Company Confidential 1 Requirements Strategy Stream General Assembly Alan Daniels York, United...

Company Confidential 1

Requirements Strategy StreamRequirements Strategy StreamGeneral AssemblyGeneral Assembly

Alan DanielsAlan DanielsYork, United Kingdom York, United Kingdom

October 22, 2010October 22, 2010

IAQG Strategic Focus

Relationship Growth Strategy

Civil Authorities - ProductionSpace

DefenseMaintenance Repair & Overhaul

Trade Associations

Improvement Strategy

Requirements

People Capability

Product & Supply Chain Improvement

Performance

Operating Management SystemOther Party Management Team

Integration Team

• Maintain focus on Quality Management System (QMS) Standards– Improve the supplier performance and customer

satisfaction, especially Product Quality & On-time Deliveries

– Take into account new requirements from aviation, space & defense and QMS standards

– Represent IAQG at the ISO (TC 176) for future QMS activities

– Stay abreast with emerging requirements (e.g.IAEG)– Sustain and improve the QMS audit and certification

process– Support the IAQG strategy : “90% of the supply chain

certified” • Harmonization of Customer Requirements and

Assessment Tools for suppliers• Work with Relationship Growth Teams

– Civil Authorities, Space, Defense & National Trade Associations, MRO (Maintenance, Repair and Overhaul) and Airlines

Requirements Strategy StreamRequirements Strategy StreamMissionMission

Establish, Develop, and Maintain Industry Quality Requirements to improve product and process integrity

• Team leadershipTeam leadership::– Team Mentor Guy Dion (Zodiac Aerospace)

– Team Leader Alan Daniels (Boeing)

– AAQG Leader Buddy Cressionnie (Lockheed Martin)

– APAQG Leader Masahiro Kawamoto (MHI)

– EAQG Leader Guy Dion (Zodiac Aerospace)

• Standards LeadersStandards Leaders::– 9100 Buddy Cressionnie (Lockheed Martin)

– 9110 Jeff Wood (Boeing)

– 9120 Dale Gordon (MPC Products Corp)

– 9101 Masahiro Kamamoto (MHI)/Hans Luijt (OPMT)

– 9115 Michelle Pierce (Lockheed Martin)

– 9137 Francisco Losada (EADS CASA)

– 9104-1 Mike Roberts (Boeing)

– 9104-2 Tim Lee (Boeing)

– 9104-2 Colin Clarke (Bombardier)

Requirements Strategy StreamRequirements Strategy StreamTeam LeadershipTeam Leadership

• Near-Term

– Continue to develop guidance materials – On going

– Monitor/update FAQ’s – On going

– Provide standard communications – On going

– Support IAQG Integration activity by monitoring and taking actions on IAQG initiatives that overlap with REQ std - Active in Integration Team

– Provide IAQG Clarifications utilizing the SDR/IDR process according to procedure 103 – On going

– Monitor and study ISO QMS activities – Active support

– 90% certification strategy support – Usage survey

Requirements Strategy StreamRequirements Strategy StreamTeam Charter/ImprovementTeam Charter/Improvement

•Mid-Term– IAQG Liaison with TC176 activity for the future

revision to ISO 9001 (next ISO 9001 & 9004) – Active engagement

– Ensure the compatibility and alignment of the Requirement Stream standards and their interfaces – Integration Team

– Update standards based on stakeholder feedback and users satisfaction surveys – In work

– Measure success in achieving the IAQG Strategy Objectives – Usage survey

•Long-Term– QMS concepts in the future: benchmarking other

QMS standards, excellence models, maturity assessment (benchmarking on standard assessment method).


Revised in 2009• 9100 - QMS – Requirements for Aviation, Space &

Defense Organizations

• 9110 - QMS – Requirements for Aviation & Defense Maintenance Organizations

• 9120 - QMS – Requirements for Aviation, Space & Defense Distributors

• 9101 – QMS – Aviation, Space and Defense QMS Audits

• 9115 – QMS Requirements for Aviation, Space and Defense Organizations – Deliverable Software

Standards to be Cancelled (Combined in 9101)

• 9111 – QMS Assessment for Maintenance Organizations

• 9121 – QMS Assessment Applicable to Stockist Distributors

Standards Revisions

9100 Series Revision

Objectives

• Incorporated ISO 9001:2008 changes

• Expanded scope to include land and sea based systems for defense applications

• Ensured alignment with IAQG strategy (on-time, on-quality performance)

• Adopted new requirements based on stakeholder needs

• Improved existing requirements where stakeholders identified need for clarification, including when a documented procedure is required

9100 Revision

Key Changes• 3.1 – Risk (added)• 3.2 – Special Requirements (added)• 3.3 – Critical Items (added)• 4.1 – QMS General Requirements (moved and expanded)• 5.2/8.2.1 – Customer Focus/Satisfaction (enhanced)• 7.1.1 – Project Management (added)• 7.1.2 – Risk Management (added)• 7.1.3 – Configuration Management (moved and expanded)• 7.1.4 – Work Transfer (moved and expanded)• 7.4.1 – Recognition of Supplier Quality Data (Added)• 7.4.1 – Approval Status for Suppliers (Enhanced)• 7.4.3 – Validation of Test Reports (Deleted)• 7.5.1.1 – Production Process Verification (Moved)• 8.2.4 – Sampling Inspection (Revised)

9110 Applicability

• This standard is intended for use by maintenance organizations whose primary business is providing maintenance, repair and overhaul services

• It is tailored for organizations with National Airworthiness Authority (NAA) repair station certification

• There are two significant themes in 9110 and they are:

– Safety

– Management Responsibility

9110 QMS Maintenance

• 9120:2009 Quality Management Systems- Requirements for Aviation, Space and Defense Distributor Organizations

– Used in organizations that are “pass through” distributors of aerospace Products

» Means that the organizations are not performing work or altering the product in any way

– Intended to meet requirements of FAA Advisory Circular (AC) 00-56 “Voluntary Accreditation of Distributors of Aviation Parts”

– Excludes clauses: 7.1.1, 7.1.2, 7.3, 7.5.2» not applicable to distributor organizations

– Added clauses: 7.1, 7.1.1, 7.1.2 » Added he new clauses from 9100 on Project Management, Risk

Management and Configuration Management

9120 QMS Distributors

9115 QMS Software

9115:2010: Quality Management Systems Requirements for Aviation, Space and Defense Organizations Deliverable Software

Key Changes

– Establishes software quality management requirements for the aviation, space and defense industry for deliverable embedded or loadable software products

– Harmonizes the content of AS9006 with the content of ISO 12207:2007 and other applicable standards, using 9100 framework

– Used as a 9100 software supplement when contractually flowed down

9101 QMS Assessment

9101:2009: Quality Management Systems Assessment

Key Changes– One document covering 9100/9110/9120 standards (was

three)– Elimination of “scoring” and “key requirements”

designation– Use of customer feedback concerning QMS organization

performance as an input for process oriented audits (e.g., OASIS, customer satisfaction/performance scores)

– In addition to conformity, also determination of effectiveness included

– More emphasis on performance measuring– Introduction of the Objective Evidence Record


9100 Support Activities

15

Deployment Support Material

– Consistency – Good

– Currency – In Work

– 9100 Updates

» FAQ’s to expand to include SR/CI Chart, Risk Mgmt content, SCMH link

» 9100:2009 Clarifications

30 Month Transition Schedule

16

Transition Schedule

Support Activities

17

Communication and Education• Articles

– Quality Digest – December 2009 Issue, Aerospace Standard for Maintenance, Repair, and Overhaul Services Improves Safety

– ASQ Quality Progress – January 2010 Issue, Above and Beyond Aerospace requirements include more than AS9100

– ASQ Quality Progress – July 2010 Issue, In Transition - Aviation, space and defense industry moves to new standards

– ASQ Quality Progress – December 2010, Dale Gordon– Others?

• Conferences– ISO 9000 Conference (March 2011): Alan and Buddy Workshop and

AS&D Breakout Session (AS&D Standards, User Perspective – Roger Ritterbeck, 9101 – Larry Beck)

– ASQ Conference (May 2011)– RMC Auditor Training (July 2011)– Others?

• SAE 2-Hour Webinar and 2-Day Workshops

Support Activities

18

Communication and Education• Send out IAQG Requirements Team Communication Letter to

all OASIS Users and Certified Auditors» 9100 Family of Standards Major Changes

» 9100/9110/9120:2009 Transition

» Deployment Support Material – IAQG Sanctioned Material

» 9101 Auditing Technique

» 9115 Deliverable Software Standard Release

» IAQG Clarification Process

• Send out a user survey to organizations after they complete 91XX implementation to include:

– Clarity and benefit of 9100/9110/9120 changes (Design Specification)

– Appropriateness and benefit of 9101 auditing technique

– If organization delivers software, questions about 9115

Support Activities

19

• Supply Chain Management Handbook Interfaces– Risk Management

» Storyboard content and awareness material was published Sept 2010 (SCMH chapter 11.2.X)

– Special Requirements/Critical Items (SCMH chapter 3.2.X)» Guidance material was published May 2010

» Short Awareness Presentation was prepared (August 2010) but not yet published

» The team will try to summarize the Self Assessment maturity model in York

– Configuration Management» Guidance was published June 2010 (SCMH chapter 11.3.X)

» Awareness presentation and Self Assessment checklist completed (August) but still not published.

Revision Activity• 9100 - QMS – Requirements for Aviation, Space & Defense

Organizations

– ISO Revision 2015 - Proposal October 2011

• 9110 - QMS – Requirements for Aviation & Defense Maintenance Organizations

– Revision in progress - 103 approved April 2010

• 9120 - QMS – Requirements for Aviation, Space & Defense Distributors

– ISO Revision 2015

• 9101 – QMS – Aviation, Space and Defense QMS Audits

– Revision proposed – Go forward decision requested

• 9115 – Deliverable Software

– Revision proposed – Go forward decision requested

• 9137 - Application of AQAP 2110 within a 9100

20

Standards Revisions

21

Standards RevisionsRequirement Strategy Stream

ScheduleTask Who Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

IAQG MeetingsWash,

DCYork

New Orleans

Bordeaux XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX XXXX

9100 Schedule 9100 Team

Project Approval (103 form) Team Leader

Stakeholders Feedack (CBs & Ind) Team LeaderStandard Incorporation (ISO9001, 9100, etc.)

Team Leader

Draft Coordination Team Leader

Ballot Team Leader

Document Release Team Leader

Deployment Support Team Leader




Team Leader


Ballot Team Leader






Team Leader


Ballot Team Leader






Team Leader


Ballot Team Leader






Team Leader


Ballot Team Leader






Team Leader


Ballot Team Leader



20162015201420142010 2012 20132011

9101 Revision Form

Completed by the appropriate IAQG Document Representative (IDR)

Date Revision Initiated: 19-10-2010

IAQG-issued Standard Number: 9101 Current Issue (letter & date): Rev , 2009

IAQG-issued Standard Title: Quality Management Systems Audit Requirements for Aviation, Space and Defense Organizations

IAQG-issued Standard Scope: Currently published in America (AS9101D), Europe (prEN9101 Edition P6) and Asia-Pacific (SJAC 9101D)

IAQG Document Representative (IDR): Hans Luijt / Masahiro Kawamoto (After York meeting)

Strategy Focus Stream Leader (SFSL): Requirements – Alan Daniels

AAQG Sector Document Representative (SDR): Tony Marino

APAQG Sector Document Representative (SDR): Masahiro Kawamoto

EAQG Sector Document Representative (SDR): Hans Luijt / Stuart Anthony (After York meeting)

Reason(s) for revision: To incorporate the changes of referenced ISO/IEC 17021 standard (currently FDIS stage), and to reflect input from FAQ, feedback from auditors/CBs/clients/TPs by survey, left-overs and other related standard (e.g. 9104/1).

Initiative deliverables: Revised 9101 standard and relating deployment support materials, such as FAQ, Changes Overview presentation, etc.

Estimated Publication Date: 01-08-2012

9115 Revision Form

a) Details of the proposed Initiative (Completed by the Originator. All Sections must be completed, incomplete proposals cannot be accepted)

Title: Non-Deliverable SoftwareIAQG REQ-08 part 2 was to analyze need for non-deliverable software standard. Team discussed and decided that 9100 did not sufficiently address the needs required for non-deliverable software and a new project needed to be pursued

Originator: Michelle Pierce Date raised: 20 October 2010

Summary: The intent of this document is to provide industry standard for non-deliverable software that are focused on its control and ensuring validation of released software in its functioning environment, appropriate configuration control of non-deliverable software through application of unique identification, and retention of relevant records for internally developed software documenting its development and validation prior to application or use.

Why this initiative is proposed: As Industry efforts increase to improve product quality and reliability and reduce production costs, use of computer software programs for automation, control and monitoring of production processes and product test, acceptance and calibration is also increasing. It is therefore vital toassure these software programs are controlled to ensure product conformity requirements are properly supported. Standard for Deliverable software (9115) has been completed. Project plate for software (IAQG REQ #008) says to analyze need for non-deliverable standard. Discussions with team and other IAQG members agreed there was a need for this effort. Manufacturing software and other non-deliverable software not sufficiently covered by any standard.

Applicable to: Aviation/Space/Defence

Planned deliverables : New standard with deployment materials including FAQs, Audit support and usage examples

Requirements Team - Look Ahead• Requirements Team Integration

– A proactive approach will be taken towards integration

– Project management of future releases based on hierarchy and dependencies

– Release parent and child requirement documents at the same time

• ISO 9001

– Preparation has begun on a major restructuring of the ISO 9001 structure

Requirements Team

Opportunities

• 9102 Input

– Opportunity to link this standards verbiage on FAI to the new text in 9100 “Production Process Verification”

• 9103 Input

– Opportunity to link new 9100 terms such as Critical Items and Special Requirements and the relationship to Key Characteristics

Requirements Strategy StreamRequirements Strategy StreamHelp and OpportunityHelp and Opportunity

26

ISO9001 TC 176ISO9001 TC 176“Proposed” Changes“Proposed” Changes

ISO9001 Status – TC176• Groundwork has begun for next full revision

– Structure likely to change radically– Target 2015 Publication– Dictated by ISO Joint Technical Coordination

Group (JTCG) – All ISO MSS - Quality, EH&S, security, food

service, risk mgt, energy, IT, road safety, CASCO, farming, automotive and more.

– The intent is to force a universally acceptable (common) High Level Structure for all MSS using a “systems approach” to include:» Identical Elements» Identical Terms & Definitions

ISO9001 Proposed Changes

Proposed High Level MSS Structure

Introduction

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10.Improvement

28


•Management Aspect Team:

– Risk Management

– Financial Resources of the Organization

– Alignment with business management/practice

– Quality Management Principles (QMP) / Leadership

– Communication

– Time, Speed, Agility and Related Aspects

29

ISO9001:2015 Proposed Concepts


• Product Aspect Team:

– Focus on product conformance

– Product and service life cycle management

– Outsourcing, purchasing, subcontracting , supply chain management

– Process Innovation

30



•System-Process Aspect Team:

– Maintenance of infrastructure

– Process management

– Knowledge management

– Competence

– Quality Tools

– Structure of QMS and Relationship with MSS Work (see first main bullet)

– Impact of Technology and Changes in Information Management

31



IAQG Survey

9100 / 9110 / 9120Certification Deployment

IAQG Documents Flow Down

Survey Summary

Sector Received Answers

Membership Number

Participa-tion Rate

AAQG 19(1) 20 (19)(1) 100 %(2)

APAQG 13 13 100 %EAQG 35 35 100 %Total IAQG 67 68 (67)(1) 100 %*

(1): Rolls-Royce North America figures included in EAQG Rolls-Royce ones

(2): 63 % for IAQG Documents Flow Down (12 answers on 19)

*: 79 % in April 2010 Washington DC meeting

Survey Summary

100 % Goal achieved

9100 Certification

Sector (1)

Internal IAQG CompaniesNumber of Companies

certified

Certification Average (2)

Company Sites Average / Member (3)

AAQG (19) 18/19 (95 %) 83,4 % 30

APAQG (13)13/13 (100

%)91,3 % 11

EAQG (35) 34/35 (97 %) 93,5 % 11

Total IAQG (67 [100 %])

65/67 (97 %) 90,2 % 16

(1): Number of answers by Sector

(2): Average of Certification percentage

(3): Average of Company sites per IAQG Company

Internal IAQG Company Certification

9100 Certification

Sector (1)IAQG Supply Chain

Supply Chain Certification

Mandatory Rate (2)


Supplier Sites Average / Member

(4)

AAQG (19) 7/18 (39 %) 71,5 % 3342

APAQG (13) 6/13 (46 %) 60,6 % 360

EAQG (35) 30/35 (86 %) 69,5 % 459

Total IAQG(67 [100 %])

42/66 (64 %) 68,7 % 887

IAQG Suppliers Certification


(2): Ratio of Number of IAQG Members mandating 9100 Certification to their Suppliers

(3): Average of Suppliers Certification percentage

(3): Average of Suppliers sites (Eligible Suppliers) per IAQG Company

9110 Certification


(2): Ratio of IAQG Companies making MRO Business


(3): Average of Company sites per IAQG Company


Sector (1)

Internal IAQG Companies

IAQG Company Rate of Companies making MRO Business (2)

Number of Companies 9110

certified

Certifi-cation

Average (3)

Company Sites

Average / Member (4)

AAQG (19) 12/19 (63 %) 3/12 (25 %) 24,7 % 10

APAQG (13) 10/13 (77 %) 2/10 (20 %) 8,3 % 2

EAQG (35) 31/35 (89 %) 9/29 (31%) 47,6 % 6

Total IAQG (67 [100 %])

53/67 (79 %) 14/51 (27%) 33,5 % 6

9110 Certification



Mandatory Rate (2)



(4)

AAQG (19) 2/12 (17 %) 0,0 % Not Provided

APAQG (13) 0/10 (0 %) Not Applicable -

EAQG (35) 11/31 (35 %) 29,2 % 53


13/53 (25 %) 24,3 % 53



(2): Ratio of Number of IAQG Members mandating 9110 Certification to their Suppliers

(3): Average of Suppliers Certification percentage

(3): Average of Suppliers sites (Eligible Suppliers) per IAQG Company

9120 Certification


(2): Ratio of IAQG Companies 9120 certified


(3): Average of Company sites per IAQG 9120 certified Company


Sector (1)Internal IAQG Company

IAQG Company Rate 9120 certified (2)


Company Sites Average / Member

(4)

AAQG (19) 1/19 (5 %) 5,3 % 2

APAQG (13) 1/13 (8 %) 7,7 % 2

EAQG (35) 2/35 (6 %) 4,7 % 3


4/67 (6 %) 5,5 % 2

9120 Certification



Mandatory Rate (2)



(4)

AAQG (19) 2/19 (11 %) Not Provided Not Provided

APAQG (13) 1/13 (8 %) 25,0 % 2

EAQG (35) 18/35 (51 %) 50,4 % 103


21/67 (31 %) 47,2 % 44


(1): Number of answers by Sector(2): Ratio of Number of IAQG Members mandating 9120 Certification to their Suppliers(3): Average of Suppliers Certification percentage per IAQG company mandating 9120(3): Average of Suppliers sites (Eligible Suppliers) per IAQG Company mandating 9120


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IAQG Documents Flow Down within IAQG Company members

Document AAQG APAQG EAQG IAQG

9102 (First Article Inspection) 10 11 32 53* (88 %)

9103 (Key Characteristics Mgt) 7 8 27 42 (70 %)

9131 (Non Conformance) 5 2 22 29 (48 %)

9134 (Supply Chain Risk Mgt) 4 1 22 27 (45 %)

9133 (Standard Parts) 2 1 11 14 (23 %)

9107 (Direct Delivery) 2 0 11 13 (22 %)

9162 (Operator Self-Verification) 2 0 10 12 (20 %)

9114 (Direct Ship) 2 1 7 10 (17 %)

9132 (Part Marking) 1 1 8 10 (17 %)

*: On 60 answers


42

Document AAQG APAQG EAQG IAQG

9102 (First Article Inspection) 10 10 31 51* (85 %)

9103 (Key Characteristics Mgt) 4 5 18 27 (45 %)

9131 (Non Conformance) 4 1 14 19 (32 %)

9133 (Standard Parts) 2 1 8 11 (18 %)

9134 (Supply Chain Risk Mgt) 0 1 8 9 (15 %)

9114 (Direct Ship) 2 1 5 8 (13 %)

9132 (Part Marking) 1 1 6 8 (13 %)

9107 (Direct Delivery) 2 0 5 7 (12 %)

9162 (Operator Self-Verification) 0 0 3 3 (5 %)

*: On 60 answers

IAQG Documents Flow Down from IAQG Company members to their Suppliers

IAQG Survey

43

Recommendations• Next step

– Based on IAQG Washington DC Council decision 9100 & 9110 certification deployments to be made on a yearly basis

– Launch of next 9100 & 9110 Certification Survey in January 2011 (2010 Results)

Results in New Orleans IAQG meeting

Questions?Questions?

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