标识和可追溯性控制程序中英文版

1.0 P URPOSE 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 S COPE 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 D EFINITIONS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 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 R EFERENCE DOCUMENTS参考文件

4.1 ISO/TS 16949 Clause 7.

5.3 Identification and Traceability 标识和可追溯性

5.0 R ECORDS 记录

5.1 FN-AS-003 Production batch record form 《生产批号记录表》

6.0 R ESPONSIBILITY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 P ROCESS 流程

7.1 Part number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 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 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, nonconformance description and Q’ty 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 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 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 inspection 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 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 products. 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 form》as

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。