FMEA

Failure Mode and Effects Analysis

Failure Mode & Effects Analysis
(FMEA)
• FMEA is a systematic method of identifying and
preventing system, product and process problems
before they occur
• FMEA is focused on preventing problems,
enhancing safety, and increasing customer
satisfaction
• Ideally, FMEA’s are conducted in the product
design or process development stages, although
conducting an FMEA on existing products or
processes may also yield benefits
 FMEA is a Tool
• FMEA is a tool that allows you to:
– Prevent System, Product and Process problems
before they occur
– reduce costs by identifying system, product and
process improvements early in the development
cycle
– Create more robust processes
– Prioritize actions that decrease risk of failure
– Evaluate the system,design and processes from a
new vantage point
 What is an FMEA?
Description:
• A procedure that examines each item in a
system, considers how that item can fail and
then determines how that failure will affect (or
cascade through) the system
Acronyms
• FMEA: Failure Modes and Effects Analysis
• FMECA: Failure Modes and Effects and
Criticality Analysis
 Benefits of FMEA
• Contributes to improved designs for products and
processes.
– Higher reliability
– Better quality
– Increased safety
– Enhanced customer satisfaction
• Contributes to cost savings.
– Decreases development time and re-design costs
– Decreases warranty costs
– Decreases waste, non-value added operations
• Contributes to continuous improvement
 Benefits
• Cost benefits associated with FMEA are usually
expected to come from the ability to identify failure
modes earlier in the process, when they are less
expensive to address.
– “rule of ten”
• If the issue costs $100 when it is discovered in
the field, then…
• It may cost $10 if discovered during the final
test…
• But it may cost $1 if discovered during an
incoming inspection.
• Even better it may cost $0.10 if discovered
during the design or process engineering phase.
 Method to Conduct an FMEA
(taken from ASM Handbook Vol. 11)

– Identify all components or systems at given

level of the design hierarchy.
– List the function of each identified component
or system.
– Identify failure modes for each
component/system. Typically there will be
several ways in which a component can fail.
– Determine the effect (both locally and globally)
on the system.
 Method to Conduct an FMEA
(taken from ASM Handbook Vol. 11)
– Classify the failure by its effects on the system
operation.
– Determine the failure’s probability of occurrence.
– Identify how the failure mode can be detected
(may point out what needs to be inspected on a
regular basis).
– Identify any compensating provisions or design
changes to mitigate the failure effects.
 DESIGN FMEA (DFMEA)
• The Design FMEA is used to analyze products before they
are
released to production.

• It focuses on potential failure modes of products  caused by

design
deficiencies.

• Design FMEAs are normally done at three levels – system,

subsystem, and component levels

• This type of FMEA is used to analyze hardware, functions

or a
combination
 PROCESS FMEA (PFMEA)

• The Process FMEA is normally used to

analyze manufacturing and assembly
processes at the system, subsystem or
component levels.

• This type of FMEA focuses on potential

failure modes of the process that are caused
by manufacturing or assembly process
deficiencies.
 Design FMEA Format
Item C O D Action Results
Potential Current Response &
Potential Potential S l c Design e R
Cause(s)/ Recommended Target S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect
IN-CLASS PROBLEM 1

Most cars have a fuel filter between the fuel tank

and the engine. Consider the consequences of
a) Anti-function (opposite of filtering)
  b) Partial function
  c) Intermittent function
  d) Excess function
 
 What to Do
• Potential Causes of failure should be
engineering related such as incorrect
material, corrosion, wear and human related
such as inexperience, misuse, etc.
• Current Design Controls are things like
inspections, testing, poke yoke, and other
design checks that are intended to prevent
the problem.
 What to Do
• Assign values to Severity, Occurrence, and
Detection using the tables on the next three
pages.
• Determine the Risk Priority Number
(Severity* Occurrence * Detection)
• Develop an action plan
• Implement an action plan
 Risk Guidelines
Effect Rank Criteria
None 1 No effect
Very Slight 2 Negligible effect on Performance. Some users may notice.
Slight 3 Slight effect on performance. Non vital faults will be noticed
by many users
Minor 4 Minor effect on performance. User is slightly dissatisfied.
Moderate 5 Reduced performance with gradual performance degradation.
User dissatisfied.
Severe 6 Degraded performance, but safe and usable. User dissatisfied.
High Severity 7 Very poor performance. Very dissatisfied user.
Very High Severity 8 Inoperable but safe.
Extreme Severity 9 Probable failure with hazardous effects. Compliance with
regulation is unlikely.
Maximum Severity 10 Unpredictable failure with hazardous effects almost certain.
Non-compliant with regulations.
 Occurrence Ranking
Occurrence Rank Criteria
Extremely Unlikely 1 Less than 0.01 per thousand
Remote Likelihood 2 0.1 per thousand rate of occurrence
Very Low Likelihood 3 0.5 per thousand rate of occurrence
Low Likelihood 4 1 per thousand rate of occurrence
Moderately Low 5 2 per thousand rate of occurrence
Likelihood
Medium Likelihood 6 5 per thousand rate of occurrence
Moderately High 7 10 per thousand rate of occurrence
Likelihood
Very High Severity 8 20 per thousand rate of occurrence
Extreme Severity 9 50 per thousand rate of occurrence
Maximum Severity 10 100 per thousand rate of occurrence
 Detection Ranking
Detection Rank Criteria
Extremely Likely 1 Can be corrected prior to prototype/ Controls will almost certainly
detect
Very High Likelihood 2 Can be corrected prior to design release/Very High probability of
detection
High Likelihood 3 Likely to be corrected/High probability of detection
Moderately High 4 Design controls are moderately effective
Likelihood
Medium Likelihood 5 Design controls have an even chance of working
Moderately Low 6 Design controls may miss the problem
Likelihood
Low Likelihood 7 Design controls are likely to miss the problem
Very Low Likelihood 8 Design controls have a poor chance of detection

Remote Likelihood 9 Unproven, unreliable design/poor chance for detection

Extremely Unlikely 10 No design technique available/Controls will not detect
 Risk Priority Number(RPN)
• Severity x Occurrence x Detection
• RPN is used to prioritize concerns/actions
• The greater the value of the RPN the greater the
concern
• RPN ranges from 1-1000
• The team must make efforts to reduce higher
RPNs through corrective action
• General guideline is over 100 = recommended
action
 RPN Considerations
• Rating scale example:
– Severity = 10 indicates that the effect is very serious
and is “worse” than Severity = 1.
– Occurrence = 10 indicates that the likelihood of
occurrence is very high and is “worse” than
Occurrence = 1.
– Detection = 10 indicates that the failure is not likely
to be detected before it reaches the end user and is
“worse” than Detection = 1.

1 5 10
 RPN Considerations (continued)
• RPN ratings are relative to a particular
analysis.
– An RPN in one analysis is comparable to other
RPNs in the same analysis …
– … but an RPN may NOT be comparable to
RPNs in another analysis.

1 5 10
 RPN Considerations (continued)
• Because similar RPN's can result in several
different ways (and represent different types
of risk), analysts often look at the ratings in
other ways, such as:
– Occurrence/Severity Matrix (Severity and
Occurrence).
– Individual ratings and various ranking tables.
1 5 10
 Recommended Actions
• Definition: tasks recommended for the purpose of
reducing any or all of the rankings
• Only design revision can bring about a reduction in
the severity ranking
• Examples of Recommended actions
– Perform:
• Designed experiments
• reliability testing
• finite element analysis
– Revise design
– Revise test plan
– Revise material specification
 Recommended Actions
Item C O D Action Results
Potential Current Response &
Potential Potential S l c Design e R
Cause(s)/ Recommended Target S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

•All critical or significant characteristics must have

recommended actions associated with them
•Recommended actions should be focused on design, and
directed toward mitigating the cause of failure, or eliminating the
failure mode
•If recommended actions cannot mitigate or eliminate the
potential for failure, recommended actions must force
characteristics to be forwarded to process FMEA for process
mitigation
 Responsibility & Target Completion
Date
Item C O D Action Results
Potential Current Response &
Potential Potential S l c Design e R
Cause(s)/ Recommended Target S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

•All recommended actions must have a person

assigned responsibility for completion of the action
•Responsibility should be a name, not a title
•Person listed as responsible for an action must also be
listed as a team member
•There must be a completion date accompanying each
recommended action
 Action Results

Item C O D Action Results

Potential Current Response &
Potential Potential S l c Design e R
Cause(s)/ Recommended Target S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

•Unless the failure mode has been eliminated, severity

should not change
•Occurrence may or may not be lowered based upon the
results of actions
•Detection may or may not be lowered based upon the
results of actions
•If severity, occurrence or detection ratings are not
improved, additional recommended actions must to be
defined
 Exercise Design FMEA
• Perform A DFMEA on a pressure cooker
 Pressure Cooker Safety Features

1. Safety valve relieves pressure before it

reaches dangerous levels.
2. Thermostat opens circuit through heating
coil when the temperature rises above 250°
C.
3. Pressure gage is divided into green and red
sections. "Danger" is indicated when the
pointer is in the red section.
 Pressure Cooker FMEA

Define Scope:
1. Resolution - The analysis will be restricted
to the four major subsystems (electrical
system, safety valve, thermostat, and
pressure gage).
2. Focus - Safety
Pressure cooker block diagram
Example: Consider the Example
following water heater system
used in a residential home.
The objective is to conduct
a failure modes and effects
analysis (FMEA) for the
system.
 Solution (cont’d)
• Define consequence categories as
I. Safe – no effect on system
II. Marginal – failure will degrade system to some
extent but will not cause major system damage or
injury to personnel
III. Critical – failure will degrade system performance
and/or cause personnel injury, and if immediate
action is not taken, serious injuries or deaths to
personnel and/or loss of system will occur
IV. Catastrophic – failure will produce severe system
degradation causing loss of system and/or multiple
deaths or injuries
• The FMEA is shown in the following table
Component Failure Effects on Effects on Consequence Failure Detection Compensating

Solution
Mode other whole system Category Likelihood Method Provisions
components
Pressure Jammed Increased gas Loss of hot I - Safe Reasonably Observe at Shut off water
relief valve open flow and water, more probable pressure supply, reseal
thermostat cold water relief valve or replace relief
operation input and gas valve
Jammed None None I - Safe Probable Manual No conseq.
closed testing unless
combined with
other failure
modes

Gas valve Jammed Burner Water temp. III - Critical Reasonably Water at Open hot water
open continues to and pressure probable faucet too faucet to relieve
operate, increase; water hot; pressure pres., shut off
pressure relief turns to steam relief valve gas; pressure
valve opens open (obs.) relief valve
compensates
Jammed Burner ceases System fails to I - Safe Remote Observe at
closed to operate produce hot faucet (cold
water water)
Thermostat Fails to Burner Water temp. III - Critical Remote Water at Open hot water
react to continues to rises; water faucet too hot faucet to relieve
temp. operate, turns to steam pressure;
rise pressure relief pressure relief
valve opens valve
compensates
Fails to Burner fails to Water I - Safe Remote Observe at
react to function temperature faucet (cold
temp. too low water)
Fundamentals
drop of
Reliability
 Example
Consider a Personal Computer System that consists of the component
parts listed in the following table. Work through the following distinct
steps to carry out an analysis:
1. Identify product or components of the product.
2. List all failure modes
3. Lay out effect of each failure mode
4. List all possible causes of failure
5. Assess numerically failure modes from experience and available
data. To do this the following need to be estimated;
P = probability of each failure mode occurring
S = seriousness of failure occurring
D = difficulty in detecting failure before delivery
Calculate criticality index: C = P  S  D
6. Indicate corrective action. Ranking on the Criticality Index, C,
allows the most important aspects to reliability to be addressed.
FMECA applied to a personal computer
 Process FMEA
• Definition:
– A documented analysis which begins with a
teams thoughts concerning requirements that
could go wrong and ending with defined
actions which should be implemented to help
prevent and/or detect problems and their
causes.
– A proactive tool to identify concerns with the
sources of variation and then define and take
corrective action.
 Inputs for PMEA
• Process flow diagram
• Assembly instructions
• Design FMEA
• Current engineering drawings and specifications
• Data from similar processes
– Scrap
– Rework
– Downtime
– Warranty
 Process Function Requirement
• Brief description of the manufacturing
process or operation
• The PFMEA should follow the actual work
process or sequence, same as the process
flow diagram
• Begin with a verb
 Team Members for a PFMEA
• Process engineer
• Manufacturing supervisor
• Operators
• Quality
• Safety
• Product engineer
• Customers
• Suppliers
 PFMEA Assumptions
• The design is valid
• All incoming product is to design
specifications
• Failures can but will not necessarily occur
• Design failures are not covered in a
PFMEA, they should have been part of the
design FMEA
 Potentional Failure Mode
• How the process or product may fail to
meet design or quality requirements
• Many process steps or operations will have
multiple failure modes
• Think about what has gone wrong from past
experience and what could go wrong
 Common Failure Modes
• Assembly • Machining
– Missing parts – Too narrow
– Damaged – Too deep
– Orientation – Angle incorrect
– Contamination – Finish not to
– Off location specification
• Torque – Flash or not cleaned
– Loose or over torque
– Missing fastener
– Cross threaded
 Potentional failure modes
• Sealant • Drilling holes
– Missing – Missing
– Wrong material – Location
applied – Deep or shallow
– Insufficient or – Over/under size
excessive material – Concentricity
– dry – angle
 Potential effects
• Think of what the customer will experience
– End customer
– Next user-consequences due to failure mode
• May have several effects but list them in
same cell
• The worst case impact should be
documented and rated in severity of effect
 Potential Effects
• End user • Next operation
– Noise – Cannot assemble
– Leakage – Cannot tap or bore
– Odor – Cannot connect
– Poor appearance – Cannot fasten
– Endangers safety – Damages equipment
– Loss of a primary – Does not fit
function – Does not match
– performance – Endangers operator
 Severity Ranking
• How the effects of a potential failure mode may
impact the customer
• Only applies to the effect and is assigned with
regard to any other rating

Potential effects of Severity

failure
Cannot assemble
bolt(5) 10
Endangers
operator(10) Take the highest effect
Vibration (6) ranking
 Classification
• Use this column to identify any requirement
that may require additional process control
– ∙KC∙ - key characteristic
– ∙F∙ – fit or function
– ∙S∙ - safety

– Your company may have a different symbol

 Potential Causes
• Cause indicates all the things that may be
responsible for a failure mode.
• Causes should items that can have action
completed at the root cause level (controllable in
the process)
• Every failure mode may have multiple causes
which creates a new row on the FMEA
• Avoid using operator dependent statements i.e.
“operator error” use the specific error such as
“operator incorrectly located part” or “operator
cross threaded part”
 Potential Causes
• Equipment • Operator
– Tool wear – Improper torque
– Inadequate pressure – Selected wrong part
– Worn locator – Incorrect tooling
– Broken tool – Incorrect feed or speed
– Gauging out of rate
calibration – Mishandling
– Inadequate fluid levels – Assembled upside
down
– Assembled backwards
 Occurrence Ranking
• How frequent the cause is likely to occur
• Use other data available
– Past assembly processes
– SPC
– Warranty
• Each cause should be ranked according to
the guideline
 Current Process Controls
• All controls should be listed, but ranking should
occur on detection controls only
• List the controls chronologically
– Don not include controls that are outside of your plant
• Document both types of process controls
– Preventative- before the part is made
• Prevent the cause, use error proofing at the source
– Detection- after the part is made
• Detect the cause (mistake proof)
• Detect the failure mode by inspection
 Process Controls
• Preventative • Detection
– SPC – Functional test
– Inspection verification – Visual inspection
– Work instructions – Touch for quality
– Maintenance – Gauging
– Error proof by design – Final test
– Method sheets
– Set up verification
– Operator training
 Detection
• Probability the defect will be detected by
process controls before next or subsequent
process, or before the part or component
leaves the manufacturing or assembly
location
• Likely hood the defect will escape the
manufacturing location
• Each control receives its own detection
ranking, use the lowest rating for detection
 Risk Priority Number (RPN)
• RPN provides a method for a prioritizing
process concerns
• High RPN’s warrant corrective actions
• Despite of RPN, special consideration
should be given when severity is high
especially in regards to safety
 RPN as a measure of risk
• An RPN is like a medical diagnostic,
predicting the health of the patient
• At times a persons temperature, blood
pressure, or an EKG can indicate potential
concerns which could have severe impacts
or implications
 Process FMEA exercise
• Task: Produce and mail sets of contribution
requests for Breast Cancer research
• Outcome: Professional looking requests to
support research for a cure, 50 sets of
information, contribution request, and
return envelope
 Requirements
• No injury to operators or users
• Finished dimension fits into envelope
• All items present (info sheet, contribution form, and return envelope)
{KEY}
• All pages in proper order (info sheet, contribution form, return
envelope) {KEY}
• No tattered edges
• No dog eared sheets
• Items put together in order (info sheet [folded to fit in legal envelope],
contribution sheet, return envelope) {KEY}
• General overall neat and professional appearance
• Proper first class postage on envelopes
• Breast cancer seal on every envelope sealing the envelope on the back
• Mailing label, stamp and seal on placed squarely on envelope {KEY}
• Rubber band sets of 25
 Process steps

• Fold information sheet to fit in legal

envelope
• Collate so each group includes all
components
• Stuff envelopes
• Affix address, postage, and seal
• Rubber bands sets of 25
• Deliver to post office for mail today by 5
pm
 10 steps to conduct a FMEA
1. Review the design or process
2. Brainstorm potential failure modes
3. List potential failure effects
4. Assign Severity ratings
5. Assign Occurrence ratings
6. Assign detection rating
7. Calculate RPN
8. Develop an action plan to address high RPN’s
9. Take action
10. Reevaluate the RPN after the actions are completed
 Reasons FMEA’s fail
1. One person is assigned to complete the FMEA.
2. Not customizing the rating scales with company specific
data, so they are meaningful to your company
3. The design or process expert is not included in the
FMEA or is allowed to dominate the FMEA team
4. Members of the FMEA team are not trained in the use of
FMEA, and become frustrated with the process
5. FMEA team becomes bogged down with minute details
of design or process, losing sight of the overall objective
 Reasons FMEA’s fail
6. Rushing through identifying the failure modes to
move onto the next step of the FMEA
7. Listing the same potential effect for every failure
i.e. customer dissatisfied.
8. Stopping the FMEA process when the RPN’s are
calculated and not continuing with the
recommended actions.
9. Not reevaluating the high RPN’s after the
corrective actions have been completed.