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目的:提出药品检验业务流程效率研究的要素,阐述流程研究对提高实验室质量管理的意义。方法:借鉴企业业务流程管理以及再造理论和实践,与药品检验业务流程特点和管理实践相结合。结果与结论:解析了业务流程和业务流程效率的概念,从目的、对象、指标、方法和基础5个方面界定了研究基本要素,从服务监管和企业客户的角度阐述了研究的意义。该研究结果可供各级药品检验机构开展流程效率管理工作借鉴。
OBJECTIVE: To put forward the elements of drug inspection business process efficiency research, and elaborate the significance of process research to improve laboratory quality management. Methods: Reference to business process management and reengineering theory and practice, combined with the characteristics of pharmaceutical inspection business processes and management practices. RESULTS AND CONCLUSION: The concept of business process and business process efficiency was analyzed. The basic research elements were defined from the five aspects of purpose, object, index, method and foundation. The meaning of the research was illustrated from the point of service regulation and enterprise customer. The results of this study can be used by all levels of drug inspection agencies to conduct process efficiency management.