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1、IntertekTestingServices第第一一章章 危危 害害IntertekTestingServicesAbiological,chemicalorphysicalagentin,orconditionof,foodwiththepotentialtocauseanadversehealtheffect是存在于食品中导致人体健康危害的生是存在于食品中导致人体健康危害的生物,化学或物理应许因素。物,化学或物理应许因素。(CODEXdefinition法典委员会定义法典委员会定义).Hazards (Food Safety)危害危害(食品平安食品平安)IntertekTestingSe
2、rvices1.Biological生物的生物的2.Chemical化学的化学的3.Physical物理的物理的Allergens&Prionsfromthesegroupsarenowofconcernandwillbedealtwithinthetext现在过敏反响正受到关注,将在下文中谈到现在过敏反响正受到关注,将在下文中谈到Food Safety Hazards食品平安危害食品平安危害IntertekTestingServicesBiological Hazards生物危害生物危害The5typesofbiologicalhazards5种生物危害种生物危害qBacteria-(Clo
3、stridiumspp.,Salmonellaspp.,Listeriamonocytogenes)细菌细菌qViruses-(Hepatitis,Rotavirus)病毒病毒qFungi-(Aspergillusspp.,Fusariumspp.)霉菌霉菌qParasites-(Fasciolahepatica,Giardialamblia,Med.fly)寄生虫寄生虫qAlgae-(dinoflagellates,blue-greenalgae,golden-brownalgae)藻类藻类IntertekTestingServicesFactors Affecting the Growth
4、 of Biological Hazards影响生物危害产生的因素影响生物危害产生的因素IntrinsicFactors内部因素内部因素qpH酸碱度酸碱度qMoisturecontent水分水分qNutrients营养营养qAnti-microbialconstituents抗微生物因素抗微生物因素qBiologicalstructures生物结构生物结构Extrinsicfactors外部因素外部因素qTemperature温温度度qHumidity湿度湿度qGases气体气体IntertekTestingServicesChemicalHazards化学危害Chemicalcompound
5、sareusedfrequentlyinthefoodsupplychainandcanpresentfoodsafetyrisksiftheiruseisnotmanaged:化学化合物常被用于食品供化学化合物常被用于食品供给链,如果未被妥,如果未被妥善运用会善运用会产生一些食品平安危机生一些食品平安危机CleaningChemicals清清洁剂Pesticides杀虫虫剂Allergens过敏源敏源ToxicMetals有毒金属有毒金属Nitrites,Nitrates&N-nitrosocompounds亚硝酸硝酸盐,硝酸,硝酸盐&N-亚硝基化合物硝基化合物PCBs多多氯联苯苯Inter
6、tekTestingServicesIntertekTestingServicesIntertekTestingServicesAllergens过敏源过敏源n Naturally occurring proteinsn自然生成的蛋白质n Minute amounts can cause allergic reactionn极少的量便可引起过敏反响n - Only 5-10 ppm can trigger reactionn只要有5-10ppm就可引起反响n - Symptoms occur within minutes and death n within hours 几分钟内便产生病症,几
7、小时内会导致死亡n Some reactions are fatal 有些反响是致命的n - Nut and seafood allergies 坚果和海产品过敏n - 1-2% of population have food allergies 有1-2%的人对食物过敏 IntertekTestingServicesMajor Food Groups containing Allergens主要包含过敏原的食品主要包含过敏原的食品 Peanut, Tree Nuts 花生,松仁花生,松仁 (Walnut, Hazelnut, etc.)(胡桃,榛仁等胡桃,榛仁等) Shell fish, s
8、eafood and fish贝类,海产品和鱼贝类,海产品和鱼 Soy bean and Soy Products大豆和豆制品大豆和豆制品 Egg and Egg Products鸡蛋和蛋制品鸡蛋和蛋制品 Wheat and related products 小麦及相关产品小麦及相关产品 Milk and Milk Products 牛奶和乳制品牛奶和乳制品n Products derived from the above groups may contain n traces of allergenic compounds. 以上产品包含过敏化合物n Other ingredients (M
9、SG, some Food Colors, n Sulphites) can cause similar reactions to the aboven listed allergens 其它成分(味精,食用色素,亚硫酸盐)也可引起类似反响IntertekTestingServicesControl Measures for Allergens include:对过敏原的控制措施包括:对过敏原的控制措施包括:n Ensure correct labels/packaging is used and n this matches product recipe n确保正确食使用标签和包装并与产品相
10、匹配n Equipment is properly cleared 设备清洁得当n Obtain full ingredient declaration from raw material suppliersn从原料供给商处获得所有的成分说明n Schedule allergen containing product lost inn production plan 在产品方案中列出过敏原所涉及的产品n Control and trace reworked products 控制并追踪重做的产品IntertekTestingServices第二章第二章 HACCP前提条件前提条件Interte
11、kTestingServicesHACCP支持性程序:为了给食品的生产卫生提供根底,用以控制厂内环境条件的程序或步骤。 GMPs,-良好操作标准SSOP,卫生标准操作规程这些通常被称HACCP的支持性程序或前提性条件。IntertekTestingServicesGMPSSOPHACCPHACCP体系的构架体系的构架IntertekTestingServices建立建立GMPGMP体系是保证食品平安的首要步骤体系是保证食品平安的首要步骤GMP - GMP - 确保食品具备良好的确保食品具备良好的卫生生产卫生生产环境环境IntertekTestingServicesGoodManufacturi
12、ngPractices良好的生产标准良好的生产标准RECOMMENDEDINTERNATIONALCODEOFPRACTICEGENERALPRICIPLESOFFOODHYGIENECAC/RCP1-1969,Rev.3(1997)q员工卫生员工卫生q建筑物与设施建筑物与设施厂房与场地厂房与场地卫生操作卫生操作卫生设施及控制卫生设施及控制q仪器和用具仪器和用具q加工和控制加工和控制q存储和发送存储和发送IntertekTestingServicesSSOP卫生标准操作规程卫生标准操作规程q是是GMP体系内的卫生控制局部体系内的卫生控制局部q是标准化的卫生操作程序是标准化的卫生操作程序Inte
13、rtekTestingServicesSanitationStandardOperatingProcedures(SSOP)卫生标准操作规程卫生标准操作规程Safetyofwater水的平安水的平安Conditionandcleanlinessoffood-contactsurfaces食品接触面的状况和洁净程度食品接触面的状况和洁净程度Preventionofcross-contamination交叉污交叉污染的防范染的防范Maintenanceofhand-washing,hand-sanitizingandtoiletfacilities厕所及手的清厕所及手的清洗消毒设施的维护洗消毒设施
14、的维护IntertekTestingServicesSanitationStandardOperatingProcedures(SSOP)continue卫生标准操作规程卫生标准操作规程Protectionfromadulterants污染物的防范污染物的防范Labeling,storageanduseoftoxiccompounds有毒化学物质的标签,存放及有毒化学物质的标签,存放及使用使用Employeehealth员工的健康员工的健康Exclusionofpests害虫的防范害虫的防范IntertekTestingServicesHACCP的前提条件qq管理保证管理保证管理保证管理保证q
15、q生产作业标准生产作业标准生产作业标准生产作业标准qq人员培训人员培训人员培训人员培训qq设备维护设备维护设备维护设备维护qq计量校准制度计量校准制度计量校准制度计量校准制度qq采购控制采购控制采购控制采购控制qq产品回收产品回收产品回收产品回收qq标识与溯源制度标识与溯源制度标识与溯源制度标识与溯源制度IntertekTestingServices第三章第三章 建立和实施建立和实施HACCP的预备步骤的预备步骤IntertekTestingServices联合国食品法典委员会中推荐建立和实施联合国食品法典委员会中推荐建立和实施HACCP的过程为的过程为12个步骤:个步骤:1.组成组成HACC
16、P小组小组2.描述产品描述产品3.明确用途明确用途4.绘制产品生产流程图绘制产品生产流程图5.验证流程图验证流程图6.进行危害分析并确定预防控制措施7.识别关键控制点8.确定关键限9.制定对关键控制点的监控程序10.确定纠正措施11.建立验证程序12.建立文件及记录管理系统IntertekTestingServices第第1步步:组成组成HACCPHACCP小组小组明确实施明确实施HACCPHACCP目的和范围目的和范围一个多专业组成的HACCP小组需要由HACCP方案所涉及的各种专业的人员组成IntertekTestingServicesHACCP小组必须明确小组必须明确:范范围围-从从哪哪
17、里里开开始始,到到哪哪里里结结束束,包包括括什什么,么,目的目的实施实施HACCP的原由的原由IntertekTestingServices Specialist knowledge may be required of:专家所必须了解的专家所必须了解的nRaw materials and ingredients 原材料和成分原材料和成分n Finished product 成品成品n Processing equipment 加工设备加工设备n Processing procedures 加工步骤加工步骤 n Pre-requisite programs 支持性程序支持性程序n The pr
18、oduction environment (premises and surroundings)生产环境生产环境(厂房和环境厂房和环境)Team Requirements成员组要求成员组要求IntertekTestingServicesSpecialists will need full knowledge of:专家要完全了解:专家要完全了解:n Hazards associated with the raw materials, the product and the process.原材料,产品和生产过程所涉及的危害原材料,产品和生产过程所涉及的危害n The likelihood an
19、d probability of these hazards occurring.危害发生的可能性危害发生的可能性n A knowledge of regulatory requirements and applicable to the food对实施于食品的规章要求了解对实施于食品的规章要求了解n Be trained in and have a thorough technical knowledge of HACCP.接受过接受过HACCP培训并对其有充分的了解培训并对其有充分的了解Team Requirements成员组要求成员组要求IntertekTestingServicesn
20、Able to evaluate data in a logical manner; 能逻辑地能逻辑地评估数据评估数据n Can systematically solve problems; 能系统地解决问能系统地解决问题题n Able to think outside the box 思维广泛思维广泛n Able to delegate 有代表性有代表性n Team players 具备团队精神具备团队精神n Organisational, time management and group meeting skills 组织能力、时间管理及会议管理技巧组织能力、时间管理及会议管理技巧n A
21、nalytical, and; 有分析能力有分析能力n Good communication skills 良好的沟通技巧良好的沟通技巧HACCP Team Member AttributesHACCP成员应具备的特质成员应具备的特质IntertekTestingServicesn Managing the design and implementation of the HACCP system (the management role). 管理管理HACCP系统的设计和执行系统的设计和执行 (管理的角色管理的角色)n Determining whether the system fulfi
22、lls the Codex guidelines and meets the applicable regulations (the regulatory role).确定系统是否在满足法典指引的同时也满足相关的法律规章确定系统是否在满足法典指引的同时也满足相关的法律规章 (调整的角色调整的角色)n Determining the effectiveness of the HACCP system (the analytical role). 确定确定HACCP系统的效果系统的效果(分析的角色分析的角色)n Reporting on the performance of the system
23、and the quality of products (the scorekeeper role) 报告报告HACCP的执行和产品的质的执行和产品的质量量(计分员的角色计分员的角色)General Responsibilities of the HACCP Team LeaderHACCP组长的职责组长的职责IntertekTestingServices Identifying areas for system improvement (the innovative role). 识别系统改善的区域(创新的角色) Liaising with other organisations or pr
24、ofessionals when the business lacks the skills to answer specific questions, or when external verification must be arranged (the ambassadors role) 当公司无法解决某些问题或需要外审时应联系其它的组织或专业人员大使的角色 Chairing the HACCP team meetings 主持HACCP会议 Completing the internal verification of the HACCP plan and signing off the
25、 validation and verification integrity of the plan. 完成HACCP方案的内审。确认方案的有效性和审核的整体性General Responsibilities of the HACCP Team Leader HACCP组长的职责组长的职责IntertekTestingServices第第2步步产品说明产品说明说明产品的具体的成份,物理/化学 特性,包装,平安信息,加工方法,贮运方法,使用方法等。 IntertekTestingServicesCodex Guidelines 食品法典委员会指引食品法典委员会指引详尽的产品描述包括以下平安信息:
26、详尽的产品描述包括以下平安信息: Composition, 成分成分 Physical /chemical structure (including aw, pH, etc.) 理理化指标化指标 Mode of preservation (e.g. heat treatment, freezing, brining, smoking etc.) 保存方式保存方式 Packaging and Durability (shelf life) 包装及保质期包装及保质期 Storage conditions 储存方式储存方式 Method of distribution.分销方式分销方式Interte
27、kTestingServicesnProduct name 品名品名nComposition 成分成分nEnd Product Characteristics最终产品性状最终产品性状n Method of Preservation 保存方式保存方式n Packaging Outer 外包装外包装 nPackaging Inner内包装内包装nStorage Conditions 储存条件储存条件n Distribution Method分销方式分销方式n Shelf Life 货架期货架期n Special Labelling标签标签n Customer Preparation 食用前准备食用
28、前准备IntertekTestingServicesn A separate finished product specification n is usually prepared for each food.每一每一产品品应有有单独的描述。独的描述。n However, in some instances like products n can be described on one specification n (a product cluster) provided the ingredients, n operational and storage conditions are n
29、 similar.在在产品配方,加工,存品配方,加工,存储方式方式类似似的情况的情况下可列外,下可列外,产品大品大类。Finished Product SpecificationsIntertekTestingServices第第3步步明确产品的用途明确产品的用途明确产品的用途及其拟供给的消费群体,明确产品的用途及其拟供给的消费群体,注意敏感人群注意敏感人群IntertekTestingServices The intended use should be based on the expected, normal uses of the product by the end user or
30、the consumer. 被定义的用途应基于最终用户对产品所期望被定义的用途应基于最终用户对产品所期望和正常的使用。和正常的使用。 In specific cases, vulnerable groups of the population: e.g., the old, the very young, the sick or hospitalised have to be considered. 在某些情况下,在某些情况下,“易感人群易感人群“包括:包括:老人,幼儿,和病人。老人,幼儿,和病人。Codex Guidelines Step 3.法典指引步骤3IntertekTestingSe
31、rvicesn Elderly 老人老人n Infants 婴儿婴儿n Pregnant 孕妇孕妇n Sick 病人病人n Those with compromised immune systems 免疫系统低下者免疫系统低下者There are five sensitive or vulnerable groups in the population.5种易受影响的群体种易受影响的群体 IntertekTestingServicesSensitive Population 易感人群易感人群 Include in the Product Description and Intended Use
32、:应包括在产品描述及可能的使用中:应包括在产品描述及可能的使用中: The product is intended for “General consumption该产品针对普通消费者该产品针对普通消费者 The product will be consumed by one of the sensitive groups in the population, e.g., infant formula marketed for infant consumption.该产品可用于某一该产品可用于某一“易感人群,如婴儿用品易感人群,如婴儿用品IntertekTestingServices第第4步步
33、制作一份工艺流程图制作一份工艺流程图 目的:为了便于对整个生产做一个系统的全面了解。 范围-所有原料-所有生产环节内容-系统的流程-连续的生产步骤-时间/温度资料-隔离-设备的类型-流程条件-产品/返工-贮运条件IntertekTestingServicesqThe flow diagram should be constructed by the HACCP team, with the help of the people working in the immediate areas.在直接参与各个环节工作的员工的配合下,由HACCP团队画出生产流程图。qThe flow diagram
34、should cover all steps in the operation. 流程图因涵盖生产各个环节。qWhen applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation. 如将HACCP运用与某一特定过程,也应对此过程之前及之后的各步骤作考虑IntertekTestingServicesThe process flow diagram should depict:qDetails of all pr
35、ocess activities including tasks, inspections, transportation, storage and delays in the process. Inputs into the process in terms of raw materials , packaging, water, and chemicals. 投入生产的原料,包装,水及化学品。qOutputs from the process e.g., finished product, waste product - in - progress, re-work and rejecte
36、d products. 。HACCP Principles - Guidelines for Implementation & Use - H7IntertekTestingServices原料至成品原料至成品23453.13.23.33.43.53.6STAGE 3: Batch Preparation to Line AssemblySTEPSSTAGES:Receipt of raw materialsto storage 原料接受及储存原料接受及储存From storage to batch preparation 储存至准备储存至准备Batch Preparation to Line
37、 assembly 准备到制造生产线准备到制造生产线Line assembly tofrozen storage 制造生产线到制造生产线到冷冻储存冷冻储存From frozen storage toDistribution 冷冻储存至分发冷冻储存至分发These steps are theindividual tasks within Stage 3. 此阶此阶段包括各独立步骤段包括各独立步骤1IntertekTestingServices第第5步步现场验证工艺流程图现场验证工艺流程图工工艺艺流流程程图图需需要要进进行行现现场场验验证证。它它应应该该由由HACCP小小组组的的全全体体成成员员在
38、在整整个个生生产产进行的过程中进行进行的过程中进行“边走边谈。边走边谈。IntertekTestingServicesqOn-Site Verification of the Process Flow Diagram is required. 需要现场验证生产流程图表 qIt should be done by all members of the HACCP team during all stages and hours of operation. 应由HACCP组所有成员在操作过程的各个环节及时段完成。 IntertekTestingServices The Golden Rule金金箴
39、箴MISS A STEP - MISS A HAZARD.漏一步 - 漏一危害IntertekTestingServices第四章第四章HACCP原理原理1:危害分析与确定预防控制措施危害分析与确定预防控制措施IntertekTestingServicesqListallpotentialhazardsassociatedwitheachstep;列出每一步骤内的潜在列出每一步骤内的潜在危害。危害。qConductahazardanalysis;anddeterminethesignificanceofeachhazard.进行危害分析;判定每个危害进行危害分析;判定每个危害的严重性。的严重性
40、。qConsideranymeasurestocontrolidentifiedhazards.针对各危害,提出控针对各危害,提出控制方法。制方法。IntertekTestingServicesPartA. HAZARDIDENTIFICATION危害分析危害分析ListAllPotentialHazards列出所有危害列出所有危害IntertekTestingServicesSourcesofPotentialHazards1.Rawmaterials原料原料2.Plantandequipmentdesign场场地及地及设备设备3.Intrinsicfactorsintheproductor
41、rawmaterials产产品或原料的内在因素品或原料的内在因素4.Processdesign(Procedures)生生产产流程流程5.Personnel(Staff/Visitors)个人个人 员员工及工及访访客客 6.Storageanddistribution 储储存及配存及配销销 IntertekTestingServicesExamplesofrawmaterialsare:qFoodingredients(chilled,frozen,dry,liquid).食品配方食品配方qWater(usedinformulationortowashorrinseproducts).水水qC
42、leaningchemicals.清洗用化学品清洗用化学品qPackaging.包装包装qPesticides,insecticides杀虫剂杀虫剂IntertekTestingServicesConductHazardAnalysisandDeterminetheSignificanceoftheidentifiedHazards危危害分析及危害的严重性分析害分析及危害的严重性分析nDetermineLikelihoodofoccurrence发生危发生危害的可能性害的可能性nDetermineSeverityInfluenceofPrerequisitePrograms预防性程序影响的严重
43、性预防性程序影响的严重性nDetermineSignificance-Method1方式1-Method2方式2IntertekTestingServices A significant hazard has the potential to cause serious illness or injury when the food-stuff is consumed.食物中存在的严重危害可导致严重的疾食物中存在的严重危害可导致严重的疾病或伤害。病或伤害。IntertekTestingServicesDetermineSignificanceofHazards-Method2MatrixMet
44、hodforFoodSafetySeverity(consequences)严严重性重性 后果后果 Fatality致命致命SeriousSickness严严重疾病重疾病 ProductRecall产产品回收品回收CustomerComplaint顾顾客投客投诉诉NotSignificant无重大影响无重大影响Likelihood (frequency) 可能性可能性 频率率A. Common Repeating 经常常B. Known to occur 会会发生生C. Could occur (published) 可可能能发生生D. Not expected to occur 应该不会不会
45、发生生E. Practically impossible 实际上不可能上不可能发生生IntertekTestingServicesHazardSignificanceMatrixforFoodSafety食品危害分析食品危害分析IntertekTestingServicesIDENTIFYCONTROLMEASURES确定预防控制措施确定预防控制措施IntertekTestingServicesIdentifyControlMeasuresqControlMeasuresareanyfactors,actionsandactivitiesthatcanbeusedtocontrolaniden
46、tifiedfoodsafetyorqualityhazard.可以是任何可以控可以是任何可以控制食品平安或制食品平安或质质量危害的方法。量危害的方法。qControlmeasuresmusteliminate,controlorreducetheeffectofahazardtoanacceptablelevel方法必方法必须须可以用以去除、控制或将危害减小可以用以去除、控制或将危害减小到可被接受的程度。到可被接受的程度。IntertekTestingServicesCONTROLMEASURESforBiologicalhazards控制生物危害的方法控制生物危害的方法qPasteuris
47、ation-applicationoftime/temperature巴氏巴氏杀杀菌菌qFermentation发发酵酵qAcidification-phcontrol控制控制pH值值qPickling-additionofsalt腌腌渍渍qDrying-Awreduction枯燥枯燥控制水活性控制水活性qFreezing/cooling冷冷冻冻/冷藏冷藏qTrainingtopreventcrosscontamination培培训训/预预防交叉感染防交叉感染IntertekTestingServicesControlMeasuresforChemicalHazardsqSupplierQua
48、lityAssurancePrograms供供给给商商质质量控制量控制qCertificateofAnalysis-signedandmeetspecification测试测试分析分析证书证书,qSanitationProgram-approvedfoodgradechemicals,visualinspections卫卫生清生清洁洁程序程序qPestManagementProgram-approvedpesticides虫害管理虫害管理qAntibioticTesting抗生素抗生素测试测试qDesignatedwith-holdingperiodforcropcontrolchemical
49、s农农作物化学残留期作物化学残留期qCorrectLabels-forproductscontainingallergens正确的表示正确的表示-针对针对含含过过敏源的敏源的产产品品IntertekTestingServicesCONTROLMEASURESforPhysicalHazards控制物理控制物理qSieves-usenitex(notmetalwire)筛筛qScreens网网qMagnets磁性磁性qFilters过滤过滤qMetalDetectors金属探金属探测测qGlassControlPolicy玻璃控制玻璃控制qGoodManufacturingPractices-p
50、ersonalhygieneprocedures良好生良好生产标产标准准-个人个人卫卫生生qUseofPlastic(notWooden)Pallets.塑料塑料货货盘盘IntertekTestingServices第五章第五章HACCP原理原理2:关键控制点的识别关键控制点的识别IntertekTestingServicesqA Critical Control Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard
51、or reduce it to an acceptable level.关键控制点: 能实施控制,从而对食品平安危害加以预 防、消除、或把它降低到可以接受的程度的一个加工点、步骤或工序。 Codex Guidelines Step 7 HACCP Principle 2: Determine the Critical Control Points (CCPs)Critical Control Point 判定关键控制点判定关键控制点IntertekTestingServicesqA Control Point (CP) is a step in the process where contro
52、l may be lost without presenting a significant food safety hazard, or where a food safety hazard will not occur at unacceptable levels. 在CP上即使失去控制也不会造成重大平安危害在可被接受范围内Control PointIntertekTestingServicesCritical Control PointsqFor every significant hazard identified during hazard analysis there must b
53、e one or more Critical Control Points (CCPs) where the hazard is controlled 必须有至少一个关键控制方法来控制重大危害IntertekTestingServicesA CCP can be used to control more than one hazard. Likewise, more than one CCP may be needed to control one hazard.一个关键控制点可被用来控制超过一个危害。同样可以是多个关键控制点来控制一个危害。IntertekTestingServicesInt
54、ertekTestingServicesCCP Decision Tree 关键控制点决策树关键控制点决策树A logical sequence of questions that is applied to each hazard in order to aid in the determination of CCPs and CPs. 在判定一个危害是CCP还是的时候,所使用的逻辑判断。IntertekTestingServicesThe HACCP Team should ask an additional question when using the decision tree at
55、 Question 1. Is this hazard controlled by existing pre-requisite programs (e.g., SSOP, GMP, GAP). If yes, then it is likely this step will be a CP not CCP. 在开始使用决策树在开始使用决策树时,还可同时考虑是否预防性程序,如时,还可同时考虑是否预防性程序,如SSOP, GMP, GAP,已经能控制此危害。如已经能控制此危害。如果是的话,此步骤往往是控制点而非关键果是的话,此步骤往往是控制点而非关键控制点。控制点。IntertekTesting
56、ServicesCCPDecisionTreeQ1. Is there a hazard at this process step?- What is it?Q2. Do preventative measures exist for the identified hazards?Q3. Is the step specifically designed to eliminate or reduce the likely occurence of the hazard to an acceptable level?Not a CCPIs control necessary at thisste
57、p for safety?Not a CCPNot a CCPyesyesnonononoQ4. Could contamination occur at orincrease to unacceptable levels?Q5. Will a s ubsequent step or action eliminate or reduce the hazards to an acceptable level?yesyesModify step, process, orproductyesnoNot a CCPnoCritical Control PointyesCCPDecisionTreeS.
58、MortimoreandC.Wallace , HACCP a Practical Approach (1994),Chapman& Hall,London.IntertekTestingServices第六章第六章HACCP原理原理3:为每个为每个CCP建立关键控制限建立关键控制限IntertekTestingServicesWhat is a Critical Limit? 什么是什么是关键控制限关键控制限qCritical limits are criteria which separate acceptable from unacceptable, safe from unsafe.
59、控制限值,区分可接受与不可接受,平安与不平安的标准。qThey are the tolerance parameters for safety or product acceptance; the boundaries of control. 产品平安或可接受的容忍度;是控制的界限。IntertekTestingServicesnPublished data公布的数据nExpert advice专家建议nExperimental date试验数据nRegulatory guidelines法规指引nMathematical modelling数学模型nBest practice 最正确实践n
60、Source of information on Critical Limits: 关键控制限的来源关键控制限的来源IntertekTestingServicesCritical Limits 控制限控制限qMust be applied to all CCPs 必须运用于所有CCPqMust be validated必须被确认有效qMust be measurable必须是可被量度的IntertekTestingServicesCritical Limits关键控制限关键控制限qIf the information needed to define the critical limits i
61、s not available, a conservative value can be selected. 如果缺乏有关信息,可采用一个较保守的值qThe rationale and reference material used to establish a critical limit should become part of the support documentation for the HACCP Plan.用以制订关键控制限的参考资料必须作为HACCP方案的支持性文件。IntertekTestingServicesTypes of Critical LimitsqPhysic
62、allimits物理物理time,temp,weight,grade,brix,absenceofmetal/wood/glass时间、温度、等级、无金属时间、温度、等级、无金属/木木/玻璃碎片。玻璃碎片。qChemicallimits化学化学pH,moisture,salt,sugar,fat,MRLs,chlorinesanitizerlevelpH值、盐、糖、脂肪、农残等值、盐、糖、脂肪、农残等qMicrobiologicallimits微生物微生物foodstandardscode106TotalPlateCount/ATPIntertekTestingServicesValidati
63、on 验证Validation of critical limits关键关键控制限的控制限的验证验证is obtaining evidence that the critical limit does in fact control the hazard是用以证是用以证明关键控制限可有效地控制危害明关键控制限可有效地控制危害IntertekTestingServicesq Operating Limits are criteria that are q more stringent than critical limits. 操作限度较关键控制限度为严格q Are used to indica
64、te process variation q before control is lost and unsafe food q is produced.在失去控制、不平安食品出现前用以指示发生的变化。Operating Limits 操作限值操作限值IntertekTestingServices第七章第七章HACCP原理原理4:监控关键控制点监控关键控制点IntertekTestingServicesCodex Guidelines Step 9, HACCP Principle 4 法典指引步骤法典指引步骤9,HACCP原理原理4 Monitoring is a the act of con
65、ducting a planned sequence of observations or measurements of control parameters to assess whether a critical control point is under control. 监控是实施预先方案好的观察及测量,以评估监控是实施预先方案好的观察及测量,以评估CCP是否在控制范围之内。是否在控制范围之内。IntertekTestingServicesThe 5 Aspects of Monitoring监控的监控的5个方面个方面1. Why monitoring is important为什
66、么监控是重要的为什么监控是重要的2. Who monitors由谁来监控由谁来监控3. How to monitor如何监控如何监控4. When to monitor何时监控何时监控5. Frequency of monitoring监控的频率监控的频率IntertekTestingServicesWhy monitoring is important为什么监控是重要的为什么监控是重要的. qKnow when CCPs & CQPs are out of controlq知道何时CCPs & CQPs 失控qIdentify problems before they occurq在问题发生
67、之前便明确qPinpoint the cause of problemsq查明问题原因qPart of verificationq审核的角色qProves due diligence “If it isnt written down, it didnt happenq“免责 辩护:“如果没有纪录,便认定为没有作过IntertekTestingServicesMonitoring Involves监控包括监控包括qAsking the right questionsq问适宜的问题qAnalyzing data to get the right informationq分析数据以获得正确的信息qK
68、nowing “Where to collectq知道“何处获取qBeing unbiasedq公正qTraining of data collectors / operators / monitorsq数据操作者/操作者/监控者的培训qAuditing the collection processq审核收集过程IntertekTestingServicesWho, How and When to Monitor 谁,如何,何时监控谁,如何,何时监控WHO谁lTrained受训的lUnbiased公正的HOW如何如何lObservation调查调查lSight看看lSmell闻闻lTaste尝
69、尝Measurement度量度量nWeight重量重量nTime时间时间nTemperature温度温度 WHEN何时何时lOn-line即时的即时的lContinuous持续的持续的lDiscontinuous间歇的间歇的Off-line 离线离线lDiscontinuous间歇的间歇的IntertekTestingServicesSamplingTechniques抽样技术qRandom Sampling 随机抽样qSystematic Sampling 系统抽样qStratified Sampling 分层抽样qCluster Sampling 分群抽样(Refer Australian
70、 Standards 1199, 1399, 2490)IntertekTestingServicesBasicCriteriaforCollectingData抽取数据的根本标准Data must be数据应qRelevant 相关的qReliable 可靠的qRepresentative 有代表性的 qReadable 可读的IntertekTestingServices第八章第八章HACCP原理原理5:确定应对偏差的纠偏措施确定应对偏差的纠偏措施IntertekTestingServicesCorrective Action 纠偏行动纠偏行动Any action to be taken
71、when the results of monitoring at a critical control point, critical quality point, or process control point indicate a loss of control.当在监控时发生超出控制限的情况时所采取的行动。IntertekTestingServicesCodex Guidelines Step 10 指引指引10HAACP Principle 5 原那么原那么5Specific corrective actions must be delivered for each critica
72、l control point in the HACCP system in order to deal with deviations when they occur.当发生偏差时必须采取特定的纠偏行当发生偏差时必须采取特定的纠偏行动动IntertekTestingServicesCodex GuidelinesqThe actions must ensure that the critical control point has been brought under control.纠偏行动必须保证重新回到CCPq Actions taken must also include prope
73、r disposition of the affected product.行动方案必须包括如可处置受影响的产品qDeviation and product disposition procedures must be documented in HACCP records.偏差及产品处置必须纪录在案IntertekTestingServicesThe Two Levels of Corrective Action 2 种种纠偏行动纠偏行动1.Immediate Action - (short term control): 立即行立即行动动 短期短期 Adjust the process to
74、 regain control.调调整生整生产过产过程,重程,重新恢复控制新恢复控制Deal with the suspect product. 处处理受影响理受影响产产品品2. Preventive Action - (long term control) to:预预防行防行动动 长长期期 Determine root cause找出根源找出根源Assign responsibility to complete preventive action 完善完善预预防行防行动动方案方案Record details of actions taken and update HACCP as requi
75、red 将行将行动纪录动纪录在案,完善在案,完善HACCP方案方案Record the details of corrective action taken详细记录详细记录所所采取的采取的纠纠偏行偏行动动IntertekTestingServices第九章第九章HACCP原理原理6:建立审核程序建立审核程序IntertekTestingServicesVerificationis“DoingitRight!验证是确保验证是确保“正确地执行正确地执行Verificationistheapplicationofmethods,procedures,testsandotherevaluations,
76、inadditiontomonitoringtodeterminecompliancewiththeHACCPPlan验证是运用方法、程序、测试和其他的评估手段对HACCP方案的符合性监控。CODEXAlimentarius97/13AIntertekTestingServicesCodexGuidelinesVerification验证验证Establish procedures for verification.建立验证程序建立验证程序 To determine if the HACCP system is working correctly, verification that incl
77、udes auditing methods, review procedures, tests, random sampling and analysis can be used . 为了确认为了确认HACCP体系是否正确的运作体系是否正确的运作,验证要包括审核、检验证要包括审核、检验、随机采样和分析验、随机采样和分析The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. 验证的频率要足够确保验证的频率要足够确保HACCP体系的有效性体
78、系的有效性IntertekTestingServicesCodexGuidelines法典指引法典指引l Examples of Verification Activities l 验证行动的例子验证行动的例子l include:l l Review of the HACCP system and its records.l 审查审查HACCP方案和记录方案和记录l Review of deviations and product dispositions.l 偏差的审查和产品的处偏差的审查和产品的处 置置l Confirmation that Control Points are under
79、 control.l 确定关键点受控制确定关键点受控制lVerificationactivitiesdeterminecompliancewiththeHACCPPlan验证能确保实际准作与HACCP方案相一致IntertekTestingServicesVerification验证qAsystemorseriesofsystemsthataredesignedtoensuretheHACCPplanisworkingeffectively.q一个体系或一系列体系用以确保一个体系或一系列体系用以确保HACCP方案的有效方案的有效性性qItistheHACCPteamsresponsibilit
80、ytoensureverificationproceduresareinplaceandtheyareeffectiveqHACCP小组有责任确保验证过程的有效和适当小组有责任确保验证过程的有效和适当qVerificationschedulesshouldoutlinethemethodandfrequencyofverificationq验证方案要简述验证的方法和频率验证方案要简述验证的方法和频率IntertekTestingServicesVerification of the HACCP Plan provides:验证可以:验证可以:1. Assurance that the syst
81、em will result in the production of safe, quality food确保在体系下能得到平安和有品质的食品产品确保在体系下能得到平安和有品质的食品产品2. Assurance that the HACCP Plan is being applied确保确保HACCP方案被实施方案被实施3. Information that can be used to improve the HACCP Plan提供信息用以改善提供信息用以改善HACCP方案方案4. Assurance that the HACCP Plan as originally designed
82、is still relevant to the process.确保最初设计的确保最初设计的HACCP方案和生产相符方案和生产相符IntertekTestingServicesVerification consists of (5) five types of activities: 验证包括以下验证包括以下 5 类行动类行动1. Review of Monitoring results 监控结监控结 果的回忆果的回忆2. Validation 确认确认3. Auditing审核审核4. HACCP System Review HACCP体体系的回忆系的回忆5. Product Testin
83、g 产品的检测产品的检测IntertekTestingServicesVerification 验证验证Verification activities determine compliance with the HACCP Plan. Example include: 验证行动要符合验证行动要符合HACCP方案。实例包括方案。实例包括nReviewofHACCPsystemanditsrecordsHACCP体系和它的记录的回忆nReviewofdeviationsandproductdispositionn偏差和产品处置的回忆nConfirmationthatCCPsarekeptunder
84、controln证实CCP在控制下IntertekTestingServices确认是确认是HACCP方案实施前必须履行的正式的过程。方案实施前必须履行的正式的过程。确认记录包括确认记录包括nListofskillsusedinpreparingtheHACCPPlann准备HACCP方案中用到的技术的列表。nListhazardsandsupportingdatan列出危害和支持的数据nCriticallimitsforallCCPsandsupportingdatanCCP的关键限和支持数据nEvidencethatmonitoringsystemscontrolthehazardsn监控
85、体系控制危害的证据nEvidencethatCorrectiveActionspreventshipmentofdefectiveproducen纠偏措施防止不合格品出货的证据IntertekTestingServicesVerification验证qShouldensurethat将确保将确保qmonitoringproceduresandcorrectiveactionsarestillbeingappliedq监控过程和纠偏措施被执行监控过程和纠偏措施被执行qinternalauditsandothertestingrequirementsareincludedbeforeandafte
86、rapplyingtheHACCPplanq在应用在应用HACCP方案前后要有内审和其方案前后要有内审和其它的检测行动它的检测行动IntertekTestingServicesVerification验证qdiffersfrommonitoringinthatMonitoringgivesusimmediatefeedbackontheprocess,theCCPs.q验证与监控的不同之处在于,监控提供验证与监控的不同之处在于,监控提供CCPs控制控制点点q上的即时的反响信息上的即时的反响信息qisacheckontheentiresystemtoensureitiscapableofprod
87、ucingsafe,qualityfood.q验证是对整个体系进行检验,确保有能力生产出平验证是对整个体系进行检验,确保有能力生产出平安和有质量保证的食品。安和有质量保证的食品。q“KNOWITTOBETRUEIntertekTestingServicesAnAudit.审核审核qIsasystematicandindependentexaminationtodeterminewhetheractivitiesandrelatedresultscomplywithplannedarrangements.q审核是系统和独立的检验以确定行动和其相关的结果是与方案安排相一致的qTodetermine
88、whetherthesearrangementsareimplementedeffectivelyandaresuitabletoachieveobjectives.q审核是确定所有的安排被有效地执行并能到达预期目标IntertekTestingServicesVerification Benefits Include: 验证的好处在于:验证的好处在于:nIncreaseawarenessandunderstandingofthesystembyallstaff提高全体员工对体系的认知度和理解力nProvidesdocumentedevidence提供文件性的证明nIndependentand
89、objectivereview独立和客观的回忆nMaintainsconfidenceintheHACCPPlan维持对HACCP方案的信心nIdentifiesopportunitiesforimprovements识别提高的时机nEnsuresobsoletedocumentshavebeenremovedn确保旧文件被去除nEnsurescontinuousimprovementthroughtheongoingauditcycle.n通过持续进行的审核确保不断地提高IntertekTestingServicesValidation and Verification - Working
90、Together确认与验证确认与验证-相辅相成相辅相成 nTheprocessesofverificationandvalidationworktogetherandcanbeseenasameansofcontinuousimprovementoftheHACCPPlann验证和确认的过程一起能持续提高HACCP方案nVerificationmayidentifychangesneededtotheHACCPPlan.Thesechangeswillneedtobevalidated,theHACCPPlanupdatedandimplemented.n验证可以识别需要对HACCP方案所作的
91、更改。而这些更改需要被确认。这样HACCP方案会被更新及实施。IntertekTestingServices第十章第十章HACCP原理原理7:建立记录和文件管理系统建立记录和文件管理系统IntertekTestingServicesCodex Guidelines 法典指引法典指引Efficient and accurate record keeping is essential to the application of a HACCP system.有效、准确的纪录保管是实施HACCP体系重要环节。程序必须文件化Documentation and record keeping should
92、 be appropriate to the nature and size of the operation.文件与纪录因与生产规模相适应。IntertekTestingServicesRecords 纪录纪录Records are written evidence that an act has taken place. 纪录是所采取行动的书面证明。A form is the template on which the results of acts are recorded. 行动的结果被纪录在表单上A completed form becomes a record. 完整的表单成为纪录
93、IntertekTestingServices HACCP Plan and Support Documents HACCP方案及支持性文件方案及支持性文件 Monitoring Records监控控纪录 Corrective Action Records纠偏措施偏措施纪录 Verification Records 认证纪录The type of HACCP records that should be kept as part of a HACCP system are:HACCP 体系应包括的纪录体系应包括的纪录IntertekTestingServicesExamples of situ
94、ations that may trigger a review are changes to:当当发发生以下生以下变变化化时应时应重新回重新回忆忆 Raw materials 原料原料 The layout of the premises 生产场地布局生产场地布局 Equipment设备设备 Cleaning program清洁程序清洁程序 Procedures生产程序生产程序 The intended consumer of the product 产品的预期客户群产品的预期客户群 New information on hazards. 有关危害的有关危害的新信息新信息IntertekTestingServices谢谢谢谢