供应商品质管理标准中英文.doc

SUPPLIER QUALITY MANAGEMENT STANDARD
供货商质量管理标准

A SUPPLIER QUALITY MANAGEMENT TOOL FROM
SUPPLIER QUALITY ENGINEERING

MITAC COMPUTER (SHUNDE) LTD.
2023
TABLE OF CONTENTS目录
1.0 QUALITY SYSTEM REQUIREMENTS
质量系统规定
1.1 Quality Program
质量计划
1.2 Management Responsibility
管理职责
1.3 Organization
品管组织架构
1.4 Quality Policies, Procedures, and Work Instructions
质量方针,流程及作业指导书
1.5 Quality Management Plan
质量管理计划
1.6 Internal Audit Program
内部审核程序
1.7 MiTAC Audits
MiTAC稽核
1.8 Training
品质培训
2.0 CONTRACT REVIEW
协议评审
3.0 DOCUMENT CONTROL
文献管控
4.0 SUPPLIER QUALITY CONTROL
供货商品质管控
4.1 Defined Quality and Technical Requirements
质量和技术规定的定义
4.2 Sub-tier Supplier Approvals
二阶供货商认可
4.3 Sub-tier Supplier Audits
二阶供货商稽核
4.4 First Article Inspections
首件检查
4.5 Records
记录
5.0 PRODUCT IDENTIFICATION AND LOT TRACEABILITY
产品辨认和追踪
6.0 PROCESS CONTROL
制程管控

6.1 Process Qualification
制程认可
6.2 Quality Metrics
质量标准
6.3 Continuous Improvement Program
连续改善计划
7.0 Inspection and Testing
检查和测试
7.1 Source/Incoming Inspection and Tests
原材料检查和测试
7.2 In-Process Inspection and Testing
制程(半成品)检查和测试
7.3 Final Inspection and Testing
最终(成品)检查和测试
7.4 Shipping Inspection (OBA Testing/Inspection)
出货检查和测试
7.5 Reliability Testing
可靠性测试
7.6 Inspection and Testing Records
检查和测试记录
8.0 CALIBRATION
校验
8.1 Calibration Procedures
校验流程
8.2 Recall List
校验提醒机制

8.3 Calibration Records
校验记录
8.4 Out of Tolerance (Calibration) Notices
校验结果超过规格告知
9.0 INSPECTION AND TEST STATUS
检查和测试状况
10.0 CONTROL OF NONCONFORMING PRODUCT
不合格品控制
10.1 Review and Disposition of Nonconforming Products
不合格品解决
10.2 Corrective Action Process
改善流程
11.0 HANDLING, STORAGE, PACKAGING, AND DELIVERY
搬运, 储存, 包装和交货
11.1 Handling
搬运流程

11.2 Storage
储存条件
11.3 Packaging
包装规定
11.4 Delivery
交货
12.0 QUALITY RECORDS
质量记录
13.0 DELIVERABLES
可交付性
13.1 Product-Specific Quality Plan
特殊产品质量计划
13.2 Sub-tier Supplier Management Plans
二阶供货商管理计划
13.3 Internal Audit Program Plan
内部稽核计划
14.0 DEFINITIONS
名词定义

SUPPLIER QUALITY MANAGEMENT STANDARD
供货商质量管理标准

MiTAC Suppliers shall comply with the quality program requirements set forth in this document. In the event of conflict between the requirements contained herein and the SQA SOP/Contract, the SQA SOP/Contract shall take precedent. Any exceptions to these requirements must be approved by MiTAC Supplier Quality Engineering (SQE).
MiTAC所有供货商都将遵守此文献中定义的质量计划规定. 当以下规定与 SQA SOP/合约相冲突时, 应当遵守SQA SOP/合约 的规定.对以下规定有异议都必须通过MiTAC SQE的核准.
1.0 QUALITY SYSTEM REQUIREMENTS
质量系统规定
1.1 QUALITY PROGRAM
质量计划
The Supplier is required to implement and maintain a quality program that shall assure design and manufacture of products is consistent with the requirements of ISO 9001. The Supplier shall assure that ISO 9001 requirements are implemented during the design phase and that ISO 9001 requirements are implemented for the manufacturing of product. The Supplier shall notify MiTAC RD/CE of any changes in its quality program prior to implementation.
供货商必须导入并保持质量计划以保证产品的设计和制造与ISO9001的规定相一致. 供货商须保证设计阶段和产品的制造执行ISO9001的规定. 质量计划的变更须在执行之前告知MiTAC RD/CE.
1.2 MANAGEMENT RESPONSIBILITY 管理职责
The Supplier’s executive management will develop a company-wide quality policy. This policy will be deployed and understood by all employees. A management review system will be implemented. The Quality policy and system will be reviewed at prescribed intervals to assess the continuing suitability and effectiveness of the quality system. This review will include the quality policy, internal audit results, product complaints/returns, process/product quality reports, and others as they apply. Executive management will appoint a management representative with the responsibility/authority to monitor compliance to the system, and to ensure corrective/preventive measures are implemented.
供货商高阶主管须制定一合用于全公司的质量政策.该质量政策需全面展开并被公司所有员工理解.导入管理评审系统.定期评审该质量政策和系统以评估质量系统的合用性和有效性.评审内容涉及质量政策, 内部稽核结果, 产品抱怨/退货, 制程/产品质量报告和其它.高阶主管需指派一管理者代表, 并赋予其监控质量系统的合用性, 保证改善/防止措施执行的职责.
1.3 ORGANIZATION
组织
The Supplier will have an organization that supports, implements and maintains the quality system at all levels.
供货商建立一组织, 以使所有阶层的成员都支持,执行和维护质量系统.
1.4 QUALITY POLICIES, PROCEDURES, AND WORK INSTRUCTIONS
质量政策,程序和作业指导书
The Supplier shall establish and maintain a documented quality program as a means of ensuring that product and/or services comply with the requirements set forth in this standard. All work affecting the quality of products and/or services shall be documented in clear and concise policies, procedures, and work instructions. The Supplier shall ensure that these documents are deployed, effectively implemented and understood within the company.
供货商需建立和保持文文献化的质量程序, 以保证产品和服务满足此标准的规定.所有会影响到产品的质量和服务的作业都需清楚简洁的文献化定义.供货商须保证此档的展开,有效执行并被公司全体理解.
1.5 QUALITY PLAN
质量计划
The Supplier shall define a Quality Plan with the SQE yearly that describes the overall quality program used for the manufacture, test, and inspection of product delivered to MiTAC. The Plan shall, at a minimum, describe the following:
供货商须与SQE年度地制定一质量计划, 该计划涉及全面质量程序, 用于供应给MiTAC的产品的制造, 测试和检查.该计划最少应涉及以下内容：

q Identification of support team for MiTAC
q 支持MiTAC的团队成员
q Quality performance goals
q 质量目的
q Manufacturing processes
q 制造流程
q Inspection/test strategies and processes
q 检查/测试的计划和流程
q Process control techniques
q 制程管控方法
q First article requirements
q 首件规定
q Internal change control procedures
q 内部变更的管控流程
q Procedures for handling discrepant material (identification, containment, root cause,
corrective action)
q 异常材料的解决流程(鉴别, 围堵措施, 主线因素, 改善措施)
q Failure analysis support for MiTAC’s line and MiTAC’s customer rejects (VLRR)
q MiTAC产线和客户不良材料的失效分析
q Engineering change requirements
q 工程变更规定
q Continuous Improvement Program (CIP)
q 连续改善计划

1.6 INTERNAL AUDIT PROGRAM
内部稽核程序
The Supplier shall implement an effective internal audit program that provides for the following:
供货商须执行有效的内部稽核计划并涉及以下：
q Gap Analysis (Audit)
q 稽核缺失分析
q System Audits
q 系统稽核
q Process/Product Audits
q 制程/产品稽核

Only qualified auditors (trained) will conduct audits and will be independent from the area being audited. The audit program shall be provided to MiTAC SQE for review. All audit results shall be maintained and made available to MiTAC SQE upon request.
仅有资格的稽核者(被培训)可主导稽核, 且不能参与本部门/区域的稽核. 稽核程序可提供应MiTAC SQE审核. 所有稽核结果应当保持, 在MiTAC SQE提出规定期可得到此稽核记录.
1.7 MITAC AUDITS
MiTAC 稽核
On a periodic basis, MITAC may conduct audits/visits at the Supplier’s manufacturing locations (local/ domestic). The Supplier shall, at MiTAC’s request, permit access to manufacturing operations involved in the production and/or inspection of MiTAC’s products, including access to sub-contractor facilities. Periodic audits will include quality inspection data and other data related to the product being produced, or process audits to verify compliance to the contractual requirements. Supplier permit access to MiTAC’s customer upon request (with advance notice) to the Supplier’s manufacturing operations involved in the production and/or inspection of customer’s products.This access may be for purposes of a visit and/or audit. Under normal circumstances, the Supplier shall be given advance notice of MiTAC’s visits.
MiTAC会定期地在供货商的制造工厂进行稽核或拜访 (只针对国内供货商).当MiTAC提出规定期,供货商应当允许MiTAC进入制造现场, 涉及MiTAC产品的生产和检查,并允许进入外包商工厂.定期稽核涉及质量检查数据和其它正在生产的相关产品的数据的稽核,或验证合约规定的一致性的制程稽核.供货商允许MiTAC的客户(客户规定并提前告知)进入制造现场,涉及客户产品的生产和检查,目的为拜访或者是稽核.正常情况下,MiTAC会在拜访前提前告知供货商.
1.8 TRAINING
培训
The Supplier shall establish and maintain a program for the identification of training requirements for all personnel that affect the quality of a product during production and installation. Qualification to perform assigned tasks shall be based on individual education, training and/or experience as required. The Supplier shall also assure that a system exists for the qualification, re-qualification, and disqualification of personnel. As a minimum, training for applicable personnel shall consist of quality system training, auditing techniques, Supplier Quality Engineering processes, assembly techniques, workmanship standards, and inspection requirements. Supervisors in the production area shall also have a working knowledge of quality systems and statistics. Records of all training shall be maintained and made available for MiTAC SQE to review upon request.
供货商须建立并维护员工培训计划,培训对象为对产品在生产和安装的质量会导致影响的员工.须根据个人的教育背景, 培训或者以规定的经验进行资格认可以完毕分派的任务.供货商应保证有员工认证, 再认证和取消员工资格的系统,员工认证的培训至少由质量系统培训,稽核技巧,供货商工艺流程,封装技术, 作业规范和检查规定组成.生产线的主管也应当具有质量系统和记录学的知识.所有培训记录应保持并利于MiTAC SQE审核.
2.0 CONTRACT REVIEW
协议评审

The Supplier shall assure that an element of the quality program provides for the effective and timely review of MiTAC mandated or implied requirements. The Supplier shall review each contract to ensure that:
供货商应当保证质量计划的有效性并定期给MiTAC审核.供货商应评审每个协议以保证：
q MiTAC requirements understood.
q 理解MiTAC的规定
q Conflicts between specifications, drawings, and contract requirements are resolved.
q 规格书,图纸和合约规定的冲突得到解决
q Assure that any requirements differing from those in the tender are resolved.
q 保证与合约不一致的规定得到解决
q The Supplier has the capability to meet contractual requirements.
q 供货商有能力满足合约的规定

3.0 DOCUMENT CONTROL
文献管控
The Supplier shall assure that all documents such as software/firmware, engineering drawings, specifications, contracts, policies, procedures, and work instructions (including test procedures) are under revision control and available to all necessary personnel in the manufacturing environment. A system shall be established for the effective updating/removal of any obsolete documentation from all areas.
供货商应保证所有文献(例如软件/硬件, 工程图纸, 规格书, 协议, 政策, 程序文献和作业指导书(涉及测试流程))都有版本管控, 且所有相关生产人员都可得到相关版本的文献,建立一个系统以有效地更新/移除所有作废档.
4.0 SUPPLIER QUALITY CONTROL
供货商品质管控
In addition to the requirements of ISO 9001, the Supplier shall implement a Supplier Management Plan for the control of its Suppliers. As a minimum, the Plan shall provide for quality goals, the performance of site surveys/audits, quality program requirements, change/revision control requirements, test/inspections, first article inspections and data package reviews.
除了ISO9001的规定,供货商须导入供货商管理计划以管控其供货商.该计划至少规定涉及质量目的,现场调查/稽核状况,质量计划规定,变更/修订 管控规定,测试/检查,首件检查和资料的评审.
4.1 DEFINED QUALITY AND TECHNICAL REQUIREMENTS
定义质量和技术规定
The Supplier shall develop and implement a system that will provide for an effective process to define quality and technical requirements to their Suppliers. Quality and technical requirements are defined as quality programs, engineering drawings, specifications and functions to be performed by sub-tier Suppliers. The Supplier may elect to use a contract, purchase order or other suitable means in defining these requirements. However, MiTAC requires that quality and technical requirements are fully documented and that the Supplier verify understanding and implementation of such requirements.
供货商应开发并执行一系统,以提供有效的流程来定义对其供货商的质量和技术规定.质量和技术规定涉及质量计划,工程图纸,规格书和二阶供货商的职责.供货商可以选择协议, 采购合约或其它适当的方式来定义这些规定.但是,MiTAC规定该质量和技术规定完全文檔化,且供货商理解并执行这些规定.,
4.2 SUB-TIER SUPPLIER APPROVALS
二阶供货商认可
The Supplier shall perform a quality review of its proposed Suppliers prior to the placement of purchasing documents and acceptance of parts/product. The approval of Suppliers shall be based on review of sub-tier Suppliers’ quality programs and ability to meet MiTAC expectations. Records of Supplier approval shall be maintained in a central location and made available for the MiTAC SQE to review upon request.
在采购和接受材料之前,供货商应对其供货商执行质量审核.供货商的认可应基于二阶供货商的质量计划和满足MiTAC盼望的能力.供货商认可记录应适本地保存维护并可便于MiTAC SQE审核.
4.3 SUB-TIER SUPPLIER AUDITS
二阶供货商稽核
The Supplier shall implement a system to assure sub-tier Suppliers are audited periodically. The Supplier’s audit process should also provide for re-assessments when quality levels drop below established quality goals or as warranted by the MiTAC SQE.
In the event that a sub-tier Supplier is responsible for final production and packing of the product (subcontractor shipping directly to MiTAC on behalf of the Supplier), the Supplier shall facilitate access to these sites so that MiTAC may conduct audits as per Section 1.7 of this document.
供货商应导入一系统,以保证定期稽核所有二阶供货商.当质量等级下降到低于定义的质量标准时或者MiTAC SQE 批准的目的,供货商的稽核流程应重新评估.假如产品的最终生产和包装由二阶供货商负责（外包商代理供货商直接出货给MiTAC）,供货商应当帮助MiTAC到二阶供货商工厂执行稽核,同此文献中1.7条.
4.4 FIRST ARTICLE INSPECTIONS
首件检查
The Supplier shall perform First Article Inspection on units from the first production run or for design changes that affect form, fit, or function. First Article Inspections shall be performed to verify built-as-designed configuration and shall include 100% dimensional verification, electrical testing, raw material certification, and compliance with drawing notes. First Article data shall be maintained and submitted for the MiTAC CE to review upon request.
在量产前或会影响成型,适配和功能的设计变更之前,供货商应执行首件检查.首件的执行应验证设计的构造,且涉及100%尺寸确认,电性测试,原材料验证及与图纸的一致性.首件数据应保存并在MiTAC CE提出规定的情况下递交给MiTAC CE审核.
4.5 RECORDS
记录
All records that provide evidence of Supplier activity such as Source Inspections and First Article Inspections shall be maintained in a central location and made available for the MiTAC SQE to review upon request.
所有供货商质量活动（如原材料检查和首件检查）的记录都应当保存并在MiTAC SQE提出规定的情况下,可供MiTAC SQE审核.
5.0 PRODUCT IDENTIFICATION AND LOT TRACEABILITY
产品标记和可追溯性
The Supplier shall establish and maintain procedures and processes for the identification and lot traceability of critical items during all stages of production, delivery, and installation. This is to be traceable through the finished product serial number or equivalent method.
供货商应建立并保持一流程和过程,以在生产, 交货和安装的所有过程中辨认和追踪关键项目.可通过成品的序列号或其它方式进行追踪.
6.0 PROCESS CONTROL
制程管控
The Supplier shall ensure that all manufacturing processes that affect the quality of a product are carried out in a controlled condition. MiTAC defines controlled conditions as:
供货商应保证所有会影响到产品质量的生产流程处在控制状态.MiTAC所定义的管制状态如下：
q Documented work instructions that provide clear and concise direction for the assembly, inspection, tests, and acceptance criteria of products.
q 文献化的作业指导书,以指导产品的封装,检查,测试及允收标准.
q Identification of critical parameters, implementation of statistical process