Design and Process Failure Modes & Effects Analysis

(DFMEA & PFMEA)

 Abstract

Failure Modes and Effects Analysis (FMEA) is a structured and systematic methodology used to
identify, assess, and prioritize potential failure modes in a product, process, or system. The
primary goal of FMEA is to proactively recognize possible failures before they occur, assess their
effects on the overall system, and implement corrective actions to mitigate or eliminate risks. By
focusing on the likelihood and consequences of failure modes, FMEA enables teams to prioritize
risks based on severity, occurrence, and detectability, often using a Risk Priority Number (RPN)
to rank them.

FMEA is widely utilized across various industries, including manufacturing, aerospace,

automotive, healthcare, and electronics, to enhance product reliability, improve safety, and
optimize quality control. It helps teams identify critical failure points that could lead to operational
disruptions, safety hazards, or financial loss. As a result, organizations can allocate resources more
effectively to address high-priority risks, improve processes, and prevent potential issues before
they impact customers or stakeholders.

The process of FMEA involves collaborative brainstorming, risk assessment, and the development
of actionable plans to reduce the probability of failure or improve detection systems. The analysis
is an ongoing effort, often revisited throughout a product's lifecycle to ensure continuous
improvement and risk mitigation. Overall, FMEA plays a crucial role in ensuring that products
and processes meet reliability standards, comply with regulatory requirements, and ultimately
contribute to the success of an organization.

This abstract summarizes the key elements and purpose of FMEA, illustrating its importance in
risk management and quality improvement across different industries.

Keywords: FMEA, severity, occurrence, detection, RPN, probability, mitigate or eliminate risks,
Prioritize High-Risk Failure Modes

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Table of Contents
1. Introduction
1.1 Definition of FMEA
1.2 Purpose and Objectives
2. History of FMEA
2.1 Early Beginnings
2.2 Evolution of FMEA in Different Industries
2.3 Key Milestones and Developments
3. Key Concepts in FMEA
3.1 Failure Modes
3.2 Effects of Failures
3.3 Causes of Failures
3.4 Risk Priority Number (RPN)
3.5 Severity, Occurrence, and Detection
4. Process steps in FMEA
4.1 Identifying Failure Modes
4.2 Assessing the Effects of Failure
4.3 Identifying the Causes of Failure
4.4 Evaluating the Risks
4.5 Prioritizing Failure Modes
4.6 Developing and Implementing Action Plans
4.7 Documentation and Communication
5. Types of FMEA
5.1 Design FMEA (DFMEA)
5.2 Process FMEA (PFMEA)
6. Benefits of FMEA
6.1 Proactive Risk Management
6.2 Improved Quality and Reliability
6.3 Enhanced Safety
6.4 Cost Reduction and Efficiency
6.5 Continuous Improvement and Compliance
7. Case Study DFMEA and PFMEA of a Ladder
8. Conclusion

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1. Introduction

1.1 Introduction to FMEA (Failure Modes and Effects Analysis):

FMEA is a systematic methodology used to identify and evaluate potential failure modes of a
product or process and their consequences. It helps prioritize risks to mitigate them before they
cause significant harm or failure, making it an essential tool for quality management and reliability
engineering. It is a step-by-step risk management and process analysis tool that identifies where
and how failures might occur in a design, manufacturing, or assembly process for a product or
service and quantifies the influence of potential failures in a process. It assesses the relative impact
of different failures in order to identify the parts of the process that need to change.

Key Components of FMEA:

1. Failure Modes: These are the ways in which a process, system, or component
could fail. In this context, "failure" could mean anything from malfunctioning, degradation
of performance, or even a complete breakdown.
2. Effects of Failures: This refers to the impact or consequences of the failure on the
system, product, or process. The effects could range from minor issues (e.g.,
inconvenience) to catastrophic failures (e.g., safety risks, financial loss).
3. Cause of Failure: These are the root causes or reasons that lead to the failure
modes. Identifying these causes is essential for prevention and corrective action.
4. Risk Priority Number (RPN): RPN is a score assigned to each failure mode based
on its severity, likelihood of occurrence, and the ability to detect it before it leads to harm.
The formula for calculating RPN is:

RPN = Severity × Occurrence × Detection

Where:
o Severity (S): How severe the effect of the failure is on the system (rated on
a scale of 1 to 10).
o Occurrence (O): The probability of the failure mode occurring (rated on a
scale of 1 to 10).
o Detection (D): The likelihood of detecting the failure before it impacts the
system (rated on a scale of 1 to 10).

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 5. Action Plan: After identifying high-RPN failure modes, corrective actions are
taken to reduce risk by either eliminating the cause, improving detection, or mitigating the
effect of the failure.

Applications of FMEA:

• Manufacturing: To assess product designs or manufacturing processes and reduce

defects.
• Healthcare: To prevent failures in medical devices or procedures that could affect
patient safety.
• Automotive and Aerospace: To ensure reliability and safety in complex systems.
• Software Development: To predict and mitigate potential software system failures
before release.

FMEA is a vital tool in any industry that values risk reduction, safety, and operational efficiency.

1.2 Purpose and Objectives of FMEA:

The objectives of conducting FMEA in a project are focused on identifying potential failure
modes, assessing their impact, and prioritizing risks to ensure that corrective actions are taken
before failures occur. These objectives align with improving product reliability, safety, and
performance while optimizing processes. Here are the key project objectives of FMEA:

1. Identify Potential Failure Modes:

o The primary objective of FMEA is to identify all possible failure modes for
a system, process, or product. This involves brainstorming and reviewing every
component, step, or feature that could potentially fail in different ways (e.g.,
mechanical failure, software malfunction, human error).
2. Assess the Impact of Failure:
o Once failure modes are identified, FMEA seeks to determine the
consequences of each failure. This includes evaluating the severity of the failure’s
effect on the product, process, or end-users. The impact assessment helps prioritize
which failure modes require immediate attention due to their potential harm or risk.
3. Prioritize Risks Based on Severity, Occurrence, and Detection:

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 o A key objective of FMEA is to assess and rank the identified failure modes
using the Risk Priority Number (RPN). This prioritization helps focus resources
on high-risk failure modes that are most likely to cause significant damage or
operational disruption.
o The prioritization is based on:
▪ Severity (S): How severe the effect of the failure is.
▪ Occurrence (O): The likelihood of the failure happening.
▪ Detection (D): The ability to detect the failure before it causes
harm.
4. Develop Mitigation and Corrective Actions:
o FMEA aims to identify actionable steps that can reduce or eliminate the
risks associated with high-priority failure modes. Corrective actions could include
redesigning a component, improving quality control measures, or enhancing
process monitoring.
o The goal is to proactively mitigate risks rather than react to failures after
they occur.
5. Improve Product or Process Reliability and Safety:
o FMEA is applied to enhance the overall reliability, safety, and performance
of a product or process by ensuring that potential risks are systematically identified
and managed. The objective is to make the system or product robust by minimizing
failure points and preventing costly and dangerous failures.
6. Document and Communicate Risks Across Teams:
o Another key objective is to create a comprehensive record of failure modes,
effects, causes, and actions taken. This documentation helps facilitate
communication among cross-functional teams (e.g., design, manufacturing,
quality assurance) and ensures that everyone involved is aware of potential risks
and the measures being taken to address them.
7. Support Continuous Improvement:
o FMEA is not a one-time activity but is part of an ongoing process of
continuous improvement. The objective is to regularly revisit and update FMEA
analysis as new risks emerge, designs change, or processes evolve. This iterative
approach helps companies stay ahead of potential issues and continuously enhance
the quality of their products and processes.

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8. Optimize Resource Allocation:
o FMEA helps prioritize risks, which ensures that resources (e.g., time,
budget, manpower) are focused on addressing the most critical failure modes that
pose the greatest threat to the project. This reduces wasted effort and improves the
efficiency of risk mitigation actions.
9. Ensure Compliance and Regulatory Requirements:
o In industries such as automotive, healthcare, and aerospace, FMEA plays a
role in meeting industry standards and regulatory requirements. The objective is to
demonstrate a proactive approach to identifying and managing risks, ensuring the
product or process complies with safety and quality standards.
10. Reduce Costs and Enhance Customer Satisfaction:
o By preventing failures before they occur, FMEA can lead to cost savings
by avoiding rework, recalls, and warranty claims. It also enhances customer
satisfaction by ensuring the reliability, safety, and quality of the product, ultimately
fostering trust and reducing the risk of reputation damage.

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2. History of FMEA

2.1 Early Beginnings:

FMEA has its roots in the early stages of engineering and quality management, particularly in
the military and aerospace industries.

2.2 Evolution of FMEA in Different Industries:

Here's a timeline of the key developments in the history of FMEA:

1. 1940s – Early Military Applications:

o The concept of FMEA can be traced back to World War II when the U.S.
military recognized the importance of reliability and quality in their equipment,
such as aircraft and munitions.
o During this time, the military began formalizing procedures to evaluate and
improve the reliability of critical systems. They wanted to prevent failures that
could lead to the loss of life or equipment. However, it was not until later that these
methods were standardized and applied more widely.
2. 1950s – Reliability Engineering and Aerospace Industry:
o In the post-World War II era, the aerospace industry became a pioneer in
the development of reliability engineering. The U.S. Department of Defense (DoD)
played a significant role in pushing for more structured analysis to predict failure
modes in complex systems.
o In 1952, the U.S. Air Force introduced MIL-P-1629, a document outlining
a formal methodology for Failure Modes and Effects Analysis. This was the first
time FMEA was defined as a structured technique, primarily aimed at improving
the reliability of military equipment and systems.
3. 1960s – Expansion Beyond Military Use:
o FMEA gained popularity in the 1960s and began to expand beyond military
and aerospace applications. The automotive industry, particularly General Motors
(GM), adopted FMEA to improve product quality and reliability.
o As the automotive industry sought to reduce defects and improve product
performance, the adoption of FMEA became more widespread, especially for
evaluating parts and systems for their potential failure modes and effects.
4. 1970s – Formalization and Standardization:

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 o During this period, FMEA became more formalized in various industries.
The methodology evolved, and the concept of the Risk Priority Number (RPN)
was introduced to prioritize risks based on the severity, occurrence, and detection
of potential failures.
o The development of guidelines, such as those published by organizations
like the Society of Automotive Engineers (SAE), further helped standardize
FMEA processes and terminology.
5. 1980s – FMEA in Quality and Continuous Improvement:
o The 1980s saw the rise of Total Quality Management (TQM) and Six Sigma
principles, which emphasized process improvement and defect reduction. FMEA
was increasingly integrated into these methodologies to assess potential failure
risks at early stages of product or process development.
o Companies across various sectors, including manufacturing, healthcare,
and electronics, began incorporating FMEA into their quality assurance processes.
6. 1990s and 2000s – Globalization and Broader Application:
o As industries became more globalized, FMEA spread to other sectors
beyond automotive and aerospace. Manufacturing, healthcare, medical devices,
and electronics began to recognize the value of FMEA for identifying and
mitigating risks.
o In 1995, the Automotive Industry Action Group (AIAG) published the
FMEA handbook, which became an industry standard, particularly for
automotive suppliers.
o The medical device industry also started incorporating FMEA techniques
in the 1990s to improve patient safety and the reliability of medical equipment.
7. 2010s to Present – Digital and Integrated Approaches:
o With advancements in software tools and digital systems, FMEA became
more automated and integrated into broader risk management and quality systems.
o Today, FMEA is a widely used methodology across various industries,
from manufacturing to healthcare, with organizations increasingly using software
to streamline the FMEA process and facilitate collaboration.

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2.3 Key Milestones:
• 1952: The U.S. Air Force’s introduction of MIL-P-1629 formalized the FMEA
process.
• 1960s: The automotive industry began adopting FMEA for product quality and
reliability.
• 1970s: Standardization and formalization of FMEA continued, with the
introduction of the Risk Priority Number (RPN) concept.
• 1980s: FMEA became an integral part of Total Quality Management (TQM) and
Six Sigma approaches.
• 1995: The AIAG published its FMEA handbook, becoming a critical reference for
the automotive industry.
• 2000s – Present: The use of FMEA expanded across various industries, supported
by advancements in digital tools and risk management systems.

Today, FMEA is a core component of risk management, quality control, and continuous
improvement processes across many sectors. It remains one of the most trusted and widely used
tools for identifying potential failures and mitigating risks before they can cause significant harm.

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3. Key Concepts in FMEA

3.1 Failure Modes:

Functional Failure: This occurs when the product or system fails to perform its intended
function. For example, a pump might fail to deliver water due to a motor malfunction.
Degradation Failure: This involves the gradual decline of performance, such as wear and tear
over time. An example could be the gradual erosion of brake pads in a car.
Design Failure: A failure that arises due to flaws in the product's design, such as a part that is too
fragile or poorly shaped.
Manufacturing Failure: Failures that occur due to defects in manufacturing processes, such as
incorrect assembly or material defects.
Process Failure: This refers to failures due to problems in the operational or production process,
such as a failure to meet quality standards or improper handling.
For example, in an FMEA for a car engine, some possible failure modes might include:
• Fuel pump failure: The engine might fail to start if the fuel pump malfunctions.
• Battery failure: The engine may not turn over if the battery loses charge.
• Overheating: If the engine cooling system fails, the engine could overheat,
causing permanent damage.

3.2 Effects of Failures:

Safety Impact: Failure could cause harm or danger to people, such as in machinery or vehicle
systems.
Performance Impact: Failure may affect how well the system or product performs, resulting in
reduced efficiency, functionality, or reliability.
Financial Impact: Failure can result in additional costs for repairs, replacements, or downtime.
Reputation Impact: A failure in a product or service could harm the company's reputation and
customer trust.
Environmental Impact: Some failures might have adverse environmental effects, such as spills,
emissions, or waste.

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Categories of Effects:

• Local Effects: The failure only affects a specific component or part of the system.
• Systemic Effects: The failure causes a broader issue that affects the entire system,
process, or product.
• End User Impact: The failure affects the end user directly, either through
malfunction or dissatisfaction.

Example : FMEA for a Car Engine

Let's consider a car engine. Some potential failure modes and their effects might be as follows:

• Failure Mode: Fuel Pump Failure

o Effect: The engine fails to start, leading to a breakdown.
o Severity: High (could leave the driver stranded, requiring costly repairs or
tow).
o Consequences: Performance is compromised, safety is impacted (if it
happens in a dangerous location), and there are financial implications (cost of
repairs).

• Failure Mode: Overheating of the Engine

o Effect: The engine could seize, causing extensive damage to internal
components.
o Severity: Very high (could lead to total engine failure, requiring a full
replacement).
o Consequences: Major performance impact, significant financial cost
(repair or replacement), and safety risk (fire hazard).

• Failure Mode: Dead Battery

o Effect: The car will not start, leaving the driver unable to use the vehicle.
o Severity: Medium (inconvenience, but not dangerous).
o Consequences: Performance is compromised, requiring a battery
replacement, which is a relatively low-cost repair compared to major engine issues.

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3.3 Causes of Failures:

Failure Mode: Product Breakdown

• Cause: Poor quality materials or defective components.

• Example: In a car, using subpar materials for the engine components leads to
overheating and engine failure.

Failure Mode: Design Deficiency

• Cause: Incorrect design specifications or overlooked factors in the design phase.

• Example: A smartphone with a poorly designed battery compartment that leads to
short circuits or overheating due to improper insulation.

Failure Mode: Manufacturing Defects

• Cause: Inconsistent or inadequate quality control processes in the production line.

• Example: A laptop's screen is cracked during the assembly process because of
improper handling or incorrect machinery settings.

Failure Mode: Human Error

• Cause: Mistakes made by operators or engineers during production, assembly, or

operation.
• Example: In a pharmaceutical plant, an employee mislabels drug containers,
leading to the distribution of incorrect medications.

Failure Mode: Environmental Conditions

• Cause: Extreme temperature, humidity, dust, or corrosive environments that

degrade the system.
• Example: A high-end computer system in a factory is exposed to excess moisture,
causing internal circuits to corrode and fail.

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Failure Mode: Wear and Tear

• Cause: Excessive use, improper maintenance, or poor-quality parts that wear out
faster than expected.
• Example: A conveyor belt in a warehouse system shows signs of fatigue and fails
after prolonged use without regular maintenance.

Failure Mode: Lack of Proper Training

• Cause: Insufficient or inadequate training for personnel operating or maintaining

equipment.
• Example: An operator misinterprets control settings on a machine, leading to a
malfunction or production defect.

Failure Mode: Software Glitch

• Cause: Errors in the software code or incompatible updates.

• Example: An automated car’s navigation system crashes due to a software bug,
causing a malfunction in the vehicle’s guidance system.

Failure Mode: Poor Packaging

• Cause: Inadequate packaging materials or methods that fail to protect the product
during shipping or handling.
• Example: Electronics arriving damaged at a store due to poor packaging that
doesn’t protect against impacts during transit.

3.4 Risk Priority Number (RPN)

RPN is calculated from the values of severity, occurrence, and detection as follows:

RPN = Severity * Occurrence * Detection (or RPN = S x O x D)

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RPN should be calculated for the entire design and/or process and documented in the FMEA. The
highest RPNs should get the highest priority for corrective measures. These measures can include
a variety of actions including new inspections, tests or procedures, design changes, different
components, added redundancy, modified limits, etc.

3.5 Severity, Occurrence, and Detection:

Determine severity

Severity refers to how serious the consequences and effects are of a failure. A numerical
number of severity is assigned to each failure, with 1 being the lowest severity and 10
being the highest. Typical FMEA severity ratings are as follows:

1 - No effect, no danger

2 - Very minor – usually noticed only by very observant users

3 - Minor – only a minor part of the system is affected; the failure is noticed by average
users

4-6 - Moderate – most users are merely inconvenienced and/or annoyed

7-8 - High – there is a loss of primary function; users are dissatisfied

9-10 - Very high – failure constitutes a safety hazard and can cause injury or death, or the
product becomes in-operative, and customers become angry

Gauge likelihood of occurrence

Examine and document the cause(s) of each failure mode and how often failure occurs.
Look at similar processes or products and their documented failure modes. Examples of
causes can include incorrect algorithms, insufficient or excess voltage, the temperature or
humidity of the operating environment. Failure modes are also assigned a number based
on occurrence, with 1 being the lowest and 10 being the highest.

1 - No documented failures on similar products or processes

2-3 - Low - relatively few failures occur

4-6 - Moderate - there are some occasional failures

7-8 - High - repeated failures are experienced

9-10 - Very high - failure is almost certain, and the results in a hazard
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Failure detection

Determine corrective actions and when they should be tested for efficacy and efficiency.
Verify and inspect procedures within the design of the system or process. A detection value
is assigned to each failure indicating how likely the failure will be detected, and ranks the
ability of identified actions to remedy or remove defects or detect failures. The higher the
value of D, the more likely the failure will not be detected.

1 - Fault is certain to be detected by testing

2 - Fault is almost certain to be detected by testing

3 - High probability that testing will detect the fault

4-6 - Moderate probability that tests will detect the fault

7-8 - Low probability that testing will detect the fault

9-10 - Fault will be passed undetected to the end-user/customer

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4.Process in FMEA

Steps

• Form a cross-functional team

• Take a recurring issue and define the problem

• Analyse functional requirements: and their effects and identify all potential areas
of failure. It’s important to consider that failure modes in one component can induce failure
in others.

4.1 Identify potential failure modes: List all failure modes per function and consider the
ultimate effect(s) of each failure mode. Examples of failure effects include overheating, noise,
abnormal vibration, shutdown, or user injury. Failure Modes are the anti-functions or
requirements not being met. There are 5 types of Failure Modes:

• Functional Failure: This occurs when the product or system fails to

perform its intended function. For example, a pump might fail to deliver water
due to a motor malfunction.
• Design Failure: A failure that arises due to flaws in the product's design,
such as a part that is too fragile or poorly shaped.
• Manufacturing Failure: Failures that occur due to defects in
manufacturing processes, such as incorrect assembly or material defects.
• Process Failure: This refers to failures due to problems in the operational
or production process, such as a failure to meet quality standards or improper
handling.
• Full Failure / replacement
• Partial Failure / repair
• Intermittent Failure - repair
• Degraded Failure – This involves the gradual decline of performance, such
as wear and tear over time. An example could be the gradual erosion of brake
pads in a car.
• Unintentional Failure / oversight

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 4.2 Assessing the Effects of Failure: Consider what would happen if each failure occurred.
Brainstorm all the ways a system, product, or process might fail.

4.3 Identifying the Causes of Failure: Find out why each failure might happen.

4.4 Evaluating the Risks: Calculate the RPN for each failure mode based on its severity,
occurrence, and detection.

4.5 Prioritizing Failure Modes: Address the most critical failure modes first (those with the
highest RPN). Risk priority numbers (RPNs) influence which actions will be taken first against
failure modes.

4.6 Developing and Implementing Action Plans: Implement solutions to reduce risk or improve
the detection of potential failures. corrective measures, calculate RPN again and document the
results in the FMEA.

4.7 Documentation and Communication: Monitor and measure the impact of the changes:
Compare the design before and after RPN, maintain a history of improvements and risk mitigation
done.

Detection
Degree of Probability of Frequency
Rating Cpk Ability to Detect Certainty
Severity Occurrence (1 in …)
(%)
Customer will Sure, failure will be
Likelihood of
not notice or > found/prevented
1 occurrence is 10,00,000 100%
effect is 1.67 before reaching the
remote
insignificant next customer
Almost certain failure
Slight Low failure rate will be
2 annoyance to the with supporting 20,000 1.33 found/prevented 99%
customer documentation before reaching the
next customer
Annoyance due Low failure rate
Low likelihood of
to slight without
3 5,000 ~1.0 reaching next 95%
performance supporting
customer undetected
degradation documentation
Customer Occasional < Controls may
4 2,000 90%
dissatisfaction failures 1.0 detect/prevent failure

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 Detection
Degree of Probability of Frequency
Rating Cpk Ability to Detect Certainty
Severity Occurrence (1 in …)
(%)
due to reduced before reaching the
performance next customer
Customer is
Moderate Moderate likelihood
uncomfortable;
5 failure rate with 500 - of reaching the next 85%
productivity
documentation customer
reduced
Moderate Controls unlikely to
Warranty repair
failure rate detect/prevent failure
6 or significant 100 - 80%
without before reaching next
complaint
documentation customer
High
dissatisfaction; High failure Poor likelihood of
7 component rate with 50 - detecting/preventing 70%
failure impacts documentation failure
productivity
Very high Very poor likelihood
High failure
dissatisfaction; of
8 rate without 20 - 60%
loss of function detecting/preventing
documentation
(non-safety) failure
Customer
endangered;
Failure almost Current controls
safety
9 certain based 10 - probably won’t detect 50%
performance
on data failure
affected (with
warning)
Customer
endangered;
Absolute certainty
safety Assured failure
10 2 - that controls will not < 50%
performance based on data
detect failure
affected (without
warning)

5. Types of FMEA
There are multiple types of FMEA (Failure Mode and Effects Analysis), including system,
process, design, concept, software, functional, and machinery FMEA.

System FMEA: Analyses failure modes for entire systems and subsystems

System Failure Modes and Effects Analysis (System FMEA) is a structured approach used
to identify and mitigate potential failure modes within a system. It focuses on analysing
the interactions between subsystems, components, and processes to ensure the overall
reliability, safety, and performance of the system.

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Objectives of System FMEA
• Identify potential failure modes in a system.
• Assess the effects of failures on system performance and safety.
• Determine root causes of failures at a system level.
• Prioritize risks based on severity, occurrence, and detection.
• Develop action plans to eliminate or reduce risks.

Benefits of System FMEA

Prevents system failures before they occur.

Improves system reliability and safety.

Enhances product development and compliance with standards.

Reduces costs associated with failures and recalls.

Process FMEA: Analyses potential failures in the processes used to produce a product

Process FMEA is a structured method for identifying and mitigating potential failure
modes in a manufacturing or business process. It focuses on preventing process-related
defects that could impact product quality, efficiency, or safety.

Objectives of PFMEA
Identify potential failures in a process.
Analyze the effects of failures on product quality and operations.

Prioritize risks using a scoring system.

Develop corrective actions to prevent failures.

Improve process reliability and efficiency.

Benefits of PFMEA
Reduces defects and rework.
Improves product quality and consistency.
Enhances customer satisfaction.

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 Lowers manufacturing costs.

Strengthens compliance with industry standards (ISO 9001, IATF 16949).

Design FMEA: Analyses potential risks in a new or changed product design

Design FMEA (DFMEA) is a systematic approach used to identify and mitigate potential
failure modes in product designs before production begins. It helps engineers ensure that
products meet reliability, safety, and performance requirements.

Objectives of DFMEA
Identify potential design-related failure modes.

Evaluate the impact of failures on product performance and safety.

Prioritize risks using a scoring system.

Develop corrective actions to improve design robustness.

Enhance product quality and reduce warranty claims.

Concept FMEA: Helps select the best concept alternatives and decide on design changes

Concept FMEA (CFMEA) is an early-stage risk assessment tool used to evaluate potential
failure modes in a system or product concept before detailed design begins. It helps
identify high-level risks related to functionality, interfaces, and environmental factors.

Objectives of CFMEA
Identify potential risks in a concept before detailed design.

Evaluate failure modes related to system functionality, interactions, and external

conditions.
Prioritize risks to guide design decisions early on.
Reduce costly changes later in the development process.

Ensure system robustness and alignment with customer needs.

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Benefits of CFMEA
Identifies risks before committing to detailed design.

Improves decision-making in early development stages.

Reduces development time and costs by preventing later-stage failures.

Enhances system safety and reliability.

Helps meet industry and regulatory standards.

Software FMEA: Analyses potential failure modes in software systems, applications, or

algorithms

Software FMEA is a structured approach used to identify, assess, and mitigate potential
failure modes in software systems. It focuses on software reliability, functionality, and
interactions with hardware and external components.

Objectives of Software FMEA

Identify potential software failure modes early in development.
Analyse their effects on system performance, security, and safety.

Prioritize risks using a structured approach.

Develop mitigation strategies to enhance software robustness.

Ensure compliance with industry standards (ISO 26262 for automotive, IEC 62304
for medical devices, etc.).

Benefits of Software FMEA

Prevents software failures that could compromise safety and performance.

Reduces debugging time and costly late-stage fixes.

Improves software reliability and cybersecurity.

Enhances compliance with safety and quality standards.

Supports robust software development processes in industries like automotive,
aerospace, and healthcare.

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Functional FMEA: Identifies and prioritizes potential functional failure modes

Functional FMEA (FFMEA) is a risk assessment method focused on identifying and

analyzing failure modes at the functional level of a system. Instead of analyzing individual
components, it examines how system functions may fail and impact overall performance,
safety, and reliability.

Objectives of Functional FMEA

Identify potential failures of system functions.
Assess how these failures affect performance, safety, and user experience.

Prioritize risks based on severity, likelihood, and detectability.

Implement design or process improvements to enhance system reliability.

Ensure compliance with industry standards and regulations.

Benefits of Functional FMEA

Ensures critical system functions operate reliably.

Reduces system failures that could cause safety or operational risks.

Improves early detection of design flaws.

Enhances compliance with safety and reliability standards.

Reduces costly redesigns and product recalls.

Machinery FMEA: Assesses and increases the reliability of machinery

Machinery FMEA (MFMEA) is a structured approach used to identify and mitigate

potential failure modes in machines, equipment, and production systems. It helps ensure
machinery reliability, safety, and efficiency by proactively addressing risks related to
mechanical, electrical, hydraulic, pneumatic, and software-controlled systems.

Objectives of Machinery FMEA

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 Identify potential failure modes in machinery and equipment.

Analyze how failures impact production, safety, and maintenance.

Prioritize risks based on severity, occurrence, and detection.

Implement preventive maintenance and design improvements.

Reduce downtime, repair costs, and operational risks.

Benefits of Machinery FMEA

Reduces unexpected machinery breakdowns.

Improves workplace safety and operator efficiency.

Extends machine lifespan and reduces maintenance costs.

Enhances production consistency and minimizes downtime.

Helps comply with safety and reliability standards (ISO 12100, ISO 13849, etc.).

5.1 DFMEA Template

24
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5.2 PFMEA Template

5.3 FMEA Instructions

1) Identify and name the process, product or service. Identify who has responsibility, and identify the
team.

2) List the item functions in column A.

3) Identify possible failure modes in column B.

4) Describe potential effect(s) of failure modes in column C.

5) Use the Ratings to identify severity in column D.

6) Identify potential causes of failure in column E. Describe these in terms of something that can be
corrected or can be controlled.

7) Rate the likelihood of the identified failure cause occurring in column F. Use the Ratings.

8) Describe the current process controls to prevent the failure mode in column G.

9) Use the Ratings to determine the likelihood that that failure cause will be detected.

10) The Risk Priority Number will be calculated automatically.

11) Use the RPN to identify further actions in columns J, K, and L. Once action is taken, recalculate RPN.

25
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Probability

In FMEA, probability is used to evaluate the likelihood of failure modes and their potential
consequences.

How is probability used in FMEA?

• Probability of occurrence: The likelihood that a failure mode will occur

• Probability of detection: The likelihood that a failure mode will be
detected
• Severity: The acceptance probability threshold, which is inversely related
to probability
• Risk priority number (RPN): A value that combines the severity and
occurrence of a failure mode

How is probability determined in FMEA?

• Occurrence ranking: A relative ranking of the likelihood of failure

modes based on an occurrence scale
• Previous studies: Information from previous studies, such as RPA, can
be used to determine the probability of failure modes
• Expert knowledge: Experts can provide subjective evaluations of failure
modes

26
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27
of
6. Benefits of FMEA

6.1 Proactive Risk Management:

Identifying and addressing potential failures before they happen.

Proactive risk management within the context of FMEA (Failure Modes and Effects Analysis)
is an approach aimed at identifying, assessing, and addressing potential risks before they
materialize. Unlike reactive risk management, which deals with issues after they occur, proactive
risk management seeks to prevent failures and mitigate their consequences in advance. FMEA is
inherently a proactive process because it identifies and evaluates failure modes early in the design
or production process, allowing teams to take preventive actions.

Here’s how proactive risk management is applied in the context of FMEA analysis:

Early Identification of Failure Modes

• FMEA involves identifying potential failure modes early in the design,
manufacturing, or operational phases of a product or process. By systematically reviewing
each component, subsystem, or process step, teams can foresee possible failures and their
consequences.
• Example: A team designs a new pump system. During FMEA, they identify that a
specific valve could wear out over time, leading to a system failure. This failure mode is
identified before the product is even produced.

Risk Assessment and Prioritization

• Once potential failure modes are identified, severity, occurrence, and detection
are assessed to calculate the Risk Priority Number (RPN) for each failure mode.
• Severity is how serious the failure is.
• Occurrence is the likelihood of the failure happening.
• Detection is the likelihood that the failure will be detected before it causes harm
or disruption.
• A high RPN signifies a high-risk failure mode, prompting the need for immediate
attention.

28
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 • Example: A component in an aircraft system is found to have a high risk of failure
due to its high occurrence and severity ratings. The FMEA analysis helps prioritize actions
to mitigate this risk.

Implementation of Preventive Actions

• Based on the identified failure modes, preventive measures or design changes
can be implemented to reduce or eliminate the risks. These actions are proactive because
they are carried out before the failure occurs.
• Example: To mitigate the risk of valve failure in the pump system, the design team
might choose to use more durable materials or implement an improved design that makes
the valve less prone to wear. This reduces the risk of failure down the line.

Mitigation and Control Measures

• Once risks are identified and prioritized, proactive risk management involves
designing and implementing mitigation and control measures to reduce the likelihood
of failure and minimize its impact. These measures may include quality control processes,
better material choices, or more frequent maintenance schedules.
• Example: A manufacturing team implements more stringent quality control
processes to ensure that faulty components are detected early in production. This is a
proactive approach to minimizing defects before they can cause failure in the final product.

Continuous Monitoring and Improvement

• Proactive risk management also includes continuous monitoring to assess the
effectiveness of implemented risk controls and identifying any new risks that may arise
during the lifecycle of the product or process.
• Example: After redesigning the pump’s valve system, the team continues to
monitor performance over time. If a new issue arises, the FMEA process can be repeated,
ensuring continuous risk management and improvement.

Cross-Functional Collaboration
• FMEA encourages collaboration among various teams (design, engineering,
manufacturing, quality control, and operations) to ensure that all potential risks are
evaluated from different perspectives. This cross-functional approach increases the
likelihood of identifying hidden risks.

29
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 • Example: The design team works with the manufacturing team to understand
potential issues in production, while the quality control team suggests testing methods that
can catch failures early.

Design for Reliability and Safety

• Proactive risk management in FMEA involves designing products or processes
with a focus on reliability and safety. This means considering the failure modes early and
designing products that are less likely to fail under normal use.
• Example: A medical device manufacturer uses FMEA to identify possible failure
modes such as battery failure or sensor malfunction. The product design incorporates
redundant systems to ensure that the failure of one component does not result in system-
wide failure.

Risk Transfer or Avoidance

• In some cases, the best proactive risk management strategy may be to transfer or
avoid risks. This could involve outsourcing certain parts of the process, using suppliers
with a proven track record, or choosing materials that have been extensively tested for
durability.
• Example: A company might choose to use a third-party testing laboratory to
conduct reliability tests on a critical component, rather than risking internal testing errors
or delays.

6.2 Improved Quality and Reliability: By preventing defects and ensuring a more reliable
product or process.
6.3 Enhanced Safety: Helps in identifying critical failure modes that could pose safety
hazards.
6.4 Cost Reduction and Efficiency: By focusing on high-risk areas, resources can be better
allocated to mitigate major risks.

6.5 Continuous Improvement and Compliance: Continuous improvement and compliance are
two key principles that FMEA (Failure Modes and Effects Analysis) can effectively support,
ensuring that products, processes, and systems meet quality standards and regulatory requirements
while progressively enhancing performance over time

30
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7. Case Study DFMEA and PFMEA of a Ladder

We will do FMEA of a Foldable Aluminium Ladder for Office / Shops / Home purpose with
Extra Strong, Scratch Resistant, Anti-Skid Wide Steps

31
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 ABC Private Limited DOC NO:
DFMEA/001
REV:0

Potential Failure Mode and Effects DATE:

Analysis (Design FMEA) 25.02.202

5
PAGE
1 OF 2
Product Name: Foldable Responsibility:
Aluminum Ladder
Model No: L-1 Part Dwg Prepared By:
No: L-1
Core Team Members:
C Current Controls
Potenti S l DR Respon Future /
S. Item Ite Requireme Poten al E a Potential EP Reco sibility Act Action
No Descript m nts tial Effects Vs Cause(s)/ T N mme and ion Result
ion Fun Failu of s Failure O nded Compl s S O D R
ctio re Failure Mechanis Curren C Curre Actio etion Ta E C E P
n Mode (System / ms t C nt n(s) Date ken V C T N
Product / Contro Contr
User)
 ls for ols for
Preven Detect
tion ion
Bendin
g test
and
torsion
tests
Ladd Cannot Ladder EN-131- Design which

1 er To help in To take take may break Incorrect 2 1 Validatio are

Asse accessing designed load expected / or bend 10 S design of guidelin n (Finite 1010 suppose
mbly different designed while rungs es used Element 0 d to be
heights load usage in Analysis) done as
designin per EN
g 131-2
testing
require
ments
need
to be
conduct
ed

2
of
62
 Bendin
g test
and
torsion
tests
Ladder cannot be EN-131- 1 Design which

should not bend bends used by Incorrect 2 Validatio are

while climbing while customer 10 design of guidelin n (FEA 1010 suppose

climbin rungs es used Analysis) 0 d to be
g in done as

S designin per EN
g 131-2
testing
require
ments
need to
be
conduct
ed
Design
Validatio
EN-131- 1 n (FEA

3
of
62
 Incorrect 2 Analysis, 1
10 design of guidelin Lateral 10
stiles es used deflection
in test,
designin bending
g tests in
place)

Weight of Design user

user and Validatio manual
items n (FEA to be
Customer carried Caution 1 Analysis, 1 provide
may fall 10 while sticker in Lateral 10 d to
climbing place deflection custome
more than test, rs
designed bending

capacity tests in
place)
As per
14122-4,
stickers
improper with 1
ladder informati Site visits 4

4
of
62
 fixing on on 40
arrangem proper
ent fixing
arrangem
ents, is
in place
Bendin
g test
and
torsion
tests
Ladder cannot be S EN-131- 1 Design which

should not breaks used by Incorrect 2 Validatio 10 are

break while while customer 10 design of guidelin n (FEA 10 suppose

climbing climbing rungs es used Analysis) 0 d to be
in done as
designin per EN
g 131-2
testing
require
ments
need to

5
of
62
 be
conduct
ed
Design
Validatio
EN-131- 1 n (FEA 1
Incorrect 2 Analysis,
10 design of guidelin Lateral 10
stiles es used deflection
in test,
designin bending
g tests in
place)
Design
Weight of Validatio user
user and 1 n (FEA 1 manual
Customer items Caution Analysis, to be
may fall 10 S carried sticker in Lateral 10 provide
while place deflection d to
climbing test, custome
more than bending rs
designed tests in

6
of
62
 capacity place)

As per
ISO
14122-4,
improper stickers 1
ladder with Site visits 4
fixing informati 40
arrangem on on
ent proper
fixing
arrangem
ents, is in
place
ISO
14122-
user should be User rest platform 4(Safety 1
able to rest after cannot customer not provided of Design 1
climbing certain rest after dissatisfac 7 in design machiner validation 7
height climbing tion y-fixed
defined ladders)
height guideline
s

7
of
62
 used in
designing
assemb
ling
rest 3 site visit instruct
platform not none / 4 ions
assembled custome 84 need to
at designed r be
height complai provide
nts d to
custome
r

8
of
62
 No anti-skid EN-131-2
Should not slip user slips customer serrations on guidelines 1 Design
while climbing from may fall 10 rungs used in validation 1 10
ladder S designing
period
ic
verific
anti-skid customer ation
serrations none 2 feedback of
worn-out s and 4 80 ladder
during usage complai to be
nts provid
ed to
the
custome
r
distance EN-131-2 Design
Should be easy difficult customer between guidelines 1 validation
to climb/hold to climb / dissatisfact 8 rungs very used in (As
hold ion high designing per ISO
14122-4)
distance EN-131-2 Design
between guidelines validation

9
of
 rungs very used in (As
low designing per ISO
14122-4)
distance EN-131-2 Design
between guidelines validation
stiles too used in (As
high designing per ISO
14122-4)
distance EN-131-2 Design
between guidelines validation
stiles too used in (As
low designing per ISO
14122-4)
Low Assembl
awareness y
difficult levels on customer manuals
should be easy to customer assembling none 2 feedback /instruct
to assemble at assemble dissatisfact 5 ladders s and 4 40 ion s to
site at ion among complai be
customer customer nts provide
site site d to
engineers/op custome
erators rs
Ladder

10
of
Component
s
Side
member of Design
the ladder Validatio
which bends EN-131- n (FEA
1 Stile supports Should not bend upon customer 1 S Incorrect 2 1 Analysis,
rungs designe may fall 0 design of guideline Lateral 1 10
meeting EN d load stiles s used in deflection
131 applicat designin test,
requirement ion g bending
s and tests in
assembly place)
testing as
per EN
14122-4
Bendin
Climbing g test
support with and
tread width torsion
from front tests
to back of bends EN-131- Design which

2 Rung over 20mm Should not bend upon customer 1 S Incorrect 2 1 Validatio are
meeting designe may fall 0 design of guideline n (FEA 1010 suppose

11
of
 design d load rungs s used in Analysis) 0 d to be
requirement applicat designin done as
s of EN 131 ion g per EN
and testing 131-2
requirement testing
s of EN require
14122-4 ments
need to
be
conduct
ed
Conne It’s a inter should help in incorrect Parent co.
3 ctor connecting connecting two cannot cannot 5 design of design is
(Intern member to ladders join assemble connectors being
al) join two ladders followed
ladders
To fasten To pass cannot Parent co.
4 Bolt connector through ladder pass cannot 5 incorrect design is 1 Design 1 5
and and through assemble design of being Validation
ladder connector and ladder bolts followed
hold firmly and
connector
Parent co.
cannot weak 6 incorrect design is 1 Design 1 6

12
of
 hold assembl design of being Validation
firmly y bolts followed
nut comes Parent co.
5 Nut To fix the Nut should not out of bolt weak 6 incorrect design is 1 Design 1 6
bolt come out while during assembl design of being Validation
usage usage y nuts followed
To increase Parent co.
6 Flat the strength should be flat washer is difficult 5 incorrect design is 1 Design 1 5
washer of not flat to design of being Validation
contact area assemble washer followed
ISO
14122-
To help the rest incorrec 4(Safety 1
7 Rest user to take Should not bend platfor customer 1 S t design of Design 1 1
platfor rest for a m may fall 0 of rest machiner validation 0
m while bends platform y-fixed
during during ladders)
climbing usage guideline
s
used in
designing
ISO
14122-
rest incorrec 4(Safety

13
of
 should not break platfor customer 1 S t design of 1 Design 1 1
m may fall 0 of rest machiner validation 0
breaks platform y-fixed
during ladders)
usage guideline
s
used in
designing
ISO
14122-
incorrec 4(Safety
user should not user customer 1 S t design of 1 Design 1 1
slip while using slips may fall 0 of rest machiner validation 0
platform y-fixed
ladders)
guideline
s
used in
designing
Identif to display improper Feedback
8 ication mandatory should not fall sticker usage of 1 S inferior none 2 from 1 2
Stick instructions off/peel off peel off ladder 0 adhesive users/oper 0
ers quality ators
Feedback

14
of
 Difficulty 5 inferior none 2 from 1 1
in adhesive users/oper 0
assembly quality ators
To close the Parent co. customer
9 End open ends of should not fall fall off customer 4 improper design is 2 feedback 6 4
cap the stiles after assembly dissatisfac design of being or 8
tion end caps followed complaints

15
of
 ABC Private Limited DOC NO:
PFMEA/001
REV:0

Potential Failure Mode and Effects DATE:

Analysis (Process FMEA) 25.02.202

5
PAGE
1 OF 3
Product Name: Foldable Responsibi
Aluminum Ladder lity:
Model No: Part Dwg Prepared
No: By:
Core Team Members:

Current Controls Action

Responsi Result
SE D R bility
Classification

Func V E P Recomm and

Pro tion / Potenti Potentia Potential OC T N ended target Act
cess Proc al l Effects Cause(s) Current C Current Correcti date of ual
No. ess Failure of of Controls Controls ve completi actio S OC D RPN
Step Requirement Mode failures failure (For (For Actions on ns E C E
Prevention Detection take V T

16
of
 ) ) n

Block to
To cut the Diagonal improper Hourly in- be fixed
10 Stile stiles as per Short length dimension 5 setting of The block 2 process 5 5 with nuts
Cuttin required gets affected reference is fixed inspection 0 and bolts
g length within block, with the by instead of
tolerance dislocation of help of supervisor tapes

block during cello tape

operation Diagonal
distance of
ladder is
verified
during
assembly
process

5 improper 2 5 50 Block to
Diagonal setting of The block Hourly in- be fixed
Excess dimension reference is fixed process with nuts
length gets affected block, with the inspection and bolts
dislocation of help of by instead of
block during cello tape supervisor tapes

17
of
 operation

Hourly in-
Edges to be 90- Cutting End cap 5 improper 1 process 5 25
degree i.e. angle is more fitment will setting of Locating inspection
cutting angle or less be incorrect cutting pin on by
should be 90 blade machine supervisor
degrees (vibration in
blade)
1) Mandrel
design at

Difficulty in 8 Raw none 4 stile 1 32

carrying out Material punching

Profile should Bend profile subsequent problem operation
be straight processes or at
Flanging
operation
2) 100
% Physical
1) Mandrel
design at
Raw None 4 stile 1 32
Difficulty in Material punching

Twist profile carrying out 8 problem operation

18
of
 subsequent or at
processes Flanging
operation
2) 100
% Physical
verification
at assembly

Burr free Burrs no

surface on profile effect
after
cutting

bolts cannot 2 5 60
9m be inserted 6
20 m Dia of holes Hole in the Die punch dia First piece incoming
En should be as undersize connector undersize inspection inspection
d per spec during
Pun assembly
chi 9mm punch none 2 in process 5 60
ng wear out inspection

more 4 2 5 40
Hole clearance problem at First piece incoming

19
of
 oversize between bolt supplier end inspection inspection
and
connector
hole

bolts cannot 6 2 5 60
distance be inserted improper guide block
between hole Distance is in the insertion of and stopper in process
and stile less than connector stile in the die in place inspection
cutting edge spec during
should be as assembly
per spec
Dimensio
stile cannot problem at none 2 incoming 5 40 nal
wall be inserted supplier end inspection inspection

Stile wall thickness into the 4 test report

thickness to be more than guide block can be

as per spec spec during taken

operation from
supplier

20
of
 pitch of the
distance between end rungs dislocation of stopper 1 In-process 5 40
end rung hole gets stopper in the provided inspection
30 Stile location and stile Distance is effected 8 fixture with guide
Punchi edge should be as less than during final pins
ng per spec spec assembly at
customer
end

pitch of the periodic

initial/end Stopper not trainings 1 In-process 5 40
Distance is rungs gets used by given to inspection
more than effected 8 operator operator to
spec after final create
assembly at awareness
customer
end

Pitch between Diagonal 35

holes should be as pitch is dimension 7 operator
per spec more/less gets negligence Machine
affected during pitch setting 1 In-process 5
ladder machine won’t allow inspection
damage at operation - ladders with

21
of
 flanging mis higher/lowe 35
operation alignment r pitch
(in case 7 with pitch
both the guide pin
stiles of
same ladder
have more
pitch)

1) Dimensi
Punch Worn- onal
out, Wrong inspectio
Punch, Lack n of 3 In-process 5 75
of awareness punch inspection
Rung of operators before
Punch size should size is less insertion 5 regarding setting
be as per spec isn't punch worn- 2) Punch is
possible out or changed
selecting right for every
punch 16 sets &
visual
inspection
by operator

22
of
 1) Dimensi
onal
Wrong Punch, inspectio
Lack of n of 2 In-process 5 50
awareness of punch inspection
operators in before
Size is more Loose 5 selecting right setting
fitting of punch 2) Punch is
Rung changed
for every
16 sets &
visual
inspection
by operator

1) Dimensi
onal
Wrong Punch, inspectio
Lack of n of 2 In-process 5 50
awareness of punch inspection
Rung operators in before
Radius as per spec Less Radius installatio 5 selecting right setting
n isn't punch 2) Punch is
possible changed
for every
23
of
 16 sets &
visual
inspection
by operator

1) Dimensi
Punch Worn- onal
out, Wrong inspectio
Punch, Lack n of 3 In-process 5 75
of awareness punch inspection
of operators before
Radius as per spec More Loose 5 regarding setting
Radius Fitting of punch worn- 2) Punch is
Rung out or changed
selecting right for every
punch 16 sets &
visual
inspection
by operator
Periodical

Worn-out inspection 4 In-process 5 80

Difficulty in Punch of tool inspection
Burr free surface Burr after insertion of 4 condition &
punching Rung on punch is
Stile changed for

24
of
 every 16
sets

25
of
 In order to
reduce Product
Insufficient Operator not periodical 4 First 5 14 occurrence, ion
Short Length flanging on 7 butting the part training to sample 0 select and supervi
ladder with the operator inspection fix 2-3 sors

40 Rungs To cut the Rung as during stopper due to of rung operators w.e.f

Cutting per required length flanging overlook or length and permanentl 1st Apr
operation negligence in process y for
inspection cutting
operation

Operator Design
Ladder negligence periodi First 14 Permanen Engr
gets 7 during cal 4 sample 5 0 t stopper (15th
Excess damaged cutting training inspection arrangeme Apr)
Length during operation - in to of rung nt on the and
flanging case of not operato length and conveyor Mainten
operation verifying the r in process to be ance
Difficulty in 5 position of inspection 10 made
assembly stopper 0
Difficulty in Raw None 5 1) Pre- 1 30
Profile should be Twist or carrying out 6 Material forming tool
 straight Bend Profile pre-forming problem
100%
Raw 4 physical 1 24
Difficulty in 6 Material None verificati
assembly problem on while
assembly
Burr free surface Burr on no effect
Rung profile
Tool life Producti
stiles come periodical to be on
radius is less closer tool wear out verification 3 in process 5 10 determine supervis
Rung Preforming during of tool inspection 5 d and tool ors

50 Prefor projection of R4 to assembly condition changes Target

ming be maintained frequency date: 1st
to be May
identified
ladder 7 first piece
gets inspection 2 incoming 5 70
damaged wrong tooling while inspection
during selection replacing of
flanging the new materials

27
of
62
 operation tool

95
less opening Periodic in process Base of the Mainten
of jaws of the verification inspection m/c to be ance In
pre forming of sensor 4 5 14 modified charge,
tool due to condition 0 for ease in Target
sensor maintenanc date:
failure/malfu e and 1st
nction proper May
visibility of
7 more opening Ejector pin 4 5 14 sensor
radius is rung may of jaws of the travel will in process 0
more crack pre forming be inspection
tool controlled
by sensors.

7 Ejector pin 2 incoming 5 70

Wrong tool travel will inspection
selection be of
controlled materials
by sensors.

28
of
62
 7 Soft rubber Trainings 1 in process 5 35
hammer not to inspection
used due to assembly
lack of operators
awareness
Operator may
ladder may be hammered Trainings in process 5 75
bend 5 more than to 3 inspection
required assembly
hammering operators
due to heavy for ladder
burrs assembly
awareness

Manual assembly damage to improper Soft rubber 2 in process 5 4

of Stile and rung, stile or rung Aesthetics hammering hammers inspection 0
60 Assem with out and during gets used
bly damages/dents on manual effected wrong
the surface assembly 4 hammer used Trainings in process
or soft rubber to assembly inspection 5 2

29
of
62
 hammer not operators 1 0
used due to
lack of
awareness

heavy burrs on
stile after stile 5 8

punching deburring 4 in process 0

operation inspection

ladder may 5 assembly Trainings to 3 In-process 5

bend hammered assembly inspection 75
heavily during operators
assembly

30
of
62
8. Conclusion

Through the FMEA process, we identified several potential failure modes in the design and
manufacturing of our automated assembly system. The most critical failure mode was related
to the failure of the motor drives, which could cause significant downtime in production. To
address this, we recommended redesigning the motor drive circuit, using higher-quality
components, and implementing a more rigorous testing process during assembly. By taking
these actions, we have reduced the risk of motor drive failures by 75%. We will continue to
monitor the performance of the system and perform periodic FMEA reviews to ensure long-
term reliability.

In summary, the conclusion of an FMEA should encapsulate the effectiveness of the analysis,
the actions taken to mitigate risks, and the steps forward to maintain or improve system
reliability. It’s a vital part of decision-making in product development, process management,
and risk reduction.