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2.0风险评估Risk Assessment:
评估对工厂内部的影响：Evaluateeffect internal
2.1.1是否可能有其它批次有相同的缺陷？If haveotherlots affected by same defect(s)?
(识别受影响的WIP，成品，半成品Identify lot numbers/part numbers affected in: WIP, Finished Goods, Subassemblies)
3.□ 让步接受Use as is理由Justification:
4.□返回给供应商Return to Supplier
5.□产品换型Change the part#,受影响文件Affected Document:
5.0处置批准DISPOSITION APPROVAL(针对有退回品的客户投诉的处置批准。Focus on the returns bycustomercomplaints)
否no有yes(如果有，列出措施If yes, list Containment action.)
2.2.2该缺陷是否对客户/发送方有潜在风险？Ifhave potential risk in customer/sending site?
否no（如果否，则说明客户/发送方是怎么识别的If no, record how to identify in customer/sending site）
责任人
Owner:
3.0措施Actions:
□需要不合格调查报告，Need investigation report
□不需要调查报告，则说明理由并列出措施 No need investigation report,record the reasonand list the actions：
理由reason：
生产Production:日期Date:
质量Quality:日期Date:
工程Engineering:日期Date:
其他Other:日期Date:
措施action：
4.0处置DISPOSITION:
(针对有退回品的客户/发送方反馈的处置。Focus on the returns bycustomer/sending site complaints)
缺陷数量Qty
1.□报废Scrap
2.□返工Rework
SeeFRM13.1.1.1ReworkSheet
Number#：
1.0不合格描述Nonconformance description:
批次号Batch No.：零件编号Part No.：
批数量Batch Qty.：不合格数量NC Qty.：
缺陷处置：QE签名：日期：
CustomerDisposition of the defect partsincustomer/Sending siteSignatureDate
有yes(如果是，列出措施Ifno, list Containment action.)
评估对现有文件/流程的影响：Evaluate effectondocuments/Procedure
2.3.1是否需要更新相关的文件？如作业指导书，FMEA，验证等。If need update related documents?eg. WI, FMEA, validation, etc.
否no（如果否，则说明理由：If no, record the reason:）
有yes(如果有，列出文件编号/信息If yes, listthe No./information)
围堵措施：(包括所有隔离，挑选，检验等措施)
ContainmentActions: (include all quarantine, sorting, inspection activitiesandetc.)
评估对客户的影响：Evaluate effect external
2.2.1是否存在相同缺陷的批次已发货的风险？If have risk about any lots with this defect left manufacturing facility?
(识别已发货的产品Identify lot numbers/part numbersshipped)
否no有yes(如果有，列出批次和围堵措施If yes, list Lot numbers and Containment action.)
2.1.2是否对后续的生产存在质量风险？If have quality risk about next production?
否no有yes(如果有，列出措施If yes, list Containment action.)
评估对工厂内部的影响：Evaluateeffect internal
2.1.1是否可能有其它批次有相同的缺陷？If haveotherlots affected by same defect(s)?
(识别受影响的WIP，成品，半成品Identify lot numbers/part numbers affected in: WIP, Finished Goods, Subassemblies)
3.□ 让步接受Use as is理由Justification:
4.□返回给供应商Return to Supplier
5.□产品换型Change the part#,受影响文件Affected Document:
5.0处置批准DISPOSITION APPROVAL(针对有退回品的客户投诉的处置批准。Focus on the returns bycustomercomplaints)
否no有yes(如果有，列出措施If yes, list Containment action.)
2.2.2该缺陷是否对客户/发送方有潜在风险？Ifhave potential risk in customer/sending site?
否no（如果否，则说明客户/发送方是怎么识别的If no, record how to identify in customer/sending site）
责任人
Owner:
3.0措施Actions:
□需要不合格调查报告，Need investigation report
□不需要调查报告，则说明理由并列出措施 No need investigation report,record the reasonand list the actions：
理由reason：
生产Production:日期Date:
质量Quality:日期Date:
工程Engineering:日期Date:
其他Other:日期Date:
措施action：
4.0处置DISPOSITION:
(针对有退回品的客户/发送方反馈的处置。Focus on the returns bycustomer/sending site complaints)
缺陷数量Qty
1.□报废Scrap
2.□返工Rework
SeeFRM13.1.1.1ReworkSheet
Number#：
1.0不合格描述Nonconformance description:
批次号Batch No.：零件编号Part No.：
批数量Batch Qty.：不合格数量NC Qty.：
缺陷处置：QE签名：日期：
CustomerDisposition of the defect partsincustomer/Sending siteSignatureDate
有yes(如果是，列出措施Ifno, list Containment action.)
评估对现有文件/流程的影响：Evaluate effectondocuments/Procedure
2.3.1是否需要更新相关的文件？如作业指导书，FMEA，验证等。If need update related documents?eg. WI, FMEA, validation, etc.
否no（如果否，则说明理由：If no, record the reason:）
有yes(如果有，列出文件编号/信息If yes, listthe No./information)
围堵措施：(包括所有隔离，挑选，检验等措施)
ContainmentActions: (include all quarantine, sorting, inspection activitiesandetc.)
评估对客户的影响：Evaluate effect external
2.2.1是否存在相同缺陷的批次已发货的风险？If have risk about any lots with this defect left manufacturing facility?
(识别已发货的产品Identify lot numbers/part numbersshipped)
否no有yes(如果有，列出批次和围堵措施If yes, list Lot numbers and Containment action.)
2.1.2是否对后续的生产存在质量风险？If have quality risk about next production?
否no有yes(如果有，列出措施If yes, list Containment action.)