FAILURE MODE AND EFFECT ANALYSIS

FMEA: A General Overview

A failure mode and effect analysis (FMEA) is an
engineering technique used to define, identify, and eliminate
known and/or potential failures, problems, errors, and so on from
the system, design, process and/or service before they reach the
customer.
The analysis of the evaluation may take two courses of
action. First, using historical data, there may be analysis of similar
data for similar products and/or services, warranty data, customer
complaints, and any other appropriate information available, to
define failures. Second, inferential statistics, mathematical
modeling, simulations, concurrent engineering and reliability
engineering may be used to identify and define failures.
 FAILURE MODE AND EFFECT ANALYSIS
FMEA: A General Overview
Any FMEA conducted properly and appropriately will provide
the practitioner with useful information that can reduce the risk
(work) load in the system, design, process, and service.

A good FMEA

 Identifies known and potential failure modes

 Identifies the causes and effects of each failure mode
 Prioritizes the identified failure modes according to the risk
priority number (RPN)-the product of frequency of occurrence,
severity, and detection
 Provides for problem follow-up and corrective action
 WHEN IS THE FMEA STARTED?

By definition the FMEA is a methodology to maximize the

satisfaction of the customer by eliminating and/or reducing
known or potential problems. To do this the FMEA must begin
as early as possible, even though all the facts and information
are not known yet. The FMEA focuses on the motto

Do the best you can, with what you have.

One should start an FMEA as soon as some information is

known (usually through a QFD) Practitioners should not wait
for all the information. If they do, they will never perform an
FMEA because they will never have all the data or
information.
 WHEN IS THE FMEA STARTED?
Specifically, an FMEA program should start
 When new systems, designs, products, processes, or
services are designed
 When existing systems, designs, products,
processes, or services are about to change regardless
of reason
 When new applications are found for the existing
conditions of the systems, designs, products,
processes, or service
 When improvements are considered for the existing
systems, designs, products, processes, or services
FAILURE MODE AND EFFECT ANALYSIS
FAILURE MODE AND EFFECT ANALYSIS
 FAILURE MODE AND EFFECT ANALYSIS
When is the FMEA Complete?

Is there a time when the FMEA may be considered

finished or complete? Yes. Only when the system,
design, product, process, or service is considered
complete and/or discontinued.

Who conducts the FMEA?

The FMEA is a team function and cannot be done on an

individual basis.
 INTERPRETATION OF THE FMEA
The essence of the FMEA is to identify and prevent known and
potential problems from reaching the customer.
There are three components that help define the priority of
failures
 Occurrence (O)
 Severity (S)
 Detection (D)
Occurrence is the frequency of the failure. Severity is the
seriousness (effects) of the failure. Detection is the ability to
detect the failure before it reaches the customer.
There are many ways to define the value of these components.
The usual way is to use numerical scales (called risk criteria
guidelines). These guidelines can be qualitative and/or
qualitative.
FAILURE MODE AND EFFECT ANALYSIS
Evaluation Criteria for OCCURRENCE

PROBABILITY OF FAILURE POSSIBLE CpK RANKING

FAILURE RATES
Very High: Failure is almost inevitable  1 in 2  0.33 10
1 in 3  0.33 9
High: Generally associated with processes 1 in 8  0.51 8
similar to previous processes that have often
failed
1 in 20  0.67 7
Moderate: Generally associated with 1 in 80  0.83 6
processes similar to previous processes which 1 in 400  1.00 5
have experienced occasional failures, but not
in major proportions 1 in 2000  1.17 4
Low: Isolated failures associated with similar 1 in 15,000  1.33 3
processes
Very Low: Only isolated failures associated 1 in 1,50,000  1.50 2
with almost identical processes
Remote: failure is unlikely. No failures ever  1 in 15,00,000  1.67 1
associated with almost identical processes
FAILURE MODE AND EFFECT ANALYSIS
Evaluation Criteria for SEVERITY

EFFECT CRITERIA : SEVERITY OF EFFECT RANKING

Hazardous Many endanger machine or assembly operator. Very high 10
- Without severity ranking when a potential failure mode affects safe
warning vehicle operation and/or involves noncompliance with
government regulation. Failure will occur without warning.
Hazardous Many endanger machine or assembly operator. Very high 9
- with severity ranking when a potential failure mode affects safe
warning vehicle operation and/or involves noncompliance with
government regulation. Failure will occur with warning.
Very High Major disruption to production line. 100% of product may 8
have to be scrapped. Vehicle/item inoperable, loss of
primary function. Customer very dissatisfied.
High Minor disruption to production line. Product may have to be 7
sorted and a portion (less than 100%) scrapped. Vehicle/item
operable, but at a reduced level of performance. Customer
dissatisfied.
Moderate Minor disruption to production line. A portion (less than 6
100%) of the product may have to be scrapped ( no sorting).
Vehicle/item operable, but some comfort/convenience
item(s) inoperable. Customers experiences discomfort.
Low Minor disruption to production line. 100% of product may 5
have to be reworked. Vehicle/item operable, but some
comfort/convenience item(s) operable at reduced level of
performance. Customers experiences discomfort.
Very Low Minor disruption to production line. The product may have 4
to be sorted and a portion (less than 100 %) reworked. Fit &
Finish/squeak & Rattle item does not conform. Defect
noticed by most customers.
Minor Minor disruption to production line. A portion (less than 100 3
%) of the product may have reworked on-line but out-of-
station. Fit & Finish/squeak & Rattle item does not conform.
Defect noticed by average customers.
Very Minor disruption to production line. A portion (less than 100 2
Minor %) of the product have to be reworked on-line but in-station.
Fit & Finish/squeak & Rattle item does not conform. Defect
noticed by discriminating customers.
None No effect 1
 FAILURE MODE AND EFFECT ANALYSIS
Evaluation Criteria for DETECTION

DETECTION Criteria : Likelihood the existence of a defect will be detected RANKING

by process controls before next or subsequent process, or
before part or component leaves the manufacturing or
assembly location
Almost No known control(s) available to detect failure mode 10
Impossible
Very remote Very remote likelihood current control(s) will detect failure mode 9
Remote Remote likelihood current control(s) will detect failure mode 8
Very Low Very low likelihood current control(s) will detect failure mode 7
Low Low likelihood current control(s) will detect failure mode 6
Moderate Moderate likelihood current control(s) will detect failure mode 5
Moderately Moderately high likelihood current control(s) will detect failure 4
High mode
High High likelihood current control(s) will detect failure mode 3
Very High Very high likelihood current control(s) will detect failure mode 2
Almost Certain Current control(s) almost certain to detect the failure mode. 1
Reliable detection controls are known with similar processes
FAILURE MODE AND EFFECT ANALYSIS
FAILURE MODE AND EFFECT ANALYSIS
FAILURE MODE AND EFFECT ANALYSIS
 VOCABULARY OF THE FMEA
Function:
The task that the system, design, process, component, subsystem,
service must perform. This function is very important in
understanding the entire FMEA process. It has to be
communicated in a way that is concise, exact, and easy to
understand. It cannot be jargon.
To facilitate this, it is recommended that an active verb be found
to describe the function. The active verb defines performance,
and performance is what a function is. Examples of this may be
found in the following words.
Lubricate Position Retain Support
 VOCABULARY OF THE FMEA

Failure: The problem, concern, error, challenge.

Failure Mode: This is the physical description of the manner in

which a failure occurs.

Examples of failure modes include the following

•Open circuit
•Leak
•Hot surface
 POTENTIAL FAILURE MODE
Bent Grounded
Blistered Leaking
Bound Melted
Brittle Mis-aligned
Broken Mis-assembled
Burrs Omitted
Corroded Open Circuited
Cracked Out of Tolerance/Requirement
Damaged Not Fulfilled
Defective Porous
Deformed Rough
Delayed Sharp Edges
Discolored Shorted
Distorted Tight
Eccentricity Warped
VOCABULARY OF THE FMEA
 VOCABULARY OF THE FMEA
Causes of Failure:
What is the root cause of the listed failure. Next to the
function, cause of failure is perhaps the most important
section of the FMEA.
Examples of causes of failure include the following:
 System
- Item does not work
- Shorted lead to ground
 Design
- Vibration
- Shock loads
 CAUSE(S) OF FAILURE
Assembly Error Inadequate Venting
Damaged Part Incorrect speeds/Feeds
Handling Damage Incorrect Tooling
Heat Treatment Shrinkage Material Failure
Improper Surface Preparation Misalignment
Improper Tool Set up Missed Operation
Improper Torque Out of Tolerance
Inaccurate Gauging Over Heating
Inadequate Control System Overload Capacity
Inadequate Gating Packaging Damage
Inadequate Holding, Clamping Tool Damage/Burrs
Inadequate or No Lubrication Worn Tooling/Gauging
POTENTIAL EFFECT(S) OF FAILURE
• Air/water Leakage
• Brake Failure
• Contamination- Valve System
• Customer Dissatisfaction
• Delay in Delivery/Payment
• Excess Interest
• Poor Brake Efficiency
• Poor Valve Performance
• Oil Carry Over
• Inadequate Service Life
• Unable to Assemble
• Wrong Material
• Wrong Delivery-Short or Excess
 VOCABULARY OF THE FMEA
Current Controls:

Controls that exist to prevent the cause(s) of the failure from

occurring in the design, process, or service. Some examples
are

• Capability studies
• Design guidelines
• Design review
• Operator(s)training
• Durability test
• Design of Experiments
 POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
FMEA Number __________
Item ________ Process Responsibility __________ Page ___ of ____
Model Year(s)/Vehicle(s) _______________ Key Date _____________________ Prepared By _________
Core T eam ______________________________________________________ FMEA Date (Orig.) ______ (Rev.) ______

Action Results
Potential
Potential Potential S C O Current Responsibility &
Process Function / Cause(s) / D Recommended O
Failure Effect(s) of E la C Process RPN Target Actions SE DE RP
Requirements Mechanism(s) of ET Action(s) C
Mode Failure V ss C Controls Completion Date Taken V T N
Failure C
 POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)

Type of Board : ML Process Responsibility : KRJ FMEA Number : F-M13-02

Customer specific / Generic : Generic Key Date : Existing Product Page 01 of 02
Core Team : HA, BSK, KRJ Prepared By : HA / BSK / Rajesh FMEA Date (Orig.) 17-9-99 (Rev.) 27-6-00

Action Results
Process Potential Potential S Potential Cause(s) / O D R R Resp. &
Current Process S O D R
Function / Failure Effect(s) of E Mechanism(s) of C E P Recommended Action(s) A Target Action(s)
Controls E C E P
Requirements Mode Failure V Failure C T N N Date Taken
V C T N
Drilling : Poor hole Rejection 8 Improper drill 1 As per SOP 7 56
Drill holes as quality parameters
per customer No input inspection 7 As per SOP 2 112 Institute new drill RA1 KRJ Drills 8 3 2 48
data for drill bit / Drill bit management system Dec-99 supplied with
chip off ring from
supplier
Misregistra Rejection 8 Improper scope drill 4 As per SOP 7 224 New tooling to be used RA2 KRJ New tooling 8 1 7 56
tion Dec-99 installed
Collet run out / 3 Periodic checks as 5 120 Increase frequency of collet RA3 KRJ Instituted true 8 3 2 48
Machine inaccuracy per SOP maintenance Dec-99 measurement
Improper pin & stack 4 As per SOP 7 224 Refer RA2 RA2 KRJ New X-Ray 8 1 7 56
Dec-99 tooling
Improper scaling 5 X-ray measure 5 200 * RA4
 WORKSHEET-4: POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA)
FMEA Number __________
Item ________ Process Responsibility __________ Page ___ of ____
Model Year(s)/Vehicle(s) _______________ Key Date _____________________ Prepared By _________
Core T eam ______________________________________________________ FMEA Date (Orig.) ______ (Rev.) ______

Action Results
Potential
Potential Potential S C O Current Responsibility &
Process Function / Cause(s) / D Recommended O
Failure Effect(s) of E la C Process RPN Target Actions SE DE RP
Requirements Mechanism(s) of ET Action(s) C
Mode Failure V ss C Controls Completion Date Taken V T N
Failure C

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