OBJECTIVE  To establish a theoretical system for drug inspectors to identify the influencing factors and models of drug quality and safety risks.

METHODS  Through combing the literature, news, policy documents and other materials related to inspectors and drug quality and safety risks, as well as in-depth interviews with eight senior inspectors, this study utilized the grounded theory to study the influencing factors of drug quality and safety risk identification by inspectors, and constructed a set of models.

RESULTS  The study found that laws and regulations were the prerequisites for risk identification of inspectors, and that pre-inspection preparation, the inspection implementation process, the management of inspection results, the management of professional and specialized inspectors, and the quality of inspectors' own competence were the practical paths for risk identification of inspectors, in which the quality of inspectors' own competence was the most important internal factor; social influence was the external factor.

CONCLUSION  The influence factors of inspectors' risk identification ability are modeled and explained through the grounded theory, and policy suggestions are made accordingly, which deepen the theoretical system and content framework, provide references and inspirations for improving the effectiveness of drug supervision.