質(zhì)量管理體系策劃控制程序(中英文版本)

文件名稱：質(zhì)量管理體系策劃控制程序DocumentTitle：Controlprocedureforqualitymanagementsystemplanning文件狀態(tài)DOC.Status文件編號(hào)Doc.No.：COP021版本Issue:03修訂Rev:01頁(yè)號(hào)PagePAGE1ofNUMPAGES12OPI001-1/02-011.0目的purpose本程序規(guī)定了為滿足產(chǎn)品、項(xiàng)目、合同和/或顧客規(guī)定的要求，確定和配備必要的控制方法、過(guò)程、設(shè)備（包括檢驗(yàn)和試驗(yàn)設(shè)備）、工藝裝備、資源和技能，使與產(chǎn)品和服務(wù)有關(guān)的工作有所依循及有效實(shí)施，確保產(chǎn)品質(zhì)量和服務(wù)符合和滿足顧客和公司要求。Thisprocedureistomeetrequirementsofproducts,items,contractsandrequirementscustomersstipulateanddetermineandequipcontrolmethod,process,equipment(includinginspectingandtestingequipment)technologyequipment,resourceandskillandmakeworkingrelevantwithserviceandproductshavebasisandiscarriedouteffectivelyandmakesureserviceandproductqualitymeetrequirementsofcustomersandcompany2.0范圍Scope適用于公司質(zhì)量管理體系產(chǎn)品范圍所涉及到的所有過(guò)程和活動(dòng)。Itcanbeappliedtoalltheprocessesandactivitiesinvolvedwithproductrangeofqualitymanagementsystem3.0職責(zé)Responsibilities3.1總經(jīng)理負(fù)責(zé)質(zhì)量管理體系的策劃、建立和完善以及質(zhì)量管理體系所需資源的配備和確定。Generalmanagerisresponsibletoplan,setupandperfectqualitymanagementsystemandequipandidentifyresourcequalitymanagementsystemneeds3.2管理者代表、各部門領(lǐng)導(dǎo)負(fù)責(zé)質(zhì)量管理體系的實(shí)施、貫徹和落實(shí)。Managementrepresentativesandleadersofeachdeptareresponsibletocarryoutqualitymanagementsystem3.3各管理層及全體員工負(fù)責(zé)質(zhì)量管理體系文件各項(xiàng)規(guī)定的執(zhí)行。Managementandallthepersonnelareresponsibletocarryoutstipulationinqualitymanagementsystemdocs3.4品保部負(fù)責(zé)質(zhì)量管理體系的內(nèi)部審核與督導(dǎo)。QAdeptareresponsibletoguidequalitymanagementsystemandresponsibleforinternalcensoring3.5各責(zé)任部門負(fù)責(zé)質(zhì)量手冊(cè)、程序文件、作業(yè)指導(dǎo)書和表單的建立與維護(hù)。Responsibledepts.areresponsibletodrawupandmaintainqualitymanual,proceduredocsandforms3.6品保部負(fù)責(zé)統(tǒng)籌組建多方論證小組。QAdeptareresponsibletoplanandsetupcrossfunctionalteam3.7工藝部負(fù)責(zé)制定《控制計(jì)劃》。MIdeptareresponsibletodrawup<controlplan>4.0簡(jiǎn)稱/定義Abbreviation/Definition4.1質(zhì)量管理體系：指為實(shí)施質(zhì)量管理所需的組織結(jié)構(gòu)、程序、過(guò)程和資源，建立質(zhì)量方針和質(zhì)量目標(biāo)，并實(shí)現(xiàn)這些目標(biāo)的相互關(guān)聯(lián)的或相互作用的一組要素的集合。Rualitymanagementsystem:setqualitypolicyandqualitygoalfororganizationstructure,procedure,processandresourceandagroupofinterrelatedandinteractionalfactorstorealizethesegoals4.2質(zhì)量策劃：指一種確定生產(chǎn)某具體產(chǎn)品或系列產(chǎn)品（如：零件、材料等）所用方法（如：測(cè)量和試驗(yàn)等）的結(jié)構(gòu)化的過(guò)程，是質(zhì)量管理的一部分，致力于制定質(zhì)量目標(biāo)并規(guī)定必要的作業(yè)過(guò)程和相關(guān)資源以實(shí)現(xiàn)其質(zhì)量目標(biāo)；與缺陷探測(cè)大不相同，質(zhì)量策劃包括防錯(cuò)和持續(xù)改進(jìn)的思想。Qualityplanning:Theprocesstodeterminethemethodweusetoproducesomeproductorseriesproducts(suchasparts,material,etc)it’sapartofqualitymanagement.itdevotesitselfintosettingqualitygoalandstipulatesnecessaryoperationprocessandrelevantresourcetorealizequalitygoal.Unlikedefectdetection,qualityplanningincludestheideaoferror-proofingandcontinuousimprovement4.3質(zhì)量計(jì)劃：指對(duì)特定的項(xiàng)目、產(chǎn)品、過(guò)程或合同，規(guī)定由誰(shuí)及何時(shí)應(yīng)使用哪些程序相關(guān)資源的文件。當(dāng)控制計(jì)劃作為質(zhì)量計(jì)劃時(shí)，質(zhì)量計(jì)劃便成為一種廣義概念。Qualityplan:itstipulatesbywhom,whenandusedocsofwhichproceduretoagivenitem,product,processorcontract.whencontrolplanisusedasqualityplan,itbecomesageneralizedconcept4.4質(zhì)量手冊(cè)：指依據(jù)公司質(zhì)量方針而擬定和執(zhí)行質(zhì)量方針為達(dá)成質(zhì)量目標(biāo)的要求，并明確其途經(jīng)和職責(zé)及有效地執(zhí)行質(zhì)量管理體系所使用之原則性的基本質(zhì)量管理活動(dòng)，為保證滿足顧客的要求和需求及期望而描述質(zhì)量管理體系要素的原則性管理的書面化文件；其目的在于提供一套執(zhí)行與維持質(zhì)量管理體系正常運(yùn)作之有效性和適切性的基本指導(dǎo)綱要原則和與程序文件的銜接橋梁。Qualitymanual:It’sdrewupinaccordancewithqualitypolicyanditregardsenforcementofqualitypolicyasrequirementsofreachingqualitygoalanddefinesitsapproachandresponsibilitiesandbasicqualitymanagementactivitiesweusetocarryoutqualitymanagementsystemeffectively.theyaredocsthatdescribefactorsofqualitymanagementsystemtoensurewecanmeetcustomers’requirementsandneedsandexpectations.itspurposeistoprovidebasicprincipleforcarryingoutqualitymanagementsystemandmaintainingnormalrunningofqualitymanagementsystemanditactsasabridgebetweenproceduredocsandqualitymanagementsystem程序文件：指為維持質(zhì)量管理體系的運(yùn)作，當(dāng)工作涉及到組織內(nèi)多種職能和部門時(shí)將其形成文件的過(guò)程，使其作業(yè)的目的、范圍、權(quán)責(zé)單位和作業(yè)內(nèi)容透過(guò)流程步驟和先后順序或流程圖式地加以說(shuō)明，以利便于各項(xiàng)工作的實(shí)施和管理；其目的在于規(guī)范管理性的質(zhì)量管理活動(dòng)，促使企業(yè)內(nèi)所有與產(chǎn)品質(zhì)量、交付和服務(wù)有關(guān)的過(guò)程得到明確規(guī)定，并延伸到質(zhì)量手冊(cè)使所有活動(dòng)更具體表現(xiàn)。Proceduredocs:Theprocesstoformdocstomaintainrunningofqualitymanagementsystemwhenworkinvolvesmanyfunctionanddepts.tomakeitsoperationpurpose,range,responsibledepts.Andoperationcontentareexplainedinorderorasflowcharttomakeiteasyforenforcementandmanagement.itspurposeistostandardizequalitymanagementactivitiesrelevantwithmanagementandmakestipulationforalltheprocessesrelevantwithproductquality,deliveryandserviceandextendtoqualitymanualtomakealltheactivitiesmanifestthemselvesbetter4.6作業(yè)指導(dǎo)書：指在質(zhì)量管理體系中為有效地實(shí)施和執(zhí)行及完成某一功能所進(jìn)行的工作（如：生產(chǎn)準(zhǔn)備工作、檢驗(yàn)和試驗(yàn)、返工和返修、設(shè)置、人員等），將每一項(xiàng)動(dòng)作的基準(zhǔn)加以詳細(xì)地說(shuō)明，包括適用范圍、機(jī)器、測(cè)量設(shè)備和監(jiān)控裝置、使用工裝/工具/模具/治具/夾具/刀具和方法或方式及人員、時(shí)間、地點(diǎn)等詳細(xì)說(shuō)明的步驟，便于第一線的作業(yè)者參考使用，以免發(fā)生錯(cuò)誤或因人的理解能力不同而有所差異，造成質(zhì)量管理體系運(yùn)作有所偏差而未能達(dá)成質(zhì)量目標(biāo)和質(zhì)量方針；其目的在于規(guī)范作業(yè)的質(zhì)量管理活動(dòng)，并具體指出與質(zhì)量有關(guān)的作業(yè)指導(dǎo)和要求。Workinginstruction:thetaskwedotocarryoutandfinishsomefunctionseffectivelyinqualitymanagementsystem(suchaspreparationforproduction,inspectionandtest,reworkandrepair,setting,personnel,etc)itdescribesstandardofeveryoperationindetail,includingdetailedspecificationsuchasapplicablescope,machine,measurementequipmentandmonitoringequipment,method,manner,personnel,time,placeofusingmoulds/tools/fixture/clamp/knivesandtobereferredbyoperatorstoavoidmistakesordifferencecausedbyunderstandingcapacity.Itspurposeistostandardizequalitymanagementactivitiesforoperationandpointoutworkinginstructionandrequirementsrelevantwithquality4.7表單/表格和記錄：指闡明所取得的結(jié)果或提供所完成活動(dòng)的證據(jù)的文件。Form/tableandrecords:Docsthatclarifyachievedresultsorprovideevidenceforfinishedactivities.5.0培訓(xùn)和資格Trainingandqualification參加質(zhì)量策劃人員，均應(yīng)參加TS16949:2002標(biāo)準(zhǔn)和本程序的培訓(xùn)。PersonnelwhoattendqualityplanningshouldattendtrainingofthisprocedureandTS16949:2002standard6.0指示內(nèi)容Indicationcontent6.1公司最高管理者(即總經(jīng)理)依據(jù)ISO/TS16949：2002版質(zhì)量管理體系要求，結(jié)合本公司質(zhì)量管理體系所制定頒布的質(zhì)量方針、目標(biāo)和公司的實(shí)際生產(chǎn)經(jīng)營(yíng)狀況及產(chǎn)品特性/性質(zhì)，規(guī)劃和建立本公司生產(chǎn)和服務(wù)所需的質(zhì)量管理體系文件結(jié)構(gòu)，公司質(zhì)量管理體系文件結(jié)構(gòu)由質(zhì)量手冊(cè)、程序文件、作業(yè)指導(dǎo)書、表單/表格和記錄等共四個(gè)層次的管理性文件組成，其文件的制定、編碼、審查、核準(zhǔn)、修訂、發(fā)放、回收、歸檔、銷毀等由品保部按《文件和資料控制程序》執(zhí)行。Thehighestmanagement(namelygeneralmanager)drawsupandplandocsstructureofqualitymanagementsystemproductionandserviceneedinaccordancewithrequirementsIn2002editionofISO/TS16949:qualitymanagementsystemandqualitypolicy,goalandactualmanagementconditionandproductcharacteristics/quality.Docsstructureofqualitymanagementsystemaremadeupofqualitymanual,proceduredocs,workinginstruction,forms,tablesandrecords.QAdrawup,code,censor,approve,revise,distribute,recycle,fileandcanceldocsinaccordancewith《controlprocedurefordocsandinformation》6.2總經(jīng)理根據(jù)公司實(shí)際的生產(chǎn)和經(jīng)營(yíng)狀況，以ISO/TS16949：2002質(zhì)量管理體系標(biāo)準(zhǔn)要求為準(zhǔn)則建立公司質(zhì)量管理體系所需要的過(guò)程及其在整個(gè)組織中的應(yīng)用，本公司質(zhì)量管理體系所需的過(guò)程包括：管理活動(dòng)，資源提供，產(chǎn)品實(shí)現(xiàn)，測(cè)量、分析和改進(jìn)。Generalmanagersetsprocessesqualitymanagementsystemneedsandapplicationofqualitymanagementsysteminwholeorganizationinaccordancewithactualproductionandmanagementconditionregardingstandardrequirementsofqualitymanagementsystemasguideline.qualitymanagementsysteminourcompanyincludesmanagementactivities,resourcesupplying,productrealization,measure,analysisandimprovement6.3公司總經(jīng)理根據(jù)質(zhì)量管理體系所需的過(guò)程決定這些過(guò)程的先后順序和其相互作用。GeneralmanagerofourCompanydecidessequenceoftheseprocessesandinteractioninaccordancewithprocessesqualitymanagementsystemneeds6.4公司各部門根據(jù)質(zhì)量管理體系所需的過(guò)程決定其所需的準(zhǔn)則和方法，以確保對(duì)這些過(guò)程進(jìn)行有效的運(yùn)行與控制。Eachdeptdecideguidelineandmethodinaccordancewithprocessesqualitymanagementsystemneedstoensurenormalrunningoftheseproceduresandtheyareundercontrol6.5公司各部門應(yīng)確保必要的資源和信息的適用性，以支持這些過(guò)程的運(yùn)行和監(jiān)控。Eachdeptshouldensureapplicabilityofnecessaryresourceandinformationtosupporttherunningandsupervisionoftheseprocesses6.6公司各部門應(yīng)對(duì)這些過(guò)程進(jìn)行測(cè)量、監(jiān)控、分析和改進(jìn)。Eachdeptshouldmeasure,monitorandimprovetheseprocesses6.7對(duì)質(zhì)量管理體系所需的過(guò)程實(shí)施必要的措施，以達(dá)成所計(jì)劃/策劃的結(jié)果并持續(xù)改進(jìn)這些過(guò)程。Carryoutnecessarymeasuretoprocessesofqualitymanagementsystemtoreachplannedresultandimprovetheseprocessescontinuously6.8當(dāng)公司選擇將某些過(guò)程委托給供應(yīng)商進(jìn)行加工時(shí)，公司按照《供應(yīng)商管理程序》、《采購(gòu)控制程序》對(duì)其監(jiān)控和管理，同時(shí)對(duì)這些委外加工過(guò)程的控制在程序中予以明確鑒別。Companymonitorandmanagesubcontractinaccordancewith《managementprocedureforsuppliers》、《controlprocedureforpurchasing》andidentifythesesubcontractingprocessesinprocedurewhenentrustingsomeprocessestosupplierstoprocess6.9為確保本公司質(zhì)量管理體系的有效運(yùn)作和其內(nèi)容的適宜性，品保部應(yīng)根據(jù)公司每年實(shí)際的生產(chǎn)經(jīng)營(yíng)狀況擬定質(zhì)量審核計(jì)劃，定期對(duì)質(zhì)量管理體系進(jìn)行審核，其具體的執(zhí)行工作按《內(nèi)部審核控制程序》執(zhí)行。QAdeptshouldmakecensoringplanandcensorqualitymanagementsystemregularlyinaccordancewithactualproductionandmanagementconditionand《controlprocedureforinternalcensoring》toensureeffectiverunningofqualitymanagementsystemandappropriatenessofitscontent6.10公司最高管理層應(yīng)根據(jù)《管理職責(zé)程序》規(guī)定定期對(duì)質(zhì)量管理體系的運(yùn)作進(jìn)行管理評(píng)審，以評(píng)價(jià)質(zhì)量管理體系的運(yùn)作狀況并予以持續(xù)改進(jìn)和不斷完善。Thehighestmanagementshouldreviewitsrunninginaccordancewithstipulationin《managementresponsibilitiesprocedure》toevaluaterunningconditionofqualitymanagementsystemandimproveandperfectitcontinuously6.11質(zhì)量策劃：為滿足產(chǎn)品、項(xiàng)目或合同和顧客規(guī)定的要求及結(jié)合本公司實(shí)際的生產(chǎn)和經(jīng)營(yíng)狀況以及產(chǎn)品特性/性質(zhì)，公司最高管理層必須對(duì)質(zhì)量管理體系覆蓋產(chǎn)品中所涉及到的所有過(guò)程和環(huán)節(jié)進(jìn)行質(zhì)量策劃；當(dāng)公司對(duì)質(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí)，應(yīng)保持質(zhì)量管理體系的完整性。Qualityplanning:Thehighestmanagementshoulddoqualityplanningforalltheprocessesandsectionsinvolvedwithproductsthatqualitymanagementsystemcoverstomeetrequirementsforproducts,itemsorcontractandcustomers’requirementsandactualmanagementandproductionconditionandproducts’characteristics/quality.Whenplanandcarryoutqualitymanagementsystemalteration,weshouldkeepcompletenessofqualitymanagementsystem6.11.1質(zhì)量策劃的時(shí)機(jī)Opportunityofqualityplanning:（1）按照ISO/TS16949：2002質(zhì)量管理體系要求建立、改進(jìn)公司質(zhì)量管理體系時(shí)；WhensettingandimprovingqualitymanagementsysteminaccordancewithISO/TS16949：2002qualitymanagementsystem（2）公司已制定并頒布和實(shí)施的質(zhì)量方針、目標(biāo)、組織結(jié)構(gòu)發(fā)生重大變化或重新制定頒布時(shí)；WhenThequalitypolicy,goalandorganizationstructurecompanyhaveissuedchangegreatlyorarere-setandissued（3）資源配置、市場(chǎng)情況發(fā)生重大變化時(shí)；Whenresourceconfiguration,marketconditionchangegreatly（4）公司引進(jìn)、開(kāi)發(fā)和試制新過(guò)程，采用新工藝或新材料，技術(shù)革新或改造以及顧客對(duì)產(chǎn)品有特定要求時(shí)。Whencompanyintroduce,developandtest-manufacturenewprocessandapplynewtechnologyormaterial,ordotechnologyrenovationoralterationandwhencustomershavespecialrequirementsforproducts6.11.2質(zhì)量策劃的原則Principleforqualityplanning:（1）與質(zhì)量管理體系協(xié)調(diào)：質(zhì)量策劃應(yīng)以已建立的質(zhì)量管理體系為基礎(chǔ)，符合公司的質(zhì)量方針和質(zhì)量目標(biāo)，并與已有的質(zhì)量管理體系文件相協(xié)調(diào)。Coordinatewithqualitymanagementsystem:QualityplanningshouldbaseonqualitymanagementsystemthathavebeendrewupandconformtoqualitypolicyandgoalandCoordinatewithdocsofqualitymanagementsystemthathavebeendrewup（2）確保過(guò)程受控：質(zhì)量策劃活動(dòng)應(yīng)確保當(dāng)公司的組織結(jié)構(gòu)、生產(chǎn)條件變化時(shí)，所有活動(dòng)過(guò)程仍然受控，并使公司的質(zhì)量管理體系得到正常運(yùn)行，以保持公司質(zhì)量管理體系的完整性。Ensureprocessesareundercontrol:qualityplanningshouldensurealltheactivityprocessesareundercontrolwhenorganizationstructureandproductionconditionchangeandmakequalitymanagementsystemrunnormallytomaintaincompletenessofqualitymanagementsystem6.11.3質(zhì)量策劃的要求Requirementsforqualityplanning:（1）質(zhì)量目標(biāo)：如公司的質(zhì)量目標(biāo)（包括公司年度質(zhì)量目標(biāo)和各部門年度質(zhì)量目標(biāo)）對(duì)某一種特定情況不完全適用時(shí)，公司最高管理層應(yīng)首先確定有針對(duì)性的質(zhì)量目標(biāo)（包括公司年度質(zhì)量目標(biāo)和各部門年度質(zhì)量目標(biāo)）。Qualitygoal:ifcompany’squalitygoalarenotapplicabletosomeconditiontotally,thehighestmanagementshoulddeterminequalitygoalforit(includingannualqualitygoalofcompanyandofeachdept)（2）過(guò)程安排：確定為滿足公司質(zhì)量方針和質(zhì)量目標(biāo)要求所需要的活動(dòng)，即：質(zhì)量管理體系的過(guò)程。Processarrangement:Determinetheactivitiesweneedtomeetrequirementsofqualitypolicyandqualitygoal,namelytheprocessofqualitymanagementsystem（3）資源：確定這些過(guò)程所需要的資源（包括使公司和各部門年度質(zhì)量目標(biāo)能達(dá)成所需要的資源）。Resource:Determineresourcetheseprocessesneed(includingresourceweneedtoreachannualqualitygoal)6.11.4質(zhì)量策劃的內(nèi)容Contentofqualityplanning:（1）針對(duì)特定產(chǎn)品、項(xiàng)目或合同所需達(dá)到的質(zhì)量目標(biāo)以及所需建立的相應(yīng)的質(zhì)量管理過(guò)程和子過(guò)程，識(shí)別關(guān)鍵的過(guò)程和活動(dòng)，對(duì)過(guò)程或涉及的活動(dòng)規(guī)定的途徑；確定過(guò)程的輸入、輸出及活動(dòng)，并對(duì)其做出相應(yīng)的規(guī)定、評(píng)審、驗(yàn)證、確認(rèn)和形成文件；Qualitygoalweneedtoreachandqualitymanagementprocessesandsub-processesweneedtosetupforsomeproducts,itemsorcontract.identifykeyprocessesandactivitiesforprocessesandmethodofinvolvedactivities.identifyinput,outputandactivitiesofprocessesandmakestipulationreview,validation,identificationforitandmakedocs（2）識(shí)別為實(shí)現(xiàn)質(zhì)量目標(biāo)所需建立的過(guò)程的資源配置、運(yùn)作階段的劃分、人員的職責(zé)/權(quán)限和相互關(guān)系；Identifyresourceconfiguration,partitionofrunningphase,responsibilities/authorityofpersonnelandinterrelationweneedtorealizequalitygoal（3）確定過(guò)程涉及的驗(yàn)證和確認(rèn)活動(dòng)及驗(yàn)收準(zhǔn)則，對(duì)過(guò)程和產(chǎn)品的關(guān)鍵或重要特性應(yīng)安排測(cè)量和監(jiān)控活動(dòng)以及確定為過(guò)程和產(chǎn)品的符合性提供證據(jù)的記錄；Identifyvalidationinvolvedwithprocessandactivitiesandacceptingguideline.arrangemeasuringandmonitoringactivitiesforkeyandimportantcharacteristicsofprocessandproductsandrecordsthatprovideevidenceforconformity（4）對(duì)實(shí)現(xiàn)公司年度質(zhì)量目標(biāo)和階段或局部的質(zhì)量目標(biāo)進(jìn)行定期評(píng)審的規(guī)定，重點(diǎn)評(píng)審過(guò)程和活動(dòng)的改進(jìn)；Reviewtherealizationofannualqualitygoalandtemporarypartialqualitygoalandemphasizeonimprovementofreviewingprocessesandactivities（5）根據(jù)評(píng)審結(jié)果尋找與質(zhì)量目標(biāo)的差距，確保持續(xù)改進(jìn)，提高公司質(zhì)量管理體系的有效性和效率Findoutdifferencebetweenreviewingresultandqualitygoalandkeepimprovingandpromotevalidityandefficiencyofqualitymanagementsystem（6）質(zhì)量策劃的結(jié)果（包括更改）應(yīng)形成文件。如質(zhì)量管理方案、質(zhì)量計(jì)劃、控制計(jì)劃等。Resultofqualityplanningshouldbeformedintodocssuchasqualitymanagementmethod,qualityplan,controlplan,etc.6.11.5質(zhì)量策劃的輸入Inputofforqualityplanning：（1）顧客和其他受益者的需求和期望：公司顧客可能是投資者或未來(lái)的生產(chǎn)者，收益者則還應(yīng)考慮社會(huì)（環(huán)境與安全）及供應(yīng)商等。Needsandexpectationsofcustomersandotherpersonsthatbenefitfromit:customersofourcompanymaybeinvestorsorproducersinfuture.societyandsupplierscanalsobeconsideredaspersonsthatbenefitshould（2）產(chǎn)品特性：提供的產(chǎn)品應(yīng)達(dá)到的特性指標(biāo)（如：尺寸、外觀、性能、功能等）。Productcharacteristics:characteristicsIndexproductsprovideshouldreach(suchassize,appearance,function,performance,etc)（3）質(zhì)量管理體系的過(guò)程業(yè)績(jī)：對(duì)質(zhì)量管理體系原有過(guò)程業(yè)績(jī)優(yōu)良者，可以直接引用，否則應(yīng)考慮更新。Processachievementofqualitymanagementsystem:Wecanusetheonesthathadexcellentachievementbeforedirectlyorweshouldconsiderupdatingit（4）以前的工作經(jīng)驗(yàn)及教訓(xùn)：公司最高管理層在進(jìn)行質(zhì)量策劃時(shí)，應(yīng)借鑒類似項(xiàng)目的成功經(jīng)驗(yàn)和付出巨大代價(jià)換來(lái)的教訓(xùn)，這對(duì)質(zhì)量策劃來(lái)說(shuō)，是一個(gè)很好的預(yù)防措施。Previousworkingexperienceandlesson:Thehighestmanagementshouldusesuccessfulexperienceandlessontheylearnofanalogousitemsasreference.thisisagoodpreventivemeasureforqualityplanning（5）改進(jìn)的業(yè)績(jī)：公司最高管理層在進(jìn)行質(zhì)量策劃時(shí)，應(yīng)汲取質(zhì)量管理體系持續(xù)改進(jìn)所取得的成果。Improvedachievement:thehighestmanagementshouldlearnfromresultsofcontinuousimprovementofqualitymanagementsystemWhendoingqualityplanning（6）風(fēng)險(xiǎn)評(píng)估及風(fēng)險(xiǎn)降低：對(duì)可能發(fā)生的產(chǎn)品和過(guò)程的失效，應(yīng)根據(jù)已有的風(fēng)險(xiǎn)評(píng)估資料采取針對(duì)性的措施，以便將風(fēng)險(xiǎn)降低到可接受的程度。Riskevaluationandriskreduction:Takepertinentmeasuresinaccordancewithriskevaluationdatawehavetoproductfailureandprocessfailurethatmayhappentoreducerisktoanacceptabledegree6.11.6質(zhì)量策劃應(yīng)開(kāi)展的工作和活動(dòng)：Workingandactivitiesweshouldcarryouttodoqualityplanning(1)確定和配備必要的控制手段、過(guò)程、設(shè)備（包括檢驗(yàn)和試驗(yàn)設(shè)備）、工藝裝備、資源和技能等，識(shí)別過(guò)程中的質(zhì)量特性，以達(dá)到所要求的質(zhì)量；Identifyandequipnecessarycontrolmethod,process,equipment(includinginspectingandtestingequipment)technologyequipment,resourceandskill,etc.identifyqualitycharacteristicsinprocessestoreachrequiredquality(2)為過(guò)程配備必要的資源（如：硬件和軟件）；Equipnecessaryresourceforprocesses(suchashardwareandsoftware)a.購(gòu)置：在市場(chǎng)上尋覓適用的產(chǎn)品；Purchase:lookforproperproductsinmarketb.研制：在技術(shù)能力有把握實(shí)現(xiàn)的范圍內(nèi)自行研制；Develop:developbyoneselfwithincapacityscopec.創(chuàng)新：超過(guò)現(xiàn)有技術(shù)水平，但能在合同規(guī)定的期限內(nèi)進(jìn)行創(chuàng)新；Innovation:innovatewithinperiodcontractstipulates,surpassingcurrenttechnologystandardd.對(duì)管理方法也應(yīng)注意可能實(shí)現(xiàn)的更新。Weshoulddopracticalupdatetomanagementmethod(3)確保生產(chǎn)過(guò)程、服務(wù)、檢驗(yàn)和試驗(yàn)程序和有關(guān)文件的相容性；Ensureproductionprocess,service,inspectingandtestingprocedurecompatiblewithrelevantdocs(4)必要時(shí)，更新質(zhì)量控制、檢驗(yàn)和試驗(yàn)技術(shù)，包括研制新的測(cè)試設(shè)備；Updatequalitycontrol,inspectingandtestingtechnology,includingdevelopnewtestingequipmentwhennecessary(5)確定所有測(cè)量要求，包括超出現(xiàn)有水平、但在足夠時(shí)限內(nèi)能開(kāi)發(fā)的測(cè)量能力；Identifyallmeasuringrequirements,includingmeasuringcapacitythatsurpassescurrentstandardbutcanbedevelopedinenoughtime(6)確定在產(chǎn)品形成適當(dāng)階段的合適的驗(yàn)證活動(dòng)；Identifypropervalidationactivitiesinproperphase(7)對(duì)所有特性和要求，包括含有主觀因素的特性和要求，明確接收標(biāo)準(zhǔn)；Makeacceptingstandardclearforallthecharacteristicsandrequirements,includingcharacteristicsandrequirementscontainingsubjectivefactors(8)確定和準(zhǔn)備質(zhì)量記錄等。Identifyandpreparequalityrecords6.11.7對(duì)于滿足產(chǎn)品質(zhì)量、交付和/或服務(wù)等要求,公司必須作出明確規(guī)定并形成書面化的文件，使質(zhì)量策劃與質(zhì)量管理體系的所有其他要求相一致，以確保與產(chǎn)品質(zhì)量、交付和/或服務(wù)等有關(guān)的相關(guān)工作有所依循及得到有效實(shí)施，并成為適用于本公司的操作性文件。Companyshouldmakeclearstipulationandformthemintodocsforproductsquality,deliveryandserviceandmakequalityplanningconformtootherrequirementstoensureproductquality,deliveryandservicehavebasisandarecarriedouteffectivelyandbecomeoperatingdocsapplicabletoourcompany6.11.8本公司產(chǎn)品的質(zhì)量計(jì)劃為“控制計(jì)劃”，為滿足和符合產(chǎn)品、項(xiàng)目或合同和顧客規(guī)定的要求，本公司產(chǎn)品的“控制計(jì)劃”由ME部依據(jù)本公司產(chǎn)品的特性/性質(zhì)并結(jié)合本公司實(shí)際的生產(chǎn)和經(jīng)營(yíng)狀況按《控制計(jì)劃管理程序》規(guī)定制定，以作為公司生產(chǎn)和/或服務(wù)所需運(yùn)用的設(shè)備（包括檢驗(yàn)和試驗(yàn)設(shè)備）、工藝裝備、技術(shù)條件、檢驗(yàn)和/或試驗(yàn)（包括接收準(zhǔn)則）、方法、人員等資源管理與控制的指導(dǎo)綱要。Qualityplanforourcompany’sproductsiscontrolplan.MEsetQualityplanforourcompany’sproductsinaccordancewithcharacteristics/qualityofourcompany’sproductsandactualproductionandmanagementconditionofourcompanyand《managementprocedureforcontrolplan》asdirectioncompendiumforequipment(includinginspectingandtestingmethod),technologyequipment,techniquecondition,inspectingandtestingmethod(includingacceptingguideline),personnelweneedinproductionandservice6.11.9其他臨時(shí)性的質(zhì)量計(jì)劃（例如：重要項(xiàng)目的質(zhì)量計(jì)劃、常規(guī)產(chǎn)品或項(xiàng)目變化的質(zhì)量計(jì)劃等），由工程部依據(jù)產(chǎn)品現(xiàn)有不同制造能力或顧客要求等需要制定，以滿足其需求及本公司的發(fā)展目標(biāo)。EngineeringdeptmakeOthertemporaryqualityplan(suchasqualityplanforimportantitems,normalproductsorqualityplanforchangeditems)inaccordancewithdifferentmanufacturecapacityofproductsorcustomers’requirementstomeettheirneedsandcompany’sdevelopinggoal6.11.10質(zhì)量策劃的實(shí)施、監(jiān)督、檢查：Enforcement,supervisionandcheckingofqualityplanning(1)公司各部門在執(zhí)行質(zhì)量策劃時(shí)應(yīng)按照質(zhì)量策劃規(guī)定的內(nèi)容、進(jìn)度、要求進(jìn)行控制和管理，并將執(zhí)行情況、存在的問(wèn)題等向公司管理層報(bào)告。Eachdeptshouldcontrolandmanageinaccordancewithcontent,progressandrequirementsstipulatedinqualityplanningwhencarryingoutqualityplanningandreportingenforcingcondition,problemsexistingtomanagement(2)必要時(shí)，品保部應(yīng)將質(zhì)量策劃實(shí)施情況的監(jiān)督檢查情況向公司管理層報(bào)告。QAdeptshouldreportmonitoringandcheckingconditionofenforcingconditionofqualityplanningtomanagementwhennecessary6.11.11在產(chǎn)品質(zhì)量策劃過(guò)程中，必須利用質(zhì)量方針、質(zhì)量目標(biāo)、內(nèi)部和外部審核結(jié)果、數(shù)據(jù)統(tǒng)計(jì)分析、糾正和預(yù)防措施、顧客抱怨/投訴、管理評(píng)審等來(lái)進(jìn)行質(zhì)量管理體系的持續(xù)改進(jìn)。Improvequalitymanagementsystemcontinuouslyusingqualitypolicy,qualitygoal,internalandexternalcensoringresult,statandanalysisofdata,correctiveandpreventivemeasures,customers’complaint/appeal,managementreviewingduringproductqualityplanning（1）本公司的質(zhì)量管理體系強(qiáng)調(diào)以預(yù)防為主的管理思想，主動(dòng)對(duì)生產(chǎn)過(guò)程中的質(zhì)量?jī)A向和趨勢(shì)進(jìn)行診斷、預(yù)防和處理，以消除發(fā)生不合格的潛在原因，對(duì)已發(fā)生的不合格現(xiàn)象，主動(dòng)給予處置和防范，防止其再次發(fā)生。Ourcompany’squalitymanagementsystememphasizesthemanagementideathatweshouldgiveprioritytopreventionanddiagnoseandpreventandhandlequalitytrendtoeliminatepotentialcauseofunsatisfactoryphenomenonandhandleunsatisfactoryphenomenonandpreventincasethatitwillhappenagain（2）通過(guò)質(zhì)量管理體系的運(yùn)行和持續(xù)改進(jìn)，不斷地達(dá)到質(zhì)量管理體系自我完善和自我規(guī)范的目的。Improveandstandardizequalitymanagementsystembyoperatingandimprovingqualitymanagementsystemcontinuously6.11.12質(zhì)量策劃的更改：如因質(zhì)量方針、目標(biāo)、內(nèi)部和外部審核結(jié)果、數(shù)據(jù)統(tǒng)計(jì)分析、糾正和預(yù)防措施、顧客抱怨/投訴、顧客要求被重新修訂和/或管理評(píng)審所造成的質(zhì)量策劃更改，則必須確保其更改在受控狀態(tài)下進(jìn)行，并且在更改期間仍需保持其質(zhì)量管理體系的完整性（如公司組織結(jié)構(gòu)的調(diào)整應(yīng)對(duì)其相應(yīng)的職責(zé)作出相應(yīng)的變更等），以確保公司質(zhì)量管理體系正常運(yùn)作。Alterationofqualityplanning:Alterationofqualityplanningthatiscausedbyqualitypolicy,goal,internalandexternalcensoring,datastatandanalysis,correctiveandpreventivemeasures,customers’complaintandappeal,revisioncustomersrequireandAlterationofquality