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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.
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
Debugging
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
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Identify Input
Data
Develop or
Obtain process
flow chart &
Validate
Determine
recommended
actions to reduce all
the priority items
Determine
responsibility and
target completion
date
Document actions
taken and recalculate
RPN
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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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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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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
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
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6 DETERMINING OCCURRENCE
RATING
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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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.
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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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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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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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EFFECT
RATING
CRITERIA
Downtime
Scrap
Downtime
Scrap
Downtime
Scrap
Downtime less than 30 minutes. No scrap, very minor rework. Operator fix
required. No safety issue
Downtime
Scrap
Downtime
Scrap
Downtime
Scrap
Downtime
Scrap
Downtime
Scrap
Safety
Safety Minor hazard ( Any lost time injury not ranked as 10)
Safety
10
CRITERIA
10,000 hrs
5,000 hrs
2,500 hrs
1,250 hrs
415 hrs
100 hrs
20 hrs
10 hrs
1 hr
5 minutes
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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.