應用六標準差改善實驗室認證評鑑不符合事項之研究

六標準差的應用能使製程中的量具既準確而又精確的符合規格，商業實驗室所提供的校正服務，可得知追溯之標準值與實際值間的差異，如此能修正量具中心值偏差的程度，並進一步評估量測不確定度的成份與離散的程度、採取改善措施、降低量測結果的變異，以精進、改善實驗室經營管理系統。目前實驗室品質系統係依ISO/IEC 17025”General requirements for the competence of calibration and testing laboratories”（檢校與測試實驗室一般能力之要求），已於1999年底發佈成為國際品質標準，並於2005年5月15日發佈為第二版新標準，多年以來已廣泛地為國內外實驗室認證機構採用，作為校正與測試實驗室品質認證之標準，其評鑑實驗室品質系統之主要項目為：第四章之管理要求(共十五個章節)、第五章的技術要求(共十個章節)，在包括國內全國認證基金會TAF（Taiwan Accreditation Foundation）與A2LA(美國實驗室認證協會)認證機構評鑑結果不符合事項之項目中發現比例具有相當之一致性，歷來統計中又以試驗與校正方法及方法確認、預防措施、文件管制等，經評鑑不符合事項比例為最高，顯然這些問題係為普遍存在各實驗室之運作中，亟待改善。本文係應用6 Sigma之管理手法，運用界定(Define)、衡量(measure)、分析(Analyze)、改善(Improve)、控制(Control)之歷程，針對實驗室運作符合ISO/IEC 17025:2005認證評鑑所產生常見之不符合事項個案中，就評估量測不確定度離散程度的過程與結果，找出潛在問題及關鍵因子，擬定對策，改善實驗室作業流程與服務品質、管理與技術能力，以供檢校與測試實驗室於認證評鑑時有所參考，並達成實驗室準、穩、精、速的目標。

關鍵字

六標準差；實驗室認證；量測不確定度； DMAIC ； ISO/IEC 17025

並列摘要

Application of Six Sigma can make the measuring tool to meet the specification accurately, Calibration laboratories traceability is to correct center value and know uncertainty factors through calibration laboratory services, and reduce the variation of measurement. In ISO/IEC 17025 " General requirements for the competence of calibration and testing laboratories" standards on May 15 in 2005, have been widely adopted as the standard of calibration and testing quality accreditation assessment in the laboratory for the domestic and international laboratory accreditation organization for many years. The laboratory quality system covers 15 sections for management requirement in chapter four and 15 sections for specification requirement in chapter five, Including TAF (Taiwan accreditation foundation) and A2LA(the laboratory accreditation association of U.S.A.) can be obtained by using statistics. Data control, preventive actions, and test and calibration methods and method validation are three major unconformity items. In this applied six sigma techniques D-M-A-I-C to improve ISO/IEC 17025:2005 unconformity items. For estimating the process and the result of uncertainty and further finding out the root causes of problems and main factors for calibration and testing the laboratory reference applying for Accreditation. The benefit service quality, and operation effectiveness, which can be enhanced management technological capability, becoming the credible standard laboratory.