风险管理程序

1、风险管理程序技术部管理规定HTS1 目的本程序规定了技术部在设计开发阶段进行风险管理的程序，以保证所设计开发的产品满足安全和法规的要求2 适用范围本程序适用于本公司在开发设计阶段所进行的技术方面的风险分析3 职责风险分析应该由系统工程师和SRE 工程师共同来完成。4 程序4 1 为了确定单一的失效模式的存在是否会影响安全方面的伤害和不符合有关法规的要求，应该在设计开发立项时对技术方面的风险进行分析，并且形成技术报告，作为DHF 文件。技术报告的具体要求请参见HTS-04-011 技术报告编写规定4 2 随设计开发的进行，应该对风险分析的报告进行更新，至少应在PRD 的 milestone 各阶

2、段进行更新和评审，为了降低风险而采取的设计措施应该形成技术报告以便追溯。4 3 技术方面的风险分析应该关注在可能危及安全或引起抱怨的领域和影响产品质量的关键方面。4 4 建议使用FMEA （ Failure Mode and Effect Analysis ）进行风险分析，也可以使用其它相关的工具进行风险分析，但应该能达到对开发的项目进行有效的风险分析的目的。4 5 风险分析在产品中一些典型的应用4 5 1 电路控制a) 暴露的移动部件b) 患者支持部分的移动c) 移动产品的运输驾驶d) 在移动设备，如有蓬货车的运输驾驶e) 安全互锁和使能功能f) 报警和警告指示g) 输出能量（变频器等）h)

3、 热的输入和输出i) 患者的电器联结j) 患者监视设备k) X 线爆光，遮光器和技术要素l) 接收数据的识别m) 产品的安全和性能告戒4 5 2 机械设备a) 支持患者部件b) 患者上方的悬挂物c) 限制危险能量（压力容器，弹簧包等）d) 校准X线e) 放置图象接收器f) 限制压力应用到患者g) 对于移动的产品或部件，如床，提供的操纵或制动措施453 软件a) 控制运动或功能b) 处理，存储或传输图象c) 影响患者辨认4 5 4 风险分析要符合EHS 的要求4 5 5 SRE 工程师和系统工程师应根据所开发产品的特点结合上面的典型应用进行风险分析。4 6 FMEA 表格填写说明0NEW ISS

4、UE韩强孙旭光赵宏Rev.PageDESCRIPTIONDATEDR.CH.APP.TITLEDOCUMENT No .Page风险管理程序HTS-04-0271 /4GEHANGWEIMEDICALSYSTEMS4 6 1 FMEA 表格各部分内容SystemPotentialFMEA NumberSubsystemFailure Mode and Effects AnalysisPrepared ByComponentKey(Design FMEA)FMEA DateDatDesign LeadeRevision DateCore TeamPageofAction ResultsPoten

5、tialPotentialPotential Cause(s)/ResponsibilityvctNItem /Current DesignRecommendedActionsecePFailureEffect(s)SevMechanism(s) ofDet& TargetSODRwwwwFunctionMode(s)of FailureFailureProbControlsRPNAction(s)CompletionTakeneeeeDateNNNNCoolantCrack/break. Leak8 Over pressure8Burst,validation 164 Testinc

6、ludedin J.P.Aguirecontainment.Burst.Sidepressure totypeand 11/1/95E.Hosewall flex.Badproductionvalidation Eglin 8/1/96connection.seal.Poortesting.Coolant fill. Mhose reteWritedowneachfailuremodeandpotentialconsequence(s)ofthatSeverity- On a scale of1-10,ratetheSeverityofeachfailure(10=mosts

7、evere).SeeSeverity sheet.Likelihood- Write down thepotential cause(s), and on ascaleof1-10,ratetheLikelihoodofeachfailure(10=mostlikely).SeeLikelihood sheet.TITLE:风险管理程序Aa-05-003Response Plans and TrackingRiskPriorityNumber-ThecombinedweightingofSeverity,Likelihood,andDetectability.RPN = Sev X Occ X

8、 DetDetectability-Examinethecurrent design, then,on a scaleof 1-10, rate the Detectabilityofeach failure(10 = leastdetectable).SeeDetectability sheet.DOCUMENT NO:PAGE:2/4HTS-04-027GEHANGWEIMEDICALSYSTEMS4 6 2 严重性等级的划分HazardouswithoutVery high severity rankingwhen a potentialfailuremodewarningaffects

9、 safe system operation without warningHazardouswithVery highseverityrankingwhen a potentialfailuremodewarningaffects safe system operation with warningVery HighSysteminoperablewithdestructivefailurewithoutcompromising safetyHighSystem inoperable with equipment damageModerateSystem inoperable with mi

10、nor damageLowSystem inoperable without damageVery LowSystemoperablewithsignificantdegradationofperformanceMinorSystem operable with some degradation of performanceVery MinorSystem operable with minimal interferenceNoneNo effect4 6 3 概率等级划分Very High: Failure is almost inevitable>1 in 2101 in 39Hig

11、h: Repeated failures1 in 881 in 207Moderate: Occasional failures1 in 8061 in 40051 in 2,0004Low: Relatively few failures1 in 15,00031 in 150,0002Remote: Failure is unlikely<1 in 1,500,000110987654321TITLEDOCUMENT No.PAGE风险管理程序HTS-04-0273/4GE HANGWEI MEDICAL SYSTEMS4 6 4 风险的设计控制的等级划分AbsoluteDesign

12、controlcannotdetectpotentialcause/mechanism10Uncertaintyand subsequent failure modeVery RemoteVery remotechance the design control will detect potential9cause/mechanism and subsequent failure modeRemoteRemote chance the designcontrolwilldetectpotential8cause/mechanism and subsequent failure modeVery

13、 LowVerylowchancethedesigncontrolwilldetectpotential7cause/mechanism and subsequent failure modeLowLowchancethedesign control will detect potential6cause/mechanism and subsequent failure modeModerateModeratechancethedesigncontrolwilldetectpotential5cause/mechanism and subsequent failure modeModerately HighModeratelyHighchancethe designcontrol willdetect4potential cause/mechanism and subsequent failure modeHighHighchancethedesign control will detect potential3cause/mechanism and subsequent failure modeVery HighVery highchancethedesigncontro