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1 SII Conference October 11, 2010 Kevin Beard Pres. NQA, Inc. Pyong Jeon VP Unitek Aerospace QMS Evolution

2 Discussion Points NQA, Inc. Discussion NQA, Inc. s Corporate Family NQA, USA Unitek NTS Evolution of Aerospace Industry QMS Assurance Product Assurance Future Areas of Focus

3 NQA, Inc. Support of Aerospace Industry Aerospace/Defense Customers NTS Unitek NQA, USA Engineering Services Incorporated Locations in the US 5 International Locations Supply Chain Management Incorporated 1973 Office in Washington DC 1 Co-Located Customer Office SII Certification Body Incorporated Offices in the US 1 Office in Canada NQA, Int. Certification Body Incorporated Global Offices

4 NQA, USA Organization NQA, USA ~3800 Certificates, US (30,000 Global Certificates) NASA, European Space Agency Boeing, Raytheon Lockheed Martin, L-3, ULA Many Other Aerospace Customers ANAB Accredited ISO 9001, ISO AS9100, AS9110, AS9120, AS9003 TL 9000 ISO 20000, ISO Other Standards TS16949 ISO (Collaborative with NQA.UK) OHSAS ESD AS5553 Counterfeit Parts Prevention

5 NQA s Interaction for Industry Needs -Knowledge Gathering & Transfer- Industry Engaged Leadership Aerospace AAQSC Voting Member AAQG/IAQG Numerous Working Groups Telecom QuEST Forum Member Active Member for 8 Years Standards Writing & CB Oversight EH&S Basil Action Network-Committee of Experts Automotive SMMT Interactions Food Safety BRC, SQF & ISO BRC USA Program Chair/Secretary

6 NTS Services Engineering Services Systems Engineering Project Management Research and Design Product Life Cycle Support Aviation & DOD Testing & Evaluation Climatic & Environmental Testing Dynamic Testing EMC, EMI, ESD, HIRF Telecommunications & Wireless Aviation, Space, DOD, Energy, Medical, Telecom, Comm. Elect, Certification Services Compatibility, Functionality, Interoperability Benchmarking, Competitive Analysis Performance Testing Load/Stress Testing, Usability Analysis, USB, WHQL, ZigBee, VESA, and MoCA Commercial Electronics Precision Cleaning Particulate Removal Chemical Cleaning Etching Passivation Ultrasonic Cleaning Space & Aviation

7 Supply Chain Management Services Specific Service Types

8 Key Clients Worldwide

9 NQA, INC.-Global Outsource Support -EITVC - What Is EITVC Engineering Design/Development V&V Planning Inspection Product Based Inspection Form & Fit Test Product Based Testing Function Verification Management System Verification Organizational Requirements Certification Management System Certification International Standards

10 NQA, Inc Supply Chain Services NQA, Inc. Aerospace Service Offerings C e r t i f i c a t i o n Product Life Cycle E n g i n e e r i n g S e r v i c e s T e s t i n g S e r v i c e s S u p p l y C h a i n S e r v i c e s

11 Global SCM Opportunity Concept USA Based Integrator Company-Foreign Country Supplier Project Managed in USA USA Based Resource Provider Global SCM Resource Provider Boeing Model

12 Global SCM Opportunity Concept In Country Integrator Company-Foreign Supplier Project Manage In-Country Integrator In Country SCM Resource Provider Use Global Resources to Manage Organization s SCM Risks International Service Provision Model

13 The Evolution of Supply Chain Quality

14 Industry Perception Industry Working Group Perceptions (IAQG, OEMs, etc.) Noncompliant Product Being Delivered By Certified Companies On Time Delivery not Always Achieved Industry Needs Continued Improvement in QMS Implementation Continued Improvement in Product Integrity Product Delivery to Committed Schedules Need For Evolution of Industry QMS Approach

15 Customer Focus - Supply Chain Risk End User/Customer Supply Chain Quality QMS Integrity Process Control Process Effectiveness Reliance on AS9100 Product Integrity Form, Fit & Function On Time Delivery Reliance on Oversight

16 Focus Of Industry Industry Push on Product Integrity Enhanced Oversight of Suppliers Added Visits to Suppliers Additional Inspections of Product Industry Push on Certification Industry Combined Industry/ANAB Oversight Metrics on Major/Minor Nonconformances Industry Specific Training Additional OEM Oversight of CBs OEM level Complaints to Registrars Supplier Performance Tied to Registrar How Will We React to this Industry Push??? How Will We Change this Industry Perception???

17 Customer Focus - Supply Chain Risk Customer Supply Chain Quality QMS Integrity Process Control Process Effectiveness Product Integrity Form, Fit & Function On Time Delivery QMS Integrity

18 IAQG Overview xxx

19 IAQG Structure

20 QMS Evolution- Management System Evolution Evolution of Requirements Evolution of Audit Approach Improvement of Auditor Competencies NQA Involvement in Improvement & Evolution AS9100c QMS Requirements AS9003 I&T QMS Requirements AS5553 Counterfeit Parts Prevention in QMS AS9101 Audit Approach Requirements AS9104 Certification Body Requirements AATT Development Auditor Competency Course SCMH Development Risk Special Requirements/Critical Items/Key Characteristics Counterfeit Parts Prevention

21 IAQG Document Relationships Other Party Mgmt System REQUIREMENTS Strategy Stream SUPPY CHAIN Strategy Stream Oversight of Certification Scheme (organization) (surveillance) (auditors) 9003 (I & T) Sales,Master Scheduling Contract & Requirt. & Sequencing Flow down 9102 FAI 9120 (Distributors) 9110 (Maintenance) 9100 (General) QMS Requirements Supply Chain Management Handbook Design and Developt Key Charact. Supplier Capacity sourcing planning & selection scheduling & approval DDA Order Managt & logistic Manufact. and inspection 9114 Direct ship Audit Process Operational managt and product validation 9131 Non conf. Non conf, corrective preventive actions Customer Support 91XX.. ICOP : Certification Scheme Best practices Maintenance of standards issued by IAQG (IAQG 103) People Capability Strategy Stream People Capability documents : dictionary

22 IAQG Document Relationships Other Party Mgmt System REQUIREMENTS Strategy Stream SUPPY CHAIN Strategy Stream Oversight of Certification Scheme (organization) (surveillance) (auditors) 9003 (I & T) Sales,Master Scheduling Contract & Requirt. & Sequencing Flow down 9102 FAI 9120 (Distributors) 9110 (Maintenance) 9100 (General) QMS Requirements Supply Chain Management Handbook Design and Developt Key Charact. Supplier Capacity sourcing planning & selection scheduling & approval DDA Order Managt & logistic Manufact. and inspection 9114 Direct ship Audit Process Operational managt and product validation 9131 Non conf. Non conf, corrective preventive actions Customer Support 91XX.. ICOP : Certification Scheme Best practices Maintenance of standards issued by IAQG (IAQG 103) People Capability Strategy Stream People Capability documents : dictionary

23 AS9100 Rewrite Drivers Noncompliant Product from Certified Companies Industry Changes with No Evolution of Standard On Time Delivery Needs Improved Product Quality Broader Inclusion of Defense & Space Sector Needs

24 IAQG Strategic Goal Product Integrity Focus Risk Focus Improvement on Nonconforming Product Escapes Address Outsourcing Changes In the Industry Broader Inclusion of Customer/Industry Specific Needs Lifecycle On-Time, On-Quality Delivery (OTOQD) Continual Improvement through people, processes and tools On Time On Quality On Cost Product Delivery Spares & service delivery Parts & data at all levels in the chain Reduced inventory Continual safety improvement Maturity, reliability & cost of ownership Freedom from design & manufacturing defects Reduced waste OTOQD generates continual reduction of costs

25 IAQG Document Relationships Other Party Mgmt System REQUIREMENTS Strategy Stream SUPPY CHAIN Strategy Stream Oversight of Certification Scheme (organization) (surveillance) (auditors) 9003 (I & T) Sales,Master Scheduling Contract & Requirt. & Sequencing Flow down 9102 FAI 9120 (Distributors) 9110 (Maintenance) 9100 (General) QMS Requirements Supply Chain Management Handbook Design and Developt Key Charact. Supplier Capacity sourcing planning & selection scheduling & approval DDA Order Managt & logistic Manufact. and inspection 9114 Direct ship Audit Process Operational managt and product validation 9131 Non conf. Non conf, corrective preventive actions Customer Support 91XX.. ICOP : Certification Scheme Best practices Maintenance of standards issued by IAQG (IAQG 103) People Capability Strategy Stream People Capability documents : dictionary

26 AS9101 Rewrite Drivers Noncompliant Product from Certified Companies To Much Focus on Compliance Not Enough Focus on Process Effectiveness Enhanced Focus on Customer Requirements

27 1 Organization: 3 Site: 8 Statement of Effectiveness: 2 Report Number: 4 Issued Date: 10 Objective Evidence, Observed Conditions, Data, and Comments to Support Effectiveness 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. Development Model for a Process-Based 9101 Process Approach Audit Records Tools Evidence of Conformance Process-Based Auditing Evidence of Effectiveness Effectiveness Assessment Record Core, Support & Management Processes 5 Core Process Assessed: Support Process Assessed: Foundation Process Assessed: /9 110/9120 Section Reference: 7 Support Process(es) Assessed: 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)? Determination Effectiveness Focused

28 Compliance vs. Effectiveness INPUTS Compliance Compliance Compliance Compliance OUTPUTS Customer Regulatory Known Design Plan Produce Inspect Product Service EFFECTIVENESS GOOD PRODUCT ON-TIME ON-BUDGET

29 Why The Changes Product Integrity Focus in The Supply Chain ISO 9001:1987 & 1994 Procedure Focus Do What you Say, Say What You Do ISO 9001:2000 & 2008 Process Focus Current State Over Simplification of the Process Model Over Focused on Micro Processes Over Focus on Conformance -vs- Effectiveness Current Need Create Balanced Focus on Micro and Macro Processes Creation of Core Product Realization Process Concept

30 Customer Focus - Supply Chain Risk Customer Supply Chain Quality QMS Integrity Process Control Process Effectiveness Product Integrity Form, Fit & Function On Time Delivery Product Integrity

31 Product Integrity Focus Risk Focused Control of Suppliers Supplement Supplier QMS Certification with Product Inspections Based on Risk AS 9100c Section f Determine and manage the risk when selecting and using suppliers (see 7.1.2) Determine the Risk When Selecting Suppliers Manage the Risk When Using Suppliers

32 Risk Focused Control of Suppliers Supplier Focus On Understanding Requirements Risk Customer Requirements Product Process End Use Specific Requirements Regulatory Compliance Risk Focused Supplier Oversight Processes End Use Impact on Supplier Oversight Form, Fit, Function Risk Based Oversight New Processes Risk Impact on Supplier Oversight Organization Change Impact on Supplier Oversight Product Integrity in Manufacturing & Inspection Parts Compliance Substandard Materials from Suppliers Counterfeit Parts Control

33 Focus On Shaping NQA For the Future Many Challenges For: Our Industry NQA Management Office Personnel Audit Staff Need All Your Efforts for us to Be Successful Improved Industry Perception of CRB s Increased Process Effectiveness Enhanced Audit Focus To Ensure Integrity Of Customer s QMS Enhanced Audit Focus To Ensure Customer s QMS Produces Good Product NQA & SII Look Forward to your Support in These Efforts

34 Customer Focus - Supply Chain Risk Customer Supply Chain Quality QMS Integrity Process Control Process Effectiveness Product Integrity Form, Fit & Function On Time Delivery

35 Expanded Unitek Services Questions???