Objective: To provide reference for optimizing testing process management, main risk factors of national drug sampling inspection process were analyzed. Methods: The potential risk factors of the inspection process collected from 2011 to 2020 were classifi ed and evaluated, and 74 failure modes weresummarized based on regulatory requirements and daily management experience, risk severity(S), occurrence (O) and leakage discrimination (D) were integrated to evaluate failure modes, calculate average Risk Priority Number(), potential mitigation strategies to high-risk failure modes were made. Results: By risk rank-order, 28 high-risk failure modes were found with(≥30), which were related with all 7 types of management work. The highrisk failure mode in management of reagent (A), people management (H), inspection report issuance management (C) were relatively high in quantity and proportion. Moreover, the numbers of qualifi ed laboratory technicians could not meet the workload requirements (H3) were considered with the highest combined risk(=65.9). Conclusion: FMECA may be an optimism approach in the analysis and evaluation of risk factors in the testing process of National Sampling and Testing Activites, and may had a certain reference and promotion role in improving the capacity of inspection process management and risk disposal.