1. Process Auditing Why do people think that this is something new? Presented by Kevin Gilson, Orion Registrar, Inc. For the ASQ ISO Users Group October 8, 2008

2. Orion Registrar, Inc. 2 So where in ISO is Process? Clause 0.2  This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system…. [ISO 9001:2000 page v]

3. Orion Registrar, Inc. 3 Why are internal audits conducted? Obtain factual input for management decisions? ---or--- Produce data needed to receive certification? Improve documentation? Enforce conformity?

4. Orion Registrar, Inc. 4 The Old-Fashioned Way of Auditing Quality audits focused on procedures and not on quality Auditors did not examine costs “Quality” was how well an outcome met the needs of those for whom it was provided  Good quality = satisfied the needs  Bad quality = failed to meet the needs

5. Orion Registrar, Inc. 5 The Old-Fashioned Way of Auditing Companies ignored outcomes and customer satisfaction when auditing Auditors were looking to “check the box” leaving performance ignored and unchallenged Conformity auditing looking to establish if specific requirement had been met Requirement may have focused on a task, not performance result or output

6. Orion Registrar, Inc. 6 Document Review and Approval Auditor looked to see if documents had been reviewed and approved by authorized person Did Auditor look for:  Competency of approver?  Why change was made?  Did change improve performance?

7. Orion Registrar, Inc. 7 More Effective Methodology Needed Focuses on performance, not just conformity Management needs to know:  Does performance meet targets?  Are there opportunities for improving performance?  Are there processes that do not support the workers?

8. Orion Registrar, Inc. 8 As an Auditor… If I invent your process then I am auditing my version of your company… and that version may NOT exist. Conflict of Interest!!!

9. Orion Registrar, Inc. 9 Process Approach to Internal Auditing

10. Orion Registrar, Inc. 10 Process Input-Output Model

11. Orion Registrar, Inc. 11 Performance Process

12. Orion Registrar, Inc. 12 Performance Process Audit Plan

13. Orion Registrar, Inc. 13 What does you Quality Manual look like? 1. Introduction 2. Scope and Exclusions 3. Definitions and Acronyms 4. Quality Management System Requirements 5. Management Responsibility 6. Human Resources 7. Product Realization 8. Measurement, Analysis and Improvement Appendix -- process maps or outlines

14. Orion Registrar, Inc. 14 Process Approach to Audit Plans Based on processes that achieve organization’s objectives Requires auditor to know what the processes are prior to conducting audit  ISO/IEC 17021 (Stage 1 and Stage 2)  Code of Practice for Registrars

15. Orion Registrar, Inc. 15 Process Approach to Audit Plans Common processes, for example:  Business management  Marketing and sales  Resource management  Purchasing Product / service realization processes are different for each organization Plan shows audit trail through business processes and across department boundaries

16. Orion Registrar, Inc. 16 Process Approach to Checklists Does not require detailed checklist Auditor can be guided by their understanding of the Standard

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19. Orion Registrar, Inc. 19 Process Approach to Audit Start with top management and business management processes Continue with resource management processes, establishing linkages  Effective resource management processes will provide competent employees and capable equipment to other processes Continue with other processes from marketing to delivery

20. Orion Registrar, Inc. 20 Value of the Process Approach Focuses on results, not procedures Determines effectiveness of the management system Evaluates the results the system delivers Tests linkages between departments and processes Follows flow of work throughout organization Determines if operations are under control and controls are effective Allows judgment on significance of findings Helps determine depth of problems across organization Focuses on benefits of correcting nonconformities related to improving organizational effectiveness

21. Orion Registrar, Inc. 21 The Process Approach requires a change in attitude across the organization!

22. Orion Registrar, Inc. 22 What the Process Auditing Approach Provides Process Auditing provides:  Data for managerial decisions on growth, technology, staff development, products / processes based on current performance, not just current conformity  Information on whether performance meets targets  Information on opportunities for improving performance through better control of processes  Information on making processes more effective and more efficient

23. Orion Registrar, Inc. 23 Five Basic Questions Basic questions can apply even though the “specific questions” will be different:  What are you trying to do?  How do you make it happen?  How do you know you are doing it right?  How do you know it’s the best way of doing it?  How do you know it’s the right thing to do?

24. Orion Registrar, Inc. 24 Five Basic Questions at Three Levels Business Level – Audit results should make the auditor confident that the organization:  Knows what it is trying to do  Knows how to make it happen  Knows that it is doing the right things  Knows that it is doing it in the best possible way  Is managing performance

25. Orion Registrar, Inc. 25 Five Basic Questions at Three Levels Managerial Level – Audit results should make the auditor confident that management:  Knows what the process aims to achieve  Knows how to design and cause processes to achieve results  Knows that it is doing the right things  Knows that it is doing it in the best possible way  Is regulating performance

26. Orion Registrar, Inc. 26 Five Basic Questions at Three Levels Operational Level – Audit results should make the auditor confident that individuals:  Know what they are supposed to do  Know they are doing the right things  Know they are doing them in the best possible way  Are regulating their own performance

27. Orion Registrar, Inc. 27 Summary Internal auditing using process approach  Can take internal audit team from mission statement to employee contributions  Identifies clear linkages between interconnected processes  Ensures requirements of the Standard fit with processes  Eliminates weaknesses of other approaches  Enables internal audit team to establish that the organization is managing processes effectively

28. Orion Registrar, Inc. 28 Orion Registrar, Inc. 7850 Vance Dr., Ste. 210 Arvada, CO 80003 303-456-6010 www.orion4value.com Westminster, MD 410-857-1748 kgilson@orion4value.com kgilson@orion4value.com 410-884-9165