本文關(guān)鍵詞： 質(zhì)量管理體系 體外診斷試劑 質(zhì)量 項(xiàng)目質(zhì)量管理　出處：《中國科學(xué)院大學(xué)（工程管理與信息技術(shù)學(xué)院）》2014年碩士論文　論文類型：學(xué)位論文

【摘要】：隨著科學(xué)技術(shù)的發(fā)展,人們健康意識的提高,體外診斷試劑(以下簡稱IVD)行業(yè)正在迅速發(fā)展,成為擁有國際市場的朝陽產(chǎn)業(yè),與此同時,產(chǎn)品質(zhì)量越來越受關(guān)注,成為企業(yè)生存的根本,而質(zhì)量管理體系的建立及有效運(yùn)行,是產(chǎn)品質(zhì)量的重要保證,尤其是研發(fā)過程的質(zhì)量管理。 本文結(jié)合IVD產(chǎn)品特性,提出“質(zhì)量源于設(shè)計”,應(yīng)從源頭控制產(chǎn)品質(zhì)量的觀點(diǎn),并圍繞如何在項(xiàng)目研發(fā)過程中進(jìn)行質(zhì)量管理的問題從以下幾方面展開研究。 (1)從質(zhì)量、質(zhì)量管理、IVD的概念以及我國IVD質(zhì)量管理體系相關(guān)情況開始闡述,引出項(xiàng)目質(zhì)量管理體系的相關(guān)內(nèi)容,為研究工作奠定理論基礎(chǔ)。 (2)從全面質(zhì)量管理的角度,探討IVD行業(yè)研發(fā)過程中質(zhì)量管理的問題。在參考大量文獻(xiàn)的基礎(chǔ)上,借鑒前人在IT行業(yè)、工程施工過程中引用項(xiàng)目管理的相關(guān)經(jīng)驗(yàn),將科學(xué)方法引入IVD產(chǎn)品開發(fā)工作中,利用項(xiàng)目質(zhì)量管理的三大模塊(質(zhì)量計劃、質(zhì)量保證、質(zhì)量控制)建立質(zhì)量保證過程模型,采用因果圖、流程圖等工具來分析解決研發(fā)過程質(zhì)量管理的相關(guān)問題。整個過程通過PDCA循環(huán),來實(shí)現(xiàn)研發(fā)過程項(xiàng)目質(zhì)量管理。 (3)從理論結(jié)合實(shí)際的角度,將質(zhì)量管理方法應(yīng)用于L公司梅毒螺旋體抗體診斷試劑盒研發(fā)過程中,從原料篩選、工藝參數(shù)確定、試生產(chǎn)等環(huán)節(jié),闡述了該公司通過制訂質(zhì)量計劃、質(zhì)量控制點(diǎn)以及加強(qiáng)各階段評審來確保設(shè)計的產(chǎn)品滿足最初質(zhì)量目標(biāo)的過程,并且以L公司運(yùn)用質(zhì)量管理后研發(fā)成本降低30%,產(chǎn)品一次檢驗(yàn)合格率100%,一次通過臨床考核,開發(fā)周期縮短等取得的成果為依據(jù),實(shí)證了本文中對質(zhì)量管理體系中三個主要過程的理論建模與分析的可行性。 實(shí)際案例中可觀的成果,說明產(chǎn)品研發(fā)過程建立質(zhì)量保證模型,不僅能從根本上解決產(chǎn)品質(zhì)量問題,而且能給企業(yè)帶來經(jīng)濟(jì)效益。此模型對同行業(yè)產(chǎn)品開發(fā)過程質(zhì)量管理方法的建立具有一定的參考意義。
[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.
【學(xué)位授予單位】：中國科學(xué)院大學(xué)（工程管理與信息技術(shù)學(xué)院）
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R954

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 梁新元;;Application of causality diagram in system safety analysis[J];Journal of Chongqing University;2005年03期

2 張付賢;王興龍;;免疫膠體金技術(shù)影響因素分析[J];中國畜牧獸醫(yī);2009年05期

3 靳達(dá)芳;;梅毒抗體的膠體金法檢測及弱陽性影響因素分析[J];白求恩軍醫(yī)學(xué)院學(xué)報;2013年01期

4 ;Linkage intensity learning approach with genetic algorithm for causality diagram[J];Journal of Chongqing University(English Edition);2007年02期

5 Colin F Duffield,David M Young;Developing a matrix to explore the relationship between partnering and total quality management in construction[J];Journal of Harbin Institute of Technology;2004年04期

6 王祖芳;李桂軍;;膠體金法檢測梅毒抗體價值及弱陽性影響因素[J];中國皮膚性病學(xué)雜志;2012年01期

7 楊凌云,竺海康;An experiment on digital library based on the method of TQM system[J];Journal of Zhejiang University Science A(Science in Engineering);2005年11期

8 譚丹華;;理解ISO13485醫(yī)療器械質(zhì)量管理的體系[J];中國醫(yī)療器械信息;2009年01期

9 郭準(zhǔn);;體外診斷試劑質(zhì)量體系考核的探討[J];中國藥事;2010年03期

10 劉歆;黃嘉華;徐鳳玲;汪澤;顧維康;;對體外診斷試劑產(chǎn)品質(zhì)量管理體系的初步研究[J];中國醫(yī)療器械雜志;2006年03期

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本文編號：1459264