Research On The Formation Mechanism And Countermeasures Of Drug Quality Risk In Company H Based On Human Factors

Pharmaceutical production enterprises are multidisciplinary and technology-intensive high-tech enterprises,and their development is related to people’s health,economic development,and social stability.In pharmaceutical production enterprises,the control of quality risks is related to the safety of people’s lives and affects the competitiveness of enterprises.Among them,human is an important factor that induces quality risk.By analyzing the risk source of quality risk caused by human factors,cutting off the risk transmission path,we can significantly reduce the adverse consequences in the process of drug quality risk transmission.As a pharmaceutical enterprise,H Company’s personnel have issues such as weak quality awareness,weak quality responsibility,and poor quality assurance capabilities.Therefore,this article aims to explore and solve the existing quality risk problems of H Company from a human perspective,providing reference for its risk management and enhancing the competitiveness of the enterprise.This article is based on the survey data of drug quality risk from Company H,exploring the formation mechanism of drug quality risk and the causal relationship between various driving factors,and proposing countermeasures and measures to address drug quality risk.Firstly,by reviewing relevant literature both domestically and internationally,the concepts and measurement dimensions related to drug quality risk have been defined and divided;Secondly,raw data was collected through in-depth interviews and questionnaire surveys,drawing on mature quality awareness,quality culture,quality ability,quality responsibility,quality assessment,professional ethics,risk perception,and deviant behavior scales.Based on previous research on drug quality risk,a drug quality risk scale was developed and validated;Thirdly,based on literature research,20 theoretical hypotheses were proposed and a conceptual model of drug quality risk was constructed;Fourthly,taking H Company as the background,after conducting reliability and validity tests and factor analysis on the survey results,empirical analysis was conducted on the structural equation model of drug quality risk,clarifying the complex causal relationship between various latent variables,and verifying the structural model of drug quality risk;Fifthly,through multi group analysis,it was found that gender has a significant moderating effect on the impact of quality culture on risk perception.Compared to male employees,cultivating and strengthening the quality culture construction of female employees has a more significant role in preventing and controlling drug quality risks;Finally,specific countermeasures and measures are proposed for the company’s risk response.This article mainly has two innovative points: firstly,based on previous research,a drug quality risk scale was designed and validated from three dimensions: health risk,economic risk,and credit risk,enriching the relevant theories of drug quality risk;Secondly,a structural equation model for drug quality risk was proposed and validated.Clarified the formation mechanism and impact path of drug quality risks,clarified the importance of various factors affecting drug quality risks,and found that the gender of employees has a significant moderating effect on the risk perception path in quality culture.