Risk Analysis Andcountermeasures In Vitro Diagnostic Reagents Production

With the development of the IVD industry,and the higher demand of industrial standard, the risks undertaken by enterprise are increasing and changing rapidly. The industrial risk management standard can only be the basis of enterprise risk management, and provide a method to enterprise. Many enterprises now paying attention to identify their own risk overall and completely, and establish their own management mode which can be manipulate easily and effectively, so that can achieve the goal of reduce accident and risk, and protect patient safety.Through summarizing references and the fact of H company, this article concludes the risk feature of IVD manufacture, and the risk feature of H company at current stage. By using WBS, the working process is decomposed. By using brain storm, the risk list is generated. By using2dimension analysis, the risk factors are found out, which are HR risk, process risk, system risk, technique risk and material/hardware risk.By using analytic hierarchy process, this thesis establishes a model regarding five major risk types. By using expert evaluation method, this article compared the mentioned five major factors, determined comparison matrix, and raised counter measure. Through calculating, the weight of each factor is got. Furthermore, by using fishbone diagram, find out the major reason. Based on expert’s raised rough counter measure, a detailed counter measure is determined.At the end, take the current production lines for example:F reagent (IEA reagent) production line and A reagent (Chemiluminescence reagent) production line, we applied the studied risk management model, and pass retrospective evaluation. The model is operability, and effective.