4M变更工作指引

1 目的Purpose规定产品的4M1E变动的范围和管理方法，确保产品的生产满足品质规范的要求。

To stipulate the range and management method of the 4M1E changes of the product, to ensure that the production of the product meets the requirements of the quality specification.2范围Scope本指引适用产品的材料，作业方法，设备，环境场所等发生变更时，在产品正式批量生产前对产品的品质进行确认对工艺过程进行验证，以确保产品品质，预防批量生产后不良的品质事故发生。

本指引包括从ECR到ECN的全部变更过程。

The instruction is used for product material, operation methods, equipment, environment change etc, to verify product quality and validate process capability, in order to ensure good product quality, and avoid batches quality accident after mass production.3 职责Responsibility3.1当4M1E发生变动时，信息流第一窗口人为ECR发起人，负责摄取变更信息，召开ECR评估会议，会议决定是否需要通知客户，是否需要进行小批量验证；When 4M1E changed, the first information flow window person should be the ECR initiator, who is responsible for taking change information, holding ECR assessment meeting. In this meeting the team need to decide whether to notify customers, and whether to need small batch validation.3.2需要客户批准时，由PM通知、协调客户相关人员，并最终提交PPAP/ISIR资料给客户；When customer approval needed, the PM should notify and coordinate customers and related person, and finally submit PPAP/ISIR file to customer.3.3需要小批量验证时：PMC物流部门负责安排生产计划；PD生产部门负责按计划生产；PE工艺部门负责工艺过程验证并提供相关数据报告；QE质量部门负责产品质量验证并提供内部验证报告。

When batch validation needed:PMC logistics department is responsible for making production plan;PD production department is responsible for production;PE technology department is responsible for process validation and providing related report;QE quality department is responsible for product quality authentication and provide internal validation report.3.4发起人将工程变更申请单及相关客户确认书、验证报告提交批准，得到批准后转入ECN量产导入流程；The initiator is responsible for collecting customer confirmation and validation report, and submitting ECR for approval. And then transfer to ECN to import mass production.3.5ECN由发起人启动（其中涉及到技术变更、BOM变更的需要由RD部门相关人员启动）。

PMC物流部门负责安排生产计划；PD生产部门负责按计划生产；PE工艺部门负责工艺过程监控跟踪；QE质量部门负责产品质量监控跟踪；ECN started by initiator (RD department should be the initiator when it involves design change or BOM change).PMC logistics department is responsible for making production plan;PD production department is responsible for production;PE technology department is responsible for process validation and providing related report;QE quality department is responsible for product quality authentication and provide internal validation report.3.6ECN首批量产导入后，小组评估确认变更结果，并将ECR/CRN相关资料文件归档。

ECN first batch production after import, the group assessment confirmed that changes as a result, and filing the ECR/CRN related information4 工作流程InstructionECR/ECN编码规则RulesXXECR- XXXX年份序号Year Serial No.XXECN- XXXX年份序号Year Serial No.说明Note：（1）年份：为两位阿拉伯数字，18代表2018年，以此类推；（2）序号：按年份从0001开始起编号，ECR与ECN的编码应相同；（3）ECR/ECN编码由R&D文控组同一创建编写并管理；（4）归档：R&D文控组创建ECR文件夹目录，按年份统一管理，ECR/ECN发起人需跟进到ECR/ECN 结束，并将相关文件提交给R&D文控组进行归档。

（1）Year: Two digits number, 18 means 2018;（2）Serial No.: Year start from 0001, ECR and ECN serial number should be the same;（3）ECR and ECN serial number should be created and managed by R&D DOC;（4）Document management: R&D DOC create ECR folder, and managed base on each year. ECR/ECN initiator should follow up the ECR/ECN process till it ends, and submit related document to R&D DOC for documentation.5 参考文件Reference6 表单Form《F-R&D- xxx_ECR 变更申请单》,《F-R&D-xxx ECN 变更通知单》页码4 /5 文件名称 4M 变更工作指引4M Change working instruction保密区分■一般 □机密7 工作流程图 Flow Chart客户要求 ECR 评审会NY客户批准 客户确认ECN 导入生产变更结束归档变更结果确认需要小批量验证吗Y 可行及需要客户批准Y 可行及不需要客户批准提交PPAP/ISIRYYNNN内部需求 供应商请求提交ECR 给SCMN 不可行Y需要小批量验证吗内部验证报告NY变更导入来源ECR 批准YECR 结束N页码5 / 5 文件名称 4M 变更工作指引4M Change working instruction保密区分■一般 □机密8 附件 AttachmentCustomer ECR ReviewNYCustomer Approved? Customer confirmedECN Lead to productionChanging DocumentationChanging confirmedBatch validation needed?Y and Need customer approvalY and No Need customer approvalPPAP/ISIR submitYYNNNInternal SupplierSubmit ECR to SCMNYBatch validation needed?Internal validation reportNYChanging FromECR ApprovedYECR EndN。