18.可乐的TCCQS(HACCP)审核模块.doc

TCCQS Ev.3Global Audit ProgramHACCP Methodology Module本模块作为审核指南，完成模块中内审的考核以确定被审公司是否符合可乐要求1) Questionnaire:YesDivNo1. Is there a HACCP study in place?有没有进行HACCP学习12. Does the organization meet HACCP program requirements?组织符合HACCP要求吗13. Is the HACCP team assembled?组建了HACCP小组吗14. Are all type of products described properly with intended use?各种产品的预期用途作了适当描述吗25. Are there flow diagrams available?有流程图吗26. Does the operation have a Hazard Analysis?有危害 分析吗27. Are all CCPs identified properly?所有的CCPs得到识别吗28. Are monitoring procedures established for each CCP?对CCP点有监控程序吗29. Are corrective actions addressed properly for each CCP?有CCP点的纠正措施吗310. Are verification and validation procedures established?建立了验证与确认程序吗311. Are documentation and record keeping requirements established?所有文件与记录要求得到保存吗32) Reference Standards List:Beverage Operations Manual BO-RQ-770 Hazard Analysis and Critical Control Points (HACCP) ProgramTCCQS updates are captured till December 15, 20053) Specifications and Requirements Summary:Specifications / RequirementsGeneral1Is there a HACCP study in place?是否有HACCP研讨BO-RQ-770 Study is done by following the seven-principle, twelve-step model described in Codex Alimentarius and relevant local authority. 进行法典里面七大原理、十二步骤的学习包括相关的地方法规 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) 所有的前提条件都得到满足，例如：个人卫生、卫生消毒、GMP和培训等（详见BO-RQ-7702Does the organization meet HACCP program requirements?组织结构是否符合HACCP要求？BO-RQ-770 Full commitment and involvement of management and the workforce 承诺与全员参与 Reviewed at least annually 至少要有年度审核 Updates take place each time a change is made to the process, product, or equipment 当工艺、产品或是设备发生改变时的更新 HACCP must be defined separately by product type, process, line and location. HACCP须界定产品类型、工艺和生产线还有场所 All personnel involved must be trained in HACCP principles.相关人员须要有HACCP原理培训3Is the HACCP team assembled?是否建立了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. 一个本厂的HACCP协调员或小组领导是不可缺的 HACCP team consists of individuals with the knowledge of process and product and expertise to develop an effective program. 由各经验丰富人员专家组成的HACCP小组制定一个有效的程序 Scope is defined by HACCP teamHACCP小组范围界定4Are all type of products described properly with intended use?对各类的意图使用进行了描述吗BO-RQ-770 HACCP team develops a full description of the product including: HACCP小组制定一个详细的产品描述- Product name- 产品名称- Relevant food safety info (physical, chemical structure, composition,- 相关的食品安全信息（物理的、化学结构、组份） - substances food contact materials)- 食品接触材料- Process / preservation method- 工艺与保存方法- Packaging- 包装- Distribution and storage (duration and shelf-life, storage conditions, distribution and transportation means)- 分销与贮存（产品保质期、存贮条件、运输与分销方法）- Normal and expected use of the product and any vulnerable groups of population- 产品的正常和预期用途，不适用人群5Are there flow diagrams available?有流程图BO-RQ-770 Flow diagrams covering each step in the process within the scope are available. 有流程图在工艺范围内涵盖每一个步骤 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. 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- 消费者投诉资料- 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- 可度量的- Carefully developed- 仔细判断的 to ensure its effectiveness. 以确保其有效性 Records for each CCP determination are available. 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 theknowledge 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- 审核危害分析书- 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.- 与HACCP小组交流验证结果 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