Anda di halaman 1dari 6

Doc

Q1

Edition
9th

Section
3.1.6/
5.6.1.1

Question
Answer
InarecentAPIQ1audit,myauditorinterpretedAPISpecQ1,
No.APISpecQ1doesnotspecifythatanauditormakesthe
Section3.1.6tomeanthatthedistributorsupplyingplasticshrink determinationofproductcriticality.APISpecQ1,Section5.6.1.1.astates,
wrapmaterialisacriticalsupplier(thusneedingaQMS
inpart,thatthe[Organizations]procedure shalladdressdetermination
complianttoISO9001).HebasedthisonthefactthatAPI5CRA ofthecriticalityofactivitiesorproducts.Subsequently,theorganization
requirestheshrinkwraptobe0.008"thick(seesection14.3.1). wouldberesponsibleforensuringthatthatprocedureiseffectively
AlthoughwespecifiedthethicknessonourPOandthevendor implemented;and,theauditorwouldberesponsibleforauditingthelevel
ofconformitytotheorganizationsimplementationofitsestablished
certifiedthethicknessonhisshippingpapers,becausehewas
notonourApprovedVendorListasacriticalvendorandaudited procedure.
ashavingaqualitysystemcomplianttoISO,thiswasconsidered
afindingintheaudit.Myquestionis,"Isthisconsistentwiththe
committee'sintention?"Becausetheshrinkwrapismoreofa
commodityitem,andwascertifiedascompliant,andhasnever
contributedtoanonconformance;Iwouldhaveneverclassified
thisvendorascritical.Instead,basedonapanelofexpertsin
supplymanagementourresourcesarebestfocusedonthe
criticalfewsuppliersthatimpactourqualitysuchasrawmaterial
vendors,testhouses,outsourcingheattreat,etc.andnotthe
trivialmanylikeashrinkwrapsupplier.

Q1

9th

3.1.21

Question:Isproductmaintenance,adjustment,repair,and/oronNo.Thetermapplicableproductspecificationappliesonlyto
siteinstallationconsideredtobeservicingonlywheninstallation installation....inthephraseonsiteinstallationwheninstallationisrequired
isrequiredbyapplicableproductspecifications?
byapplicableproductspecification.Clause5.7.1.2aspecifiesservicingto
includereviewandimplementationoftheorganizations,customer
specific,productservicing,andotherservicingrequirements.Therefore,
servicingmaybeapplicableasmandatedbycompanyprocedure,contract
orathirdparty,aswell.

Q1

9th

4.4

Question:WhenAPIproductorotherexternalspecification
requirements,includingaddenda,errataandupdatesareusedin
thedesignormanufactureofproduct,theorganizationshall
maintainadocumentedprocedurefortheintegrationofthese
requirementsintotheproductrealizationprocessandanyother
affectedprocesses.Whenweuseexternalspecification(ex:
ASTM,ASME,etc.)asworkingmethodreferenceinour
procedure,doweneedtoalwaysupdated(uselatestone)?

No.APIQ1,Section4.4.3states,Documentsofexternaloriginshallbe
controlledtoensurethattherelevantversionsareusedandmaintained.
NOTE:Useofaspecificeditionofanexternalorreferencedocumentcan
bebasedoncontractualobligationsorAPI/industryproductspecifications.

Q1

9th

4.4

Q1

9th

4.4

Q1

9th

4.4.4

Q1

9th

5.1.2b

Question:Whenourprocedureuseexternaldocumentnot
update(2yearbackbeforenewone)andthelatestrevisionhas
nonegativeimpactchangestoourprocedure,doesitviolate
clause4.4.4?
Question:HasAPIsetyearlimitationforupdatesexternal
specification?

No.NOTE:Participationincertificationorlicensingprogramsmay
requireuseofcurrentorthemostuptodatereferencedocuments.
Checkprogramrulesforspecificrequirementsforrelevanceofthespecific
documenteditions.
ThisisnotarequirementthatisaddressedbyAPISpecQ1.Required
updatestoexternalspecificationsmaybestipulatedbycustomer
requirementsorbyrequirementsidentifiedin3rdpartycertificationor
licensingprograms.
Background:APIQ1inSection4.4.4requiresWhenAPIproduct Thisquestioncannotbeanswered.SpecQ1doesnotaddressmonogram
orotherexternalspecificationrequirements,includingaddenda, requirements.However,totheextentthattheproductrealization
errata,andupdates,areusedinthedesignormanufactureofthe processincludesproductspecificationrequirementsthatmaybe
product,theorganizationshallmaintainadocumented
applicabletothemonogramprogram,theserequirementsmustbe
procedurefortheintegrationoftheserequirementsintothe
includedintheinternalaudit
productrealizationprocessandanyotheraffectedprocesses
andSection6.2.2.1requiresTheorganizationshallidentifythe
auditcriteria,scope,frequency,andmethodstoensurethatall
processesofthequalitymanagementsystemclaiming
conformitytotherequirementsofthisspecificationareaudited
atleastevery12months.
Question:Isthistobeinterpretedthatcompanieswith
MonogramsmustincludetheapplicableProductSpecaspartof
theirInternalAudits?

Question:Wehavenumerousproprietarylicense
Yes.Butperthedefinitionoflegalrequirements(3.1.13,Obligation
agreements/contractsaswellasAPImonogramlicenses.As
imposedonanorganization,includingthosethatarestatutoryor
thesearemandatedlegalrequirementsfortheproduct(s),isthis regulatory),theexamplesprovidedmayonlybepartofalargerlistof
acceptableevidencetofulfilltherequirementsof5.1.2.b?
documentsthatarerequiredtomeetthisclause.

Q1

9th

5.7.1.5

Question:PurchasedmaterialsWhenmaterialssuchas
forgingsandwroughtmaterialsarepurchasedfromsteel
manufacturers(whoperformtheheattreatmentandinsome
casesNDT),isitarequirementofAPISpecQ1,9thEdition,
Section5.7.1.5forthelicenseetoalsovalidatethesteel
manufacturersprocesscontrolsforprocessesrequiring
validation?

No.Basedontheinformationprovided,thisisapurchaseissueand
thereforeallthatisrequiredisverificationofthattheproductmeetsthe
contractrequirementsonreceipt(5.6.3).Outsourcing(5.6.1.6)and
validation(5.7.1.5)donotapplysincetheproductrequirementsdonot
expectthattheorganizationperformtheforgingactivityitself,butsimply
touseforgedproduct.Therefore,byextension,validationofthose
processessuchasforgingdoesnotapply.
Notehowever,thatvalidationofasuppliersprocessesislikelytobe
requiredintwocases:
a)Whenthisisincludedintheprocessoftheinitialqualificationofa
criticalsupplierper5.6.1.2andforreevaluation(optionally)per5.6.1.4;or
b)Whentheactivitydoesbecomeoneofoutsourcing(Section5.6.1.6),i.e.
thesupplierisperformingtheactivityonbehalfoftheorganizationwhen
suchanactivityisrequiredbytheproductspecorotherobligation
(contract).

Q1

9th

5.7.1.5

Background:Apipemillwasauditedrecentlyandthemillwas Yes,butonlywhentheapplicable[product]specificationdoesnot
makingAPI2BpipesandAPI5Lpipesandmonogrammingthose explicitlyidentifytheNDTprocessasonethatrequiresvalidation.
pipes.Duringverificationofvalidationofprocesses,asper
NOTEBasedonthelimitedinformationprovidedinthebackground,
5.7.1.5ofAPIQ1,Ninthedition,Nondestructivetesting(NDT)
validationofNDTprocedures(forconformancetoAPIQ1,5.7.1.5)maynot
processesweretakenforsampling.Documentedprocedurefor beapplicabletoAPI5Lsincethisdocumentdoesidentifyprocesses
validatingthecurrentNDTprocedureswasrequested.The
requiringvalidation(seeAPI5L,Section8.2)andNDTisnotlistedtherein.
However,thevalidationofNDTprocessesandevidenceofconformanceto
OrganizationdemonstratedbyshowingthecurrentNDT
procedures.CurrentNDTproceduresdidnotcomplywith
APIQ1DOESapplyforAPI2Bmanufacturedproductsincethisdocument
requirementsforvalidatingtheNDTprocedures.Thecurrent
doesnotspecificallyidentifytheprocessesrequiringvalidation.Therefore,
NDTprocedurescomplywithAnnexureEandAnnexureKofAPI thelistofprocessesneedingvalidationidentifiedinAPIQ1doesapply,
5L45thedition.Butthereisnoevidencetodemonstratethese includingNDT.Therequirementsofonespecification(5L)cannotbe
currentprocedurescomplywith5.7.1.5requirementsfor
appliedtoanotherspecification(2B),unlessthelatterspecifiesthe
validatingthoseprocedures.
requirementsnormatively(2Bdoesnotreference5Lforperformanceof
Question:IsittheintentionofQ1satisfiedbydemonstratingthe NDT).
currentNDTproceduresasanevidencefor5.7.1.5?

Q1

9th

5.7.6

Question:Inclause5.7.6,doesthedefinitionofproductinclude
finishedproductonly(whichisinourcaseispipe);orinclude
equipmentusedtoproducefinishedproduct(pipe),suchas
sparepartstobeusedformaintenanceofequipment?

Yes(onlytothefirstpartofthequestion).Inthiscase,product
preservation(perAPIQ1,5.7.6)wouldimpactonlytheitembeingmade
andapplicableconstituentpartsunderthespecification.Itdoesnot
includetheequipmentusedinmakingtheequipment.Suchequipment
wouldbecoveredunderAPIQ1,5.7.8and5.8,asapplicable.

Q1

9th

5.7.7.3

Background:WhileperforminganAuditonafacilitythatis
transitioningtothe9thedition,theyuseamachinisttodoin
processinspectionoftheirownworkwhichisacceptableunder
Clause5.7.7.2(InprocessInspectionandTesting ).These
finishedcomponentscanbesoldtoacustomeronaPOand
therewasnodefinitionoffinishedproductinAPIQ19th
edition.
Queston:Iffinishedproductiswhateverislistedonthe
Purchaseorder,canacompanymeetClause5.7.7.3Final
InspectionandTestingrequirementPersonnelotherthanthose
whoperformedordirectlysupervisedtheproductionofthe
productshallperformfinalacceptanceinspectionatplanned
stagesoftheproductrealizationprocesssimplybyjusthaving
anInspectorreviewthedimensionalinspectionreportofthe
Machinist(whoinspectedhisownwork)andthensignoffthe
productasclearedtostock?

No.Finalacceptanceinspection(SpecQ1,Section3.1.2,Demonstration
throughmonitoringormeasurementthattheproductconformsto
specifiedrequirements)mustbeperformedbysomeoneotherthanthe
personwhoperformedagivenactivity.Areviewofinprocessinspection
reportsmayprovideverificationoftheworkthatwasperformed.
However,itdoesnotmeettheintentofperformingtheactualfinal
acceptanceinspectionbysomeonenotdirectlyinvolvedinthe
manufactureoftheproduct.

Q1

9th

5.7.7.3

Background:Inmostofourfacilities,theTesting&Assembly
No.
departmentsarecombinedandtheassemblerperformsthe
actualtestingoftheproduct.Testresultsaredocumentedby
thetestertodemonstratecompliancewiththequalityplan
and/ordocumentedprocedures.Aqualifiedindividualother
thantheonewhoassembledandtestedtheproductordirectly
supervisedtheassemblyandtestingoftheproductperformsthe
finalacceptanceinspectionbasedonmonitoringandreviewof
thetestingdocumentation.
Question:ThesecondparagraphofAPISpecificationQ1,9th
Editionclause5.7.7.3establishesrequirementsforpersonnel
whoperformfinalacceptanceinspection.Isittheintentofthis
paragraphtoalsoestablishrequirementsforpersonnelwho
performtestingofproduct?

Q1

9th

5.7.7.3

Question:Oneofourfacilitiesisconsideringdeployingatruecell No.APIQ1onlyrequiresthatthefinalinspectionbeperformedby
manufacturingconceptwheretherewillbeacellleader
someoneindependentofthemanufacturingoftheproductthatistobe
responsibleforallproductrealizationprocessesforthe
inspectedbutdoesnotaddresshowthatpersonfitsintothe
manufacturingcell.Inthisconcept,theinspectorswhoperform organizationsreportingstructureororganizationalhierarchy.
finalacceptanceinspectionofthepartsmanufacturedinthecell
reporttothecellleaderbutareindependentofthemachinists
manufacturingtheparts.Thecellleaderisclearlyheld
accountableforallproductrealizationprocessesforthecellasif
itwasaseparatemanufacturingentity.Isitarequirementof
Clause5.7.7.3forpersonnelperformingfinalacceptance
inspectiontoreportindependentlyfromproductionsupervision?

Q1

9th

5.11.2d

Question:DoIneedanMOC,ifIamrewritingpartsofa
Yes.PertheorganizationsprocedureforcontroloftheMOCprocess,
procedure,introducingnewverbage,inhouse?Nocustomer
whentheproposedchangemayproduceanegativeimpactontheproduct
involvement.BasicallyforinstanceifIwanttochangefrom
(APIQ1,5.11.2).
cleaningaunitwithhosesintheyardtoremovethehosesbefore and
cleaning,thisrequiresanMOC?
No.Whentheproposedchangehaslittlenegativeimpactontheproduct.

Q1

9th

6.2.2

InternalAuditsWehavebeenaskedinrecentauditsfor
No.Aseparateinternalauditspecificallyagainsttheproductspecification
evidencethatourinternalauditshavecoveredtheAPIProduct isnotrequiredbyanyclausein6.2.2.However,theorganizationis
expectedtoprovideobjectiveevidencethattheproductrequirements
Specsforwhichwehavealicense.Section6.2.2detailsthe
requirementsfortheinternalauditsoftheQualityManagement havebeenauditedinternally.Thismayincludeevidenceofproduct
System,butdoesnotdiscusstheauditingoftheAPIProduct
requirementsbeingincludedandmaintainedinapplicableinternal
Specificationrequirementsasarequirement.Section6.2.3does proceduresthatwereapartoftheinternalaudit(seeNOTEin6.2.2.2).
addressprocessevaluationsandproductcompliance,buthasa
notethatindicatestheperformanceofaninternalauditand
managementreviewsatisfiestherequirement.WhenQMS
auditsareconductedfortheProductRealizationProcesses,the
productsrequirementsarereviewedandthedegreeof
complianceisusedasthebasisfordeterminingcompliancelevel
duringtheaudits.
Question:Basedonthelanguageof6.2.2,isitarequirementof
APISpecificationQ1,9thEditionfortheuserorganizationto
conductdocumentedauditsagainsttheproductspecification
requirements?

Q1

9th

6.2.2

Q1

9th

6.2.2.1/
6.5.1

Q1

9th

6.2.2.2

Question:Isitrequiredtouseadocumentedchecklistinthe
No.
performanceoftheInternalAudit?
Background:Clause6.2.2.1Theorganizationshallidentifythe Yes.
auditcriteria,scope,frequency,andmethodstoensurethatall
processesofthequalitymanagementsystemclaiming
conformitytotherequirementsofthisspecificationareaudited
atleastevery12months.Clause6.5.1Theorganizationsquality
managementsystemshallbereviewedatleastevery12months
bytheorganizationsmanagementTomeetrequirementsof
Clause6.2.2.1and6.5.1theorganizationconducts1internal
auditateachfacilityinaparticularmonthand1Management
ReviewinMarcheveryyear,respectively.Forexample,a
companyconductsManagementReviewonMarch11in2015,
andin2016planstoconducttheManagementReviewonMarch
18.
Question:Doesanauditormanagementreviewconductedthe
samemontheachyearmeettherequirementsofclause6.2.2.1
andclause6.5.1ofAPISpecificationQ1NinthEdition?

Background:APIQ1inSection6.2.2.2requiresAuditsshallbe No.Thespecificrequirementsforcompetencyareestablishedbytheuser
performedbycompetentpersonnel(see4.3.2.2)independentof ofthedocument.
thosewhoperformedordirectlysupervisedtheactivitybeing
auditedtoensureobjectivityandimpartialityoftheaudit
processandSection4.3.2.2requiresPersonnelshallbe
competentbasedontheappropriateeducation,training,skills,
andexperienceneededtomeetproductandcustomer
requirements.
Question:DoesthismeanthatInternalAuditorsrecordsneedto
stateAuditorAPIQ1competency?