Objective:By using the advanced quality control tools,we analyzed and evaluated the risk of planning designs of gamma knife treatment prospectively,and improved the key events. Methods:A quality reconstruction team of physicists,oncologists and therapists conducted failure risk assessment analysis toward 200 gamma knife treatment plans and 100 treatment designs were performed by using failure mode and effect analysis (FEMA),and failure cause and countermeasures were analyzed by using causal factor analysis and fault tree analysis. Results:The risk priority number was significantly decreased[ average of (61.125 ± 8.125)%] after conducting improvement on 9 potential failure modes and 16 potential causes of failure. Conclusion:FMEA is a effective tool to improve the quality of gamma knife treatment planning designs. It helps reduce the potential risks as well.