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.

Severity Occurrence Detection RPN

10 10 10 1000
9 9 9 729
8 8 8 512
7 7 7 343
Scoring the FMEA
6 6 6 216
5 5 5 125
4 4 4 64
3 3 3 27
2 2 2 8
1 1 1 1

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 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.
•

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 Decision making

• Highest RPNs require action (Above 80)

• Severity of 9 or 10 should receive action

• When RPN is low, SO & SD calculations should be reviewed

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 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

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 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.

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 Types of FMEA

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

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 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

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 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 WCM
the o ry

Step 7 Initial Flow Check safety, quality,

maintainability etc

Step 6 Trial Production Debugging

Step 5 Installation Installation of the equipment considering past projects

and approved learning

Step 4 Manufacture Confirm machine design and reliability

Equipment FMEA
Detailed Based on Safety, Quality Assurance and approved learning from projects in
Step 3 Design the past
Process FMEA
Step 2 Design goals, life cycle cost, quality etc
Basic Design

Step 1 Conceptual Planning 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 Line operators

• Production supervisor

• METHOD 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

Select Identify Potential Failure Modes

Determine
Appropriate Team
Identify Adverse Effects for each Failure Mode recommended actions to
Members
reduce all the priority
Determine the Severity Rating for Each Effect items
Identify Input
Data
Classify Critical Characteristics based on these Determine responsibility
Effects and target completion
Develop or Obtain
date
process flow chart
& Validate Identify Potential Causes for the Failure modes
Document actions taken
Determine the Occurrence rating for each and recalculate RPN
potential Cause

Identify current Process controls

Determine the Detection rating of each control as

related to each cause

Calculate the Risk Priority Number for each During the product life,
failure mode scenario (priority of failure) 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 with incoming materials or parts.

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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
Process Function
Heat thermal oil to 550 degF
Supply Oil to heaters Process Function
Etc………..
Requirements
Requirements
Correct Air Flow
Correct thermal flow Requirements
Correct Gas Flow
Containment of fluid in piping Etc…………
Correct Ignition
Etc………… ………………
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

Process Step and

No Process Requirement Potential Failure Mode
Function

The manner in which a

process step could fail to
Process step and the What are the requirements to successfully
meet the process
function that it performs. complete the process step?
requirements and/or
design intent.

*Low Air Flow

Heater:
Correct Air Flow *High Air Flow
1 Heat Thermal Oil Fluid to
*etc……………...
550 deg F.

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

Process Step and Potential Effect(s) of

No Process Requirement Potential Failure Mode
Function Failure (Consequence)

The manner in which a The effects of a failure

process step could fail to mode on the customer(s)
Process step and the What are the requirements to successfully
meet the process next process,
function that it performs. complete the process step?
requirements and/or downstream operations,
design intent. or government regulation

*Low Fluid
Temperature/Process
Heater: Delay,
Correct Air Flow
1 Heat Thermal Oil Fluid to Low Air Flow *Incomplete (rich)
550 deg F. combustion, soot in
emissions.
*etc…………..

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

Ranking Severity Description

1 None Minor. The customer might not even notice this effect. It will not have any effect on the performance of the product nor on any subsequent processing.

Minor disruption to production line. Some minor rework which can be effected on-line but in station. Non-functional appearance aspect does not conform. A discriminating
2 Very minor
customer would notice defect.
Minor disruption to production line. Some minor rework which can be effected on-line but out of station. Non-functional appearance aspect does not conform. Average customer
3 Minor
would notice defect.
Minor disruption to production line. The product may have to be sorted and a portion reworked. Non-functional appearance aspect item does not conform. Defect noticed by
4 Minor
most customers.
Minor disruption to production line. 100% of product may have to be reworked. Unit / item is operable, but some convenience item(s) operate at reduced level of performance.
5 Low
Customer experiences some dissatisfaction.
Minor disruption to production line. A portion of product may have to be scrapped (no sorting). Unit / item is operable, but some convenience item(s) inoperable. Customer
6 Moderate
experiences discomfort

7 High Minor disruption to production line. Product may have to be sorted and a portion scrapped. Unit/ item is operable, but at a reduced level performance. Customer dissatisfied.

8 Very high Major disruption to production line. 100% of product is scrapped. Unit/ item is inoperable, loss of primary function. Customer very dissatisfied.

9 Hazardous May endanger machine or assembly operator severity ranking when safety of unit operation or non compliance to government regulations. Failure will occur with warning

May endanger machine or assembly operator. Very high severity ranking when safety of unit operation or non-compliance to government regulations. Failure will occur without
10 Hazardous
warning.

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

Potential Cause(s)/
Process Step and Potential Effect(s) of CLASSIFI-
No Process Requirement Potential Failure Mode SEV Mechanism(s) of
Function Failure (Consequence) CATION
Failure
A process deficiency
The manner in which a The effects of a failure Regulatory that may result in a
process step could fail to mode on the customer(s) Safety failure mode,
Process step and the What are the requirements to successfully Effect of the
meet the process next process, Quality described in terms of
function that it performs. complete the process step? failure mode.
requirements and/or downstream operations, Reliability something that can be
design intent. or government regulation Productivity corrected or
controlled.
*Low Fluid
*Plugged filter
Temperature/Process
Heater: *Fan Failure
Correct Air Flow Delay,
1 Heat Thermal Oil Fluid to Low Air Flow 9 Regulatory *Air Flow Control
*Incomplete (rich)
550 deg F. Valve Failure
combustion, soot in
*etc…………….
emissions.

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 6 – Determining Occurrence Rating

Ranking Probability Possible Cpk Failure rates

1 Remote: Failure unlikely. <1 in 1,500,000 >1.67 No failures ever associated with almost identical process

2 Very Low 1 in150,000 >1.50 Only isolated failures associated with similar processes

3 Low 1 in 15,000 >1.33 Isolated failures with similar processes

Generally associated with processes similar or previous processes, which have experienced occasional
4 Moderate: Occasional failures 1 in 2,000 >1. 17
failure, but not in major proportions.
Generally associated with processes similar or previous processes, which have experienced occasional
5 Moderate 1 in 400 >1.00
failure, but not in major proportions.
Generally associated with processes similar or previous processes, which have experienced occasional
6 Moderate 1 in 80 >0.83
failure, but not in major proportions.

7 High 1 in 20 >O.67 General associated with similar or previous processes which have often failed.

8 High: Repeated failures 1 in 80 >0.51 General associated with similar or previous processes which have often failed.

9 High: Repeated failures 1 in 3 >0.33 Failure is almost inevitable

10 Very High: Failure is almost inevitable >1 in 2 <0.33 Failure is almost inevitable

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

Ranking Likelihood of Detection Description

1 ALMOST CERTAIN Current control(s) almost certain to detect the potential cause / mechanism and subsequent failure mode.

2 VERY HIGH Very high likelihood current control(s) will detect a potential cause / mechanism and subsequent failure mode.

3 HIGH High likelihood current control(s) will detect a potential cause / mechanism subsequent failure mode.

4 MODERATELY HIGH Moderately high likelihood current control(s) will detect cause / mechanism and subsequent failure mode.

5 MODERATE Moderate likelihood current control(s) will detect a potential cause / mechanism and subsequent failure mode.

6 LOW Low likelihood current control(s) will detect potential cause / mechanism and subsequent failure mod

7 VERY LOW Very low likelihood current control(s) will detect potential cause and subsequent failure mode.

8 REMOTE Remote likelihood current control(s) will detect potential cause and subsequent failure mode.

9 VERY REMOTE Very remote likelihood current control(s) will detect a potential cause / mechanism and subsequent failure mode.

10 ALMOST IMPOSSIBLE No know control(s) available to detect a potential cause / mechanism and subsequent failure mode.

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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 80)

• 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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 ACTIONS TAKEN / RECALCULATE RPN

Recommended Responsibility + Corrective Actions

pSEV pOCC pDET p(S × O) p(S × D) pRPN
Corrective Action Target Timing Completed

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 1 Downtime less than 5 minutes. No scrap, no rework

Scrap No safety issue.

Downtime 2 Downtime less than 5 minutes. No scrap, no rework. Operator fix required. No
Scrap safety issue.

Downtime 3 Downtime less than 30 minutes. No scrap, very minor rework. Operator fix
Scrap required. No safety issue

Downtime 4 Downtime less than 30 minutes. No scrap, rework. Operator fix required. No
Scrap safety issue

Downtime 5 Downtime 30 – 60 minutes. No scrap, rework

Scrap required. Quality control required. No safety issue.

Downtime 6 Downtime 1 to 2 hours. No scrap, No scrap, rework required. Quality control

Scrap required. No safety issue.

Downtime 7 Downtime 2 to 4 hours. Scrap one part lost

Scrap No safety issue.

Downtime 8 Downtime more than 4 hours. Scrap more than one part.
Scrap No safety issue.

Safety 9 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 1 One failure in 2 years

5,000 hrs 2 One failure per year

2,500 hrs 3 One failure every 6 months

1,250 hrs 4 One failure every 3 months

415 hrs 5 One failure per month

100 hrs 6 One failure per week

20 hrs 7 One failure per day

10 hrs 8 One failure per shift

1 hr 9 One failure per hour

5 minutes 10 One failure every 5 minutes or less

 Equipment FMEA - Detection

DETECTION RATING CRITERIA

Almost certain 1 Design controls will almost certainly detect a potential cause and subsequent failure mode and will not
require Equipment controls.

Very high 2 Very high chance the Design controls will detect a potential cause and subsequent failure mode and will
not require Equipment controls.
High chance the Design Controls will detect a potential cause and subsequent failure mode and may
High 3 require Equipment controls.

Moderately high 4 Moderately high chance the Design controls will detect a potential cause and subsequent failure mode
and may require Equipment controls.
Moderate 5 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 chance the Design controls will detect a potential cause and subsequent failure mode, or
Low 6 Equipment control will prevent an imminent failure (stop machine).

Very Low 7 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 8 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 chance the Design / Equipment controls will detect a potential cause and subsequent
Very Remote 9
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.