API不符合项整改结果英文

1/15API不符合项整改安排表2/15编号对应的标准条款不符合原因分析纠正及纠正措施[由谁采取?提供什么证据？]完成日期责任人3/151-----第8文档API标准Ｑ１第九版5.7.1.5条款体系不符合主要不符合：在生产工艺—锻造，热处理，无损伤检验等特殊工艺按照要求应被验证其有效。无证据显示上述工艺被确认为有效。原因分析：Thespecialprocessinthecompanyqualitysystemhadbeenidentifiedandcontrolled,butvalidationabouttheintervalnotbeenimplementedaccordingtoAPIQ15.7.1.5.证据：Correction：1Thetehnicaldepartmentfinisheddefining《processvalidationcontrolprocedure》byJune,6.moredetailseeattachment.2ByJune,12,theHRdepartmentorganizedandimplementedtrainingonthedocumentforrelatedstaff(seeattachment2).Forspecialprocessoperators,thejobqualificationandcertificationimplementedrespectively(seeattachment).3DuringJune,20—June,30,thetechnicaldepartmentimplementedthevalidationprocessandreported.(seeattachment)Evidence：Attachment1:allprocessvalidationcontrolprocedure；Attachment2:trainingrecord；Attachment3-1:HToperatorandforgingoperatorqualification；Attachment3-2:UT,MTcheckingreportandcertification；Attachment4:NDEoperatorqualification；Attachment5validationreportforspecialprocess；Attachment6forgingprocess；Attachment7:HTprocessAttachment8:UT,MTprocessregulation；Attachment9specialprocessre-validationreport（PT,UT,MT）Attachment10CorrectioncontentCorrectionaction：FromJuly,1toJuly28,2015improvingactionswasimplementedhostedbytopmanagerandorganizedbymanagementdeputywhichfocusonimprovinginproductionprocessvalidtion,includingidentifictionandplanning,verificationforspecialprocessandinteractionsbetweentheprocesses.Aswellasrevisingthemanual.《qualitymanagementmanual》willbecompletedtranslationbyealyAugustanduploadedtoAPIwebsite.１５.６.３0郝永平4/152-----第6文档APIＱ１第九版5.4.2bAPI-6A款4.2.3.1;表6,7,9;4.6;10.1.2.2轻度不符合：1输入未包括在API产品规范要求中2设计输出未符合设计输入要求3完成该设计的个人同时审核了最终设计4设计变动未按照计划完成不符合证据：在设计和包装环节：法兰6B,BL,RTJ,41/16”,5000psi,L,60K,PSL4;法兰,6B,WN,RTJ,41/16”,5000psi,L,60K,PSL4;1无证据显示该设计输入注明了材料等级2审核图#1，#2后，其化学合成及机械性能按照ASMEA694,F60要求，却并未符合API6A中标6,7,9所规定条款3执行设计审查的任海瑞先生同时也进行了设计输出的工作4未存在设计包的成品，故也缺少尺寸检验记录和最终审核检验记录原因分析：1DesignanddevelopmentpersonalsdidnotrealizeandidentifytheAPIQ1documentsandspecificationscompletely.2designanddevelopmentdivisionpersonalsdidnothaveclearjobresponsibilityandnothavedefinetheplanstageclearly.3Theprocessofdesignanddevelopmentdidnotbesupervisedstrictlybythemanagingpersonals.Corection：1ToaddressthematerialtypeoftheproductinthedesignpackageandadressapplicableAPIrequirements.Chemicalcompositionrequirementsmeetthe6,7,9clauseofAPI.2Revisethedesignpackage,makethedrawingsanddesigninputmeetrequirementsofdesignoutput.3Addproductdemensioninspectionrecordsandfinalinspectionrecordsintothedesignpackage.4ArrangeMrRenHairuiberesposiblefordesignoutputandMrFuGuangmingberesposiblefordesignaudit.Evidence：Attachment1designdocumentinwhichmaterialgradeanddesigneraddressed;Attachment2APIdrawingrevisionAttachment3trainingrecordCorrectionaction：1ConducttrainingforrelatedpersonnalsandmakethemknowabouttheAPIQ1.12Makedesigndivisionrealizetheirresponsibilitiesandplanstagerespectively.2Theregulationsforprojectdesignprocesscanbeconsidertobedefinedaswellasitsfollow-upandcheck.Ordefinemanagersresponsibilitiesforplan,supervisingandexamination.１５.６.３0任海瑞5/153-----第3文档API标准Ｑ１第九版4.4.3条款API-6A条款2轻度不符合：文件未被认证外部原文件未控制（不符合证据：1API-6A材料使用技术规范spec.#CJY/GC-7.3-3-2015-1,rev.B/0;未列入程序文件清单中wasnotlistedinDocumentmasterlist#Jan.1,20152API-6AED20，工厂对应的附件3未找到3以下为参照的目前有效的外部技术规范清单ASTMA370-2012a(实际为2011),ASTMA388-2011;ASTME709-2008;）1ForAPI6Aspec，itisnotupdatedinthedocument.2Inthetechnicaldocumentlist,notupdatethereferencespecificationintimecauseidentificationoftherelatedspecificationnotsoclearly.Correction：1AddtheAPI6Aspeintothedocumentlist.2PurchasetheamendmentofAPI6AED20.3Examineandupdateorbuytheupdatedrelatedspecification.Evidence：Attachemnt1proceduredocumentcontent;Attachment2CoverpictureofAPI6A20thED;Attachemnt3applicablestandardlistCorectionaction：1Providetrainingtorelatedpersonnalsandfoundmethodofupdatingspecficaitononthewebsite.2DesignateMSHaoWeiqinberesponsibleforrelatedspecificationsfollow-up,updatingoracquisitioninexternaltechnicaldocumentlist１５.６.３0任海瑞杨向东6/154-----第7文档API标准Ｑ１第九版5.6.1.1B条款API-6A条款9.2轻度不符合：无证据表明供方产品符合API6A标准第9.2部分的技术要求，意味着管家营公司不具备供应该产品的供货能力。（标准要求：船运前，设备或零件金属表面保护层在环境温度50度以内不应发生流挂。）原因分析：Didnotevaluateandcontroltherequirementsof9.2inAPI6Atoverifythesurfacepaintingsaggingin50°C.Correction：1Requirethatthepackagedivisiontoimplementstablityassessemntofthepaintingsaggingtestbelow50°C.Observetheresult,ifsaggingcomingup,thenneedchangematerialortechniccalprocesstomeettherequirements.Ifthenosaggingcomingup,thentheresultshallbewrittenintothe《workinginstructions》2Accordingtothetestpractice,paintingiscapableofnosaggingcomingupin50°C.pleaseseethefollowingpicturesinattachment.Evidence:Attachment1:Testpractice;Attachment2:AssessingresultpictureCorrectionaction:Strictlyimplementtheoperationsbythe《workinginstructions》１５.６.３0张水开杨向东7/15５-----第2文档API标准Ｑ１第九版4.4.2条款轻度不符合：审核设备程序时，无证据显示应用了以下要求1第5.7.1.2技术要求2第5.8部分关于计算机软件及MME部分３第6.2.2.1关于内部审核应在12个月之内进行（描述：此技术规范中并没有对所有程序进行了文字记录及归档。）原因分析：1.ThecompanydidnotorganizeenoughtrainingtomakerelatedAPIrequirementsbecomprehended