气相再确认方案.doc

OPERATIONALQUALIFICATIONPROTOCOL运行确认方案PageofNUMPAGES32YSTEMDESCRIPTION:系统名称GC气相色谱仪OCATION:位置QCChemLabQC化学实验室DOCUMENTNO.文件编号1-071-PQ-01AUTHOR:作者PRE-EXECUTIONAPPROVAL执行前批准DEPARTMENT部门PRINTNAME/TITLE姓名/职务SIGNATURE签名DATE日期SYSTEMOWNER系统所属部门QA质量保证部OQCOMPLETIONOQ完成ThisOQhasbeencompletedsuccessfullyandisreadyforfinalapproval.本OQ已成功完成，有待批准。Signature:签名Date:日期FINALREVIEWOFDATAANDAPPROVAL数据最终审核及批准DEPARTMENT部门PRINTNAME/TITLE姓名/职务SIGNATURE签名DATE日期SYSTEMOWNER系统所属部门QA质量保证部APPROVALDATE:批准日期COMMENTS备注OPERATIONALQUALIFICATIONPROTOCOL运行确认方案PageofNUMPAGES32YSTEMDESCRIPTION:系统名称GC气相色谱仪LOCATION:位置QCChemLabQC化学实验室DOCUMENTNO.文件编号1-071-PQ-01Purpose:Toidentifyalltheindividualswhosignorinitialanydatasheetsinthisprotocol.目的：识别所有签字和草签本方案任何数据表的人员。SIGNATURE/INITIALSLOG签名/草签确认PRINTNAME姓名TITLE/COMPAMY职务/公司SIGNATURE签名INITIALS草签TRAINEDONPROTOCOL(Y/N)是否接受方案的培训（是/否）DATE日期GENERALREQUIREMENTS要求1)ExecutionRules&Practices执行原则Eachtestwillbeperformedaccordingtotheestablishedtestingprocedure.Ifanyadditionalinformationneedstobedocumented,thecommentssectionwillbeused.Theacceptancecriteriaareconsideredtobemetwhenthecollecteddatademonstratedthattheequipmentconditionand/oroperationareconsistentwiththerequirementsandacceptancecriteriadescribedinthisprotocol.ThepersonwhoexecutesthisprotocolwillsigntheirnameorinitialsanddateintheCOMPLETEDBYbox.ThedataobtainedwillbereviewedbyasecondpersontocertifythatthetestwasperformedcompletelyandthispersonwillsigntheirnameorinitialsanddateintheREVIEWEDBYbox.GoodDocumentationPractices(KSPSOPQA-011)willbefollowedduringexecutionoftheprotocol.依照方案中的测试程序执行每一个测试。在备注栏记录附加信息。若所收集的数据证明设备的状态或运行符合方案中规定的要求及验收标准即可判定符合验收标准。方案执行者在填表人一栏中签名及日期。要求第二个人审核数据以确实执行过程及结果，并在审核人一栏中签名及日期。方案执行中需遵照良好的文件记录规范（KSPSOPQA-011）。2)ExceptionalCondition异常情况Whenexpectedresultsdonotmeetacceptancecriteriaordeviationtoanapprovedprotocol,anexceptionalcondition(EC)istriggered.AnyECwillleadtoacheckmarkin“No”boxforansweringthequestionof“AcceptanceCriteriamet?”RecordthesequentialEC#(01,02etc.)onthebottomoft