SQP質(zhì)量驗廠要求及標準

SQP質(zhì)量驗廠要求及標準SQPStandardrequirement#SQPREQUIREMENT/CRITERIA/REFERENCESQP要求/標準/參考TotalPossibleScore最高可能得分PointsScored實際得分Yes/No是/否Majororminor主要/輕微FacilitiesandEquipment廠房/設備FE1Isthefacilityclean(internal/external)?Throughoutthecourseoftheassessment,observationofcleanlinessshouldbetaken.Cleanlinessshouldbedefinedasanenvironmentthatreducesand/oreliminatesthepotentialforcontamination.工廠是否干凈（評估的整個過程都要觀察工廠清潔情況，工廠應該有定義清潔的環(huán)境要素并持續(xù)改善清潔狀況）200FE2Aretherewrittenproceduresaddressingthemaintenanceofthe

facility?

PreventiveMaintenancepoliciesandschedulesshouldbedocumented.Recordsshouldbeavailableforreviewandshouldcontaininformationregardingdailypre-operationequipmentinspection,dailymonitoringofequipmentfunction,dailyhousekeepingactivities,sanitationactivitiesandanyothernecessaryactivitiestomaintainthesafetyandqualityofproduct.有沒有書面的廠房/設施維護程序？預防性維護的政策和程序。每日開機檢查記錄，每日設備功能檢查記錄，每日打掃衛(wèi)生記錄，以及其他所需的工作來保證產(chǎn)品的安全和質(zhì)量……200FE3Istherealistofapprovedchemicalsformaintainingthesanitationofthefacility?Chemicalsusedforanyoftheaboveactivitiesshouldbedefinedwithintheapprovedproceduresandpolicies.MaterialSafetyDataSheetsshouldbemaintainedforallchemicals.AnappropriatesampleofchemicalsshouldbeselectedandMSDSrequestedforeach.IfanychemicalsareobservedinusewithoutapprovalorifanyofthechemicalsselecteddonothaveMSDSprovided,theanswerisNO.是否有清潔用化學品清單。這些用來清潔的化學品應該有合適的批準程序批準，有MSDS數(shù)據(jù)。如果發(fā)現(xiàn)任何沒有在清單中的化學品，或則沒有MSDS，答案就應該是“No”100FE4Isstorageofchemicalsusedinthefacilityadequate?EnsurethatallchemicalsarestoredinamannerconsistentwiththeinstructionspertheirMSDSsheets.Additionally,ensurethatthemethodofstorageisinsuchamannertoeliminateproductcontamination.AnswerisNOifstorageconflictswitheitherrequirementabove.存儲化學品的設施是否合適/充足？確保所有化學品都按照其MSDS要求合適存儲，避免污染。否則答案為“NO”300FE5Isthefacilityinsatisfactorystructuralcondition?

NoRodentEntryPoints,NobrokenGlassorWindows,Ceilingdoesnotindicatewaterdamageorstructuraldefects.廠房結構是否令人滿意，沒有蟲害入侵點，沒有破碎的玻璃或窗戶。天花板沒有漏水的痕跡。300FE6Iswastematerialhandledappropriately?

Ensure

thedumpsterareasarecleanandwellorganized.Externalwasteisnotexcessive.肥料處理是否合適，垃圾桶附近干凈整潔。100FE7Isthedesignofthefacilityadequatetoallowforsmoothflowof

materialsandreducepotentialforcontamination?工廠平面結構設計是否合理，可以是物料流轉順暢，避免潛在的污染風險200FE8Arethereadequateenvironmentalcontrolsforthebuilding?

If

theproductunderassessmentrequiresenvironmentalcontrols,ensurethatthesupplierhascontrolledandverifiedtemperatureatcriticalareas.Ifenvironmentalcontrolisinadequate,theanswerisNO.Ifenvironmentalcontrolisnotapplicabletotheproduction,theanswerisN/A.建筑物是否有合適的環(huán)境控制，如果產(chǎn)品有環(huán)境控制需求，請確保供應商有控制和確認溫度。300FE9Isthelightingadequateforthebuilding?建筑內(nèi)部照明是否充足100FE10Isthepestcontrolprogramadequate?

Ensurethatacontractexiststhatdocumentsaregularlyscheduledpestcontrolserviceprogram.Thecontractpackageshouldincludeataminimum:a)writtendocumentationregardingtheserviceperformedandtypeofmaterialsused;b)acurrentmapindicatingthelocationsofallrodenttraps;c)copiesofthelicensesandcertificatesofinsuranceforthepestcontrolcompanyandcurrentlicenseforinspectors.Reviewarepresentativesampleofinspectionrecordsfromthelast12months.Ensurethatanypestproblemsnotedhavebeenaddressedandhadbeenaddressedpriortothenextinspection.Ensurethetraps/devicesaretraceableeitherbynumericallabeling,barcodingorothermethod.Ensurethatthepestcontrolinspectorhasinitialedorprovidedsomeotherdocumentationtosupportthatalltrapshadbeenproperlyinspected.Finally,toreceiveaYESforthisquestion,nosignofrodentactivity

wasnotedduringthecourseofthisassessment.蟲害控制程序是否合適？確保有外發(fā)的定期蟲害控制合約，合約至少包括a)服務內(nèi)容和所有材料b)鼠籠的安放位置圖c)蟲害防治公司的營業(yè)執(zhí)照，檢查12個月的蟲害控制記錄，鼠籠等設備有編號，可以追溯。鼠籠等設備合適安裝并定期檢查證據(jù)300FE11Arethewashroomsandtoiletscleanandingoodworkingorder?

Clean,stockedwithAntibacterialSoapandsingleusenapkin/towel,runninghotwater.水房和廁所是否良好？干凈，有防菌肥皂和一次性紙巾，熱水300FE12Isanorganizedsparepartsinventorykeptonhandatthefactory?

Lookforaroomorareaseparatefromproductionthatcontainssparepartsfortheproductionequipment.Doesnotneedtobeallspareparts,butataminimumshouldbecriticalpartsneededtokeeptheequipmentrunning.Factoryshouldhaveinventorylist.備件倉是否組織良好？備件倉需同生產(chǎn)隔離。關鍵零件必須要備件并有清單控制100TOTALSCOREFORTHISSECTION2500QualitySystem品質(zhì)系統(tǒng)OrganizationandPersonnel組織和人員QS1IsaTableofOrganization(ToO)availableforreview?Current?

Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.組織架構圖？最新，有批準和受控200QS2Isqualityassuranceindependentofmanufacturing?

Ensure

thattheToOdescribesseparationofmanufacturingauthorityandqualityassuranceauthority.有沒有獨立于生產(chǎn)的品質(zhì)保證部門。組織架構同應該有體現(xiàn)200QS3Areuptodatebiographies(CVs)availableforsupervisory

personnelshownontheToO?主管以上人員必須要簡歷保存100QS4Doesthequalitydepartmenthaveadequatecoverageduringall

shifts?

Reviewlast30daysofshiftschedules.Foreveryproductionshift,theremustbedocumentedQCcoveragetoscoreaYES.*Guidance:“DocumentedQCCoverage”maybedemonstratedthroughacombinationofbothofthefollowingpractices:1)Designationof“QualityResponsible”operator(s)duringa2ndor3rdshift.Thisisacceptablesolongasverificationoftrainingmaybeprovidedandconclusiondrawnthatdesignated“QualityResponsible”operatorshavetheeducation,experienceandknowledgetoactintheroleofQC.2)ThevendormusthaveprocedureandrecordstoensurethatQAreviewsandreleasesallbatchespriortoshipment.品質(zhì)部門是否有足夠的人員去覆蓋所有的生產(chǎn)班次?檢查最近30天的生產(chǎn)安排，每個生產(chǎn)班，都必須有品質(zhì)文件，“品質(zhì)文件”是指：1）每班有指定合格的品質(zhì)負責人，且品質(zhì)負責人有合適的培訓，經(jīng)驗和知識2)供應商必須有程序和記錄確保出貨前qa檢查每批貨物。300QS5IsthereawrittenprocedureforgeneralGMPtraining?This

shouldbeaprocedureorotherdocumentsdefiningfrequencyoftraining,generalscopeoftraining,trainingproviderandmethodologyfordeterminingcompetency.GMP培訓程序？程序要定義培訓頻率，培訓范圍，講師和培訓方法100QS6Aretrainingrecordsavailableforindividualsrandomlyselected?Randomlyselectanappropriatesamplebasedonthesizeofoperationtoverifytrainingrecordsexist.Ifnorecordexistsforsampledemployees,scoreNO.隨機檢查培訓記錄100QS7Dotrainingrecordscontainnames(trainer/trainee),datesand

subjectmatter?AlsoensuretherecordsdemonstrateconformancewiththeproceduretoscoreYES.培訓記錄是否報考名字（講師和學員），日期和培訓主題。200QS8Isthereasufficientmeansforverifyingtraineecomprehension?

Reviewthemethodoftrainingverification.Ensurethatitisappropriatetotheextentofresponsibilityfortheproduct.是否有合適培訓效果確認方法200QS9Aresatisfactorytrainingmaterialsavailableforreview?

Slides,

handouts,otherdocumentationtodemonstratetrainingprovidedconformstoprocedure.是否有合適的培訓材料，幻燈片，印刷材料100QS10DoGMPtrainingmaterialsadequatelyaddressfacilitysanitation,

personalhygiene,andrecordkeeping?培訓材料是否有涵蓋廠房清潔衛(wèi)生，個人衛(wèi)生和記錄保存200QS11Doemployeespracticesanitationandhygieneinthemanufacturingoperations?Duringthewalkthroughofproduction,storage,etc.observeemployeestoensureallsanitationandhygienepoliciesareimplemented.Ifobservationdeterminespoliciesarenotbeingfollowed,mustscoreNO.員工是否按照衛(wèi)生要求開展工作，在現(xiàn)場走訪時觀察員工和實施的人身狀況300QS12Areonthejob(OTJ)trainingrecordsavailableforindividuals

randomlyselected?

Specificallyverifyanyemployeeobservednotfollowingsanitationandhygiene

policiestodetermineifthey'vebeenprovidedthetraining.隨機檢查員工在職培訓記錄，特別檢查那個沒有按照衛(wèi)生要求做事的員工200QS13AreOTJtrainingrecordscompleteandadequate?Containsnames(trainer/trainee),datesandsubjectmatter,specificreferencetomachine,process,oractivity.崗位培訓記錄是否詳實，包括姓名（講師和學員），日期，主題，參考材料和相關活動200QS14AreSOPsavailableforreview?

SOPs

shouldcoverallcriticalprocessesutilizedforthecontrolledmanufactureofproduct(s)includedintheassessmentscopetoscoreYES.有沒有SOP（標準作業(yè)程序），SOP應該涵蓋所有關鍵受控工序300QS15AreSOPswritten,identifiedandapprovedinasatisfactory

manner?Current?Approved?Controlled?MustbeabletosayYEStothesesubsequentrequirementsinordertoscoreYES.SOP是否文件化，有編號和被批準。最新，有審批和受控300QS16IsdistributionofnewandrevisedSOPsandretrievalofobsolete

SOPsadequate?有沒有SOP修改，分發(fā)控制程序200QS17DodocumentedINSPECTIONproceduresorinstructionsexist?

Reviewinspectionproceduredocumentation.檢查作業(yè)指導書，100QS18AreSOPsreviewedperiodicallytoensuretheirapplicabilityto

currentpractices?SOP定期審查100QS19Isthereadocumentedchangecontrolprocedureforplannedand

unplannedchangestoproductionprocesses?有沒有文件化的變更控制程序，包括計劃內(nèi)的生產(chǎn)工序變更和非計劃的變更300QS20Arechangesrelatingtomanufacturing/packagingprocesses

adequatelyapproved,wherenecessary?ThesechangesshouldbeapprovedbytheresponsiblepartiesidentifiedinthechangecontrolprocedureindicatedabovetoscoreYES.有關生產(chǎn)/包裝的變更是否有合適的批準程序。300QS21Arelogbooksavailableforreviewwithrespecttoproduction?生產(chǎn)登記本100QS22Istheuseoflogbooksdetailedinawrittenprocedure?文件化的生產(chǎn)登記本使用說明100QS23Arelogbooksclearwithrespecttoactionstakenbyindividuals?生產(chǎn)登記本記錄清晰，可以看清楚沒有人的動作

記錄。100QS24Dologbooksexhibitgooddocumentationpracticeswithrespectto

changes,legibilityandsequenceofevents?

Nowhiteout,scratchoutmarks,etc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.生產(chǎn)登記本是否更改謹慎，清晰易讀100QS25Arelogbooksperiodicallyreviewedtoensuretheiradequacy?生產(chǎn)登記本記錄是否定期檢查100QS26Isthereanadequatewrittenprogramforthemaintenanceof

productionrecordsforeachfinishedproductmanufactured?是否有合適的文件化程序來維護每批產(chǎn)品的生產(chǎn)記錄300QS27Dobatchproductionrecordscontainadequateinformationwith

respecttothepackagingoffinishedproducts?

Ensurepackaginglabels/informationincludeadequateinformationtosupportthatproductionrecordsareaccuratewithrespecttoidentification,quantity,weight,material,etc.批生產(chǎn)記錄是否包括關于成品包裝的合適信息，標簽信息300QS28Dobatchproductionrecordscontaintherequiredinformation

necessarywithrespecttoassuringthequalityoffinishedproducts?Ensureproductionrecordscontainidentificationofthetypeofmaterial,amountofmaterial,andverificationofanycriticalstepsperthespecificationtoscoreYES.批生產(chǎn)記錄是否包含原材類型，數(shù)量個關鍵步驟確認規(guī)范300QS29Dobatchrecordsexhibitgooddocumentationpracticeswith

respecttochanges,legibilityandadequacyofentries?

Nowhiteout,scratchoutmarksetc.Changestotheserecordsshouldbemadewithasinglecross-outandbeinitialedanddatedtoscoreYES.批生產(chǎn)記錄改動謹慎，清晰易讀。沒有涂鴉，修改有備注時間和簽名100QS30ArebatchrecordsreviewedbyQApriortoarchival?批記錄在存檔前必須有QA檢查確認300QS31Areadequaterecordsmaintainedwithrespecttothese

investigations?不良品原因調(diào)查是否有記錄200QS32Doinvestigationsincludeareviewofproductionandlaboratory

eventswhichmaycontributetoorbethecauseofthefailure?調(diào)查是否包括檢查生產(chǎn)記錄，實驗室記錄200QS33Ifinvestigationsareinconclusiveandretestingisconducted,isthe

approachtoretestingbasedonsoundrationale?如不良調(diào)查得出結論需要從新測試，那么測試方法是有合適300QS34Doallinvestigationsconcludeanactualorprobablecauseforthefailure?是否所有調(diào)查都給出實際或可能的原因200QS35Areinvestigationscompletedwithinareasonabletimeframe?失效調(diào)查是否在合理的時間內(nèi)完成300QS36DoesQualityAssuranceadequatelyreviewthefailureinvestigations?品質(zhì)部門是否合適地審查這些調(diào)查300AnnualProductReview/InternalAudits/CorrectiveandPreventativeActions年度產(chǎn)品審核/內(nèi)審/預防改善QS37IsthereanadequatewrittenprocedureforconductingProduct

Reviews?

Thisshouldcontainfrequency,methodology,responsiblepartiesandrecordkeepingrequirements.是否有合適的程序來主導產(chǎn)品審查，包括審核頻率，方法，責任人和記錄保持100QS38Isthereanadequatewrittenprocedureforconductinginternal

audits?

Thisshouldcontainfrequency,methodology,responsibleparties,record

keepingrequirements,authority,followuporcorrectiveactionreferencebased

oninternalauditresults.是否有內(nèi)審程序，包括頻率，方法，責任方，記錄，擁有者和改善行動跟進200QS39Areinternalauditsbeingconductedaccordingtotheprocedure?內(nèi)審是否按程序進行200QS40Issupportingdocumentation(schedules,auditreports,CAreports)fortheauditsavailable?

Dothesedocumentsandrecordsdemonstrateconformancetotheprocedure?內(nèi)審計劃，內(nèi)審報告，內(nèi)審改善報告，200QS41Areresponsestotheauditfindings/observationsintheformof

correctiveand/orpreventativeactions(CAPA)addressingrootcause?內(nèi)審負責撰寫改善行動的人是否有也謝清楚了不良發(fā)生的原因200QS42AreCAPAsbeingcompletedandinstitutedwithinareasonable

timeframe?改善行動是否在合理的時間內(nèi)完成200QS43DoesQualityAssurancefollow-upanddetermineiftheappropriate

CAPAhasbeencompleted?

Thisshouldbe

documentedviatheCorrectiveActionformorrecordutilizedbythefactoryOR

viaasubsequentinternalauditofthedeficientarea.QA是否跟進并確保執(zhí)行合適的改善行動300QS44Arecorrectiveactionplansdevelopedanddocumentedbasedon

theresultsoftheweeklyQCmeetings?

Isthere

documentationofcorrectiveactionplansintheQCmeetingnotes?MustseetoscoreaYES.是否在每周的品質(zhì)會議中開發(fā)改善行動記錄。200TOTALSCOREFORTHISSECTION8900MaterialSystem&SupplierQualityManagement原材料和供應商品質(zhì)管理ComponentsHandling/HoldingandDistribution部件/零件的處理與分發(fā)MS1Doesthefactoryhaveadocumentedprocesstomakesurethat

incomingrawmaterials,components,and/orsub-assembliesconformtospecifications,qualitystandardsandUSSafetyrequirements?

Verifythatthereisaprocessdocumentedtoensureallincomingrawmaterials,componentsand/orsub-assembliesconformtospecificationsandUSSafetyrequirements.Painttestedforleadcontent,etc.工廠是否有文件化的程序來確保原材料，零件，外發(fā)加工品符合產(chǎn)品規(guī)范，品質(zhì)標準和美國安全要求，美國安全標準包括油漆測試，鉛含量等300MS2Isthereanadequateprocedureforthereceipt,samplingand

identificationofallrawmaterials?

Ensurethatinspectionproceduresextendtoreceiptandqualificationofrawmaterial.Ensurethatrecordsexisttosupportconformancetoprocedure.Ifnoprocedureorrecordsexist,scoreNO.是否有文件化的檢查程序來接受，抽樣和標識所有原材料。確保檢查程序包括接受和認證原材料。確保所有檢查記錄按照程序進行300MS3Arethereadequatespecificationsforallcomponentsandrawmaterialsreceived?Identification,type,grade,size,amount,weight,supplier,etc.原材料/零件的產(chǎn)品規(guī)格，包括識別，類型，等級，大小，數(shù)量，重量，供應商等信息300MS4ArerawmaterialsadequatelyquarantineduntilreleasebyQAto

production?Samplemultiplerawmaterialsandensurearecordexiststotracefromreceipttoqualification.Ifnotrailexists,scoreNO.是否所有原材料在分發(fā)給生產(chǎn)部之前都有QA檢查記錄，抽樣300MS5Areallcomponents(rawmaterials,primaryandsecondary

packaging)beingtestedagainstappropriateandestablishedspecifications?所有零件（原材料，主要和次要包裝材料）都按照和事的規(guī)格測試300MS6Whererawmaterialsarenotfullytestedagainstspecifications,isthereaprogramforqualifyingsuppliers?如果原材料沒有合適的測試，有沒有供應商認可程序300MS7Wherehistoricaldataisusedtoqualifysuppliers,doeshistorical

dataincludeinformationonallthecharacteristicslistedinthespecification?如果歷史數(shù)據(jù)用來認證供應商，這些歷史數(shù)據(jù)是否包括材料規(guī)格書中列出的所有特征。200MS8Doesthehistoricaldatasupporttheuseofreducedtesting?是否有歷史數(shù)據(jù)來支持減少測試的動作200MS9Whereauditsareusedtoqualifysuppliers,areauditreportsadequateandavailableforreview?

Auditreportsshouldcontainnameofsupplierandauditor.Theyshouldcontaininformationregardingtheprocessand/ordepartmentscovered.Theyshouldreferencethemethodologyand/orrequirementsusedtoassessthesupplier.如果用審查來認可供應商，那么是否有審查報告，這些報告包括供應商名字，審核員，他們也應該包括流程，部門。應該有審查方法，要求等200MS10Doesaprogramforperiodicauditingofvendors(materialand

servicesuppliers)exist?是否有對供應商定期審查200MS11IfCertificatesofAnalysisareaccepted,verifythatatleastonone

lotperyeartheitemisfullytested?如果接受分析認證。至少對原材料每年測試一批300MS12Arerawmaterials,in-processmaterialsandfinishedproducts

adequatelystoredandhandledsoastoavoidexposuretophysical,chemicalandmicrobiologicalcontamination?原材料，在制品和成品存儲是否良好，避免暴漏在物料理，化學和微生物污染的環(huán)境中300MS13IsthereanadequateprogramtoensureFIFO?是否有先進先出控制？100MS14Isthereaformalprogramforthere-qualificationofrawmaterials

storedforlongperiodsoftime?

Iftheproductunderassessmentrequirespotentmaterials,ensurethatthesupplierhaseffectivecontrolofexpiredorlesspotentmaterial.Ensurethatrequalificationprocessisadequatetoensurethepotencyofrawmaterial.Ifre-qualification

isinadequate,theanswerisNO.Ifpotencyisnotapplicabletotheproduction,

theanswerisN/A.有沒有正式的材料重新測試程序(材料長時間存放后需要做測試)300MS15Arerawmaterials,in-processandfinishedproductsadequatelydispositionedwhenfailingtomeetestablishedspecifications?

Ensurethataprocessexistsforlabelingand(ifappropriate)quarantineofnonconformingmaterialexists.Ensurethatrecordsexisttodemonstratedispositionofnonconformingmaterial.Ifnoprocessorrecordsexist,scoreNO.對于不良品是否有合適的處理，確保不良品有合適的標識，有相關的記錄來追蹤不良品處理300MS16Isthereanadequateprogramtoestablishthequalificationsand

reliabilityofsuppliersprovidingrawmaterialsiffulltestingisnotconductedonincomingrawmaterials?

Suppliersmustbequalifiedbasedonsoundreasoning.Whatistheimpacttothefinalproduct?Howdoesthefactorysourcenewsuppliers?ThesequestionsmustbeassessedinordertoscoreaYES.如果不是對原材料進行fulltest,是否建立一個合適的程序300MS17Doesthefactorydocumentandtracktheirsupplierreliability

(performance)?Reviewfactory'ssupplierreliability/performancetrackingdocument.RecordsshouldincludeCompany,item,incomingquantityandrejectedquantity.供應商是否追蹤供應商的表現(xiàn)，追蹤記錄必須報還公司，物料編號，來料允收/退貨300MS18Arerawmaterialsstoredinacontrolledareatoavoidtheft,loss,

damage,deterioration?Allrawmaterialshouldbeinanareathatiswithinfactoryperimeter,inasecureareathathasaroofandisnotsubjectedtobadweather,waterontheground,etc.

Rawmaterialsshouldbeplacedonpalletsorstoredonshelving.Thereshould

beassignedpersonneltomonitorthisarea.所有原材料必須放在一個受控的區(qū)域，避免被盜，丟失，損壞和變質(zhì)。須有房頂不受天氣影響，材料放在棧板上，有專門的看護人員300MS19Doesfactoryusesubcontractorsbasedonqualificationandverification?

Doesthefactorysubcontactphaseofproductioni.e.printing,embroidery,washing,packaging,etc.工廠是否使用被認真的分包商？300MS20Isproductinventoriedandreconciledwhenreceivedfrom

subcontractor?

DoesthefactorycounttheproductwhenitissenttotheSubConandreceivedfromtheSubConandcomparethenumbersagainsttheirrecordstomakesurethateverythingisaccountedfor?從分包商收回的部件是否點數(shù)300MS21Isproductreceivedfromsubcontractorinspected?(Records

mustexisttosupport.)

DoesthefactoryQCTeaminspecttheproductreceivedfromtheSubcontractor?Askforprocessdocumentationandreports.Processdocumentationshouldindicatequantitytobeinspectedandtheprocessbasedontheproductoroperationperformed.Reportsshouldincludethefollowinginformation:Inspectorsname,date,incomingquantity,samplesize,defectsfoundandcorrectiveaction(ifapplicable).BothmustbeavailabletoreceiveaYES.從分包商發(fā)回來的物料是否有品質(zhì)檢查-檢查記錄300MS22Doesevidencesupportsubcontractorhasadocumentedquality

controlprocess?

CanthefactoryprovidedocumentedevidencethattheSubcontractorusesforQC?Lookforprocessflows,DCLorsimilardocumentswithinspectionresultsperformedbySubcontractor,defects,etc.是否有證據(jù)證明分包商有自己的品質(zhì)控制程序。300TOTALSCOREFORTHISSECTION6000ProductionSystemManufacturingControlsPR1Dobatchproductionrecordsforeachformulatedfinishedproduct

containtherequiredinformationregardingtypesandamountsofmaterials?批生產(chǎn)記錄是否包含原物料類型，數(shù)量信息300PR2Dobatchproductionrecordscontainadequateinstructionswith

respecttothemanufactureoffinishedproducts?批生產(chǎn)記錄是否包含成品生產(chǎn)的充足指示200PR3Aretheactionsofindividualsincompliancewithestablished

procedures?員工的作業(yè)是否符合已經(jīng)建立的程序200PR4Arecriticalstepsinthemanufacturingoperationcheckedbya

secondindividual?關鍵工序的制造操作是否有第二個人檢查確認300PR5IsQAinvolvedinmonitoringtheproductionoffinishedproducts?

QAmustbeprovidedthefinishedproducttoconductinspectionactivitiesrequiredbyspecifications.QA是否監(jiān)測成品的生產(chǎn)，QA必須按照產(chǎn)品規(guī)范檢查成品300PR6AredocumentedPRODUCTIONproceduresorinstructionspresent

ateachproductionoperation?

Whileontheproductionfloor,lookforproductionproceduresateachoperation/machinery.MustbeavailabletoreceiveaYES.是否每個工位都有生程序或生產(chǎn)指示。在生產(chǎn)車間的每個作業(yè)點，機器旁尋找作業(yè)程序/指導書100PR7Doesthefactoryperforminlineinspections?

Reviewthefactory'sdocumentedinlineinspectionprocedure.ThedocumentmustexisttoreceiveaYES.工廠是否進行在線檢查？查看工廠在線檢查程序。300PR8Isthereaformalprogramforensuringthequalificationofall

processingequipmentwithrespecttoinstallation,operationandperformance(IQ/OQ/PQ)?

Ensurethatequipmenthasbeeninstalled,qualifiedandcalibratedadequately.Ensurethatprocessparametershavebeenidentifiedandthatverificationpracticesareineffect.Ensurethatanychangetoequipment(i.e.partreplacement,etc.)havebeeninstalled,qualifiedandcalibratedadequately.Ifrecordscannotsupportthispractice,scoreNO.是否有機器設備安裝，操作，運行的認可程序？確保所有機器正確安裝，充分認可以及充足的校驗。確保有效識別確認生產(chǎn)參數(shù)。確保任何針對設備變更（例如更換零件）都得到充分的認證和校驗。300PR9Isequipmentproperlyinstalledastoallowforreasonablecleaning,maintenanceandcalibration?設備是否安裝合理以便于清潔，保養(yǎng)和校驗200PR10Aretherewrittenproceduresforensuringthecleanliness,maintenanceandcalibrationofequipment?是否有針對設備清潔，保養(yǎng)和校驗的程序200PR11Isequipment(includingutensils)adequatelylabeledwithrespect

toitsconditionregardingcleanlinessandoperationalcapacity?設備（包括治具）是否標識出設備狀態(tài)，如清潔和操作能力200PR12Doesequipmentstatuscorrelatetocleaninglogentries?機器狀況是否和清潔記錄相符合100PR13Iscleanedequipment(includingutensils)adequatelyprotected

fromcontaminationpriortonextuse?

Ensurethatthestorageofequipmentisadequatetoprotectagainstcontaminationthatwouldimpactthequalityoftheproduct.Ifnotstoredadequately,scoreNO.機器（包括治具）是否定期清潔確保下次使用沒有污染？確認生產(chǎn)設備存儲能防止污染到產(chǎn)品的污染源300PR14Isthehandlingofwastematerials(liquids,dust,solids)adequate?

Ensurethatpaperwaste,productionwasteandliquidwasteareproperlydisposedofanddonotposeacontaminationthreattoproduction.Additionally,ensurethatwastecontainersareemptiedonanongoingbasisandwasteisnotoverflowingontothefloor.廢棄物處理（廢水，廢棄，廢渣）是否合適。確保廢紙，生產(chǎn)廢料和廢液合理處理，不會威脅到產(chǎn)品受污染。定期傾倒廢棄物。確保他們沒有溢出到地板上。100PR15Areretainsamplesofallbatchesproducedmaintainedappropriately?Wheresamplesareretained,ensurethatthestorageareaisconstructedsothatmixupiseliminatedandtheareadoesnotposeaphysical,chemicalormicrobialcontaminationthreattoscoreYES.保留樣是否保養(yǎng)合理？樣品留置區(qū)域構建合理，能有效避免混亂。隔絕物理/化學或微生物污染。100ComplaintHandling/Recall/Re-workPR16Isthereawrittenprocedureforhandlingconsumercomplaintsand

adverseevents?

Proceduremustcontainresponsibleparties,methodologies,timelineforevents,record

keepingrequirementsandreferencetocustomernotificationwhereapplicable.是否有消費者投訴或不良事件處理程序？程序必須報考責任方，方法，完成時間。記錄保存，以及通知客戶（如適用）300PR17Iseachcomplaint/eventuniquelyidentified?是否每個投訴都有制定的識別碼/編號？100PR18Doestheprocedurerequirethatthecomplaintberesolved/investigatedwithinaspecifictimeframe?客戶投訴處理程序是否要求投訴必須在制定的事件內(nèi)處理/調(diào)查完成200PR19Canthecompleteness/timelinessoftheinvestigationsbeverifiedbyarandomexaminationofthecomplaintfiles?

Reviewallcomplaintsrelatingtoproductsandrandomlysamplecomplaintsrelatingtoproductssuppliedtoprivatelabelcustomers.Ensurethatcomplaintprocedure

hasbeeneffectivelyfollowed.Ifanycomplaintrecorddemonstratesnon-conformancetoestablishedprocedure,scoreNO.是否可能隨機檢查投訴文件確認調(diào)查是否按時完成？審查所有關于產(chǎn)品的投訴，隨機檢查DI的主要產(chǎn)品。確保投訴處理程序被正確執(zhí)行。發(fā)現(xiàn)任何不符合，答案是NO。300PR20Areretainsamplesexaminedortested,asnecessary,duringacomplaintinvestigation?如有需要，是否在做投訴調(diào)查的時候檢查/測試保留樣品。200PR21Hastherebeenarecallofanyproductwithinthelastfiveyears

andifso,wastherecallprocedureutilizedeffectively?

Ifnorecall,scoreN/A.Iftherehasbeen,ensureallrequirementsoftheprocedurehavebeenfollowedaccordinglytoscoreYES.在過去5年內(nèi)是否有產(chǎn)品召回，如果有，產(chǎn)品召回程序是否有效？如果沒有產(chǎn)品召回，SCOREN/A.300PR22Isthereawrittenprocedureoutliningtheprocessforconductinga

recall?Proceduremust

containresponsibleparties,methodologies,timelineforevents,recordkeepingrequirementsandreferencetocustomernotification,whereapplicable.是否有產(chǎn)品召回程序，程序界定責任方，方法，時間期限，記錄保存以及參考客戶通知（如適用）300PR23Doestheprocedurerequireconducting“mock”recallsorsome

othermeanstoverifytheadequacyandeffectivenessoftheprocedure?產(chǎn)品召回程序是否有關于模擬召回的規(guī)定或其他方式確認程序的有效性200PR24Isthereanadequateformalwrittenprogramfortheadministration

ofreturnedproducts?

Thisprogrammustensurethesafety,identification,quality,potency,andquantityofreturnedproductsareverifieduponreceiptofreturnedmaterial.是否有書面的程序管理被退回的產(chǎn)品？這個程序必須確保產(chǎn)品一旦被退回，受到后立即確認安全識別數(shù)量效能和品質(zhì)200PR25Isthereevidencethatreturnedproductsarebeingappropriatelyprocessedaccordingtowrittenprocedures?

Recordsforreturnedproductsmustcontaindeterminationofreasonforreturn,determinationofscrap,rework,restock,orotherdispositionaccordingtotheprocedure.Recordsmustalsocontainassociateddatesandauthority.是否有證據(jù)證明被退回產(chǎn)品按照書面流程處理。處理記錄必須包括退回原因，報廢，返工，重新出貨或其他處置。記錄必須包括相關日期和作者200PR26Isthereawrittenprocedureforin-processmaterialsorfinished

productsthatfailtomeettherequiredmanufacturingstandards/specifications?Recordsforin-processproductsplacedon"HOLD"mustcontaindeterminationofreasonforreturn,determinationofscrap,re-work,restockorotherdispositionaccordingtotheprocedure.Recordsmustalsocontainassociateddatesandauthority.是否有在制品/成品的不良處理程序。關于生產(chǎn)“onhold”的不良必須有不良原因，報廢，重工，重新裝車或其他處理方式。要包括相關日期和作者300PR27Aretheinvestigationsofthenon-conformingmaterialsbeing

conductedinatimelymanner,asdescribedinthewrittenprocedure?不合格品是否按照程序及時處理300PR28Areinvestigationsinvolvingnon-conformingmaterialsadequately

documented?針對不良原材料的調(diào)查是否被歸檔200PR29Arenon-conformingmaterialsre-workedbaseduponadequate

qualification,asdefinedbytheprocedure?不合格材料重工是否依照程序被充分認證200PR30DoesQAapproveallofthere-workprocedures?QA是否批準重工程序300PR31Isthereanadequateformalwrittenprocedurefortheretentionofreservesamplesforeachbatchofproductmanufactured?

Thisprogrammustincludetimerequirements,responsibleparties,location,andanyotherrequirementnecessarybythetypeofproducttoensureconsistencyofthesamplewhencomparedtoreleasedfinishedproducts.是否有程序來規(guī)定保留每次不良的不良樣品。這個程序必須包括時間要去，責任方，位置和任何其他根據(jù)產(chǎn)品類型來確保樣品和處理樣品想比較的信息200TOTALSCOREFORTHISSECTION7000PackagingSystemComponentTestingProgramPA1Arefinishedproductsadequatelycontrolleduntilreleasetodistribution?Samplemultiplefinishedmaterialandensurearecordexiststotracefromfinalinspectiontorelease.Ifnotrailofrecordexists,scoreNO.成品在出貨之前有合適的控制，抽取一些材料來驗證是否有成品檢查記錄，如果沒有則為NO.300PA2DoesQAhavefullauthoritytoacce