基于精益六西格玛方法的S公司疫苗开发流程优化研究

发布时间：2018-02-07 12:30

本文关键词： 生物制药精益六西格玛疫苗新产品项目流程优化　出处：《中国科学院大学(工程管理与信息技术学院)》2016年硕士论文　论文类型：学位论文

【摘要】：随着我国进入世界贸易组织,我国生物制药企业不得不直接面对更为严酷的国际竞争环境。我国生物制药企业要想在竞争中立足,就必须提高自身竞争力。精益六西格玛管理是精益生产与六西格玛这两种管理理念的有机结合,现已在制造行业中被成功应用,是帮助生物制药企业提高自身竞争力的“最佳实践”。S公司是国内一家生物制药企业,其新疫苗产品开发流程存在缺陷,从而导致了产品合格率低、过程控制不稳定等问题,无法达到预期的目标。本课题研究通过对国内外精益六西格玛理论研究和分析,结合S公司和国内生物制药企业的普遍现状,应用精益六西格玛管理的思想和工具,对S公司新疫苗开发流程进行了改进和优化。通过“定义-测量-分析-改进-控制(以下简称DMAIC)"问题解决模型,在定义阶段(D)应用Pareto图工具确定改进的具体目标；在测量阶段(M)应用失败模式效果分析(FMEA)工具,结合开发产品的工艺流程,进行质量风险分析,得到各关键工序的风险值排序,进而确定主要风险因素；在分析阶段(A)针对上一阶段得出的多个主要风险因素分别开展单因子方差分析,根据分析结果确定问题的相关因素和无关因素；在改进阶段(I)进行实验设计(DOE),得到各相关因素的最优解,即技术改进方案；在控制阶段(C)应用鱼骨图工具和精益生产的理念,对原有的开发质量管理流程进行了优化和改进。最终,通过本研究项目使S公司疫苗开发项目中存在的问题得到解决,产品合格率提升至90%以上,产量较优化前提升13%以上,过程西格玛水平提升至5以上,达到了预期标准。S公司基于精益六西格玛的疫苗开发流程优化项目为国内其它生物制药企业以精益六西格玛思想指导项目的实施有良好的借鉴作用。应用精益六西格玛,为生物制药企业如何在新产品开发中优化流程、提高效率、保证质量,将研究成果投入生产提供了一套行之有效的理论依据与分析方法。
[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.
【学位授予单位】：中国科学院大学(工程管理与信息技术学院)
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：F273;F426.72

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