发布时间 : 星期五 文章SOP-3-7034-MD528(Rev N) NPI Procedure更新完毕开始阅读1a32e2bfad51f01dc281f1be
Document Number: SOP-3-7034-MD528 Revision: N Page 17 of 27
NEW PRODUCTION INTRODUCTION 新产品导入 验证协议和报告审核批准之后才可进行批量生产。如果客户要求在完成验证之前交货，验证小组组长一定要确认客户批准正式的量产前放行授权书Form-SOP-3-7034-MD528-12。
4.11
Product Identification & Traceability: NPI Group shall review and document requirements for Key Components and record in Form-SOP-3-7034-MD528-04. Key components List shall be identified and requested by customer (If customer doesn’t require any key components, SANM Kunshan doesn’t need to prepare Key Components List, but need to get instruction from Customer as evidence). PE applies document number for the Key components list from DCC department, after Key components list finished; PE releases it in Agile system and then send the Customer Authorization Sheet to customer for the final approval and upload into system as evidence. The Key components list shall identify all key components that are to be specified and recorded in Form-SOP-3-7034-MD528-04 for traceability with specific requirement from customer, as described in SOP-3-7026-MD528 Product Identification and Traceability. This procedure describes how traceability is maintained in Device History Records.
产品标识和可追溯性：新产品导入小组应对关键组件要求进行评估并记录在Form-SOP-3-7034-MD528-04中，关键组件需由客户辨认或要求(如果客户没有要求任何关健部件，SANM 昆山不需要准备关键部件清单但是要有客户相关说明做为证据)，PE向DCC 申请关健组件编号，将完成后的关健组件清单在Agile系统中发行并发客户确认表给客户签字确认上传系统做为证据。关键组件清单应按照总公司程序文件SOP-3-7026-MD528 Product Identification and Traceability 描述,根据客户特殊要求记录到Form-SOP-3-7034-MD528-04中来追踪所有主要组件。此程序描述了如何在设备历史记录中维持可追溯性。
4.12
Technology Transfer: Transfer of technology happens when development efforts to define processes and qualify equipment needed have been achieved. Certification of technology transfer is acquired from the transferor and recorded. Production line is qualified for operation after production validation testing has been approved and released. When NPI transfer action happened, need to record the action on Form-SOP-3-7034-MD528-08 NPI Transfer Action Log. 技术转移：当为定义工艺及所需设备的资格认定已经获得时，就生了技术的转移。在生产验证测试已被批准和发布后，生产线方可进行生产。
Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use.
Official document and revision history is available on Agile. Form-SOP-3-4000-MD528-01, Rev E
Document Number: SOP-3-7034-MD528 Revision: N Page 18 of 27
NEW PRODUCTION INTRODUCTION 新产品导入 生产线可于程序确认测试，批准及发于后投入生产。技术转移证明需向转移者索取并记录。在NPI转移动作发生时需记录在Form-SOP-3-7034-MD528-08 NPI Transfer Action Log中。
4.13
NPI Project hand over to Mass Production: After customer buy off the Prototype and approve the mass production, the project should hand over to the mass production operation. Information transfer should refer to the Form-SOP-3-7034-MD528-07.
当客户确应首件及批准量产后, 项目将交由相关生产部门管理, 数据转移请参照Form-SOP-3-7034-MD528-07.
4.14
Bill of Material (BOM): Where possible, ensure customer revision is embedded in the Sanmina (Kunshan) part number string when part numbers are created by the plant to support new product launch activity. Document and maintain Sanmina (Kunshan)’s BOM loaded into the Oracle system including all change activity through to product release.
物料清单（BOM）：在可能的情况下，确保顾客的修订是嵌入在四海电子（昆山）料号链当这些料号被工厂创建以支持新产品的推出活动。存档和维护四海电子（昆山）的BOM通过产品发布系统加载到Oracle系统，包括所有变更活动。
4.15
Purchased parts购买的零件
? Tooling, sourcing and lead/cycle time requirements. 模具，采购和交付/循环时间的要求。
? Compliance with all regulatory requirements such as 21 CFR 820, RoHS, Underwriters Laboratories, etc. 符合监管要求，如21 CFR820，ROHS，保险商实验室等。
? Identification of any outstanding/significant supplier quality issues including those for customer-specified suppliers.
识别任何显著/重大的供应商的质量问题，包括那些为客户指定的供应商。 ? Latest supplier purchased part drawings.
最新供应商购买零件图纸。
? Selection of suppliers in accordance with QAP-07.4, Supplier Quality Management Practices.
Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use.
Official document and revision history is available on Agile. Form-SOP-3-4000-MD528-01, Rev E
Document Number: SOP-3-7034-MD528 Revision: N Page 19 of 27
NEW PRODUCTION INTRODUCTION 新产品导入 按照QAP-07.4供应商质量管理规范，选择供应商。
? Incoming inspection for parts including documented inspection procedure, test equipment required, test environment required, frequency, acceptance criteria, problem tracking and resolution and required records. 零件的进货检验包括存档的检查程序，需要的测试设备，需要的测试环境，频率，验收标准，问题跟踪和解决。
Note: Use of customer-designated sources, including tool/gauge suppliers, does not relieve Sanmina (Kunshan) of the responsibility for ensuring the quality of purchased items. 注：使用客户指定的来源，包括工具/仪表供应商，并不能免除四海电子（昆山）确保购买的物品的质量的责任。
4.16
Sanmina manufactured parts四海电子制造的零件 ? Tooling, sourcing and lead time requirements. 模具，采购和交货时间的要求。
? Process development including determination of criteria and methods needed to ensure that both the operation and controls are effective. 过程开发包括需要的标准和方法的确定，以确保操作和控制是有效的。 ? Manufactured part compliance with regulatory requirements such as RoHS, Underwriters Laboratories, etc.
制造零件符合监管要求，如RoHS，保险商实验室等。
? Documented inspection procedure for parts including test equipment required, test environment required, frequency, acceptance criteria, problem tracking and resolution and required records.
存档零件的进货检验包括存档的检查程序，需要的测试设备，需要的测试环境，频率，验收标准，问题跟踪和解决。 Customer-supplied parts客户提供的零件:
? Lead time requirements and tracking methods. 交货期的要求和跟踪方法。
? Incoming inspection including documented inspection procedure, test equipment required, test environment required, frequency, acceptance criteria, problem tracking and resolution and required records.
4.17
Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use.
Official document and revision history is available on Agile. Form-SOP-3-4000-MD528-01, Rev E
Document Number: SOP-3-7034-MD528 Revision: N Page 20 of 27
NEW PRODUCTION INTRODUCTION 新产品导入 进货检验包括存档的检查程序，需要的测试设备，需要的测试环境，频率，验收标准，问题跟踪和解决。
4.18
Test Fixtures测试夹具:
? Tooling, sourcing and lead/cycle time requirements. 模具，采购和交付/循环时间的要求。
? Compliance with regulatory requirements such as RoHS, Underwriters Laboratories, etc.
符合监管要求，如21 CFR820，ROHS，保险商实验室等。
? Identification of any outstanding/significant supplier quality issues. 识别任何/显著重大的供应商的质量问题。
? Selection of suppliers in accordance with QAP-07.4, Supplier Quality Management Practices. 按照QAP-07.4供应商质量管理规范，选择供应商。 ? Latest supplier purchased part drawings. 最新供应商购买零件图纸。
? Test fixture identification and acceptance plans with documented results.
测试夹具的鉴定和验收计划与记录结果。
? Documented work instructions for use including test equipment required, test environment required, frequency, acceptance criteria, problem tracking/resolution and required records.
存档使用的作业指导书，包括需要的测试设备，需要的测试环境，频率，验收标准，问题跟踪/解决和需求纪录。
Note: Use of customer-designated sources, including tool/gauge suppliers, does not relieve Sanmina (Kunshan) of the responsibility for ensuring the quality of purchased items.
注：使用客户指定的来源，包括工具/仪表供应商，并不能免除四海电子（昆山）确保购买的物品的质量的责任。
4.19
Labeling标签：
? Labeling requirements by description, quantity and location including applicable kit, sub-assembly and top-level assembly (TLA) labels. 标注要求要通过描述，数量和位置，被包括适用的整套组装，子装配和高级组装（TLA）标签。
Copies of this document are considered uncontrolled, unless otherwise specified. Verify the revision before use.
Official document and revision history is available on Agile. Form-SOP-3-4000-MD528-01, Rev E