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

10. Process Input-Output Model

11. Performance Process

12. Performance Process Audit Plan

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. 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 (Stage 1 and Stage 2)
Code of Practice for Registrars

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

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

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. 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. 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. 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. 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. 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