Managing Product and Process Risk through Failure Mode and Effects Analysis (FMEA)

Conducted early in the process development cycle, the Failure Modes and Effects Analysis tool is used to identify risks and then adjust the manufacturing or service process to reduce the identified risks and improve quality. Attendees will learn practical application of Failure Mode and Effects Analysis (FMEA) as it is applied to product, process, or system design.

The course will teach identification of potential failure modes, the risk attached and indicate their relationship to product design or manufacturing process, along with their effects, if known, on the end use of the product. Root cause analysis, risk mitigation and assessing residual risk will be addressed as part of the FMEA process. Also to be discussed are FMEA history, methods, types, responsibilities, documentation, implementation, and software. Attendees will receive an FMEA excel template that they can customize and begin immediately using.

Areas Covered in the Session : 

• How to Manage designated personnel with the skills to conduct and complete an FMEA of products or processes
• Define types of FMEA’s
• The important benefits of FMEA
• Be familiar with components of FMEA
• Understanding process requirements
• How to select cross-functional teams

Who Should Attend:

• Design Managers
• Design Engineers
• Manufacturing Personnel
• Process Managers
• Process Engineers
• Quality Assurance Personnel
• Reliability Research Personnel
• Development Department
• Safety Engineering Personnel

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.