食品安全体系评价：Section IIIDeveloping HACCP Plans

1、Section III Developing HACCP Plans,Initial Tactics in developing HACCP plans Hazard analysis and identification of CCPs Monitoring and corrective actions Recordkeeping and verification procedures Workshop flow diagrams and forms,Definitions of HACCP,CCP decision tree a sequence of questions to deter

2、mine whether a control point is a CCP,CCP判断树,C C P,不是CCP,1、针对已辨明的危害，在本步或随后的步骤中是否有相应的预防措施？,是,修改工艺,否,在本步进行控制是达到安全所必须的吗？,是,2、能在此步将显著危害发生的可能性消除或降低到可接受水平吗？,是,3、已确定的危害造成的污染能否超过可接受水平或增加到不可接受水平？,4、下一步能否消除危害或将发生危害的可能性降低到可接受水平？,是,是,否,否,否,否,CCP Decision Tree,Hazard,Is control of this hazard necessary for Food

3、Safety?,Could contamination occur at this step or increase to unacceptable levels?,Will a subsequent step eliminate this hazard?,Are procedures in place and will they reduce or eliminate this hazard?,Critical Control Point,YES,NO,YES,YES,NO,NO,NO,YES,Continuous Monitoring: uninterrupted collection a

4、nd recording of data such as temperature on a strip chart. Control: a. to manage the conditions of an operation to maintain compliance with established criteria. b. The state wherein correct procedures are being followed and criteria are being met. Control Point: Any point, step, or procedure at whi

5、ch biological, physical, or chemical factors can be controlled.,Corrective action: procedures to be followed when a deviation occurs. Criterion: a requirement on which a judgment or decision can be based. Critical control point (CCP): a point, step, or procedure at which control can be applied and a

6、 food safety hazard can be prevented, eliminated,or reduced to acceptable levels.,Critical defect: a deviation at a CCP which may result in a hazard. Critical limit: a criterion that must be met for each preventive measure associated with a critical control point. Deviation: failure to meet a critic

7、al limit.,HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed to assure the control of a specific process or procedure. HACCP system: The result of the implementation of the HACCP plan HACCP Team: The group of people who are

8、 responsible for developing a HACCP plan.,HACCP Plan Reevaluation: One aspect of verification in which a documented periodic review of the HACCP plan is done by the HACCP team with the purpose of modifying the HACCP plan as necessary. HACCP Plan Validation: The initial review by the HACCP team to en

9、sure that all elements of the HACCP plan are accurate.,Hazard: A biological, chemical, or physical property that may cause a food to be unsafe for consumption. Monitor: To conduct a planned sequence of observation or measurements to assess whether a CCP is under control and to produce an accurate re

10、cord for future use in verification. Preventive Measure: Physical, chemical, or other factors that can be used to control an identified health hazard.,Random Checks: Observations or measurements which are performed to supplement the scheduled evaluations required by the HACCP plan. Risk: An estimate

11、 of the likely occurrence. Severity: The seriousness of a hazard. Sensitive ingredients: An ingredient known to have been associated with a hazard and for which there is reason for concern.,Target levels: criteria which are more stringent than critical limits and which are used by an operator to red

12、uce the risk of a deviation. Verification: the use of methods, procedures, or tests in addition to those used in monitoring to determine if the HACCP system is in compliance with the HACCP plan and/or whether the HACCP plan needs modification and revalidation.,Seven Principles of HACCP,Conduct a haz

13、ard analysis. Prepare a list of steps in the process where significant hazards occur and describle the preventive measures. Identify the CCPs in the process. Establish critical limits for preventive measures associated with each identified CCP. Establish CCP monitoring requirements. Establish proced

14、ures for using the results of monitoring to adjust the process and maintain control. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit. Establish effective record-keeping procedures that document the HACCP system. Establis

15、h procedures for verification that the HACCP system is working correctly.,Developing a HACCP Plan,Assemble the HACCP Team Describe the food and its distribution Identify intended use and consumers of the food Develop a process flow chart Verify the process flow chart Conduct hazard analysis (Princip

16、le 1),Figure. First six steps for development of a HACCP plan (lists steps used in the application of Principle 1),1. Assemble the HACCP team,2. Describe the food and its Distribution,3. Identify intended use and consumers of the food,4. Develop flow diagram,5. Verify flow diagram,6. Conduct hazard

17、analysis,Introduction the initial tactics in developing HACCP plans,HACCP plans must be specific for the product and process. Each plan must be developed based upon the unique conditions which define and produce each food product: Suppliers Ingredient specifications Batches of ingredients Formulatio

18、n Product specifications,Facility and layout Types of equipment Equipment design Preparation design Operating condition Processing parameters Employee practices,Packaging materials Storage and warehousing Distribution Retail handling and display Product shelf-life Label Instruction to the consume,As

19、semble the HACCP team,HACCP Coordinator The HACCP team Describe the food and its intended use Develop a flow diagram which describe the process Verify the flow diagram,Knowledge and experience to correctly: identify potential hazards; assign levels of severity and risk; recommend controls. criteria,

20、 and procedures for monitoring and verification; recommend appropriate corrective actions when a deviation occurs; recommend research related to the HACCP plan if important information is not known; predict the success of the HACCP plan.,2. Describe the food and the method of its distribution A sepa

21、rate HACCP plan must be developed for each food product that is being processed in the establishment. The HACCP team must fully describe the food, including the recipe or formulation, storage method, the potential for abuse in the distribution channel and by consumers.,Described questions:,What is t

22、he product? (e.g., frozen fried chicken things; buttermilk pancake mix; chocolate ice cream) What is the intended use? (e.g., retail, food service, further manufacturing) What is the nature of the product? (e.g. fresh, canned, dried, vacuum packaged) What type of storage and distribution is required

23、? (e.g., frozen, refrigerated, ambient),What is the self-life of the product? What preparation procedures are required? (e.g., ready-to eat, heat-and-serve, prepare and bake, reconstitution) What is the potential for mishandling? Are there any other special considerations which need to be addressed?

24、 Note: the questions will vary according to the individual product. a detailed formula for the product is important.,3. Identify the intended use and consumers of the food The intended use of the food should be based upon the normal use of the food by end users or consumers. The intended consumers m

25、ay be the general public or a particular segment of the population, such as infants, the elderly, etc.,Example 1: Ice-cream with chocolates,产品描述： 巧克力冰激凌(产品名称)是一种含有加热灭菌成分(与食品安全有关的特性)又含有未加热灭菌成分的冷冻即食产品(加工方式和预期用途)。经过加热杀菌的成分是脱脂奶粉，奶油，糖和水(产品成分)，未经加热杀菌的成分是香料和巧克力屑(产品成分)。 本产品可直接食用，消费对象是普通人群，也包括高危险人群(最终用户和消费者)

26、。,Example 2: Meat Products,Example 3: Concentrated apple juice,4. Develop a flow diagram which describe the purpose,A detailed compilation of material associated with the ingredients, storage, preparation, processing, packaging, storage and distribution of the product. A simple block flow diagram. T

27、he equipment used is important. 5. Verify the flow diagram an on-site inspection, updated and modified for accuracy and completeness,肉糜制品工艺流程图,各类添加剂验收,各类添加剂入库,混合,二次打浆,原料肉验收,一次冻藏,去筋,分割,绞肉,打浆,二次冻藏,成型(肉丸),煮制,摊冻,包装,金属探测,成品冻藏,出货,非肉成分验收,非肉成分入库,面粉制皮,辅料清洗,手包(烧卖),蒸制,肉糜制品工艺说明,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危

28、害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,危害分析工作单,Summary,HACCP should gather necessary information by: Describing the food, its intended use, shelf-life, distribution, consumes, etc. 2. Developing a flow diagram an

29、d comprehensive information concerning preparation and processing operations. 3. Verifying, on-site, that the flow diagram is accurate and complete.,Hazard analysis,Key element Safety issues( not quality and economic issues) The significance of the hazards must be determined based upon their likelih

30、ood or occurrence and their severity. Hazards of low risk are typically addressed through “GMPs” and other “prerequisite” programs.,Examples of questions to be considered in a hazard analysis,Ingredients Dose the food contain any sensitive ingredients that may present microbiological hazards (e.g.,

31、Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass. metal)? 2. Is potable water used in formulating or in handling the food?,B. Intrinsic factors Physical characteristics and composition (e.g., pH, type of acid

32、ulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing. Which intrinsic factors of the food must be controlled in order to assure food safety? Dose the food permit survival or multiplication of pathogens and /or toxin formation in the food during pro

33、cessing? Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain? Are there other similar products in the market place? What has been the safety record for these products?,C. Procedures used for processing Dose the process include

34、 a controllable processing step that destroys pathogens? Consider both vegetative cells and spores. Is the product subject to recontamination between process (e.g., cooking, pasteurizing) and packaging?,D. Microbial content of the food Is the food commercially sterile (e.g.,low acid canned food?) Is

35、 it likely that the food will contain viable sporeforming or nonsporeforming pathogens? What is the normal microbial content of the food? Does the microbial population change during the normal time the food is stored prior to consumption? Does the subsequent change in microbial population alter the

36、safety of the food?,E. Facility Design Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat foods if this is important to food safety? 2. Is positive air pressure maintained in product packaging area? Is this essential for product safety? 3. Is the traffi

37、c pattern for people and moving equipment a significant source of contammination?,F. Equipment Design Will the equipment provide the time-temperature control that is necessary for safe food? Is the equipment properly sized for volume of food that will be processed? Can the equipment be sufficiently

38、controlled so that the variation in performance will be within the tolerances required to produce a safe food? Is the equipment reliable or is it prone to frequent breakdowns? Is the equipment designed so that it can be cleaned and sanitized? Is there a chance for product contamination with hazardou

39、s substances; e.g., glass? What product safety devices are used to enhance consumer safety?,G. Packaging Does the method of packaging affect the multiplication of microbial pathogens and /or the formation of toxins? Is the package clearly labeled ”Keep refrigerated” if this is required for safety? D

40、ose the package include instructions for safe handling and preparation of the food by the end user? Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination? Are tamper-evident packaging features used? Is each package and case legibly and accurately co

41、ded? Does each package contain the proper label?,Sanitation Can sanitation impact upon the safety of food that is being processed Can the facility and equipment be cleaned and sanitized to permit the safe handling of food? Is it possible to provide sanitary conditions consistently and adequately to

42、assure safe foods?,Employee health, hygiene and education Can employee health or personal hygiene practices impact upon the safety of the food being processed? Do the employees understand the process and the factors they must control to assure the preparation of safe foods? Will the employees inform management of a problem wh