So where in ISO is Process?

1. 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]

2. Why are internal audits conducted? • Obtain factual input for management decisions? ---or--- • Produce data needed to receive certification? • Improve documentation? • Enforce conformity?

3. 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

4. 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

5. 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?

6. 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?

7. 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!!!

8. Process Approach to Internal Auditing

9. Process Input-Output Model

10. Performance Process

11. Performance Process Audit Plan

12. 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

13. 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

14. 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

15. Process Approach to Checklists • Does not require detailed checklist • Auditor can be guided by their understanding of the Standard

18. 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

19. 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

20. The Process Approach requires a change in attitude across the organization!

21. 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

22. 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?

23. 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

24. 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

25. 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

26. 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