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Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow

9104-1 ’Requirements for Aviation, Space, and Defense Quality Management System Certification Programs’. Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow Auditor Training and Workshop Session Minneapolis, MN July 30-31, 2009.

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Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow

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  1. 9104-1’Requirements for Aviation, Space, and Defense Quality Management System Certification Programs’ Prepared and Presented by Michael C. Roberts, Boeing Technical Fellow Auditor Training and Workshop Session Minneapolis, MN July 30-31, 2009

  2. Michael C. Roberts (mini-bio) • Boeing Technical Fellow – Quality Technology • 35 Years in Failure Analysis, Reliability, & Quality at McDonnell Douglas and Boeing IDS • Focus Areas in Microelectronics, Metrology, and Quality Technology • Past Chair and Charter Member of the RMC • Past Co-Chair and Charter Member of the OPMT • RMC Member at Large and OPMT Alternate Member • Education: BSEE, MSEE, MSEngMgt • Boards: SAE Institute, UL-DQS • ASQ Certs: CQE, CQM

  3. Caveat Emptor Note: The 9104/1 Standard Has Neither Been Balloted Nor Published. Therefore, All Information Contained Herein Is Considered “Proposed” and “Subject to Change”

  4. There was AIR 5359 … In the beginning … … and everything was right and proper in the aerospace world. But man was not satisfied … … so he asked for OASIS … and surveillance … and ICOP. And the ABs, CBs and Auditors multiplied.

  5. It was Internationally harmonized … So, 9104 was born ! … and became the standard from which the Aerospace Industry managed ICOP. But man was still not satisfied … … so he asked for a separate Surveillance doc, … and a separate Training and Qualification doc, … and wanted a number of topics redefined. And thus, the 9104 Trilogy was created.

  6. The 9104 TRILOGY General Requirements -1 9104 -2 -3 Oversight Activity Training and Qualification

  7. History of 9104-series Releases: • AS9104A Jan 2005 • Quality Management System Certification/Registration Programs • AS9014 July 2006 • AAQG Requirements for AQMS Certification/Registration Programs • AS9104-2 Mar 2007 • Oversight of Aerospace QMS Registration/Certification Programs • AS9104-3 Mar 2007 • Aerospace Auditor Competency and Training Programs • AS9104-1 Est. 1Q2010 • Aviation, Space and Defense QMS Certification Programs

  8. Today’s Game Plan • International Team Approach • Review of Changes to 9104-1 • High Level Changes Per Chapter • Discuss Audit Day Table • Discuss Multiple Site Certifications • What’s Next • Schedule / Predictions • Questions ?

  9. 9104-1 International Re-write Team

  10. Chapters, Book Bosses, Etc.

  11. Chapters, Book Bosses, Etc. (continued)

  12. Significant Changes to 9104-1 Note: 9104-1 is a total rewrite of the original 9104 document. This presentation will only focus on the major changes that deviate significantly from the past standard and implementation practices.

  13. Changes to 9104-1(C 1) • 1. Scopesignificant changes • Introduces ICOP • Sets Applicability to SMS, OPMT, ABs, CBs, and CBMCs • Expands Applicability to IAQG Member Companies, AABs, TPABs, etc. • Defines AQMS as 9100, 9110, & 9120 • Sets Confidentiality Expectations

  14. Changes to 9104-1(C 2) • 2. Referencessignificant changes • Upgrades to the New ISO/IEC Documents • 17011, 17021, etc. • Upgrades to the New IAF Documents • MD 1, MD 2, MD 3, MD 4, MD 5, ML 4, GD 3, etc. • References IAQG Procedures • Establishes Equivalencies for AS, EN, JISQ, SJAC, NBR, etc. (sector publications)

  15. Changes to 9104-1(C 3) • 3. Definitionssignificant changes • Increased # of Definitions from 11 to 27 • 17 new, 1 deleted, most others slight changes • Added Definitions for • AQMS, AAB, CBMC, ICOP, OPMT, TPAB • Assessment, Audit, Containment, Pre-Audit, Office Assessment, Witness Audit, Witness Assessment • Multiple Site Organization, Single Site Organization, Head Office • Cross Frontier

  16. Changes to 9104-1(C 4) • 4. General replaced with • 4. Requirements for Sector Mgt Structure • Defines authority for the SMS, CBMC for • Review and Recognition of ABs, Accreditation of CBs • Review and Recognition of AABs and TPABs • Data Reporting to OPMT and OASIS • Approval, Suspension and Withdraw of Entities • Defining a Process for Resolutions • Define and Enforce impartiality / Conflict of Interest

  17. Changes to 9104-1(C 5a) • 5. Accreditation Bodies significant changes • Defines requirements for • Conformance to ISO 17011 and IAF ML 4 • AB Personnel Aviation Experience • CB Application and Review Process • Scope of Accreditation • Right of Access • Surveillance Requirements (new table) • # of CB Client Files to be Reviewed Annually • # of Witness Assessments

  18. Changes to 9104-1(C 5b) • 5. Accreditation Bodies (cont.)significant changes • Defines requirements for (continued) • Auditor Competency • Marks and Logo Use • Suspension and Withdrawal Process • Closure of Nonconformities • Records Retention • Complaint/Issue Resolution Process • Personnel / Assessor Team Requirements

  19. Changes to 9104-1(C 6a) • 6. Certification Bodies significant changes • Defines requirements for • Conformance to ISO 17021 and IAF MD & ML Docs • CB Maintaining ISO 9001 Accreditation • CBs Audit Program Must Conform to 9101 • CBs Certification Function Must Have a Person with Aviation, Space, or Defense competence • CB Auditors Must Be Competent and Authenticated to ISO/IEC 17021, 9104/3, and this standard • Periodic Surveillance and Oversight • CB is Responsible for Ensuring Data is Accurately Entered Into OASIS

  20. Changes to 9104-1(C 6b) • 6. Certification Bodies (cont.)significant changes • Defines requirements for (continued) • CBs Must Have an OASIS Administrator • CBs Must Have a Complaint/Resolution Process • CBs Audit Program Must Conform to 9101 • NO CB Consultancy • Responsibility for Integrity and Validity of Certificates • CB Suspension and Withdrawal • CB Rules for ASRP and CAAT • Audits Involving Areas and Materials Which Are Classified and/or Export Controlled

  21. Changes to 9104-1(C 7) • 7. Auditors reference to 9104/3 • Re-states (simplified) requirements for • Auditor Competency Detailed in 9104/3 • Responsibility for Evaluation, Authentication, and Re-Authentication of AQMS Auditors • “Auditors Authenticated in One IAQG Sector Shall Be Recognized by the Other Sectors” • Withdrawn Auditors May NOT Re-Apply for 12 Months in Any IAQG Sector

  22. Changes to 9104-1(C 8a) • 8. Audits and Reporting significant changes • Defines requirements … • Audit Team Leader Must Be an AEA and Be On-Site and Participating in All Audits, Including Multi-site • Audit Team Leader Shall Be Limited to a Maximum of Two Consecutive Certification Cycles at Same Client • Audit Team Leader Must Provide Nonconformity Reports (re. 9101) at the Closing Meeting • Cannot Issue Certification or Re-Certification Until … • All Major and Minor Nonconformities Have Been Contained, Satisfactorily Corrected with Root Cause Analysis, Corrective Action Has Been Implemented, Reviewed, Accepted, and Verified by the CB.

  23. Changes to 9104-1(C 8b) • 8. Audits and Reporting (cont.)significant changes • Defines requirements (continued) … • Duration of Audit • New Audit Day Table • NO Reductions From Audit Day Table Is Allowed • Increases To Audit Day Table Is Allowed and Expected • Table is Compliant to IAF MD 5 • New Table Specifies Initial, Surveillance, & Recertification Days for 9100/9110, 9100/9110 Less Design, and 9120. • Audit Day Table DOES NOT Include Non-Audit Time (travel, meals, breaks, etc.) • Audit Day Table DOES NOT Include Auditor Time for Audit Planning, Writing of Reports, Filling Out 9101 Forms, etc.

  24. New Audit Day Table (partial)

  25. Changes to 9104-1(C 8c) • 8. Audits and Reporting (cont.)significant changes • Defines requirements (continued) … • Audit Days • Audit Day is 8 Hours • Working Longer Still Counted As 8 Hours (cannot do 4 days of 10 hrs to equal 40 hours) • Must Audit All Working Shifts • Table is Compliant to IAF MD 5 • Shift Auditing Still Meets 8 Hour Daily Limitation • Audit Day Rules for Multiple AQMS Standards • Audit Day Rules for Adding AQMS Standards

  26. Changes to 9104-1(C 8d) • 8. Audits and Reporting (cont.)significant changes • Defines requirements for (continued) … • Multiple Site Certifications • Must Comply with IAF MD 1, PLUS Requirements in 9104/1 • IAF MD 1 Section 0.4 is not applicable for aviation, space and defense organization certifications • “Temporary sites” is also not applicable • All Sites Audited to the Complete and Applicable AQMS Standard Prior to Certificate Issuance • Sampling of Sites for Surveillance and Recertification is ONLY Allowed for 9120, and Limited to Same Country

  27. Changes to 9104-1(C 8d) • 8. Audits and Reporting (cont.)significant changes • Defines requirements for (continued) … • Multiple Site Certifications • For 9100 and 9110 Certifications, Two (2) Categories of Certification of Multiple Sites Are Defined • Cat 1 Sites meet eligibility criteria for IAF MD 1 • Cat 2 Sites meet eligibility criteria for IAF MD 1 & 3 • Note: It is anticipated that 90+% will seek/attain Category 1, and less than 10% will seek or achieve Category 2.

  28. New Multiple Site Certification Categories 28

  29. Changes to 9104-1(C 8e) • 8. Audits and Reporting (cont.)significant changes • Defines requirements for (continued) … • Multiple Site Certifications (Categories 1 & 2) • Central Function MUST Be Identified and Meet Criteria • Audit Days Calculated For Employee Count For Each Individual Site (NOT the cumulative sum of employees at all sites covered by the certification) • Central Function Audited Yearly • All Sites Visited At Least Once During Certification Cycle • Once Total Audit Day Requirement is Calculated, Some Allowance Is Given to Reduce Time At One Site and Add Time At Another Site For Proper Justification. (Time at one site cannot be reduced by more than 33% for Cat 1 or 50% for Cat 2.)

  30. Changes to 9104-1(C 8f) • 8. Audits and Reporting (cont.)significant changes • Defines requirements for (continued) … • Issuance of Certificates • Required Info (e.g.. AQMS Std, Rev Level, Audit in Accordance with AS9104/1, CB Identity, Issue & Expiration Dates, Scope, Multi-site info, Marks/Logos) in English • Information Posted to OASIS • Transfer of Certificates • Loss of Certification • ASRP • CAAT

  31. Changes to 9104-1(C 9) • 9. Oversight Process reference to 9104/2 • Defines requirements … • Refers to 9104/2 for Detailed Requirements • Requires ICOP Declaration Form Completed and Filed • Sharing of Results

  32. Changes to 9104-1(C 10) • 10. Auditor Auth. Bodies new section • Defines requirements … • AAB Must Be In Accordance With ISO 17024 • AAB Must Comply with 9104/3 • Agree to Oversight / Surveillance • Auditor Complaint / Appeal Process • Activities Outside of Region / Sector • Process to Determine Auditor Competency • Marks / Logos • Suspension / Withdrawal • Record Retention

  33. Changes to 9104-1(C 11) • 11. Train Prov. Approval Bodies new section • Defines requirements … • TPAB Must Comply with 9104/3 • Agree to Oversight / Surveillance • Conflict of Interest • Auditor Complaint / Appeal Process • Activities Outside of Region / Sector • Suspension / Withdrawal • Re-application After 12 Months • Record Retention

  34. Changes to 9104-1(C 12) • 12. OASIS new section • Defines requirements … • OPMT Has the Responsibility for OASIS • OASIS Administrators Required • Only CB Administrator Can Enter Audit Data Into OASIS • Client Administrator to Input/Validate Demographic Data • Withdrawn CBs Visible for 6 Months • Created a Responsibility Matrix for Data Correctness

  35. Changes to 9104-1(C 13) • 13. Other Party Mgt. Team new section • Defines requirements … • The OPMT Has The Authority to Publish the 9104-Series Standards Per IAQG Procedure 103 • Sector Reviews (Audits) Required Every 2 Years • OPMT Has the Responsibility for OASIS • Periodic Reviews of OASIS Management, Operations • Reports to IAQG (Int’l OPMT and Sectors) • Improvements to ICOP Scheme • Monitor Feedback Process

  36. Changes to 9104-1(C 14) • 14. OASIS Feedback Process new section • Defines requirements for

  37. Changes to 9104-1(C 15) • 15. Sector Mgt. Structure further definition • Defines requirements … • ICOP Scheme Globally Supported by SMS • Authority / Recognition • AB and CB Suspensions • Resolutions • SMS Represented on OPMT

  38. IAQG Council IAQG OPMT European SMS Americas SMS Asia Pacific SMS EU OPMT AAQG - RMC APAQG - RMC (OPMT) (tentative) Oversight/Surveillance Team Oversight/Surveillance Team Oversight/Surveillance Team Auditor Authentication & Training Review Team Auditor Authentication & Training Review Team Auditor Authentication & Training Review Team xx Documentation Documentation Documentation CBMCs per country RMCs (CBMCs） Oversight/Surveillance Teams Oversight/Surveillance Teams Auditor Review Team Auditor Review Team Sector Management Structure

  39. Changes to 9104-1(C 16) • 16. Cross Frontier new section • Defines requirements … • Compliance to IAF GD 3 • ABs, SMSs, and CBMCs Conducting Oversight In Countries Other Than Their Country of Accreditation • ABs Can Sub-Contract Work to Other ABs/Sectors • Accrediting AB Retains Responsibility • Fees Can Be Levied On CBs For Oversight Outside SMS/CBMC Region.

  40. Changes to 9104-1(C 18) • 18. Certified Organizations new section • Defines requirements … • Certified Organizations Must Allow CB to Post Tier 1 and Tier 2 Audit Data to OASIS Database. • Agree Tier 1 Is Public Information • Agree to Provide Access to Tier 2 Upon Request of Aviation, Space, and Defense Customers (unless justification of competition confidentiality, conflict of interest, etc.) • Agree to Notify Their Aviation, Space, and Defense Customers in Case of Loss of Certification • Shall Provide ‘Right of Access’ to Their Facilities, People, and Processes For Review by Customers and Authorities.

  41. Changes to 9104-1(C 19) • 19. Fees and Financials minor changes • Defines requirements ... • OPMT Can Recommend Fees For Registration of Audit Data in the OASIS Database • OPMT Must Prepare an Annual Budget • Submit to IAQG Treasurer • Estimate Contract Labor, Meeting/Workshop Costs, Sector ICOP Projects, and OASIS Sustainment and Improvements

  42. What’s Next Schedule / Predictions

  43. Revised Schedule

  44. 9101 Release OPMT Go- Ahead Est. 1Q2011 Est. 1/1/2012 Maximum 6 Months Maximum 12 Months Maximum 12 Months Develop Auditor Training Training of Certification Bodies and Auditors All Companies Must Upgrade to New Standard At Next Surveillance Audit Or Re-Certification Earliest Opportunityfor Certification to New Standard (i.e. the early adopters) Maximum Allowed Time to Upgrade 9100/9101 Transition Plan (Proposed) Release of 9104/1

  45. 9104/1 Transition Plan (Proposed) Est. 9-12 Months 9104/1 Ballot 9104/1 Release 1 Month 2 Months 6-9 Months ~ 5 Months Existing Contracts Must Be Changed to Meet 9104/1 At Next Audit (I,S,R) Maximum Allowed Time to Upgrade All ABs & CBs Must Be Compliant to New 9104/1, Except Audit Day Times and M/S All New Contracts Must Be Written to New Auditor Time Tables and 9104/1 Requirements

  46. QUESTIONS? Interrogação? Poser une question?

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