1. Boston, MA July 21-22, 2011 Tony Marino, Tom Gallagher, Larry Beck
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. Note: product performance/results driven
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 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-oriented audit 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. Model for Process Based Auditing - 9101
Records
Methods/Tools
Process Approach
Process-Based Auditing
Inputs
Outputs
Performance Focused
NCRs
PEARs
OER
Evidence of conformity
Evidence of effectiveness
Controls
Resources
Boston, MA
July 21-22, 2011

9. Process based approach Organization Performance focus
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 with 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. Kick-off meeting for 9101 re-write April 2011 in New Orleans, LA
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. ECD for balloting: March, 2012 ECD Publication: July, 2012
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