F016 內(nèi)部審核報(bào)告INTERNAL AUDIT REPORT v3

Version3內(nèi)部審核報(bào)告INTERNALAUDITReport審核日期AuditDate(s):參考審核計(jì)劃RefAuditPlan:審核部門/項(xiàng)目/產(chǎn)品Department/Project/ProductAudited:審核天數(shù)LengthofAuditinDays:審核組AuditTeam:1.1.覆蓋區(qū)域（描述包括在審核中的產(chǎn)品，過程，地點(diǎn)和/或職能區(qū)域）AREA(S)COVERED(describeproducts,processes,locationsand/orfunctionalareasincludedintheaudit):不符合項(xiàng)總數(shù)TOTALNONCONFORMITIES:建議項(xiàng)總數(shù)TOTALCOMMENTS:2.2.總體情況和評(píng)價(jià)（包括正面和負(fù)面的評(píng)價(jià)，程序和良好規(guī)范）GENERALCONDITION&COMMENTS(includepositiveandnegativecomments,proceduresandbestpractices):審核結(jié)論等級(jí)和復(fù)審要求AUDITRESULTSRATINGANDRE-AUDITREQUIREMENTS重大不符合項(xiàng)需采取糾正預(yù)防措施/需重審SIGNIFICANTCAPAINDICATED/RE-AUDITRECOMMENDED建議按下面要求的范圍和說明進(jìn)行重審Recommendre-auditwithscope&explanationasbelowSuggestedDateofRe-audit:符合的審核結(jié)果SATISFACTORYAUDITRESULTS建議使用已建立的審核頻率EstablishedAuditFrequencyRecommended.需要提高NeedsImprovement建議使用已建立的審核頻率EstablishedAuditFrequencyRecommended.3.審核范圍AuditscopeVersion3檢查項(xiàng)目CheckItems管理承諾ManagementCommitment策劃Planning資源Resources溝通Communication職責(zé)與權(quán)力ResponsibilityandAuthority管理評(píng)審ManagementReview內(nèi)部審核InternalAudit文件控制DocumentationControl培訓(xùn)Training設(shè)計(jì)控制DesignControls客戶溝通CustomerCommunication生產(chǎn)和過程控制Production&ProcessControls采購控制PurchasingControls過程確認(rèn)ProcessValidation監(jiān)測設(shè)備控制ControlofMonitoring/MeasuringDevices標(biāo)識(shí)與可追溯性IdentificationandTraceability標(biāo)簽，包裝，操作和分發(fā)Labeling,Packaging,Handling&Distribution器械主記錄DeviceMasterRecords器械歷史記錄DeviceHistoryRecords驗(yàn)收活動(dòng)AcceptanceActivities糾正預(yù)防措施CorrectiveandPreventiveAction不合格品控制ControlofNonconformingProduct數(shù)據(jù)分析AnalysisofDataAUDITED?發(fā)現(xiàn)項(xiàng)編號(hào)NC#/Comments#注釋Remark注：上表用于覆蓋所有可用的美國FDA法規(guī)，ISO9001:2008,ISO13485:2003和醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范植入性醫(yī)療器械實(shí)施細(xì)則ChinaGMP2014。Note:TheabovechecklistsweredesignedtocovertheapplicablerequirementsofFDAQSReg,ISO9001:2008,ISO13485:2003andChinaGMP20144.4.不符合項(xiàng)及建議項(xiàng)清單NONCONFORMITY&OBSLIST4.1不符合項(xiàng)Nonconformities編號(hào)NC#要求Requirement不符合項(xiàng)描述NonConformityDescriptionCriticalMajorMinor級(jí)別ClassificationVersion3CriticalCriticalCriticalCriticalCritical4.2.建議項(xiàng)Comments編號(hào)Com#建議項(xiàng)描述COMMENTSDESCRIPTIONCom1審核組審核組Auditor