Risk based Thinking to quality Audit

Risk Elimination. Risk Management. Risk Mitigation. This is the language of upper management, that we as auditors from any industry must learn, if we truly want to effect positive change throughout our environment.

During this presentation, the various phases of the audit process will be viewed through the lens of ISO 31000 and ISO 14971. Attendees will learn how to define, recognize, and manage risk through their audit program. Case studies will be reviewed, as we discuss how to incorporate risk management thought, language and techniques into our internal audit process. In short, this presentation will show attendees how to transform an audit program from one that is compliance based and backward facing, to one that is risk managing, continuous improvement driving and forward seeking.

We will take definitions, rationale and process structure from ISO 31000 and ISO 14971, then segue way into case studies and practical applications of incorporating risk management into the auditing process. This session IS NOT meant to be a line-by-line analysis of either ISO 31000 or ISO 14971, but rather, the standards are used to provide a logical framework to guide the discussion. The overarching goal of this session is to expand how we think about the audit process – in this case through the incorporation of risk management techniques.

Areas Covered in the Session : 

• Auditing fundamentals
• Defining, identifying and managing risk
• Risk assessment and the internal audit program
• Integration of risk management into the audit program
• Audit program reporting

Who Should Attend:

• Quality Auditors
• Internal Auditors
• Audit Program Managers
• Quality Engineers
• Quality Managers
• Production Supervisors
• Operations Managers

Course Director: LANCE B. COLEMAN ‎

Lance B. Coleman has over 20 years of leadership experience in the areas of quality engineering, Lean implementation, quality and risk management in the Medical Device, Aerospace and other regulated industries. He has a degree in Electrical Engineering Technology from the Southern Polytechnical University in Marietta, GA and is an American Society for Quality Senior Member as well as, Certified Quality Engineer, Six Sigma Green Belt, Quality Auditor and Biomedical Auditor.  He is also an Exemplar Global Principal QMS Auditor. Lance is Chair of US TAG 302 – guidelines for auditing management systems as well as a voting member of US TAG 176- quality management and quality assurance. He is the author of  “Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press 2015)” and “The Customer Driven Organization: Employing the Kano Model (Productivity Press 2014)”, as well as many articles on quality, risk management and Lean implementation. Additionally, Lance is an instructor for the ASQ Certified Quality Auditor Exam Preparatory and FMEA courses.  As Principal Consultant of Full Moon Consulting, he has presented, trained and consulted throughout the United States and abroad.