FMECA FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS

Item or Process: Prepared by: FMECA number:

Model: Approved by: FMECA Date (Orig):
Core Team: FMECA Date (Last Revised): Rev:

Key: Sev = Severity, Occ = Occurrence, Det = Detection, CN = Criticality Number (Sev x Occ), RPN = Risk Priority Number (Sev x Occ x Det) Color-coded Limits: ≤10%=Green, 11%-40%=Yellow, >40%=Pink/Red
Initial FMEA Improvement Activities Post-Improvement Results

S Potential O D R S O D R
Potential Failure Potential Failure Current C Recommended Responsibility Completion C
# Item or Process e Cause(s) of c e P Actions Taken e c e P
Mode Effect(s) Controls N Action(s) for Completion Date N
v Failure c t N v c t N

1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
4 0 0 0 0
5 0 0 0 0
6 0 0 0 0
7 0 0 0 0
8 0 0 0 0
9 0 0 0 0
10 0 0 0 0
11 0 0 0 0
12 0 0 0 0
13
14 0 0 0 0
15 0 0 0 0
16 0 0 0 0
17 0 0 0 0
18 0 0 0 0
19 0 0 0 0
20 0 0 0 0

Page 1 of 13
 FMECA FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS

Item or Process: Prepared by: FMECA number:

Model: Approved by: FMECA Date (Orig):
Core Team: FMECA Date (Last Revised): Rev:

Key: Sev = Severity, Occ = Occurrence, Det = Detection, CN = Criticality Number (Sev x Occ), RPN = Risk Priority Number (Sev x Occ x Det) Color-coded Limits: ≤10%=Green, 11%-40%=Yellow, >40%=Pink/Red
Initial FMEA Improvement Activities Post-Improvement Results

S Potential O D R S O D R
Potential Failure Potential Failure Current C Recommended Responsibility Completion C
# Item or Process e Cause(s) of c e P Actions Taken e c e P
Mode Effect(s) Controls N Action(s) for Completion Date N
v Failure c t N v c t N

1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
4 0 0 0 0
5 0 0 0 0
6 0 0 0 0
7 0 0 0 0
8 0 0 0 0
9 0 0 0 0
10 0 0 0 0
11 0 0 0 0
12 0 0 0 0
13
14 0 0 0 0
15 0 0 0 0
16 0 0 0 0
17 0 0 0 0
18 0 0 0 0
19 0 0 0 0
20 0 0 0 0

Page 2 of 13
 FMECA FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS

Item or Process: Prepared by: FMECA number:

Model: Approved by: FMECA Date (Orig):
Core Team: FMECA Date (Last Revised): Rev:

Key: Sev = Severity, Occ = Occurrence, Det = Detection, CN = Criticality Number (Sev x Occ), RPN = Risk Priority Number (Sev x Occ x Det) Color-coded Limits: ≤10%=Green, 11%-40%=Yellow, >40%=Pink/Red
Initial FMEA Improvement Activities Post-Improvement Results

S Potential O D R S O D R
Potential Failure Potential Failure Current C Recommended Responsibility Completion C
# Item or Process e Cause(s) of c e P Actions Taken e c e P
Mode Effect(s) Controls N Action(s) for Completion Date N
v Failure c t N v c t N

1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
4 0 0 0 0
5 0 0 0 0
6 0 0 0 0
7 0 0 0 0
8 0 0 0 0
9 0 0 0 0
10 0 0 0 0
11 0 0 0 0
12 0 0 0 0
13
14 0 0 0 0
15 0 0 0 0
16 0 0 0 0
17 0 0 0 0
18 0 0 0 0
19 0 0 0 0
20 0 0 0 0

Page 3 of 13
 Severity, Occurrence & Detection Criterion with Ratings

Ranking Criteria Severity (Impact) of Effect

Failure Mode could cause catastrophic injury to personnel
Catastrophic
or significant property damage.
Failure Mode could cause minor injury to personnel or minor
Hazardous
property damage.
Failure Mode could result in complete product or service
failure, leading to loss of use (e.g., inoperable / halt in
production), and/or consequential damages (e.g., loss of
Critical productivity, material waste, nonconforming product /
material disopsitioned for scrap/inventory spoilage).
Customer is extremely dissatisfied.

Failure Mode could result in intermittent product or service

failure, leading to inconsistent, temporary loss of use with
Extremely High minimal, if any, consequential damages (e.g., temporary
Significance loss of productivity, material waste, nonconforming product /
material must be disopsitioned for repair). Customer is very
dissatisfied.
Failure Mode could result in the degraded / reduced
High performance of a primary function (e.g., resulting in
Significance nonconforming product that must be reworked). Customer is
dissatisfied.
Failure Mode could result in partial product or service
failure, leading to partial loss of use (e.g., reduced level of
Moderately High performance/productivity, decreased processing speed,
Significance potentially leading to unacceptable delivery delays).

Failure Mode could result in the degraded / reduced

performance of a secondary function (e.g., user/operator
Moderate inconvenience, slightly reduced level of
Significance performance/productivity, slightly decreased processing
speed).
Failure Mode would have minimal impact. It is a minor
inconvenience for the user / operator (e.g., a consistent,
Minimal noticeable squeak/rattle). Is easily detected and quickly
Significance corrected (adjusted) by a qualified technician (e.g., through
adding lubrication, tightening a bolt/screw).
 Failure Mode would have only a marginal impact. It is a very
minor inconvenience for the user / operator (e.g., an
inconsistent/intermittent squeak/rattle). Is easily detected
Marginal and quickly corrected (adjusted) by a qualified technician
(e.g., through adding lubrication, tightening a bolt/screw).

Failure Mode would have almost no impact what-so-ever. It

Insignificant is easily detected and quickly corrected by the user /
operator (e.g., changing a battery, adjusting/tuning).

Ranking Criteria Likelihood of Occurrence

Occurrence is almost certain (≥6.67%) because there are

Almost Certain no controls currently in place to adequately mitigate the
Failure Mode or its subsequent Failure Effect.
Occurrence is highly likely / probable because there is a
Extremely High very remote probability the current control(s) will mitigate
the Failure Mode or its subsequent Failure Effect.

Occurrence is very likely / probable because there is only a

Very High remote probability the current control(s) will mitigate the
Failure Mode or its subsequent Failure Effect.

Occurrence is highly likely / probable because there is a

High very low chance the current control(s) will mitigate the
Failure Mode or its subsequent Failure Effect.
There is a Low probability the current control(s) will mitigate
Moderate the Failure Mode or its subsequent Failure Effect. (Note: A
Cpk of 1.33 is considered "barely" capable).
There is a Moderate probability the current control(s) will
Low mitigate the Failure Mode or its subsequent Failure Effect.

There is a Moderately High probability the current control(s)

Very Low will mitigate the Failure Mode or its subsequent Failure
Effect.

There is a High probability the current control(s) will mitigate

Remote the Failure Mode or its subsequent Failure Effect.

There is a Very High probability the current control(s) will

Very Remote mitigate the Failure Mode or its subsequent Failure Effect.
 There is an almost certain probability the current control(s)
Almost None will mitigate the Failure Mode or its subsequent Failure
Effect.

Ranking Criteria Likelihood of Detection

There are no controls currently in place to detect the Failure
None
Mode or its subsequent Failure Effect.
There is a very remote probability the current control(s) will
Very Remote detect the Failure Mode or its subsequent Failure Effect
(<10% probability for detection).
There is a remote probability the current control(s) will
Remote detect the Failure Mode or its subsequent Failure Effect (10
- 20% probability for detection)
There is a very low chance the current control(s) will detect
Very Low the Failure Mode or its subsequent Failure Effect (20 - 30%
probability for detection)
There is a Low probability the current control(s) will detect
Low the Failure Mode or its subsequent Failure Effect (30 - 40%
probability for detection)
There is a Moderate probability the current control(s) will
Moderate detect the Failure Mode or its subsequent Failure Effect (40
- 60% probability for detection)
There is a Moderately High probability the current control(s)
Moderately High will detect the Failure Mode or its subsequent Failure Effect
(60 - 80% probability for detection)
There is a High probability the current control(s) will detect
High the Failure Mode or its subsequent Failure Effect (80 - 90%
probability for detection)
There is a Very High probability the current control(s) will
Very High detect the Failure Mode or its subsequent Failure Effect (90
- 99% probability for detection)
There is an almost certain probability the current control(s)
will detect the Failure Mode or its subsequent Failure Effect
Almost Certain (>99% probability for detection) before reaching the next
step in the process.
Ratings

Rating
10

3
 2

For use when Failure Rates are known

Sigma - Short
Percent
Rating Failure Rates Yield Cpk Term (Sigma
Defective
Shift 1.5)

10 1 in 15 6.67% 93.33% 1 3σ

9 1 in 25 4.00% 96.00% 1.08 3.25 σ

8 1 in 50 2.00% 98.00% 1.18 3.55 σ

7 1 in 100 1.00% 99.00% 1.27 3.82 σ

6 3 in 500 0.60% 99.40% 1.33 4σ

5 1 in 500 0.20% 99.80% 1.46 4.38 σ

4 1 in 1,000 0.10% 99.90% 1.54 4.58 σ

3 3 in 10,000 0.03% 99.97% 1.64 4.93 σ

2 1 in 10,000 0.01% 99.99% 1.74 5.22 σ

 1 4 in 100,000 0.004% 99.996% 1.81 5.44 σ

Rating
10

1
 FMECA FAILURE MODE EFFECTS AND CRITICALITY ANALYSIS

Item or Process: Attach armrest to chair Prepared by: J. Doe FMECA number: 123456
Model: A-12 Approved by: FMECA Date (Orig): 1/15/2021
Core Team: J. Doe (Engineering), J. Smith (Production), B. Jones (Quality) FMECA Date (Last Revised): 2/15/2021 Rev: 2

Key: Sev = Severity, Occ = Occurrence, Det = Detection, CN = Criticality Number (Sev x Occ), RPN = Risk Priority Number (Sev x Occ x Det)Color-coded Limits: ≤10%=Green, 11%-40%=Yellow, >40%=Pink/Red
Initial FMEA Improvement Activities Post-Improvement Results

S Potential O D R S O D R
Potential Failure Potential Failure Current C Recommended Responsibility Completion C
# Item or Process e Cause(s) of c e P Actions Taken e c e P
Mode Effect(s) Controls N Action(s) for Completion Date N
v Failure c t N v c t N

End user: Loose

Develop & provide 4- Provided 4-bit drill
seat cushion and
Verify correct Insufficient number bit drill assembly to assembly to drill
noise. Operator error / Operator training
1 number of holes of holes drilled into 6 2 1 12 12 drill holes J. Doe & J. Smith 2/9/2021 holes simultaniously 6 1 1 6 6
Assembly: Stop oversight and instructions
drilled into chair. chair simultaniously to to Production
work, sort and
Production process. process.
rework.

Verify the correct

Assembly: Unable to
number and type of Insufficient number Correct type or
attach armrests to
armrests are or incorrect type of number of armrests Operator training 6 6 0 0
2 seat (nonconforming 6 1 1 None N/A N/A None
available for armrests available not provided by and instructions
product). Stop work,
attachment to the for chair. stock room.
sort and rework.
chair.

Assembly: Unable to
properly align
armrest in order to Improper drilling of
Orient holes in seat Holes not properly
attach it to seat holes in either chair Operator training 7 7 0 0
3 to align with those in oriented to align with 7 1 1 None N/A N/A None
(nonconforming or armrest by and instructions
armrest armrest holes
product). Stop work, Production.
sort and rework or
repair.

Implement Kanban
Kanban tray system
tray system at
now at assembly
Correct number of assembly station(s)
Verify proper number Correct number of Unable to affix Operator training station(s) to ensure
4
of screws provided. screws not provided armrest to seat.
5 screws not provided 3
and instructions
4 15 60 to ensure that the B. Jones 2/9/2021
that the number of
5 1 1 5 5
by stock room. number of screws
screws provided is
provided is always
always available.
available.

End User: If screws Re-Locate size and Re-Located size and

are too small, loose type of screws type of screws
armrest; possibly needed for armrest needed for armrest
Verify proper size & Correct size/type of
Wrong size/type of leading to armrest Operator training 18 36 into a different into a different 6 6
5 type of screws 6 screws not provided 3 2 B. Jones 2/9/2021 6 1 1
screws provided failure. and instructions location in stock location in stock
provided. by stock room.
Assembly: Stop room; away from room; away from
work, sort and other similar other similar
rework. size/types of screws. size/types of screws.

Either re-drill (if too

Tighten screws
small) or place
through armrest Holes of incorrect Armrest will not affix Operator training
6
holes into pre-drilled diameter armrest to seat.
7 inserts (if too large) 2
and instructions
2 14 28 None N/A N/A None 0 0
into holes to correct
chair holes.
for the diameter.

End User: Srews

either too tight or too
Standardize 5S with Standardized 5S
loose. See below.
No torque screw Lack of control over
7 " Stop work until 5 3 Operator training 1 15 15 shadow board for all J. Smith 2/12/2021
with shadow boards
5 1 1 5 5
driver provided tools. specified assembly for all chair assembly
specified torque
tools. tools.
screw driver can be
provided.

End User: Srews Multiple types of

either too tight or too torque screw drivers
Standardized 5S
Incorrect torque loose. See below. located in assembly
Operator training 20 60 with shadow boards 5 5
8 " screw driver Stop work until 5 area; with none 4 3 See above. J. Smith 2/12/2021 5 1 1
and instructions for all chair assembly
provided specified torque dedicated to any
tools.
screw driver can be specific assembly
located. process.

End User: Loose

armrest due to loose Revised Work
screw, squeeking Identify specific
Instruction to include
Screw torque either noise, and/or No clear torque torque value (with
9 "
too low or too high. missing screw
6
value specified.
7 Operator training 10 42 420 tolerances) in Work
J. Smith 2/15/2021 a specific torque 6 1 1 6 6
value (with
(havingfallen out). Instructions.
tolerances).
Assembly: Stop
work, sort and
rework.
Multiple types of Assign dedicated Assigned dedicated
torque screw drivers torque screw drivers torque screw drivers
Assembly: Stop located in assembly to assembly area. to assembly area.
Screw torque too Operator training 24 96 6 6
10 " work, sort and 6 area; with none 4 4 And add color coded J. Smith 2/15/2021 And added color 6 1 1
low. and instructions
rework. dedicated to any labels to identify pre- coded labeling to
specific assembly set torque screw identify pre-set
process. drivers. torque screw drivers.

End User: Loose Multiple types of

armrest due to torque screw drivers
subsequent fracture located in assembly
Screw torque too Operator training 28 112 7 7
11 " of screw and noise. 7 area; with none 4 4 See above. J. Smith 2/15/2021 See above. 7 1 1
high. and instructions
Assembly: Stop dedicated to any
work, sort and specific assembly
rework. process.
12 0 0 0 0
13
14 0 0 0 0
15 0 0 0 0
16 0 0 0 0
17 0 0 0 0
18 0 0 0 0
19 0 0 0 0
20 0 0 0 0

Page 10 of 13
FMECA vs FMEA
An "FMECA" is a "Failure Mode, Effects and Criticality Analysis", and is similar to a FMEA (Failure Mode a
difference is that the FMECA includes columns to rank the "criticality" if each "failure mode" identified (pre

Criticality Number = "Severity" x "Occurrence"

RPN (Risk Priority Number) = "Severity" x "Occurrence" x "Detection"

The reason for calculating and displaying the CN (Criticality Number) ranking separately from the RPN (Ris
acceptable RPN could co-exist with an unacceptable CN level. The analysis should consider each separat
overall acceptability of the risks revealed in the FMECA.

How to Use
Phase 1 - Initial FMEA
Step 1: Identify the process activity (step in process). It is important to focus on the "value-added" steps in
"Current Controls". Risk "Controls" are evaluated separately... based upon their effectiveness in mitigating
Step 2: Identify the "Failure Mode" (i.e., What can go wrong).
Step 3: Describe the consequences / effects of the "Failure Mode".
Step 4: Rate the "Severity" of the consequences/ effects of the "Failure Mode" (In the "SEV" column).
Step 5: Identify / Describe the "Potential Cause(s) of Failure" (Answer the question: "What could cause the
Step 6: Rate the likelihood (probability) of this problem happening (In the "OCC" column).
Step 7: Describe the "Current Controls" in place to prevent the problem from happening.
Step 8: Rate the likelihood (probability) of this problem being "Detected" (In the "DET" column) through the
Step 9: Assess the "Criticality Number" (CN) of each potential failure (risk).
Step: 10 Assess the "Risk Priority Number" (RPN) of each potential failure (risk).

Phase 2 - Improvement Activities

Step 1: Identify additional controls ("Recommended Actions") to eliminate or mitigate the current risks.
Step 2: Identify the individual(s) assigned responsibility for implementing the additional controls ("Respons
Step 3: Identify the target date for complete implementation of the additional controls ("Completion Date").

Phase 3 - Post-Improvement Results

Step 1: Identify the actual controls added ("Actions Taken") to eliminate or mitigate the "potential failures" (
Step 2: Based on the actual controls, re-rank the "Severity" (SEV), "Occurrence" (OCC), and "Detection" (D
Step 3: Identify the target date for complete implementation of the additional controls ("Completion Date").
Step 4: Assess the updated "Criticality Number" (CN) of each potential failure (risk); for acceptability of the
Step: 5 Assess the updated "Risk Priority Number" (RPN) of each potential failure (risk); for acceptability o

The contents of this spreadsheet, by SQSA (http://www.sqsa.org), is licensed under a Creative Commons
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Use the above “Potential Sources of Risks” fishbone chart to “kick start” some risk assessment ideas! Y
risks through "controls" contained in documented methods (procedures), training materials, etc.

An important problem-solving​skill is to understand the difference between "correlation" and "c

exists between two or more events does not necessarily mean that a correlating event is the c
some risk assessment ideas! You’ve probably already mitigated many of these
), training materials, etc.

between "correlation" and "causation". Simply because a correlation

t a correlating event is the cause of a separate event.