项目质量管理在体外诊断试剂研发过程中的应用

发布时间：2018-01-24 05:18

本文关键词： 质量管理体系体外诊断试剂质量项目质量管理　出处：《中国科学院大学（工程管理与信息技术学院）》2014年硕士论文　论文类型：学位论文

【摘要】：随着科学技术的发展,人们健康意识的提高,体外诊断试剂(以下简称IVD)行业正在迅速发展,成为拥有国际市场的朝阳产业,与此同时,产品质量越来越受关注,成为企业生存的根本,而质量管理体系的建立及有效运行,是产品质量的重要保证,尤其是研发过程的质量管理。本文结合IVD产品特性,提出“质量源于设计”,应从源头控制产品质量的观点,并围绕如何在项目研发过程中进行质量管理的问题从以下几方面展开研究。 (1)从质量、质量管理、IVD的概念以及我国IVD质量管理体系相关情况开始阐述,引出项目质量管理体系的相关内容,为研究工作奠定理论基础。 (2)从全面质量管理的角度,探讨IVD行业研发过程中质量管理的问题。在参考大量文献的基础上,借鉴前人在IT行业、工程施工过程中引用项目管理的相关经验,将科学方法引入IVD产品开发工作中,利用项目质量管理的三大模块(质量计划、质量保证、质量控制)建立质量保证过程模型,采用因果图、流程图等工具来分析解决研发过程质量管理的相关问题。整个过程通过PDCA循环,来实现研发过程项目质量管理。 (3)从理论结合实际的角度,将质量管理方法应用于L公司梅毒螺旋体抗体诊断试剂盒研发过程中,从原料筛选、工艺参数确定、试生产等环节,阐述了该公司通过制订质量计划、质量控制点以及加强各阶段评审来确保设计的产品满足最初质量目标的过程,并且以L公司运用质量管理后研发成本降低30%,产品一次检验合格率100%,一次通过临床考核,开发周期缩短等取得的成果为依据,实证了本文中对质量管理体系中三个主要过程的理论建模与分析的可行性。实际案例中可观的成果,说明产品研发过程建立质量保证模型,不仅能从根本上解决产品质量问题,而且能给企业带来经济效益。此模型对同行业产品开发过程质量管理方法的建立具有一定的参考意义。
[Abstract]:With the development of science and technology and the improvement of people's health consciousness, in vitro diagnostic reagent (IVD) industry is developing rapidly, becoming a sunrise industry with international market, at the same time. More and more attention has been paid to product quality, which has become the basis of enterprise survival. The establishment and effective operation of quality management system is an important guarantee of product quality, especially the quality management of R & D process. Based on the characteristics of IVD products, this paper puts forward that "quality originates from design", which should be controlled from the source. And how to carry out quality management in the process of project research and development from the following aspects. 1) starting from the concept of quality, quality management and the relevant situation of IVD quality management system in China, the relevant contents of project quality management system are introduced, which lays a theoretical foundation for the research work. From the perspective of total quality management, this paper discusses the problem of quality management in the research and development process of IVD industry. On the basis of a large number of references, the author draws lessons from the predecessors in the IT industry. In the process of engineering construction, the relevant experience of project management is cited, and the scientific method is introduced into the development of IVD products, and the three modules of project quality management (quality planning, quality assurance) are used. Quality control) establish quality assurance process model, use causality diagram, flow chart and other tools to analyze and solve the problems related to R & D process quality management. The whole process through PDCA cycle. To achieve R & D process project quality management. From the angle of theory and practice, the quality management method is applied to the R & D process of Treponema pallidum Antibody Diagnostic Kit in L Company, which includes the selection of raw materials, determination of technological parameters, trial production and so on. Describes the company's process of ensuring that the designed product meets its initial quality objectives by developing quality plans, quality control points and strengthening the various stages of review. And based on the L company after the use of quality management research and development costs to reduce 30%, the product one test qualified rate 100, once through clinical examination, development cycle shortening and other achievements as the basis. The feasibility of theoretical modeling and analysis of the three main processes in the quality management system is demonstrated. The considerable results in the actual case show that the establishment of a quality assurance model in the process of product development can not only fundamentally solve the problem of product quality. This model has certain reference significance for the establishment of quality management method of product development process in the same industry.
【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】：2014
【分类号】：R954

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