药品GMP检查员胜任力模型构建及实证研究

Construction of competence model for GMP inspectors and empirical research

目的:构建药品GMP检查员胜任力模型,为药品GMP检查员相关制度建设提供参考。方法:采用问卷调查和专家讨论的形式调研了药品GMP检查员的胜任力特征,对调研结果进行了汇总和提取,构建了药品GMP检查员胜任力模型。利用实证研究的方法对B市药品GMP检查员开展了问卷调查,分析了调查结果的信度和效度,对构建的胜任力模型进行了验证。结果:调查问卷的Cronbach'sα系数为0.786,KMO值为0.797,Bartlett球形度检验近似χ~2值为6 391.542(P<0.000),解释的总方差为81.19%。结论:胜任力模型通过了Cronbach'sα系数、KMO值检验和Bartlett球形度检验,表面效度、内容效度和架构效度较高。

Objective ： To construct the competency model of drug GMP inspectors, and provide reference for construction of relevant system of drug GMP inspectors. Methods： the competency characteristics of drug GMP inspectors were investigated by means of questionnaire and expert interview. The research results were summarized and extracted, and the competency model of drug GMP inspectors was constructed. Then the method of empirical research was used to carry out a questionnaire survey of GMP inspectors in city B, and the reliability and validity of the survey results were analyzed. Results： The Cronbach＇s alpha coefficient of the questionnaire was 0. 786, the KMO value was 0. 797, and the Bartlett sphericity test was approximated by chi 2, and the value was 6 391. 542 （P 〈0. 000）, and the total variance explained was 81. 19%. Conclusion： the competency model through the Cronbach＇s alpha coefficient, KMO value test and Bartlett spherical degree test, the surface validity, content validity and structure validity is high.