haccp培训资料2-1课件

1、第一章 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 & Prions from these groups are n

2、ow 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Bacteria - (Clostridium spp., Salmonella spp., Listeria monocytogenes) 细菌Viruses - (Hepatitis, Rotavirus) 病毒Fungi - (Aspergillus spp., Fusarium sp

3、p.) 霉菌Parasites - (Fasciola hepatica, Giardia lamblia, Med. fly)寄生虫Algae - (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pH 酸碱度Moisture content 水分Nutrients 营养Anti-microbial constituents抗微生物因素Biological struc

4、tures生物结构Extrinsic factors外部因素Temperature 温度Humidity 湿度Gases 气体Chemical Hazards.化学危害 Plasticisers and Packaging Migration 增塑剂和包装转移Veterinary Residues 兽药残留Chemical Additives 化学添加剂Seafood toxins 海产品毒素Zootoxins 动物性毒素Phyllotoxins 叶黄素Physical Hazards物理危害Physical hazards are objects not normally found in

5、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Glass 玻璃Metal 金属Stones, twigs, leaves 石头，树枝，叶片Wood 木片Pests 有害物Jewelry 珠宝Plastic 塑料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 fi

6、sh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 Products derived from the above groups may contain traces of allergenic compounds. 以上产品包含过敏化合物 Other ingredients (MSG, some Food Colors, Sulphites) can cause similar

7、 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： Ensure correct labels/packaging is used and this matches product recipe 确保正确食使用标签和包装并与产品相匹配 Equipment is properly cleared 设备清洁得当 Obtain full ingredient declaration from raw material

8、 suppliers从原料供应商处获得所有的成分说明 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 Control and trace reworked products 控制并追踪重做的产品第二章 HACCP前提条件GMPSSOPHACCPHACCP 体系的构架建立GMP体系是保证食品安全的首要步骤GMP - 确保食品具备良好的卫生生产环境SSOP卫生标准操作规程是GMP体系内的卫生控制部分是标准化的卫生操作程序Sanitation Standard Operating Proce

9、dures (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-sanitizing 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 fro

10、m 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的前提条件管理保证生产作业标准人员培训设备维护计量校准制度采购控制产品回收标识与溯源制度第三章 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. 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

11、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Raw materials and ingredients 原材料和成分 Finished product 成品 Processing equipment 加工设备 Processing procedures 加工步骤 Pre-requisite programs 支持性程序 The produc

12、tion environment (premises and surroundings)生产环境(厂房和环境)Team Requirements成员组要求 Able to evaluate data in a logical manner; 能逻辑地评估数据 Can systematically solve problems; 能系统地解决问题 Able to think outside the box 思维广泛 Able to delegate 有代表性 Team players 具备团队精神 Organisational, time management and group meeting

13、 skills 组织能力、时间管理及会议管理技巧 Analytical, and; 有分析能力 Good communication skills 良好的沟通技巧HACCP Team Member AttributesHACCP成员应具备的特质 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) Determining whether the system fulfills the Codex guidelines and meets

14、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 (调整的角色) Determining the effectiveness of the HACCP system (the analytical role). 确定HACCP系统的效果(分析的角色) 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)Gener

15、al Responsibilities of the HACCP Team LeaderHACCP组长的职责 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 professionals when the business lacks the skills to answer specific questions, or when external verification must be arranged (

16、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 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

17、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： Composition, 成分 Physical /chemical structure (including aw, pH, etc.) 理化指标 Mode of preservation (e.g. heat treatment, freezing, brining, smoking etc.) 保存方式 Packaging and Durability (shel

18、f life) 包装及保质期 Storage conditions 储存方式 Method of distribution.分销方式Product name 品名Composition 成分End Product Characteristics最终产品性状 Method of Preservation 保存方式 Packaging Outer 外包装 Packaging Inner内包装Storage Conditions 储存条件 Distribution Method分销方式 Shelf Life 货架期 Special Labelling标签 Customer Preparation 食

19、用前准备 A separate finished product specification is usually prepared for each food.每一产品应有单独的描述。 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）。Fini

20、shed Product Specifications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

21、 hospitalised have 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3 Elderly 老人 Infants 婴儿 Pregnant 孕妇 Sick 病人 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 Pro

22、duct Description 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

23、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 The 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。The flow diagram should cover all steps in the operation. 流程图因涵盖生产各个环节

24、。When 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The process flow diagram should depict:Details of all process activities including tasks, inspections, transportation, storage and del

25、ays 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。Outputs from the process e.g., finished product, waste product - in - progress, re-work and rejected products. 。HACCP Principles - Guidelines for Implementation & Use - H7原料至成品23

26、453.13.23.33.43.53.6STAGE 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 toDistribution 冷冻储存至分发These steps are th

27、eindividual 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”。On-Site Verification of the Process Flow Diagram is required. 需要现场验证生产流程图表 It 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

28、环节及时段完成。 The Golden Rule金箴MISS A STEP - MISS A HAZARD.漏一步 - 漏一危害第四章 HACCP原理1：危害分析与确定预防控制措施 List all potential hazards associated with each step; 列出每一步骤内的潜在危害。Conduct 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。Consider any measures to control identified hazards

29、.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. Personnel (Staff / Visitors)个人（员工及访客）6. S

30、torage and distribution （储存及配销）Examples of raw materials are:Food ingredients (chilled, frozen, dry, liquid).食品配方Water (used in formulation or to wash or rinse products).水 Cleaning chemicals.清洗用化学品Packaging.包装Pesticides, insecticides杀虫剂Conduct Hazard Analysis and Determine the Significance of the id

31、entified Hazards危害分析及危害的严重性分析 Determine Likelihood of occurrence发生危害的可能性 Determine Severity Influence of Prerequisite Programs 预防性程序影响的严重性 Determine Significance Method 1 方式 1 Method 2方式 2 A significant hazard has the potential to cause serious illness or injury when the food-stuff is consumed.食物中存在

32、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） Fatality 致命 Serious Sickness 严重疾病 Product Recall 产品回收 Customer Complaint 顾客投诉 Not Significant 无重大影响Likelihood (frequency) 可能性 （频率）A. Common Repeating 经常B. Known to occur 会发生C. Co

33、uld 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IDENTIFY CONTROL MEASURES确定预防控制措施Identify Control MeasuresControl Measures are any factors, actions and activities that can be used to control an identified food

34、 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。Control measures must eliminate, control or reduce the effect of a hazard to 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Pasteurisation - application of time/temperature巴氏杀菌Fermentation发酵Acidification

35、 - ph control 控制pH值Pickling - addition of salt腌渍Drying - Aw reduction干燥 控制水活性Freezing/cooling 冷冻/冷藏Training to prevent cross contamination培训/预防交叉感染Control Measures for Chemical HazardsSupplier Quality Assurance Programs供应商质量控制Certificate of Analysis - signed and meet specification 测试分析证书，Sanitation

36、Program - approved food grade chemicals, visual inspections 卫生清洁程序Pest Management Program - approved pesticides虫害管理Antibiotic Testing抗生素测试Designated with-holding period for crop control chemicals农作物化学残留期Correct Labels - for products containing allergens正确的表示-针对含过敏源的产品CONTROL MEASURES for Physical Ha

37、zards控制物理Sieves - use nitex (not metal wire)筛Screens网Magnets 磁性Filters过滤Metal Detectors金属探测Glass Control Policy玻璃控制Good Manufacturing Practices - personal hygiene procedures良好生产规范-个人卫生Use of Plastic (not Wooden) Pallets. 塑料货盘第五章 HACCP原理2：关键控制点的识别 A Critical Control Point (CCP) is a step at which con

38、trol can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.关键控制点： 能实施控制，从而对食品安全危害加以预 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A Contr

39、ol Point (CP) is a step in the process where control 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安全危害（在可被接受范围内）Control PointCritical Control PointsFor every significant hazard identified during

40、 hazard analysis there must be 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A 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。CCP Decision Tree 关键

41、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。The HACCP Team should ask an additional question when using the decision tree at Question 1. Is this hazard controlled by existing pre-requisite progra

42、ms (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。如果是的话，此步骤往往是控制点而非关键控制点。CCP Decision TreeQ1.Is there a hazard at this process step?- What is it?Q2.Do preventative measures exist for the identified hazards?Q3.Is the

43、step specifically designed to eliminate or reduce the likely occurence of the hazard to an acceptable level?Not a CCPIs control necessary at thisstep for safety?Not a CCPNot a CCPyesyesnonononoQ4.Could contamination occur at orincrease to unacceptable levels?Q5.Will a subsequent step or action elimi

44、nate or reduce the hazards to an acceptable level?yesyesModify step, process, orproductyesnoNot a CCPnoCritical Control PointyesCCP Decision TreeS. Mortimore and C. Wallace, HACCP a Practical Approach (1994), Chapman &Hall, London.第六章 HACCP原理3：为每个CCP 建立关键控制限 What is a Critical Limit? 什么是关键控制限Critica

45、l limits are criteria which separate acceptable from unacceptable, safe from unsafe. 控制限值，区分可接受与不可接受，安全与不安全的标准。They are the tolerance parameters for safety or product acceptance; the boundaries of control. 产品安全或可接受的容忍度；是控制的界限。Published data公布的数据Expert advice专家建议Experimental date试验数据Regulatory guidel

46、ines法规指引Mathematical modelling数学模型Best practice 最佳实践Source of information on Critical Limits: 关键控制限的来源Critical Limits 控制限Must be applied to all CCPs 必须运用于所有CCPMust be validated必须被确认有效Must be measurable必须是可被量度的Critical Limits关键控制限If the information needed to define the critical limits is not availabl

47、e, a conservative value can be selected. 如果缺乏有关信息，可采用一个较保守的值The 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计划的支持性文件。Types of Critical LimitsPhysical limits物理time, temp, weight, grade, b

48、rix, absence of metal/wood/glass时间、温度、等级、无金属/木/玻璃碎片。Chemical limits化学pH, moisture, salt, sugar, fat, MRLs, chlorine sanitizer level pH值、盐、糖、脂肪、农残等Microbiological limits微生物food standards code106 Total Plate Count /ATPValidation 验证Validation of critical limits关键控制限的验证is obtaining evidence that the cri

49、tical limit does in fact control the hazard是用以证明关键控制限可有效地控制危害 Operating Limits are criteria that are more stringent than critical limits. 操作限度较关键控制限度为严格 Are used to indicate process variation before control is lost and unsafe food is produced.在失去控制、不安全食品出现前用以指示发生的变化。Operating Limits 操作限值第七章 HACCP原理4

50、：监控关键控制点 Codex Guidelines Step 9, HACCP Principle 4 法典指引步骤9，HACCP原理4 Monitoring is a the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a critical control point is under control. 监控是实施预先计划好的观察及测量，以评估CCP是否在控制范围之内。The 5 Aspects of Monitorin

51、g监控的5个方面1. Why monitoring is important为什么监控是重要的2. Who monitors由谁来监控3. How to monitor如何监控4. When to monitor何时监控5. Frequency of monitoring监控的频率Why monitoring is important为什么监控是重要的. Know when CCPs & CQPs are out of control知道何时CCPs & CQPs 失控Identify problems before they occur在问题发生之前便明确Pinpoint the cause

52、 of problems查明问题原因Part of verification审核的角色Proves due diligence “If it isnt written down, it didnt happen”“免责” 辩护：“如果没有纪录，便认定为没有作过”Monitoring Involves监控包括Asking the right questions问合适的问题Analyzing data to get the right information分析数据以获得正确的信息Knowing “Where” to collect知道“何处”获取Being unbiased公正Training

53、of data collectors / operators / monitors数据操作者/操作者/监控者的培训Auditing the collection process审核收集过程Who, How and When to Monitor 谁，如何，何时监控WHO谁Trained受训的Unbiased公正的HOW如何Observation调查Sight看Smell闻Taste尝Measurement度量Weight重量Time时间Temperature温度WHEN何时On-line即时的Continuous持续的Discontinuous间歇的Off-line 离线Discontinuo

54、us间歇的Sampling Techniques抽样技术Random Sampling 随机抽样Systematic Sampling 系统抽样Stratified Sampling 分层抽样Cluster Sampling 分群抽样(Refer Australian Standards 1199, 1399, 2490)Basic Criteria for Collecting Data抽取数据的基本标准Data must be数据应Relevant 相关的Reliable 可靠的Representative 有代表性的 Readable 可读的第八章 HACCP原理5：确定应对偏差的纠偏措

55、施 Corrective Action 纠偏行动Any action to be taken 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。Codex Guidelines Step 10 指引10HAACP Principle 5 原则5Specific corrective actions must be delivere

56、d for each critical 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动Codex GuidelinesThe 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CCP Actions taken must also include proper disposition of the aff

57、ected product.行动计划必须包括如可处置受影响的产品Deviation and product disposition procedures must be documented in HACCP records.偏差及产品处置必须纪录在案The Two Levels of Corrective Action 2 种纠偏行动1.Immediate Action - (short term control): 立即行动（短期）Adjust the process to regain control.调整生产过程，重新恢复控制Deal with the suspect product.

58、 处理受影响产品2. Preventive Action - (long term control) to:预防行动 （长期）Determine root cause找出根源Assign responsibility to complete preventive action 完善预防行动计划Record details of actions taken and update HACCP as required 将行动纪录在案，完善HACCP计划Record the details of corrective action taken详细记录所采取的纠偏行动第九章 HACCP原理6：建立审核程

59、序 Verification is “Doing it Right”! 验证是确保“正确地执行” Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP Plan验证是运用方法、程序、测试和其他的评估手段 对HACCP计划的符合性监控。CODEX Alimentarius 97/13ACodex Guidelines Verification 验证Est

60、ablish procedures for verification.建立验证程序 To determine if the HACCP system is working correctly, verification that includes auditing methods, review procedures, tests, random sampling and analysis can be used . 为了确认HACCP体系是否正确的运作,验证要包括审核、检验、随机采样和分析The frequency of verification should be sufficient t