QUALITY AND

RELIABILITY
ENGINEERING
TOPIC
FAILURE MODE EFFECT AND ANAYLISIS (FMEA)
DALSANIYA JAYDEEP (190280119021)
DIV –AB
INTRODUCTION:

• Failure Mode and Effects Analysis, or FMEA, is a methodology aimed at allowing organizations to
anticipate failure during the design stage by identifying all of the possible failure in a design or
manufacturing process.
• FMEA was Developed in the 1950s, FMEA was one of the earliest structured reliability improvement
method. Today it is still a highly effective method of lowering the possibility of failure.
• Failures are prioritized according to how serious their consequences are, how frequently they occur, and
how easily they can be detected.
PURPOSE OF USING FMEA:

• The purpose of using FMEA is to take actions to eliminate or reduce failures, starting with the highest –
priority ones.
• It is an effective in evaluating both new and existing processes and systems. For new processes, it
identifies potential bottlenecks or unintended consequences prior to implementation.
• FMEA involves identifying and eliminating process failures for the purpose of preventing an undesirable
event.
• “Failure Modes” means the ways, or modes, in which something might fail. Failures are any errors or
defects, especially ones that affects the customers, and can be potential or actual.
• “Effects analysis” refers to studying the consequences of those failures.
FMEA INCLUDES REVIEW OF THE
FOLLOWING
• Steps in the process
• Failure modes (What could go wrong?)
• Failure causes (Why would the failure happen?)
• Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that
may exist within the design of a product or process.
• Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead
to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed
to identify, prioritize and limit these failure modes.
AREA OF APPLICATION

There are several times at which it makes sense to perform a Failure Mode Effects Analysis, like as:
• When a process, product, or service is being designed or redesigned, after Quality Function
Deployment(QFD).
• When an existing process, product, or service is being applied in a new way.
• Before developing control plans for a new or modified process.
• When improvement goals are planned for an existing process, product, or service.
• Periodically throughout the life of the process, product, or service.
MAJOR TYPES OF FMEA
• There are two broad categories of FMEA, Design FMEA(DFMEA) and process FMEA(PFMEA).
(1) Design FMEA: Design FMEA (DFMEA) explores the possibility of a product malfunctions, reduced
product life, and safety and regulatory concerns derived from:
• Material properties
• Geometry
• Tolerances
• Interfaces with other components and/or systems
• Engineering noise: Environments, user profile, degradation, systems interactions.
(2) Process FMEA : Process FMEA (PFMEA) discovers failures that impacts product quality, reduces
reliability of the process, customer dissatisfaction and safety or environmental hazards derived from:
• Human factors
• Methods followed while processing
• Machines used
• Machines utilized
• Measurement systems impact on acceptance
• Environment factors on process performance.
BASIC STEPS TO DEVELOPING FMEA
FMEA is performed in seven steps with key activities at each steps. The steps are separated to assure that
only the appropriate team members for each step are required to be present.
The seven steps are:
Step-1 : Planning and preparation
Step-2 : Structure analysis
Step-3 : Function analysis
Step-4 : Failure analysis
Step-5 : Risk analysis
Step-6 : Optimization
Step-7 : Results documentation.
Step 1 : Planning and preparation
 The FMEA study starts with a purposeful and careful definition of the scope. The management team is
responsible for setting the scope of the study. This step involves the collection and creation of key
documents.
Step 2 : Structure analysis
 Structure analysis is used to identify and break down the process into sequential steps, interfaces and
logistical elements. It uses the boundaries stipulated in the definition of scope done in step 1 in order to
identify each stage, interface and logistical element in the process at hand.
 Structure analysis is aimed at facilitating complete understanding of the process. Start with the central
element of your scope, identify the process it is part of and, finally, indicate all elements related directly
to it.
Step 3 : Function analysis
 Every part of the product or of the process has a purpose. It exists because it must fulfil requirements
such that the product can work properly or that the process operates as intended. These requirements
are fulfilled by functions in this step of the analysis.
 There should be an exploration of what the product should be doing in the function analysis step, as
well as of what should be executed in the general process (and each one of its activities) and how this
functionality is facilitated. Using the structure analysis developed in step 2, each element is analysed
separately in terms of its function and corresponding requirements.
Step 4 : Failure analysis
 When a part of the product or of the process deviates from the function in a significant way (or fails to
perform it completely), failures are generated. These failures are, of course, assigned to the relevant
function.
Step 5 : Risk analysis
 Every failure cause represents a risk of the product or of the process. The severity of the risk depends
on three factors.
a) The probability of a failure cause occurring in spite of existing preventive actions (if such actions exist).
b) The probability of a failure cause being detected with the application of appropriate detection actions.
c) The severity of the failure effects to which the failure cause will lead (via a failure mode).
 In step 5, the severity, occurrence and detection of each failure chain is evaluated. An appropriate
priority level of “high, medium or low” is obtained based on evaluations which establish a Risk Priority
Number (RPN) for actions needed, aimed at reducing the risk of failure to function as intended.
 The RPM is calculated by multiplying the three rankings together.
RPM = Severity x Occurrence x Detection.
Step 6 : Optimization
 The primary objective of the optimization step is to develop actions that reduce risks and increase
customer satisfaction, improving the product.
 Most actions will likely involve lowering the likelihood of the occurrence of failure causes or improving
detection controls, either approach leads to a more robust design.
Step 7 : Results documentation
 The results of each FMEA study should be fully documented. An FMEA study is not finished until Step 7
has been completed.
FORMAT OF FMEA
BENEFITS OF USING FMEA
• Discovering a failure early in Product Development (PD) using FMEA provides the benefits of:
• Multiple choices for mitigating the risk.
• Higher capability of verification and validation of changes.
• Collaboration between design of the product and process.
• Improved Design for Manufacturing and Assembly (DFMA).
• Contributes to control plans and other quality assurance procedures.
• Lower cost solutions
• Legacy, tribal knowledge, and standard work utilization.
• Results in higher reliability and better quality.
• Increases safety, enhances customer satisfaction and reduce costs.
Thank you