《質(zhì)量風(fēng)險(xiǎn)管理》

1、.Global Industrial Operations.介紹風(fēng)險(xiǎn)管理系統(tǒng)要求和指南的來源背景GSK/GSK Bio 風(fēng)險(xiǎn)內(nèi)部控制和框架GSKBS 風(fēng)險(xiǎn)管理方法概況Global Industrial Operations.英國Turnbull指南公司丑聞 Enron, WorldCom, Parmalat, etc.美國塞班斯法案backgroundGlobal Industrial Operations.在應(yīng)該對公司的監(jiān)管，通過一系列的委員會審核和報(bào)告，變得愈來愈嚴(yán)格:-1992 Cadbury report （建立公司財(cái)務(wù)監(jiān)管標(biāo)準(zhǔn)）Use of board committeesSepar

2、ate roles of Chairman and Chief Executive1995 Greenbury report（對高管薪酬進(jìn)行管理）Disclosure of directors remuneration and compensation in company reports 1998 Hampel committee and report （要求公司制定內(nèi)部控制體系保障股東利益）Reviewed the Cadbury Code and its implementation, followed up on matters arising from Greenbury repor

3、tAddressed the role of shareholders and auditors in corporate governance issues1998 UK Listing Authority Combined Code14 Code Principles and 45 Code provisionsKey principle relates to boards maintenance of a sound system of internal controlCode provision references risk management 1999 Turnbull repo

4、rt Provides guidance on the internal control and internal audit provisions of the 1998 Combined Code Risk based approachbackgroundGlobal Industrial OperationsMay 2007.Companys internal control system should: be embedded within its operations and not be treated as a separate exercise be able to respo

5、nd to changing risks within and outside the company enable each company to apply it in an appropriate manner related to its key risksRequires companies to identify, evaluate and manage their significant risks and to assess the effectiveness of the related internal control systemBoard directors are t

6、o regularly review and annually assess on internal controls.backgroundGlobal Industrial OperationsMay 2007.Corporate MisstepsbackgroundGlobal Industrial OperationsMay 2007.The Sarbanes-Oxley Act provides a comparable rule in the US Management must assess annually the internal controls and procedures

7、 for financial reporting CEO must certify quarterly and annually that financial statements are fairly presented Independent auditors must attest to and report on managements assessment of internal controls.backgroundGlobal Industrial OperationsMay 2007.公司的響應(yīng)公司的響應(yīng):內(nèi)部的控制模式內(nèi)部的控制模式GSK RM overviewGlobal

8、Industrial OperationsMay 2007.控制的氛圍控制的氛圍風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理政策和規(guī)程政策和規(guī)程信息和溝通信息和溝通監(jiān)控監(jiān)控Five interrelated componentsGlobal Industrial OperationsMay 2007.控制的氛圍控制的氛圍風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理政策和規(guī)程政策和規(guī)程信息和溝通信息和溝通監(jiān)控監(jiān)控控制的氛圍控制的氛圍人人 正直誠信正直誠信 職業(yè)道德職業(yè)道德 能力能力運(yùn)營環(huán)境運(yùn)營環(huán)境Global Industrial OperationsMay 2007.控制的氛圍控制的氛圍風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理政策和規(guī)程政策和規(guī)程信息和溝通信息和溝通監(jiān)控監(jiān)

9、控政策、規(guī)程和標(biāo)準(zhǔn)政策、規(guī)程和標(biāo)準(zhǔn)公司公司 法律合規(guī)法律合規(guī)ITGMPGSK RM overviewGlobal Industrial OperationsMay 2007.控制的氛圍控制的氛圍風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理政策和規(guī)程政策和規(guī)程信息和溝通信息和溝通監(jiān)控監(jiān)控信息和溝通信息和溝通運(yùn)營、財(cái)務(wù)和合規(guī)報(bào)告運(yùn)營、財(cái)務(wù)和合規(guī)報(bào)告溝通流程溝通流程教育和培訓(xùn)教育和培訓(xùn)Global Industrial OperationsMay 2007.控制的氛圍控制的氛圍風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理政策和規(guī)程政策和規(guī)程信息和溝通信息和溝通監(jiān)控監(jiān)控監(jiān)控監(jiān)控管理者審核管理者審核審計(jì)審計(jì)Global Industrial Operatio

10、nsMay 2007.Control EnvironmentRisk ManagementPolicies and ProceduresInformation and CommunicationMonitoring風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)管理組織框架組織框架Global Industrial OperationsMay 2007.3.1 GeneralAll managers have responsibility and accountability for managing the risks arising intheir areas of responsibility.The focus of t

11、his policy is on risks of failing to comply with legal requirements (e.g.,quality/GMP requirements in manufacturing, or anti-competitive laws in sales andmarketing ); and financial, operational and reputational risks which could be significantto GSK (e.g., a recall or supply failure of a major produ

12、ct). These are referred tocollectively as “Significant Risks.”Policy Excerpts:Policy HighlightsGSK Policy POL-GSK-500 Risk Management and Legal ComplianceApproved in 2001GSK RM overviewGlobal Industrial OperationsMay 2007.Policy Excerpts:Policy HighlightsGSK Policy POL-GSK-500 Risk Management and Le

13、gal ComplianceApproved in 2001GSK RM overviewGlobal Industrial OperationsMay 2007.3.3 Internal Control FrameworkWhile line management has responsibility for implementing effective internalcontrols for risk management and legal compliance, GSK has also established anInternal Control Framework to ensu

14、re that Significant Risks are reviewed andmonitored and that specific issues and incidents (e.g. a compliance failure) arefollowed up and corrected.Policy Excerpts:Policy HighlightsGSK Policy POL-GSK-500 Risk Management and Legal ComplianceApproved in 2001GSK RM overviewGlobal Industrial OperationsM

15、ay 2007.董事會審計(jì)委員會風(fēng)險(xiǎn)監(jiān)管和合規(guī)委員會商業(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)查識別評估潛在風(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Global Industrial OperationsMay 2007.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)證建立面對審計(jì)的信心

16、但不是為了幫偏離和缺陷找理由Global Industrial OperationsMay 2007.Global Industrial OperationsMay 2007.This is cute, butGlobal Industrial OperationsMay 2007.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。可能性：暴露在危險(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）What is risk?Global Industrial O

17、perationsMay 2007.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)定義風(fēng)險(xiǎn)定義Global Industrial OperationsMay 2007.預(yù)算運(yùn)營計(jì)劃工廠戰(zhàn)略審工廠戰(zhàn)略審核核評估部門風(fēng)評估部門風(fēng)險(xiǎn)險(xiǎn)評估工廠評估工廠風(fēng)險(xiǎn)風(fēng)險(xiǎn)Top Down 更新計(jì)劃預(yù)算更新計(jì)劃預(yù)算 實(shí)施實(shí)施計(jì)劃計(jì)劃BCP工廠驗(yàn)證主計(jì)劃風(fēng)險(xiǎn)清單優(yōu)先級分類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Global Industrial OperationsMay 200

18、7.風(fēng)險(xiǎn)管理工具風(fēng)險(xiǎn)管理工具:工藝流程清單初步危害分析 Preliminary Hazard Analysis (PHA)Hazard Analysis of Critical Control Points (HACCP)Hazard Operability Analysis (HAZOP)Fault tree analysis (FTA)Failure Mode Effects and Analysis (FMEA)Failure Mode Effects and criticality Analysis (FMECA)Risk ranking and FilteringInformal r

19、isk managementGlobal Industrial OperationsMay 2007.Areas for likely impactNo.ProcessRisk NameDescription of Potential Risk Impact FinanceSupplyEHSQAPeopleCICurrent Control MechanismsConsequence 1-5Likelihood 1-5Risk Index ValueDate last reviewedEscalate ToRisk OwnerRisk TreatmentConsequence 1-5Likel

20、ihood 1-5Risk Index ValuePlanned Risk ReductionACTIONSTATUS/HISTORY風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控風(fēng)險(xiǎn)記錄清單格式Global Industrial OperationsMay 2007.1-風(fēng)險(xiǎn)識別風(fēng)險(xiǎn)識別 (編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述):通過魚骨圖對各個(gè)流程的風(fēng)險(xiǎn)進(jìn)行系統(tǒng)識別通過魚骨圖對各個(gè)流程的風(fēng)險(xiǎn)進(jìn)行系統(tǒng)識別:Numbering principle:F

21、inance (No: start with 1, 1.1, 1.2, . )Supply (No: start with 2, 2.1, 2.2, . )QA (No: start with 3, 3.1, 3.2, . )EHS (No: start with 4, 4.1, 4.2, . )People (No: start with 5, 5.1, 5.2, . )CI (No: start with 6, 6.1, 6.2, . )Process: refer to process list-level 3影響可能性評估影響可能性評估編號編號流程流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述影

22、響后果影響后果財(cái)務(wù)財(cái)務(wù)供應(yīng)供應(yīng)EHSQA人員人員持續(xù)改進(jìn)持續(xù)改進(jìn)當(dāng)前控制措施當(dāng)前控制措施嚴(yán)重性嚴(yán)重性 1-5可能性可能性 1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值更新日期更新日期上報(bào)上報(bào)風(fēng)險(xiǎn)所有者風(fēng)險(xiǎn)所有者分險(xiǎn)處理分險(xiǎn)處理嚴(yán)重性嚴(yán)重性 1-5可能性可能性1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到到行動(dòng)狀態(tài)、歷史行動(dòng)狀態(tài)、歷史風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控Global Industrial OperationsMay 2007.編號編號 + 流程流程 + 風(fēng)險(xiǎn)

23、名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述失去商業(yè)利益失去商業(yè)利益和長期生存能和長期生存能力力合作者合作者 環(huán)境環(huán)境政治政治TheftEarthquakeFloodDistributorsSuppliersContractorsFireSabotage社會、經(jīng)濟(jì)社會、經(jīng)濟(jì)政府機(jī)構(gòu)政府機(jī)構(gòu)InspectionsRegulatorsTaxesPopulation Profile Policies, LawsPrice controls商務(wù)商務(wù) Competitor activityShift in customer Power Technological changeAccidental Disaster

24、eg crash , environmental, loss of power lines, infrastructure .Epidemics外部風(fēng)險(xiǎn)外部風(fēng)險(xiǎn)Just for your referencesGlobal Industrial OperationsMay 2007.編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述領(lǐng)導(dǎo)力、戰(zhàn)略、聲譽(yù)領(lǐng)導(dǎo)力、戰(zhàn)略、聲譽(yù) 可能影響可能影響沒有增長沒有增長失去聲譽(yù)失去聲譽(yù)訴訟訴訟 虧損虧損銷售市場下降銷售市場下降股東利益受損股東利益受損 無效率的管理模式無效率的管理模式業(yè)務(wù)發(fā)展無法滿足發(fā)展需要業(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

25、圍無效率的文化和工作氛圍失去聲譽(yù)、相關(guān)人失去信心失去聲譽(yù)、相關(guān)人失去信心Poor PR management Irregular risk management Unclear decision making responsibilities Lack of opennessQuality / Risk management not considered important Insufficient action and Resolution follow up No regular governance meetings/ agendas No, wrong or not communica

26、ted strategy, vision No or wrong volume forecasts No external sensing of needsPoor Shadow of the leaderNo consistency of messageMiss the big pictureNo proactive involvement With stakeholdersDont keep up with New requirements/ policiesPoor employee relationships Peoples needs not take into account Hi

27、gh stress / accidents Blame culture Issues hidden Poor communication Poor morale motivation Lack of marketing intelligenceScope for future Business opportunities not considered Poor Reward / recognition IE not embeddedDont walk the talkPoor feedback Lack of accountabilityActions not followed upPoor

28、process measuresUnethical practices Adverse eventFailure to meet regulatory complianceGlobal Industrial OperationsMay 2007.可能后果可能后果資產(chǎn)流失資產(chǎn)流失公司資源被誤用公司資源被誤用 壞帳壞帳1.3 公司資產(chǎn)沒有很好管理公司資產(chǎn)沒有很好管理1.1 信息慢，不準(zhǔn)信息慢，不準(zhǔn)1.2 不合規(guī)不合規(guī)Poor credit controlchanges in business lawchanges in tax lawAsset register / managementLow l

29、iquidityDebt collectionCorruption FraudNon existent employees, suppliers . Deliveries, customers , expensesCustoms & exciseLong cash to cash cycleData and information maintenanceInaccurate project costingPoor project cost controlBudget process /controlForecast accuracyLost sales - tenders Costs of m

30、aterials not understood by usersPay roll / Pensions -contractorsSupport of businessDecision makingDivision of dutiesUnder insuredTheft or assets used for non business use財(cái)務(wù)財(cái)務(wù)Monthly closing Stock taking accuracy編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述Share serviceInventory controlShare serviceShare serviceG

31、lobal Industrial Operations.供應(yīng)供應(yīng) 計(jì)劃計(jì)劃Critical Parameters not understood可能后果可能后果供應(yīng)能力不能滿足需求供應(yīng)能力不能滿足需求物料、人無法完成生產(chǎn)計(jì)劃物料、人無法完成生產(chǎn)計(jì)劃由于加班造成成本增加由于加班造成成本增加外包服務(wù)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、供應(yīng)、訂單能力沒有平衡，或不能滿足成本、服務(wù)要求服務(wù)要求2.1 客戶要求沒有轉(zhuǎn)為生產(chǎn)指令客戶要求沒有轉(zhuǎn)為生產(chǎn)指令2.2 不清楚供應(yīng)能力不清楚供應(yīng)能力Demand not levelledBottlenecks not iden

32、tified, managedLong lead timesPlans not based on demonstrated capacity materials High /low inventoryForecast demand not Visible/ highly variableLong lead timesPatient, Doctor HospitalLogistics, Wholesaler,Retailer Brand strategyPromotionsCSAsService levelsNot agreedDisruptive/Unsuccessful tendersInf

33、lexible supplyToo high /low Contingency stocks/safety stock levelsHigh overtimeInaccurate BoMFinished goods, WIPWrite offsStock outsUnsupported plansBOM rationalisationNo scenario planningSource changes (SUPPLIER)Increasing complexityProduct mixInsufficient capacityHigh utilisation編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱

34、風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述Global Industrial OperationsMay 2007.可能后果可能后果 產(chǎn)品質(zhì)量差造成返工、產(chǎn)品質(zhì)量差造成返工、召回召回不合規(guī)造成不好的政府不合規(guī)造成不好的政府關(guān)系：產(chǎn)品收回、推遲關(guān)系：產(chǎn)品收回、推遲批準(zhǔn)批準(zhǔn). 改進(jìn)措施沒有效果造成改進(jìn)措施沒有效果造成成本提高成本提高. 3.1 產(chǎn)品質(zhì)量和服務(wù)差產(chǎn)品質(zhì)量和服務(wù)差 3.2 不合規(guī)不合規(guī) Poor validationLow quality/ high variability of materialDeviation from SOPRework Insufficient knowledge Poor

35、 quality culture / leadership does not put quality firstCritical to quality parameters not understoodEquipment failurePoor materialsTrainingSOP not in use SOPsSpecs, MethodsToo manyOut of datepoorInadequate resource Specification failure3.3 質(zhì)量基礎(chǔ)流程質(zhì)量基礎(chǔ)流程Slow or incorrect Batch releaseSlow or poor CAP

36、As Poor document controlNon approval of new product Adverse audits or inspections Complaints RecallsFailed or wrong material usedPPRs poor quality does not improve process capability Validation - high cost / status not maintained Uncontrolled changes to material, process, equipment Product not made

37、in line with filingDeviations not root causedQMS in place not in useSlow feedback when processMoving out of control limits質(zhì)量質(zhì)量編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述Global Industrial OperationsMay 2007.環(huán)境Energy usageUse of non-sustainable resourcesNew legislation eg carbon taxWaste managementReduce, Reuse,

38、recycle,Water usageEmissionsAirWaterHazardous materialsinformationContaminationGroundwaterLandAsbestosPCBsRadiation OdoursNoiseFire water.Environmental accidentsBio diversity Land usage Erosion , infringement of historic areas, Wild lifeSafety Accidents:- at work , travellingAlcohol / drug abuse4.2

39、& 4.3 健康安全健康安全Stress / Poor work life balanceHighAbsenceAbsence processProtectiveclothingPoor Ergonomics and Job designEquipment not used/PoorPoor safety Audit processPoor 5S/ housekeepingHigh Sound levelsPoor LightingAir qualityInfectious diseaseFlu Insufficient knowledge Poor EHS culture / leaders

40、hip does not put EHS as priority SOPsSpecs, MethodsInadequate resourceAdverse audits or inspections Too manyOut of datepoor4.1 不合規(guī)不合規(guī)EHS可能后果可能后果 工傷事故工傷事故不合規(guī)造成不好的政府不合規(guī)造成不好的政府關(guān)系關(guān)系編號編號 + 流程流程 + 風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱+ 風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述Global Industrial OperationsMay 2007.為了進(jìn)行風(fēng)險(xiǎn)識別，應(yīng)有風(fēng)險(xiǎn)臺帳來更好為了進(jìn)行風(fēng)險(xiǎn)識別，應(yīng)有風(fēng)險(xiǎn)臺帳來更好幫助風(fēng)險(xiǎn)記錄清單的更新流程幫助風(fēng)險(xiǎn)記

41、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)記錄應(yīng)記錄. .Global Industrial OperationsMay 2007.風(fēng)險(xiǎn)評估:收集相關(guān)歷史數(shù)據(jù) 當(dāng)前控制評估可能后果和可能的發(fā)生頻率1.評估風(fēng)險(xiǎn)重要性和優(yōu)先性風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控影響可能性評估影響可能性評估編號編號流程流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述影響后果影響后果財(cái)務(wù)財(cái)務(wù)供應(yīng)供應(yīng)EHSQA人員人員持續(xù)改進(jìn)持續(xù)改進(jìn)當(dāng)前控制措施當(dāng)前控制措施

42、嚴(yán)重性嚴(yán)重性 1-5可能性可能性 1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值更新日期更新日期上報(bào)上報(bào)風(fēng)險(xiǎn)所有者風(fēng)險(xiǎn)所有者分險(xiǎn)處理分險(xiǎn)處理嚴(yán)重性嚴(yán)重性 1-5可能性可能性1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到到行動(dòng)狀態(tài)、歷史行動(dòng)狀態(tài)、歷史Global Industrial OperationsMay 2007.后果嚴(yán)重性評估-財(cái)務(wù):potential consequences當(dāng)同一風(fēng)險(xiǎn)造成不同的后果，選高分Global Industrial OperationsMay 2007.potential consequencesWhen one risk has different levels

43、 consequences, go for the higher one后果嚴(yán)重性評估-供應(yīng):Global Industrial OperationsMay 2007.potential consequencesWhen one risk has different levels consequences, go for the higher one后果嚴(yán)重性評估-質(zhì)量:Global Industrial OperationsMay 2007.potential consequencesWhen one risk has different levels consequences, go fo

44、r the higher one后果嚴(yán)重性評估-人員Global Industrial OperationsMay 2007.probability of occurrence可能性評估Global Industrial Operations.Risk index value風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值優(yōu)先性高優(yōu)先性高 (Red): risk index value in range 10-25+catastrophic risks中度優(yōu)先中度優(yōu)先(Amber): risk index value in range 5-9低優(yōu)先低優(yōu)先(Green): risk index value in range

45、 1-4后果嚴(yán)重性風(fēng)險(xiǎn)系數(shù)值= x 發(fā)生后果可能性Global Industrial Operations.Escalation向上匯報(bào): 2 級- 工廠級別 和 工廠以上級別渠道:從部門向工廠匯報(bào)：每月管理會從工廠向總部匯報(bào)：月報(bào)和風(fēng)險(xiǎn)報(bào)告風(fēng)險(xiǎn)匯報(bào)風(fēng)險(xiǎn)匯報(bào)Global Industrial Operations.消除評估 + 修改和制定風(fēng)險(xiǎn)消除計(jì)劃:影響可能性評估影響可能性評估編號編號流程流程風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)名稱風(fēng)險(xiǎn)描述風(fēng)險(xiǎn)描述影響后果影響后果財(cái)務(wù)財(cái)務(wù)供應(yīng)供應(yīng)EHSQA人員人員持續(xù)改進(jìn)持續(xù)改進(jìn)當(dāng)前控制措施當(dāng)前控制措施嚴(yán)重性嚴(yán)重性 1-5可能性可能性 1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值更新日期更新日期上報(bào)

46、上報(bào)風(fēng)險(xiǎn)所有者風(fēng)險(xiǎn)所有者分險(xiǎn)處理分險(xiǎn)處理嚴(yán)重性嚴(yán)重性 1-5可能性可能性1-5風(fēng)險(xiǎn)系數(shù)值風(fēng)險(xiǎn)系數(shù)值計(jì)劃風(fēng)險(xiǎn)系數(shù)值降計(jì)劃風(fēng)險(xiǎn)系數(shù)值降到到行動(dòng)狀態(tài)、歷史行動(dòng)狀態(tài)、歷史風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控Global Industrial OperationsMay 2007.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)評估時(shí)重新評估到. 如何風(fēng)

47、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)營計(jì)劃中考慮消除評估消除評估 + 修改和制定風(fēng)險(xiǎn)消除計(jì)劃修改和制定風(fēng)險(xiǎn)消除計(jì)劃:Global Industrial Operations.指定專人負(fù)責(zé)(accountable)重要風(fēng)險(xiǎn) (red and amber)必須是部門負(fù)責(zé)人重大風(fēng)險(xiǎn)必須準(zhǔn)備 STP- 每月在部門會議上評估然后，重新評估風(fēng)險(xiǎn)系數(shù)值(Consequence, Likelihood, Risk Index Value)日期日期題目題目形勢形勢目標(biāo)目標(biāo)建議建議狀態(tài)狀態(tài)Give reason for escalationEnsure STP is standalone (

48、i.e. it makes sense on its own)Specify what the issue/opportunity isSpecify the risk of doing nothingSpecify what you want to achieveSpecify how you will measure that you have achieved itEstimate anticipated benefitsDefine what will be done, by whom, and by whenEstimate costs and resources requiredS

49、pecify the scope of the proposal and impactSpecify what agreement/support from impacted groups is needed or obtained 原因原因Reason: 問題問題Issue/可能性可能性O(shè)pportunity:如果什么都不做風(fēng)險(xiǎn)是什么如果什么都不做風(fēng)險(xiǎn)是什么 Risk of doing nothing:目的目的To achieve:衡量衡量Measure:利益利益Benefits:什么什么What:誰誰Who:何時(shí)何時(shí)When:成本資源成本資源Costs and resources:范圍和影

50、響范圍和影響Scope and impact:Agreement/support from impacted groups:消除評估消除評估 + 修改和制定風(fēng)險(xiǎn)消除計(jì)劃修改和制定風(fēng)險(xiǎn)消除計(jì)劃:Global Industrial Operations.實(shí)施計(jì)劃通過項(xiàng)目管理的方式對風(fēng)險(xiǎn)消除行動(dòng)計(jì)劃進(jìn)行管理依據(jù)計(jì)劃對進(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)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控Global Industrial Operations.內(nèi)部觸發(fā)內(nèi)部觸發(fā)外部觸發(fā)外部觸

51、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：新文號的申請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)管理流程圖風(fēng)險(xiǎn)識風(fēng)險(xiǎn)識別別風(fēng)險(xiǎn)評風(fēng)險(xiǎn)評估估消除評消除評估估修改和制定修改和制定風(fēng)險(xiǎn)消除計(jì)風(fēng)險(xiǎn)消除計(jì)劃劃實(shí)施計(jì)實(shí)施計(jì)劃劃觸發(fā)觸發(fā)審核和監(jiān)審核和監(jiān)控控Global Industrial OperationsMay 2007.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

52、單 (risk register).組織/人員Organization/People流程Process流程描述流程描述Process DescriptionProcess SOP Training KPI Risk Resp Material職責(zé)描述職責(zé)描述JobDescriptions人員目標(biāo)人員目標(biāo)People Objectives變更變更Change QA027原因原因Trigger (項(xiàng)目Project, 偏差Deviation, 審計(jì)發(fā)現(xiàn)Audit finding, 市場需求Market Request, 數(shù)據(jù)分析KPI Analysis, 新機(jī)器New machine, )分類分類Classi