风险管理程序

1效HT衰S购风更险爷管要理逐程激序精技术撑部管中理规劫定抢目的渠本程惭序规自定了凡技术吸部在兰设计掌开发席阶段拾进行惩风险致管理饶的程范序，侍以保晚证所墓设计寄开发叛的产通品满猾足安垒全和兄法规占的要镇求豪适用绕范围捉本程截序适森用于甘本公师司在旨开发俭设计改阶段样所进暗行的灭技术拦方面闸的风岭险分像析灿职责最风险麦分析厨应该谣由系坚统工辱程师裳和怪SR损E撑工程伯师共牺同来遮完成欺。坡程序爽1为弄了确独定单河一的哗失效技模式海的存芦在是无否会倒影响趋平安贵方面庸的伤饺害和边不符局合有呈关法豪规的沸要求地，应愈该在节设计喂开发强立项眯时对丛技术遗方面牙的风温险进鹿行分蚁析，聪并且武形成藏技术层报告百，作傲为服DH彩F换文件安。技及术报顽告的忌具体料要求句请参坏见淘HT便S-狼04洗-0虏11份?技厨术报解告编魔写规画定?值4．匪2烦随设盾计开括发的孔进行阴，应酒该对懒风险佳分析轿的报林告进译行更租新，哥至少迫应在唉PR铜D蓄的充mi愤le吹st棚on叉e饼各阶团段进赏行更血新和打评审扣，为俩了降信低风喝险而狗采取母的设趟计措耍施应景该形践成技愚术报拒告以眨便追嫌溯。残4．丛3须技术固方面禾的风设险分另析应亡该关屯注在高可能涨危及聚平安忙或引壤起抱伸怨的职领域凶和影哥响产必品质送量的幼关键颜方面叼。漠4．龟4牌建议矮使用专FM梯EA堡〔戴Fa盈il瞒ur目e各Mo懂de育a技nd信E翼ff辽ec远t骄An驳al易ys从is全〕进子行风拦险分栋析，河也可述以使手用其蜘它相室关的殖工具便进行江风险兽分析址，但惯应该留能达折到对季开发夕的项常目进痕行有摩效的怕风险轨分析场的目辟的。筑4．调5风俭险分芝析在计产品恶中一堡些典灵型的梯应用辅4．态5．职1遗电路剂控制绩暴露亲的移乞动部毯件透患者前支持惑局部洁的移银动栗移动旺产品咽的运懂输驾威驶低在移秩动设柳备，揉如有非蓬货在车的改运输绩驾驶崇平安版互锁端和使剃能功忽能这报警散和警伟告指馅示职输出千能量间〔变技频器役等〕粘热的汁输入执和输追出国患者推的电企器联奶结搂患者哲监视秤设备舅X聚线爆甚光，皂遮光狡器和缝技术撇要素燥接收债数据说的识生别佳产品忆的安储全和画性能猾告戒术4．岔5．匙2产机械惰设备跌支持丙患者晋部件欧患者日上方吨的悬勺挂物阅限制禽危险喝能量眠〔压鸣力容遭器，冈弹簧挨包等拾〕虎校准曾X贸线丙放置树图象导接收抱器尺限制裳压力绸应用词到患狠者置对于观移动告的产铜品或溉部件其，如堂床，妙提供缠的操色纵或屡制动践措施晋4．额5．旁3宣软件女控制粒运动面或功厉能齿处理软，存拦储或脚传输材图象扣影响暗患者撕识别忆4亿．5幕．4毫风拳险分沈析要奴符合咬EH圈S汽的要露求进4．痛5．呼5勇SR馋E疯工程丙师和猾系统誉工程夫师应渣根据垮所开矩发产看品的除特点椅结合盼上面脆的典兵型应敲用进霞行风是险分煎析。嚼4．岗6越FM偶EA突表格陕填写溉说明丽0祖NE谣W泻I玉SS偏UE嗓20您01扔.7暑.1呀2份韩强胶孙旭拆光脉赵宏嗓Re疏v.它Pa茧ge冻耽易亦届依堤针娇洁悬碧笨叙屿伴甘梢茧止DE找SC都RI厚PT远IO咸N阶DA验TE壶DR叙.莲CH披.估AP案P.届TI雁TL怠E沈风匆险忘期管犁理敌掘程专序粘DO迫CU越ME脑NT负N稍o肾.愁HT瑞S-闲04标-0竖27骑Pa诊ge统俩1搂/僚4浙Aa凤-0算5-艇D0掠1GEHANGWEIMEDICALSYSTEMS1轧4．炒6．略1替FM甲EA劳表格厌各部剪分内吃容SystemPotentialFMEANumberSubsystemFailureModeandEffectsAnalysisPreparedByComponent(DesignFMEA)FMEADateDesignLeadKeyDateRevisionDateCoreTeamPageofActionResultsItem/FunctionPotentialFailureMode(s)PotentialEffect(s)

ofFailureSevPotentialCause(s)/Mechanism(s)ofFailureProbCurrentDesignControlsDetRPNRecommended

Action(s)Responsibility&TargetCompletionDateActionsTakenNewSevNewOccNewDetNewRPNCoolantcontainment.Hoseconnection.Coolantfill.MCrack/break.Burst.Sidewallflex.Badseal.PoorhosereteLeak8Overpressure8Burst,validationpressurecycle.164Testincludedinprototypeandproductionvalidationtesting.J.P.Aguire11/1/95E.Eglin8/1/96Writedowneachfailuremodeandpotentialconsequence(s)ofthatfailure.Writedowneachfailuremodeandpotentialconsequence(s)ofthatfailure.ResponsePlansandTrackingResponsePlansandTrackingSeveritySeverity-Onascaleof1-10,ratetheSeverityofeachfailure(10=mostsevere).SeeSeveritysheet.RiskPriorityNumberRiskPriorityNumber-ThecombinedweightingofSeverity,Likelihood,andDetectability.

RPN=SevXOccXDetLikelihoodLikelihood-Writedownthepotentialcause(s),andonascaleof1-10,ratetheLikelihoodofeachfailure(10=mostlikely).SeeLikelihoodsheet.DetectabilityDetectability-Examinethecurrentdesign,then,onascaleof1-10,ratetheDetectabilityofeachfailure

(10=leastdetectable).SeeDetectabilitysheet.冬TI繁TL咱E:形风记险索好管望理顽律程评序绪DO你CU场ME塞NT晚N器O:饭HT柴S-坏04抓-0惰27浆PA微GE支:延迟2帖/4Aa-05-003 GEHANGWEIMEDICALSYSTEMS1讲4怎．6箩．2抽严糊重性小等级慌的划挠分HazardouswithoutwarningVeryhighseverityrankingwhenapotentialfailuremodeaffectssafesystemoperationwithoutwarning10HazardouswithwarningVeryhighseverityrankingwhenapotentialfailuremodeaffectssafesystemoperationwithwarning9VeryHighSysteminoperablewithdestructivefailurewithoutcompromisingsafety8HighSysteminoperablewithequipmentdamage7ModerateSysteminoperablewithminordamage6LowSysteminoperablewithoutdamage5VeryLowSystemoperablewithsignificantdegradationofperformance4MinorSystemoperablewithsomedegradationofperformance3VeryMinorSystemoperablewithminimalinterference2NoneNoeffect1虾4．匠6．景3般概率寿等级蚁划分VeryHigh:Failureisalmostinevitable>1in2101in39High:Repeatedfailures1in881in207Moderate:Occasionalfailures1in8061in40051in2,0004Low:Relativelyfewfailures1in15,00031in150,0002Remote:Failureisunlikely<1in1,500,0001方TI汇TL绢E眠风牌险泉疑管用理要炎程鼻序仆DO出CU胀ME泛NT振N朴o.凤HT格S-咳04栋-0袄27交PA翁GE著秃葡3/或4Aa-05-002GEHANGWEIMEDICALSYSTEMS驶4．停6．岗4暂风险贷的设赖计控堆制的导等级诊划分AbsoluteUncertaintyDesigncontrolcannotdetectpotentialcause/mechanismandsubsequentfailuremode10VeryRemoteVeryremotechancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode9RemoteRemotechancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode8VeryLowVerylowchancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode7LowLowchancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode6ModerateModeratechancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode5ModeratelyHighModeratelyHighchancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode4HighHighchancethedesigncontrolwilldetectpotentialcause/mechanismandsubsequentfailuremode3VeryHighVeryhighchancethedesigncontrolwilldetectpotentialcause