风险管理程序

1、HTS风 险 管 理 程 序 技术部管理理规定目的本程序规定定了技术术部在设设计开发发阶段进进行风险险管理的的程序，以以保证所所设计开开发的产产品满足足安全和和法规的的要求适用范围本程序适用用于本公公司在开开发设计计阶段所所进行的的技术方方面的风风险分析析职责风险分析应应该由系系统工程程师和SSRE工工程师共共同来完完成。程序1为了确定定单一的的失效模模式的存存在是否否会影响响安全方方面的伤伤害和不不符合有有关法规规的要求求，应该该在设计计开发立立项时对对技术方方面的风风险进行行分析，并并且形成成技术报报告，作作为DHHF文件件。技术术报告的的具体要要求请参参见HTTS-004-0011技技术

2、报告告编写规规定42 随随设计开开发的进进行，应应该对风风险分析析的报告告进行更更新，至至少应在在PRDD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 技技术方面面的风险险分析应应该关注注在可能能危及安安全或引引起抱怨怨的领域域和影响响产品质质量的关关键方面面。44 建建议使用用FMEEA（Faiilurre MModee annd EEffeect Anaalyssis）进进行风险险分析，也也可以使使用其它它相关的的工具进进行风险险分析，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

3、风险险分析在在产品中中一些典典型的应应用4511 电路路控制暴露的移动动部件患者支持部部分的移移动移动产品的的运输驾驾驶在移动设备备，如有有蓬货车车的运输输驾驶安全互锁和和使能功功能报警和警告告指示输出能量（变变频器等等）热的输入和和输出患者的电器器联结患者监视设设备X线爆光，遮遮光器和和技术要要素接收数据的的识别产品的安全全和性能能告戒4522 机械械设备支持患者部部件患者上方的的悬挂物物限制危险能能量（压压力容器器，弹簧簧包等）校准X线放置图象接接收器限制压力应应用到患患者对于移动的的产品或或部件，如如床，提提供的操操纵或制制动措施施4533 软件件控制运动或或功能处理，存储储或传输输图象

4、影响患者辨辨认4544 风险险分析要要符合EEHS的的要求4555 SRRE工程程师和系系统工程程师应根根据所开开发产品品的特点点结合上上面的典典型应用用进行风风险分析析。46 FFMEAA表格填填写说明明0NEW ISSSUE2001.7.112韩强孙旭光赵宏Rev.Page DEESCRRIPTTIONNDATEDR.CH.APP.TITLEE 风 险 管 理 程 序DOCUMMENTT Noo. HTSS-044-0227Page 1 /4Aa-055-D001 GE HANGWEI MEDICAL SYSTEMS 4611 FMMEA表表格各部部分内容容SystemPotentialF

5、MEA 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 Design ControlsDe

6、tRPNRecommended 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 in prototype

7、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. Write down each failure mode and potential consequence(s) of that failure. Response Plans and Tracking Response Plans and Tracking Severity - On a scale of

8、 1-10, rate the Severity of each failure (10= most severe). See Severity sheet.Severity - On a scale of 1-10, rate the Severity of each failure (10= most severe). See Severity sheet. Risk Priority Number - The combined weighting of Severity, Likelihood, and Detectability.Risk Priority Number - The c

9、ombined 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.Likelihood - Write down the potential cause(s), and on a scale of 1-1

10、0, rate the Likelihood of each failure (10= most likely). See Likelihood sheet. Detectability - Examine the current design, then, on a scale of 1-10, rate the Detectability of each failureDetectability - Examine the current design, then, on a scale of 1-10, rate the Detectability of each failure(10

11、= least detectable). See Detectability sheet. TITLEE: 风风 险险 管管 理理 程程 序序DOCUMMENTT NOO: HTSS-044-0227PAGE: 2/4 Aa-05-003GE HANNGWEEI MMEDIICALL SYYSTEEMS4622 严重重性等级级的划分分EffectSEVERITY of EffectRankingHazardous without warningVery high severity ranking when a potential failure mode affects safe system

12、 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 damage7ModerateSystem inoperable

13、with minor damage6LowSystem inoperable without damage5Very LowSystem operable with significant degradation of performance4MinorSystem operable with some degradation of performance3Very MinorSystem operable with minimal interference2NoneNo effect14633 概率率等级划划分PROBABILITY of Failure Failure ProbRankin

14、gVery High: Failure 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 1,500,0001TITLEE 风风 险险 管管 理理 程程 序序DOCUMMENTT Noo. HHTS-04-0277PAG

15、E 33/4Aa-055-0002 GE HANNGWEEI MMEDIICALL SYYSTEEMS 4644 风险险的设计计控制的的等级划划分DetectionLikelihood of DETECTION by Design ControlRankingAbsolute UncertaintyDesign control cannot detect potential cause/mechanism and subsequent failure mode10Very RemoteVery remote chance the design control will detect poten

16、tial cause/mechanism and subsequent failure mode9RemoteRemote chance the design 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

17、 detect potential cause/mechanism and subsequent failure mode6ModerateModerate 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 c