标识和可追溯性控制程序（中英版）

1、LOGOQUALITY SYSTEM PROCEDURE 质 量 体 系 程 序Number 文件编号:PD-C3-02Department 部门:Quality Dept Subject 文件名称:Identification and traceability Control Procedure 标识与追溯性管理程序Revision版本: 1.0Effective Date生效日期:2012-01-01Page 3 of 3批准：审核：作成：Change History 变更记录Revision 版本Effective Date生效日期Originator编写人Reasons for Cha

2、nge修改原因1.0 PURPOSE 目的1.1 This procedure defines the product Identification and Traceability system to prevent unintended use and ensure the traceability for production and quality.定义产品标识和追溯性系统，防止产品混用，确保对产品质量及形成的过程实现可追溯性。2.0 SCOPE 范围2.1 Apply to the materials, semi-products and finished products.适用于原

3、料，半成品及成品的标识和追溯。3.0 DEFINITIONS定义3.1 Product identification: make clear and understandable mark by special number, part number or comparable mark and status mark.产品标识：通过特定的编号、零件号、或可比较的记号和状态标记，对产品做出清楚的、易理解的标记。3.2 Traceability: the capability to trace the history, application or location, it refers to

4、resource of material and component, manufacturing process, distribution status of delivered products. 可追溯性：追溯产品的历史、应用情况或所处场所的能力，涉及材料和零件的来源 、加工过程、交付后产品的分布状况。4.0 REFERENCE DOCUMENTS参考文件4.1 ISO/TS 16949 Clause Identification and Traceability 标识和可追溯性5.0 RECORDS 记录5.1 FN-AS-003 Production batch record fo

5、rm 生产批号记录表6.0 RESPONSIBILITY职责6.1 Program department create part number.项目部负责创建材料和产品料号。6.2 Quality Dept identifies for inspection status of products.质量部负责对产品的检验状态进行标识。6.3 Logistics Dept makes identification on the raw materials and finished goods in WH.物流部对仓库内的原材料、成品进行标识。7.0 PROCESS 流程7.1 Part numbe

6、r创建料号Program Dept create new part numbers according to related principle to ensure identifiable and unique.项目部根据相应原则创建材料和产品料号，确保可识别和唯一性。7.2 Identification for products and materials产品和物料的标识7.2.1 Supplier should put clear identification on the materials, including part name/number ，lot number and qua

7、ntity.供应商提供的物料在外包装应有明确清晰的标识，包括品名/料号、批号 、数量。7.2.2 For the good materials, warehouse keeper paste labels in material box and QI mark on the labels, then WH transfer stock shelf and with bin no. in the shelf. 检验合格后，仓库在外包装上贴产品标识，QI贴合格标识，仓库收货后上架入库，货架上标识库位号。7.2.3 For NG materials, QI paste red label P/N,

8、nonconformance description and Qty on the box and move to nonconformance area.对检验不合格的产品置于隔离区，QI每箱贴不合格标签，标明品名/料号、数量，不合格原因，放置在不合格区。7.2.4 Materials on production line are placed in the fixed stations and identified with Part No and name.生产现场材料应放置于固定区域、货架或指定地点，且标明品名/料号等。7.2.5 Inspectors make identificat

9、ion on the non-conforming products in the production line.检验员对生产过程中的不合格品进行标识。7.2.6 For finish goods, warehouse paste manufacturing label on the package with part name, part no, lot no and date. Different products refer to the different requirements.对于成品，仓库按作业指导书贴标签于产品外包装上，标明品名、料号、批次号、日期。7.2.7 If ins

10、pection OK, inspectors paste qualified lables on the package.检验合格后，检验员在外包装上贴合格标签。7.2.8 The finish goods are placed in WH bin with bin no.入库后的成品，货架上标识库位号。 7.2.9 Except the above status, any materials and products such as lab test samples, QI samples, trial samples and so on, should be identified with

11、 product name, status.除以上状态以外的材料、产品，如实验室试验、分析用、进料检验留样产品、打样样品等，都应进行标识，如品名、状态等。7.2.10 The products and materials without identification should be treated as nonconforming products.标识不明或没有标识的产品或物料按不合格品处理。7.3 Traceability 追溯性7.3.1 We trace the products from the Lot no or production order number in the p

12、roducts. We can trace the production operators, manufacturing and inspection information from the PO no and manufacturing date.The production dept to fill the production batch record formas a tracking evidence everyday.根据产品标签上的批次号进行追溯，追溯到当时的生产人员、设备、生产和检验信息等。并由生产部每日填写FN-AS-003生产批号记录表作为追溯的依据。7.4 Recor

13、d and Evidence for Traceability 用于追溯的记录和证据7.4.1 WH keeps Goods Receive Slip for incoming materials with supplier name, part name, incoming date, quantity and etc.原材料进货由仓库保存收货单，注明供应商名称、进货名称、日期、 数量等。7.4.2 QI inspect the materials and record in Incoming Inspection Record including Part name, part no, l

14、ot no, quantity, data and result.检验员对材料进行检验，在进料检验记录上记录产品名、料号、数量、批次号、检验数据和结果。7.4.3 Product Dept. record production record according to WI or Control plan.生产部按作业指导书/控制计划等规定的项目、频次及责任人员，填写生产记录。7.4.4 Quality inspector sample and inspect products before stocking, record P/N, date and result in the report. Inspector sign on the Finish-goods Transfer Slip if inspection OK.检验员按作业指导书/控制计划对半成品和成品进行抽样检查，记录品名、日期、检验结果，检验合格后在入库单上签字。7.4.5 Production dept. transfers the products into WH with Finish-goods Transfer Slip.生产部将检验合格的产品凭入