quality-management-system

QualityManagementSystemsThequalitymanagementsystemofanorganizationisthecollectivebodyofprocesses,operatingprocedures,objectives,responsibilities,resourcesandinfrastructureneededtoimplementeffectivemanagementofquality.Thefirststepinsettingupaqualitymanagementsystemwithinacompanyistogenerateaqualitymanual.Thisshouldbedoneevenbeforeanyqualityproceduresorspecificationsarewritten.Thequalitymanualisthecompany'squalitybibleorconstitution.Itisadocumentthatstatesinaconciseandbriefformatthehigh-levelpoliciesandobjectivesofthecompanyrequiredtoachieveitsdesiredlevelofquality.Itshouldalsoshowhowthecompany'sover-alldocumentationofspecificationsisstructured.Itisgoodpracticeforacompanytochooseaninternationalqualitystandardasbasisofitsqualitymanagementphilosophybeforeitwritesupitsqualitymanual.OnesuchstandardthatsemiconductorcompanieshaveembracedovertheyearsistheISO9000seriesofstandards.Assuch,mostsemiconductorcompaniesbasetheirqualitymanualontheISO9000standards.AnISO9000-basedqualitymanualmustaddresseveryISOelementorsectionoftheISO9000standardthatthecompanywantstobecertifiedto.EachISOqualitysectionorelementaddressedbythequalitymanualshouldbewrittenwithatleastthreeparts,i.e.,Scope,PolicyandResponsibilities.TheScopeportionshouldsimplystatethepurposeofthecoveredarea.ThePolicyportionshouldstatethecompanypolicyregardingtheapplicableISOclause.TheResponsibilityportionshouldstatewho,ingenerictitlesorpositions,isresponsibleforthepolicy.Qualityattainmentandmaintenanceneedmoney(referredtoasthecostofquality)sothequalitysystemoftheorganizationshouldnotexceedwhat'sneededtomeettheorganization'squalityobjectives.Itisthereforeessentialforacompanytoclearlydocumentitsqualityobjectives,andtheprocessesbywhichitwillachievetheseobjectives.Theembodimentofthesequalityobjectivesisthecompany'squalitystandard,anditisuptothequalitysystemtoensurethatthecompany'sdocumentedprocedures,actualoperation,andqualityrecordsallconformtothisstandard.Aqualitysystemshouldencompassnotonlythequalityofthefinishedproductofacompany,butshouldcoverthequalityofoperationalprocessesaswell.Infact,itnotonlymustcovertheover-allin-processqualityofthecompany,butshouldalsoconsiderthequalitysystemsofitssuppliersandsubcontractors,aswellasthoseofthecustomers.Inthesemiconductorindustry,thequalitysystemofacompanyisthebackboneofhowitdoesitsbusiness.Acompanythathasagreatproductcanfailifthequalityofitsoperationsisinferior.Eventhebasictaskofgettingcustomersreliesgreatlyonthequalitysystemofthecompany.Forinstance,asemiconductorcompanyneedsISOcertificationbeforeitcanattractcustomers,andISOcertificationrevolvesaroundanextensiveauditofthequalitysystemofthecompany.I.QualitySystemPlanningQualitysystemplanningisthefirststageinsettingupaqualitymanagementsystemwithinthecompany.Thispertainstotheidentificationandacquisitionofresources,logistics,andmanpowerneededtodefineandachievetherequiredqualityofthecompany.IfthecompanyistobecertifiedtoISO9000,thenqualityplanningshouldensurethatthecompany'squalitysystemwilleventuallyconformtoalltherequirementsoftheISO9000elements.Qualityplanningshouldincludecompatibilityamongthevariousaspectsofthecompany'soperationsfromstarttofinish:productdesign,production,andproductinspection/testing.Itshouldalsoincludedefinitionofproductandprocessspecifications.Identificationofthenecessarymonitorsaswellasinspection/verificationstationsatsuitablepointsalongtheproductionprocessshouldalsobeaddressedasearlyasqualityplanning.Measurementcapabilityrequirementsmustlikewisebedefinedduringqualityplanning.II.QualitySystemDocumentationOncethequalitysystemplanofthecompanyhasbeencompleted,thequalitysystemmustundergofulldocumentationthatcomprehendsthecomplexityoftheproductionprocess,themanpowerskillsrequiredforproduction,andthetrainingrequirementstoachievethesemanpowerskills.Attheminimum,qualitysystemdocumentationshouldincludethecompany'squalitymanualandspecificationsshowingthecompanyprocesses,workinstructionsinsupportoftheseprocesses,andproduction/qualityrecordsrequiredbytheseworkinstructions.III.QualitySystemImplementationThelaststageofsettingupaqualitysystemis,well,itsimplementation.Bythetimethisstageisreached,theover-allqualitysystemshouldhavebeendefinedanddocumented,andsupportedbyproduct-orprocess-specificqualityplans.Implementationshouldinvolveeverybodyinthecompany-themanagementforenforcing,reviewing,andcontinuouslyimprovingthequalitysystem,andthepersonneltocomplywiththequalitysystemtoachievethecompany'squalityobjectives.Qualityauditsmustbeconductedregularlytoensurethattheactualimplementationofthequalitysystemisinfullconformancewiththequalitysystemdocumentation.Anyorganizationneedsamechanismbywhichitcancheckwhetherornotitsoperationsarecomplyingwithallstandardsdefinedtomeetitscharterandobjectives.Thisisthepurposeofqualityaudits:toensurethatthecompanyhasdocumentedstandardsorspecificationsonhowtodothingsandthatthesestandardsarecompliedwithatalltimes.Simplyput,aqualityauditconsistsofpreparingalistofitems(procedures,equipmentset-ups,qualityrecords,measurements,etc.)tocheckandgoingtotheareasres