1、HTS風險管理理程序技術部管管理規定定目的本程序規規定了技技術部在在設計開開發階段段進行風風險管理理的程序序，以保保證所設設計開發發的產品品滿足安安全和法法規的要要求適用范圍圍本程序適適用于本本公司在在開發設設計階段段所進行行的技術術方面的的風險分分析職責風險分析析應該由由系統工工程師和和SREE工程師師共同來來完成。程序1為了確確定單一一的失效效模式的的存在是是否會影影響安全全方面的的傷害和和不符合合有關法法規的要要求，應應該在設設計開發發立項時時對技術術方面的的風險進進行分析析，并且且形成技技術報告告，作為為DHFF文件。技術報報告的具具體要求求請參見見HTSS-044-0111技技術報告

2、告編寫規規定42 隨設計計開發的的進行，應該對對風險分分析的報報告進行行更新，至少應應在PRRD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 技術方方面的風風險分析析應該關關注在可可能危及及安全或或引起抱抱怨的領領域和影影響產品品質量的的關鍵方方面。44 建議使使用FMMEA（Faiilurre MModee annd EEffeect Anaalyssis）進行風風險分析析，也可可以使用用其它相相關的工工具進行行風險分分析，但但應該能能達到對對開發的的項目進進行有效效的風險險分析的的目的。45風風險分析析在

3、產品品中一些些典型的的應用451 電電路控制制暴露的移移動部件件患者支持持部分的的移動移動產品品的運輸輸駕駛在移動設設備，如如有蓬貨貨車的運運輸駕駛駛安全互鎖鎖和使能能功能報警和警警告指示示輸出能量量（變頻頻器等）熱的輸入入和輸出出患者的電電器聯結結患者監視視設備X線爆光光，遮光光器和技技術要素素接收數據據的識別別產品的安安全和性性能告戒戒452 機機械設備備支持患者者部件患者上方方的懸掛掛物限制危險險能量（壓力容容器，彈彈簧包等等）校準X線線放置圖象象接收器器限制壓力力應用到到患者對于移動動的產品品或部件件，如床床，提供供的操縱縱或制動動措施453 軟軟件控制運動動或功能能處理，存存儲或傳傳

4、輸圖象象影響患者者辨認454 風風險分析析要符合合EHSS的要求求455 SSRE工工程師和和系統工工程師應應根據所所開發產產品的特特點結合合上面的的典型應應用進行行風險分分析。46 FMEEA表格格填寫說說明0NEW ISSSUEE20011.7.12韓強孫旭光趙宏Rev.Pagee DDESCCRIPPTIOONDATEEDR.CH.APP.TITLLE風 險險 管管 理理 程程 序序DOCUUMENNT NNo.HTS-04-0277Pagee 11 /44Aa-005-DD01GE HHANGGWEII MEEDICCAL SYSSTEMMS 461 FFMEAA表格各各部分內內容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:風 險險 管管 理理 程程 序序DOCUUMENNT NNO:HTS-04-0277PAGEE: 22/4Aa-005-0003GE HANNGWEEI MMEDIICALL SYYSTEEMS462 嚴嚴重性等等級的劃劃分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 概概率等級級劃分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風 險險 管管 理理 程程 序序DOCUUMENNT NNo.HTS-04-0277PAGEE 3/44Aa-005-0002

13、GE HHANGGWEII MEEDICCAL SYSSTEMMS464 風風險的設設計控制制的等級級劃分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