The Certified Quality Process Handbook Chapter 6: Audits

1. The Certified Quality Process HandbookChapter 6: Audits Presented by Dr. Joan Burtner Certified Quality Engineer Associate Professor and Chair Dept. of Industrial Engineering and Industrial Management Mercer University

2. Introduction to Audits • Audit definition: an evaluation of an organization, its processes, or its products. • Audit purpose: to provide decision makers such as senior managers with unbiased information of which decisions can be made • Data collection for audits • Auditor’s observations • Data that is maintained by the audited organization • Assessment: collected data is compared to established standards, regulations, or practices Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

3. Classification of Audits • Internal • Designed and conducted by the organization being audited • Results delivered to the organization being audited • Auditor is typically a trained member of the organization • Often conducted before an external audit • External • Designed and conducted by an agency outside the audited company (independent auditing firm or government agency) • May be initiated by the organization itself or may be required by an external agency • A third-party audit occurs when an external agency requires the audit and contracts with an outside source to perform the audit (The first-party is the company being audited; the second-party is the agency that requires the audit; the third-party is the independent company that performs the audit) Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

4. Audit Process: Preparation (1) • Obtain formal authorization • Granted by upper management • Identifies audit team leader as well as the general resources necessary to plan and execute the audit • Establish the purpose of the audit • The purpose should be made clear to the auditors and auditees alike. • Establish the scope of the audit • Clear definition during the preparation phase will help avoid “scope creep” • The scope may change after the audit begins • Identify the necessary resources Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

5. Audit Process: Preparation (2) • Form a team • Assign team roles and responsibilities • Identify the audit requirements • Forms that need to be completed, detailed interview questions, debriefing activities, etc. • Schedule the audit activities • Set dates and times for delivery of required documents • Monitor progress by setting milestones in the schedule when the status of the audit activities can be assessed Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

6. Audit Process: Execution • Manage and administer the audit process • Conduct meetings and interviews • Manage scope creep • Create working papers • Conduct a kick-off meeting • Collect data • Analyze data • Conduct an exit meeting Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

7. Audit Process: Closure • Ideally occurs after all corrective actions have been successfully completed • Final report • Final report with exceptions • Terms and conditions for closure • Agreements between agent authorizing the audit and the company being audited (auditee) Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering