ISO22000-如何完成風(fēng)險評估課件

HowtocompleteaRiskAssessment

如何完成“風(fēng)險評估”？ISAChina培訓(xùn)課程1HowtocompleteaRiskAssessm風(fēng)險（Risk）vs.危害（Hazard）?風(fēng)險（Risk）：風(fēng)險通常為某危害（hazard）和危害發(fā)生的發(fā)生的可能（likelihood）的綜合結(jié)果。

『即：

Probability

xHazard=Risk』

發(fā)生的可能（likelihood）在這里可表達為概率（rate）或可能性（probability）。例如：空腸彎曲桿菌（Campylobacter）的風(fēng)險可以表述為每5年發(fā)生1次（likelihood）。危害（Hazard）：食品中含有或在某狀態(tài)下有潛在可能導(dǎo)致對健康的負(fù)面影響的某種生物、化學(xué)或物理物質(zhì)。2Properitary&Confidential風(fēng)險（Risk）vs.危害（Hazard）?風(fēng)險（Ris風(fēng)險評估（RiskAssessment）風(fēng)險分析（riskanalysis）：識別和降低風(fēng)險的結(jié)構(gòu)性目標(biāo)。風(fēng)險評估（riskassessment）：根據(jù)危害的暴露（程度），評價已知影響或負(fù)面影響。注：以上定義摘自BRCNon-GM標(biāo)準(zhǔn)。3Properitary&Confidential風(fēng)險評估（RiskAssessment）風(fēng)險分析（risk風(fēng)險評估的目的：識別潛在的危害；應(yīng)用適當(dāng)?shù)姆椒ǎ烙嬑：Πl(fā)生的可能（likelihood）和不確定性（uncertainty）；提供降低風(fēng)險的其他解決方案；估計上述解決方案的有效性；為風(fēng)險管理的決定提供信息；估計與分析相關(guān)的不確定性。4Properitary&Confidential風(fēng)險評估的目的：識別潛在的危害；4Properitary&風(fēng)險評估的程序和步驟：危害（hazard）識別；評估風(fēng)險的暴露和負(fù)面影響之間的關(guān)系；暴露的評估（exposureassessment）-評估導(dǎo)致風(fēng)險暴露的狀況；風(fēng)險特性描述（riskcharacterization）-描述負(fù)面影響（這里指危害）的類型、可能性及隱藏在這些描述后面證據(jù)的效力（通常使用可能性和數(shù)據(jù)來完成）。5Properitary&Confidential風(fēng)險評估的程序和步驟：危害（hazard）識別；5Prope怎樣估計風(fēng)險（Risk）？使用歷史數(shù)據(jù)；模型方式；如果手頭沒有數(shù)據(jù)，可將系統(tǒng)分解成子系統(tǒng)的方式，使用事件樹（eventtrees）或錯誤樹（faulttrees）等方式；模擬相似的狀況；或與類似行為比較。6Properitary&Confidential怎樣估計風(fēng)險（Risk）？使用歷史數(shù)據(jù)；6Properita風(fēng)險評估案例分析：某工廠生產(chǎn)烘培產(chǎn)品，在多年生產(chǎn)的基礎(chǔ)上，該工廠已經(jīng)完成危害分析和研究…7Properitary&Confidential風(fēng)險評估案例分析：某工廠生產(chǎn)烘培產(chǎn)品，在多年生產(chǎn)的基礎(chǔ)上，該風(fēng)險評估案例分析：543211

2345SeverityLikelihood8Properitary&Confidential風(fēng)險評估案例分析：543211

2345SeverityLi風(fēng)險評估案例分析（改進方案）：543211

2345SeverityLikelihood9Properitary&Confidential風(fēng)險評估案例分析（改進方案）：543211

2345Seve風(fēng)險評估案例分析：Riskdetermination:Withthediagramforriskdetermination,itisdeterminedifandhowthehazardhastobecontrolledforfoodsafety.Foreveryhazardthechance(Likelihood)thatthehazardoccurs,isdeterminedwiththe‘chancedeterminationtable’onthenextpage.Theeffect(severity)isdetermined(rightline)withthe‘effectdetermination’table.Bymultiplyingthechanceandtheeffect,theriskisquantifiedandthekindofcontrolisdetermined.Inthisway,anunderstandingforleveldifferencesisdeveloped,butquantifyingrisksisextremelydifficult.Iftheriskis9orless,controllingwithgeneralcontrolmeasuresorpreventionsareenough(PRPs).Iftheriskis10ormore,theriskhastobecontrolledbyaneffectivecontrolmeasure.TheCodexdecisiontreeisusedtodeterminetheCCPs.Ifthe3questionsareansweredwithNo,Yes,Yes,theriskiscontrolledbyaspecificmeasureinaspecificstepintheprocessanditiscalledaCCP(=CriticalControlPoint).10Properitary&Confidential風(fēng)險評估案例分析：Riskdetermination:10LikelihoodTermOntimebaseOnincidentbase5ProbablyPerday(s)>20incidents/year4ReasonablePerweek(s)11–20incidents/year3PossiblePermonth(s)4–11incidents/year2UnlikelyPeryear(s)1–3incidents/year1VeryunlikelyPer10year(s)<1incident/year11Properitary&ConfidentialLikelihoodTermOntimebaseOniSeriousnessTermRemarks5DisastrousSeverehealthinjuryordeathLargeamountofpeopleseriouslyill/injured4VeryseriousSeriousillnessorhospitalisedLargeamountofpersonsill3SeriousTeethdamageorvisittodoctorSeveralillnessespeopleLargeamountofunsatisfiedcustomers2LessseriousApersonisillorlightlyallergicSeveralunsatisfiedcustomers1SmallinconvenienceNoticeable,butnoharmfulonthehealthofpersonOnesinglecustomer12Properitary&ConfidentialSeriousnessTermRemarks5Disas如何確定“危害”

HazarddeterminationDiagramIsthepresenceofapotentialhazardinrawmaterialprobable?Isthepresenceofapotentialhazardinthelineortheenvironmentprobable?Isreduction,ifany,atafurtherstepadequate?(Significant)HAZARDIsanunacceptablelevel,survival,persistenceorincreaseatthisstepprobable?Isanunacceptablecontaminationatthisstepprobable?NoHazard*YESYESYESYESNoHazard**NONONONONOYES***Notahazardtobecontrolledatthisstep.**ReductionstepthusbecomesaCCP.13Properitary&Confidential如何確定“危害”

Hazarddetermination如何確定某可管理的CCP點－原料

HowtodetermineamanageableCCP?Q1.Isitlikelythattherawmaterialcontainsthehazardunderstudyatunacceptablelevels?Q2.Willprocessing,includingexpectedconsumeruse,eliminatethehazardorreduceittoanacceptablelevel?NotaCCPYESNONotaCCPYESRawmaterialmustberegardedasaCRITICALCONTROLPOINTforthishazard.NO14Properitary&Confidential如何確定某可管理的CCP點－原料

Howtodeterm如何確定某可管理的CCP點－加工過程

HowtodetermineamanageableCCP?Q3.Istheformulation/compositionorstructureoftheintermediateproduct/finalproductessentialforpreventing

thehazardunderstudyfromincreasingtounacceptablelevels?Q4.Isitlikelythat,atthisstep,ahazardwillbeintroducedoranexistinghazardwillincreasetounacceptablelevels?NotaCCPNOFormulation/compositionorstructureisaCRITICALCONTROLPOINTforthishazard.YESNOQ5.Willsubsequentprocessingsteps,includingexpected

consumeruse,guaranteeremovalofthehazardor

reductiontoanacceptablelevel?Q6.Istheprocessstepintendedtoeliminateorreducethehazardtoanacceptablelevel?ThisprocessstagemustberegardedasaCRITICALCONTROLPOINTforthishazard.YESYESNONotaCCPYESNO15Properitary&Confidential如何確定某可管理的CCP點－加工過程

HowtodeteNrProcessstepHazardKindControlmeasureLSRQ1Q2Q3CCPY/N……22DosageintoblueboxesBoxesarenotclean(FB)PInspectandcleanbeforeusing23623OrganizingofreworkNotcompetentoperatorsNoPR16Trainingonthejob22424MoisturecontentToohighToolowPoorsampletakingTimebetweenbakingandanalyzingtolargeGrindingnotstandardizedOperatornottrainedinmoistureanalyseEquipmentnotcalibratedMNoMMMMMCheckmoisturecontentPR16TrainingonthejobPR16TrainingonthejobBuyastandardizedgrinder(Retchmill)PR16TrainingonthejobPR143223224333331266966NYYCCP125TransportintosiloContaminatedwithFBPoorhygienePPMOpenprocess;generalcontrolmeasuresPR03,GMPaudits3243126NYN26SilostorageContaminatedwithFBHumidityofairtoohighWrongsiloPoorsiloidentificationRemainsofotherbiscuitsInfestationPMPPMPPOpenprocess;generalcontrolmeasuresMonitorhumidityandventilateextraifnecessaryPR09,identificationPR09,identificationPR03,visualinspectionPR05pestcontrol,GMPaudits3222324422131284436NYN……16Properitary&ConfidentialNrProcessstepHazardKindCo17Properitary&Confidential17Properitary&ConfidentialHowtocompleteaRiskAssessment

如何完成“風(fēng)險評估”？ISAChina培訓(xùn)課程18HowtocompleteaRiskAssessm風(fēng)險（Risk）vs.危害（Hazard）?風(fēng)險（Risk）：風(fēng)險通常為某危害（hazard）和危害發(fā)生的發(fā)生的可能（likelihood）的綜合結(jié)果。

『即：

Probability

xHazard=Risk』

發(fā)生的可能（likelihood）在這里可表達為概率（rate）或可能性（probability）。例如：空腸彎曲桿菌（Campylobacter）的風(fēng)險可以表述為每5年發(fā)生1次（likelihood）。危害（Hazard）：食品中含有或在某狀態(tài)下有潛在可能導(dǎo)致對健康的負(fù)面影響的某種生物、化學(xué)或物理物質(zhì)。19Properitary&Confidential風(fēng)險（Risk）vs.危害（Hazard）?風(fēng)險（Ris風(fēng)險評估（RiskAssessment）風(fēng)險分析（riskanalysis）：識別和降低風(fēng)險的結(jié)構(gòu)性目標(biāo)。風(fēng)險評估（riskassessment）：根據(jù)危害的暴露（程度），評價已知影響或負(fù)面影響。注：以上定義摘自BRCNon-GM標(biāo)準(zhǔn)。20Properitary&Confidential風(fēng)險評估（RiskAssessment）風(fēng)險分析（risk風(fēng)險評估的目的：識別潛在的危害；應(yīng)用適當(dāng)?shù)姆椒?，估計危害發(fā)生的可能（likelihood）和不確定性（uncertainty）；提供降低風(fēng)險的其他解決方案；估計上述解決方案的有效性；為風(fēng)險管理的決定提供信息；估計與分析相關(guān)的不確定性。21Properitary&Confidential風(fēng)險評估的目的：識別潛在的危害；4Properitary&風(fēng)險評估的程序和步驟：危害（hazard）識別；評估風(fēng)險的暴露和負(fù)面影響之間的關(guān)系；暴露的評估（exposureassessment）-評估導(dǎo)致風(fēng)險暴露的狀況；風(fēng)險特性描述（riskcharacterization）-描述負(fù)面影響（這里指危害）的類型、可能性及隱藏在這些描述后面證據(jù)的效力（通常使用可能性和數(shù)據(jù)來完成）。22Properitary&Confidential風(fēng)險評估的程序和步驟：危害（hazard）識別；5Prope怎樣估計風(fēng)險（Risk）？使用歷史數(shù)據(jù)；模型方式；如果手頭沒有數(shù)據(jù)，可將系統(tǒng)分解成子系統(tǒng)的方式，使用事件樹（eventtrees）或錯誤樹（faulttrees）等方式；模擬相似的狀況；或與類似行為比較。23Properitary&Confidential怎樣估計風(fēng)險（Risk）？使用歷史數(shù)據(jù)；6Properita風(fēng)險評估案例分析：某工廠生產(chǎn)烘培產(chǎn)品，在多年生產(chǎn)的基礎(chǔ)上，該工廠已經(jīng)完成危害分析和研究…24Properitary&Confidential風(fēng)險評估案例分析：某工廠生產(chǎn)烘培產(chǎn)品，在多年生產(chǎn)的基礎(chǔ)上，該風(fēng)險評估案例分析：543211

2345SeverityLikelihood25Properitary&Confidential風(fēng)險評估案例分析：543211

2345SeverityLi風(fēng)險評估案例分析（改進方案）：543211

2345SeverityLikelihood26Properitary&Confidential風(fēng)險評估案例分析（改進方案）：543211

2345Seve風(fēng)險評估案例分析：Riskdetermination:Withthediagramforriskdetermination,itisdeterminedifandhowthehazardhastobecontrolledforfoodsafety.Foreveryhazardthechance(Likelihood)thatthehazardoccurs,isdeterminedwiththe‘chancedeterminationtable’onthenextpage.Theeffect(severity)isdetermined(rightline)withthe‘effectdetermination’table.Bymultiplyingthechanceandtheeffect,theriskisquantifiedandthekindofcontrolisdetermined.Inthisway,anunderstandingforleveldifferencesisdeveloped,butquantifyingrisksisextremelydifficult.Iftheriskis9orless,controllingwithgeneralcontrolmeasuresorpreventionsareenough(PRPs).Iftheriskis10ormore,theriskhastobecontrolledbyaneffectivecontrolmeasure.TheCodexdecisiontreeisusedtodeterminetheCCPs.Ifthe3questionsareansweredwithNo,Yes,Yes,theriskiscontrolledbyaspecificmeasureinaspecificstepintheprocessanditiscalledaCCP(=CriticalControlPoint).27Properitary&Confidential風(fēng)險評估案例分析：Riskdetermination:10LikelihoodTermOntimebaseOnincidentbase5ProbablyPerday(s)>20incidents/year4ReasonablePerweek(s)11–20incidents/year3PossiblePermonth(s)4–11incidents/year2UnlikelyPeryear(s)1–3incidents/year1VeryunlikelyPer10year(s)<1incident/year28Properitary&ConfidentialLikelihoodTermOntimebaseOniSeriousnessTermRemarks5DisastrousSeverehealthinjuryordeathLargeamountofpeopleseriouslyill/injured4VeryseriousSeriousillnessorhospitalisedLargeamountofpersonsill3SeriousTeethdamageorvisittodoctorSeveralillnessespeopleLargeamountofunsatisfiedcustomers2LessseriousApersonisillorlightlyallergicSeveralunsatisfiedcustomers1SmallinconvenienceNoticeable,butnoharmfulonthehealthofpersonOnesinglecustomer29Properitary&ConfidentialSeriousnessTermRemarks5Disas如何確定“危害”

HazarddeterminationDiagramIsthepresenceofapotentialhazardinrawmaterialprobable?Isthepresenceofapotentialhazardinthelineortheenvironmentprobable?Isreduction,ifany,atafurtherstepadequate?(Significant)HAZARDIsanunacceptablelevel,survival,persistenceorincreaseatthisstepprobable?Isanunacceptablecontaminationatthisstepprobable?NoHazard*YESYESYESYESNoHazard**NONONONONOYES***Notahazardtobecontrolledatthisstep.**ReductionstepthusbecomesaCCP.30Properitary&Confidential如何確定“危害”

Hazarddetermination如何確定某可管理的CCP點－原料

HowtodetermineamanageableCCP?Q1.Isitlikelythattherawmaterialcontainsthehazardunderstudyatunacceptablelevels?Q2.Willprocessing,includingexpectedconsumeruse,eliminatethehazardorreduceittoanacceptablelevel?NotaCCPYESNONotaCCPYESRawmaterialmustberegardedasaCRITICALCONTROLPOINTforthishazard.NO31Properitary&Confidential如何確定某可管理的CCP點－原料

Howtodeterm如何確定某可管理的CCP點－加工過程

HowtodetermineamanageableCCP?Q3.Istheformulation/compositionorstructureoftheintermediateproduct/finalproductessentialforpreventing

thehazardunderstudyfromincreasingtounacceptablelevels?Q4.Isitlikelythat,atthisstep,ahazardwillbeintroducedoranexistinghazardwillincreasetounacceptablelevels?NotaCCPNOFormulation/compositionorstructureisaCRITICALCONTROLPOINTforthishazard.YESNOQ5.Willsubsequentprocessingsteps,includingexpected

consumeruse,guaranteeremovalofthehazardor

reductiontoanacceptablelevel?Q6.Istheprocessstepintendedtoeliminateorreducethehazardtoanacceptablelevel?ThisprocessstagemustberegardedasaCRITICALCONTROLPOINTforthishazard.YESYESNONotaCC