대한임상검사과학회지 (Korean Journal of Clinical Laboratory Science)
- 제37권2호
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- Pages.65-70
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- 2005
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- 1738-3544(pISSN)
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- 2288-1662(eISSN)
6 시그마와 총 오차 허용범위의 개발에 대한 연구
A Study of Six Sigma and Total Error Allowable in Chematology Laboratory
- 장상우 (녹십자의료재단, 고객지원 및 QA부) ;
- 김남용 (녹십자의료재단, 고객지원 및 QA부) ;
- 최호성 (녹십자의료재단, 관리부) ;
- 김영환 (녹십자의료재단, 화학혈액 검사실) ;
- 추경복 (녹십자의료재단, 화학혈액 검사실) ;
- 정혜진 (녹십자의료재단, 화학혈액 검사실) ;
- 박병옥 (녹십자의료재단, 화학혈액 검사실)
- Chang, Sang-Wu (Technical Information & QA Division, Department of Green Cross Reference Laboratories) ;
- Kim, Nam-Yong (Technical Information & QA Division, Department of Green Cross Reference Laboratories) ;
- Choi, Ho-Sung (Division of Operation Management, Department of Green Cross Reference Laboratories) ;
- Kim, Yong-Whan (Division of Chematology, Department of Green Cross Reference Laboratories) ;
- Chu, Kyung-Bok (Division of Chematology, Department of Green Cross Reference Laboratories) ;
- Jung, Hae-Jin (Division of Chematology, Department of Green Cross Reference Laboratories) ;
- Park, Byong-Ok (Division of Chematology, Department of Green Cross Reference Laboratories)
- 발행 : 2005.08.31
초록
Those specifications of the CLIA analytical tolerance limits are consistent with the performance goals in Six Sigma Quality Management. Six sigma analysis determines performance quality from bias and precision statistics. It also shows if the method meets the criteria for the six sigma performance. Performance standards calculates allowable total error from several different criteria. Six sigma means six standard deviations from the target value or mean value and about 3.4 failures per million opportunities for failure. Sigma Quality Level is an indicator of process centering and process variation total error allowable. Tolerance specification is replaced by a Total Error specification, which is a common form of a quality specification for a laboratory test. The CLIA criteria for acceptable performance in proficiency testing events are given in the form of an allowable total error, TEa. Thus there is a published list of TEa specifications for regulated analytes. In terms of TEa, Six Sigma Quality Management sets a precision goal of TEa/6 and an accuracy goal of 1.5 (TEa/6). This concept is based on the proficiency testing specification of target value +/-3s, TEa from reference intervals, biological variation, and peer group median mean surveys. We have found rules to calculate as a fraction of a reference interval and peer group median mean surveys. We studied to develop total error allowable from peer group survey results and CLIA 88 rules in US on 19 items TP, ALB, T.B, ALP, AST, ALT, CL, LD, K, Na, CRE, BUN, T.C, GLU, GGT, CA, phosphorus, UA, TG tests in chematology were follows. Sigma level versus TEa from peer group median mean CV of each item by group mean were assessed by process performance, fitting within six sigma tolerance limits were TP (