【作者】 李亚；

【导师】 刘子先；

【作者基本信息】 天津大学 ， 工程管理， 2019， 硕士

【摘要】 确认和验证是制药工程项目的关键环节,也是制药工程项目与一般建筑项目的区别之一。制药工程项目因为确认和验证阶段超期而导致项目进度延期现象比较普遍。当前对确认和验证的研究还是停留在法规符合度上,针对确认和验证进度的优化改善研究比较少。本文以确认和验证进度优化为出发点,意在通过深入研究,改善确认和验证过程中的延期现象,从根本上保证项目进度。本文主要通过确认阶段的流程优化和减少确认阶段的工作内容两方面提升确认阶段的进度。在对确认流程优化过程中,首先从项目层面,利用关键路径法对确认活动进行分解,构建简化的合理的确认活动网络图。其次通过IDEF0信息模型的构建,识别确认过程文件体系的优化空间。最后通过ASME流程分析法对确认过程中的重复工作进行分析,识别非增值活动。减少确认阶段的工作内容主要是指减少确认前置阶段质量问题的流入,通过根本原因分析法结合鱼骨图、故障树等工具对质量问题发生的根本原因进行定性和定量分析,识别出影响质量问题的三大要素:人员、流程和时间。研究结果表明,简化的确认模型和缺陷移除模型对确认进度的提升有着积极的作用。第一简化的确认模型是通过关键路径法、IDEF0信息模型和ASME流程分析法三者相结合,对传统确认模型进行由表及里,由外至内的逐层分析最终达到确认进度优化的目的。配对T检验法证实简化的确认模型在进度优化方面强于传统确认模型。第二缺陷移除模型是基于影响确认进度的三大要素:人员、流程和时间构建的,确认和验证前置生命周期中缺陷移除越低,越增加确认环节的工作负担,造成确认延期,反之亦然。将新的确认模型和缺陷移除模型模拟应用于N制药工厂扩展项目,并对数据进行分析,阐明新的确认模型对于确认工作的积极作用以及缺陷移除模型用于进度监控评估的实际作用,为其他制药工程项目的实施提供参考。更多还原

【Abstract】 Qualification and validation are the key actions in pharmaceutical construction project,and it is also the difference between pharmaceutical construction project and general construction project.It is quite common that the projects schedule delayed due to qualification phase overdue.Currently,the study on qualification is still limited to the compliance of regulation,just few study on the schedule optimization of qualification activities.The purpose of this thesis is to optimize the qualification schedule by deep study,and then to guarantee the project schedule.The qualification schedule optimization is mainly through qualification procedure optimization and qualification workload minimized.In the qualification procedure optimization,firstly,a simple and optimized network is optimized by qualification activity decomposed with the method of critical path.Secondly,identify the optimization area by IDEF0 information model.Finally,identify non-value activities by ASME analysis for the repeat activities.Reduce the workload of qualification is to by reducing quality activities input from previous stage of qualification.Three major factors(person,process and time)are assessed by root cause analysis with tools of fish born,fault tree and etc.The results show that the simplified qualification model and defect removal model have positive effects on qualification progress.Firstly,the simplified qualification mode is set up by the critical path,IDEF0 information mode and ASME process analysis,and the analysis is from up to down,from outside to inside,layer and layer analyzing.Paired t-test method proves that the simplified validation model is better than the traditional validation model in schedule optimization.Secondly,defect removal model is constructed based on the three elements: personnel,process and time.The lower the defect removal rate in the pre-phase of qualification,the higher workload of the qualification phase,the more possibility that qualification phase delayed,and vice versa.Simulate apply the new qualification model and defect removal model to N pharmaceutical factory expansion project with the project data analysis,to clarify the positive effects of the new qualification mode and defect removal model for schedule monitoring and evaluation.It provides reference for other pharmaceutical construction projects.更多还原