供應(yīng)商現(xiàn)場審核表

如有你有幫助，請購置下載，感謝！供給商現(xiàn)場審核表本次審核的目的：審核范圍：審核人員：審核時間：審核內(nèi)容 審核記錄1、供給商信息供給商名稱供給商法定代表供給商治理者代表供給商資質(zhì)內(nèi)容2、一般性問題IrradiationMethodUsed使用的輻照方法GammaIrradiation伽馬射線輻照 □Continuos □Batch批量Source鈷源ElectronBeam電子束輻照Energy能源StandardUsed:使用的標(biāo)準(zhǔn)體系認(rèn)證證書NameofCertificationBody認(rèn)證機(jī)構(gòu)名稱:CompliancewithEN552/ISO11137included?是否符合EN552/ISO11137所包含的要求3、輻照設(shè)備Shapeofsourcerack能源支架的外形Irradiationunits輻照單位傳送系統(tǒng)

□鈷-60Co60 □銫-13C137□≤10Mev〔百萬電子伏〕 □>10Mev□EN552 □ISO11137□ISO9000/EN46000 □ISO11137□ISO13485□YES □NO□Flat〔平板〕 □Cylindric圓筒的□singlecarton〔單箱〕 □pallet托盤吊式方法引導(dǎo)〔傳送單〕1頁Irradiationgeometric輻照分布4、Installationqualification備審查Generaldescriptionofmaincharacteristicsavailable?有主要特征的整體概

如有你有幫助，請購置下載，感謝！Source □productoverlapping產(chǎn)品疊放□YES □NONotefortheauditor:structureoffacility,construction,installation,conveyorsystem,activityofsource,equipment,calibration,processcontrol(instrumentation,dosimeters),processdocumentation,maintenance&repair審核人員需留意以下：設(shè)施的構(gòu)造、施工、安裝、輸送系統(tǒng)、活動源、設(shè)備、校準(zhǔn)，過程掌握〔儀表，劑量計〕、過程文檔、維護(hù)和修理Irradiatordosemapping(dosedistribution)available?輻照器劑量分布是否有效〔劑量場分布方案〕

YES □NONotefortheauditor:Thisincludes:characteristicsofirradiator,useofmaterialwithhomogenousdensity,filledtotheirdesignedvolumelimits,adsorbeddoseatvariousdepthinthematerial,dosimetersplacedatmultipleinternallocations審計員需要留意：輻照器的特性，同密度下原料的使用，此原料填充到設(shè)計好的容量限制，這種原料中不同深度下的吸附劑，被放置在溶液內(nèi)不同位置的劑量計4.3Determinationofagnitude,distributionandreproductibilitysufficent?□YES□NO劑量測定，分布及再生產(chǎn)力是否可測定Operatingparameterscontrolled/checkedperiodically? 工作參數(shù)是否認(rèn)期受控/定期□YES□NO檢查Howoften?多長時間檢查一次?Notefortheauditor:criticalparametersarecycletimers,conveyorspeed,timesetting 審計人員需要留意：重要的參數(shù)周期計時器，輸送速度，時間設(shè)定4.4Arecontrolinstrumentsundercalibrationcontrol?全部的儀器是否在校正掌握之下Requalification requirementsdefined?是否已定義合格的要求？

YES □NOYES □NODateofqualification/lastrequalification:合格的評定日期/上一次評定日期

YES □NO5、OperationalQualification操作審核〔劑量場分布方案〕作業(yè)指導(dǎo)書2頁Dosimeterdistributionacc.definedpatternavailable?是否已定義了輻照分布模式?Routinedosimeteronpre-definedplace?常規(guī)劑量計會否提前安裝在確定的位置？Determinationofadsorberdose(min./max.)?是否確定了吸取劑量〔最小/最大劑量〕Arithmeticalrelationshiptoroutineposition?是否計算過常規(guī)位置的關(guān)系？Performedforrepresentativenumberofirradiationcontainerstocovervariabilityofadsorbeddose?是否已選定具有代表性的幾個輻照容器來確定吸附劑量的可變性？Repeatedfor-eachproduct/productcategory是否對每種/每類產(chǎn)品進(jìn)展反復(fù)測定loadingpattern裝載的模式pathforprocessing?加工流程Recordsretained?是否保存記錄

如有你有幫助，請購置下載，感謝！YES □NOYES □NOYES □NOYES □NOYES □NOYES □NOYES □NOYES □NOYES □NODateofperformancequalification/lastrequalification:資格評定日期/上一次評定日期：ProcessSpecificationavailable?是否有加工過程的標(biāo)準(zhǔn)Notefortheauditors:Thisincludes:〔審核員留意：包括〕

YES □NOdescriptionofproductincl.dimension&density,orientationinpackaging,acceptedvariationinspecification產(chǎn)品描述包括規(guī)格和密度，包裝方式，說明書中已說明的可以承受的變化loadingpatterninirradiationcontainer在輻照箱中的裝載的方式dimensionsofirradiationcontainer輻照箱的尺寸minimum&maximumdose最小和最大劑量routinedosimeterpositioning劑量計吧擺放的位置relationshiproutinedosimeterreadingtoadsorbedmin./max.dose 劑量計讀取的最小或最大的吸取劑量acceptedrangeofdensitiesofotherproductsinirradiatoratthesametime同時在輻照箱中輻照的其他產(chǎn)品的可承受的密度范圍requirementsforperformancerequalification性能評定的要求6、RoutineOperation常規(guī)操作6.1Arethefollowingparametersmonitoredduringroutineoperation?在常規(guī)操作中是否對相關(guān)的變更進(jìn)展監(jiān)管?Radiationsourceinposition輻射源位□YES □NO置3頁如有你有幫助，請購置下載，感謝！Productinposition產(chǎn)品的位置□YES□NOExposuretime曝光時間□YES□NO6.2Isthedecayoftheactivityoftheradiationsourcetakenintoconsideration?□YES□NO是否考慮到輻射源的衰減？How?如何考慮的？Arethereanyprovisionforunderdosed/overdosedproduct?針對放射量缺乏/放射量過量產(chǎn)品的是否有預(yù)防措施?Useofroutinedosimeters:常規(guī)劑量計的使用Areroutinedosimetersusedasanadditionalcontroloftheadsorbed

YES □NOdose?常規(guī)劑量計是否被用作額外的劑量計來掌握吸取劑量？Istheredose?常規(guī)劑量計是否被用作額外的劑量計來掌握吸取劑量？Isthereapredefinedlocationforthosedosimeters?在那些劑量計上是□YES□NO否是預(yù)設(shè)定的位置？Istherelationshipwiththemin.and/ormax.doseknown?是否了解最□YES□NO小劑量與最大劑量之間的關(guān)系6.5Whatarethereleasecriterias？發(fā)放的標(biāo)準(zhǔn)是什么exposuretime曝光時間□YES□NOadsorbeddose吸附劑量□YES□NOanythingelse?還有別的嗎？Whoperformstherelease?誰來執(zhí)行發(fā)放？7、Dosimeters劑量計7.1Whichtypeofdosimetersisused?使用哪種劑量計referencedosimeters參考劑量計-cericsolution高鈰溶液□YES□NO-dichromatesolution重鉻酸鹽溶液□YES□NOsolidalanine固體丙氨酸□YES□NO4頁other其它routinedosimeters常規(guī)劑量計dyedplasticstrips染色塑料板plasticfilms塑料薄膜other其它Manufacturerof:制造商referencedosimeters:參考劑量計routinedosimeters:常規(guī)劑量計Uncertaintyknown?是否知道不確定性？Uncertainty:不確定性referencedosimeters:參考劑量計routinedosimeters:常規(guī)劑量計agreementreference/routinedosimeter<5%?參考劑量計/常規(guī)劑量計<5%Calibration:校準(zhǔn)Whoperformsthecalibrationof誰來做校準(zhǔn)？referencedosimeters:參考劑量計routinedosimeters:常規(guī)劑量計Traceabletonationalstandards?是

如有你有幫助，請購置下載，感謝！YES □NOYES □NOYES □NOYES □NO否可追溯到國家標(biāo)準(zhǔn)7.4.3Calibrationperformedunderthe否可追溯到國家標(biāo)準(zhǔn)7.4.3Calibrationperformedunderthesameconditionsthanthelaterroutinedosimetry?校準(zhǔn)是與常規(guī)劑量在同一種狀□YES□NO況下執(zhí)行還是校準(zhǔn)后于常規(guī)劑量設(shè)定執(zhí)行的？7.4.4Areenvironmentalconditionstakenintoconsideration?環(huán)境狀況是否考慮在□YES□NO內(nèi)？doserate劑量率□YES□NO5頁irradiationtemperature輻照溫度humidity濕度storagebeforeirradiation輻照前的存儲storageafterirradiation輻照后的存儲7.4.5Doescalibrationincludeeachitemofthedosimetricsystem?校準(zhǔn)是否包含放射量儀系統(tǒng)中每個部件?spectrophotometer分光光度計thicknessgauge厚度儀other其它Isthereanadequateprotectionofdosimetersaftercalibration?在校準(zhǔn)之后對劑量計進(jìn)展充分的保護(hù)嗎？

如有你有幫助，請購置下載，感謝！YES □NOYES □NOYES □NOYES □NOYES □NOYES □NOYES