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职业化药品检查员胜任力模型构建研究

Research on the Construction of Competency Model for Professional Drug Inspectors
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摘要 目的:通过对职业化药品检查员群体进行研究,构建职业化药品(含医疗器械、化妆品)检查员胜任力模型,以期为科学提升检查员队伍整体的精细化管理水平提供新的理论参考依据。方法:采用定性加定量的研究方法,前期通过文献回顾、岗位分析初步提取职业化药品检查员胜任力要素并进行定义;中期召开专家咨询会,对初拟的胜任力要素及要素定义逐项进行筛选与修正;最后编辑并发放问卷,对问卷数据进行统计学分析,验证模型科学性。结果:调查问卷结果显示,各维度的克隆巴赫系数(Cronbach'sα)介于0.82~0.93之间,KMO值为0.87,Bartlett球形检验的近似卡方为3339.74,P<0.05,旋转后的累计方差解释率达到67.62%(>60%)。结论:经信度分析及探索性因子分析,本研究构建的职业化药品检查员胜任力模型基本符合预期值,模型具有一定的科学性。 Objective:To construct a competency model for professional drug(including medical device and cosmetic)inspectors by studying the group of professional drug inspectors,with a view to providing a new theoretical reference basis for scientifically improving the overall level of fine management of the inspector team.Methods:This study used both qualitative and quantitative research methods.The elements of competency for professional drug inspectors were initially extracted and defined through literature review and job analysis.An expert consultation meeting was held in the mid-stage to screen and amend the preliminary competency elements and element definitions.Finally,a questionnaire was edited and distributed,and the data were statistically analyzed to verify the model's scientific validity.Results:The questionnaire results showed that the Cronbach'sαcoefficient for each dimension ranged from 0.82 to 0.93,the KMO value was 0.87,the approximate chi-square of Bartlett test of sphericity was 3339.74,P<0.05,and the cumulative variance explained rate after rotation reached 67.62%(>60%).Conclusion:After reliability and exploratory factor analysis,the competency model for professional drug inspectors constructed in this study basically meets the expected standards and demonstrates a certain level of scientific validity.
作者 张慧茹 王盛松 殷富靓 宋英杰 肖杰 王凤山 ZHANG Hui-ru;WANG Sheng-song;YIN Fu-liang;SONG Ying-jie;XIAO Jie;WANG Feng-shan(School of Pharmaceutical Sciences,Shandong University;Institute of Regulatory Science for Medical Products,Shandong University;Shandong Center for Food and Drug Evaluation&Inspection;School of Pharmaceutical Sciences,Wuhan University)
出处 《中国食品药品监管》 2024年第6期106-115,共10页 China Food & Drug Administration Magazine
关键词 职业化 药品检查员 胜任力模型 人力资源利用 精细化管理 professionalization drug inspectors competency model human resource utilization fine-tuning management
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