产品标识和可追溯程序.doc

1 目的规定了产品的标识与可追溯性管理程序，以识别不同的产品和过程，实现产品的追溯。2 范围适用于从原材料接收至产品交付整个过程中各阶段的产品标识和规定场合的产品跟踪追溯。3 参考文件3.1 001-7502过程控制程序3.2 001-7505产品防护程序3.3 001-8203 产品的监视和测量程序3.4 001-8301不合格品控制程序4 定义与缩写MD：指Medical device ,医疗器械产品：本文件内所提到的产品，包括生产各阶段的物料、在制品、成品。5 职责5.1 生产物料控制部负责从原材料接收到产品交付整个流程的跟踪，并会同相关部门确定需作追溯的产品的控制与管理。质量保证部、生产部、仓库负责实施并做好记录。5.2 生产物料控制部对顾客提供的产品标识，经工程部共同确认后进行控制和管理。对顾客提供的产品标识有异议时，通过生产物料控制部与顾客协商决定。 5.3 质量保证部负责制定检验和试验状态标识标准，及特殊场合下产品的可追溯性的确定。5.4 工程部负责将合同规定/公司规定需进行追溯的产品编订相关文件。5.5 进料检验、工序检验和最终检验状态的标识由质量部负责，生产现场所有人员均应自觉保护有关检验和试验状态的标识。生产控制部负责成品检验和试验状态标识的延续。 5.6 MD产品的状态标识:应根据监视和测量的要求,识别产品的状态。在产品的生产、贮存、安装和服务的全过程中保持产品状态的标识,以确保只有通过所要求的检验和试验(或在授权让步下放行)的产品才能被发送、使用或安装。 6 工作程序6.1 产品的检验和试验状态标识采用的方法有标签、标记、容器、随产品的检验记录及放置地点(并非指正常生产流程中产品所处的位置）。 6.2 标识的名称和用途6.2.1 标签a.合格标签：产品经检验且合格（盖有蓝色“ACCEPT”章的标签）。b.不合格标签：产品经检验但不合格（盖有红色“REJECT”章的标签）。 若产品经确认不符合RoHS有害物质含量要求，此时还需加盖有红色“RoHS NG”章予以特别标示.c.待处理标签：产品须经处理才可判定结果。（填写相应的“HOLD LABLE”见附件1及附件3，QA部门还需盖红色“HOLD”章）。d.条件使用标签：产品经客户或相关部门经理认可特采。（盖有“WAIVE”章的标签）。6.2.2 区域a.不合格区: Non-RoHS不合格区：放置Non-RoHS不合格品的区域。该区域用“Non-RoHS不合格区”字样加以标识。 RoHS不合格区：放置RoHS不合格品的区域。该区域用“RoHS不合格区”字样加以标识。在此区域的HSF不合格产品需有红色“RoHS NG”章予以特别标示。b.合格区: Non-RoHS合格区：放置Non-RoHS合格品的区域。该区域用“Non-RoHS合格区”字样加以标识。 RoHS合格区：放置RoHS合格品的区域。该区域用“RoHS合格区”字样加以标识。c.待检区： Non-RoHS待检区: 放置未经检验Non-RoHS产品的区域。该区域用“Non-RoHS待检区”字样加以标识。 RoHS待检区: 放置未经检验RoHS产品的区域。该区域用“RoHS待检区”字样加以标识。d.检验区： Non-RoHS检验区：放置正在检验的Non-RoHS产品的区域。该区域用“Non-RoHS检验区”字样加以标识。 RoHS检验区：放置正在检验的RoHS产品的区域。该区域用“RoHS检验区”字样加以标识。e.待处理区： Non-RoHS待处理区:放置须经处理的Non-RoHS产品的区域。该区域用“Non-RoHS待处理区”字样加以标识。 RoHS待处理区:放置须经处理的RoHS产品的区域。该区域用“RoHS待处理区”字样加以标识。 放置于待处理区的产品必须按批标贴相应的“HOLD LABEL”。6.2.3 容器a.原包装容器：放置合格品的器具。b.贴有红色标签的容器：放置不合格的产品的器具。c.贴有黄色标签的容器：放置待处理的产品的器具。待处理的产品指无法立即作判断是否可以接收的、需进一步确认的产品。6.2.4 个别产品的质量状态直接挂或粘在产品上。6.3 物料接收工作程序 6.3.1 补充说明6.3.1.1 经检验和试验合格，由质量保证部检验员贴上合格标签，仓库管理人员置于接受区域；如不合格，仓库管理人员负责置于NCRB区域。NCRB会议后，检验员根据会议决定贴相应的标签，仓库管理人员将该批物料转移至接受区域或退货区域。 6.3.1.2 成品、半成品入库公司制作的成品、半成品，仓库凭质量保证部检验员的标签及验收章入库，将其摆放在规定的区域，以标签形式在货架上标明成品、半成品名称，并在物料卡（BIN CARD）上记录。 6.4 工序过程的标识6.4.1 工序标识a.对需要追溯的产品或客户指定要追溯的产品，物料部发放工单时必须按客户或工程部的要求作好相关的产品标识。 b.对需要追溯的产品或客户指定要追溯的产品在生产线流转时，产品标识规定用跟踪卡。生产部负责管理并正确填写跟踪卡或按工艺文件要求在产品上做好追溯标识。标识的资料应包括工单号、生产日期、班次等。 c. 没有规定或要求追溯的产品，在生产线流转时必须有产品的标识，可以用标签作产品追溯标识。6.4.2 过程检验标识过程检验的标识由质量部负责以印章的形式在跟踪卡上或产品标签上标明。6.4.3 最终检验后的标识a. 对成品最终检验后的标识由生产部负责在包装标签上注明产品名称、工单号（即批号）、跟踪卡号(当有时）、包装日期等。b. 对半成品检验完成后由生产部负责在工序标签上注明产品名称、员工号等。有追溯要求时，还应注明工单号、跟踪卡号、包装日期等。c. 经检验合格的Non-RoHS半成品、成品，由质量保证部的检验员贴合格标签,置于Non-RoHS合格区域；对于合格的RoHS半成品、成品，则置于RoHS合格区域. 经检验不合格的Non-RoHS半成品、成品，由质量保证部的检验员贴不合格标签，置于Non-RoHS不合格区域；对于RoHS不合格的半成品、成品，则置于RoHS不合格区域； 待处理的Non-RoHS半成品、成品，由质量保证部的检验员贴上待处理标签，置于Non-RoHS待处理区域。对于待处理的RoHS半成品、成品，则置于RoHS待处理区域。6.4.4 紧急放行的标识a. 生产物料控制部负责在工单上注明“紧急放行”并在工单上注明紧急放行物料的批号或供应商发票号。b. 生产部负责在跟踪卡上注明。6.4.5 特采的标识a. 对于特采的来料，质量保证部负责在来料标签上以检验章的形式注明“特采”（WAIVE）。b. 对于特采的自制半成品，质量保证部负责在工序标签上注明“特采”。c. 对于成品特采，客户要求时，在包装标签备注栏内注上“特采”，并预先通知客户。6.4.6 客户提供产品的标识a. 仓库负责将客户提供的产品放置于适当区域，并单独建立OW（客供）BIN卡，且区分于OA（自供）BIN卡管理。内外包装标签上的产品代码以库别的形式加以区分，客户提供材料以“OW”为字首。当客户有特别要求时按客户要求处理，例如将客户的P/N置于内外包装上。 b. 发料至生产线时，生产物料控制部负责在工单上以物料代码的形式注明客户提供产品或以客户的要求作相应的标识。6.4.7 客户投诉后的库存品，由质量保证部检验员贴上“待处理标签”，并立即置于待处理区域。库存品经复检后，合格的重新贴合格标签，置于合格区域，不合格的按不合格品控制程序执行。 6.4.8 当顾客要求时，应对产品进行附加的验证/标识。6.4.9 质量保证部负责合格品的放行，具有独立的质量判决权。6.4.10 MD产品的标识:应在产品实现的过程中,使用适宜的方法识别产品,以确保返回组织的MD均能被识别,且能与合格的产品区分开来.6.5 产品的追溯6.5.1 产品追溯场合的确定a. 当合同规定或根据产品质量实际要求需进行追溯的产品b. 特殊情况（如对某工序、某材料等发生疑义时）c. 工艺性试验6.5.2 追溯产品的确认和管理a. 对于6.5.1 a 情况，由生产物料控制部组织协调负责，必要时由工程部编入相关文件，由实施部门进行实施。b. 对于6.5.1 b 情况，由质量保证部组织协调及负责，生产物料控制部和生产部配合。c. 对于6.5.1 c 情况，由工艺试验负责人确定与协调，生产物料控制部和生产部配合。6.5.3 MD产品的可追溯性:其范围为从原材料接收至产品交付各阶段的产品的可追溯性,并保留相应的记录。有源植入MD和植入型MD专用要求：记录应包括可能导致MD不满足其规定要求的所有组件、材料、工作环境条件的记录，应要求其代理商或经销商保持MD的分销记录以便追溯,当检查需要时,可获得此类记录,并保持货运包装收件人的名字和地址。6.5.4 追溯的标识a.对于6.5.1 a 情况，生产物料控制部负责根据合同或文件规定在工单上注明所使用来料的资料，包括供应商发票号码或来料批号、自制半成品的工单号以及客户要求填写的任何资料。生产部以跟踪卡形式跟踪。客户要求时，跟踪卡将跟随产品一起发往客户。b.对于6.5.1 b 及6.5.1 c 情况，生产物料控制部负责按追溯要求部门的要求在工单上注明所使用的来料的资料，包括来料批号或供应商的发票号、自制半成品的工单号等。生产部以跟踪卡进行跟踪。根据客户特殊要求,为准确追踪LED的生产批次,须在LUMILEDS产品的RUNCARD上完整填写每个REEL上LED的BIN号,BUNDLE ID 或DATE CODE,若PCB板上有多个LED,应记录不同BIN号对应PCB板上位置编号.6.5.5 物料的封存与清查当产品出现质量问题时，由质量保证部下达指令，由生产部、生产物料控制部负责对被追溯到的相关来料半成品、成品进行封存和清查。7. 质量记录所有质量记录应根据记录控制程序处理。8. 附页8.1 附页1：各标签的样品及RoHS NG章样版 Attachment 1： Attachment 2: Sample of“RoHS NG”stamp Attachment 3: Sample of HOLD LABEL for PD 1. Purpose Establish procedure to identify different products and processes and realize the traceability of product.2. ScopeAdapt to the product identification from material receiving to product delivery and products traceability.3. Reference Documents3.1 001-7502Process Control Procedure3.2 001-7505Product Preservation Procedure3.3 001-8203 Monitoring and Measurement of Product Procedure3.4 001-8301Control of Nonconforming Product Procedure4. Definition and Abbreviation MD：Medical device Product: what mentioned in this procedure, including material, semi-product and finish goods throughout the production.5. Responsibility5.1 PMC is responsible for product and status tracking from material receiving to product delivery, and coordinate with other dept. to define the need of control and management for tracing. QA, PD and warehouse are responsible for implementation and record. 5.2 PMC identify customer provided products and perform control and management after confirmed by engineering department. If theres any dissension about customer products identification, PMC communicate with customer. 5.3 QA department is responsible for establishment of inspection and testing status identification standard and determination of product traceability in special situation.5.4 Engineering department is responsible for establishing documents according to contract and companrequirements.5.5 QA department is responsible for coming material, in-process products and finished products inspection status identification. Operators shall self-consciously protect inspection and testing identification. PMC is responsible for identification extending. 5.6 Status identification for MD: Shall identify the product status with respect to monitoring and measurement requirements.The identification of product status shall be maintained throughout production,storage,installation and servicing of the product to ensure that only product that has passed the required inspections and tests(or released under an authorized concession) is dispatched,used or installed. 6. Procedure6.1 Identification can use label, mark, case, inspection record and placed area. The placed area is not products located area in normal process. 6.2 Label Name and Use6.2.1 Labela. Accept Label: Products are through inspection and accepted, which stamp with blue ACCEPT.b. Reject Label: Products are through inspection and rejected, which stamp with red REJECT. If products are through confirmation and harzardous substances nonconformance with RoHS requirement, should add red “RoHS NG”stamp to identify specially.c. Hold Label:Products need to dispose, refer to related HOLD LABEL in attachment 1&3, if hold by QA, need to stamp with red HOLD.d. Waive Label: Products can be special used after approved by customer or related department managers, which stamp with WAIVE.6.2.2 Areaa. Reject Area: Non-RoHS Reject Area: Place rejected Non-RoHS products, and marked with Non-RoHS Reject Area. RoHS Reject Area:Place rejected RoHS products, and marked with RoHS Reject Area. HSF Nonconforming product in this area should add“RoHS NG”stamp to identify specially.b. Accept Area: Non-RoHS Accept Area: Place accepted Non-RoHS products, and marked with Non-RoHS Accept Area. RoHS Accept Area: Place accepted RoHS products, and marked with RoHS Accept Area.c. Waiting Area: Non-RoHS Waiting Area : Place Non-RoHS products waiting for inspection, and marked with Non-RoHS Waiting Area. RoHS Waiting Area : Place RoHS products waiting for inspection, and marked with RoHS Waiting Area.d. Inspection Area: Non-RoHS Inspection Area: Place Non-RoHS products being inspected, and marked with Non-RoHS Inspection Area. RoHS Inspection Area: Place RoHS products being inspected, and marked with -RoHS Inspection Area.f. Hold Area: Non-RoHS Hold Area: Place Non-RoHS products being disposed, and marked with Non-RoHS Hold Area. RoHS Hold Area: Place RoHS products being disposed, and marked with RoHS Hold Area Products on hold area must be identified with HOLD LABEL by lot no.6.2.3 Casea. Original Packing Case: Place accepted products.b. Sticking Red Label Case: Place nonconforming products.c. Sticking Yellow Label Case: Place the pending products. The pending products mean the products cant be judged immediately and need to be verified. 6.2.4 Some products quality status can hang or stick on product itself.6.3 Material Receiving Procedure 6.3.1 Supplement6.3.1.1 QA inspector sticks accept label on the products through inspection and warehouse put it in accept area, if reject, warehouse put it in NCRB area. After NCRB meeting, inspector will stick relevant label according to decision and warehouse will transfer the material to accept area or returned area.6.3.1.2 Finished and Semi-finished Products StoreWarehouse stores the products according to label and stamper and put in related area.Mark products name on label at shelf and record on Bin Card. 6.4 Process Identification6.4.1 Process Identificationa. As for required or customer appointed products need for tracing, PMC shall make relevant identification according to customer or engineering departments requirement when issue work order.b. Shall use run card as identification for the products that need for tracing or customer required tracing. PD department is responsible for management and filling in R/C correctly or making the traceable mark on products according to documents requirement. Identification information should include work order, production date, shift and so on. c. As for the products that have no requirement or need to trace, shall have identification when use in production line, which should use label as product identification.6.4.2 In-process Inspection IdentificationQA stamp on run card or remark on product label.6.4.3 Final Inspection Identificationa. As for finished products, PD remark on packing label with product name, work order, R/C if has, inspector,packing date and so on.b. As for semi-finished products, PD remark on in-process label with product name, inspector, inspection date and so on. If has traceable requirement, shall also remark work order, R/C, packing date and so on.c. As for accepted Non-RoHS semi-finished and finished products, QA inspector stick accept label and put in Non-RoHS accept area; For accepted RoHS semi-finished and finished products, stick accept label and put in RoHS accept area; As for rejected Non-RoHS products, stick reject label and put in Non-RoHS reject area; For rejected RoHS products, stick reject label and put in RoHS reject area; As for Non-RoHS hold products, stick hold label and put in Non-RoHS hold area; For RoHS hold products, stick hold label and put in RoHS hold area.6.4.4 Identification of Urgent Releasea. PMC remark Urgent Release and lot number or supplier invoice number of urgent release material on work order.b. PD remark on run card.6.4.5 Identification of Special Usea. As for special used incoming material, QA stamp on incoming label with Waive.b. As for special used semi-finished products, QA remark Waive on in-process label.c. As for finished products, when customer requires, remark Waive on packing label and inform customer in advance.6.4.6 Identification of Customer-Supplied Productsa. Warehouse put customer-supplied products in seperate area and build the OW (customer supplied) BIN card separated from OA (self-supplied) BIN card. Product code of internal and external packing label is distinguished by warehouse. The first letter OW represents customer-supplied product. Dispose the material according to customer requirements if any. For example, mark part number on internal and external package. b. When the material is used in production line, PMC shall remark customer-supplied products with material code on work order or identify according to customer requirements.6.4.7 Stock products complained by customer shall be stick Hold label by QA and put in Hold area. After stock products are re-inspected, sticks Accept label and put in Accept area if accept otherwise handle the products according to the Control of Nonconforming Product Procedure.6.4.8 Perform additional verification or identification when customer requires.6.4.9 QA is responsible for accepted products release and has individual quality judgement puissance. 6.4.10 Identification for MD:Shall identify the product by suitable means throughout product realization,and shall establish documented procedures for such product identification to ensure that MD returned to the organization are identified and distinguished from conforming product.6.5 Product Traceability6.5.1 Determination of Product Traceability Situationa. The products that contract required or product quality required.b. Special situation, such as doubtable process or material.c. Process experiment.6.5.2 Determination and Management of Traceable Productsa. As for 6.5.1 a, PMC is responsible for organization and coordination. If necessary, engineering department draft it into documents and performed by responsible departments.b. As for 6.5.1 b, QA is responsible for organization and coordination. PMC and PD are responsible for cooperation.c. As for 6.5.1 c, the principal of process experiment is responsible for determination and coordination. PMC and PD are responsible for cooperation.6.5.3 Traceability for MD:The product traceability is from material receiving to product delivery and retain the records.Particular requirements for active implantable MD and implantable MD:In defining the records required for traceability ,the organization shall include records of all components,materials and work environment conditions,if these could cause the MD not to satisfy its specified requirements. And shall require that its agents of distributors maintain records of the distribution of MD to allow traceability and that such records are available for inspection. Records of the name and address of the s