發(fā)布時(shí)間：2023/2/11 9:02:45   發(fā)布來(lái)源：9x5c.cn    作者：通翔顧問(wèn)

  所需文件/證件清單

  General?Requirements?一般要求

  Factory?profile工廠概況:

  1.1 Brief?introduction?of?factory?工廠簡(jiǎn)介

  1.2 Business?license?營(yíng)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(shū)或其他質(zhì)量保證系統(tǒng)

  1.7產(chǎn)品測(cè)試報(bào)告Relevant?product?lab?test?reports

  ManagementCommitmentand?ContinualImprovement管理承諾和持續(xù)改善

  2.1 Quality?manual?質(zhì)量手冊(cè)

  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(biāo)和監(jiān)控記錄

  2.5 Management?review?records?管理評(píng)審記錄

  2.6 Documents?control?records?文件更改收發(fā)記錄

  RiskManagement風(fēng)險(xiǎn)管理

  3.1 External?documents?list?and?control?records?外來(lái)文件清單和管控記錄

  3.2Products?risk?assessment?procedure?and?records?產(chǎn)品風(fēng)險(xiǎn)評(píng)估程序和記錄

  3.3Products?risk?assessment?action?and?validation?產(chǎn)品風(fēng)險(xiǎn)評(píng)估措施和驗(yàn)證

  QualityManagementSystems質(zhì)量管理體系

  4.1 Design?control?procedure?開(kāi)發(fā)設(shè)計(jì)控制程序

  4.2 Design?input?and?review?record?設(shè)計(jì)輸入和評(píng)審記錄

  4.3 Verification?and?validation?records?驗(yàn)證和確認(rèn)記錄

  4.4 Design?testing?and?record?設(shè)計(jì)產(chǎn)品檢測(cè)及報(bào)告

  4.5 Design?output?(technical?file,?BOM,?Packing?and?using?description)?設(shè)計(jì)輸出(技術(shù)文件，物料單，?包裝、使用說(shuō)明)

  4.6 Engineering?Change?Notice?設(shè)計(jì)變更記錄(ECN)

  4.7 Monitoring?procedure?and?records?of?suppliers/subcontractor?供應(yīng)商/分包商評(píng)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(píng)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

  4.13Recall?procedure?and?records召回程序和記錄

  4.14 Internal?audit?plan?and?records?內(nèi)部審核計(jì)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(jì)劃

  Sites?andFacilitiesManagement工廠和設(shè)施管理

  5.1Potable?water?test?report(Cosmetic?products)飲用水測(cè)試報(bào)告(化妝品廠)

  5.2Microbiological?test?procedure?and?record(Cosmetic?products)微生物測(cè)試程序和記錄?(化妝品廠)

  5.3Testing/measuring?equipments?calibration?list?and?records?測(cè)試儀器設(shè)備清單、內(nèi)外校記錄報(bào)告

  5.4Equipment?maintenance?plan?and?records?設(shè)備維護(hù)計(jì)劃和記錄

  5.5Master?Sanitation?Schedule?(MSS)主清潔計(jì)劃

  5.6Standard?Sanitation?Operating?Procedure?(SSOP)衛(wèi)生標(biāo)準(zhǔn)操作規(guī)程

  5.7Sanitation?inspection?record衛(wèi)生管理記錄

  5.8Foreign?materials?control?procedure?and?records異物(玻璃，?利器，化學(xué)品，蟲(chóng)害)控制程序和記錄

  5.9Factory?drinking,?smoking?policy廠內(nèi)飲食，抽煙政策

  5.10Chemical?control?program化學(xué)品控制程序

  5.11MSDS-Material?Safety?Data?Sheet?化學(xué)品物料安全數(shù)據(jù)表

  5.12Wood?control?policy?木材控制政策

  ProductControl?產(chǎn)品控制

  6.1 Materials?storing?environment?control?procedure原料存儲(chǔ)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(gòu)單、采購(gòu)合同

  6.4 Quality?guaranty?for?exempt?from?inspection?of?incoming?material?來(lái)料中免檢產(chǎn)品的質(zhì)量保證書(shū)

  6.5 IQC?standard?and?specifications?來(lái)料檢驗(yàn)標(biāo)準(zhǔn)及規(guī)格書(shū)

  6.6 IQC?reports?來(lái)料檢查、測(cè)試報(bào)告

  6.7 Incoming?material?receiving?and?distribution?records?來(lái)料收發(fā)記錄

  6.8 Control?procedure?and?concession?records?for?defect?incoming?material來(lái)料不良品退貨、讓步接收記錄

  6.9 Pre-production?meeting?records產(chǎn)前會(huì)議記錄

  6.10 Working?instructions?作業(yè)指導(dǎo)書(shū)

  6.11 First?sample?inspection?records首件檢驗(yàn)記錄

  6.12 IPQC?inspection?standard?and?records?制程檢驗(yàn)測(cè)試標(biāo)準(zhǔn)、記錄

  6.13 FQC/OQC?inspection?standard?and?reports?終檢檢驗(yàn)測(cè)試標(biāo)準(zhǔn)、記錄

  6.14 Release?records?發(fā)貨記錄

  6.15 Defect?goods?control?records?不良品處理記錄

  PersonnelTraining?andCompetency?人員培訓(xùn)和能力

  7.1 Worker?training?plan?for?QC,?operators,??machine?maintenance

  employees,test?employees,?calibration?operator,?internal?auditor,?riskassessment?member,?GMP?(檢驗(yàn)人員，操作人員，設(shè)備保養(yǎng)人員，測(cè)試人員，計(jì)量員，內(nèi)審員，風(fēng)險(xiǎn)評(píng)估人員，GMP內(nèi)容)培訓(xùn)計(jì)劃

  7.2 Training?records?員工質(zhì)量培訓(xùn)記錄

  Industry?requirement?行業(yè)要求

  Toys?玩具:

  8.1Chemical?analysis?for?raw?materials?(plastics,?pigments,?paints,?solventsetc.)?原材料(塑料,顏料,涂料,溶劑等)的化學(xué)分析報(bào)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(cè)試報(bào)告

  8.4 Impact?test?and?fitment?test?on?injection?parts?(Plastic?Toys)?注塑件的測(cè)試報(bào)告(塑料玩具)

  8.5Adhesive?test?reports?for?paints?(Plastic?Toys)?涂層附著力測(cè)試報(bào)告(塑料玩具)

  8.6Testing?reports?against?standards?of?EMC?Directive,?EN?62115,?ESDetc?(Electrical?Toys)?產(chǎn)品按EMC?Directive,?EN?62115,?ESD等標(biāo)準(zhǔn)測(cè)試的報(bào)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(cè)記錄(毛絨玩具)

  8.9 Metal?detector?calibration?records??驗(yàn)針機(jī)校驗(yàn)記錄

  8.10 Dispose?records?of?the?products?when?detector?is?disable?探測(cè)器失效時(shí)，產(chǎn)品處理記錄

  E&E?電子電器

  8.1 CE/?EMC/?Relevant?product?lab?test?reports.?CE/EMC/相關(guān)的產(chǎn)品測(cè)試化驗(yàn)報(bào)告

  8.2 Hi-pot?mark?test?records?(if?applicable)?高壓測(cè)試記錄?(如果有)

  8.3Regular?analyses?of?the?tin?bath?of?soldering?machine?(if?applicable)?焊線機(jī)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

  8.5 Regular?validation?records?of?key?parameter?settings?/?key?items?關(guān)鍵參數(shù)設(shè)定/重點(diǎn)項(xiàng)目的定期驗(yàn)證記錄

  8.6 Finished?products?test?records?成品測(cè)試記錄

  Softline紡織品

  8.1 Fabric?shrinkage?test?records?布料縮水測(cè)試記錄

  8.2 Pre-production?meeting?records?產(chǎn)前會(huì)議記錄

  8.3 In-line?inspection?records?過(guò)程檢驗(yàn)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(cè)記錄

  8.7 Metal?detector?calibration?records??驗(yàn)針機(jī)校驗(yàn)記錄