1. Alignment by Design Risk-Based Quality Auditing Going Beyond Compliance In Pursuit of Effectiveness Thomas Bradley, PhD [email_address] Alignment by Design, Inc.

2. An Introduction to Risk-Based Quality Auditing Summary Going Beyond Compliance - In Pursuit of Effectiveness Compliance-based Audits Pitfalls of Traditional Compliance-based Audits Going Beyond Compliance Presentation Outline

3. Going Beyond Compliance - In Pursuit of Effectiveness Compliance-based Audits Pitfalls of Traditional Compliance-based Audits Going Beyond Compliance

9. Organizational Effectiveness Going Beyond Compliance – In Pursuit of Effectiveness Compliance We Must Raise Our Sights Going Beyond Compliance Risk-Based Quality Auditing

10. Going Beyond Compliance Risk-Based Quality Auditing Makes Successive Developmental Capabilities a True Reality Compliance Effectiveness Excellence

11. An Introduction to Risk-Based Quality Auditing

12. “ Without changing our patterns of thought, we will not be able to solve the problems we created with our current patterns of thought” - Albert Einstein Profound Knowledge We Must Break With the Past – We Must Do Things Differently

13. In a Risk Based Quality Audit the rules are challenged. A fundamental goal of a Risk Based Quality Audits is to be proactive – it consistently asks the question, “can the enterprise get from here to there with the controls its has in place.” It takes a much closer look at the organization Interworkings Risk Based Quality Audits

17. Risk-Based Quality Auditing A Total Organizational Perspective Business Level Risks Process Level Risks Risks must be identified both top-down & bottom-up Project Level Risks Product Risks People Risks

19. The Alignment by Design Business-of-Business Basics Questions 5. Where there are gaps in performance or risks in our ability to achieve our objectives, what are we going to do? 1. What do we want to achieve? 2. How are we going to achieve our objectives? 3. Are our processes capable of achieving our objectives? 4. Where are we in respect to achieving our objectives?

21. Risk-Based Quality Auditing Strategic Planning & Management Assessment Strategic Alignment Analysis ISO-Based Process Audits Performance Analysis Capability Maturity Assessments Risk Assessments Tools Assessment Reference Model

22. Risk-Based Quality Auditing A Balanced View

23. Summary

24. Risk Based Quality Audits Is a new and exciting weapon in an organization’s arsenal for performance improvement and in their quest for organizational effectiveness. A powerful organizational diagnostic assessment tool that provides management with data and information to truly address the serious questions regarding organizational effectiveness & excellence

25. Risk Based Quality Audits Proactively identifies risks that hinders the attainment of organizational objectives at both the strategic and tactical levels and drive improvements while driving Compliance to established requirements and controls Increases an organization’s capacity to achieve its strategic goals and objectives

26. For more information on This exciting and powerful methodology Visit our web site at www.alignmentbydesign.com or, Contact Tom Bradley, PhD via email at [email_address]