The Certified Quality Process Handbook Chapter 2 Audits

The Certified Quality Process Handbook Chapter 2: Audits Presented by Dr. Joan Burtner Certified Quality Engineer Associate Professor and Chair Dept. of Industrial Engineering and Industrial Management Mercer University

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 and interviews § Data that is maintained by the audited organization Assessment: collected data is compared to established standards, regulations, or practices IDM 404 Spring 2020 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 2

Classification of Audits Internal (first-party audit) § Designed and conducted by the organization being audited § Results delivered to the organization being audited § Auditor is typically a trained member of the organization, but may be consultants or contracted personnel § Often conducted before an external audit External (page 15) § 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 second-party audit is performed by a customer to verify that a supplier conforms to applicable requirements. § A third-party audit is performed by auditors who are independent of both the auditee and the requesting agency. IDM 404 Spring 2020 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 3

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. Determine the audit type (product, process, or system) 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 IDM 404 Spring 2020 the necessary resources Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 4

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 Communicate IDM 404 Spring 2020 Slide 5

Audit Process: Performance Begin with an opening meeting for auditing staff and senior management § Present scope and time frame § Notification of potential interviews Conduct interviews (open-ended questions are very useful) Examine records and observe activities in order to obtain objective evidence Conforming or nonconforming Communicate progress and issues Daily briefings and team meetings Analyze IDM 404 Spring 2020 data and create findings Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 6

Audit Process: Reporting The reporting should be balanced to give both negative and positive feedback. Findings sheets state problem and supporting facts Nonconformities are documented when a requirement is not being met Note positive practices to reinforce good things The objective report will state conformances, nonconformances, and observations for improvement IDM 404 Spring 2020 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 7

Audit Process: Closure Closing meeting § Final report with exceptions § Terms and conditions for closure § Agreements between agent authorizing the audit and the company being audited (auditee) The audit is considered closed when both parties agree that all corrective actions have been verified and successfully completed. IDM 404 Spring 2020 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 8

Audit Roles and Responsibilities See § § § descriptions on pages 20 and 21 Agent authorizing the audit Senior management Audit team leader Auditor Auditee IDM 404 Spring 2020 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering Slide 9