WEEK - 7

QUALITATIVE RISK
MANAGEMENT II (FMEA)
mb.its.ac.id RISK MANAGEMENT TEAM TEACHING 2023
 OUTLINE
UNDERSTANDING THE FUNDAMENTAL
DEFINITIONS AND CONCEPTS OF FMEAS

TYPES OF FMEA

TEN STEPS OF FMEA

CREATING AN FMEA : CASE STUDY

RECIPE IN FMEA
 UNDERSTANDING THE
FUNDAMENTAL DEFINITIONS AND
CONCEPTS OF FMEAS
 WHAT IS
FMEA ?
FMEA = FAILURE MODE EFFECT ANALYSIS
POTENTIAL

FAILURE TYPES , WAYS

POSSIBILITIES

MODE NEGATIVES EFFECT ON

PROCESS UNDER STUDY

EFFECT STUDY RISK AND

REDUCE IT

ANALYSIS
“ What can go WRONG in your process or product”
 WHAT IS
FMEA ?
An FMEA should be the guide to the development of a
complete set of actions that will reduce risk associated
with the system, subsystem, and component or
manufacturing/assembly process to an acceptable level.
 WHAT IS
FMEA ?
An FMEA is an engineering analysis:
• done by a cross-functional team of subject matter experts
• that thoroughly analyzes product designs or
manufacturing processes
• early in the product development process.
• Finds and corrects weaknesses before the product gets
into the hands of the customer.
 WHAT IS
FMEA ?
• Performing an FMEA just to fill a checkbox in the Product
Development Process and then filing it away, never to be
seen again, is a waste of time and adds no value
• If not for use as guidance through the development process,
why waste the time and resources to do it in the first place?
• If effectively used throughout the product life cycle, it will
result in significant improvements to reliability, safety,
quality, delivery, and cost.
DEFINITION OF FMEA
Failure Mode and Effects Analysis (FMEA) is a method designed
to:

1. Identify and fully understand potential failure modes and their

causes, and the effects of failure on the system or end users,
for a given product or process.

2. Assess the risk associated with the identified failure modes,

effects and causes, and prioritize issues for corrective action.

3. Identify and carry out corrective actions to address the most

serious concerns.
PRIMARY OBJECTIVE
OF FMEA
• For System FMEA —> to improve the design of the
system

• For Design FMEA —> to improve the design of the

subsystem or component

• For Process FMEA —> to improve the design of the

manufacturing process
PRIMARY OBJECTIVE
OF FMEA
There are many other objectives for doing FMEAs, such as:
• Identify and prevent safety hazards
• Minimize loss of product performance or performance degradation
• Improve test and verification plans (in the case of System or Design FMEAs)
• Improve Process Control Plans (in the case of Process FMEAs)
PRIMARY OBJECTIVE OF
FMEA
• Consider changes to the product design or
manufacturing process
• Identify significant product or process
characteristics
• Develop Preventive Maintenance plans for in-
service machinery and equipment
• Develop online diagnostic techniques
TYPES
OF
FMEAS
 TYPES OF
FMEA
The three most common types of FMEAs are:

SYSTEM FMEA

FMEA DESIGN FMEA

PROCESS FMEA
GENERAL OVERVIEW
THREE types of FMEAs are:
GENERAL OVERVIEW
 GENERAL
OVERVIEW
When is the FMEA complete?

• System & Design FMEA - These are complete when

the product is obsolete

• Process FMEA - Complete when the product or

process becomes obsolete
 SYSTEM FMEA
Analysis is at highest-level analysis of an entire system,
made up of various subsystems
Example :
• System FMEA is a bicycle. The scope of a bicycle
System FMEA is the entire bicycle as a system
• The purpose is to ensure the bicycle will accomplish its
intended Functions in a safe and reliable manner as well
as to ensure the overall risk of the bicycle system is low.
 SYSTEM FMEA
System Safety and
System Integration

Interfaces between subsystems or

with other systems
FOCUS = is on
system-related INCLUDING
Interactions between subsystems
deficiencies or with the surrounding
environment

Single-point failures (where a

single component failure can
result in complete failure of the
entire system)
 SYSTEM FMEA
Functions and relationships that
are unique to the system as a
whole
FOCUS = is on
system-related INCLUDING Human interactions
deficiencies
Service

Some practitioners separate out human interaction and

service into their own respective FMEAs
 DESIGN FMEA
Analysis is at the subsystem level (made up of various components) or
component level

Example :
• Design FMEA at the subsystem level is the hand brake of a bicycle
• The scope is the design of the entire hand brake subsystem, including
the interfaces of the various components of the hand brake subsystem
• The objective is to ensure the hand brake subsystem accomplishes its
intended functions safely and reliably, and the risk due to the
subsystem design is low
 DESIGN FMEA
Ensuring product operation is
safe and reliable during the
useful life the design
Improving
EMPHASIS
FOCUS = is on ON ensuring product operation is
product design- safe and reliable during the
useful life
related
deficiencies ensuring
Interfacesproduct
betweenoperation
adjacent is
safe and reliable during the
components
useful life

Design FMEA usually assumes the product will be

manufactured according to specifications
 PROCESS
FMEA
Analysis is at the manufacturing/assembly process level

Example :
• Process FMEA is the manufacturing and assembly of a bicycle
• The scope of a bicycle Process FMEA is the entire set of
manufacturing and assembly operations of the bicycle.
• The objective is to ensure that the assembly operations are
accomplished as intended in a safe and reliable manner, and
ensure the risk due to manufacturing and assembly is low.
 PROCESS
FMEA Improving the
manufacturing process is built to
Ensuring the product
design requirements in a safe
manner, with minimal downtime,
FOCUS = is EMPHASIS scrap and rework
on ON
manufacturing
related ensuring product operation is safe
deficiencies Manufacturing and assembly
and reliable during the useful life
operations, shipping, incoming
parts, transporting of materials,
storage, conveyors, tool
maintenance, and labeling

Process FMEAs most often assume the design is sound

 WORKSHEET
FOR FMEA
This is the generic worksheet—> can be used in Design FMEa

Analysis is at the manufacturing/assembly process level

Example :

BUT NOT FOR THE PROCESS FMEA

THE WORKSHEET can be used AS FOLLOW
WORKSHEET
FOR FMEA
PROCESS FMEA WORKSHEET

THERE IS NO ITEM IN HERE BUT PROCESS STEP

TEN STEPS OF FMEAS
TEN STEP OF FMEA
All product/design and process FMEAs follow these
steps :
 TEN STEP OF
FMEA
All product/design and process FMEAs follow these
steps :
 STEP 1.REVIEW THE
PROCESS OR PRODUCT
To ensue that everyone has the same understanding about the
process or product
• If the team is considering a product —> Review the
engineering drawing of the product
• If the team considering a process —> Review the operation
flowchart
• For a product —> Should physically see the product and
operate it
• For a process —> Should physically walk through the
process exactly as the process flows.
 STEP 1.REVIEW THE
PROCESS OR PRODUCT
If the system is a large system—> Breakdown the system
into components and sub-components
• Example : water system that supplies an industrial
process —> the pump = critical component inside the
system and A motor pump = critical subcomponent
• The motor pump should be broken down into more
subcomponents —> such as the motor’s bearings and the
rotor shaft
 STEP 2. BRAINSTORM
POTENTIAL FAILURE MODES
• 1st = everyone in the team has an understanding about the product
or the process —> Should begin thinking about the potential failure
modes that could affect
• Focusing should be on the different elements (people, material,
equipment, method,…etc)
• 2nd = Once the brainstorming is completed, the ideas should be
organized by grouping them into like categories
• Example : grouped by type of failure (electrical, mechanical,
user created), Where on the product or process the failure occurs.
 STEP 2. BRAINSTORM
POTENTIAL FAILURE MODES
Main Rules :
1. Do not comment on, judge or critique ideas
at the time they are offered
2. Encourage creative and offbeat ideas

3. The goal = end up with a large number of

ideas; and evaluate later
4. Each idea should be listed and numbered
exactly as offered, on a flip chart
5. Expect to generate at least 50 to 60
concepts in a 30-minute brainstorming
session.
STEP 3. LIST POTENTIAL EFFECTS
OF EACH FAILURE MODES
"For some of the failure modes, there may be one effect, while for other
modes, there may be several effects"

1. One failure mode could have several effects

• Example, an electrical cutoff in the home could stop the refrigerator and
damage food or prevent you from doing work on the computer

2. Several failure modes could have one effect.

• Example : A dead car battery or tire failure has the same effect on your
vehicle
The team must determine the end-effect each failure mode =
examining how each failure affects the entire system, the
facility or the other connected processes
 STEP 4-6 ASSIGN SEVERITY,
OCCURRENCE AND DETECTION
RANKINGS FOR EACH FAILURE
MODES

Each of these three rankings is based on 10-point scale,

with 1 being the lowest ranking, and 10 the highest.
 STEP 4. ASSIGN
SEVERITY RANKINGS
FOR EACH EFFECT
Effect of failure is determined by the worst case outcome
with respect to :

1. Safety and environment impact

2. Production availability

3. Direct economic cost

4. All that in numerical measure which are identified from

ranking criteria
 STEP 5. ASSIGN
OCCURRENCE RANKINGS
FOR EACH FAILURE MODE
• The best method for determining the occurrence ranking —> use
actual data from the process (in the form of failure logs)
• When actual failure data are not available —> the team must
estimate
• better estimate on how likely a failure mode is to occur and at what
frequency by knowing the potential cause of failure
• The potential causes have been identified —> an occurrence ranking
can be assigned
STEP 6. ASSIGN OCCURRENCE
RANKINGS FOR EACH FAILURE
MODE
For each failure mode —> may be several failure cause

1. Assign a Cause for each failure mode

2. Select only potential failure to get failure causes.

3. Use Why Why Technique to get the root causes

4. Identifying the failure cause (the second option to determine the

occurrence if no data is available)
“ The probability of failure Occurrence during
the expected life of the system “potential
occurrence”
 STEP 6. ASSIGN DETECTION
RANKINGS FOR EACH FAILURE
MODE AND/OR EFFECT
1. The current control should be listed for all of the failure modes, or effects

2. The detection rankings assigned.

• If one failure mode or effect has several causes, Detection and
occurrence rankings should be assigned based on these causes.
• When potential causes are eliminated, the risk of failure is lowered
3. Each detection method should be assigned for each failure mode or effect
 STEP 6. ASSIGN DETECTION
RANKINGS FOR EACH FAILURE
MODE AND/OR EFFECT
RANK DESCRIPTION

1-2 Very High Probability Of Detection

3-4 High Probability Of Detection

5-7 Moderate Probability Of Detection

8-9 Low Probability Of Detection

10 Very Low Probability Of Detection

STEP 7. CALCULATE THE
RISK PRIORITY NUMBER
FOR EACH EFECT
The Risk Priority number= Severity x Occurrence x Detection

• This number alone is meaningless because each FMEA has a

different number of failure modes and effect

• However, it can serve as a gauge to compare the revised RPN

once the recommended actions has been instituted
 STEP 7. CALCULATE THE
RISK PRIORITY NUMBER FOR
EACH EFECT
1. Contribute in
Risk Assessment
The Risk Priority Number
Calculation Benefits :

2.Compare
components to
determine priority for
corrective action
 STEP 8. PRIORITIZE THE
FAILURE MODES FOR THE
ACTION
• This Failure modes should be prioritized by ranking them in order, from the
highest to the lowest

• The team must now decided which item to work for —> helps to set a cutoff
RPN (cutoff point)*

•*= any failure modes with an RPN above that point are attended to and
Those below the cutoff are left alone for the time being

• High-risk priority numbers should be given attention first ( RPN > 100 )
• If several failure modes have the same risk priority number, that failure mode
with the highest severity should be given more priority
 STEP 9.
TAKE ACTION TO ELIMINATE OR
REDUCE THE HIGH RISK FAILURE
MODES
• It is using the problems-solving approaches and implement actions
• The easiest way —> increase the detectability of the failure,
• Increase the detection rate = assigning a schedule Preventive Monitoring action such as ;
1. use a proper condition monitoring program

2. Or consider a mistake proofing method in the design

• Example : ac computer software will automatically warn incase of low disk space.
 STEP 10.
CALCULATE THE RESULTING RPN AS
THE FAILURE MODES ARE REDUCED
OR ELIMINATED
• Actions have been taken to reduce the RPN=
1. A new ranking for the severity, occurrence, and detection should be calculated
2. A resulting RPN is calculated
• Expectation is at least 50 percentage reduction in RPN
• The question —> “ how much relative risk the team is willing to take “ And The Answer
—> depend on the industry and the seriousness of the failure
• For example : in the nuclear industry, there is a little margin for errors,; they can’t risk a
disaster occurring
CREATING AN FMEA
CASE STUDY FMEA
• We will conduct an FMEA on the
All Ranks Club coffee example
• A Black Belt wants to improve
customer satisfaction with the
coffee served at the All Ranks
Club
• Use the process map and
completed C&E matrix folloW
WHAT MAKES AN
FMEA ?
RISK ASSESSMENT -
CREATING FMEA
• For The FMEA process begins by identifying
“Failure Modes,” the ways in which a product,
service or process could fail The Customer
Requirement

• A project team examines every element of a service,

starting from the inputs and working through to the
output delivered to the customer
 RISK ASSESSMENT -
CREATING FMEA
For At each step, the team ASK ONE QESTION ?”

WHAT CAN GO WRONG HERE

WHAT IS CUSTOMER
REQUIREMENTS ?

CRITICAL TO CUSTOMER
Analyze how your process can fail to deliver
CTC
LET US MAKE A COFFEE
FOR OUR CUSTOMER

CTQ :
1. Taste
2. Strength
3. Temperature
 INPUT OUTPUT
MAPPING
INPUTS
PROCESSING OUTPUT

Let us do the process

flow map of Coffee
making process
 ALL RANKS CLUB
COFFEE PROCESS MAP
WORKSHEET FOR PFMEA
FOR MAKING COFEE
USUALLY USING THE GENERIC WORKSHEET

Analysis is at the manufacturing/assembly process level

Example :

BUT FOR THE PROCESS FMEA WE USE THE

WORKSHEET AS FOLLOW
PROCESS FMEA
FORM
PROCESS FMEA WORKSHEET

THERE IS NO ITEM IN HERE BUT PROCESS STEP

 STEP 1
DETERMINE
POTENTIAL FAILURE
MODE
PROCESS FMEA FORM
STEP 1 :DETERMINE POTENTIAL FAILURE MODE

List various ways how the Process can fail to deliver at various aspects of CTQ (CTQ = TASTE )

We can use the following Key Process Inputs to identify failures

Raw Material / Information SOP / WI / Checklist
Equipment / Infrastructure Process Control / Method / Policy

Utilities Environment / Regulation Environment / Regulation

Human Resources Human Resources Measurement

PROCESS FMEA FORM
STEP 1 :DETERMINE POTENTIAL FAILURE MODE

SINCE THE PRIMARY CTQ =

TASTE, THE PROCESS STEP
WILL BE UNDER INVESTIGATE
IS " FILL CARAFE WITH
WATER "
PROCESS FMEA FORM
STEP 1 :DETERMINE POTENTIAL FAILURE MODE

THIS ARE THE POTENTIAL

FAILURE MODE FOR STEP
FILL CARAFE WITH WATER
 STEP 2
IDENTITY
POTENTIAL
EFFECT AND
SEVERITY
PROCESS FMEA FORM
STEP 2 :DETERMINE POTENTIAL FAILURE MODE

How the product can fail to deliver

satisfaction to customer if the failure
mode occurs?
PROCESS FMEA FORM
STEP 2 :IDENTIFY POTENTIAL EFFECTS AND SEVERITY

THIS ARE THE POTENTIAL

EFECT FOR EACH FAILURE
MODE
PROCESS FMEA FORM
STEP 2 :IDENTIFY POTENTIAL EFFECTS AND SEVERITY

Numerically rate what is the Severity of this Failure

Effect on the Customer

Example : Which consequence is more severe?

1. A fire in an open area where no one was present
2. A fire in a house with 3 people affected
3. A fire in a factory with 30 employees affected MOST SEVERE
PROCESS FMEA FORM
STEP 2 :IDENTIFY POTENTIAL EFFECTS AND SEVERITY

SEVERITY RATING
PROCESS FMEA FORM
STEP 2 :IDENTIFY POTENTIAL EFFECTS AND SEVERITY

6
 STEP 3
IDENTITY POTENTIAL CAUSES /
OCCURRENCE
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES/OCCURENCE

STEPS :
5
• Now we have to find the CAUSEs of the Failure
Modes
5
• Brainstorm among process experts what are the
6 causes of failure in the system

ASK WHY ?
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES / OCCURRENCE

REMEMBER :
One failure mode can have more then 1 Effects Each
effect can have more then one Causes

THIS IS THE POTENTIAL

CAUSES OF THE FAILURE
MODE
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES / OCCURRENCE

Numerically rate what is the Occurrence of this Failure

Cause

EXAMPLE : Which probability is more?

1. Chances of rain in the month of July MOST CERTAIN
2. Chances of rain in the month of January
3. Chances of rain in the month of September
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES / OCCURRENCE

PROBABILITY RATINGS
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES / OCCURRENCE

Let us give the Occurrence Ratings for the Causes based

on Probability Chart

IMPORTANT :
• Evaluate how often this Cause has occurred in
the past
• Based on:
1. Past Data
2. Trend
3. Experience
PROCESS FMEA FORM
STEP 3 :IDENTIFY POTENTIAL CAUSES / OCCURRENCE
 STEP 4
LIST CURRENT CONTROL AND
SCORE
PROCESS FMEA FORM
STEP 4 :LIST CURRENT CONTROL AND SCORE

What are Present Controls to

Detect that this Causes have
occurred
PROCESS FMEA FORM
STEP 4 : LIST CURRENT CONTROL AND SCORE

Numerically rate what is the Present Control

Detection
10 = Most Difficult to Detect and 1 = Most
easy to detect
EXAMPLE :
Which Detection is the best is more?
1. Manual Check by operator for Defects
2. Machines give alarm if defects occurs
3. Machine stops if defect occurs

BEST
NUMBER 3 DETECTION
PROCESS FMEA FORM
STEP 4 : LIST CURRENT CONTROL AND SCORE
DETECTION RATINGS
PROCESS FMEA FORM
STEP 4 : LIST CURRENT CONTROL AND SCORE

HOW GOOD IS MY TECTION

SYSTEM?
Rate it NUMERICALLY
PROCESS FMEA FORM
STEP 4 : LIST CURRENT CONTROL AND SCORE
 STEP 5
CALCULATE RPNs
PROCESS FMEA FORM
STEP 5 : CALCULATE RPNs
PROCESS FMEA
FORM
By Getting RPN for failure
mode :
we Complete the stage 1 of
FMEA is……
RISK
ASSESSMENT

The stage 2 is……

RISK
MITIGATION
 STEP 6
DEVELOP RECOMMENDED
ACTIONS
PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION
PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION
RISK CONTROL - ACTING ON FMEA

POTENTIAL
SEVERIT OCCURENC DETECTIO
FAILURE RPN
Y E N RPN
MODES

Should be as low as
MIN 1 1 1 1
possible
MAX 10 10 10 1000

RPN LEVEL ACTION

> 300 Critical Take quick action get RPN to 100

100 - 300 Major Take action get RPN to 100

< 100 Minor TO be acted upon later

PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION
SPECIFIC CASES AND THUMB RULES
PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION
SPECIFIC CASES AND THUMB RULES
PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION

RPN to 100

So we have to reduce Severity

Occurrence Detection

NOTE
= Sev —> Severity can’t be changed,
it remains the same

OCC —> Reduce the Occurrences of

Failure by Act on the Root Causes, fix
the problem

DET —> Improve Controls to Detect

failure modes
PROCESS FMEA FORM
STEP 6 : DEVELOP RECOMMENDED ACTION
 STEP 6
COMPARE RPNs BEFORE AND
AFTER
PROCESS FMEA FORM
STEP 7 : COMPARE RPN BEFORE AND AFTER
 RECIPE
IN FMEA
RECIPE IN FMEA
• What can Go Wrong in Process/Product – Failure Mode
• Potential Failure Effect on Product
Quantify Severity of Effect on Product
• Potential Cause of the Failure Mode
Quantify Occurrence of Cause
• Present Controls to detect of cause Failure Mode
Quantify Detection of Cause
• Calculate RPN (Risk Priority Number)
RPN = Severity x Occurrence x Detection

Act and Control High RPN Causes

ANY QUESTION
 THANK YOU
mb.its.ac.id