ISO9001-2015不合格品处理程序(中英文)

德信诚培训网 Molding Process Spraying Painting Process Printing Process Assembly Process IJMRBYYYYXXX SPMRBYYYYXXX PPMRBYYYYXXX ASMRBYYYYXXX 适用于生产部正常累积的不良品报废。（即生产部在生产中产生的不良率低于BOM中规定的不良率） Apply to normal generating defective products piled up by production (i.e.: The defective rate is below the scrap rate stated in BOM.) Where: YYYY: Year (Indicated in 4 digital numbers, such as 2008); MM: Month (Indicated in 2 digital numbers, such as 08); XXX: Serial No., start from 001, end with 999. YYYY: 年(用4位数的阿拉伯数字表示,如2008), MM:月(用2位数的阿拉伯数字表示,如03);XXX:流水号,从001开始,直999结束. 6.16 各部门/各工序需指定专人负责《不合格品处置报告》和8D的编号工作和登记，以免重复或遗漏。

Each department/Process shall appoint one special person to number the and <8D Report> in order that the repeated/missing number do not occur. 6.0 关文件和数据 Relevant document and data﹕

6.1 FQP-CFR02 《客户退货处理》 6.2 FQP-CAR01 《纠正和预防措施控制》 6.3 QE001 6.4 FQP-PQC01《制程检验》

6.5 FQP-FQC01《产品终检程序》 7.0 品质记录Quality Records﹕

Record Description 记录名称 Form No 记录的表格编号 Keep by 保管人 Retention Obsolete Time(Min) Disposition 保存期限 过期处理办法 书面记录撕掉，不合格品处置报告 Nonconforming Materials / WIPs / Finished-goods Disposition Report 退货单/Returning product form QF-SH-004 Warehouse QF-QC-005 QC/IQC 3 years 电子档删除 Tear the hardcopy and delete the ISO9001-2015内审员升级培训(100元) ISO9001-2015内审员培训(200元) ：http://www.55top.com

德信诚培训网 8D Report QF-QC-022 QC / IQC softcopy 针对医疗产品，则保存10年。For medical product, Kept for 10 years. 8.0 流程图 Flow Chart: 见下页 See the below page.

ISO9001-2015内审员升级培训(100元) ISO9001-2015内审员培训(200元) ：http://www.55top.com

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不 合 格 品 处 理 流 程 图

若有库存，IQC/QC必须对在库品进行追溯溯， 是 是否有同样不良 否 结束 根据MRB处置办法, IQC或IPQC或FQC 标识不良品。 生产部/货仓/采购根 据不良品处置办法处置相应的不良品。 若为来料，IQC颁发《不合格品处置报告》给采购部，货仓, PPC（若需要时），，财务(需要时)，PM（需要时）,生产部(需要时)。 若为半成品/成品，IPQC/FQC颁发《不合格品处置报告》给 PPC，货仓, 生产部， PM(若需要时)。 NG 来料检查时，IQC 发现整批不良 生产过程中，某一工序发现供应商/上一工序来料大量不良 终检时,FQC 发现整批不良 制程检查时,IPQC 发现不良不可接受 出货检查时,FQC发现整批不良 生产部填写《不合格品处置报告》QF-QC-005交IQC/QC确认 IPQC进行追溯，以确定生产部生产的不良品总数 不合格品隔离。针对来料，IQC通知货仓将货拉到不合格品区域；针对本厂生产的 WIP/成品，IPQC/FQC通知生产部组长将待处理的WIP/成品拉到待处理区域。 IQC/IPQC/FQC将不合格品内容填写入《不合格品处置报告》中， 并将《不合格品处置报告》交IQC/QC主管 IQC主管/QC主管/QE召集MRB成员开会，以确定不良品的处置办法, IQC主管/QC主管/QE将MRB会议决定的不合格处置办法填写在 《不合格品处置报告》中，并交MRB人员签名以示确认。 采取纠正措施 解决不良 反馈不良信息给生产部或供应商 供 应 商 生 产 部 IQC主管/QC主管/QE将填写好了不合格品处置办 法的《不合格品处置报告》交回IQC/IPQC/FQC. 否 供应商回复8D 是否 需要发放 8D 是 颁发8D予生产部/供应商 异常原因分析 拟定纠正措施 措施核准 NG OK 实施 OK 效果确认 结束 ISO9001-2015内审员升级培训(100元) ISO9001-2015内审员培训(200元) ：http://www.55top.com

NG

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Non-conforming Product Disposition Flow Chart

Yes Same defect detected? No End If any stock in warehouse, IQC/QC must trace them and perform inspection again. IQC found the whole lot reject during incoming material inspection During Mass Production, Production FQC rejected the IPQC found defect found a mass of non-conforming whole batch/lot unacceptable during incoming materials/WIP from in-process after final suppliers or previous process inspection inspection Production fills out QF-QC-005 and sent it to IQC/QC for confirmation. FQC rejected the whole lot/batch after outgoing inspection IPQC trace and identify the total nonconforming Qty For non-conforming incoming materials, IQC inform warehouse of transferring them to NG area. For non-conforming WIP/finished goods produced by FP, QC informs production of transferring them to NG area. IQC/IPQC/FQC fills out and sent it to IQC/QC supervisor IQC Supervisor / QC Supervisor / QE have a meeting with all MRB members for determining disposition method. IQC Supervisor / QC Supervisor / QE fill the disposition method in the and sent it to them for approval. Take corrective actions Feedback the defect No to the supplier or production Suppliers reply 8D Supplier IQC Supervisor / QC Supervisor / QE send the back to IQC/IPQC/FQC. Need to release 8D Yes Issue 8D to suppliers or Production IQC/IPQC/FQC labels For non-conforming incoming the nonconforming material, IQC distribute products as per to Warehouse, Purchasing, PPC (if necessary), Finance (if necessary), Production/Warehouse/PM (If necessary), Production (if Purchasing handles necessary). For non-conforming with the WIP/Finished-goods produced by non-conforming FP, QC distributes it to Warehouse, products as per MRB Production, PPC, and PM (If disposition. necessary). Root Cause Analysis Production Initiate corrective actions NG Approved? OK Implementation Verify the effectiveness NG End ISO9001-2015内审员升级培训(100元) ISO9001-2015内审员培训(200元) ：http://www.55top.com