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