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Failure Mode Effect Analysis
Introduction and Example
Dr. Kylash Makenji
• Introduction and Overview
• What is Failure Mode Effect Analysis (FMEA)?
• Who uses FMEA?
• Pre-requisites
• Working through a FMEA, Example
• RPN’s, What to do next
• Team exercise
Contents
Introduction and Overview
What is FMEA?
Who uses FMEA?
• Automotive
– Jaguar Land rover, Ford, BMW, Honda, VW group
– All of the others……
• Aerospace
– Boeing, Airbus, NASA
• Military
– Armed forces, Air and Sea
• Prior to FMEA you need
– A design, process or function
– Bill of materials (BOM)
– A specification, target or objective
– Cross functional team, designer, engineer, manufacturing team………
• Additionally
– Standard operating procedure
– Ability to influence or change
– Team skills and competencies, who does what
Pre-requisites
Working through a FMEA
Document and steps overview
Use FMEA anywhere
Buying some milk
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Log, dates, team members, design numbers and versions
List a design, function or process items
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Record any and all potential
failure modes
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
List the potential effects of the
failure
• How severe is the failure mode to customers?
– 10 = very severe, may kill
– 1 = no effect
Effect SEVERITY of Effect Ranking
Hazardous without warning Very high severity ranking when a potential failure mode affects safe system operation without warning 10
Hazardous with warning Very high severity ranking when a potential failure mode affects safe system operation with warning 9
Very High System inoperable with destructive failure without compromising safety 8
High System inoperable with equipment damage 7
Moderate System inoperable with minor damage 6
Low System inoperable without damage 5
Very Low System operable with significant degradation of performance 4
Minor System operable with some degradation of performance 3
Very Minor System operable with minimal interference 2
None No effect 1
Severity
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
List the causes of failure
• How likely will the fault occur ?
– Use data, explicit and tacit knowledge
– If available, look at warranty and customer data
OCCURRENCE of Failure Failure Prob Ranking
Very High: Failure is almost inevitable >1 in 2 10
1 in 3 9
High: Repeated failures 1 in 8 8
1 in 20 7
Moderate: Occasional failures 1 in 80 6
1 in 400 5
1 in 2,000 4
Low: Relatively few failures 1 in 15,000 3
1 in 150,000 2
Remote: Failure is unlikely <1 in 1,500,000 1
Occurrence
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
If available use warrantee and
customer data
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
What is in place to prevent the
failure occurring
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
What is in place to detect the
failure occurring
• How likely are you to detect the failure through
controls, before your customer does?
Detection Likelihood of DETECTION by Design Control Ranking
Absolute Uncertainty Design control cannot detect potential cause/mechanism and subsequent failure mode 10
Very Remote Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode 9
Remote Remote chance the design control will detect potential cause/mechanism and subsequent failure mode 8
Very Low Very low chance the design control will detect potential cause/mechanism and subsequent failure mode 7
Low Low chance the design control will detect potential cause/mechanism and subsequent failure mode 6
Moderate Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode 5
Moderately High Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode 4
High High chance the design control will detect potential cause/mechanism and subsequent failure mode 3
Very High Very high chance the design control will detect potential cause/mechanism and subsequent failure mode 2
Almost Certain Design control will detect potential cause/mechanism and subsequent failure mode 1
Detection
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Risk Priority Number, (RPN)
Severity x occurrence x detection = RPN
• Sort the FMEA in descending order
– Create actions to reduce RPN value
– Strive to continually improve
– If you have further data, rework back into FMEA
– Some actions may not reduce the RPN significantly
• Beyond economical feasibility
• Simulate and test to measure the impact to the RPN score
RPN’s, What to do Next?
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
KM – 01/09/15 £120K of
investment
required, unable
to justify given
payback period
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Work with the
highest RPN, and
downwards, striving
to continually
improve
Actions, targets etc
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
KM – 01/09/15 £120K of
investment
required, unable
to justify given
payback period
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Recalculate
new RPN
with action
completed or
to predict
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
KM – 01/09/15 £120K of
investment
required, unable
to justify given
payback period
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36
Some actions
may not be
feasible to put
into place,
technical or
economic
considerations
Action Results
Item / Function
Potential Failure
Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
r
Current Design
Controls - Prevention
Current Design
Controls - Detection
D
e
t
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
NewSev
NewOcc
NewDet
NewRPN
Buy milk for
lactose intolerant
child
None available in
store
No breakfast for
the little one
3 Shop runs out of
milk
4 Stock management,
EPOS, monitoring level
of sales,
Review of stock levels,
visual check of shelves
and warehouse
3 36
3 Shop does not
store that variety
10 Store policy Review of stock levels,
visual check of shelves
and warehouse
1 30
I buy the incorrect
one
Child has
breakfast and has
a bad reaction
7 Not in the same
location in the
store
3 Standard stock and
store layout
Clear labelling of the
storage area, team
training
4 84Not all team
members can
read English,
investigate how
to improve
Mgr., xx/xx/xx English test and
training
Incorrect milk in
container,
labelling error
Child has
breakfast and has
a bad reaction
7 Dairy has filled
the incorrect
container
1 Dedicated lactose free
production line
Batch testing of the
milk
2 14
7 Dairy has used
the wrong labels
2 Dedicated lactose free
production line, and
packaging
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 28
Spill milk before I
get home
No breakfast for
the little one
3 Screw on cap not
secure
2 Screw cap fitting is
automated, torque
setting on equipment
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
6 36Investigate
calibrated screw
on and off device
Milk on floor,
danger of
slippage
6 Container too thin
to hold milk, split
in side wall
3 Automated and
established process, in
line wall section
checks
Batch testing of the
milk and packaging,
consignment
acceptance check,
training of staff
2 36Next time if you are doing a similar product or
process use an existing FMEA, develop and
improve
Team Activity
Team 1 – Installing the sliding switch
Team 2 – Connecting the sliding switch
Team 3 – User behaviour, using the sliding switch
Volume Slide
• Specification and details:-
– Moving slide left to right will increase volume
– Calibrated slide
• 50% movement = 50% sound increase
– Steel body construction
– Plastic slide knob
– Held in place by 2 screws, onto the PCB
– 2 black wires to connect it to the PCB
Slide Volume
PLAN VIEW
UNDERSIDE / ELECTRICAL CONNECTION
ELECTRICAL
CONNECTIONS
x2
FIXING LUGS
x2
SLIDER
• Function is part of the design which is intentional as part of the
overall specification
• How is the specification being delivered
– i.e. a volume slide
– What can go wrong with it?
• Function, assembly
Function and potential failure mode
• What can go wrong with function and design of the volume
slide?
• Brainstorm
– Ishikawa diagram
Brainstorm
Ishikawa diagram (fishbone)
EQUIPMENT PROCESS PEOPLE
MATERIALS ENVIRONMENT MANAGEMENT
PROBLEM
POOR SOLDERING
-INCORRECT EQUIPMENT
-TOO HOT / COLD
- NOT CALIBRATED
Item / Function Potential Failure Mode(s)
Potential Effect(s)
of Failure
S
e
v
Potential Cause(s)/
Mechanism(s) of Failure
O
c
c
u
r
r
Current Design Controls - Prevention Current Design Controls - Detection
D
e
t
R
P
N
Scoring overview
SEVERITY OCCURRENCE FAILURE PROBABILITY DETECTION RANKING
Hazardous without warning Very High: Failure is inevitable >1 in 2 Absolute Uncertainty 10
Hazardous with warning 1 in 3 Very Remote 9
Very High High: Repeated failures 1 in 8 Remote 8
High 1 in 20 Very Low 7
Moderate Moderate: Occasional failures 1 in 80 Low 6
Low 1 in 400 Moderate 5
Very Low 1 in 2,000 Moderately High 4
Minor Low: Relatively few failures 1 in 15,000 High 3
Very Minor 1 in 150,000 Very High 2
None Remote: Failure is unlikely <1 in 1,500,000 Almost Certain 1
Any questions?

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Failure Mode Effect Analysis

  • 1. Failure Mode Effect Analysis Introduction and Example Dr. Kylash Makenji
  • 2. • Introduction and Overview • What is Failure Mode Effect Analysis (FMEA)? • Who uses FMEA? • Pre-requisites • Working through a FMEA, Example • RPN’s, What to do next • Team exercise Contents
  • 5. Who uses FMEA? • Automotive – Jaguar Land rover, Ford, BMW, Honda, VW group – All of the others…… • Aerospace – Boeing, Airbus, NASA • Military – Armed forces, Air and Sea
  • 6. • Prior to FMEA you need – A design, process or function – Bill of materials (BOM) – A specification, target or objective – Cross functional team, designer, engineer, manufacturing team……… • Additionally – Standard operating procedure – Ability to influence or change – Team skills and competencies, who does what Pre-requisites
  • 10. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Log, dates, team members, design numbers and versions List a design, function or process items
  • 11. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Record any and all potential failure modes
  • 12. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the potential effects of the failure
  • 13. • How severe is the failure mode to customers? – 10 = very severe, may kill – 1 = no effect Effect SEVERITY of Effect Ranking Hazardous without warning Very high severity ranking when a potential failure mode affects safe system operation without warning 10 Hazardous with warning Very high severity ranking when a potential failure mode affects safe system operation with warning 9 Very High System inoperable with destructive failure without compromising safety 8 High System inoperable with equipment damage 7 Moderate System inoperable with minor damage 6 Low System inoperable without damage 5 Very Low System operable with significant degradation of performance 4 Minor System operable with some degradation of performance 3 Very Minor System operable with minimal interference 2 None No effect 1 Severity
  • 14. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 15. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 List the causes of failure
  • 16. • How likely will the fault occur ? – Use data, explicit and tacit knowledge – If available, look at warranty and customer data OCCURRENCE of Failure Failure Prob Ranking Very High: Failure is almost inevitable >1 in 2 10 1 in 3 9 High: Repeated failures 1 in 8 8 1 in 20 7 Moderate: Occasional failures 1 in 80 6 1 in 400 5 1 in 2,000 4 Low: Relatively few failures 1 in 15,000 3 1 in 150,000 2 Remote: Failure is unlikely <1 in 1,500,000 1 Occurrence
  • 17. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 If available use warrantee and customer data
  • 18. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to prevent the failure occurring
  • 19. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 What is in place to detect the failure occurring
  • 20. • How likely are you to detect the failure through controls, before your customer does? Detection Likelihood of DETECTION by Design Control Ranking Absolute Uncertainty Design control cannot detect potential cause/mechanism and subsequent failure mode 10 Very Remote Very remote chance the design control will detect potential cause/mechanism and subsequent failure mode 9 Remote Remote chance the design control will detect potential cause/mechanism and subsequent failure mode 8 Very Low Very low chance the design control will detect potential cause/mechanism and subsequent failure mode 7 Low Low chance the design control will detect potential cause/mechanism and subsequent failure mode 6 Moderate Moderate chance the design control will detect potential cause/mechanism and subsequent failure mode 5 Moderately High Moderately High chance the design control will detect potential cause/mechanism and subsequent failure mode 4 High High chance the design control will detect potential cause/mechanism and subsequent failure mode 3 Very High Very high chance the design control will detect potential cause/mechanism and subsequent failure mode 2 Almost Certain Design control will detect potential cause/mechanism and subsequent failure mode 1 Detection
  • 21. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 22. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Risk Priority Number, (RPN) Severity x occurrence x detection = RPN
  • 23. • Sort the FMEA in descending order – Create actions to reduce RPN value – Strive to continually improve – If you have further data, rework back into FMEA – Some actions may not reduce the RPN significantly • Beyond economical feasibility • Simulate and test to measure the impact to the RPN score RPN’s, What to do Next?
  • 24. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 25. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36
  • 26. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Work with the highest RPN, and downwards, striving to continually improve Actions, targets etc
  • 27. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Recalculate new RPN with action completed or to predict
  • 28. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device KM – 01/09/15 £120K of investment required, unable to justify given payback period Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36 Some actions may not be feasible to put into place, technical or economic considerations
  • 29. Action Results Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N Recommended Action(s) Responsibility & Target Completion Date Actions Taken NewSev NewOcc NewDet NewRPN Buy milk for lactose intolerant child None available in store No breakfast for the little one 3 Shop runs out of milk 4 Stock management, EPOS, monitoring level of sales, Review of stock levels, visual check of shelves and warehouse 3 36 3 Shop does not store that variety 10 Store policy Review of stock levels, visual check of shelves and warehouse 1 30 I buy the incorrect one Child has breakfast and has a bad reaction 7 Not in the same location in the store 3 Standard stock and store layout Clear labelling of the storage area, team training 4 84Not all team members can read English, investigate how to improve Mgr., xx/xx/xx English test and training Incorrect milk in container, labelling error Child has breakfast and has a bad reaction 7 Dairy has filled the incorrect container 1 Dedicated lactose free production line Batch testing of the milk 2 14 7 Dairy has used the wrong labels 2 Dedicated lactose free production line, and packaging Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 28 Spill milk before I get home No breakfast for the little one 3 Screw on cap not secure 2 Screw cap fitting is automated, torque setting on equipment Batch testing of the milk and packaging, consignment acceptance check, training of staff 6 36Investigate calibrated screw on and off device Milk on floor, danger of slippage 6 Container too thin to hold milk, split in side wall 3 Automated and established process, in line wall section checks Batch testing of the milk and packaging, consignment acceptance check, training of staff 2 36Next time if you are doing a similar product or process use an existing FMEA, develop and improve
  • 30. Team Activity Team 1 – Installing the sliding switch Team 2 – Connecting the sliding switch Team 3 – User behaviour, using the sliding switch
  • 31. Volume Slide • Specification and details:- – Moving slide left to right will increase volume – Calibrated slide • 50% movement = 50% sound increase – Steel body construction – Plastic slide knob – Held in place by 2 screws, onto the PCB – 2 black wires to connect it to the PCB
  • 32. Slide Volume PLAN VIEW UNDERSIDE / ELECTRICAL CONNECTION ELECTRICAL CONNECTIONS x2 FIXING LUGS x2 SLIDER
  • 33. • Function is part of the design which is intentional as part of the overall specification • How is the specification being delivered – i.e. a volume slide – What can go wrong with it? • Function, assembly Function and potential failure mode
  • 34. • What can go wrong with function and design of the volume slide? • Brainstorm – Ishikawa diagram Brainstorm
  • 35. Ishikawa diagram (fishbone) EQUIPMENT PROCESS PEOPLE MATERIALS ENVIRONMENT MANAGEMENT PROBLEM POOR SOLDERING -INCORRECT EQUIPMENT -TOO HOT / COLD - NOT CALIBRATED
  • 36. Item / Function Potential Failure Mode(s) Potential Effect(s) of Failure S e v Potential Cause(s)/ Mechanism(s) of Failure O c c u r r Current Design Controls - Prevention Current Design Controls - Detection D e t R P N
  • 37. Scoring overview SEVERITY OCCURRENCE FAILURE PROBABILITY DETECTION RANKING Hazardous without warning Very High: Failure is inevitable >1 in 2 Absolute Uncertainty 10 Hazardous with warning 1 in 3 Very Remote 9 Very High High: Repeated failures 1 in 8 Remote 8 High 1 in 20 Very Low 7 Moderate Moderate: Occasional failures 1 in 80 Low 6 Low 1 in 400 Moderate 5 Very Low 1 in 2,000 Moderately High 4 Minor Low: Relatively few failures 1 in 15,000 High 3 Very Minor 1 in 150,000 Very High 2 None Remote: Failure is unlikely <1 in 1,500,000 Almost Certain 1