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ISO22716咨询|ISO22716内审培训|何为成品?成品的放行、储存、装运与退回如何管?


8 Finished products 成品




8.1 Principle 原则


Finished products should meet the defined acceptance criteria.


成品应当满足确定的接受准则。


Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished products.


用适当的方式对储存,装运,退回进行管理以保持成品的质量


8.2 Release 放行


8.2.1Prior to being placed on the market, all finished products should be controlled in accordance with established test methods and should comply with acceptance criteria.在产品投放市场前,所有成品应按规定检测合格。


8.2.2Product release should be carried out by the authorized personnel responsible for quality.产品放行需要经过相关授权质量人员的批准。



8.3 Storage 储存


8.3.1 Finished products should be stored in defined areas under appropriate conditions for an appropriate length of time. If necessary, finished products should be monitored while stored.成品在特定区域,合适的条件储存一段时间,必要时要对其进行库存检查


8.3.2Storage areas should permit organized storage.储存应当是有组织、有条不紊的。


8.3.3When finished products are released, quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.


当成品被放行、隔离和拒绝时,它们要被储存在各自对应的存贮位置,或者可以采用其它方法来处理如果能达到相同效果。


8.3.4 Identification of finished product containers should indicate: 盛装容器应包含以下信息


a)name or identifying code;名称和识别码


b)batch number;批号


c)storage conditions when such information is critical to assure the quality of the product;当储存条件对产品质量关键那就要标明。


d) quantity.数量


8.3.5 Measures should be set up to ensure stock turnover.建立确保库存周转的方法


Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.除了特殊情况,要保证先进先出原则


8.3.6 Periodic inventory checks should be performed to:定期盘点


a)ensure inventory accuracy;保证库存数据准确性


b)ensure that acceptance criteria are met.保证符合标准


Any significant discrepancy should be investigated.  要分析任何显著的异常情况



8.4 Shipment 装运



Measures should be taken to ensure the shipment of the defined finished product.要采取措施来保证产品运输顺利。 Precautions should be taken to maintain the finished product quality, when appropriate.必要时需采取预防措施来保证产品质量,(如防冻措施等)



8.5 Returns 退回



8.5.1 Returns should be identified in an appropriate way and stored in defined areas.


退回的产品应适应标识并在特定区域贮存


8.5.2 Returns need to be evaluated against established criteria to determine their disposition.


退回的产品必须根据规定的标准进行评估,从而确定如何处理这些产品。


8.5.3 Release should be given before placing returns on the market again.退回产品重新投放市场前要有放行的批准。


8.5.4 Measures should be established to distinguish any reprocessed return. Measures should be taken to avoid the inadvertent redistribution of unreleased finished product.应制订措施以区分返工的退回产品,应采取措施以避免因疏忽而重新发出未经放行的成品。。



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