供应商品质管理标准
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.
2007
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
1.6 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
持續改善計劃
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
改善流程
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
T he 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/產品品質報告和其他.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, 保證改善/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：
?Identification of support team for MiTAC
?支援MiTAC的團隊成員
?Quality performance goals
?品質目標
?Manufacturing processes
?製造流程
?Inspection/test strategies and processes
?檢驗/測試的計劃和流程
?Process control techniques
?製程管控方法
?First article requirements
?首件要求
?Internal change control procedures
?內部變更的管控流程
?Procedures for handling discrepant material (identification, containment, root cause, corrective action)
?異常材料的處理流程(鑒別, 圍堵措施, 根本原因, 改善措施)
?Failure analysis support for MiTAC’s line and MiTAC’s customer rejects (VLRR)
?MiTAC產綫和客戶不良材料的失效分析
?Engineering change requirements
?工程變更要求
?Continuous Improvement Program (CIP)
?持續改善計劃
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：
?Gap Analysis (Audit)
?稽核缺失分析
?System Audits
?系統稽核
?Process/Product Audits
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 manufa cturing 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他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：
?MiTAC requirements understood.
?理解MiTAC的要求
?Conflicts between specifications, drawings, and contract requirements are resolved.
?規格書,圖紙和合約要求的衝突得到解決
?Assure that any requirements differing from those in the tender are resolved.
?保證與合約不一致的要求得到解決
?The Supplier has the capability to meet contractual requirements.
?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.供應商可以選擇合同, 採購合約或其他適當的方式來定義這些要求.但是,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 a lso 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他方式進行追蹤.
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：
?Documented work instructions that provide clear and concise direction for the assembly, inspection, tests, and acceptance criteria of products.
?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.
?Identification of critical parameters, implementation of statistical process controls, and initiation of corrective actions when necessary. Additionally, triggers shall be defined and documented for the
purpose of initiating a stop build and/or stop shipment action.
?關鍵參數的識別,統計過程式控制制的執行,必需改善措施的導入.另外,須定義造成生産停綫和停止出貨的標準並檔化.
?Proofing out the manufacturing, inspection and test processes prior to mass production.
?量產前核實生産,檢驗和測試流程.
?Validation that manufacturing equipment (including fixtures) can produce a product meeting design intent and customer requirements. This should include formal gage repeatability and reproducibility (GR&R) studies where appropriate.
?生産設備（包括治具）的校驗,確保生産的產品滿足設計目的和客戶要求.包括必要時的Gage R&R 分析.
?Detailed workmanship criterion that stipulates the highest standard of quality.
?詳細的作業標準以保證品質的最高水準
?Preventive maintenance program for all equipment used in the manufacturing, inspection, and test of products.
?用於產品的製造, 檢驗和測試的所有設備的預防保養計劃
6.1 PROCESS QUALIFICATION
製程承認
All processes shall be qualified by MiTAC as outlined in the following paragraphs before
commencement of volume production. The Supplier must obtain written approval from MiTAC prior to any change to a qualified manufacturing process or material.
所有制程在量產前都須按照以下要求經MiTAC承認.已經承認合格的原材料或製造流程在變更前,供應商都必須取得MiTAC的書面批准書.
Special test or burn-in requirements may be necessary to assure delivery of product to provide zero defects. This request may occur based on the process evaluation presented, and also the prior
performance of the product.
要求進行特殊測試或燒錄以保證供應產品零缺點,這些要求需建立在製程的評估的基礎上,且在產品生産前.
Process qualification shall include Supplier-generated process capability assessments.
製程承認應包括供應商製程能力評估.
MiTAC expects that process stability is demonstrated and maintained. In this endeavor, sound
statistical methods should be utilized, particularly control charts and analysis by variables. In some
cases, specific control chart data or a certificate of conformance may be a required attachment to the Supplier’s shipment.
MiTAC希望製程能夠保持一定穩定性.充分利用統計方法,定期繪製管制圖並進行變量分析以實現製程穩定性.在某些情況下,供應商需要在出貨時附上詳細的管制圖數據或者相關的證明.
6.2 QUALITY METRICS
品質標準
The Supplier shall use quality metrics as a basis to monitor the quality of its products and processes.
Additionally, the Supplier’s quality program shall define the metrics for a stop ship and/or stop build action. Quality metrics, as a minimum shall include:
供應商須使用品質標準來管控產品和製程的品質.另外,供應商的品質程式須定義停止出貨或停止生産的標準.品製目標至少應包括以下：
?Incoming Quality Control (IQC) results
?來料品質管控
?Manufacturing Yields
?產率
?Test Station Yields
?測試達成率
?Inspection Yields
?檢驗達成率
?Mean Time Between Failures (MTBF) demonstration data
?平均故障間隔時間
?Out of Box Audits (OBA)
?開箱檢驗
?Annualized Failure Rate (AFR)/Annualized Return Rate (ARR) performance
?年度不良率
?Reliability test results
?可靠性測試結果
?MiTAC Verified Line Reject Rate (VLRR)
?MiTAC 產綫不良率
6.3 CONTINUOUS IMPROVEMENT PROCESS
持續改善程式
The Supplier shall develop and implement a Continuous Improvement Process (CIP) that will provide for a cost-effective reduction in process-related excursions. The program at a minimum shall include: 供應商應開發並導入持續改善程式以減少製程中的變異.該程式至少包括以下：
? A documented, systematic approach for identifying CIP focus areas
?系統化的方法以鑒別CIP的執行範圍並文件化
?Supplier management strategy
?供應商管理策略Manufacturing process controls
?製造過程管控
?VLRR reduction plans to achieve MiTAC goals
?降低不良率的計劃以達到MiTAC的目標
The Supplier shall provide status of the implementation and results upon MiTAC SQE request.
在MiTAC SQE的要求下,供應商應提供CIP的執行狀況及結果.
7.0 INSPECTION AND TESTING
檢驗和測試
The Supplier shall develop and maintain processes and procedures for the effective quality
assessment of product and equipment through the utilization of inspection and testing techniques. As
a minimum, the Supplier shall implement the following:
供應商應開發並保持以流程,以通過檢驗和測試的方法對產品和設備進行有效的品質評估.
?Source/Receiving Inspection and Tests
?原材料的檢驗和測試
?In-Process Inspections and Testing
?製成（半成品）檢驗和測試
?Final Inspection and Testing
?成品檢驗和測試
?Shipping Inspection (OBA Testing/Inspection)
?出貨檢驗
?Reliability Testing
?可靠性測試
?Maintain Inspection and Test Records
?保留檢驗和測試結果
Testing implemented at Supplier manufacturing sites shall assure product meets MiTAC’s VLRR.
供應商工廠的測試應該保證產品能達到MiTAC的VLRR的目標值.
7.1 SOURCE/INCOMING INSPECTION AND TESTS
原材料檢驗和測試
The Supplier shall implement a Source/Incoming Inspection program that will provide for the
verification of components and subassemblies to design drawings and specifications.
Source/Incoming Inspections shall be conducted using clear and concise work instructions that define parameters to be verified, measuring tools, sample size, etc. In the event the Supplier chooses to
utilize sampling inspection techniques, the Supplier shall document the sample plan and process to be used for normal, tightened, reduced, and/or skip lot inspections. Additionally, the Supplier shall inform MiTAC SQE of any sampling plan changes with supporting data. This is considered an informal
notification; formal approval from MiTAC is not required if these changes are part of the documented sample plan. The Supplier shall maintain records of all inspections to be made available for the
MiTAC SQE to review upon request.
供應商應執行原材料檢驗程式,並有設計圖紙和規格書以驗證元件和組件.來料檢驗應使用簡明的作業指導書,定義需要驗證的參數,量測工具,樣品數量等.如果供應商選擇使用抽樣檢驗方法,供應商須文檔化定義抽樣計劃及正常檢驗,加嚴檢驗,減量檢驗或跳過批次檢驗.另外,供應商應將抽樣計畫的變更通知
MiTAC SQE並提供相應的資料.這是不正式的通知.如果這些變更是文檔化抽樣計畫的一部分則不需要MiTAC的正式的批准.供應商應保持所有檢驗記錄以便於MiTAC SQE進行審核.
7.2 IN-PROCESS INSPECTION AND TESTING
制程核對總和測試
The Supplier shall inspect and test product as defined in the quality plan and procedures. As a
minimum, the Supplier shall assure that products are manufactured in accordance with approved
processes, work, and disposition instructions. Workmanship and functionality of products shall be the main focus of such inspections and tests. The Supplier may elect to perform in-process inspections utilizing process-auditing techniques or sample inspections as provided for in documented procedures.
Products shall not be released for shipment until all necessary in-process inspections and tests are performed. In the event of a nonconformance, product shall be identified per documented procedures and segregated.
供應商應按照品質計畫和流程中的定義進行產品核對總和測試.至少,供應商應保證產品在合格的生產線和作業指導書下進行生產.產品的核對總和測試應包括外觀和功能.供應商可以利用文檔化的流程中定義的制程稽核方式或抽樣檢驗進行制程檢驗.當所有必需的制程核對測試完成時產品才可以出貨.當發現一個不合格品時,產品應根據文檔化的流程進行識別和隔離.
7.3 FINAL INSPECTION AND TESTING
最終核對總和測試
The Supplier shall ensure that all inspections and tests are performed as described in the quality plan and documented procedures. All products shall undergo a final inspection and test prior to shipment, including MiTAC specific requirements, if applicable. As a minimum, the final inspections and tests shall ensure workmanship, assembly verification, and functionality to test requirements. Product not meeting specified requirements shall be identified and segregated per documented procedures.
Products shall not be released for shipment to MiTAC without completion of all final inspections and tests.
供應商應保證所有核對總和測試按照品質計畫和文檔化的流程執行.所以產品出貨前都要經過最終核對總和測試,包括MiTAC特殊要求,最終核對總和測試至少確保操作,封裝的驗證,和功能測試.未滿足規格要求的產品應按照文檔化的流程進行識別和隔離.未完成所有最終核對總和測試的產品不能出貨給MiTAC
7.4 SHIPPING INSPECTION (OBA TESTING/INSPECTION)
出貨檢驗（開箱測試/檢驗）
Prior to shipment, the Supplier shall assure that the lot passes OBA testing and all applicable
miscellaneous hardware such as cables and power cords, user material, MiTAC unique labeling
requirements, and packaging are verified.
出貨前,供應商應保證所有批次通過OBA測試和硬體材料的應用測試, 如線材和電源線,驗證MiTAC特有的標籤和包裝.
7.5 RELIABILITY TESTING
可靠性測試
Prior to, or during shipment to MiTAC, the Supplier shall ensure that the lot passes extended reliability testing. If product is shipped before completion of testing, the Supplier will ensure proper controls are in place for identification and recall of any failed lots. Any failed lots are required to be contained by Supplier until released by MiTAC SQE/CE.
在出貨時或出貨給MiTAC前,供應商應保證所有批次通過可靠性測試.如果產品在完成測試前出貨,供應商應確保進行過適當的管控以識別並召回所有不合格的批次.任何不合格批次要求圍堵在供應商端直到被MiTAC SQE/CE放行.
7.6 INSPECTION AND TESTING RECORDS
核對總和測試記錄
The Supplier shall maintain records of all inspection and test activity, which will provide the objective evidence that products have passed acceptance criteria. These records shall be made available for the MiTAC SQE to review upon request.
供應商應保持所有核對總和測試記錄,提供產品達到允收標準的客觀憑證.在有要求的情況下, 該記錄可以供MiTAC SQE審核.
8.0 CALIBRATION
校驗
The Supplier shall develop and maintain a system to assure all equipment used for the acceptance of product is calibrated with traceability to an internationally/nationally recognized Standards Institute such as the National Institute of Standards and Technology. Where appropriate, this should also
include formal GR&R studies. These records shall be made available for the MiTAC SQE to review upon request.
供應商應開發並保持一系統以保證所有用於承認材料的設備都要進行校驗,包括必要時的GR&R 分析,所有記錄應能夠給MiTAC SQE 審核.
8.1 CALIBRATION PROCEDURES
校驗程式
Calibration procedures shall be established that define the measurements to be made, accuracy
required, temperature/humidity required, and test equipment to be used in performing metrology
verifications.
校驗程式應確定並定義尺寸,精確度要求,溫濕度要求以及用於驗證量程的測試設備.
8.2 RECALL LIST
校驗提醒機制
The Supplier shall maintain a listing of all equipment requiring calibration and shall identify them by assigned tracking number, location, and re-calibration frequency. As a minimum, the recall system shall provide for early notification that an instrument is due for calibration.
供應商應保持所有校驗設備清單並通過編碼,位置和校驗頻率對其進行識別.至少,提醒校驗系統應提前通知以便準備好校驗器具進行校驗.
8.3 CALIBRATION RECORDS
校驗記錄
The Supplier shall maintain records of all calibrations performed. Calibration records shall as a
minimum address the calibration procedure used, personnel performing the calibration, results,
calibration status, and traceability to a Primary or Secondary Standard. These records shall be made available for the MiTAC SQE to review upon request.
供應商應保持所有校驗記錄.校驗記錄至少需指出使用的校驗流程,校驗人員,校驗結果,校驗狀態,及參照的主要或副標準.在有要求的情況下,該記錄能夠便於MiTAC SQE 評審.
8.4 OUT OF TOLERANCE (CALIBRATION) NOTICES
超出規格通知
In the event that tools or equipment used for product manufacturing, testing, or inspection are found to be out of tolerance or out of calibration, the Supplier shall implement a system that will provide for the review of all product produced and accepted by the defective instrument. The Supplier shall also
implement a plan to repair/replace the equipment. The MiTAC SQE will be notified of the results of any such review and determination will be made at that time as to status of products built for MiTAC.
如果發現用於產品生產、測試、或者檢驗的工具或設備超出規格,供應商應導入一系統能夠對被有缺陷工具生產和允收的產品進行審核.同時供應商應制定維修/更換設備的計畫.任何審核的結果應通知MiTAC SQE 並同時確定為MiTAC生產的產品的狀況.
9.0 INSPECTION AND TEST STATUS
核對總和測試狀況
The Supplier shall assure that a system exists that will readily discern the inspection and test status of components, subassemblies and assemblies. That is, the Supplier shall be capable of tracing the
acceptance status of such items and assuring that nonconforming product is not co-mingled with
acceptable product. The Supplier may use tags, electronic bar codes, routing cards, or other suitable means for tracking status.
供應商應確保有系統能夠較容易地辨別原材料,半成品和成品的核對總和測試狀態.更確切地說,供應商應有能力追蹤材料的允收狀況,並保證不良品不會混入良品中.供應商可以使用標籤,條碼,追蹤卡或其他合適的方式進行追蹤.
10.0 CONTROL OF NONCONFORMING PRODUCT
不合格品控制
T he Supplier’s quality program shall have an effective system for controlling nonconforming product.
The system shall provide for the identification, documentation, evaluation, segregation, and timely disposition of nonconforming products. The Supplier’s sy stem shall include controls for product
returned from MiTAC.
供應商品質計畫中應包括一個有效的不合格品控制系統.系統應提供不合格品的鑒定,分類,評估,隔離和及時處理.供應商系統應包括從MITAC退回產品的管控.
10.1 REVIEW AND DISPOSITION OF NONCONFORMING PRODUCTS
不合格品的檢查和處理
The Supplier shall establish, document and implement a process for the effective review and
disposition of nonconforming products. The Supplier’s process shall include the following dispositions:
供應商應建立, 文檔化和實施一個流程以有效地檢查和處理不合格品.該流程包括以下步驟：
?Rework – product reworked to meet specified requirements
重工－重工產品滿足規格要求的要求
?Use as Is – no actions taken on product, product does not meet specified requirements, but is functional
照原來的樣子－不對產品進行任何處理,產品不能滿足規格要求但是具有功能性.
?Repaired – product has been reworked to be functional but does not meet specified requirements 維修－維修產品滿足功能要求但是不能滿足規格要求
?Scrap – product not useable and does not meet specified requirements
?報廢－產品失效且不能滿足規格要求
?Screen – additional product test/inspection to meet specification
?篩選－附加的產品測試/檢驗以滿足規格要求.
The Supplier shall implement a Material Review Board (MRB) and a Return Material Authorization (RMA) to review and disposition nonconforming product and customer return. As a minimum, the
MRB shall consist of representatives from Design Engineering, Manufacturing Engineering,
Procurement, and Quality Engineering. When assigning the “Use As Is” disposition the MiTAC SQE will be contacted for final approval. All MRB/RMA records shall be maintained by the Supplier and made available for the MiTAC SQE to review upon request.
供應商應導入材料審查小組和返回材料認可來檢查和處理不合格產品和安排客戶退貨.材料審查小組至少應由設計工程師、製造工程師、採購和品質工程師的代表組成.當結果為“照原來樣子”處理的時候,應聯繫MiTAC SQE做最終批准.所有的材料審查和退貨的記錄都由供應商保管,並便於MiTAC SQE進行審查.
10.2 FAILURE ANALYSIS & CORRECTIVE ACTION PROCESS
失效分析和改善措施流程
The Supplier shall develop and implement a failure analysis & corrective action process that utilizes structured problem solving techniques to:
供應商應開發和導入失效分析和改善措施流程,該程式是利用結構化的問題解決技巧：
?Investigate the root causes of nonconforming product and identify the corrective actions needed to prevent a recurrence.
調查不合格品的根本原因和確定改善措施防止再發生.
?Analyze all processes, work operations, quality records, service reports, and MiTAC complaints to detect and eliminate potential causes of nonconforming product.
分析所有流程,操作,品質記錄,維修報告和MiTAC的抱怨,以偵測和消除不合格品的潛在原因.
?Apply controls to ensure that corrective actions are taken and that they are effective.
?管控改善措施的執行及其有效性.
?Implement and record change in procedures as a result of corrective actions taken.
執行並記錄流程的變更以作為改善措施的實施結果.
Additionally, the Supplier’s corrective action process shall provide for documentation that identifies the following:
另外,供應商的改善流程應提供文檔以識別以下項目：
?Specific defect
?失效細節
?Technical investigation/analysis
?技術方面的調查和分析
?Root cause
?根本原因
?Containment for defect
?失效的圍堵政策
?Corrective action plan
?改善措施計畫
?Preventive actions to preclude a recurrence
?預防措施以排除再發生
?Verification of effectiveness of actions
?改善措施效果的驗證
Implementation of corrective actions shall be done in less than 5 working days(local suppliers) and 30 working days(oversea suppliers) from the issuance of a nonconformance document from MiTAC
unless otherwise directed by MiTAC SQE. The Supplier shall utilize its CIP procedures to address
cases of “regular” product nonconformance issues contained within the Supplier production line.
改善措施的導入須在MiTAC發出不合格品通知後5個工作日內（國內供應商）完成,海外供應商在30個工作日內完成.供應商應利用CIP的流程來解決常規的品質問題,使不合格品不流出供應商生產線.
11.0 HANDLING, STORAGE, PACKAGING, AND DELIVERY
搬運,儲存,包裝和運輸
The Supplier’s quality program shall provide for the establishment, documentation, and maintenance of procedures for handling, storage, packaging, and delivery of product.
供應商品質計畫應提供產品搬運、儲存、包裝和運輸的制定、文檔和保養程式.
11.1 HANDLING
搬運
The Supplier shall provide for methods of handling product during all stages of inventory and
production to prevent damage and deterioration. As a minimum, component, subassemblies and
assemblies shall be protected from the environment, Electrostatic Discharge (ESD), and from damage incurred during shipment and transfer within stages of manufacture.
供應商應提供在生產和存貨的各個階段中產品搬運的方法以防止產品損壞和變壞.至少, 原材料、半成品和成品應受到環境和ESD保護,且在運輸和製造工序的交接過程應避免被損壞
11.2 STORAGE
儲存
The Supplier shall ensure that provisions are in place to provide for secure storage areas or stock
rooms to prevent damage or deterioration of product prior to consumption and/or delivery to MiTAC.
The Supplier shall use appropriate methods to protect product from the environment, ESD, and from damage incurred during shipment and transfer within all stages of manufacturing. The Supplier shall implement a First In First Out (FIFO) system for disbursement of product from storage.
供應商應保證所供應產品儲存在安全可靠的倉庫以防止產品在交貨給MiTAC之前或使用之前被損壞或過期.供應商應使用合適的方法使產品受到環境和ESD保護,以避免在運輸和製造工序的交接過程被損壞.
供應商應導入先進先出的成品倉庫系統.
11.3 PACKAGING
包裝
The Supplier shall ensure all parts/products are packed, marked and preserved as defined in
specifications. Parts/products shall be packaged to prevent damage and/or deterioration while
facilitating usage requirements on the MiTAC manufacturing lines. The Supplier shall ensure
conformance to MiTAC packaging requirements and shall identify, preserve and segregate all
products until delivered to MiTAC.
供應商應確保所有零件和產品的包裝,標識和保存與規格書相一致.零件和產品的包裝要防損壞和變壞並容易滿足MiTAC工廠產線的使用要求.供應商應確保包裝要求與MiTAC一致,在運送到MiTAC前,零件和產品應相互間標識,保存和分開.
11.4 DELIVERY
交貨
MiTAC requires the Supplier to be responsible for product quality until point of issue to MiTAC
manufacturing sites.
MiTAC要求供應商在產品進入MiTAC工廠之前對產品品質負責.
12.0 QUALITY RECORDS
品質記錄
The Supplier shall establish and maintain procedures for identification, collection, indexing, filing,
storage, maintenance, and disposition of quality records. Records shall be kept either the entire
warranty period, or the period established in the specification – whichever is longer – and made
available for the MiTAC SQE to review upon request.
供應商應建立並保持一程式, 以識別,收集,檢索,歸檔,存儲,保持和處理品質記錄.品質記錄要保持在有效期內,或規定的一定週期,以便MiTAC SQE進行審核.
13.0 DELIVERABLES
可交付性
The Supplier shall provide MiTAC with the required documentation on request (or have it readily
available for review).
供應商應提供MiTAC要求的文檔（或可供審核）
13.1 QUALITY PLAN
品質計畫
The Supplier shall jointly own with MiTAC Supplier Quality Engineering, the Quality Plan for MiTAC prior to RTS at MiTAC.
供應商應和MiTAC SQE 制定品質計畫.在出貨給MiTAC之前簽訂品質計劃
The Supplier shall define the Quality Plan with MiTAC SQE by yearly. The Plan shall address the
requirements in Section 1.5 of this document. MiTAC SQE will review and provide approval authority.
供應商應每年與MiTAC SQE制定品質計畫.該計畫應滿足此檔中1.5的要求.MiTAC SQE 將對此計畫進行審核和批准.
13.2 SUB-TIER SUPPLIER MANAGEMENT PLANS
二階供應商管理計劃
Supplier shall provide the MiTAC SQE with its Supplier Management Plans for review. These plans shall be submitted within 30 days from notification of contract award.
供應商應該提供其供應商管理計劃給MiTAC SQE審核. 該計劃應於收到通知後30天內提交.
13.3 INTERNAL AUDIT PROGRAM PLAN
內部審核計劃
The internal audit program plan shall be submitted to the MiTAC SQE for review. This plan may be included as a subset of the overall quality plan. Submittal of this plan is required within 30 days from notification of contract award.
供應商應提供其內部審核計劃給MiTAC SQE審核.總體的品質計劃中應包括內部審核計劃.該計劃應於收到通知後30天內提交.
14.0 DEFINITIONS
名詞解說
AFR –Annualized Failure Rate 年度不合格率
ARR –Annualized Return Rate 年度退貨率
CIP –Continuous Improvement Program 持續改善計畫
DPPM – Defective Parts Per Million 每百萬中的失效數
ESD –Electro Static Discharge 靜電放電
FAI –First Article Inspection 首件檢查
FIFO –First In First Out 先進先出
FMEA – Failure Mode Effects Analysis 失效模式分析
GR&R – Gage Repeatability & Reproducibility 量測再生性&再現性
SQE –Supplier Quality Engineer 供應商品質工程師
IFIR –Initial Field Incident Rate 海外首次失效率
IQC–Incoming Quality Control 進料檢驗
VLRR – Verified Line Reject Rate 驗證的產線不良率
MRB –Material Review Board 材料審查小組
MTBF – Mean Time Between Failures 平均故障間隔時間
OBA –Out of Box Audit 開箱檢驗
ORT –On-going Reliability Testing 持續可靠性測試
RTS –Ready To Ship 準備出貨
RMA - Return Material Authorization 材料退貨許可