精實六標準差(Lean Six Sigma)，是具一套有系統的邏輯思考模式，其結合精實(Lean)原理與六標準差(Six Sigma)二個方法論之優點，可用來改善影響造成顧客之嚴重拖延業務流程活動與解決關鍵品質要素。精實六標準差已經廣泛地使用於製造業與服務業中。
本研究應用精實六標準差改善動物實驗流程之作業時間，透過六標準差DMAIC架構，首先定義影響顧客之關鍵品質特性，接著繪製價值溪流圖，找出動物實驗流程中之非加值活動，並運用特性要因圖分析主要原因。本研究以團隊合作方式擬定改善方案，來去除作業流程中之浪費，以提升流程週期效益。執行改善建議之後，結果顯示，除了動物實驗流程時間已小於產業界中擬定之標準之外，投藥前動物實驗作業流程總體的週期流程效率已增為35% (增加16%)，投藥後動物實驗作業流程之總體週期流程效率也增為52% (增加18%)。動物實驗作業流程時間，從667分鐘降至249分鐘，整體作業流程時間縮短418分鐘。委託案件數從181件提升至389件，年總產值高達1.9億元，總接案產出率提升46.5%。
本研究顯示，導入精實六標準差不僅是降低了作業流程時間，更提升了醫藥研發動物實驗單位之流程作業品質及營運績效，同時也為動物實驗產業帶來新的思考邏輯。

Lean Six Sigma (LSS) is a systematic logical thinking model that combines the advantages of Lean and Six Sigma (SS) methodology. LSS can be used to reduce the process delay and improve the customer’s critical-to-quality (CTQ) issues. LSS has been widely used in manufacturing and service industries.
In this study, we used LSS to improve the working time of animal experiments. Through the Six Sigma DMAIC framework, we first defined the critical to quality characteristics that affect customers, and constructed Value Stream Map (VSM) to find out the non-value-added (NVA) activities in the animal experiment process. Cause and effect diagram was used to analyze the main reasons. Several improvement solutions were proposed to remove waste in the process to improve process cycle efficiencies. After implementing the improvement solutions, the results showed that the animal experiment process time was less than the standard in the industry and the overall cycle process efficiency of the animal experiment process before the drug administration had increased to 35% (16% increase). The overall cycle process efficiency of the workflow was also increased by 52% (an increase of 18%). The animal experiment process time was reduced from 667 minutes to 249 minutes, and the overall operation time was shortened by 418 minutes. The contract proposal cases have increased from 181 to 389, with an annual total output value of 190 million yuan and a total output rate of 46.5%.
This study shows that the introduction of Lean Six Sigma of precision is not only to reduce the operation time, but also to improve the process operation quality and operational performance of the animal research and development animal experimental unit. In addition, this study bring new thinking logic to the animal experiment industry.

目錄
摘要..................I
Abstract.............II
誌謝.................IV
目錄..................V
圖目錄..............VII
表目錄...............IX
第一章 緒論
1.1 研究背景與動機..................................1
1.2 研究目的.......................................3
1.3 研究架構.......................................4
第二章 文獻探討
2.1 藥物動力學......................................5
2.1.1 動物實驗..................................6
2.1.2 醫學實驗動物學.............................7
2.1.3 實驗動物發展的3R和5F趨勢...................10
2.2 六標準差........................................13
2.2.1 六標準差改善流程步驟.......................16
2.2.2 六標準差於實驗動物實驗室研究產業之應用.......17
2.3 精實生產............................18
2.3.1 精實之定義....................18
2.3.2 精實於醫藥實驗室產業之應用.....20
第三章 精實六標準差
3.1 精實六標準差之概念.........21
3.2 精實六標準差之方法論.......23
3.2.1 定義................23
3.2.2 衡量................24
3.2.3 分析................26
3.2.4 改善................29
3.2.5 控制................30
第四章 個案研究
4.1 案例背景..............31
4.2 定義階段..............35
4.3 衡量階段..............39
4.4 分析階段..............44
4.5 改善階段..............52
4.6 控制階段..............63
4.7 效益分析..............65
第五章 結論
5.1 結論..................69
5.2 未來展望..............71
參考文獻
英文......................72
中文......................75

英文
1.Basu, R. and Wright, J.N., 2003, Quality beyond six sigma,
Butterworth-Heinemann.
2.Cloete, B.C. and Bester, A., 2012, A Lean Six Sigma approach to
the improvement of the selenium analysis method, Onderstepoort J
Vet Res., 79 (1): E1-E13.
3.Committee for the update of the guide for the care and use of
laboratory animals, National Research Council.（張維正譯，2015，實
驗動物照護及使用指南，第八版）.
4.Dagmara, Scalise., 2003, Six sigma in action hospita & health,
Network, Chicago, 77, 55 .
5.George, M L., 2002, Lean Six Sigma combining Six Sigma quality
with lean speed.（樂為良譯，2002，精實六標準差）.
6.George, M L. Rowlands, D. and Kastel, B., 2004, What is Lean Six
Sigma? McGraw-Hill.（丁惠民譯，2005，精實六標準差簡單講，麥格羅希
爾）.
7.George, M L. Rowlands, D. Price, M. and Maxey, J., 2004, The
Lean Six Sigma Pocket Tool book, McGraw-Hill.（丁惠民譯，2006，精
實六標準差工具手冊，麥格羅希爾）.
8.Inal, TC., Goruroglu Ozturk O., Kibar F., Cetiner S., Matyar S.,
Daglioglu G., Yaman A., 2017, Lean six sigma methodologies
improve clinical laboratory efficiency and reduce turnaround
times.
9.Linville, J., Schumann, D., Aston, C., Defibaugh-Chavez, S.,
Seebohm, S. and Touhey, L., 2016, Using a six sigma fishbone
analysis approach to evaluate the effect of extreme weather
events on salmonella positives in young chicken slaughter
establishments. Journal of Food Protection, Vol. 79 No. 12, pp.
2048-2057.
10.Liguori, G. R., Jeronimus, B. F., Liguori, T. T. D. A.,
Moreira, L. F. P. & Harmsen, 2017, Ethical Issues in the Use of
Animal Models for Tissue Engineering: Reflections on Legal
Aspects, Moral Theory, 3Rs Strategies, and Harm-Benefit
Analysis. Tissue Engineering Part C Methods., 23 (12): 850–862.
11.Linderman, Kevin, Roger G. Schroeder, Srilata Zaheer, and
Adrian S. Choo., 2003, Six sigma: a goal-theoretic
perspective, Journal of Operation Management, 21, No. 2, 193-
203.
12.McAdam, R. and Evans, A., 2004, The organizational contextual
factors affecting the implementation of Six Sigma in a high
technology mass-manufacturing environment.
13.Okpe, O. and Kovach, JV., 2017, A Redesign Approach for
Improving Animal Care Services for Researchers, J Am Assoc Lab
Anim Sci. Jul; 56 (4): 462–471.
14.Pande, P.S., Neuman, R.P. and Cavanagh, R.R., 2000, The Six
Sigma Way: How GE, Motorola, and Other Top Companies are Honing
Their Performance, McGraw-Hill, New York .
15.Pande, P.S., Neuman, R.P. and Cavanagh, R.R., 2001, The Six
Sigma Way Team Fieldbook, McGraw-Hill.（樂為良譯，2002，六標準差團
隊實戰指南，麥格羅希爾）.
16.Stacy, P. 2015, Process improvement concepts. Animal Lab News
Magazine 13:20–21.
17.Taylor K, Gordon N, Langley G, Higgins W., 2008, Estimates for
worldwide laboratory animal use in 2005. ATLA. 36: 327-342.
18.Womack, J.P. and Jones, D. T., 1996, Lean Thinking: Banish
Waste and Create Wealth in your Corporation. Simon and
Schuster, New York.
19.Womack, J.P. Jones, D. T., and Roos, D., 1990, The Machine That
Changed the World : The Story of Lean Production, Rawson and
Associates, New York.
20.Womack, J. P. Jones, D. T. and Roos, D., 1991, The Machine that
Changed the World: The Story of Lean Production. Harper
Perennial. United States of America.
 

中文
1.__，2018，臨床試驗審查IND，財團法人醫藥品查驗中心。
2.__，2008，實驗動物簡介，行政院農業委員會。
3.丁崇原，2016，實驗動物分類遺傳特性及命名法則簡介，樂斯科生物科技股份有
限公司。
4.何誠，2015，實驗動物學(第2版)，中國農業大學出版社。
5.沈永銘，2016，105年度實驗動物人道管理年報，行政院農業委員會。
6.林懿宏、林宏欣，2001，「六個希格瑪在歐洲推行成效」，管理雜誌，第326
期，8月，pp.58-63。
7.洪紹竹，1996，實驗動物技術人員訓練手冊（二版），國家實驗動物繁殖級研究
中心。
8.周辰熹、鄭靜玲，2015，藥物在體內PK防守，科學發展505 期。
9.周鈺璇，2009，「應用精實六標準差改善物料配送績效」，清華大學工業工程與
工程管理學系碩士班論文。
10.秦咸靜、陳立人、朱賢斌，2017，科學發展538 期。
11.秦咸靜，2010，動物實驗倫理新挑戰。
12.許漢仁，2018，提高產能及降低生產成本之運用DMAIC改善案例，MKC知識管理
中心。
13.陳品旻、蕭業庭，2016，生活中的實驗動物。
14.葉嘉萃，2012，生物安全第二等級動物實驗室概論。
15.楊培茹，2010，應用精實六標準差改善急性心肌梗塞病患之血管再灌注時間，
清華大學工業工程與工程管理學系碩士班論文。
16.鄭榮郎，2002，「推動 6 sigma 組織架構與基本認知」，能力雜誌，9月，90-93。
17.鄧哲明，2013，科學月刊 第四十四卷第二期
18.蘇朝墩 ，2009，「六標準差」，前程文化。
19.蘇朝墩 ，2010，「品質管理」，前程文化。
20.蘇朝墩、陳麗妃、許俊欽，2014，「六標準差綠帶」，前程文化。