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1、 . . . . .文件分发号：文件分发号：_Distribution No.审批过程审批过程 ApprovalApproval起草人起草人 Initiator*Name审阅人审阅人 Reviewer批准人批准人 Approver职务职务 Title分发表分发表DistributionDistribution部门部门 Dept.Dept.QA/QC生产部分发号分发号 Distributed No.Distributed No.0103部门部门 Dept.Dept.仓储部技术部分发号分发号 Distributed No.Distributed No.0204更改履历更改履历 Change Sum
2、mary版本号VERSION011.新文件New document更改描述DESCRIPTION OF CHANGE1.01.0目目的的PurposePurpose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 preventproduct mi*ups and wrong using in all stages from material receiving to product distribution, usingappropriate
3、 method to identify the product and its status so as to achieve the traceability of product.2.02.0范围范围ScopeScope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 productrealization stages from material receiving, in proces
4、s production, inspection and test until productdistribution.3.03.0责任责任3.13.2ResponsibilityResponsibility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.4.04.0产品标识产品标识IdentificationIdentifications. .-4.
5、1.产品标识的范围 The scope of product identification4.1.1.4.1.2.4.1.3.原材料Material过程产品（包括半成品）Process product (include semi-finished product)成品Finished product4.2.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
6、、生产日期、失效日期等；Material: Product name, product code, receiving lot number, vendorname,size,quantity,manufacture date and e*pired 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。Processproduct: Product name,product code,lot number and process description, manufacturedate, e*pired date.成品：产品名称、编号,批号,生产日期,失效期等
7、.Finished product: Productname,code,lot number,manufacture date and e*pired date.4.2.3.4.3.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 identification of the vendor,and ask buyerto response
8、 to vendor if any missing information found.Warehouse personal is alsoresponsible 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 processproduct.Usually white label will be used for
9、 identification.4.3.3.4.3.4.成品：生产人员负责成品标识。Finished product.Manufacturing personal isresponsible for identify the finished product.对产品标识的特别说明：Special description for product identification4.3.2.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。5.05.0检验和试验状态的标识检验和试验状态的标识 Inspection a
10、nd testing Status identificationInspection and testing Status identification5.1.检验和试验状态标识的分类 Inspection and testing 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 whichnot. z.-finished inspection, or due to some special reason such
11、as process deviation, productreturned, it is not confirmed that the product is qualified or not.5.1.2.5.1.3.5.2.合格Qualified不合格Non-conformity状态标识的颜色规定 The color provision of status identification5.2.1.5.2.2.5.2.3.待验/待决：黄色Quarantine/Pending: yellow合格：绿色Qualified: green不合格：红色Non-conformity: red5.3.状态标识
12、方法 The method of inspection and testing status identification5.3.1.采购产品的标识方法 Identification for purchasing product5.3.1.1 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 chemicalmaterial,the quarantine label shall be attached
13、 on each single package.5.3.1.2 质量部对采购产品检验后： After inspection by QA,a. 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 everypackage 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
14、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 packageof this batch,and then warehouse personal shall isolate it todisqualifiedarea.5.3.2 过程产品的状态标识方法：Identification for process product5.3.2.1 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-ch
15、eck 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 qualified product through self-inspection,it will be put in the related containerand then identified. z.-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 “Disqualified”label
16、ed.5.3.3 最终产品的标识方法：Identification for finished product5.3.3.1 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，并在每托上贴上一*待验证。Warehouse personnel will put it in quarantine area,then pack every pallet with membranes, and attach the“Quarantine” label on every pallet.5.3.3.2 质量部对最终产品检验后： When the testing finished by QA
17、,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 replaced with “Qualified” labelfor 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 disqualifiedproduct,the “Quarantine” label will be replaced with“Disqualified” label,warehouse personnel will also isola
18、ted them in the disqualifiedarea.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 cant be determined the final disposalright away,warehouse personnel will put these product in “Recalled/ReturnedProduct” area and waiting for final disposal.5.4 检验和试验
19、状态标识的保护Protect of inspection and testing status identification5.4.1 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 cant be removed or changed by the personnel without confirmationof QA, the status identification change shall be confirmed by QA.5.4.2 如在搬运过程中丢失或
20、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. z.-6.06.0可追溯性可追溯性TraceabilityTraceability6.1.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。The material, process product, finished product can be traced by batchwith related batch
21、number. Details see SOP20-0086Batch/lot Numbering Procedure.追溯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, deliveryrecord, batch record and test record etc.6.2.7.07.0相关文件相关文件Document RelatedDocument Related7.1.批号的编制程序Batch/
22、lot numbering procedure8.08.0附录附录 Appendi* Appendi*附录 1:物料标签式样Appendi* 1:Material Label Format附录 1 Appendi* 1英妃原料标识卡英妃原料标识卡AKM Raw Material ID CardAKM Raw Material ID Card原料批号原料批号Batch NumberBatch Number：原料名称原料名称Material NameMaterial Name：数量数量 QtyQty：供应商供应商 SupplierSupplier：入库日期入库日期Receiving DateRec
23、eiving Date：仓管员仓管员Material HandlerMaterial Handler：检验状态检验状态Quality Status:Quality Status:合格合格 qualifiedqualified 不合格不合格 unqualifiedunqualified扣留扣留 on holdon hold 待检待检 pending testpending test复检日期复检日期Recheck Date:Recheck Date:检检 验验 员员QC InspectorQC Inspector：. z.-英妃成品标识卡英妃成品标识卡AKM Finished Product ID
24、 CardAKM Finished Product ID Card成品批号成品批号Batch Number:Batch Number:成品名称成品名称Product Name:Product Name:颜色颜色 Shade:Shade:数量（数量（PCS)Qty:PCS)Qty:灌装日期灌装日期Filling Date:Filling Date:线线 长长Line Leader:Line Leader:检验状态检验状态Quality Status:Quality Status:检检 验验 员员QC Inspector:QC Inspector:配制批号配制批号Batch NumberBatch
25、 Number：品名品名Product NameProduct Name：颜色颜色 ShadeShade：重量重量（Kg/L)WeightKg/L)Weight完成日期完成日期pletion Datepletion Date：制作人制作人Made byMade by：检验状态检验状态Quality StatusQuality Status：复检日期复检日期Recheck Date:Recheck Date:香味香味 Aroma:Aroma:箱号箱号 Carton Number:Carton Number:复检日期复检日期 Recheck Date:Recheck Date:线别线别 Line
26、Number: Line Number:合格合格 qualifiedqualified不合格不合格 unqualifiedunqualified扣留扣留 on holdon hold待检待检 pending testpending test检验日期检验日期 Inspection Date:Inspection Date:英妃配制半成品识卡英妃配制半成品识卡AKM Semi-finished Product ID CardAKM Semi-finished Product ID Card香味香味 AromaAroma：. .年年 yearyear月月 monthmonth日日 dayday合格合格 qualifiedqualified 不合格不合格 unqualifiedunqualified扣留扣留 on holdon hold 待检待检 pending testpending test. z.-检检 验验 员员检验日期检验日期 Inspection DateInspection DateQC InspectorQC Inspector：. z.
