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환경분야 시험 · 검사방법의 유효성 검증 기법 연구

Study on the Validation of Environmental Test Methods

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초록

The results of environmental testing and inspection are important as objective data for judging whether the basic criteria of environmental policies and standards are fulfilled. The results of environmental testing and inspection are measured by standard methods of an environmental analysis (Environmental Test Standards (ES) and Korean Industrial Standards (KS)) for quantifying environmental pollutants in the test samples. Therefore, a procedure is required to provide objective evidence that the standards of environmental analysis are appropriate for use and are reliable and reproducible. This study is performed to establish a quality control plan for standard environmental test methods because the operation management of ES and KS are integrated into the National Institute of Environmental Research. The research conducted on the literature available from all over the world has made it possible to develop quality and validation method for the standard to meet the performance and quality level when test methods are developed. The validation of the environmental test methods in the European Union is carried out in two stages robustness test and inter-laboratory test. Parameters of robustness test include selectivity, sensitivity, detection limit, quantitation limit, medium effect, etc., and involves setting the minimum recommended number of tests and the target value. Therefore, this study aims to establish ‘Guidelines for Validation of Standards of an Environmental field’ to ensure uniformity and accuracy of the methods before enactments and amendments of ES and KS.

Abstract

The results of environmental testing and inspection are important as objective data for judging whether the basic criteria of environmental policies and standards are fulfilled. The results of environmental testing and inspection are measured by standard methods of an environmental analysis (Environmental Test Standards (ES) and Korean Industrial Standards (KS)) for quantifying environmental pollutants in the test samples. Therefore, a procedure is required to provide objective evidence that the standards of environmental analysis are appropriate for use and are reliable and reproducible. This study is performed to establish a quality control plan for standard environmental test methods because the operation management of ES and KS are integrated into the National Institute of Environmental Research. The research conducted on the literature available from all over the world has made it possible to develop quality and validation method for the standard to meet the performance and quality level when test methods are developed. The validation of the environmental test methods in the European Union is carried out in two stages robustness test and inter-laboratory test. Parameters of robustness test include selectivity, sensitivity, detection limit, quantitation limit, medium effect, etc., and involves setting the minimum recommended number of tests and the target value. Therefore, this study aims to establish ‘Guidelines for Validation of Standards of an Environmental field’ to ensure uniformity and accuracy of the methods before enactments and amendments of ES and KS.

참고문헌 (18)

  1. 식품의약품안전청, "의약품등 시험방법 검증 가이드라인 적용을 위한 해설서" (2012)
  2. EURACHEM, "the Fitness for Purpose of Analytical Methods - A Laboratory Guide to Method Validation and Related Topics", ~ (2014)
  3. NATA, "Guidelines for the validation and verification of quantitative and qualitative test methods", ~ (2013)
  4. KOLAS, "화학적 시험방법의 유효성 확인을 위한 지침", ~ (2012)
  5. CEN, "Guide 13 Validation of environmental test methods", ~ (2008)
  6. EPA, "Guidance on Environmental Data Verification and Data Validation", ~ (2002)
  7. Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis (IUPAC Technical Report), , ~
  8. "ISO", IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
  9. 한국인터넷사물협회, "2017년 사물인터넷 서비스 및 제품편람", pp.133~147 (2017)
  10. 김승호, "IoT 기반의 대기환경 측정 및 분석 시스템 개발", 한국통신학회논문지, 42(9), pp.1750~1764 (2017), 한국통신학회[DOI]
  11. 환경분야 시험.검사 방법의 유효성 검증 기법 개발, 국립환경과학원보고서, "김금희", ~ (2017)
  12. "ISO Guide 99 International vocabulary of metrology-Basic and general concepts and associated terms", ~
  13. "KS A ISO5725-1 제1부:일반적인 원리 및 정의", ~
  14. "KS A ISO5725-2 제2부:표준 측정 방법의 반복 정밀도 및 재현 정밀도를 구하기 위한 기본적 방법", ~
  15. "KS A ISO5725-3 제3부:표준 측정 방법의 중간 정밀도", ~
  16. "KS A ISO5725-4 제4부:표준 측정 방법의 진도를 구하기 위한 기본적 방법", ~
  17. "KS A ISO5725-5 제5부:표준 측정 방법의 정밀도를 구하기 위한 대체법", ~
  18. "KS A ISO5725-6 제6부:정확도에 관한 값의 실용적사용 방법", ~

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