Y公司X产品设计开发质量管理改进研究

发布时间：2018-04-25 03:01

本文选题：质量管理 + 质量控制计划　；参考：《华南理工大学》2014年硕士论文

【摘要】：随着世界经济、科技的发展，人类在满足日益增长的物质和精神需求的同时，越来越关注自身的健康，越来越多的资源投向了医疗服务行业。近几十年来人类发现仅依靠药物无法应对各种疾病的研究、诊断、预防、监护、治疗以及替代人体组织、支持或者维持生命，于是医疗器械开始出现并迅速发展。从无到有、不断改进，医疗器械有着与其他产品不一样的产品特性要求-安全、有效。这也就意味着医疗器械质量管理的重点在产品的设计开发阶段。在医疗器械产品的设计开发阶段做好质量管理，对今后产品的制造、上市、销售、使用和回收过程起着决定性的作用，能够提高企业的经济效益，能够预知、控制产品在制造、销售、使用过程的风险，减少对病人造成的伤害。 Y医疗科技公司成立于1996年，有优秀的产品设计开发和质量管理的团队，在十几年的运营中积累了一些设计开发和和质量管理的经验，拥有十几项发明专利和实用外型专利，该企业是国内同行业的龙头企业，参与制定多项的国家标准。本文将采用案例研究的方式，以Y公司X产品设计开发项目的质量管理为研究对象，介绍PDCA、质量控制计划、风险管理、过程确认、质量功能展开、失效模式分析等改进的措施和工具，描述X医疗器械产品在设计开发阶段质量管理的现状和过程，，通过总结X产品设计开发的质量管理存在的问题和分析，对产品设计开发的质量管理提出改进措施和对改进前后进行效果对比。本文对X产品设计开发质量管理存在问题的分析和提出改进措施，对于Y公司设计开发、质量管理能力的提高和持续改进有重要意义，也为医疗器械行业其它公司新产品的设计开发质量管理提供参考和借鉴。
[Abstract]:With the development of the world economy and science and technology, human beings pay more and more attention to their health while meeting the increasing material and spiritual needs, and more and more resources are directed to the medical service industry. In recent decades, human beings have found that drugs alone can not cope with the research, diagnosis, prevention, monitoring, treatment and replacement of human tissues, support or life support, so medical devices began to appear and develop rapidly. From scratch, continuous improvement, medical devices have different product characteristics from other products-safe, effective. This also means that the focus of medical device quality management in the product design and development phase. In the stage of design and development of medical device products, quality management plays a decisive role in the manufacture, marketing, sale, use and recovery of future products. It can improve the economic benefits of enterprises, predict and control the products in manufacture. Sales, use of the process of risk, reduce the damage caused to patients. Y medical science and technology company was founded in 1996, has excellent product design and development and quality management team, has accumulated some design development and quality management experience in the operation of more than ten years, has more than ten invention patents and practical external patents, The enterprise is the leading enterprise in the same industry, participating in the formulation of a number of national standards. This paper will adopt the method of case study, take the quality management of X product design and development project of Y Company as the research object, introduce PDCA, quality control plan, risk management, process confirmation, quality function development, This paper describes the current situation and process of quality management in the design and development phase of X medical device products, and summarizes the existing problems and analysis of quality management in the design and development of X products by means of improved measures and tools such as failure mode analysis. Improve the quality management of product design and development and compare the effect before and after improvement. This paper analyzes the problems existing in the quality management of X product design and development and puts forward the improvement measures, which is of great significance to the design and development of Y Company, the improvement of quality management ability and the continuous improvement. Also for other companies in the medical device industry new product design and development quality management to provide reference and reference.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F273.2;F426.4

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