基于FMECA的高效液相串联质谱联用仪可靠性分析  

Reliability Analysis of High Performance Liquid Chromatography Tandem Mass Spectrometry Based on FMECA

作　　者：杨文凤[1] 吴婷[1] 欧阳颖怡 张慧文[1] YANG Wenfeng;WU Ting;OUYANG Yingyi;ZHANG Huiwen(Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《今日药学》2022年第11期841-847,共7页Pharmacy Today

基　　金：广东省市场监督管理局科技项目(2021CB03)。

摘　　要：目的探讨风险评估模型在药品检验机构的精准应用,研究可靠性评价在高效液相串联质谱联用仪(LC/MS/MS)管理的分析和实际应用,提高正常使用率,确保检验的准确性、时效性和安全性。方法采用以可靠性为中心的维修理论制定预防性维修(PM)决策逻辑决断,针对LC/MS/MS进行故障相关性分析和逻辑决断,结合故障模式、影响和危害度分析技术识别和定量故障带来的风险,并在风险三因子的基础上增加考察可修复度指标,反映故障发生的可接受程度以及故障可能导致的连锁影响的判断,确定可靠性评价关键指标,针对可靠性评价关键指标判断PM工作类型,确定PM大纲和提出相应的维修策略。结果归纳PM内容和策略,设计记录格式并坚持故障记录,制定持续改进的规则,从经济效益角度验证和考察PM有效性。结论以评估LC/MS/MS可靠性为例,建立维修逻辑决断及可靠性评价体系分析模型,科学反映设备的总体运行状态,为维修有效性以及整个生命周期的成本效益分析提供测评数据。OBJECTIVE To explore the precise application of risk assessment model in drug inspection institutions,study the analysis and practical application of reliability assessment in the management of high performance liquid chromatography tandem mass spectrometry(LC/MS/MS),so as to improve the normal utilization rate and ensure the accuracy,timeliness and safety of inspection.METHODS Preventive maintenance(PM)decision-making logic decision was made based on the reliability centered maintenance theory.Fault correlation analysis and logic decision were made for LC/MS/MS,and the risk caused by fault was identified and quantified by combining the fault mode,impact and hazard analysis technology.The repairability index was added on the basis of the three risk factors to reflect the acceptability of fault occurrence and the judgment of the possible chain effect caused by the fault.The key indicators of reliability evaluation were determined,the type of PM according to the key indicators of reliability evaluation was judged,the PM program was determined and propose corresponding maintenance strategies was proposed.RESULTS PM contents and strategies were summarized,record format was designed and thefault was adhered to record,formulate rules were continuously improved,the effectiveness of PM from the perspective of economic benefits were verified and investigated.CONCLUSION Taking the evaluation of LC/MS/MS reliability as an example,the maintenance logic decision and reliability evaluation system analysis model applicable to large-scale instruments and equipment are established to scientifically reflect the overall operation status of the equipment and provide evaluation data for maintenance effectiveness and cost-benefit analysis of the whole life cycle.

关 键 词：风险评估模型 设备可靠性评价 故障模式影响及危害性分析(FMECA) 预防性维修 可修复度 

分 类 号：R917[医药卫生—药物分析学]