| Objective: To apply of FMEA method in analysis the risk of drug inspection process. Methods: Use?the?following?steps,such as establishing analysis team, decomposing process, establishing scoring criteria, identifying and analyzing failure modes, analyzing and evaluating the severity of each failure mode, estimating the occurrence degree, determining the detection degree, and calculating the number of risk priority number, more than 100 risk points in drug inspection process was analyzed quantitatively. Results:Through the analysis process, it was found that there were 9 failure modes with RPN score greater than 150 in a drug inspection agency, and different preventive or corrective measures were proposed for different failure modes. Conclusion:FMEA can be used for risk analysis and management in drug inspection process, and can effectively improve the risk management ability in drug inspection. |