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TCCQS Ev.3Global Audit ProgramHACCP Methodology Module全球审核程序 HACCP模块This module serves as a guide to the auditor in completing the assessment of the HACCP plan during the audits. The auditor will determine whether or not the facility is complying with the specifications and requirements of The Coca-Cola Company by completing this audit module. This module is not intended to be used as a HACCP Certification Audit Tool. 此模块可作为审核员完成HACCP计划评估的指南。审核员完成此模块可以决定工厂是否符合可口可乐公司的规范要求。但此模块不能用作HACCP认证审计的工具。Plant工厂: Date日期 Auditor(s)审核员: 1) Questionnaire调查表:YesDivNoGeneral概要1Is there a HACCP study in place? 是否建立HACCP？2Does the organization meet HACCP program requirements? 组织结构是否符合HACCP程序要求？3Is the HACCP team assembled? 是否建立HACCP小组？4Are all type of products described properly with intended use? 所有品种的产品流程描述是否适当？5Are there flow diagrams available? 是否有适合的流程图？6Does the operation have a Hazard Analysis? 操作是否有危害分析？7Are all CCPs identified properly? 所有确定CCP点都得到确认吗？8Are monitoring procedures established for each CCP? 每个CCP点是否都建立监控程序？9Are corrective actions addressed properly for each CCP? 每个CCP点都有采取适当的更正措施吗？10Are verification and validation procedures established? 是否建立验证和确认程序？11Are documentation and record keeping requirements established? 文件和记录是否按要求保存？2) Reference Standards Lis t参考标准单:Beverage Operations Manual饮料操作手册 BO-RQ-770 Hazard Analysis and Critical Control Points (HACCP) Program危害分析及关键控制点（HACCP）程序3) Specifications and Requirements Summary标准和要求概要:Specifications / Requirements标准/要求General概要1Is there a HACCP study in place?是否建立HACCP？BO-RQ-770 Study is done by following the seven-principle, twelve-step model described in Codex Alimentarius and relevant local authority. 研究是按照法律和地方法规规定的七大原则、十二个步骤来进行 All prerequisite requirements are met prior to application e.g. sanitation, personnel hygiene, GMP, training etc.(Refer to document BO-RQ-770 for prerequisite requirements) 在申请前所有前提要求都要达到，如卫生设施，个人卫生，GMP，培训等（参考BO-RQ-770文件里的前提要求）2Does the organization meet HACCP program requirements? 组织结构是否符合HACCP程序要求？BO-RQ-770 Full commitment and involvement of management and the workforce管理层和员工的职责与参与 Reviewed at least annually至少每年反馈一次 Updates take place each time a change is made to the process, product, or equipment每次对流程、产品或设备作更改后，均应更新HACCP must be defined separately by product type, process, line and location. HACCP必须按照不同产品类型、流程、生产线及位置制定 All personnel involved must be trained in HACCP principles. 所有参与人员都要培训HACCP原则3Is the HACCP team assembled?是否建立HACCP小组？Typical HACCP team includes representatives from engineering, production, sanitation, quality, and microbiology. 一般的HACCP小组队员应包含工程、生产、杀菌、品质、微生物等各部门人员BO-RQ-770 A local HACCP coordinator or a team leader is appointed. 任命一位HACCP协调员或小组领导HACCP team consists of individuals with the knowledge of process and product and expertise to develop an effective program. HACCP小组应由了解生产流程和产品知识并由建立一整套有效程序的能力的人组成Scope is defined by HACCP team HACCP小组决定工作范围4Are all type of products described properly with intended use?所有品种的产品流程描述是否适当？BO-RQ-770HACCP team develops a full description of the product including: HACCP小组对产品的全面说明内容包括：- Product name产品名称- Relevant food safety info (physical, chemical structure, composition, substances food contact materials) 相关食品安全信息（理化结构、化学结构、成分、相关与食品接触物料）- Process / preservation method 加工及保存方法- Packaging包装- Distribution and storage (duration and shelf-life, storage conditions, distribution and transportation means) - 分销与储存（保存时间、货龄、储存条件、分销与运输方式）- Normal and expected use of the product and any vulnerable groups of population 正常的和预期的使用这种产品，任何易受影响的人群5Are there flow diagrams available?是否有适合的流程图？BO-RQ-770Flow diagrams covering each step in the process within the scope are available.涉及到生产过程中每一步骤的流程图是都已具备 Diagrams include outsourced processes, subcontracted work, rework, recycling and waste removal. 流程图包括代加工、返工、重做、回收和要扔掉废弃物 Flow diagrams are confirmed to be correct by comparing them to actual operations.确认流程图是根据实际操作情况作了修订6Does the operation have a Hazard Analysis? 操作是否有危害分析？A significant food safety hazard in one operation may not be significant in an other operation producing the same or similar product. 在一个操作中的食物安全危害的严重性在另一个生产同样或类似产品的操作中可能不是重大危害A Supportive Safety Measure may be a process , procedure or component of a functioning prerequisite program such as GMP食品安全的支持程序包括建立有效的程序或组成部分，如GMP.BO-RQ-770 All potential biological, chemical and/or physical hazards are listed and categorized. 所有潜在的生物的、化学的、物理的危害要列出来并分类 A hazard analysis is conducted to identify which hazards are of a nature that their prevention, elimination or reduction to acceptable level is essential. 通过危害分析确认哪一种危害是可以预防或消除或减少到可接受水平。 Each hazard is evaluated against: 通过下列因素评估每个危害：- Severity or seriousness 严重性- Likeliness to occur 发生的可能性- Scientific data about the nature of the hazard 关于危害点的科学数据分析- Consumer complaints data 消费者投诉数据- Effectiveness of existing control measures 现行控制点的有效性 Records of deliberations and rational developed during the analysis is maintained. 保存危害点分析过程中合理的数据分析记录 Control measures are decided and categorized a “Critical Control Measures” or Supportive Control Measures” 确定控制措施并分为“关键控制点”或“次要控制点” Where a potential hazard is specifically addressed in a HACCP plan, it is categorized as “significant food safety hazard” and a “Critical Control Measure” is established for each CCP. 如果一个潜在危害在HACCP纲要里被特别说明，就可归为“重大食品安全危害”并建立一个“关键控制点”来解决每个CCP Analysis is conducted for each product type and production line and repeated prior to any change in ingredients, packaging materials, product use, formulation and production line layout. 危害点分析应针对每一种类型的产品、每条生产线，并且在配方、包装、材料、产品的使用、规格及生产线布局变化时重新进行7Are all CCPs identified properly?所有确定CCP点都得到确认吗？At a process step where control is necessary for a significant hazard, yet no control measure exists, the product or process must be modified at that step, or at any earlier or later stage, to include a control measure.在某一可能产生重大危害的处理环节，应有控制点存在，则在此环节的生产或流程必须修改，或在此环节之前（之后）存在控制点的环节必须修改More than one control measure may control a significant hazard; a single Critical control measure may control more than one. 一种或以上的控制措施可以只针对一个重大危害，一个关键控制点措施可以针对多于一个的危害点In some cases more than one Critical limit may be elaborated at a CCP.某些情况下，一个以上的关键限值可用于一个CCP点BO-RQ-770 Each significant hazard is addressed in determining CCPs. 每个严重危害都被确认为CCP点 Identification for each CCP is accurate and complete. 每一个CCP点的识别是准确、完整的 Each CCP is 每个CCP是- Justifiable 合理的- Validated 有效的- Measurable 可衡量的- Carefully developed 仔细判断的 to ensure its effectiveness. . 以确保其有效性 对每一个CCP点的确定所作的各种记录应保存完好 CCPs are monitored and the procedure /method is documented in HACCP plan. CCP点的受控流程/方法应在HACCP计划书中规定 HACCP team specified, validated and documented the justification and measurement criteria for critical limits at each CCP. HACCP小组应对每一个CCP关键限值作出定义，确认的理由及测量标准有效性的确认，并形成文件化 Critical limits are scientifically based and measurable. 关键限值要建立在科学的基础上并可度量8Are monitoring procedures established for each CCP? 每个CCP点是否都建立监控程序？When feasible, continuous monitoring is always preferred. 若条件许可，持续性监控最理想BO-RQ-770 All activities associated with control of CCP and the actions to take when any deviation occurs are addressed in HACCP plan. 所有关于控制CCP点和发生偏差时采取措施的要在HACCP纲要里说明 Each CCP is effectively monitored. 每个CCP点要得到有效监控 Monitoring procedure for a CCP includes对于CCP点的监控措施包括- Scheduled physical, chemical or microbiological measurement or observation of a CCP relative to its critical limit to indicate control of the process对于CCP点的关键限值控制过程应为定期的理化、微生物指标的检测或观察- Detection of loss of control at the CCP and definition of how to be monitored防止CCP点偏离限值的监控方法- Evaluation of the monitoring data by a responsible person with the knowledge and authority to carry out corrective actions由具备执行纠正措施能力及授权负责人对监控数据进行评估- Sufficient frequency of monitoring , if not continuous - 若非持续监控，则应制定保证监控效果的足够频率 All records and document associated with CCP monitoring are dated and signed by the person responsible for monitoring and by a management representative trained in HACCP for evaluation (typically HACCP coordinator) 所有与CCP点监控相关的记录与文件应有日期记录，并由负责监控的人员及受过HACCP评估培训（最好是HACCP协调员）的管理代表签字确认 Personnel monitoring the CCP fully understand their purpose and importance and trained in the monitoring technique that he/she is responsible. 监控CCP点的人员要完全理解他们工作的目的和重要性，并在所负责的监控技术方面受过培训9Are corrective actions addressed properly for each CCP? 每个CCP点都有采取适当的更正措施吗？BO-RQ-770 Specific corrective actions are developed and documented for each CCP. 对每一个CCP都指定纠偏行动，并文件化 At a minimum, these activities are specified in HACCP plan as: HACCP计划书中至少应明确下列项目- what to do when a deviation occurs- 当发生偏离时该做什麽- who is responsible for implementing corrective actions- 谁负责执行纠偏措施- the development and maintenance of a record of actions taken and results.- 采取的纠编行动及结果的记录的建立及保持10Are verification and validation procedures established?是否建立验证和确认程序？BO-RQ-770 Verification frequency for HACCP plan is max. 12 months, and also takes place when changes occur that could affect hazard analysis or HACCP plan. 验证HACCP计划的频率至少每年一次，此外当发生了能影响到危害分析或HACCP计划的变化后也应进行验证 Verification procedure includes: 验证内容包括- Review of hazard analysis documentation- 危害分析文件的验证- Review of audit results, which review occurs within seven days from the day the records are made- 审核结果的复查，复查应在审核记录7日内进行- Review of process monitoring data for confirmation that CCPs are kept under control- 确保CCP处于控制之下的各工序监控数据的复查（确定关键控制点处于控制中）- Calibration of process monitoring instruments- 过程监控及测量设备的校准- Communication of verification results to the HACCP team.- 验证结果与HACCP小组交流 Validation of HACCP program includes actions to confirm the elements of the HACCP plan are effective. 包括确认HACCP计划中各要素有效性实施的HACCP程序有效性验证11Are documentation and record keeping requirements established?文件和记录是否按要求保存？BO-RQ-770 Establish, implement and maintain documentation and record keeping procedures appropriate to the nature and size of the operation. 建立、保存程序性文件及记录的流程适合与生产的特点及规模 Documentation includes: 文件包括- Hazard analysis- 危害分析- CCP determination- CCP点判定- Critical limit determination- 关键限值的判定 Records includes: 记录包括- CCP monitoring activity- CCP监控活动- Deviations and associated corrective actions- 偏差及相应的纠偏行动- Modifications to the HACCP program- HACCP程序的修改- Verification activities- 验证程序 HACCP documentation is included as a part of the organizations Product Release Authorization plan and reviewed by the HACCP coordinator. Product release includes confirmation that no Deviation occurred. HACCP文件作为该机构产品放行认可计划的一部分并由HACCP小组成员审查。产品放行包括对是否有偏离产生的检查 Record retention duration is established according to company and local requirements. HACCP文件作为该机构产品放行认可计划的一部分并由HACCP小组成员审查。产品放行包括对是否有偏离产生的检查4) Comments & Remarks备注:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Document nr.: GAP-COM-HMRevision date:01/01/2004Edition nr.: 1Page 5 of 5Revised by:TK
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