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LOGOQUALITYSYSTEM

PROCEDURE

質(zhì)量體系程序Number文件編號(hào):MC-M3-01Department部門(mén):QA質(zhì)量部Subject文件名稱(chēng):InternalAuditprocedure內(nèi)部審核程序Revision版本:3.0EffectiveDate生效日期:2021-05-10Page1of7批準(zhǔn):審核:作成:ChangeHistory

變更記錄,Revision版

本EffectiveDate生效日期Originator

編寫(xiě)人ReasonsforChange

修改原因1.02017-01-01OriginRevision2.02018-03-13Update4.3.1&4.4.4,Addinternalauditorevaluation

andproductauditexplanation3.02020-05-10Update43.1,Deleteinternalauditorevaluation4.02021-02-05增加過(guò)程/產(chǎn)品審核的頻次定義1.0Purpose目的ThisproceduredescribeshowinternalauditsoftheManagementSystem(includingQuality

ManagementSystemandEnvironmentalManagementSystem)areconducted,howNon-conformances

arerecordedandhowcorrectiveactionsareagreed,implementedandverified.本程序描述了如何對(duì)公司管理體系(包括質(zhì)量管理體系和環(huán)境管理體系)進(jìn)行內(nèi)部審核,如何記錄不符

合事項(xiàng)以及如何制定、實(shí)施和驗(yàn)證糾正措施2.0Scope范圍ThisprocedureappliestoManagementSystem(includingQualityManagementSystemand

EnvironmentalManagementSystem)internalaudit,processauditandproductauditin***.本程序適用于本公司與管理體系(包括質(zhì)量管理體系和環(huán)境管理體系)有關(guān)的審核活動(dòng),包括質(zhì)量管理

體系審核、環(huán)境管理體系審核、過(guò)程審核、產(chǎn)品審核。3.0Definitions定義IMSAJnternalManagementSystemAudit/內(nèi)部管理體系審核;InternalAuditor:Basedontraining,apersonwhoiscapableandqualifiedtoaudittheperformance

ofManagementSystem.內(nèi)審員:經(jīng)過(guò)相應(yīng)培訓(xùn),具有能力和資格對(duì)公司管理體系狀況進(jìn)行審核的員工AuditTeamLeader:Apersonwhoisrecommendedtotakechargeintheinternalaudit.內(nèi)審組長(zhǎng):指定的負(fù)責(zé)全程內(nèi)審的人員AuditCriteria:Aseriesofpolicies,proceduresandrequirements,whichareusedasbasisforaudit.

審核準(zhǔn)則:所依據(jù)的一系列的方針、程序或要求AuditEvidence:Anyfact,recordorotherinformationthatcanbegotduringaudit.審核證據(jù):與審核有并能夠證實(shí)的記錄、事實(shí)陳述或其他信息AuditFinding:Theresultafterevaluatingtheauditevidencebasedontheauditcriteria.審核發(fā)現(xiàn):所收集到的審核證據(jù)對(duì)照審核準(zhǔn)則進(jìn)行評(píng)價(jià)的結(jié)果SystemAudits:Systematicassessmentforqualityandenvironmentalmanagementtoverifythe

effectiveness.體系審核:對(duì)質(zhì)量和環(huán)境管理體系進(jìn)行審核,以確認(rèn)體系運(yùn)行的有效性。ProcessAudits:auditeachmanufacturingprocesstodetermineitseffectiveness.

過(guò)程審核:對(duì)每個(gè)制造過(guò)程進(jìn)行審核,以確定其有效性.ProductAudits:Assessmentofproductsatappropriatestagesofproductionanddeliverytoverify

conformitytoallspecifiedrequirements,suchasproductdimensions,functionality,packagingand

labeling,atadefinedfrequency.產(chǎn)品審核:在生產(chǎn)和交付的適當(dāng)階段對(duì)產(chǎn)品進(jìn)行審核,以驗(yàn)證符合所有要求,如產(chǎn)品尺寸、功能、包

裝和標(biāo)簽等.CriticalNonconformity:Thenonconformitywillaffecttheoperationofwholemanagementsystem;

thesamenonconformityhappensinseveraldepartmentsandw川affecttheoperationofwhole

system;theoperationisseverenonconformingwithmanuaΓsrequirements.嚴(yán)重不符合事項(xiàng):影響整個(gè)管理體系運(yùn)行的重大不符合;或同一類(lèi)不符合事項(xiàng)發(fā)生在數(shù)個(gè)部門(mén)足以影

響整個(gè)體系運(yùn)行;或執(zhí)行的事項(xiàng)與手冊(cè)的規(guī)定嚴(yán)重不符合時(shí)。CommonNonconformity:Exceptthecriticalnonconformities,otheroperationormistakesthatdon,t

complywiththeprocedureornotreachtherequirements.一般不符合事項(xiàng):除上述主要不符合事項(xiàng)外,其余沒(méi)有遵守公司工作程序的某一項(xiàng)過(guò)失或沒(méi)有達(dá)到規(guī)

定要求時(shí),稱(chēng)之為一般不符合事項(xiàng)。3.120bservedItem:Theoperationhasnotdisobeyedthesystemrequirementsorhasnoevidenceto

showthatauditfindingsareconformity,buttheoperationresultmaybewillaffectthesystem.觀察事項(xiàng):雖未違反體系要求或沒(méi)有客觀證據(jù)可證明所發(fā)現(xiàn)的事實(shí)足以構(gòu)成不合格,但結(jié)果可能會(huì)影

響體系的事項(xiàng)。ProcedureandFlowchart程序及流程圖Responsibilityandauthority職責(zé)與權(quán)限TheQEMSRepresentativeisresponsibleforapprovaloftheauditplanandensuringthat

theinternalauditsareconductedinaccordancewithauditschedule.管理者代表批準(zhǔn)審核計(jì)劃,確保按照內(nèi)審計(jì)劃實(shí)施內(nèi)部審核;QualityDept,isresponsibleformakingauditplan,coordinatingtheimplementationofinternalaudit,

summarizingtheauditresultandfollowingupthecorrectiveactionandeffectiveness.質(zhì)量部負(fù)責(zé)制訂審核計(jì)劃,協(xié)調(diào)內(nèi)審實(shí)施,匯總審核結(jié)果,跟蹤審核改善和效果。Aninternalauditteamleaderisresponsibleforwholeauditactivity.

內(nèi)審組長(zhǎng)負(fù)責(zé)整個(gè)的內(nèi)審過(guò)程。Theauditorsareresponsibleforreportingthedetailsofanyfindings,issueCAR,and

subsequentlyverifyingthecorrectiveactionstaken.內(nèi)部審核員負(fù)責(zé)實(shí)施審核,匯報(bào)審核發(fā)現(xiàn),提出糾正和預(yù)防措施要求,并跟蹤驗(yàn)證糾正預(yù)防

措施的執(zhí)行。OtherdeptassistauditandtakecorrectiveandpreventiveactionforNon-conformance.

其他部門(mén):配合審核,并對(duì)不符合采取糾正預(yù)防措施。AuditPlan審核計(jì)劃Qualitydepartmentmakeinternalauditplan,includingQMS&EMSaudit,processauditandproduct

audit,thengetapprovalfromManagementRepresentative.質(zhì)量部制定年度內(nèi)部審核計(jì)劃,包括質(zhì)量體系審核、環(huán)境體系審核、過(guò)程審核、產(chǎn)品審核,

并由管理者代表批準(zhǔn)。TheQMSandEMSaudit,processauditandproductauditwillbeconductonceperyear.Process

auditandproductauditshouldbeperformedaccordingtocustomers9frequencywhiletheyhadthe

specialauditfrequencyrequirements.ManagementRepresentativecanincreasethefrequency

consideringthepreviousperformance,theimportanceofprocessandproduct,intemalandexternal

nonconformanceandcriticalcustomercomplaint.審核頻次:每年1次質(zhì)量體系審核、環(huán)境體系審核、過(guò)程審核、產(chǎn)品審核,當(dāng)客戶(hù)有對(duì)過(guò)程

審核及產(chǎn)品審核有特定要求時(shí),頻度按照客戶(hù)要求實(shí)施,具體參見(jiàn)審核計(jì)劃。管理者代表可

根據(jù)以往的質(zhì)量/環(huán)境績(jī)效、過(guò)程/產(chǎn)品重要性、內(nèi)外部不符合、重大客戶(hù)投訴事件等,增加各

類(lèi)審核的頻次。管理者代表視需要可不定期舉行內(nèi)部審核。(開(kāi)發(fā)階段:在客戶(hù)簽署PPAP前完成過(guò)程/產(chǎn)品審核;量產(chǎn)階段:PPAP簽署后每年進(jìn)行一次過(guò)

程、產(chǎn)品審核)AuditorQualifications審核員資格TheQMSandEMSinternalauditorsshallbetrainedbythequalifiedtraininginstituteandgetthe

certification.QMS/EMS內(nèi)審員:有資質(zhì)的培訓(xùn)機(jī)構(gòu)培訓(xùn)的IATF16949和ISO14001內(nèi)審員,并取得合格證書(shū)。Processauditor:engineerfamiliarwiththeproductionprocessandwithoneyearexperience.

過(guò)程審核員:熟悉產(chǎn)品生產(chǎn)過(guò)程,公司工作一年以上的工程師。Productauditor:qualityengineerfamiliarwithproductrequirementsandwithoneyearexperience.

產(chǎn)品審核員:具備產(chǎn)品檢驗(yàn)?zāi)芰?,熟悉產(chǎn)品要求,公司工作一年以上的質(zhì)量工程師。Preparationofaudit審核準(zhǔn)備AuditormakeinternalsystemauditchecklistInternalAuditchecklist.內(nèi)審員制定內(nèi)部體系審核的審核表《內(nèi)部審核檢查表》。ThesysteminternalauditcriterionisIATF16949andISO14001Standards,Qualityand

EnvironmentManual,ProceduresandWorkingInstruction,ContractrequirementsandNationallegal

requirements,etc.體系審核以IATF16949和ISO14001標(biāo)準(zhǔn)、公司的質(zhì)量和環(huán)境管理手冊(cè)、程序文件、相關(guān)的

作業(yè)指導(dǎo)書(shū)、規(guī)范及國(guó)家的法律法規(guī)等為依據(jù)。Processauditassessthequalityabilityformanufacturingprocess.Qualitydeptprepareengineering

specification,processrequirement,productstandardtomakeProcessAuditchecklist.過(guò)程審核是對(duì)產(chǎn)品制造過(guò)程的質(zhì)量能力進(jìn)行評(píng)定,質(zhì)量部準(zhǔn)備各類(lèi)準(zhǔn)則技術(shù)要求,工序準(zhǔn)

則,文件,產(chǎn)品標(biāo)準(zhǔn),確定《過(guò)程審核表》。Productauditassessproductqualitylevel,includingproductdimension,appearance,function,

packing,labelandetc.Qualitydeptprepareengineeringspecification,productstandard,defectgrade

table,testplanandetc.tomakeProductAuditchecklist.產(chǎn)品審核:對(duì)已檢驗(yàn)合格的產(chǎn)品進(jìn)行再檢查,包括產(chǎn)品尺寸,外觀,性能,包裝,標(biāo)簽等,

以評(píng)價(jià)其質(zhì)量水平以及是否需采取改進(jìn)措施。質(zhì)量部準(zhǔn)備各類(lèi)技術(shù)資料產(chǎn)品標(biāo)準(zhǔn),缺陷分級(jí)

表,試驗(yàn)計(jì)劃等,確定《產(chǎn)品審核表》。Auditimplementation審核的實(shí)施Internalsystemaudit內(nèi)部體系審核Qualitydepartmentleadtoauditteamandchooseappropriateauditor,determinetheteamleader,

andthensendInternalAuditSchedule.質(zhì)量部主導(dǎo)成立審核小組,選擇合適的體系審核員,確認(rèn)審核組長(zhǎng),發(fā)出《內(nèi)部審核實(shí)施

計(jì)劃》。TheAuditteamleadercallopenmeetinginaccordancewithauditscheduleandconfirmtheaudit

schedulewithauditors,relateddepartmentmanagers.審核組長(zhǎng)按計(jì)劃召開(kāi)體系審核的首次會(huì)議,審核員、受審核部門(mén)的負(fù)責(zé)人和相關(guān)管理人員

參加,確認(rèn)審核行程。Auditorlooksfortheevidenceofconformanceaccordingtoauditplanandauditchecklistand

recordtheauditfindings.內(nèi)審員按審核計(jì)劃和審核表進(jìn)行審核,尋找符合性證據(jù),并在審核表上記錄審核發(fā)現(xiàn)。TheAuditteamleadercallclosemeetingandreporttheauditresult,confirmthenonconforming

itemswithrelateddepartment.現(xiàn)場(chǎng)審核結(jié)束后,審核組長(zhǎng)召開(kāi)末次會(huì)議,報(bào)告審核結(jié)果,確認(rèn)不符合項(xiàng)。TheAuditteamleadersummarizestheauditresultandsubmitsthe,FN-QA-046Internalsystem

AuditReporttoalldepartmentsandManagementrepresentative,andasoneinputofmanagement

review.審核組長(zhǎng)匯總審核結(jié)果,提交FN-QA-046內(nèi)部體系審核報(bào)告給各部門(mén)和管理者代表,并

作為管理評(píng)審的輸入之一。ProcessauditandProductaudit過(guò)程審核和產(chǎn)品審核Auditorlooksfortheevidenceofconformanceaccordingtoauditplanandauditchecklistand

recordtheauditfindings.***followsVDA6.3toperformprocessauditforeachstationifthere,s

nocustomerspecialrequest.審核員按審核計(jì)劃和審核表進(jìn)行審核,尋找符合性證據(jù),并在審核表上記錄審核。如果客

戶(hù)沒(méi)有特殊要求時(shí);本公司參考VDA6.3的要求對(duì)每個(gè)過(guò)程進(jìn)行過(guò)程審核。TheAuditorsummarizestheauditresultandsubmits(heinternalauditsummaryreporttoall

departmentsandManagementrepresentative,andasoneinputofmanagementreview.審核員匯總審核結(jié)果,提交審核結(jié)果給各部門(mén)和管理者代表,并作為管理評(píng)審的輸入之OCorrectiveandimprovementaction糾正改進(jìn)措施TheauditorissueCorrectiveandPreventiveActionReport(CAR/PAR)fornonconformance

findingstotheresponsibledept.審核中發(fā)現(xiàn)不符合,審核員開(kāi)出FN-QA-056不符合報(bào)告,交責(zé)任部門(mén)限期改善。Theauditeddepartmentshallprovidecorrectiveandpreventiveactionplaninoneweektoimprove

andavoidhappeningagain.被審核部門(mén),應(yīng)針對(duì)審核所發(fā)現(xiàn)的各項(xiàng)缺失,于審核后一周內(nèi)提出糾正與預(yù)防措施,以改善

問(wèn)題及防止問(wèn)題再發(fā)生。Afterimplementationofaction,theauditorverifiestheactionimplementationandeffectiveness,re-

auditonsiteifnecessary,thentheauditorrecordtheresultintheCAR/PAR.Iftheactioniseffective,

closetheCAR/PAR;otherwiserejecttotheres

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