风险管理程序

1、HTS风险管理理程序技术部管管理规定定目的本程序规规定了技技术部在在设计开开发阶段段进行风风险管理理的程序序，以保保证所设设计开发发的产品品满足安安全和法法规的要要求适用范围围本程序适适用于本本公司在在开发设设计阶段段所进行行的技术术方面的的风险分分析职责风险分析析应该由由系统工工程师和和SREE工程师师共同来来完成。程序1为了确确定单一一的失效效模式的的存在是是否会影影响安全全方面的的伤害和和不符合合有关法法规的要要求，应应该在设设计开发发立项时时对技术术方面的的风险进进行分析析，并且且形成技技术报告告，作为为DHFF文件。技术报报告的具具体要求求请参见见HTSS-044-0111技技术报告

2、告编写规规定42 随设计计开发的的进行，应该对对风险分分析的报报告进行行更新，至少应应在PRRD的millesttonee各阶段段进行更更新和评评审，为为了降低低风险而而采取的的设计措措施应该该形成技技术报告告以便追追溯。43 技术方方面的风风险分析析应该关关注在可可能危及及安全或或引起抱抱怨的领领域和影影响产品品质量的的关键方方面。44 建议使使用FMMEA（Faiilurre MModee annd EEffeect Anaalyssis）进行风风险分析析，也可可以使用用其它相相关的工工具进行行风险分分析，但但应该能能达到对对开发的的项目进进行有效效的风险险分析的的目的。45风风险分析析在

3、产品品中一些些典型的的应用451 电电路控制制暴露的移移动部件件患者支持持部分的的移动移动产品品的运输输驾驶在移动设设备，如如有蓬货货车的运运输驾驶驶安全互锁锁和使能能功能报警和警警告指示示输出能量量（变频频器等）热的输入入和输出出患者的电电器联结结患者监视视设备X线爆光光，遮光光器和技技术要素素接收数据据的识别别产品的安安全和性性能告戒戒452 机机械设备备支持患者者部件患者上方方的悬挂挂物限制危险险能量（压力容容器，弹弹簧包等等）校准X线线放置图象象接收器器限制压力力应用到到患者对于移动动的产品品或部件件，如床床，提供供的操纵纵或制动动措施453 软软件控制运动动或功能能处理，存存储或传传

4、输图象象影响患者者辨认454 风风险分析析要符合合EHSS的要求求455 SSRE工工程师和和系统工工程师应应根据所所开发产产品的特特点结合合上面的的典型应应用进行行风险分分析。46 FMEEA表格格填写说说明0NEW ISSSUEE20011.7.12韩强孙旭光赵宏Rev.Pagee DDESCCRIPPTIOONDATEEDR.CH.APP.TITLLE风 险险 管管 理理 程程 序序DOCUUMENNT NNo.HTS-04-0277Pagee 11 /44Aa-005-DD01GE HHANGGWEII MEEDICCAL SYSSTEMMS 461 FFMEAA表格各各部分内内容Sy

5、stemPotentialFMEA NumberSubsystemFailure Mode and Effects AnalysisPrepared ByComponent(Design FMEA)FMEA DateDesign LeadKey DateRevision DateCore TeamPageofAction ResultsItem / FunctionPotential Failure Mode(s)Potential Effect(s) of FailureSevPotential Cause(s)/ Mechanism(s) of FailureProbCurrent Des

6、ign ControlsDetRPNRecommended Action(s)Responsibility & Target Completion DateActions TakenNew SevNew OccNew DetNew RPNCoolant containment. Hose connection. Coolant fill. MCrack/break. Burst. Side wall flex. Bad seal. Poor hose reteLeak8Over pressure8Burst, validation pressure cycle.164Test included

7、 in prototype and production validation testing.J.P. Aguire 11/1/95 E. Eglin 8/1/96 Write down each failure mode and potential consequence(s) of that failure. Response Plans and Tracking Severity - On a scale of 1-10, rate the Severity of each failure (10= most severe). See Severity sheet. Risk Prio

8、rity Number - The combined weighting of Severity, Likelihood, and Detectability.RPN = Sev X Occ X Det Likelihood - Write down the potential cause(s), and on a scale of 1-10, rate the Likelihood of each failure (10= most likely). See Likelihood sheet. Detectability - Examine the current design, then,

9、 on a scale of 1-10, rate the Detectability of each failure(10 = least detectable). See Detectability sheet. TITLLE:风 险险 管管 理理 程程 序序DOCUUMENNT NNO:HTS-04-0277PAGEE: 22/4Aa-005-0003GE HANNGWEEI MMEDIICALL SYYSTEEMS462 严严重性等等级的划划分Hazardous without warningVery high severity ranking when a potential fai

10、lure mode affects safe system operation without warning10Hazardous with warningVery high severity ranking when a potential failure mode affects safe system operation with warning9Very HighSystem inoperable with destructive failure without compromising safety8HighSystem inoperable with equipment dama

11、ge7ModerateSystem inoperable with minor damage6LowSystem inoperable without damage5Very LowSystem operable with significant degradation of performance4MinorSystem operable with some degradation of performance3Very MinorSystem operable with minimal interference2NoneNo effect1463 概概率等级级划分Very High: Fa

12、ilure is almost inevitable1 in 2101 in 39High: 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 unlikely1 in 1,500,0001TITLLE风 险险 管管 理理 程程 序序DOCUUMENNT NNo.HTS-04-0277PAGEE 3/44Aa-005-0002

13、GE HHANGGWEII MEEDICCAL SYSSTEMMS464 风风险的设设计控制制的等级级划分Absolute UncertaintyDesign control cannot detect potential cause/mechanism and subsequent failure mode10Very RemoteVery remote chance the design control will detect potential cause/mechanism and subsequent failure mode9RemoteRemote chance the desi

14、gn control will detect potential cause/mechanism and subsequent failure mode8Very LowVery low chance the design control will detect potential cause/mechanism and subsequent failure mode7LowLow chance the design control will detect potential cause/mechanism and subsequent failure mode6ModerateModerat

15、e chance the design control will detect potential cause/mechanism and subsequent failure mode5Moderately HighModerately High chance the design control will detect potential cause/mechanism and subsequent failure mode4HighHigh chance the design control will detect potential cause/mechanism and subsequent failure mode3Very HighVery high chance the design control will detect potential