Teaching an Old FMEA New Tricks

Eugene R. Bukowski
Senior Engineering Manager
GE Healthcare Systems
Learning Objectives
• Potential failure modes of the FMEA tool
• Realize that some RPN values are more
sensitive to error than others
• How to perform sensitivity analysis of RPN
values for better decision making
• How to update standard FMEA templates in
order to quantify marginal risk
Outcomes Based Innovation for FMEAs
• Immediate utility in the form of better
decisions for risk mitigation
• Clearly identify risk assessments that may
be sensitive to errors & marginal changes
• Identify the critical few risk sensitive RPNs
• Simplification of FMEA refresh frequency
• Simple formulas and two easy column
additions to the FMEA spreadsheet
Use the FMEA when…
• Designing or redesigning
• New applications for existing
• Before developing process controls
• Planning improvement goals
• Failure analysis
• Periodic reviews
Exercise Part 1

Work independently to
complete the following row
from an FMEA:

Potential
Potential Potential S O Current D R
Cause(s)/
Process Function Failure Effect(s) e c Process e P
Mechanism(s)
Mode of Failure v c Controls t N
of Failure

Driving to a Car from

Head-on
destination on a opposite Driver
collision
2-lane undivided lane crosses distraction
at 55mph
highway yellow line
Exercise Part 2
Class statistics for RPN values:

100

Current thinking does NOT recommend the use of

an RPN threshold to initiate the need for action.
Potential FMEA Tool Failure Modes
• Potential Effect of Failure
- Lack of customer focus
• Potential Cause/ Mechanism of Failure
- Causes that cannot be corrected or controlled
- Ambiguous phrases
Potential FMEA Tool Failure Modes
• Severity
- Subjective correlation to Occ and Det rankings
• Occurrence
- Frequency of the effect rather than the cause
• Detection
- Ambiguous definition of the customer
- Subjective correlation to Occ ranking
- Random quality checks to improve rankings
- Assigning good rankings for visual inspection
 Potential Failure Modes of the FMEA
• Inaccurate Risk Priority Number
- Variation of input rankings
- Assumption that all actions reduce rankings
- Arbitrary action threshold of significance

It is important to recognize that some RPN

values are more sensitive to errors than others.
Action Threshold Greater Than 100

Potential
Potential Potential S O Current D R
Cause(s)/
Process Function Failure Effect(s) e c Process e P
Mechanism(s)
Mode of Failure v c Controls t N
of Failure

Driving to a Car from

Head-on Visual NO
destination on a other lane Driver
collision 10 8 identificat 1 80
2-lane undivided crosses
at 55mph
distraction
ion ACTION
highway yellow line

BUT WHAT IF YOU

WERE WRONG?

Driving to a Car from

Head-on Visual
destination on a other lane Driver
collision 10 8 identifica 2 160
2-lane undivided crosses distraction
at 55mph tion
highway yellow line
 Suggested Evaluation Criteria (AIAG)
Process Controls Detect the Defect Before Next
Detection Ranking
Process or Before Component Leaves Mfg Location
Almost No known controls available to detect failure mode
10
Impossible
Very Very remote likelihood controls will detect failure mode
9
Remote
Remote Remote likelihood controls will detect failure mode 8
Very Low Very low likelihood controls will detect failure mode 7
Low Low likelihood controls will detect failure mode 6
Moderate Moderate likelihood controls will detect failure mode 5
Moderately Moderately high likelihood controls will detect failure
4
High mode
High High likelihood controls will detect failure mode 3
Very High Very high likelihood controls will detect failure mode 2
Almost Current controls almost certain to detect failure mode
1
Certain
Risk Sensitive Priority Number (RSPN)
Original Marginal Change
SEV 10 10
OCC 8 8
DET 2 Error +1 3
RPN 160 RSPN 240
Min Max

1 500 RPNs out here 1,000

100
don’t last very
long
RSPN Matrix for Severity = 10
10 200/100 300/200 400/300 500/400 600/500 RSPN/RPN
9 180/90 270/180 360/270 450/360 540/450
8 160/80 240/160 320/240 400/320 480/400
7 140/70 210/140 280/210 350/280 420/350
6 120/60 180/120 240/180 300/240 360/300
5 100/50 150/100 200/150 250/200 300/250
4 80/40 120/80 160/120 200/160
3 60/30 90/60 120/90
2 40/20 60/40
1 20/10
1 2 3 4 5

RSPN/RPN RSPN exceeds 100/ RPN is less than 100

RSPN Matrix for Severity = 8
10 160/80 240/160 320/240 400/320 480/400 RSPN/RPN
9 144/72 216/144 288/216 360/288 432/360
8 128/64 192/128 256/192 320/256 384/320
7 112/56 168/112 224/168 280/224 336/280
6 96/48 144/96 192/144 240/192 288/240
5 80/40 120/80 160/120 200/160 240/200
4 64/32 96/64 128/96 160/128
3 48/24 72/48 96/72
2 32/16 48/32
1 16/8
1 2 3 4 5

RSPN/RPN RSPN exceeds 100/ RPN is less than 100

 RPN Action Threshold = 100
SEV OCC DET RPN RSPN
10 7 2 140 210
9 2 6 108 162
8 6 2 96 144
10 3 3 90 120
9 5 2 90 135
7 2 5 70 105
7 3 3 63 84
8 7 1 56 112
9 1 6 54 108
7 2 3 42 63

A more conservative strategy for risk mitigation is to

also consider initiating action for high RSPN values.
RSPN Spreadsheet Calculation
The RSPN value is the re-calculated RPN value
after a 1-unit (marginal) change in input ranking:

RSPN Marginal Change

=max(S,O,D)
*median(S,O,D)
*(min(S,O,D)+1)
RPN = (S)  (O)  (D)
S = Severity, O = Occurrence, D = Detection
Marginal RPN Spreadsheet Calculation
The MRPN value is the change in RPN value after
a 1-unit (marginal) change in input ranking:

MRPN= (RSPN – RPN)

Marginal Change

RPN = Risk Priority Number

RSPN = Risk Sensitive Priority Number
MRPN = Marginal RPN
1 ≤ MRPN ≤ 100
Minimal Modification to Existing FMEAs
Simple formulas & minimal modifications to existing,
completed FMEAs can provide immediate utility:

R M
Potential Potential Potential
Item and S O Current D R S R
Failure Effect(s) Cause(s)
function Controls E P P
Mode of Failure E of Failure C P
V C T N N N
Rough
handling
Power
Short Fire 10 during 1 None 9 90 180 90
cord*
shipping
process
*Adapted from Jan-2016 QP article on the FMEA
Summary
• The FMEA is a useful risk management tool

• Watch out for FMEA failure modes that may

result in ranking errors

• RPN values sometimes can be inaccurate

• Some RPN values are more sensitive to

marginal changes/errors than others

• RSPN & MRPN indices have been introduced

for the FMEA tool to assess marginal risk
Learning Objectives
Potential failure modes of the FMEA tool
Realize that some RPN values are more
sensitive to error than others
How to perform sensitivity analysis of RPN
values for better decision making
How to update standard FMEA templates in
order to quantify marginal risk