内审员ISO22000培训相关资料.ppt

1、考试复习资料,ISO 22000:2005,Food safety management systems Requirements for any organization in the food chain 食品安全管理体系食品链中各类组织的要求,ISO 22000 DevelopmentISO 22000 演变,60年代美国太空计划 95年美国水产品HACCP法规 97年CACHACCP体系应用指南 2002年质检总局出口食品厂应用 2004年6月ISO/TC34委员会DIS版 2005年5月FDIS版 2005年9月1日ISO22000：2005标准版,ISO 22000 Develop

2、mentISO 22000 演变,Background 背景 Globalising the flow of commodity of food-products 食品流通全球化 Increasing number of standards: GFSI (IFS, BRC,), SQF, Own-Brand Standards, e.g. 各类标准数量的增加，如GFSI (IFS, BRC,), SQF, Own-Brand Standards等 International standards:WHO/FAO Codex Alimentarius (HACCP), ISO 9001, etc.

3、 国际标准的发布，如WHO/FAO 法规(HACCP),ISO 9001等,Family of standards ISO FSMS标准之家- ISO FSMS,ISO 22000:2005 Requirements for any organization in the food chain 食品链中各类任何组织的要求 ISO 22003:2007 Requirements for bodies providing audit and certification of food safety management systems 对食品安全管理体系进行审核和认证的团体的要求 ISO 2200

4、4:2006 Food safety management systems Guidance on the application of ISO 22000:2005 食品安全管理体系- ISO 22000:2005的申请指导,Focus 焦点,IFS/BRC For European food market适用于欧洲食品市场 ISO 9001:2000 QMS certified, international,all systems/producer QMS认证，国际性，适用于所有体系和生产商 ISO 22000:2005 FSMS certified, international (glo

5、bal players), all food/feed systems/producer FSMS认证，国际性，适用于所有食品，农场体 系和供应商,IFS/BRC Food vs. ISO 22000IFS/BRC 食品 vs. ISO 22000,Food Safety Systems Findings/problems in the past食品安全体系过去的发现/问题,Low commitment from the management 管理承诺不明 Only safe products in part/parts of the chain 只与食品链中安全产品的部分有关 No cont

6、inuous improvement in the systems. 体系没有持续改进 No/not-sufficient validation of the system. 体系确认没有或不充分,Food Safety Systems Findings/problems in the past食品安全体系过去的发现与问题,No/not-sufficient verification of the system. 体系验证没有或不充分 CCP:s not relevant Not possible to monitor and measure. Not enough focus on real

7、 CCP:s 关键控制点没有相关的无法监控和测量。对真实的关键控制点的关注不够 Not sufficient internal and external communication 内外部信息交流不充分,ISO 22000:2005,The standard gives an opportunity to achieve international harmonisation in the field of food safety standards and it also provides a tool to implement HACCP throughout the food suppl

8、y chain. 本标准提供了一个在食品安全标准方面达到与国际接轨的机会，并且它还支持将HACCP贯彻实行于整个食品供应链中。,ISO 22000:2005 Key elements主要组成部分,The standard combines generally recognized key elements to ensure food safety along the food chain: 这个标准通过各主要组成部分的结合来保证食品链中的食品安全 interactive communication 相互沟通 requirements for a management system 体系管理

9、requirements for good manufacturing practice or pre-requisite programmes 良好作业规范及前提方案的要求 requirements for HACCP according to the principles of Codex Alimentarius 按照食品营养药典原理对HACCP的要求，即HACCP原理,ISO 22000,ISO 22000:2005 Added value 增值,meets food industry expectations 达到食品工业期望 provides a reference for the

10、 food chain as a whole 为食品链提供一个总体参考 imposes structured and targeted communications 影响组成的目标性的交流 subjects all control measures to hazard analysis 在危害分析基础上建立控制措施 fills the gap between ISO 9001 and HACCP 弥补了ISO 9001和HACCP 之间的空白 can serve as a reference base for national legislation 可以作为国家立法的参考 focus on

11、continous improvement of the FSMS 关注FSMS的持续改进 and more 更多,1 范 围,本标准为食品链中需要证实有能力控制食品安全危害、确保食品人类消费安全的组织，规定了其食品安全管理体系的要求。 1) 策划、实施、运行、保持和更新食品安全管理体系，确保提供的产品按预期用途对消费者是安全的； 2) 证实其符合适用的食品安全法律法规要求；,1 范 围 （续）,）为增强顾客满意，评价和评估顾客要求，并证实其符合双方商定的、与食品安全有关的顾客要求； 4）与供方、顾客及食品链中的其他相关方在食品安全方面进行有效沟通； 5）确保符合其声明的食品安全方针； 6）证

12、实符合其他相关方的要求； 7）为符合本准则,寻求由外部组织对其食品安全管理体系的认证或注册，或进行自我评价,自我声明。,1 范 围（续）,通用的要求，旨在适用于各种类型、不同规模和提供不同产品的食品链中任何组织。 允许组织，如小型和/或欠发达组织（如小农场，小分包商，小零售或食品服务商）实施外部开发的控制措施组合。,ISO 22000-Scope范围,All organizations, which produce, manufacture, handle or supply food/feed-所有组织，如食品/原料制造商，生产商，买家和供应商: Farming 农场 Feed Correc

13、tive actions 监控；纠正措施,Verification 验证,Improvement 改进,联合国食品法典委员会推荐建立和实施食品安全计划的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.确定关键限值 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,Chapter 4 第四单元: Food safety management system FSMS 食品安全管理体系,The requirements of c

14、lause 4 blanket all others to assure a working food safety management system 这个单元的要求就是保证一个能有效运行的食品安全管理体系,Chapter 4: Food safety management system FSMS食品安全管理系统,4.1General requirements 一般要求 The Organisation shall 食品链中某组织应要 establish, document, implement and maintain an effective FSMS and update it whe

15、n necessary in accordance with the requirements of this International standard 组织应按本准则要求建立有效的食品安全管理体系，形成文件，加以实施和保持，并在必要时进行更新 define the scope of the FSMS (specify the products or product categories, processes and production sites that are addressed by the FSMS) 定义FSMS的范围(指定产品或产品类别，过程和生产场地) 注，企业可能有几条

16、线生产，只涉及其中部分生产线,Chapter 4: Food safety management system FSMS食品安全管理系统,4.1 General requirements 总要求 The Organisation shall 组织应当 a) Ensure that safety hazards that may be reasonably expected to occur in relation to products within the scope of the system are identified, evaluated and controlled in such

17、 a manner that the products of the organization do not, directly or indirectly, harm the consumer 确保在体系范围内合理预期发生的、与产品相关的食品安全危害得到识别、评价和控制，以避免组织的产品不直接或间接伤害消费者,Chapter 4: Food safety management system FSMS食品安全管理系统,b) Communicate appropriate information throughout the food chain regarding food safety is

18、sues related to its products 在整个食品链内沟通与产品安全有关的适宜信息 c) Communicate information concerning development, implementation and updating of the throughout the organization, to the extent necessary to ensure the food safety required by this International standard 在组织内就有关食品安全管理体系建立、实施和更新进行必要的信息沟通，以满足本标准的要求，确

19、保食品安全,Chapter 4: Food safety management system FSMS食品安全管理系统,d) System to ensure that the system reflects the organizations activities and incorporates the most recent information on the food safety hazards subject to control. 定期评价食品安全管理体系，必要时更新，以确保体系反映组织的活动并包含需控制的食品安全危害的最新信息 Where an organization ch

20、ooses to outsource any process that may affect end product conformity, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified and documented within the FSMS. 组织应确保控制所选择的任何可能影响终产品符合性且源于外部的过程，并应在食品安全管理体系中加以识别，形成文件,Chapter 4: Food safety mana

21、gement system FSMS食品安全管理系统,4.2Documentation requirements 文件要求 4.2.1General (FSMS) 总则: The FSMS documentation shall include 食品安全管理体系文件应包括: documented statements of a food safety policy and related objectives (see 5.2) 形成文件的食品安全方针和相关目标的声明（见5.2） b) documented procedures and records required by this Int

22、ernational Standard 本标准要求的形成文件的程序与记录 c) documents needed by the organization to ensure the effective development, implementation and updating of the food safety management system. 组织为确保食品安全管理体系有效建立、实施和更新所需的文件 注：外来文件；文件详略程度；文件,Chapter 4: Food safety management system FSMS食品安全管理系统,4.2.2Control of docu

23、ments 文件控制 Documents required by the FSMS shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.3. 食品安全管理体系所要求的文件应予以控制。记录是一种特殊类型的文件，应依据4.2.3的要求进行控制 The controls shall ensure that all proposed changes are reviewed prior to imple

24、mentation to determine their effects on food safety and their impact on the food safety management system. 文件控制应确保所有提出的更改在实施前加以评审，以明确其对食品安全的效果以及对食品安全管理体系的影响。,Chapter 4: Food safety management system FSMS食品安全管理系统,A documented procedure shall be established to define the controls needed 应编制文件化的程序，以规定以

25、下方面所需的控制 a) to approve documents for adequacy prior to issue 文件发布前得到批准，以确保文件是充分与适宜的 b) to review and update documents as necessary, and re-approve documents 必要时对文件进行评审与更新，并再次批准 c) to ensure that changes and the current revision status of documents are identified, 确保文件的更改和现行修订状态得到识别,Chapter 4: Food s

26、afety management system FSMS食品安全管理系统,d) to ensure that relevant versions of applicable documents are available at points of use 确保在使用处获得适用文件的有关版本 to ensure that documents remain legible and readily identifiable 确保文件保持清晰、易于识别 to ensure that relevant documents of external origin are identified and the

27、ir distribution controlled 确保相关的外来文件得到识别，并控制其分发 to prevent the unintended use of obsolete documents, and to ensure that they are suitably identified as such if they are retained for any purpose 防止作废文件的非预期使用，若因任何原因而保留作废文件时，确保对这些文件进行适当的标识,Chapter 4: Food safety management system FSMS食品安全管理系统,4.2.3Cont

28、rol of records 记录控制: A documented procedure shall be established to define the controls needed for the correction, identification, storage, protection, retrieval, retention time and disposition of records. 应编制形成文件的程序，以规定记录的标识、 贮存、保护、检索、保存期限和处理所需的控制, Vision,Management systems the red thread through y

29、our organisation管理体系 您组织中的红丝带, SWOT analysis, Objectives, Policy, Success factor, Substantial environmental aspects and critical safety and health risks, Targets Action plans Control Follow up,Chapter 5: Management responsibility第五单元：管理职责,5.1 Management commitment 管理承诺 Top management shall provide e

30、vidence of its commitment to the development and implementation of the FSMS and to continually improving its effectiveness by： 最高管理者应通过以下活动，对其建立、实施食品安全管理体系并持续改进其有效性的承诺提供证据： a) showing food safety is supported by the business objectives of the organization, 表明组织的经营目标支持食品安全 b) communicating to the org

31、anization the importance of meeting the requirements of this International Standard, any statutory and regulatory requirements, as well as customer requirements relating to food safety, 向组织传达满足与食品安全相关的法律法规、本标准以及顾客要求的重要性 c) establishing the food safety policy, 制定食品安全方针 d) conducting management review

32、s, 进行管理评审 e) ensuring the availability of resources. 确保资源的获得,Chapter 5: Management responsibility第五单元：管理职责,5.2Food safety policy 食品安全方针 Top Management shall define, document and communicate its food safety policy. 最高管理者应制定食品安全方针，形成文件并对其进行沟通 Top management shall ensure that the food safety policy 最高管

33、理者应确保食品安全方针 is appropriate to the role of the organization in the food chain, 与组织在食品链中的作用相适宜 b) conforms with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers, 既符合法律法规的要求，又符合与顾客商定的对食品安全的要求 c) is communicated, implemented and maintained at all

34、levels of the organization, 在组织的各层次进行沟通、实施并保持 d) is reviewed for continued suitability (see 5.8), 在持续适宜性方面得到评审（5.8）； e) adequately addresses communication (see 5.6), 充分体现沟通(5.6) f) is supported by measurable objectives. 由可测量的目标来支持 ,Chapter 5: Management responsibility第五单元：管理职责,5.3Food safety managem

35、ent system planning食品安全管理体系策划 Top management shall ensure that 最高管理者应确保： planning of the FSMS is carried out to meet requirements given in 4.1 as well as the objectives of the organization that support food safety, 对食品安全管理体系的策划，以满足4.1的要求，同时实现支持食品安全的组织目标 b) the integrity of the FSMS is maintained whe

36、n changes to the FSMS are planned and implemented. 在对食品安全管理体系的变更进行策划和实施时，保持体系的完整性 .,Chapter 5: Management responsibility第五单元：管理职责,5.4 Responsibility and authority 职责与权限 Top management shall ensure that responsibilities and authorities are defined and communicated within the organization to ensure th

37、e effective operation and maintenance of the FSMS. 最高管理者应确保规定各项职责和权限并在组织内进行沟通，以确保食品安全管理体系有效运行和保持 All personnel shall have responsibility to report problems with the FSMS to identified person(s). Designated personnel shall have defined responsibility and authority to initiate and record actions. 所有员工

38、有责任向指定人员报告与食品安全管理体系有关的问题。指定人员应有明确的职责和权限，以采取措施并予以记录 ,Chapter 5: Management responsibility第五单元：管理职责,5.5 Food safety team leader食品安全小组组长 Top management shall appoint a food safety team leader who, irrespective of other responsibilities, shall have the responsibility and authority 组织的最高管理者应任命食品安全小组组长，无论

39、其在其他方面的职责如何，应具有以下方面的职责和权限： a) to manage a food safety team (see 7.3.2) and organize its work 管理食品安全小组(7.3.2)，并组织其工作 b) to ensure relevant training and education of the food safety team members (see 6.2.1) 确保食品安全小组成员的相关培训和教育,Chapter 5: Management responsibility第五单元：管理职责,c) to ensure that the FSMS is

40、established, implemented, maintained and updated 确保建立、实施、保持和更新食品安全管理体系 d) to report to the organizations top management on the effectiveness and suitability of the FSMS 向组织的最高管理者报告食品安全管理体系的有效性和适宜性 NOTE The responsibility of the food safety team leader may include liaison with external parties on mat

41、ters relating to the FSMS. 注：食品安全小组组长的职责可包括与食品安全管理体系有关事宜的外部联络,Chapter 5: Management responsibility第五单元：管理职责,5.6 Communication 沟通 5.6.1 External communication 外部沟通 To ensure that sufficient information on issues concerning food safety is available throughout the food chain, the organization shall est

42、ablish, implement and maintain effective arrangements for communicating with 为确保在整个食品链中能够获得充分的食品安全方面的信息，组织应制定、实施和保持有效的措施，以便与下列各方进行沟通： a) suppliers and contractors 供方和承包方,Chapter 5: Management responsibility第五单元：管理职责,b) customers or consumers, in particular in relation to product information (includi

43、ng instructions regarding intended use, specific storage requirements and, as appropriate, shelf life), enquiries, contracts or order-handling including amendments, and customer feedback including customer complaints -顾客或消费者，特别是在产品信息（包括预期用途、特定贮存要求以及保质期等信息的说明）、问询、合同或订单处理及其修改，以及顾客反馈信息（包括抱怨）等方面进行沟通 c)

44、statutory and regulatory authorities 立法和监管部门 d) other organizations that have an impact on, or will be affected by, the effectiveness or updating of the FSMS 对食品安全管理体系的有效性或更新具有影响或将受其影响的其他组织,Chapter 5: Management responsibility第五单元：管理职责,5.6.1 External communication 外部沟通 Such communication shall provi

45、de information on food safety aspects of the organizations products that may be relevant to other organizations in the food chain. This applies especially to known food safety hazards that need to be controlled by other organizations in the food chain. Records of communications shall be maintained 外

46、部沟通应提供组织的产品在食品安全方面的信息，这些信息可能与食品链中其他组织相关。这种沟通尤其适用于那些需要由食品链中其他组织控制的已知的食品安全危害。沟通记录应予以保持。 Food safety requirements from statutory and regulatory authorities and customers shall be available 应获得来自顾客和立法与监管部门的食品安全要求。,Chapter 5: Management responsibility第五单元：管理职责,5.6.1 External communication 外部沟通 Designated

47、 personnel shall have defined responsibility and authority to communicate externally any information concerning food safety. Information obtained through external communication shall be included as input to system updating (see 8.5.2) and management review (see 5.8.2). 指定人员应具有规定的职责和权限以进行有关食品安全信息的对外沟

48、通。通过外部沟通获得的信息应作为体系更新（见8.5.2）和管理评审（见5.8.2）的输入。,Chapter 5: Management responsibility第五单元：管理职责,5.6.2 Internal communication 内部沟通 The organization shall establish, implement and maintain effective arrangements for communicating with personnel on issues having an impact on food safety 组织应制订、实施和保持有效的安排，以便

49、与有关人员就影响食品安全的事项进行沟通。 In order to maintain the effectiveness of the FSMS, the organization shall ensure that the food safety team is informed in a timely manner of changes, including but not limited to the following 为保持食品安全管理体系的有效性，组织应确保食品安全小组及时获得变更的信息，包括但不限于以下方面：: a) products or new products-产品或新产品;

50、 b) raw materials, ingredients and services-原料、辅料和服务; c) production systems and equipment-生产系统和设备; d) production premises, location of equipment, surrounding environmen-生产场所，设备位置，周边环境;,Chapter 5: Management responsibility第五单元：管理职责,5.6.2 Internal communication 内部沟通 e) cleaning and sanitation programm

51、es-清洁和消毒程序; f) packaging, storage and distribution systems-包装、贮存和分销系统; g) personnel qualification levels and/or allocation of responsibilities and authorizations-人员资格水平和（或）职责及权限分配; h) statutory and regulatory requirements-法律法规及有关标准要求; i) knowledge regarding food safety hazards and control measures 与

52、食品安全危害和控制措施有关的知识; j) customer, sector and other requirements that the organization observes-组织遵守的顾客、行业和其他要求; k) relevant enquiries from external interested parties-来自外部相关方的有关问询;,Chapter 5: Management responsibility第五单元：管理职责,5.6.2 Internal communication 内部沟通 l) complaints indicating food safety hazar

53、ds associated with the product-表明与产品有关的食品安全危害的抱怨; m) other conditions that have an impact on food safety-影响食品安全的其他条件. The food safety team shall ensure that this information is included in the updating of the FSMS (see 8.5.2)-食品安全小组应确保食品安全管理体系的更新（见8.5.2）包括上述信息。 Top management shall ensure that relev

54、ant information is included as input to the management review (see 5.8.2)-最高管理者应确保将相关信息作为管理评审的输入（见5.8.2）。,Chapter 5: Management responsibility第五单元：管理职责,5.7 Emergency preparedness and response应急准备和响应 Top management shall establish, implement and maintain procedures to manage potential emergency situa

55、tions and accidents that can impact food safety and which are relevant to the role of the organization in the food chain. 最高管理者应建立、实施并保持程序，以管理可能影响食品安全的潜在紧急情况和事故，并应与组织在食品链中的作用相适宜。 .识别预案响应演练,Chapter 5: Management responsibility第五单元：管理职责,5.8 Management review 管理评审 5.8.1General 总则 Top management shall r

56、eview the organizations food safety management system at planned intervals to ensure its continuing suitability,adequacy and effectiveness.This review shall include assessing opportunities for improvement and the need for change to the food safety management system,including the food safety policy.R

57、ecords of management reviews shall be maintained(see 4.2.3)。 最高管理者应按策划的时间间隔评审食品安全管理体系，以确保其持续的适宜性、充分性和有效性。评审应包括评价食品安全管理体系改进的机会和变更的需求，包括食品安全方针。 管理评审的记录应予以保持（见4.2.3）,Chapter 5: Management responsibility第五单元：管理职责,5.8.2Review input 评审输入 The input to management review shall include, but is not limited to,

58、 information on 管理评审输入应包括但不限于以下信息： a) follow-up actions from previous management reviews 以往管理评审的跟踪措施 b) analysis of results of verification activities (see 8.4.3) 验证活动结果的分析（见8.4.3） c) changing circumstances that can affect food safety (see 5.6.2) 可能影响食品安全的环境变化（见5.6.2）,Chapter 5: Management responsib

59、ility第五单元：管理职责,d) emergency situations, accidents (see 5.7) and withdrawals, incl. recall (see 7.10.4) 紧急情况、事故（见5.7）和撤回（见7.10.4） e) reviewing results of system-updating activities (see 8.5.2) 体系更新活动的评审结果（见8.5.2） f) review of communication activities, including customer feed-back (see 5.6.1) 顾客顾客反馈的沟通活动的评审（见5.6.1） g) external audits or inspections 外部审核或检验 ,Chapter 5: Management responsibility第五单元：管理职责,5.8.3Review output 评审输出 The output from the management review sha