FMEA

Failure Mode Effects Analysis

 AGENDA
• Ice breaker
• Opening
• DFMEA
• Break
• DFMEA exercise
• Lunch
• PFMEA
• Break
• PFMEA Exercise
• FMEA Jeopardy
• Closing and Survey
 Quality and Reliability
• Quality is a relative term often based on customer
perception or the degree to which a product meets
customer expectations
• Manufacturers have long recognized that products
can meet specifications and still fail to satisfy
customer expectations due to:
– Errors in design
– Flaws induced by the manufacturing process
– Environment
– Product misuse
– Not understanding customer wants/needs
 Quality, Reliability and Failure
Prevention
• Traditionally quality activities have focused
on detecting manufacturing and material
defects that cause failures early in the life
cycle

• Today, activities focus on failures that

occur beyond the infant mortality stage

• Emphasis on Failure Prevention

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/FMECA History
• The history of FMEA/FMECA goes back to
the early 1950s and 1960s.
– U.S. Navy Bureau of Aeronautics, followed by
the Bureau of Naval Weapons:
– National Aeronautics and Space
Administration (NASA):
• Department of Defense developed and
revised the MIL-STD-1629A guidelines
during the 1970s.
 FMEA/FMECA History (continued)
• Ford Motor Company published instruction
manuals in the 1980s and the automotive
industry collectively developed standards in
the 1990s.
• Engineers in a variety of industries have
adopted and adapted the tool over the years.
 Published Guidelines
• J1739 from the SAE for the automotive
industry.
• AIAG FMEA-3 from the Automotive
Industry Action Group for the
automotive industry.
• ARP5580 from the SAE for non-
automotive applications.
 Introduction

Other Guidelines
• Other industry and company-specific guidelines
exist. For example:
– EIA/JEP131 provides guidelines for the electronics
industry, from the JEDEC/EIA.
– P-302-720 provides guidelines for NASA’s GSFC
spacecraft and instruments.
– SEMATECH 92020963A-ENG for the
semiconductor equipment industry.
– Etc…
 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
 A Systematic Process
• FMEA provides a systematic process to:
– Identify and evaluate
• potential failure modes
• potential causes of the failure mode
– Identify and quantify the impact of potential failures
– Identify and prioritize actions to reduce or eliminate
the potential failure
– Implement action plan based on assigned
responsibilities and completion dates
– Document the associated activities
 Purpose/Benefit
• cost effective tool for maximizing and
documenting the collective knowledge,
experience, and insights of the engineering
and manufacturing community
• format for communication across the
disciplines
• provides logical, sequential steps for
specifying product and process areas of
concern
 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.
FMEA as Historical Record
• Communicate the logic of the
engineers and related design and
process considerations

• Are indispensable resources for new

engineers and future design and
process decisions.
 System Design Process
Components Components
Manpower
Subsystems Subsystems
Machine
Main Systems Main Systems
Method
Material
Measurement
Focus: Focus: Environment
Minimize failure Minimize failure
effects on the effects on the Focus:
System Design Minimize failure
effects on the
Objectives/Goal: Objectives/Goal:
Machines Processes
Maximize System Maximize Design
Quality, reliability, Quality, reliability, Tools, Objectives/Goal:
Cost and Cost and Work Stations, Maximize
maintenance maintenance Production Lines, Total Process
Operator Training, Quality, reliability,
Processes, Cost and
Gauges maintenance
 Why do FMEA’s?
• Examine the system for failures.
• Ensure the specs are clear and assure the
product works correctly
• ISO requirement-Quality Planning
– “ensuring the compatibility of the design, the
production process, installation, servicing, inspection
and test procedures, and the applicable
documentation”
 What tools are available to meet
our objective?
• Benchmarking
• customer warranty reports
• design checklist or guidelines
• field complaints
• internal failure analysis
• internal test standards
• lessons learned
• returned material reports
• Expert knowledge
 What are possible outcomes?
• Actual/potential failure modes
• customer and legal design requirements
• duty cycle requirements
• product functions
• key product characteristics
• Product Verification and Validation
How to Fmea…The Pre-Team
Meeting
• Prior to assembling the entire team, it
may be useful to arrange a meeting
between two or three key engineers
• This could include persons
responsible for design, quality, and
testing.
 How to FMEA.. (cont.)
• The purpose of this meeting is to:
– Determine scope
– Gather background reference material
– Create update block diagrams
– Identify team members
– Prepare an agenda, schedule, milestones
– Identify item functions, failure modes and
their effects
 Assumptions of DFMEA
• All systems/components are manufactured
and assembled as specified by design

• Failure could, but will not necessarily,

occur
 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
 General
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

•Every FMEA should have an assumptions document

attached (electronically if possible) or the first line of the
FMEA should detail the assumptions and ratings used for the
FMEA.
•Product/part names and numbers must be detailed in the
FMEA header
•All team members must be listed in the FMEA header
•Revision date, as appropriate, must be documented in the
FMEA header
Function-What is the part supposed to do
in view of customer requirements?
• Describe what the system or component is
designed to do
– Include information regarding the environment in
which the system operates
• define temperature, pressure, and humidity ranges
• List all functions
• Remember to consider unintended functions
– position/locate, support/reinforce, seal in/out, lubricate,
or retain, latch secure
 Function
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

•EXAMPLE:
•HVAC system must defog windows and heat or cool cabin to 70
degrees in all operating conditions (-40 degrees to 100 degrees)
• - within 3 to 5 minutes
• or
• - As specified in functional spec #_______; rev.
date_________
 Potential Failure mode
• Definition: the manner in which a system,
subsystem, or component could potentially fail to
meet design intent
• Ask yourself- ”How could this design fail to meet
each customer requirement?”
• Remember to consider:
– absolute failure
– partial failure
– intermittent failure
– over function
– degraded function
– unintended function
 Failure Mode
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

•EXAMPLES:
•HVAC system does not heat vehicle or defog windows
• HVAC system takes more than 5 minutes to heat vehicle
•HVAC system does not heat cabin to 70 degrees in below
zero temperatures
•HVAC system cools cabin to 50 degrees
•HVAC system activates rear window defogger
Consider Potential failure modes
under:
• Operating Conditions
– hot and cold
– wet and dry
– dusty and dirty
• Usage
– Above average life cycle
– Harsh environment
– below average life cycle
Consider Potential failure modes
under:
• Incorrect service operations
– Can the wrong part be substituted inadvertently?
– Can the part be serviced wrong? E.g. upside down,
backwards, end to end
– Can the part be omitted?
– Is the part difficult to assemble?
• Describe or record in physical or technical terms,
not as symptoms noticeable by the customer.
 Potential Effect(s) of Failure
• Definition: effects of the failure mode on the function as
perceived by the customer
• Ask yourself- ”What would be the result of this failure?”
or “If the failure occurs then what are the consequences”
• Describe the effects in terms of what the customer might
experience or notice
• State clearly if the function could impact safety or
noncompliance to regulations
• Identify all potential customers. The customer may be an
internal customer, a distributor as well as an end user
• Describe in terms of product performance
 Effect(s) of Failure
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

•EXAMPLE:
•Cannot see out of front window
•Air conditioner makes cab too cold
•Does not get warm enough
•Takes too long to heat up
 Examples of Potential Effects
• Noise • Intermittent operations
• loss of fluid • rough surface
• seizure of adjacent • unpleasant odor
surfaces • poor appearance
• loss of function • potential safety hazard
• no/low output • Customer dissatisfied
• loss of system
 Severity
• Definition: assessment of the seriousness of
the effect(s) of the potential failure mode on
the next component, subsystem, or
customer if it occurs
• Severity applies to effects
• For failure modes with multiple effects, rate
each effect and select the highest rating as
severity for failure mode
 Severity
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

•EXAMPLE:
•Cannot see out of front window – severity 9
•Air conditioner makes cab too cold – severity 5
•Does not get warm enough – severity 5
•Takes too long to heat up – severity 4
 Classification
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

•Classification should be used to define potential critical and significant

characteristics
•Critical characteristics (9 or 10 in severity with 2 or more in occurrence-suggested) must
have associated recommended actions
•Significant characteristics (4 thru 8 in severity with 4 or more in occurrence -suggested)
should have associated recommended actions
•Classification should have defined criteria for application

•EXAMPLE:
•Cannot see out of front window – severity 9 – incorrect vent location – occurrence 2
•Air conditioner makes cab too cold – severity 5 - Incorrect routing of vent hoses (too
close to heat source) – occurrence 6
 Potential Cause(s)/Mechanism(s) of
failure
• Definition: an indication of a design
weakness, the consequence of which is the
failure mode
• Every conceivable failure cause or
mechanism should be listed
• Each cause or mechanism should be listed
as concisely and completely as possible so
efforts can be aimed at pertinent causes
 Cause(s) of Failure
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

•EXAMPLE:
•Incorrect location of vents
•Incorrect routing of vent hoses (too close to heat
source)
•Inadequate coolant capacity for application
 Potential Cause Mechanism
• Tolerance build up •Yield
• insufficient material
•Fatigue
• insufficient lubrication capacity
• Vibration •Material instability
• Foreign Material
• Interference •Creep
• Incorrect Material thickness specified
•Wear
• exposed location
• temperature expansion •Corrosion
• inadequate diameter
• Inadequate maintenance instruction
• Over-stressing
• Over-load
• Imbalance
• Inadequate tolerance
 Occurrence
• Definition: likelihood that a specific
cause/mechanism will occur
• Be consistent when assigning occurrence
• Removing or controlling the
cause/mechanism though a design change is
only way to reduce the occurrence rating
 Occurrence
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

•EXAMPLE:
•Incorrect location of vents – occurrence 3
•Incorrect routing of vent hoses (too close to
heat source) – occurrence 6
•Inadequate coolant capacity for application –
occurrence 2
 Current Design Controls
• Definition: activities which will assure the design adequacy
for the failure cause/mechanism under consideration
• Confidence Current Design Controls will detect cause and
subsequent failure mode prior to production, and/or will
prevent the cause from occurring
– If there are more than one control, rate each and select the lowest for
the detection rating
• Control must be allocated in the plan to be listed, otherwise
it’s a recommended action
• 3 types of Controls
– 1. Prevention from occurring or reduction of rate
– 2. Detect cause mechanism and lead to corrective actions
– 3. Detect the failure mode, leading to corrective actions
 Current Design Controls
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

•EXAMPLE:
•Engineering specifications (P) – preventive control
•Historical data (P) – preventive control
•Functional testing (D) – detective control
•General vehicle durability (D) – detective control
 Examples of Controls
• Type 1 control • Type 2 and 3 controls
– Warnings which alert – Road test
product user to – Design Review
impending failure – Environmental test
– Fail/safe features
– fleet test
– Design – lab test
procedures/guidelines/
– field test
specifications
– life cycle test
– load test
 Detection
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

•Detection values should correspond with AIAG, SAE

•If detection values are based upon internally defined criteria, a reference
must be included in FMEA to rating table with explanation for use
•Detection is the value assigned to each of the detective controls
•Detection values of 1 must eliminate the potential for failures due to design
deficiency

•EXAMPLE:
•Engineering specifications – no detection value
•Historical data – no detection value
•Functional testing – detection 3
•General vehicle durability – detection 5
 RPN (Risk Priority Number)
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

•Risk Priority Number is a multiplication of the severity,

occurrence and detection ratings
•Lowest detection rating is used to determine RPN
•RPN threshold should not be used as the primary trigger for
definition of recommended actions

•EXAMPLE:
•Cannot see out of front window – severity 9, – incorrect vent
location – 2, Functional testing – detection 3, RPN - 54
 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
 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.
 PFMEA as a tool…
• To access risk or the likelihood of
significant problem
• Trouble shoot problems
• Guide improvement aid in determining
where to spend time and money
• Capture learning to retain and share
knowledge and experience
 Customer Requirements
Deign Specifications
Key Product Characteristics
Machine Process Capability

Process Process Operator

Flow Process FMEA Control Job
Diagram Plan Instructions

Conforming Product
Reduced Variation
Customer Satisfaction
 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
Recommended actions

Control

Influence

Can’t control or influence at this time

 Recommended Action
• Definition: tasks recommended for the
purpose of reducing any or all of the
rankings
• Examples of Recommended actions
– Perform:
• Process instructions (P)
• Training (P)
• Can’t assemble at next station (D)
• Visual Inspection (D)
• Torque Audit (D)
 PMEA as a Info Hub

Current or
Customer Process
Expected Process Implementation
Design Flow
quality Changes and verification
requirements Diagram
performance

Recommended
Corrective actions
Process FMEA document i.e.
Error proofing

Continuous Improvement Efforts

Process And RPN reduction loop
Control
Plan

Operator
Job Communication of standard
Instructions of work to operators
FMEA process flow
 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.
 Software Recommendations
• Numerous types and specialized formats
• Many have free trials
– X-FMEA Reliasoft
– FMEA Pro-7
– Access Data bases
– Excel formats
 Methods SOD Rankings
Potpourri
$100 $100 $100 $100

$200 $200 $200 $200

$300 $300 $300 $300

$400 $400 $400 $400

$500 $500 $500 $500

Sample