A制药企业设备停产检修的项目化管理研究

发布时间：2018-03-08 03:13

本文选题：制药企业　切入点：设备停产检修　出处：《山东大学》2015年硕士论文　论文类型：学位论文

【摘要】：制药行业作为战略性新兴产业,是国家创新能力和综合竞争力的重要体现,近年来受到世界各国的广泛关注和高度重视。制药设备作为制药行业重要的生产要素之一,其平稳运行是制药行业健康发展的基本前提,关系到药品生产从业者、用药患者、社会环境等各个方面。近年来,制药企业从生产安全、药品质量安全、环境保护、企业运营等多方面出发,都将设备停产检修工作列入企业生产活动的重要组成部分,定期或不定期地在停产状态下组织设备停产检修工作。制药行业设备停产检修既具有大多数企业设备停产检修工作的一般性特点,也具有制药行业本身的特殊之处,本文通过分析制药企业设备停产检修工作的特殊之处,提出应该高度重视制药企业设备停产检修工作,在具体管理实践中将设备停产检修工作视为一个具有完整生命周期的项目,运用项目化的思维和方法进行组织实施。在介绍设备检修和项目管理等相关理论中,概述了设备检修的分类和检修进度、检修质量、检修成本、检修安全等关键指标,介绍了项目管理、项目生命周期等有关理论,同时对制药企业设备停产检修工作项目化管理的可行性和必要性进行了论证,为本文A制药企业设备停产检修工作采用项目化管理打下了理论基础,提供了方法工具。本文以A制药企业设备停产检修工作为例,通过介绍其过去在设备停产检修中的基本情况,揭示其存在的问题和不足,并深入分析导致这些问题的原因,为科学管理其停产检修工作指明方向。根据A制药企业过去停产检修工作的情况分析,本文借鉴管理学有关理论和方法,对A制药企业设备停产检修工作采取项目化管理的方式,将A制药企业设备停产检修工作全过程划分为启动阶段、实施阶段、收尾阶段3个阶段,根据每个阶段工作的内容和特点,围绕顺利实现检修进度、检修质量、检修成本和检修安全4个关键指标,从启动阶段组织机构的设立、流程的完善、文件的编制,到实施阶段控制4个关键指标,再到收尾阶段联机调试、设备档案的整理、考核的落实等重点工作着手,设计出具体的、可操作的方案,实现项目化的全程管理和控制,以期通过每个阶段的精细管理实现设备停产检修工作的整体目标。此外,本文又对在设备停产检修工作中起到重要保障作用的设备清理、人员管理和现场管理3个方面又进行了深入探讨,就如何做好这3个方面具体工作来保障A制药企业设备停产检修工作顺利实施作了说明。本文立足于解决A制药企业设备停产检修这一实际工作,将管理理论与企业实际运用密切结合,针对制药企业设备停产检修这一特殊的工作,采取项目化管理的方式分阶段管理,为A制药企业本身及与A制药企业类似的企业开展此项工作提供一个参考和借鉴,实现设备停产检修工作项目化、科学化、有序化。
[Abstract]:The pharmaceutical industry as a strategic emerging industry, is an important manifestation of the national innovation capacity and competitiveness, attracted widespread attention in recent years and the world's attention. Pharmaceutical equipment as one of the important factors of production in pharmaceutical industry, its stable operation is the basic premise for the healthy development of the pharmaceutical industry, related to drug production practitioners, patients, social environment other aspects. In recent years, the pharmaceutical enterprises from production safety, drug safety, environmental protection, and other aspects of business operations, will be an important part of equipment production maintenance work in their production activities, regularly or irregularly organize equipment in the production under the condition of production maintenance work. The pharmaceutical industry not only has the equipment maintenance shutdown the general characteristics of most enterprise equipment production maintenance work, also has the particularity of the pharmaceutical industry itself, this paper through the analysis of system Special equipment for medicine enterprises production maintenance work, we should attach great importance to pharmaceutical enterprise equipment production maintenance work, in the specific management practice in equipment production maintenance work as a complete life cycle of the project, by using theories and methods of project was implemented. In the introduction of equipment maintenance and project management and other related theories the classification, and the maintenance schedule, the maintenance of equipment maintenance quality, maintenance cost, maintenance safety and other key indicators, introduces the related theory of project management, project life cycle, and to pharmaceutical companies, equipment production feasibility and necessity of the maintenance work of project management are discussed, for the A pharmaceutical enterprise equipment maintenance shutdown work with project management theory foundation, provides methods and tools. This paper takes A pharmaceutical enterprise equipment production maintenance work as an example, through the introduction of the In the past, the basic situation of production equipment maintenance, to reveal the existing problems and shortcomings, and in-depth analysis of the causes of these problems, for scientific management of the production maintenance work direction. According to the analysis of A pharmaceutical companies in the past production maintenance work, according to management theories and methods, take project management the way of A pharmaceutical enterprise production equipment repair work, the A pharmaceutical enterprise equipment production maintenance work of the whole process is divided into the start-up phase, the implementation stage, the final stage of the 3 stages, each stage according to the work contents and characteristics, around the smooth realization of the maintenance schedule, quality of maintenance, maintenance cost and maintenance safety from the 4 key indicators. The establishment of the start-up phase of the organization, procedure, document preparation, implementation stage control 4 key indicators, and then to the final stage of debugging, equipment archives, assessment The implementation of other key work to design a specific, workable solutions, implementation of management and control project, to achieve the overall goal of equipment production maintenance work through the fine management of each stage. In addition, this article also in the production equipment cleaning plays an important role in safeguarding the equipment maintenance work, 3 aspects of personnel management and site management are discussed, to guarantee the A pharmaceutical enterprise equipment production maintenance work smoothly explains how to do specific work in the 3 aspects. The thesis aims to solve the A pharmaceutical enterprise equipment production of the actual work of maintenance, management theory and enterprise practice closely, for pharmaceutical equipment business shutdowns this special work, take project management mode to the stage management, the development of the A pharmaceutical companies and the enterprises similar to A pharmaceutical companies The work provides a reference and reference to realize the project of equipment shutdown and maintenance project, scientific and orderly.

【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F273.4;F426.72

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