FMECA
Failure Mode Effects Criticality Analysis
• Systematic & proactive approach to
preventing failures before they occur
• Completed prior to implementation of a new
system, or redesign of a system in early stage
of development
• Systems or processes already in place.
FMECA not so new
• Used in high risk industries like aerospace
(since 1960’s), chemical processing,
nuclear, and airline industries
• Added to JC standards in 2001 requiring
healthcare organizations to proactively
address patient safety using system safety
tools like FMEA
• Used in Healthcare to focus on what could
go wrong, before it does
Various Adaptations for Healthcare
• Many variations available for use in complex
systems like Healthcare
• Simple fill in the blank templates like “QI
Macros” are available
• I have no financial interest in this product or
company
Components of FMECA
• Identify known or potential failures
• Analyze the way the process/sub process
can fail or the manner in which the failure
occurs (failure mode)
• Determine effect of the failure mode
• Estimate severity & probability of each
mode/effect combination
• Evaluate how to reduce/eliminate risk of
failure
Getting Started
• Select a project of common interest or
severity, one that will be supported by
leadership (resource heavy)
• Select team specifically designated for the
project, cross-functional &
multidisciplinary, and disband after project
completed
• Designate impartial facilitator
• Determine boundaries for the project
• Flowchart or review how existing
product/process works if applicable
• Brainstorm potential failure modes –
determining all the ways each process/sub
process could fail
• Identify potential causes of each failure mode
• List potential effects of each failure mode on
the patient
• Assign Risk Codes (RPI) for each potential
failure-mode effect combination
• Develop Actions or Countermeasures to
reduce risk
• Re-assign Risk Codes if/after
implementation of countermeasures
• Assign responsibility for actions
• Re-assess for “slippage”
Example of FMECA
• Patient to ED at unknown hospital requires
rapid sequence intubation post MVA
• Medication given
• Patient’s secretions clog filter
• No alarms heard
• RN hears gurgling sound and responds
• Patient rescued