不符合品控制程序（Nonconforming Product Control Procedure）.doc

修订履历 Revision History修订日期Date版本Rev.修订内容Updated Content作者Originator备注Remark2011,5,23AFirst releasedSummer制作Prepared By: 审核Checked By: 批准 Approved By:日期Date: 日期Date: 日期Date: 1.0 PURPOSE 目的To define the process for controlling products or components suspected of not meeting: specification, print or other contractual requirements，as well as the nonconforming process. 本程序定义了控制可能与规格、印刷或其他合同要求不符合之产品或零件的过程,及其不合格过程的控制过程。2.0 Application 适用范围 The nonconforming products or components generally include the followings: 不合格品通常包括如下几个方面： a. Incoming (Verifications/Inspections/Audits)来料(验证/检验/稽核发现的)；b. In-Process (Operator, Auditor)半成品(作业员，稽核员发现的)；c. Finished Goods成品；d. Customer Returns客退品。3.0 Definition定义a. RMA = Return Material Authorization (electronic)b. MRB = Material Review Board (electronic)c. CAPA = Corrective & Preventative Action (electronic) 4.0 Reference参考文件4.1WI-QA-0002WI for Incoming Inspection Plan来料检验4.2WI-QA-0024 WIP for In-process, production Inspection 制程和产品检验指导4.3 WI-QA-0027WI for Production Identification & Traceability 产品标签与追溯作业指导书4.4WI-QA-0016 WI for Customer Complaints and Product Return客户抱怨和产品退货作业指导书4.5 WI-QA-0028 WI for MRB MRB作业指导书 4.6 QP-853 Corrective and Preventive Actions Procedure纠正和预防措施程序5.0 Responsibility职责5.1 General speaking, the person who discovers the nonconforming products is responsible for preparing the MRB reports. Nonconforming of WIP/F/G on line are by production; incoming and Customers complaint are by QA; ECN and design by PE; overmolding parts by molding department;PMC charges the dead stock, shelf life expiration and others.通常发现不良品者有责任准备MRB报告。制程不良(物料, 半成品/成品)由生产负责, 来料,客诉不良由QA负责,产品设计变更/设计问题引起由PE负责. 注塑部负责overmolding零件;呆料/长期库存/超出使用寿命等由PMC负责;5.2 MRB which consists of (but not limit to) QA , Production, Manufacture Engineering , Production Engineering, PMC, Soucing(C/S), Finance and Operation Manager, are responsible for reviewing, evaluating and disposing nonconforming products, GM need to review and give comment if cost of failure is larger than 5,000 RMB, MRB Signature and Follow up Flow as Attachment 1.MRB由QA、生产、制工,工程、PMC经理、采购部、财务和运作经理组成，负责对不良品进行判定, 当失效金额大于5,000元人民币,总经理需要审核;MRB会签流程见附件1.5.3 QA Engineer will review the nonconforming materials and make the proposed disposition after inspection.QA 工程师检查不良品后对其作出适当的处理意见。5.4 MRB final disposition result follow up responsibilities: RTV/Rework by Vendor charged by Sourcing, Rework, Sorting(By vendor or on line) by PMC, Scrap by Store; Deduction on RTV and rework/sorting cost by Finance.MRB最终结论跟踪责任：采购负责RTV/供应商返工，PMC负责安排产线重工,挑选使用，仓库负责报废，退货，返工挑选扣款由财务执行。6.0 Procedure 程序6.1Nonconforming found by IQC 来料不良品6.1.1 Nonconforming material found by QC inspector during incoming inspection is identified with “Rejection” label. The nonconforming material is transferred to rejection area by storekeeper, QC reported to the QA Engineer with defective samples (if any) . Then the QA Engineer convenes MRB and call PE, sourcing, PMC & Production and others (if necessary) discussing the disposition of the nonconforming products if QA engineer cant make a decision, otherwise, QA engineer have access to accept the nonconforming material if the nonconformity doesnt affect the using of function. QC检验员在检查过程中发现来料不良，贴 “Rejection”标签明示，仓库管理员将不良转移到不良品区域，QC带上不良样品报告QA工程师，如果QA工程师不能对不良品做出判断,则QA工程师主持MRB并召集产品相关人员包括PE/采购/PMC/生产/或其它有必要部门一起讨论如何处理,否则,如果不合格品不会影响产品使用功能, QA工程师 有权判定来料是否合格。6.1.2The QA Engineer makes proposal disposition of the nonconforming material/product on MRB area of IIR (incoming inspection report). The disposition made can be:QA工程师处置不良来料，处理结果如下： 6.1.2.1 "UAI"( the material is used as it is ), The IIR must be countersigned by QA/PE /ME/PROD . "UAI" label is used by QC and passed the material to the store.讨论决定特采，相关人员QA/PE/ME/PROD在IIR上会签，QC贴UAI标签;6.1.2.2 "Rework/Sorton line”, MRB decide the possibility whether the material is rework or sort. The IIR must be countersigned by QA/SR/PMC/PROD. The nonconforming material is transferred to rejection area by storekeeper and identified in "Rework/Sort" label by QC, PMC arranges Rework or Sort.来料如产线判返工/挑选，QA/PE/SR/PMC/PROD在IIR上会签，仓库管理员将不良材料转移到拒收区域, QC 在来料上贴相应标签,PMC安排返工/挑选。6.1.2.3 "Rework/Sortby supplier”, MRB decide the possibility whether the material is rework or sort. The IIR must be countersigned by QA/SR/PMC/PROD. The nonconforming material is transferred to rejection area by storekeeper and identified in "Rework/Sort" label by QC, Sourcing arranges supplier Rework or Sort.来料需要供应商来我们产线判返工/挑选，QA/SR/PMC/PROD在IIR上会签，仓库管理员将不良材料转移到拒收区域, QC 在来料上贴相应标签, 采购安排供应商到厂返工/挑选。6.1.2.4 If "Rework/Sorton line”, production need finish the IIR full check result includes quantity of OK & NG parts,and work hours spent. QC should check the OK/NG products, stick PASS label on OK materials, RTV label on NG materials,and update the MRC sheet, store has the OK materials in warehouse, ; If “Rework/Sort-By supplier, QC will re-inspect the OK products, stick PASS label on OK materials, RTV label on NG materials,and update the MRC sheet, store has the OK materials in warehouse.来料如产线判返工/挑选, 则产线需完成IIR上最终结果包括合格品和不合格品的数量和所用工时, QC负责再检, 合格品则贴上合格标签, 不合格品贴上RTV标签,并且更新MRC单上的数量,仓库负责对合格品入库,不良品则由采购开退货单; 如供应商返工或挑选,则QC负责再检OK品, 合格品则贴上合格标签, 不合格品贴上RTV标签,并且更新MRC单上的数量,仓库负责对合格品入库,不良品则由采购开退货单;6.1.2.5 "Scrap" - some samples may scrap after inspection/testing. 检查和测试后样品可以报废。6.1.2.6 “RTV”-the nonconforming material return to vendor. The IIR must be countersigned by QA/SR/PMC, RTV” label is used by QC. and the material is passed to the Reject Area. The Sourcing engineer issues the Return To Vendor Notice and arranges for returning the material to the vendor.来料决定退回供应商(包括全检/挑选之不良品), 由QA/PMC/SR会签，QC 贴“RTV”标签,材料放入拒收仓库，采购员发给供应商退货单并且安排退货。6.1.3QC leader is responsible for distributing the IIR to concerned department for actionsQC leader 负责分发IIR至相关部门采取相关的行动。6.2Nonconforming material in in-process.制程中的不良品6.2.1All the nonconforming WIP is handled as following:制程不良品一般处置如下：6.2.1.1 Nonconforming material is found by QA inspector or operator and confirmed by QAEngineer to be identified by “Rejection” labels arrange QA inspector to check the same lot materials in warehouse, then release “Nonconforming Material Notice” to warehouse to segregate them in MRB area and stick the rejection label on them.QA检验员或操作员发现来料不良，由QA工程师确认后检验员贴“Rejection” 标签, 同时安排QA检验员检查在仓库里同一批来料, 如果同样发现来料不良则发出”仓库不良物料通知单”要求仓库把这些不良物料隔离到MRB区域,并且在不良品上贴上拒收标签.6.2.1.2 QA Engineer makes the disposition of the nonconforming material and the relative section leader issues the MRB report with defective samples (if any) to the concerned processes. Disposition of nonconforming WIP is either one of the followings:QA工程师处置不良品，相关部门主管发行MRB并附带样品.不良品一般处置如下：A.“UAI” is “Used As Is”. The WIP is accepted in deviate and released for use in the next operation. If the UAI WIP does not conform to customers requirement, the written authorization from the customer is required.“UAI”是“Used As Is”（特采），接受并且放行至下一个工站，如果UAI不符合客户的要求，需要得到客户的认可。B.“RWK” is “Rework/Sort”. The WIP is reworked/sorted according to the instruction described in MRB. The WIP is re-inspected and only accepted WIP is passed to the next operation, the NG WIP will be “RWK”是返工/挑选, 依据MRB挑检/返工制成品。再次检查并确认可接受后才可以放行到下一个工站。C.Scrap.不良品直接报废。D.“RTV” is “Return to vendor”. The inspector identifies them with “RTV” labels and the materials are passed to the Reject Store. The sourcing arranges for returning.“RTV”是退货给供应商，检验员确认“RTV”标签，不良品生产安排退仓，仓库将其放置到拒收仓，采购安排退货。6.2.1.3 Production reviews the MRB report/lot to determine the actions taken. 生产主管依据MRB处置结果决定采取的行动.6.2.2If the nonconforming WIP is found “Rework/Sort”, when it is urgent materials for production, PMC and relative department leader should sign on the log inspection sheet and agree to Rework/Sort on next process, the materials can be passed to next process temporarily, but must be follow actions as below:如果不良品是依MRB决定是“返工/挑选”，但生产急需使用时，需PMC和相关部门主管在检查表上签字，并且一致同意在下个工序返工/挑选，产品可先放行，但必须按以下程序执行：6.2.2.1 QA issues Rejection form with defective samples (if any) and acknowledge the process which is responsible for rework/sorting.QA 发行拒收通知单并附有不良品，通知负责返工工站。6.2.2.2QA inspector identifies the nonconforming WIP with “MRB” labels.QA 检查员在不良品上明示“MRB” 标签6.2.2.3 The nonconforming WIP with “MRB” label is transferred to store, segregated in rework/sort location and issued to next process for reworking/sorting.贴有 “MRB”标签的不良品转移到仓库，放置于返工/全检区域以便于下工序返工。6.2.2.4Production operators identify and segregate them for good parts.生产作业员将不良品与良品分开并明示。6.2.2.5 Production supervisor reviews the rejection notice ,QA Engineer suggests how to sort and rework.生产主管确认拒收通知单,并按QA工程师的建议进行全检和返工。6.2.2.6After reworking/sorting, the good units are segregated, examined by QC. 全检返工后，QC确认返工结果。6.2.2.7 The nonconforming WIP that cannot be reworked are separated, identified with “Rejection”label and rechecked by QA inspector and then waited for disposed by MRB. The finaldisposition of nonconforming material follow up 6.2.1.2.不能返工的不良品在外箱上明示 “Rejection”标签，并由QA检察员复查后等待MRB处理,处理结果遵循6.2.1.2.6.2.3 When a batch of nonconforming WIP are found during assembly processing, the nonconforming WIP are to be registered in “Process Nonconformity Statistic Sheet“ , after confirmed by QC&QA Engineer, the nonconforming WIP are to be segregated and waited for disposed by MRB. Assembly supervisor initiates a MRB Report and records the proposed disposition. The MRB Report is circulated to the MRB members for approval. The final disposition of nonconformingmaterial follow up 6.2.1.2.当装配在生产过程中发现批量不良时，需将不良发现登记于制程不良统计表，并将不良品给QC和QA工程师确认，确认后的不良品分开存放以等待MRB处置,装配主管发行MRB,记录处理结果并将MRB报告分发给相关部门，最终的不良品处理结果遵循6.1.2.6。6.3Nonconforming product in final QA (including component and finished goods stage).终检发现不良品 (包括部品和成品).6.3.1 Nonconforming (NC) product from production成品不良品6.3.1.1 QA inspector segregates the NC products with “Rejection” label, records on the InspectionReport that is reviewed and approved by QA Engineer.QA检察员隔离不良品并贴上“Rejection”标签，记录检查结果由QA工程师确认.6.3.1.2 QA issues Rejection Notice CAPA form with defective samples (if any) to concerned production department for taking actions.QA发行拒收通知CAPA单并附带不良品给生产部门以便于其采取行动.6.3.1.3 Production reviews the NC products and QA Engineer suggests how to rework/sort.生产部门确认不良品并按QA工程师的建议进行返工或挑选.6.3.1.4 7.3.1.4NC product after reworking/sorting is routed back to QA for re-inspection.返工/挑选后送给QA再次检查。6.3.1.5 When nonconforming goods can't be reworked, the nonconforming goods are to be registered in “ Process Nonconforming Statistic Sheet” , After confirmed by QC&QA, the nonconforming goods are to be segregated and waited for disposed by MRB . Assembly supervisor initiates a MRB Report, records the proposed disposition and takes action as per disposition of MRB.6.3.1.6 当不良成品不能返工时，不良品须先登记于制程不良统计表，经QC和QA确认后，生产部门将不良品分开存放以等待MRB处置。装配主管发行MRB，记录MRB处理结果并按处理结果采取行动。6.3.2When nonconforming product is found from subcontractors, QA inspector segregates the nonconforming product and identifies them with "Rejection" labels. The inspection results are recorded on the Incoming Inspection Report (IIR) and submitted to the QA Engineer.当发现供应商提供的成品有不良，QA检验员将隔离不良品并贴上"Rejection"标签，检查结果记录到IIR，并将报告递交给QA工程师。6.3.2.1 Engineer reviews the IIR and makes disposition of the nonconforming product.QA工程师确认IIR，决定如何处置不良品。6.3.2.2 The disposition can be one of the following:处置方法如下：A "UAI" - the product is used as is and released for delivery. If the UAI product does not conform to the customer's requirements, a written authorization from the customer is required."UAI"产品可以使用并出货。如果UAI不符合客户的要求，需要得到客户的认可。B If the disposition is "Sort" or "Rework", the nonconforming product is transferred to store and identified with "Rework/Sort" labels. PMC arranges rework/sort.如果处置为返工/挑选，不良品转入仓库并贴上"返工/挑选"标签，PMC安排生产部返工/挑选。C Scrap - some sample may scrap after inspection.报废 - 检查后可以报废的样品。DIf the disposition is "RTV", A "RTV" label is stuck on and the product is passed to theReject Store. The sourcing issues the Return To Vendor Notice (RTVN) and arrange for returning the product to the subcontractor.如果处置为"RTV"，产品贴上"RTV"标签并放置到拒收仓库。采购员发行 (RTVN)并且安排退货。6.3.2.3 The disposition is recorded on the IIR. 处理内容记录在检验报告上。6.3.2.4 QA leader is responsible for distributing the copies. The related departments take action as perthe disposition.QA 组长负责发行报告,相关部门按处理结果采取行动。6.3.2.5The sourcing arranges for returning the NC product to vendor.采购员安排将不良品退给供应商。6.3.3Nonconforming (NC) product from Sister Divisions, Sister Division appointed Distributor or suppliers;兄弟单位或兄弟单位指定供应商的不良品6.3.3.1QA found the nonconforming FG during inspection and informed QA Engineer and CS for determine the further actions.QA在检查过程中发现不良品，通知QA工程师和CS去决定进一步的处置。6.3.3.2QA Engineer makes one of the following dispositions:QA工程师实施的处置如下：A. “UAI” Due to urgent shipment for product, QA engineer will review the quality of the items. If it is minor problem and not affect any function, it is identified as “Used As Is” .“UAI”生产物料紧急，QA工程师将确认不良项目。如果是轻微的品质问题并且不影响任何功能，将在产品上贴“Used As Is”。B. “Rejection” The product is rejected due to not conform to our specification.“Rejection” 拒收不符合规格的产品。C. “RTV” If the action is “RTV”, “RTV” label is stuck on and the product is transferred to theReject Location. The CS personnel arrange the NC product to the Supplier.如果是“RTV”，在产品上贴“RTV”标签并将其放入拒收仓库内。CS安排将不良产品退货。6.4Nonconforming product returned by customer客户退回的不良品6.4.1All customers returned products are kept separately in the Customer Material Return Store.所有客户退回的不良品都要放置在客户退料仓库。6.4.2The Store Supervisor issues a Customer Return Receiving Sheet (CRRS) with serial number to the QA Engineer upon the receipt of the returned product.仓库主管在收到退货后，发行客户退货接收单 (CRRS)给QA工程师。6.4.3 The QA Engineer performs analysis on the returned product and records the findings on theCRRF.QA工程师分析不良品并且记录。6.4.4 The QA Engineer initiates a MRB report and records the proposed disposition on the report. The MRB Report is circulated to the MRB members for approval.QA工程师发行MRB报告及处置方法，MRB报告发行给相关人员承认。6.4.5 Disposition of nonconforming product return is either o