食品安全计划

有效的管理控制 一个全面的食品安全机制 有效的管理控制基础 餐厅经理要对那些会引发食物性传播疾病的安全食品加工过程负责监控管理。 管理人员和工作人员要对食品安全方面的问题具备相关知识。 有效的管理控制基础 工作人员培训 书面的标准操作程序 (SOPs) 监控计划和文档保存 食品安全检查 Additional Information is available at: http://www.cfsan.fda.gov/~acrobat/fc05-a4.pdf Food Safety Plan

食物性传播疾病的风险因素 在美国，食品与药物管理局确定了五种最容易引发食物性传播疾病的风险因素： 食物来自不安全的源头 食物烹制不当 温度使用不正确 设备受到污染 个人卫生习惯不佳 Food Safety Plan

什么是 HACCP？ HACCP（危害分析关键控制点）是一种用来确定，评估和控制食品安全危害的系统方法。 危害是指生物的、化学的、物理的因素，如不控制可能会导致伤病。 HACCP防止食品安全的危害胜于应对这种危害。 要制定一个HACCP计划，需遵循七个原则。 HACCP

何时需要HACCP计划 并非所有的餐饮机构都要求有一个HACCP计划 如果实际运作中涉及下列操作，就需要一个HACCP 计划： 用真空包装食物 供应生肉 包装鲜榨橙汁 从池、箱中直接供应贝类动物 熏制保存食物 HACCP

前提条件计划 重视员工，设备和设施。 前提条件计划内容的实例: 疾病防治办法 清洁和消毒程序 垃圾的清运 害虫的控制 设备的选用 员工的个人卫生 HACCP

1: 开展危害分析 结合具体的项目来确定危害。 危害可能是生物的、化学的和物理的。 列出容易出现的，以及如果不控制就会导致严重后果的危害。 1: 开展危害分析 结合具体的项目来确定危害。 准备一张描述从接货到供应（上菜）过程中所有加工处理步骤的流程图。 列出每个步骤可能会有的危害。 确定如何防止这些危害。 危害可能是生物的、化学的和物理的。 列出容易出现的，以及如果不控制就会导致严重后果的危害。 风险不大的，不需特别考虑的危害。 PRINCIPLE #1: HAZARD ANALYSIS (a) Purposes The hazard analysis process accomplishes three purposes: Hazards of significance are identified;   The hazard analysis provides a risk basis for selecting likely hazards;   Identified hazards can be used to develop preventive measures for a process or product to ensure or improve food safety. Before beginning to develop a HACCP plan, a team should be assembled that is familiar with the overall food operation and the specific production processes to be included in the plan. The team's goal and each member's responsibilities in reaching that goal must be clearly defined. The first step in the development of a HACCP plan for a food operation is identification of hazards associated with the product. A hazard may be a biological, chemical, or physical property that can cause a food to be unsafe. The analysis of hazards requires the assessment of two factors with respect to any identified hazard, i.e., the likelihood that the hazard will occur and the severity if it does occur. Hazard analysis also involves establishment of preventive measures for control. Hazards that involve low risk and that are not likely to occur need not be considered for the purposes of HACCP. To be effectively addressed, hazards must be such that their prevention, elimination, or reduction to acceptable levels is attained. Numerous issues have to be considered during hazard analysis. These relate to factors such as ingredients, processing, distribution, and the intended use of the product. These issues include whether a food contains sensitive ingredients that can create microbiological, chemical, or physical hazards; or whether sanitation practices that are used can introduce these hazards to the food that is being prepared or processed. An example is whether the finished food will be heated by the consumer, if it is consumed off the premises. Even factors beyond the immediate control of the food establishment, such as how the food will be treated if taken out by the consumer and how it will be consumed, must be considered because these factors could influence how food should be prepared or processed in the establishment. (b) Flow Diagram Consequently, a flow diagram that delineates the steps in the process from receipt to sale or service forms the foundation for applying the seven principles. The significant hazards associated with each step in the flow diagram should be listed along with preventative measures proposed to control the hazards. This tabulation will be used under Principle 2 to determine the CCPs. The flow diagram should be constructed by a HACCP team that has knowledge and expertise on the product, process, and the likely hazards. Each step in a process should be identified and observed to accurately construct the flow diagram. Some examples of flow diagrams are found at the end of this Annex. (c) Biological Hazards Foodborne biological hazards include bacterial, viral, and parasitic organisms. These organisms are commonly associated with humans and with raw products entering the food establishment. Many of these pathogens occur naturally in the environment where foods are grown. Most are killed or inactivated by adequate cooking and numbers are kept to a minimum by adequate cooling during distribution and storage. Bacterial pathogens comprise the majority of reported foodborne disease outbreaks and cases. A certain level of the pathogens can be expected with some raw foods. Temperature abuse, such as improper hot or cold holding temperatures, can significantly magnify this number. Cooked food which has been subject to cross-contamination with pathogens often provides a fertile medium for their rapid and progressive growth. Enteric viruses can be foodborne, waterborne, or transmitted from a person or from animals. Unlike bacteria, a virus cannot multiply outside of a living cell. Hepatitis A and Norwalk viruses are examples of viral hazards associated with ready-to-eat foods. Parasites are most often animal host-specific and can include humans in their life cycles. Parasitic infections are commonly associated with undercooking meat products or cross contamination of ready-to-eat food. Fishborne parasites in products that are intended to be eaten raw, marinated, or partially cooked can be killed by effective freezing techniques. The following table provides an assessment of severity of the biological hazards which may be associated with food being prepared, served, or sold in food establishments. TABLE 1. Hazardous Microorganisms and Parasites Grouped on the Basis of Risk Severitya Severe Hazards Clostridium botulinum types A, B, E, and F Shigella dysenteriae Salmonella Typhi; paratyphi A, B Hepatitis A and E Brucella abortus; B. suis Vibrio cholerae 01 Vibrio vulnificus Taenia solium Trichinella spiralis Moderate Hazards: Potentially Extensive Spreadb Listeria monocytogenes Salmonella spp. Shigella spp. Enterovirulent Escherichia coli (EEC) Streptococcus pyogenes Rotavirus Norwalk virus group Entamoeba histolytica Diphyllobothrium latum Ascaris lumbricoides Cryptosporidium parvum Moderate Hazards: Limited Spread Bacillus cereus Campylobacter jejuni Clostridium perfringens Staphylococcus aureus Vibrio cholerae, non-01 Vibrio parahaemolyticus Yersinia enterocolitica Giardia lamblia Taenia saginata a Adapted from International Commission on Microbiological Specifications for Food (ICMSF) (1986). Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 1992. Chapman & Hall, New York, NY. b Although classified as moderate hazards, complications and sequelae may be severe in certain susceptible populations. (d) Chemical Hazards Chemical hazards in foods should be considered during a hazard analysis. Chemical contaminants may be naturally occurring or may be added during the processing of food. Harmful chemicals at very high levels have been associated with acute cases of foodborne illnesses and can be responsible for chronic illness at lower levels. The following table provides some examples of chemical hazards found within the naturally occurring and added chemical categories. The Code of Federal Regulations, Title 21, provides guidance on naturally occurring toxic substances and allowable limits for many of the chemicals added during processing (food additives). The FDA Compliance Policy Guidelines also provide information on other naturally occurring chemicals. Table 2. Types of Chemical Hazards and Examplesa Naturally Occurring Chemicals Mycotoxins (e.g., aflatoxin) from mold Scombrotoxin (histamine) from protein decomposition Ciguatoxin from marine dinoflagellates Toxic mushroom species Shellfish toxins (from marine dinoflagellates) Paralytic shellfish poisoning (PSP) Diarrhetic shellfish poisoning (DSP) Neurotoxic shellfish poisoning (NSP) Amnesic shellfish poisoning (ASP) Plant toxins Pyrrolizidine alkaloids Phytohemagglutinin Added Chemicals Agricultural chemicals: Pesticides, fungicides, fertilizers, insecticides, antibiotics and growth hormones Polychlorinated biphenyls (PCBs) Industrial chemicals Prohibited substances (21 CFR 189)   Direct   Indirect Toxic elements and compounds:   Lead, zinc, arsenic, mercury, and cyanide a Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 1992. Chapman & Hall, New York, NY and adapted. Food additives:   Direct - allowable limits under GMPs Preservatives (nitrite and sulfiting agents) Flavor enhancers (monosodium glutamate) Nutritional additives (niacin) Color additives Secondary direct and indirect Chemicals used in establishments (e.g., lubricants, cleaners, sanitizers, cleaning compounds, coatings, and paints) Poisonous or toxic chemicals intentionally added (sabotage) (e) Food Allergens Each year the Food & Drug Administration (FDA) receives reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods. Food allergies are abnormal responses of the immune system, especially involving the production of allergen-specific IgE antibodies, to naturally occurring proteins in certain foods that most individuals can eat safely. Frequently such reactions occur because the presence of the allergenic substances in the foods is not declared on the food label. To combat this problem, the agency issued a letter titled "Notice to Manufacturers," dated June 10, 1996, which addressed labeling issues and Good Manufacturing Practices (GMPs). This letter is available on FDA's web site, www.cfsan.fda.gov/~lrd/allerg7.html. FDA believes there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies. Peanuts Soybeans Milk Eggs Fish Crustacea Tree nuts WheatCurrent FDA policy, as reflected in FDA Compliance Policy Guide (CPG) 555.250 with regard to direct addition as ingredients or sub-ingredients, is: Products which contain an allergenic ingredient by design must comply with 21 U.S.C. 343(i)(2). Where substances that are, bear, or contain allergens are added as ingredients or sub-ingredients (including rework), the Federal Food, Drug, and Cosmetic Act (the Act) requires a complete listing of the food ingredients (section 403(i)(2); 21 U.S.C. 343(i)(2); 21 C.F.R.101.4 (689 KB)) unless a labeling exemption applies. FDA's Regulations (21 CFR 101.100(a)(3) (689 KB)), provide that incidental additives, such as processing aids, which are present in a food at insignificant levels and that do not have a technical or functional effect in the finished food are exempt from ingredient declaration. Some manufacturers have asserted to FDA that some allergens used as processing aids qualify for this exemption. FDA, however, does not consider food allergens eligible for this exemption. Evidence indicates that some food allergens can cause serious reactions in sensitive individuals upon ingestion of very small amounts; therefore, the presence of an allergen must be declared in accordance with 21 CFR 101.4 (689 KB). Allergens may be unintentionally added to food as a result of practices such as improper rework addition, product carry-over due to use of common equipment and production sequencing, or the presence of an allergenic product above exposed product lines. Such practices with respect to allergenic substances can be insanitary conditions that may render the food injurious to health and adulterate the product under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. (f) Physical Hazards Illness and injury can result from hard foreign objects in food. These physical hazards can result from contamination and/or poor procedures at many points in the food chain from harvest to consumer, including those within the food establishment. As establishments develop their HACCP programs, the following table can be used to further identify sources of potential physical risks to the food being prepared, served, or sold. Table 3. Main Materials of Concern as Physical Hazards and Common Sourcesa,b Material Injury Potential Sources Glass fixtures Cuts, bleeding; may require surgery to find or remove Bottles, jars, light, utensils, gauge covers Wood Cuts, infection, choking; may require surgery to remove Fields, pallets, boxes, buildings Stones, metal fragments Choking, broken teeth Cuts, infection; may require surgery to remove Fields, buildings, machinery, fields, wire, employees Insulation Choking; long-term if asbestos Building materials Bone Choking, trauma Fields, improper plant processing Plastic Choking, cuts, infection; may require surgery to remove Fields, plant packaging materials, pallets, employees Personal effects Choking, cuts, broken teeth; may require surgery to remove Employees a Adapted from Corlett (1991). b Used with permission, "HACCP Principles and Applications", Pierson and Corlett, Eds. 1992. Chapman & Hall, New York, NY. (f) Determining Level of Risk The potential significance or risk of each hazard should be assessed by considering its likelihood of occurrence and severity. The estimate of risk for a hazard occurring is based upon a combination of experience, epidemiological data, and information in the technical literature. Severity is the degree of seriousness of the consequences of a hazard if it were to become an actuality. Hazard identification in conjunction with risk estimation provides a rational basis for determining which hazards are significant and must be addressed in the HACCP plan. To determine risk during the hazard analysis, safety concerns must be differentiated from quality concerns. A food safety hazard is a biological, chemical, or physical property that may cause a food to be unsafe. There may be differences of opinion, even among experts, as to the risk of a hazard. The food establishment must rely upon the expert opinion published in peer reviewed literature or experts who actively assist in the development of the HACCP plan. The hazards must at least include those that are commonly associated with a specific product. If a hazard that is commonly associated is dismissed from the plan, the basis for rejecting it must be clearly stated in the hazard analysis so that it is understood and agreed to by the regulatory authority reviewing the HACCP plan. (g) Hazard Analysis Process This point in hazard analysis consists of asking a series of questions which are appropriate to each step in the flow diagram. The hazard analysis should question the effect of a variety of factors upon the safety of the food. Ingredients   Does the food contain any sensitive ingredients that are likely to present microbiological hazards (e.g., Salmonella, Staphylococcus aureus), chemical hazards (e.g., aflatoxin, antibiotic, or pesticide residues) or physical hazards (stones, glass, bone, metal)?   Intrinsic factors of food   Physical characteristics and composition (e.g., pH, type of acids, fermentable carbohydrate, water activity, preservatives) of the food during and after preparation can cause or prevent a hazard.   Which intrinsic factors of the food must be controlled in order to ensure food safety?   Does the food permit survival or multiplication of pathogens and/or toxin formation in the food before or during preparation?   Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps of preparation, storage, or consumer possession?   Are there other similar products in the market place? What has been the safety record for these products?   Procedures used for preparation/processing   Does the preparation procedure or process include a controllable step that destroys pathogens or their toxins? Consider both vegetative cells and spores.   Is the product subject to recontamination between the preparation step (e.g., cooking) and packaging?   Microbial Content of the Food   Is the food commercially sterile (i.e., low acid canned food)?   Is it likely that the food will contain viable sporeforming or nonsporeforming pathogens?   What is the normal microbial content of the food stored under proper conditions?   Does the microbial population change during the time the food is stored before consumption?   Does that change in microbial population alter the safety of the food?   Facility design   Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat foods?   Is positive air pressure maintained in product packaging areas? Is this essential for product safety?   Is the traffic pattern for people and moving equipment a potentially significant source of contamination?   Equipment design   Will the equipment provide the time/temperature control that is necessary for safe food?   Is the equipment properly sized for the volume of food that will be prepared?   Can the equipment be sufficiently 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 hazardous substances, e.g., glass?   What product safety devices such as time/temperature integrators are used to enhance consumer safety?   Packaging   Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?   Is the packaging material resistant to damage, thereby preventing the entrance of microbial contamination?   Is the package clearly labeled "Keep Refrigerated" if this is required for safety?   Does the package include instructions for the safe handling and preparation of the food by the consumer?   Are tamper-evident packaging features used?   Is each package legibly and accurately coded to indicate production lot?   Does each package contain the proper label?   Sanitation   Can the sanitation practices that are employed impact upon the safety of the food that is being prepared?   Can the facility be cleaned and sanitized to permit the safe handling of food?   Is it possible to provide sanitary conditions consistently and adequately to ensure safe foods?   Employee health, hygiene, and education   Can employee health or personal hygiene practices impact the safety of the food being prepared?   Do the employees understand the food preparation process and the factors they must control to ensure safe foods?   Will the employees inform management of a problem which could impact food safety?   Conditions of storage between packaging and the consumer   What is the likelihood that the food will be improperly stored at the wrong temperature?   Would storage at improper temperatures lead to a microbiologically unsafe food?   Intended use   Will the food be heated by the consumer?   Will there likely be leftovers?   Intended consumer   Is the food intended for the general public, i.e., a population that does not have an increased risk of becoming ill.   Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the elderly, the infirm, and immunocompromised individuals)?   (h) Developing Preventive Measures The preventive measures procedure identifies the steps in the process at which hazards can be controlled. After identifying the hazards the food establishment must then consider what preventive measures, if any, can be applied for each hazard. Preventive measures are physical, chemical, or other factors that can be used to control an identified health hazard. More than one preventive measure may be required to control a specific hazard and more than one hazard may be controlled by a specified preventive measure. For example, if a HACCP team were to conduct a hazard analysis for the preparation of hamburgers from frozen beef patties, enteric pathogens on the incoming raw meat would be identified as a potential hazard. Cooking is a preventive measure which can be used to eliminate this hazard. Thus, cooking, the preventive measure, would be listed along with the hazard (i.e., enteric pathogens) as follows: Step Identified Hazard Preventive Measures Cooking Enteric pathogens Cooking sufficiently to kill enteric pathogens HACCP

2: 决定CCPs 控制点是指生物的、化学的或物理的因素能被控制的任何一点，一步或一个过程。 一个关键控制点是指一个明确的危害能被防止、消除或减少到可接受的水平的某一点，某一步或某个程序。 关键控制点比一般控制点更加频繁地受到监控。 HACCP

3: 制定临界极限 这一步骤包括：在关键控制点上制定标准，该标准必须能够满足防止、消除或减少明确的危害，以保证食物的食用安全。 3: 制定临界极限 这一步骤包括：在关键控制点上制定标准，该标准必须能够满足防止、消除或减少明确的危害，以保证食物的食用安全。 临界极限的实例: 温度、时间、外观尺寸、水活性、pH值和有效氯。 临界极限可能来自调整的标准和指南、科学文献，实验性研究和专家的建议。 HACCP

4: 建立监控程序 监控是一个有计划的观察或测量 监控的实例包括: 来检查一个关键控制点是否受控 目测 温度的测量 时间的估算 pH值测量 4: 建立监控程序 监控是一个有计划的观察或测量 来检查一个关键控制点是否受控 监控的实例包括: 目测 温度的测量 时间的估算 pH值测量 水活性测量 HACCP

5: 采取纠正的行动 纠正的行动偏重于: 纠正行动的实例: 有时，把食物扔掉也是一个纠正的行动。 保留完备的所有纠正行动的记录。 5: 采取纠正的行动 纠正的行动偏重于: 食物不满足临界极限时怎么办。 纠正行动的实例: 烹制好的汉堡包的温度是140oF （一个关键控制点）。 临界极限是汉堡包必须被加热到155oF 或更高的温度。 继续加热汉堡包直到155oF 或更高温度。 有时，把食物扔掉也是一个纠正的行动。 保留完备的所有纠正行动的记录。 HACCP

6: 制定确认程序 个HACCP计划需要确认四个阶段: 确定所有的关键控制点的临界极限都合理、可靠。 6: 制定确认程序 个HACCP计划需要确认四个阶段: 确定所有的关键控制点的临界极限都合理、可靠。 保证机构中的HACCP计划得到了正确的贯彻落实。 有管理人员来评议计划，保证其得以正确地贯彻落实。 检查所有监控设备的准确性。 HACCP

7: 保存记录 以下的材料构成了HACCP 计划的记录： HACCP团队及其职责的清单。 每一条职责的具体描述。 7: 保存记录 以下的材料构成了HACCP 计划的记录： HACCP团队及其职责的清单。 每一条职责的具体描述。 标识关键控制点的每一项流程图。 与每一个关键控制点关联的危害及防止措施。 临界极限 监控程序 纠正行动计划 记录保存程序 确认HACCP计划的程序 HACCP