发布时间 : 星期一 文章ISO9001-2015不合格品处理程序(中英文)更新完毕开始阅读48a179cd77232f60dccca160
不合格品处理程序
Management of Nonconforming Product
（ISO9001：2015）
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 3.2 3.3 3.4 3.5 3.6
DXC: DXC的简称：DXC is short for DXC.
UAI：特采，也称让步接受。UAI is short for use as it is, also calling concession. PM/PA: 项目经理/项目助理 Program manager / Program Assistant. QE: 品质工程师 Quality Engineer ME: 制程工程师 Manufacturing Engineer
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 isn’t indicated/marked or the quality of materials/semi-products/finished products may have deteriorated because of package damaged or over shelf life.
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3.8 3.9
WIP：半成品Work In-Process.
PFMEA：过程失效模式及影响分析Process Failure Modes and Effect Analysis
3.10 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 Instruction
3.12 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 Manager ME Manager
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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:
4.1 IQC/IPQC/FQC
4.1.1 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 对不合格来料/半成品/成品的处理结果进行跟踪和记录。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负责对制程、终检、出货检查中的不合格品提出处理意见。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
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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/Concession
5.1 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 Report》QF-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 Report》QF-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 a《Nonconforming Materials / WIPs / Finished-goods Disposition Report》QF-QC-005 which submitted to MRB for
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