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FAILURE MODES AND EFFECTS ANALYSIS

Preparation FMEA Process Improvement

Vocabulary:
FAILURE MODE: How a part or process can fail to meet
specifications.
CAUSE: A deficiency that results in a failure mode
sources of variation
EFFECT: Impact on customer if the failure mode is not
prevented or corrected.
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FAILURE MODES AND EFFECTS ANALYSIS


Preparation FMEA Process Improvement
a. Identify the ways in which process inputs can vary (causes)
and identify associated FAILURE MODES. These are ways
that critical customer requirements might not be met.
b. Assign severity, occurrence and detection ratings to each
cause and calculate the RISK PRIORITY NUMBERS (RPNs).
c. Determine recommended actions to reduce RPNs.
d. Estimate time frames for corrective actions.
e. Take actions and put controls in place.
f. Recalculate all RPNs.
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FAILURE MODES AND EFFECTS ANALYSIS (FMEA)


The FMEA Process is a structured approach that has the goal of
linking the FAILURE MODES to an EFFECT over time for the
purpose of prevention. The structure of FMEA is as follows:

Preparation FMEA Process Improvement


a. Select the team
b. Develop the process map and steps
c. List key process outputs to satisfy internal and external
customer requirements
d. Define the relationships between outputs and process variables
e. Rank inputs according to importance.
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Overview Objective
Failure Mode Effect Analysis (FMEA)
Provide a Basic familiarization with a tool
that aids in quantifying severity,
occurrences and detection of failures, and
guides the creation of corrective action,
process improvement and risk mitigation
plans.

Agenda
FMEA History
What IS FMEA
Definitions
What it Can Do For You

Types of FMEA
Team Members Roles
FMEA Terminology
Getting Started with an FMEA
The Worksheet
FMEA Scoring
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FMEA History
This type of thinking has been around
for hundreds of years. It was first
formalized in the aerospace industry
during the Apollo program in the 1960s.
Initial automotive adoption in the 1970s.
Potential serious & frequent safety issues.

Required by QS-9000 & Advanced Product Quality Planning Proc


in 1994.
For all automotive suppliers.

Now adopted by many other industries.


Potential serious & frequent safety issues or loyalty issues.
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What is FMEA ?

Cause & effect, Root Cause Analys


Fishbone Diagram Etc

Failure Mode Effect Analysis

What is FMEA ?
Definition: FMEA is an Engineering Reliability Tool
That:
Helps define, identify, prioritize, and eliminate known and/or
potential failures of the system, design, or manufacturing
process before they reach the customer. The goal is to
eliminate the Failure Modes and reduce their risks.
Provides structure for a Cross Functional Critique of a
design or a Process
Facilitates inter-departmental dialog.

Is a mental discipline great engineering teams go


through, when critiquing what might go wrong with the
product or process.
Is a living document which ultimately helps prevent, and not rea
to problems.
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What is FMEA ?
What it can do for you!
1.) Identifies Design or process related Failure Modes
before they happen.
2.) Determines the Effect & Severity of these failure modes.
3.) Identifies the Causes and probability of Occurrence of
the Failure Modes.
4.) Identifies the Controls and their Effectiveness.
5.) Quantifies and prioritizes the Risks associated
with the Failure Modes.
6.) Develops & documents Action Plans that will
occur to reduce risk.
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Types of FMEAs ?
System/Concept S/CFMEA- (Driven by System
functions) A system is a organized set of parts or
subsystems to accomplish one or more functions. System
FMEAs are typically very early, before specific hardware has
been determined.
Design DFMEA- (Driven by part or component
functions) A Design / Part is a unit of physical hardware
that is considered a single replaceable part with respect
to repair. Design FMEAs are typically done later in the
development process when specific hardware has been
determined.
Process PFMEA- (Driven by process functions &
part characteristics) A Process is a sequence of tasks
that is organized to produce a product or provide a
service. A Process FMEA can involve fabrication,
assembly, transactions or services.
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Types of FMEAs ?
System/Concept S/CFMEA- (Driven by System
functions) A system is a organized set of parts or
subsystems to accomplish one or more functions. System
FMEAs are typically very early, before specific hardware has
been determined.
Design DFMEA- (Driven by part or component
functions) A Design / Part is a unit of physical hardware
that is considered a single replaceable part with respect
to repair. Design FMEAs are typically done later in the
development process when specific hardware has been
determined.
Process PFMEA- (Driven by process functions &
part characteristics) A Process is a sequence of tasks
that is organized to produce a product or provide a
service. A Process FMEA can involve fabrication,
assembly, transactions or services.
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The FMEA Team Roles


Champion
// Sponsor
Champion
Sponsor
Provides resources & support
Provides resources & support
Attends
Attendssome
somemeetings
meetings
Promotes
team
Promotes teamefforts
efforts
Shares
authority
/
power
Shares authority / powerwith
withteam
team
Kicks
Kicksoff
offteam
team
Implements
Implementsrecommendations
recommendations

Team Leader

Watchdog of the project


Good leadership skills
Respected & relaxed
Leads but doesnt dominate
Maintains full team participation
Typically lead engineer

FMEA
FMEA Core
Core Team
Team
4466Members
Members

Expertise
Expertisein
inProduct
Product/ /Process
Process
Cross
functional
Cross functional
Honest
HonestCommunication
Communication
Active
participation
Active participation
Positive
Positiveattitude
attitude
Respects
other
Respects otheropinions
opinions
Participates
Participatesin
inteam
teamdecisions
decisions

Facilitator

Watchdog of the process


Keeps team on track
FMEA Process expertise
Encourages / develops team dynami
Communicates assertively
Ensures everyone participates

Recorder
Recorder
Keeps documentation of teams efforts

Keeps documentation of teams efforts


FMEA
FMEAchart
chartkeeper
keeper
Coordinates
meeting
Coordinates meetingrooms/time
rooms/time
Distributes
Distributesmeeting
meetingrooms
rooms&&agendas
agendas

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FMEA Terminology
1.) Failure Modes: (Specific loss of a function) is a
concise

description of how a part , system, or manufacturing


process may potentially fail to perform its functions.
2.) Failure ModeEffect: A description of the consequence or
Ramification of a system or part failure. A typical failure mode ma
have several effects depending on which customer you conside
3.) Severity Rating: (Seriousness of the Effect) Severity is the
numerical rating of the impact on customers.
When multiple effects exist for a given failure mode, enter the worst
case severity on the worksheet to calculate risk.

4.) Failure ModeCauses: A description of the design or proces


deficiency (global cause or root level cause) that results
in the failure mode .
You must look at the causes not the symptoms of the failure. Most failure
Modes have more than one Cause.
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FMEA Terminology (continued)


5.) Occurrence Rating: Is an estimate number of
frequencies or cumulative number of failures (based on
experience) that will occur (in our design concept) for a
given cause over the intended life of the design.
6.) Failure ModeControls: The mechanisms,
methods, tests,
procedures, or controls that we have in place to PREVENT
the Cause of the Failure Mode or DETECT the Failure Mode
Designshould
Controlsitprevent
or Cause
occur or
. detect the Failure Mode prior to engineering
release

7.) Detection Rating: A numerical rating of the probability that a


set of controls WILL DISCOVER a specific Cause of Failure Mode to
prevent bad parts leaving the facility or getting to the ultimate cu

Assuming that the cause of the failure did occur, assess the capabilities of th
controls to find the design flaw..
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FMEA Terminology (continued)


8.) Risk Priority Number (RPN): Is the product of
Severity, Occurrence, & Detection. Risk= RPN= S

xOx

DOften the RPNs are sorted from high to low for consideration in the action plann
step (Caution, RPNs can be misleading- you must look for patterns).

9.) Action Planning: A thoroughly thought out and well


developed FMEA With High Risk Patterns that is not
followed with corrective actions has little or no value, other
than having a chart for an audit
Action plans should be taken very seriously.
If ignored, you have probably wasted much of your valuable time.
Based on the FMEA analysis, strategies to reduce risk are focused
on:
Reducing the Severity Rating.
Reducing the Occurrence Rating.
Reducing the detection Rating.

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Getting Started on FMEA


What Must be done before FMEA
Begins!
Understand your
Customer
Needs

Develop & Evaluate


Product/Process
Concepts

Create
an Effective
FMEA Team

=QFD

Ready?

=Brain Storming

=4 to 6 Consensus Based Multi


Level Experts

= What we
Define the FMEA are and are
Scope
not working

Determine
3
Effects of
The Failure
Mode

Develop and
Drive
7
Action Plan

Severity Rating

Determine4
Determine1
2
Determine
Causes of
Product or
Failure Modes The Failure
Process
of Function
Mode
Functions

Occurrence Rating

Determine5
Controls

66

Calculate &
Assess Risk

Detection Rating
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The FMEA Worksheet


Product
or
Process

Failure
Mode

Determine
Product or
Process
Functions

S
O
Failure
E Causes C Controls
Effects
V
C

Determine
Effects of
The Failure
Mode
Severity
Determine
Rating
Failure
Modes
of Function

Determine
Causes of
The Failure
Mode
Occurrence
Rating

D R
Actions
E P
/ Plans
T N

Resp. &
Target
Complete
Date

p
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Develop
and
Drive
Action Plan

Determine
Controls
Detection
Rating
Calculate
&
Assess
Risk

If an FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly
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p
R
P
N

FMEA Scoring

None

Low

Moderate

High

Extreme

Severity
SeverityofEffect

Rating

Mayendangermachineoroperator.Hazardouswithoutwarning

10

Mayendangermachineoroperator.Hazardouswithwarning

Majordisruptiontoproductionline.Lossofprimaryfunction,100%scrap.Possiblejiglockand
MajorlossofTaktTime
Reducedprimaryfunctionperformance.ProductrequiresrepairorMajorVariance.
NoticeablelossofTaktTime
Mediumdisruptionofproduction.Possiblescrap.Noticeablelossoftakttime.
Lossofsecondaryfunctionperformance.RequiresrepairorMinorVariance
Minordisruptiontoproduction.Productmustberepaired.
Reducedsecondaryfunctionperformance.
Minordefect,productrepairedor"UseAsIs"disposition.
Fit&Finishitem.Minordefect,maybereprocessedonline.

8
7
6
5
4
3

MinorNonconformance,maybereprocessedonline.

Noeffect

1
18

<.33

10

1in3

>.33

1in8
Process is not in statistical control.
Similar processes have experienced problems.
1in20

>.51

>.67

1in80

>.83

>1.00

1in2000

>1.17

1in15k

>1.33

Process is in statistical control. Only isolated1in150k


failures associated with almost identical processes.

>1.50

Failure is unlikely. No known failures associated


1in1.5M
with almost identical processes.

>1.67

Moderate

High

1in2

Low

LikelihoodofOccurrence

Failure Capability
Rate
(Cpk) Rating

Remote

VeryHigh

FMEA
Scoring
Occurrence
Failure is almost inevitable

Process is in statistical control but with isolated failures.


Previous processes have experienced occasional 1in400
failures or out-of-control conditions.

Process is in statistical control.

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FMEA
Scoring
Detection
VeryLow

Rating

No known control(s) available to detect failure mode.


10

Low

Likelihoodthatcontrolwilldetectfailure

Controls have a remote chance of detecting the failure.

9
8

Moderate

Controls may detect the existence of a failure

High

4
Controls have a good chance of detecting the existence
of a failure

VeryHigh

The process automatically detects failure.


2
Controls will almost certainly detect the existence of
a failure.
1

6
5
3

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FMEA
Scoring
RPN or
Risk Priority Number
The Calculation !

Severity x Occurrence x Detection=


RPN

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(FMEA) Part or Process Improvement

Failure Modes & Effect Analysis

FMEA is a technique utilized to define, identify, and eliminate


known or potential failures or errors from a product or a process.
Identify each candidate Part or Process, list likely failure
mode, causes, and current controls
Prioritize risk by using a ranking scale for severity,
occurrence, and detection
Mitigate risk Can controls be added to reduce risk?
Recalculate RPN.
Characteristics with high Risk Priority Numbers should be
selected for Improvement and Action Plans Created
Recalculate RPN After Completion of Action Plans to Validate
Improvements
Product
or
Process

Failure
Mode

Failure
Effects

S
O
E Causes C Controls
V
C

Wrong
Drill Bit
Used

Ball Gage

8 Visual Insp 3

120

Hole
Oversize Unable to
Drilling
Hole Install BP 5
Fastener

D R
Actions
E P
/ Plans
T N

Kit Drill
Bits

Resp. &
Target
Complete
Date

010103

p
S
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p
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