Document Name文件名称 Supplier Development, Management Procedure 供应商开发和管理程序 Document No. 文件编号 XX-XX-XXXX Version版本 A 5.6.6 Sourcing engineer provides RFI/RFQ to the supplier. RFQ includes project information including specifications, drawings, quantity required, target price, quality standard, quotation reply date, quotation guidance. The supplier shall provide specific price components, including material cost, processing cost, etc.
5.6.6寻购工程师向供应商提供RFI/RFQ，RFQ包括项目信息包括：规格，图纸，需求数量，目标价格，质量标准，报价回复日期，报价指导。供应商报价尽量提供明细价格组成包括物料成本，加工成本等。
Note: the sourcing engineer needs to obtain quotations from at least three suppliers. (if less than three require special instructions)
注：寻购工程师至少需要获得三家以上的供应商报价。（如果少于三家需要作出特殊说明）
5.6.7 Analyze the quotation and do price cost structure analysis, negotiate with suppliers on critical terms (lead time, unit price, minimum order quantity, payment terms, etc.) of the quotation to obtain the best overall price and submit the cost to the GM for approval.
5.6.7 寻购工程师分析报价并做价格成本结构分析，对于报价单上关键的条款(供货期,单价,最低订货量,付款条件等)与供应商进行谈判以获得最优的总体价格，提交价格给供应链经理批准后，递交总经理批准。 5.7 SUPPLIER APPROVE : 5.7 供应商准入 :
5.7.1 After the supplier completes the supplier review and quotation, and the supplier enters the sampling stage. 5.7.1 供应商完成供应商审核和报价后，进入供应商样品打样阶段。
Note: For sample recognition, please refer to sample control procedure XXX-XX-XXXX 注：样品承认请参见：XXX-XX-XXXX 样品控制程序
5.7.2 Supplier sample admitted later, to find the source and supplier quality engineering department need to sign the procurement agreement and supplier quality agreement, the supplier information such as terms of payment, the bank information, delivery period and relevant materials such as information such as price to engineering procurement after joining the K3 and OS.
5.7.2 供应商样品承认以后，寻购部和供应商质量工程部需要同供应商签订《采购协议》《质量协议》，将供应商信息如付款条件，银行信息，交货周期等及相关物料信息如价格加入到K3及OS 系统中。
5.7.3 The supplier information and material information have been forwarded to the purchasing department. The purchasing department arranges the order and tracks the delivery.
5.7.3将供应商相关信息及物料信息已经转交单给采购部门，采购部门安排下单并跟踪交货。
5.7.4 The purchasing department shall record the approved supplier information by the classification of the list of qualified suppliers; The list of qualified suppliers should be signed by the sourcing manager, engineering manager, and general manager and updated annually.
5.7.4 寻购部将批准的供应商信息按照分类记录合格供应商清单；合格供应商清单需要寻购经理，工程经理，总经理签核，并每年更新一次。
6. SUPPLIER MAINTENANCE AND MANAGEMENT: 6. 供应商维护和管理:
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Document Name文件名称 Supplier Development, Management Procedure 供应商开发和管理程序 Document No. 文件编号 XX-XX-XXXX Version版本 A 6.1. SUPPLIER PERFORMANCE SCORE 6.1供应商绩效评分：
Evaluate supplier performance every quarter, fill in supplier performance evaluation form, and report to the supply chain purchasing department at the beginning of each quarter.
每个季度对供应商进行绩效评分，填写《供应商业绩评估表》于每个季度的月初报供应链采购部。
Note: please refer to the supplier management procedure of XXX-XX-XXXX for the supplier performance evaluation scheme.
注：供应商业绩评估方案请参见：XXX-XX-XXXX 供应商管理程序 。 6.2 SUPPLIER ANNUAL AUDIT: 6.2供应商年度审核:
The supplier quality engineering department shall, at the beginning of each year, make an annual audit plan for the supplier based on the delivery performance of the previous year and the importance of the supplier and conduct an annual audit for the supplier according to the plan.
供应商质量工程部需要在每年年初根据上一年的交货表现以及供应商的重要程度对供应商制定年度审核计划，并按照计划对供应商进行年度审核。
Note: please refer to the supplier management procedure of XXX-XX-XXXX . 注：供应商年度审核请参见：XXX-XX-XXXX 供应商管理程序
Note: the supplier quality engineering department needs to make the supplier audit plan for the next year in December each year.
注：供应商质量工程部需要在每年12月份制定出下一年的供应商审核计划。 6.3 SUPPLIER QUALITY CONTROL: 6.3 供应商质量管控:
The supplier quality engineering department needs to track the supplier's delivery and production line defects every month for defect rate statistics.
供应商质量工程部需要每月对供应商的交货产线不良进行跟踪做不良率统计。
The incoming inspection of the quality department shall make statistics on the batch yield of the supplier and provide them to the supplier quality engineering department every month.
质量部的进料检验需要对供应商的批次良率进行统计并每月提供给供应商质量工程部。（超标索赔）
Note: please refer to the supplier management procedure of XXX-XX-XXXX 注：供应商详细指标参见：XXX-XX-XXXX 供应商管理程序 6.4 SUPPLIER PROBLEM IMPROVEMENT AND PREVENTION ： 6.4 供应商问题改善和预防：
The supplier quality engineering department shall issue a CAPA(NCR) report to the supplier for non-conforming
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Document Name文件名称 Supplier Development, Management Procedure 供应商开发和管理程序 Document No. 文件编号 XX-XX-XXXX Version版本 A deliveries and follow up the corrective and preventive actions.
对于供应商不合格的交货，供应商质量工程部需向其发出CAPA(NCR)报告并跟踪其纠正及预防措施的执行。
Note: please refer to the supplier management procedure of XXX-XX-XXXX . 注：供应商年度审核请参见：XXX-XX-XXXX 供应商管理程序。 6.5 SUPPLIER REMOVAL ： 6.5供应商踢除：
For detailed rules, please refer to the supplier management procedures of XXX-XX-XXXX 。 详细规则参见：XXX-XX-XXXX 供应商管理程序 。 6.6 SUPPLIER INFORMATION CHANGE 6.6 供应商变更
Supplier location, product design, material changes, manufacturing processes, process parameters, inspection methods, and personnel changes should be notified to AAA supply chain management.
供应商厂址，产品设计，材料变更，生产过程，工艺参数，检验方法，人员变动都需要通知AAA供应链管理部。 For detailed rules, please refer to the supplier management procedures of XXX-XX-XXXX 。 详细规则参见：XXX-XX-XXXX 供应商管理程序 7. REFERENCES: 7. 参考文件: XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX XXX-XX-XXXX 8. RELEVANT FORM 8. 相关表单
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采购程序 Purchasing procedure 供应商管理程序 Supplier management procedure 美国联邦法规-质量体系管理 CFR law-quality system management 医疗器械-质量管理系统-管理要求 Medical equipment- quality system management-Management requirements 加拿大医疗法规 Canadian medical law 医疗器械指令 Medical Device Directive 医疗器械指令的修正案 Amendment of Medical Device Directive 化妆品-良好生产规范 Cosmetics-Good Manufacturing Practices Document NameSupplier Development, Management Procedure Document No. Version文件名称 供应商开发和管理程序 文件编号 XX-XX-XXXX 版本 8.1 XXX-XX-XXXX Standard Purchasing Agreement 标准采购合同
8.2 XXX-XX-XXXX Supplier capability assessment 供应商能力评估报告 8.3 XXX-XX-XXXX Supplier Evaluation Form供应商审核报告。 8.4 XXX-XX-XXXX Vendor Annually Audit Plan供应商年度审核计划 8.5 XXX-XX-XXXX Suppliers Performance Appraisal 供应商业绩评估表 8.6 XXX-XX-XXXX Approved vendor list 合格供应商清单 8.7 XXX-XX-XXXX Quality assurance agreement 质量保证协议 8.8 XXX-XX-XXXX Confidentiality agreement保密协议 Note: the above records should be kept for three years 注：以上相关记录需要保存5年 A Page 14 of 16
Document NameSupplier Development, Management Procedure Document No. Version文件名称 XX-XX-XXXX 供应商开发和管理程序 文件编号 版本 9. ATTACHMENT
9. 附表
A Page 15 of 16
Document NameSupplier Development, Management Procedure Document No. Version文件名称 供应商开发和管理程序 文件编号 XX-XX-XXXX 版本
A Page 16 of 16
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