《标识和可追溯性控制程序》由会员分享，可在线阅读，更多相关《标识和可追溯性控制程序（11页珍藏版）》请在金锄头文库上搜索。
1、Amelia Knight英妃STANDARD OPERATING PROCEDURE 标准操作程序文件编号：SOP20-0164DOCUMENT NO: 版本号：01 VERSION:第1页共10页PAGE 1 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE文件分发号：Distribution No.审批过稈分发表Distribution部门 Dept.分发号Distributed No.部门 Dept.分发号Distributed No.QA/QC01仓储部02生产部03技术部04更改
2、履历Change Summary版本号VERSION更改描述DESCRIPTION OF CHANGE011.新文件New documentAmelia Knight英妃STANDARD OPERATING PROCEDURE 标准操作程序文件编号：SOP20-0164DOCUMENT NO: 版本号：01 VERSION:第2页共10页PAGE 2 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE1.0 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
3、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
4、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Responsibility3.1 质量部负责本程序的起草修订。QA is responsible fo
5、r 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Identification4.1. 产品标识的范围The scope of product identification4.1.1. 原材料Material4.1.2. 过程产品(包括半成品)Process product (include semi-finished product)4.1.3. 成品Finished productAmelia
6、 Knight英妃STANDARD OPERATING PROCEDURE 标准操作程序文件编号：SOP20-0164DOCUMENT NO: 版本号：01VERSION:第3页共10页PAGE 3 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE4.2. 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
7、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,
8、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 identification4.3.1. 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 identifi
9、cation 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 identi
10、fy 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
11、认填写完成，成品应由生产部在粘贴和 填写完整。Amelia Knight英妃STANDARD OPERATING PROCEDURE 标准操作程序文件编号：SOP20-0164DOCUMENT NO: 版本号：01 VERSION:第4页共10页PAGE 4 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE5.0 检验和试验状态的标识Inspection and testing Status identification5.1. 检验和试验状态标识的分类Inspection and test
12、ing status identification type5.1.1.待验,包括未完成检验,以及因一些特殊的原因,如生产过程有异常，或返回的 产品，还不能确定其是否合格的状态。Quarantine. Including material which not finished inspection, or due to some special reason such as process deviation, product returned, it is not confirmed that the product is qualified or not.5.1.2.合格Qualified
13、5.1.3.不合格Non-conformity5.2. 状态标识的颜色规定The color provision of status identification5.2.1.待验/待决：黄色Quarantine/Pending: yellow5.2.2.合格：绿色Qualified: green5.2.3.不合格：红色Non-conformity: red5.3. 状态标识方法The method of inspection and testing status identification5.3.1.采购产品的标识方法5Identification for purchasing produc
14、t3.1.1仓管员将未经检验的产品放入原料库待检区，对于化学原材料,需要在每件单个包装上贴上待验证Warehouse personal shall put the not inspected material in quarantine area, for chemical material, the quarantine label shall be attached on each single package. .5.3.1.2质量部对采购产品检验后After inspection by QA,Amelia Knight英妃STANDARD OPERATING PROCEDURE 标准操
15、作程序文件编号：SOP20-0164DOCUMENT NO: 版本号：01VERSION:第5页共10页PAGE 5 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDUREa.确定为合格的产品，该批产品的每一单个外包装上贴上合格证，然后 仓管员将产品放入合格品区；For the qualified product, the “Qualified Label” shall be attached on the every package of material, then warehouse personal will put then in qualified area.b.确定为不合格的，其每一单个外包装上需贴上不合格证，仓管员将产品放入 不合格品区，并进行隔离；For the unqualified product, “Disqualified Label” shall be attached to every pac
