2018/06/20

FMEA
A practical guide
Karl van der Merwe

An Overview

1
 2018/06/20

Current to Future State

What is FMEA?
• Systematic analysis of:
• A product design
• Production process
• Delivery system

2
 2018/06/20

History of FMEA

Now
1970’s Widespread
Cars
1960’s
Military

1940’s
Safety

Primary Objective

3
 2018/06/20

Robust Processes - Services

• Compare:
services vs manufacturing?

Types of FMEA
• System FMEA (SFMEA)
• Design/Product (DFMEA)
IT system

• Process FMEA (PFMEA)

Supply: power/money ATM Currency

Customer/card

4
 2018/06/20

SFMEA – Kitchen Fire Suppression System

Fast food fire suppression system
• What is it made up of?

SFMEA – Procurement System

5
 2018/06/20

DFMEA – ATM

DFMEA – Fire Extinguisher

6
 2018/06/20

DFMEA – Tank Container

PFMEA – Receipt and Inspection

Receipt and Inspection

7
 2018/06/20

FMEA - Types Summary

• System FMEA would encompass the entire logistics chain.
• Design/product FMEA would look at the actual product being
produced or any of the other components of the system.
• Process FMEA could examine the making of the product or the
loading process.

Industry 4.0

8
 2018/06/20

FMEA and Quality/Improvement

• How does FMEA fit into the bigger picture?
• What is a Quality Management System?
• International Organisation for Standardisation
• FMEA and ISO 9000:2015, ISO/TS 16949
• Lean and Six Sigma

Quality Defined
• Write your definition of quality in less than 50
words

Quality is not an act it is a habit - Aristotle

Quality means doing it right when no one is looking – Ford
Quality is everyone’s responsibility- Deming
Quality has to be caused, not controlled - Crosby
Quality is always the result of intelligent effort - Ruskin

9
 2018/06/20

Quality Defined

Transcendent: excellence
Product-based: Quantities of product attributes
User-based: Fitness for intended use
Value-based: Quality versus price
Manufacturing-based: conformance to specifications

Quality Defined – the “experts”

Three of the most famous quality experts offer these
definitions:
• “Meeting of customer’s needs” – W. Edwards Deming
• “Fitness for use” – J.M. Juran
• “Conformance to requirements” – Philip B. Crosby

10
 2018/06/20

Quality Management System (QMS)

Broadly speaking the goals of QMSs include:
• Ensuring compliance with company and industry standards.
• Defining processes that result in the production of quality
products and services.

A quality management system (QMS) is the

organisational structure, procedures,
processes and resources needed to implement
quality management.

International Organisation for Standardisation

(ISO)

• “The standards provide guidance and tools for

companies and organizations who want to
ensure that their products and services
consistently meet customer’s requirements, and
that quality is consistently improved.”
Source: ISO Standards Website

11
 2018/06/20

ISO Standards

ISO 9001:2015

12
 2018/06/20

FMEA in ISO
A number of actions are listed for each of these principles and QMP 4, in particular, refers to:
 The management of risks that can affect outputs of the processes and overall outcomes of the quality
management system.
QMP 7 refers to an ongoing focus on improvement in the organisation and cites actions for enacting this
principle:
 Educate and train people at all levels on how to apply basic tools and methodologies to achieve
improvement objectives.
 Ensure people are competent to successfully promote and complete improvement projects.
 Develop and deploy processes to implement improvement projects throughout the organization.
 Track, review and audit the planning, implementation, completion and results of improvement projects.
 Integrate improvement considerations into the development of new or modified goods, services and
processes.

Lean and Six Sigma

13
 2018/06/20

FMEA as a Project
A project is a unique endeavour undertaken to solve a
problem or seize an opportunity, which utilises limited
resources, often from various sources, in a
coordinated and controlled manner with the ultimate
aim of reaching a collaborative goal in a
predetermined timeframe.

FMEA Project
FMEA Plan FMEA Current State FMEA Future State FMEA Closure

• Scope Statement • Map steps (SFMEA, • Identify out-of-limit • Present FMEA

• Team Selection PFMEA) or RPN's • Set revison date
• Start-up components • Develop • Document control
(DFMEA) countermeasures
• Identify failure • Implement
modes countermeasures
• Identify failure • Revise RPN
effects
• Assign 3-point
failure mode ratings
• Calculate RPN

14
 2018/06/20

FMEA Process Phase Activity

FMEA Plan Scope Statement
Team Selection
Start-up

FMEA Current State Map Steps/Components

Identify Failure Modes
Identify Failure Effects
Assign 3-point Failure Mode
Ratings
Calculate RPN

FMEA Future State Identify out-of-limit RPN’s

Develop Countermeasures
Implement Countermeasures
Revise RPN

FMEA Closure Present FMEA

Set Revision Date
Document Control

FMEA Success Factors

• know FMEA concepts and definitions
Best practice • know the FMEA phases/procedure

• logistics in place
Resources • right team in place

• capture lessons
Learning • incoporate lessons

• experienced
Facilitation • coaching style

• part of QMS
Comprehensive • company-wide

15
 2018/06/20

PART B: FMEA PROJECT PHASES

FMEA Plan FMEA Current State FMEA Future State FMEA Closure

• Scope Statement • Map steps (SFMEA, • Identify out-of-limit • Present FMEA

• Team Selection PFMEA) or RPN's • Set revison date
• Start-up components • Develop • Document control
(DFMEA) countermeasures
• Identify failure • Implement
modes countermeasures
• Identify failure • Revise RPN
effects
• Assign 3-point
failure mode ratings
• Calculate RPN

Scope Statement

A scope statement typically sets out the

FMEA boundaries and constraints
associated with the process or product as
well as identifying key stakeholders.

16
 2018/06/20

Design Scope Statement

Design/Product FMEA Scope Statement
Product description
Scope owner
Date
i. Suppliers Who are the internal and external
components/service suppliers?

ii. Customers Who are the internal and external

product customers?

iii. Purpose What is its primary purpose?

iv. Features How does it achieve this purpose?

v. Operation How is it used?

vi. Limitations Range of operational conditions?

vii. Components Which components or sub-

assemblies are to be included?

viii. Packaging Will packaging be included?

ix. Storage Is storage included?

x. Transport Is transport included?

Process Scope Statement

Process FMEA Scope Statement
Process description
Scope owner
Date
i. Suppliers Who are the internal and external
suppliers?

ii. Customers Who are the internal and external

process customers?

iii. Purpose What is its primary purpose?

iv. Support processes Which support processes are to

be included?

v. Location Where is the process typically

conducted?

vi. Equipment What equipment is required to

carry out the process?

vii. Personnel Which personnel are involved?

viii. Packaging Will packaging be included?

ix. Storage Is storage included?

x. Transport Is transport included?

17
 2018/06/20

Team Selection
Size

A team can be defined as a

group of people possessing the Expertise
cumulative skills necessary
achieve a desired outcome.

Team Training

Start-up
Activities:
• Publicise the FMEA project
• Finalise logistics
• Gather info

18
 2018/06/20

Your turn
• In teams, write up a scope statement for
conducting a PFMEA at the local McDonalds for
drive through order, payment and collection.

FMEA Current State

identify identify
Map the Assign Calculate
Failure Failure
process Ratings RPN
Modes Effects

19
 2018/06/20

Stages

Current State Future State

Map the Product/Process

An item at system level is the

system itself, at design level it
may be the sub-system while for
a process FMEA it describes a
step in a process.

20
 2018/06/20

Map the Product/Process

System FMEA:
1.0 Electric Scooter System
Electric Scooter System Hierarchy
1.0 Electric Scooter system
1.1 Frame subsystem
1.2 Front wheel subsystem Design FMEA:
1.3 Rear wheel subsystem 1.8 Battery Subsystem
1.4 Seat subsystem
1.5 Drive subsystem
1.6 Brake subsystem
1.7 Cockpit subsystem Design FMEA:
1.8 Battery subsystem 1.8.3 Charge Indicator
1.8.1 Batteries
1.8.2 Charge connector
1.8.3 Charge indicator
1.9 Light subsystem Process FMEA:
1.10 Suspension subsystem Charge Indicator Assembly

Function
A function is the intended
purpose of the item or
Purpose?
process step.

Verb -noun

Purpose?

21
 2018/06/20

Function

Verb Noun

Provides a visual readout of the charge

remaining in the battery subsystem.

Identify Failure modes

Cambridge Dictionary defines failure as:
“the fact of something not working, or stopping
working as well as it should”

and mode as:

“a way of operating or behaving”

22
 2018/06/20

How do things fail?

 Full function failure
 Partial / degraded function failure
 Intermittent function failure
 Over function failure
 Unintended function failure

How do things fail?

Example for a touch screen interface:
• Total Failure - Does not accept user input, Partial
• Failure - Some screen areas function while other do not,
• Intermittent Failure – Difficulty interpreting user entries,
• Over Function - Interprets single input as double press,
• Unintended Function - Misinterprets user entry.

Failure modes should be specific, avoiding subjective terms like

“bad”, “not right”, “too loose/tight”, “and improper”, etc.
Reference requirement(s)/specifications where possible.

23
 2018/06/20

Example
LED charge indicator does not come on when ignition key is turned.

Or,
LED charge indicator is too dim to read

Or,
LED charge indicator shows incorrect battery level.

The third failure mode could also be further divided into:

LED charge indicator show full when the batteries are empty.
Or
LED charge indicator shows empty when the batteries are fully charged.

Identify failure effects

• An effect is the consequence of the failure

For the battery indicator subsystem:

LED charge indicator does not come on
when ignition key is turned.

Potential effect is that the scooter

operator will potentially run out of power
prior to reaching his destination
effectively stranding him.

24
 2018/06/20

Assign ratings
• Severity: how severe is the consequence
of the failure?
• Occurrence: how often does the cause of
the failure occur?
• Detection: how likely is it that the failure
will be detected based on current
controls?

Rating Process

Cause Control
• Severity of the • How often? • Likelihood of
consequence? • Identify root • Current control
cause controls in detecting
place cause?

Severity Occurence Detection

25
 2018/06/20

Scooter Example
C O D
Potential
Potential Potential S l c Current e
Cause(s)/
Process/Item Function Failure Effect(s) of e a c Process t
Mechanism(s)
Mode Failure v s u Controls e
of Failure
s r c

Shows charge User Harness plug

Charge indicator No readout 6 2 50% inspection 5
remaining stranded disconnected

Severity Rating Scale

Rating Description Definition
10 Dangerously high Failure could injure the customer or an employee.

9 Extremely high Failure would create non-compliance with government

regulations.
8 Very high Failure renders the unit inoperable or unfit for use.

7 High Failure causes a high degree of customer dissatisfaction.

6 Moderate Failure results in a subsystem or partial malfunction of the

product – customer would complain.
5 Low Failure creates enough of a performance loss to cause the
customer to complain.
4 Very low Failure overcome with modifications to the customer’s process or
product, but there is minor performance loss.
3 Minor Failure would create minor nuisance to the customer, but the
customer can overcome this without performance loss.
2 Very minor Failure not readily apparent to the customer, but would have a
minor effect on the customers process or product.
1 None Failure would not be noticeable to the customer and would not
affect the customer’s process or product.

26
 2018/06/20

Potential Causes
• Determine potential causes of the failure mode

Environment Materials People

Sealer Skill in application

Lighting
Application Too quick/slow
poorly lit Thin
Consistency
Not steady
Temp Adhesion
Temp
Sealer run
Vehicle height Pressure system
What constitutes
Temp a “run”
Gun grip
Sealer gun
Temp

Methods Equipment Measurement

Occurrence Rating Scale

Rating Description Definition
10 Very High: failure inevitable More than once per day, more than three in ten
(Cpk < 0.33)
9 High: Failures occur regularly One occurrence every three or four days, three in ten
(Cpk = 0.33)
8 High: Repeated failures One occurrence per week, 5 in 100
(Cpk =0.67)
7 High: failures occur often One per month, one in 100
(Cpk = 0.83)
6 High: Frequent failures One in three months, 3 in 1000
(Cpk = 1.00)
5 Moderate: Occasional failures One occurrence in six months/one year, five in 10 000
(Cpk 1.17)
4 Moderate: Infrequent failures One occurrence per year, 6 in 100 000 (Cpk = 1.33)

3 Low: Relatively few failures
2 Low: very infrequent failures
1 Remote: Almost never fail
One occurrence one to htree years, 6 in 10 000 000
(Cpk = 1.67)
One occurrence three to five years, 2 in 1 billion
(Cpk = 2.00)
One occurrence in > five years, less than 2 in 1 billion
(Cpk> 2.00)

27
 2018/06/20

Detection Rating Scale

Rating Description Definition
10 Absolute uncertainty The product is not inspected or the failure is undetectable.
9 Very remote Product is sampled, inspected and released on Acceptable
Quality Level (AQL) sampling plans.
8 Remote Product is accepted based on no defective units in a sample
7 Very low Product is 100% manually inspected in the process
6 Low Product is 100% manually inspected in the process
5 Moderate Some statistical process control (SPC) is used in process and
product is final inspected offline.
4 Moderately high SPC is used and there is immediate reaction to out-of-control
conditions.
3 High An effective SPC program is in place with process capabilities
(Cpk) greater than 1.33)
2 Very high All product is 100% automatically inspected.
1 Almost certain The defect is obvious or there is 100% automatic inspection
with regular measurement system analysis (MSA).

Calculate RPN
• Risk Priority Number (RPN)

Severity x Occurrence x Detection = RPN

In the scooter example the RPN value is 60:

6 x 2 x 5 = 60

28
 2018/06/20

Your turn
1. Identify failure modes for the following products
a. Erasable whiteboard pen
b. Smoke detector system
c. Wrist mounted heart rate monitor

2. Is 100% human inspection effective in high volume

situations? Justify your answer.

3. Conduct an DFMEA Current State exercise on a CO2 fire

extinguisher.

FMEA Future State

• RPN Action Priority Guidelines
• Pareto analysis
• Actions

29
 2018/06/20

RPN Action Priority Guidelines

• Setting thresholds
• Anomalies
Consider the following to RPN sets:
9 (S) x 4 (O) x 5 (D) = 180
and,
4 (S) x 6 (O) x 8 (D) = 192

Pareto Analysis
Failure mode code RPN
SC - 1 30
SC - 2 6
SC - 3 60
SC - 4 48
SC - 5 294
SC - 6 24
SC - 7 252
SC - 8 8
FMEA Total RPN 722

30
 2018/06/20

Pareto Analysis
Failure mode RPN Percent Cumulative Line
code of total percent
SC - 5 294 41% 41% 80%
SC - 7 252 35% 76% 80%
SC - 3 60 8% 84% 80%
SC - 4 48 7% 91% 80%
SC - 1 30 4% 95% 80%
SC - 6 24 3% 98% 80%
SC - 8 8 1% 99% 80%
SC - 2 6 1% 100% 80%
FMEA Total 722 100%
RPN

Pareto Analysis

31
 2018/06/20

Actions

Problem Solving

Six Sigma Process

32
 2018/06/20

Your turn
Failure mode code S O D

GB - 1 4 2 4
GB - 2 3 3 3
GB - 3 1 2 5
GB - 4 3 1 2
Given the failure mode scores for the
GB - 5 5 6 6
FMEA shown, develop a Pareto chart
GB - 6 3 3 6
based on RPN USING Excel.
GB - 7 1 2 3
GB - 8 8 4 7
GB - 9 2 3 5
GB - 10 1 4 4
GB - 11 3 2 6
GB - 12 7 4 7

FMEA Cycle

33
 2018/06/20

FMEA Closure

FMEA Closure
• FMEA Review
• Document Control
• Follow-up Procedure
• Common Mistakes in FMEA

34
 2018/06/20

FMEA Review
• Check the thoroughness/completeness
• Has the exercise added value?

Document Control
• Where will the FMEA be stored?
• How can it be retrieved?
• Which version is it?

35
 2018/06/20

Follow-up Procedure
Sustained improvements
Typical questions include:
 How well is the process/service managed?
 Can it be managed by numbers?
 Is it automated or manual?
 Is it an assembly operation?
 High level complex design?
 Is the new process well documented?

Auditing FMEAs (Carl Carlson, Reliasoft)

1. DESIGN IMPROVEMENTS The FMEA drives product design or process improvements as the primary objective.
2. HIGH-RISK FAILURE MODES The FMEA addresses all high-risk failure modes with effective and executable action plans.
3. DVP/CONTROL PLAN The Design Verification Plan (DVP) or the Process Control Plan (PCP) considers the failure modes from the
FMEA.
4. INTERFACES The FMEA scope includes integration and interface failure modes in both block diagram and analysis.
5. LESSONS LEARNED The FMEA considers all major "lessons learned" (such as high warranty, campaigns, etc.) as input to failure
mode identification.
6. LEVEL OF DETAIL The FMEA provides the correct level of detail in order to get to root causes and effective actions.
7. TIMING The FMEA is completed during the "window of opportunity" whence it can most effectively influence the product or
process design.
8. TEAM The right people are adequately trained in the procedure and participate on the FMEA team throughout the analysis.
9. DOCUMENTATION The FMEA document is completely filled out "by the book," including "Action Taken" and final risk
assessment.
10. TIME USAGE Time spent by the FMEA team is an effective and efficient use of time with a value added result.

36
 2018/06/20

Common Mistakes in FMEA

• Superficial FMEA
• Omitting high-risk RPNs
• Interface omissions Interface

• Not following procedure

excluded

• Late in product life-cycle

• Inefficient use of time

37