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FMEA Training


The PathWise FMEA training course uses concepts and steps that align with ISO 14971 and ICH Q9 guidance related to Quality Risk Management. This includes Risk Assessment, Risk Control, and Risk Review. This training will ensure the use of the FMEA tool will build a culture that emphasizes prevention of issues or problems before they occur. The FMEA tool helps to spot risks early on in the development of processes. It can be used throughout the risk management process to identify, analyze, evaluate and reassess risk. This information can also be used to document risks and suggest performance and process improvements.

Attendees of this course will learn how to:

  • Explain how FMEA’s fit within a Risk Management System
  • Create an FMEA to include Risk Identification, Risk Analysis, Risk Estimation and Risk Control
  • Identify potential failures and their effects
  • Prioritize failure modes
  • Create action plans to eliminate or control risks

Integrated into the course is the completion of an actual FMEA to reinforce  the concepts presented.

These steps include:

  • List items/Function
  • Identify failure modes
  • Identify potential effects and assign severity rating
  • Identify potential cause and assign occurrence rating
  • Identify current controls and assign detectability rating
  • Calculate the Risk Priority Number (RPN)
  • Determine if further actions are necessary


  • Apply critical thinking to processes and systems
  • Create a working FMEA document to support QRM methodology


  • Raise awareness of QRM tools
  • Approach risk in a proactive manner

Failure Mode & Effects Analysis is appropriate for individuals who are regularly called upon to complete Design or Process FMEAs. Examples include research and design engineers, quality assurance, and regulatory and compliance personnel.

FMEA Training is a one day Instructor led training course.

TrainingThe most cost effective training option is to have PathWise come to your location. We have trainers across the globe, and trained in 14 different countries in 2015 alone, covering almost every continent!

To schedule a course at your site fill out the form below and a PathWise representative will get back with you shortly!

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TrainingPathWise workshops

We understand that training is essential to achieve and maintain a compliant, effective and efficient quality system, which is why 90% of our courses are taught on-site at our client’s locations.  For individuals and organizations in need of training but unable to make an on-site training commitment, we offer many of our courses as events at a variety of locations across the globe.

View the PathWise Events page to find out about our options for a public workshop.