AEROSPACE QUALITY MANAGEMENT SYSTEM 9100 Dale K. Gordon Past Chairman Americas Aerospace Quality Group SAE Aerospace Committee G-14 March 14th 2002.

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Presentation transcript:

AEROSPACE QUALITY MANAGEMENT SYSTEM 9100 Dale K. Gordon Past Chairman Americas Aerospace Quality Group SAE Aerospace Committee G-14 March 14th 2002

Dale K. Gordon 2 Aerospace Quality Standards Numbering System International Standards - 91xx International Standards - 91xx –Are planned for harmonization across all 3 aerospace sectors and are recognized globally Americas Standards - 90xx Americas Standards - 90xx –Are published for use by AAQG, may become an 91XX standard at a later date “AS” Standards - Americas “AS” Standards - Americas –Published by Society of Automotive Engineers “EN” Standards - Europe “EN” Standards - Europe –published in Europe by AECMA “JIS Q”or “SJAC” is the Japan / Asia Equivalent “JIS Q”or “SJAC” is the Japan / Asia Equivalent

Dale K. Gordon 3 Aerospace Quality System Standards INTERNATIONAL STANDARDS INTERNATIONAL STANDARDS – Quality System for Aerospace Manufacturers – Checksheet for 9100 – Quality System for Aerospace Repair Stations – Checksheet for EAQG only – Quality System for “Pass-Through” Distributors – Checksheet for 9120

Dale K. Gordon 4 Aerospace Quality Standards (cont.) International First Article Inspection (9102) First Article Inspection (9102) Management of Key Characteristics (9103) Management of Key Characteristics (9103) Record Retention (9130) Record Retention (9130) Nonconformance Documentation (9131) Nonconformance Documentation (9131) 2D Bar Coding (9132) 2D Bar Coding (9132) Part Qualification Process 9133) Part Qualification Process 9133) Americas AS “Less than” 9100 AS “Less than” 9100 Production Process Planning Verification (software) Production Process Planning Verification (software) Software Quality (Embedded / Product Acceptance) Software Quality (Embedded / Product Acceptance) Internal Auditing Requirements Internal Auditing Requirements Sub-tier Supplier Control Sub-tier Supplier Control Direct Shipments (ARP 9004) Direct Shipments (ARP 9004) Electronic Signatures Electronic Signatures

HISTORY OF 9100

Dale K. Gordon 6 Background - Early to mid- 1990s DoD canceled quality system specifications DoD canceled quality system specifications FAA lacks a definitive description of a quality system FAA lacks a definitive description of a quality system Primes began to flow ISO 9000 series plus unique requirements to suppliers Primes began to flow ISO 9000 series plus unique requirements to suppliers Suppliers asked industry to standardize Suppliers asked industry to standardize –Needed to operate a single quality system –Already adopting ISO 9000 series

Dale K. Gordon 7 U.S. Industry Response Supplier Management and Quality Assurance professionals from: AlliedSignalPratt & Whitney Boeing Rockwell Collins GE Engines Rolls-Royce Allison Lockheed Martin Sundstrand McDonnell DouglasNorthrop Grumman Sponsors Aviation/Space & Defense Division ofAviation/Space & Defense Division of American Society for Quality SAE Aerospace CouncilSAE Aerospace Council

Dale K. Gordon 8 FAA D ISO-9001 MIL-I MIL-Q DoD Company Specific Req’mts NASA Inputs AS9000:1997 Writing Team Formed

Dale K. Gordon 9 Global Quality Standard Activity

Dale K. Gordon 10 ISO TC20 - WG11 ISO Technical Committee 20 - Aircraft & Space Vehicles –Established Working Group 11 (April 1997) Chartered to develop and publish an international quality system standard based upon ISO 9001 for the aerospace industryChartered to develop and publish an international quality system standard based upon ISO 9001 for the aerospace industry United States (Gene Barker) ConvenerUnited States (Gene Barker) Convener Members:Members: BrazilChinaFrance GermanyJapanMexico United KingdomUnited States

Dale K. Gordon 11 ISO TC 20 WG11 AS9100 EN 9100 AS9000 prEN Americas Standard European Standard ISO World Aerospace Quality Standard ; AS/EN/JIS Q 9100 International Quality System Standard Creation 1998

Dale K. Gordon 12 TC20 / WG 11 to IAQG Upon completion/approval of the new standard, WG 11 transfers responsibility for technical content to newly formed International Aerospace Quality Group (IAQG). Upon completion/approval of the new standard, WG 11 transfers responsibility for technical content to newly formed International Aerospace Quality Group (IAQG). WG11 is disestablished (June 1999). WG11 is disestablished (June 1999). IAQG takes responsibility for 91XX documents and publishes 9100 in each of the 3 Sectors (1999) IAQG takes responsibility for 91XX documents and publishes 9100 in each of the 3 Sectors (1999) –AMERICAS - SAE AS9100 –EUROPE - AECMA-STAN EN9100 –ASIA - JIS Q9100 (Japan)

Dale K. Gordon 13 Why 9100? To standardize Aerospace quality expectations on a global level To standardize Aerospace quality expectations on a global level To achieve improvements in quality and reduce costs throughout the value stream 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 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 Captures aerospace supplements agreed to at an international level

Dale K. Gordon 14 Aerospace Quality System 9100 Standard versus ISO :1999 added 83 additional and specific requirements to the 20 elements of ISO :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 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

Dale K. Gordon 15 Year 2000 ISO 9000 Revisions A moving target...

Dale K. Gordon Standard Alignment with ISO 9001:2000 IAQG had the responsibility IAQG had the responsibility Aligned aerospace requirements with the new ISO 9001:2000 Aligned aerospace requirements with the new ISO 9001:2000 Incorporated lessons learned - clarified requirements Incorporated lessons learned - clarified requirements Coordination and resolution was by geographic sectors Coordination and resolution was by geographic sectors Americas (AAQG)Europe (EAQG)Asia (SJAC) Goal to publish revision to est. June 2001 Goal to publish revision to est. June 2001 AS9100A published by SAE in August 2001 AS9100A published by SAE in August 2001 JIS Q 9100:2001 published by JSA in November 2001 JIS Q 9100:2001 published by JSA in November 2001

Dale K. Gordon :2001 Highlights (cont.) Intent of aerospace-unique requirements are not changed in new version of 9100 Intent of aerospace-unique requirements are not changed in new version of 9100 –ISO 9001:2000 revision now has requirements desired by industry, eliminating some requirements from 9100:1999 version –Some requirements from ISO 9001:1994 are desired by industry and were added back to 9100:2001 version –9100:2001 contains 80 aerospace unique requirements and 18 amplifications/notes

Dale K. Gordon 18 ISO 9001:2000 / 9100:2001 Timeline DEC ISO 9001: ISO 9001: : : A:2001 will include both ISO 9001:1994 and ISO 9001:2000 models until December :2003 ?

Dale K. Gordon 19 FAA Endorsement of AS9100:1999 “ The Aircraft Certification Service believes that the effective implementation of AS9100 will enhance an organization’s overall performance, as long as the statement...Other Quality System requirements imposed by the applicable Regulatory Authorities shall be included or referenced in the Quality System documentation is strictly adhered to. Though the FAA does not require the use of the additional elements found in AS9100, it recognizes their benefits to the aviation in increasing an organizations’ efficiency and reducing product and system variance.”

Dale K. Gordon 20 Current USA DoD Position Proposed Department of Defense (DoD) Adoption of the AS9100: 2001 Quality Management Systems - Aerospace - Requirements (Nov. 2001) Proposed Department of Defense (DoD) Adoption of the AS9100: 2001 Quality Management Systems - Aerospace - Requirements (Nov. 2001) –prepared... DoD adoption notice for the AS 9100:2001 to provide information for document visibility and facilitate document availability to DoD personnel. International Aerospace Quality Standard AS 9100, 2001 edition, Quality Management Systems--Aerospace Requirements, was adopted on March 1, 2002 for use by the Department of Defense (DoD). The standard specifies additional requirements identified by the aerospace industry specifically for an aerospace quality management system based on ISO 9001:2000 Quality Management Systems Requirements. International Aerospace Quality Standard AS 9100, 2001 edition, Quality Management Systems--Aerospace Requirements, was adopted on March 1, 2002 for use by the Department of Defense (DoD). The standard specifies additional requirements identified by the aerospace industry specifically for an aerospace quality management system based on ISO 9001:2000 Quality Management Systems Requirements.

Dale K. Gordon 21 Current NASA Position on AS9100 “AS 9100 is identified in the Federal Acquisition Regulation (FAR) as a higher-level quality standard, has been recognized by the Federal Aviation Administration, is being adopted by the Air Force, and is currently used by a number of NASA programs.” “AS 9100 is identified in the Federal Acquisition Regulation (FAR) as a higher-level quality standard, has been recognized by the Federal Aviation Administration, is being adopted by the Air Force, and is currently used by a number of NASA programs.” Office of Procurement are presently reviewing...intent for NASA to adopt this standard. After (a) thirty-day comment period,... the Office of Procurement (may) implement this change in acquisition policy. Office of Procurement are presently reviewing...intent for NASA to adopt this standard. After (a) thirty-day comment period,... the Office of Procurement (may) implement this change in acquisition policy.

Dale K. Gordon 22 SPACE CONSIDERATIONS ISO TC20 / SC14 and IAQG have on-going project to supplement 9100 w/ special considerations for Space needs ISO TC20 / SC14 and IAQG have on-going project to supplement 9100 w/ special considerations for Space needs –Includes Risk Management & Safety and Mission Assurance emphasis –Use as supplement to 9100 –Consideration for full inclusion at next revision of 9100 Other Space considerations with IAQG process / documents to be considered as appropriate Other Space considerations with IAQG process / documents to be considered as appropriate

Dale K. Gordon Checklist IAQG developed 9101 Common Checklist to be used by industry to cover all ISO 9001 & 9100 elements - allows industry to share audit information 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 Certification Bodies when performing 9100 audits Must be used by Certification Bodies when performing 9100 audits Optional scoring feature is currently used by AECMA-EASE Optional scoring feature is currently used by AECMA-EASE

Dale K. Gordon Repair Station Quality System EN 9110 developed and implemented in Europe for facilities that perform maintenance and repairs of aircraft and aircraft products EN 9110 developed and implemented in Europe for facilities that perform maintenance and repairs of aircraft and aircraft products –Based on 9100 requirements and FAA / JAA - JAR 145 requirements Corresponding 9111 checklist has also been developed and published International harmonized version for is being worked

Dale K. Gordon Distributor Quality System EN 9120 developed and implemented in Europe for “pass through” stockists / distributors that handle parts and supplies that are used in aerospace products EN 9120 developed and implemented in Europe for “pass through” stockists / distributors that handle 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 Listening l Agreed to improve the overall approach to quality l Major Aerospace Companies have agreed upon Quality Management System approval approaches l A key objective is to reduce the number of audits l There are significant benefits to the Aerospace Industry l Working to develop our International processes to incorporate the new approach l International approach is based on a single agreed standard, harmonization of system application and shared information

Dale K. Gordon 27 Industry Acceptance / Usage  The IAQG implementation metrics show that;  50+% of members have implemented 9100 internally and to their suppliers  20+% of members have implemented 9102, FAI, internally and to their suppliers.  8% of companies have implemented the recently published 9103, Component Proving, internally and to their suppliers. –Implementation is gaining momentum and this will increase, particularly when the new Boeing Quality System is reissued. –The sector implementation approaches are also making good progress but the benefits from global mutual recognition of Quality System audits is still not quite there yet - we need the global database.

Dale K. Gordon 28 International Aerospace Sector Certification Scheme Each geographic region or area needs to establish a system, based on a set of agreed criteria, which defines how 9100 will be implemented which defines how 9100 will be implemented We will then have agreed and compatible systems acceptable to all, which allows us to share audit results and approvals resulting in multiple assessment reduction and process improvement

Dale K. Gordon 29 What is the Goal of the System? The goal of the system is for a supplier to receive one 9100 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 given in other Sectors.

Dale K. Gordon 30 International Requirements for Certification International Aerospace Supplier Quality System Evaluation/Certification Active Industry participation Approved Aerospace Auditors Oversight/control by IAQG and Sectors Inter-National Aviation Authority endorsement One audit accepted by all Primes Approved Cert. Bodies& Registrars Single global standards 9100 Inter-National Accreditation control Harmonised systems of application Data easily available to all participantsGlobal acceptance by supplier base

Basic structure of the system International Aerospace 3rd Party Accreditation Americas Americas Scheme Accreditation Body Accreditation Body Registrars Registrars Auditors Auditors Assessment Assessment Suppliers Suppliersdata Data Base Data Base IAQG Scheme issued by SAE / AECMA / SJAC Europe Aerospace Industry Participants Access Usage Asia Asia Scheme Asia Scheme Europe Scheme Europe Scheme (equivalent) (equivalent) requirements IAQG “oversight” Accreditation Body Accreditation Body Registrars Registrars Auditors Auditors Assessment Assessment Suppliers Suppliersdata Data Base Data Base Accreditation Bodies Accreditation Bodies Registrars Registrars Auditors Auditors Assessment Assessment Suppliers Suppliersdata Data Base Data Base oversightoversightoversight WHAT HOW

Dale K. Gordon 32 Aerospace Supplier Quality System Certification by the IAQG Sectors Based on Deployment of Sector Processes Based on Deployment of Sector Processes –AIR5359 / 5493 (Americas) –AECMA (Europe) –SBAC TS157 (UK) –SJAC 9010 / 9011 (Asia) IAQG Document 104 Released Jun ‘01 Industry Database Under Construction

Dale K. Gordon 33 IAQG Procedure 104 Important Considerations Includes requirements for AB’s and CB’s Includes requirements for AB’s and CB’s Includes requirements for auditors Includes requirements for auditors –Training requirements are stated Includes requirements for reporting results of audits Includes requirements for reporting results of audits Includes minimum audit times and guidelines Includes minimum audit times and guidelines Industry involvement 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

Dale K. Gordon 34 IAQG Oversight Establishes industry Oversight Function (IAQG OT) Establishes industry Oversight Function (IAQG OT) The following is not part of IAQG 104: The following is not part of IAQG 104: –IAQG OT will: 1.) Monitor each Sector’s administration of their plan 2.) Review IAF peer evaluation of ABs 3.) Monitor feedback from IAQG members, CRBs, suppliers using the system 4.) Periodic review of Lessons Learned & any changes to Sector schemes 5.) Ensure data base effectiveness 6.) Provide summary report to IAQG at Council meetings

Dale K. Gordon Registration Attributes Salient Points about Registration Salient Points about Registration –OEM’s are not absolving themselves of any responsibilities with respect to the supply chain / products –Registration increases the level of surveillance by covering suppliers that the OEM’s do not cover directly. –Provides for consistent application of requirements throughout the supply chain (9100). –Provides for active industry participation and control. –Provides for data sharing amongst primes and benchmarks the industry in terms of Quality System compliance. –Supplements OEM’s own surveillance process and allows for more focused process and products audits.

Dale K. Gordon 36 Summary l Industry Co-operation on Quality System Requirements l A single global 9100 Aerospace standard l An agreed International process for procedure creation l Sector processes for 2nd or 3rd party approvals l Individual sector plans launched / global plans in work l Implementation planned progressively during 2001 l Establish a mechanism for data exchange l International auditor training and qualifications l Communication to Authorities and Stakeholders l Industry will Monitor results and maintain momentum

Dale K. Gordon 37 QUESTIONS