QSA

Q168

Has the design verification been planned, established, documented and assigned to competent verification personnel?
設計輸出文件是否經審查和同意後再發放?
Is there a requirement to verify the product meets design specifications prior to mass production? (e.g., design review/verification)
是否在量產前要求驗證產品之於設計規格的符合性?(例如, 設計審查/驗證)
Are the records for design control, review, verification, and validation properly documented and maintained?
設計審查記錄是否適當地書面化並維持?

Q168

Supplier Quality Control (供應商品質管制)
s there a documented procedure for selecting suppliers requiring that the type and extent of controls applied be dependent upon the effect of the purchased product on subsequent product realization and recording approved suppliers on an Approved Supplier List?  
是否有文件說明選擇供應商的程序對使用類型和管制程度已購買的供應商對產品確認和在一個認可的供應商目錄上記錄合格(AVL)供應商 ？
Is there a documented supplier rating system with criteria and frequency specified?
是否一套標準文件說明的供應商評分標準和稽核頻率?
Are supplier ratings recorded, communicated back to the supplier, and appropriate action plans documented to improve unacceptable ratings?
供應商評分記錄，是否有向供應商傳遞回覆和改進不可接受評分分數的文件說明合適的改正計畫嗎？
Is subcontractor qualification done by quality system audit and process quality analysis?
分包商的資格認證是否根據品質系統的稽核和生產品質流程的控管
Do you perform quality surveys/audits of your suppliers?
你是否有執行對你的供應商的品質調查/ 審計嗎？
Does your Quality organization have a role in the selection, evaluation and re-evaluation of suppliers?   
你的品質組織在選擇過程中是否有一個單位做供應商評估嗎？