供应商品质管理标准.doc

供应商品质管理标准

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2020年6月23日
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SUPPLIER QUALITY MANAGEMENT STANDARD
供應商品質管理標準

A SUPPLIER QUALITY MANAGEMENT TOOL FROM
SUPPLIER QUALITY ENGINEERING

MITAC COMPUTER (SHUNDE) LTD.

TABLE OF CONTENTS目錄
1.0 QUALITY SYSTEM REQUIREMENTS
品質系統要求
1.1 Quality Program
品質計劃
1.2 Management Responsibility
管理職責
1.3 Organization
品管組織架構
1.4 Quality Policies, Procedures, and Work Instructions
品質方針,流程及作業指導書
1.5 Quality Management Plan
品質管理計劃
16 Internal Audit Program
內部審核程式
1.7 MiTAC Audits
MiTAC稽核
1.8 Training
品質培訓
2.0 CONTRACT REVIEW
合同評審
3.0 DOCUMENT CONTROL
文件管控
4.0 SUPPLIER QUALITY CONTROL
供應商品質管控
4.1 Defined Quality and Technical Requirements
品質和技術要求的定義
4.2 Sub-tier Supplier Approvals
二階供應商承認
4.3 Sub-tier Supplier Audits
二階供應商稽核
4.4 First Article Inspections
首件檢查
4.5 Records
記錄
5.0 PRODUCT IDENTIFICATION AND LOT TRACEABILITY
產品識別和追蹤
6.0 PROCESS CONTROL
製程管控

6.1 Process Qualification
製程承認
6.2 Quality Metrics
品質標準
6.3 Continuous Improvement Program
持續改进計劃
7.0 Inspection and Testing
檢驗和測試
7.1 Source/Incoming Inspection and Tests
原材料檢驗和測試
7.2 In-Process Inspection and Testing
製程(半成品)檢驗和測試
7.3 Final Inspection and Testing
最終(成品)檢驗和測試
7.4 Shipping Inspection (OBA Testing/Inspection)
出貨檢驗和測試
7.5 Reliability Testing
可靠性測試
7.6 Inspection and Testing Records
檢驗和測試記錄
8.0 CALIBRATION
校驗
8.1 Calibration Procedures
校驗流程
8.2 Recall List
校驗提醒機制

8.3 Calibration Records
校驗記錄
8.4 Out of Tolerance (Calibration) Notices
校驗結果超出規格通知
9.0 INSPECTION AND TEST STATUS
檢驗和測試狀況
10.0 CONTROL OF NONCONFORMING PRODUCT
不合格品控制
10.1 Review and Disposition of Nonconforming Products
不合格品處理
10.2 Corrective Action Process
改进流程
11.0 HANDLING, STORAGE, PACKAGING, AND DELIVERY
搬運, 儲存, 包裝和交貨
11.1 Handling
搬運流程

11.2 Storage
儲存條件
11.3 Packaging
包裝要求
11.4 Delivery
交貨
12.0 QUALITY RECORDS
品質記錄
13.0 DELIVERABLES
可交付性
13.1 Product-Specific Quality Plan
特殊產品品質計劃
13.2 Sub-tier Supplier Management Plans
二階供應商管理計劃
13.3 Internal Audit Program Plan
內部稽核計劃
14.0 DEFINITIONS
名詞定義

SUPPLIER QUALITY MANAGEMENT STANDARD
供應商品質管理標準

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所有供應商都將遵守此檔中定義的品質計劃要求. 當以下要求與 SQA SOP/合約相衝突時, 應該遵守SQA SOP/合約 的規定.對以下要求有異議都必須經過MiTAC SQE的核准.
1.0 QUALITY SYSTEM REQUIREMENTS
品質系統要求
1.1 QUALITY PROGRAM
品質計劃
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.
供應商必須導入並保持品質計劃以保證產品的設計和製造與ISO9001的要求相一致. 供應商須保證設計階段和產品的製造執行ISO9001的要求. 品質計劃的變更須在執行之前通知MiTAC RD/CE.
1.2 MANAGEMENT RESPONSIBILITY 管理職責
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.
供應商高階主管須制定一適用於全公司的品質政策.該品質政策需全面展開並被公司所有員工理解.導入管理評審系統.定期評審該品質政策和系統以評估品質系統的適用性和有效性.評審內容包括品質政策, 內部稽核結果, 產品抱怨/退貨, 製程/產品品質報告和其它.高階主管需指派一管理者代表, 並賦予其監控品質系統的適用性, 保證改进/預防措施執行的職責.
1.3 ORGANIZATION
組織
The Supplier will have an organization that supports, implements and maintains the quality system at all levels.
供應商建立一組織, 以使所有階層的成員都支持,執行和維護品質系統.
1.4 QUALITY POLICIES, PROCEDURES, AND WORK INSTRUCTIONS
品質政策,程式和作業指導書
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.
供應商需建立和保持文檔化的品質程式, 以保證產品和服務滿足此標準的要求.所有會影響到產品的品質和服務的作業都需清晰簡潔的文件化定義.供應商須保證此檔的展開,有效執行並被公司全體理解.
1.5 QUALITY PLAN
品質計劃
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:
供應商須與SQE年度地制定一品質計劃, 該計劃包括全面品質程式, 用於供應給MiTAC的產品的製造 測試和檢驗.該計劃最少應包括以下內容:

q Identification of support team for MiTAC
q 支援MiTAC的團隊成員
q Quality performance goals
q 品質目標
q Manufacturing processes
q 製造流程
q Inspection/test strategies and processes
q 檢驗/測試的計劃和流程
q Process control techniques
q 製程管控方法
q First article requirements
q 首件要求
q Internal change control procedures
q 內部變更的管控流程
q Procedures for handling discrepant material (identification, containment, root cause,
corrective action)
q 異常材料的處理流程(鑒別, 圍堵措施, 根本原因, 改进措施)
q Failure analysis support for MiTAC’s line and MiTAC’s customer rejects (VLRR)
q MiTAC產綫和客戶不良材料的失效分析
q Engineering change requirements
q 工程變更要求
q Continuous Improvement Program (CIP)
q 持續改进計劃

1.6 INTERNAL AUDIT PROGRAM
內部稽核程式
The Supplier shall implement an effective internal audit program that provides for the following:
供應商須執行有效的內部稽核計劃並包括以下:
q Gap Analysis (Audit)
q 稽核缺失分析
q System Audits
q 系統稽核
q Process/Product Audits
q 製程/產品稽核

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.
僅有資格的稽核者(被培訓)可主導稽核, 且不能參加本部門/區域的稽核. 稽核程式可提供給MiTAC SQE審核. 所有稽核結果應該保持, 在MiTAC SQE提出要求時可得到此稽核記錄.
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會定期地在供應商的製造工廠進行稽核或拜訪 (只針對國內供應商).當MiTAC提出要求時,供應商應該允許MiTAC進入製造現場, 包括MiTAC產品的生産和檢驗,並允許進入外包商工廠.定期稽核包括品質檢驗資料和其它正在生産的相關產品的資料的稽核,或驗證合約要求的一致性的製程稽核.供應商允許MiTAC的客戶(客戶要求並提前通知)進入製造現場,包括客戶產品的生産和檢驗,目的為拜訪或者是稽核.正常情況下,MiTAC會在拜訪前提前通知供應商.
1.8 TRAINING
培訓
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.
供應商須建立並維護員工培訓計劃,培訓對象為對產品在生産和安裝的品質會造成影響的員工.須根據個人的教育背景, 培訓或者以要求的經驗進行資格承認以完成分配的任務.供應商應保證有員工認證, 再認證和取消員工資格的系統,員工認證的培訓至少由品質系統培訓,稽核技巧,供應商工藝流程,封裝技術, 作業規範和檢驗要求組成.生産綫的主管也應該具備品質系統和統計學的知識.所有培訓記錄應保持並利於MiTAC SQE審核.
2.0 CONTRACT REVIEW
合同評審

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:
供應商應該保證品質計劃的有效性並定期給MiTAC審核.供應商應評審每個合同以保證:
q MiTAC requirements understood.
q 理解MiTAC的要求
q Conflicts between specifications, drawings, and contract requirements are resolved.
q 規格書,圖紙和合約要求的衝突得到解決
q Assure that any requirements differing from those in the tender are resolved.
q 保證與合約不一致的要求得到解決
q The Supplier has the capability to meet contractual requirements.
q 供應商有能力滿足合約的要求

3.0 DOCUMENT CONTROL
文件管控
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.
供應商應保證所有檔(例如軟件/硬體, 工程圖紙, 規格書, 合同, 政策, 程式檔和作業指導書(包括測試流程))都有版本管控, 且所有相關生産人員都可得到相關版本的文件,建立一個系統以有效地更新/移除所有作廢檔.
4.0 SUPPLIER QUALITY CONTROL
供應商品質管控
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的要求,供應商須導入供應商管理計劃以管控其供應商.該計劃至少要求包括品質目標,現場調查/稽核狀況,品質計劃要求,變更/修訂 管控要求,測試/檢驗,首件檢驗和資料的評審.
4.1 DEFINED QUALITY AND TECHNICAL REQUIREMENTS
定義品質和技術要求
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.
供應商應開發並執行一系統,以提供有效的流程來定義對其供應商的品質和技術要求.品質和技術要求包括品質計劃,工程圖紙,規格書和二階供應商的職責.供應商能够選擇合同, 採購合約或其它適當的方式來定義這些要求.可是,MiTAC要求該品質和技術要求完全文檔化,且供應商理解並執行這些要求.,
4.2 SUB-TIER SUPPLIER APPROVALS
二階供應商承認
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.
在採購和接受材料之前,供應商應對其供應商執行品質審核.供應商的承認應基於二階供應商的品質計劃和滿足MiTAC期望的能力.供應商承認記錄應適當地保存維護並可便於MiTAC SQE審核.
4.3 SUB-TIER SUPPLIER AUDITS
二階供應商稽核
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.
供應商應導入一系統,以保證定期稽核所有二階供應商.當品質等級下降到低於定義的品質標準時或者MiTAC SQE 批准的目標,供應商的稽核流程應重新評估.如果產品的最終生産和包裝由二階供應商負責( 外包商代理供應商直接出貨給MiTAC) ,供應商應該幫助MiTAC到二階供應商工廠執行稽核,同此文件中1.7條.
4.4 FIRST ARTICLE INSPECTIONS
首件檢驗
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.
在量產前或會影響成型,適配和功能的設計變更之前,供應商應執行首件檢驗.首件的執行應驗證設計的構造,且包括100%尺寸確認,電性測試,原材料驗證及與圖紙的一致性.首件數據應保存並在MiTAC CE提出要求的情況下遞交給MiTAC CE審核.
4.5 RECORDS
記錄
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.
所有供應商品質活動( 如原材料檢驗和首件檢驗) 的記錄都應該保存並在MiTAC SQE提出要求的情況下,可供MiTAC SQE審核.
5.0 PRODUCT IDENTIFICATION AND LOT TRACEABILITY
產品標識和可追溯性
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.
供應商應建立並保持一流程和過程,以在生産, 交貨和安裝的所有過程中識別和追蹤關鍵項目.可通過成品的序列號或其它方式進行追蹤.
6.0 PROCESS CONTROL
製程管控
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:
供應商應保證所有會影響到產品質量的生産流程處於控制狀態.MiTAC所定義的管制狀態如下:
q Documented work instructions that provide clear and concise direction for the assembly, inspection, tests, and acceptance criteria of products.
q 文件化的作業指導書,以指導產品的封裝,檢驗,測試及允收標準.