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FAILURE MODE

AND EFFECTS
ANALYSIS

FMEA
Failure Mode and Effects Analysis (FMEA) is
a systematic process for identifying
potential / known failures, problems and
errors from a process / piece of equipment,
with the intent to eliminate them or
minimise the risk associated with them.
By itself it is not a problem solver, it must
be used in combination with other problem
solving tools. The FMEA presents the
opportunity but does not solve the
problem.
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PRIORITISING BY RPN
Risk Priority Number (RPN) is product of the
severity (S) multiplied by occurrence (O)
and detection (D). The RPN is used to rank
the potential and known failures and
ensure that those with the highest RPN are
assigned for solution first.

Scoring the FMEA

CALCULATING SO & SD
Evaluate RPN with assistance of calculating
severity x occurrence (SO) and severity x
detectability (SD)
SO If the items detectability is good (1 or
2) and the event being analysed has
moderate to high severity and occurs on a
regular basis this could effect product
quality and productivity.
SD If Occurrence is low (1 or 2) this level
indicates that a severe situation could go
undetected and reach the customer.

DECISION MAKING
Highest RPNs require action (Above 250)
Severity of 9 or 10 should receive action
When RPN is low, SO & SD calculations
should be reviewed

BENEFITS OF FMEA
Improves customer satisfaction
Helps to identify potential failure modes
early
Reduces costs and enhances product
quality
reliability and Safety
Establishes priorities for improvement
Assists in the analysis of new or revised
manufacturing processes
Team benefits, improving knowledge of
the process / equipment via the FMEA
process

WATCH OUTS
Should be developed by a team, not by
one individual
FMEA should not be done to tick the
box, should be used to improve the
process or equipment
FMEA should not be developed too late,
i.e when equipment is being
manufactured, eg, Process FMEA should
be done at step 2 of the EEM process.

TYPES OF FMEA
1)Design FMEA
2)Process FMEA
3)Equipment FMEA

DESIGN FMEA
Addresses the product design and failure
because of a design issue
Looks at components and raw materials for
failure modes
Tests the robustness of design verification
methods to ensure design flaws are
detected prior to production

PROCESS FMEA
Analyses the manufacturing process
looking for potential failures in the
manufacturing system.
Reviews individual process steps looking at
potential or known failure modes of the
manufacturing process.
Tests the robustness of current
manufacturing controls to ensure that
defective material is not shipped to the
customer.
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EQUIPMENT FMEA
Analyses the Equipment looking for
potential failures,
Reviews the equipment at component level
looking at potential or known failure modes
including Mean Time Between Failure
(MTBF)
Tests the robustness of current
maintenance controls and reviews Mean
Time To Repair (MTTR)
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7 STEPS OF EEM
Step 7

Step 6
Step 5

Equipment FMEA

Step 4

Step 3

Process FMEA
Step 2

Step 1

Detailed
Design

Basic Design

Conceptual
Planning

Trial
Production

Installation

Manufacture

Initial Flow

Check safety, quality,


maintainability etc

Debugging

Installation of the equipment considering past


projects and approved learning

Confirm machine design and reliability

Based on Safety, Quality Assurance and approved learning from


projects in the past

Design goals, life cycle cost, quality etc

The purpose of the investment, timing and profitability

FMEA TEAM MEMBERS


The FMEA team should include all the people who cover the 4Ms of
the process / equipment, this could be:

MAN

METHOD

Line operators
Production supervisor
Project Leader
Site WCM manager and Early Management pillar leader

MACHINE
Technical person from Equipment supplier
Project engineers
Maintenance engineers

MATERIALS Packaging / product development leader


Technical person from Material supplier
Quality manager

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DEFINITION POTENTIAL FAILURE


MODE
Manner in which a part, sub assembly, or
system could potentially fail to meet its
designed intent, fulfil processing or
customer requirements.
Examples: Broken, Short Circuited, Hole
Missing

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DEFINITION PROCESS FUNCTION


Anything that the analysed process step
does to meet the process function or
requirement.
Example: Batch Mixing
Thorough mixing of ingredients A & B
Less than 2% solids
Example: Steel Bracket
4 Mounting Holes
90 degree angle
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DEFINITION POTENTIAL EFFECT


OF FAILURE
Describes effect of failure in terms of what
the customer might notice. The most
severe effect could be the next
downstream operation.
Examples:
Extreme customer dissatisfaction
Will cause a jam at next operation
Personal Injury
Poor appearance
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DEFINITION POTENTIAL CAUSES


How the failure could occur, described in
terms of something that can be controlled
or corrected in the manufacturing process.
Examples:
Incorrect material used
Insufficient dosage of material

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DEFINITION CURRENT CONTROLS


Current inspection or manufacturing
controls which will detect the failure mode
as early as possible. Controls intended to
prevent or reduce occurrence of the cause
of failure should be considered when
estimating the occurrence rating not the
detection rating.
Examples:
Limit Switches / warning devices
Process verification testing
Sample inspection
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PROCESS FMEA DEVELOPMENT


Identify Process Functions and list
Identify Potential Failure Modes
Select
Appropriate
Team Members

Identify Adverse Effects for each Failure


Mode

Identify Input
Data

Determine the Severity Rating for Each


Effect

Develop or
Obtain process
flow chart &
Validate

Classify Critical Characteristics based on


these Effects
Identify Potential Causes for the Failure
modes
Determine the Occurrence rating for each
potential Cause

Determine
recommended
actions to reduce all
the priority items
Determine
responsibility and
target completion
date
Document actions
taken and recalculate
RPN

Identify current Process controls


Determine the Detection rating of each
control as related to each cause
Calculate the Risk Priority Number for each
failure mode scenario (priority of failure)

During the product


life, revisit the
Process FMEA as
appropriate

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ASSUMPTIONS TO MAKE
In developing a Process FMEA it is assumed
that the design is correct. The product
designed will meet the design intent. If this
assumption is not made the FMEA team are
in danger of developing a design and a
process FMEA at the same time & not
accomplish the task.
At any process step during development it
should be assumed that the incoming
materials / parts are correct to that process
step, exceptions can be made where
previous results indicate prior problems
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SELECT APPROPRIATE TEAM


MEMBERS
5 to 7 team members
Ensure process / product expertise
Determine level of FMEA process
knowledge
Ensure at least one FMEA-knowledgeable
person is on the team
Conduct Process FMEA training with team
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IDENTIFY INPUT DATA


QP Matrix
Maintenance Prevention Information
Defect Prevention Information
Engineering Drawings
Product Specifications
Previous / Similar FMEAs
Process Flow Diagrams
Customer / Consumer Complaints
D Incidents
Quality KPIs / Losses
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DEVELOP OR OBTAIN PROCESS


FLOW DIAGRAM & VALIDATE

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IDENTIFY PROCESS FUNCTIONS


AND LIST
A process flow chart is necessary to identify
those steps in the process that can be
analysed.
At the time the process flow is developed,
the question should be asked, What is the
purpose of the process step? What are the
requirements to successfully complete this
step?
Process Function
Heat thermal oil to 550
degF
Requirements
Correct Air Flow
Correct Gas Flow
Correct Ignition
Etc.

Process Function
Supply Oil to heaters

Requirements
Correct thermal flow
Containment of fluid in
piping
Etc

Process Function
Etc..
Requirements
Etc

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STEPS ONCE PROCESS


FUNCTIONS IDENTIFIED
1 Identify Potential Failure Modes
2 Identify Potential Effects for each failure mode
3 Determine the severity rating for each effect
4 Classify critical characteristics based on these
effects
5 Identify potential causes for the failure modes
6 Determine the occurrence rating for each cause
7 Identify current process controls
8 Determine the detection rating of each control as
related to each cause
9 Calculate the RPN
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BUILDING THE PROCESS FMEA

One of the important team outputs of developing a Process FMEA is the


improved (shared) knowledge of the process and the brain storming by
team members regarding the potential failure modes and the potential
cause mechanisms of failure.
During the development do not restrain brainstorming because of
artificial restraints such as the form size on a computer screen.

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1 IDENTIFY POTENTIAL FAILURE


MODES
Brainstorm and collect data on all potential failure
modes at each process step.
Examples of Sources:Consumer Complaints
Breakdown History / M/C Ledger
Internal scrap or rework history
FMEA team expertise
Potential failure mode is defined as the manner
in which a process step could potentially fail to
meet the process requirements and / or the
design intent.

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1 IDENTIFY POTENTIAL FAILURE


MODES

Do not immediately list all potential failure modes on the FMEA form.
Brainstorm all of the failure modes onto a separate page. Then, list
the potential failure modes one at a time and brainstorm for all of the
causes for each failure mode before moving onto the next failure
mode. Some potential failure modes could have multiple causes.
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2 POTENTIAL EFFECTS OF
FAILURE

The potential effects of failure are defined as the effects of the failure
mode on the customer(s) next process or downstream operations. The
customer could be the next operation(s) or the end item user. Choose the
most severe effects anticipated, usually more than one.
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3 DETERMINING SEVERITY
RATING

Severity is defined as an assessment of the seriousness of the effects


listed in the previous column (Potential effects of Failure)
Severity should be scored once for all effects, using the most
severe rating
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4 CLASSIFICATION
The classification column should be used to
identify the area of impact.
Example:Regulatory
Safety
Quality
Reliability
Productivity

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5 POTENTIAL CAUSE
MECHANISMS
A potential or known cause of a failure is defined as a process
deficiency that may result in a failure mode, described in terms
of something that can be corrected or can be controlled.
Identification of causes should start with those failure modes
that have the highest severity rating.
Brainstorm and list every conceivable cause assignable to the
failure mode being addressed. The understanding of cause and
effect is important here, problem solving tools may need to be
employed here i.e 5 Why.
Work on one failure mode at a time, list the failure mode, then
all of the causes, then continue on to the next failure mode. List
only specific causes, avoid ambiguous statements such as
machine malfunction.
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5 POTENTIAL CAUSE
MECHANISMS

33

6 DETERMINING OCCURRENCE
RATING

Occurrence is the likelihood that a specific cause / mechanism will


occur over the life of the design. When developing the FMEA, every
cause will have an occurrence rating.
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7 IDENTIFY CURRENT PROCESS


CONTROLS
The current process controls are descriptions of controls that
will prevent a potential failure mode from occurring or
detect a failure mode should it occur. These controls are
evaluated for each cause, examples are:
Prevention-based i.e POKE YOKE
Detection leading directly to corrective action
Detection only i.e inspection
Examples:Inspection of material orientation
Quality Checks / Inspections
Supplier Material Certification
Operator visual checks
Warning lights, sirens and sensors
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8 DETERMINING DETECTION
RATING

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8 DETERMINING DETECTION
RATING
The detection assessment addresses
whether current or proposed controls will
detect a potential cause / mechanism
(weakness) before the product is affected.
Consider operator inspection or random
quality audits as unlikely to detect a
random defect (usually rank from 5 to 9).

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9 CALCULATING THE RISK


PRIORITY NUMBER (RPN)
RPN defines the priority of the failure in the
Process FMEA and and to obtain corrective action
to improve the process deficiencies.
RPN is the Product of Severity, Occurrence and
Detection and it will have a ranking of between 1
and 1000.
RPN = S x O x D

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PRIORITISING RECOMMENDED
ACTIONS TO REDUCE RISK
1) Highest RPNs require action (Above 250)
2) Severity of 9 or 10 should receive action
3) SO & SD above 65 should be considered for action
To reduce probability of Occurrence, process or design revisions
are required.
Only a design change or a process revision can address a
reduction in Severity Ranking.
Improve Detection Ranking by improving evaluation techniques
(Adding additional manual quality inspection should only ever be
considered as a temporary fix. It will not reduce the number of
failures, it will only catch them so that the customer does not
receive them.
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MISTAKE PROOFING
Taking responsibility for a permanent fix
and redesigning the component or
processing step so the problem will never
re-occur.

40

DEVELOPING ACTIONS
In developing recommended actions,
emphasis should be placed on prevention
methods such as:Mistake-Proofing (Poke Yoke)
Statistical Process Control
Process Changes
Visualisation (sensors)
Closed loop control

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ACTIONS TAKEN / RECALCULATE


RPN

List actual steps, targeted completion date and accountability for when
action plan is complete.
After actions are included in the process, it is now worthwhile for the
FMEA team to evaluate the new process and recalculate the RPN. This
will provide an idea if the new revised process is going to reduce the
potential risk of failures.
If no actions are taken, the columns should state no action taken.
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MAINTAINING AND IMPROVING


FMEA
The FMEA should be revisited and
maintained during the life of the product.
This is a roadmap to potential failures and
appropriate actions taken to improve the
product / process.
It should be reviewed whenever a design
change occurs, any time a process change
is planned, when large amounts of waste or
quality defects / complaints occur, and also
at a regular interval (once or twice per
year).
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REVIEW OF FMEA
During a review of the FMEA the failure
modes should be reviewed and the
rankings of S, O and D should be verified
and RPNs recalculated if required.
Establish and action team(s) if appropriate
as a result of a recalculated RPN.
Review recommended actions and check
for completion

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THE END

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RANKINGS FOR EQUIPMENT FMEA

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Equipment FMEA - Severity

EFFECT

RATING

CRITERIA

Downtime
Scrap

Downtime less than 5 minutes. No scrap, no rework


No safety issue.

Downtime
Scrap

Downtime less than 5 minutes. No scrap, no rework. Operator fix required. No


safety issue.

Downtime
Scrap

Downtime less than 30 minutes. No scrap, very minor rework. Operator fix
required. No safety issue

Downtime
Scrap

Downtime less than 30 minutes. No scrap, rework. Operator fix required. No


safety issue

Downtime
Scrap

Downtime 30 60 minutes. No scrap, rework


required. Quality control required. No safety issue.

Downtime
Scrap

Downtime 1 to 2 hours. No scrap, No scrap, rework required. Quality control


required. No safety issue.

Downtime
Scrap

Downtime 2 to 4 hours. Scrap one part lost


No safety issue.

Downtime
Scrap

Downtime more than 4 hours. Scrap more than one part.


No safety issue.

Safety

Safety Minor hazard ( Any lost time injury not ranked as 10)

Safety

10

Safety Immediate life or limb threatening hazard

Equipment FMEA - Occurrence


MTBF RATING

CRITERIA

10,000 hrs

One failure in 2 years

5,000 hrs

One failure per year

2,500 hrs

One failure every 6 months

1,250 hrs

One failure every 3 months

415 hrs

One failure per month

100 hrs

One failure per week

20 hrs

One failure per day

10 hrs

One failure per shift

1 hr

One failure per hour

5 minutes

10

One failure every 5 minutes or less

Equipment FMEA - Detection


DETECTION

RATING

CRITERIA

Almost certain

Design controls will almost certainly detect a potential cause and subsequent failure mode and will not
require Equipment controls.

Very high

Very high chance the Design controls will detect a potential cause and subsequent failure mode and will
not require Equipment controls.

High

High chance the Design Controls will detect a potential cause and subsequent failure mode and may
require Equipment controls.

Moderately high

Moderately high chance the Design controls will detect a potential cause and subsequent failure mode
and may require Equipment controls.

Moderate

Moderate chance the Design controls will detect a potential cause and subsequent failure mode, or
Equipment control will prevent an imminent failure (stop machine) and isolate cause.

Low

Low chance the Design controls will detect a potential cause and subsequent failure mode, or
Equipment control will prevent an imminent failure (stop machine).

Very Low

Very low chance the Design controls will detect a potential cause and subsequent failure mode, or
Equipment control will prevent an imminent failure (stop machine).

Remote

Remote chance the Design controls will detect a potential cause and subsequent failure mode, or
Equipment control will provide an indicator of an imminent failure.

Very Remote

Very remote chance the Design / Equipment controls will detect a potential cause and subsequent
failure mode.

Almost impossible

10

Current controls will not and / or cannot detect the cause or subsequent failure. There is no Design or
Equipment control.

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