| Pharmaceutical manufacturers, the multidisciplinary integration high-tech enterprise, are related to national health, economic development and social stability. The quality risk management and control level of pharmaceutical manufacturers are related to people lives and affects the enterprise competitiveness and the government credibility. Under the influence of internal and external factors, quality risk affairs of pharmaceutical manufacturers often happen, and the events of quality risk conduction continuous outbreak. However, the quality risk is controllable, it can reduce the adverse consequences from the quality risk conduction of pharmaceutical manufacturers brings, and reduce the public panic and improve the government’s reputation through analyzing the status and problems of quality risk management and control of the pharmaceutical manufacturers’ quality risk source, cut the risk conduction path and control the risk conduction carriers. Therefore, pharmaceutical manufacturers and governmental authority not just recognize the status and problems of quality risk management, but also realize the serious harm of quality risk conduction. On the one hand, pharmaceutical manufacturers should establish and improve the system of quality risk management and control of pharmaceutical manufacturers from the view of risk conduction. On the other hand, government should take measures to control the pharmaceutical manufacturers quality risk from the view of risk conduction to improve the whole community medicine quality level and people’s happiness index.Based on the research background, research purpose, research significance and literature review,the thesis defines the definition of pharmaceutical manufacturers quality risk,overall analyses internal and external factors influencing pharmaceutical manufacturers quality risk,and problems and causing reasons existing quality risk management and control of pharmaceutical manufacturers.Chapter 3 deeply analyses risk conduction risk resources,risk conduction path,risk conduction carriers and risk conduction effects.Taking LAIWUJIA Affair and Poison Capsule Affair as typical cases,chapter 4 analyses the key factors of quality risk conduction of pharmaceutical manufacturers,and concludes case analysis conclusion.Chapter 5 proceeds System dynamics simulation for quality risk conduction of pharmaceutical manufacturers.It including system boundaries and the system assumes, causal analysis, the system modeling and simulation test. Chapter 6 clears objectives and targets of evaluation, designs a complete evaluation process and draws an evaluation conclusions. Evaluation process includes selecting evaluation methods, ensuring evaluation indexes and determining determines the quality risk conduction level. From the viewpoint of risk conduction, Three-pronged Model of quality risk conduction of pharmaceutical manufacturers is built in Chapter 7. Pharmaceutical manufacturers quality risk conduction management and control strategies and suggestion are proposed from risk conduction sources, risk conduction carriers and risk conduction path to provide thinking of control quality risk conduction for pharmaceutical manufacturers, and for the relevant authorities making decision. Finally,the whole study conclusion and research outlook are proceeded. |
