Documente Academic
Documente Profesional
Documente Cultură
ETI Group
Thisguidetoimplementingan
AS9100CQualityManagement
System(QMS)waspreparedby
ETIGroup.Theguideisbased
onourexperiencesassisting
morethan650small,medium
andlargecompaniesthrough
thecompleteISO9001/AS9100
implementationprocessfrom
starttosuccessfulregistration.
CopyrightETIGroup2014
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ETI Group
ThoughtforToday
Qualitymanagementsucceeds
whenthecostofthesystemisless
thanthecostofdefectsandpoor
servicewhichwouldotherwise
result.
CopyrightETIGroup2014
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TABLE OF CONTENTS
SubjectHeading
Page#
Introduction
ManagingChange
WhatisaQualityManagementSystem?
10
WhyImplementaQualityManagementSystem?
16
TheAS9100Standard
18
15StepstoImplementAS9100
36
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Introduction
Formoreandmorecompanies,especiallyintheAerospaceIndustry
supplychain,implementingaQualityManagementSystem(QMS)based
onAS9100isbecominganecessity!Itcanhelpwinnewcustomersas
wellasretainexistingones.Whilethegoalistoachieveregistrationto
thestandard,itisnottheonlygoal.Theinternalbenefitsof
implementinganeffectiveQMSaresignificant.
ThisebookisintendedtobeaguidetoimplementinganAS9100QMS
inanyorganization.Asthesizeandnatureoforganizationsvary,wemay
notcoverallofthecircumstancesuniquetoyourcompany.Wedo
howeverdetailthetypicalprocessthatETIGroupconsultantsusewhen
assistingacompanytoimplementanAS9100QMS.
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Introduction
ImplementinganAS9100QMSmayseemdaunting,especiallyforthe
smallerbusiness,fortunatelythestandardsareflexibleandmandate
requirementsforyourorganizationtofollowbutallowyoutofulfillthe
requirementsinawaythatmakessenseforyourbusiness.Thisallowsa
widerangeofcompanies,bothlargeandsmall,manufacturingand
servicetocreateaQMSthatmeetsthespecificneedsoftheirbusiness
aswellastherequirementsoftheAS9100Cstandard.
TheAS9100frameworkalsoprovidesanexcellentandpracticalmodel
fromwhichtoimplementtheadditionalrequirementsforanISO13485
orISO/TS16949QMS.
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Introduction
Everyorganizationhasmanagementproceduresandinstructionsfor
creatinganddeliveringtheirproductsandservicestocustomers.Most
haveevolvedovertheyears,andaregenerallyadequate ifthey
werent,organizationswouldquicklygooutofbusiness.
Howeverpoormanagementsystemscanleadtowastefulprocesses,
poorproductsandservices,anddissatisfiedcustomers.Anefficient
organizationcantypicallybecharacterizedby:
Explicitawarenessof,and
concernfor,theneedsof
customersandother
stakeholders(suppliers,
employees,society,etc.),
Seniorandmiddlemanagers
whounderstandandfocuson
businessneeds,
Acommitmenttocontinuouslyimproveproductsandservices,
Employeedevelopmentandtrainingprogramsthatmeettheneedsof
theorganization,
Processesdesignedtoidentifyandreducewastedresources,
Complete,current,clearandrelevantdocumentation.
OrganizationsareincreasinglyintroducingformalQualityManagement
Systems(QMS)togaintheseandotherbenefits.
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Managing Change
Thegreatestresourceacompanyhasisitspeople,inevitablytherewillbe
resistancetochangeswhenimplementingandmaintainingyourQMS.
Theoldway
TransitionZone
Thenewway
Peoplefeeldoneto
Newwayfeelschaotic
Peopledonthearthings
Oldanimositiesmaysurface
Newopportunitiesareidentified
Productivitymaytemporarilydecline
Resistancehasmanyfacesincludingdenial,lackofmotivationand
questioningofthemotivationbehindthedecisiontoimplementa
QMS.Strategiesformanagingchangeshouldbeaddressedduring
implementationplanning.
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Managing Change
ThejourneyfromapreQMSorganizationtoonethatoperateswiththe
qualityandcontrolsnecessaryforcertificationisnotacasualtaskandis
unlikelytosucceedwithoutthecommitmentanddedicatedsupportof
topmanagement.
ForManagement
Forthepeopleaffected
changeis
changeis
Planned
Outoftheircontrol
Gradual
Sudden
ASolution
Problematic
Logical
Arbitrary
Opportunistic
Disruptive
Intentional
Disruptive
Somecommonformsofresistanceandsuggestedsolutionsare
detailedonthefollowingpage.
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Managing Change
CommonFormsofResistance
CommonComplaint
RootCause
ProvenSolution
Thisisjustanother
flavorofthemonth.
Pastinitiativeshave Demonstrateleadershipbelief
beenlaunchedwith Selectbestpeopleastrainers
highfanfareandlittle Minimizefanfare
results
Idonthave
timecannotfreeup
resources.
Toomanyprojects/
activitiesinprocess
Thiscantworkinmy
areaofthebusiness.
Misconceptionabout AS9100hasbeensuccessfully
implementedineverybusiness
howaQuality
ManagementSystem sector.
Showexamplesfromother
worksorlackof
similarcompaniesthatare
informationabout
howitapplies
AS9100registered.
Stopotherinitiativesnotrelated
tocurrentprioritiesorthatonly
makeaminorcontribution.
Fatiguefrommany
Howisthisdifferent
frompastimprovement improvement
initiatives?
initiatives
Explain/showkeydifferences.
Isthisincrementalto
myexistingbusiness
plan?
Dontwanttoaddto
existingworkload
AlignAS9100implementation
worktodirectlysupportthe
existingbusinessplan
Doesmanagement
reallybelieve/support
it?
Lackofconfidence
thateveryoneison
board
Genuineleadership
commitmenttoimplementation
isrequired notjusttalk.
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What is a Quality
Management System?
DevelopedbytheInternationalAerospaceQualityGroup(IAQG),
AS9100comprisesasetofrequirementsthatreflecttimeproven,
universallyacceptedgoodbusinesspractices,themajorityofwhichare
mandatory.AS9100CincludesalloftheISO9001:2008requirementsin
theirentiretyplusadditionalAerospaceIndustryspecificrequirements.
Acommonsensewayof
ORGANIZINGTHE
BUSINESSPROCESSES
thataffectthequality
ofyourproductsandservices
TheaimofaQMSisto
assurethatanorganization
consistentlymeetscustomer
needsbycontrollingthecore
processesthataffectthem
suchassalesorders,design,
production,inspection,
delivery,etc.
Therequirementsalsogobeyondthese"core"processestoaddress
supportprocesseslikepurchasing,training,calibration,maintenance,and
performancemetrics.
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What is a Quality
Management System?
AProcessApproach
AnimportantaspectofaQMSisitsprocessorientedapproach.Insteadof
lookingatdepartmentsandindividualprocesses,itrequiresanorganization
tolookathowprocessesinteractandintegratewitheachother.
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What is a Quality
Management System?
AQMSismuchmorethanacomprehensivesetofrules.Itwillhelpyou
manageyourbusinessmoreeffectivelyandimprovetheperformance
ofyourorganizationonanongoingbasis.
Saywhatyoulldo!
Dowhatyousay!
ProveIt!
ImproveIt!
Basically,AS9100requirements
fallunderfourmajorcategories:
Requirementsthathelpassure
thattheorganizations
productsand/orservicesmeet
customerspecifications.
Requirementsthatassurethe
QMSisconsistently
implementedandverifiable.
Requirementsformeasuringtheeffectivenessofthevarious
componentsofthesystem.
Requirementsthatsupportthecontinualimprovementofthe
companysabilitytomeetcustomerneeds.
SaywhatyoulldothroughtheQualityManagementSystem(QMS)
documentation.
DowhatyousaythroughdisciplineduseoftheQMS.
ProveitusingInternalAudits(andExternalones).
ImproveitusingtheCorrectiveandPreventiveActionSystem.
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What is a Quality
Management System?
ThegeneralcomponentsofaQualityManagementSystem(QMS),as
definedbyISOTechnicalCommittee,TC176,areasfollows:
CustomerFocus:Customersneedsandexpectationsneedtobe
identifiedandachieved.
Leadership:TopManagementmustshowtheircommitmenttotheQMS
byleading,communicatingandunitingeveryoneintheorganizationto
achievethecompanysdesiredgoalsandbyprovidingtheresources
necessarytoaccomplishthem.
Involvementofpeople:Irrespectiveoftheirpositioninthecompany
everyoneisinvolvedintheQMS.
Process Approach: Allactivitiesinthecompanyaretreatedasaprocess.
Thiswillprovideforasystematicdefinitionofactivitiesinordertomeet
thestatedgoalsandidentifytheresourcesrequiredtomeetthosegoals.
SystemsApproachtoManagement:Requiresidentifyingallofthe
processesinthecompanyandtheirinterdependenceandthen
managingtheseprocessesasacompletesystem.
ContinualImprovement:ContinualImprovementofthecompanyisa
neverendingprocessinvolvingestablishinggoalsandmeasuring
progresstowardsachievingthosegoals.
FactualApproachtoDecisionMaking:Thisisthemethodofcollecting
andanalyzingdataandthenusingittomakesounddecisionsonwhat
pathtotake.
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What is a Quality
Management System?
QualityManagementSystemRequirements
ToachieveAS9100certificationyourcompanymustestablish,
documentandimplementaQMSandmaintainitseffectivenessin
accordancewiththestandard.Controlleddocumentsaretypically
organizedandwrittenaccordingtoahierarchyshownbelow.
Policy
Manual
4.2.2QualityManual
Procedures
(BusinessProcesses)
4.2.3ControlofDocuments
WorkInstructions
4.2.4ControlofRecords
Records
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What is a Quality
Management System?
Documents
QMSdocumentsdetailprocessesandprocedurestoensuretheymeet
theneedsofyourbusinessaswellastherequirementsofthe
standard.Thiswillensurethat:
Employeesperformthesametask,thesameway,everytime
Informationisrecordedinthesameway,everytime
Newemployeesaretrainedtoaconsistentstandard.
Everyone!
Everywhere!
EveryTime!
ControlledDocuments
Documentsmustbecontrolledtoensureonlythecurrentversionis
availabletoemployeeswhileperformingtheirduties.Aprocedureis
requiredtodetailthemanagementofallcontrolleddocuments.
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Reduced
Costs
Reduced
Employee
Turnover
Other
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C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N
5 Management
responsibility
R
E
Q
U
I
R
E
M
E
N
T
S
8 Measurement,
analysis,
Resource
6 management
Input
improvement
Product
7 realization
Product
C
U
S
T
O
M
E
R
Output
ModelofaprocessbasedQualityManagementSystem
Areliableprocessproducesaconsistent,predictableoutcome,andis:
Consciouslydeveloped:Factsanddataarecollected,themethodis
thoughtaboutbyparticipants,debated,andagreedto,beforethe
methodisimplemented.
Explicitlyestablished:Themethodiscarefullydocumentedin
sufficientdetailforthepurposesneeded.Everyattemptismadeto
makethemethoderrorproof.
Consistentlyfollowed:Everyonefollowsthemethodasdocumented!
Currentlybelievedtobebestway:Themethodisuseduntil
someonethinksofabetterway.
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AS9100emphasizesaddressingcustomerandapplicable
statutoryandregulatoryQMSrequirementsandalsofocuseson
controlsthatminimizeerror.
Aerospacespecificrequirementsareaddedtomostofthe
sectionsoftheISO9001Standard,withanemphasison:
Conformancetocustomer,regulatoryandstatutory
requirements(safety&airworthiness)
Flowdownofrequirementstosuppliersandsubtier
suppliers
Riskmanagementwithconsiderationofspecial,criticaland
keycharacteristics
ConfigurationManagement
ProductionProcessVerification(FirstArticleInspection)
Changecontrol(documents,designs,processes,equipment,
tooling,etc.)
Note1:AS9100includesalloftherequirementsofISO9001inits
entiretyplusadditionalAerospaceIndustryrequirements.
Note2:IntheoverviewoftheAS9100clausesthatfollow,ISO9001
requirementsareshowninregulartypeandtheadditionalAS9100
requirementsareshowninbolditalictype.
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applicableregulatoryrequirements
4.2DocumentationRequirements
DescribesinformationstructureofyourQMS
Shouldthinkintermsofinformation
managementandcontrolrather
thandocumentmanagement
AS9100emphasizesaccesstoandawarenessof
relevantdocumentationbypersonnel
AS9100alsorequirescontrolofrecordscreatedand/or
retainedbysuppliers
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ManagementCommitment
5.2
CustomerFocus
5.3
QualityPolicy
5.4
Planning
5.5
Responsibility,Authority&
Communication
5.6
ManagementReview
Implication
Thissystembelongsto
management!
Strongemphasison
responsibilities of
management!
6 ResourceManagement
6.1ProvisionofResources
Determine&provideresourcesneeded
6.2
Implement&maintain&
ContinuallyimproveQMS
Enhancecustomersatisfaction
HumanResources
Assignmentofpersonnel
Competence,training,andawareness
6.3
Infrastructure buildings,utilities,equipment,transport,IT
6.4
WorkEnvironment temperature,humidity,lighting,
cleanliness,ESDprotection,etc.
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Customer
Related
Processes
7.2
Policies,Plans,Resources
Design
and
Developmen
t
7.3
Purchasing
7.4
Customer
Production
AndService
Provision
7.5
ControlofMonitoring&MeasuringEquipment 7.6
PlanningofProductRealization 7.1
Sequenceofprocesses&subprocessesneededtoproducethe
productStrongemphasisonsequenceofprocesses&interactions
7.1
PlanningofProductRealization
ConsistentwithotherrequirementsforyourQMS
Documentedinasuitableform(QualityPlanorestablishedQMS)
Determine:
Qualityobjectivesforproduct,projectorcontract
Specificresource&processneedsforproduct
Verification,validation,monitoring,measurement,inspection
andtestactivitiesneeded(includingacceptancecriteria)
Recordrequirements
Planningmustbedoneforeachproduct,projectorcontract
AS9100includesresourcesforoperationandmaintenanceofthe
product(postdelivery).
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PlanningofProductRealization(continued)
ThereareadditionalAS9100elementsthatcover:
ProjectManagement
RiskManagement
ConfigurationManagement
ControlofWorkTransfers
7.2
CustomerRelatedProcesses
7.2.1Determinationofrequirements
relatedtotheproduct
7.2.2Reviewofrequirements Can
wedoit?Isthereachange?
AS9100addsrequirementthatrisksareidentifiedand
specialrequirementsdetermined.
7.2.3
CustomerCommunication questions,orders
andchanges,feedback,complaints
Note:Specialrequirementsarethosewhichhavehighriskstobeing
achieved,suchasperformancerequirementsatthelimitofindustry
capabilityortheorganizationstechnicalorprocesscapability
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Planning projectplanwithdesignstages,tasks,responsibilities
7.3.2
Inputsthedesignrequirements
7.3.3
Outputs thedocumenteddesign,theproductspecification
7.3.4
Review checkingoutputagainstinputforeachstage
7.3.4
Review checkingoutputagainstinputforeachstage
7.3.5
Verification makingsurethedesignwillmeetrequirements
7.3.6
Validation makingsuretheproductwillmeetrequirements
7.3.7
ControlofChanges ensurechangesareidentified,evaluated,
controlledandrecorded
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Structuredandthoroughprojectplanning
Specificationofcriticalitems,includingkeycharacteristics,and
specificactionstobetaken
Definitionofdatarequiredtoallowproducttobeidentified,
manufactured,inspected,tested,usedandmaintained
Maintenanceofconfigurationmanagementthroughoutthe
designverification&validationprocess
Designreviewauthorizationforprogressiontonextstage
Controloftestingprocessesandrecordsofresults
Approvalofdesignchangesbycustomers/regulatoryauthorities
asrequired.
Note: Projectplanningmustconsidercomplexityandsafetyandfunctional
objectivesinaccordancewithcustomer/regulatoryrequirements,aswellas
abilitytoproduce,inspect,testandmaintaintheproduct.
Criticalitems mayresultfromthespecialrequirementsidentifiedduringthe
riskassessmentmentionedpreviously.Theyareitemsthathaveasignificant
effectontheproductrealizationanduseoftheproduct,includingsafety,
performance,form,fit,function,producibility,servicelife,etc.Theyrequire
specificactionstoensuretheyareadequatelymanaged.
Akeycharacteristic isaattributeorfeaturewhosevariationhasasignificant
effectonproductfit,form,function,performance,servicelifeor
producibility,thatrequiresspecificactionsforthepurposeofcontrolling
variation.Acriticalitemmaybefurtherclassifiedasakeycharacteristicifits
variationneedstobecontrolled.
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Purchasing
PurchasingProcess Select&managesuppliers
AS9100statesthattheorganizationisresponsiblefor
productquality,includingcustomerdesignatedsources
AS9100hasspecific
requirementsregarding
suppliermanagement
7.4.2PurchasingInformation
Specifyrequirementsforwhat
youwanttobuy
AS9100addsspecificsregarding:
Identification
Data,inspections,tests,testspecimens
Notificationofchanges/nonconformity
Rightsofaccessbyorganization,customer,regulatory
authoritiestosupplierfacility&recordsasapplicableto
order
Requirementsforsuppliertoflowdownrequirementsto
subtiersuppliers
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VerificationofPurchasedProduct Toinspectornotto
inspect?
AS9100additionsare:
Examplesofverification
Positiverecall
Delegationofverificationtosupplier
Note:AS9100notesthatcustomerverificationactivities(asin
sourceinspectionattheorganizationssupplier)shouldnotbeused
asevidenceofeffectivecontrolofqualitybyeithertheorganization
oritssupplier,anddoesnotabsolvetheorganizationof
responsibilityforcompliancewithrequirementsandproduct
conformance.
7.5ProductionandServiceProvision
7.5.1
ControlofProductionandServiceProvision
Infothatdescribestheproduct
WorkInstructionsasneeded
Suitableequipment
Availabilityanduseofmonitoring&measuring
equipment
Inspectionsandtests
Release,deliveryandpostdeliveryactivities
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ControlofProductionandServiceProvision(continued)
AS9100addsspecificrequirementsfor:
Accountabilityforallproductduringproduction
Inprocessverificationconsiderations,evidenceof
completionofallproductionand
inspection/verificationoperations
Provisionfortooling,utilities,removalofforeign
objects,
Workmanshipcriteria
ProductionProcessVerification(formerlycalledFirst
ArticleInspection)
Controlofprocesschanges
Controlofequipment,tooling,softwareprograms
Planningforcriticalitemsandprocesscontrolofkey
characteristics
Postdeliverysupport
7.5.2 ValidationofProcessesforProductionandServiceProvision
specialprocesses
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IdentificationandTraceability ID,pass/failstatus,unique
IDasrequired
AS9100additionsfor:
Configurationidentification
Acceptanceauthoritymedia
Examplesoftraceabilityrequirements
7.5.4
CustomerProperty safeguardcustomersupplied
product,equipment,software,intellectualproperty,
personaldata
7.5.5
PreservationofProduct protectproductfromstartto
finish
AS9100includesconsiderationsfor:
Cleaning,foreignobjects
Specialhandlingforsensitiveproducts/hazardous
materials
Markingandlabelingincludingsafetywarnings
Shelflifecontrolandstockrotation
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ControlofMonitoringandMeasurementEquipment
A.K.A.Calibration
Calibratedorverifiedatspecifiedintervals,orpriortouse,
againsttraceablemeasurementstandards
Identifiedtoenablestatustobedetermined
Recordcalibration/verificationresults
Assess&recordvalidityofpriorresultsifdevicesarefoundto
notconformtorequirements takecorrectiveactionon
equipmentandaffectedproduct
AS9100 adds some specifics for methods
8 Measurement,AnalysisandImprovement
8.1
General Plan&determinemethods(statisticaltechniques)
10 0
andextentofuse
8.2
Monitoring&Measurement
8.3
ControlofNonconformingProduct
8.4
AnalysisofData
8.5
Improvement
80
60
40
20
0
10 0
80
60
40
20
0
J
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Monitoring&Measurement
CustomerSatisfaction monitorperceptionofquality
AS9100Additions:
8.2.2
Monitoringofproductconformity,
ontimedeliveryand
customercomplaints&CArequests.
Requirementtodevelop&implementimprovement
planstoaddressdeficiencies&assesseffectiveness
ofresults.
Auditsmustbeplannedandrecorded,
objectiveandimpartial,with
timelyCorrectiveActiontakenbyManagementand
followuptoverifyactionstaken.
Resultsmustbereported.
AS9100clarifiesthatcustomercontractual
requirementsarepartoftheplanned
arrangementstobeauditedforconformance
Note: ThepurposeofanInternalAuditisnottopassthetest.
Thegoalistosurfaceissuesandopportunitiesandaddressthem
throughtheCorrectiveandPreventiveActionSystem.
Whilenotexplicitlystated,thegeneralexpectationisthatInternal
AuditorsreceivetrainingonauditingtechniquesandtheStandard;
sixteenhoursoftrainingaretypical.
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8.2.4
Monitoring&MeasurementofProcesses
Abilitytomeetperformanceobjectives
Maintaincapabilityandimproveifneeded
AS9100statesactions
requiredintheeventof
processnonconformity
Monitoring&Measurement
ofProduct
Verifyrequirementsaremet
Resultsrecorded
Recordauthorityresponsibleforreleasetocustomer
AS9100additionalrequirements:
Keycharacteristicsmonitoredandcontrolled
Samplingplanspecifics
Positiverecallconsideration
DocumentationofInspectionplans,instructions,
measuringinstrumentsandrecordstoprovide
evidenceofproductqualification
Documentsaccompanyingproductarepresentat
delivery
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ControlofNonconformingProduct
Identificationandcontrolofanydefective
material/producttopreventitsuse
Determinationofactionstotake
Reverificationafterrework/repair
Evaluationofneedforrecallofshippedproduct
AS9100additionalrequirements:
Appliestocustomerreturns
Processforapprovalofpersonnelwhodisposition
product
Restrictionsonuseasisorrepairdispositions
Takingactionstocontaintheeffectof
nonconformityonotherprocessesorproducts
Requirementsforscrapmarkinganddisposal
Timelyreportingofnonconformingproductto
otherparties
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AnalysisofData
Determine,collectandanalyze appropriatedata,Purpose:
DemonstratesuitabilityandeffectivenessofQMS
Evaluateimprovementopportunities
Includedatageneratedbymonitoring/measuringactivities&other
relevantsources
Analyzedataforinformationon:
Customersatisfaction
Conformitytoproductrequirements
Characteristics&trendsofprocessesandproducts
LookforPreventiveActionopportunities
Supplierperformance
8.5
Improvement
8.5.1
ContinualImprovement
Continuallyimprove organizationsperformance
Use Policy,objectives,audits,data,CAPAandManagementReview
tofacilitateimprovement
AS9100additions:
Organizationmustmonitorimplementationofimprovement
activitiesandevaluateeffectivenessofresults.
Opportunitiescanresultfromlessonslearned,problemresolution,
benchmarkingofbestpractice
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Defined,documentedprocess;comprehensive
Eliminatecause(s)topreventrecurrence
Appropriatetotheimpact
AS9100addsrequirementsfor:
FlowdownofCorrectiveAction(CA)tosuppliers
Specificactionswheretimely&/oreffectiveCAnotachieved
Determiningwhetheradditionalnonconformitiesexistbasedon
causesfound,andtakingappropriateaction
CorrectiveActionversusPreventiveAction
8.5.3 PreventiveAction
BasicallysameprocessasCorrectiveActionbutusesdataproactively
AS9100notesPreventiveAction(PA)examplessuchasrisk
management,errorproofing,FMEA,informationonproduct
problemsreceivedfromexternalsources
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15 Steps to Implement
AS9100
Designing,documentingandimplementinganAS9100QMSisa
significantundertaking.Typically,ETIGrouprecommendsandusesafour
phaseapproachtoassistclientsinimplementingasystemthatmeetsthe
specificneedsoftheirbusiness.
Phase1
Phase2
Planningand
Design
Establish
Measurement
Program
Documentation
Development
Design/Document
Operations
Processes
EstablishQuality
SystemStructure
Phase3
Implementation
Design/Document
Management
Processes
Phase4
Assessmentand
Registration
ThisapproachhasbeensuccessfullyusedbyETIGrouptoassistmorethan
650organizations,bothlargeandsmall,manufacturingandserviceto
implementaQMS.Ataskbytaskoverviewofthisapproachisprovidedon
thefollowingpages.
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15 Steps to Implement
AS9100
PHASE1:PLANNINGANDDESIGN
Step1 DecisionMakingandCommitment
Thefirsttaskisfortopmanagementtodecideifthecompanyshould
pursueAS9100registration.
Tomakeaninformeddecision,topmanagementshouldhaveagood
understandingofAS9100fromabusinesspointofview,theconcepts
behindAS9100,thegeneralprocessforimplementationandthe
requirementsofthestandardastheyapplytoyourcompany.
Topmanagementmustalsodemonstrateitscommitmentand
determinationtoimplementanAS9100QualitySysteminthe
organization.Withouttopmanagementcommitment,noquality
initiativecansucceed.
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15 Steps to Implement
AS9100
1.1TopManagementCommitment
Toprovideevidenceofcommitmenttothedevelopmentand
implementationofaQMSandcontinuallyimproveitseffectiveness,top
managementcanachievethisby:
Communicatingtotheorganizationtheimportanceofmeeting
customer,statutoryandregulatoryrequirements,
Definingtheorganization'squalitypolicyandmakingthisknownto
everyemployee,
Ensuringthatqualityobjectivesareestablishedatalllevelsand
functions,
Ensuringtheavailabilityofresourcesrequiredforthedevelopmentand
implementationofthequalitymanagementsystem,and
Conductingtherequiredmanagementreviewmeetings.
Topmanagementshouldalsoconsider
actionssuchas:
Leadingtheorganizationbyexample,
Participatinginimprovementprojects,
Encouragingtheinvolvementofall
employees.
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15 Steps to Implement
AS9100
1.2TopManagementCommitment
Topmanagementshouldidentifythegoalstobeachievedthroughthe
QualitySystem.Typicalgoalsmaybe:
Tobecomemoreefficientandprofitable
Toproduceproductsandservicesthatconsistentlymeetcustomers'
needsandexpectations
Improvecustomerssatisfaction
Increasemarketshare
Reducecostsandliabilities
Step2 ImplementationTeam&ManagementRepresentative
AS9100isimplementedbypeople.Thenextstepistoestablishan
implementationteamandappointaManagementRepresentative(MR)as
itscoordinatortoplanandoverseeimplementation.Implementationteam
membersshouldincluderepresentativesofallorganizationalfunctions
Marketing,Design,Development,Planning,Production,Qualitycontrol,etc.
TheManagementRepresentativeisyour
company'spointpersonandsoontobeexperton
AS9100.Inthecontextofthestandard,thisperson
actsastheinterfacebetweenyourtop
managementandtheAS9100registrar. This role
is,infact,muchbroaderthanthat.The
ManagementRepresentativeshouldalsoactas
theorganizationsQualitySystemChampion."
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15 Steps to Implement
AS9100
2.1ManagementRepresentative(MR)Responsibilities
TheMRmustbeapersonwith:
The totalbackingoftheCEO,
Agenuineandpassionatecommitmentto
qualityingeneralandtheQuality
ManagementSystemsinparticular,
Therespectresultingfromrankand/or
senioritytoinfluencepeopleatalllevelsand
functionsoftheorganization,and
Agoodknowledgeofqualitymethodsin
generalandAS9100inparticular.
ThestandardmakesitveryclearthattheManagementRepresentative
takesonthethreeresponsibilitiesdescribedbelow.
1.QualitySystemMaintenance. EnsuringthatQualityManagement
Systemprocessesareestablished,implementedandmaintained.
2.ReportingonQualitySystemperformance. Reportingtotop
managementonhowwell,orpoorly,theQualityManagementSystemis
performing,includingidentifyinganyneedsforimprovement.
3.Promotingcustomerrequirements. Ensuringallemployeesareaware
ofcustomerrequirements.Itisessentialthatallemployeesunderstand
whatthecustomerneeds,andhowtheycanaffecthowwellthecompany
satisfiestheseneeds.
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Step3 EmployeeAwarenessTraining
Itisimportanttoinformemployeesasearlyaspossibleofyourplanto
becomeAS9100registered.Youwillneedtoexplaintheconceptofa
QMSandhowitwillaffectemployeesinordertogaintheirbuyinand
support.Don'tdelaythissimplestep,ifnegativerumorsandgossip
develop,yourimplementationeffortswillbecomemuchmoredifficult!
SinceAS9100affectsalltheareasandallpersonnelintheorganization,
trainingprogramsshouldbestructuredfordifferentcategoriesof
employees seniormanagers,middlelevelmanagers,supervisorsand
workers.Thistrainingshouldcover:
Thebasicconceptsofquality
systemsandthestandard,
Theoverallimpactonthe
companysstrategicgoals
Thechangedworkprocesses,
andthelikelyworkculture
implicationsofthequality
system.
Inaddition,initialtrainingmayalsobenecessaryonwritingquality
manuals,proceduresandworkinstructions.Whentheinhouseabilityto
providethistrainingisnotavailable,itmaybenecessarytoparticipatein
externaltrainingcoursesrunbyaprofessionaltrainingorganizationsor
anexternaltrainingorganizationcouldprovidethistraininginhouse
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Step4 PerformaGapAssessment
Thenextstepintheimplementationprocessistocompareyourexisting
qualitysystemwiththerequirementsoftheAS9100standard.Thisis
oftenreferredtoas"gapassessment'withthegoalofdetermining:
Whatexistingcompanyprocessesand
proceduresalreadymeetAS9100
requirements
Whatexistingproceduresandprocesses
needtobemodifiedtomeetAS9100
requirements
Whatadditionalproceduresand
processesneedtobecreatedtomeet
AS9100requirements
Ingeneral,thestepstoperformagapassessmentare:
1. Whatisthepresentoperation/process?Whatalreadyexists?,
2. AnalyzetherelevantsectionsoftheAS9100standardtodetermine
whatisactuallyrequired?
3. Documentthegaps.
Thegapassessmentcanbeperformedinternallyiftherequired
knowledgeexists,oranexperiencedAS9100consultingfirmcanprovide
thisserviceforyou.
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Step5 ImplementationPlanning
Afterthegapassessment,youshouldhaveaclearpictureofhowyour
existingQualitySystemcompareswiththeAS9100standard.
Adetailedimplementationplanshouldbedeveloped thatidentifiesand
describestaskrequiredtomakeyourQualitySystemfullycompliantwith
thestandard.Thisplanshouldbethoroughandspecific,detailing:
Qualitydocumentationtobedeveloped
TherelevantAS9100standardsection
Personorteamresponsible
Approvalsrequired
Trainingrequired
Resourcesrequired
Estimatedcompletiondate
Theseelementsshouldbeorganizedintoadetailedchart,tobereviewed
andapprovedbytopmanagement.Theplanshoulddefineresponsibilities
ofdifferentdepartmentsandpersonnelandsettargetdatesforthe
completionoftasks.Onceapproved,theManagementRepresentative
shouldcontrol,reviewandupdatetheplanasdocumentationandthe
implementationprocessproceeds.
Ahighlevel12monthimplementationactionplanisshownonthe
followingpage.
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15 Steps to Implement
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Month1
Month3
Month5
Month7
Month9
Month10
Month12
AppointMR&
establishteam
Employee
awarenesstraining
Gapassessment&
planning
Developdocumentation
RegistrarSelection
ImplementQualitySystem
&trainemployees
InternalAudits
ManagementReview
andcorrectiveactions
Stage1
RegistrationAudit
CorrectiveActions
Stage2
RegistrationAudit
Highlevel12monthimplementationplan
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PHASE2:DOCUMENTATIONDEVELOPMENT
Step6 DocumentationDevelopment
ThereisnorightorwrongwaytodocumentyourQualityManagement
System. Webelievethatyourcompanyshouldstartwiththeminimum
requirements.ThiswouldincludeyourQualityManualandsix
documentedproceduresthatarecurrentlyrequiredtocreateanAS9100
QMS:DocumentControl;ControlofRecords;InternalAudit;Non
ConformingProduct;CorrectiveActionandPreventiveAction.
Therewillbesomeadditionaldocumentedproceduresthatwillbe
helpfulforyourstafftofollowwhileworkingonyourcompanysvarious
processes.Thesecanbedeterminedduringtheplanningstageand
shouldbeincludedinyourimplementationprojectplan.
TheRightSizeQualityManagementSystem
MinimumRequirements
QualityManual
6Procedures
20Records
PlusAdditionalKeyProcesses
Overkill
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6.1OrganizingandDocumentingYourQualitySystem
Documentation istypicallyorganizedandwrittenaccordingtoahierarchy
shownbelow.Alistofthedocumentstobepreparedshouldhavebeen
drawnupandtheresponsibilityforwritingdocumentsassignedtothe
personsresponsibleforeachofthequalitysystemprocessesinyour
companyduringimplementationplanning.
Quality
Manual
Procedures
(BusinessProcesses)
WorkInstructions
Forms&Records
TheQualityManual Ahighleveldocumentthattypicallyincludes:
AstatementexplainingthescopeoftheQMS,includingexclusions
anddetailsfortheirjustification
AdescriptionoftheQMSprocessesandtheirinteractions
Thecompanysqualitypolicyandqualityobjectives
Ancompanyprofileshowingtherelationshipsandresponsibilities
ofpersonswhoseworkaffectsquality
Anoverviewofthesystemlevelprocedures
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QualityManual(Continued)
TheQualityManualisusuallywrittenearlyoninyourQMSimplementation.
Processesandproceduresmaychangeasyourorganizationworksthrough
thedocumentationprocess.Itwillbenecessarytogobackandrevisethe
QualityManualtobringitbackuptodateandensurethatthecorrectprocess
interfacesaredefinedandresponsibilitiesandauthoritiesdocumented.
Procedures arehighleveldocumentsthatdetailhowtheorganizations
processesaredesignedandcontrolledandthechecksthatarecarriedout.
WorkInstructionsareveryspecific,
anddetailallnecessaryinstructions
requiredforperformingaspecifictask.
Listsprovideinformation.Theycan
alsobeincorporatedintothebackofa
procedureasadditionalinformation
(Appendix,Attachments,etc.).
Forms capturerecordsfordata/informationrequiredtosupportorconfirm
processes.Formscanbeseparatelycontrolleddocumentsand/orincluded
withintheappropriateprocedure.
Records mustbemaintainedtoshowcompliancetoqualitysystem
requirements.
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6.2RecordKeeping Qualityrecordsprovideobjectiveevidenceofyour
compliancetomanyoftheAS9100requirements.Youmustkeepyour
recordsuptodatetoprovecomplianceduringyourregistrationor
subsequentsurveillanceaudits.Minimumrequiredrecordsincludebut
arenotlimitedto:
Evidencethatmetricsareusedtomonitorandimprove
processes(QualityObjectives)
ManagementReviewMeetings
EmployeeCompetence,Awareness,andTraining
Productplanningmeetscustomerrequirements
Contractreviewandactionsarisingfromthereview
Designanddevelopmentplanning,inputs,reviews,
verification,validation(includingchangestodesigns)
Supplierevaluationandreevaluation
Resultsofmonitoringandmeasuring
InternalAudits
Approvaltoreleaseproductfordelivery
Actiontakenonnonconformingproduct
CorrectiveAction
PreventiveAction
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6.3Documentation GettingStarted
Yourcompanyprobablyalreadyhassomedocumentedpoliciesand/or
procedures.Althoughtheymaybeincomplete,lackspecificdetail,beout
ofdate,orarenotintegratedwithotherbusinessprocessesasrequiredby
theAS9100standard.
Makealistofallthesedocuments,includingprocedures,workinstructions,
formsandlistsandincludetheircurrentstatusincomplete,lackingdetail,
outofdate,inaccurate,notintegratedwithotherbusinessprocesses,etc.
Theremayalsobesomeareasofthebusinesswhichyouchoosenotto
includewithinthescopeofyourQMS,suchasfinanceorbusinessstrategy
documents.
Areasdeemedoutofscopemustnothaveanimpactonproductquality
andshouldnotbeincludedinyourQMDdocumentation,althoughthese
areasshouldbelistedintheexclusionsdocumentedinyourQuality
Manual.
Considertheprimaryaudienceforthedocumentanduselanguageand
vocabularythatisappropriateforthecompanyandfortheusers.
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6.4Documentation MapCurrentProcesses
Maptheprocessesusedtomanagethequalityframework,including
theirsequenceandinteractionwitheachother.Ensurethatall
stakeholdersareincludedinthemappingprocessandgapsarenoted
wheredocumentsaremissingorwhereaprocessneedstobeupdated
tomeetarequirementoftheAS9100standard.
Start
Purchasing
Verify Price &
Availability with
Supplier
Requestor
Purchase Request
Form
FORM # 7.4 - 2
Identify Product
Service to Purchase
Requestors Mgr
.
Requestors Mgr
.
Return with
Explanation
Review / Approve
Purchase Request
Purchasing
Create Purchase
Order
Purchasing Mgr
Review and
Approve PO
No
Purchase Order
Approved ?
Purchasing
Yes
Approved Vendor
List
Supplier on
Approved
List ?
Forward to
Supplier
Yes
Purchasing
No
Supplier
Evaluation &
Selection Process
Monitor Supplier
Performance
Done
TypicalProcessMap
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6.5TemplatesforControlledDocuments
Templatesshouldbedevelopedforallofthecontrolleddocumenttypes
youintendtouse.Templatesshouldhaveconsistentstylesandformatsso
thatdocumentsareeasytoreadandnavigate.
Eachtemplatemustmeetcontrolled
documentrequirements.Procedures
andWorkInstructionsshouldhave
Purpose,ScopeandResponsibilities
sections.Acompanylogocanalsobe
includedwiththedocumentheader.
DocumentingyourQualitySystemischallengingandtimeconsumingbut
canbesimplifiedwithgoodpredesignedtemplatesorthehelpofan
experiencedconsultingfirm.Ifyouchoosetopurchasetemplatesthey
shouldbechosencarefullyastheywillhaveasignificantimpactonthe
effortyouspendonimplementation,andevenmoreimportantly,onhow
efficientandbusinessfriendlyyourcompany'sQualitySystemwillbe.
6.6CreateaCompanyQualityPolicy
WehaveallreadanorganizationspostedMissionStatementwhen
enteringtheirestablishment.AQualityPolicyissimilarbutaddressesthe
specificrequirementsofAS9100.ThisisthefoundationofyourQMSand
establishestopmanagementscommitmenttoQuality.Itshouldalsobe
communicatedthroughoutyourorganization.
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6.7TopLevelQualityObjectives
TheframeworkfordeterminingyourQualityObjectivesis
establishedinyourorganizationsQualityPolicy,these
objectivesarepresentatalllevelsoftheorganization,they
establishmeasureableprocessestoassureyourproductor
servicemeetsstatedrequirements.
6.8DeterminingInteractions
Oneofthemanybenefitsincreating
yourQMSisimprovedcommunications
betweendepartmentalfunctions.
AS9100
AFoundation
Accomplishingthisrequiresthatyou
forExcellence
clearlydefinethesedepartmental
functionsandidentifytheirinteractions.
YoucanusetheQualityManual,
DocumentedProcedures,oraProcessFlowCharttodothis.
6.9DetermineAuthorities
AnotherbenefitofyourQMSistherequirementtoclearlydefineand
documentauthorities.Itisnotuncommoninmanyorganizationsto
makestaffresponsibleforsomethingwithoutgivingthemaclearly
definedauthoritytoseethetaskthrough.Thisoftenleadstostressand
lowmorale.
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6.10DocumentControl
A DocumentationControlSystemmustbecreatedtomanagethe
creation,approval,distribution,revision,storage,anddisposalofthe
varioustypesofdocumentationthatyourcompanydevelops.Your
documentcontrolsystemsshouldbeassimpleandaseasytooperateas
possiblebutsufficienttomeetAS9100requirements.Itshouldinclude:
Auniqueidentification,usuallya
lettercodeforthetypeof
document(e.g.SOP,WI,LST)and
asequentialnumber.
Revisioncontrolwhereeach
updatetothedocumentmust
resultinanincrementalincrease
intherevisionnumber.
Achangehistorysummarizingchangesmadetoadocument
Signaturesofthepersonpreparingandthepersonapprovingthe
document.Averificationsignatureisalsousuallyrequiredto
confirmthatthecontentsofthedocumentareaccurate.
Thedateoftheversionorrevision
TheprincipleofAS9100documentcontrolisthatemployeesshouldhave
accesstothedocumentationandrecordsneededtofulfiltheir
responsibilities.
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Step 7 Review and Release Documents
Managementshouldreviewallof
thedocumentationtoensureit
meetstheoperationalneedsofthe
businessaswellasAs9100
requirements.Followingthe
reviews,subsequentrevisions,and
finalmanagementapproval,
documentationisreleasedforuse
PHASE3:IMPLEMENTATION
Step8 ImplementationandEmployeeTraining
ThenewlydocumentedQuality
Systemisputintopractice
throughoutthecompany.
Managementandemployees
aretrainedonthenewor
revisedworkprocesses,
proceduresandwork
instructionsasformalizedin
yourdocumentation.
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Step9 QualitySystemRegistrarSelection
ItisadvisabletoselectaRegistrationBodythatissuitedtoyour
organizationearlyinyourimplementationproject.Theregistrationbody
isanindependentorganizationthatisofficiallyaccreditedtoissueQuality
Systemcertifications.Theregistrarwillaudityour
company'sQualitySystemandiftheauditis
successful issuetheQualitySystemcertificate.
Whenchoosingacertificationbodytocarryout
yourAs9100registrationaudit,someselection
criteriashouldbetakenintoaccount:
Isthecertificationbodyaccreditedand,ifso,
bywhom?Accreditationmeansthatthe
certificationbodyhasbeenofficially
approvedascompetenttocarryout
certificationbyanationalaccreditationbody.
Isthecertificationbodyrecognizedbyyourcompanyscustomers?
Doesthecertificationbodyauditor(s)haveexperienceinyour
organizationsbusinesssector?
Isyouorganizationcomfortableworkingwithyourauditor(s)asboth
sideshavetoworktogetherforalongperiodoftime?
Lastbutnotleast,weconsideritimportantthatyouractualauditoris
basedgeographicallyclosetoyou,otherwisetravelexpensesforyour
auditorsvisittoyourfacilitycouldbeveryhigh?
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Step10 InternalAuditorTraining&CommenceInternalAudits
AS9100andrelatedstandardsrequirethatyourcompanyperiodically
performaninternalaudittoevaluatetheeffectivenessofyourQuality
SystemandcheckthatitcomplieswithAS9100requirementsaswell
asyourorganizationsowndocumentedworkpractices.
Aqualityauditisa:Systematic,independentanddocumentedprocess
forobtainingauditevidenceandevaluatingitobjectivelytodetermine
theextenttowhichauditcriteriaarefulfilled.
InternalauditsarealsoagreathelpimplementingyourQualitySystem
andacompleteinternalauditofyourQualitySystemisrequiredbefore
youcanpassyourregistrationaudit.
Yourinternalauditprogramshouldbe
planned,takingintoconsideration
thestatusandimportanceofthe
differentprocessesthatarerunning
inyourorganization.
Atleasttwoofyouremployees
willneedtobetrainedas
internalauditors.
Thecriteriafortheaudit,scopes,frequenciesandmethodsshouldalsobe
defined.Theperson(s)responsiblefortheaudit,shouldbeobjectiveand
impartial,theonlyrestrictionisthattheycannotaudittheirownwork.
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Step11.ManagementReview
WhenyourQualityManagementSystemhasbeenoperatingforthreeto
sixmonthsandaninternalauditofyourQualitySystemhasbeen
completedaManagementReviewshouldbeconductedandcorrective
actionsimplementedasnecessary.
Managementreviewsareconductedtoensurethecontinuingsuitability,
adequacyandeffectivenessofyourQualitySystem.Thereviewshould
includeassessingopportunitiesforimprovementandtheneedfor
changestotheQualitySystem,includingthequalitypolicyandquality
objectives.Theinputtomanagementreviewshouldinclude:
Resultsofaudits,
Customerfeedback
Processperformanceand
productconformity
Statusofpreventiveand
correctiveactions
Followupactionsfromprevious
managementreviews
ChangesthatcouldaffecttheQualitySystem,and
recommendationsforimprovements
ManagementReviewsshouldalsoaddresspitfallstoeffective
QualitySystemimplementation
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PHASE4:ASSESSMENTANDREGISTRATION
Step12 Stage1RegistrationAudit
WhenyouQualitySystemhas
beeninoperationforafew
monthsandhasstabilized,itis
normallytimetoscheduleyour
stage1registrationaudit.
Yourselectedregistrationbody
willfirstcarryoutanauditof
yourdocumentationandthen,if
yourdocumentsmeetthe
requirementsofthestandard,
theregistrarwillvisityourfacility
andperformastage1AudittoensureallapplicableAS9100orrelated
standardrequirementshavebeenmet.
Step13 CorrectiveActions
Followingyourstage1audit,managementwillreviewtheresultsand
makecorrectiveactionstofixanynonconformances(activitiesthatare
notincompliancewiththerequirementsofthestandardand/oryour
owndocumentedworkpractices)foundduringthestage1registration
audit
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Task14 Stage2RegistrationAudit
YourselectedRegistrarwillperformastage2RegistrationAudittoensure
allapplicableAS9100orrelatedstandardrequirementshavebeenmet
andthatyouhavecorrectedanynonconformancesfoundduringthe
stage1audit.
Followingthesuccessfulcompletionofthestage2audityourcompany
willbeawardedanAS9100certificate,generally
foraperiodofthreeyears.Duringthisthreeyearperiod,your
registrationbodywillcarryoutperiodicsurveillanceauditstoensurethat
thesystemiscontinuingtooperatesatisfactorily.
Task15 ContinualImprovement
CertificationtoAS9100shouldnotbeanend.
Youshouldcontinuallyseektoimprovethe
effectivenessandsuitabilityofyourQuality
Systemthroughtheuseofyour:
Qualitypolicy
Qualityobjectives
Auditresults
Analysisofdata
Correctiveandpreventiveactions
Managementreview
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ETIGroup:
Todate,ETIGrouphasassistedmore650companiestoachieveQuality
ManagementSystem(QMS)Certificationallpassedtheirregistration
auditsatthefirstattempt.Ourservicesinclude.OurQualityManagement
SystemservicescoverthefullrangeofISO9001/AS9100andrelated
standards:
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