COURSE DESCRIPTION

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 SHOULD ATTEND

Engineers and Managers in New Product Development, Reliability, and Quality

COURSE OUTLINE

• 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