医疗设备使用风险分析方法的对比改进与应用

归纳了当前医疗设备生产行业的主要风险分析方法,评价了这些方法对医疗机构的适用性.在此基础上提出了面向医疗机构的设备使用风险分析模型,并结合模糊数学和灰色关联理论对定量评估方法进行了改进,形成了以FMEA为核心的设备使用风险预测和控制的流程体系.最后给出了方法的实际应用案例.     

改进FMECA的工业机器人失效风险分析

针对传统失效模式、影响及危害性分析(FMECA)方法利用风险优先数(RPN)对失效风险进行量化排序存在RPN量化取值不连续,指标自身无明确物理意义、受主观影响较大,指标设计未考虑权重因子等缺陷,该文提出一种基于风险度量和风险排序的改进FMECA模糊综合评判法,设计重复偏差率P、维修费用W和发生概率O的全新评估指标集,利用模糊综合评判,引入层次分析法进行权重赋值。结果表明:该方法可以有效改善FMECA方法量化排序不合理、重复现象,实现指标评价的客观化、意义化和风险评价指标的量化连续性、权重化,提高工业机器人失效风险分析结果可信性。     

卫星成本风险分析与评估

从卫星成本不确定性分析入手,在已有的风险分析方法的基础上,针对卫星成本风险管理的特点,提出了实用的改进方法,给出了降低和控制成本风险的原则和方法。     

电磁计量为安全医疗和健康医疗服务

<正>根据ISO14971-2007《医用装置风险管理:风险分析应用》推荐的方法进行风险分析,与电磁计量相关的心脏除颤器、高频电刀等医疗设备的风险值评估均排在前几位。它们通常配置在重症监护室、手术室、急症室等可能出现生命危急的场所,其计     

基于过程能力指数的抽样风险研究

如果将生产过程中上一道工序的加工过程（设备）视为生产者,而紧邻的下一道工序的加工过程（设备）视为使用者,则上道工序加工的零部件在通过质量抽样检验进入下道工序的过程中．就将产生抽样风险。而由抽样风险确定的抽样方案直接关系到加工过程质量控制和检验成本控制等加工效率问题。考虑到许多大批量自动生产线的检验设备已经具备在线计算过程能力指数的能力．提出了一个基于过程能力指数的抽样风险分析方法,通过计算过程能力指数,得到相应的抽样风险．进而确定合理的抽样检验方案,从而将加工过程的重要指标——过程能力指数与抽样检验方案之间建立了联系。最后,以某汽车发动机曲轴生产线加工过程为例进行了抽样风险分析。     

基于因果贝叶斯网络的风险建模与分析

为验证基于因果贝叶斯网络的风险建模与分析（CBN based RMA）的有效性,引入4种常见模式简化该方法的结构建模,以降低随后参数建模中专家判断工作量,然后将该改进方法应用于巴基斯坦NEELUM JHELUM水电站隧洞掘进工程风险分析中,有效控制了项目施工风险,获得远超预期的盈利。该案例应用结果表明,改进的CBN based RMA方法具有很强的可操作性,可显著提高工程风险管理效率。     

婴儿培养箱质量控制规范的研究

婴儿培养箱属于高危医疗设备，为保证临床应用中的婴儿培养箱的安全性和有效性，必须对其进行质量控制。本文介绍了婴儿培养箱临床使用中常见的风险，并从风险防范的角度出发来制定婴儿培养箱质量控制规范，以解决婴儿培养箱在临床应用中的质量控制问题。     

二氧化碳风险控制及空分工厂布置优化

周围大气环境对安装在工业区的空分设备的运行可靠性与安全性有较大的影响。大气中二氧化碳含量随工业化进程在世界范围内逐年增高,它对空分设备而言是一种有害的堵塞气体。介绍二氧化碳的性质和危害以及空分设备所采取的风险控制。阐述为优化空分工厂布置应进行的二氧化碳定量风险分析和扩散计算,从而控制二氧化碳的影响和相应风险。     

基于故障模式的输变电设备故障风险分析

输变电设备,对于电力系统的整体运行工作,起着十分重要的影响作用,需要积极采用有效方式和手段,保障其运行的可靠性。需要注意的是,输变电设备在实际运行过程中,容易出现一些故障,从故障模式的角度出发,积极开展输变电设备故障风险分析工作,十分必要。本文主要是从故障模式的基本情况出发,针对基于故障模式的输变电设备故障风险分析情况进行细致分析和说明,相应的介绍了一些控制和解决输变电设备故障风险的有效措施。     

250W@4.5K氦制冷机故障模式、效应及危害度分析

为了评估中国科学院理化技术研究所研制的一台250 W@4.5 K氦制冷机的可靠性,建立了250 W@4.5 K氦制冷机的故障模式、效应及危害度(FMECA)模型。收集了国内相似制冷机用户的低温设备失效数据,利用寿命数据软件Weibull拟合了失效数据分布,从而获得低温部件的失效率。采用了国际热核试验反应堆组织(ITER)的FMECA评价准则,分析了制冷机主要部件的故障模式及其对制冷机相关功能的影响,找出了危害度较大的关键零部件。提出了改进措施,将高风险的故障模式降低到了中低风险。     

Fuzzy TOPSIS approach for failure mode,effects and criticality analysis

In this paper, an alternative multi‐attribute decision‐making approach for prioritizing failures in failure mode, effects and criticality analysis (FMECA) is presented. The technique is specifically intended to overcome some of the limitations concerning the use of the conventional US MIL‐STD‐1629A method. The approach is based on a fuzzy version of the ‘technique for order preference by similarity to ideal solution’ (TOPSIS).The use of fuzzy logic theory allows one to avoid the intrinsic difficulty encountered in assessing ‘crisp’ values in terms of the three FMECA parameters, namely chance of failure, chance of non‐detection, and severity. With the proposed approach, the definition of a knowledge base supported by several qualitative rule bases is no longer required. To solve the fundamental question of ranking the final fuzzy criticality value, a particular method of classification is adopted, allowing a fast and efficient sorting of the final outcome. An application to an important Italian domestic appliance manufacturer and a comparison with conventional FMECA are reported to demonstrate the characteristics of the proposed method. Finally, a sensitivity analysis of the fuzzy judgement weights has confirmed that the proposed approach gives a reasonable and robust final priority ranking of the different causes of failure. Copyright © 2003 John Wiley & Sons, Ltd.     

Test sample allocation method for testability verification test

An extended failure mode effect and criticality analysis (FMECA)-based sample allocation method for testability verification is presented in this study to deal with the poor representativeness of test sample sets and the randomness of the testability evaluation results caused by unreasonable selection of failure samples. First, the fault propagation intensity is introduced as part of the extended information of FMECA, and the sample allocation impact factors of component units and failure modes are determined under this framework. Then, the failure mode similarity and impact factor support are defined, and the game decision method for weighing the relationship between similarity and support is proposed to obtain the weight of failure mode impact factor. Finally, a two-step allocation framework of test samples is formulated to realize the sample allocation of component units and failure modes. This method is applied to the testability verification test of a launch control system. Results show that this method can obtain more representative test samples compared with the traditional sample allocation method while effectively reducing randomness of single testability evaluation result.     

基于FMEA的临床路径医疗风险成本估计

为了解决目前医疗风险成本研究主要关注医疗风险结果成本,忽视临床路径医疗风险成本估计的问题,提出了一种基于可靠性理论的临床路径医疗风险成本估计的方法。为了验证该方法的性能,以北京市某三级甲等医院食道癌手术临床路径为例,运用事故树分析（FTA）、失效模式与影响分析（FMEA）明确临床路径关键风险因素,并结合临床路径风险频率及严重度评分表与平均风险消除成本,对临床路径医疗风险成本进行量化。计算结果表明：该医院食道癌手术术中加权平均风险消除成本为14 710元,全年食道癌手术术中加权平均医疗风险消除成本为397 290元。所提出方法可以有效地估计临床路径医疗风险成本,并为实际应用提供指导。     

通用弹药失效辅助分析数据库的设计与研究

主要设计了用于弹药失效分析系统的数据库,着重描述了数据库的逻辑设计.通过故障模式、影响及危害度分析方法总结了对弹药进行失效辅助分析所用的基本数据,建立了各个数据之间的逻辑关系.在现有资料基础上收集了通用弹药的失效模式、失效机制、失效案例等数据.该数据库的建立能够为从事弹药失效分析工作的人员提供相关信息并提供操作上的方便.     

Reliability analysis techniques for mechanical systems

This paper discusses the application of known system reliability analysis techniques and identifies problems encountered in the practical implementation of these methods, revealing that no single technique is sufficient or even feasible in the case of complex mechanical systems. A new functional analysis method as well as a (new) criticality quantitative approach and failure mechanism analysis are presented and used to analyse an aircraft fuel system. A rigorous and detailed FMECA is still required. Besides its main function it will supply much of the valuable information for many other techniques.     

突跳式温控器的失效分析

突跳式温控器失效会导致电茶壶、电饭煲等家电产品控温和过热保护功能失效.采用FMECA分析方法,确定导致突跳式温控器失效的关键元件,通过关键元件失效分析,得到突跳式温控器的失效机理,提出提高突跳式温控器工作可靠性的技术措施.FMECA分析表明,突跳式温控器的主要失效模式为触头粘结、簧片断裂和温度漂移,引起突跳式温控器失效的关键元件为触头、簧片、热双金属片.关键元件失效分析表明,触头粘结现象是由于触头燃弧引起的,簧片断裂现象是由于簧片受到的疲劳应力超过疲劳强度引起的,温度漂移现象是由于热双金属片尺寸参数改变或热双金属片层间分离引起的.     

Monte Carlo simulation approach for a modified FMECA in a power plant

This paper presents a new tool for failure mode and effect analysis developed for a new Integrated Gasification and Combined Cycle plant in an important Italian oil refinery. The methodology is based on the integration between a modified Failure Mode Effect and Criticality Analysis (FMECA) and a Monte Carlo simulation as a method for testing the weights assigned to the measure of the risk priority numbers (RPNs). The RPN proposed consists of a weighted sum of six parameters (safety, machine importance for the process, maintenance costs, failure frequency, downtime length, and operating conditions) multiplied by a seventh factor (the machine access difficulty). Adopting this tool and considering the budget constraints, the best maintenance policy has been selected for each plant facility (about 140 in total). Copyright © 2000 John Wiley & Sons, Ltd.     

基于电子器件失效分析流程对失效LED分析方法的研究

结合一般电子器件失效分析方法,系统地设计了针对已失效LED器件的分析流程,并从封装结构和光、热特性几个方面比较了LED与一般器件失效分析方法的不同之处。通过分析发现了一般分析难以检测到的表面污染物污染、内部芯片断层等失效模式。实验证明,此方法对判断LED失效模式、推测失效机理更加准确,并可以有效地避免一般分析方法中过早的破坏性分析引入的损伤,以及将光电检测中电流和温度应力导致的损伤误判为器件原有失效因素。     

基于FMEA和FTA的老年人汽车人机界面交互设计研究

目的 提升老年人汽车界面满意度,设计适合老年人使用的汽车界面.方法 提出基于失效模式与效应分析(FMEA)、故障树分析(FTA)的研究方法,首先成立会议小组进行SHERPA分析,绘制汽车界面层次任务分析图;随后运用FMEA找出汽车界面中的潜在失效模式,计算风险优先数值;接着选取风险优先数值高的失效模式,运用FTA寻找其发生的原因,对其以图形化表示;再对故障树进行定性定量分析,计算故障树的最小切集和失效事件发生概率,找到失效发生的核心因素;最后对失效事件进行改良并对改良后的结果进行验证.结论 以老年人汽车界面为例进行研究,该方法可以有效发现老年人操作汽车界面发生错误的原因,不仅可以帮助设计师找到改良的重点,还可以使老年人获得良好的驾驶体验.     

A linguistic risk prioritization approach for failure mode and effects analysis: A case study of medical product development

Failure mode and effects analysis (FMEA) is a widely used risk management technique for identifying the potential failures from a system, design, or process and determining the most serious ones for risk reduction. Nonetheless, the traditional FMEA method has been criticized for having many deficiencies. Further, in the real world, FMEA team members are usually bounded rationality, and thus, their psychological behaviors should be considered. In response, this study presents a novel risk priority model for FMEA by using interval two‐tuple linguistic variables and an integrated multicriteria decision‐making (MCDM) method. The interval two‐tuple linguistic variables are used to capture FMEA team members' diverse assessments on the risk of failure modes and the weights of risk factors. An integrated MCDM method based on regret theory and TODIM (an acronym in Portuguese for interactive MCDM) is developed to prioritize failure modes taking experts' psychological behaviors into account. Finally, an illustrative example regarding medical product development is included to verify the feasibility and effectiveness of the proposed FMEA. By comparing with other existing methods, the proposed linguistic FMEA approach is shown to be more advantageous in ranking failure modes under the uncertain and complex environment.