中英文不合格品控制程序.doc

標題： 不合格品管制 TITLE: Control of Nonconforming ProductDOC No. Rev文件編號： FQP-NCP01 版次：APages: 17 of 17 Procedure 程序 Issue 版本：1Revision History更改记录Issue版本Page#页码Rev版次CHANGE更改內容WRITTEN BY编写DATE日期Review and Approval審查和批准Review x x x x x x x Signature / DateQS Officer:_QC Sup:_QE Sup: _QA Mgr&MR:_Program Director: _Store Mgr:_Purchasing Mgr:_N/APMC Sup:_N/AShipping Sup:_N/AFacility Mgr: _Review x x x x Signature / DateFacility Engineering Mgr:N/A_ME Mgr:_1st process Mgr:_2nd Process Mgr:_PPC Mgr: _Tooling Repair & Maintenance Mgr:N/A_N/AHR Mgr: _N/AADM Mgr:_ APP x Signature / DatePlant. Manager:_Checked by DCC / Date: 文控審核/日期:Effective date Expiry date 文件生效日期：_ 文件失效日期：_1.0 目的Purpose: 本程序对不合格品的标识、隔离、评估、处置、记录提供指引。This procedure provides the instructions for the identification, quarantine, evaluation, disposition, documentation of non-conformance associated with incoming materials, in-process incoming materials, semi-product, finished product. .2.0 范围Scope: 适用于本厂所有不合格来料，半成品及成品。 Apply to all non-conforming incoming materials, semi-products and finished products. 3.0 定义Definition: 3.1 FP: 伟创力塑胶公明厂的简称：FP is short for Flextronics Plastics GongMing Site.3.2 UAI：特采，也称让步接受。UAI is short for use as it is, also calling concession.3.3 PM/PA: 项目经理/项目助理 Program manager / Program Assistant.3.4 QE: 品质工程师 Quality Engineer3.5 ME: 制程工程师 Manufacturing Engineer3.6 不合格品：不符合既定的品质标准/要求或客户要求的所有来料、半成品、成品。Nonconforming Product: All incoming materials, WIP, finished products are non-compliant with established quality standard/requirements or customers.3.7 可疑物品/物料：检验或试验状态标识不明确或没有标识，或储存超过保存期限或由于包装受损等原因可能引起品质变异或降低的物料/半成品/成品。Suspicious products/materials：The status of inspection or testing isnt indicated/marked or the quality of materials/semi-products/finished products may have deteriorated because of package damaged or over shelf life. 3.8 WIP：半成品Work In-Process.3.9 PFMEA：过程失效模式及影响分析Process Failure Modes and Effect Analysis3.10 IQC II: 来料检验作业指导书 Incoming Quality Control Inspection Instruction.3.11 QC II: 品质检验作业指导书 Quality Control Inspection Instruction3.12 MRB：物料评审委员会，也称不合格品评审委员会，职责是：定期或紧急状态下，评审及处理不合格来料及生产线发现的不良半成品及成品。Material Review Board，also calling non-conforming product review board, is responsible for reviewing and disposing non-conforming incoming material / WIP / finished products on a regular or urgent basis.3.13 MRB成员如下MRB member for incoming material as below：LEVEL I: IQC (仅适用于不良来料处置Only for nonconforming incoming material)Planner (PPC) Buyer (Purchasing) (仅适用于不良来料处置Only for nonconforming incoming material)QE (as necessary) ME (as necessary)QC Supervisor (仅适用于不良半成品/成品的处置only for nonconforming WIP/Finished Product)Production Supervisor(仅适用于不良半成品/成品的处置only for nonconforming WIP/Finished Product)LEVEL II:QA ManagerME ManagerPurchasing Manager (仅适用于不良来料处置Only for nonconforming incoming material)PPC ManagerProduction Manager (as required)Program Manager (as required)Plant Manager (as required)4.0 职责Responsibility: 4.1 IQC/IPQC/FQC4.1.1 按规定的检验标准检验来料/生产的半成品及产品，正确地判定来料/生产的产品是否合格，并对不合格品进行标识。Inspecting/measuring/testing incoming materials or WIP/Finished products produced as per the approved quality control inspection instruction (QC II), and judge whether the incoming material / WIP/Finished products is pass or fail, and marking the non-conforming incoming material lot or WIP or finished products with the established label. 4.1.2 對不合格来料/半成品/成品的處理結果進行跟蹤和記錄。Following up and recording the disposition of nonconforming incoming materials/WIP/finished products.4.2 IQC主管/工程师负责将发现的来料不良问题及时通告相关的MRB成员，若有必要时安排并主持MRB会议。IQC Supervisor/Engineer is responsible for handling nonconforming incoming materials and informs the related MRB member of the nonconformance. If necessary, IQC should arrange the MRB meeting.4.3 QC主管/QE負責對制程、终检、出货检查中的不合格品提出處理意见。当出现的不合格半成品/成品严重影响到生产进度或交货时，须及时将生产过程中产生的不合格半成品/成品信息通告给生产部或PPC，或ME，或项目经理和品质部经理，并紧急召集生产部，PPC或ME或项目经理共同讨论对不合格半成品/成品的处置办法。QC Supervisor / QE are responsible for determining the disposition method for nonconforming products which found by in-process & final inspection & out-going inspection. When nonconforming WIP/finished products will badly affect production progress or delivery, QC Supervisor / QE need to timely inform production or PPC or ME or Program manager and quality manger of non-conforming WIP or finished products status, and call an urgent meeting for deciding how to dispose of these non-conforming WIP or finished products.4.4 QA经理 QA Manager：主持不合格品评审会议 Chairing MRB meeting.4.5 生产部和相关部门（包括采购，PPC，仓库，半成品仓，ME，项目部）执行不合格品处置决定。Production and related departments (including Purchasing, PPC, Warehouse, WIP store, ME, Program) carry out the disposition of nonconforming incoming materials/WIP/finished products.5.0 特采条件：The prerequisites for UAI/Concession5.1 对不影响使用要求的不合格来料/半成品/成品进行让步使用或放行，需经MRB授权人员的批准，并且不得违背法规要求。The conditions for concession/UAI: Only meet the regulatory and statutory requirements and have no effect on product intended use and approved by the MRB members, then the non-conforming products/materials are accepted and released by concession。5.2 针对医疗产品的特采，本公司必须发出不合格品处置报告QF-QC-005给客户核准，且以客户核准的意见为最终处置决定。For medical product concession, Flex GongMing Site must send the Nonconforming Materials / WIPs / Finished-goods Disposition ReportQF-QC-005 to customer for approval. Customers disposition decision prevails. 6.0 程序Procedures: 6.1 来料不合格品管制 Control of nonconforming incoming materials6.1.1 IQC抽样检验时，如发现不良情形超出可接收标准，IQC将发行不合格品处置报告QF-QC-005并提交MRB讨论。如果来料不良为功能失常或安全问题或在线不良率超过3%或连续3批来料同样问题发生，则需分发8D ReportQF-QC-022给供应商分析原因及改善措施，并由IQC部门跟进改善结果。IQC performs the sampling inspection to incoming materials and issue aNonconforming Materials / WIPs / Finished-goods Disposition ReportQF-QC-005 which submitted to MRB for discussion if nonconformity status beyond accepted standard. If the defect is functional failure or safety issue or on-line defective rate more than 3% or the same defect recurs successively more than 3 lots for the incoming part, IQC will issue QF-QC-022 to the vendor for improvement and followed up until closed. 6.1.2 若需召开MRB会议，IQC需在MRB会议之前准备好不良样品及相应报告。If need to held a meeting, IQC should prepare NG samples and corresponding report before MRB meeting.6.1.3 IQC/IQC主管将MRB成员共同讨论决定的不良来料处理方法填入不合格品处置报告QF-QC-005中，MRB相关成员需在不合格品处置报告QF-QC-005中签名以示确认。不良来料处理原则与方法请参见FQWIQC04来料不良处置方法指引。Disposition method of nonconforming incoming material determined by MRB members together will be fill in Nonconforming Materials / WIPs / Finished-goods Disposition ReportQF-QC-005 by IQC/IQC Supervisor and MRB member will sign on it for approval. For the disposition principles of nonconforming incoming material, please see the FQWIQC04.6.1.4 IQC应立即依处理方法标识相应物料。Disposition status label should be attached to the relevant incoming material by IQC immediately.6.1.5 仓库根据标识对物料进行相应隔离处理。若标识为“退回供应商”或“加工/挑选”，则将物料放入仓库不合格品区；若标识为“报废”，则放入报废品区。Warehouse handles the incoming material according to its label. If the label marks returned to vendor or sorting/reworking, then the material should be moved to nonconforming area in the warehouse. If the label marks scrap, then the material should be moved to scrap area in the warehouse.6.1.6 生产线发现不良来料处理 Disposition method of nonconforming material (including sub-out parts) on line：6.1.6.1 经IQC检验合格的物料，如在生产过程中发现仍有少量不良品，将由生产部门标明不良情况，并分类统计(我方生产过程导致的损坏应自行报废)，不良品经IQC确认后，由生产部将不良品包装好后定期退至货仓。每次车间退料货仓时，生产部必须开出不合格品处置报告QF-QC-005 和“ 来料不良退料单”(QF-MW-004B)交IQC的确认。不良品退仓时必须与不合格品处置报告同行，否则货仓拒收退料。此种情况下的不合格品处置报告只须生产主管，IQC签名确认即可。不合格品处置报告的系列编号由二工序按本程序第6.15条款规定的不合格品处置报告编码办法进行。If few non-conforming incoming material is found on line, Production makes statistics and classify (The material that is damaged in our production is taken as scrap). When nonconforming material is confirmed by IQC, Production Dept. packs it and returns it to the warehouse regularly. Production shall issues the QF-QC-005 and QF-MW-004B to IQC for each returns. Warehouse can accept the returned incoming material until accompanying the approved the QF-QC-005. In such case, The QF-QC-005 only need to be signed for confirmation by Production Supervisor and IQC. The Serial No. of shall be numbered by Production as per item 6.15 - The numbering method of .6.1.6.2 经IQC检验合格的物料，如在生产过程中发现大量不良品(在线不良率超过3%及以上)，或严重影响品质不良，或安全问题，生产部将填写不合格品处置报告QF-QC-005并通知IQC确认(不合格品处置报告的系列编号由IQC按本程序第6.15规定的不合格品处置报告编码办法进行)。IQC确认情况后将提交MRB讨论，由MRB成员共同决定处理意见。IQC必须对同一批或同类原材料的库存重新进行检查，若不合格须提交MRB讨论后决定处理意见。且IQC必须根据处理意见对不良物料进行标识。仓库根据标识对物料进行相应隔离处理。若标识为“退回供应商”或“加工/挑选”，则将物料放入仓库不合格品区；若标识为“报废”，则放入报废品区。The incoming material that is passed by IQC, if a mass of nonconforming incoming material or badly effect on product quality on line or safety issue, Production informs IQC through issuing QF-QC-005 of confirming nonconforming status. After confirming it is true, IQC will submit it to MRB for discussing disposition method. （Note: The Serial No. of shall be numbered by IQC as per item 6.15 - The numbering method of ）. IQC must re-inspect the same lot/kind incoming material in the material warehouse in order to confirm whether the same defect exists. If yes, IQC must submit it to MRB for discussing disposition method. Warehouse handles the incoming material according to its label. If the label indicates returned to vendor or sorting/reworking, then the material should be moved to nonconforming area in the warehouse. If the label indicates scrap, then the material should be moved to scrap area in the warehouse.6.1.6.3 对于MRB判批退的来料不良品，采购需及时联系供应商将OK 品补回。For reject incoming material which is judged by MRB, Purchasing contact the supplier to make up the good material/parts. 6.1.7 对于来料不良确定由我厂选别/加工的情况下，生产部将统计投入的人数与工时，汇总后填写于不合格品处置报告，提交采购部，财务部。采购联系供应商收取选别/加工费用。When rework/sort/process is determined to done by FP, Production shall make statistics of person and time those throw into nonconforming incoming material and fill it in the and submit it Purchasing dept. and Accounting dept. Purchasing contact the supplier and take the fee of sorting & processing from the supplier.6.1.8 生产过程中发现上一工序不良品处理 Disposition of nonconforming parts from previous process found during production：6.1.8.1 第二工序各生产部门如在生产过程中发现由上一工序流入的部品中有少量不良品（在BOM允许的不良率范围内），将由各生产部门标明不良情况，并分类统计，不良品经IPQC确认后，由二工序自行报废。但在每次报废前二工序需填写和报废单(QF-PM-016)交IPQC确认。If few nonconforming parts is found during production and NG rate is below the defective rate stated in BOM, the workshop of the second process mark the status of nonconforming and makes statistics and classify. When nonconforming parts are confirmed by IPQC, the workshop packs it and scraps it by itself. Second Process shall fill out QF-PM-016 and sent it for QC for confirmation before each scrap.6.1.8.2 第二工序各生产部门如在生产过程中发现由上一工序流入的部品中有大量不良品(在线不良率高于BOM允许的不良率)，或严重影响品质不良品，生产部门将填写不合格品处置报告并通知QC确认。（不合格品处置报告的系列编号由QC按本程序的第6.15规定的不合格品处置报告编码办法进行），QC确认情况后将提交QC组长/QE/QC主管确定处理办法。当生产紧急或必要时，QC主管或QE（当QC主管不在时）须及时将不合格半成品信息通告给生产部或PPC，或ME或项目经理，并紧急召集生产部，PPC，或ME或项目经理和品质经理共同讨论对不合格半成品/成品的处置办法。QC根据处理办法对不合格品进行标识，及通知前一工序QC清查库存。若有同一批或同一类产品库存，QC须进行复检，若不合格，上报QC组长/QE/QC主管决定处理办法。QC根据处理办法对不合格品进行标识。If a mass of nonconforming parts (NG rate is over the acceptable rate of BOM) or nonconforming parts from previous process badly influence on the product quality is found during production, the workshops of the second process informs QC through issuing of confirming nonconforming status.（Note: The Serial No. of shall be numbered by QC as per item 6.15 - The numbering method of ）. After confirm that it is true, QC submit it to QC leader /supervisor / QE for discussing disposition method. If Production is in urgent need, QC supervisor / QE must timely inform the defective status to Production, PPC, ME or PM (if need) and hold a meeting with all concerned parties for discussing the disposition methods. QC shall mark the non-conforming products status as per MRB disposition method, and inform QC of previous process of check whether there are same lot/kind parts in WIP store. If yes, QC must re-inspect them in order to confirm whether the same defect exists. If the same defect is detected, QC must inform QC leader / QC supervisor / QD to determine the disposition method. QC marks the non-conforming WIPs status according to MRB disposition.6.2 制程及终检不合格品管制。 Control for nonconforming product found by in-process & final inspection6.2.1 如是注塑制程，生产车间员工自检发现不合格品时，将其放入红色不良品箱中待打水口，由操作员将不良数量、不良项目记录于QFPM014生产线员工自检不良品情况记录中，由生产组长和QC不定时确认。如发现不良数量在某段时间超过生产数量的5%，需及时通知相关责任者处理至解决。 In injection process, the operators carry out self-inspection and put the rejected product into the red box as the grinding material, as well as recording the reject quantity and items in QF-PM-014. Production leader and QC perform sampling check randomly. If found reject rate is more than 5%, immediately inform relevant responsibility for disposition for that Qty in a certain period.6.2.2 如是第二工序制程，检查要求同4.2.1，但有如下不同点： Inspection requirements in the second process are same as 4.2.1 but some more different points:装配工序检查员需对不合格缺陷进行标识。 Assembly QC should mark the defect detected on the reject WIP/finished goods.6.2.3 IPQC对制程中产品依制程检验FQPPQC01中的要求进行检查及判定，若判定结果为不合格时，需立即对不合格品发生的时间和数量进行追溯，并需对该不良样本进行标识，且需将该批不良品加贴红色不合格”标签，并与良品分开摆放，同时发出Process Discrepancy RequisitionQF-QC-005A/B，交QC组长/QE/QC主管决定处理意见并将处理意见填入不合格品报告中后连同标识过的不良样本一并交生产部作出相应处理(如：翻工、加工，解体、报废)，生产部记录处理后结果。特别说明事项：(1) 当二工序发现一工序生产的半成品来料不良时, 由二工序和一工序QC主管共同确认, 如需一工序选别或加工时, 须通知一工序经理/主管参与决定过程，避免因不同意见导致选别/加工不能及时和有效执行。(2) 生产部返工后每一返工完毕的产品外箱上应加贴“巳返工”标识以便QC复检时特别控制。Both IPQC and FQC should carry out sampling inspection according to In-Process Inspection procedure FQP-PQC01, IF any nonconforming products found during their sampling inspection, they should analysis and trace time and defect quantity. If non-conformance confirmed, defect samples shall be identified and the “Rejected” identification labels shall be attached with the product, rejected parts should be segregated from the accepted parts, QC leader/supervisor/QE will determine the disposition method and QC have to issue QF-QC-005 to production. The report and rejected samples have to be passed to Production dept for disposal. (e.g. rework/sort, scrap etc.). The Production dept. records the results of disposition and takes the relevant improvement action, IPQC and FQC should follow up until all items closed. Special Notice: (1) When Second Process find that all plastic parts from Injection Molding Process need to be lot rejected, QC supervisor from Injection Molding Process shall confirm how to dispose off them together with the Molding QC supervisor. If the initial disposition is rework/sort/repair/reprocess by 1st process, then QC supervisor from Second Process must inform Injection Molding Manager/supervisor of participating in making the finial disposition. If no molding supervisor/manager involvement, the disposition of rework/sort/processing by Molding is invalid.(2) Special Note: After finishing rework/sort, the “rework done” label need to be attached to each carton box outside by production so that special control have to be taken when these parts re-inspected by QC.6.2.4 FQC在终检中若判定某批产品为不合格时，由QC组长/QE/QC主管决定不合格品处理意见，由QC部门发出并跟进Process Discrepancy RequisitionQF-QC-005A/B。When FQC find quality issues, QC leader / supervisor / QE will decide the disposition methods. QC will issue Process Discrepancy RequisitionQF-QC-005A/B to production and followed up. 6.3 可疑物品/物料的处理：由发现者通报IQC或QC复检确认（说明：IQC负责原材料的复检确认，QC负责半成品/成品的复检确认）。若检查结果为合格，针对无标识或标识不明的物料/半成品/成品，则IQC或QC重新盖合格品章。针对超出保存期限的物料，则更新原标签。针对包装破损的物料，重新包装和标识后通知IQC/QC再检查。若合格IQC/QC盖合格印章。若不合格，则当不良品进行处理。由IQC/QC填写不合格品处置报告QF-QC-005。Suspicious Materials/Products Handling Process: If any suspicious materials/WIP/finished products are detected, detectors need to notify IQC or QC of re-inspection (Remark: IQC is responsible for incoming material, IPQC/FQC is for WIP and finished products). I