• Title/Summary/Keyword: Comparability assessment

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An Examination of Variation in Risk Assessment Practices in Relation to Assessors' Goals: American and International Practices

  • Park, Lorenz R. mberg
    • Toxicological Research
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    • v.17
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    • pp.219-225
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    • 2001
  • The basic structure for assessment of potential health risks from environmental chemicals is widely agreed upon, but many of the details of risk assessment procedures differ among practitioners. Government regulatory agencies typically have guidelines or standard procedures for their risk assessments, established to ensure consistency and comparability, to set standards for adequacy, and to embody underlying tenets. In setting and updating such guidelines, each agency takes into account not only the prevailing thinking about appropriate procedures, but also its own goals and responsibilities and the precedents it has set for itself in past analyses. This results in variations in methods, and consequently in characterization of risks, among regulatory assessments, even when they are based on the same data. As a result, adopting existing assessments from a variety of regulatory bodies needs to be done with caution. This paper examines some of the variants in risk assessment approaches among American federal regulatory agencies and relates them to the variations in regulatory responsibilities of those groups. Comparisons to international practices are also drawn. The impact on development of world-wide risk standards is discussed.

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Assessment for the Comparability between Korean Ministry of Environment Standard and ISO Standard for the Determination of Heavy Metals in Soil (토양 중금속 함량 측정에 대한 토양오염공정시험기준과 국제표준간의 적합성 평가)

  • Shin, Gun-Hwan;Lee, Goon-Teak;Lee, Won-Seok;Kim, Ji-In;Kim, Bo-Kyong;Park, Hyun-Jeong
    • Journal of Soil and Groundwater Environment
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    • v.17 no.3
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    • pp.1-9
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    • 2012
  • According to the agreement on WTO/TBT, we are under the situation to adopt international standard (ISO standard) as a national standard if it exists. However, in case of environmental area, it is a domestic legal obligation to use Korean environmental standard method(KESM) for analyzing various contaminants. Therefore it is necessary to assess the comparability between KEM and ISO standard prior to apply ISO standard to soil conservation law in Korea. The main purpose of this study is to assess the comparability of both methods for analyzing heavy metals in soil. We looked over various aspects like pre-treatment, calibration curve range, detection wavelength, soil organic matter content and so on. Apparently, the procedure of both methods is almost same. However in details, both methods are different in stationary time before aqua-regia extraction using reflux system, calibration curve range for Cu, Pb, Ni and measuring wavelength for Pb. According to the results of comparison test, the results were significantly different when the different calibration range was used. In case that all the extracts independent of methods were reanalyzed with the same calibration range of each method, both methods showed statistically same results. Other conditions like different stationary time, measuring wavelength of AAS and soil organic matter content did not have any influence on the analytical result. Therefore, we suggest to extend the calibration curve range to 0~8 mg/L which is used in KS I ISO standard(Korean standard related with environment which is translation version of ISO standard without any technical change). In case of $Cr^{6+}$, the results showed no significant differences between two methods even though the pretreatment, instrumentation and other analysis conditions were different. In addition to UV/Visble spectrometry of KESM for soil contamination, we suggest to adopt ion chromatography of ISO 15192(US EPA method 7199) for analyzing $Cr^{6+}$ with the consideration of laboratory work efficiency.

Statistics Quality Assessment and Improvement of Small & Medium Enterprises Survey (중소기업실태조사의 품질진단과 개선에 관한 연구)

  • Kim, Moon Sun;Chun, Sae Rom;Nam, Kyung H.
    • Journal of Korean Society for Quality Management
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    • v.40 no.4
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    • pp.577-588
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    • 2012
  • Purpose: This paper aims to evaluate the quality of Small & Medium Enterprises(SMEs) Survey and to provide some desirable directions and improvements for the future SMEs Survey, conducted by the Government. Methods: The diagnosis were performed by employing the quantitative and qualitative approaches with the official guideline provided by the Ministry of Statistics. Results: Results show that follow-up management are evaluated relatively low in specific processes, and timeliness are evaluated relatively lower than accuracy, accessibility, relevance, comparability and consistency in statistical qualities. Conclusion: we propose the alternatives which enhance the quality level of SMEs by using the 6 tools of Quality Management for Statistics.

Measurement Issues across Different Cultures

  • Lee, Ju-Hee;Jung, Duk-Yoo
    • Journal of Korean Academy of Nursing
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    • v.36 no.8
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    • pp.1295-1300
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    • 2006
  • Purpose. The purposes of this methodologic paper are to (1) describe theoretical background in conducting research across different cultures; (2) address measurement issues related to instrument administration; and (3) provide strategies to deal with measurement issues. Methods. A thorough review of the literature was conducted. A theoretical background is provided, and examples of administering instrument in studies are described. Results. When applying an instrument to different cultures, both equivalence and bias need to be established. Three levels of equivalence, i.e., construct equivalence, measurement unit equivalence, and full score comparability, need to be explained to maintain the same concept being measured. In this paper, sources of bias in construct, method, and item are discussed. Issues related to instrument administration in a cross-cultural study are described. Conclusion. Researchers need to acknowledge various group differences in concept and/or language that include a specific set of symbols and norms. There is a need to question the philosophical and conceptual appropriateness of an assessment measure that has been conceptualized and operationalized in a different culture. Additionally, testing different response formats such as narrowing response range can be considered to reduce bias.

Optimization of Shape Descriptor for Comparability Assessment of Protein Structure (지역적/전역적 형태기술자 최적화를 통한 단백질 구조 동등성 평가)

  • Suh, Jung-Keun;Chun, Sung-Hwan;Choi, Yoo-Joo
    • Proceedings of the Korea Information Processing Society Conference
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    • 2019.05a
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    • pp.631-634
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    • 2019
  • 단백질의 구조적 동등성을 평가를 위한 형태 기반의 기술자에 대한 연구는 제한적으로 이루어지고 있으며 대부분 지역적 특성 값으로 표현된 지역적 접근 방법이 다수를 이루고 있다. 지역적 특성과 전역적 특성을 포함하는 형태기술자의 경우 각 특성들이 동등한 중요도로 결합되어 있다. 본 연구에서는 선형 회귀분석을 적용하여 각 특성에 대한 중요도를 최적화하여 형태기술자를 재정의 하였다. 최적화된 형태기술자를 단백질의약품인 인슐린 모델에 적용하여 구조적 동등성을 평가할 수 있는 방법론을 제시하였다. 최적화된 형태기술자는 동일한 그룹에 속한 인간 인슐린 단백질 모델과 지역적으로 다른 구조를 가지는 인슐린 아날로그 그룹을 명확히 구분할 수 있음을 확인하였고 이러한 성능은 이전 연구의 형태기술자와 3D 저니크 기술자보다 더 좋은 성능을 보였다. 또한 제안한 방법은 고해상도 단백질 3차 구조 정보를 활용하여 유사성을 판별한 RMSD 방법과 유사하게 서로 다른 표면 구조를 가지는 단백질을 구별할 수 있음을 확인하였다. 이러한 결과로부터 본 연구에서 제시하는 형태기술자 및 최적화된 동등성 평가 함수는 SAXS 분석과 같이 저해상도 단백질 표면 모델을 확보할 수 있는 분석에 적용하여 단백질의 구조적 동등성을 판별할 수 있는 기반을 제공할 수 있을 것으로 판단된다.

A Case Study of National Food Safety Control System Assessment in the U.S. (미국의 국가식품안전관리체계 평가 사례연구)

  • Lee, Heejung
    • Journal of Food Hygiene and Safety
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    • v.32 no.3
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    • pp.179-186
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    • 2017
  • For more efficient and proactive safety control of imported food, new trend in U.S. is emerging, which assesses the food safety control systems of exporting countries using Systems Recognition Assessment Tool and helps ensure safety of imported foods. This study examines trends in development and application of assessmemnt tool and country assessment reports in U.S. where an active discussion on this issue is in progress. The expert interviews were also conducted. U.S. Systems Recognition Assessment Tool was developed by FDA to recognize the potential value in leveraging the expertise of foreign food safety systems and help ensure safety of imported food. The tool is comprised of ten standards and provides an objective framework for determining the robustness of trading partners' overall food safety systems. Using its own tool, the U.S. FDA conducted a preliminary assessment of the food safety control systems of New Zealand and Canada. According to the U.S.-New Zealand and the U.S.-Canada assessment reports, the overall structure of the systems was similar between the countries. In summarizing the opinions of experts, such a trend in National Food Safety Control System Assessment may be utilized in the sanitary assessment and the control of imported food border inspection frequency before importing food. It would contribute to more effective distribution of national budget and increased public trust. Additionally, international collaboration as well as securing of qualified experts and sufficient budget appear to be crucial to further increase the utility of National Food Safety Control Systems Assessment. In conclusion, firstly, it is critically important for the competent authority of South Korea to proactively respond to international trend in National Food Safety Control System Assessment by identifying the details of its background, assessment purpose, core assessment elements, and assessment procedures. Secondly, it is necessary to identify and complement the weaknesses of Korea's food safety control system by reviewing it with U.S. Systems Recognition Assessment Tool. Thirdly, by adapting the assessment results from imported countries' food safety control systems to the imported food inspection intensity, the resources previously used in inspecting the imported food from accredited countries can be redistributed to inspecting the imported food from unaccredited countries, and it would contribute to more efficient imported food safety control. Fourthly, the competent authority of South Korea should also consider developing its own assessment tool designed to reflect the unique characteristics of its food safety control system and international guidelines.

Study on Developing Assessment Guideline for Safety and Performance of Electric Cupping Apparatus (전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구)

  • Yi, Seung-Ho;Kim, Eun-Jung;Shin, Kyung-Hoon;Nam, Dong-Woo;Kang, Jung-Won;Lee, Seung-Deok;Lee, Hye-Jung;Lee, Jae-Dong;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.6
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    • pp.101-110
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    • 2009
  • Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.

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Development and Evaluation of Criterion-Referenced Performance Assessment Items Based on the 7th National Science Curriculum -Subject Unit of Reproduction and Biological Accumulation- (제7차 교육과정에 근거한 준거지향적 수행평가 문항의 개발과 평가 -고등학교 과학 "생식"과 "생물 농축" 단원을 중심으로-)

  • Chung, Young-Lan;Park, Jin-Joo
    • Journal of The Korean Association For Science Education
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    • v.24 no.3
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    • pp.519-531
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    • 2004
  • In recent years, there has been an increased emphasis on performance assessment to evaluate students' abilities. Our nation has introduced a change in testing and assessment. Additional work on the efficacy, reliability, and comparability in order to develop the performance assessment item has been needed in the enforcement of the 7th National Science Curriculum. Also, criteria for professional and technical standards has been needed to be developed. The purpose of this study was to draw out various key concepts and to develop achievement standards, assessment standards and performance assessment items based on the 7th National Science Curriculum on the subject matter of reproduction(chapter 13) and biological accumulation(chapter 17). And also, this study examined the validity of completed performance assessment items based on classical test theory and polytomous item response theory. Twelve key concepts in chapter 13(reproduction) and four from chapter 17(biological accumulation) were abstracted. Twenty-six achievement standards in chapter 13(reproduction), and nine in chapter 17(biological accumulation) were developed. The achievement standards were determined in terms of knowledge(K), process skill(P) and attitude(A). Twenty-five assessment standards in chapter 13(reproduction) and nine in chapter 17(biological accumulation) were developed. Based on the developed achievement standards and assessment standards, twenty-two performance assessment items(seventeen open-ended questions, three essays, and two portfolios) with concrete grading criteria were developed. Eight open-ended items were applied to 240 10th graders to evaluate reliabilities of the test which consisted of four items per each chapter. The results would be suggested that the applied items were valid for performance assessment because item difficulties and item discriminations were proper. There was not much differences in item discrimination between interpretation from classical test theory and that from polytomous item response theory. However, there were some differences in item difficulties between the interpretations of two theories because the characteristics of examinees were reflected in classical test theory.

Food Ingestion Factors of the Korean Exposure Factors Handbook

  • Jang, Jae-Yeon;Jo, Soo-Nam;Kim, Sun-Ja;Myung, Hyung-Nam;Kim, Cho-Il
    • Journal of Preventive Medicine and Public Health
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    • v.47 no.1
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    • pp.18-26
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    • 2014
  • The purpose of this study was to establish food ingestion factors needed to assess exposure to contaminants through food ingestion. The study reclassified the raw data of the Korean National Health and Nutrition Examination Survey in 2001 into 12 subcategories including grain products, meat products, fish and shellfish, and vegetables for international comparability of exposure evaluation. The criteria for food intake calculation were unified according to the characteristics of food groups, and recommended values for food ingestion factors were calculated through moisture correction and recategorization of cooked, processed, and mixed foods for each group. The average intake rate for grain and grain products was 6.25 g/kg-d per capita and the men's intake rate was approximately 8% higher than that of the women. The average intake rate of meat and meat products was 1.62 g/kg-d per capita and the men's intake rate was 30% higher than that of the women, on average. The average intake rate of fish and shellfish was 1.53 g/kg-d per capita, and the age groups of 1 to 2 and 3 to 6 recorded higher capita intake rates than other age groups, 2.62 g/kg-d and 2.25 g/kg-d, respectively. The average intake rate of vegetables was 6.47 g/kg-d per capita, with the age group of 1 to 2 recording the highest per capita intake rate of 9.79 g/kg-d and that of 13 to 19 recording the lowest mean. The study also offers recommended values for food ingestion factors of other food groups by gender, age, and region. The food ingestion exposure factors will need future updates in consideration of ongoing changes in food consumption behavior.

Quantitative Approaches for the Determination of Volatile Organic Compounds (VOC) and Its Performance Assessment in Terms of Solvent Types and the Related Matrix Effects

  • Ullah, Md. Ahsan;Kim, Ki-Hyun;Szulejko, Jan E.;Choi, Dal Woong
    • Asian Journal of Atmospheric Environment
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    • v.11 no.1
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    • pp.1-14
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    • 2017
  • For the quantitative analysis of volatile organic compounds (VOC), the use of a proper solvent is crucial to reduce the chance of biased results or effect of interference either in direct analysis by a gas chromatograph (GC) or with thermal desorption analysis due to matrix effects, e.g., the existence of a broad solvent peak tailing that overlaps early eluters. In this work, the relative performance of different solvents has been evaluated using standards containing 19 VOCs in three different solvents (methanol, pentane, and hexane). Comparison of the response factor of the detected VOCs confirms their means for methanol and hexane higher than that of pentane by 84% and 27%, respectively. In light of the solvent vapor pressure at the initial GC column temperature ($35^{\circ}C$), the enhanced sensitivity in methanol suggests the potential role of solvent vapor expansion in the hot injector (split ON) which leads to solvent trapping on the column. In contrast, if the recurrent relationships between homologues were evaluated using an effective carbon number (ECN) additivity approach, the comparability assessed in terms of percent difference improved on the order of methanol (26.5%), hexane (6.73%), and pentane (5.24%). As such, the relative performance of GC can be affected considerably in the direct injection-based analysis of VOC due to the selection of solvent.