1、HACCP 原理2003，7，7 一二请在这里输入您的主要叙述内容整体概述三请在这里输入您的主要叙述内容请在这里输入您的主要叙述内容第一章 HACCP概述HACCP是什么qH-?qA-?qC-?qC-?qP-?HACCP 是:qH- Hard 艰难!qA- Agonizing 痛苦!qC- Confusing 迷茫!qC- Complicated 混淆!qP -Paper work 书面文章!HACCP全称为Hazard Analysis Critical Control Points 危害分析及关键控制点CODEX DEFINITION （食品法典委员会的定义）HACCP is a syst
2、em which identifies, evaluates, and controls hazards which are significant for food safetyHACCP是用以分析评估和控制能导致重大食品安全问题的体系。HACCP的起源q起源于60年代的美国太空计划q随后被食品界和政府机构采用进行危害分析并確定控制措施确定关键控制点(CCP)建立关键控制限度(CL)对关键控制点进行监控建立纠偏措施以对付关键控制限度的偏差建立审核程序建立文件记录保存体系q建立HACCP的12个步骤组成HACCP小组描述产品确定产品用途绘制生产流程图验证流程图.联合国食品法典委员会CAC/RC
3、P1969，Rev.3，1997食品卫生通则附件HACCP体系及应用导则qUSA美国qE U 欧共体qCanada加拿大qJapan日本国际上的应用特点qHACCP是一种控制危害的预防性体系，而不是反应性体系。qHACCP不是一个孤立的体系,必须建立在已有的良好操作规范(GMP)和卫生标准操作程序(SSOP)的基础之上，有较强的针对性。qHACCP是一种用于保护食品防止生物的、化学的、物理的危害的管理工具。每个HACCP计划都反映了某种食品加工方法的专一特性，其重点在于预防，设计上在于防止危害进入食品。qHACCP体系作为食品安全控制方法已为全世界所认可，虽然HACCP不是零风险体系，不能完全
4、保证消灭所有的危害，但HACCP可用于尽量减少食品安全危害的风险，达到一个可接受的水平。q HACCP的概念可推广、延伸应用到食品质量的其他方面，控制各种食品缺陷。q HACCP 有助于改善工厂与管理部门的关系以及工厂与消费者的关系，树立食品安全的信心。HACCP的理念从农场到餐桌，对整个食品链进行系统、全面的危害分析，针对相关实施相应的预防控制措施，将危害预防、消除或降低至可以接受的水平。 英国食源性疾病发病报告05000100001500020000250003000035000400004500019801982198419861988199019921994空肠弯曲菌沙门氏菌食物中毒主
5、要原因The Major Causes of Food Borne Incidents are :n Contaminated raw materials 原料污染n Mishandling raw materials 原料处理失当n Change in product formulation产品配方改变n Change in the product process产品加工改变n Cross-contamination交叉感染n Inadequate cleaning 清洁不充分n Inadequate maintenance 维护保养不充分n Addition of incorrect in
6、gredients 配方不正确Food Safety Incidents and Outcomesn Mexican-Style Cheese, USA - Listeriosis from cheese contaminated with raw milk - 142 confirmed cases, 47 deaths - Cost ?, Executives to jailn Salmonella in dried baby food, UK - Contamination through cracks in drier - 76 ill, 1 death - Cost: $30 mil
7、lion, one factory closedn Frozen French Fries - Wire bristle contamination - Destruction of 18 million pounds of product - Cost: $4 millionn World-wide recall of bottled water - Benzene contamination - Filtration system not changed in 18 months - Cost: $40 million in US and lost market share 食品的安全卫生
8、控制始终是食品生产企业质量管理的基础与核心q食品生产者肩负着法律和道德双重责任结论1为了企业的生存和发展q我们需要HACCP检验把关型质量保证模式的弊端q检验结果的滞后性q样品代表性的有限性q检验结果的准确度的相对性质量成本质量成本包括: 1. 废品成本 a) 内部 b) 外部 2. 鉴定成本 3. 预防成本 质量控制投入外部质量成本内部质量成本 鉴定成本 预防成本外部质量成本内部质量成本 鉴定成本预防成本成本OldNew结论2为了完善我们的质量体系q我们需要HACCPHACCP 能给企业带来什么好处？q使品管体系更完善，管理更科学q降低质量管理成本q易学好用，经济实用q全球认同的食品安全体系
9、q是企业无形资产的积累q为企业的形象增加新的亮点，给客户以信心第二章 危 害A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect 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。(CODEX definition法典委员会定义).Hazards (Food Safety)危害(食品安全)1. Biological 生物的2. Chemical 化学的3. Physical 物理的Allergens &
10、 Prions from these groups are now of concern and will be dealt with in the text现在过敏反应正受到关注，将在下文中谈到Food Safety Hazards食品安全危害Biological Hazards生物危害The 5 types of biological hazards 5种生物危害qBacteria - (Clostridium spp., Salmonella spp., Listeria monocytogenes) 细菌qViruses - (Hepatitis, Rotavirus) 病毒qFung
11、i - (Aspergillus spp., Fusarium spp.) 霉菌qParasites - (Fasciola hepatica, Giardia lamblia, Med. fly)寄生虫qAlgae - (dinoflagellates, blue-green algae, golden-brown algae)藻类Factors Affecting the Growth of Biological Hazards影响生物危害产生的因素Intrinsic Factors内部因素qpH 酸碱度qMoisture content 水分qNutrients 营养qAnti-micr
12、obial constituents抗微生物因素qBiological structures生物结构Extrinsic factors外部因素qTemperature 温度qHumidity 湿度qGases 气体Chemical Hazards化学危害Chemical compounds are used frequently in the food supply chain and can present food safety risks if their use is not managed: 化学化合物常被用于食品供应链，如果未被妥善运用会产生一些食品安全危机qCleaning Ch
13、emicals 清洁剂qPesticides 杀虫剂qAllergens 过敏源qToxic Metals 有毒金属qNitrites, Nitrates &N-nitroso compounds亚硝酸盐，硝酸盐&N-亚硝基化合物qPCBs 多氯联苯Chemical Hazards.化学危害 qPlasticisers and Packaging Migration 增塑剂和包装转移qVeterinary Residues 兽药残留qChemical Additives 化学添加剂qSeafood toxins 海产品毒素qZootoxins 动物性毒素qPhyllotoxins 叶黄素Phy
14、sical Hazards物理危害Physical hazards are objects not normally found in food that may cause illness or injury to the consumer: 物理危害是指在食品中发现非正常物品，其引发了消费者的疾病和伤害qGlass 玻璃qMetal 金属qStones, twigs, leaves 石头，树枝，叶片qWood 木片qPests 有害物qJewelry 珠宝qPlastic 塑料Allergens过敏源n Naturally occurring proteins自然生成的蛋白质n Minut
15、e amounts can cause allergic reaction极少的量便可引起过敏反应 - Only 5-10 ppm can trigger reaction只要有5-10ppm就可引起反应 - Symptoms occur within minutes and death within hours 几分钟内便产生症状，几小时内会导致死亡n Some reactions are fatal 有些反应是致命的 - Nut and seafood allergies 坚果和海产品过敏 - 1-2% of population have food allergies 有1-2%的人对食
16、物过敏 Major Food Groups containing Allergens主要包含过敏原的食品 Peanut, Tree Nuts 花生，松仁 (Walnut, Hazelnut, etc.)(胡桃，榛仁等) Shell fish, seafood and fish贝类，海产品和鱼 Soy bean and Soy Products大豆和豆制品 Egg and Egg Products鸡蛋和蛋制品 Wheat and related products 小麦及相关产品 Milk and Milk Products 牛奶和乳制品n Products derived from the ab
17、ove groups may contain traces of allergenic compounds. 以上产品包含过敏化合物n Other ingredients (MSG, some Food Colors, Sulphites) can cause similar reactions to the above listed allergens 其它成分(味精，食用色素，亚硫酸盐)也可引起类似反应Control Measures for Allergens include:对过敏原的控制措施包括：n Ensure correct labels/packaging is used an
18、d this matches product recipe 确保正确食使用标签和包装并与产品相匹配n Equipment is properly cleared 设备清洁得当n Obtain full ingredient declaration from raw material suppliers从原料供应商处获得所有的成分说明n Schedule allergen containing product lost in production plan 在产品计划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第三章 H
19、ACCP前提条件HACCP支持性程序：为了给食品的生产卫生提供基础，用以控制厂内环境条件的程序或步骤。 GMPs, - 良好操作规范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。建立GMPGMP体系是保证食品安全的首要步骤GMP - GMP - 确保食品具备良好的卫生生产环境Good Manufacturing Practices良好的生产规范 RECOMMENDED INTERNATIONAL CODE OF PRACTICE GENERAL PRICIPLES OF FOOD HYGIENE CAC/RCP 1-1969, Rev.3 (1997)q员工卫生q
20、建筑物与设施厂房与场地卫生操作卫生设施及控制q仪器和用具q加工和控制q存储和发送mei SSOP卫生标准操作规程q是GMP体系内的卫生控制部分q是标准化的卫生操作程序Sanitation Standard Operating Procedures (SSOP)卫生标准操作规程Safety of water水的安全Condition and cleanliness of food-contact surfaces食品接触面的状况和洁净程度Prevention of cross-contamination交叉污染的防范Maintenance of hand-washing, hand-saniti
21、zing and toilet facilities厕所及手的清洗消毒设施的维护Sanitation Standard Operating Procedures (SSOP) continue卫生标准操作规程Protection from adulterants污染物的防范Labeling, storage and use of toxic compounds有毒化学物质的标签，存放及使用Employee health 员工的健康Exclusion of pests害虫的防范HACCP的前提条件第四章 建立和实施HACCP的预备步骤联合国食品法典委员会中推荐建立和实施HACCP的过程为12个步
22、骤：1. 组成HACCP小组2. 描述产品3. 明确用途4. 绘制产品生产流程图5. 进行危害分析并确定预防控制措施6. 识别关键控制点7. 确定关键限8. 制定对关键控制点的监控程序9. 确定纠正措施10. 建立验证程序11. 建立文件及记录管理系统第1步：组成HACCPHACCP小组明确实施HACCPHACCP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HACCP小组必须明确: 范围 - 从哪里开始，到哪里结束，包括什么，目的 实施HACCP的原由 Specialist knowledge may be required of:专家所必须了解的nR
23、aw materials and ingredients 原材料和成分n Finished product 成品n Processing equipment 加工设备n Processing procedures 加工步骤 n Pre-requisite programs 支持性程序n The production environment (premises and surroundings)生产环境(厂房和环境)Team Requirements成员组要求Specialists will need full knowledge of:专家要完全了解：n Hazards associated
24、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n The likelihood and probability of these hazards occurring.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n Be trained in and have a thorough technical knowledge of HACCP.接受过HACCP培训并对其有充分的了
25、解Team Requirements成员组要求n Able to evaluate data in a logical manner; 能逻辑地评估数据n Can systematically solve problems; 能系统地解决问题n Able to think outside the box 思维广泛n Able to delegate 有代表性n Team players 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n Analytical, and; 有分析能力
26、n Good communication skills 良好的沟通技巧HACCP Team Member AttributesHACCP成员应具备的特质n Managing the design and implementation of the HACCP system (the management role). 管理HACCP系统的设计和执行 (管理的角色)n Determining whether the system fulfills the Codex guidelines and meets the applicable regulations (the regulatory r
27、ole).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)n Determining the effectiveness of the HACCP system (the analytical role). 确定HACCP系统的效果(分析的角色)n Reporting on the performance of the system and the quality of products (the scorekeeper role) 报告HACCP的执行和产品的质量(计分员的角色)General Responsibilities of the HACCP Team Lead
28、erHACCP组长的职责n Identifying areas for system improvement (the innovative role). 识别系统改善的区域(创新的角色)n Liaising with other organisations or professionals 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
29、联系其它的组织或专业人员（大使的角色）n Chairing the HACCP team meetings 主持HACCP会议n Completing the internal verification of the HACCP plan and signing off the validation and verification integrity of the plan. 完成HACCP计划的内审。确认计划的有效性和审核的整体性General Responsibilities of the HACCP Team Leader HACCP组长的职责第2步 产品说明 说明产品的具体的成份，物
30、理/化学 特性，包装，安全信息，加工方法，贮运方法，使用方法等。 Codex Guidelines 食品法典委员会指引详尽的产品描述包括以下安全信息：n Composition, 成分n Physical /chemical structure (including aw, pH, etc.) 理化指标n Mode of preservation (e.g. heat treatment, freezing, brining, smoking etc.) 保存方式n Packaging and Durability (shelf life) 包装及保质期n Storage conditions
31、 储存方式n Method of distribution.分销方式nProduct name 品名nComposition 成分nEnd Product Characteristics最终产品性状n Method of Preservation 保存方式n Packaging Outer 外包装 nPackaging Inner内包装nStorage Conditions 储存条件n Distribution Method分销方式n Shelf Life 货架期n Special Labelling标签n Customer Preparation 食用前准备n A separate fini
32、shed product specification is usually prepared for each food.每一产品应有单独的描述。n However, in some instances like products can be described on one specification (a product cluster) provided the ingredients, operational and storage conditions are similar.在产品配方，加工，存储方式类似的情况下可列外，（产品大类）。Finished Product Specif
33、ications第 3步 明确产品的用途 明确产品的用途及其拟供应的消费群体，注意敏感人群 The intended use should be based on the expected, normal uses of the product by the end user or the consumer. 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。 In specific cases, vulnerable groups of the population: e.g., the old, the very young, the sick or hospitalised have
34、to be considered. 在某些情况下，“易感人群“包括：老人，幼儿，和病人。Codex Guidelines Step 3.法典指引步骤3n Elderly 老人n Infants 婴儿n Pregnant 孕妇n Sick 病人n Those with compromised immune systems 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 Sensitive Population 易感人群 Include in the Product Descripti
35、on and Intended Use: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 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“易感人群”，如婴儿用品第 4步 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
36、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 qThe 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 should cover all steps in the operation. 流程图因涵盖生产各个环节。qWhen appl
37、ying 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The process flow diagram should depict:qDetails of all process activities including tasks, inspections, transportation, storage and delays in th
38、e process.详述各加工活动，包括：检验，储运，生产停顿等qInputs 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 rejected products.产出品如，成品，废料，需再加工，废弃产品。HACCP Principles - Guidelines for
39、 Implementation & Use - H7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From storage to batch preparation 储存至准备Batch Preparation to Line assembly 准备到制造生产线Line assembly tofrozen storage 制造生产线到冷冻储存From frozen storage toDistr
40、ibution 冷冻储存至分发These steps are theindividual tasks within Stage 3. 此阶段包括各独立步骤1第 5 步 现场验证工艺流程图 工艺流程图需要进行现场验证。它应该 由HACCP小组的全体成员在整个生产进行的过程中进行“边走边谈”。qOn-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
41、 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。 The Golden Rule金箴MISS A STEP - MISS A HAZARD.漏一步 - 漏一危害第五章 HACCP原理1：危害分析与确定预防控制措施 qList all potential hazards associated with each step; 列出每一步骤内的潜在危害。qConduct a hazard analysis; and determine the significance of each hazard.进行危害分析；判定每个危害的严重性。qConsider any
42、measures to control identified hazards.针对各危害，提出控制方法。Part A. HAZARD IDENTIFICATION危害分析 List All Potential Hazards列出所有危害Sources of Potential Hazards1. Raw materials原料2. Plant and equipment design场地及设备3. Intrinsic factors in the product or raw materials产品或原料的内在因素4. Process design (Procedures) 生产流程5. Pe
43、rsonnel (Staff / Visitors)个人（员工及访客）6. Storage and distribution （储存及配销）Examples of raw materials are:qFood ingredients (chilled, frozen, dry, liquid).食品配方qWater (used in formulation or to wash or rinse products).水 qCleaning chemicals.清洗用化学品qPackaging.包装qPesticides, insecticides杀虫剂Conduct Hazard Analy
44、sis and Determine the Significance of the identified Hazards危害分析及危害的严重性分析n Determine Likelihood of occurrence发生危害的可能性n Determine Severity Influence of Prerequisite Programs 预防性程序影响的严重性n Determine Significance- Method 1 方式 1- Method 2方式 2 A significant hazard has the potential to cause serious illnes
45、s 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病或伤害。Determine Significance of Hazards - Method 2 Matrix Method for Food SafetySeverity (consequences)严重性（后果）n Fatality 致命 nSerious Sickness 严重疾病 nProduct Recall 产品回收n Customer Complaint 顾客投诉1. Not Significant 无重大影响Likelihood (frequency) 可
46、能性 （频率）A. Common Repeating 经常B. Known to occur 会发生C. Could occur (published) 可能发生D. Not expected to occur 应该不会发生E. Practically impossible 实际上不可能发生Hazard Significance Matrix for Food Safety食品危害分析FREQUENCY 频率频率 A B C D E CONSEQUENCE 后果后果 1 1 2 4 7 11 2 3 5 8 12 16 3 6 9 13 17 20 4 10 14 18 21 23 5 15
47、19 22 24 25 IDENTIFY CONTROL MEASURES确定预防控制措施Identify Control MeasuresqControl Measures are any factors, actions and activities that can be used to control an identified food safety or quality hazard.可以是任何可以控制食品安全或质量危害的方法。qControl measures must eliminate, control or reduce the effect of a hazard to
48、an acceptable level方法必须可以用以去除、控制或将危害减小到可被接受的程度。CONTROL MEASURES for Biological hazards 控制生物危害的方法qPasteurisation - application of time/temperature巴氏杀菌qFermentation发酵qAcidification - ph control 控制pH值qPickling - addition of salt腌渍qDrying - Aw reduction干燥 控制水活性qFreezing/cooling 冷冻/冷藏qTraining to prevent
49、 cross contamination培训/预防交叉感染Control Measures for Chemical HazardsqSupplier Quality Assurance Programs供应商质量控制qCertificate of Analysis - signed and meet specification 测试分析证书，qSanitation Program - approved food grade chemicals, visual inspections 卫生清洁程序qPest Management Program - approved pesticides虫害管
50、理qAntibiotic Testing抗生素测试qDesignated with-holding period for crop control chemicals农作物化学残留期qCorrect Labels - for products containing allergens正确的表示-针对含过敏源的产品CONTROL MEASURES for Physical Hazards控制物理qSieves - use nitex (not metal wire)筛qScreens网qMagnets 磁性qFilters过滤qMetal Detectors金属探测qGlass Control
