不合格品控制程序中英文版.pdf

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1、 Procedure 程序Issue 版本：1 QF-QA-026/01 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. 文件編號：FQP-NCP01Pages: 1 of 16Revision 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 / Date QS Officer:_ QC Sup:_ QE Sup: _ QA Mgr&MR:

2、_ Program Director: _ Store Mgr:_ Purchasing Mgr:_ PMC Sup:_ Shipping Sup:_ Facility Mgr: _ Review x x x x Signature / Date Facility Engineering Mgr: _ ME Mgr:_ 1st process Mgr:_ 2nd Process Mgr:_ PPC Mgr: _ Tooling Repair & Maintenance Mgr: _ HR Mgr: _ ADM Mgr:_ APP x Signature / Date Plant. Manage

3、r: _ 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： _ N/A N/A N/A N/A N/A N/A N/A Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 2 of 16QF-QA-027/01 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 procedu

4、re 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 mater

5、ials, semi-products and finished products. 3.0定义 Definition: 3.1FP: 伟创力塑胶公明厂的简称：FP is short for Flextronics Plastics GongMing Site. 3.2UAI ：特采，也称让步接受。UAI is short for use as it is, also calling concession. 3.3PM/PA: 项目经理 /项目助理 Program manager / Program Assistant. 3.4QE: 品质工程师 Quality Engineer 3.5ME:

6、 制程工程师 Manufacturing Engineer 3.6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。Suspiciou

7、s products/materials：The status of inspection or testing isn t indicated/marked or the quality of materials/semi-products/finished products may have deteriorated because of package damaged or over shelf life. 3.8WIP：半成品 Work In-Process. 3.9PFMEA ：过程失效模式及影响分析Process Failure Modes and Effect Analysis

8、3.10IQC II: 来料检验作业指导书 Incoming Quality Control Inspection Instruction. 3.11QC II: 品质检验作业指导书 Quality Control Inspection Instruction 3.12MRB ：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

9、 and disposing non-conforming incoming material / WIP / finished products on a regular or urgent basis. 3.13MRB 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) Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconfo

10、rming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 3 of 16QF-QA-027/01 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 fo

11、r nonconforming WIP/Finished Product) LEVEL II: QA Manager ME Manager Purchasing Manager (仅适用于不良来料处置Only for nonconforming incoming material) PPC Manager Production Manager (as required) Program Manager (as required) Plant Manager (as required) 4.0职责 Responsibility: 4.1IQC/IPQC/FQC 4.1.1 按规定的检验标准检验来

12、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-conformi

13、ng 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. 4.2IQC 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

14、 responsible for handling nonconforming incoming materials and informs the related MRB member of the nonconformance. If necessary, IQC should arrange the MRB meeting. 4.3QC 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

15、 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 Superviso

16、r / QE need to timely inform production or PPC or ME or Program manager and Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 4 of 16QF-QA-027/01 quality manger of non-conforming WIP or finished products status, and call an urgent meeting

17、for deciding how to dispose of these non-conforming WIP or finished products. 4.4QA 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 dispositio

18、n 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

19、 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

20、ReportQF-QC-005 to customer for approval. Customer s disposition decision prevails. 6.0 程序 Procedures: 6.1 来料不合格品管制 Control of nonconforming incoming materials 6.1.1 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

21、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 a Nonconforming Materials / WIPs / Finished-goods Disposition Report QF-QC-005 which submitted to MRB for discussion if nonconformity status beyond accepted standard. If the defect is functional failure or safe

22、ty 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 prep

23、are NG samples and corresponding report before MRB meeting. 6.1.3IQC/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FQW-IQC04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 Nonc

24、onforming Materials / WIPs / Finished-goods Disposition Report QF-QC-005 by Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 5 of 16QF-QA-027/01 IQC/IQC Supervisor and MRB member will sign on it for approval. For the disposition principle

25、s of nonconforming incoming material, please see the FQW -IQC04. 6.1.4IQC 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

26、 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 nonconform

27、ing 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

28、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 wareho

29、use 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 Se

30、rial No. of shall be numbered by Production as per item 6.15 - The numbering method of . Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 6 of 16QF-QA-027/01 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

31、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

32、 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 shal

33、l 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

34、 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

35、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 statisti

36、cs 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 prev

37、ious process found during production： Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 7 of 16QF-QA-027/01 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)

38、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 markthe status of nonconforming and makes statistics and classify. When nonconforming parts are confirmed by IPQC, the workshop packs it and scra

39、ps 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

40、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 par

41、ts from previous process badly influence on the product quality is found during production, the workshops of the second process informs QC through issuing ofconfirming nonconforming status. （Note: The Serial No. of shall be numbered by QC as per item 6.15 - The numbering method of ）. After confirm t

42、hat 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 dispositio

43、n 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

44、, QC must inform QC leader / QC Procedure 程序Issue 版本：1 標題： 不合格品管制TITLE: Control of Nonconforming ProductDOC No. Rev 文件編號：FQP-NCP01版次： A Pages: 8 of 16QF-QA-027/01 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

45、制。 Control for nonconforming product found by in-process & final inspection 6.2.1 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QF-PM-014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

46、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 per

47、iod. 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FQP-PQC01 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

48、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 Requisition QF-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

49、)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 Inspectionprocedure FQP-PQC01, IF any nonconforming products found during their sampling inspection, they should analysis and trace time and defect quantity. If non-conformance co

50、nfirmed, 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 repor