风险管理程序

1、.精品资料网cnshu25万份精华管理资料，2万多集管理视频讲座：.；精品资料网cnshu 专业提供企管培训资料HTS风 险 管 理 程 序 技术部管理规定目的本程序规定了技术部在设计开发阶段进展风险管理的程序，以保证所设计开发的产品满足平安和法规的要求适用范围本程序适用于本公司在开发设计阶段所进展的技术方面的风险分析职责风险分析应该由系统工程师和SRE工程师共同来完成。程序1为了确定单一的失效方式的存在能否会影响平安方面的损伤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展分析，并且构成技术报告，作为DHF文件。技术报告的详细要求请参见HTS-04-01142 随设计开发的进

2、展，应该对风险分析的报告进展更新，至少应在PRD的milestone各阶段进展更新和评审，为了降低风险而采取的设计措施应该构成技术报告以便追溯。43 技术方面的风险分析应该关注在能够危及平安或引起埋怨的领域和影响产质量量的关键方面。44 建议运用FMEAFailure Mode and Effect Analysis进展风险分析，也可以运用其它相关的工具进展风险分析，但应该能到达对开发的工程进展有效的风险分析的目的。45风险分析在产品中一些典型的运用451 电路控制暴露的挪动部件患者支持部分的挪动挪动产品的运输驾驶在挪动设备，如有蓬货车的运输驾驶平安互锁和使能功能报警和警告指示输出能量变频器等

3、热的输入和输出患者的电器结合患者监视设备X线爆光，遮光器和技术要素接纳数据的识别产品的平安和性能告戒452 机械设备支持患者部件患者上方的悬挂物限制危险能量压力容器，弹簧包等校准X线放置图象接纳器限制压力运用到患者对于挪动的产品或部件，如床，提供的支配或制动措施453 软件控制运动或功能处置，存储或传输图象影响患者识别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运用进展风险分析。46 FMEA表格填写阐明0NEW ISSUE2001.7.12韩强孙旭光赵宏Rev.Page DESCRIPTIONDATEDR.CH.APP.TITLE 风

4、 险 管 理 程 序DOCUMENT No. HTS-04-027Page 1 /4Aa-05-D01 GE HANGWEI MEDICAL SYSTEMS 461 FMEA表格各部分内容SystemPotentialFMEA NumberSubsystemFailure Mode and Effects AnalysisPrepared ByComponent(Design FMEA)FMEA DateDesign LeadKey DateRevision DateCore TeamPageofAction ResultsItem / FunctionPotential Failure Mo

5、de(s)Potential Effect(s) of FailureSevPotential Cause(s)/ Mechanism(s) of FailureProbCurrent Design ControlsDetRPNRecommended Action(s)Responsibility & Target Completion DateActions TakenNew SevNew OccNew DetNew RPNCoolant containment. Hose connection. Coolant fill. MCrack/break. Burst. Side wall fl

6、ex. 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 potential consequence(s) of that failure. Response Plans and Tracking Severity - On a s

7、cale 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 down the potential cause(s), and on a scale of 1-10, rate the Likelihood of each fa

8、ilure (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 程 序DOCUMENT NO: HTS-04-027PAGE: 2/4 Aa-05-003GE HANGWEI MEDICAL SYSTEMS462 严重性等级

9、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 potential failure mode affects safe system operation with warning9Very HighSystem

10、 inoperable with destructive failure without compromising safety8HighSystem inoperable with equipment damage7ModerateSystem inoperable with minor damage6LowSystem inoperable without damage5Very LowSystem operable with significant degradation of performance4MinorSystem operable with some degradation

11、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 in 207Moderate: Occasional failures1 in 8061 in 40051 in 2,0004Low: Relatively fe

12、w 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 ControlRankingAbsolute UncertaintyDesign control cannot detect potential cause/

13、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/mechanism and subsequent failure mode8Very LowVery low chance the design contro

14、l 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 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