London area. Exceptionally high standards of remediation, control and documentation were a requirement for the work undertaken here.aken here.

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A Quality Assurance Study for the Application of Cook/Chill System in School Foodservice Operation (II) - Pork Bulgogi (Broiled Sliced Pork with Sauces) - (학교급식에 Cook/Chill System 적용을 위한 품질보증연구(II) - 돼지불고기 -)

  • Kwak, Tong-Kyung;Moon, Hye-Kyung;Park, Hye-Won;Hong, Wan-Soo;Ryu, Kyung;Chang, Hye-Ja;Kim, Sung-Hee;Choi, Eun-Jung
    • Journal of Food Hygiene and Safety
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    • v.13 no.4
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    • pp.319-331
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    • 1998
  • The purposes of this study were to develop Hazard Analysis Critical Control Point plan applicable to cook/chilled Pork Bulkogi (broiled sliced pork with sauces) in school foodservice operations and to establish reasonable shelf-life limits by assessing food quality during chilled storage period of 5 days. During the product flow, time-temperature profile was recorded and microbiological analyses including mesophilic and psychrotrophic total plate counts, coliform, and fecal coliform and qualitative analyses of Salmonella and Listeria monocytogenes were done. Chemical analyses (pH, acid value, total volatile basic nitrogen), sensory evaluation, and quantitative analysis of thiamin were conducted for 5 days of chilled storage. The number of mesophiles in raw pork ($4.26{\pm}0.11\;Log\;CFU/g$), seasoning mixture ($5.97{\pm}O.04\;Log\;CFU/g$) and marinated pork ($5.56{\pm}0.21\;Log\;CFU/g$) were below the microbial standards for "requires further cooking" food items. Listeria monocytogenes was detected in seasoning mixture. After heating, the number of mesophiles ($5.17{\pm}0.04\;Log\;CFU/g$) were slightly reduced but it did not meet the microbial guidelines of $5\;Log\;CFU/g$ for "ready-to-eat" foods. No other microbes including pathogens were detected. By reheating the menu item after chilled storage, the number of mesophiles were reduced in every phase of 1st day ($4.62{\pm}0.22\;Log\;CFU/g$), 3rd day ($4.55{\pm}0.20\;Log\;CFU/g$) and 5th day ($4.25{\pm}0.16\;Log\;CFU/g$) of chilled storage, and the number of microbes was below the standard limits for "ready-to-eat" foods. At the fifth day of chilled storage, pH (p<0.05), acid value (p<0.01) and TVBN (p<0.05) showed significant increases. Sensory evaluation results did not show any significant change for 5 days of chilled storage. Thiamin content showed a decrease for 5 days of chilled storage. Consequently, the ideal shelflife recommended for Pork Bulkogi was within 3 days of chilled storage. CCPs for Pork Bulkogi were purchasing and receiving of raw meat and some seasoning ingredients, heating, chilling, chilled storage, reheating, and distribution.

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