風(fēng)險(xiǎn)管理程序

1、HTS風(fēng) 險(xiǎn) 管 理 程 序 技術(shù)部管理理規(guī)定目的本程序規(guī)定定了技術(shù)術(shù)部在設(shè)設(shè)計(jì)開(kāi)發(fā)發(fā)階段進(jìn)進(jìn)行風(fēng)險(xiǎn)險(xiǎn)管理的的程序，以以保證所所設(shè)計(jì)開(kāi)開(kāi)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(kāi)開(kāi)發(fā)設(shè)計(jì)計(jì)階段所所進(jìn)行的的技術(shù)方方面的風(fēng)風(fēng)險(xiǎn)分析析職責(zé)風(fēng)險(xiǎn)分析應(yīng)應(yīng)該由系系統(tǒng)工程程師和SSRE工工程師共共同來(lái)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(huì)影響響安全方方面的傷傷害和不不符合有有關(guān)法規(guī)規(guī)的要求求，應(yīng)該該在設(shè)計(jì)計(jì)開(kāi)發(fā)立立項(xiàng)時(shí)對(duì)對(duì)技術(shù)方方面的風(fēng)風(fēng)險(xiǎn)進(jìn)行行分析，并并且形成成技術(shù)報(bào)報(bào)告，作作為DHHF文件件。技術(shù)術(shù)報(bào)告的的具體要要求請(qǐng)參參見(jiàn)HTTS-004-0011技技術(shù)

2、報(bào)告告編寫(xiě)規(guī)規(guī)定42 隨隨設(shè)計(jì)開(kāi)開(kāi)發(fā)的進(jìn)進(jìn)行，應(yīng)應(yīng)該對(duì)風(fēng)風(fēng)險(xiǎn)分析析的報(bào)告告進(jìn)行更更新，至至少應(yīng)在在PRDD的millesttonee各階段段進(jìn)行更更新和評(píng)評(píng)審，為為了降低低風(fēng)險(xiǎn)而而采取的的設(shè)計(jì)措措施應(yīng)該該形成技技術(shù)報(bào)告告以便追追溯。43 技技術(shù)方面面的風(fēng)險(xiǎn)險(xiǎn)分析應(yīng)應(yīng)該關(guān)注注在可能能危及安安全或引引起抱怨怨的領(lǐng)域域和影響響產(chǎn)品質(zhì)質(zhì)量的關(guān)關(guān)鍵方面面。44 建建議使用用FMEEA（Faiilurre MModee annd EEffeect Anaalyssis）進(jìn)進(jìn)行風(fēng)險(xiǎn)險(xiǎn)分析，也也可以使使用其它它相關(guān)的的工具進(jìn)進(jìn)行風(fēng)險(xiǎn)險(xiǎn)分析，但但應(yīng)該能能達(dá)到對(duì)對(duì)開(kāi)發(fā)的的項(xiàng)目進(jìn)進(jìn)行有效效的風(fēng)險(xiǎn)險(xiǎn)分析的的目的。45

3、風(fēng)險(xiǎn)險(xiǎn)分析在在產(chǎn)品中中一些典典型的應(yīng)應(yīng)用4511 電路路控制暴露的移動(dòng)動(dòng)部件患者支持部部分的移移動(dòng)移動(dòng)產(chǎn)品的的運(yùn)輸駕駕駛在移動(dòng)設(shè)備備，如有有蓬貨車(chē)車(chē)的運(yùn)輸輸駕駛安全互鎖和和使能功功能報(bào)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(jié)患者監(jiān)視設(shè)設(shè)備X線爆光，遮遮光器和和技術(shù)要要素接收數(shù)據(jù)的的識(shí)別產(chǎn)品的安全全和性能能告戒4522 機(jī)械械設(shè)備支持患者部部件患者上方的的懸掛物物限制危險(xiǎn)能能量（壓壓力容器器，彈簧簧包等）校準(zhǔn)X線放置圖象接接收器限制壓力應(yīng)應(yīng)用到患患者對(duì)于移動(dòng)的的產(chǎn)品或或部件，如如床，提提供的操操縱或制制動(dòng)措施施4533 軟件件控制運(yùn)動(dòng)或或功能處理，存儲(chǔ)儲(chǔ)或傳輸輸圖象

4、影響患者辨辨認(rèn)4544 風(fēng)險(xiǎn)險(xiǎn)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(yīng)根根據(jù)所開(kāi)開(kāi)發(fā)產(chǎn)品品的特點(diǎn)點(diǎn)結(jié)合上上面的典典型應(yīng)用用進(jìn)行風(fēng)風(fēng)險(xiǎn)分析析。46 FFMEAA表格填填寫(xiě)說(shuō)明明0NEW ISSSUE2001.7.112韓強(qiáng)孫旭光趙宏Rev.Page DEESCRRIPTTIONNDATEDR.CH.APP.TITLEE 風(fēng) 險(xiǎn) 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(fēng)風(fēng) 險(xiǎn)險(xiǎn) 管管 理理 程程 序序DOCUMMENTT NOO: HTSS-044-0227PAGE: 2/4 Aa-05-003GE HANNGWEEI MMEDIICALL SYYSTEEMS4622 嚴(yán)重重性等級(jí)級(jí)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(jí)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(fēng)風(fēng) 險(xiǎn)險(xiǎn) 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(fēng)險(xiǎn)險(xiǎn)的設(shè)計(jì)計(jì)控制的的等級(jí)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