15记录控制程序

盐城捷康三氯蔗糖制造有限公司第1页共5页文件名称Filename记录控制程序RecordControllingProcedure文件编号FileNo.LAB/CX-15编制/日期Compiledby/Date版号/修订次Version/ReviseNo.B/2审核/日期Reviewedby/Date分发至Issuedto质管部、实验室QA,Lab.批准/日期Approvedby/Date生效日期EFF.from编制依据CompilationBasisISO/IEC17025检验与校准实验室认可准则Inspectionandcalibrationlaboratoryaccreditationcriteria.1目的Purpose对记录保持识别、收集、索引、存档、存放、维护和清理。Keeprecordidentification,collection,index,archive,storage,maintenanceandclean.2适用范围Scope所有质量/技术记录。Thewholequality/technicalrecords.3职责Dutiesa)质量/技术负责人组织对质量/技术记录进行编制。Quality/TechnicalLeaderisresponsibleforcompilingquality/technicalrecords.b)实验室主任批准质量/技术记录。LaboratoryDirectorisresponsibleforapprovingquality/technicalrecords.4工作程序Workingprocedure4.1质量/技术记录的编制、审核、批准Compilation,reviewandapprovalofquality/technicalrecords质量/技术负责人根据《质量手册》、《程序文件》、《管理规程》、《标准操作规程》组织人员编制相应的记录，记录按照过程来编制，以满足过程的复现性。其编制、审核、批准、变更执行《文件控制程序》Quality/TechnicalLeaderisresponsibleforcompilingtherelatedrecordsinaccordancewithQualityManual,ProgramFiles,ManagementProcedure,andStandardOperatingProcedure.Thecompilationshallconformtotheirprocesstomeetthereproducibility.Thecompilation,review,approvalandchangerefertoFileControllingProcedure.4.2记录的识别RecordIdentification采用记录的文件名称、记录编号来进行识别。规定如下：Identifytherecordswithfilenameandrecordnumber.Theprovisionsareasthefollowing:序号No.文件类别FileType编号SerialNumber编号说明Instruction1质量记录QualityrecordsLAB/RECZL-NN(or或NN.N)LAB-实验室代号LaboratoryNo.SC-质量手册QualityManualDDDD-发布年份Year盐城捷康三氯蔗糖制造有限公司第2页共5页CX-程序文件ProgramFilesNN(或NN.N)-文件顺序号SerialNumberNNN(或NNN.N)-文件顺序号SerialNumberRECZL-质量记录QualityRecord2技术记录TechnicalrecordsLAB/RECJS-NN(or或NN.N)RECJS-技术记录TechnicalRecord01-取样记录SamplingRecord02-成品检验记录InspectionRecordofFinishedProduct03-中间控制检验记录InspectionRecordofIntermediateControl04-原料检验记录InspectionRecordofRawMaterials05-水质检验记录InspectionRecordofWaterQuality06-包材检验记录InspectionRecordofPackingMaterials07-环境监测记录EnvironmentSupervisionRecord08-检验报告InspectionReport09-试剂和溶液记录ReagentandSolventRecord010-内校记录InternalCalibrationRecord011-各种统计记录012-验证(012.1-仪器验证方案；012.2-仪器验证报告；012.3-分析方法验证方案；012.4-分析方法验证报告)4.3记录的填写RecordsFillingina)各种质量/技术记录应实时如实记录，认真填写、内容完整；Allthequality/technicalrecordsshallbetimelyandfaithfullyrecordedandcarefullyfilledinwithintactcontents.b)记录采用黑水钢笔或签字笔规范填写、字迹清晰，不得潦草。不得使用圆珠笔或者铅笔填写；Recordsshallbestandardlyfilledinwithblackpenorrollerpenandthewritingshallbeclearwithoutscrawl.Donotuseballpenorpensil.c)记录表格不允许出现空项，数据项不需要填写时，应用斜线“/”；Anycolumnintheformshallnotappearsempty.Ifthedataitemneednotfillingin,writeaslash/.d)检验工作完成后，由熟悉该项目的检验人员对记录进行复核，复核是否完整、正确。Afterinspectionsarefinished,inspectorswhoarefamiliarwiththatprojectshallreviewthe盐城捷康三氯蔗糖制造有限公司第3页共5页integrityandcorrectnessoftherecords.4.4记录的更改RecordChanges记录形成后发现错误时,不允许涂改，应划改，并签上姓名、日期。并能清楚辨识更改前的记录；Ifmistakesarefoundafterrecordshavebeenformed,donotobliterate,butcrossoutandrewrite,thensignwithnameanddate.Thepreviousrecordsshallbeclearlyidentified.4.5记录的收集、归档RecordCollectionandArchive检测人员负责及时收集、整理，保证记录不丢失和损坏，保证记录的完整和清晰，按照月或年度定期送文件管理员归档，文件管理员填写《记录归档登记》。Inspectorsareresponsiblefortimelycollectingandsortingouttoensurethatrecordswon’tbelostanddamagedandtokeeprecordintegrityandclarity.Inspectorsshallmonthlyoryearlyarchiverecords,andfillinRegistrationFormofRecordArchive.4.6记录的索引RecordIndex文件管理员对保存的记录，按要求进行分类、编制索引目录，以便于检索。Asforthereservedrecords,filemanagershallclassifyandcompileindexcataloginaccordancewithrequirements,sothatitwillbeconvenienttosearch.4.7记录的存档RecordArchive记录保存在有防止损坏、变质、丢失的适宜环境的设施中。文件管理员编制《记录清单》，规定各种记录的保存期限。一般情况下人员、设备档案、验证、稳定性试验等技术资料长期保存；电子记录保存时间至少10年，产品检验记录保存至有效期后一年。Recordsshallkeptinasuitableenvironmentwhichcanpreventrecordsfromdamage,deteriorationandlost.FileManagerisresponsibleforcompilingRecordListandstipulatingtheretentionperiodofeachrecord.Ingeneral,technicalinformationincludingpersonnel,equipmentfiles,validationandstabilitytestsshallbekeptinlongterm；electronicrecordsshallbekeptforatleast10years;productinspectionrecordsshallbekeptforoneyearaftertheexpirydate.4.8记录的维护RecordMaintenance存放于硬盘、软盘等介质中的记录数据每一年时间，必须把数据刻录成光盘，以便保存；资料柜应具备空气流通、防潮、防火、防霉变、防虫蛀、防丢失等措施，必要时应有温度与湿度控制措施，外来人员未经许可不得进入；Yearlyrecordthedatawhichisstoredinharddisks,floppydisksandothermediaintoaCDinordertopreserve.Filingcabinetshallbeprotectedwithmeasureswichcanpromoteairflowandpreventmoisture,fire,mildew,mothandlose,andbeequippedwithtemperatureandhumilitycontrollingdevicesifnecessary.Unauthorizedvisitorsarenotallowedtoenterin.在保护客户机密的前提下，记录可以借阅。借阅人必须是实验室与对应检验项目有关人员，其它人员不得查阅。借阅时须填写《文件借阅登记》，经文件管理员确认；Inthepremiseofprotectingclientconfidentiality,recordscanbeborrowed.Theborrowermustbesomeoneinthelaboratorywhoisrelatedwiththecorrespondinginspectionitem,andothersarenotallowedtoborrow.Whileborrowing,theborrowershallfillinFileBorrowingRegistrationFormwhichshouldbeconfirmedbyfilemanager.盐城捷康三氯蔗糖制造有限公司第4页共5页记录须复制时须经质量负责人批准，审批证明材料由文件管理员随记录保存。Thecopyofrecordsshallbesubjecttoqualityleader’sapprovalandtheapprovedsupportingevidenceshallbekepttogetherwithrecordsbyfilemanager.4.9记录的清理RecordCleaning对超过保存期限的记录，由文件管理员列出过期记录清单，报质量负责人审核、实验室主任批准后销毁。销毁时须有两人以上在场并签字确认，填写《文件销毁记录》。FileManagershalllisttho