摘要
为持续改进质量管理,确保检验检测工作质量,在实验室质量管理中,运用失效模式和效益分析(failure mode and effects analysis,FMEA)进行风险管理。本文基于FMEA的实验室质量管理方式,以人、机、料、法、环为分类方式,结合近6年内外部评审中所产生的不符合项、原因分析及纠正措施的具体示例进行评估分析。通过将实验室风险评估后的风险等级结合实验室现有的5S管理体系,提出针对性的应对措施,以期能有效地控制风险,更好地开展实验室质量管理。FMEA模型在实验室质量管理中的运用,可以清晰分析出实验室当前存在的风险,防止高风险质量问题的发生,有效促进5S管理体系逐步开展,不断完善实验室质量管理。
To continuously promote quality management and ensure the quality of the inspection and testing work,failure mode and effects analysis(FMEA)is used to strengthen the quality management of laboratories.The paper is based on the FMEA laboratory quality management method,and conducts evaluation and analysis on the examples of non-conformity,cause analysis and corrective actions happened in the internal and external review in the past six years,which are classified by man,machine,material,method,environments.Based on the laboratory risk assessment results and the 5S System applied by laboratories,the paper proposes targeted measures to effectively control risks and better carry out the laboratory quality management.The application of FMEA in laboratory quality management can clearly find out the current risks and prevent high-risk quality problems,which effectively promotes the gradual application of the 5S System and continuously improves the quality management in the laboratory.
作者
黄思嘉
张芳芳
丁豪
HUANG Si-jia;ZHANG Fang-fang;DING Hao(Shanghai Food and Drug Packaging Material Control Center)
出处
《中国标准化》
2024年第7期193-199,共7页
China Standardization
