風險管理程序

1、HTS風 險 管 理 程 序 技術部管理理規(guī)定目的本程序規(guī)定定了技術術部在設設計開發(fā)發(fā)階段進進行風險險管理的的程序，以以保證所所設計開開發(fā)的產(chǎn)產(chǎn)品滿足足安全和和法規(guī)的的要求適用范圍本程序適用用于本公公司在開開發(fā)設計計階段所所進行的的技術方方面的風風險分析析職責風險分析應應該由系系統(tǒng)工程程師和SSRE工工程師共共同來完完成。程序1為了確定定單一的的失效模模式的存存在是否否會影響響安全方方面的傷傷害和不不符合有有關法規(guī)規(guī)的要求求，應該該在設計計開發(fā)立立項時對對技術方方面的風風險進行行分析，并并且形成成技術報報告，作作為DHHF文件件。技術術報告的的具體要要求請參參見HTTS-004-0011技技術

2、報告告編寫規(guī)規(guī)定42 隨隨設計開開發(fā)的進進行，應應該對風風險分析析的報告告進行更更新，至至少應在在PRDD的millesttonee各階段段進行更更新和評評審，為為了降低低風險而而采取的的設計措措施應該該形成技技術報告告以便追追溯。43 技技術方面面的風險險分析應應該關注注在可能能危及安安全或引引起抱怨怨的領域域和影響響產(chǎn)品質質量的關關鍵方面面。44 建建議使用用FMEEA（Faiilurre MModee annd EEffeect Anaalyssis）進進行風險險分析，也也可以使使用其它它相關的的工具進進行風險險分析，但但應該能能達到對對開發(fā)的的項目進進行有效效的風險險分析的的目的。45

3、風險險分析在在產(chǎn)品中中一些典典型的應應用4511 電路路控制暴露的移動動部件患者支持部部分的移移動移動產(chǎn)品的的運輸駕駕駛在移動設備備，如有有蓬貨車車的運輸輸駕駛安全互鎖和和使能功功能報警和警告告指示輸出能量（變變頻器等等）熱的輸入和和輸出患者的電器器聯(lián)結患者監(jiān)視設設備X線爆光，遮遮光器和和技術要要素接收數(shù)據(jù)的的識別產(chǎn)品的安全全和性能能告戒4522 機械械設備支持患者部部件患者上方的的懸掛物物限制危險能能量（壓壓力容器器，彈簧簧包等）校準X線放置圖象接接收器限制壓力應應用到患患者對于移動的的產(chǎn)品或或部件，如如床，提提供的操操縱或制制動措施施4533 軟件件控制運動或或功能處理，存儲儲或傳輸輸圖象

4、影響患者辨辨認4544 風險險分析要要符合EEHS的的要求4555 SRRE工程程師和系系統(tǒng)工程程師應根根據(jù)所開開發(fā)產(chǎn)品品的特點點結合上上面的典典型應用用進行風風險分析析。46 FFMEAA表格填填寫說明明0NEW ISSSUE2001.7.112韓強孫旭光趙宏Rev.Page DEESCRRIPTTIONNDATEDR.CH.APP.TITLEE 風 險 管 理 程 序DOCUMMENTT Noo. HTSS-044-0227Page 1 /4Aa-055-D001 GE HANGWEI MEDICAL SYSTEMS 4611 FMMEA表表格各部部分內(nèi)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: 風風 險險 管管 理理 程程 序序DOCUMMENTT NOO: HTSS-044-0227PAGE: 2/4 Aa-05-003GE HANNGWEEI MMEDIICALL SYYSTEEMS4622 嚴重重性等級級的劃分分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 概率率等級劃劃分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 風風 險險 管管 理理 程程 序序DOCUMMENTT Noo. HHTS-04-0277PAG

15、E 33/4Aa-055-0002 GE HANNGWEEI MMEDIICALL SYYSTEEMS 4644 風險險的設計計控制的的等級劃劃分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