Americas Aerospace Quality Group
AAQG Project Management
AAQG Project #61 (IAQG REQ-009)
IAQG 9101:2009 Revision - Quality
Management System Assessment
Reported by: Tony Marino
Date of Report: 2009-March-11
What happened and where is 9101?
• Released in October 2008 for ballot
– AAQG writing team members did not agree it was ready.
– Consulted with AAQG leadership to release or move for sector
rejection – decision for sector rejection.
• Primary Issues
– Writing was a balanced writing addressing both Conformity and
Effectiveness.
– Writing structure – too confusing.
– Contained guidance material.
– Differences of opinion on what could be changed during and after
ballot.
• Document revisions have been made and process of
finalization for ballot.
IAQG REQ-009 Working Group Members
Hans Luijt – Team Lead
Stuart Anthony
Eddy Benattar
Alain Bonnel
Conny Flink
Michel Jacquaniello
Marie-Laurence Petit
Brian Burroughs*
Michel Clément*
Larry Beck
Tom Gallagher
Tony Marino
Robert Keys*
Paul Dionne*
Masahiro Kawamoto
ASD-EASE - Netherlands
Rolls-Royce UK
IAI - Israel
SAFRAN - France
Volvo Aero - Sweden
Zodiac - France
Airbus - France
LRQA – UK
Bureau Veritas - France
Lockheed Martin – US (TX)
Hamilton Sundstrand (UTC)-US
The Boeing Company – US (WA)
DNV – US (TX)
Intertek
Mitsubishi Heavy Industries – Japan
9101: Revision Objectives
•
•
Ensure alignment with IAQG strategy (on-time, on-quality performance,
Strengthen of Other Party certification)
Support the process approach for quality management systems as
described in the 9100-series standards
•
Incorporate ISO 17021 changes and ICOP resolutions
•
Define requirements for all activities of audit program
•
Define adequate audit report that provides useful information to
stakeholders on Organization Processes Performance And
Effectiveness ( PEAR ) and conformity (Objective Evidence Record) to
9100 series .
•
Define audit records (objective evidence,…) to support ICOP Scheme
Americas Aerospace Quality Group - Project Plate
AAQG P61 - IAQG 9101:2008 Revision - Quality
Management System Assessment
Date of project approval:
AAQG Project
Leader:
Champion:
Tony Marino
Jack Flecher
Project Plate Revision:
2006-Oct-05
Problem Statement and Scope:
Deliverables:
IAQG Gate 0 Approved October 5, 2006 - Seville Spain (REQ-009)
1. Revised 9101
1. Current 9101 does not focus 9100 assessments on process
based management
2. Develop position and decision to obsolete 9111 and 9121
2. Too much emphasis on conformity of assessment – not auditing
what is important i.e. performance, continuous improvement,
customer satisfaction
3. Aerospace Experienced Auditor training and certification/
recertification recommendations
3. Linkage to certification: certificate too much of a ‘drivers license,
instead of a tool to prevent ‘accidents’.
4. Scoring is complex, time consuming, subjective and purpose of
is unclear.
5. Strong relationship of assessment documents (9101, 9111 and
9121).
Root Causes:
Success Criteria:
1. Upon release of ISO9001:2000, assessment tool and methods for
9100 was not updated to assess the process approach.
1. Publication of 9101
2. New 9100 release in April 2009 will require update of 9101
3. Greater fidelity of information in audit reports
Solution:
Metrics:
1. Update 9101 to be more than an assessment (checklist)
document.
1. Project Milestone
2. Publish assessment methods and tools that will provide more
meaningful information to the supplier, client and stakeholders
3. Consolidate 9101, 9111 and 9121 into one document
2. Auditor efficiency increase
)6/20/08
Americas Aerospace Quality Group - Project 4-Square
Date of last report:
2008-Sept, 11
P61 - IAQG 9101:2008 Revision - Quality Management
System Assessment
Project Leader:
Date of this report:
AAQG Champion:
Status:
Y
2009-March, 11
Project description / benefits:
Tony Marino
Kristy Heffernan
Recent accomplishments (since last report):
Project Description
•
•
Restructure 9101 with the next revision of 9100 to
combine the 9101/9111/9121 standards to reflect a
process based auditing approach of 9100, 9110 and 9120
standards.
•
AAQG SWOT and sector rejection of ballot document Nov 23,
2008.
•
Training specification and competency requirements
development Nov 17-20, 2008 – Paris
Auditor training and competency requirements
development.
•
Team F2F to address issues and actions. Huntington Beach
CA. Jan. 2009.
•
Proposed 2nd ballot draft complete Feb 22, 2009.
•
Team comments submitted updated draft. Feb 24, 2009
•
Completed comment incorporation – March 10, 2009
Benefit of project
•
Alignment of assessment tools and methods to process
based management QMS.
•
Shift audit focus to process, product, system
performance and customer satisfaction.
•
Reduced variation of training and training expectations.
Unresolved issues & decisions (if any):
None – Sector rejection by the AAQG and member
rejection by EAQG – Germany, triggered a revision
to the document and 2nd ballot process.
Schedule for 2nd ballot complete.
Next steps (30-60-90 day look ahead):
1.
2.
AAQG Briefing F2F Portland. March 10-12, 2009
IAQG Release of reballot. March 11, 2009
3.
4.
5.
6.
7.
AAQG Release of 2nd ballot. March 20, 2009
AAQG Ballot cycle. March 20-April 20, 2009
EAQG Ballot cycle. March 20-May 20, 2009
APQG Ballot cycle. March 20-May 20, 2009
Target Release July 2009
Development Model for a
Process-Based 9101
Process Approach
Audit
Records
Evidence of Conformance
Tools
Process-Based Auditing
Evidence of Effectiveness
Effectiveness Assessment Record
1
2
Report Number:
3
4
Issued Date:
Organization:
Site:
□ Core Process Assessed:
□ Support Process Assessed:
□ Foundation Process Assessed:
5
Core, Support & Management
Processes
6
9100/9110/9120 Section Reference:
7
Support Process(es) Assessed:
8
Statement of Effectiveness:
Inputs
Output
□The assessed core/support/foundation process has been determined to be effective.
□The assessed core/support/foundation process has been determined to be ineffective.
9
How was process effectiveness determined (methodology)?
10
Objective Evidence, Observed Conditions, Data, and Comments to Support Effectiveness
Determination
11
Assessment Team Leader
12
Signature and Date
Signature indicates that all relevant requirements (including requirements for support processes identified in Block #7)
have been assessed to determine effectiveness of the core or support process identified in Block #5.
Effectiveness Focused
9101: Major Changes Review
 Introduction in the audit report of:
 an “Process Effectiveness Assessment Record”
form (PEAR) which :
 State if for the audited process has been determined that
– planned activities and results are realized
– planned activities are realized but planned results are not realized
– planned activities and results are not realized
 Give objective evidence, observed conditions, data, and comments to
support effectiveness determination
 a process based “Audit Completeness Record”
 an “Objective Evidence Record” capturing quality manual and
procedures with objective evidence of conformity
9101: What has not changed
• Determining conformance to the standard.
• Nonconformance discovered during the audit
are to be documented and must be closed
before certification.
• Based on information collected during the
assessment, the auditor will have to draw
conclusions on conformance of the
organization quality management system.
Note: Conclusions on effectiveness are new
9101: Progress Status
•
Issue of a coordination draft : 30 June 2008
(Limit date for comments : 7 July 2008)
•
Review of the comments
(8-11 July in Amsterdam)
–
•
9101
Formal
Ballot
450 comments received, 233 accepted, 15 partially accepted
126 comments reviewed and disposition from ballot rejection (January 9-12, 2009
in Huntington Beach
•
•
•
•
Publication of the 9101 Formal ballot : Sept./Oct 2008
Disposition on comments : end Nov. 2008 – Rejected
Comments addressed – January 2009
Preparing for ballot release – March 2009
9101
Release
Target Release – July, 2009
9101 Status Update
• Ballot version published 26 September 2008
• Results of ballot:
– APQAG : passed, with comments
– AAQG: rejected, with comments
– EAQG:
•
•
•
•
•
•
France: passed, as is
Germany: rejected, with comments
Italy: passed, as is
UK: passed, as is
Switzerland: abstention, no experts
Sweden (VAC): passed, with comments
• 9101 team conclusion: address the comments and go for
2nd ballot
Feedback summary
 126 detailed comments received
 Major comments:
– Checklist / record for objective evidence is missing
(US, Germany, Sweden)
– Structure of the document needs improvement (AAQG)
– During OP assessment NO attention should be given to customer
specific QMS requirements (Germany)
– PEAR form and approach is too complex, e.g.‘all processes’
 9101 team proposals:
– To add record for objective evidence
– To restructure part of the standard:
• All methodology / approach issues will be combined in one chapter
• Recommended practices will be in a separate document (ARP, TR?)
– Use of PEAR form limited to Product Realization Processes only
Dispositions
• 126 comments received
• Team meeting in Huntington Beach 10-12 February, 2009
• Disposition statistics:
–
–
–
–
–
Accepted: 59
Partially accepted: 17
Rejected: 39
Deferred: 8
Noted: 3
AAQG P61 - IAQG 9101:2009 Revision March 10, 2009
Planned Vs. Actual with Slips
Page 1 of 1
ID
Name
2008
% Comp
2009
2010
2011
N D J F MAM J J A SO N D J F MAM J J A SO N D J FMAM J J A S O ND J FMAM J J
9101 Development and Rewrite
100%
1st Ballot Release
100%
2nd Ballot Release
69%
IAQG Release of reballot
0%
AAQG Release of 2nd ballot
0%
EAQG Ballot cycle
0%
APQG Ballot cycle
0%
Ballot Call for Vote
0%
Review/Dispostion Comment from Reballot
(Possible F2F)
0%
Publish 9101:2009
0%
Implemenation of 9101
2%
Current Plan
Baseline
Status
9101 Release Schedule
Maximum 30 month Implementation from Publication
01/09
9100:2009
Publication
02/09
03/09
04/09
07/09
9101
Ballot start
IAQG
Phoenix
New 9101
Publication
Notes:
• All changes in 2nd version are related to comments
• No new requirements, except use of Objective Evidence Record as
checklist
Request: to reduce 2nd ballot in Europe to 2 months
Questions
Comments/Feedback to:
[email protected]
Back Up
AS9101 Process Audit Flow From
Pre-audit
Planning
Stage 1
1.0
Conduct Process and
Business Research
4.0
Data Collection
8/20/08 – 9/3/08
3.0
Complete appendix # 6
Customer Quality Data
2.0
Conduct
Planning Interview
5.0
Complete appendix # 1
Identify clauses and
processes
(not applicable for this audit)
6.0
Complete appendix # 5
Stage 1 Audit
7.0
Develop micro audit plan
Due 9/3/08
Due 9/3/08
Stage 2
8.0
Conduct Interviews
& follow Audit Plan
Conclusions
& Reporting
Audit Lead
Auditors
12.0
Complete appendix # 7
EAR Form
9.0
Complete appendix # 4
Summary
13.0
Convene team for
Consolidation / roll up
(at lead discretion)
10.0
Update appendix # 1
11.0
Complete appendix # 2
Write NCRs
14.0
Complete appendix # 3
Audit Report
Beta Test Results – 1st Party View
• Review and analysis of AS9101 Coordination Draft
• Conclusion made by the auditors was that the approach is
good. Our auditors are trained in the process approach and
use the ISO 9001 Auditing Practices Group guidance
documents.
• All elements of a process audit were captured and defined but
lacked sequencing of the activities.
• Process flow was created.
• Audit team formed and training on the process was conducted.
AAQG Project #61 (IAQG REQ-009)
Scope
Amend 9101 Assessment standard in order to enhance its clarity and compatibility
with process based management QMS (ISO 9001) and IAQG 9100 Standard update
to be published mid 2009
AAQG Project #61 (IAQG REQ-009)
Purpose of Revision
•
Focus a methodological approach of quality systems audits
•
Enhance clarity of standard to resolve issues on how to use the standard
•
Keep a standard report format
•
Consider all stakeholder needs
•
Ensure that the audit approach is more process oriented
•
Extend the scope of the audit process not only to determine conformity but
to include the assessment of the organization’s ability to meet customer, regulatory
and the organization’s own requirements
Meeting 13-15 November 2007
Toulouse
Summary of discussions/decisions
•
Scoring will no longer be required under the new 9101
•
Audit Process Matrix list with future 9101 topics agreed
•
Inputs for new 9101 determined:
•
•
•
•
•
•
Audit Process Matrix List
ISO TC 176 APG material
Stakeholder inputs
Automotive IATF material for for auditing ISO/TS 16949
Requirements flow down chapter from SCMH
Referenced documents determined:
•
•
•
•
ISO/IEC 17021 Part 1 and 2 (if available)
ISO 19011
IAQG 9104
IAQG 9100/9110/9120
•
Relation with new 9101 structure and referenced documents ‘mapped’
•
Detailed writing rules for drafting new 9101 were agreed
•
Writing tasks assigned to sub-teams
•
Schedule revised, now aligned with 9100 schedule
Meeting 12-13 February 2008
Orlando
Summary of discussions/decisions
• Sub-team report out
• Assembled working draft
• Working Draft Review
• Some requirements had direct relationship to AS9104 rewrite
• Developed list of input for Berlin OPMT meeting
• Team size is becoming a factor.
• Agreed after Naples working session, team would be scoped
down increase velocity of development.
• Output of smaller team would come back to original team.
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