标识和可追溯性控制程序

文件分发号：__________

Distribution No.

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1.0目的

Purpose

对产品及其状态以适当的方式进行标识，防止从原材料进入公司至成品交付的全过程产品混淆和误用。通过适当的控制和记录实现产品的可追溯性。

The purpose of this procedure is to prevent product mixups and wrong using in all stages from material receiving to product distribution, using appropriate method to identify the product and its status so as to achieve the traceability of product..

2.0范围

Scope

本程序适用于从原材料入库、生产过程、检验和试验过程到成品交付各阶段产品的标识控制和可追溯性控制。

This procedure is applicable for identification and traceability control of all product realization stages from material receiving, in process production,

inspection and test until product distribution.

3.0责任

Responsibility

3.1质量部负责本程序的起草修订。

QA is responsible for draft and revising of this procedure.

3.2各相关部门负责按程序实施。

The related department is responsible for its implementation.

4.0产品标识

Identification

4.1.产品标识的范围

The scope of product identification

4.1.1.原材料

Material

4.1.2.过程产品（包括半成品）

Process product (include semi-finished product)

4.1.3.成品

Finished product

4.2.产品标识内容

Product identification

产品标识的内容包括,但不限于以下内容,

Product identification includes but not limited below contents,

4.2.1.原材料：产品名称、编号,接收批号、生产厂家、产品规格、数量、生产日

期、失效日期等；

Material: Product name, product code, receiving lot number, vendor

name, size, quantity, manufacture date and expired date.

4.2.2.过程产品：产品名称、编号,批号,工序名称,生产日期, 失效期等。

Process product: Product name, product code, lot number and process

description, manufacture date, expired date.

4.2.3.成品：产品名称、编号,批号,生产日期,失效期等.

Finished product: Product name, code, lot number, manufacture date

and expired date.

4.3.产品标识方法

The method of product identification

4.3.1.原材料：仓管人员在收货时应核对供应商的标识进行检查，如发现有缺失采

购人员应马上联系供应商。同时仓管理人员应贴上本公司物料标识。

Material. Warehouse personal shall check the identification of the

vendor, and ask buyer to response to vendor if any missing

information found. Warehouse personal is also responsible for

identify the material with AMO identification label.

4.3.2.过程产品：生产过程中的标识由生产部门人员负责进行标识.标识一般由白标

签进行标识。

Process product. Manufacturing personal is responsible for identify

the process product. Usually white label will be used for

identification.

4.3.3.成品：生产人员负责成品标识。

Finished product. Manufacturing personal is responsible for

identify the finished product.

4.3.4.对产品标识的特别说明：

Special description for product identification

. 对原料和成品应分别采用专用的印刷标签粘贴，原料标签上信息应在入库时由

技术部和仓储部人员共同确认填写完成，成品应由生产部在粘贴和

填写完整。