System

Ice Cream Production

Potential
Failure Mode and Effects Analysis
(Design FMEA)

Subsystem
Component
Design Lead
Core Team

FMEA Number
Prepared By
FMEA Date

Rubn Gmez Navarro

Key Date
Manuel Bustillo Guerrero, Rubn Gmez & Luis Ren Lpez

Revision Date

Manuel Bustillo
10/26/2015
10/26/2015

Arrival of wrong Ordered Wrong

Raw Materials Raw Materials

Raw Material
Arrival

Inspection of the
raw ingredients

Late Arrival of
all/some Raw
Materials

Fail to detect
defective
material

Quality of
blending
inspection

Machine Fail

Fail to detect
defective
material

Reject good
material

Potential Cause(s)/
Mechanism(s) of
Failure

6 human mistake

Supplier sent
wrong raw
material
Late order if
materials

6 human mistake

Late send of
materials

6 human mistake

Distraction

8 human mistake

Critical Point
wasn't detected
Reject good
Reject of a good
material
lot because of a
couple bad raw
material
Transportation Throw the load Human Factor
to blender
to the floor
Vehicle factor

Blending
process

S
e
v

6 human mistake

8 human mistake
5 human mistake

6 human mistake
6 Lack of
mantinience

Human Factor

6 human mistake

Machine Factor

6 Lack of
mantinience

Distraction

7 human mistake

Critical Point
wasn't detected
Reject of a good
lot because of a
couple bad raw
material

7 human mistake
6 human mistake

Current Design
Controls

D
e
t

R
P
N

3 Work
instructions and
software aid
3 Robust contract
and work
instruction
3 Software aid

18

18

18

2 Robust contract
and work
instruction
3 Quality
incoming
Inspection Plan
2 Robust Quality
Inspection
4 Statistical AID

12

24

32

20

2 Pokayoke
Vehicule
2 GooD
mantinience
plan
3 Work
instructions and
3 GooD
mantinience
plan
3 Quality
incoming
Inspection Plan
2 Robust Quality
Inspection
4 Statistical AID

12

12

18

18

21

14

24

Recommended
Action(s)

Responsibility &
Target Completion
Date

Actions Taken

New RPN

Potential Effect(s)
of Failure

New Det

Potential Failure
Mode(s)

New Occ

Item / Function

New Sev

Action Results
P
r
o
b

Transportation Throw the load Human Factor

to pasteurization
to the floor
Vehicle factor

Pauzterization
process

Transportation
to Maduration
tanks

Maduration

Ice Cream
Quality Test

Lack of
Innocuous

Human factor

Throw the load Human Factor

to the floor

Over
maduration/
lack of
maduration
Fail to detect
defective
material

6 human mistake

1 Pokayoke
Vehicule

6 Lack of
mantinience

1 GooD
mantinience
plan
1 Good
mantinience
plan and robust
poka yoke and
software aid
3 Pokayoke
Vehicule

10

18

4 GooD
mantinience
plan
3 Work
instructions and
software aid

24

18

3 Quality
incoming
2 Robust Quality
Inspection
4 Statistical AID

18

12

24

6 human mistake

3 Pokayoke
Vehicule

18

6 Lack of
mantinience

4 GooD
mantinience
plan
3 Work
instructions and
software aid
4 GooD
mantinience
plan
3 Pokayoke
Vehicule

24

18

24

18

4 GooD
mantinience
plan
3 Good
mantinience
plan

24

24

10 Machine
fail/human
mistake

6 human mistake

Vehicle factor

6 Lack of
mantinience

Human Factor

6 human mistake

Distraction

6 human mistake

Critical Point
wasn't detected
Reject good
Reject of a good
material
lot because of a
couple bad raw
material
Transportation Throw the load Human Factor
to Flavor Mix
to the floor
batch Freezer
Vehicle factor

6 human mistake

Mixer Process

6 human mistake

Unconform mix Human Factor

Machine Factor

Transportation
to freezer
warehouse

Throw the load Human Factor

to the floor
Vehicle factor

Storage

melted ice cream machine factor

6 human mistake

6 Lack of
mantinience
6 human mistake

6 Lack of
mantinience
8 Lack of
mantinience

Severity

Effect

SEVERITY of Effect

Ranking
10

High

Very high severity ranking when a potential failure mode

affects safe system operation without warning
Very high severity ranking when a potential failure mode
affects safe system operation with warning
System inoperable with destructive failure without
compromising safety
System inoperable with equipment damage

Moderate

System inoperable with minor damage

Low

System inoperable without damage

Very Low

System operable with significant degradation of performance

Minor

System operable with some degradation of performance

Very Minor

System operable with minimal interference

None

No effect

Hazardous without
warning
Hazardous with
warning
Very High

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Probability

PROBABILITY of Failure
Very High: Failure is almost inevitable

High: Repeated failures

Moderate: Occasional failures

Low: Relatively few failures

Remote: Failure is unlikely

Failure Prob Ranking

>1 in 2

10

1 in 3

1 in 8

1 in 20

1 in 80

1 in 400

1 in 2,000

1 in 15,000

1 in 150,000

<1 in 1,500,000

Page 4

Detectability

Detection
Absolute
Uncertainty
Very Remote
Remote
Very Low
Low
Moderate
Moderately High
High
Very High
Almost Certain

Likelihood of DETECTION by Design Control

Ranking
Design control cannot detect potential cause/mechanism and
10
subsequent failure mode
Very remote chance the design control will detect potential
cause/mechanism and subsequent failure mode
Remote chance the design control will detect potential
cause/mechanism and subsequent failure mode
Very low chance the design control will detect potential
cause/mechanism and subsequent failure mode
Low chance the design control will detect potential
cause/mechanism and subsequent failure mode
Moderate chance the design control will detect potential
cause/mechanism and subsequent failure mode
Moderately High chance the design control will detect
potential cause/mechanism and subsequent failure mode
High chance the design control will detect potential
cause/mechanism and subsequent failure mode
Very high chance the design control will detect potential
cause/mechanism and subsequent failure mode
Design control will detect potential cause/mechanism and
subsequent failure mode

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