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CustomerComplaintHandling客户投诉处理Page1of31.Purposeandscope目的和范围Thepurposeofthisprocedureistodefinehowtohandlecustomercomplaintsreceiveddirectlyfromcustomerortransferredfromsalesofficesandresponsibilityofrelateddepartments.本程序的目的是规定如何处理直接来自于客户的或由各个分公司转发的客户投诉以及相关部门的职责。ThisprocedurewillapplytoallCustomercomplaintsregardingcompany’sproducts.本程序适用于所有与公司产品有关的客户投诉。2.Definitions定义LogisticrelatedComplaint与物流有关的投诉Complaintclaimingdeficienciesinshipmentcomparedtothecustomerorder(forexampleincorrectquantities,incorrecttypeofgoods,shippingconditions,etc.)客户对物流过程的投诉(如数量,品种或运输条件不正确等。)ProductrelatedComplaint与产品有关的投诉Complaintclaimingtechnicaldeficienciesoncosmeticorfunctionoftheproduct.客户对产品在外观或功能方面的投诉。Quarantinearea隔离区Area/locationdesignatedforitemsthatarerejectedandnotavailabletoproductionline.指定存放被拒收的物品的区域/场所,这些物品不得用于生产线。3.Authorityandresponsibility职责和权限CustomerCareDepartment客服部Responsibleforimplementationandmaintenanceofthisprocedure,makingregistrationandkeepingtrackofcustomercomplainthandlingprocess.负责本程序的履行和维护;登记并跟踪客户投诉处理过程。QualityDepartment质量部Responsibleforcorrective/preventiveactionvalidationandclosure.负责跟踪采取相应的纠正/预防措施的有效性验证和关闭。EngineeringDepartment工程部Responsibleforanalysisqualityissueofproducts.负责产品质量问题的分析。Responsibility相关责任单位ResponsibletodealwithproblemwithprobleminvestigationandCAPAimplementation.责任部门进行原因分析和纠正预防措施的制定和执行。4.References参考文件n/a5.Method方法5.1RegistrationofComplaint登记投诉CustomerCaredepartmentshouldregisterthereportintime;makeinitialinvestigationandanalysistoseeifthereisanyproblemwithourproductorlogisticprocess,toevaluatethehazardCustomerComplaintHandling客户投诉处理Page2of3ofuserandmalfunctionproblemsaswell.Ifthereisanydeathorinjuryproblemhappened,servicepeoplemustinformqualitydept.managementrepresentativeandtopmanagementteamimmediatelyforinvestigationandquickactions.IfmightberaisedontheMDRaccordingtotheregulations.客服部将客户投诉信息及时登记在案,对投诉进行初步的调查和分析,确认投诉的内容是否由产品问题或物流过程中引起的;确认其功能失效情况和对人员伤害情况进行分类登记以及国别,联系方式等信息。如果客户反馈存在死亡或是严重伤害、一般伤害事件、严重产品质量问题时,应该立即同时质量部门、管理者代表和公司高层展开调查并采取必要的紧急措施;当满足美国21CFRPart803或加拿大CMDR法规要求时,需启动美国MDR、加拿大强制性问题报告和忠告性通知等流程。5.3Investigation投诉调查5.3.1Engineeringdept.toleadtheinvestigationontheproductfailures,andcustomercaredept.toleadtheinvestigationonothers,forexample:logistic,delivery,paymentissue.如果反应是产品质量问题相关的投诉,由工程部门负责组织调查;非产品质量问题,如物流、付款、运输方面的问题,由客服部门负责组织调查。5.3.2Engineering/Customercaredept.needdecidetheownerofcomplaintbasedonthelabanalysisonthereturnedproduct,thisanalysisneedbecompletedwithinoneweeknormally.Toraisetheactionimprovementifapplicable,andholdthereviewmeetingaswellifnecessary..实验室对顾客退货产品进行试验分析(对顾客退货产品的试验/分析必须在一周内完成),工程部/客服部并依据调查和分析的结果判定其责任归属,适当时通知相关责任单位要求进行改善;必要时,以工程部/客服部为主导召集缺失责任部门召开客户投诉检讨会。5.4Respondofcomplaint响应投诉Nomatterwhatcausesthecomplaint,CustomerCaredepartmentshouldrespondtothecustomerwithin12hours,Ifnoproblemisfoundwithourproductionorlogisticprocess,explanationshouldbemadeinreplywithpossiblehelp,thisactioncouldberecordedinproperway.不论何种原因引起投诉,客服部都应在收到投诉后12小时内以邮件或是其他适当方式答复客户,如果调查和分析的结果表明,投诉的内容不是由产品或物流过程引起,应向客户说明理由并尽可能提供帮助。对于以上任何形式的回复必须做好相关记录并保存。5.5Initiatecorrective/preventiveaction启动纠正/预防措施行动Oncecriticalproblem,injury,criticalmalfunctionfound,itwillinitiateCorrective/PreventionAction8DReport)shouldbefilledinbyengineeringlabwithin5workingdays.Thefailureownershouldmaketheinvestigationtotakethecorrectiveandpreventiveactionstoavoidre-occurs.TorefertotheCorrectiveandPreventiveActionProcedureondetails.Inaddition,managementrepresentativeneedsevaluatethereportprogramaccordingtotheUSFDA820andCanadaMDRregulationstoinitiatetheMDR(USA)orMPR(Canada)programifnecessary.CustomerComplaintHandling客户投诉处理Page3of3一旦发现死亡或是伤害事件或是严重功能问题时,应立即启动CAPA程序;实验室应在5天之内完成8D管理改善报告;相关责任单位根据投诉的主要原因拟定纠正与预防措施,以防止类似事件的再次发生。CAPA改善过程按照纠正预防措施程序执行。根据客户所反馈问题的情况,由管代根据美国和加拿大医疗器械管理的法规要求评估是否需要启动报告程序,参考文件医疗器械报告程序。5.6Keepcontactwithcustomer保持与客户的联系InthewholeprocessofCorrective/preventionaction,CustomerCaredepartmentorlogisticdept.shouldkeepincontactwithcustomeraccordingtocorrectiveaction/preventiveactionplan,respondanyrequirementfromcustomerintime.在整个纠正/预防措施过程中,客服部或物流部们应根据纠正/预防措施计划与客户保持联系;及时响应客户提出的要求,如客户报告回复或退换货事宜等。5.7Closeoftheprocess完成处理过程Qualitydepartmentshouldkeeptrackoftheprocessandmakesurecustomercomplaintreportandlinked8Dhavecompletedwithalltheactionsclosed.质量部应跟踪CAPA改善过程来验证措施的执行和有效性,确保客户投诉报告和相关联的8D全部关闭,所有行动计划完成。5.8Returnedproduct退回产品Ifthereisanyproductreturnedfromcustomer,itshouldbeidentifiedandputinquarantinedareawhenreceived,itwillbedealwithaccordingtocorrective/preventiveactionprocedurefterQAinspectioncompleted.如果客户将产品退回,在收到退回的产品时,应做好标识,注明情况并放在隔离区域。如果是产品质量问题而造成的退货,QA应该组织对产品进行检验,根据其统计分析结果是否启动CAPA程序;如需启动则参考纠正/预防措施程序执行。5.9Customercaredept.needtomakethecomplaintanalysisonthemonthlybasis,itwillbetheinputofqualitytrendandcustomersatisfactionindicator.针对每月的客户投诉和客户退货产品的状况由市场部将其统计汇整,以作为公司数据和资料的分析和使用的资料和信息。5.10Itshouldbereviewedonthecomplaintreportsduringthemanagementreviewmeetingwhichbringthehighattentiontothetopmanagementoncustomerfeedbackonthequality,deliveryandservice,etc.客户投诉的次数及处理情况由质量部/市场部在每次的管理评审会议上进行提报/评审,以便让公司高阶管理层和相关部门了
本文标题:医疗器械客户投诉处理-Customer-complaint-handling-procedure
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