COSTCO驗廠Chuangsheng Csr
112017-7
Costco QMS & GMP審核所需文件（SGS版）
信息來源：驗廠之家 瀏覽次數(shù)：4867次
1.1 Brief introduction of factory 工廠簡介
1.2 Business license 營業(yè)執(zhí)照1.3 Organization chart 公司組織架構(gòu)圖
1.4 Factory’s plane figure-factory floor plans (公司)廠區(qū)/廠房平面圖
1.5 Production process chart 生產(chǎn)工序流程圖
1.6 ISO 9000 certificate or other Quality Assurance systems. ISO9000證書或其他質(zhì)量保證系統(tǒng)
1.7 產(chǎn)品測試報告Relevant product lab test reports
2.1 Quality manual 質(zhì)量手冊
2.2 Quality policy 質(zhì)量方針
2.3 Procedures 程序文件 （文件，記錄，不合格，內(nèi)審，糾正措施和預(yù)防措施控制程序）
2.4 Quality objectives and monitoring records 質(zhì)量目標和監(jiān)控記錄
2.5 Management review records 管理評審記錄
2.6 Documents control records 文件更改收發(fā)記錄
3.1 External documents list and control records 外來文件清單和管控記錄
3.2 Products risk assessment procedure and records 產(chǎn)品風險評估程序和記錄
3.3 Products risk assessment action and validation 產(chǎn)品風險評估措施和驗證
4.1 Design control procedure 開發(fā)設(shè)計控制程序
4.2 Design input and review record 設(shè)計輸入和評審記錄
4.3 Verification and validation records 驗證和確認記錄
4.4 Design testing and record 設(shè)計產(chǎn)品檢測及報告
4.5 Design output (technical file, BOM, Packing and using description) 設(shè)計輸出（技術(shù)文件，物料單， 包裝、使用說明）
4.6 Engineering Change Notice 設(shè)計變更記錄（ECN）
4.7 Monitoring procedure and records of suppliers/subcontractor 供應(yīng)商/分包商評審程序及記錄
4.8 Qualified supplier list 合格供應(yīng)商清單
4.9 Order review and customer focus procedure and records 訂單評審和客戶關(guān)注程序及記錄
4.10 Complaint handling procedure 客戶投訴處理程序 □ □ □
4.11 Complaint handling records (if applicable) 客戶投訴處理記錄 (如果有) □ □ □
4.12 Customer satisfication investigation and action records 客戶滿意度調(diào)查和改善措施記錄
4.13 Recall procedure and records召回程序和記錄
4.14 Internal audit plan and records 內(nèi)部審核計劃、記錄
4.15 Records of corrective actions and preventative actions for internal audit 內(nèi)審糾正與預(yù)防措施記錄
4.16 Business emergency contingency plan業(yè)務(wù)緊急意外事件計劃
5.1 Potable water test report（Cosmetic products）飲用水測試報告（化妝品廠）
5.2 Microbiological test procedure and record（Cosmetic products）微生物測試程序和記錄 （化妝品廠）
5.3 Testing/measuring equipments calibration list and records 測試儀器設(shè)備清單、內(nèi)外校記錄報告
5.4 Equipment maintenance plan and records 設(shè)備維護計劃和記錄
5.5 Master Sanitation Schedule (MSS)主清潔計劃
5.6 Standard Sanitation Operating Procedure (SSOP)衛(wèi)生標準操作規(guī)程
5.7 Sanitation inspection record衛(wèi)生管理記錄
5.8 Foreign materials control procedure and records異物（玻璃， 利器，化學(xué)品，蟲害）控制程序和記錄
5.9 Factory drinking, smoking policy廠內(nèi)飲食，抽煙政策
5.10 Chemical control program化學(xué)品控制程序
5.11 MSDS-Material Safety Data Sheet 化學(xué)品物料安全數(shù)據(jù)表
5.12 Wood control policy 木材控制政策
6.1 Materials storing environment control procedure原料存儲環(huán)境控制程序
6.2 Container inspection procedure貨柜檢查程序
6.3 Purchase orders and purchase contracts 采購單、采購合同
6.4 Quality guaranty for exempt from inspection of incoming material 來料中免檢產(chǎn)品的質(zhì)量保證書
6.5 IQC standard and specifications 來料檢驗標準及規(guī)格書
6.6 IQC reports 來料檢查、測試報告
6.7 Incoming material receiving and distribution records 來料收發(fā)記錄
6.8 Control procedure and concession records for defect incoming material 來料不良品退貨、讓步接收記錄
6.9 Pre-production meeting records產(chǎn)前會議記錄
6.10 Working instructions 作業(yè)指導(dǎo)書
6.11 First sample inspection records首件檢驗記錄
6.12 IPQC inspection standard and records 制程檢驗測試標準、記錄
6.13 FQC/OQC inspection standard and reports 終檢檢驗測試標準、記錄
6.14 Release records 發(fā)貨記錄
6.15 Defect goods control records 不良品處理記錄
7.1 Worker training plan for QC, operators, machine maintenance employees,test employees, calibration operator, internal auditor, risk assessment member, GMP (檢驗人員，操作人員，設(shè)備保養(yǎng)人員，測試人員，計量員，內(nèi)審員，風險評估人員，GMP內(nèi)容)培訓(xùn)計劃
7.2 Training records 員工質(zhì)量培訓(xùn)記錄
8.1Chemical analysis for raw materials (plastics, pigments, paints, solvents etc.) 原材料(塑料,顏料,涂料,溶劑等)的化學(xué)分析報告
8.2 Sharp tool control procedure and records 利器控制程序和記錄
8.3 Inspection and testing reports of finished products 成品檢查和測試報告
8.4 Impact test and fitment test on injection parts (Plastic Toys) 注塑件的測試報告(塑料玩具)
8.5 Adhesive test reports for paints (Plastic Toys) 涂層附著力測試報告(塑料玩具)
8.6 Testing reports against standards of EMC Directive, EN 62115, ESD etc (Electrical Toys) 產(chǎn)品按EMC Directive, EN 62115, ESD等標準測試的報告(電子玩具)
8.7 Broken needle records 斷針記錄
8.8 Metal detection records (Stuffing Toys) 金屬探測記錄(毛絨玩具)
8.9 Metal detector calibration records 驗針機校驗記錄
8.10 Dispose records of the products when detector is disable 探測器失效時，產(chǎn)品處理記錄
8.1 CE/ EMC/ Relevant product lab test reports. CE/EMC/相關(guān)的產(chǎn)品測試化驗報告
8.2 Hi-pot mark test records (if applicable) 高壓測試記錄 (如果有)
8.3Regular analyses of the tin bath of soldering machine (if applicable) 焊線機錫槽定期分析的記錄 (如果有)
8.4 Reworked products re-inspection records 返工產(chǎn)品重檢記錄
8.5Regular validation records of key parameter settings / key items 關(guān)鍵參數(shù)設(shè)定/重點項目的定期驗證記錄
8.6 Finished products test records 成品測試記錄
8.1 Fabric shrinkage test records 布料縮水測試記錄
8.2 Pre-production meeting records 產(chǎn)前會議記錄
8.3 In-line inspection records 過程檢驗記錄
8.4 Sharp tool control procedure and records 利器控制程序和記錄
8.5 Broken needle control procedure and records 斷針控制程序和記錄
8.6 Metal detection records 金屬探測記錄
8.7 Metal detector calibration records 驗針機校驗記錄
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