AEROSPACE QUALITY MANAGEMENT SYSTEMS · 19/10/2003 · Including Operator Certs (e.g. NDT, Welding) • Manufacturing Process Verifications – Manufacturing Routing Sheets. –

October 19th, 2003 Cincinnati General Assembly 1 of 40

AEROSPACEAEROSPACEQUALITY MANAGEMENT QUALITY MANAGEMENT

SYSTEMSSYSTEMSDale K. GordonDale K. Gordon

SAESAEPast ChairmanPast Chairman

Americas Aerospace Quality GroupAmericas Aerospace Quality Group


Tier 4Tier 4 -- Make to Print / Machine Shops/ Make to Print / Machine Shops/ ProcessorsProcessors

Tier 2Tier 2Integrators /Integrators /

Source Control/Source Control/Software Dev./Software Dev./

Major AssembliesMajor Assemblies

Tier 5Tier 5 -- Distributors (Fasteners, Raw Materials,Distributors (Fasteners, Raw Materials,Commodities, Adhesives, Special Materials)Commodities, Adhesives, Special Materials)

Tier 3Tier 3 -- Integrators /Integrators /Source Control / SpecialtySource Control / Specialty

Electronics / Wiring / CompntsElectronics / Wiring / Compnts

Tier 6Tier 6 -- Raw Materials (Castings, Forgings, Sheet, etc)Raw Materials (Castings, Forgings, Sheet, etc)

Aerospace Supply ChainAerospace Supply Chain

Tier 1Tier 1

Special Proces

ses

Special Proces

ses

91009100

91209120

90039003

Tier 1Tier 1Vehicle / Airframe /Vehicle / Airframe /Propulsion ManufacturePropulsion Manufacture Variation Reduction

Variation Reduction910291029103

9103

91109110MR&OMR&O


Aerospace Quality System Aerospace Quality System ModelModel

Company

Reqmnts

AS/EN/JIS Q9100

Int’lReqmnts

&CompanyReqmnts

Internationally Agreed Implementation Processes

Risk Mgnt

Prgrm Mgnt

Special Process

Process Rqmts

Deliverable

Non-Deliver

MRO 9110

Dist. 9120

Service Specific

Requirements

Quality System Requirements - International Standard ISO 9001

Common Aerospace Quality System Requirements - International Requirements 9100

Program Specific

Requirements

Hardware Specific

Requirements

Software Specific

Requirements


Aerospace Quality StandardsAerospace Quality StandardsNumbering SystemNumbering System

•• International Standards International Standards -- 91xx91xx–– Are planned for harmonization across all 3 aerospace Are planned for harmonization across all 3 aerospace

sectors and are recognized globallysectors and are recognized globally

•• Americas Standards Americas Standards -- 90xx90xx–– Are published for use by AAQG, may become an Are published for use by AAQG, may become an

91XX standard at a later date91XX standard at a later date

•• ““ASAS”” Standards Standards -- AmericasAmericas–– Published by Society of Automotive EngineersPublished by Society of Automotive Engineers

•• ““ENEN”” Standards Standards -- EuropeEurope–– published in Europe by AECMApublished in Europe by AECMA

•• ““JIS QJIS Q””or or ““SJACSJAC”” is the Japan / Asia Equivalentis the Japan / Asia Equivalent


Aerospace Quality SystemAerospace Quality SystemStandardsStandards

•• INTERNATIONAL STANDARDSINTERNATIONAL STANDARDS–– 9100 9100 -- Quality System for Aerospace Quality System for Aerospace

ManufacturersManufacturers–– 9102 9102 -- First Article InspectionFirst Article Inspection–– 9103 9103 -- Management of Key CharacteristicsManagement of Key Characteristics–– 9104 9104 –– Requirements for Registration of AQMSRequirements for Registration of AQMS–– 9110 9110 -- Quality System for Aerospace Repair Quality System for Aerospace Repair

Stations Stations –– 9120 9120 -- Quality System for Quality System for ““PassPass--ThroughThrough””

DistributorsDistributors–– Special Process ApprovalSpecial Process Approval


Why 9100?Why 9100?

•• To standardize Aerospace quality To standardize Aerospace quality expectations on a expectations on a globalglobal levellevel

•• To achieve improvements in quality and To achieve improvements in quality and reducereduce costscosts throughout the value streamthroughout the value stream

•• ISO 9000 model for quality does not ISO 9000 model for quality does not capture capture regulatory requirements or regulatory requirements or importance of safety, reliability or importance of safety, reliability or maintainabilitymaintainability

•• Captures aerospace Captures aerospace supplementssupplements agreed agreed to at an international levelto at an international level


9100:2001 conforms to 9001:20009100:2001 conforms to 9001:2000Model of a process based quality Model of a process based quality management systemmanagement system

CUSTOMERCUSTOMERCUSTOMER

Continual Improvement of the Quality Management System

ManagementResponsibility



ProductRealization

CUSTOMERCUSTOMER

ProductRequirements

Satisfaction

input output

Value added activities

Information Flow


9100 Specifics 9100 Specifics (where ISO 9001 (where ISO 9001 implies implies –– 9100 requires)9100 requires)

ISO 9001:ISO 9001:•• Generic quality management system standard Generic quality management system standard -- applicable applicable

to anvils to airplanesto anvils to airplanes

9100:9100: (9100:2001)(9100:2001)•• Includes all ISO 9001 requirementsIncludes all ISO 9001 requirements•• Adds the expectations of the aerospace industry for a robust quaAdds the expectations of the aerospace industry for a robust quality lity

management system for aerospace productsmanagement system for aerospace products

Continuous Improvement:Continuous Improvement:•• Continuous improvement processes shall include provision for usiContinuous improvement processes shall include provision for using the ng the

quality policy, quality objectives, audit results, measurement aquality policy, quality objectives, audit results, measurement and analysis of nd analysis of data, data, variability reductionvariability reduction, corrective and preventive action, and management , corrective and preventive action, and management review review (all but variability reduction are part of 9001:2000 requirement(all but variability reduction are part of 9001:2000 requirements)s)


ISO9001 versus 9100ISO9001 versus 9100

•• 9100 version is formatted to match ISO 9001:2000 and 9100 version is formatted to match ISO 9001:2000 and added “requirements” that provide for added “requirements” that provide for --

•• Regulatory organizations interfacesRegulatory organizations interfaces•• Configuration ManagementConfiguration Management•• Design and Development V& V., & V&V testingDesign and Development V& V., & V&V testing•• Control of changes in Production ProcessControl of changes in Production Process•• Control of production equipment, tools, NC machinesControl of production equipment, tools, NC machines•• Control of work in outside facilitiesControl of work in outside facilities•• Control of service operationsControl of service operations•• First Article InspectionFirst Article Inspection•• Inspection documentationInspection documentation

•• These added requirements enables a standardized These added requirements enables a standardized approach to supplier flow down requirementsapproach to supplier flow down requirements


9100: Quality Management 9100: Quality Management Systems (ISO Clause 4)Systems (ISO Clause 4)

•• Requirements of regulatory authorities must be Requirements of regulatory authorities must be included in documentationincluded in documentation–– Including access by authorities to the records, Including access by authorities to the records,

documentation and change approval (as documentation and change approval (as req’dreq’d))

•• Must show relationship of 9100 standard to Must show relationship of 9100 standard to lower level procedureslower level procedures

•• Documented procedure for records controlDocumented procedure for records control•• Requires Configuration Management for the Requires Configuration Management for the

product / processproduct / process


•• Design and Development output includes:Design and Development output includes:–– Identification of Key Characteristics (FMECA)Identification of Key Characteristics (FMECA)–– All necessary data to manufacture the productAll necessary data to manufacture the product–– Gated Design ReviewsGated Design Reviews–– Documentation of both Design Verification and Documentation of both Design Verification and

Design Validation (reports / calculations / etc.)Design Validation (reports / calculations / etc.)–– Design Verification and Validation testingDesign Verification and Validation testing

•• Design Change ControlDesign Change Control–– Includes customer and regulatory approval as Includes customer and regulatory approval as

necessarynecessary

9100:9100:Product Realization (ISO Clause 7)Product Realization (ISO Clause 7)


•• PurchasingPurchasing–– Responsible for all suppliers (incl. customer Responsible for all suppliers (incl. customer

designated ones)designated ones)–– Must have a list of suppliersMust have a list of suppliers–– Supplier performance review processSupplier performance review process–– Control of special process sourcesControl of special process sources–– Whoever approves a supplier, can disapprove them Whoever approves a supplier, can disapprove them

as wellas well–– Stringent flow down requirements Stringent flow down requirements -- subsub--tiertier–– Notification of nonconformance / process changeNotification of nonconformance / process change–– Right of access by customer and regulatory personnelRight of access by customer and regulatory personnel



•• Planning for Production and Service:Planning for Production and Service:–– Control plans and process controlsControl plans and process controls–– InIn--process verification for hidden featuresprocess verification for hidden features–– Design of tooling for variable measurementsDesign of tooling for variable measurements

•• Controlled ProductionControlled Production–– accountability of product during manufactureaccountability of product during manufacture–– evidence all operations are completeevidence all operations are complete–– FOD controlFOD control–– monitoring of environmental influencesmonitoring of environmental influences–– criteria for workmanshipcriteria for workmanship–– Use of approved data and specified tooling with Use of approved data and specified tooling with

instructionsinstructions



ISO 9001:2000 / 9100:2001ISO 9001:2000 / 9100:2001TimelineTimeline

DEC. 2003

ISO 9001:1994

2000 2001 2002 2003

ISO 9001:2000

9100 : 1999 9100 : 2001

9100A:2001 includes both ISO 9001:1994 and ISO 9001:2000 models until December 2003

9100:2003 ?

Note: AS9000 / 9100 section 2 phase out December 15, 2003Certificates are expected to expire in line with ISO 9001 requirements

Does NOT mean that “approvals” are invalid











Tier 1Tier 1

Special Proces

ses

Special Proces

ses

91009100

91209120

90039003



9103

91109110MR&OMR&O


9100 Introduces Two important 9100 Introduces Two important Concepts for AerospaceConcepts for Aerospace

•• First Article InspectionsFirst Article Inspections–– Always requiredAlways required–– 9102 is mentioned for Guidance9102 is mentioned for Guidance–– 9102 is only mandatory when specifically required 9102 is only mandatory when specifically required

in contractsin contracts

•• Key CharacteristicsKey Characteristics–– When specifiedWhen specified–– 9103 is referenced for guidance9103 is referenced for guidance–– 9103 is only mandatory when specifically required 9103 is only mandatory when specifically required

in contracts and key characteristics are identifiedin contracts and key characteristics are identified


9102 First Article Inspection9102 First Article Inspection

•• FAIsFAIs apply:apply:–– to assemblies and all levels of parts within to assemblies and all levels of parts within

an assembly, including castings and an assembly, including castings and forgingsforgings

–– Suppliers responsible for ensuring that Suppliers responsible for ensuring that characteristics conform to Customer characteristics conform to Customer requirementsrequirements

–– SubSub--tier suppliers and processors of parts tier suppliers and processors of parts and materials for suppliersand materials for suppliers


What is Included in First Article What is Included in First Article Inspection?Inspection?

•• Verification of All Design Characteristics:Verification of All Design Characteristics:–– Dimensional Verification via MarkedDimensional Verification via Marked--up (or “Ballooned”) Drawings that up (or “Ballooned”) Drawings that

Correlate Characteristic Number from FAI to the Drawing.Correlate Characteristic Number from FAI to the Drawing.–– Part MarkingPart Marking

•• Material and Special Process CertificationsMaterial and Special Process CertificationsIncluding Operator Including Operator CertsCerts (e.g. NDT, Welding)(e.g. NDT, Welding)

•• Manufacturing Process VerificationsManufacturing Process Verifications–– Manufacturing Routing Sheets.Manufacturing Routing Sheets.–– Referenced Exhibits Supporting the FAI (e.g. CMM Data Printouts,Referenced Exhibits Supporting the FAI (e.g. CMM Data Printouts, Test Test

Data, Acceptance Test Procedures, Process Certifications, etc.).Data, Acceptance Test Procedures, Process Certifications, etc.).–– Process Capability Studies, As Applicable.Process Capability Studies, As Applicable.–– Gauge Correlation, As Applicable.Gauge Correlation, As Applicable.–– Tooling Traceability, If Tooling Is Used to Verify Design CharacTooling Traceability, If Tooling Is Used to Verify Design Characteristicsteristics

•• Nonconformance ResolutionsNonconformance Resolutions


9102 First Article Inspection9102 First Article Inspection

• Any 9100 compliant organization in absence of a contractual requirement to use 9102 or other specific FAI customer requirement, can devise any methods and processes it chooses to meet the requirements of this clause and the "extent" of an FAI is also at the discretion of the organization as along as it is applied to each " new part" and subsequent changes thereto.

• New part means – Parts, sub-assemblies and assemblies, however FAI’s are progressive


9103 Key Characteristics9103 Key Characteristics

• Variation Management of Key Characteristics will provide a common standard for expectations for KC’s within the aerospace industry.

• Key Characteristic (9100): The features of a material or part whose variation has a significant influence on the fit, performance, service life, or manufacturability.– Dimensional features - thickness, diameter, length, etc.– Chemical concentrations– Time, Pressure, speed, rates, temperature, etc.


Variation Management of Key Variation Management of Key Characteristics Purpose (9103)Characteristics Purpose (9103)

Intent to drive the improvement of the manufacturing processes through adequate planning and effective management of Key Characteristic variation.

• Methodology for component/process proving focused onKey Characteristics.

! Understanding processes! Using appropriate tools! Demonstrating acceptable process capabilities! Guidelines for reporting process capability data

to primes.


Take action from study

Take action from study

Analyzedata

Analyzedata

Process Based Variation Management Process Based Variation Management of Key Characteristics (9103)of Key Characteristics (9103)

Operate the process

Operate the process

Yes

! Output for each stage.! Report to a common form.

Plan a manufacturing

process

Plan a manufacturing

process

UnderstandKey

Characteristics

UnderstandKey

Characteristics

Is a process change

required ?

Continue to monitor

performances

Continue to monitor

performancesNo











Tier 1Tier 1

Special Proces

ses

Special Proces

ses

91009100

91209120

90039003



9103

91109110MR&OMR&O


9120 9120 Distributor Quality SystemDistributor Quality System

•• 9120 developed and implemented for 9120 developed and implemented for ““pass pass throughthrough”” stockistsstockists / distributors that handle / distributors that handle parts and supplies that are used in aerospace parts and supplies that are used in aerospace productsproducts–– Checklist 9121 is also availableChecklist 9121 is also available–– Based on 9100, but only appliesBased on 9100, but only applies

necessary system requirementsnecessary system requirements..–– Expected flowExpected flow--down requirementdown requirement–– Registration plans are available (just begun)Registration plans are available (just begun)











Tier 1Tier 1

Special Proces

ses

Special Proces

ses

91009100

91209120

90039003



9103

91109110MR&OMR&O


9110 9110 Repair Station QualityRepair Station QualitySystemSystem

•• Why 9110?Why 9110?–– Manufacturers want a Quality Management Manufacturers want a Quality Management

System flowSystem flow--down requirement for their MR&O down requirement for their MR&O activityactivity

–– Manufacturers want reputable suppliers that have Manufacturers want reputable suppliers that have repair station approvals and a defined quality repair station approvals and a defined quality systemsystem

–– There is a need to put all of the expectations in There is a need to put all of the expectations in one document for Maintenance, Repair and one document for Maintenance, Repair and Overhaul organizationsOverhaul organizations

–– Military is very interested in having defined Quality Military is very interested in having defined Quality System requirements for MR&OSystem requirements for MR&O


9110 9110 Repair Station QualityRepair Station QualitySystemSystem

•• 9110 developed and implemented in for 9110 developed and implemented in for facilities that perform maintenance & facilities that perform maintenance & repair of aerospace productsrepair of aerospace products–– Based on 9100 requirements and FAA / Based on 9100 requirements and FAA /

JAA JAA -- 145 requirements (new version)145 requirements (new version)• Corresponding 9111 checklist

has also been developed

• Registration plans are in development and expect full implementation in 2004











Tier 1Tier 1

Special Proces

ses

Special Proces

ses

91009100

91209120

90039003



9103

91109110MR&OMR&O


9100 Special Process 9100 Special Process RequirementsRequirements

•• 7.5.2 Validation of processes for production and service7.5.2 Validation of processes for production and service•• …processes …where the resulting output cannot be verified by …processes …where the resulting output cannot be verified by

subsequent monitoring or measurement. subsequent monitoring or measurement. NOTE: NOTE: These processes are frequently referred to as special processes.These processes are frequently referred to as special processes.

•• …demonstrate the ability of these processes to achieve planned r…demonstrate the ability of these processes to achieve planned results.esults.•• …establish arrangements for these processes including, as applic…establish arrangements for these processes including, as applicableable•• a) defined criteria for review and approval of the processes,a) defined criteria for review and approval of the processes,

qualification and approval of special processes prior to use,qualification and approval of special processes prior to use,•• b) approval of equipment and qualification of personnel,b) approval of equipment and qualification of personnel,•• c) use of specific methods and procedures,c) use of specific methods and procedures,

control of the significant operations and parameters of special control of the significant operations and parameters of special processes in accordance with documented process specifications processes in accordance with documented process specifications and changes thereto,and changes thereto,

•• d) requirements for records (see 4.2.4), andd) requirements for records (see 4.2.4), and•• e) revalidation.e) revalidation.


Special Process Approval Special Process Approval ObjectivesObjectives

•• To put in place industry controlled process for To put in place industry controlled process for meeting requirements of 9100 clause 7.5.2meeting requirements of 9100 clause 7.5.2–– Supplier processes are an extension of the OEM processesSupplier processes are an extension of the OEM processes

•• To reduce redundant audits for the special To reduce redundant audits for the special process at suppliers and improve the global process at suppliers and improve the global quality levelquality level–– Common requirements (auditors and audit questionnaires)Common requirements (auditors and audit questionnaires)–– Harmonized assessment processHarmonized assessment process–– Data exchangeData exchange–– Demonstrated industry managed processDemonstrated industry managed process–– Process oversightProcess oversight–– Mutual system recognitionMutual system recognition


International Aerospace Sector International Aerospace Sector Certification SchemeCertification Scheme

Each geographic region or area is establishingEach geographic region or area is establishinga system, based on a set of agreed criteria, a system, based on a set of agreed criteria, which defines how 9100 will be implementedwhich defines how 9100 will be implemented

The IAQG will have agreed and compatible systemsThe IAQG will have agreed and compatible systemsacceptable to all, which allows sharing of audit results acceptable to all, which allows sharing of audit results

and approvals resulting in multiple assessment reductionand approvals resulting in multiple assessment reductionand process improvementand process improvement


What is the Goal of the System?

The goal of the system is for a supplier to receive oneaerospace quality systems approval that will be acceptable to all aerospace OEMs throughout the world.

The key element in this is confidence. The aerospace OEMs must have confidence in the approvals being performed on a global basis

All Aerospace organizations will be able to take advantage of the system for supplier control purposes


International Requirements for International Requirements for Certification / RegistrationCertification / Registration

International AerospaceInternational AerospaceSupplier Quality SystemSupplier Quality SystemEvaluation/CertificationEvaluation/Certification

Active IndustryActive Industryparticipationparticipation

ApprovedApprovedAerospaceAerospaceAuditorsAuditors

Oversight/control Oversight/control by IAQGby IAQG

and Sectorsand Sectors

InterInter--NationalNationalAviation AuthorityAviation Authority

endorsementendorsement

One audit One audit accepted byaccepted byall Primesall Primes

ApprovedApprovedCert. Bodies&Cert. Bodies&

RegistrarsRegistrars

SingleSingleglobal standards global standards

91009100

InterInter--NationalNationalAccreditationAccreditation

controlcontrol

Harmonised systemsHarmonised systemsof applicationof application

Data easily Data easily available to allavailable to all

participantsparticipants

GlobalGlobalacceptance byacceptance bysupplier basesupplier base


Important Considerations about Important Considerations about Certification / RegistrationCertification / Registration

•• Industry Controlled ProcessIndustry Controlled Process–– Includes requirements for ABIncludes requirements for AB’’s and s and CRBCRB’’ss–– Includes requirements for auditorsIncludes requirements for auditors

•• Training requirements are statedTraining requirements are stated–– Includes requirements for reporting results of Includes requirements for reporting results of

auditsaudits–– Includes minimum audit times and guidelinesIncludes minimum audit times and guidelines

•• Industry involvementIndustry involvement–– Must require suppliers to notify OEMMust require suppliers to notify OEM’’s of status of s of status of

Registration and any changes theretoRegistration and any changes thereto–– Must report problems with RegistrarsMust report problems with Registrars–– Track suppliers vs. Registrars Track suppliers vs. Registrars vsvs performanceperformance


O.A.S.I.S. O.A.S.I.S. -- DatabaseDatabase

•• OnOn--line Aerospace Supplier Information line Aerospace Supplier Information SystemSystem

•• Went “Live” 1 July 2003Went “Live” 1 July 2003–– Assessments are entered by Assessments are entered by CRB’sCRB’s

•• Assessment results are to be entered when Assessment results are to be entered when performed or can be entered now for performed or can be entered now for assessments prior to 1 Jul 03assessments prior to 1 Jul 03

•• Organizations can access information nowOrganizations can access information now•• Restricted access to dataRestricted access to data


Why OASIS?Why OASIS?

The database is The database is essentialessential to provide independent to provide independent verification of the status of certification, thereby verification of the status of certification, thereby validating the entire other party process to stakeholdersvalidating the entire other party process to stakeholders

Enables the acceptance of a Enables the acceptance of a single assessmentsingle assessment globally globally thus preventing multiple visits / audits by multiple thus preventing multiple visits / audits by multiple stakeholdersstakeholders

Without the database OEMs would have to Without the database OEMs would have to independently verifyindependently verify each auditor, CRB and each auditor, CRB and assessment resultsassessment results


OASIS BenefitsOASIS Benefits

•• Customers / OEM’s / SuppliersCustomers / OEM’s / Suppliers–– Provides UpProvides Up--toto-- date and complete information on date and complete information on

Aerospace QMS approvals, with data on Who, How, Aerospace QMS approvals, with data on Who, How, When and What is Approved, including results. When and What is Approved, including results.

•• AB’s / AB’s / CRB’sCRB’s / Auditors/ Auditors–– Current information on Who is Approved and for What Current information on Who is Approved and for What

by the Aerospace Industryby the Aerospace Industry

•• NAAsNAAs / / DoD’sDoD’s and Space Agenciesand Space Agencies–– Complete oversight information available in one source Complete oversight information available in one source

with no conflicting information (i.e. multiple data entries)with no conflicting information (i.e. multiple data entries)


OASIS BenefitsOASIS Benefits

•• OASIS should be part of the OEM / Supplier’s OASIS should be part of the OEM / Supplier’s process of supplier managementprocess of supplier management

–– The database should allow a supplier to be added to an ASL The database should allow a supplier to be added to an ASL without additional showing of QMS approvalwithout additional showing of QMS approval

–– OEMs need to insist that suppliers be listed in OASISOEMs need to insist that suppliers be listed in OASIS–– Available to entire Aerospace Supply ChainAvailable to entire Aerospace Supply Chain

•• Fee for every Fee for every INITIAL INITIAL certification/registration into the certification/registration into the IAQGIAQG--OASIS database OASIS database –– invoiced via the CRB.invoiced via the CRB.

–– The recurring fee for reassessment (normally in 3 years) The recurring fee for reassessment (normally in 3 years) ––WILL BE LESSWILL BE LESS

“If a database entry saves 1 Day of an OEM / “If a database entry saves 1 Day of an OEM / supplier’s time in a QMS audit it will be worth supplier’s time in a QMS audit it will be worth the fee”the fee”

●● Agreed to improve the overall approach to qualityAgreed to improve the overall approach to quality

●● Major Aerospace Companies have agreed upon Major Aerospace Companies have agreed upon Quality Management System approval approachesQuality Management System approval approaches

●● A key objective is to improve performance and A key objective is to improve performance and reduce the number of auditsreduce the number of audits

●● There are significant benefits to the entire There are significant benefits to the entire Aerospace Industry supply chainAerospace Industry supply chain

●● International approach is based on agreed International approach is based on agreed standards, standards, harmonizationharmonization of system application of system application and shared informationand shared information

Industry Leaders are ListeningIndustry Leaders are Listening


QUESTIONSQUESTIONS

Documents

AEROSPACE QUALITY MANAGEMENT SYSTEMS · 19/10/2003 · Including Operator Certs (e.g. NDT, Welding) • Manufacturing Process Verifications – Manufacturing Routing Sheets. –