标识和可追溯性控制程序

1、Amelia Knight英妃STANDARD OPERATING PROCEDURE标准操作程序文件编号：SOP20-0164DOCUMENT NO:版本号：01VERSION: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.审批过程Approval姓名Name职务Title起草人Initiator审阅人Reviewer批准人 Approver分发表Distribution部门Dept.分发号Distributed N

2、o.部门Dept.分发号Distributed No.QA/QC01仓储部02生产部03技术部04更改履历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：01VERSION: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 PROCEDUR

3、E1.0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 th

4、e 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Responsi

5、bility质量部负责本程序的起草修订。QA is responsible for draft and revising of this procedure.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产品标识的范围The scope of product identification原材料Material过程产品(包括半成品)Process product (include semi-finished product)成品Finished prod

6、uctAmelia 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 PROCEDURE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,原材料：产品名

7、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.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

8、.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.产品标识方法The method of product identification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 buy

9、er to response to vendor if any missing information found. Warehouse personal is also responsible for identify the material with AMO identification label.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 lab

10、el will be used for identification.成品：生产人员负责成品标识。Finished product. Manufacturing personal is responsible for identify the finished product.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。Amelia Knight英妃STANDARD OPERATING

11、PROCEDURE标准操作程序文件编号：SOP20-0164DOCUMENT NO:版本号：01VERSION: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 identification检验和试验状态标识的分类Inspection and testing status identification type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

12、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.合格Qualified不合格Non-conformity状态标识的颜色规定The color provision of status identification待验/待决：黄色

13、Quarantine/Pending: yellow合格：绿色Qualified: green不合格：红色Non-conformity: red状态标识方法The method of inspection and testing status identification.采购产品的标识方法Identification for purchasing product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

14、, for chemical material, the quarantine label shall be attached on each single package.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 PROCEDU

15、REa.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 beattached 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,aDisqualified Label sh

16、all beattached to every package of this batch, and then warehouse personal shall isolate it to disqualified area.过程产品的状态标识方法：Identification for process product工序产品由生产部对生产的产品的进行过程自检，然后：Manufacture operators shall self-check the process product, and then,a.各车间的产品经自检确认合格后，装入相应的容器，并在相应的容器上予以 标识。For the

17、qualified product through self-inspection, it will be put in the related container and then identified.b.将不合格品放入贴有红色“不合格品”字样的容器内；For the nonconformity product, it will be put in the container with a Disqualified labeled.最终产品的标识方法：Identification for finished product仓库将包装好的产品接收至成品接收区；仓库对接收后的成品每托进行包 膜，

18、并在每托上贴上一张待验证。Warehouse personnel will put it in quarantine area, then pack every pallet with membranes, and attach thea Quarantine label on everypallet.Amelia Knight英妃STANDARD OPERATING PROCEDURE标准操作程序文件编号：SOP20-0164DOCUMENT NO:版本号：01VERSION:第6页共10页PAGE 6 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND

19、 TRACEAQBILITY CONTROL PROCEDURE5.3.3.2质量部对最终产品检验后：When the testing finished by QA, a.确定为合格产品的，将该批产品的待验证换成合格证。For the qualified product, the“Quarantine“ will be replacedwith a Qualified label for every pallet.b.确定为不合格的，将该批产品的待验证换成不合格证，仓管员将产品放入不 合格品区，并进行隔离； For disqualified product, the“ Quarantine l

20、abel will bereplaced with a Disqualified label, warehouse personnel will also isolated them in the disqualified area.5.3.3对于召回/退回的产品，无法马上确定处理的产品，仓管人员应将该些物品 放在召回/退回区域等待最终的处理。For the recalled and returned product which can t be determinedthe final disposal right away, warehouse personnel will put thes

21、e product in “ Recalled/Returned Product area and waiting for final disposal.5.4检验和试验状态标识的保护Protect of inspection and testing status identification非质保部人员确认不得擅自移动或更改产品检验和试验状态标识；如需移动需得到质 保的确认。Inspection and testing status identification can t be removed or changedby the personnel without confirmation

22、of QA, the status identification change shall be confirmed by QA.如在搬运过程中丢失或损坏了标识，则应立即报告质量部，并采取补救措施。If the status label missed during transition, it shall be report to QA and take action as remedy.6.0可追溯性Traceability6.1.对原材料、过程产品、成品以批为单位追溯，对应相应的批号。具体批号原则见批 号的编制程序。Amelia Knight英妃STANDARD OPERATING PRO

23、CEDURE标准操作程序文件编号：SOP20-0164DOCUMENT NO:版本号：01VERSION:第7页共10页PAGE 7 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDUREThe material, process product, finished product can be traced by batch with related batch number. Details see SOP20-0086 Batch/lot NumberingProcedure .6.2.追溯

24、方法可通过相应的记录实现追溯，如收货入库记录、发货记录、批记录、检验记录等。Traceability can be realized via related record, such as material receiving record, delivery record, batch record and test record etc.7.0相关文件Document Related7.1.批号的编制程序Batch/lot numbering procedure8.0附录Appendix附录1:物料标签式样Appendix 1: Material Label FormatAKM RnwMd

25、减睛rCardupplier e:Receiving Date 锄| j|PCS)Qty:Material HandlerFilling ,Date:卷ualityStatus:Line Leader:QuChyck Date:SfetUs:员QC Inspector :检验员QC Inspector:Amelia Knight英妃STANDARD OPERATING PROCEDURE标准操作程序文件编号：SOP20-0164DOCUMENT NO:版本号：01VERSION:第8页共10页PAGE 8 OF 10标题：标识和可追溯性控制程序TITLE: IDENTIFICATION AND

26、 TRACEAQBILITY CONTROL PROCEDURE附录1Appendix 1原料批号jBatchLNumber - BOChNUmber:期丽祢Name prOduQtName:香味 Aroma:一箱号 Carton Number: _人上检 日.期 Recheck Date:合格qualified口下合格 unqualified口扣留 on hold 口待检 pending test线别 Line Number: 口 合格qualified口 不合格 unqualified口扣留on hold口 待检pending test验日期 Inspection Date: Amelia Knight英妃STANDARD OPERATING PROCEDURE标准操作程序文件编号：SO