FMEA (Failure Modes and Effects Analysis)

A tool to enable potential errors or faults to be predicted during the early

design stages.

Many companies use FMEA as a central pillar of their design process. FMEA
provides a structured approach to the analysis of route causes (of failure),
the estimation of severity or impact, and the effectiveness of strategies for
prevention. The ultimate output is the generation of action plans to prevent,
detect or reduce the impact of potential modes of failure.
In a nutshell, it encourages the design team to consider:

 What could wrong

 How badly it might go wrong

 What needs to be done to prevent or mitigate the problem

FMEA emerged from the US Military in the late 1940s as a tool to improve the
evaluation of reliability of equipment. It has since become a core tool in
product development in many organisations and is recommended as a part
of an organisation's quality management system.

The basic logic can be applied at a number of levels, including organisational

issues, strategy issues, product design issues, production processes and
individual components. Typically, it is used to analyse either a product design
or production process:

Improved Product and Process Quality

 Early identification of potential failures: This allows for proactive

measures to prevent issues.

 Reduced defects: By addressing potential problems upfront, you can

significantly lower defect rates.

 Enhanced customer satisfaction: Delivering higher quality products

or services leads to increased customer satisfaction.

Cost Reduction

 Reduced rework and scrap: Identifying potential issues early saves

time and resources.

 Lower warranty claims: Fewer product failures mean lower warranty

costs.
  Optimized processes: FMEA can help streamline operations and
eliminate waste.

Risk Mitigation

 Identification of safety hazards: FMEA can help prevent accidents

and injuries.

 Reduced legal liabilities: By proactively addressing potential issues,

you can minimize legal risks.

 Improved product reliability: FMEA helps ensure products perform

as expected.

Enhanced Decision Making

 Data-driven decisions: FMEA provides quantitative data to inform

decision-making.

 Prioritization of actions: By assessing the severity and likelihood of

failures, you can focus on critical areas.

 Improved resource allocation: FMEA helps allocate resources

effectively to address potential issues.

Other Benefits

 Documentation: FMEA creates a valuable record of potential failures

and mitigation strategies.

 Communication: The FMEA process fosters collaboration among

teams.

 Continuous improvement: FMEA is a cyclical process that supports

ongoing improvement efforts.

Product FMEA vs. Process FMEA

Product FMEA

A Product FMEA focuses on potential failures of a product during its intended

use. It's a proactive approach to identify and address potential weaknesses
in the product design that could lead to problems or failures once the product
is in the hands of the customer.

Key considerations in Product FMEA:

 Potential failure modes: What could go wrong with the product?

  Potential failure effects: What are the consequences of the failure?

 Potential failure causes: What could cause the failure to occur?

 Severity rating: How critical is the failure?

 Occurrence rating: How likely is the failure to occur?

 Detection rating: How likely is the failure to be detected before

reaching the customer?

 Risk Priority Number (RPN): A calculated value based on severity,

occurrence, and detection to prioritize actions.

Process FMEA

A Process FMEA focuses on potential failures within the manufacturing or

assembly process that could lead to a product defect or non-conformance.
It's a systematic way to identify and prevent errors in the production process.

Key considerations in Process FMEA:

 Potential failure modes: What could go wrong in the process?

 Potential failure effects: How does the process failure impact the
product?

 Potential failure causes: What could cause the process to fail?

 Severity rating: How critical is the impact on the product?

 Occurrence rating: How likely is the process failure to occur?

 Detection rating: How likely is the process failure to be detected

before the product reaches the customer?

 Risk Priority Number (RPN): A calculated value based on severity,

occurrence, and detection to prioritize actions.

Key Differences

Feature Product FMEA Process FMEA

Manufacturing or
Focus Product design
assembly process

Potential
Product-related failures Process-related failures
failures

Impact Product performance and Product quality and

customer satisfaction
 conformity to design

Relationship Between Product and Process FMEA

It's important to note that Product and Process FMEA are interconnected.
Issues identified in a Product FMEA might lead to process improvements in a
Process FMEA, and vice versa. A comprehensive quality management system
often involves both types of FMEA to ensure product excellence.

Types of F.M.E.Ab

Let's delve deeper into some of the most common ones:

Core FMEA Types

 Design FMEA (DFMEA): Focuses on identifying potential failures in a

product design and their impact on the customer.

 Process FMEA (PFMEA): Concentrates on potential failures in a

manufacturing or assembly process and their impact on product
quality.

Other FMEA Variations

 System FMEA: Examines potential failures at a system level,

considering interactions between components and subsystems.

 Equipment FMEA: Specifically analyzes potential failures of

equipment or machinery and their impact on the overall process.

 Software FMEA: Identifies potential failures in software and their

consequences.

 Service FMEA: Focuses on potential failures in service delivery and

their impact on customer satisfaction.

 Concept FMEA: Applied early in the product development process to

evaluate the feasibility and potential risks of a concept.

Additional FMEA Types

 Maintenance FMEA: Analyzes potential failures in maintenance

processes and their impact on equipment reliability.

 Environmental FMEA: Evaluates potential environmental impacts of

a product or process.
Reliability

Reliability defined: The probability of a product to perform as expected for a

certain period of time, under the given operating conditions, and at a given
set for product performance characteristics.

Why is Reliability Important?

• Reputation

• Customer Satisfaction

• Warranty Costs

• Repeat Business

• Cost Analysis

• Customer Requirements

• Competitive Advantage

FMEA Documentation

Purpose of FMEA documentation is to allow all involved engineers to have

access to others’ thoughts and to design and manufacture using this
collective group of thoughts, thus promoting team approach. Representatives
from all affected areas must be consulted and their input always included. It
must be continually updated as changes occur throughout the design and
manufacturing process.

Key Points from Summary:

 Knowledge Sharing: Documentation facilitates collaboration and

information exchange among team members.

 Team Approach: Encourages a collective effort to identify and

mitigate risks.
  Continuous Improvement: The document serves as a living record,
allowing for updates as the project progresses.

 Comprehensive Involvement: Input from all relevant stakeholders is

essential.

Block Diagrams: A Visual Overview

A block diagram is a simplified visual representation of a system, process, or

component. It uses boxes (blocks) to represent different parts or functions
and lines to indicate relationships and interactions between them.

Essentially, block diagrams provide a high-level understanding of how a

system works by showing what goes in (input), what happens (function), and
what comes out (output). They are particularly useful for:

 Understanding complex systems: Breaking down intricate

processes into manageable components.

 Communicating ideas: Effectively conveying system behavior to

others.

 Designing new systems: Visualizing the structure and flow of a

proposed system.

 Improving existing systems: Identifying potential areas for

optimization or modification.

By offering a clear and concise overview, block diagrams serve as a valuable

tool in various fields, including engineering, systems analysis, and project
management.

Certainly! Let’s break down the stages of Failure Mode and Effects Analysis
(FMEA):

1. Specifying Possibilities:

o Define its functions (what it’s supposed to do).

o List possible failure modes (ways it can go wrong).

o Investigate root causes of these failures.

o Consider the effects of each failure (impact on safety, quality,

etc.).
 o Evaluate detection and prevention methods.

2. Quantifying Risk:

o Assess the probability of each cause leading to failure.

o Evaluate the severity of the effect if the failure occurs.

o Determine the effectiveness of existing controls to prevent the

cause.

o Calculate the Risk Priority Number (RPN) using the formula:

RPN =Probability ×Severity ×Effectiveness

3. Correcting High-Risk Causes:

o Prioritize work based on RPN (focus on high-risk items).

o Detail corrective actions to address root causes.

o Assign responsibility for implementing these actions.

o Set checkpoints to track progress.

4. Re-evaluation of Risk:

o Recalculate RPN after implementing corrective actions.

o Ensure risks are reduced to an acceptable level.

Remember that FMEA helps prevent failures and improve processes by

systematically analyzing potential risks. If you have any specific questions or
need further clarification, feel free to ask! 😊

Certainly! The Failure Mode and Effects Analysis (FMEA) methodology is

a systematic approach used to identify and mitigate potential failures in
systems or processes. Let’s summarize the key steps:

1. System or Process Definition:

o Clearly define the system or process under analysis.

o Understand its functions and purpose.

2. Determination of Failure Modes:

o Identify all possible ways in which the system can fail.

o List these failure modes comprehensively.

3. Determination of Cause:

o Investigate the root causes behind each failure mode.

 o Understand why these failures occur.

4. Assessment of Effect:

o Evaluate the impact of each failure on safety, quality, or other

critical factors.

o Consider the consequences of failure.

5. Estimation of Probability of Occurrence (O):

o Assess how likely each cause is to lead to failure.

o Quantify the probability of occurrence.

6. Estimation of Detecting a Defect (D):

o Evaluate the effectiveness of existing detection methods.

o How likely are defects to be detected before they cause harm?

7. Classification of Severity (S):

o Assign a severity rating to each failure mode.

o Consider the severity of consequences if the failure occurs.

8. Computation of Criticality (Risk Priority Number - RPN):

o Calculate the Risk Priority Number using the formula:

RPN = (S) \times (O) \times (D)

9. Determination of Corrective Action:

o Prioritize high-risk failure modes based on RPN.

o Develop corrective actions to address root causes.

o Assign responsibilities for implementing these actions.

Remember that FMEA helps organizations proactively identify and mitigate

risks, ensuring better system reliability and safety. If you have any further
questions or need clarification, feel free to ask! 😊
Step 1. Product / Process Definition

• Describe product and its design or the process and its operations

• Identify the purpose or function of each component or each operation

• Use functional diagrams, design drawings, flow charts and other

graphical techniques

• Include each significant element that is likely to fail

Step 2. Determination of Failure Modes

• A failure mode is the manner in which a process could potentially fail to

meet the process requirement or the design intent.

• It is a statement of non-performance or a non-conformance to a design

specification.

• It is described in technical terms, not in terms describing what the

customer will see as the failure.

• Questions to be answered include:

 how can the process/part fail to meet specifications?

 regardless of the specifications, what would customer find

objectionable?
Examples of Failure Modes

• Ruptures

• Fractures or cracks

• Short or open circuits

• Deformation

• Contamination

• Loss of power

• Buckling

Step 3. Determination of Cause

• Identify how the failure could occur

• Find the root cause!

• State in terms of something that can be corrected

• Attempt to establish an exhaustive list

• Further analysis may be required to isolate cause (e.g. a design of

experiments)

Potential Failure Mode Causes

 Abnormalstress. usually external or environmental, could be an internal

power surge

 Mechanicalstress. Continued vibration may loosen fittings, for example.

 Contamination. Dirt can cause electrical failure.

 Evaporation. Filaments age because of filament molecules evaporating.

 Fatigue. Physical changes in material may result in fracture.

 Friction.This is a common cause of failures in belts, gears, and

machinery

 Temperature cycling. Repeated expansion and contraction

 Aging / wearout. not a prime cause, but prolonged exposure to other

causes.
  Substandard or defective parts. poor quality control during
manufacture.

 Poor workmanship. Lack of training or proper motivation, fatigue

 Operator-ormaintenance-inducederror.human error.

 Corrosion.This is chemical change that weakens material.

Step 4. Assessment of Effect

• Assess the effect of the failure mode on the customer

• Customer may be next operation, subsequent operations, the end-

user, or the seller

• Answer the question - what might the customer observe or experience.

Failure Mechanisms, Modes, And Effects

FMEA Worksheet

Step 5. Estimation of Probability of Occurrence (O)

• Occurrence refers to how frequently the specific failure mode will be

observed.

• Estimated on a scale from “1” to “10”

• Statistical analysis may be used if historical data is available

• Otherwise estimated subjectively

Probability of Failure

Step 6. Estimation of Detecting a Defect (D)

• The probability that the current process controls will detect the failure
mode before the part or component leaves the process.

• Assume failure has occurred, and then assess the likelihood that the
product will continue to its next stage.

• Rank on scale of “1” (almost certain to detect) to “10” (no way of

detecting failure)

Likelihood of Detection
Step 7. Classification of Severity (S)

• An assessment of the seriousness of the effect of the failure mode on

the customer

• Estimated on a scale of “1” to “10.”

• Assessed against

 safety; i.e. injury or death

 extent of damage

 or amount of economic loss

Step 8. Computation of Criticality

Risk Priority Number (RPN)

• Risk Priority Number (RPN)

• Product of Severity (S), Probability of Occurrence (O), and Detecting a

Defect (D)

• RPN = (S) x (O) x (D)

• Range is 1 to 1000 with the higher the number, the more critical the
failure mode.

• Rank order RPN from highest to lowest

Step 9. Corrective Action

• Removing the cause of the failure,

• Decreasing the probability of occurrence, or

• Increase the likelihood of detection, or

• Reducing the severity of the failure.

CHp 7
Sure! Here’s a detailed explanation of each management and problem-
solving tool you've listed:

### 1. **5 Whys (Why-Why Analysis)**

The 5 Whys technique is a simple but effective tool for identifying the root
cause of a problem. By repeatedly asking the question "Why?" (typically five
times), you can move past symptoms and uncover the underlying issue.

**Steps:**

- **Identify the problem:** Clearly state the problem you are facing.

- **Ask "Why?"**: Ask why the problem occurs, and write down the answer.

- **Repeat:** Take the answer and ask "Why?" again. Continue this process
until you've asked "Why?" five times, or until the root cause is identified.

**Example:**

- **Problem:** The car won't start.

1. **Why?** The battery is dead.

2. **Why?** The alternator is not working.

3. **Why?** The alternator belt is broken.

4. **Why?** The belt was beyond its service life.

5. **Why?** The car wasn't maintained properly.

**Use Cases:**

- Identifying the root cause of quality problems.

- Troubleshooting recurring issues.

- Simplifying complex problems by breaking them down.

### 2. **Force Field Analysis**

Force Field Analysis is a tool used to analyze the forces for and against a
change. It’s often used in change management to identify and evaluate
factors that could impact the success of a decision.

**Steps:**

- **Define the change:** Clearly state the change or decision to be made.

- **Identify driving forces:** List all the factors that support the change.

- **Identify restraining forces:** List all the factors that resist the change.

- **Evaluate:** Assign a score to each force to weigh its impact.

- **Plan:** Use the analysis to strengthen driving forces and reduce or

eliminate restraining forces.

**Example:**

- **Change:** Implementing a new software system.

- **Driving Forces:** Increased efficiency, modern tools, reduced errors.

- **Restraining Forces:** Cost of implementation, staff resistance, training

required.

**Use Cases:**

- Managing organizational change.

- Making strategic decisions.

- Evaluating pros and cons of a decision.

### 3. **Nominal Group Technique (NGT)**

The Nominal Group Technique is a structured method for brainstorming that

allows every participant to contribute ideas equally. It’s designed to prevent
dominance by a single person and to ensure balanced participation.

**Steps:**

- **Silent generation of ideas:** Participants write down their ideas

individually and silently.
- **Round-robin recording:** Each participant shares one idea at a time in a
round-robin format, and the ideas are recorded for everyone to see.

- **Discussion:** The group discusses each idea for clarity and

understanding.

- **Ranking:** Participants rank the ideas individually.

- **Final decision:** The rankings are compiled to determine the most

favored ideas.

**Example:**

- **Topic:** Improving customer service.

- **Ideas generated:** Increase training, reduce wait times, implement a

feedback system.

- **Ranking:** Participants rank these ideas based on impact and feasibility.

**Use Cases:**

- Prioritizing options in group decision-making.

- Generating and ranking ideas in brainstorming sessions.

- Ensuring balanced participation in discussions.

### 4. **Affinity Diagram**

An Affinity Diagram is a tool used to organize large amounts of data or ideas

into natural groupings. It helps teams see patterns and relationships in the
data.

**Steps:**

- **Generate ideas:** Collect ideas or data through brainstorming.

- **Group related ideas:** Sort the ideas into groups based on their similarity
or relationship.

- **Label the groups:** Create a header for each group that describes the
common theme.

- **Analyze:** Discuss and analyze the groups to understand the key themes
or issues.
**Example:**

- **Scenario:** Organizing customer feedback.

- **Groups:** Feedback might be grouped into categories like "Product

Features," "Customer Support," and "Pricing."

**Use Cases:**

- Organizing complex information.

- Grouping ideas after brainstorming sessions.

- Identifying themes in qualitative data.

### 5. **Interrelationship Digraph (Interrelationship Diagram)**

An Interrelationship Digraph is a tool used to identify and map out the cause-
and-effect relationships among different factors or problems. It helps in
understanding how various factors influence each other.

**Steps:**

- **Identify factors:** List the factors or problems to be analyzed.

- **Draw connections:** Draw arrows between factors to show cause-and-

effect relationships.

- **Analyze:** Count the arrows in and out of each factor to identify key
drivers and outcomes.

**Example:**

- **Problem:** Low employee morale.

- **Factors:** Poor communication, lack of recognition, high workload, limited

career growth.

- **Interrelationships:** Arrows might show that poor communication leads to

a high workload, which then affects morale.

**Use Cases:**

- Understanding complex problems with multiple causes.

- Visualizing the impact of various factors on an issue.

- Identifying the most influential factors in a situation.

### 6. **Tree Diagram**

A Tree Diagram is a tool used to break down a broad concept into finer levels
of detail. It helps in organizing tasks, ideas, or problems into a hierarchical
structure.

**Steps:**

- **Identify the main goal or issue:** Write it at the top of the diagram.

- **Break it down:** Divide the goal or issue into major components.

- **Subdivide further:** Continue breaking down each component into

smaller, more detailed parts until you reach a sufficient level of detail.

**Example:**

- **Goal:** Launch a new product.

- **Branches:** Market research, product development, marketing strategy,

distribution plan.

- **Further branches:** Under "Product Development," you might have

"Design," "Testing," and "Manufacturing."

**Use Cases:**

- Planning projects.

- Breaking down complex problems.

- Organizing information in a structured way.

### 7. **Matrix Diagram (Matrice Diagram)**

A Matrix Diagram is a tool used to show the relationship between two or

more sets of elements. It helps in comparing and analyzing the interactions
between these elements.

**Types:**

- **L-shaped:** Compares two sets of data.

- **T-shaped:** Compares three sets of data.

- **X-shaped:** Compares four sets of data.

- **Y-shaped:** Compares three sets of data in a circular relationship.

- **C-shaped:** Compares three sets of data in a triangular relationship.

**Steps:**

- **Identify the elements:** List the elements you want to compare.

- **Create the matrix:** Draw the matrix with one set of elements on one
axis and the other set on the other axis.

- **Fill in the matrix:** Indicate the relationship between each pair of

elements.

**Example:**

- **Scenario:** Analyzing the relationship between departments and

customer requirements.

- **Matrix:** Departments on one axis and customer requirements on the

other.

- **Analysis:** The matrix might show which departments are responsible for
which requirements.

**Use Cases:**

- Comparing different options or strategies.

- Analyzing the relationship between tasks and team members.

- Prioritizing tasks based on impact and effort.

### 8. **Prioritization Matrix**

A Prioritization Matrix is a tool used to prioritize tasks or options based on

multiple criteria. It helps in making decisions by ranking options according to
their importance, feasibility, or impact.

**Steps:**

- **Identify options:** List the tasks or options that need to be prioritized.

- **Set criteria:** Determine the criteria for prioritization (e.g., cost, impact,
feasibility).

- **Rate options:** Assign a score to each option based on each criterion.

- **Calculate totals:** Sum the scores to determine the priority ranking.

**Example:**

- **Scenario:** Prioritizing projects.

- **Criteria:** Cost, impact, ease of implementation.

- **Ranking:** Projects with the highest scores are prioritized.

**Use Cases:**

- Making decisions when multiple factors are involved.

- Prioritizing tasks in project management.

- Selecting the best options based on defined criteria.

### 9. **Process Decision Program Chart (PDPC)**

A Process Decision Program Chart (PDPC) is a tool used to map out possible
events and outcomes related to a decision or plan. It helps in preparing for
potential problems and developing contingency plans.

**Steps:**

- **Identify the plan or decision:** Clearly define the plan or decision to be

analyzed.

- **Break it down:** Subdivide the plan into smaller steps or tasks.

- **Identify potential problems:** For each task, identify possible issues or

risks.

- **Develop contingency plans:** Plan responses to these potential problems.

**Example:**

- **Scenario:** Launching a marketing campaign.

- **Steps:** Planning, designing, launching.

- **Potential problems:** Delays in design, low engagement, negative
feedback.

- **Contingencies:** Have a backup design, adjust strategy based on

feedback.

**Use Cases:**

- Planning complex projects.

- Identifying and mitigating risks.

- Preparing for unexpected events.

### 10. **Activity Network Diagram (AND)**

An Activity Network Diagram (AND) is a project management tool used to

represent the sequence of activities and their relationships in a project. It
helps in identifying the critical path and optimizing the project timeline.

**Steps:**

- **List activities:** Identify all the activities required to complete the project.

- **Determine dependencies:** Identify which activities depend on others.

- **Draw the diagram:** Create a visual representation of activities and their

dependencies.

- **Identify the critical path:** Determine the sequence of activities that

takes the longest time to complete.

**Example:**

- **Scenario:** Planning a product launch.

- **Activities:** Design, manufacturing, marketing, distribution.

- **Critical path:** The sequence from design to manufacturing to marketing

might be the critical path

**Use Cases:**
- Planning and scheduling projects.

- Identifying bottlenecks in a project.

- Optimizing project timelines.

These tools are essential in various aspects of management, especially in

decision-making, problem-solving, and project management. They help in
organizing thoughts, analyzing complex situations, and ensuring that
decisions are made systematically and effectively.

It looks like you're listing various management and problem-solving tools,

though some of the names seem to have typographical errors. I'll provide
you with the correct names and a brief explanation of each:

1. **5 Whys (Why-Why Analysis)**:

- A technique used to explore the root cause of a problem by repeatedly

asking the question "Why?" Typically, five iterations of asking "Why?" are
sufficient to get to the root cause, though the number can vary.

2. **Force Field Analysis**:

- A tool used to identify the forces that support or hinder a change. It helps
in understanding the factors that can aid in driving change and those that
might resist it.

3. **Nominal Group Technique (NGT)**:

- A structured method for brainstorming that encourages contributions

from everyone. Participants rank ideas, and the group discusses the highest-
ranked ideas for decision-making.

4. **Affinity Diagram**:

- A tool used to organize ideas and data into groups based on their natural
relationships. It is often used after brainstorming sessions to sort ideas into
themes.

5. **Interrelationship Digraph (Interrelationship Diagram)**:

 - A tool used to visualize the relationships among different factors or
causes of a problem. It helps in identifying the most influential factors.

6. **Tree Diagram**:

- A tool that breaks down broad categories into finer levels of detail,
helping to identify and organize the necessary tasks or causes.

7. **Matrix Diagram (Matrice Diagram)**:

- A tool used to analyze the relationship between different variables. It

often helps in decision-making by showing how different elements interact.

8. **Prioritization Matrix**:

- A tool used to prioritize tasks or options based on multiple criteria. It

helps in making decisions by ranking options according to their importance
or impact.

9. **Process Decision Program Chart (PDPC)**:

- A tool used to map out every possible outcome of a decision, helping to

prepare for potential problems. It is useful for contingency planning.

10. **Activity Network Diagram (AND)**:

- A tool used in project management to represent the sequence of activities

and the relationships between them. It helps in identifying the critical path
and optimizing the project timeline.

These tools are commonly used in project management, quality

management, and problem-solving to facilitate decision-making and ensure
systematic analysis.