FMEA - Failure modes and effects analysis

Introduction

Product development and operations managers can run a failure modes and effects analysis (FMEA) to analyze potential failure risks
within systems, classifying them according to severity and likelihood, based on past experience with similar products or processes. The object of
FMEA is to help design identified failures out of the system with the least cost in terms of time and money. FMEA defines the term “failure
mode” to identify defects or errors, potential or actual, in a product design or process, with emphasis on those affecting the customer or end
user. A “failure effect” is the result of a failure mode on the product or system function as perceived by the user. Failure effects can be described
in terms of what the end user may see or experience. The study of consequences of identified failures is called effects analysis. FMEA prioritizes
failures according to severity, frequency and detectability. Severity describes the seriousness of failure consequences. Frequency describes how
often failures can occur. Detectability refers to degree of difficulty in detecting failures. FMEA also involves documenting current knowledge
about failure risks. FMEA seeks to mitigate risk at all levels with resulting prioritized actions that prevent failures or at least reduce their severity
and/or probability of occurrence. It also defines and aids in selecting remedial activities that mitigate the impact and consequences of failures.
FMEA can be employed from the earliest design and conceptual stages onward through development and testing processes, into process control
during ongoing operations throughout the life of the product or system

Process steps in FMEA

• Step 1: Identify potential failures and effects

• Step 2: Determine severity

• Step 3: Gauge likelihood of occurrence

• Step 4: Failure detection

• Risk priority number (RPN)

Step 1: Identify potential failures and effects

The first FMEA step is to analyze functional requirements and their effects to identify all failure modes. Examples: warping, electrical short
circuit, oxidation, fracture. Failure modes in one component can induce them in others. List all failure modes per function in technical terms,
considering the ultimate effect(s) of each failure mode and noting the failure effect(s). Examples of failure effects include: overheating, noise,
abnormal shutdown, user injury.

Step 2: Determine severity

Severity

Severity is the seriousness of failure consequences of failure effects. Usual practice rates failure effect severity (S) on a scale of one to 10 where
one is lowest severity and 10 is highest. The following table shows typical FMEA severity ratings and their meanings:

Rating Meaning
1 No effect, no danger
2 Very minor – usually noticed only by discriminating or very observant users
3 Minor – only minor part of the system affected; noticed by average users
4-6 Moderate – most users are inconvenienced and/or annoyed
7-8 High – loss of primary function; users are dissatisfied
9-10 Very high – hazardous. Product becomes inoperative, customers angered.
Failure constitutes a safety hazard and can cause injury or death.

Step 3: Gauge likelihood of occurrence

Examine cause(s) of each failure mode and how often failure occurs. Look at similar processes or products and their documented failure modes.
All potential failure causes should be identified and documented in technical terms. Failure causes are often indicative of weaknesses in the
design.
Examples of causes include: incorrect algorithm, insufficient or excess voltage, operating environment too hot, cold, humid, etc. Failure modes
are assigned an occurrence ranking (O), again from one to 10, as shown in the following table.

Rating Meaning
1 No documented failures on similar products/processes
2-3 Low – relatively few failures
4-6 Moderate – some occasional failures
7-8 High – repeated failures
9-10 Very high – failure is almost certain

Step 4: Failure detection

After remedial actions are determined, they should be tested for efficacy and efficiency. Also, the design should be verified and inspections
procedures specified.

1. Engineers inspect current system controls that prevent failure mode occurrence, or detect failures before they impact the user/customer.

2. Identify techniques used with similar products/systems to detect failures.

These steps enable engineers to determine the likelihood of identifying or detecting failures. Then, each combination from steps one and two is
assigned a detection value (D), which indicates how likely it is that failures 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.

Rating Meaning
1 Fault is certain to be caught by testing
2 Fault almost certain to be caught by testing
3 High probability that tests will catch fault
4-6 Moderate probability that tests will catch fault
7-8 Low probability that tests will catch fault
9-10 Fault will be passed undetected to user/customer

Risk priority number (RPN)

After the foregoing basic steps, risk assessors calculate Risk Priority Numbers (RPNs). These influence the choice of action against failure modes.
RPN is calculated from the values of S, O and D as follows:

RPN = S * O * D (or RPN = S x O x D)

RPN should be calculated for the entire design and/or process and documented in the FMEA. Results should reveal the most problematic areas,
and the highest RPNs should get highest priority for corrective measures. These measures can include a variety of actions: new inspections, tests
or procedures, design changes, different components, added redundancy, modified limits, etc. Goals of corrective measures include, in order of
desirability:

• Eliminate failure modes (some are more preventable than others)

• Minimize the severity of failure modes

• Reduce the occurrence of failure modes

• Improve detection of failure modes

When corrective measures are implemented, RPN is calculated again and the results documented in the FMEA.
10 Steps to do a Design FMES
STEP 1:  Review the design
 Use a blueprint or schematic of the design/product to identify each component and interface.
 List each component in the FMEA table.
 If it feels like the scope is too large, it probably is.  This is a good time to break the Design Failure Mode and Effects Analysis into
more manageable chunks.

STEP 2:  Brainstorm potential failure modes

 Review existing documentation and data for clues about all of the ways each component or interface can fail.
 Get an exhaustive list – it can be pared down and items can be combined after this initial list is generated.
 There will likely be several potential failures for each component.

STEP 3:  List potential effects of each failure

 The effect is the impact the failure has on the end customer or on subsequent components.
 There will likely be more than one effect for each failure.

STEP 4:  Assign Severity rankings

 Rate the severity of each effect using customized ranking scales as a guide.

STEP 5:  Assign Occurrence rankings

 Determine how frequently the failure is likely to occur.

STEP 6:  Assign Detection rankings

 What are the chances the failure will be detected prior to the customer finding it.

STEP 7:  Calculate the RPN

 Severity x Occurrence x Detection
STEP 8:  Develop the action plan
 Decide which failures will be worked on based on the Risk Priority Numbers.  Focus on the highest RPNs.
 Define who will do what by when.

STEP 9:  Take action

 Implement the improvements identified by your Design Failure Mode and Effects Analysis team.

STEP 10:  Calculate the resulting RPN

 Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.

10 Steps to do a Process FMES

STEP 1:  Review the process
 Use a process flowchart to identify each process component.
 List each process component in the FMEA table.
 If it starts feeling like the scope is too big, it probably is.  This is a good time to break the Process Failure Mode and Effects
Analysis into more manageable chunks.

STEP 2:  Brainstorm potential failure modes

 Review existing documentation and data for clues about all of the ways each component can failure.
 The list should be exhaustive – it can be paired down and items can be combined after this initial list is generated.
 There will likely be several potential failures for each component.

STEP 3:  List potential effects of each failure

 The effect is the impact the failure has on the end product or on subsequent steps in the process.
 There will likely be more than one effect for each failure.

STEP 4:  Assign Severity rankings

 Based on the severity of the consequences of failure.
STEP 5:  Assign Occurrence rankings
 Rate the severity of each effect using customized ranking scales as a guide.

STEP 6:  Assign Detection rankings

 What are the chances the failure will be detected prior to it occurring.

STEP 7:  Calculate the RPN

 Severity x Occurrence x Detection

STEP 8:  Develop the action plan

 Decide which failures will be worked on based on the Risk Priority Numbers.  Focus on the highest RPNs.
 Define who will do what by when.

STEP 9:  Take action

 Implement the improvements identified by your Process Failure Mode and Effects Analysis team.

STEP 10:  Calculate the resulting RPN

 Re-evaluate each of the potential failures once improvements have been made and determine the impact of the
improvements.
Design VS Process FMEA
While the basic steps for conducting an FMEA are the same regardless of the focus of the FMEA, some of the tactics are
different if it is a DFMEA or PFMEA.  This table highlights the key differences between the two.

Criteria DFMEAs PFMEAs

To uncover potential failures associated

To uncover potential process failures that can:
with the product that could cause:
 Impact product quality.
 Product malfunctions.
Primary Objectives  Reduce process reliability.
 Shortened product life.
 Cause customer dissatisfaction.
 Safety hazards while using the
 Create safety or environmental hazards.
product.

The basis of the A blueprint, detailed product schematic

A process flowchart or detailed traveler.
review or prototype.

How potential
Identifying and assessing potential risks with process
failures of intended Identifying and assessing potential risks
operating parameters and meeting product
functions are of the design requirements.
specifications.
evaluated
 Criteria DFMEAs PFMEAs

The evaluation An evaluation of the ability of design An evaluation of the ability of process controls
criteria for controls (related to the product or (mistake-proofing, fail-safes, gages) to prevent a
Detection ratings process) to prevent or detect failure mode (or cause) from occurring or detect the
usually focuses on: mechanisms of failure. effect of a failure if a failure has occurred.

Introduction to Failure Mode and Effects Analysis (FMEA)

There are numerous high-profile examples of product recalls resulting from poorly designed products and/or processes.
These failures are debated in the public forum with manufacturers, service providers and suppliers being depicted as incapable of
providing a safe product. Failure Mode and Effects Analysis, or FMEA, is a methodology aimed at allowing organizations to
anticipate failure during the design stage by identifying all of the possible failures in a design or manufacturing process.

Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today it is still a highly
effective method of lowering the possibility of failure.

What is Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the
design of a product or process.
 Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or
harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure
modes.

FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and
experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure.

There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA

(PFMEA).

Design FMEA
Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns
derived from:

 Material Properties

 Geometry

 Tolerances

 Interfaces with other components and/or systems

 Engineering Noise: environments, user profile, degradation, systems interactions

Process FMEA
Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction,
and safety or environmental hazards derived from:
 Human Factors
 Methods followed while processing
 Materials used
 Machines utilized
 Measurement systems impact on acceptance
 Environment Factors on process performance
Design FMEA Worksheet
Process FMEA Worksheet
Why Perform Failure Mode and Effects Analysis (FMEA)
Historically, the sooner a failure is discovered, the less it will cost. If a failure is discovered late in product development or launch, the
impact is exponentially more devastating.

FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Discovering a failure
early in Product Development (PD) using FMEA provides the benefits of:

 Multiple choices for Mitigating the Risk

 Higher capability of Verification and Validation of changes
 Collaboration between design of the product and process
 Improved Design for Manufacturing and Assembly (DFM/A)
 Lower cost solutions
 Legacy, Tribal Knowledge, and Standard Work utilization

Ultimately, this methodology is effective at identifying and correcting process failures early on so that you can avoid the nasty
consequences of poor performance.
Late Failure Mode Discovery

When to Perform Failure Mode and Effects Analysis (FMEA)

There are several times at which it makes sense to perform a Failure Mode and Effects Analysis:
 When you are designing a new product, process or service
 When you are planning on performing an existing process in a different way
 When you have a quality improvement goal for a specific process
 When you need to understand and improve the failures of a process
In addition, it is advisable to perform an FMEA occasionally throughout the lifetime of a process. Quality and reliability must be
consistently examined and improved for optimal results.
Early Failure Mode Discovery
Early Failure Mode Discovery
How to Perform Failure Mode and Effects Analysis (FMEA)

FMEA is performed in seven steps, with key activities at each step. The steps are separated to assure that only the appropriate
team members for each step are required to be present. The FMEA approach used by Quality-One has been developed to avoid
typical pitfalls which make the analysis slow and ineffective. The Quality-One Three Path Model allows for prioritization of activity
and efficient use of team time.

There are Seven Steps to Developing an FMEA:

1. FMEA Pre-Work and Assemble the FMEA Team

2. Path 1 Development (Requirements through Severity Ranking)

3. Path 2 Development (Potential Causes and Prevention Controls through Occurrence Ranking)

4. Path 3 Development (Testing and Detection Controls through Detection Ranking)

5. Action Priority & Assignment

6. Actions Taken / Design Review

7. Re-ranking RPN & Closure

The Steps for conducting FMEA are as follows:

1. FMEA Pre-Work and Assembly of the FMEA Team

Pre-work involves the collection and creation of key documents. FMEA works smoothly through the development phases when an
investigation of past failures and preparatory documents is performed from its onset. Preparatory documents may include:

 Failure Mode Avoidance (FMA) Past Failure

 Eight Disciplines of Problem Solving (8D)
 Boundary/Block Diagram (For the DFMEA)
 Parameter Diagram (For the DFMEA)
 Process Flow Diagram (For the PFMEA)
 Characteristics Matrix (For the PFMEA)

A pre-work Checklist is recommended for an efficient FMEA event. Checklist items may include:
 Requirements to be included
 Design and / or Process Assumptions
 Preliminary Bill of Material / Components
 Known causes from surrogate products
 Potential causes from interfaces
 Potential causes from design choices
 Potential causes from noises and environments
 Family or Baseline FMEA (Historical FMEA)
 Past Test and Control Methods used on similar products
 2. Path 1 Development- (Requirements through Severity Ranking)

Path 1 consists of inserting the functions, failure modes, effects of failure and Severity rankings. The pre-work documents assist in
this task by taking information previously captured to populate the first few columns (depending on the worksheet selected) of the
FMEA.
 Functions should be written in verb-noun context. Each function must have an associated measurable. Functions may include:
o Wants, needs and desires translated
o Specifications of a design
o Government regulations
o Program-specific requirements
 o Characteristics of product to be analyzed
o Desired process outputs
 Failure Modes are written as anti-functions or anti-requirements in five potential ways:
o Full function failure
o Partial / degraded function failure
o Intermittent function failure
o Over function failure
o Unintended function failure
 Effects are the results of failure, where each individual effect is given a Severity ranking. Actions are considered at this stage if the
Severity is 9 or 10
o Recommended Actions may be considered that impact the product or process design addressing Failure Modes on High Severity
Rankings (Safety and Regulatory)
3. Path 2 Development – (Potential Causes and Prevention Controls through Occurrence Ranking)

Causes are selected from the design / process inputs or past failures and placed in the Cause column when applicable to a specific
failure mode. The columns completed in Path 2 are:
 Potential Causes / Mechanisms of Failure
 Current Prevention Controls (i.e. standard work, previously successful designs, etc.)
 Occurrence Rankings for each cause
 Classification of Special Characteristics, if indicated
 Actions are developed to address high risk Severity and Occurrence combinations, defined in the Quality-One Criticality Matrix
4. Path 3 Development- (Testing and Detection Controls through Detection Ranking)

Path 3 Development involves the addition of Detection Controls that verify that the design meets requirements (for Design FMEA) or
cause and/or failure mode, if undetected, may reach a customer (for Process FMEA).
 The columns completed in Path 3 are:
o Detection Controls
o Detection Ranking
 Actions are determined to improve the controls if they are insufficient to the Risks determined in Paths 1 and 2. Recommended Actions
should address weakness in the testing and/or control strategy.
 Review and updates of the Design Verification Plan and Report (DVP&R) or Control Plans are also possible outcomes of Path 3.
5. Action Priority & Assignment
The Actions that were previously determined in Paths 1, 2 or 3 are assigned a Risk Priority Number (RPN) for action follow-up.
RPN is calculated by multiplying the Severity, Occurrence and Detection Rankings for each potential failure / effect, cause and
control combination. Actions should not be determined based on an RPN threshold value. This is done commonly and is a practice
that leads to poor team behavior. The columns completed are:
 Review Recommended Actions and assign RPN for additional follow-up
 Assign Actions to appropriate personnel
 Assign action due dates
6. Actions Taken / Design Review

FMEA Actions are closed when counter measures have been taken and are successful at reducing risk. The purpose of an FMEA is to
discover and mitigate risk. FMEAs which do not find risk are considered to be weak and non-value added. Effort of the team did not
produce improvement and therefore time was wasted in the analysis.
7. Re-Ranking RPN and Closure

After successful confirmation of Risk Mitigation Actions, the Core Team or Team Leader will re-rank the appropriate ranking value
(Severity, Occurrence or Detection). The new rankings will be multiplied to attain the new RPN. The original RPN is compared to the
revised RPN and the relative improvement to the design or process has been confirmed. Columns completed in Step 7:
 Re-ranked Severity
 Re-ranked Occurrence
 Re-ranked Detection
 Re-ranked RPN
 Generate new Actions, repeating Step 5, until risk has been mitigated
 Comparison of initial RPN and revised RPN
FMEA Document Analysis
Deciding when to take an action on the FMEA has historically been determined by RPN thresholds. Quality-One does not
recommend the use of RPN thresholds for setting action targets. Such targets are believed to negatively change team behavior
because teams select the lowest numbers to get below the threshold and not actual risk, requiring mitigation.
The analysis of an FMEA should include multiple level considerations, including:
  Severity of 9 / 10 or Safety and Regulatory alone (Failure Mode Actions)
 Criticality combinations for Severity and Occurrence (Cause Actions)
 Detection Controls (Test and Control Plan Actions)
 RPN Pareto
When completed, Actions move the risk from its current position in the Quality-One FMEA Criticality Matrix to a lower risk
position.
RPN Action Priority
When risk is determined to be unacceptable, Quality-One recommends a priority of action to be applied as follows:
1. Error Proofing (Eliminate Failure Mode or Address Cause)
o Failure Mode (Only Severity of 9 or 10)
o Causes with High Occurrence
2. Improve Potential Process Capability
o Increase Tolerance (Tolerance Design)
o Reduce Variation of the Process (Statistical Process Control and Process Capability)
3. Improve Controls
o Mistake Proofing of the tooling or process
o Improve the inspection / evaluation techniques

FMEA Relationship to Problem Solving

The Failure Modes in a FMEA are equivalent to the Problem Statement or Problem Description in Problem Solving. Causes in a
FMEA are equivalent to potential root causes in Problem Solving. Effects of failure in a FMEA are Problem Symptoms in Problem
Solving. More examples of this relationship are:
 The problem statements and descriptions are linked between both documents. Problem solving methods are completed faster by utilizing
easy to locate, pre-brainstormed information from an FMEA.
 Possible causes in an FMEA are immediately used to jump start Fishbone or Ishikawa diagrams. Brainstorming information that is already
known is not a good use of time or resources.
 Data collected from problem solving is placed into an FMEA for future planning of new products or process quality. This allows an
FMEA to consider actual failures, categorized as failure modes and causes, making the FMEA more effective and complete.
 The design or process controls in an FMEA are used in verifying the root cause and Permanent Corrective Action (PCA).
 The FMEA and Problem Solving reconcile each failure and cause by cross documenting failure modes, problem statements and possible
causes.
FMEA Example
This FMEA Example has one item with a progression through multiple recommended Actions. With each instance, the revised RPN
has improved. The final RPN of 10 indicates the issue has been mitigated successfully. The new state should be captured as Standard
Work.
FMEA Three Path Model
Boundary Diagram Example
Parameter Diagram Example
Process Flow Diagram
Characteristics Matrix
FMEA Severity Table
FMEA Occurrence Table
FMEA Detection Table
RPN Action Example
FMEA Criticality Matrix
FMEA Example

Learn More About Failure Mode and Effects Analysis (FMEA)

Quality-One offers Quality and Reliability Support for Product and Process Development through Consulting, Training and Project
Support. Quality-One provides Knowledge, Guidance and Direction in Quality and Reliability activities, tailored to your unique
wants, needs and desires. Let us help you Discover the Value of FMEA Consulting, FMEA Training or FMEA Project Support.
Additional resources: FMEA