Embed Size (px)
Citation preview
AAmericas mericas AAerospace erospace QQuality uality GGrouproupAAQG AAQG Project ManagementProject Management
AAQG Project #61 (IAQG REQ-009)AAQG Project #61 (IAQG REQ-009)
IAQG 9101:2009 Revision - Quality IAQG 9101:2009 Revision - Quality Management System AssessmentManagement System Assessment
Reported by: Tony MarinoReported by: Tony MarinoDate of Report: 2009-March-11Date of Report: 2009-March-11
What happened and where is 9101?What happened and where is 9101?
• Released in October 2008 for ballotReleased in October 2008 for ballot– AAQG writing team members did not agree it was ready.AAQG writing team members did not agree it was ready.
– Consulted with AAQG leadership to release or move for sector Consulted with AAQG leadership to release or move for sector rejection – decision for sector rejection.rejection – decision for sector rejection.
• Primary IssuesPrimary Issues– Writing was a balanced writing addressing both Conformity and Writing was a balanced writing addressing both Conformity and
Effectiveness.Effectiveness.
– Writing structure – too confusing.Writing structure – too confusing.
– Contained guidance material.Contained guidance material.
– Differences of opinion on what could be changed during and after Differences of opinion on what could be changed during and after ballot.ballot.
• Document revisions have been made and process of Document revisions have been made and process of
finalization for ballot.finalization for ballot.
Microsoft Word Document
Microsoft Word Document
IAQG REQ-009 Working Group MembersIAQG REQ-009 Working Group Members
Hans Luijt – Team Lead ASD-EASE - Netherlands
Stuart Anthony Rolls-Royce UK
Eddy Benattar IAI - Israel
Alain Bonnel SAFRAN - France
Conny Flink Volvo Aero - Sweden
Michel Jacquaniello Zodiac - France
Marie-Laurence Petit Airbus - France
Brian Burroughs* LRQA – UK
Michel Clément* Bureau Veritas - France
Larry Beck Lockheed Martin – US (TX)
Tom Gallagher Hamilton Sundstrand (UTC)-US
Tony Marino The Boeing Company – US (WA)
Robert Keys* DNV – US (TX)
Paul Dionne* Intertek
Masahiro Kawamoto Mitsubishi Heavy Industries – Japan
9101: Revision Objectives9101: Revision Objectives
• Ensure alignment with IAQG strategy (on-time, on-quality performance, Ensure alignment with IAQG strategy (on-time, on-quality performance, StrengthenStrengthen of Other Party certification) of Other Party certification)
• Support the process approach for quality management systems as Support the process approach for quality management systems as described in the 9100-series standards described in the 9100-series standards
• Incorporate ISO 17021 changes and ICOP resolutionsIncorporate ISO 17021 changes and ICOP resolutions
• Define requirements for all activities of audit programDefine requirements for all activities of audit program
• Define adequate audit report that provides useful information to Define adequate audit report that provides useful information to stakeholders on Organization Processes Performance And stakeholders on Organization Processes Performance And Effectiveness ( PEAR ) Effectiveness ( PEAR ) andand conformity (Objective Evidence Record) to conformity (Objective Evidence Record) to 9100 series . 9100 series .
• Define Define audit recordsaudit records (objective evidence,…) to support ICOP Scheme (objective evidence,…) to support ICOP Scheme
Date of project approval: Project Plate Revision:
Solution:
Root Causes:
Metrics:
Deliverables:
Success Criteria:
Americas Aerospace Quality Group - Project PlateAmericas Aerospace Quality Group - Project Plate
AAQG ProjectLeader:Champion:
Problem Statement and Scope:
AAQG P61 - IAQG 9101:2008 Revision - Quality Management System Assessment
2006-Oct-05 )6/20/08
Tony MarinoJack Flecher
IAQG Gate 0 Approved October 5, 2006 - Seville Spain (REQ-009)
1. Current 9101 does not focus 9100 assessments on process based management
2. Too much emphasis on conformity of assessment – not auditing what is important i.e. performance, continuous improvement, customer satisfaction
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).
1. Upon release of ISO9001:2000, assessment tool and methods for 9100 was not updated to assess the process approach.
2. New 9100 release in April 2009 will require update of 9101
1. Update 9101 to be more than an assessment (checklist) document.
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
1. Revised 9101
2. Develop position and decision to obsolete 9111 and 9121
3. Aerospace Experienced Auditor training and certification/ recertification recommendations
1. Publication of 9101
2. Auditor efficiency increase
3. Greater fidelity of information in audit reports
1. Project Milestone
Project description / benefits:
AAQG Champion:Date of last report:
Date of this report:
Status:
Unresolved issues & decisions (if any):
Recent accomplishments (since last report):
Next steps (30-60-90 day look ahead):
Project Leader:
Americas Aerospace Quality Group - Project 4-SquareAmericas Aerospace Quality Group - Project 4-Square
P61 - IAQG 9101:2008 Revision - Quality Management System Assessment
Kristy Heffernan2008-Sept, 11 2009-March, 11
Tony Marino
Y
• AAQG SWOT and sector rejection of ballot document Nov 23, 2008.
• Training specification and competency requirements development Nov 17-20, 2008 – Paris
• 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
1. AAQG Briefing F2F Portland. March 10-12, 2009
2. IAQG Release of reballot. March 11, 2009
3. AAQG Release of 2nd ballot. March 20, 2009
4. AAQG Ballot cycle. March 20-April 20, 2009
5. EAQG Ballot cycle. March 20-May 20, 2009
6. APQG Ballot cycle. March 20-May 20, 2009
7. Target Release July 2009
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.
• Auditor training and competency requirements development.
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.
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.
Development Model for aDevelopment Model for aProcess-Based 9101Process-Based 9101
AuditRecords
Tools
Process Approach
Process-Based Auditing
Inputs Output
Core, Support & Management Processes
Effectiveness Focused
Evidence of Conformance
Evidence of Effectiveness
3Site: 4Issued Date:
7Support Process(es) Assessed:
69100/9110/9120 Section Reference:
5□ Core Process Assessed:
□ Support Process Assessed:
□ Foundation Process Assessed:
Effectiveness Assessment Record1Organization: 2Report Number:
8Statement of Effectiveness:
□The assessed core/support/foundation process has been determined to be effective.
□The assessed core/support/foundation process has been determined to be ineffective.
9How was process effectiveness determined (methodology)?
10Objective Evidence, Observed Conditions, Data, and Comments to Support Effectiveness Determination
11Assessment Team Leader 12Signature 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.
9101: Major Changes Review9101: Major Changes Review
Introduction in the audit report of:Introduction in the audit report of: an “Process Effectiveness Assessment Record” an “Process Effectiveness Assessment Record”
form form (PEAR)(PEAR) which : which :
State if for the audited process has been determined thatState if for the audited process has been determined that– planned activities and results are realizedplanned activities and results are realized– planned activities are realized but planned results are not realizedplanned activities are realized but planned results are not realized– planned activities and results are not realizedplanned activities and results are not realized
Give objective evidence, observed conditions, data, and comments to Give objective evidence, observed conditions, data, and comments to support effectiveness determinationsupport effectiveness determination
a process based “Audit Completeness Record”a process based “Audit Completeness Record”
an “Objective Evidence Record” capturing quality manual and an “Objective Evidence Record” capturing quality manual and procedures with objective evidence of conformityprocedures with objective evidence of conformity
9101: What has not changed9101: What has not changed
• Determining conformance to the standard.Determining conformance to the standard.• Nonconformance discovered during the audit Nonconformance discovered during the audit
are to be documented and must be closed are to be documented and must be closed before certification.before certification.
• Based on information collected during the Based on information collected during the assessment, the auditor will have to draw assessment, the auditor will have to draw conclusions on conformance of the conclusions on conformance of the organization quality management system. organization quality management system. Note: Conclusions on effectiveness are newNote: Conclusions on effectiveness are new
• Issue of a coordination draft : 30 June 2008Issue of a coordination draft : 30 June 2008(Limit date for comments : 7 July 2008)(Limit date for comments : 7 July 2008)
• Review of the commentsReview of the comments(8-11 July in Amsterdam)(8-11 July in Amsterdam)
– 450 comments received, 233 accepted, 15 partially accepted450 comments received, 233 accepted, 15 partially accepted
• 126 comments reviewed and disposition from ballot rejection (January 9-12, 2009 126 comments reviewed and disposition from ballot rejection (January 9-12, 2009 in Huntington Beachin Huntington Beach
• Publication of the 9101 Formal ballot : Sept./Oct 2008Publication of the 9101 Formal ballot : Sept./Oct 2008
• Disposition on comments : end Nov. 2008 – RejectedDisposition on comments : end Nov. 2008 – Rejected
• Comments addressed – January 2009Comments addressed – January 2009
• Preparing for ballot release – March 2009Preparing for ballot release – March 2009
9101 9101 Formal Formal BallotBallot
9101 9101 Formal Formal BallotBallot
9101: Progress Status9101: Progress Status
9101 9101 ReleaseRelease
9101 9101 ReleaseRelease Target Release – July, 2009Target Release – July, 2009
9101 Status Update9101 Status Update
• Ballot version published 26 September 2008Ballot version published 26 September 2008• Results of ballot:Results of ballot:
– APQAG : passed, with commentsAPQAG : passed, with comments– AAQG: rejected, with commentsAAQG: rejected, with comments– EAQG:EAQG:
• France: passed, as isFrance: passed, as is• Germany: rejected, with commentsGermany: rejected, with comments• Italy: passed, as isItaly: passed, as is• UK: passed, as isUK: passed, as is• Switzerland: abstention, no expertsSwitzerland: abstention, no experts• Sweden (VAC): passed, with commentsSweden (VAC): passed, with comments
• 9101 team conclusion: address the comments and go for 9101 team conclusion: address the comments and go for 2nd ballot2nd ballot
Feedback summaryFeedback summary
126 detailed comments received126 detailed comments received
Major comments:Major comments:– Checklist / record for objective evidence is missing Checklist / record for objective evidence is missing
(US, Germany, Sweden)(US, Germany, Sweden)– Structure of the document needs improvement Structure of the document needs improvement (AAQG)(AAQG)– During OP assessment NO attention should be given to customer During OP assessment NO attention should be given to customer
specific QMS requirements specific QMS requirements (Germany)(Germany)– PEAR form and approach is too complex, PEAR form and approach is too complex, e.g.‘all processes’e.g.‘all processes’
9101 team proposals:9101 team proposals:– To addTo add record for objective evidence record for objective evidence – To restructure part of the standard: To restructure part of the standard:
• All methodology / approach issues will be combined in one chapterAll methodology / approach issues will be combined in one chapter
• Recommended practices will be in a separate document (ARP, TR?)Recommended practices will be in a separate document (ARP, TR?)
– Use of PEAR form limited to Product Realization Processes onlyUse of PEAR form limited to Product Realization Processes only
DispositionsDispositions
• 126 comments received126 comments received• Team meeting in Huntington Beach 10-12 February, 2009 Team meeting in Huntington Beach 10-12 February, 2009 • Disposition statistics:Disposition statistics:
– Accepted: 59Accepted: 59
– Partially accepted: 17Partially accepted: 17
– Rejected: 39Rejected: 39
– Deferred: 8Deferred: 8
– Noted: 3Noted: 3
2008 2009 2010 2011
N D J FMAM J J A SON DJ F MAM J J A SOND J FMAM J J A S OND J FMAM J J
Current Plan Baseline Status
Page 1 of 1
Planned Vs. Actual with Slips AAQG P61 - IAQG 9101:2009 Revision March 10, 2009
% CompNameID
100%9101 Development and Rewrite
100%1st Ballot Release
69%2nd Ballot Release
0%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
2%Implemenation of 9101
9101 Release Schedule9101 Release Schedule
01/09 04/09 07/09
Maximum 30 month Implementation from PublicationMaximum 30 month Implementation from Publication
IAQGPhoenix
9100:2009Publication
New 9101Publication
9101Ballot start
03/0902/09
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
Back UpBack Up
AS9101 Process Audit Flow FromAS9101 Process Audit Flow From
3.0Complete appendix # 6Customer Quality Data(not applicable for this audit)
5.0Complete appendix # 1
Identify clauses and processes
6.0Complete appendix # 5
Stage 1 Audit
8.0Conduct Interviews& follow Audit Plan
9.0Complete appendix # 4
Summary
10.0Update appendix # 1
12.0Complete appendix # 7
EAR Form
14.0Complete appendix # 3
Audit Report
Audit LeadAuditors
11.0Complete appendix # 2
Write NCRs
Stage 1
Stage 2
Conclusions & Reporting
2.0Conduct
Planning Interview
Pre-auditPlanning
7.0Develop micro audit plan
1.0Conduct Process and
Business Research
13.0Convene team for
Consolidation / roll up(at lead discretion)
4.0Data Collection
8/20/08 – 9/3/08 Due 9/3/08 Due 9/3/08
Beta Test Results – 1Beta Test Results – 1stst Party View Party View
• Review and analysis of AS9101 Coordination DraftReview and analysis of AS9101 Coordination Draft
• Conclusion made by the auditors was that the approach is Conclusion made by the auditors was that the approach is good. Our auditors are trained in the process approach and good. Our auditors are trained in the process approach and use the use the ISO 9001 Auditing Practices GroupISO 9001 Auditing Practices Group guidance guidance documents.documents.
• All elements of a process audit were captured and defined but All elements of a process audit were captured and defined but lacked sequencing of the activities.lacked sequencing of the activities.
• Process flow was created.Process flow was created.
• Audit team formed and training on the process was conducted.Audit team formed and training on the process was conducted.
AAQG Project #61 (IAQG REQ-009)AAQG Project #61 (IAQG REQ-009)ScopeScope
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)AAQG Project #61 (IAQG REQ-009)Purpose of RevisionPurpose 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 butto include the assessment of the organization’s ability to meet customer,
regulatoryand the organization’s own requirements
Meeting 13-15 November 2007 Meeting 13-15 November 2007 ToulouseToulouse
Summary of discussions/decisionsSummary 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-teamsWriting tasks assigned to sub-teams
• Schedule revised, now aligned with 9100 scheduleSchedule revised, now aligned with 9100 schedule
Meeting 12-13 February 2008Meeting 12-13 February 2008OrlandoOrlando
Summary of discussions/decisionsSummary 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.
