• Title/Summary/Keyword: Requirements of Compliance

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Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards

  • Han, Ji-Eun;Park, Minjung;An, Tteul-E-Bom;Park, Jong-Hyun;Oh, Danny;Kim, Kyeong Han;Sung, Soo-Hyun
    • Journal of Pharmacopuncture
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    • v.24 no.2
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    • pp.59-67
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    • 2021
  • Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

Investigating Structural Stability and Constructability of Buildings Relative to the Lap Splice Position of Reinforcing Bars

  • Widjaja, Daniel Darma;Rachmawati, Titi Sari Nurul;Kwon, Keehoon;Kim, Sunkuk
    • Journal of the Korea Institute of Building Construction
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    • v.23 no.3
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    • pp.315-326
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    • 2023
  • The design principles and implementation of rebar lap splice in architectural structures are governed by building regulations. Nevertheless, the minimization of rebar-cutting waste (RCW) is often impeded by the mandatory requirements pertaining to the rebar lapping zone as prescribed in design codes. In real-world construction scenarios, compliance with these rules often falls short due to hurdles concerning productivity, quality, safety, time, and cost. This discrepancy between code stipulations and on-the-ground construction practices necessitates an academic exploration. The goal of this research was to delve into the effect of rebar lap splice placement on the robustness and constructability of building edifices. The study initially took on a review of the computation of rebar lapping length and the rules revolving around the lapping zone. Following this, a structural robustness and constructability examination was undertaken, focusing on adherence to the lap splice zone. The interpretations and deductions of the research led to the following insights: (1) the efficacy of rebar lap splice is not solely contingent on the moment, and (2) the implementation of rebar lap splice beyond the specified zone can match the structural integrity and robustness of those confined within the designated area. As a result, the constraints on the rebar lapping zone ought to be revisited and possibly relaxed. The conclusions drawn from this research are anticipated to reconcile the disconnect between building codes and practical construction conditions, furnishing invaluable academic substantiation to further the endeavor of achieving near-zero RCW.

A Experimental Study on Performance Improvement Factors of Used V4 Steel Pipe Support (재사용 V4 강재 파이프 서포트의 성능향상 요인에 관한 실험적 연구)

  • Choi, Myeongki;Park, Jongkeun
    • Journal of the Korean Society of Safety
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    • v.35 no.3
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    • pp.43-48
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    • 2020
  • It is considered that most of reusable pipe supports, which are used as formwork support posting at construction sites, do not meet the performance standard. Due to the use of reusable pipe supports that do not meet such performance standard the potential risk of collapse accident is increasing. Therefore, this study identifies the status of compliance with performance standard, and presents the requirements for improving quality control to prevent the collapse of pipe supports reused at the construction site. First, if the female thread of the product with no clearance and new support pin with the diameter of 12mm are replaced at the same time for use, it is considered that the performance will be improved. Second, as the quality performance during use can be improved in the case of larger thickness of inner diameter compared to the case of larger thickness of outer diameter, it is necessary to increase the inner pipe thickness greatly than the current thickness. Based on the results of this study, it is expected that the performance the reusable pipe support (V4) can be improved, if the diameter of the support pin is 12mm, the female thread has a small clearance, and the inner tube thickness is 2.3 ~ 2.7mm. In addition, it is considered that other performance improvement factors included in the study results could be used as important data for improving the performance of reusable pipe support.

Evaluation of Quality Management of Domestic Asbestos Survey and Monitoring Service Providers (국내 석면조사기관의 품질관리 수준에 대한 평가)

  • Kwon, Jiwoon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.29 no.2
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    • pp.217-225
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    • 2019
  • Objectives: The aim of this study is to evaluate the quality management systems of domestic asbestos survey and monitoring service providers and the relationships with the number of licenses or designations and sales performances. Methods: Data on quality management systems were collected by assessors who were assigned by the Korea Occupational Safety and Health Agency(KOSHA) during a pilot evaluation program for designated asbestos survey and monitoring service providers in 2016 using evaluation criteria developed by KOSHA. Basic characteristics, evaluated scores, and sales performance were gathered and statistically analyzed. Results: The median and arithmetic mean of the total scores were 0.64 and 0.66. Evaluation fields that scored highly with the highest percentages were sales performance, installation and availability of equipment, compliance with the mandatory minimum number of airborne samples, laboratory independence, and results of proficiency analytical testing, in that order. Evaluation fields that received low marks with the highest percentages were the training of personnel, blank field samples, calibration of flow rates, preliminary check and visual inspection of the work area prior to the clearance test, and review and approval of final reports, in that order. Comparison of normalized scores between service providers registered for asbestos and other tasks and those designated for only asbestos showed significant differences in their evaluated scores. Sales performance did not show a positive correlation with evaluated scores. Conclusions: The quality management systems of domestic asbestos survey and monitoring service providers were poor. High scores were recorded mostly in evaluation fields related to regulatory requirements. Low scores were recorded mostly in evaluation fields related to documentation and recordkeeping. Considering the low influence of quality on sales performance, the government needs to evaluate the quality management of asbestos survey and monitoring service providers and provide the results to public in order to address their low levels of quality management.

Changes in Food Companies' Product and Promotion Activities after Restriction of TV Advertising of Energy-Dense and Nutrient-Poor Foods in Korea (고열량.저영양 식품의 TV 광고 제한에 따른 식품회사의 제품 및 촉진 활동 변화)

  • Kim, Hyungjun;Yoon, Jihyun;Lee, Youngmi
    • Journal of the East Asian Society of Dietary Life
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    • v.24 no.3
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    • pp.291-300
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    • 2014
  • This study determined the effects of television (TV) advertising restriction of Energy-Dense and Nutrient-Poor Foods on product and promotion activities by food companies producing or selling children's favorite foods. A survey using a selfadministered questionnaire was conducted via on-line or fax by marketers or R&D managers from 108 food companies. The data from 55 respondents (50.9%) were analyzed. Restriction exerted positive effects on food products with respect to compliance with labeling requirements (4.0 out of 5 points) and reinforcement of nutritional contents examination of new products (3.7 out of 5 points). Reformulations of products such as reduction of nutrients like sodium, sugar and fat were also reported. In addition, food companies underwent diverse changes in promotional activities, including modification of package designs and displays in stores, offering free gifts, discounts, etc. In conclusion, restriction of TV food advertising may contribute to improvement of children's food environment by encouraging food companies to make favorable product changes. On the other hand, the results also revealed that food companies adopt diverse marketing channels that are not yet under regulation. Hence, to make policies more effective, regulation needs to be extended from TV to other marketing channels to which children are easily exposed.

Investigation of Key Factors to measure on-site Performance of a Construction firm

  • Lee, Young-Dai;Kim, Jung-Ki;Acharya, Nirmal Kumar
    • Korean Journal of Construction Engineering and Management
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    • v.8 no.6
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    • pp.246-262
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    • 2007
  • The performance of projects has always been an area of interest in the construction industry. Roles of all construction supply chain partners are necessary; however the role of a contractor firm in the construction project is pivotal. So, this research intended to explore a Construction Firm's performance criteria which could measure the level of performance of that firm in an ongoing project. Data was collected from construction professionals working in three principal project participant organizations, namely Owner, Consultant and Contractor. A total of 113 nos. of performance measuring items were sorted from literature review and used to collect data. Statistical tools processed by SPSS program was employed to analyze the data. Out of total 113 items, only 65 nos. of variables were found to be acceptable to every population group of this study. Factor analysis revealed 12 key performance predicting factors (KPPF) with 53 predictive indicators. 12 KPPFS with index weight are: work progress and smoothening (9.3%), change order management and work accuracy (9.1%), business relationship building (8.1%), adequacy of construction work procedure (8.6%), quality performance (8.0%), health and site safety adequacy (8.8%), Innovative contractor (8.0%), adequacy of construction site information (6.8%), compliance with contract plan/specification requirements (8.9%), creditworthiness and financial capability (8.3%), intra-agency relationship and responsiveness (7.0%) and resource management (9.2%). These results could be useful to project management body to evaluate performance of its contractor firm on site as well as the contractor itself to assess own performance and its subcontractors on-site.

Investigation on the Validation for Designating Air Quality Control Region among Provincial Cities by the Data Measured with Air Quality Monitoring Network (대기오염 측정 자료에 의한 지방도시의 대기환경규제지역 설정에 관한 타당성 검토)

  • Yu, Mee-Seon;Yang, Sung-Bong;Woo, Kyung-Bin
    • Journal of Environmental Science International
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    • v.25 no.1
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    • pp.181-190
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    • 2016
  • Regional air quality regulation is a system that allows the Minister of Environment to designate the local area as air quality control region where the concentrations of air pollutants are exceeding the environmental standards, and the local governments that administrate the regulated area have to develop and practise a plan for reducing the air pollutants. From the data observed yearly by the monitoring stations in 8 provincial cities with more than 0.5 million people was judged the compliance with air quality standards in each municipality for the period of 2003 to 2013. As the result of investigation on air pollutants concentrations of each city, it was found that there was no station that exceeds the ambient air quality standards of CO, $SO_2$ and 24-hour $NO_2$. But all municipalities exceeded the standards of 8-hour $O_3$, annual and 24-hour $PM_{10}$, and therefore 8 municipalities can be designated to be under the local air regulation. For the annual $NO_2$ were the monitoring sites necessary requirements for designation of the air quality regulation region in Cheongju, Cheonan, Daejeon and Gwangju area. Incase of 1-hour $O_3$, some of stations in Pohang, Cheongju, Cheonan and Changwon area were over the designation standards for the air quality control region.

Video Image Analysis in Accordance with Power Density of Arcing for Current Collection System in Electric Railway (전기철도 집전장치의 아크량에 따른 비디오 이미지 분석)

  • Park, Young;Lee, Kiwon;Park, Chulmin;Kim, Jae-Kwang;Jeon, Ahram;Kwon, Sam-Young;Cho, Yong Hyun
    • The Transactions of The Korean Institute of Electrical Engineers
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    • v.62 no.9
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    • pp.1343-1347
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    • 2013
  • This paper presents an analysis methods for current collection quality in catenary system by means of video image based monitoring system. Arcing is the sparking at the interface point between pantograph and contact wire when the electric trains have traction current values at speed. Percentage of arcing at maximum line speed is measurable parameters for compliance with the requirements on dynamic behaviour of the interface between pantograph and contact wire in accordance with requirement of IEC and EN standards. The arc detector and video is installed on a train aim at the trailing contact strip according to the travel direction. The arc detector presented and measured verity of value such as the duration and power density of each arc and the video image is measured a image when the arc is occurred in pantograph. In this paper we analysis of video image in accordance with power density of arcing from arc detector and compared with video image and power density of arcing so as to produce quality of arcing from image.

Issues of Harmonization of ISO 9001 Standard and the Law 09-08. Protection of Personal Data in Morocco: Potentials and Risks

  • Adil CHEBIR ;Ibtissam EL MOURY;Adil ECHCHELH;Omar TAOUAB
    • International Journal of Computer Science & Network Security
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    • v.23 no.10
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    • pp.57-66
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    • 2023
  • Since 2009, Morocco has had a law governing the processing of personal data, the law 09-08, and a supervisory authority, the CNDP (National Commission for the Protection of Personal Data). Since May 2018, the European General Regulation on the Protection of Personal Data (GDPR) entered into force, which applies outside the EU in certain cases and therefore to certain Moroccan companies. The question of the protection of personal data is primarily addressed to the customer. The latter may not only be a victim of crime linked to ICT, but also have to face risks linked to the collection and abusive processing of his personal data by the private and public sectors. Often the customer does not really know how their data is stored, nor for how long and for what purpose. This fact raises the question of satisfying customer requirements, in particular for organizations that have adopted a quality approach based on ISO 9001 standard.In order to master these constraints, Moroccan companies have to adopt strategies based on modern quality management techniques, especially the adoption of principles issued from the international standard ISO 9001 while being confirmed by the law 09-08. It is through ISO 9001 and the law 09-08 that these companies can refer to recognized approaches in terms of quality and compliance. The major challenge for these companies is to have a Quality approach that allows the coexistence between the law 09-08 and ISO 9001 standard and this article deals within this specific context.

Effects of Enzyme Treatment and Skin Contact Time on the Characteristics of Dae-hong Peach Wine (대홍복숭아 과실주의 품질 특성에 미치는 효소와 침용 시간의 영향)

  • Bora Lim;Dahye Kim;Ji-Eun Kang;Gui-Jeong Han;Seok-Tae Jeong;Chan-Woo Kim
    • Journal of the Korean Society of Food Culture
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    • v.38 no.6
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    • pp.442-455
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    • 2023
  • This study investigated the effects of pectinase treatment and skin contact time on the quality characteristics of Dae-hong peach wine. Wine was produced with variations in enzyme treatment and skin contact time (1 hour, 2 hours, 1 day, 2 days, and until the completion of fermentation). Enzyme treatment increased the production yield by 6%, as well as ethanol and redness levels, compared to the non-treated control. Volatile components were higher when the skin contact time was 2 hours or 1 day. Results were compared according to enzyme treatment and skin contact time and found to be influenced by methanol and 3-methyl-1-butanol. Enzyme treatment effectively enhanced yields and volatile compound contents. However, skin contact should be concluded a day before 1 day to ensure compliance with methanol legislative requirements. Therefore, our findings show that enzymatic treatment with shorter skin contact time preserves the distinctive characteristics of Dae-hong peaches and ensures the production of safe and flavorful wine.