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9101 – Ask the Experts

9101 – Ask the Experts. Boston, MA July 21-22 , 2011 Tony Marino, Tom Gallagher, Larry Beck. Auditor Workshop Boston, MA July 21-22, 2011. Agenda Summary of Changes – Tony Marino (Boeing) Sector/CB Feedback – Tom Gallagher (UTC) Future Changes – Larry Beck (Lockheed). Boston, MA

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9101 – Ask the Experts

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  1. 9101 – Ask the Experts Boston, MA July 21-22, 2011 Tony Marino, Tom Gallagher, Larry Beck Auditor Workshop Boston, MA July 21-22, 2011

  2. Agenda Summary of Changes – Tony Marino (Boeing) Sector/CB Feedback – Tom Gallagher (UTC) Future Changes – Larry Beck (Lockheed) Boston, MA July 21-22, 2011

  3. 9101 Team Membership 13 Members on the 9101 Team Representing: Americas, Europe, and Asia-Pacific IAQG Sectors 6 Different Countries 8 IAQG member companies Certification Body community (4 members) Boston, MA July 21-22, 2011

  4. 9101 Stakeholders Civil Aviation Industry and Authorities Defense Industry and Authorities Space Industry and Authorities Certification/Accreditation Bodies Auditors Suppliers IAQG Member Companies IAQG Strategy Streams and Teams Boston, MA July 21-22, 2011

  5. 9101 Revision Objectives Ensure alignment with the IAQG strategy (on-time, on-quality performance, improved control of Other Party certification) Incorporate the 9100:2009-series changes and align with the ISO 17021 content (new ISO assessment standard) Support the process approach for quality management systems as described in the 9100-series standards Incorporate the ICOP (Industry Controlled Other Party) resolutions and improve the value of OP auditing Define the requirements for all activities of the audit program Provide an adequate audit report to stakeholders on Performance of Organizational Processes. Note: product performance/results driven Boston, MA July 21-22, 2011

  6. 9101 Process Approach target Definition of the audit process phases with audit planning, execution, analysis and reporting:(Pre-audit, Stage 1, Stage 2, Surveillance, Re-Certification) Audit of the organization’s processes and continual improvement approach, as required in 9100-series standards Development of performance-based, process-orientedaudit methods and techniques. Recording of objective evidence of process conformity and effectiveness Reporting of audit results in a uniform, transparent and standardized way Boston, MA July 21-22, 2011

  7. 9101 Major Revision Summary 9101 completely rewritten reflecting now an enhanced audit process for evaluating “process based management systems” One audit standard covering 9100/9110/9120 QMS standards. Elimination of “Scoring” and “Key Requirements”. Use of Customer feedback concerning Organization QMS 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 a new Objective Evidence Record Introduction of a new Process Effectiveness Assessment Report Boston, MA July 21-22, 2011

  8. Process Approach OER Audit Records Methods/Tools PEARs Process-Based Auditing NCRs Inputs Outputs Controls Resources Performance Focused Evidence of effectiveness Evidence of conformity Model for Process Based Auditing - 9101 Boston, MA July 21-22, 2011

  9. 9101: Core principles Customer driven Process based approach Organization Performance focus Audit methods included Quality Management System effectiveness, in addition to conformity Improved reporting of audit results Boston, MA July 21-22, 2011

  10. 5 Areas of Sector/Certification Body Feedback Audit Planning Increased preparation time Need to clarify and confirm expectations for 4.2.1with respect to timing and 9104/1 auditor days Some clients refusing to provide proportion of business as a percentage for each customer Audit plans must be written in terms of client’s QMS processes – not departments or generic ISO/AS clauses There must be continuity between the terminology (e.g. process names) used in audit plan to those in Process Matrix and PEARs Boston, MA July 21-22, 2011

  11. 5 Areas of Sector/Certification Body Feedback Stage 1 Audit A good way to determine readiness on process approach/measurement of process effectiveness. Should be mandatory for transition audits as well Send Stage 1 Report to client 1-2 months prior to audit. Have them send back to auditor partially completed, this will help with time management Auditors say that 1 auditor day (for small size organizations) for Stage 1 audit is sometimes not enough In the text of 9101D at Stage 1 audit areas of concern might be identified. But in audit report (stage 1) “Has organization been requested to submit a corrective action plan prior to the stage 2 audit?” Needs more explanation. Boston, MA July 21-22, 2011

  12. 5 Areas of Sector/Certification Body Feedback Stage 2 Surveillance / Recertification Better focus on process effectiveness through the PEAR + Better focus on Customer Satisfaction + Lead auditors spend a lot of time to explain changes in the audit methodology. Help (communication) from industry seems necessary. When based on PEAR results, closing meeting generates higher interest from top management + A more detailed audit team meeting is needed than before. For example, to prepare PEAR, detailed communication about assessing the process is needed. Effectiveness of the audit itself is increasing + Boston, MA July 21-22, 2011

  13. 5 Areas of Sector/Certification Body Feedback Reporting Forms are difficult and time consuming (e.g. format issues, pagination, redundant information, etc.) Suggest modification of header to include ‘common’ information for copying/cut & pasting. Suggest combining all forms (w/exception of NCR) with OER and call it Audit Report Headcount (required for OASIS entry)only appears on Stage 1 report form PEAR , QMS Process Matrix, OER, NCR, Stage 1 Audit Report – various comments & suggestions for improvement Signature requirements is ‘19th century’ Boston, MA July 21-22, 2011

  14. 5 Areas of Sector/Certification Body Feedback Time Audit preparation time has increased Time required to complete forms is onerous and takes away from actual audit time Technical review and OASIS entry time has increased More time needed for audit planning and post-audit activities than before … must mandate minimum time for reporting in our new 9104/1 document Boston, MA July 21-22, 2011

  15. What’s next for 9101? Kick-off meeting for 9101 re-write April 2011 in New Orleans, LA Expected topics include: Feedback Discussion OER Changes Forms Simplification/Consolidation Efficiency Discussion Boston, MA July 21-22, 2011

  16. 9101 Revision plan: Input for Next Revision ISO/IEC 17021:2011 FAQ list  Notes or  Requirements “Left overs” Risk based auditing “Biased auditing” “Intelligent auditing” Team Evaluation “Survey” Feedback from auditors/CB/Client. Feedback from TP trainers (combine with feedback to the training package) 9104/1 input Boston, MA July 21-22, 2011

  17. 9101 Revision Form: Boston, MA July 21-22, 2011

  18. 9101 Revision Milestone: • ECD for balloting: March, 2012 • ECD Publication: July, 2012 Boston, MA July 21-22, 2011

  19. 9101 Questions Boston, MA July 21-22, 2011

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