Failure Modes and Effects Analysis (FMEA) steps

 Failure Modes and Effects Analysis (FMEA) Tool

Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. FMEA includes review of the following:

Steps in the process

Failure modes (What could go wrong?)

Failure causes (Why would the failure happen?)

Failure effects (What would be the consequences of each failure?)

Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.

Background

Failure Modes and Effects Analysis (FMEA) was developed outside of health care and is now being used in health care to assess risk of failure and harm in processes and to identify the most important areas for process improvements. FMEA has been used by hundreds of hospitals in a variety of Institute for Healthcare Improvement programs, including Idealized Design of Medication Systems (IDMS), Patient Safety Collaborative, and Patient Safety Summit.

 

Process Failure Mode and Effects Analysis must be done in a step-wise fashion since each step builds on the previous one.  Here’s an overview of the 10 steps to a Process FMEA.

STEP 1:  Review the process

Use a process flowchart to identify each process component.

List each process component in the FMEA table.

If it starts feeling like the scope is too big, it probably is.  This is a good time to break the Process Failure Mode and Effects Analysis into more manageable chunks.

STEP 2:  Brainstorm potential failure modes

Review existing documentation and data for clues about all of the ways each component can failure.

The list should be exhaustive – it can be paired down and items can be combined after this initial list is generated.

There will likely be several potential failures for each component.

STEP 3:  List potential effects of each failure

The effect is the impact the failure has on the end product or on subsequent steps in the process.

There will likely be more than one effect for each failure.

STEP 4:  Assign Severity rankings

Based on the severity of the consequences of failure.

STEP 5:  Assign Occurrence rankings

Rate the severity of each effect using customized ranking scales as a guide.

STEP 6:  Assign Detection rankings

What are the chances the failure will be detected prior to it occurring.

STEP 7:  Calculate the RPN

Severity X Occurrence X Detection

STEP 8:  Develop the action plan

Decide which failures will be worked on based on the Risk Priority Numbers.  Focus on the highest RPNs.

Define who will do what by when.

STEP 9:  Take action

Implement the improvements identified by your Process Failure Mode and Effects Analysis team.

STEP 10:  Calculate the resulting RPN

Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.