TOC验证方案

PROTOCOLNUMBER文件编号:IOQ-01-0084PAGE1OF49第1页共49页***COMPANY***公司PROTOCOLTITLE文件标题:INSTALLATION/OPERATIONALQUALIFICATIONTOTALORGANICCARBONANALYZER总有机碳分析器安装/操作确认EXECUTIONAPPROVALSIGNATURES批准执行签名Thesignaturesbelowindicateapprovalofthisprotocolanditsattachmentsandindicatethatitisreadyforexecution.Anychangesormodificationstotheintentortheacceptancecriteriaofthisprotocol,followingapproval,requiresthegenerationofanamendmentwhichmustbeapprovedpriortoexecution.下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。***CompanyLTD:Date***:Date***:DatePROTOCOLNUMBER文件编号:IOQ-01-0084PAGE2OF49第2页共49页***COMPANY***公司PROTOCOLTITLE文件标题:INSTALLATION/OPERATIONALQUALIFICATIONTOTALORGANICCARBONANALYZER总有机碳分析器安装/操作确认1.0SCOPE:范围....................................................................................................................................................................42.0PURPOSE:范围...............................................................................................................................................................43.0BACKGROUND:背景....................................................................................................................................................44.0INTRODUCTION:介绍..................................................................................................................................................45.0REFERENCES:参考书目...............................................................................................................................................56.0RESPONSIBLEPARTIESANDRESPONSIBILITIES:责任方及其责任................................................................77.0SYSTEMDESCRIPTION:系统说明.............................................................................................................................98.0TESTINGPROCEDURES:测试程序.........................................................................................................................109.0ACCEPTANCECRITERIA:验收标准:......................................................................................................................11ATTACHMENT1-VALIDATIONTESTEQUIPMENTANDMATERIALS附件1—确认测试设备和材料......................................13ATTACHMENT2-SPECIFICATIONANDPURCHASEORDERVERIFICATION附件2—规范和采购单确认.................................14ATTACHMENT3-ENGINEERINGDRAWINGLIST附件3—工程图纸清单...............................................................................15ATTACHMENT4-STANDARDOPERATINGPROCEDURESLIST附件4—标准操作程序清单...................................................16ATTACHMENT5-PREVENTIVEMAINTENANCE附件5—预防性维护.....................................................................................17ATTACHMENT6-OPERATIONANDMAINTENANCEMANUALLIST附件6—操作和维护手册清单........................................18ATTACHMENT7-MAJORCOMPONENTLABELINGLIST附件7—主要部件标签清单............................................................19ATTACHMENT8-CRITICALINSTRUMENTLIST附件8—关键仪器清单.................................................................................20ATTACHMENT9-NON-CRITICALINSTRUMENTLIST附件9—非关键仪器清单.....................................................................21ATTACHMENT10-SPAREPARTSLIST附件10—备件清单.....................................................................................................22ATTACHMENT11-UTILITYDATASHEET:ELECTRICAL附件11—公用工程数据表：电......................................................23ATTACHMENT12-UTILITYDATASHEET:COMPRESSEDAIR附件12—公用工程数据表：压缩空气..................................20ATTACHMENT13-OPERATIONALTESTING,TOCANALYZER附件13—操作测试，TOC分析器......................................241ATTACHMENT14-ROMANDCONFIGURATIONTEST附件14—ROM和构造测试.............................................................262ATTACHMENT15-MECHANICALCHECKTEST附件15—机械检查测试...............................................................................29ATTACHMENT16-FLOWTEST附件16—流量测试................................................................................................................31ATTACHMENT17-LINEARITY/SAMPLEMEASUREMENTTEST附件17—线性/样品测量测试..............................................33ATTACHMENT18-OPERATIONALTESTING,TOCAUTOSAMPLER附件18—操作测试，TOC自动取样.............................30ATTACHMENT19-MECHANICALTEST附件19—机械测试...................................................................................................41ATTACHMENT20-SAMPLETEST附件20—样品测试............................................................................................................43ATTACHMENT21-SPARGETEST附件21—喷射测试.............................................................................................................44ATTACHMENT22-MAGNETICSTIRRERTEST附件22—磁力搅拌器测试..............................................................................45ATTACHMENT23-SIGNATUREVERIFICATIONLIST附件23—签名确认清单........................................................................36ATTACHMENT24-PROTOCOLDEVIATIONLOG附件24—文件偏差日志..............................................................................37PROTOCOLNUMBER文件编号:IOQ-01-0084PAGE3O