HEALTHCARE FAILURE MODE AND EFFECT ANALYSIS
The Modification of Traditional
FMEA known as Healthcare Failure mode and effect analysis (HFMEA), was
introduced in 2001 by US department of veterans affairs National centre for
Patient safety. HFMEA was derived from FMEA to be used specifically in the
healthcare setting because specific healthcare issues were inadequately dealt
with by using FMEA.
HFMEA combines
1. CONCEPT, COMPONENT AND DEFINITION from FMEA,
2.
Hazard
analysis, critical control points (HACCP) and root cause analysis
Definition of HFMEA
“A prospective assessment that
identifies and improves steps in a process thereby reasonably ensuring a safe
and clinically desirable outcome.”
“A systematic approach to
identify and prevent product and process problems before they occur.”
Difference between FMEA and HFMEA
First three steps in HFMEA are
identical to those in FMEA. Although action and outcome of severity and probability are substantially
modified in HFMEA.
HFMEA includes some new
components that are not used in FMEA, Such as
1. HFMEA scoring
matrix
2. HFMEA Decision
tree.
IN HFMEA, important parameter “RPN” is replaced by a Hazard score” that is read from HFMEA hazard scoring matrix, which was specifically designed by the National center for patient safety.
In HFMEA “degree of Severity” are defined as
1. Minor
2. Moderate
3. Major
4. Catastrophic
In HFMEA Probability are defined as
1. Remote (Unlikely to occur, May occur
sometimes in 1-30 years)
2. Uncommon (Possible to occur /may happens in
2-5 years)
3. Occasional (probably will occur may happens
several times in period of 1-2 years)
4. Frequent ( Likely to occur immediately or
within a short period of time/ may happen a few times a year).
 |
| Degree of Probability |
Advantage of HFMEA over the FMEA
Through minimizing the “number of score” available to the HFMEA team, the process is simplified.
The
Hazard score is calculated by multiplying the score for severity by the score
for probability.
Hazard score= Score of severity × score for probability.
Therefore the value of the hazard score can range from 1 to 16 rather than 1 to 1000 for RPN in case of FMEA.
Sample Severity Rating
 |
Sample
Probability rating
Process for doing HFMEA
1.
Step
1-Define the issue or problem
Statement of
problem has to be define
2.
Step
2 -Assemble the T
Multi-disciplinary
has to be assigned
3.
Step
3 -Graphically Describe the Process
Focus on the
Step and identify and validate the process and represent in the flow diagram
4.
Step
4 -Conduct the Analysis
a.
List out the failure modes
b.
Determine Severity & Probability
c.
Use the Decision Tree
d.
List all Failure Mode Causes
5.
Step 5
-Identify Actions and Outcome Measures
a.
Failure mode cause identified has to be
“Eliminate, Control or Accept.
b.
Describe an action for each failure mode cause
that will eliminate or control it.
c.
Analyse the outcome measures and take decision
to check the re-designed process.
HFMEA Decision Tree Analysis
HFMEA Decision tree analysis is used to prioritize the failure modes.
Through this process the DETECT ABILITY of
failure mode is identified similar to FMEA. But in addition the CRITICALITY
and EFFECTIVE CONTROL MEASURES of the failure mode are evaluated.
The decision to pursue the action is based on
1. Detectability of the cause
2. Current effective control measures
3. Criticality of the out come
Decision to implement action is made when the
failure mode is not detectable
effective control measures does not currently
exits
Out come of failure mode is critical
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