This document provides an introduction to Failure Mode and Effects Analysis (FMEA). It discusses what FMEA is, the types of FMEA (Design and Process), why FMEA is performed, when to perform it, and the steps to perform an FMEA. FMEA is a systematic method to identify potential failures, assess risks, and mitigate issues in the design or manufacturing process. It involves identifying failure modes and their causes and effects, then prioritizing failures based on severity, occurrence, and detection rankings. The goal is to address high-risk failures early in the design or process development stages to reduce costs and improve quality and safety.

1. Presented by
Dr. R. RAJA, M.E., Ph.D.,
Assistant Professor, Department of EEE,
Muthayammal Engineering College, (Autonomous)
Namakkal (Dt), Rasipuram – 637408
MUTHAYAMMAL ENGINEERING COLLEGE
(An Autonomous Institution)
(Approved by AICTE, New Delhi, Accredited by NAAC, NBA & Affiliated to Anna University),
Rasipuram - 637 408, Namakkal Dist., Tamil Nadu.
Introduction to Failure Mode and Effects Analysis (FMEA) in TQM

2. FMEA
Introduction to Failure Mode and Effects Analysis (FMEA)
 There are numerous high-profile examples of product recalls resulting from
poorly designed products and/or processes.
 These failures are debated in the public forum with manufacturers, service
providers and suppliers being depicted as incapable of providing a safe product.
 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 failures in a design or manufacturing process.
 Developed in the 1950s, FMEA was one of the earliest structured reliability
improvement methods. Today it is still a highly effective method of lowering
the possibility of failure.
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3. What is Failure Mode and Effects Analysis (FMEA)
 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.
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4.  FMEA is not a substitute for good engineering. Rather, it enhances good
engineering by applying the knowledge and experience of a Cross Functional
Team (CFT) to review the design progress of a product or process by assessing
its risk of failure.
 There are two broad categories of FMEA, Design FMEA (DFMEA) and
Process FMEA (PFMEA).
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5. Design FMEA
Design FMEA (DFMEA) explores the possibility of 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
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6. Process FMEA
Process FMEA (PFMEA) discovers failure that impacts product quality, reduced
reliability of the process, customer dissatisfaction, and safety or environmental
hazards derived from:
 Human Factors
 Methods followed while processing
 Materials used
 Machines utilized
 Measurement systems impact on acceptance
 Environment Factors on process performance
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7. Why Perform Failure Mode and Effects Analysis (FMEA)
 Historically, the sooner a failure is discovered, the less it will cost. If a failure is
discovered late in product development or launch, the impact is exponentially
more devastating.
 FMEA is one of many tools used to discover failure at its earliest possible point
in product or process design. 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 (DFM/A)
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Late Failure Mode Discovery
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Early Failure Mode Discovery
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10.  Lower cost solutions
 Legacy, Tribal Knowledge, and Standard Work utilization
Ultimately, this methodology is effective at identifying and correcting process
failures early on so that you can avoid the nasty consequences of poor performance.
When to Perform Failure Mode and Effects Analysis (FMEA)
There are several times at which it makes sense to perform a Failure Mode and
Effects Analysis:
 When you are designing a new product, process or service
 When you are planning on performing an existing process in a different way
 When you have a quality improvement goal for a specific process
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11.  When you need to understand and improve the failures of a process
In addition, it is advisable to perform an FMEA occasionally throughout the lifetime of a
process. Quality and reliability must be consistently examined and improved for optimal
results.
How to Perform Failure Mode and Effects Analysis (FMEA)
 FMEA is performed in seven steps, with key activities at each step. The steps are
separated to assure that only the appropriate team members for each step are
required to be present.
 The FMEA approach used by Quality-One has been developed to avoid typical
pitfalls which make the analysis slow and ineffective.
 The Quality-One Three Path Model allows for prioritization of activity and efficient
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12. There are Seven Steps to Developing an FMEA:
 FMEA Pre-Work and Assemble the FMEA Team
 Path 1 Development (Requirements through Severity Ranking)
 Path 2 Development (Potential Causes and Prevention Controls through
Occurrence Ranking)
 Path 3 Development (Testing and Detection Controls through Detection
Ranking)
 Action Priority & Assignment
 Actions Taken / Design Review
 Re-ranking RPN & Closure
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14. Stages of FMEA
Process Failure Mode and Effects Analysis must be done in a step-wise fashion since
each step builds on the previous one. Here’s an overview of the 10 steps to a
Process FMEA.
STEP 1: Review the process
 Use a process flowchart to identify each process component.
 List each process component in the FMEA table.
 If it starts feeling like the scope is too big, it probably is. This is a good time to
break the Process Failure Mode and Effects Analysis into more manageable
chunks.
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15. STEP 2: Brainstorm potential failure modes
 Review existing documentation and data for clues about all of the ways each
component can failure.
 The list should be exhaustive – it can be paired down and items can be
combined after this initial list is generated.
 There will likely be several potential failures for each component.
STEP 3: List potential effects of each failure
 The effect is the impact the failure has on the end product or on subsequent
steps in the process.
 There will likely be more than one effect for each failure.
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16. STEP 4: Assign Severity rankings
 Based on the severity of the consequences of failure.
STEP 5: Assign Occurrence rankings
 Rate the severity of each effect using customized ranking scales as a guide.
STEP 6: Assign Detection rankings
 What are the chances the failure will be detected prior to it occuring.
STEP 7: Calculate the RPN
 Severity X Occurrence X Detection
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17. STEP 8: Develop the action plan
 Decide which failures will be worked on based on the Risk Priority
Numbers. Focus on the highest RPNs.
 Define who will do what by when.
STEP 9: Take action
 Implement the improvements identified by your Process Failure Mode and
Effects Analysis team.
STEP 10: Calculate the resulting RPN
 Re-evaluate each of the potential failures once improvements have been made
and determine the impact of the improvements.
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18. Thank You
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