Objective To explore the process of using failure mode and effect analysis (FMEA) to optimize the management of specimens from relatives of patients and analyze its effects. Methods The data of the specimens tested by the family members of hospital patients between October 2019 and June 2020 in the Children’s Hospital of Fudan University were collected. The data between October 2019 and March 2020 were taken as the pre-FMEA group, and the data between April 2020 and June 2020 were taken as the FMEA group. We used FMEA method to evaluate the risk points in the management of specimens from relatives of patients, analyzed the reasons to propose improvement measures, and compared the effect of optimizing the management of specimens from relatives of patients before and after the implementation of FMEA. Results A total of 12 117 specimens from relatives of patients were included, including 6 132 cases in the pre-FMEA group and 5 985 cases in the FMEA group. A total of 13 potential failure modes were found, including 3 high risk, 3 medium risk and 7 low risk. After the implementation of FMEA, the 3 high risk failure modes, 1 medium risk failure modes “inspection type application error” and 1 low risk failure modes “diagnosis error” were lower than that pre-FMEA (P<0.05). The interview results showed that the job satisfaction and work risk awareness of relevant medical staff were improved after the implementation of FMEA. Conclusions The use of FMEA to optimize the management process of patient family specimens accurately captures the risk points. After the implementation of the improvement, the potential risk of the process is reduced, possible errors are prevented, work efficiency and job satisfaction are improved, and it can be used as a reference for hospital managers.