MGB自我评审报告-（12）产能

发布者：admin 发布时间：2012-11-9 15:12:42 阅读：13

Section 12: Manufacturing Operations / Capabilities

12.1 Are working instructions available for operator as a guideline at an accessible place or work station to ensure legality, quality & safety of product?
是否有作业指导书作为确保产品符合法规，质量和安全的指引？
12.2 Is there any traceability and confirm information on the approved sample? Are the samples well stored and controlled?
确认样上是否有可追溯的信息和确认的信息？确认样是否良好地存放和控制？
12.3 Are there pre-production meetings conducted prior to production of new or substantially changed products, and to evaluate and approve the processes? Are the meeting records available?
当生产新产品或产品本质变更时，是否召开产前会议来评估和确认相关的生产过程?是否保留会议记录？
12.4 Does the factory have first sample checking record?
是否有首件样确认记录？
12.5 Does the factory adjust or calibrate the identified measuring and monitoring devices to ensure accuracy? Verification and maintenance at defined period and recorded?
是否对计量设备/工具进行校准或检定？是否保留相关的记录及证书？
12.6 Does the factory have a well organized maintenance team to give immediate response to a machinery breakdown or emergency that affects production? Or have maintenance cover sub-contracted with a guaranteed response time? What is guaranteed time?
是否有机修组对故障设备立即响应？或机修业务外包的话，是否保证响应时间？响应时间是多少小时？

12.7 Are there procedures in place for action to be taken if equipment if found not to be operating within specified limits?
如果发生设备失效或操作偏差，是否有程序在放行前确认产品的安全状况，并采取适当的措施？
12.8 Are raw materials, semi-processed products, part-used materials, finished products and materials pending investigation adequately identified to ensure traceability?
原材料，半成品，成品的状态是否充分标识，以确保可追溯性？（现场的状态标识：已检，待检，合格，不合格，待处理等）
12.9 Are final products suitably marked to allow adequate identification and in accordance to legislative and safety requirements and customer specific requirements?
成品是否根据法规，安全要求和顾客的特殊要求加以标识？如CE，WEEE
12.10 When the same component or material is sourced from more than one supplier, can the traceability system ensure that the lots / batches from each supplier can be identified if the component / material are identified as critical to safety, quality or legality?
当影响产品质量及安全合法性的物料来源于不同供应商时，是否有可追溯体系确保能识别不同供应商的物料批次？
12.11 Are the changes in materials, processes or components traceable if they could affect the safety, quality or legality of the product?
影响产品质量及安全合法性的物料、过程或组件的变更是否可追溯？
12.12 Are there further traceability chain based on the risk assessment and any legal or specific customer requirements being established?
基于风险分析及法规的或顾客的具体要求，是否建立进一步的追溯链？
12.13 Does the factory has appropriate storage arrangement and instructions such as special and segregated areas for storage of flammable and explosive substances, highly toxic substances, rejected and recalled materials or returned goods?
是否针对易燃易爆物质，剧毒物质，拒收及召回材料或产品，有适当的存放区域和指示?
12.14 Does the factory have mechanism prior to release of all finished products?
是否有产品放行规定？

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