ISO9001-2015不合格品控制程序(中英文)

不合格品控制程序

Control of Nonconforming Product

（ISO9001：2015）

1. purpose目的

为有效地杜绝不合格的物料、半成品及成品的误用、流出; 并对其予以恰当处理.

To avoid nonconforming materials, semi-finished products and finished products from misuse and Outflow, and dispose them properly.

2. scope范围

适用于不同阶段的产品及物料：如进料、制程、成品、库存及客户退货.

Applicable for material and products in different level: Incoming, process, finished goods, stock and customer returns.

3.流程图 Flow Chart: 无N/A

4. Reference Document参考文件

4.1《MRB运作程序》 MRB operation procedure

4.2《记录管理程序》 Record control procedure

4.3《进料品质控制程序》 Incoming quality control procedure

4.4《过程质量控制程序》 Process quality control procedure

4.5《出货质量控制程序》 Outgoing quality control procedure

4.6《纠正与预防措施管理程序》 Corrective and preventive action management

procedure

4.7《产品标识及追溯性管理程序》Product identification and traceability

management procedure

5. Definition定义

5.1 合格：满足要求.

Conforming: Satisfy the requirement

5.2 不合格：未满足要求.

Nonconforming: Disatisfy the rewuirement.

6. Responsibility职责

6.1 品质部：负责对不合格原料及成品的检验判定及标识。

QA Dept.: Responsible for inspection, judgment and identification of nonconforming material and products.

6.2 生产部：负责对在线不合格物料及产品的隔离。

Production Dept.: Responsible for separation of nonconforming material or products in process.

6.3货仓部：负责对不合格物料及成品的隔离

Warehouse Dept.: Responsible for separation of nonconforming materials

and finished products.

7. General procedure一般程序

7. 1总则General

7.1.1 本公司的不合格品的处理方式为：退货、暂允收货、返工、挑选使用、报废。

Disposal ways for nonconforming product are: reject, use as is, rework, sorting and scrapped.

7.1.2经检验判定、标识与隔离的不合格品，在未做适当处理决议前, 任何人不得领用或使用。

No one should use nonconforming material or products which were judged, identified and separated unless there is a proper decision.

7.1.3不合格品之判定，应参照对应的检验规范或确认样品。

Decision on nonconforming products shall refer to the relevant

inspection standard or approved sample.

7.1.4不合格品应该进行标识与隔离。

Nonconforming products must be identified and separated.

7.1.5经过返工/修理后的产品必须再次接受检验, 并保留检验记录.

Reworked and repaired products must be re-inspected and keep an inspection record.

7.2进料不合格品

Incoming Nonconforming Materials

7.2.1拒收不合格品需贴红色“IQC不合格标签”, 并放置在不合格品区域;

Rejected materials shall be stuck with a red “ IQC rejection label”

and placed in nonconforming material area.

7.2.2检验员将不合格现象及判定结果记录于《来料检查报告》中，交品管部主管及经理审核;

Nonconforming phenomena and judgments are recorded in Incoming Inspection Report by inspector and send to supervisor and manager for approval.

7.2.3当不合格物料生产急需时，可通过MRB会议对物料进行评审, 其结果记录在《MRB 报告》中，具体参见《MRB运作程序》。

In case the nonconforming material is urgently used, a MRB meeting is held to review it. Result will record in MRB Report, the details refers to MRB Operation Procedure

7.2.4品质部分发《来料检查报告》, 通知物控部, 品质部同时将纠正及预防措施报告

分发给供应商，要求供应商回复改善对策。

Incoming Inspection Report is distributed by QA Dept to inform MC Dept and