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FDA水产品HACCP法规-21CFR123,1240FDA水产品HACCP法规•SubpartA–Definitions定义–GoodManufacturingPractices（GMP）–HazardAnalysis&HazardAnalysisCriticalControlPointplan（HACCP计划）–CorrectiveActions纠正措施–Verification验证–Records记录–Training培训–Sanitation卫生（SSOP）–RequirementsofImportedProducts对进口产品的要求FDA水产品HACCP法规•SubpartB-SmokedFish烟熏鱼FDA水产品HACCP法规•SubpartC-RawMolluscanShellfish生的软体贝类FDA水产品HACCP法规•HACCP只适用于:食品安全的危害FDA水产品HACCP法规•SubpartA适用于所有加工者FDA水产品HACCP法规•不受法规制约的设施:•–FishingVessels捕捞船–TransportationVehicles运输工具–RetailEstablishments,IncludingRestaurants包括餐馆在内的零售设施FDA水产品HACCP法规•Definitions:–Processing加工-Handling,storing,preparing,heading,eviscerating,shucking,freezing,changingform,manufacturing,preserving,packing,labeling,docksideunloading,orholding.FDA水产品HACCP法规•Definitions:–Fish水产-allformsofaquaticanimallifeintendedforhumanconsumption;includingamphibians,mollusks,androe.FDA水产品HACCP法规•Definitions:–FisheryProducts水产制品-anyhumanfoodproductinwhichfishisthecharacterizingingredient.FDA水产品HACCP法规•GoodManufacturingPractices(GMP’s)–TiesGMP’sHACCPregulationsFDA水产品HACCP法规•IncludesallsevenprinciplesofHACCP七个原则或原理::–ConductingaHazardAnalysis危害分析–IdentifyingCriticalControlPoints(CCP)确定关键控制点–EstablishingCriticalLimits建立关键限值–MonitoringEachCCP监测每个CCP点–EstablishingCorrectiveActionstobeTakenWhenaCriticalLimitDeviationOccurs纠正措施–EstablishingaRecord-KeepingSystem记录保持系统–EstablishingVerificationProcedures验证程序FDA水产品HACCP法规•Conductingahazardanalysis:–Aretherefoodsafetyhazardsassociatedwithmyproductthatarereasonablylikelytooccur?–AretherepreventativemeasuresthatIcanapplytocontrolthesehazards?Hazardsaredefinedasphysical,microbiologicaland/orchemical物理、化学与生物危害FDA水产品HACCP法规•Hazardmustbeonethatisreasonablylikelytooccur极可能发生的危害FDA水产品HACCP法规•Noonewaytodoahazardanalysis进行危害分析的途径很多•BecertaintousetheGuide一定要使用《指南》Nohazards-NoHACCPplanisnecessary没有（显著）危害，就不需要HACCP计划FDA水产品HACCP法规•TheHACCPPlan–EachLocation–EachProductHACCP计划是针对于每一个加工地点、每一种产品FDA水产品HACCP法规•HACCP计划必须包括:–TheFoodSafetyHazard食品安全危害–TheCriticalControlPointsofEachHazard每一个危害的关键控制点–TheCriticalLimits关键限值–TheMonitoringProcedures监测程序–TheRequiredRecords要求的记录–ACorrectiveAction纠正措施–TheVerificationProcedures验证程序FDA水产品HACCP法规•HACCPPlan-Hazardstobeconsidered要考虑到的危害:–NaturalToxins天然毒素–Microbiological微生物–ChemicalPesticides化学杀虫剂（农药）–DrugResidues药物（兽药）残留–UnapprovedUsesofFoodandColorAdditives未经批准使用的食品添加剂和色素–PhysicalHazards物理的危害–DecompositionRelatedtoSafety与安全有关的腐败FDA水产品HACCP法规•HACCPPlan-CriticalControlPointsandCriticalLimits:–CriticalControlPoints关键控制点-Apointinprocessingwherecontrolsneedtobeinplace–CriticalLimits关键限值-Alimitexpressedasavalue(i.e.timeortemperature)listedatacriticalcontrolpoint.FDA水产品HACCP法规•MonitoringProcedures监测程序:–WhatWillBeMonitored监测什么？–HowWillMonitoringBeDone怎样监测？–FrequencyofMonitoring监测频率、时间？–Who?谁负责监测？–Where?在哪监测？FDA水产品HACCP法规•CorrectiveAction-Predetermined预先确定好的纠正措施:–CorrectiveActionPlans纠正措施计划FDA水产品HACCP法规•Verification验证-Reassessment重新评估:–VerifyPlansNoLessThanOnceAYear验证HACCP计划每年至少一次FDA水产品HACCP法规•Verification-ListChanges以下改变必须验证:–RawMaterialsorSourcesofRawMaterials原料或原料来源–ProductFormulation产品配方–ProcessingMethodsorSystems加工方法或系统–FinishedProductDistribution成品的配发–IntendedUseoftheFinishedProductbyConsumers消费者对成品预期用途FDA水产品HACCP法规•Verification-VerifyingPerformance验证的措施:–ConsumerComplaints消费者投诉–CalibratingInstruments(i.e.,thermometers)校准仪器–Testing检测–ReviewingRecords审核记录FDA水产品HACCP法规•Verification-ReassessHazardAnalysis重新评估危害分析:–ReassessHazardAnalysis-WheneverThereIsaChange一旦有改变，就必须重新进行危害分析。FDA水产品HACCP法规•Records-Types文件记录的类型:–HACCPPlanHACCP计划–MonitoringRecords监测记录–CorrectiveActionRecords纠偏记录–VerificationMeasures验证记录–SanitationRecords卫生方面的记录–ImporterVerificationRecords进口商验证记录FDA水产品HACCP法规•Records-RequiredInformation记录的信息:–NameandLocationofProcessororImporter加工者或进口商的名称和地点–DateandTimeofActivityBeingRecorded被记录活动的日期和时间–SignatureorInitialsofPersonMakingRecord记录人员的签名–ProductIdentityandCode(whenappropriate)产品名称和代码FDA水产品HACCP法规•Records-Retention记录保留的时间:–RefrigeratedProducts-1Year冷藏产品一年–FrozenProducts-2Years冷冻产品二年FDA水产品HACCP法规•Records-Access:–FDAHasAccesstoHACCPRecordsandPlansandmaycopythem(fordomesticprocessors)–FDAHasAccesstoImporterRecordsFDA有权检查有关记录，并进行复印。FDA水产品HACCP法规•PlanContents(复习)HHACCP计划的内容包括：–Hazards危害–CriticalControlPoints关键控制点–CriticalLimits关键限值–CorrectiveActions纠正措施–Records记录–Verification验证FDA水产品HACCP法规•Training-Options培训方面的要求:–TraininginHACCP参加相当的培训–On-TheJobExperience有一定工作经验“TheSeafoodHACCPAlliance”美国水产品HACCP联盟FDA水产品HACCP法规•Training-Choices:–OneTrainedEmployee工作人员参加培训–TrainedConsultant请培训过的专家顾问FDA水产品HACCP法规•Training-IndividualShall下列工作必须要有一定资格的人员来进行:–DeveloporAmendtheHACCPPlan制订或修改HACCP计划–Reassessand/orModifytheHACCPPlan重新评估、修改HACCP计划–ReassessandModifytheHazardAnalysis重新评估和修改危害分析–ReviewAllRecords审核所有的记录FDA水产品HACCP法规•Sanitation-PrerequisitHACCP的前提条件:PrerequisitetoHACCP–Monitoring监测–Records记录–Corrections纠偏FDA水产品HACCP法规•Sanitation-8Areas:SSOP至少包括8个方面–SafetyofWaterThatComesinContactWithFood,FoodContactSurfaces,orUsedtoMakeIce–ConditionofFoodContactSurfaces–PreventionofCrossContamination–ExclusionofPests–Main