Internal Audit procedure內(nèi)部審核程序(中英文)

LOGOQUALITYSYSTEM

PROCEDURE

質(zhì)量體系程序Number文件編號(hào)：MC-M3-01Department部門：QA質(zhì)量部Subject文件名稱：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：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.

過程審核：對(duì)每個(gè)制造過程進(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；或同一類不符合事項(xiàng)發(fā)生在數(shù)個(gè)部門足以影

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，其余沒有遵守公司工作程序的某一項(xiàng)過失或沒有達(dá)到規(guī)

定要求時(shí)，稱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)審組長負(fù)責(zé)整個(gè)的內(nèi)審過程。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：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、過程審核、產(chǎn)品審核，當(dāng)客戶有對(duì)過程

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

根據(jù)以往的質(zhì)量/環(huán)境績效、過程/產(chǎn)品重要性、內(nèi)外部不符合、重大客戶投訴事件等，增加各

類審核的頻次。管理者代表視需要可不定期舉行內(nèi)部審核。（開發(fā)階段:在客戶簽署PPAP前完成過程/產(chǎn)品審核；量產(chǎn)階段:PPAP簽署后每年進(jìn)行一次過

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。Processauditor:engineerfamiliarwiththeproductionprocessandwithoneyearexperience.

過程審核員：熟悉產(chǎn)品生產(chǎn)過程，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、規(guī)范及國家的法律法規(guī)等為依據(jù)。Processauditassessthequalityabilityformanufacturingprocess.Qualitydeptprepareengineering

specification,processrequirement,productstandardtomakeProcessAuditchecklist.過程審核是對(duì)產(chǎn)品制造過程的質(zhì)量能力進(jìn)行評(píng)定，質(zhì)量部準(zhǔn)備各類準(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，發(fā)出《內(nèi)部審核實(shí)施

計(jì)劃》。TheAuditteamleadercallopenmeetinginaccordancewithauditscheduleandconfirmtheaudit

schedulewithauditors,relateddepartmentmanagers.審核組長按計(jì)劃召開體系審核的首次會(huì)議，審核員、受審核部門的負(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，審核組長召開末次會(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)告給各部門和管理者代表，并

作為管理評(píng)審的輸入之一。ProcessauditandProductaudit過程審核和產(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

戶沒有特殊要求時(shí)；本公司參考VDA6.3的要求對(duì)每個(gè)過程進(jìn)行過程審核。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，審核員開出FN-QA-056不符合報(bào)告，交責(zé)任部門限期改善。Theauditeddepartmentshallprovidecorrectiveandpreventiveactionplaninoneweektoimprove

andavoidhappeningagain.被審核部門，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

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

auditonsiteifnecessary,thentheauditorrecordtheresultintheCAR/PAR.Iftheactioniseffective,

closetheCAR/PAR;otherwiserejecttotheres