北科公司医疗产品研发项目中质量管理问题分析及对策研究

发布时间：2018-11-20 11:11

【摘要】：成功的项目管理是在计划的范围、成本、进度及要求的质量下,达到项目干系人的期望。质量管理是项目管理的重要方面,它与范围、成本、时间共同成为项目成功的关键因素。北科公司是一家提供医疗健康服务的企业,主要是为社区、家庭和个人提供包括健康管理、医疗监护、医疗就诊等在内的一系列医疗服务。在公司的整个运营环中,核心的医疗器械是由公司内部的研发团队研发出来的。这种研发都是按项目形态进行组织的,所以项目过程的质量管理对产品的质量起到至关重要的作用。本文以北科公司研发项目为背景,对研发项目质量管理涉及的多个阶段和不同的主体进行分析和研究,调查北科公司在项目研发过程中的质量问题现状。本文首先分析了项目在研发过程中发现的各种问题,包括缺陷在评审和测试阶段不能被有效的识别,核心的需求实现速度慢,往往到后期才能发现设计和实际的差距、弱矩阵式组织结构带来的质量意识的下降、由于准备不足导致研发阶段无法顺利的导入到小批量生产阶段;其次,对导致上述问题的原因进行了分析,包括评审和测试有效性差、研发模型选择不合理、品质分析机制没有及时建立、缺少对项目执行力的组织保证、缺少导入到小批量生产的准备阶段等;最后,在相关理论和其他公司优秀实践的基础上提出了探索性的问题解决方案,包括为提高测试效果的自动化测试方案的提出、为减少缺陷的漏出而采用品质分析的方法、为提升质量意识提出调整项目组织模式和优化绩效考核方案,为提升核心需求的实现速度从传统的瀑布式开发改为敏捷式开发,为保证研发到生产的顺利导入增加"确认和转换"阶段等。该方案的提出为公司的质量改进提供参考,为相同类型的组织的质量改进提供依据,为相关人员研究项目中的质量管理课题时提供参考意见。
[Abstract]:Successful project management meets stakeholder expectations within the scope, cost, schedule, and quality of the project. Quality management is an important aspect of project management, which, together with scope, cost and time, is the key factor of project success. Beike is a health care provider that provides a range of health services to communities, families and individuals, including health management, medical care, and medical care. In the company's entire operating ring, the core medical devices are developed by the company's internal R & D team. This kind of research and development is organized according to the form of the project, so the quality management of the project process plays a vital role in the quality of the product. Under the background of R & D project, this paper analyzes and studies several stages and different subjects involved in R & D project quality management, and investigates the current situation of quality problems in the R & D process of Beike Company. This paper first analyzes the problems found in the research and development process of the project, including defects can not be effectively identified in the review and testing phase, the core requirements are slow to achieve, often to the later stage to discover the gap between the design and the actual. The weak matrix organization structure brings the decline of the quality consciousness, because of the lack of preparation, the R & D phase can not be smoothly imported to the small batch production stage; Secondly, the causes of the above problems are analyzed, including poor effectiveness of evaluation and testing, unreasonable choice of R & D model, lack of timely establishment of quality analysis mechanism, lack of organizational guarantee for project execution. Lack of import to small batch production preparation phase; Finally, on the basis of relevant theories and excellent practices of other companies, an exploratory problem solution is proposed, including an automated test scheme to improve the test effect and a quality analysis method to reduce the leakage of defects. In order to improve the quality consciousness, the project organization model and the performance appraisal scheme are adjusted. In order to improve the realization speed of the core requirements, the traditional waterfall development is changed to the agile development. In order to ensure the smooth introduction of R & D to production to increase the "confirmation and conversion" phase. The proposal provides a reference for the quality improvement of the company, provides the basis for the quality improvement of the same type of organization, and provides reference advice for the relevant personnel to study the quality management project in the project.
【学位授予单位】：东北大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F719;F273.2

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