Abstract: OBJECTIVE To prevent the risk events of drug gene experiment and to improve the operation quality of drug gene experiment by applying healthfailure mode and effect analysis(HFMEA) model. METHODS Failure mode and effect analysis(FMEA) activity group was established in the pharmaceutical laboratory. The brainstorming method and HFMEA model were used to identify and analyze the possible risk events caused by operation, instrument and environment on the quality control of drug gene experiment before, during and after the process of drug gene experiment, and formulate corresponding solutions accordingly. RESULTS After HFMEA, the risk events before, during and after drug gene experiment were prevented and remedied. The risk priority number value of risk coefficient decreased from 1 375 points to 62.36 points, with a decrease of 95.47%(P<0.01). The activity team members had significantly improved their quality control methods, problem-solving skills, communication and cooperation, enthusiasm and so on. CONCLUSION HFMEA activity helps to reduce the frequency of risk events in drug gene experiment, so as to save laboratory materials and reduce time cost.