Failure
Mode
Effective
Analysis (FMEA)
Dr. TSRTR. Rajab
MBBS MBA MSc EMBA
June 2024
Dr. TSRTR. Rajab trrtsr067@gmail.com
trrtsr067@gmail.com
FMEA
• Failure modes means the ways, or modes, in which something might
fail. Failures are any errors or defects, especially ones that affect the
patient, and can be potential or actual.
• Effects analysis refers to studying the consequences of those failures.
• Failures are prioritized according to how serious their consequences
are, how frequently they occur, and how easily they can be detected.
• The purpose of the FMEA is to take actions to eliminate or reduce
failures, starting with the highest-priority ones.
• Annually select at least one high risk process and do FMEA: a
requirement from JCI (2001)
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FMEA procedure
1. Select a process with high potential for having an adverse impact
on the safety of individuals served.
2. Assemble a cross functional team with diverse knowledge of
process and FMEA analysis
3. Map the scope of process through flow chart and make sure every
team members understand each step in detail
4. Map the identifying information on the FMEA matrix
5. Re-assess to ensure the new process remains in place and
effective at regular intervals
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1. Selecting a high risk clinical process
1. Medication
administration
2. LSCS To identify the potential hazards
3. Blood Transfusions involved in the laboratory process in
4. Resuscitative care the pre analytical phase & quantify
5. Endo tracheal their effects by FMEA through RPN
intubation score pre- and post-intervention
6. A&E Process
7. Transporting
critically ill patient
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2. Assemble a cross functional team
The team comprised of The team attended a period training
• Quality coordinator session on FMEA, and on making Flow
• lab manager, chart
• Haematologist,
And analysed the process through
• Ward consultant, brainstorming, interviews and taking
• Medical superintendent, notes during direct observations.
• Nursing supervisor,
• Infection control officer.
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FMEA Matrix
3. Flowchart the functions of your scope.
• Ask, "What is the purpose of this 1. Test ordering
system, design, process, or
service? What do our customers
expect it to do?" Name it with a 2. Sample collection
verb followed by a noun.
3. Sample transport
• Usually one will break the scope
into separate subsystems,
items, parts, assemblies, or 4. Sample received
process steps and identify the
function of each. 5. Sample processing
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No
Function
Potential Failure mode
Potential effects of failure
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matrix
4. FMEA
Severity of effects (S)
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Potential causes of failure
Frequency of Occurance (O)
Current process control
Availability of failure
Detecion system (D)
RPN (Pre-interventions)
RPN Rank
Reccommended actions
Responsible person
Target date
Action taken
New Severity (S)
New Occurance (O)
New Detectability (D)
RPN (post- Interventions)
Risk Priority Number (RPN) = S X O X D
RPN Rank
FMEA Matrix
Brainstorm potential failure modes: Rsik Analysis
• For each function, identify Function Potential failure
all the ways failure could mode
happen.
1 Test 1.1 Illegible hand
• These are potential failure ordering writing
modes. 1.2 Inappropriate
• If necessary, go back and test selected
rewrite the function with 2 Sample 2.1 Inappropriate
more detail to be sure the Collection Sample quantity
failure modes show a loss 2.2 Improper
of that function. Tube labelling
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trrtsr067@gmail.com
FMEA Matrix
Brainstorm potential effects of the failure
• For each failure mode, identify Potential Failure Potential Effects S
all the consequences on the modes of the failure
system, process, related
processes, product, service, or 1.1 Illegible hand Delay in
regulations. writing getting result
• These are potential effects of 1.2 Inappropriate Delay in
failure. test selected daignosis
2.1 Inappropriate Return of
• Ask, "What does the customer
experience because of this Sample quantity Sample
failure? What happens when 2.2 Improper Wrong test
this failure occurs?" Tube labelling result
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FMEA Matrix
Rating Severity (S)
Potential Failure Potential Effects S
• Severity is usually rated on
modes of the failure
a scale from 1 to 10
1.1 Illegible hand Delay in 3
• 1 is insignificant and 10 is writing getting result
catastrophic
1.2 Inappropriate Delay in 5
• If a failure mode has more test selected daignosis
than one effect, write on 2.1 Inappropriate Rejection of 4
the FMEA matrix only the Sample quantity Sample
highest severity rating for
2.2 Improper Wrong test 10
that failure mode.
Tube labelling result
Dr. TSRTR. Rajab trrtsr067@gmail.com
trrtsr067@gmail.com
FMEA Matrix
Determine all the potential root causes.
• For each failure mode, Potential Failure Cause O
determine all the potential modes
root causes. 1.1 Illegible hand Work load
• Use root cause analysis tool writing
such as fishbone, why why, 1.2 Inappropriate Poor knowledge
or pareto, as well as the best test selected
knowledge and experience of
the team. 2.1 Inappropriate Poor cannulation
Sample quantity technique
• List all possible causes for
each failure mode on the 2.2 Improper Carelessness
FMEA matrix. Tube labelling
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FMEA Matrix
Rating Occurance (O)
• For each cause, determine the Failure modes Cause O
occurrence rating
• This rating estimates the 1.1 Illegible hand Work load 8
probability of failure occurring writing
for that reason during the 1.2 Inappropriate Poor knowledge 5
lifetime of your scope. test selected
• Occurrence is usually rated on 2.1 Inappropriate Poor phlebotomy 6
a scale from 1 to 10 Sample quantity technique
• Where 1 is extremely unlikely 2.2 Improper Carelessness 5
and 10 is inevitable. Tube labelling
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FMEA Matrix
Identify current process controls.
• For each cause, identify current Cause Current process D
process controls. control
• These are tests, procedures or 1.1 Work load Nil
mechanisms
• These controls might prevent 1.2 Poor knowledge Clinical meetings
the cause from happening,
reduce the likelihood that detect 2.1 Poor phlebotomy Rejection from Lab
failure after the cause has technique
already happened but before the 2.2 Carelessness Double check
customer is affected.
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FMEA Matrix
Rating Detection (D)
• For each control, determine the Cause Current D
detection rating, or D.
process control
• This rating estimates how well
the controls can detect either the 1.1 Work load Nil 10
cause or its failure mode
• Detection is usually rated on a 1.2 Poor knowledge Clinical 4
scale from 1 to 10 meetings
• 1 means the control is absolutely
certain to detect the problem and 2.1 Poor phlebotomy Rejection from 3
10 means the control is certain technique Lab
not to detect the problem (or no
control exists). 2.2 Carelessness Double check 5
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FMEA Matrix
Risk Priority Number (RPN= S X O X D) & Ranking
Potential Potential Effects S Cause O Current D RPN RPN
Failure modes of the failure process control rank
Illegible hand Delay in 3 Work load 8 Nil 9 216 2
writing getting result
Inappropriate Delay in 5 Poor knowledge 5 Clinical 4 100 3
test selected daignosis meetings
Inappropriate Rejection of 4 Poor phlebotomy 6 Rejection from 3 72 4
Sample quant. Sample technique Lab
Improper Wrong test 9 Carelessness 5 Double check 5 225 1
Tube labelling result
We are looking for failures that are most severe, occur often, and are hard to detect
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FMEA Matrix
Identify recommended actions
• Identify recommended RPN RPN Reccommonded Respon Target Action
actions. rank actions sibilty date taken
• These actions may be 216 2 Stop handwriting MS 03.12. 75%
design or process Introducing HHIMS 2024
changes to lower severity 100 3 Performance Consul 15.09. 50%
or prevent occurrence or monitoring tant 2024
improve detectability 72 4 Staff training & NOIC 10.06. 100%
availability of user 2024
• Also note who is
guide
responsible for the
actions and target 225 1 Introduce check, NOIC 18.06. 100%
completion dates. double ck, again 2024
ck
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5. Re-asses: Calculate new RPN- Post Interventions
S O D RPN RPN Reccommonded Respon Target Action S O D New New
rank actions sibilty date taken RPN rank
3 8 9 216 2
Stop handwriting MS 03.12. 100% 1 2 3 6 3
Introducing HHIMS 2024
5 5 4 100 3 Performance Consu 15.09. 50% 3 3 3 27 1
monitoring ltant 2024
4 6 3 72 4 Staff training & NOIC 10.06. 100% 1 2 2 4 4
availability of user 2024
guide
9 5 5 225 1 Introduce check, NOIC 18.06. 100% 2 3 2 12 2
double ck, again ck 2024
•At regular intervals, re-assess to ensure the new process remains in place and effective
Dr. TSRTR. Rajab trrtsr067@gmail.com
trrtsr067@gmail.com
When to use FMEA
1. When a process, product, or service is
• FMEA is a team-based being designed or redesigned
systematic and proactive 2. When an existing process, product, or
approach for identifying service is being applied in a new way
the ways that a process 3. Before developing control plans for a new
can fail, why it might fail, or modified process
the effects of that failure, 4. When improvement goals are planned for
and how it can be made an existing process, product, or service
safer. 5. When analysing failures of an existing
process, product, or service
6. Periodically throughout the life of the
process, product, or service
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FMEA Excell sheet
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Group exercises on FMEA
A. To analyse using FMEA tool for evaluating risks and identifying
preventive measures to reduce the risks in blood transfusion
B. To provide patients with safe preoperative preparatory procedures
by removing any risk factors from the preparatory procedures by
using failure mode and effects analysis
C. Using FMEA to evaluate the potential risk causes in the process of
infectious medical waste disposal, and propose feasible plans for
facilitating the detection of exceptional cases of infectious waste
D. To analyze, using the FMEA tool, mobilization of intubated critical
ill patients to tertiary care hospital
Dr. TSRTR. Rajab trrtsr067@gmail.com
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