标识和可追溯性控制程序

文献分发号：_ Distribution No. 审批过程Approval姓名Name职务Title起草人Initiator审视人Reviewer批准人Approver分刊登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更改履历Change Summary版本号VERSION 更改描述DESCRIPTION OF CHANGE 011. 新文献New document1.0 目 的Purpose对产品及其状态以合适的方式进行标记，避免从原材料进入公司至成品交付的全过程产品混淆和误用。通过合适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 范畴Scope本程序合用于从原材料入库、生产过程、检查和实验过程到成品交付各阶段产品的标记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 for draft and revising of this procedure. 3.2 各有关部门负责按程序实行。The related department is responsible for its implementation.4.0 产品标记Identification4.1. 产品标记的范畴The scope of product identification4.1.1. 原材料Material4.1.2. 过程产品（涉及半成品）Process product (include semi-finished product)4.1.3. 成品Finished product4.2. 产品标记内容Product identification产品标记的内容涉及,但不限于如下内容,Product identification includes but not limited below contents,4.2.1. 原材料：产品名称、编号,接受批号、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. 产品标记措施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记进行检查，如发既有缺失采购人员应立即联系供应商。同步仓管理人员应贴上我司物料标记。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：生产过程中的标记由生产部门人员负责进行标记.标记一般由白标签进行标记。 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记。Finished product. Manufacturing personal is responsible for identify the finished product.4.3.4. 对产品标记的特别阐明：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毕，成品应由生产部在粘贴和填写完整。5.0 检查和实验状态的标记Inspection and testing Status identification5.1. 检查和实验状态标记的分类Inspection and testing status identification type 5.1.1. 待验,涉及未完毕检查,以及因某些特殊的因素,如生产过程有异常，或返回的产品，还不能拟定其与否合格的状态。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Qualified5.1.3. 不合格Non-conformity5.2. 状态标记的颜色规定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. 状态标记措施The method of inspection and testing status identification5.3.1. 采购产品的标记措施 Identification for purchasing product5.3.1.1仓管员将未经检查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查后： After inspection by QA,a. 拟定为合格的产品，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. 拟定为不合格的，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 package of this batch, and then warehouse personal shall isolate it to disqualified area. 5.3.2过程产品的状态标记措施： 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-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记。For the 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 “Disqualified” labeled.5.3.3最后产品的标记措施： Identification for finished product5.3.3.1仓库将包装好的产品接受至成品接受区；仓库对接受后的成品每托进行包膜，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 the “Quarantine” label on every pallet.5.3.3.2 质量部对最后产品检查后： When the testing finished by QA,a. 拟定为合格产品的，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” label for every pallet.b. 拟定为不合格的，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” label will be replaced with “Disqualified” label, warehouse personnel will also isolated them in the disqualified area.5.3.3对于召回/退回的产品，无法立即拟定解决的产品，仓管人员应将该些物品放在召回/退回区域等待最后的解决。 For the recalled and returned product which cant be determined the final disposal right away, warehouse personnel will put these product in “Recalled/Returned Product” area and waiting for final disposal.5.4检查和实验状态标记的保护 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查和实验状态标记；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 confirmation of QA, the status identification change shall be confirmed by QA.5.4.2如在搬运过程中丢失或损坏了标记，则应立即报告质量部，并采用补救措施。 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，相应相应的批号。具体批号原则见批号的编制程序。The material, process product, finished product can be traced by batch with related batch number. Details see SOP20-0086 Batch/lot Numbering Procedure. 6.2. 追溯措施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、检查记录等。Traceability can be realized via related record, such as material receiving record, delivery record, batch record and test record etc.7.0 有关文献Document Related7.1. 批号的编制程序Batch/lot numbering procedure 8.0 附录 Appendix附录1:物料标签式样Appendix 1: Material Label Format附录1 Appendix 1 英妃原料标记卡 AKM Raw Material ID Card原料批号 Batch Number：原料名称 Material Name：数量Qty：供应商Supplier：入库日期 Receiving Date：仓管员 Material Handler：检查状态 Quality Status:合格qualified 不合格unqualified 扣留on hold 待检pending test复检日期 Recheck Date:检 验 员 QC Inspector：英妃成品标记卡 AKM Finished Product ID Card成品批号 Batch Number:成品名称 Product Name:颜色Shade: 香味Aroma:数量（PCS)Qty: 箱号Carton Number:灌装日期 Filling Date: 复检日期Recheck Date:线 长 Line Leader: 线别 Line Number:检查状态 Quality Status:合格qualified 不合格unqualified 扣留on hold 待检pending test检 验 员 QC Inspector: 检查日期Inspection Date:英妃配制半成品识卡 AKM Semi-finished Product ID Card配制批号 Batch Number：品名 Product Name：颜色Shade：香味Aroma：重量（Kg/L)Weight .完毕日期 Completion Date： 年year 月month 日day制作人 Made by：检查状态 Quality Status：合格qualified 不合格unqualified 扣留on hold 待检pending test复检日期 Recheck Date:检 验 员 QC Inspector：检查日期Inspection Date