Non-coning Product Control Procedure中英.doc

TITLE:Non-Conforming Product Handling Procedure TITLE : Non-Conforming Product Handling Procedure不合格品处理控制程序Doc.No.RevisionRevision DatePageSGS-QA-08 012004.1.054Originator: Cathy ChengDate : 2004.01.05Signature:Date :Approved By: David ChenDate : 2004.01.05Signature:Date :Approved By: David ChenDate : 2004.01.05Signature: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 SCOPEThis 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/A5.0 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 PROCEDURE6.1 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：6.1.1.1 In-process material that fail inspection or specification. 进料检验时不合格6.1.1.2 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。6.1.1.3 Material that exceed the shelf life.原材料超过保存期限6.1.1.4 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6.2.1 Responsible 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。6.2.2 Non-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。6.2.3 The 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。6.2.4 The 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。6.4 Customer Return procucts客户退回产品6.4.1 If 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。6.4.2 The 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。6.4.3 If 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。6.4.4 At 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。6.4.5 All product after sorting or rework shall be verified by QA again according to the