IMSP05糾正措施控制程序

精選優(yōu)質(zhì)文檔傾情為你奉上精選優(yōu)質(zhì)文檔傾情為你奉上專(zhuān)心專(zhuān)注專(zhuān)業(yè)專(zhuān)心專(zhuān)注專(zhuān)業(yè)精選優(yōu)質(zhì)文檔傾情為你奉上專(zhuān)心專(zhuān)注專(zhuān)業(yè)Prepared:ApexHeVerified:DepartmentVerifiedDepartmentVerifiedQualityFacility&EHSApproved:Date:SandvikMiningandConstruction(China)Co.,Ltd.AssemblyCenter(Jiading)糾正措施控制程序CAControlProcedureIMSP-05

ModificationRecordRev.&Mod.No.Issue.DateDescriptionPreparedVerifiedApprovedCommentR00V002013.6.8NewReleaseFrankZhuSeemainpageDanielJSun/R01V002014-4-28ModificationFrankZhuGordonGeGordonGe/R02V002016-4-22Completelyrewriteaccording2015QMSApexHeSeemainpageGordonGe/Purpose目的Toidentifythedetectedorpotentialnonconformities,determinepropertycorrectiveandpreventiveactionstoeliminatetherootcauseofnonconformities,andtopreventtheiroccurrence.對(duì)已經(jīng)發(fā)生或潛在的事故、事件、不符合進(jìn)行識(shí)別、分析和改進(jìn)，查明不合格或不符合的根本原因，采取適當(dāng)?shù)募m正及預(yù)防措施，防止類(lèi)似事故、事件及不符合重復(fù)發(fā)生。Scope范圍Besuitabletocorrectivethedetectedorpotentialnonconformitiesoccurredinintegratemanagementsystem.本程序適用于山特維克礦山工程機(jī)械（中國(guó)）有限公司嘉定裝配中心礦山機(jī)械產(chǎn)品的整合管理體系中已發(fā)生或潛在的不符合的改進(jìn)。Definition定義Correction:actiontoeliminateadetectednonconformity;糾正：為消除已發(fā)現(xiàn)的不合格所采取的措施；Correctiveaction:actiontoeliminatethecauseofanonconformity(3.4.3)andtopreventrecurrence；糾正措施：用來(lái)消除不合格的原因并防止再次發(fā)生的措施；CA:Correctiveaction;糾正措施：縮寫(xiě)為CA；Responsibility職責(zé)QualityDept.isresponsiblefortheestablishandtheupdateofthedocumentcontrolprocedure;質(zhì)量部負(fù)責(zé)本程序的建立和更新；EachdepartmentisresponsiblefortheexecuteofCAoftheirown.各部門(mén)負(fù)責(zé)各自部門(mén)糾正措施的執(zhí)行；QualityDept.andFacility&EHSDept.isresponsibleforthearchiveandmanagementofCAdocumentsandrecords.質(zhì)量部和設(shè)備及環(huán)境健康安全部負(fù)責(zé)CA文件和記錄的保存和管理；Otherresponsiblepersonfordetailcansee”5.3”;過(guò)程中的確認(rèn)、驗(yàn)證以及批準(zhǔn)的責(zé)任人詳見(jiàn)“5.3”P(pán)rocedure流程Theresourceofdetectedofpotentialnonconformitycouldbe:已發(fā)生或潛在不符合的來(lái)源主要有以下幾方面：Auditfinding:thenonconformityidentifiedduringaudit;審核發(fā)現(xiàn)：審核中的發(fā)現(xiàn)的不符合項(xiàng)；Non-auditfinding,includingcustomerfeedbackandinternalimprovement,suchas:非審核發(fā)現(xiàn)，包括客戶(hù)反饋和內(nèi)部改進(jìn)，具體有：Interestedpartiescomplainandfeedback;相關(guān)方的抱怨及反饋意見(jiàn)；Resultofmanagementreview;管理評(píng)審的結(jié)果；Monitoringandmeasurementofin-process;產(chǎn)品實(shí)現(xiàn)過(guò)程的監(jiān)視和測(cè)量結(jié)果；Checkresultofrelatedinstitute;有關(guān)部門(mén)的檢查結(jié)果；Nonconformitycausedbythechangeoflaws,regulationsandstandards;法律、法規(guī)、標(biāo)準(zhǔn)變更引起的不符合；Nonconformityfoundduringthesurveyofsomeaccident;事故、事件調(diào)查時(shí)發(fā)現(xiàn)的不符合；Self-assessmentofIMSandproductionquality;管理體系以及產(chǎn)品質(zhì)量自我評(píng)價(jià)的結(jié)果；Changesininternalandexternalissues.內(nèi)外部因素的變化。Nonconformitygradejudgment:不符合項(xiàng)嚴(yán)重程度的判定：Nonconformitycanbedividedinto3grades—observation,minorandmajor:不符合項(xiàng)可分為觀察項(xiàng)、輕微以及嚴(yán)重三個(gè)等級(jí)：Observation:nonconformityreportandcorrectiveactionisnotrequired,onlyoralorwrittenattentionisenough.Butshouldpayattentiontoit’strend;觀察項(xiàng)：可不開(kāi)列不合格報(bào)告，不要求采取糾正措施，只做口頭或書(shū)面的提示，但應(yīng)注意其發(fā)展趨勢(shì)；Minor:happenedaccidently,theresultisnotsoseriousandeasytobecorrective;輕微：指偶發(fā)、孤立，后果不嚴(yán)重，易于糾正的不符合項(xiàng)；Major:loseeffectivenessinsomearea,andtheresultisserious;嚴(yán)重：指系統(tǒng)性以及區(qū)域性失效，造成的后果嚴(yán)重；Thetypeofroot-cause/CAPAanalysisandrelatedresponsibleperson各類(lèi)不符合原因分析形式及相關(guān)責(zé)任人：不符合的影響程度原因分析及糾正措施制定的形式原因分析及糾正措施的確認(rèn)人跟蹤驗(yàn)證批準(zhǔn)關(guān)閉非審核過(guò)程中發(fā)現(xiàn)或潛在的輕微不符合由各部門(mén)管理人員在其職權(quán)范圍內(nèi)，召集有關(guān)人員，分析不合格或不符合原因，制定CA相關(guān)主管或部門(mén)經(jīng)理質(zhì)量部或設(shè)備及環(huán)境健康安全部，相關(guān)主管或部門(mén)經(jīng)理部門(mén)經(jīng)理非審核過(guò)程中發(fā)現(xiàn)的或潛在的嚴(yán)重不符合由質(zhì)量部或設(shè)備及環(huán)境健康安全部經(jīng)理、相關(guān)負(fù)責(zé)人以及問(wèn)題發(fā)生部門(mén)經(jīng)理共同分析原因并制定CA質(zhì)量部或設(shè)備及環(huán)境健康安全部經(jīng)理及問(wèn)題發(fā)生部門(mén)經(jīng)理質(zhì)量部或設(shè)備及環(huán)境健康安全部管理者代表審核過(guò)程中發(fā)現(xiàn)的不符合項(xiàng)由質(zhì)量部和設(shè)備及環(huán)境健康安全部、審核小組成員（內(nèi)審時(shí)）以及被審核部門(mén)經(jīng)理或指定人員共同分析原因并制定CA部門(mén)經(jīng)理質(zhì)量部和設(shè)備及環(huán)境健康安全部或?qū)徍诵〗M成員（內(nèi)審時(shí)）管理者代表Thetypeofroot-causeanalysisandrelatedresponsiblepersonEffectdegreeofnonconformityThetypeofroot-cause/CAanalysisRoot-cause/CAconfirmFollowandresultconfirmApprovedtobeclosedbyDetectedorpotentialminorNCwhichisnotfoundinnon-auditDept.leaderandrelatedpersontoanalyzerootcausetogetheranddetermineCAPARelatedsupervisorordept.managerQualityDept.orFacility&EHSDept.,relatedsupervisorordept.managerDept.managerDetectedorpotentialmajorNCwhichisnotfoundinnon-auditQualityorFacility&EHSDept.Manageranddetecteddept.leadertoanalyzerootcausetogetheranddetermineCAPAQualityorFacility&EHSDept.manageranddetecteddept.managerQualityorFacility&EHSDept.ManagementRepresentativeNCfoundinauditQualityDept.orFacility&EHSDept.,auditteammember(internalaudit),auditeddept.managerorappointedpersontoanalyzerootcausetogetheranddetermineCAPADept.managerQualityDept.orFacility&EHSDept.orauditteammembers(internalaudit)ManagementRepresentativeContentandrequirementsforshort-termcorrectionandlong-termCA:短期糾正方案以及長(zhǎng)期糾正措施的內(nèi)容和要求：Thecontentshouldincluding:其內(nèi)容應(yīng)包括：Howtohandlecurrentproduction(replace,rework,repairscrap)andincident;針對(duì)現(xiàn)有產(chǎn)品（換貨、返工、返修、報(bào)廢）和事件的處理；Thelong-termCAPAshouldbedeterminedtoeliminatetherootcauseofeachfindings;長(zhǎng)期措施應(yīng)針對(duì)所列出的問(wèn)題產(chǎn)生的各項(xiàng)原因采取相應(yīng)的糾正及預(yù)防措施；Thedocumentswhichneedtobeadded/changedaccordingtoCA;因糾正預(yù)防措施要求需新增/更改的文件；Educationandtraining;教育培訓(xùn)；Requirements要求：Actionsshouldbespecificandaccurate.Quantitativeindexshouldbeusedtodescribeaction.措施應(yīng)具體、明確、用可量化的指標(biāo)來(lái)描述；Actionsshouldincluding:why,when,who,where,what,how(5W1H);措施應(yīng)列明以下內(nèi)容：誰(shuí)在什么時(shí)候，什么地方，采取什么措施？怎么做？（5W1H）；Eachactionshouldappointedresponsiblepersonandimplementationperiod;每項(xiàng)措施都應(yīng)指定相應(yīng)的責(zé)任人和實(shí)施期限；Shouldtopreve