The Research Of Risk Management In Development Process Of HD Biochip Product

Hereditary deafness biochip (HD biochip), as an invitro diagnostic reagent, plays a very important role in disease prevention, clinical diagnosis, epidemiological investigation, prenatal screening and newborn screening. The development phase of HD biochip is the basement of its medical application and directly impact on its effect. Beacuse of numerous factors impact on the HD biochip complex research and development phases, how to identify and evaluate the impact of the HD biochip development phase, has increasingly become a very important problem for many enterprises which produce vitro diagnostic reagents including biochip. In this thesis, we study on risk identification and assessment in HD biochip development phase based on risk management theory.The main contents and conclusions are as follows:1. According to the properties of invitro diagnostic reagent products and HD biochip development phase analysis, we summarize9kinds of poblem releant of biochip product development phase.The development phase is divided to six categories and21kinds of risk factors using system decomposition method. We analysis the impact of risk factors on product features, and identifythe relevant and the degree between these21risk factors and HD biochip product issues using matrix method. Meanwhile, the matrix diagram is drawn for identification of the risk factors and building of risk identification framework in biochip development phase.2. According to the biochip development phase risk identification framework, the tertary structure of risk assessment index system is established. The quality of risk source weight is confirmed prliminary by the calculation of matrix in the chart and confirmed finally by the experts investigation method and analytic hierarchy process. The risk factor assessment standards and risk accept criteria are established. Using the analytic hierarchy process and fuzzy evaluation theory, the risk assessment index system and assessment method model is established. Furthermore, we assess the probability and losses, and define the risk level by using risk matrix. In this thsis, we find that the risk probability in HD biochip development phase issmall,and the risk of loss is medium after assessment. Then,the risk in HD biochip development phase is medium and acceptable through comprehensive assessment. By using the evaluation model and risk matrix diagram of the level of risk, the reliability and availability of assessment model is proved by the analysis of the development process of HD biochip II and the market of HD biochip I in the first year.At the same time, risk control measure are put forward to reduce the probability and the losses of HD biochip development process.