标识可追溯性管理程序文件编号Document ID:版次Version:A/0 Identification and RX-QP-09 Traceability Management Procedure 修改日期 Revision date: 页次Page:4 /7 5.2.6 The purchased product batch number, the supplier delivery plan and the material
information on the package shall be taken as the uniqueness identification of the product so as to ensure traceability. 5.3生产过程产品标识
5.3 Identification of production process product
5.3.1 生产线上所有产品都需贴有标签。标签能反映生产时间、工序、数量,包装等。质量部检验员抽检合格后须盖质量合格章,以便对上工序进行追溯。
5.3.1 All products on the production line shall pasted with label. The label can reflect the production time, process, quantity and packing. The quality department inspector shall stamp the quality conformance seal for tracing the last process after proving the product to be qualified through spot check.
5.3.3待检品或不合格品:发至质量待确认仓并张贴标签,放置于检验待定区域。合格品:由检验员在产品标签上加盖质量合格章确认。
5.3.3 Products waiting for inspection or nonconforming products: Send them to the quality confirmation storehouse and paste labels and place in the inspection area. Qualified products: The inspector shall stamp the quality conformance seal on the label of the product.
5.3.4 生产过程中产品应在标签上建立唯一性产品批次标识,与产品实物批号、移库记录、包装记录生产日期及检验记录单均应保持一致,确保产品的可追溯性。
5.3.4 As to product in the production process, the unique product batch identification shall be established on the label, which shall stay the same as the product batch number, warehouse transfer record, packing record, production date and inspection record so as to ensure product traceability. 5.4成品标识
5.4 Identification of finished product
5.4.1加工完成的成品,由操作工进行自检后张贴成品标签。
5.4.1 As to finished product, the operator shall perform self-check, then paste finished product label.
标识可追溯性管理程序文件编号Document ID:版次Version:A/0 Identification and RX-QP-09 Traceability Management Procedure 修改日期 Revision date: 页次Page:5 /7 5.4.2质检员按流程进行抽检合格后加盖合格章由物料工将合格产品移入成品库区。仓库员根据标签核对零件数量,办理入库手续。
5.4.2 The quality inspector shall stamp the quality conformance seal after proving it to be qualified through spot check according to the procedure and the material personnel shall move the qualified product to the finished product warehouse. The warehouse keeper shall check the quantity of the parts according to the label and handle warehouse entry procedure.
5.4.3 成品检验不合格,检验员张贴标签,并放置于不合格品区域。不合格品处理按《不合格品控制程序》规定执行。
5.4.3 If the finished product is proven to be disqualified through inspection, the inspector shall paste labels, and place in the nonconforming product area. Disposal of nonconforming product shall be done according to the Nonconforming Product Control Procedure. 5.5 可发货成品标识
5.5 Identification of deliverable finished product
5.5.1物流部收集客户对于标识的要求,设计与制作可发货成品标签。
5.5.1 The logistics department shall collect the customer’s requirement for identification, design and make deliverable finished product labels.
5.5.2物流部成品仓管员按照客户要求,对发货成品进行标识。
5.5.2 The finished product warehouse keeper of the logistics department shall identify the deliverable finished product according to the requirement of the customer. 5.6标识管理
5.6 Identification management
5.6.1由质量部负责所有标识的设计,并对其有效性进行监控。
5.6.1 The quality department shall design all identifications and monitor their effectiveness. 5.6.2各部门负责所属区域内各类标识的制作和维护,如发现标识有损坏、遗失等情况,需报原标识部门进行处理。
5.6.2 Each department shall make and maintain all kinds of identifications with its region and report to the original identification department for disposal if finding that the identification is
标识可追溯性管理程序文件编号Document ID:版次Version:A/0 Identification and RX-QP-09 Traceability Management Procedure 修改日期 Revision date: 页次Page:6 /7 damaged or lost.
5.6.3材料出库必须做好标识的转移和保护,无标识的材料不准进入生产现场。
5.6.3 When materials leaving the warehouse, transfer and protect the identifications well; materials without identification are not allowed to enter the production field. 5.6.4在生产过程中,标识随工序同步流转,无标识的产品,操作工应拒绝加工。
5.6.4 In the production process, the identification shall be transferred along with the process; the operator shall refuse to process product without identification. 5.6.5 标识应清晰、统一、准确、及时和有效。
5.6.5 Identification shall be clear, uniform, accurate, timely and effective. 5.7产品的追溯 5.7 Product tracing
5.7.1当顾客投诉或产品出现重大质量问题时,或相关法律、法规、组织提出追溯要求时,由质量部组织相关部门进行追溯。
5.7.1 When the customer complains or great quality problems occur or related laws, regulations and organizations put forward tracing requirement, the quality department shall organize relevant department to trace the product.
5.7.2采购产品追溯可根据采购产品批号,通过进货登记台帐追溯至相关检验报告单及供应商。 5.7.2 As to tracing of purchased product, trace related inspection report and the supplier according to the purchased product batch number and the incoming registration account. 5.7.3生产过程产品、成品和包装成品追溯可根据系统标签追溯至生产日期、工序作业人员以及材料批号等。
5.7.3 As to tracing of product in progress, finished product and packed finished product, trace the production date, process operator and material batch number according to the system label. 5.7.4出具追溯报告。
5.7.4 Provide traceability report.
6、相关文件
标识可追溯性管理程序文件编号Document ID:版次Version:A/0 Identification and RX-QP-09 Traceability Management Procedure 修改日期 Revision date: 页次Page:7 /7 6. Reference documents
序号 6.1 6.2 文件编号 RX-QP-18 RX-QP-26 文件名称 采购管理程序 不合格品控制程序 序号 文件编号 6.3 RX-QP-08 文件名称 生产过程控制程序 7、相关记录 7. Records
无None
8、附件 Annex
附 录A 流程图 Annex A: Flow Chart
标识可追溯性管理程序文件编号Document ID:版次Version:A/0 Identification and RX-QP-09 Traceability Management Procedure 修改日期 Revision date: 页次Page:8 /7 标识和可追溯生产部质量部确认标识和可追溯性要求采购物料标识物流部相关记录进货检验报告单”生产过程产生品标识成品标识包装标识标识管理确定产品批号确定追溯方式查找标识记录出具追溯报告
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