International Aerospace Quality Group. AS9100 Getting more out of QMS Alan Daniels. May, 2015

Transcription

1 International Aerospace Quality Group AS9100 Getting more out of QMS Alan Daniels May, 2015

2 A Global Team International Aerospace Quality Group IAQG Council General Assembly Forums AAQG (Americas) EAQG (Europe) APAQG (Asia Pacific) 19 AAQG members 13 APAQG 33 EAQG members members 2

3 General Assembly IAQG Membership Americas (AAQG) Boeing Bombardier GE Aviation Lockheed Martin Northrop Grumman Parker Raytheon Spirit AeroSystems Textron United Technologies Asia Pacific (APAQG) AVIC Fuji Heavy Industries (FHI) IHI Corporation Europe (EAQG) AgustaWestland Airbus Airbus Defense and Space Seat 1 KAL-ASD Airbus Defense and Space Kawasaki Heavy Industries (KHI) Airbus Helicopters Alenia Aermacchi Avio Areo BAE Systems Rolls-Royce SAAB SAFRAN Mitsubishi Heavy Industries (MHI) Seat 2 3

4 Objectives Establish commonality of aviation, space and defense quality systems, as documented and as applied Establish and implement a process of continual improvement to bring initiatives to life Establish methods to share best practices aviation, space and defense industry Coordinate initiatives and activities with regulatory/government agencies and other Stakeholders in the industry Only 1 management system throughout the whole Supply Chain 4

5 IAQG Strategic Focus Relationship Growth Strategy Civil Authorities - Production Space Defense Maintenance, Repair & Overhaul Trade Associations Improvement Strategy Requirements People Capability Product & Supply Chain Improvement Performance IAQG Operating Management System IAQG Other Party Management Team Integration Team 3 Axes Aligned to Address Challenges

6 IAQG Requirements Team IAQG Chairman: Alan DANIELS (Boeing) AAQG EAQG APAQG Leader: Buddy CRESSIONNIE (Lockheed Martin) Leader: Judy LASLEY (Rolls-Royce) Leader: Tatsuya SHIRAI (Kawasaki Heavy Industry) IAQG Document Representatives 9100 : Alan DANIELS (Boeing) 9101 : Masahiro KAWAMOTO (MHI) 9102 : Carl ZIMMERMAN (Spirit Aerosystems) 9103 : Hervé BIGAND (Snecma) : Tim LEE (Boeing) : Tim LEE (Boeing) : Will TATE (Triumph) 9107 : Ed BAYNE (Boeing) 9110 : Agathe MOLL (Airbus) 9114 : Ed BAYNE (Boeing) 9115 : Raymond WRIGHT (Raytheon) 9116 : Mike QUINN (Boeing) 9117 : Jan SOMMARBERG (GKN) IAQG Document Representatives 9120 : Elizabeth WALTERS (Boeing) 9131 : Claus MAYR (MTU) 9132 : Craig MANERS (Rolls-Royce) 9133 : Phil EDWARDS (Rolls-Royce) 9134 : Albrecht FELDSMANN (Airbus) 9136 : Bernard LAURAS (Airbus) 9137 : Juan I. MARTIN (Airbus Military) 9138 : Dan FITZSIMMONS (Boeing) 9139 : Jesse MANGUAL (Moog) 9145 : Deborah OBERHAUSEN (PW/UTC) 9162 : Mark VOGAL (Triumph) 9146 : Matt BARRON (Boeing) 9147 : Jerome AUPHAND (Airbus)

7 Aviation, Space and Defense Why does AS&D have their own standards? High risk products High cost products Tightly controlled industry requirements Statutory Regulatory Customer Safety is a must Quality is required Failure is not an option

8 What is AS9100? AS9100 International Aviation, Space and Defense Quality Model APPROXIMATELY 105 ADDITIONAL REQUIREMENTS - Configuration Management - Risk Management - Special Requirements - Critical Items - On Time Delivery - Project Management - Supplier Scope of Approval ISO 9001 Quality Management System

9 IAQG 9100 Revision AS9100 needs to change to: incorporate changes to the ISO 9001:2015 ISO/TC 176/SC 2/WG23 N106 consider Aviation, Space and Defense stakeholders needs (web survey performed in 2013) incorporate clarifications to 9100 series requested by IAQG users since the last revision (requirements clarified or notes added)

10 9100 Timeline C o m p l e t e Oct 2013 Apr 2014 Jun 2014 Jul 2014 Jul 2014 Oct 2014 July 2015 Dec 2015 Apr 2016 Apr 2016 Stakeholder Feedback Resolution Concept Sub-team Proposals Integrate ISO 9001 Draft with 9100 ISO 9001:2015 Draft Comments Structure Draft (team) Working Draft (team) Coordination Draft (IAQG) Ballot (IAQG) Support Material 9100 Series Publication These dates are contingent on consensus on decisions / ballots to proceed at each stage Actual standards publication depends on sector publication scheme & schedule

11 9100 Series The term 9100-series standards includes the following IAQG standards, with 9100 being the IAQG Series Baseline Standard: IAQG 9100 Quality Management Systems - Requirements for Aviation, Space and Defense Organizations IAQG 9110 Quality Management Systems - Requirements for Aviation Maintenance Organizations IAQG 9115 Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software IAQG 9120 Quality Management Systems - Requirements for Aviation, Space and Defense Distributors

12 IAQG 9100 Series Team IAQG 9100 Series Team Alan Daniels 9100 IDR Team Leader Boeing Buddy Cressionnie Masahiro Kawamoto Brigitte Clamens 9100 AAQG SDR 9100 EAQG SDR 9100 APAQG SDR Lockheed Martin Zodiac Aerospace Mitsubishi Heavy Industries Jim Clifford Roberto Ciaschi Chen Zhongyuan 9100 AAQG Representative 9100 EAQG Representative 9100 APAQG Representative United Technologies Corporation European Space Agency Aviation Industry Corporation (AVIC) Kim Roy Stuart Anthony Tatsuya Shirai 9100 AAQG Representative 9100 EAQG Representative 9100 APAQG Representative Triumph Rolls-Royce Kawasaki Heavy Industries Integration of Standards Masahiro Kawamoto Agathe Moll 9120 IDR 9110 IDR 9101 IDR Aerojet Airbus Mitsubishi Heavy Industries Ray Wright 9115 IDR Raytheon Insert Picture Here Dale Gordon Wayne Johnson 9100 Scribe IAQG

13 IAQG 9100 Revision SIPOC Stakeholder Input & Survey IAQG 9100 Series Standard Plan Project Plan Integrated Schedule SWG Enlarged Strategy Act Design Specification Do ISO 9001 Gap Analysis Aviation, Space & Defense Industries Priority Focus Teams Master Comments Review IAQG Team Data Mining - Ma ster Com ments Review Te mplate As of Deployment Support Material I AQG 9100 Team D isposi ti on Options Risk Assessment I tem # S takeholder C ode Clause No. 45 S urvey Tit le Remove "Qualit y" from t it le Managm ent Sy st em Rejec t IS O 53 S urvey Tit le Title C hange Com ment Modif y tit le to B us ines s Managment S ys tem vs. Quality Management S ys tem Proposed C hange Rati onale / Benefi t e. g., c larific at ion, improve qual ity, reduce c os t, other Rejec t IS O The f irs t word is "Quallit y" and every one immediat ely thinls i t is a Quality func t ion/res ponsibilit y, not a Management f unct ion. R equirem ents are inc orporated for entire bus ines s, and individuals continuously focus on Quality w hen address ing s tandard. Change tit le of s tandard from "Quality Manangement We've c ome a long way, but some st ill Sy s tem" t o "B us ines s Management Sy s tem" feel impliment at ion and adhearanc e t o t he s tandard is t he job of Quali ty. Us e: "Qualit y Management S ys tems " and make changes When S MS i s int roduc ed it is no longer for cons is tenc y t hroughout t he doc ument res tric ted to a qualit y sy s tem. A ccept/ Rej ect/ N oted Team P roposal X ISO t ex t. X S urvey Tit le C AA Tit le Ex pand the tit le t o cover SM S 323 E AQG Tit le Title is m ore bias ed t ow ards A eros pac e than inc lus ive of Defens e Amend wording f rom Aeros pace Standard t o Defens e St andard 187 AAQG Foreword verbi age confus ing (no header at s tart of 1s t st at ement t o define the incomplet e sentenc e and ext ra c ommas ) "To as sure c ust omer sat isfac tion, aviat ion, s pace and c larific at ion defense organiz at ions must produc e, and c ont inually improve, s af e, reliable product s " should be "Object ive: To ass ure c us tomer s atis fac ti on, aviation, spac e and defense organiz at ions must produc e and continually improve s afe, reliable product s " Ac cept in Writ ing Team to c onsi der comment s Principle 113 C AA 0. 1 There is no need to ex plain t he pot enti al application of t he s tandard when i t has many different uses. This I nt ernational St andard c an be used by int ernal and The c urrent "us ed by " is not exhaus tive ext ernal part ies, includi ng c ertif ication bodies, t o and m ight be mi sinterpret ed. ass es s t he organiz at ion's abilit y to meet cust om er, st at ut ory and regulat ory requirement s applic able to t he product, and t he organiz at ion's own requirements. P endi ng DI S 254 E AQG 0. 2 Cl ause N 0. 2: IS O Text Fi rs t, t he s entence: "The international Standard - Introduc e the adoption of a process approach as a requirem ent needed to develop, implem ent and improve the promot es t he adoption of a proc es s approac h", c an be underst ood as a recommandat ion and not a requirement. effec t ivenes s of a qualit y management sy s tem; That is not c onsis tent wit h the "General requirement s", - Preconize t o identif y 3 proc es s es family / groupe: c lause n 4. 1 where a proces s approac h impl ement at ion is Management proc es s; R ealiz at ion proc es s and Support c learly required: "The organizati on s hall determi ne t he process. process es needed for the qual ity management s yst em and their appl ication t hroughout t he organiz at ion" This requirement appears als o in several s ub-c laus es (e;g., e h ): "The organiz ation shall est abli sh, impl ement and maintain a process f or" C larific at ion 1 LinkedIn 0. 4 Clause 0.4 from ISO 9001 (c overing compat abilit y wit h ot her Re-i nt roduce ISO 9001 Clause 0.4 t o cl arify the relativit y of management s ys tems ) has been omit ted from AS/ EN wit h ot her management S tandards. C larific at ion Incl us ive of all s ec tors Action Com plete ISO t ex t Rejec t IS O ISO t ex t. R eject SMS will be covered by s ub-t eam X X R eject X P endi ng DI S If int ent of proposal is ac cept ed - any "shal l" or requirement mus t be es tabli shed in the requirement s sec tion of the st andard (Cl ause 1-10) Improve quality Publishing Sectors P endi ng DI S Coordination Draft Ballot Check SUPPLIERS INPUTS PROCESS OUTPUTS CUSTOMERS

14 9100 Series High Level Summary 9100 Series Changes - High Level Summary No Requirements New process model Added a PDCA model Added Risk-based thinking Emphasis on defining the QMS and context of the organization Clause 1 Scope Clause 2 Normative ref Clause 3 Terms and definitions Clause 6 Planning for the QMS When planning the QMS, determine the actions needed to address opportunities and risks (preventive) Increases requirements for planning of changes Clause 7 Support Determine knowledge management requirements Awareness of contribution to compliance and product safety Clause 8 Operation Planning for product obsolescence Plan activities needed to assure product safety Prevention of counterfeit parts Process to validate test reports for raw material used in critical item Release of products and services No normative references ISO 9001 terms and definitions moved to ISO 9000 Added 9100 product safety, counterfeit product Clause 4 Context of the organization Quality manual not required, maintained documentation is required. Justified exclusions not limited to Realization/Operations processes QMS processes have performance indicators Clause 5 Leadership QMS compatible with strategic direction QMS requirements integrated into business processes Processes deliver their intended outputs Clause 9 Performance evaluation Assess performance of QMS processes Added Note to evaluate performance indicators on internal audits Clause 10 Improvement Evaluation the need for action based on human factors All ISO MS standards will now have this common 10 clause structure

15 9100 Areas of Focus Areas of focus Team approach Product Safety Added in carefully selected areas with consideration of current 9110 requirements Human Factors Added as a consideration in the Nonconformity/ Corrective Action clause Risk Merged current 9100 requirements with the new ISO requirements Preventive Action Current clause requirements absorbed into Risk, Opportunities and Nonconformance Counterfeit Parts Enhanced in carefully select areas while successfully limiting new requirements Configuration Management Clause clarified and improved considerably to address stakeholder needs Product Realization & Planning Clarified and enhanced planning throughout the standard

16 9100 Areas of Focus Areas of focus Team approach Post Delivery Support Merged current 9100 requirements with the new ISO requirements Project Management Combined with Operation Planning clause to address user interpretation issues Design Development and Supplier Management Gap analysis - ISO text has been added back in a few places to meet the IAQG needs Quality Manual Note added pointing to the requirements that make up a Quality Manual or the equivalent Management Representative Requirement added back in for Management Representative QMS oversight

17 Industry Application 9100 Quality Management Systems Requirements for Aviation, Space and Defense Organizations All IAQG aviation, space and defense companies are certified to a version of 9100, 9110 or 9120 All IAQG and Sector member companies flow down 9100, 9110 or 9120 to their supply chain Note: Supply chain flow down of 9100 on eligibility criteria and the allow deviations is based organization may as applicable

18 Support Material AS9100 Revision D Tools for review and implementation AS9100 Key Changes Frequently Asked Questions Correlation Matrix (before & after) 9100:2016 to 9100: :2016 Correlation Matrix Frequently Asked Questions (FAQs) 9100: Context of the organization Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 5 Leadership 5.1 Leadership and commitment 5.2 Customer focus 5.3 Quality policy Developing the Quality Policy Communicating the Quality Policy 5.4 Organizational roles, responsibilities and authorities Scope General 1.1 General Application Quality manual Quality management system General Management responsibility Management commitment Customer focus Quality policy Quality policy Quality policy Responsibility and authority Management representative Quality management system planning Planning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Support Resources Quality management system planning 6 Resource management 6 Resource management General People Infrastructure Environment for the operation of processes Monitoring and measuring resources General May, : Quality management system planning Preventive action Quality objectives 7.6 Provision of resources Provision of resources Infrastructure Work environment Control of monitoring and measuring equipment Control of monitoring and measuring 1. Questions about the change 1. Why has it been decided to issue a new version of 9100? Business needs and the needs and expectation of other interested parties have changed significantly since the last major revision of ISO 9001 in the year Examples of these changes are ever more demanding customers, the emergence of new technologies, increasingly more complex supply chains and a much greater awareness of the need for sustainable development initiatives. 2. Does 9100 still apply to all organizations - big, small, different sectors and different items products, services? The concept of the standard has not changed; it's applicable to any type of organization, regardless of the size, type or its core business. 3. Has the structure of the standard been substantially changed? Yes, the structure has been changed to align with the common 10 clause high level structure developed by ISO to ensure greater harmonization among its many different management system standards. The new revision to ISO will also adopt this same structure, which is built around the PDCA (Plan-Do-Check-Act) sequence. This will make it easier for organizations to address the requirements of more than one ISO Management System Standard within a single, integrated system. Process Approach Risk-based Thinking/ Management Counterfeit Product Product Safety 4. What are the structural differences between the old and new version? - A new additional clause 4 now addresses the Context of the Organization - The old clause 5 of 9100:2009 is now separated into clause 5 Leadership and clause 6 Planning and has more content in each clause - The Measurement, Analysis and Improvement clause 8 of 9100:2009 is now separated into clause 9 Performance Evaluation and clause 10 Improvement - These changes are addressed in detail in the 9100:2009 to 9001:2016 Correlation Matrix (link) 5. What are the main differences in content between the old and new version? There is more flexibility regarding documentation, but with a greater emphasis on the organization being able to manage its processes in order to provide consistently conforming products and services. The application of the standard to service organizations is emphasized, as well as those making tangible product; there are more stringent requirements for leadership by top management; the term preventive action is replaced by the concept of risk based thinking that permeates And more 18

19 Supply Chain Management (SCMH) The SCMH provides guidance material to help continuously improve On Time, On Quality Delivery (OTOQD) It is provided at no cost and is available to all levels of the supply chain Link: / Handbook

20 On-Line Aerospace Supplier Information System (OASIS) OASIS Database 17,000 + Sites Database where all information related to certifications, auditors and audit results is stored Only general information such as accreditation bodies, certification bodies, certified supplier sites, approved auditors is publicly accessible Audit results data available when authorized by organization Includes a robust stakeholder feedback process to industry leaders, certification bodies and document representatives

21 9100 Revision - Next Steps 9100 Team Next Steps 9100:2016 Coordination Draft to be completed to the ISO 9001 Final Draft International Standard (FDIS) in July Coordination Draft support material to be completed in July Leverage ISO 9001 deployment support material for use with the 9100 Series Coordination draft and support material will be routed to IAQG member companies and key stakeholders for comment Disposition of comments to be completed in October Ballot targeted for December 2015

22 Benefits for Aerospace IAQG members agree to use standards internally and with suppliers Focus on the complete supply chain and stakeholders True global aerospace cooperation and harmonization System for third party approval Shared supplier approval database (OASIS) Common assessment scheme with focus on process effectiveness (9101 QMS Audit) Across Aviation, Space, and Defense

23 IAQG Summary How AS&D gets more out of its QMS? Raise stakeholder input and participation to a higher level Use a widely accepted and respected baseline standard Address the questions many are asking of their QMS, add value, reduce cost, improve quality time delivery CEOs How to Across Aviation, Space, and Defense

24 Resources IAQG Website AAQG Website Excellent starting points for resources.

25 Questions?