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Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA)


It is a procedure in product development and operations management

FMEA Where is it used?

Analysis of potential failure modes within a system Classification by the severity and likelihood of the failures

Types of FMEA
Design FMEA Analysis of products prior to regular production It helps to evaluate the design requirements for the product Process FMEA Analysis of manufacturing and assembly processes It focuses on controls to reduce the occurrence of unacceptable outcomes Other FMEAs Systems and Subsystems Components (Software, Hardware) Services

When is an FMEA needed?


New design Current process in a new environment or application

New technology

Current design in a new environment or application

FMEA
New process

Modifications to the current process

Modifications to the current design

Advantages of the FMEA


Improve the quality, reliability and safety of a product/process Increase user satisfaction

Reduce system development timing and cost

Collect information to reduce future failures

Capture engineering knowledge

Early identification and elimination of potential failure modes

Emphasize problem prevention

Catalyst for teamwork and idea exchange between functions

The FMEA Requires Teamwork


Engage people from all areas affected by the design/process
Manufacturing, quality, engineering, customer satisfaction, etc.

The more heterogeneous your team is, the more failures modes are detected

The customer may be involved in the FMEA process

The FMEA Development Process


Define/Understand the Process, Product and/or Requirements List Potential Failure Modes Define the Effects of the Failure Modes

Define the Probability of Occurrence

Define the Causes for the Failure Modes

Define the Severity of the Failure Modes

Define the Current Control Methods for the Failure Modes

Determine Detection Using Current Controls

Calculate the Risk Priority Number

Evaluate the Actions Taken

Define Recommended Actions and assign Responsible

Define/Understand the Process, Product and/or Requirements

Create a Process Map (PMAP) to help you understand the system

Include interfaces, inputs and outputs

To start it is necessary to describe the system and its function

A good understanding simplifies further analysis

This PMAP gives an overview of the major components or process steps and the way they are related

List Potential Failure Modes

Only realistic FM must be considered. A potential FM could be the cause of a higher failure mode. Usually this is the opposite to the expected output.

FM must be described in technical/physical terms.

A potential Failure Mode (FM) is a condition where the system, process or design could fail.

Define the Effects of the Failures


It is what the user/customer will see if the failure happens

How to document them?


Write them down in terms of what the user/customer might see or experience

There could be more than one effect for each Failure Mode

What is the effect?

How many effects?

Process or Function

Failure Mode Failure 1

Effects Effect 1 Effect 2 Effect 3

Step 1
Failure 2

Define the Severity of the Failure Modes


The Severity (S) is the value associated with the most serious effect for a given Failure Mode How serious is the effect for the potential Failure Mode from the user/customer perspective Each effect is given a severity number from 1 (no discernible effect) to 10 (dangerous, critical) These numbers help to prioritize the Failure Modes and their effects

Scale 10 9 8 7 6

Severity Dangerous without warning Dangerous with warning Very High High Moderated

Scale 5 4 3 2 1

Severity Low Very Low Minor Less than Minor None

Define the Causes for the Failure Modes

The cause for the Failure Mode must be the root cause

A Failure Mode cause is looked upon as a design weakness

All the potential causes for a Failure Mode should be identified and documented.

Identify what can cause the Failure Mode occur

Process or Function

Failure Mode Failure 1

Effects Effect 1 Effect 2 Effect 3

Severity 5 7 2

Cause Cause 1 Cause 2 Cause 3

Step 1
Failure 2

Define the Probability of Occurrence


Probability Very High Scale 10 9 Index > 1 out of 2 1 out of 3 1 out of 8 1 out of 20 1 out of 80 1 out of 400 1 out of 2000 1 out of 15000 1 out of 150000 < 1 out of 1150000

The occurrence is the likelihood that a specific cause/mechanism will occur resulting in the Failure Mode within the design/process life.

High

8 7

Moderated

6 5 4

Low Very Low

3 2 1

It is based in the status-quo of the product/process.

It contains an evaluation of the probability that a cause occurs and the Failure Mode (and consequently the effect) appears.

Remote

Define the Current Control Methods for the Failure Modes

Define the controls that are currently in place to detect or prevent that the Failure Mode occurs (before the effect occurs)

Hereafter one should identify testing, analysis, monitoring and other techniques that can be or have been used on similar systems to detect Failure Modes

From these controls one can learn how likely it is for a Failure Mode to be identified or detected

Process or Function

Failure Mode Failure 1

Effects Effect 1 Effect 2

Severity 5 7 2

Cause Cause 1 Cause 2 Cause 3

Occurrence 5 3 4

Current Controls Control 1 Control2 Control 3

Step 1 Failure 2

Effect 3

Determine Detection Using Current Controls


Detection is the rank associated with the best detection control listed in the current design/process control method A high detection number indicates that the chances of detection are low When more than one control is identified, it is recommended that the detection ranking of each control be included

Scale 10 9 8 7 6

Detection Almost Impossible Very Remote Remote Very Low Low

Scale 5 4 3 2 1

Detection Moderated Highly Moderated High Very High Always

Calculate the Risk Priority Number


Risk Priority Numbers (RPN) play an important part in the choice of an action against failure modes.

After ranking the severity (S), occurrence (O) and detection (D), the RPN can be easily calculated by multiplying these three numbers: RPN = S O D

The RPN help us to understand where to focus first

It is recommended to take actions for failure modes with an RPN >= 100 or with a high Severity ranking, then high Occurrence ranking, then high Detection ranking
Process or Function Failure Mode Failure 1 Step 1 Failure 2 Effects Effect 1 Effect 2 Effect 3 S 5 7 2 Cause Cause 1 Cause 2 Cause 3 O 5 3 4 Current Controls Control 1 Control 2 Control 3 D 8 6 6 RPN 200 126 48

Define Recommended Actions and Assign Responsible


After highest RPN Failure Modes are selected, recommended actions with responsible and target date of implementation are noted. These actions can include specific inspection, testing or quality procedures, redesign, adding more redundancy and limiting environmental stresses or operating range

The objective is to reduce any or a combination of the Severity, Occurrence or Detection

Process or Function

Failure Mode Failure 1

Effects Effect 1

S 5

Cause Cause 1

O 5

Current Controls Control 1

D 8

RPN 200

Action Plan Responsible Action Plan 1 Responsible 1 Due Date 1 Action Plan 2 Responsible 2 Due Date 2 None

Step 1 Failure 2

Effect 2

Cause 2

Control 2

126

Effect 3

Cause 3

Control 3

48

How to take Actions?

Evaluate the Actions Taken


Once the actions have been implemented, the S, O and D are evaluated again Whenever a design or a process changes, the FMEA must be updated

The new RPN should be calculated to confirm the improvements

Process or Function

Failure Mode

Effects

Cause

Current Controls

RPN

Action Plan Responsible

New S

New O

New D

New RPN

Effect 1 Failure 1 Step 1 Effect 2 Failure 2 Effect 3

Cause 1

Control 1

200

Action Plan 1 Responsible 1 Due Date 1 Action Plan 2 Responsible 2 Due Date 2 None

80

Cause 2

Control 2

126

84

Cause 3

Control 3

48

NA

NA

NA

NA

Questions?
Failure Modes

Effect FMEA

Exercise
Group in teams of 5 people

Share your results with the rest of the class

Create an FMEA for the organization of your next Vacations

Draw the PMAP including inputs and outputs

Fill out the FMEA form considering at least one possible Failure Mode for each process step

Options: Graduation party Concert Opening a new restaurant Repairing a house Launching a new product Others