Identification and traceability标识和可追溯性控制程序(中英文).docx

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1、Approval批准Reviewer审核Originator作成Change History变更记录Revision版本Effective Date生效日期Originator编写人Reasons for Change修改原因1.0 PURPOSE 目的1.1 This procedure defines the product Identification and Traceability system to prevent unintendeduse and ensure the traceability for production and quality.定义产品标识和追溯性系统，防止

2、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 orcomparable 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

3、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 resource ofmaterial 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 169

4、49 Clause 7.5.3 Identification and Traceability 标识和可追溯性5.0 RECORDS 记录5.1 FN-AS-003 Production batch record form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

5、 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 number 创建料号Program Dept create new part numbers according to related principle to ensure identifiable andunique.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

6、.2.1 Supplier should put clear identification on the materials, including part name/number, lotnumber and quantity.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 thelabels, then WH transfer stock shelf and with bin no. i

7、n 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 PN, nonconformance description and Q,ty on the boxand 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 station

8、s and identified with Part No andname.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 identification 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 no1 lot no and date. Dif

9、ferent 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 inspection OK1 inspectors paste qualified labels 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

10、 and products such as lab test samples, QI samples,trial samples and so on, should be identified with 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 nonconformingproducts.标识不明或没有标识的产品或物料按不合格品处理

11、。7.3 Traceability 追溯性7.3.1 We trace the products from the Lot no or production order number in the products. We cantrace the production operators, manufacturing and inspection information from the PO noand manufacturing date. The production dept to fill the production batch record form asa tracking

12、evidence every day.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 Record 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、口期、数量等。7.4.2

13、 QI inspect the materials and record in Incoming Inspection Record including Part name,part no, lot 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 Wl 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

14、inspector sample and inspect products before stocking, record PN, date and resultin 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库单入库。7.4.6 WH ship according to Shipping request from PP and keep packing list.仓库根据计划的发货申请发货，保存装箱单。7.5 If customer has special requirements, please follow the customers request to trace.如客户有特殊追溯要求，按客户要求进行追溯性管理。8.0 FLOW CHART 流程图N。无