FMEA

FAILURE MODE AND EFFECTS ANALYSIS

By: Subhransu Sekhar Mohanty

OVERVIEW

1. Origins in the Military:

FMEA was first developed by the U.S. military in 1949 as part of the MIL-P-1629
procedure, titled “Procedures for Performing a Failure Mode, Effects, and Criticality
Analysis.” Its purpose was to improve the reliability of military systems.
2. Adoption in Aerospace:
The aerospace industry, including NASA, adopted FMEA in the 1960s to ensure the
safety and reliability of complex space systems, such as the Apollo program.
3. Industry Expansion:
By the 1980s, FMEA became widely used in the automotive sector, driven by
manufacturers like Ford and Chrysler. Today, it is a standard tool across numerous
industries.
3 FACTORS
OF FMEA
Severity: The extent of the impact of
FMEA prioritizes 1
the failure.
failures based on
three factors: Occurrence: The likelihood of the
2
failure happening.

Detection: The probability of detecting

3
the failure before it causes harm.

PAGE 03
APPLICATIONS AND BENEFITS

FMEA serves as a knowledge

repository that documents
identified risks, mitigations, Process FMEA (PFMEA):
Focuses on identifying
and improvement actions. It risks in manufacturing or
operational processes.

supports continuous
Design FMEA (DFMEA):
improvement by refining Focuses on preventing
design-related failures
processes and designs to during the early stages of
development.

prevent recurrence of failures.

FMEA is commonly used across
multiple phases:
 WHEN TO USE
FMEA

FMEA is valuable in various scenarios, such as:

Designing, redesigning, or evaluating a process,
product, or service. BUILD A TEAM SET THE SCOPE IDENTIFY SET SCOPE
Following Quality Function Deployment (QFD) to INFORMATION FUNCTIONS
translate customer needs into specifications.
Applying an existing process, product, or service in a
new context.
Developing control plans for new or modified
processes.
Setting improvement goals for existing operations.
Investigating failures in current processes, products,
or services.
IDENTIFY IDENTIFY RATE DETERMINE
By proactively addressing risks, FMEA contributes to
improved reliability, quality, and safety, enhancing FAILURE CONSEQUENCES SEVERITY ROOT CAUSES
customer satisfaction and reducing operational costs. POTENTIAL
PAGE 05
 FMEA: STEP-BY-STEP

1. Build a Team
• Assemble a cross-functional team with diverse expertise relevant to the process, product, or service under evaluation. This team
should include representatives from areas such as design, manufacturing, quality, testing, reliability, maintenance,
procurement (including suppliers), sales, marketing (including customers), and customer service. The varied perspectives ensure
a comprehensive risk analysis.

2. Set the Scope

• Clearly define the scope of the FMEA. Specify whether it focuses on a concept, system, design, process, or service. Outline
boundaries and determine the required level of detail. Flowcharts can help visualize the scope and ensure all team members
fully understand it.

3. Identify Information
• Begin by documenting basic identifying details on the FMEA form, such as the project name, team members, and dates. These
initial steps lay the foundation for filling out the form as the analysis progresses.

4. Set Scope Functions

• Identify the purpose of the system, design, process, or service within the defined scope. Clarify the functions by asking
questions like, “What is its intended purpose?” and “What do customers expect?” Use a verb-noun format (e.g., “transmit data”)
and break the scope into smaller subsystems, items, parts, or process steps to define each function. to aid this process.
 FMEA: STEP-BY-STEP

5. Build a Team
• Assemble a cross-functional team with diverse expertise relevant to the process, product, or service under evaluation. This team
should include representatives from areas such as design, manufacturing, quality, testing, reliability, maintenance,
procurement (including suppliers), sales, marketing (including customers), and customer service. The varied perspectives ensure
a comprehensive risk analysis.

6. Set the Scope

• Clearly define the scope of the FMEA. Specify whether it focuses on a concept, system, design, process, or service. Outline
boundaries and determine the required level of detail. Flowcharts can help visualize the scope and ensure all team members
fully understand it.

7. Identify Information
• Begin by documenting basic identifying details on the FMEA form, such as the project name, team members, and dates. These
initial steps lay the foundation for filling out the form as the analysis progresses.

8. Set Scope Functions

• Identify the purpose of the system, design, process, or service within the defined scope. Clarify the functions by asking
questions like, “What is its intended purpose?” and “What do customers expect?” Use a verb-noun format (e.g., “transmit data”)
and break the scope into smaller subsystems, items, parts, or process steps to define each function. to aid this process.
TYPES OF FMEA

Design FMEA (DFMEA):

• Focuses on potential failures in a product’s design phase.
• Objective: Ensure the product meets functional, safety, and regulatory requirements.
• Common Applications: Automotive components, electronics, medical devices.

Process FMEA (PFMEA):

• Targets failures that could arise in manufacturing or assembly processes.
• Objective: Optimize process controls and reduce defects.
• Common Applications: Assembly lines, chemical processes, machining operations.
System FMEA:
• Analyzes failure modes at the system level, considering interactions between subsystems.
• Objective: Enhance system reliability and ensure compatibility between subsystems.

Service FMEA:
• Evaluates failures in service operations.
• Objective: Improve customer satisfaction and service delivery.
FMEA METRICS

Key metrics guide the prioritization of risks:

Risk Priority Number (RPN):
o Formula: RPN = Severity × Occurrence × Detection
o Purpose: Quantify the risk level to rank failure modes for corrective action.
o Scale: Typically ranges from 1 to 1000.
Action Priority (AP):
o An enhancement over traditional RPN to prioritize actions more effectively.
o Considers non-linear relationships between severity, occurrence, and
detection.
BENEFITS OF FMEA

Proactive Risk Management:

FMEA helps identify potential issues before they manifest, reducing downtime
and costs.
Enhanced Product Quality:
By addressing failure modes, organizations produce more reliable and customer-
satisfying products.
Improved Compliance:
Many industries (e.g., automotive, aerospace, healthcare) require FMEA for
regulatory compliance.
Knowledge Retention:
FMEA documentation serves as a valuable reference for future projects, aiding
continuous improvement.
CHALLENGES IN FMEA IMPLEMENTATION

Time-Intensive Process:
The detailed nature of FMEA can be resource-intensive, especially for complex
systems.
Reliance on Expertise:
A lack of diverse team expertise can lead to incomplete analysis.
Data Dependence:
Insufficient or unreliable data may result in inaccurate prioritization of risks.
Over-Reliance on RPN:
While useful, RPN alone might oversimplify risk prioritization. Action Priority
(AP) is a more modern approach.
BEST PRACTICES FOR FMEA

Start Early:
Begin the FMEA process in the conceptual or design phase to maximize its impact.
Use Visual Tools:
Flowcharts, process maps, and diagrams can clarify functions and failure points.
Review Regularly:
Update FMEA as products, processes, or services evolve to ensure ongoing
relevance.
Integrate with Other Tools:
Combine FMEA with tools like Fault Tree Analysis (FTA), Control Plans, and
Statistical Process Control (SPC) for comprehensive risk management.
Automate When Possible:
Leverage software solutions to streamline the FMEA process and ensure
consistency.
FMEA ACROSS INDUSTRIES

Automotive Industry:
o Widely used to ensure reliability and safety of components (e.g., brakes, airbags).
o Standardized through tools like AIAG-VDA FMEA Handbook.
Aerospace Industry:
o Ensures system reliability under extreme conditions.
o Often used alongside Fault Tree Analysis (FTA).
Healthcare:
o Focuses on preventing medical errors in devices, procedures, and medication delivery.
Manufacturing:
o Reduces defects, ensures quality, and improves productivity on assembly lines.
IT and Software Development:
Adapts to failure modes like code bugs, system downtime, and cybersecurity risks.
TYPES OF FAILURES ADDRESSED BY FMEA

1. Functional Failures:
When a system, component, or process does not perform its intended function (e.g., a
motor failing to start).
2. Performance Failures:
When the output is outside acceptable limits (e.g., a machine producing parts with
dimensions beyond tolerances).
3. Safety Failures:
Failures that pose risks to people or the environment (e.g., a chemical leak in a
manufacturing plant).
4. Regulatory Failures:
When a product or process fails to meet industry standards or legal requirements.
KEY CONCEPTS IN FMEA

1. Control Plans: These are documents outlining the methods to monitor and control
potential failure modes identified in FMEA.
2. Criticality Analysis (FMECA): This is an extension of FMEA that incorporates the
probability of failure occurrence and severity to calculate a criticality index. It is often
used in aerospace and defence.
3. Detection Methods:
These refer to the systems and processes in place to identify failures before they impact
operations or customers. Examples include:
o Automated sensors in manufacturing.
o Visual inspections.
• Quality control checkpoints.
MODERN ENHANCEMENTS TO FMEA

1. AI and Data Analytics Integration:

o Predictive analytics tools can identify potential failure modes using historical data and machine
learning.
o Real-time monitoring systems enhance detection capabilities.
2. Advanced Software Solutions:
o Tools like APIS IQ-FMEA, Xfmea, and others automate calculations and document management.
o Interactive dashboards allow for better visualization of risks and RPN trends.
3. Action Priority (AP):
o Introduced by AIAG-VDA to overcome limitations of traditional RPN.
o Focuses more on severity and detection, allowing better prioritization of mitigation efforts.
EXAMPLES OF FMEA APPLICATIONS ACROSS
INDUSTRIES

1. Automotive Industry:
o DFMEA: Used during engine design to address issues like overheating or improper fuel
combustion.
o PFMEA: Applied on production lines to prevent assembly errors or suboptimal welding.
2. Healthcare Sector:
o Service FMEA: Used in hospital operations to prevent medication errors or delays in patient care.
o Design FMEA: Applied in the development of medical devices to address risks like mechanical
failures or incorrect dosage delivery..
EXAMPLES OF FMEA APPLICATIONS ACROSS
INDUSTRIES

3. IT and Software Development:

o Identifies potential software bugs or system crashes.
o Mitigates cybersecurity vulnerabilities by assessing risks during coding and system architecture
design.
4. Manufacturing:
o Reduces downtime by analyzing failure modes in machinery.
• Prevents supply chain disruptions by evaluating risks in logistics processes.
EXAMPLES OF MITIGATION ACTIONS POST-FMEA

1. Automotive Assembly Line:

o Problem: Incorrect torque applied to bolts.
o Solution: Implementation of automated torque wrenches with real-time feedback sensors.
2. Pharmaceutical Manufacturing:
o Problem: Contaminated packaging materials.
o Solution: Enhanced supplier audits and stricter incoming material inspections.
3. Software Development:
o Problem: System failure during peak usage.
• Solution: Load testing and redundancy systems to handle high traffic volumes.
DETAILED ROLE OF FMEA IN RISK
MANAGEMENT
1. Proactive vs. Reactive Approach:
o Proactive: FMEA identifies potential failure modes before they occur, enabling the design of
preventive actions.
o Reactive: When failures occur, FMEA helps analyze their causes and refine future designs or
processes to prevent recurrence.
2. Risk Prioritization and Mitigation:
o FMEA provides a structured approach to evaluate risk severity, occurrence likelihood, and detection
capabilities.
o Risks are addressed systematically, starting with those that pose the highest threat to safety, quality, or
performance.
3. Improved Reliability:
o Enhances reliability of systems and processes by addressing design weaknesses and implementing
robust control mechanisms.
FMEA VARIANTS AND RELATED TECHNIQUES

Reverse FMEA (rFMEA):

o Unlike traditional FMEA, which is proactive, rFMEA focuses on validating whether existing control
mechanisms effectively detect and prevent failures.
o Often conducted on manufacturing lines to evaluate real-world scenarios.
Failure Modes, Effects, and Diagnostic Analysis (FMEDA):
o Extends FMEA by adding diagnostic coverage.
o Used in safety-critical systems, such as automotive electronics and industrial automation, to evaluate both
failure risks and the ability to detect them.
Hazard and Operability Study (HAZOP):
o Similar to FMEA but focuses on hazards in processes, primarily in chemical and oil industries.
o Evaluates deviations from intended operations and their impacts.
Risk-Based Maintenance (RBM):
o Combines FMEA insights with maintenance planning, focusing resources on the most critical equipment and
processes.
 PHASES OF FMEA IMPLEMENTATION

Preparation Phase: Analysis Phase: Action Phase: Follow-Up Phase:

• Forming a • Listing potential failure • Prioritizing failure modes • Monitoring the
knowledgeable team. modes, effects, causes, based on RPN/AP scores. effectiveness of
• Identifying scope and and controls. • Developing mitigation corrective actions.
objectives. • Assigning severity, strategies (e.g., process • Updating FMEA as
• Gathering relevant occurrence, and improvements, design processes or designs
documentation detection ratings. changes, training). evolve.
(blueprints, process • Calculating RPN or Action
maps, historical data). Priority (AP).
HOW FMEA DRIVES CONTINUOUS IMPROVEMENT

Root Cause Analysis:

o FMEA helps organizations uncover root causes of failures, leading to permanent corrective
actions rather than temporary fixes.
Preventative Measures:
o By addressing high-priority risks early, organizations can prevent failures and reduce costs
associated with downtime, defects, and recalls.
Feedback Loops:
o Insights from completed FMEAs can be used to refine future designs and processes.
Cultural Impact:
o Promotes a proactive mindset across teams, emphasizing prevention over reaction.
ADVANCED TOOLS FOR FMEA

Automated Software:
o APIS IQ-FMEA, ReliaSoft XFMEA, and PTC Windchill Quality Solutions streamline FMEA
processes by providing templates, built-in calculations, and collaboration features.
o Integrated reporting capabilities make it easier to share findings and track actions.
Visual Aids:
o Flowcharts, Pareto charts, and fishbone diagrams help teams understand failure modes and their
relationships.
Simulation Tools:
Digital twins and Monte Carlo simulations allow testing of potential failure scenarios virtually, saving
time and resources.
INDUSTRIES BENEFITING FROM FMEA
Energy and Utilities:
o Addresses risks in power generation, transmission, and distribution.
o Identifies potential failures in renewable energy systems (e.g., wind turbines, solar panels).
Food and Beverage:
o Ensures safety and compliance with HACCP principles.
o Analyzes risks in packaging, storage, and distribution processes.
Defense and Aerospace:
o Mandatory for mission-critical systems.
o Often coupled with fault tree analysis and redundancy planning.
Electronics Manufacturing:
o Prevents issues like solder joint failures, circuit overheating, and component mismatches.
Pharmaceuticals:
• Used in drug development and production to prevent contamination, ensure dosage accuracy, and comply
with FDA/EMA standards.
COMMON MISTAKES IN FMEA

Inadequate Team Composition:

o Relying on a single department’s input limits the scope and accuracy of the analysis.
Overlooking Minor Risks:
o Dismissing low-priority failure modes can lead to cumulative effects later.
Failure to Update FMEA:
o FMEA must be revisited and revised as designs, processes, or operating conditions change.
Overreliance on RPN:
• Using RPN alone to prioritize risks may overlook scenarios with high severity but low
occurrence/detection.
FMEA AS PART OF INTEGRATED RISK MANAGEMENT
SYSTEMS
1. FMEA and ISO Standards:
o ISO 9001 (Quality Management Systems): FMEA supports the clause on risk-based thinking.
o ISO 31000 (Risk Management): Aligns with principles of systematic risk identification and
prioritization.
o IATF 16949 (Automotive QMS): FMEA is critical for design and process development in
automotive industries.
2. FMEA and Lean Six Sigma:
o Combines with Six Sigma tools like DMAIC (Define, Measure, Analyze, Improve, Control) to
enhance process efficiency.
o Example: Using FMEA during the "Analyze" phase to identify critical failure points.
3. FMEA in Agile Development: Supports iterative improvements by continuously evaluating risks during
Agile sprints or development cycles.
ADVANTAGES OF FMEA
1. Enhanced Customer Satisfaction:
o Reduces the likelihood of customer complaints by addressing potential failure
modes proactively.
2. Lower Costs:
o Prevents costly recalls, rework, and warranty claims by identifying risks early.
3. Regulatory Compliance:
o Demonstrates due diligence in risk management, aiding compliance with industry-
specific regulations.
4. Increased Team Collaboration:
o Encourages cross-departmental communication and fosters a culture of shared
responsibility for quality and reliability.
CHALLENGES IN IMPLEMENTING FMEA

1. Time-Intensive Process: Requires significant time and effort, particularly for

complex systems or products.
2. Inconsistent Scoring: Severity, occurrence, and detection ratings can be subjective
without standardized criteria.
3. Overlooking Rare Failures: FMEA may miss rare, high-impact failures if data is
incomplete or team expertise is limited.
4. Resistance to Change: Teams may resist adopting FMEA due to perceived
complexity or lack of familiarity.
UNDERSTANDING RISK PRIORITY NUMBER
(RPN)
Formula:
RPN=Severity (S)×Occurrence (O)×Detection (D)
• Severity (S): How serious the impact of the failure is on the customer or system.
o Scale: Typically 1 (minor) to 10 (catastrophic).
• Occurrence (O): The likelihood of the failure happening.
o Scale: Typically 1 (rare) to 10 (frequent).
• Detection (D): The ability to detect the failure before it causes harm or reaches the
customer.
o Scale: Typically 1 (high likelihood of detection) to 10 (low likelihood of detection).
The RPN value helps prioritize risks, with higher RPNs indicating greater urgency for
corrective actions.
HOW TO USE RPN IN FMEA

Assign Ratings: For each failure mode, assign values for severity, occurrence, and detection based on defined
criteria.
Calculate RPN: Multiply the assigned values for S, O, and D to calculate the RPN for each failure mode.
Prioritize Actions:
o Rank failure modes based on their RPNs.
o Set a threshold value (e.g., RPN > 125) to identify high-priority risks.
Take Corrective Actions:
o Focus on reducing the RPN by addressing the components:
▪ Reduce Severity: Improve design or process to minimize the impact of failure.
▪ Reduce Occurrence: Implement preventive measures to lower the likelihood of failure.
▪ Improve Detection: Enhance monitoring and inspection methods.
Reassess: After implementing corrective actions, recalculate RPN to ensure risks are mitigated effectively.
ADVANTAGES OF USING
RPN LIMITATIONS OF RPN

Nonlinear Impact:
Prioritization: o Two failure modes with the same RPN can have
o Simplifies decision-making by providing a clear,
vastly different risk profiles. For example:
numerical method to rank risks.
▪ RPN 120: (S = 10, O = 2, D = 6) vs. (S = 4, O
Resource Allocation: = 6, D = 5).
o Helps allocate resources to address the most
critical issues. ▪ The first case is more critical due to higher
severity but might be overlooked if using
Continuous Improvement: RPN alone.
o Reassessing RPN post-action ensures the FMEA
process supports ongoing risk reduction. Subjectivity:
o Assigning S, O, and D values can vary between
team members, leading to inconsistent results.
Single Metric Dependence: Over-reliance on RPN
might ignore other qualitative aspects of risk.
DEEP DIVE INTO RPN AND ITS ROLE IN FMEA

Expanding the Use of RPN in FMEA

1. Breaking Down Each Factor in RPN
• Severity (S):
o Measures the impact of a failure mode on the system, customer, or safety.
o Key considerations:
▪ How critical is the failure?
▪ Does it compromise safety or compliance?
▪ Will it lead to major customer dissatisfaction?
o Example: In automotive design, a brake failure has high severity due to potential loss of life.
DEEP DIVE INTO RPN AND ITS ROLE IN FMEA

Expanding the Use of RPN in FMEA

• Occurrence (O):
o Frequency or likelihood of the failure occurring.
o Based on historical data, simulations, or expert judgment.
o Example: A weak solder joint in electronics may have a high occurrence due to repetitive stress.
• Detection (D):
o Assesses the probability of detecting the failure mode before it reaches the customer or causes
harm.
o Example: A manufacturing line with automated sensors for defect detection will have a lower
detection rating than one relying solely on manual inspections.
ADDRESSING CHALLENGES WITH RPN

Problem: High RPN but Low Severity

o Example: Frequent cosmetic defects on a product that don't affect performance but annoy
customers.
o Solution: Apply a hybrid approach to consider customer satisfaction alongside safety and
operational risks.
Problem: Equal RPNs but Different Risk Profiles
o Example:
▪ Failure A: (S = 10, O = 1, D = 5) → Catastrophic but rare and detectable.
▪ Failure B: (S = 5, O = 5, D = 2) → Moderate impact but frequent and harder to detect.
o Solution: Create separate priority categories for high severity versus high occurrence risks.
EXAMPLES OF REAL-WORLD RPN USAGE

Example 1: Consumer Electronics Example 2: Pharmaceutical Manufacturing

• Scenario: Overheating in a smartphone battery. • Scenario: Contamination risk during tablet
• Initial RPN: S = 9, O = 5, D = 6 → RPN = 270. packaging.
• Actions: • Initial RPN: S = 8, O = 4, D = 7 → RPN = 224.
o Improved thermal design (reduced severity). • Actions:
o Better raw material inspection (reduced o Introduced HEPA filters (reduced
occurrence).
severity).
o Automated quality control (improved
o Strict raw material handling protocols
detection).
(reduced occurrence).
Updated RPN: S = 7, O = 2, D = 3 → RPN = 42.
o Inline contaminant monitoring
(improved detection).
Updated RPN: S = 6, O = 2, D = 3 → RPN = 36.
EXAMPLES OF REAL-WORLD RPN USAGE

Example 1: Consumer Electronics Example 2: Pharmaceutical Manufacturing

• Scenario: Overheating in a smartphone battery. • Scenario: Contamination risk during tablet
• Initial RPN: S = 9, O = 5, D = 6 → RPN = 270. packaging.
• Actions: • Initial RPN: S = 8, O = 4, D = 7 → RPN = 224.
o Improved thermal design (reduced severity). • Actions:
o Better raw material inspection (reduced o Introduced HEPA filters (reduced
occurrence).
severity).
o Automated quality control (improved
o Strict raw material handling protocols
detection).
(reduced occurrence).
Updated RPN: S = 7, O = 2, D = 3 → RPN = 42.
o Inline contaminant monitoring
(improved detection).
Updated RPN: S = 6, O = 2, D = 3 → RPN = 36.
THANK YOU !