QUALITY MANAGEMENT

SYSTEM

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 FMEA

Failure Mode and

Effects
Analysis
(AIAG MANUAL-4th Edition)

FMEA - FAILURE MODE and EFFECTS ANALYSIS

FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Purpose of FMEA
Preventive costs • Cost of validation Warranty costs

• Identify and eliminate • Detection and • Detection and correction

potential defects correction of defects • EXTERNAL defects

Validatio
n tests
D-FMEA

P-FMEA

•
•
•

• Product • Project • Pre-

developmen planning • Production • Lifetime
• production
t

• Manufacturer / supplier • Customer

Preventive costs to identify potential defects by FMEA’s are relatively low compared to in-
house detection and correction of defects and even much lower than recovery costs if
defects are found by our Customers.
 Origin
• Procedures for conducting FMECA were
described in US Armed Forces Military Procedures
document MIL-P-1629 (1949); revised in 1980 as
MIL-STD-1629A.
• By the early 1960s, contractors for the NASA were
using variations of FMECA or FMEA under a
variety of names.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Origin
• The civil aviation industry was an early
adopter of FMEA, with the Society for
Automotive Engineers (SAE) publishing
ARP926 in 1967.
• After two revisions, ARP926 has been
replaced by APR 4761, which is now
broadly used in civil aviation.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Origin
• During the 1970s, use of FMEA and related techniques
spread to other industries.
• In 1971 NASA prepared a report for the U S Geological
Survey recommending the use of FMEA in assessment of
offshore petroleum exploration.
• A 1973 U.S Environment Protection Agency report
described the application of FMEA to wastewater treatment
plants.
• FMEA as application for HACCP on the Apollo Space
Program moved into the Food industry in general.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Origin
• The automotive industry began to use
FMEA by the mid 1970s.
• The Ford Motor Company introduced FMEA
to the automotive industry for safety and
regulatory consideration.
• Ford applied the same approach to
processes (PFMEA) to consider potential
process induced failures prior to launching
production.
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Origin
• In 1993 the Automotive Industry Action
Group (AIAG) first published an FMEA
standard for the automotive industry.
• It is now in its fourth edition.
• The SAE first published related standard
J1739 in 1994which is also now in its fourth
edition.
•

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 History

 First used in the 1960’s in the Aerospace industry

during the Apollo missions
 In 1974, the Navy developed MIL-STD-1629
regarding the use of FMEA
 In the late 1970’s, the automotive industry was
driven by liability costs to use FMEA
 Later, the automotive industry saw the advantages
of using this tool to reduce risks related to poor
quality

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 What is FMEA?
• Was one of the first highly structured,
systematic techniques for failure Analysis.

• It was developed by reliability Engineers in

the late 1950s to study problems that might
arise from malfunctions of military systems.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 FMEA?
• An FMEA is often the first step of a system
reliability study.
• It involves reviewing as many components,
assemblies, and subsystems as possible to
identify failure modes, and their causes and
effects.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 FMEA?
For each component, the failure modes and
their resulting effects on the rest of the
system are recorded in a specific FMEA
worksheet.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 What is FMEA?
FMEA is an analytical methodology used to
ensure that potential problems have been
considered and addressed throughout the APQP
process
Most visible result is the documentation of the
collective knowledge of cross functional teams
Part of the evaluation and analysis is the
assessment of fore seable risk

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Learning Objectives

Enable participants to understand the

importance of FMEA in achieving robust
capable designs and processes.
Teach participants how to improve the
efficiency and effectiveness of their FMEA
efforts.
Get the right people involved in the process of
FMEA, and get results.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Advantages
• Improve the quality, reliability, and safety of
a product/process
• Improve company image and
competitiveness
• Increase user satisfaction
• Reduce system development time and cost
• Collect information to reduce future failures,
capture engineering knowledge
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Advantages
• Reduce the potential for warranty concerns
• Early identification and elimination of
potential failure modes
• Emphasize problem prevention
• Minimize late changes and associated cost
• Catalyst for teamwork and idea exchange
between functions

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Advantages
• Reduce the possibility of same kind of
failure in future
• Reduce impact on company profit margin
• Improve production yield
• Maximizes profit.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Benefits

 Establishes disciplined approach for prevention of

problems.
 Improves the Quality, Reliability and Safety of
products.
 Helps to increase customer satisfaction.
 Reduces product development timing and cost.
 Documents and tracks actions taken to reduce
risk.
 Avoids post mortems and associated cost penalty.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 FMEA?
• It provides a documented method for
selecting a design with a high probability of
successful operation and safety.
• A documented uniform method of assessing
potential failure mechanisms, failure modes
and their impact on system operation,
resulting in a list of failure modes ranked
according to the seriousness of their system
impact and likelihood of occurrence.
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 FMEA?
• Early identification of single failure points
(SFPS) and system interface problems,
which may be critical to mission success
and/or safety.
• They also provide a method of verifying that
switching between redundant elements is
not jeopardized by postulated single
failures.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 FMEA?
• An effective method for evaluating the effect
of proposed changes to the design and/or
operational procedures on mission success
and safety.
• A basis for in-flight troubleshooting
procedures and for locating performance
monitoring and fault-detection devices.
• Criteria for early planning of tests.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Risk
• Uncertainty to achieve objectives
• Risk is the combination of End Effect
Probability of occurrence and Severity where
probability and severity includes the effect
on non-detectability

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 The impact of the failure
• Severity (S)
• Determine the Severity for the worst-case
scenario adverse end effect (state). It is
convenient to write these effects down in
terms of what the user might see or
experience in terms of functional failures

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Probability of occurrence
• Probability (P)
• Use Historical Data
• Recall the past incidents and arrive at the
probability of occurrence
• Facts of the past record will throw light as to what
frequency the failure occurs.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 controls
• Preventive Controls
• Detective Controls

• Detection (D)
• The means or method by which a failure is
detected, isolated by operator and/or
maintainer and the time it may take

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 classification
Special process characteristics
Critical, Key, Major, Significant etc.,
For Components, systems, sub-systems,
Which needs additional process controls

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Classification

This column may be used to highlight high

 priority failure modes and their associated
 causes or to classify any special
 product/process characteristics (ex – critical,
key, major, significant) for components,
 subsystems or systems that may require
additional product / process controls

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Review frequency of FMEA?
• The FMEA should be updated whenever:
• A new cycle begins (new product/process)
• Changes are made to the operating
conditions
• A change is made in the design
• New regulations are instituted
• Customer feedback indicates a problem

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Types of FMEA

 System FMEA
– Focuses on how interactions among systems might fail.
 Design FMEA
– Focuses on how product design might fail.
 Process FMEA
– Focuses on how processes that make the product might fail.
 Machinery FMEA
– Focuses on how machinery that perform processes might
fail.
- The focus for this evening is on Process FMEA.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Model for Quality Planning

Concept PFMEA &

Initiation- DFMEA- MFMEA
Planning Product Design & Process Design
Development
Proto Type

Pilot Run-Process
and Product
Validation

Feedback
and Production
Finetuning

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 When do you do FMEA?

It is meant to be a “Before – the – event”

action.
Not an “After – the – fact” exercise.
To achieve the greatest value, FMEA must
be done before the implementation of a
product / a process in which the failure
mode exists

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Multi Disciplinary Approach

 A team approach is necessary.

 Team should be led by the Process Owner who is the
responsible manufacturing engineer or technical person, or
other similar individual familiar with FMEA.
 The following should be considered for team members:
 – Design Engineers – Operators
 – Process Engineers – Reliability
 – Materials Suppliers – Suppliers
 – Customers

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Precursor

Develop a Process Flow Diagram

Identify Input
Determine Output
Identify Resources
Identify Support System
Determine Process Controls
Determine Metrics

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Data collection

 Drawings
 BOM
 Process flow diagrams
 Customer complaints
 Application details
 Rejections at particular process stages
 Current method of measurements
 Process validation results
 Functional objectives / Targets
 WWR/WWR Analytical data
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 The Steps

 Identify Potential Failure Modes

 Identify Potential Failure Causes
 Identify Potential Effects (Severity)
 Prioritize the Risk
 Identify Existing Controls
 Identify Additional Controls, if necessary
 Implementation, Responsibility and Timeline
 Verification of Actions implemented
 Re-Do the Risk assessment after implementing the
controls.
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Inputs for FMEA Preparation
• • Process Flow Diagram
• • Drawing & DFMEA
• • AIAG FMEA manual 4th edition as guideline standard for PFMEA preparation.
• • PFMEA check sheet for carrying out the PFMEA.
• • Historical data (e.g. Customer Return / Warranty Rejection, In-house
Rejection, Process Capability Report etc)
• • Quality and Reliability History
• • Occurrence matrix and feedback ratio
• • CFT approach for making PFMEA.
• • Identify the potential failure mode of each process and find out the effect of
each potential failure mode at the current operation, next operation(s) and at
customer end.
• • Lesson learned cards (LLCs)
• • List of M/C tools, Gauges

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Identify potential effects on
the following:
 Next Operation
 Downstream users
 Ultimate customer
 Vehicle operation
 Operator safety
 Compliance with government regulations
 Machines / Equipment
 For a Process FMEA, downstream users can include
an Assembly operation / plant, or a Service (dealer)
operation.
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 FMEA development, either design or process,
uses a common approach to address:

• Potential product or process failure to meet expectations

• Potential consequences
• Potential causes of the failure mode
• Application of current controls
• Level of risk
• Risk reduction
• Before the FMEA document is started, the team must
define the scope of the project and collect existing
information which is necessary for an effective and
efficient FMEA development process

FMEA - FAILURE MODE and EFFECTS ANALYSIS

• System FMEA
• A system FMEA is made up of various subsystems. Examples of systems
include: Chassis System, Powertrain System, or Interior System, etc. The
focus of the System FMEA is to address all interfaces and interactions
among systems, subsystems, the environment and the customer.
• Subsystem FMEA
• A Subsystem FMEA is a subset of a system FMEA. An example of a
subsystem is the front suspension subsystem, which is a subset of the
chassis system. The focus of the Subsystem FMEA is to address all
interfaces and interactions among the subsystem components and
interactions with other subsystems or systems.
• Component FMEA
• A Component FMEA is a subset of a subsystem FMEA. For example, a
brake pad is a component of the brake assembly, which is a subsystem
of the chassis system.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Define the Customers
End users
OEM Assembly, Manufacturing Centres
Supply Chain Manufacturing
Regulators

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Traditional Format

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Failure Mode

Failure mode is defined as the manner in which

a product or process could fail to meet the
process requirements
Assumption is made that the failure could occur
but may not necessarily occur
Should be described in technical terms and not
as a symptom necessarily noticeable by the
customer

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Examples of Failure Mode
PFMEA - Example - Potential Failure Modes

Process Step
Requirement Potential Failure mode
/Function
Four screws Fewer than four screws
Wrong screw used (larger
Specified screws
dia)
Operation 20: Assembly sequence : First Screw placed in any other
Attach seat cushion to screw in right front hole hole
track using a torque gun Screws fully seated Screws not fully seated
Screws torqued to Screw torqued too high
dynamic torque
specification Screw torqued too low

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Causes of Failure

Potential cause of failure is defined as an

indication of how the failure could occur,
described in terms of something that can be
corrected or can be controlled.
Potential cause is for the failure mode
There is direct relation between a cause and its
resultant failure mode (i.e. if the cause occurs,
then the failure mode occurs)

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Cause and Effect Diagram

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Examples of Potential Causes
Potentialof
CauseFailure
of failure mode - PFMEA

Requirement Potential Failure mode Cause

Nut runner not held
Screws torqued until fully
Screws not fully seated perpendicular to work
seated
surface by operator
Torque setting set too high
by non-set-up personnel
Screw torqued too high
Torque setting set too high
Screws torqued to dynamic by set-up personnel
torque specification Torque setting set too low
by non-set-up personnel
Screw torqued too low
Torque setting set too low
by set-up personnel

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Failure Effect

 Potential effects of failure are defined as the effects of

failure mode as perceived by the customer
 To be described in terms of what the customer might
notice or experience
 Customer may be an internal as well as the end user
 Includes analysis of the consequences of failures and
the severity or seriousness of those consequences

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Failure Effect

An effect is the immediate consequence of the

failure mode.
• What is the pain that is felt by the end user?
• What is the pain felt by downstream
manufacturing or assembly operations?

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Failure Effect

For External customers

– Noise, High effort, Unpleasant odor,
– Intermittent operation, Water leak, Rough idle
– Unable to adjust, Difficult to control, Poor
appearance

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Potential Failure Effect

For Internal customers

– Unable to assemble at operation X
– Unable to attach at customer facility
– Unable to connect at customer facility
– Cannot bore at operation Y
– Causes excessive tool wear at operation A
– Damages equipment at operation B
– Endangers operator at customer facility
– Rejection, Rework, scrap
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Examples of Failure Effect
PFMEA - Example - Potential Effects of Failure Modes

Requirement Failure mode Effect

End User Manufacturing and

Assembly

Stop shipment and

Loose seat cushion and
Four screws Fewer than four screws additional sort and rework
noise
due to affected portion

Unable to install screw in

Specified screws Wrong screw used (larger dia) _
station
Difficult to install
Assembly sequence : First
Screw placed in any other hole _ remaining screws in
screw in right front hole
station
Loose seat cushion and Sort and rework due to
Screws fully seated Screws not fully seated
noise affected portion
Loose seat cushion due to
Sort and rework due to
Screw torqued too high subsequent fracture of
affected portion
Screws torqued to dynamic screw and noise
torque specification
Loose seat cushion due to
Sort and rework due to
Screw torqued too low gradual loosening of screw
affected portion
and noise

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Identify Current Controls

Current Process Controls describe planned activities or

devices that can prevent or detect the cause of a failure or a
failure mode itself.
There are two classes of controls:
– Preventive controls either eliminate the causes of the failure
mode or the failure mode itself, or reduce how frequently it
occurs.
– Detective controls recognize a failure mode or a cause of failure
so associated countermeasures are put into action.
Preventive controls are the preferred approach because
they are most cost effective.
 Severity

Severity – is an assessment of the level of impact of

a failure on the customer
 Severity is the value associated with the most
serious effect for a given failure mode
 Severity is a relative ranking within the scope of
individual FMEA
The team should agree on an evaluation criteria and
a ranking system and apply them consistently, even if
modified for individual process analysis
FMEA - FAILURE MODE and EFFECTS ANALYSIS
Severity Rating

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Probability of Occurrence

It is the occurrence of effect of failure or failure

mode or the cause of the failure mode
Probability of Occurrence
Historical data available with the organization
can be an indicator.
How often the cause occurs resulting in failure
( Remember cause and effect?)

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Occurrence rating

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Detection Mechanism

Detection – is an assessment of how well the

product or process controls detect the cause of
the failure or the failure mode
Could be preventive controls
Could be detective controls

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Detection Rating

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 RPN

• Risk level is known by RPN (RISK PRIORITY

NUMBER)
• RPN is the product of the severity,
occurrence, and detection scores.

• The use of an RPN threshold is NOT a

recommended practice for determining the need
for actions

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Is RPN the deciding factor?

 If the RPN is higher for characteristic B

than characteristic A, the priority should be
to work on A with the higher severity of 9,
although its RPN lower and below the
threshold

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Recommended Actions

The intent with recommended actions is to

reduce risk.
 Recommended actions will be focused to:
– Reduce Severity
– Reduce Frequency of Occurrence
– Improve Detection

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Recommended Actions

 Recommended actions and results – The intent of recommended

actions is to reduce the overall risk and likelihood that the failure
mode will occur
 Recommended actions address reduction of the severity,
occurrence and detection
 Following are some of the actions :
 Ensuring design requirements including reliability are achieved
 Reviewing engineering drawings and specifications
 Confirming incorporation in assembly / manufacturing processes
 Reviewing related FMEA’s, control plans and operations instructions

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Recommended Actions

Responsibility and timing to complete the

recommended actions should be recorded
Once actions are completed and results
captured, the updated ratings for severity,
occurrence and detection should also be
recorded
Management owns the FMEA process

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Recommended Actions

Transfer FMEA action items onto the

mechanism used to track and ensure closure of
open issues on the project.
Decisions to take different actions or not to act
must be approved.
Review status of FMEA action items on a
regular basis.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Responsibility for the recommended
action(s)
Enter the name of the individual and
organization responsible for completing each
recommended action including the target
completion date
 The process responsible engineer /team leader
is responsible for ensuring that all actions
recommended have been implemented or
adequately addressed

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Management Responsibility
Management owns the FMEA process.
 Management has the ultimate responsibility
of selecting and applying resources and
ensuring an effective risk management
process including timing.
Management responsibility also includes
providing direct support to the team through
on-going reviews, eliminating roadblocks,
and incorporating lessons learned.
FMEA - FAILURE MODE and EFFECTS ANALYSIS
 Verify Results

Whenever you change a process one of two

things happen:
– Things Get Better
– Things Get Worse
• Verify actual performance following the
implementation of the recommended actions

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Verify Results

 Action results – This section identifies the results of

any completed actions and their effect on S, O, D
rankings and RPN
 Action(s) taken and completion date – After the action
has been implemented, enter a brief description of the
action taken and actual completion date
 Re do the RPN Exercise to evaluate whether the
occurrence and/or the severity has come down and the
possibilities of detection has improved.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Verify Results

 All revised rankings should be reviewed.

 Actions alone do not guarantee that the problem
was solved (i.e., cause addressed),
 An appropriate analysis or test should be
completed as verification.
 If further action is considered necessary, repeat
the analysis.
 The focus should always be on continuous
improvement

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Key points to remember

 Upon successful completion of this course, you should know:

 1. Potential FMEA Reference Manual is the authoritative reference.
 2. Severity scores of 9 or 10 must be used for safety related risks.
 3. Occurrence ranks how often each cause is likely to result in failure.
 4. It is appropriate to focus on high severity items first.
 5. Credit for preventive actions shows up in the frequency of occurrence.
 6. Risk Priority Numbers provides a rank order to risks and action items.
 7. An effective approach is to continually focus on the top five concerns.
 8. Process FMEA should result in tangible improvement to process
performance

FMEA - FAILURE MODE and EFFECTS ANALYSIS

Process FMEA Report

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Maintaining FMEA
 PFMEA is a living document and should be
reviewed whenever there is a product or process
design change and updated, as required.
 PFMEAs should include a periodic review.
 Specific focus should be given to
Occurrence and Detection rankings.
 In cases where either field issues or production
issues, such as disruptions, have occurred, the
rankings should be revised accordingly.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 review

How often you review the FMEA?

Whenever any changes take place, in the spec,
drawing, process, method, people, machinery,
toolings, inspection activities, control plan, Test
plan, .
Literally any change, review the FMEA and
update.

FMEA - FAILURE MODE and EFFECTS ANALYSIS

 Leveraging PFMEAs

• The use of a fundamentally sound PFMEA is

the starting point that provides the greatest
opportunity to leverage the use of past
experience and knowledge

FMEA - FAILURE MODE and EFFECTS ANALYSIS