FMEA FAILURE MODE AND EFFECTS ANALYSIS

An analytical methodology to ensure potential problems are considered and

addressed throughout the product and process (APQP) development stages
Timing of FMEA is critical Before the event action is what is needed and not
After the event of failure
Design FMEA should be done during project initialization phase and process
FMEA before tooling or manufacturing equipments are developed / purchased
Cross functional expert inputs remain mandatory
Risk assessment product & process design phase is vital
Basic cases for FMEA application that remains mandatory;
o New design, new technology, new process
o Modification of existing design or process
o Use of an existing design or process in a new environment, location,
application or usage profile(duty cycle, regulatory requirements etc)
FOCUS OF FMEA
o Plan and define program
o Product design and development
o Process design and development
o Product and process validation
o Feedback, assessment and corrective action
Clear statements, concise terminology and focus on actual effects are the key to
effective identification and mitigation of risk issues.
FMEA is a living document effective communication to all affected
activities/functional is ultimately necessary to give life to a proper effective
thorough, thought-out FMEA.
o Review designs, processes and related records to ensure recommended
o

actions have been implemented

Confirmation of incorporation of changes to

design/assembly/manufacturing documents
o Review design/process FMEAs, special applications and control plans
COMMON APPROACH
o Potential product/process failure modes need to be identified
Different ways or manner by which a product/process could fail
o
o

Potential

Potential

to meet the design intent or process requirements

consequences need to be discussed upon
Effects of the failure as perceived by the customer/end user
causes for each mode need to be identified
Indication of how the failure might occur
Direct proportionality to failure modes, if the risk causing factor
occurs, the probability of failure mode happening is very high

Control plans need to be drafted for each of the failure causes

Application of current control plan needs to be verified
Prevention or identification of failure or failure modes
It is important to understand what is causing the failure, why

Level of

and how to prevent the recurrence

Controls focused on prevention will provide greatest returns
risk should be analyzed
Severity effect on the customer
Occurrence how often the cause may occur
Detection how well the control plan detects the cause of failure

mode
Reduction of risk is the key
Recommended actions for each of the failure mode is important
Ensuring design requirements including reliability are achieved
Reviewing engineering drawings and specifications

Confirming incorporation in process

Reviewing related FMEAs, control plans and operation

instructions
Responsibility and time plan to complete recommended actions

should be recorded
At closure of every action, rating for severity, occurrence and
detection should be recorded

FMEA REQUIREMENTS
o Functions, requirements and deliverables of product/process being
o
o
o
o
o
o
o
o
o
o
o
o
o
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analyzed
Failure modes when functional are not met
Effects and consequences of failure modes
Action plan and control plan to address each failure modes
Preventive action plan to control recurrence of failure mode
General purpose of the product
Safety
Government regulations
Reliability life of the function
NVH limitations
Fluid retentions
Ergonomics
Appearance
Packaging and shipping
Service

o Design for assembly

o Design for manufacturability
Scope of FMEA should be very clear to the CFT before drafting the FMEA what
is to be excluded is as important as what is to be included in discussion
o System FMEA
o Subsystem FMEA
o Component FMEA
BLOCK DIAGRAM
o Block diagram shows physical and logical relationships between
o

components of the product

It indicates interaction of components and subsystems within the scope of

design
o Flow of information, energy, fore or fluid
PARAMETER (P) DIAGRAM
o A structured tool to help understand the physics related to the functions of
o

design
Potential failure modes are clearly listed