Failure Mode Effects and Criticality Analysis Method of Armored Equipment Based on Testability Growth

In view of the low level testability of armored equipment,the important significance of armored equipment testability growth is discussed in this paper.The failure mode effects and criticality analysis( FMECA) method to realize testability growth is introduced.Centering on the testability growth demands of new armored equipment,the deficiencies of traditional FMECA are analyzed.And an enhanced FMECA( EFMECA) method is proposed.The method increases the analysis contents,combines the information before the failure occurrence and impending failure modes together organically.Then the failure symptoms is analyzed,the failure modes and effects is determined,and the state development trend is predicted.Finally,the application of EFMECA method is illustrated by the example of the failure mode of typical armored equipment engine.

Impact of failure mode and effects analysis-based emergency management on the effectiveness of craniocerebral injury treatment

BACKGROUND Craniocerebral injuries encompass brain injuries,skull fractures,cranial soft tissue injuries,and similar injuries.Recently,the incidence of craniocerebral injuries has increased dramatically due to the increased numbers of traffic accidents and aerial work injuries,threatening the physical and mental health of patients.AIM To investigate the impact of failure modes and effects analysis(FMEA)-based emergency management on craniocerebral injury treatment effectiveness.METHODS Eighty-four patients with craniocerebral injuries,treated at our hospital from November 2019 to March 2021,were selected and assigned,using the random number table method,to study(n=42)and control(n=42)groups.Patients in the control group received conventional management while those in the study group received FMEA theory-based emergency management,based on the control group.Pre-and post-interventions,details regarding the emergency situation;levels of inflammatory stress indicators[Interleukin-6(IL-6),C-reactive protein(CRP),and procalcitonin(PCT)];incidence of complications;prognoses;and satisfaction regarding patient care were evaluated for both groups.RESULTS For the study group,the assessed parameters[pre-hospital emergency response time(9.13±2.37 min),time to receive a consultation(2.39±0.44 min),time needed to report imaging findings(1.15±4.44 min),and test reporting time(32.19±6.23 min)]were shorter than those for the control group(12.78±4.06 min,3.58±0.71 min,33.49±5.51 min,50.41±11.45 min,respectively;P<0.05).Pre-intervention serum levels of IL-6(78.71±27.59 pg/mL),CRP(19.80±6.77 mg/L),and PCT(3.66±1.82 ng/mL)in the study group patients were not significantly different from those in the control group patients(81.31±32.11 pg/mL,21.29±8.02 mg/L,and 3.95±2.11 ng/mL respectively;P>0.05);post-intervention serum indicator levels were lower in both groups than pre-intervention levels.Further,serum levels of IL-6(17.35±5.33 pg/mL),CRP(2.27±0.56 mg/L),and PCT(0.22±0.07 ng/mL)were lower in the study group than in the control group(30.15±12.38 pg/mL,3.13±0.77 mg/L,0.38±0.12 ng/mL,respectively;P<0.05).The complication rate observed in the study group(9.52%)was lower than that in the control group(26.19%,P<0.05).The prognoses for the study group patients were better than those for the control patients(P<0.05).Patient care satisfaction was higher in the study group(95.24%)than in the control group(78.57%,P<0.05).CONCLUSION FMEA-based craniocerebral injury management effectively shortens the time spent on emergency care,reduces inflammatory stress and complication risk levels,and helps improve patient prognoses,while achieving high patient care satisfaction levels.

Comprehensive Reliability Allocation Method for CNC Lathes Based on Cubic Transformed Functions of Failure Mode and Effects Analysis

Reliability allocation of computerized numerical controlled（CNC）lathes is very important in industry.Traditional allocation methods only focus on high-failure rate components rather than moderate failure rate components,which is not applicable in some conditions.Aiming at solving the problem of CNC lathes reliability allocating,a comprehensive reliability allocation method based on cubic transformed functions of failure modes and effects analysis（FMEA）is presented.Firstly,conventional reliability allocation methods are introduced.Then the limitations of direct combination of comprehensive allocation method with the exponential transformed FMEA method are investigated.Subsequently,a cubic transformed function is established in order to overcome these limitations.Properties of the new transformed functions are discussed by considering the failure severity and the failure occurrence.Designers can choose appropriate transform amplitudes according to their requirements.Finally,a CNC lathe and a spindle system are used as an example to verify the new allocation method.Seven criteria are considered to compare the results of the new method with traditional methods.The allocation results indicate that the new method is more flexible than traditional methods.By employing the new cubic transformed function,the method covers a wider range of problems in CNC reliability allocation without losing the advantages of traditional methods.

Risk Evaluation in Blood Donation Using Failure Mode and Effective Analysis

The recognition and management of risk in donation process and blood product is critical to ensure donor and patient safety. To achieve this goal, the failure mode and effects analysis (FMEA) is a convenient method;moreover it was used to prevent the occurrence of adverse events and look at what could go strong at each step. This study aimed to utilize FMEA in central blood bank in Khartoum to evaluate the potential risk and adverse event that may occur during the donation process. According to the severity, occurrence and the detection of each failure mode, the risk priority number (RPN) was calculated to determine which of the failures should take priority to find a solution and applying corrective action to reduce the failure risk. The statistical package for social sciences (SPSS) version 11 was used as descriptive and analytical statistics tool. The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error, and in this study a satisfactory outcome was reached.

Application of Fuzzy Decision-Making Theory and Conflict-Resolution Method to Failure Mode and Effect Analysis of Industrial Valve

It is not objective to rate the decision-making factors in the traditional failure mode and effect analysis,so fuzzy semantic theory is used in this paper.Six fuzzy semantic scales and their corresponding semantics are summarized,and a defuzzification method is studied to obtain the fuzzy value table of the six fuzzy semantic scales.For the conflicts between experts in the traditional failure mode and effects analysis,a conflict-resolution algorithm is studied to obtain the failure risk order.Finally,a certain type of industrial valve is used as an example to prove the validity of the theory proposed in this paper.

Effect of Healthcare Failure Mode and Effect Analysis on Reducing Error Risk of Neonatal Parenteral Nutrition Solution Dispensing

[Objectives]To investigate the effect of healthcare failure mode and effect analysis(HFMEA)on reducing error risk of neonatal parenteral nutrition solution dispensing.[Methods]A research team was established to identify the failure mode(FM)in each link of the formulation process of neonatal parenteral nutrition solution by HFMEA,quantify the severity(S),occurrence(O)and detection(D)of FM,and evaluate FM by risk priority number(RPN).For FM with the values of RPN>16,failure cause analysis was conducted,and corresponding improvement measures were formulated.The weight coefficient and random consistency ratio(CR)of deployment process were calculated in Matlab R2018a by compiling the Analytic Hierarchy Process(AHP)program.Six months after the implementation of improvement measures,the implementation effect was evaluated by comparing the changes of the values of RPN which was evaluated comprehensively and the rate of dispensing errors before and after the implementation of HFMEA.[Results]In the preparation process of neonatal parenteral nutrition solution,a total of 13 FMs with medium and above risk were found,the weight coefficient of medical order review,dosing and mixing was 0.2703,the weight coefficient of drug dispensing check and review was 0.1432,the weight coefficient of print label was 0.1015,the weight coefficient of distribution was 0.0716,and CR=0.0491<0.1.After six months of intervention,the total RPN value decreased by 64.81%from 127.8 to 45.0.The deployment error rates were significantly lower after the implementation,and the difference was statistically significant(P<0.05).[Conclusions]HFMEA can effectively reduce the error risk in preparation of neonatal parenteral nutrition solution,improve the quality of dispensing and promote the safety of neonatal medication.

Failure Mode and Effects Analysis （FMEA） by Fuzzy Data Envelop Analysis （Fuzzy-DEA）

Failure mode and effects analysis （FMEA） offers a quick and easy way for identifying ranking-order for all failure modes in a system or a product. In FMEA the ranking methods is so called risk priority number （RPN）, which is a mathematical product of severity （S）, occurrence （0）, and detection （D）. One of major disadvantages of this ranking-order is that the failure mode with different combination of SODs may generate same RPN resulting in difficult decision-making. Another shortfall of FMEA is lacking of discerning contribution factors, which lead to insufficient information about scaling of improving effort. Through data envelopment analysis （DEA） technique and its extension, the proposed approach evolves the current rankings for failure modes by exclusively investigating SOD in lieu of RPN and to furnish with improving sca.les for SOD. The purpose of present study is to propose a state-of-the-art new approach to enhance assessment capabilities of failure mode and effects analysis （FMEA）. The paper proposes a state-of-the-art new approach, robust, structured and useful in practice, for failure analysis.

System failure analysis based on DEMATEL–ISM and FMECA

A new method of system failure analysis was proposed. First, considering the relationships between the failure subsystems,the decision making trial and evaluation laboratory(DEMATEL) method was used to calculate the degree of correlation between the failure subsystems, analyze the combined effect of related failures, and obtain the degree of correlation by using the directed graph and matrix operations. Then, the interpretative structural modeling(ISM) method was combined to intuitively show the logical relationship of many failure subsystems and their influences on each other by using multilevel hierarchical structure model and obtaining the critical subsystems. Finally, failure mode effects and criticality analysis(FMECA) was used to perform a qualitative hazard analysis of critical subsystems, determine the critical failure mode, and clarify the direction of reliability improvement.Through an example, the result demonstrates that the proposed method can be efficiently applied to system failure analysis problems.

核级典型电动截止阀FMECA及试验验证

作为核反应堆系统中的关键能动设备,阀门在核反应堆系统中起着至关重要的作用,其安全性直接决定着核反应堆安全及人员安全。本文针对安注系统电动截止阀,基于使用特点对其开展故障模式、影响及危害性分析(FMECA),找出其结构中潜在的故障模式及其原因与影响,并根据失效分析结果有针对性地开展寿命试验,以激发潜在的故障,验证分析结果并获得该阀最为典型的失效模式。

基于家用轮式助行器的FMECA及其失效数据分析

中国人口老龄化速度的逐渐加快导致对助行器的需求加大。可靠性是助行器的重要属性之一,然而目前助行器的可靠性研究较少。该文以家用轮式助行器为例,对其展开故障模式、影响及其危害性分析。通过收集、整理和分析26种故障模式,得到影响其可靠性关键模块为坐姿-站姿转换系统。针对此关键模块,该文开展了故障数据的采集及分析,检验其寿命分布符合对数正态分布模型,该模块可靠寿命t_(0.9)的0.95置信下限为2489.4 h。该研究针对家用轮式助行器开展的可靠性分析可以为其他有源医疗设备的可靠性分析提供思路,并推动形成符合我国医疗器械监管法规要求的可靠性研究审评要点,供业界参考。

Analysis of Computer Network Reliability and Criticality: Technique and Features

The paper describes modern technologies of Computer Network Reliability. Software tool is developed to estimate of the CCN critical failure probability (construction of a criticality matrix) by results of the FME(C)A-technique. The internal information factors, such as collisions and congestion of switchboards, routers and servers, influence on a network reliability and safety (besides of hardware and software reliability and external extreme factors). The means and features of Failures Modes and Effects (Critical) Analysis (FME(C)A) for reliability and criticality analysis of corporate computer networks (CCN) are considered. The examples of FME(C)A-Technique for structured cable system (SCS) is given. We also discuss measures that can be used for criticality analysis and possible means of criticality reduction. Finally, we describe a technique and basic principles of dependable development and deployment of computer networks that are based on results of FMECA analysis and procedures of optimization choice of means for fault-tolerance ensuring.

复杂电子系统的FMECA高效集成分析方法

针对新研大型复杂电子系统开展故障模式、影响及危害性分析(FMECA)工作费时费力、甚至无法有效实施的挑战,研究了基于EXCEL和国产化CARMES平台工具的FMECA高效集成分析方法,有效提高了复杂电子系统FMECA的效率和质量,丰富了基于国产化CARMES平台工具的FMECA技术。首先,梳理了复杂电子系统工程应用中的FMECA高效集成分析总体流程;然后,结合工程项目实践,研究细化了该方法的详细工作实施步骤;最后,给出了基于某新研大型复杂电子系统的工程应用成果,验证了该方法的有效性和适用性。

Analysis of Potential Failure Modes in an Assembly Line by Fuzzy Expert Systems

The failure modes and effects analysis （FMEA） is widely applied in manufacturing industries in various phases of the product life cycle to evaluate the system, its design and processes for failures that can occur. The FMEA team often demonstrates different opinions and these different types of opinions are very difficult to incorporate into the FMEA by the traditional risk priority number model. In this paper, for each of the Occurrence, Severity and Detectivity parameters a fuzzy set is defined and the opinion of each FMEA team members is considered. These opinions are considered simultaneously with weights that are given to each individual based on their skills and experience levels. In addition, the opinion of the costumer is considered for each of the FMEA parameters. Then, the Risk Priority Numbers （RPN） is calculated using a Multi Input Single Output （MISO） fuzzy expert system. The proposed model is applied for prioritizing the failures of Peugeot 206 Engine assembly line in IKCo （Iran Khodro Company）.

Failure Modes of Machining Center in Test Run

To analysis the early failures of machining centers,the failure mode effect and criticality analysis( FMECA) method was used. Based on the failure data collected from production lines in test run,all the failure modes of machining centers were summarized and criticality of all subsystems is figured out. And the process of FMECA was improved. The most critical subsystem was manipulator subsystem. The most critical failure mode was impacted manipulator. Reasons and effect of some important failure modes were analyzed. And some suggestions to solve failures were given.

Numerical analysis of pile–slope stability and the soil arching around two adjacent piles

Seismic pile–slope stability analysis and the formation mechanism of soil arching have not been well studied. This study used a threedimensional(3D) finite difference to determine soil and pile parameter changes in the static and seismic stability of the pile–slope caused by the interaction between stabilizing piles. Pile–slope stability analysis was performed to determine the optimal design of piles along a slope and the corresponding failure mode involving the formation of soil arching around two adjacent piles. The Factor of Safety(FS) of the slope was evaluated using the shear strength reduction method for static and seismic analyses. The results of the analysis show that suitable pile spacing(S) and a suitable pile diameter(D) in the middle of a slope result in the maximum FS for the pile–slope system and the formation of soil arching around two adjacent piles. FS of the pile–slope increased negligibly in the seismic analysis of piles located at the slope crest and toe. An optimized pile diameter and installation location afforded the maximum FS for the slope that corresponded to a specified slope failure mode for different pile locations. A pile spacing S ≤ 2.5D for piles installed in the middle of the slope is suggested for increasing the static and seismic pile–slope stability.

基于SFMECA的危害和风险及关键性分析研究

作为核电厂仪控系统验证与确认(V&V)活动中重要的初始和基础任务,软件危害和风险及关键性分析为系统的可靠性和稳定性提供了有效保证。为研究软件危害和风险及关键性分析的可操作性分析方法,基于软件故障模式、影响和关键性分析(SFMECA)技术及V&V技术,对软件危害和风险及关键性分析进行研究,并制定了一套定量分析方法。通过系统性、定量化的分析方法,提高了软件危害和风险及关键性分析的操作性。同时,探索了软件风险和危害与关键性程度的关联,使关键性分析的过程得到危害和风险分析结论的有效支撑。该研究为后续项目在实施初期尽早识别技术危害和风险提供了新的定量分析方法,改善了软件质量,进而保证了交付质量。

基于FMEA法的住院药房智能药柜用药安全研究

目的提高住院药房智能药柜(ADC)的用药安全管理。方法采用失效模型和效应分析(FMEA)法,经医院护士、药师等讨论后,从信息系统、人员操作、药品信息、硬件设备、管理方法5个方面建立20个失效模型(包括32个风险点),汇总为调查问卷,并通过专家咨询和药师讨论后建立问卷评分标准。于干预前发放问卷进行调查,根据发现的风险对其中30个可操作的风险点设定干预措施,持续干预5个月后(干预后)再次进行问卷调查,比较干预前后的风险优先级数(RPN)。结果干预后,30个风险点的RPN值均不同程度降低,其中22个显著降低(P<0.05)。管理方法方面的全部风险点RPN值均显著降低(P<0.05);硬件设备方面的全部风险点RPN值均无显著改变(P>0.05)。结论FMEA法用于住院药房ADC的用药安全研究,可减少其用药风险,促进药护共同管理安全使用ADC规则的形成,尤其适用于麻醉药品等特殊药品的用药管理。

失效模式与效应分析在骨科机器人手术流程改善中的应用

目的:探究失效模式与效应分析(FMEA)在骨科机器人手术流程改善中的应用效果。方法:选取2021年1月—2022年12月在我院实施骨科机器人手术的病人为研究对象,将2021年1月—12月(流程改善前)的300例病人作为对照组,将2022年1月—12月(流程改善后)的300例病人作为研究组。对照组实施常规骨科机器人手术流程,研究组实施采用FMEA改善后的骨科机器人手术流程。比较两组手术流程管理失效模式风险优先指数得分、手术时间、术中出血量、住院时间、并发症发生情况及病人满意度。结果:研究组手术流程管理失效模式风险优先指数得分低于对照组;研究组手术时间为(39.12±5.68)min,住院时间为(3.56±1.71)d,均短于对照组[手术时间为(48.31±6.71)min,住院时间为(5.12±1.98)d];研究组术中出血量为(65.23±8.36)mL,少于对照组(71.36±9.11)mL;研究组并发症发生率为3.33%,低于对照组(7.00%);研究组病人满意度为95.00%,高于对照组(89.67%),差异均有统计学意义(P<0.05)。结论:采用FMEA方法能够根据量化指标确定风险因素,从而制定针对性的预防措施,帮助临床医生改善骨科机器人手术流程,降低手术风险,提高手术质量。

医疗失效模式与效应分析在临床试验方案偏离管理中的应用

目的规范临床试验的管理,降低方案偏离的发生率,为提高临床试验的质量提供参考。方法运用医疗失效模式与效应分析方法(HFMEA)确定目前方案偏离发生的潜在失效模式,量化并评估失效模式发生频率、严重程度及可探测度,计算风险优先数(RPN),提出相应的改进措施,统计分析HFMEA实施前后RPN值,评估改进效果。结果开展HFMEA活动后,14项潜在失效模式的RPN值明显下降(P<0.05);12项潜在失效模式的风险等级下降。HFMEA小组成员在发现问题和解决问题能力、沟通配合等方面得到了显著提高。结论HFMEA活动的实施有助于临床试验方案偏离的管理,可有效降低方案偏离的发生,为提高药物临床试验质量提供经验。

基于FMEA的药剂科岗位廉政风险防控

目的:降低药剂科岗位廉政风险。方法:运用失效模式与效应分析方法评估药剂科各岗位流程中潜在的失效模式,将各班组岗位相似的失效模式进行整合,进而分析整改措施并实施;将实施前后失效模式优先风险值(RPN)进行配对t检验。结果:实施整改措施后,药剂科各岗位RPN值显著下降(P<0.05)。结论:失效模式与效应分析法的运用和改进措施的实施可以有效降低药剂科岗位廉政风险,促进药剂科开展科学、有效的廉政建设工作。