About the Training Course

This is not just the usual Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA) class. Those topics are covered to be sure, but this class prescribes an approach that integrates the Risk Management process into New Product Development to save time and money by getting the product designed right the first time, starting with product architecture.
Conformity with ISO 14971:2007(E) and Title 21 CFR is clearly emphasized, but rather than just exposing what the regulations say, a simple way to conform with the least “side effort” is offered. A way is shown to automatically get congruence between complaint management, Medical Device Reporting, and new product launch. Comments about criteria for Field Corrective Action are made.
Class exercises (using actual products in closed classes) and class discussion make each session unique.

Who is this training course for?

Training Course Content

• Introduction
• Historical Note
• What is Risk Management
• Why Do Risk Management?
• Minimal Risk Management Process
• Risk Analysis
• Stakeholders Viewpoint
• Severity of Harm
• Probability of Occurrence of Harm
• Feedback from Experience
• Risk Evaluation
• Product Volume and the Risk Table
• Risk Control
• Risk Control Options
• Production & Post-Production Information
• Risk Control by Product Architecture
• The Complete Risk Management Process
• The Risk Management File
• The Risk Management Plan
• Start the RM Report – Identify Hazards
• Failure Mode and Effects Analysis
• Application FMEA
• Design FMEA
• Process FMEA
• Complete the RM Report – CE Submission
• Wrap-up, Closure, Evaluation

About the Lecturer

Mr. Chet Haibel,
M.S.E.E., Senior Principal Reliability Engineer, Medtronic ERS, Redmond, WA

Individual contributor, coach, and mentor in Quality, Reliability, Risk Management, and Lean Sigma after 12 years managing quality and reliability engineers in computer peripherals and medical devices in a QSR / ISO 13485 environment. Spent 15 successful years developing a rich variety of new products at Hewlett-Packard.
B.S. and Master of Engineering from Cornell University, Regulatory Affairs Certified, Senior member of and certified by the American Society for Quality as: Quality Auditor, Quality Auditor-Biomedical, Quality Engineer, Software Quality Engineer, Reliability Engineer, and Quality Manager. Certified Johnson & Johnson Six-Sigma Green Belt.