The Study To The Emergency Management Of In Vitro Diagnostic Reagents After-sales Accident Due To Quality

In vitro diagnostic (IVD) reagents are used for diseases prevention, diagnosis, treatment monitoring, prognosis observed health status evaluation and prediction of genetic diseases, which will affect the quality of each test by health and safety. IVD industry has developed rapidly, the accident due to quality can not be completely avoided, some IVD reagents quality accident led to misdiagnosis, and medical malpractice occurred, causing serious harm to patients, the manufacturers also have paid a heavy price, which also affect the corporate reputation and brand, and therefore, the study of the quality of IVD reagents after-sales accident emergency management is significant and important for IVD enterprises.Firstly, this thesis analyze the mechanism of IVD reagents after-sales accidents due to quality, and the causes of after-sales accidents due to IVD reagents quality, the mechanism of accidents due to the quality, the mechanism of the development of accidents due to the quality, the mechanism of accidents disposal due to the quality. This thesis is grading accidents due to quality, based on the severity of the IVD products quality problems and severity of accidents due to quality; establishes the emergency plan of IVD reagents after-sales accidents due to quality. This thesis made different treatment plans according to different levels with the IVD after-sales accident disposal due to quality. This thesis develops treatment plans with after-sales particularly serious accident due to quality as an example, treatment plans uses the methods of project management, and makes the work breakdown with the after-sales accident disposal project due to quality, and the responsibility matrix disposal projects, do network plan of the disposal projects, and analyze the critical path of the disposal project according to network plan. Finally, analyze the cases of actual work, and the shortcomings of conventional management quality accident disposal, put forward their own proposals.Through the study of IVD reagents after-sales quality emergency management, this thesis expects to improve the attention and accident response capacity of the enterprises about after-sales accidents due to quality, establishing contingency plans to carry out IVD reagents for quality after-sales companies to work with emergency management reference; using the method of project management to establish the accident management disposal plan, and improve the efficiency of the accident disposal.