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MBA毕业论文_公司新产品开发项目管理流程优化方案研究PDF

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H公司新产品开发项目管理流程优化方案研究 国内体外诊断研制水平的滞后,严重制约了国内医疗检测水平的发展。随着生物 信息技术的发展、政策激励措施的密集出台,加之人民生活水平的提高,越来越多的 慢性病受到人们的关注,人民群众对健康保健方面的意识也在不断增强,医疗器械也 迎来了飞速发展的时机,从而促使了新产品研制热情的高涨。 新产品的快速开发是企业快速发展的核心动力。如何既能符合医疗器械国家法规 的要求,又能快速、高效的开发新产品,少走弯路,成为企业比较关注的问题。国内 外大量的企业成功的实践经验告诉:我们企业必须立足于现状,结合自身战略发展的 需要,科学、合理的设计一套新产品开发项目管理流程方法,为实现新产品快速、高 效、高质量的开发提供有利的保障。 本文作者试图通过研究H公司现有新产品开发项目管理流程以及存在的问题,主 要以如何避免现有问题的再次出现,如何提高整个开发效率,如何规范医疗器械产品 研制过程,避免因为流程管理、法律法规因素而造成产品开发的失败,快速地将产品 推向市场,结合项目管理中的门径管理、时间管理、流程再造、项目整合管理、项目 沟通管理等管理理论知识及方法,分析和解决存在的问题,对现有新产品开发流程进 行优化,将原有的5个流程4个评审节点细化成8个流程4个技术评审节点+ 6个决策 评审节点,并进行优化前后流程的一系列的比对,新的流程不仅分工更加清晰,职责 更加明确、流程更加完善,使项目形成有效的闭环管理,而且还补充一系列的子流程, 增加每个节点的风险评估及分析,通过变更控制,记录整个产品前后的变化,使产品 的开发过程保持很好的追溯性。 最后立足公司现阶段发展情况,针对新的优化方案提出一系列实施计划及保障措 施,参考华为建立有效的技术、知识管理库,最后通过PDCA循环方法,不断进行后续 的持续优化,保证新的产品开发流程更加高效、顺畅的执行,也希望能为医疗器械行 业其它公司新产品的开发提供参考和借鉴。 关键词: 项目管理,新产品开发流程管理,门径管理,医疗器械 III Abstract Research on Optimization Scheme of New Product Development Project Management Process in H Company The lag of domestic in vitro diagnosis research and development has seriously restricted the development of domestic medical detection level. With the development of life science and technology, various favorable policies have been issued continuously, and people's life is getting better and better, chronic diseases have gradually attracted people's attention. People have become more concerned about their health, and medical devices are also ushering in the opportunity of rapid development, which promotes the enthusiasm of new product development. The rapid development of new products is the core power for the development of companies. Companies pay more attention to how to develop new products quickly and efficiently, and new products need to meet the requirements of national regulations on medical devices. A large number of successful cases at home and abroad tell us that the campany must design a scientific and reasonable new method suitable for their own companies, in order to quickly and effectively find new products that meet the needs of their own strategic development, and can successfully complete the development of new products with high quality. This paper tries to study the existing new product development process and existing problems of H company, focuses on how to avoid repeated problems, how to improve efficiency, how to make the research of medical device products standardize, avoid the failure of product development due to the development process and legal factors, and make products enter the market quickly. This paper discusses and solves the existing problems, optimizes the existing new product development process based on the management theories and methods of gate management, time management, process reengineering, project integration management and project communication management, refines the original 5 processes, 4 review nodes into 8 processes, 4 technical review nodes, 6 decision review nodes, and carries out a series of flow before and after optimization The new process not only has clearer division of labor, clearer responsibilities and more perfect process, so as to form an effective closed-loop management of the project, but also adds a series of subprocesses to increase the risk assessment and analysis of each node, and records the changes of the whole product through change control, so as to maintain good traceability of IV the product development process. Finally, based on the development of the company at this stage, a series of implementation plans and safeguard measures are proposed for the new optimization scheme. With reference to Huawei, an effective technology and knowledge management database is established. Finally, the PDCA cycle method is used to optimize the follow-up process and it can ensure more efficient and smooth development of new products. It is also for the development of new products of other companies in the medical device industry Provide reference and reference. Keywords: Project management, New product development process, Gate management, Medical devices V 目 录 第1章 绪论 ...................................................................................................... 1 1.1 选题背景及意义 ...................................................................................... 1 1.2 研究目的与主要内容 .............................................................................. 5 1.3 研究的主要方法 ...................................................................................... 6 1.4 论文总体结构 .......................................................................................... 6 第2章 新产品开发项目管理流程理论.......................................................... 8 2.1 项目管理研究 .......................................................................................... 8 2.1.1 项目管理过程 .................................................................................... 9 2.1.2 项目整合管理 .................................................................................. 10 2.1.3 项目时间管理 .................................................................................. 11 2.1.4 项目质量管理 .................................................................................. 11 2.1.5 项目沟通管理 .................................................................................. 13 2.2 新产品开发流程管理研究 .................................................................... 14 2.2.1 新产品开发流程 .............................................................................. 14 2.2.2 新产品开发漏斗模型 ...................................................................... 17 2.2.3 新产品开发流程管理模式 .............................................................. 17 2.2.4 门径管理 .......................................................................................... 19 2.2.5 流程再造 .......................................................................................... 21 第3章 H公司新产品开发项目管理流程现状及问题分析 ....................... 23 3.1 H公司概况 ............................................................................................ 23 3.1.1 H公司组织架构 .............................................................................. 23 3.1.2 H公司发展现状 .............................................................................. 24 3.2 H公司新产品开发项目管理流程现状分析........................................ 25 VI 3.2.1 H公司新产品开发项目管理流程简介 ......................................... 25 3.2.2 H公司新产品开发项目管理流程存在的问题 ............................. 29 3.2.3 H公司新产品开发项目管理流程问题分析 ................................. 31 第4章 H公司新产品开发项目管理流程优化方案设计 ........................... 34 4.1 新产品开发项目管理流程框架优化设计 ........................................... 35 4.2 新产品开发项目管理流程过程优化设计 ........................................... 39 4.2.1 概念收集、可行性及立项阶段优化设计 ..................................... 39 4.2.2 设计开发及验证、设计转移及确认阶段优化设计 ..................... 41 4.2.3 注册、上市评价、项目结题阶段优化设计 ................................. 42 4.2.4 流程优化前后对比..............................