9101:2009 Revision Workshop

1. 9101:2009 Revision Workshop Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations “It’s All About Performing” Tony MarinoThe Boeing Company Other Party (OP) Assessor Workshop San Diego, CA January 20, 2011

2. 9101 Team Charter “Revise 9101 to align with the next revision of 9100 and upcoming ISO 17021, review scope and identify any additional stakeholder needs and restructure the standard for a more process-based assessment approach to auditing an organization’s quality management system.” 13 Members on the 9101 Team representing: Americas, Europe, and Asia-Pacific IAQG Sectors 6 Different Countries 8 IAQG member companies 4 Certification Bodies IAQG Initiative Study dated 30 Sept 2006 and presented at the IAQG meeting in Seville, Spain on 5 Oct 06. 2

3. 9101 Major Changes • One document covering 9100/9110/9120 standards. • Elimination of “Scoring” and “Key Requirements” designation. • Use of Customer feedback concerning QMS Organization performance as an input for process oriented audits (e.g., OASIS, customer satisfaction/performance scores). • In addition to conformity, also determination of Effectivenessincluded. • More emphasis on performance measuring. • Introduction of the Objective Evidence Record (OER).

4. WHAT’S NEW? Expanded the Scope (QMS Audit Req’mts for Aviation, Space, Defense Orgs) Eliminated scoring Eliminated use of the clause based questionnaire (replaced by Objective Evidence Record) Greater emphasis on audit planning(more pre-work, on-site Stage 1 by Team Leader) Introduces audit methodologies Strengthened NCR requirements (standard form, containment, single entry, recurring finding upgrade, 30-day C/A response window) 4

5. WHAT’S NEW? Greater Focus on evaluation of process effectiveness (use of the Process Effectiveness Assessment Record form for each audited product realization process) Use of a QMS Process Matrix form Use of Standard Audit Report forms Provides Special Audits criteria (in response to a customer/interested party request, scope change, certification transfer) Replaces existing versions of 9101, 9111 and 9121 5

6. What has not Changed • Determining conformity to the standard's. • Nonconformity’s discovered during the audit are to be documented. • Based on information collected during the audit, the lead auditor will have to draw conclusions on conformity and effectiveness of the organizations quality management system.

7. Process Approach OER Audit Records Methods/Tools Process-Based Auditing NCRs PEARs Inputs Outputs Controls Resources Performance Focused Evidence of effectiveness Evidence of conformity Development Model for Process Based Auditing - 9101

8. What is the Effectiveness of anOrganization? • Process not implemented; planned results are not achieved? • Process implemented; planned results are not achieved and appropriate actions not taken? • Process implemented; planned results are not achieved, but appropriate actions being taken? • Process implemented; planned results are achieved?

9. What is Effectiveness? Extent to which planned activities are realized and planned results achieved (Reference ISO 9000Quality management systems – Fundamentals and Vocabulary)

10. What will this Mean to the Auditor? Will use client and client customer performance data to plan audit activities. Review and examine an organization’s “Effectiveness” from: • The customer viewpoint; Satisfaction and performance. • Organizational leadership goals and objectives. • Operational processes of the organization. Construct and follow “audit trails”.

11. What will this Mean to an Organization? A QMS Organization should be able to… • Demonstrate conformity of the QMS Organization to the standard. • Show process mapping (identified, sequence and interaction). • Explain process measures identified: • Who reviews the data? • Targets defined? • Targets are met? • Are the measures actionable? • How is the data used? • Show actions taken when product quality and on-time delivery performance targets are not met. The ultimate measure of a QMS Organizational effectiveness – Customer Satisfaction

12. As an OP Assessor You will See Change in the Auditor’s Planning, Conduct and Results Influences in the planning of the audit. (9101 4.2.1) Knowledge of the client processes, sequence and interaction. (9101 4.1.2.5) Looking at organizational and process performance. (9101 4.2.2.1) Testing defined measures (targets defined and are they actionable). Appropriate actions taken when defined measures are not met. (9101 4.1.2.1) Development of audit trails based on data and performance (9101 4.1.2.4) Make up of the audit package. (9101 Appendices) 12

13. Exercise Witness Audit Auditor is evaluating metric/scorecard package for Management Review. You (OP Assessor) observe a scorecard for 3 programs from customer “X” reflects Red in quality for each program for the past 3 months. Auditor makes inquiry about frequency of Management Reviews, minutes and action logs. No questions regarding customer “X” asked at this moment in time. Thanks the MR and moves on the next part of the audit plan. No further inquiry is made throughout the course of the audit. Audit concluded with no NCR’s. As an observer, what issue might be here? 13

14. The Gains • Emphasizes process approach within organizations. • Shifts energies from completing the clause based questionnaires to determining and documenting conformity and effectiveness of processes. • Provides useful information to stakeholders concerning process performance and effectiveness.

15. 9101 SUMMARY • 9101D represents a significant advancement to aerospace auditing. Although auditing for effectiveness has always been an expectation of the standard and to customers, the reality is that most auditors focus on process conformity to procedural requirements overlooking process results. • Customers have long complained about “certified” suppliers that continually have poor performance issues (on-time and/or quality). This standard addresses performance in a way that has not been approached before. • This change sets a stage for a new journey and as with any journey, there will be challenges. We must stay on course.

16. QUESTIONS ?