本文關(guān)鍵詞： 生物制藥 精益六西格瑪 疫苗 新產(chǎn)品項(xiàng)目 流程優(yōu)化　出處：《中國(guó)科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)》2016年碩士論文　論文類型：學(xué)位論文

【摘要】：隨著我國(guó)進(jìn)入世界貿(mào)易組織,我國(guó)生物制藥企業(yè)不得不直接面對(duì)更為嚴(yán)酷的國(guó)際競(jìng)爭(zhēng)環(huán)境。我國(guó)生物制藥企業(yè)要想在競(jìng)爭(zhēng)中立足,就必須提高自身競(jìng)爭(zhēng)力。精益六西格瑪管理是精益生產(chǎn)與六西格瑪這兩種管理理念的有機(jī)結(jié)合,現(xiàn)已在制造行業(yè)中被成功應(yīng)用,是幫助生物制藥企業(yè)提高自身競(jìng)爭(zhēng)力的“最佳實(shí)踐”。S公司是國(guó)內(nèi)一家生物制藥企業(yè),其新疫苗產(chǎn)品開發(fā)流程存在缺陷,從而導(dǎo)致了產(chǎn)品合格率低、過(guò)程控制不穩(wěn)定等問(wèn)題,無(wú)法達(dá)到預(yù)期的目標(biāo)。本課題研究通過(guò)對(duì)國(guó)內(nèi)外精益六西格瑪理論研究和分析,結(jié)合S公司和國(guó)內(nèi)生物制藥企業(yè)的普遍現(xiàn)狀,應(yīng)用精益六西格瑪管理的思想和工具,對(duì)S公司新疫苗開發(fā)流程進(jìn)行了改進(jìn)和優(yōu)化。通過(guò)“定義-測(cè)量-分析-改進(jìn)-控制(以下簡(jiǎn)稱DMAIC)"問(wèn)題解決模型,在定義階段(D)應(yīng)用Pareto圖工具確定改進(jìn)的具體目標(biāo)；在測(cè)量階段(M)應(yīng)用失敗模式效果分析(FMEA)工具,結(jié)合開發(fā)產(chǎn)品的工藝流程,進(jìn)行質(zhì)量風(fēng)險(xiǎn)分析,得到各關(guān)鍵工序的風(fēng)險(xiǎn)值排序,進(jìn)而確定主要風(fēng)險(xiǎn)因素；在分析階段(A)針對(duì)上一階段得出的多個(gè)主要風(fēng)險(xiǎn)因素分別開展單因子方差分析,根據(jù)分析結(jié)果確定問(wèn)題的相關(guān)因素和無(wú)關(guān)因素；在改進(jìn)階段(I)進(jìn)行實(shí)驗(yàn)設(shè)計(jì)(DOE),得到各相關(guān)因素的最優(yōu)解,即技術(shù)改進(jìn)方案；在控制階段(C)應(yīng)用魚骨圖工具和精益生產(chǎn)的理念,對(duì)原有的開發(fā)質(zhì)量管理流程進(jìn)行了優(yōu)化和改進(jìn)。最終,通過(guò)本研究項(xiàng)目使S公司疫苗開發(fā)項(xiàng)目中存在的問(wèn)題得到解決,產(chǎn)品合格率提升至90%以上,產(chǎn)量較優(yōu)化前提升13%以上,過(guò)程西格瑪水平提升至5以上,達(dá)到了預(yù)期標(biāo)準(zhǔn)。S公司基于精益六西格瑪?shù)囊呙玳_發(fā)流程優(yōu)化項(xiàng)目為國(guó)內(nèi)其它生物制藥企業(yè)以精益六西格瑪思想指導(dǎo)項(xiàng)目的實(shí)施有良好的借鑒作用。應(yīng)用精益六西格瑪,為生物制藥企業(yè)如何在新產(chǎn)品開發(fā)中優(yōu)化流程、提高效率、保證質(zhì)量,將研究成果投入生產(chǎn)提供了一套行之有效的理論依據(jù)與分析方法。
[Abstract]:With China's entry into the World Trade Organization, Chinese biopharmaceutical enterprises have to face a more severe international competitive environment. Lean six Sigma management is an organic combination of lean production and six sigma management concepts and has been successfully applied in the manufacturing industry. Is a "best practice" for biopharmaceutical enterprises to improve their own competitiveness. S is a domestic biopharmaceutical enterprise. Its new vaccine product development process is flawed, resulting in problems such as low qualified rate of products, unstable process control, and so on. Through the theoretical research and analysis of Lean six Sigma at home and abroad, combined with the general situation of S Company and domestic biopharmaceutical enterprises, the thesis applies Lean six Sigma management thought and tool. The new vaccine development process of S Company is improved and optimized. Through the problem solving model of "Definitions-Measurement-Analysis-improvement-Control" (hereinafter referred to as DMAICI), the Pareto diagram tool is used to determine the specific goal of the improvement in the definition stage. In the measurement stage, the FMEA tool is used to analyze the quality risk of each key process, and then the main risk factors are determined. In the stage of analysis, according to the main risk factors obtained from the previous stage, single factor analysis of variance is carried out, and the relevant factors and irrelevant factors of the problem are determined according to the results of the analysis. In the stage of improvement, the experimental design was carried out to obtain the optimal solution of the relevant factors, namely, the technical improvement scheme, and the concept of fish bone map tools and lean production was used in the control phase. The original development quality management process has been optimized and improved. Finally, the problems existing in the vaccine development project of S Company have been solved through this research project. The qualified rate of the product has been increased to more than 90%, and the output has increased by more than 13% compared with that before the optimization. The Sigma level rose to more than 5, The vaccine development process optimization project based on Lean six Sigma has good reference value for other domestic biopharmaceutical enterprises to implement Lean six Sigma thought guiding project. It provides a set of effective theoretical basis and analysis method for biopharmaceutical enterprises how to optimize the process, improve efficiency, guarantee quality and put the research results into production.
【學(xué)位授予單位】：中國(guó)科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：F273;F426.72

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