|
6: Product Identification and Lot Traceability 产品标识和批次追溯
"Are there procedures defining product identification requirements for all products?
是否有程序文件定义对所有产品的标识要求?"
"Are in-stock and in-process materials properly identified and controlled?
是否对在仓库和在制程的物料进行适当地标识和控制?"
"Is there an on line WIP tracking system existed? (Shop floor control information system or Bar code system) (a) Is it real time controlled for Shop Floor Information Control System? (b) Can all materials in warehouse be traceable (including FIFO materials)? (c) Can all WIP and finished goods link to customer EDI system?
是否有在线的在制品追溯系统?(SFC系统或者条码系统).现场信息控制系统是否实时进行监控?是否能够追溯在仓库中的所有物料?(包括先进先出的物料).所有在制品和成品的信息是否与客户的数据交换系统联接?"
"Is there evidence to demonstrate effective traceability achieved: Is the key components from subcontractor (datecode, lot number, ... etc.) , WIP and finished goods in factory and shipping destination can be traceable?
是否有证据证明系统的可追溯性确实起作用:二级供应商提供的主要的组件(如生产周期、批号等)、工厂的在制品和成品、产品的发货地点能被追踪"
"Where traceability is a specified requirement, do individual products or batches have a unique identification?
对于有可追溯性要求的,是否每件或每批产品都有唯一的ID?"
"Are the required contents of both Product ID and supplier in process identity label (Bar code label or S/N label) crossed linked?
产品ID和供应商加工中的识别标签(条形码或者序列标签)中所需要的内容是否被交叉关联?"
"Are assemblies properly marked and tracked through the assembly process to ensure no steps in the process flow are missed?
是否组件都被适当地标识和跟踪以确保在整个装配过程中没有漏掉任何工序?"
"Is lot combination prohibited
生产过程中是否禁止批次合并?"
"Can every lot number link to every process' equipment and operator?
能否根据产品批次信息追溯到每个工序是由哪个设备和人员制造出来的?"
"Does traceability system cover end to end whole process(such as distributer center, transfer warehouse and distributor)?
追溯系统能否追溯到从出货到客户的全过程(如是否包括分发中心,中转库,代理商等)?"
"Will distributer center/distributor/transfer warehouse lose traceability information(such as repack activity ect.)?
物流过程是否会把可追溯性破坏(如拆包后重新包装等)?"
11: Handling, Packaging, Storage & Delivery 运输、包装、存贮和交付
"Are there procedures for handling, storing, packaging and delivery of product and materials?
是否建立了关于产品和原材料搬运,存储,包装和交货的程序文件"
"Does the procedure define the proper vehicles and tools for transporting and handling product/ materials?Are those vehicles and tools regularly maintained to be under good condition?
该程序是否对产品和物料的运输,搬运工具及方法做了规定?是否对产品的运输或搬运工具进行定期维护或保养"
"Are the material control records maintained per the procedures defined?
是否根据程序要求对物料的管制记录进行保存。"
"Does the supplier provide methods and means of handling that prevent damage or deterioration?
供应商是否提供预防原材料受损或变质的处理方法或方式"
"Are all ESD-sensitive materials stored in anti-static containers?
对ESD敏感的物料是否储存在防静电的存储箱里面。"
"Are flammable, corrosive, and toxic materials properly stored and segregated?
易燃,腐蚀性和有毒物料的储存方法是否正确并且隔离储存"
"Are necessary protection means in place for flammable, corrosive and toxic materials?
对于易燃,腐蚀性和有毒物料,是否建立必要的预防保护措施。"
"Does the supplier provide secure storage areas to prevent damage or deterioration of product, pending use or delivery?
供应商是否有安全的储存区域以保证暂存和交付物料不损坏和变质。"
"Are defective product/ materials segregated to prevent mixing?
缺陷产品是否被隔离储存以免混料。"
Are appropriate environment control (temperature and humidity…) defined and monitored in these storage areas on a regular basis?是否对存储区域的环境进行合理的规定(如温湿度)并定期监控.
"Is shelf life control properly defined and implemented for required product and materials?
对有存储期控制的物料,文件是否明确介定并执行。"
"Is the condition of product in stock assessed at appropriate intervals in order to detect deterioration?
为提早发现产品是否变质,是否定期对产品的存储状态进行评估"
"Are methods for verification and disposition of materials defined when deterioration or out of shelf life found?
当物料存储期超期时,是否界定验证或处理方法。"
Does the supplier control packing, preservation and marking processes to ensure conformance to specified requirements?供应商是否对包装,存储和标识进行管控,以满足规格要求。
Are the materials issued according to FIFO?是否按照先入先出原则控制物料的发放 |
|