Internal Auditor Training

1. Internal Auditor Training An Audit of the SYSTEM, Not the PEOPLE

2. Agenda • Basic review of QS9000 • Ground Rules for Auditors • Planning ahead for an effective audit • Performing an audit • Objective Evidence • Reporting • Closing out Corrective Actions/Follow-up

3. QS9000 Quality System Requirement • QS9000 was developed by Chrysler/Ford/General Motors Supplier Quality Requirements Task Force. • The Goal of QS9000 is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. What does that mean to us?

4. That Means... • We will have the structured tools to improve our quality. • Which in turn will improve our business. • Which in-turn means a bright future?

5. Quality System Structure

6. 4.1 - Management Responsibility 4.2 - Quality System 4.3 - Contract Review 4.4 - Design Control 4.5 - Document & Data Control 4.6 - Purchasing 4.7 - Control of Customer Supplied Product 4.8 - Product Identification and Traceability 4.9 - Process Control 4.10 - Inspection and Testing 4.11 - Control of Inspection, Measuring and Test Equipment 4.12 - Inspection and Test Status 4.13 - Control of Nonconforming Product 4.14 - Corrective and Preventive Action 4.15 - Handling, Storage, Packaging, Preservation and Delivery 4.16 - Control of Quality Records 4.17 - Internal Quality Audits 4.18 - Training 4.19 - Servicing 4.20 - Statistical Techniques Elements of QS9000

7. What is an Audit? A planned, independent and documented assessment to determine whether agreed-upon requirements are being met. -- ASQC Quality Auditing Technical Committee

8. Why Conduct an Audit? Typically, audits are done: • To tell if the quality system elements comply with set requirements; QS9000. • To ensure we strive for continuous improvement. • To measure and evaluate ourselves as a company. Audits are not done to: • Get a department or an employee into trouble. • Point fingers. • Revenge.

9. Types of Audits • 1st Party - This is an internal audit in which we audit our own system. • 2nd Party - This is an external audit in which a customer assesses our quality system, or we assess one of our suppliers quality system. • 3rd Party - This is an independent body (called a registrar) assessing our quality system to determine compliance to a specific requirement.

10. Other Types of Audits... • System Audit - (Desk Audit) A review of the quality manual or other quality documents to ensure outside quality requirements, such as QS9000, are being met on paper. • Process Audit - An audit of the processes to ensure that the organization is following established policies, procedure and work instructions.

11. Audit objectives... • To determine compliance or noncompliance of the quality system to the requirements. • Determine the effectiveness of the quality system. • Discover opportunities to improve the quality system. • Meet the requirements of 4.17 Internal Quality Audits.

12. What an auditor should be... • Prepared • Professional • Honest • Observant • Impartial • Unbiased • Thick skinned

13. What an auditor should not be... • Augmentative • Unprofessional • Dishonest • Lazy • Biased • Unobservant • Thin Skinned

14. Independence of the Auditor • The auditor must be directly independent of the area being audited.

15. The Audit Steps... • Schedule the Audit - Corporate • Review the Documentation - All Auditors • Conduct an opening meeting - All Auditors • Conduct the Audit - All Auditors • Conduct a closing meeting - All Auditors • Prepare and distribute the Audit Report • Corrective Action Follow-up

16. The auditor’s task is to gather objective evidence through: Observations. Interviews. Tours of departments / Areas. Inspections of documents, product, processes, etc. Observations and Objective Evidence

17. When Interviewing… • Who? • What? • Where? • When? • Why? • How?

18. Ask Questions... • Show me how… • Show me where… • Show me what and when...

19. Listening Listen to what is being said and look for your answers as well as the next question.

20. Checklists... • The use of checklists is a great way to stay on target and to ensure you ask the important questions. • Checklists can be prepared or already exist. • Procedures and work instructions are a type of checklist.

21. Major A total breakdown of one or more elements of the quality system or the combination of several minors for the same element Nonconformities... • Minor A small discrepancy or “hick-up” in the quality system that could lead to further problems or an isolated problem.

22. When documenting a nonconformity... • Establish and document the facts • Collect all the available objective evidence • State when, where, what, why and who

23. Observations... • An observation is an area that you feel could be improved. • If left alone could result in a nonconformity.

24. Audit Report... • Complete all findings of noncompliance and compliance on the audit report forms. • Be sure to sign the reports and check them for completion.

25. Don’t Forget... • Document objective evidence of compliance as well as noncompliance. • Don’t be negative, try to point out as many or more positive things you found.

26. Corrective Action... • Following the Procedure QP-17.1 and the work instruction WI-0205 for internal auditing, the corrective actions must be proposed then accepted prior to being implemented. • Once accepted, the plant may implement the corrective action. Which leads the auditor into follow-up.

27. Follow-up... • Follow-up activities are scheduled according to the established time frames in the procedure / work instruction. • Follow-ups must be done and the auditor must feel that the finding has been corrected to close out the nonconformity report.

28. Close out... • Once all of the follow-up is complete and the auditor is satisfied with the corrective action, he or she may close out the audit and submit it to the Corporate Lead Auditor for filling. • Copies should go to: the auditor, the auditee and the lead auditor.

29. That’s it...