文章摘要
黄宝斌,杨玥莹,黄清泉,成双红.从业务流程视角谈药品检验质量与效率的监管[J].中国药事,2020,34(2):141-145
从业务流程视角谈药品检验质量与效率的监管
Management Research of Testing Quality and Efficiency from the Perspective of Business Processes
投稿时间:2019-09-16  
DOI:10.16153/j.1002-7777.2020.02.002
中文关键词: 业务流程  检验  质量  效率
英文关键词: business process management  testing  quality  efficiency
基金项目:
作者单位
黄宝斌 中国食品药品检定研究院, 北京 100050 
杨玥莹 中国食品药品检定研究院, 北京 100050 
黄清泉 中国食品药品检定研究院, 北京 100050 
成双红 中国食品药品检定研究院, 北京 100050 
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中文摘要:
      目的: 采用企业业务流程管理理论,分析检验质量与效率影响因素,提出改进检验质量,提升检验效率的措施,为检验机构业务管理工作提供参考。方法: 企业业务流程管理理论。结果与结论: 检验质量的影响因素有检品信息不完整、受理信息转移过程中出错和信息出口把关不严等方面;提升检验质量的措施有加强受理后信息审核,改现场手工填写申请信息为在线填写,规范报告审核操作,明确报告审核要点等方面。检验效率影响因素分为内部和外部两方面,内部因素主要是流程设计不合理,流程运行不畅,无故停滞和折返;外部因素主要是由于申请人准备不充分造成过程中补充资料和其他监管任务进入等方面;提升检验效率的措施有优化流程、评估流程运行等方面。此外,检验机构还应注重客户服务,加强客户培训与教育,做好检验与审评和核查的衔接。
英文摘要:
      Objective: To analyze the influencing factors of testing quality and efficiency, put forward measures to improve testing quality and efficiency, and provide references for business management of testing institutions according to business process management theory. Methods: Business process management theory. Results and Conclusion: The influnencing factors of the quality of testing include incomplete information of testing products, errors in the process of acceptance and transferring of information, information export control being not strict and so on. Measures to improve the quality of testing are as follows, strengthening information audit after acceptance, changing from manual filling in on-site to online filling in, standardizing the operation of report audit, and defining the main points of report audit. The influnencing factors of the quality of testing can be divided into internal and external factors. Internal factors are mainly unreasonable process settings and poor process operation. External factors are mainly due to inadequate preparation of applicants, which results in supplementary materials in the process and the entry of other regulatory tasks. Measures to improve the efficiency of testing include optimizing process settings and evaluating the operation of the process. In addtion, the testing institutions should also pay attention to customer service, strengthening training and education of customers, and establish a sound communication mechanism between testing, review and audit.
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