z質(zhì)量風(fēng)險(xiǎn)管理課件

風(fēng)險(xiǎn)管理介紹風(fēng)險(xiǎn)管理系統(tǒng)要求和指南的來源背景GSK/GSKBio風(fēng)險(xiǎn)內(nèi)部控制和框架GSKBS風(fēng)險(xiǎn)管理方法概況目的英國(guó)Turnbull指南公司丑聞Enron,WorldCom,Parmalat,etc.美國(guó)塞班斯法案風(fēng)險(xiǎn)管理的歷史background在應(yīng)該對(duì)公司的監(jiān)管，通過一系列的委員會(huì)審核和報(bào)告，變得愈來愈嚴(yán)格:-1992Cadburyreport（建立公司財(cái)務(wù)監(jiān)管標(biāo)準(zhǔn)）UseofboardcommitteesSeparaterolesofChairmanandChiefExecutive2019Greenburyreport（對(duì)高管薪酬進(jìn)行管理）Disclosureofdirectorsremunerationandcompensationincompanyreports2019Hampelcommitteeandreport（要求公司制定內(nèi)部控制體系保障股東利益）ReviewedtheCadburyCodeanditsimplementation,followeduponmattersarisingfromGreenburyreportAddressedtheroleofshareholdersandauditorsincorporategovernanceissues2019UKListingAuthorityCombinedCode14CodePrinciplesand45CodeprovisionsKeyprinciplerelatestoboard’smaintenanceofasoundsystemofinternalcontrolCodeprovisionreferencesriskmanagement2019TurnbullreportProvidesguidanceontheinternalcontrolandinternalauditprovisionsofthe2019CombinedCodeRiskbasedapproach一些英國(guó)的歷史….backgroundCompany’sinternalcontrolsystemshould:beembeddedwithinitsoperationsandnotbetreatedasaseparateexercisebeabletorespondtochangingriskswithinandoutsidethecompanyenableeachcompanytoapplyitinanappropriatemannerrelatedtoitskeyrisksRequirescompaniestoidentify,evaluateandmanagetheirsignificantrisksandtoassesstheeffectivenessoftherelatedinternalcontrolsystemBoarddirectorsaretoregularlyreviewandannuallyassessoninternalcontrols.TurnbullRequirementsbackgroundMay2019GSKBSCorporateMisstepsbackgroundMay2019GSKBSTheSarbanes-OxleyActprovidesacomparableruleintheUSManagementmustassessannuallytheinternalcontrolsandproceduresforfinancialreportingCEOmustcertifyquarterlyandannuallythatfinancialstatementsarefairlypresentedIndependentauditorsmustattesttoandreportonmanagement’sassessmentofinternalcontrols.塞班斯法案-Y2019

關(guān)于公司管理的匯報(bào)要求backgroundMay2019GSKBS公司的響應(yīng):內(nèi)部的控制模式GSKRMoverviewMay2019GSKBS內(nèi)部控制的要素控制的氛圍風(fēng)險(xiǎn)管理政策和規(guī)程信息和溝通監(jiān)控FiveinterrelatedcomponentsMay2019GSKBS控制的氛圍風(fēng)險(xiǎn)管理政策和規(guī)程信息和溝通監(jiān)控控制的氛圍人

正直誠(chéng)信

職業(yè)道德

能力運(yùn)營(yíng)環(huán)境內(nèi)部控制的要素May2019GSKBS控制的氛圍風(fēng)險(xiǎn)管理政策和規(guī)程信息和溝通監(jiān)控政策、規(guī)程和標(biāo)準(zhǔn)公司

法律合規(guī)ITGMPGSKRMoverview內(nèi)部控制的要素May2019GSKBS控制的氛圍風(fēng)險(xiǎn)管理政策和規(guī)程信息和溝通監(jiān)控信息和溝通運(yùn)營(yíng)、財(cái)務(wù)和合規(guī)報(bào)告溝通流程教育和培訓(xùn)內(nèi)部控制的要素May2019GSKBS控制的氛圍風(fēng)險(xiǎn)管理政策和規(guī)程信息和溝通監(jiān)控監(jiān)控管理者審核審計(jì)內(nèi)部控制的要素May2019GSKBSControlEnvironmentRiskManagementPoliciesandProceduresInformationandCommunicationMonitoring風(fēng)險(xiǎn)管理組織框架內(nèi)部控制的要素May2019GSKBSPolicyExcerpts:PolicyHighlightsGSKPolicyPOL-GSK-500RiskManagementandLegalComplianceApprovedin2019GSKRMoverviewMay2019GSKBSPolicyExcerpts:PolicyHighlightsGSKPolicyPOL-GSK-500RiskManagementandLegalComplianceApprovedin2019GSKRMoverviewMay2019GSKBSPolicyExcerpts:PolicyHighlightsGSKPolicyPOL-GSK-500RiskManagementandLegalComplianceApprovedin2019GSKRMoverviewMay2019GSKBS風(fēng)險(xiǎn)管理的層次董事會(huì)審計(jì)委員會(huì)風(fēng)險(xiǎn)監(jiān)管和合規(guī)委員會(huì)商業(yè)風(fēng)險(xiǎn)管理和合規(guī)組合規(guī)和風(fēng)險(xiǎn)管理團(tuán)隊(duì)運(yùn)營(yíng)團(tuán)隊(duì)監(jiān)控和審核內(nèi)部控制體系的有效性和充分性。包括合規(guī)控制和風(fēng)險(xiǎn)管理。匯報(bào)給董事識(shí)別所有重大風(fēng)險(xiǎn).監(jiān)控實(shí)施風(fēng)險(xiǎn)控制的有效性.確保為管理層的年度審核提供信息和報(bào)告

建立和實(shí)施重大風(fēng)險(xiǎn)審核流程，以及確保風(fēng)險(xiǎn)控制管理的有效性建立內(nèi)部控制系統(tǒng)：

標(biāo)準(zhǔn),政策,規(guī)章

流程.

提供建議和實(shí)施審計(jì)和調(diào)查識(shí)別評(píng)估潛在風(fēng)險(xiǎn).消除、監(jiān)控和報(bào)告風(fēng)險(xiǎn)確保重大風(fēng)險(xiǎn)通過內(nèi)部管理框架被迅速溝通May2019GSKBS鼓勵(lì)新技術(shù)的應(yīng)用資源和優(yōu)化管理理解流程，例如驗(yàn)證…建立面對(duì)審計(jì)的信心但不是為了幫偏離和缺陷找理由風(fēng)險(xiǎn)管理的好處May2019GSKBSMay2019GSKBS我們說了很多風(fēng)險(xiǎn)的背景來源、管理框架…..

那么

風(fēng)險(xiǎn)是什么?

如何識(shí)別風(fēng)險(xiǎn)?

如何管理風(fēng)險(xiǎn)?Thisiscute,but……May2019GSKBS風(fēng)險(xiǎn)：是能通過可能性和后果衡量的，一個(gè)事件發(fā)生后的可感知的后果?？赡苄裕罕┞对谖ｋU(xiǎn)下的可能性。后果：一個(gè)事件的結(jié)果重大風(fēng)險(xiǎn)：給公司帶來重大影響的違法（規(guī)）風(fēng)險(xiǎn)，和財(cái)務(wù)、運(yùn)營(yíng)和合規(guī)的風(fēng)險(xiǎn)法律風(fēng)險(xiǎn)：有法規(guī)問題的風(fēng)險(xiǎn)（如：潛在的違法、違規(guī)，承擔(dān)潛在法律責(zé)任）風(fēng)險(xiǎn)的定義Whatisrisk?May2019GSKBS輕視風(fēng)險(xiǎn)不能完全消除風(fēng)險(xiǎn)應(yīng)該被:降低改變接受控制風(fēng)險(xiǎn)不可能被:忽略風(fēng)險(xiǎn)無處不在風(fēng)險(xiǎn)定義May2019GSKBS預(yù)算運(yùn)營(yíng)計(jì)劃工廠戰(zhàn)略審核評(píng)估部門風(fēng)險(xiǎn)評(píng)估工廠風(fēng)險(xiǎn)TopDown更新計(jì)劃預(yù)算

實(shí)施計(jì)劃BCP工廠驗(yàn)證主計(jì)劃風(fēng)險(xiǎn)清單優(yōu)先級(jí)分類STP–重大風(fēng)險(xiǎn)風(fēng)險(xiǎn)記錄工廠戰(zhàn)略ISHIKAWA外部風(fēng)險(xiǎn)輸入過程輸出流程清單ISHIKAWA風(fēng)險(xiǎn)臺(tái)帳工廠戰(zhàn)略部門戰(zhàn)略STP–重大風(fēng)險(xiǎn)風(fēng)險(xiǎn)管理方式May2019GSKBS風(fēng)險(xiǎn)管理工具:工藝流程清單初步危害分析PreliminaryHazardAnalysis(PHA)HazardAnalysisofCriticalControlPoints(HACCP)HazardOperabilityAnalysis(HAZOP)Faulttreeanalysis(FTA)FailureModeEffectsandAnalysis(FMEA)FailureModeEffectsandcriticalityAnalysis(FMECA)RiskrankingandFilteringInformalriskmanagementMay2019GSKBSAreasforlikelyimpactNo.ProcessRiskNameDescriptionofPotentialRiskImpactFinanceSupplyEHSQAPeopleCICurrentControlMechanismsConsequence1-5Likelihood1-5RiskIndexValueDatelastreviewedEscalateToRiskOwnerRiskTreatmentConsequence

1-5Likelihood1-5RiskIndexValuePlannedRiskReductionACTION

STATUS/HISTORY風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控風(fēng)險(xiǎn)記錄清單格式May2019GSKBS1-風(fēng)險(xiǎn)識(shí)別(編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述):通過魚骨圖對(duì)各個(gè)流程的風(fēng)險(xiǎn)進(jìn)行系統(tǒng)識(shí)別:Numberingprinciple:Finance(No:startwith1,1.1,1.2,….)Supply(No:startwith2,2.1,2.2,….)QA(No:startwith3,3.1,3.2,….)EHS(No:startwith4,4.1,4.2,….)People(No:startwith5,5.1,5.2,….)CI(No:startwith6,6.1,6.2,….)Process:refertoprocesslist-level3影響可能性評(píng)估編號(hào)流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述影響后果財(cái)務(wù)供應(yīng)EHSQA人員持續(xù)改進(jìn)當(dāng)前控制措施嚴(yán)重性1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值更新日期上報(bào)風(fēng)險(xiǎn)所有者分險(xiǎn)處理嚴(yán)重性

1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到行動(dòng)狀態(tài)、歷史風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控May2019GSKBS編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述失去商業(yè)利益和長(zhǎng)期生存能力合作者

環(huán)境政治TheftEarthquakeFloodDistributorsSuppliersContractorsFireSabotage社會(huì)、經(jīng)濟(jì)政府機(jī)構(gòu)InspectionsRegulatorsTaxesPopulationProfilePolicies,LawsPricecontrols商務(wù)

CompetitoractivityShiftincustomerPowerTechnologicalchangeAccidentalDisasteregcrash,environmental,lossofpowerlines,infrastructure….Epidemics外部風(fēng)險(xiǎn)JustforyourreferencesMay2019GSKBS編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述領(lǐng)導(dǎo)力、戰(zhàn)略、聲譽(yù)

可能影響沒有增長(zhǎng)失去聲譽(yù)訴訟

虧損銷售市場(chǎng)下降股東利益受損

無效率的管理模式業(yè)務(wù)發(fā)展無法滿足發(fā)展需要無效率的文化和工作氛圍失去聲譽(yù)、相關(guān)人失去信心PoorPRmanagementIrregularriskmanagementUncleardecisionmakingresponsibilities

LackofopennessQuality/Riskmanagementnotconsideredimportant

InsufficientactionandResolutionfollowupNoregulargovernancemeetings/agendasNo,wrongornotcommunicatedstrategy,vision

Noorwrongvolumeforecasts

NoexternalsensingofneedsPoorShadowoftheleaderNoconsistencyofmessageMissthebigpictureNoproactiveinvolvementWithstakeholdersDon’tkeepupwithNewrequirements/policiesPooremployeerelationships

Peoplesneedsnottakeintoaccount

Highstress/accidentsBlameculture–Issueshidden

Poorcommunication

Poormoralemotivation

Lackofmarketing’intelligence’ScopeforfutureBusinessopportunitiesnotconsidered

PoorReward/recognitionIEnotembeddedDon’twalkthetalkPoorfeedbackLackofaccountabilityActionsnotfollowedupPoorprocessmeasuresUnethicalpracticesAdverseeventFailuretomeetregulatorycomplianceMay2019GSKBS可能后果資產(chǎn)流失公司資源被誤用

壞帳1.3公司資產(chǎn)沒有很好管理1.1信息慢，不準(zhǔn)1.2不合規(guī)PoorcreditcontrolchangesinbusinesslawchangesintaxlawAssetregister/managementLowliquidityDebtcollectionCorruptionFraudNonexistentemployees,suppliers.Deliveries,customers,expensesCustoms&exciseLongcashtocashcycleDataandinformationmaintenanceInaccurateprojectcostingPoorprojectcostcontrolBudgetprocess/controlForecastaccuracyLostsales-tendersCostsofmaterialsnotunderstoodbyusersPayroll/Pensions-contractorsSupportofbusinessDecisionmakingDivisionofdutiesUnderinsuredTheftorassetsusedfornonbusinessuse財(cái)務(wù)MonthlyclosingStocktakingaccuracy編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述ShareserviceInventorycontrolShareserviceShareserviceMay2019供應(yīng)－計(jì)劃CriticalParametersnotunderstood可能后果供應(yīng)能力不能滿足需求物料、人無法完成生產(chǎn)計(jì)劃由于加班造成成本增加外包服務(wù)造成成本增加2.3供應(yīng)、訂單能力沒有平衡，或不能滿足成本、服務(wù)要求2.1客戶要求沒有轉(zhuǎn)為生產(chǎn)指令2.2不清楚供應(yīng)能力DemandnotlevelledBottlenecksnotidentified,managedLongleadtimesPlansnotbasedondemonstratedcapacitymaterialsHigh/lowinventoryForecastdemandnotVisible/highlyvariableLongleadtimesPatient,DoctorHospitalLogistics,Wholesaler,RetailerBrandstrategyPromotionsCSAsServicelevelsNotagreedDisruptive/UnsuccessfultendersInflexiblesupplyToohigh/lowContingencystocks/safetystocklevelsHighovertimeInaccurateBoMFinishedgoods,WIPWriteoffsStockoutsUnsupportedplansBOMrationalisationNoscenarioplanningSourcechanges(SUPPLIER)IncreasingcomplexityProductmixInsufficientcapacityHighutilisation編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述可能后果

產(chǎn)品質(zhì)量差造成返工、召回不合規(guī)造成不好的政府關(guān)系：產(chǎn)品收回、推遲批準(zhǔn).改進(jìn)措施沒有效果造成成本提高.3.1產(chǎn)品質(zhì)量和服務(wù)差

3.2不合規(guī)

PoorvalidationLowquality/highvariability ofmaterialDeviationfromSOPRework

Insufficientknowledge

Poorqualityculture/leadershipdoesnotputqualityfirstCriticaltoqualityparametersnotunderstoodEquipmentfailurePoormaterialsTrainingSOPnot‘inuse’

SOPsSpecs,MethodsToomanyOutofdatepoorInadequateresource

Specificationfailure3.3質(zhì)量基礎(chǔ)流程SloworincorrectBatchreleaseSloworpoorCAPAsPoordocumentcontrolNonapprovalofnewproductAdverseauditsorinspectionsComplaintsRecallsFailedorwrongmaterialusedPPRs–poorqualitydoesnotimproveprocesscapabilityValidation-highcost/statusnotmaintainedUncontrolledchangestomaterial,process,equipmentProductnotmadeinlinewithfilingDeviationsnotrootcausedQMSinplace–notinuseSlowfeedbackwhenprocessMovingoutofcontrollimits質(zhì)量編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述May2019GSKBS環(huán)境EnergyusageUseofnon-sustainableresourcesNewlegislationegcarbontaxWastemanagementReduce,Reuse,recycle,WaterusageEmissionsAirWaterHazardousmaterialsinformationContaminationGroundwaterLandAsbestosPCBsRadiationOdoursNoiseFirewater….EnvironmentalaccidentsBiodiversityLandusageErosion,infringementofhistoricareas,WildlifeSafety

Accidents:-atwork,travellingAlcohol/drugabuse4.2&4.3健康安全Stress/PoorworklifebalanceHighAbsenceAbsenceprocessProtectiveclothingPoorErgonomicsandJobdesignEquipmentnotused/PoorPoorsafetyAuditprocessPoor5S/housekeepingHighSoundlevelsPoorLightingAirqualityInfectiousdiseaseFlu

Insufficientknowledge

PoorEHSculture/leadershipdoesnotputEHSaspriority

SOPsSpecs,MethodsInadequateresourceAdverseauditsorinspectionsToomanyOutofdatepoor4.1不合規(guī)EHS可能后果

工傷事故不合規(guī)造成不好的政府關(guān)系編號(hào)+流程+風(fēng)險(xiǎn)名稱+風(fēng)險(xiǎn)描述May2019GSKBS為了進(jìn)行風(fēng)險(xiǎn)識(shí)別，應(yīng)有風(fēng)險(xiǎn)臺(tái)帳來更好幫助風(fēng)險(xiǎn)記錄清單的更新流程其中所有可能導(dǎo)致潛在細(xì)微風(fēng)險(xiǎn)的危害都應(yīng)記錄.May2019GSKBS風(fēng)險(xiǎn)評(píng)估:收集相關(guān)歷史數(shù)據(jù)＋當(dāng)前控制評(píng)估可能后果和可能的發(fā)生頻率評(píng)估風(fēng)險(xiǎn)重要性和優(yōu)先性風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控影響可能性評(píng)估編號(hào)流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述影響后果財(cái)務(wù)供應(yīng)EHSQA人員持續(xù)改進(jìn)當(dāng)前控制措施嚴(yán)重性1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值更新日期上報(bào)風(fēng)險(xiǎn)所有者分險(xiǎn)處理嚴(yán)重性

1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到行動(dòng)狀態(tài)、歷史May2019GSKBS后果嚴(yán)重性評(píng)估-財(cái)務(wù):potentialconsequences當(dāng)同一風(fēng)險(xiǎn)造成不同的后果，選高分May2019GSKBSpotentialconsequencesWhenoneriskhasdifferentlevelsconsequences,goforthehigherone后果嚴(yán)重性評(píng)估-供應(yīng):May2019GSKBSpotentialconsequencesWhenoneriskhasdifferentlevelsconsequences,goforthehigherone后果嚴(yán)重性評(píng)估-質(zhì)量:May2019GSKBSpotentialconsequencesWhenoneriskhasdifferentlevelsconsequences,goforthehigherone后果嚴(yán)重性評(píng)估-人員May2019GSKBSprobabilityofoccurrence可能性評(píng)估May2019GSKBSRiskindexvalue風(fēng)險(xiǎn)系數(shù)值優(yōu)先性高(Red):riskindexvalueinrange10-25+catastrophicrisks中度優(yōu)先(Amber):riskindexvalueinrange5-9低優(yōu)先(Green):riskindexvalueinrange1-4

后果嚴(yán)重性風(fēng)險(xiǎn)系數(shù)值= x

發(fā)生后果可能性Escalation向上匯報(bào):2級(jí)-工廠級(jí)別和工廠以上級(jí)別渠道:從部門向工廠匯報(bào)：每月管理會(huì)從工廠向總部匯報(bào)：月報(bào)和風(fēng)險(xiǎn)報(bào)告風(fēng)險(xiǎn)匯報(bào)消除評(píng)估+修改和制定風(fēng)險(xiǎn)消除計(jì)劃:影響可能性評(píng)估編號(hào)流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述影響后果財(cái)務(wù)供應(yīng)EHSQA人員持續(xù)改進(jìn)當(dāng)前控制措施嚴(yán)重性1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值更新日期上報(bào)風(fēng)險(xiǎn)所有者分險(xiǎn)處理嚴(yán)重性

1-5可能性1-5風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到行動(dòng)狀態(tài)、歷史風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控紅色風(fēng)險(xiǎn)必須有風(fēng)險(xiǎn)消除計(jì)劃，目的至少是將風(fēng)險(xiǎn)由紅色降為黃色黃色風(fēng)險(xiǎn)必須有風(fēng)險(xiǎn)消除計(jì)劃，目的至少是將風(fēng)險(xiǎn)由黃色降為綠色綠色風(fēng)險(xiǎn)不用有進(jìn)一步的整改行動(dòng)，但必須記錄，并且下一輪風(fēng)險(xiǎn)評(píng)估時(shí)重新評(píng)估到.

如何風(fēng)險(xiǎn)后果達(dá)到嚴(yán)重程度（5分），盡管可能性為罕見，必要在《持續(xù)運(yùn)營(yíng)計(jì)劃》中考慮消除評(píng)估+修改和制定風(fēng)險(xiǎn)消除計(jì)劃:May2019GSKBS指定專人負(fù)責(zé)(accountable)重要風(fēng)險(xiǎn)(redandamber)必須是部門負(fù)責(zé)人重大風(fēng)險(xiǎn)必須準(zhǔn)備STP-每月在部門會(huì)議上評(píng)估然后，重新評(píng)估風(fēng)險(xiǎn)系數(shù)值(Consequence,Likelihood,RiskIndexValue)日期題目形勢(shì)目標(biāo)建議狀態(tài)GivereasonforescalationEnsureSTPisstandalone(i.e.itmakessenseonitsown)Specifywhattheissue/opportunityisSpecifytheriskofdoingnothingSpecifywhatyouwanttoachieveSpecifyhowyouwillmeasurethatyouhaveachieveditEstimateanticipatedbenefitsDefinewhatwillbedone,bywhom,andbywhenEstimatecostsandresourcesrequiredSpecifythescopeoftheproposalandimpactSpecifywhatagreement/supportfromimpactedgroupsisneededorobtained原因Reason:問題Issue/可能性O(shè)pportunity:如果什么都不做風(fēng)險(xiǎn)是什么Riskofdoingnothing:目的Toachieve:衡量Measure:利益Benefits:什么What:誰Who:何時(shí)When:成本資源Costsandresources:范圍和影響Scopeandimpact:Agreement/supportfromimpactedgroups:消除評(píng)估+修改和制定風(fēng)險(xiǎn)消除計(jì)劃:實(shí)施計(jì)劃通過項(xiàng)目管理的方式對(duì)風(fēng)險(xiǎn)消除行動(dòng)計(jì)劃進(jìn)行管理依據(jù)計(jì)劃對(duì)進(jìn)展進(jìn)行監(jiān)控和審核CAPA監(jiān)控系統(tǒng)風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控內(nèi)部觸發(fā)外部觸發(fā)公司內(nèi)部審計(jì)發(fā)現(xiàn)的不符合項(xiàng)新法規(guī)、新藥典來自產(chǎn)品事故審核委員會(huì)的要求來自于供應(yīng)商、分銷商的變更（組織結(jié)果，所有者，財(cái)務(wù)，質(zhì)量法規(guī)）新產(chǎn)品，包括：新文號(hào)的申請(qǐng)政府檢查的重要不符合項(xiàng)技術(shù)轉(zhuǎn)移公眾觀念的變化組織結(jié)構(gòu)變更新技術(shù)出現(xiàn)定期產(chǎn)品回顧中的重大發(fā)現(xiàn)召回和重大產(chǎn)品事故的原因分析重大投資新廠房、擴(kuò)建供應(yīng)鏈變更，分銷商、供應(yīng)商風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識(shí)別風(fēng)險(xiǎn)評(píng)估消除評(píng)估修改和制定風(fēng)險(xiǎn)消除計(jì)劃實(shí)施計(jì)劃觸發(fā)審核和監(jiān)控當(dāng)任何觸發(fā)點(diǎn)出現(xiàn)，必須馬上更新風(fēng)險(xiǎn)記錄清單(riskregister)觸發(fā)點(diǎn)-重要變更May2019GSKBS組織/人員Organization/People流程Process流程描述ProcessDescription

ProcessSOPTrainingKPIRiskRespMaterial職責(zé)描述JobDescriptions人員目標(biāo)PeopleObjectives變更Change[QA027]原因Trigger

(項(xiàng)目Project,偏差Deviation,

審計(jì)發(fā)現(xiàn)Auditfinding,市場(chǎng)需求MarketRequest,數(shù)據(jù)分析KPIAnalysis,新機(jī)器Newmachine,…)分類Classification(R1,R2,Eng,Doc…)做Go/不做NoGo展開Roll-out結(jié)束Closure變更Change[沒有SOPnoSOP]原因Trigger

重組Re-organization