ISO 9000:2000 Internal Audits

1. ISO 9000:2000 Internal Audits Rene’ Jones October 7, 2003

2. Overview: ISO 9000:2000 Internal Audit • ISO Audit Requirements • Getting Started • Steps to an effective audit • Planning • Execution • Follow up • Cessna’s Approach

3. ISO 9000 Audit Requirements Internal audits are required (4.17) • Must be conducted by personnel independent of responsibility for process being audited • Results must be recorded • Must follow organizational objectives • Frequency should be determined by the organizational need

4. Defined: An ISO 9000:2000 internal audit is a method for verifying the efficiency and performance of an organizations quality system. It ensures that the quality system meets or exceeds the required standard for certification by the chosen registrar.

5. Benefits and Uses: • Can facilitate continuous improvement • Can Identify System Failures • Provide feedback to Management regarding efficiency of the Quality System

6. How does this apply to my organization?

7. Steps to a Successful Internal Audit • Decide the scope of the audit • Full • Partial • How will it be conducted • Upstream • Downstream • Across Processes

8. Scope of the Audit • Full audit of the entire Quality System • How many auditors will be needed • How will responsibilities be divided • Appoint a lead auditor to keep the audit focused • Partial • Which departments or processes • Which clause of the standard

9. How Will the Audit Be Conducted • Upstream-starting with the final process and working backwards to the beginning • Downstream-starting with the first process and flowing forward • Horizontal-across similar processes

10. Steps to a Successful Internal Audit cont. • Develop a checklist • Perform the audit • Record findings • Follow-up

11. Develop a Checklist • Become familiar with the processess and the associated documentation to be audited • Make notes on possible questions • List items to look for and observe • Note paragraph of the standard being checked next to the item being audited • Leave space to record observations • Use only one sheet per process or area

12. Sample checklist Wavesolder Process 3/3.0 Component and Board Handling 3/3.2 Are components labeled and stored properly? ________ Are operators following proper board handling procedures? ______ Safety Procedures 3/3.6 Are operators wearing appropriate safety equipment? ________ Is the area clean and obstacle free? ____________ Interview two operators What is the procedure for loading a board into the machine? How far apart should the boards be in the machine When is it necessary to wear safety glasses?

13. The Internal Audit • Maintain control of the audit • Be professional • Remain objective-look at the facts • Observe everything

14. Audit Interviews • Ask open-ended questions • Use hypothetical questions • Encourage free speaking • Observe body language of the interviewee and adapt question if needed • Maintain eye contact

15. Audit Interviews cont. • Minimize note taking during interview • Restate your understanding of their response

16. Recording Observations • Record location of observation • List the names of interviewees and their position • Notes on non-conformances should be short and to the point but thorough

17. Non-conformances • Issue Corrective Action Requests (CAR) • Make sure it is thorough • Note ownership • Note the paragraph of the standard that has been violated • State requirements of resolutions

18. CAR Response • Must have specific details of implementation • Must have timeline for completion

19. Report to Management • Reports should be thorough and specific • Must be reviewed by management to be effective

20. The External Audit • Prior to the audit by the registrar • Let employees know what to expect from the external audit • Let employees know what is expected of them

21. Cessna’s Approach • Previous Audit System • Viewed as disruption • Viewed as a policing process • Viewed as non-beneficial • Program was suspended

22. Cessna’s Approach • New Audit System • Thorough Phased Procedure Developed • Teams with representatives from each quality department • Monthly rolling audits • Fosters continuous improvement of their quality system

23. Quiz • How does auditing facilitate quality improvement? • What does ISO require in regards to audits?

24. Summary: • Internal audits can be a tool for retaining certification • Can also be a tool for process improvement • Improves organizational awareness • Improves communication

25. Bibliography: Mills,Charles A.; The Quality Audit, A Management Evaluation Tool. USA: McGraw-Hill, 1989. Goetsch, David L., and Davis, Stanley B.; ISO 9000 and ISO Standards. Upper Saddle River, NJ: Prentice-Hall, 2000. Craig, Robert J.; The No Nonsense Guide to Achieving ISO 9000 Registration. New York: The American Society of Mechanical Engineers, 1994.

26. Bibliography cont. Burr John T.; Keys to a Successful Internal Audit.Quality Progress, Vol. 30, No. 4, April 1997. Eaton, Brian D.J.; Cessna’s Approach to Internal Quality Audits.IIE Solutions, 10851259, Volume 27, No. 6, June 1995. Beeler, Dewitt L.; Internal Auditing: The Big Lies. Quality Progress, May 1999.

27. Bibliography cont. • Karapetrovic, Stanislov, and Wilborn, Walter; Audit System; Concepts and Practices. Total Quality Management, 09544127, Vol. 12, No. 1, January 2001