Risk Based Quality Audit Part 1

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  • guest07f3c68b,
    Thanks for your feedback and comments. Note, it is not so much the strategic planning process that is important but the strategic goals and objectives that are derived from it. Risks are defined as hindrance to the attainment of objectives. It is those two fundamentals that are foundational to the methodology. Secondly, a Risk-Based Quality Audit is a performance audit and hence requires the documentation as defined by the GAO standard. More over, I have defined a proprietary assessment methodology and an associated tool to support the audits.It uses a Baldrige-like scoring but without the allocation of 1000 points. So after a Risk-Based Quality Audit engagement a very detail assessment is left with the organization/client that serves as their baseline for performance improvement.

    I am open and available to discuss further over the weekend.; let me kow when/where/how.
    Dr. Bradley
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  • This presentation takes Quality from compliance to product and ISO requirements to compliance with the vision in the strategic plan. This is the next discipline needed by black belts. I really like the combination of using the Elliott model to help companies better articulate their vision / mission in their strategic plan. When you add the tools of Risk Based Quality audits one can identify the organizational design and or performance gaps to achieve the dream. This is really profound knowledge.
    Robert E. Perez
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  • For more information on Risk Based Quality Auditing and other offerings of Alignment by Design, Inc. visit our web site at: www.alignmentbydesign.com
       Reply 
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Risk Based Quality Audit Part 1

  1. 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. 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. 3. Going Beyond Compliance - In Pursuit of Effectiveness Compliance-based Audits Pitfalls of Traditional Compliance-based Audits Going Beyond Compliance
  4. 4. Going to a Higher Orbit <ul><li>Compliance-based Audits </li></ul><ul><li>Performance Audits </li></ul><ul><li>Risk-based Quality Audits </li></ul>Must Seek to Optimize Value
  5. 5. <ul><li>Basically - a documentation review </li></ul><ul><li>The auditor usually conduct a ‘gap analysis’ between what is specified or required in a standard and what is presently done </li></ul><ul><li>This gap reveals a binary situation: compliance or noncompliance </li></ul><ul><li>Are reactive in nature </li></ul>Compliance-based Audits They are necessary but not sufficient
  6. 6. <ul><li>Looks for conformance to the rules: the requirements, policies and procedures </li></ul><ul><li>Are designed to give assurance that activities have been performed properly </li></ul><ul><li>Don’t challenge the rules </li></ul><ul><li>Provide little to no room for judgment </li></ul>Compliance-based Audits They are necessary but not sufficient
  7. 7. Pitfalls of Traditional Compliance-based Audits <ul><li>Only determines compliance to a set of policies or requirements. </li></ul><ul><li>Reactive versus proactive </li></ul><ul><li>Provides a static versus dynamic perspective </li></ul><ul><li>Compliance don’t mean effective </li></ul>They have their limits
  8. 8. Pitfalls of Traditional Compliance-based Audits <ul><li>Don’t identify risks associated with the QMS achieving objectives </li></ul><ul><li>Don’t assess performance or effectiveness of the QMS </li></ul><ul><li>Compliance don’t correlate to customer satisfaction or business results </li></ul>They have their limits
  9. 9. Organizational Effectiveness Going Beyond Compliance – In Pursuit of Effectiveness Compliance We Must Raise Our Sights Going Beyond Compliance Risk-Based Quality Auditing
  10. 10. Going Beyond Compliance Risk-Based Quality Auditing Makes Successive Developmental Capabilities a True Reality Compliance Effectiveness Excellence
  11. 11. An Introduction to Risk-Based Quality Auditing
  12. 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. 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
  14. 14. To Address Organizational Performance Assessment Challenges <ul><li>To understand the root causes of organizational performance constraints </li></ul><ul><li>To determine the bottlenecks/constraints to organizational effectiveness and excellence </li></ul><ul><li>To establish an organizational foundation that enhances its ability to be ‘built to last’ and to move from ‘good to great’ </li></ul>Why Risk-Based Quality Auditing?
  15. 15. <ul><li>Focuses Upon: </li></ul><ul><li>Effectiveness – the ability to achieve goals and objectives </li></ul><ul><li>Organizational capability maturity development </li></ul><ul><li>Assessing organization-wide risks </li></ul><ul><li>Prioritizing performance improvement efforts </li></ul><ul><li>Integration of all quality tools (i.e., Six Sigma, Lean, process mapping, problem-solving, etc.) </li></ul><ul><li>Builds upon compliance efforts </li></ul>Risk Based Quality Audits
  16. 16. <ul><li>Focuses Upon: </li></ul><ul><li>Effectiveness – the ability to achieve goals and objectives </li></ul><ul><li>Organizational capability maturity development </li></ul><ul><li>Assessing organization-wide risks </li></ul><ul><li>Prioritizing performance improvement efforts </li></ul><ul><li>Integration of all quality tools (i.e., Six Sigma, Lean, process mapping, problem-solving, etc.) </li></ul><ul><li>Builds upon compliance efforts </li></ul>Risk Based Quality Audits
  17. 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
  18. 18. <ul><li>That must be answered in order to successfully compete in the 21 st century global, knowledge-based economy </li></ul>The ‘Business-of-Business’ Questions: <ul><li>Every executive must continually ask. </li></ul><ul><li>Every quality leader must facilitate the answers. </li></ul><ul><li>All stakeholders want assurance that are being addressed. </li></ul>The Search for Profound Knowledge We must first pose the right questions in order to seek the right answers
  19. 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?
  20. 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
  21. 22. Risk-Based Quality Auditing A Balanced View
  22. 23. Summary
  23. 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
  24. 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
  25. 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]

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