QUALITY MANAGEMENT HANDBOOKMeasuring Analysis and ImprovementWord下载.docx

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8.5Improvement11

8.5.1Planningcontinuousimprovement11

8.5.2Correctiveandpreventativemeasures12

8.6Otherapplicabledocumentation14

8.1General

Plannedmeasuring,monitoringandanalysisofmeasuringresultsandimprovementsshouldensurethattheproductsconformwiththeproductrequirements,thattheprocesses（thoseforproductrealisation,aswellasintheadministrativesector）aremonitoredandcontrolled,andthatefficiencyoftheprocessesandtheirresultsaremeasurableandassessable.Planningshouldensureanorganisedimplementationandcomparabilityofmeasurements.Recordingofthemonitoringandmeasuringresultsensuresthatthemeasurementscanbeverifiedandtraced.Analysisofdataservestheperformanceevaluationandderivationofimprovementmeasures.

Scopeofvalidity

Alldefinitionsinthischapterareapplicableforproductsandproductionprocesses,aswellasforallbusinessprocesses.

Responsiblefunctionalareas

Allbusinesssectors.

Terms

Verificationistheprovisionandconfirmationofevidencewhichprovesthatdefinedrequirementshavebeenfulfilled.

Validationistheprovisionandconfirmationofevidencewhichprovesthattherequirementsforaspecificintendeduseoraspecificintentionalapplicationhavebeenfulfilled.

Conformityisthefulfilmentofarequirement

Anerrorisfailuretofulfilarequirement（non-conformity）

Apreventativemeasureisameasurewhichisimplementedtorectifythecauseofapotentialerror,oranother,potentiallyundesiredsituation.

Acorrectivemeasureisameasureimplementedtorectifythecauseofadetectederror,oranotherdetectedundesiredsituation.

8.2Monitoringandmeasuring

8.2.1Measuringandmonitoringofcustomersatisfaction

DeterminingefficiencyoftheQMsystemsisachieved,amongstotherthings,bymeasuringcustomersatisfaction.

Thecustomersurveysareconductedbythesalesdepartmentbywayof„customersurvey“formstobecompletedinwriting.

Dataformeasuringcustomersatisfactionisimplementedinthemanagementevaluation.Customersatisfactionrelatesdirectlytotheendbuyerortheauthoriseddealer.

8.2.2Internalaudit

Purpose:

Internalauditsareperiodicalchecksofthequalitymanagementsystemforcompleteness,efficiencyandusefulness.Atthesametime,theyaredesignedtomonitorcomplianceofthequalityinstructions,andwherenecessary,topinpointvulnerabilities,determinetheircausesandimplementcorrectivemeasures.

Scopeofvalidity:

Thisprocedureoftheinternalsystemauditisappliedbyallinternalpositionswithinthecompanyinvolvedwithproductdevelopment.

Definitionofterms:

Systemaudit:

Assessmentofefficiencyofthequalitymanagementsystemoritselementsbywayofanindependentanalysis

Auditor:

Personresponsiblefortheimplementationofaqualityaudit

Qualityaudit:

Assessmentofefficiencyofthequalityassurancebywayofanalysisofaspecificnumberofendproductsand/orparts,orassessmentofthequalityassurancebywayofassayingexpertiseofthepersonnel,andcomplianceandusefulnessofcertainprocedures.

Procedure:

Thecompanymanagementhasherebydecreedthatscheduledandunscheduledinternalsystemauditsaretobeimplementedinaccordancewiththefollowingscope:

ScheduledsystemauditsaretobeimplementedinaccordancewithanauditprogramdevisedbytheQAmanagement.Thisprovidesinformationregarding

-theareaswhicharebeingassessed,

-deadlinesofthesystemaudits（includingsubsequentauditsnecessaryforthemonitoringofcorrectivemeasures）

Unscheduledsystemauditsandqualityauditsthenbecomenecessarywherever

-essentialchangesintheQMmanagementandproceduralelementshavebeeninitiatedor

-thereisariskthatqualityrequirementsfortheproductarenolongerbeingfulfilled

-deviationsorseriousfindingshavebeenascertainedintheQMsystemoritselementsfollowingtheimplementationofascheduledsystemaudit.

Salesandshippingaudit:

AuditsofthesesectorsareincludedwithintheimplementationoftheCOP-inspections.

ThecapitalsandproceduresdefinedintheQM-handbookaretobeassessed:

-Qualitymanagementsystem

-Responsibilitiesofthemanagement

-Managementofresources

-Productrealisation

-Measuring,analysisandimprovement

IftheaforementionedQMelementshaveadirectinfluenceonproductsafety,ontheenvironmentoronworkingsafetyorhealthprotection,relevantpriorityshouldbeaccordedtotheassessments.

Theassessmentalsoencompasses

-areviewofspecificationsprescribedbytheindividualspecialistareasforimplementationofthemeasuresapplyingthequalityrequirements

-implementationofthemeasuresapplyingthespecificationsprescribedbytheindividualspecialistareas.

Prerequisitesforpersonnel:

Systemauditsandqualityauditsaretobeimplementedbypersonsindependentofthesectorsbeingaudited.Theauditteammustbeassembledinaccordancewiththetaskformulationandtherespectivescopeoftheaudit.Eachmemberoftheteammustpossesstherelevantqualifications,wherebytheyhavedemonstratedsufficientknowledgeandhaveundergonethoroughinstructionregardingtheauditingtasksassignedtothem.

Documentation（auditreport）:

Inconclusionoftheinspection,anauditreportmustbecompiledwhichclearlydefinestheactualstatusasaresult.Information,observationsanddeviationsaretobeallocatedinaccordancewiththeseverityoftheobjectionandcause,takingtherespectivestandardintoconsideration.

Adeadlinefortherectificationofeachindividualobjection,aswellasthepositionresponsibleforthisrectification,mustbespecified.Thedeadlineforthesubsequentaudit,forwhichthecorrectivemeasuresaretobeimplemented,istobedeclared.Itisimperativethattheauditreportsarethensubmittedtothemanagement.

Otherapplicabledocumentation:

Qualityauditsaretobeimplementedonthebasisofproceduralinstruction

QSA217-1,"

Internalqualityaudits"

whichregulatestheparticularsandreferstotherelevantstandards（ISO19011）..

8.2.3Monitoringandmeasuringprocesses

Measuringandmonitoringofprocessesrelatestothebusinessprocesses（processesandproceduressuchassales,development,planning,orderprocessing）,aswellasproductionprocesses.

TogaugeefficiencyoftheQMsystem,measuredparametersaredefinedforimportantbusinessprocessesintheaffiliatedproceduralinstructions.Thepersonsresponsiblefortherespectiveprocessesarealsoresponsibleforgenerationandevaluationofthedata,aswellasforreportingthekeyfiguresascertained.Thepersonsresponsiblefortheprocessesaredesignatedintheorganisationplan.Thekeyfiguresarereportedintheintervalsprescribedbythemanagementandarerelayedformanagementevaluation.

Therespectivepersonsresponsiblefortheprocessesarealsoresponsibleforcontinuousevaluationandimprovementoftherelevantprocesses.

Improvementmeasuresaredocumented.

Furtherneedforimprovementisdefinedwithinthecourseofmanagementevaluationbasedontheexistingactualdataandplanningdata.Ifnecessary,temporaryprojectteamsareappointedfortheimplementationofimprovementmeasures.

（seechapter5.6„Managementevaluation"

）

Measurementsforproductionprocessescanrelatetoprocessparameterswhicharemonitoredtoensureconformityoftheproducts（e.g.temperature,pressureetc.）.Thesemeasurementsaredefinedduringthecourseofprocessplanninganddevelopment.MeasurementsformonitoringofproductionefficiencyaredefinedinQSA207-1„Query,offerandorderprocessing“.

8.2.4Monitoringandmeasuringoftheproduct

Afixedprocedurefortheplanningandimplementationofqualityinspectionsduringtheproductdevelopmentphasesensurethatdeviationsinstipulatedrequirementsareascertainedatanearlystageatthepointoforigin,thaterrorscanberectifiedwithminimumexpenditureandcorrectivemeasuresimplemented.

Thescopeofvaliditycoversallpurchasedmaterialsandproducts,allproductdevelopmentphasesandthestart-upandutilisationphase.

Definitionofterms

Self-inspection:

Stageofthequalityinspectionnecessaryforqualitycontrolcarriedoutbytheoperatorsthemselves

Intermediateinspection:

Qualityinspectionsduringtherealisationofaunit

Finalinspection:

Lastofthequalityinspectionspriortohandoveroftheunittothereceiver

Receivinginspection:

Approvalinspectionofadeliveredproduct

Qualityinspection:

Ascertainmentofthedegreetowhichaunitfulfilsthequalityrequirements

Craneinspection:

Inspectionsincompliancewithtradeassociationdirectives"

BGVD6Cranes"

.

Procedure

Receivinginspection

Thedeliveryofexternally-manufacturedpartsisresultedinthereceivedgoodsdepartment.

Ifadeliveryisnotsubjecttoinspection（Skiplot）,thedeliverycanbestoredappropriatelyortransferreddirectlytoitsplaceofuseinproductionorassembly.

ThedefinitionsforthereceivinginspectionarespecifiedinaccordancewithQSA206-3andQSA241ff.Dynamicsamplingandregularityofsampletesting（attributiveorvariablesinspection）canbeobtainedfromhere.

Deliverieswhichhavepassedthereceivinginspectionsareindicatedonthedeliverynotew