— 分析URS 及其可行性分析
— 項目計劃Project Plan (Gantt)
— 質(zhì)量計劃Quality Plan (QP)
— 設(shè)計確認(rèn),含Design Qualification (DQ)
— 外形尺寸圖(GAD) ,P&ID
— 公共工程界面協(xié)議 (UIA)
— 軟件界面協(xié)議(SIA) Software Interface Agreement
— 電路圖(ED) Electrical Diagram
— 氣動圖 (PD) Pneumatic Diagram
— 材料清單 (BOM) Bill of materials/components
— 功能說明 Functional Design Specification (FDS)
— 軟件設(shè)計說明 Software Design Specification (SDS)
— 硬件設(shè)計說明 Hardware Design Specification (HDS)
— 安裝及用戶手冊 Installation User and Maintenance Manual
— 設(shè)備及軟件驗證手冊 Machine and software Validation Manual (MSVM)
— 焊接手冊 Welding Validation Manual (WVM)
— 工廠預(yù)驗收測試 Factory Acceptance Test (FAT)
— 現(xiàn)場驗收測試 Site Acceptance Test (SAT)
— 設(shè)備定位,安裝,啟動 Machine positioning, Installation, Start-up
— 安裝及操作確認(rèn)(IQ & OQ) Installation and operation qualification (IQ & OQ)
— 培訓(xùn)課程 Training courses
— 預(yù)防性保養(yǎng)計劃 Program of preventive maintenance
— 零件及耗材清單 Spare parts and consumable products list