It is essential to establish an end-to-end, precision-oriented risk management system, so as to ensure the legal compliance, biospecimen quality and safety, data and information security, as well as facility, equipment and biosafety of the biobank in a general hospital.

Guided by GB/T 37864-2019/ISO 20387:2018 "Biotechnology-Biobanking-General requirements for biobanking" and based on an analysis of practical work cases, this paper summarizes the strategies, processes and key points for the construction of the risk management system.

The construction strategies and a four-step risk control process (risk identification, risk assessment, risk control, and effectiveness analysis) are clarified. Taking the construction practice of the risk management system in the Clinical Biobank Centre of Zhujiang Hospital, Southern Medical University as a case study, the construction path and key points are further elaborated, including a four-level document system, a four-level organizational structure, a quantitative risk assessment matrix, the integration of daily risk identification and control with annual systematic review, and the strengthening of training for proactive risk management. Adhering to the principles of standard guidance, practical verification and systematic integration, a total of 107 biobank risk factors covering 13 modules were established. This paper also provides an empirical illustration of risk management processes and effectiveness analysis methods by assessing the top 20 high-risk factors in the center, formulating and implementing corresponding control measures, and comparing the incidence rates of risk events before and after implementation.

The methodology for establishing a risk management system elaborated in this paper integrates theory with practice, featuring strong operability, and is applicable for reference and continuous improvement in the construction of biobank risk management systems.