风险管理程序

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1、 欢迎阅读本文档，希望本文档能对您有所帮助!HTS风 险 管 理 程 序 技术部管理规定1 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42 随设计开发的进行，应该对风险分析的报告进行更新

2、，至少应在PRD的milestone各阶段进行更新和评审，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。43 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。44 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。45风险分析在产品中一些典型的应用451 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

3、出能量（变频器等）h) 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452 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454 风险分析要符合EHS的要求455 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。46 FMEA表格填写说明0NEW ISS

4、UE2001.7.12韩强孙旭光赵宏Rev.Page DESCRIPTIONDATEDR.CH.APP.TITLE 风 险 管 理 程 序DOCUMENT No. HTS-04-027Page 1 /4Aa-05-D01 GE HANGWEI MEDICAL SYSTEMS 感谢阅读本文档，希望本文档能对您有所帮助!461 FMEA表格各部分内容SystemPotentialFMEA NumberSubsystemFailure Mode and Effects AnalysisPrepared ByComponent(Design FMEA)FMEA DateDesign LeadKey D

5、ateRevision DateCore TeamPageofAction ResultsItem / FunctionPotential Failure Mode(s)Potential Effect(s) of FailureSevPotential Cause(s)/ Mechanism(s) of FailureProbCurrent Design ControlsDetRPNRecommended Action(s)Responsibility & Target Completion DateActions TakenNew SevNew OccNew DetNew RPNCoola

6、nt containment. Hose connection. Coolant fill. MCrack/break. Burst. Side wall flex. Bad seal. Poor hose reteLeak8Over pressure8Burst, validation pressure cycle.164Test included in prototype and production validation testing.J.P. Aguire 11/1/95 E. Eglin 8/1/96 Write down each failure mode and potenti

7、al 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 Priority Number - The combined weighting of Severity, Likelihood, and Detectability.RPN = Sev X Occ X Det Likelihood - Write dow

8、n 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, on a scale of 1-10, rate the Detectability of each failure(10 = least detectable). See Detectability sheet. TITLE: 风 险 管 理

9、程 序DOCUMENT NO: HTS-04-027PAGE: 2/4 Aa-05-003GE HANGWEI MEDICAL SYSTEMS462 严重性等级的划分EffectSEVERITY of EffectRankingHazardous without warningVery high severity ranking when a potential failure mode affects safe system operation without warning10Hazardous with warningVery high severity ranking when a p

10、otential failure mode affects safe system operation with warning9Very HighSystem inoperable with destructive failure without compromising safety8HighSystem inoperable with equipment damage7ModerateSystem inoperable with minor damage6LowSystem inoperable without damage5Very LowSystem operable with si

11、gnificant degradation of performance4MinorSystem operable with some degradation of performance3Very MinorSystem operable with minimal interference2NoneNo effect1463 概率等级划分PROBABILITY of Failure Failure ProbRankingVery High: Failure is almost inevitable1 in 2101 in 39High: Repeated failures1 in 881 i

12、n 207Moderate: Occasional failures1 in 8061 in 40051 in 2,0004Low: Relatively few failures1 in 15,00031 in 150,0002Remote: Failure is unlikely1 in 1,500,0001TITLE 风 险 管 理 程 序DOCUMENT No. HTS-04-027PAGE 3/4Aa-05-002 GE HANGWEI MEDICAL SYSTEMS 464 风险的设计控制的等级划分DetectionLikelihood of DETECTION by Design

13、 ControlRankingAbsolute 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 design control will detect potential cause

14、/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 mode6ModerateModerate chance the design control will detec

15、t 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 cause/mechanism and subsequent failure mode2Almost CertainDesign control will detect potential cause/mechanism and subsequent failure mode1TITLE 风 险 管 理 程 序DOCUMENT No. HTS-04-027PAGE 4/4Aa-05-002 GE HANGWEI MEDICAL SYSTEMS