AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARD AS / EN / JIS Q9100

Transcription

AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARD AS / EN / JIS Q9100
AEROSPACE QUALITY
MANAGEMENT SYSTEM
STANDARD AS / EN / JIS Q9100
Dale K. Gordon
Chairman
Americas Aerospace Quality Group
SAE Aerospace Committee G-14
Aerospace Quality Standards
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
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Aerospace Quality System
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
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HISTORY - The need to Standardize
Aerospace Quality System Requirements
Inputs
D1-9000
AAQG
Process
Output
AS9000
AAQG formed in 1995
to Standardize Quality
Requirements for the
Industry
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International Quality System
Standard Creation 1998
Americas
Standard
AS9000
European
Standard
ISO 9001
1994
prEN 9000-1
World Aerospace Quality
Standard ; AS/EN/JIS Q 9100
AS9100
ISO TC 20
WG11
EN 9100
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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
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Aerospace Quality System 9100
Standard 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
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Aerospace Quality System
9100 versus ISO 9001
Aerospace added Requirements (#)
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)
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ISO 9001:2000 QUALITY
STANDARD 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. 2003
2000
2001
2002
2003
DEC. 2003
ISO 9001:1994
ISO 9001:2000
9100 : 1999
9100 : 2001
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ISO 9001:2000 QUALITY
STANDARD REVISION IMPACT

Aerospace unique requirements
are not changed in new version of
9100
– ISO 9000 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
– 9100:2000 contains 80 aerospace unique
requirements and 18 amplifications
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9100 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 each
site that purchases
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9110 Repair Station Quality
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
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9120 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
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Industry Leaders are Listening

Agreed to improve the overall approach to quality

Major Aerospace Companies have agreed upon Quality
Management System approval approaches

A key objective is to reduce the number of audits

There are significant benefits to the Aerospace Industry

Working to develop our International processes to
incorporate the new approach

International approach is based on a single agreed
standard, harmonization of system application and shared
information
Basic structure of the system
International Aerospace 3rd Party Accreditation
IAQG Scheme issued by SAE/AECMA/SJAC
IAQG “oversight” WHAT
requirements
Americas
(equivalent)
Americas Scheme
oversight
Accreditation Body
Registrars
Auditors
Asia
(equivalent)
Asia Scheme
Suppliers
Accreditation Body
Registrars
Auditors
Suppliers
Accreditation Bodies
Registrars
Auditors
Assessment
Suppliers
data
Data Base
Access
Usage
Aerospace Industry Participants
HOW
oversight
Assessment
data
Data Base
Europe Scheme
oversight
Assessment
Europe
data
Data Base
Process plan for
development/implementation
Describe
the system
Get
acceptance
Communicate
the system
Implement
the system
ISSUE DOCUMENTS
•document sector schemes
•define elements
•compare regional schemes
•analyse gaps
•establish equivalence +
harmonisation
•amend Sector schemes
•document international
scheme
September 2000
•obtain sector/IAQG
acceptance
•advise authorities
•obtain Accreditation
bodies agreement (IAF)
•Establish a single IAQG
procedure
•Final update Sector
schemes
December 2000
•to Accreditation Bodies
•to Registrars/Certification
Bodies
•to the Regulatory
Authorities
•to OEM’s & Trade
Associations
•to suppliers
•to the International
community
1st Q 2001
•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
2nd Q 2001
Audits and Approvals
Can you imagine a
world without audits
What a sad place that
would be
And what would we
do with all that spare
time
IMPROVEMENT
We could focus on
other things
Like product quality and
project specific requirements
9100 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”
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Certification / 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
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AIR5359A
Important 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
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AS9100 Implementation
(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
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AS9100 Implementation
(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
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9100 Registration
Attributes

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.
Single Global Procedure

Based on SAE AIR 5359A

Embraces all of the key criteria

Utilizes generic acronym 9100

It is a 2nd / Other party scheme

Includes Registrars and Certification Bodies

Sector Management Structure (SMS)

Minimum summary data

Contains minor sector variants

The document has sub-team agreement
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RGM/TS/10073
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Tomorrow’s world - on our way
Single
global standards
AS/EN9100
Oversight/control
by IAQG
and Sectors
Inter-National
Aviation Authority
endorsement
One audit
accepted by
all Primes
Harmonised systems
of application
Inter-National
Accreditation
control
International Aerospace
Supplier Quality System
Evaluation/Certification
Active Industry
participation
Data easily
available to all
participants
Global
acceptance by
supplier base
Approved
Cert. Bodies&
Registrars
Approved
Aerospace
Auditors
Summary

A single 9100 Aerospace standard

An agreed single International procedure of application

Sector scheme procedures harmonised and complete

Individual sector launch plans confirmed

Implementation planned progressively during 2001

Establish a mechanism for data exchange

International auditor training and qualifications

Communication to Authorities and Registrars continues

No major barriers to implementation

Team will co-ordinate implementation programs

Monitor and maintain progress
COPIES OF STANDARDS, REPORTS
AND CHECKLISTS ARE AVAILABLE
FROM SAE
WWW.SAE.ORG
Society of Automotive Engineers
400 Commonwealth Drive
Warrendale, PA 15096-0001
QUESTIONS
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