ISO22000-如何完成風(fēng)險評估

1、How to complete a Risk Assessment如何完成“風(fēng)險評估”？ISA China 培訓(xùn)課程1風(fēng)險（Risk）vs.危害（Hazard）?風(fēng)險（Risk）：風(fēng)險險通常為為某危害害（hazard）和危害害發(fā)生的的發(fā)生的的可能（likelihood）的綜合合結(jié)果。即：ProbabilityxHazard=Risk發(fā)生的可可能（likelihood）在這里可可表達(dá)為為概率（rate）或可能性（probability）。例如：空空腸彎曲曲桿菌（Campylobacter）的風(fēng)險險可以表表述為每每5年發(fā)生1次 （likelihood）。危害（Hazard）：食品品中含有有或在某某

2、狀態(tài)下下有潛在在可能導(dǎo)導(dǎo)致對健健康的負(fù)負(fù)面影響響的某種種生物、化學(xué)或或物理物物質(zhì)。2Properitary& Confidential風(fēng)險評估估（RiskAssessment）風(fēng)險分析析（riskanalysis）：識別別和降低低風(fēng)險的的結(jié)構(gòu)性性目標(biāo)。風(fēng)險評估估（riskassessment）：根據(jù)危危害的暴暴露（程程度），評價已已知影響響或負(fù)面面影響。注：以上上定義摘摘自BRCNon-GM標(biāo)準(zhǔn)。3Properitary& Confidential風(fēng)險評估估的目的的：識別潛在在的危害害；應(yīng)用適當(dāng)當(dāng)?shù)姆椒ǚǎ烙?jì)計(jì)危害發(fā)發(fā)生的可可能（likelihood）和不確確定性（uncertainty）；

3、提供降低低風(fēng)險的的其他解解決方案案；估計(jì)上述述解決方方案的有有效性；為風(fēng)險管管理的決決定提供供信息；估計(jì)與分分析相關(guān)關(guān)的不確確定性。4Properitary& Confidential風(fēng)險評估估的程序序和步驟驟：危害（hazard）識別；評估風(fēng)險險的暴露露和負(fù)面面影響之之間的關(guān)關(guān)系；暴露的評評估（exposureassessment）-評估導(dǎo)致致風(fēng)險暴暴露的狀狀況；風(fēng)險特性性描述（riskcharacterization）-描述負(fù)面面影響（這里指指危害）的類型型、可能能性及隱隱藏在這這些描述述后面證證據(jù)的效效力（通通常使用用可能性性和數(shù)據(jù)據(jù)來完成成）。5Properitary& Confide

4、ntial怎樣估計(jì)計(jì)風(fēng)險（Risk）？使用歷史史數(shù)據(jù)；模型方式式；如果手頭頭沒有數(shù)數(shù)據(jù)，可可將系統(tǒng)統(tǒng)分解成成子系統(tǒng)統(tǒng)的方式式，使用用事件樹樹（event trees）或錯錯誤樹（faulttrees）等方式式；模擬相似似的狀況況；或與類似行行為比較較。6Properitary& Confidential風(fēng)險評估估案例分分析：某工廠生生產(chǎn)烘培培產(chǎn)品，在多年年生產(chǎn)的的基礎(chǔ)上上，該工工廠已經(jīng)經(jīng)完成危危害分析析和研究究7Properitary& Confidential風(fēng)險評估估案例分分析：5432112345SeverityLikelihood8Properitary& Confidential風(fēng)險

5、評估估案例分分析（改改進(jìn)方案案）：5432112345SeverityLikelihood9Properitary& Confidential風(fēng)險評估估案例分分析：Risk determination:With thediagram forrisk determination, it is determinedifand howthehazard hastobecontrolled forfood safety.Foreveryhazard thechance(Likelihood)thatthehazard occurs,isdeterminedwith thechance determin

6、ationtable on thenext page.Theeffect(severity) is determined(right line) withthe effectdeterminationtable.Bymultiplyingthechance andtheeffect,theriskisquantified andthekindofcontrol is determined. In thisway,anunderstanding forleveldifferencesisdeveloped, butquantifyingrisksisextremelydifficult.Ifth

7、eriskis9 or less, controlling withgeneralcontrol measures or preventions areenough(PRPs).Iftheriskis10ormore,theriskhastobecontrolledbyaneffectivecontrolmeasure.TheCodexdecisiontreeisused to determinetheCCPs.If the3 questionsareansweredwithNo,Yes,Yes, therisk is controlledbyaspecificmeasure in aspec

8、ificstepintheprocessanditiscalled aCCP(=CriticalControl Point).10Properitary& ConfidentialLikelihoodTermOn time baseOn incident base5 ProbablyPer day(s) 20 incidents / year4 ReasonablePer week(s)11 20 incidents / year3 PossiblePer month(s)4 11 incidents / year2 UnlikelyPer year(s)1 3 incidents / yea

9、r1 Very unlikelyPer 10 year(s) 1 incident / year11Properitary& ConfidentialSeriousnessTermRemarks5 DisastrousSevere health injury or deathLarge amount of people seriously ill / injured4 Very seriousSerious illness or hospitalisedLarge amount of persons ill3 SeriousTeeth damage or visit to doctorSeve

10、ral illnesses peopleLarge amount of unsatisfied customers2 Less seriousA person is ill or lightly allergicSeveral unsatisfied customers1 Small inconvenienceNoticeable, but no harmful on the health of personOne single customer12Properitary& Confidential如何確定定“危害害”HazarddeterminationDiagramIsthepresenc

11、eofapotentialhazard in rawmaterialprobable?Isthepresenceofapotentialhazardinthe lineortheenvironmentprobable?Isreduction, if any,atafurtherstep adequate?(Significant) HAZARDIsanunacceptablelevel,survival,persistenceorincreaseatthis stepprobable?Isanunacceptablecontamination at thisstepprobable?NoHaz

12、ard*YESYESYESYESNoHazard*NONONONONOYES* Nota hazardtobecontrolled at thisstep.*Reductionstepthus becomesaCCP.13Properitary& Confidential如何確定定某可管管理的CCP點(diǎn)原料Howtodetermine amanageableCCP?Q1.Isitlikely thatthe rawmaterialcontainsthehazard under study at unacceptablelevels?Q2.Willprocessing,includingexpec

13、tedconsumeruse,eliminatethe hazardorreduceittoanacceptable level?NotaCCPYESNONotaCCPYESRawmaterialmustberegardedasa CRITICAL CONTROLPOINTfor thishazard.NO14Properitary& Confidential如何確定定某可管管理的CCP點(diǎn)加工過過程Howtodetermine amanageableCCP?Q3.Isthe formulation/composition or structureoftheintermediate produc

14、t/finalproductessentialfor preventingthehazard under study fromincreasingtounacceptablelevels?Q4.Isitlikely that, at thisstep,ahazardwillbeintroduced or an existing hazardwill increase to unacceptablelevels?NotaCCPNOFormulation/compositionorstructureisaCRITICALCONTROL POINT forthis hazard.YESNOQ5.Wi

15、llsubsequent processingsteps, includingexpectedconsumeruse, guaranteeremoval of thehazardorreductiontoanacceptablelevel?Q6.Isthe processstepintendedtoeliminateorreduce thehazardtoanacceptablelevel?This processstagemustberegardedasa CRITICAL CONTROLPOINTfor thishazard.YESYESNONotaCCPYESNO15Properitar

16、y& ConfidentialNr Process step Hazard Kind Control measure LSRQ1Q2Q3CCPY/N 22Dosage into blue boxesBoxes are not clean (FB)PInspect and clean before using23623Organizing of reworkNot competent operatorsNoPR16 Training on the job22424Moisture contentToo highToo lowPoor sample takingTime between bakin

17、g and analyzing to largeGrinding not standardizedOperator not trained in moisture analyseEquipment not calibratedMNoMMMMMCheck moisture contentPR16 Training on the jobPR16 Training on the jobBuy a standardized grinder (Retch mill)PR16 Training on the jobPR143223224333331266966NYYCCP125Transport into siloContaminated with FBPoor hygienePPMOpen process; general control measuresPR03, GMP audits3243126NYN26Silo storageContaminated with FBHumidity of air too highWrong siloPoor silo identificationRemains of other bis