11/18- Failure Mode and Effects Analysis (FMEA)

Define failure modes and effects analysis (FMEA)

Failure Modes and Effects Analysis is one type of proactive risk assessment tool in which the process is mapped, the potential ways the process can fail are identified, and the consequences of these failures are determined – all of which help the organization identify and implement improvements for patient safety.

Identify topics that are appropriate for FMEA

High-risk or high-vulnerability process

• Potential for safety issues

• New tech

• New applications of existing tech

• History of errors in the process 

• Potential for important regulation issues

• Mission critical processes

Define failure modes

Failure modes: means the different ways or modes in which the particular process or subprocess step can fail to accomplish its intended purpose

Explain how severity, occurrence, and detectability scores are assigned and what they

mean

Severity	Determined by the worst possible effect of the failure mode
Occurrence	Determined by the frequency of the cause of the failure mode
Detectability	Determined by the likelihood the failure will be caught - Best detection control

Differentiate prevention and detection controls

Prevention Controls	Detection Controls
Prevent the cause from happening and reflected in the occurrence score	Prevent the failure from reaching the end user and are reflected in the detectability score

Calculate the risk priority number (RPN)

RPN= Severity x Occurrence x Detectability

Describe how the FMEA team prioritizes failure modes and causes for action

It can be prioritized by severity THEN RPN. The FMEA team should develop criteria for how many RPNs they will address with actions

Explain why the FMEA team should recalculate the RPN after actions have been

implemented

The purpose of FMEA is to reduce risk in the process. recalculation of RPN demonstrated whether that objective has been achieved

Recognize the similarities and differences between FMEA and RCA and when each tool

should be used

FMEA is used to predict and prevent potential problems before they happen. RCA is used to find and fix the root cause of a problem after it occurs.