Welcome to the Workshop on

FMEA

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 Why FMEA ?
• Increased demand from customers for high
quality,reliable products.
• Challenge is building reliability & quality in
early stages of development cycle.
• Increased cost pressures
• Demand from customers to reduce design &
dev lead times.Customers always want it
yesterday.

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 What is FMEA?
 Failure mode effect analysis
 Systematic group of activities
 Recognizes & evaluates Potential failures
 Recognizes effects of failures
 Prioritizes actions
 Identifies actions to prevent failures
 Key element in APQP process
 Definition: FMEA is a specific methodology to
evaluate a System, Design, Process or service for
possible ways in which failures (problems, errors,
risks, concerns)can occur.
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 Relation to APQP
PLANNING PLANNING

PRODUCT DESIGN

PROCESS DESIGN
PRODUCT & PROCESS VALIDATION

PRODUCTION

CA/PA/CI

DFMEA Ppk SPC

PFMEA MSA MSA MSA
Feasibility MSA
Review
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 Applications
• Product design(DFMEA)

• Process design(PFMEA)

• Sectors:Automotive,Aerospace,Electronics,
• Healthcare,NASA,Home appliances, Medical
Devices……….unlimited

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 DFMEA
Considers what can go wrong during design of
a product ,its effect , causes ,controls &
evaluates the risk to prioritize actions.

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 Block Diagram
• Show Physical & Logical relationship between
components of product
• It indicates interaction between components
& sub systems
• Indicates flow of Energy, Force, Fluid etc.

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 Function of item
• Functions of items to meet design Intent
based on customer requirements
• List Each function separately if there are more
than one function of a item
• E.g. What is Function of a Washing machine
cover? Prevent water from coming out?
Prevent cloths from coming out?

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 Requirements
• Specifications against each Function . This
explains function in specific terms
• E.g. How much leak proof the cover should
be ? Leak rate ?

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 Potential Failure mode
• The manner in which a component , system or
sub system could potentially fail to meet or
deliver intended function.
• Failure modes are described in Technical
terms & not as symptoms noticed by
customer.
• Large no of FM against single requirement
indicates that requirement is not well defined.
• E.g. Water leakage from cover
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 Potential Effects of Failure
• Effects of Failure mode on Functions as
perceived by customer
• Describe what customer might experience or
Notice
• Customer can be Internal or external

• E.g. Washing not possible ? Chances of

accident ?
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 Severity
• Value Associated with most serious effects of
a given Failure mode.
• It is a relative ranking

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 Classification
• Highlight High Priority failure modes & their
causes
• Identify special characteristics

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Potential Mechanisms of Failure mode

• Physical, chemical, Electrical, Thermal or other

processes that result in failure mode
• Chain of events leading to Failure mode

• E.g. Failure of Sealing between body & cover

of washing machine

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 Potential Causes of Failure Mode
• Indication of how design process could allow
failures to occur
• Described in terms that can be corrected or can
be controlled
• Indication of Design weakness
• Investigation need to focus on Failure mode &
not on effects
• Assume that design will be manufactured &
assembled to the design intent
• E.g. Failure of Sealing of cover due to wrong
material specification
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 Occurrence
• Likelihood that specific cause/mechanism will
occur within design life
• Has a relative meaning

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 Current controls-Preventive
• Eliminates the cause of mechanism of failure
or failure mode from occurring or reduce its
rate of occurrence
• e.g. Design Standards, Best practices, lessons
learnt

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 Current controls-Detective
• Identify(Detect) the existence of a cause ,the
resulting mechanism of failure or the failure
mode from occurring either by analytical or
physical method before item is released for
production.
• Design Reviews
• Design Verification
• Design Validation

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 Detection
• Rank associated with best detection control

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 Risk Evaluation & Actions
• Focus on high severity items
• For low severity items focus on high
occurrence & detection
• Risk Priority no=S*O*D
• Reduce ranking in following order: Severity,
Occurrence, Detection

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 PFMEA
• Identifies what can go wrong In process , its
effects , causes, detection methods
• Analyzes Risk & Prioritizes actions
• Assumes product as designed will meet design
intent
• Gives feedback to Design e.g. Error proofing in
product design
• Assumes incoming material is OK
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 Process Flow Diagram
Cutting

Forging

Trimming

Grinding

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 Characteristics Matrix
Cutting Forging Trimming Grinding
Weight x
Mismatch x
Dim x x
Dim y x
No x
Flashes

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Item/ Potential Responsib Action Results
Process Potential Potential Cause(s)/ Current Recomme ility
Controls nded & Target Action
Function Failure Effect(s) Mechanism(

Classification

Occurrence

Detection
Severity
of s) Action(s) Completio s S O D R.

R.P.N.
Mode
Failure of Failure n Taken e c e P.
What are What can be done ?
Requirement the Effect(s) Date v c t N.
? - Design Changes
s
What is - Process Changes
the
Problem How bad is it ? - Special Controls
?
- Changes to
standards,
Procedures, or
How often Guides
What are does it
the happen?
What can go wrong ? Cause(s)?

- No Function

- Partial/ Over/
Degraded Function
How good is
How can this
- Intermittent Function this method
be found?
of finding?
- Unintended Function
 Process Function
• What is expected out of the process?
• Cutting: Weight/Length?
• Forging: Dimensions/mismatch?
• Grinding: No Flashes?
• Packaging: No Damage/Rust ?
• Logistics: No Damage/ Rust ?

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 Key Definitions-PFMEA
 Potential Failure Mode: The manner in which the
process could potentially fail to meet the process
requirements and / or design intent as described in
process function/requirement column.
 Potential effects of failure: The effects of the failure
mode on the customers
 Severity: Rank associated with the most serious
effect for a given failure mode.
 Customer: End user,OEM assly & manufacturing
centeres,supply chain manufacturing,regulators.

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 Key Definitions-PFMEA
• Potential Causes/Mechanism of failures: How
the failure can occur described in terms of
something that can be corrected or can be
controlled.
• Occurrence: Likelihood that a specific
cause/mechanism of failure will occur.
• Detection: Rank associated with the best
control listed in process control column.

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 Key Definitions-PFMEA
• Risk Priority Number:S x O x D

• S:Severity

• O:Occurrence

• D:Detection

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 Risk Evaluation & Actions
• Focus on high severity items
• For low severity items focus on high
occurrence & detection
• Risk Priority no=S*O*D
• Reduce ranking in following order: Severity,
Occurrence, Detection

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 When FMEAs are Generated?
• Case1:New Designs,New Technology,New
Process.
• Case 2:Modifications to existing designs or
process
• Case3:Use of existing design or process in new
environment, location or application.

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 FMEA review
• New product or process
• Change in operating conditions of
product/process
• Change in product/process design
• New regulations
• Customer feedback / field issues
• Revision in PPM targets
• New measurement system
• Internal failures
• Internal improvements
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 Pitfalls
• Used as After the Fact exercise
• Prepared for PPAP submission/audit
• MDT Team is not Involved
• Rankings adjusted
• Only junior management team is part of team
• Management does not feel it is useful tool
• To generic FMEAs
• Not updated for current failures
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 Tips for Successful FMEA
• Do not use only RPN as action criteria
• Use before Equipment/Tooling is designed
• Use clear & Short Descriptions
• Describe FM in Technical terms whereas FE as
Perceived by customer
• Cause is something which can be corrected

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 Tips for Successful FMEA
• Focus on Preventive controls than detection
• Try to reduce Severity, Occurrence &
Detection in sequence
• Assume that incoming Material is OK
• Include Material Handling, Packaging &
Logistics

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 Typical Issues
• To generic FMEAs
• CFT not involved
• Knowledge of core team
• Special characteristics not considered
• CSRs not considered
• Not updated based on new failure modes etc
• High severity items not considered as SC
• Process function/requirement column not filled
correctly
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 Typical Issues
• All causes not identified
• No focus on preventive controls
• Rankings not based on data
• No linkage to control plans
• No criteria for actions
• No recommended actions
• RPN after actions not calculated
• Reduction of severity without design change

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 Typical Issues
• Process wise FMEAs instead of product family
• Receipt Inpection,Packaging,Logistics not
considered
• No inputs from DFMEA
• No /incomplete knowledge of end application
• No linkage to corrective action system
• No linkage to change control mechanism
• No input to management review
• Internal auditors not competent in FMEA
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 Typical Issues
• All process steps not covered e.g.Washing
• Impact of all process parameters not considered
e.g. Coolant concentration
• No linkage to PFD ,Characteristics matrix
• FMEA not identified as competency requirement
in Skill matrix for appropriate personnel
• Confusion between Failure mode,Effect,causes
• Outsources processes not covered

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 Typical Issues
• Supplier FMEAs & its linkage to PFD, Control plan
etc not verified by competent people
• Supplier FMEAs not updated based on
organizations complaints to suppliers
• Ranking tables not used consistently
• SPC not identified as control for SC
• Effects on all customers not considered
• Original date & Rev date on FMEA does not
match with Product development timing plan

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 Thank you

Questions ?

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