NonconformingProductControlProcedure中英

TITLE : Non-Conforming Product Handling Procedure
不合格品处理控制程序
Doc.No. Revision Revision Date Page
SGS-QA-08 01 2004.1.05 4
Originator: Cathy Cheng Date : 2004.01.05 Signature:Date :
Approved By : David Chen Date : 2004.01.05 Signature : Date :
Approved By : David Chen Date : 2004.01.05 Signature : Date :
1.0 PURPOSE目的
The purpose of this procedure is to establish an in-house standard to ensure that proper control is exercised for identification, segregation and documentation of all non conforming Products
为规范不合格品在公司内部的标识、隔离和相关处理流程，制定本程序。

2.0 SCOPE
This procedure shall be applicable to all non-conforming Products found during manufacturing and Quality Assurance (QA) inspection.
本程序适用于公司内生产和检验过程中发现的不合格品。

3.0 REFERENCE DOCUMENTS
3.1Quality manual质量手册
3.2 Product Identification and Tracebility Control Procedure标识和可追溯性控制程序
3.3Product testing procedure检验与测试控制程序
3.4Corrective and Preventive action procedure纠正和预防措施控制程序
4.0 DEFINITIONS定义
N/A
5.0 RESPONSIBILITICES职责
5.1 It is the responsibility of respective supervisor to ensure that non-
conforming material are identified, documented and segregated in
accordance with this procedure.
各部门主管参照本程序标识、隔离和记录不合格品。

5.2 It is the responsibility of QA engineer to chair review meeting which
consist of the representative from production, engineering, test
engineering, material or program administrator.
QA工程师召产品工程师、测试工程师、项目管理评审不合格品。

6.0 PROCEDURE
6.1 Non conforming material不合格原材料
6.1.1 Non conforming material is classified as,不合格原材料可分为：
In-process material that fail inspection or specification.
进料检验时不合格
Material or product during production that does not conform to the
acceptance criteria and can not be restored under standard
rework or repair procedure.
生产过程中材料不符合接收标准不能被返修和返工的材料。

Material that exceed the shelf life.
原材料超过保存期限
Material that do not confirm, include suspect materials.
材料不符合要求且有疑问的材料
6.1.2 Non conforming material may be identified .If necessary, move the
material into a controlled hold area.
需要时，不合格材料要被标识且移到被管理的区域。

6.1.3 Material Reject Report (MRR) shall be issued by responsible supervisor
and ensured that the quantity and item reported on MRR correspond with
the non conforming item.
责任主管发行《不合格报告》并确认报告中不符合。

6.1.4 Non conforming material shall be reviewed and disposition by
Engineeing
相关的工程师将评审并处理不合格材料。

6.1.5 Non conforming material shall be confirmed by QA Engineer.
不合格材料处理由QA 工程师处理.
6.2 Working In Progress procucts作业过程中
6.2.1Responsible personnel such as Engineeing or or QA shall perform
the activities of production, inspection and/or testing, per the
established Working Instructions.
相关人员如工程师或QA执行相关的检验、测试。

6.2.2Non-conforming units are detected at various steps of the process
by means of inspection and testing at the end of the process, pre-
and post-inspection at each operation, or quality process audits.。

不合格品的发现包括生产过程中的检验和测试、作业前后的检
验以及质量审核。

6.2.3The non-conforming units thus identified must be segregated from
the other units.
不合品必须标识且与其它品隔离开来。

6.2.4The Engineeing shall provide disposition for the non-conforming
units. The QA Engineer shall provide verification if required. A
disposition may result in the screening, reworking, scrapping or
shipping, of the units. In each case, the line leaders shall take the
appropriate steps.
工程师交处理不合格品，若需要QA工程师将提供确认。

处置
的结果包括筛选，返工，报废及正常放行。

在这种情况下，作
业领班须协助安排。

6.3 Finished Goods成品
6.3.1 QA Inspectors shall perform Outgoing Quality Assurance (OQA)
prior to transfer to stock.Any lot that fails the sampling plan will be
identified with an OQA “Reject” label and returned to the product
line for further action. This may take the form of rescreening,
reworking or scrapping, of the lot.
QA 将执行出货检验在产品入库前，任何判为批退将贴上“Reject”标签并将产品退回制造作进一步的处理，本批将被
选别，返工或报废。

6.3.2 It is the prerogative of the QA Engineer to issue an Internal
Corrective and Preventive Action Request, as the situation warrants.
QA根据不合格的情况有权力向相关部门发行“Internal Corrective and Preventive Action Request”
6.3.3 At all times, QA or Engineeing must ensure that these units are
clearly identified and segregated from normal production units.
在所有的过程中，QA 或工程师们必须确保处理的部分能够
标识且和正常产品分开。

6.4Customer Return procucts客户退回产品
6.4.1If an quality issue is detected by the customer and a return of the
non-conforming products is desired, the QA Engineer shall request
for reject samples and/or photographs. Upon confirmation of non-
conformance, a Return Materials Authorization (RMA) number
shall be issued to the customer to facilitate the return of the non-
conforming units. Otherwise, the issue shall be reviewed further
with the customer. The RMA number may also be issued at the
discretion of the QA Engineer.
如查因产品质量问题由顾客发现，且顾客希望退回时，QA工
程师向顾客索取样品或照片，由此来确认不合格的状况。

为了
便于处理组成评审小组来处理不合格品，小组有必要时可进一
步同顾客确认，评审小组可有QA 工程师直接确定。

6.4.2The QA shall receive all non-conforming units that are returned by
the customer and ensure that the documentation describing the
nature of the return are also provided. These will then be returned
to the appropriate product line under scrap control for further action.
若QA接收到顾客退回的不合格品。

QA将确认顾客提供的退
回品的文件的描述，并对退回品作适当的进一步的处理。

6.4.3If deemed necessary, a Internal Corrective and Preventive
Action Request shall be issued by the QA.
如果有必要，QA将发行“Internal Corrective and Preventive
Action”要求相关部门改进。

6.4.4At all times, the Production or QA must ensure that these units
are clearly identified and segregated from normal production
units.
在任何时间，作业部门及QA一定要清楚地标识并与正常品隔
离开来。

6.4.5All product after sorting or rework shall be verified by QA
again according to the standards.
所有的产品筛选和返工后必须有QA重新参照相关的标准进
行检验
7.0 PROCEDURE HISTORY修改记录
Revision 01--New release版本01—新发行
8.0 APPENDICES AND RECORDS
8.1 Non_Conforming Part Requisition Form
8.2. Material Reject Report (MRR).
8.3 Disposal Form for Customer Return。