What is FMEA Technic for Risk Management

Rami.Azulay March 15th, 2011 Posted by Rami Azulay( ) ISO 14971, Risk Management

FMEA – Failure Mode and Effect Analysis


A methodology to identify, quantify, prioritize and evaluate potential failure mode


Failure mode: What could go wrong

Effect analysis: How would it happen, how likely is it to go wrong, how bad would that be


  1. Reduce risk of failure
  2. Ensure failures are detectible
  3. Prevent failure from happening.

Prevention: A way to figure out what can go wrong and what can be done in order to avoid it


Ahead of time or during the project lifecycle when a potential risk is discovered

We do FMEA for procedures that can be risky or costly


Preventing problem is cheaper than cleaning it

Some things are too risky or costly to incur mistakes


Gather all relevant participants from several verticals to give their insight of potential risks

  1. Analyze risks
  2. Define the most critical and include them in the control plan

Define potential failure mode for each Process (can have several failure modes)

  • Cause of failure (Root cause) – what might cause this failure mode
  • Effect of failure (Impact of failure)
  • Current control – what is done today in order to prevent the failure
  • Hazard Score (RPN=Risk Priority Number, is the product of Severity, Occurrence, and detection rating)
    • Occurrence/Probability (how likely to occur) [F]
    • Detection [D]
    • Severity [S]
  • Prevention/Mitigation/Control (recommended actions)
  • Revised RPN – after hazard mitigation

About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.



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