QSA

Q168

Quality System
Management responsibilities
管理職責
Has the supplier defined and documented its corporate quality policy?
是否有書面界定公司的品質政策、品質目標與對品質的承諾?  

(a) Is the Quality Policy appropriate to the purpose of the organization?
組織是否符合品質政策要求
(b) Does the Quality Policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
品質政策是否包括或者為滿足客戶需求和進行持續改善而採用的公司品質目標,管理承諾作為參考依據.
(c) Does the Quality Policy provide a framework for establishing and reviewing quality objectives?
品質政策是否提供架構為建立及審核品質目標
(d) Is the Quality Policy communicated and understood within the organization?
品質政策是否認識和了解? (是否所有員工對於品質政策都有所了解.)
(e) Is the Quality Policy reviewed for continuing suitability?
管理審查過程中是否針對品質政策之適用性進行審查.

Is the Quality Assurance group functionally separate from production and does it report to a higher level?
品質保證組織就其功能作用與生產分開及向更高的階層報告？
Does your Quality Assurance group have sufficient authority, responsibility, and freedom of action to identify and evaluate quality problems and initiate, recommend or provide solutions?
你的品質保證組織是否有足夠權力，責任，和自主行動確認和評估品質問題及執行，提出或是提供解決辦法？

Q168

Has a 8S strategy (Seili,Seiton,Seisoa,Standardize ,Sustain,Safty,Save & Study) for attaining and maintaining workplace organization and cleanliness been implemented?
是否有一個8 S 策略(整理，整頓，清掃，標準化，紀律，安全，節約和學習)  和維護工作場所的組織和清潔方法嗎？
Is quality and trend data reported to management and used to improve performance?
是否有品質和趨勢數據報告來管理和改善的成果嗎？
Is there a quality system implemented with supporting documentation, (e.g.  Quality Manual, procedures, flow diagrams, sampling plans)?
是否有一個品質系統文件，(例如品質手冊，程序，流程圖，取樣計劃) ?
Is there a documented process for determining and documenting the verification, validation, monitoring, inspection and test activities specific to a product and the criteria for product acceptance at appropriate points of the product realization process?
是否有一個文件程序來確定和確認,批准,監控和特殊測試動作,
Are defect prevention and error proofing methods used to prevent manufacture of nonconforming products?
是否有不良預防，錯誤驗証法用來防止不合格產品的製造嗎？

Q168

Do quality system measurements and data collection ensure that quality objectives are met?
品質系統測量和數據收集保證品質目標被滿足嗎？
Has the supplier provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products?
供應商是否為其內部驗證活動例如檢驗、測試、監控以及審查流程和產品提供了充分的資源?
Has the improvement effectiveness verified (record/evidence required)?
改善需經有效性確認(紀錄/佐證資料)
Has the management representative tracked and drove the improvement on quality management system performance with record/report.
管理代表是否有追蹤及跟催品質報告及紀錄
Does the supplier conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals?
是否按適當的週期對品質管理系統的適宜性和有效性進行管理審查?

Q168

Quality Control System Requirements
Does your company have a materials requirement planning (MRP) system?
你公司是否有材料需求計畫 (MRP)  系統嗎？
Does supplier have ISO 14001 certification? If not, does supplier have a plan/roadmap to achieve the certification ?
是否有ISO 14000 證照,如果沒有是否有安排申請計劃何時可得到證照
Is your company currently registered to ISO 9001?
你的公司目前是否有ISO 9001註冊嗎？
Does supplier have OHSAS 18001 certification? If not, does supplier have a plan/roadmap to achieve the certification ?
是否有OHSAS 18001證照,如果沒有是否有安排申請計劃何時可得到證照
Does your company currently hold any safety/regulatory approvals (e.g. UL/CSA/TUV/EMC/CE)?  
你公司目前是否有拿到任何安全/ 規章的認可(例如  UL / CSA / TUV / EMC /CE) ?   

Q168

Document Control
Does the supplier have established and documented procedures for
供應商是否建立及書面化程序關於:
(a) a Quality Manual?
    品質手冊
(b) Procedures to support Quality System defined in Quality Manual ?
    提供在品質手冊方面明確的質量系統程序
(c) Design documents and technical spec./ drawings?
    設計文件和技術圖面  
(d) Process control documents?
    製程管制文件
(e) Work instructions?
    作業指導書
(f) Audit documents?
    稽核文件

Q168

Have the procedures and work instructions been consistently and effectively implemented?
程序和工作指示是否一貫和有效施行？
Are there documents to specify the guidelines for design doc./ technical spec. drawings/ process control doc./ procedure and W/I preparation?
是否有文件明確說明設計文件指南/技術規格.圖/製程管制文件/程序和W/I準備?
Is there a documented procedure requiring establishment, control, review, approval and distribution of quality documents?
是否有文件建立要求,管制，檢驗，認可和分發的品質資料 ?
Does the document control procedure ensure that relevant versions of applicable documents are available at points of use?
是否有文件管制程序保證適用文件的相關譯本在場所可提供使用？
Does the procedure ensure that documents remain legible, readily identifiable?
是否有程序保證文件保持易讀，容易可識別嗎？
Does the procedure ensure that all obsolete documents are promptly removed from all points of issue or use?
是否這些程序可以確保所有失效文件即時從所有發放或使用場所撒走?
Does the procedure ensure suitable identification of obsolete documents if they are retained for any purpose ?
如果他們為任何目的保留，是否有程序保證失效的文件被適當的確認嗎？

Q168

If paperless documents used, does the system ensure that their version, identification, storage and distribution are well controlled?
如果使用無紙資料,是否有能保證系統版本，確認，儲存和分發被控制得好 ?
Are quality documents reviewed and approved for adequacy by authorized personnel prior to issue?
品質文件審查和承認是否在發布之前經授權的人員做適合確認並且認可嗎？
Is there a procedure to govern engineering changes?
是否有工程變更管理程序?
Are engineering changes reviewed and approved by authorized personnel prior to implementation?
工程變更是否在導入前經授權的人員承認並且批准?
Are the engineering change notifications distributed to all affected functional areas once approved?
工程變更通知變發行是否全部影響功能範圍再次承認？
Is there a system to ensure engineering change notifications are being implemented?
是否有一個系統保證工程變更通知正被執行嗎？
Is there a system to ensure engineering change is implemented only after needed training/ tools & equipment provided and W/I updated?
是否有系統保證工程變更後施行訓練/工具& 設備條件和W/I 更新需要?

Q168

Is there a system to verify and feedback the effectiveness of engineering changes?
是否有有效系統核對和回饋工程變更?
Is there a documented procedure requiring the review and updating of documents at a specified frequency and is it followed?
是否有一文件要求文件回收和更新資料的頻率被遵循？
Are obsolete documents (including drawings) discarded or suitability identified to prevent their unintended use?
過時的資料(包括圖) 丟掉或是適合確認阻止他們被誤用 ？
Is there a policy regarding writing on released documents (e.g., in margin or red-line copies) and is it effective?
有關於在發布資料上寫的一個方法 (例如，在邊或者紅線複製) 它是有效的嗎？
Copy資料發行是否區隔有效的 與正本相符 DC章

Q168

Does the documentation system include all documents needed to ensure the effective planning, operation and control of processes?
是否有文件系統包括全部資料需要保證有效計畫，作業和製程的控制?
Is there a documented procedure for communicating special customer requirements to all affected departments?
是否有用一文件把特別客戶要求傳達給全部受影響的部門的程序嗎
Are documents of external origin identified and their distribution controlled?
外部來的的資文件是否被分發確認及管制嗎？
Are supplier & customer Product Change Notices (PCN) and Engineering Change Notices (ECN) controlled by the quality system?
供應商，用戶產品改變通知(PCN)  和工程改變通知(ECN)  透過品質管理系統管制嗎？
Are records of inspection and process control maintained for a minimum of 3 years?
檢查的和製程管控記錄至少3 年嗎？  
Are certificates of conformance/analysis supported by quality records?
是否有分析單據 (如CAR or FA report) 去支持品質紀錄 ?(COA 品質報告)
Is cycle time and process defined for red line document control?(e.g. handwriting document)
是否有時間週期和流程定義紅色線筆跡文件管制(如手寫文件)?
Are there established procedures for new product introduction/transfer? (e.g., established work instructions, documentation checklist, equipment checklist, conduct pilot run, pre-production, first article review, etc.)
是否有建立關於新產品引入的相關程序?(例如, 建立工作指導書、文件查檢表, 設備查檢表, 進行試生產, 生產前準備, 首件審查….等程序)

Q168

Design Control  (設計管制 )
Are there procedures to control, review, verify, and validate the design of the product to ensure it is meeting all requirements?
是否建立關於控制和驗證產品設計的相關程序以確保符合設計所有的要求?
Have trial products change process (change notification, labeling, if there is a separate control)
是否有試做品變更流程（變更通報，標示，是否有單獨管控）
The trial products make standard of writing assignments, in order to control and verify?
試作品有無制定書面化作業規範,以便於管制與查證?  
Are obsolete design documents removed from the application area?
失效的設計文件是否從生產和一般使用場所撒走?
Is there enough testing equipment/tools do design verification and procedure, to ensure that the design output meet the design input requirements?
是否有足夠的測試設備/工具和程序做設計驗證，以確保設計輸出滿足設計輸入的要求？
Is there a clearly defined product input, the control program. And personnel and responsibilities, and have a program to solve the problem of each stage and incomplete design?
是否有明確定義產品输入，廠内控制程序。及人員及權責，且有一程序來解決各階段的問題點及設計的不完整?
PPAP Productive component approval procedures (PFMEA) has perfect?
PPAP生產性零組件核準程序(PFMEA)有否完善?
Are there quantifiable measurements defined for phase exit/entry criteria?
設計輸出文件是否包括或指導接收標准以明確規格?