風(fēng)險管理程序

1、HTS風(fēng)險管理理程序技術(shù)部管管理規(guī)定定目的本程序規(guī)規(guī)定了技技術(shù)部在在設(shè)計開開發(fā)階段段進(jìn)行風(fēng)風(fēng)險管理理的程序序，以保保證所設(shè)設(shè)計開發(fā)發(fā)的產(chǎn)品品滿足安安全和法法規(guī)的要要求適用范圍圍本程序適適用于本本公司在在開發(fā)設(shè)設(shè)計階段段所進(jìn)行行的技術(shù)術(shù)方面的的風(fēng)險分分析職責(zé)風(fēng)險分析析應(yīng)該由由系統(tǒng)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(guān)法法規(guī)的要要求，應(yīng)應(yīng)該在設(shè)設(shè)計開發(fā)發(fā)立項時時對技術(shù)術(shù)方面的的風(fēng)險進(jìn)進(jìn)行分析析，并且且形成技技術(shù)報告告，作為為DHFF文件。技術(shù)報報告的具具體要求求請參見見HTSS-044-0111技技術(shù)報告

2、告編寫規(guī)規(guī)定42 隨設(shè)計計開發(fā)的的進(jìn)行，應(yīng)該對對風(fēng)險分分析的報報告進(jìn)行行更新，至少應(yīng)應(yīng)在PRRD的millesttonee各階段段進(jìn)行更更新和評評審，為為了降低低風(fēng)險而而采取的的設(shè)計措措施應(yīng)該該形成技技術(shù)報告告以便追追溯。43 技術(shù)方方面的風(fēng)風(fēng)險分析析應(yīng)該關(guān)關(guān)注在可可能危及及安全或或引起抱抱怨的領(lǐng)領(lǐng)域和影影響產(chǎn)品品質(zhì)量的的關(guān)鍵方方面。44 建議使使用FMMEA（Faiilurre MModee annd EEffeect Anaalyssis）進(jìn)行風(fēng)風(fēng)險分析析，也可可以使用用其它相相關(guān)的工工具進(jìn)行行風(fēng)險分分析，但但應(yīng)該能能達(dá)到對對開發(fā)的的項目進(jìn)進(jìn)行有效效的風(fēng)險險分析的的目的。45風(fēng)風(fēng)險分析析在

3、產(chǎn)品品中一些些典型的的應(yīng)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(chǎn)品品的運(yùn)輸輸駕駛在移動設(shè)設(shè)備，如如有蓬貨貨車的運(yùn)運(yùn)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(lián)結(jié)結(jié)患者監(jiān)視視設(shè)備X線爆光光，遮光光器和技技術(shù)要素素接收數(shù)據(jù)據(jù)的識別別產(chǎn)品的安安全和性性能告戒戒452 機(jī)機(jī)械設(shè)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(zhǔn)X線線放置圖象象接收器器限制壓力力應(yīng)用到到患者對于移動動的產(chǎn)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(yùn)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(rèn)454 風(fēng)風(fēng)險分析析要符合合EHSS的要求求455 SSRE工工程師和和系統(tǒng)工工程師應(yīng)應(yīng)根據(jù)所所開發(fā)產(chǎn)產(chǎn)品的特特點結(jié)合合上面的的典型應(yīng)應(yīng)用進(jìn)行行風(fēng)險分分析。46 FMEEA表格格填寫說說明0NEW ISSSUEE20011.7.12韓強(qiáng)孫旭光趙宏Rev.Pagee DDESCCRIPPTIOONDATEEDR.CH.APP.TITLLE風(fēng) 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(nèi)內(nèi)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(fēng) 險險 管管 理理 程程 序序DOCUUMENNT NNO:HTS-04-0277PAGEE: 22/4Aa-005-0003GE HANNGWEEI MMEDIICALL SYYSTEEMS462 嚴(yán)嚴(yán)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(fēng) 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(fēng)風(fēng)險的設(shè)設(shè)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