本研究的目的在探討企業施行零缺陷活動之效益評估，並透過文獻收集、零缺陷問卷調查、零缺陷文化推廣等活動加以研究分析，並比較不同國家之零缺陷問卷結果，依據本研究結果顯示，歸納以下三點之結論：
1. 跨國企業推行零缺陷活動之結果呈現了與當地文化特色相關聯性，不同國家及組織氣候造成了結果多元差異化，也符合跨國企業強調的多元包容。
2. 組織內不同層級考量造成部分結果呈現不一致，與組織成熟度及組織氣候有關聯，領導團隊在推行企業文化時應考慮當時的氛圍採取不一樣的策略，並且將跨國文化交融部分納入考量。
3. 透過多元包容性，組織多樣化有助於企業發展及因應快速變化的市場需求，透過零缺陷文化推廣，企業的社會責任更加明確。

The purpose of this study is to explore business purposes defect benefit assessment activities, and through the literature collection, defect survey, zero defect culture promotion activities to be analyzed, and the results of the questionnaire defect comparing different countries, according to the results of this study show summarized the following three conclusions:
1. The multinational implementation of zero defects activities is associated with local cultural characteristics, nationality and organizational climate causes pluralistic differentiation in line with diversity and inclusiveness multinational emphasized.
2. Different levels caused some considerations presented inconsistent results, and organizational maturity and organizational climate related, consideration of prevailing climate leadership team to implement the corporate culture should be taken different policies within the organization, and the cross-cultural blend components into consideration.
3. Through multivariate inclusive, diverse organizations contribute to the development of enterprises and in response to rapidly changing market demand, zero defect culture through the promotion of corporate social responsibility more clearly.

論文摘要 I
ABSTRACT II
誌謝 III
目錄 IV
圖目錄 VI
表目錄 VII
第壹章 緒論 1
第一節 研究背景與動機 1
第二節 原廠藥及學名藥 1
第三節 藥物召回 2
第四節 研究目的 4
第五節 研究架構 9
第貳章 文獻探討 10
第一節 製藥產業 10
第二節 品質管理 13
第三節 六標準差 14
第四節 零缺陷（ZERO DEFECTS, ZD） 19
第五節 戴明迴圈(DEMING CYCLE) 30
第參章 研究方法 36
第一節 問卷調查法 36
第二節 零缺陷調查問卷(ZERO DEFECTS SURVEY) 36
第肆章 研究結果 40
第一節 零缺陷調查(ZERO DEFECTS SURVEY) 40
第二節 統計結果 41
第三節 結果分析 50
第伍章 結論與意涵 53
第一節 零缺陷管理 53
第二節 零缺陷實踐 53
參考文獻 55

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