AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARD AS / EN / JIS Q9100 Dale K. Gordon Chairman Americas...
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Transcript of AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARD AS / EN / JIS Q9100 Dale K. Gordon Chairman Americas...
AEROSPACE QUALITY AEROSPACE QUALITY MANAGEMENT SYSTEM MANAGEMENT SYSTEM STANDARD AS / EN / JIS Q9100STANDARD AS / EN / JIS Q9100
Dale K. Gordon
ChairmanAmericas Aerospace Quality Group
SAE Aerospace Committee G-14
20 February 2001 2
Aerospace Quality StandardsAerospace Quality Standards Numbering System Numbering System
International Standards - 91xx– Are planned for harmonization across all 3
aerospace sectors and are recognized globally
Americas Standards - 90xx– Are published for use by AAQG, may become an
91XX standard at a later date
“AS” Standards - Americas– Published by Society of Automotive Engineers
“EN” Standards - Europe– published in Europe by AECMA
“JIS Q” is the Japan / Asia Equivalent
20 February 2001 3
Aerospace Quality SystemAerospace Quality System Standards Standards
INTERNATIONAL STANDARDS
– 9100 - Quality System for Aerospace Manufacturers
– 9101 - Checksheet for 9100
– 9110 - Quality System for Aerospace Repair Stations - EAQG
– 9111 - Checksheet for 9110 - EAQG only
– 9120 - Quality System for Distributors - EAQG
– 9121 - Checksheet for 9120 - EAQG
20 February 2001 4
FAA
D1-9000ISO-9001
MIL
-IMIL-QDoD
CompanySpecific Req’mtsNA
SA
AS9000
Inputs
AAQGProcess
Output
European
Specific Stds
AAQG formed in 1995 to Standardize Quality Requirements for the Industry
HISTORY - The need to StandardizeHISTORY - The need to StandardizeAerospace Quality System RequirementsAerospace Quality System Requirements
20 February 2001 5
ISO TC 20WG11
AS9100 EN 9100
AS9000 prEN 9000-1
AmericasStandard
EuropeanStandardISO 9001
1994
World Aerospace Quality Standard ; AS/EN/JIS Q 9100
International Quality SystemInternational Quality SystemStandard Creation 1998Standard Creation 1998
20 February 2001 6
Why AS9100?Why AS9100?
To standardize Aerospace quality expectations on a global level
To achieve improvements in quality and reduce costs throughout the value stream
ISO 9000 model for quality does not capture regulatory requirements or importance of safety, reliability or maintainability
Captures aerospace supplements agreed to at an international level
20 February 2001 7
Aerospace Quality System 9100Aerospace Quality System 9100Standard versus ISO 9001Standard versus ISO 9001
9100:1999 added 83 additional and specific requirements to the 20 elements of ISO 9001– 11 amplifications of ISO 9001 paragraphs are
also inserted
Emphasis is placed on Design Control, Process Control, Purchasing, Inspection & Testing and Control of Nonconformances– All areas that have the greatest impact on
safety and reliability for aerospace products
20 February 2001 8
Aerospace Quality SystemAerospace Quality System 9100 versus ISO 9001 9100 versus ISO 9001
4.1 Management Resp. (2)
4.2 Quality Systems (7)
4.3 Contract Review (3)
4.4 Design Control (11)
4.5 Document and Data Control (2)
4.6 Purchasing (13)
4.8 Product Identification and Traceability (2)
4.9 Process Control (13)
4.10 Inspection and test. (10)
4.11 Control of Insp., Measure & Test Equipment (3)
4.12 Inspection & Test status (2)
4.13 Control of Nonconforming Product (7)
4.14 Corrective and Preventive Action (2)
4.15 Handling, storage, package, preservation and delivery (1)
4.16 Control of Quality Records (1)
4.17 Internal Quality Audits (2)
4.18 Training (1)
4.20 Statistical Techniques (1)
Aerospace added Requirements (#)
20 February 2001 9
ISO 9001:2000 QUALITYISO 9001:2000 QUALITYSTANDARD REVISION IMPACTSTANDARD REVISION IMPACT Released in US, EUROPE & JAPAN 1999
• International Writing Team reconvened March 2000 to begin work on ISO 9000:2000 incorporation
• Work is almost complete, planned release for standard based on ISO 9000:2000 would be mid 2001
• 9100:1999 & 9100:2001 would co-exist until Nov. 2003DEC. 2003
ISO 9001:1994
2000 2001 2002 2003
ISO 9001:2000
9100 : 1999
9100 : 2001
20 February 2001 10
ISO 9001:2000 QUALITYISO 9001:2000 QUALITYSTANDARD REVISION IMPACTSTANDARD REVISION IMPACT
Aerospace unique requirementsare not changed in new version of9100– ISO 9000 revision now has requirements
desired by industry, eliminating somerequirements from 9100:1999 version
– Some requirements from ISO 9001:1994 are desired by industry and were added back to 9100:2001 version
– 9100:2000 contains 80 aerospace unique requirements and 18 amplifications
20 February 2001 11
9100 Checklist - 91019100 Checklist - 9101
IAQG developed 9101 Common Checklist to be used by industry to cover all ISO 9001 & 9100 elements - allows industry to share audit information
Must be used by Registrars when performing 9100 audits
Optional scoring feature Purchase of 1 copy from SAE
will give rights to make unlimited copies for eachsite that purchases
20 February 2001 12
9110 Repair Station Quality9110 Repair Station Quality System System
EN 9110 developed and implemented in Europe for facilities that perform maintenance and repairs of aircraft and aircraft products– Based on 9100 requirements and JAA - JAR
145 requirements
• Corresponding 9111 checklist has also been developed and published
•International harmonized version for is being worked
20 February 2001 13
9120 Distributor Quality System9120 Distributor Quality System
EN 9120 developed and implemented in Europe for “pass through” distributors that broker or distribute parts and supplies that are used in aerospace products– Checklist 9121 is also available
in Europe– Based on 9100, but only applies
necessary system requirements.– Americas already has several
distributor standards (ASA 100, AS7103)– International harmonized standard is being worked
Industry Leaders are ListeningIndustry Leaders are Listening Agreed to improve the overall approach to qualityAgreed to improve the overall approach to quality
Major Aerospace Companies have agreed upon Quality Major Aerospace Companies have agreed upon Quality Management System approvalManagement System approval approachesapproaches
A key objective is to reduce the number of auditsA key objective is to reduce the number of audits
There are significant benefits to the Aerospace IndustryThere are significant benefits to the Aerospace Industry
Working to develop our International processes to Working to develop our International processes to incorporate the new approach incorporate the new approach
International approach is based on a single agreed International approach is based on a single agreed standard, standard, harmonizationharmonization of system application and shared of system application and shared informationinformation
Basic structure of the systemBasic structure of the system International Aerospace 3rd Party Accreditation International Aerospace 3rd Party Accreditation
AmericasAmericas
Americas SchemeAmericas Scheme
Accreditation BodyAccreditation Body RegistrarsRegistrars AuditorsAuditors AssessmentAssessment
SuppliersSuppliersdatadata
Data BaseData Base
IAQG Scheme issued by SAE/AECMA/SJACIAQG Scheme issued by SAE/AECMA/SJAC
EuropeEurope
Aerospace Industry ParticipantsAerospace Industry Participants
Access UsageAccess Usage
AsiaAsia
Asia SchemeAsia Scheme Europe SchemeEurope Scheme
(equivalent)(equivalent) (equivalent)(equivalent)
requirementsrequirements IAQG “oversight”IAQG “oversight”
Accreditation BodyAccreditation Body RegistrarsRegistrars AuditorsAuditors AssessmentAssessment
SuppliersSuppliersdatadata
Data BaseData Base
Accreditation BodiesAccreditation Bodies RegistrarsRegistrars AuditorsAuditors AssessmentAssessment
SuppliersSuppliersdatadata
Data BaseData Base
oversightoversight oversightoversight oversightoversight
WHATWHAT
HOWHOW
Process plan for Process plan for development/implementationdevelopment/implementation
Describe Describe the systemthe system
Get Get acceptanceacceptance
Communicate Communicate the systemthe system
Implement Implement the systemthe system
•document sector schemesdocument sector schemes•define elementsdefine elements•compare regional schemescompare regional schemes•analyse gapsanalyse gaps•establish equivalence + establish equivalence +
harmonisationharmonisation•amend Sector schemesamend Sector schemes•document international document international
schemescheme
•obtain sector/IAQG obtain sector/IAQG
acceptanceacceptance•advise authoritiesadvise authorities•obtain Accreditation obtain Accreditation
bodies agreement (IAF)bodies agreement (IAF)•Establish a single IAQG Establish a single IAQG
procedureprocedure•Final update Sector Final update Sector
schemesschemes
•to Accreditation Bodiesto Accreditation Bodies•to Registrars/Certification to Registrars/Certification
BodiesBodies•to the Regulatory to the Regulatory
AuthoritiesAuthorities•to OEM’s & Trade to OEM’s & Trade
AssociationsAssociations•to suppliersto suppliers•to the International to the International
communitycommunity
ISSUE DOCUMENTSISSUE DOCUMENTS
•Establish IAQG control mechanism
•establish Sector control mechanism
•approve ‘a’ registrar and‘an’ auditor
•install register(s) of Registrars and Aerospace auditors
•set up data exchange•run the system•monitor and maintain progress
September 2000September 2000 December 2000December 2000 1st Q 20011st Q 2001 2nd Q 20012nd Q 2001
Audits and ApprovalsAudits and Approvals
And what would weAnd what would wedo with all that sparedo with all that spare
timetime
Can you imagine a Can you imagine a world without auditsworld without audits
Like product quality andLike product quality andproject specific requirementsproject specific requirements
We could focus on We could focus on other thingsother things
What a sad place that What a sad place that would bewould be
IMPROVEMENTIMPROVEMENT
20 February 2001 18
9100 Implementation9100 Implementation
Most IAQG Companies are pursuing phased in approach to 9100 most have agreed to put on purchase contract by end of 2001– Many are targeting specific type of Suppliers for application
Some Companies will accept only 2nd Party Approvals– Some will accept 2nd Party Shared Approvals
Some Companies will accept 3rd Party Approvals– Some Accept ISO 9001 Certification with 2nd Party audits of
9100 or elements
– Some are using 9100 approval as a means for Risk Reduction for 2nd Party Audits
FAA has issued Order 8120.12 use of “Other Parties”
20 February 2001 19
Certification / RegistrationCertification / Registration
“Other Party” Plans being developed for Certification processes– SBAC procedure TS157 for United Kingdom– SAE AIR5359A for Registrar approval for use by AAQG
member companies• AIR5493 - Auditor training requirements
– AAQG / EAQG / JAQG to prepare and present procedures
for cross evaluation by others (for international use)
2nd Party shared process– AECMA - EASE is being used in EUROPE– Expanded AECMA - EASE being consider for worldwide
use
20 February 2001 20
AIR5359AAIR5359AImportant ConsiderationsImportant Considerations
Includes requirements for OEM’s to share audits Includes requirements for auditors
– Training requirements are in AIR5493 Includes requirements for reporting results of
audits Includes minimum audit times and guidelines Para 9.8 Industry involvement
– Must require suppliers to notify OEM’s of status of Registration and any changes thereto
– Must report problems with Registrars– Should track suppliers vs. Registrars vs performance
20 February 2001 21
AS9100 ImplementationAS9100 Implementation(Americas Companies)(Americas Companies)
2nd Party - Customer Shared Audits
– SAE AIR5359A has sharing plan built-in– Customer can ask if Supplier wishes to participate– Auditors must meet requirements in AIR 5359A– AS9101 Checklist and AIR5359A report must be
used and results left with the Supplier– Supplier is then free to offer a copy of results to
any other customer– Results may be used in-lieu of an audit or to
reduce the amount and intensity of an audit
20 February 2001 22
AS9100 ImplementationAS9100 Implementation(Americas Companies)(Americas Companies)
Controlled “Other” Party Plan– AAQG is implementing SAE AIR 5359A document– AIR 5359A is approved & awaiting publication– AAQG is working directly with Accreditation Bodies
to approve Registrars and Auditors– 21 Registrars (150 auditors) submitted by RAB have
been Accredited to AS9000– 2 Registrars (and 14 auditors) are Accredited to
AS9100 at this time. More are expected soon– Japan is implementing a similar system to AIR 5359A– Europe is planning a variation on the same theme– UK has implemented a compatible scheme
20 February 2001
9100 Registration9100 RegistrationAttributesAttributes
Salient Points about RegistrationSalient Points about Registration– OEM’s are not absolving themselves of any OEM’s are not absolving themselves of any
responsibilities with respect to the supply chain / responsibilities with respect to the supply chain / productsproducts
– Registration increases the level of surveillance by Registration increases the level of surveillance by covering suppliers that the OEM’s do not cover directly.covering suppliers that the OEM’s do not cover directly.
– Provides for consistent application of requirements Provides for consistent application of requirements throughout the supply chain (9100).throughout the supply chain (9100).
– Provides for active industry participation and control.Provides for active industry participation and control.– Provides for data sharing amongst primes and Provides for data sharing amongst primes and
benchmarks the industry in terms of Quality System benchmarks the industry in terms of Quality System compliance.compliance.
– Supplements OEM’s own surveillance process and Supplements OEM’s own surveillance process and allows for more focused process and products audits.allows for more focused process and products audits.
20 February 2001 24
Single Global ProcedureSingle Global Procedure
Based on SAE AIR 5359ABased on SAE AIR 5359A
Embraces all of the key criteriaEmbraces all of the key criteria
UtilizesUtilizes generic acronym 9100 generic acronym 9100
It is a 2nd / Other party schemeIt is a 2nd / Other party scheme
Includes Registrars and Certification BodiesIncludes Registrars and Certification Bodies
Sector Management Structure (SMS)Sector Management Structure (SMS)
Minimum summary dataMinimum summary data
Contains minor sector variantsContains minor sector variants
The document has sub-team agreementThe document has sub-team agreement
RGM/TS/10073RGM/TS/10073
Tomorrow’s world - on our wayTomorrow’s world - on our way
International AerospaceInternational AerospaceSupplier Quality SystemSupplier Quality SystemEvaluation/CertificationEvaluation/Certification
Active Industryparticipation
ApprovedAerospaceAuditors
Oversight/control Oversight/control by IAQGby IAQG
and Sectorsand Sectors
Inter-NationalInter-NationalAviation AuthorityAviation Authority
endorsementendorsement
One audit One audit accepted byaccepted byall Primesall Primes
ApprovedCert. Bodies&
Registrars
Single global standards
AS/EN9100
Inter-National Accreditation
control
Harmonised systemsof application
Data easily Data easily available to allavailable to all
participantsparticipants
GlobalGlobalacceptance byacceptance bysupplier basesupplier base
SummarySummary A single 9100 Aerospace standard A single 9100 Aerospace standard
An agreed single International procedure of applicationAn agreed single International procedure of application
Sector scheme procedures harmonised and completeSector scheme procedures harmonised and complete
Individual sector launch plans confirmedIndividual sector launch plans confirmed
Implementation planned progressively during 2001Implementation planned progressively during 2001
Establish a mechanism for data exchangeEstablish a mechanism for data exchange
International auditor training and qualificationsInternational auditor training and qualifications
Communication to Authorities and Registrars continuesCommunication to Authorities and Registrars continues
No major barriers to implementationNo major barriers to implementation
Team will co-ordinate implementation programsTeam will co-ordinate implementation programs
Monitor and maintain progressMonitor and maintain progress
COPIES OF STANDARDS, REPORTS COPIES OF STANDARDS, REPORTS AND CHECKLISTS ARE AVAILABLE AND CHECKLISTS ARE AVAILABLE FROM SAEFROM SAE
WWW.SAE.ORGSociety of Automotive Engineers
400 Commonwealth Drive
Warrendale, PA 15096-0001
20 February 2001 28
QUESTIONSQUESTIONS