Proiect Quality Management Application In Vitro Diagnostic Reagents R&D Process

With the development of science and technology, people’s awareness of keeping health is getting stronger. The in vitro diagnostic reagents (hereinafter referred to as IVD) industry is developing rapidly and is becoming a sunrise industry in the international market. In the mean time, the quality of products is getting more concern, and has become a foundation of enterprises production. The establishment of an effective quality management system and operation is an important guarantee of product quality, especially the quality management for R&D process.In view of the IVD product characteristics, we raised an opinion that we shall control product quality from source, and quality came from design, while expand research focusing on the following aspects around the problems of how to conduct quality control during the R&D process.First, let’s discuss from the aspects of quality, quality management, the concept of IVD and related situations of IVD quality management system in our country, so as to demonstrate the related content of the quality management system while laying a theoretical foundation for research work.Second, in view of the total quality management, let’s discuss the problems of quality management in the process of IVD industry research and development. On the basis of a large number of literature and taking references to the previous experiences of introducing project management into the process of IT industry and the engineering construction project management, we introduce the scientific method into the IVD product development work, so as to use project quality management of the three modules (quality planning, quality assurance, quality control) to establish quality assurance process model, and to the use causality diagram, flow chart and other tools to analyze and solve related problems of quality management in the research and development process. The whole process realizes project quality management in the research and development process by PDCA circulation.Third, in view of the theory combined with the actual situations, we apply quality management method to L company’s treponema pallidum antibody diagnostic kit in the process of research and development, and from the aspects of raw material selection, process parameters and trial production, we try to tell the stories of the company by the quality plan, quality control points and strengthening in different stages of the review to ensure that the design of the product meets the quality objectives of the initial process. On the other hand, On the basis of the results obtained, we try to confirm feasibility of three main theoretical modeling and analysis in the process of quality management system by the facts of a30%reduction of the L company’s research and development costs after using quality management and its product inspection qualified rate, say100%, that passes the examination smoothly in one time while shorten the development cycle, etc.Considerable achievements in practical cases prove that in the product research and development process, to establish quality assurance model, not only can fundamentally solve the problem of product quality, but also can bring economic benefits to enterprises. This model has a certain reference value for the same industries in the establishment of the quality management method of the product during research and development process.