1701内部质量审核控制程序

目的Objective本程序规定了公司内部质量审核的基本内容、工作程序和管理原则，以审查本公司质量体系、产品的符合性和有效性，确保体系及产品持续符合标准的要求，完善和提高质量体系的运行效果及提高和改进产品质量。Thisprocedurehasspecifiedthebasiccontents,workproceduresandmanagementprinciplesofAICQinternalqualityaudits,soastoassesstheconformanceandeffectivenessofAICQqualitysystemandproducts,toensurethesystemandproductsincontinuouscompliancewiththestandards,toperfectandenhancethequalitysystemoperationeffects,andtoincreaseandimproveproductquality.适用范围ApplicableScope适用于本公司质量体系审核。ThisisapplicabletoAICQqualitysystemaudit.职责Responsibility管理者代表负责组织质量审核，指导具体审核工作，并负责任命审核组组长，指派审核员。负责审批审核计划和审核报告。Themanagementrepresentativeisresponsibletoorganizequalityaudits,toinstructauditpractice,tonominateauditteamleaderandtodesignateauditortoberesponsibleforassessingauditplanandreport.质量部负责编制年度内部质量审核计划。TheQualityDepartmentisresponsibletoformulatetheinternalqualityannualauditplan.各职能部门负责配合审核小组开展工作，服从其安排。Thefunctionaldepartmentsareresponsibletocoordinatetheauditteamandfollowitsassignment.工作程序WorkProcedures基本要求Thebasicrequirement内部质量审核是审核公司有关质量活动是否符合规定的计划程序和实施要求，其结果是否达到预期目的，从而明确计划、程序要求是否采取纠正措施，实施过程改善等，以提高本公司的质量管理水平，验证公司质量体系与标准要求的符合性、运行有效性。Internalqualityauditisconductedbyauditcompanytoassessifqualityactivitiesconformtotheplan,procedureandrequirements,iftheresultshavereachedtheexpectedobjectiveandifitisnecessarytoenhancequalitymanagementthroughcorrectiveactionsandprocessimprovementtoevaluatewhetherthecompanyqualitysystemisuptostandardandwhetheritoperateseffectively.内部质量审核必须是独立的、有计划、有组织的定期进行，并作出审核报告。Theinternalauditmustbeindependent,wellplannedandwellorganizedonperiodicalbasis,accompaniedbyauditreport.由管理者代表负责组织和确定审核小组，质量审核小组具体执行，开展各项工作的计划、组织、协调、督促和检查。Themanagementrepresentativeisresponsibletoorganizeandestablishauditteam,whiletheauditteamisresponsibleforimplementation,planning,organizationcoordination,supervisionandinspectionofactivities.审核小组人员要求及组成Qualification&CompositionofAuditTeamMembers审核小组人员与被审核部门无直接责任关系，审核人员（包括从事体系、过程、产品审核）应具备以下条件：Theauditteammembersshallhavenodirectresponsibilityrelationshipwiththedepartmenttobeaudited.Theteammembers(includingthoseforsystem,processandproductaudits)shouldhavethefollowingqualifications:通过内审员培训；PassedInternalQualityAuditortraining从事体系审核的内审员须通过QS-9000（第三版）标准培训；TheauditorsforqualitysystemauditsshouldpassQS-9000(3rdVersion)training.具备一年以上与质量管理有关经验，掌握各种质量技术；Overone-yearexperiencerelatedtoqualitymanagementandunderstandingofvariousqualitytechniques.审核员须正直、诚实、有判断能力、分析能力、容易接受新知识素质；Theauditorsmustberighteousandhonest,withgoodjudgmentability,analysisability,andthequalificationtolearnnewknowledge.具备通过调查、询问、评价和报告方法等验证评定技术；Knowhowtoverifytheaudittechniquesthroughinvestigation,enquiry,assessmentandreport.年度内部质量审核计划InternalQualityAnnualAuditPlan质量部根据全年的质量工作安排和公司实际情况，编制年度内部质量审核计划，报管理者代表批准。Qualitydepartmentshall,accordingtothewhole-yearqualityjobsplanandcompany’sactualsituation,workoutyearlyinternalqualityauditplanandsubmittomanagementrepresentativeforapproval.内部质量体系审核确保每年至少进行1次，每次审核须覆盖全部要素/生产班次，当体系结构有重大变化或产品/过程出现重大问题时，或有顾客抱怨时，应增加审核的频次，以验证体系运行的有效性。InternalQualitySystemAuditmustbeensuredtobemadeatleastonceeveryyear.Eachauditshallcoverallelements/productionshifts.Incaseofsignificantchangesinsystem审核准备PlanningofAudits管理者代表根据年度审核计划，指定每次审核的审核组长及内审员。Themanagementrepresentativeshall,accordingtotheannualauditplan,appointauditteamleaderandinternalqualityauditorsforeachaudit.审核组长制定审核工作计划时应按照活动的实际情况和重要性来安排日程计划（适当的工作条件、环境和日常现场管理应纳入审核范围）。审核工作计划应包括：Whenformulatingauditplan,theauditteamleadershallarrangetheschedulesaccordingtotheactualconditionsandimportanceoftheactivities(Appropriateworkingconditions,environmentandroutinesitemanagementshallbecoveredintheaudits).Theauditplanshallinclude:审核目的、范围；Objectiveandscopeofaudits;审核依据；Basisofaudits;受审核部门；Thedepartmentstobeaudited;审核员分工；Jobdivisionofauditors;时间安排等。Timeschedule,etc.审核员根据分工（内审员应与被审核的活动、事项无直接责任），编制检查表，检查表须包括以下内容：Theauditorsshallformulatethechecklistaccordingtothejobdivision.(Theauditorsshallhavenodirectresponsibilitywiththeactivitiesanditemstobeaudited).Thechecklistshallinclude:受审核部门的职能及所涉及的相关部门；Thefunctionsofthedepartmentstobeaudited,andtherelevantdepartmentsconcerned;审核文件要点；Theessenceoftheauditdocuments;检查的主要内容及时间安排，时间安排须覆盖所有班次；Themaincontentsandtimescheduleoftheaudits.Thetimescheduleshallcoverallshifts.取样方法。Samplingmethods.内审组长提前五个工作日向审核部门发出审核通知。Theauditteamleadershallsendtheauditnotificationtothedepartmenttobeauditedfivedaysinadvance.受审核部门如对审核时间、审核项目有异议，在接到通知两个工作日内与审核组协商，更改审核项目必须经管理者代表批准后另行安排。Ifthedepartmentstobeauditedhavedisputesagainsttheaudittimeanditems,theyshallnegotiatewiththeauditteamwithintwodaysafterreceiptofthenotification.Thechangeofaudititemsmustbeagreedbythemanagementrepresentative.审核实施ConductingtheAudits内审组长主持首次会议，明确审核目的、范围及其它事项。Theinternalauditteamleaderpresidesovertheinitialmeeting,inwhichtheauditobjective,scopeandotheritemsmustbeclearlyidentified.内审员依据检查表，通过看、听、查、问的方法，收集证据，检查内部质量运行情况。Theinternalauditorsshall,inreferencetothechecklist,collectevidenceandinspecttheinternalqualityoperationthroughlooking,listening,checkingandasking.审核过程中发现不符合项时，不应加入个人的责备，审核员让被审核单位的相关人员确认，以保证不符合完全被理解，以便于纠正。Ifanynon-conformanceisfoundduringauditing,theauditorshallnotexertitspersonalaccuse,butbringingthenon-conformancetoattentionandconfirmationoftherelevantperson,inordertoensurethenon-conformancecouldbefullyunderstoodandcorrected.由内审组长主持末次会议，报告审核结果。Theinternalauditteamleadershallpresidethelastauditmeetingandpresenttheauditresults.内审组长编写审核报告，经管理者代表批准后，发放到受审核部门。Theinternalauditteamleadershallformulatetheauditreports,whichwillbereleasedtotheauditeddepartmentsafterbeingapprovedbythemanagementrepresentative.受审核部门接到审核报告后，在一周之内，对不符合项制定和实施纠正措施，若不能在一周内完成纠正措施的，受审核部门应与审核组取得联系，并协商提出书面申请，经审核组组长同意，方可延长纠正措施期限。Withinoneweekatreceiptoftheauditreport,theauditeddepartmentshallformulateandconductcorrectiveactionstofixthenon-conformance.Ifthecorrectiveactionscannotbeaccomplishedwithinoneweek,theauditeddepartmentshallcontacttheauditteamandsubmitwrittenapplicationforpostponingthetimelimit.Thecorrectiveactioncanonlybepostponedsubjecttotheapprovaloftheauditteamleader.内审组长组织审核员在规定的时间内对受审核部门的纠正措施实施效果进行跟踪验证。Theinternalauditteamleadershallorganizetheauditorstofollowupandverifytheeffectivenessofthecorrectiveactionswithinthespecifiedtimelimit.内部质量审核结果由管理者代表提交管理评审。Theresultsofinternalqualityauditshallbesubmittedbythemanagementrepresentativeformanagementreview.对于质量体系审核中出现以下问题作为严重不合格项，其它为一般不合格项。Thefollowingproblemsfoundinthecourseofqualitysystemauditandprocessauditsshallberegardedasseriouslyunacceptableitems,whileotherproblemsareregardedasgenerallyunacceptableitems.不合格项经由审核员判断及经验表明有可能导致质量体系失效；Theunacceptableitemsthatmightcausethequalitysystemoutofcontrol,asaccordingtothejudgmentandexperienceoftheauditor.不合格项可能导致不合格品出厂；Theunacceptableitemsthatmightcauseunacceptableproductstoleavefactory.有多个不合格项集中在某一部门负责的某一要素上；Severalunacceptableitemshappeninacertaincircumstanceofacertaindepartment.严重不符合质量体系要求。Seriousnon-conformancetothequalitysystemrequirements.5相关文件SpecificDocuments5.1AICQ/QP-0101-00《管理评审控制程序》