ISO9001-2015不合格品处理程序(中英文)

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:
3.1DXC: DXC的简称：DXC is short for DXC.
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: 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。

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.
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
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 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)
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
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.
4.2IQC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 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。