Classification of Quality Characteristics

❖ Garvin’s eight dimensions of quality

❖ 1 Performance
❖ 2 Features
❖ 3 Reliability
❖ 4 Conformance
❖ 5 Durability
❖ 6 Serviceability
❖ 7 Aesthetics or Style
❖ 8 Perceived Quality
 Classification of Quality Characteristics
❖ 10 Service quality dimensions
❖ Reliability,
❖ Responsiveness,
❖ Competence,
❖ Access,
❖ Courtesy,
❖ Communication,
❖ Credibility,
❖ Security,
❖ Understanding the customer
❖ Tangibles
 Classification of Quality Characteristics
❖ 10 Service quality dimensions reduced
to five:
Reliability: the ability to perform the promised Reliability,
service dependably and accurately Responsiveness,
Assurance: the knowledge and courtesy of Competence,
employees and their ability to convey trust and Access,
confidence Courtesy,
Tangibles: the appearance of physical facilities, Communication,
equipment, personnel and communication Credibility,
materials Security,
Understanding the customer
Empathy: the provision of caring, individualized Tangibles
attention to customers
Responsiveness: the willingness to help
customers and to provide prompt service
 Design & Development
❖ 8.3 Design and development of
products and services (ISO 9001:2015)
❖ 8.3.1 General
❖ 8.3.2 Design and development planning
❖ 8.3.3 Design and development inputs
❖ 8.3.4 Design and development controls
❖ 8.3.5 Design and development outputs
❖ 8.3.6 Design and development changes
 Design Inputs
❖ Considerations
❖ functional and performance requirements
(Customer needs)
❖ statutory and regulatory requirements;
❖ information derived from previous similar
design and development activities;
❖ standards or codes of practice that the
organization has committed to implement;
❖ potential consequences of failure due to
the nature of the products and services
(Robust design techniques: FMEA, QFD,
DFX, DFSS)
 Topic Covered
❖ Robust Design
❖ FMEA
❖ QFD
❖ DFX
❖ DFSS
 Robust Design
❖ The idea behind robust design is to improve the
quality of a product by minimizing the effects of
variation without eliminating the causes.
❖ Robust design has minimum sensitivity to variations in
uncontrollable factors.
 Control and Noise Factors
Control factors
❖ factors which can easily be controlled.
❖ such as in welding – electrode selection, position,
preheating etc.
Noise factors
❖ are factors that are difficult or impossible or too
expensive to control.
❖ Such as weather, humidity during welding
Inputs Process Output

Noise
 Control and Noise Factors
❖ Noise factors are primarily response for causing a
product’s performance to deviate from its target
value.
❖ Parameter design seeks to identify settings of the
control factors which make the product insensitive to
variations in the noise factors.
❖ Three design stages: Conceptual, Parameter, and Tolerance
❖ Make the product more robust, without actually
eliminating the causes of variation.
 Noise Factors
Outer Noise
❖ Consumer’s usage conditions, Temperature change,
Shock, Vibration, Humidity, Light
Inner Noise
❖ Deterioration, Rusting
Between Product Noise
❖ Piece to piece variation where they are supposed to
be the same
 Ways to Reduce the Effect of Noise
Reduce Noise
❖ Make choices that reduce the variation
in the noise.
Interactions
❖ Make choices that reduce the slope of
the transfer function
Nonlinear Effects
❖ For non-linear transfer functions use a
flatter portion of the curve
 Ways to Reduce the Effect of Noise
Reduce Noise
❖ Make choices that reduce the variation
in the noise.
Interactions
❖ Make choices that reduce the slope of
the transfer function
Nonlinear Effects
❖ For non-linear transfer functions use a
flatter portion of the curve
 Ways to Reduce the Effect of Noise
Reduce Noise
❖ Make choices that reduce the variation
in the noise.
Interactions
❖ Make choices that reduce the slope of
the transfer function
Nonlinear Effects
❖ For non-linear transfer functions use a
flatter portion of the curve
 Signal to Noise Ratio
SNR
❖ Ratio of signal power (controllable factors) to the
noise power (non-controllable factors)
❖ The ideal product will only respond to the operator's
signals and will be unaffected by random noise factors
(weather, temperature, humidity, etc.).
❖ So our goal should be to increase the SNR. That way
the noise will have minimum impact on the output.
 Signal to Noise Ratio
SNR
❖ Three formulas for:
❖ Smaller-is-better: (wear, damage, loss, time to do the task)
S/N = -10 *log(mean squared response) = −10 *log(Σ(Y2)/n))

❖ Larger-is-better (yield)
S/N = −10 *log(mean square of resiprocal response)
= −10 *log(Σ(1/Y2)/n)

❖ Nominal-is-better (dimensions, weight)

S/N = 10 *log(mean response squared/ variance) = 10 *log(Y2/s2)
 Topic Covered
❖ Robust Design
❖ FMEA
❖ QFD
❖ DFX
❖ DFSS
 FMEA
❖ Failure Mode and Effect Analysis:
❖ The FMEA is a design tool used to
systematically analyze potential failures
and identify the their effects.
❖ Identify
❖ Prioritize
 FMEA Concept
FMEA

Design FMEA Process FMEA

Identifies failures associated Identifies failures associated
with: with:

•Product malfunctions •Product quality Design FMEA Process FMEA

•Product life •Process reliability
•Safety hazards •Customer dissatisfaction
FMEA
Concept
FMEA

Design Process
FMEA FMEA

- System
Production Assembly
- Subsystem
FMEA FMEA
- Component
FMEA
- System - System
- Subsystem - Subsystem
- Component - Component
FMEA FMEA
 FMEA
❖ Failure Mode and Effect Analysis:
❖ It is proactive tool (Before the problem
happens / not the after effect analysis)
❖ It is a living document
 FMEA
Process / Failure Mode Failure Severity Cause(s) of Occurrence Current Detection R Recommende
Requirement Effect (1-10) failure mode (1-10) Controls (1-10) P d actions
(KPIVs) N
Perfume (1-10) • Unclear (1-10) • Review and 4 96
Making • Inconsistent specificatio 3 approve
quality 8 n specification
• Receiving • Wrong by design
ingredients
• Substandard 6 • Third party 4 192
material certification
supplied by • In house test
supplier lab
• Mixing
 FMEA
❖ Risk Priority Number (RPN)
❖ Severity (1-10) x Occurrence (1-10) x
Detection (1-10)

❖ Severity
❖ Severity 1 – No effect/ client might not
even notice it
❖ Severity 10 – Serious safety hazard
without warning
 FMEA
❖ Occurrence
❖ Occurrence 1 – Rare event, no data of such
type of failure in past
❖ Occurrence 10 – Failure almost inevitable
❖ Detection
❖ Detection 1 – Current system almost
certainly detect the problem (automation)
❖ Detection 10 – Current system can not
detect the problem
 FMEA
❖ Identify key process steps
❖ Identify failure mode
❖ Identify failure effects/severity
❖ Identify causes/occurrence
❖ Identify controls /detection
❖ Calculate Risk Priority Number (RPN)
❖ Prioritize by RPN – Higher RPN first
❖ Determine action plan
❖ Recalculate RPN
 FMEA
❖ Update FMEA when there is plan to
change / actual change of :
❖ Design
❖ Application
❖ Material
❖ Process

❖ FMEA is a living document

Quality Function Deployment
 Design for X
Activities to
❖ Design for Manufacturing/Manufacturability (DFM)
❖ Design for Assembly
❖ Design for Maintainability
❖ Design for Cost
❖ Design for Logistics
 Design for Manufacturing/Assembly
Activities to

❖ Reduce number of parts and ease of assembly

❖ Part features
 Design for Maintainability
Activities to

❖ Reduce down time

❖ Ease of detecting issue
❖ Ease and low cost of maintenance
❖ Availability o parts
❖ Standardized replacement parts
❖ Reduced skill level for maintenance
 Design for Reliability
Ability of an item to serve the purpose over a period of
time.

❖ Reducing the probability of failure

❖ Look at the past data to analyze how it can fail
❖ Improve reliability – stress, wear out
❖ Important factors for critical activities
❖ Airlines, medical equipment, automobile.
 Design for Reliability
Summary

❖ Design for useful life

❖ Consider early failures
❖ Consider wear out
❖ Remove weaknesses
 Design for Logistics
Activities to
❖ Facilitate easy transport and storage
❖ Easy to track – Bar codes
❖ Standardized
❖ Packing material - reuse
 Design for Environment
Minimizing environmental impact

❖ Repair, Reuse, Recycle

❖ Disposal
 Design for X
❖ 80% of costs are fixed at the time of design
❖ Conflicting Xs with each other – Integrated product
development teams
 Design for X
Some common actions

❖ Reduced number of parts

❖ Joining 2 parts as one – Adverse effect on maintainability
❖ Minimize fasteners
❖ Use standard parts – industry standard
❖ Low lead time, more reliable, cheaper, easily available
 DFSS Methodologies
❖ DMADV

❖ DMADOV

❖ IDOV
 DFSS Methodologies
❖ DMADV

❖ DMADOV

❖ IDOV
DMADV

DEFINE MEASURE ANALYZE DESIGN VERIFY

Define the Measure Analyze Detail Verify
process or Critical to designs design of the chosen
design goals Quality product or design
aspects process
 DMADOV

DEFINE MEASURE ANALYZE DESIGN OPTIMIZE VERIFY

Define the Measure Analyze Detail Refine the Verify
process or Critical to designs design of the design chosen
design goals Quality product or design
aspects process
IDOV

IDENTIFY DESIGN OPTIMIZE VERIFY

Define the Detail Analyze Verify
Voice of design of the designs chosen
Customer product or design
process
 Review Design Review
❖ reviews are conducted to evaluate
the ability of the results of design
Design and development to meet
requirements
Control
Validation Verification
 Design Review
❖ Reviews are conducted as the design
work progresses. Some industries use
30%, 60% and 90% design completion
stages for design reviews.
❖ Multi discipline review for complex
products or projects.
 Design Review
❖ Areas of review (typical examples):
❖ Design meets product objective
❖ Assumptions validation
❖ Competitor analysis
❖ Alternative approaches
❖ Demonstration of model (3D) or product
❖ Risks and uncertainties
❖ Budget, schedule, safety, quality concerns
❖ Layout and maintainability
2022 – Changes in the BoK – 3B
2022 – Changes in the BoK – 3B
❖ Topics removed from the BoK
❖ None
❖ Topics added to the BoK
❖ Critical to Quality (CTQ)
❖Topics moved from other sub-section to 3B2 (Design Techniques)
❖ Quality Function Deployment (QFD) from subsection 1G/3B1
❖ Design for X from subsection 3B1
❖ Design for Six Sigma (DFSS) from subsection 3B1
Voice of the customer (VOC)
❖ Voice of the customer (VOC) is a term used to describe the
in-depth process of capturing a customer's expectations,
preferences and aversions. (stated and unstated)
Critical to Quality (CTQ)
❖ VOCs can be vague and difficult to define, that’s where
CTQs come in.
❖ The customer may identify a requirement that is difficult to
measure directly so it will be necessary to break down what is
meant by the customer into identifiable and measurable
terms
Critical to Quality (CTQ)
VoC Drivers CTQ
Time –
Registering to
calling < 5 mins.
Timely
Time – Doctor
consulting > 10
mins
Good service in
Cleanliness
clinic

Cost

Less Specific More

Hard Hard/Easy Easy

to Measure
 Technical Drawing and Specifications
❖ Views – First angle and Third angle
projections
❖ Title Block
❖ Lines
❖ Dimensioning
❖ Tolerances
❖ GD&T (Geometric Dimensioning and
Tolerancing)
 First and Third Angle Projection
❖ Let’s look at a part from different sides.
❖ Front view
❖ Top view
❖ Side view

❖ Solid line for the edge which is visible

and dotted line for the hidden edge.
 First and Third Angle Projection
❖ Types of views.
❖ Plan view (top/bottom)
❖ Elevation view (front and side)

❖ In the Plan view you see length and width

❖ In elevation view you see the height and
length/width
 First and Third Angle Projection
❖ Four quadrants
 First and Third Angle Projection
❖ First Angle Projection
 First and Third Angle Projection
❖ First Angle Projection
 First and Third Angle Projection
❖ Third Angle Projection
 First and Third Angle Projection
❖ Third Angle Projection
 First and Third Angle Projection
❖ First Angle vs Third Angle Projection

First Angle Third Angle

Object is first quadrant Object is third quadrant
Object lies between the The plane of projection
observer and the plane of lies between the observer
projection and object
Plane of projection is non Plane of projection is
transparent transparent
 Title Block
❖ Typical Title Block information:
❖ Organization’s name/logo
❖ Drawing title
❖ Drawing number
❖ Sheet number
❖ Revision number
❖ Approvals – Prepared, Checked, Approved
❖ Units of measurement
❖ Scale
❖ First Angle/Third Angle projection
❖ Other details as applicable: Tolerances,
Finish, Weight, Heat treatment etc.
 Title Block
❖ Additional information:
❖ Bill of materials
❖ Notes
❖ Zones – e.g. A5, B3
 Lines
❖ Construction line – light solid

❖ Outline – Object boundary

❖ Hidden details

❖ Centerline
 Lines
❖ Dimension line

❖ Break line

❖ Cutting Plane

❖ Section lines / Hatch lines

 Dimensioning
❖ Chain Dimensioning
❖ Where the accumulation of tolerances
does not affect the functional
requirements.
❖ Parallel Dimensioning
❖ A number of single dimension lines are
drawn parallel to one another
❖ Running Dimensioning
❖ Similar to parallel dimensioning
❖ Dimensions are superimposed in one line.
❖ Origin point should be marked.
 Tolerances
❖ Tolerance provide the lowest and the
highest value a dimension can have.
❖ Two common ways to show tolerance
❖ Plus /minus tolerance
❖ Upper and lower value
❖ Tolerances allow for interchangeability
of parts.
 Tolerances
❖ Least Material Condition (LMC)
The limit defined by a tolerance or combination
of tolerances that exists on or inside the
material of a feature(s).
❖ Maximum Material Condition (MMC)
The limit defined by a tolerance or combination
of tolerances that exists on or outside the
material of a feature(s).
 Tolerances
❖ Clearance Fit
❖ When there is extra space between two
mating parts.
❖ Interference Fit
❖ When two mating parts interfere when
assembled.
❖ Transition Fit
❖ It can be clearance or interference fit
depending upon the actual dimension.
 GD&T Symbols
❖ Geometric Dimensioning and
Tolerancing
❖ Structured language of symbols, rules and
definitions that allows the geometrical
features of mechanical parts to be defined
according to functional limits of
imperfection.
❖ Provides universal language for supplier,
checker, and the buyer.
Simple Example of a Sheet
1000 mm +/- 5 mm

500 mm +/- 5 mm
Simple Example of a Glass Sheet
1000 mm +/- 5 mm

500 mm +/- 5 mm
Simple Example of a Glass Sheet
1000 mm +/- 5 mm

500 mm +/- 5 mm
Simple Example of a Glass Sheet
1000 mm +/- 5 mm

500 mm +/- 5 mm
Flatness:
Two Sets of Parallel Planes
where the entire referenced
surface must lie.

0.2
Simple Example of a Glass Sheet
1000 mm +/- 5 mm

500 mm +/- 5 mm
 Datum VS Datum Feature
❖ A Datum is a perfect point, line, plane or
surface.
❖ Datum only exists theoretically
❖ However a Datum Feature is a tangible
surface, point or axis on a part where
that theoretical datum is located.
Datum Feature

Datum
 Datum Reference Frame
❖ Three perpendicular datum planes.

z
y

x
 Datum Reference Frame
❖ Six degrees of freedom
❖ Primary datum – controls 3 degrees of
freedom
❖ Secondary datum – controls 2 degrees
of freedom
❖ Tertiary Datum – controls 1 degrees of
freedom
GD&T Symbols

Ref: ASME Y 14.5 - 2009

 MMC and LMC
❖ Maximum Material Condition (MMC)
refers to a feature-of-size that contains
the greatest amount of material, yet
remains within its tolerance zone. Some
examples of MMC include:
– Smallest hole diameter
– Largest pin diameter
 MMC and LMC
❖ Least Material Condition (LMC) refers to
a feature-of-size that contains the least
amount of material, yet remains within
its tolerance zone. Some examples of
LMC include:
– Largest hole diameter
– Smallest pin diameter
 MMC and LMC
MMC
condition of a feature which
contains the maximum amount
of material, that is, the smallest
hole or largest pin
LMC
condition of a feature which
contains the least amount of
material, that is, the largest hole
or smallest pin
 Review Design Review
❖ reviews are conducted to evaluate
the ability of the results of design
Design and development to meet
requirements
Control
Validation Verification
 Verification
ISO 9001:2015 Requirement: (8.3.4c)
❖ verification activities are conducted to
ensure that the design and development
outputs meet the input requirements;
 Validation
ISO 9001:2015 Requirement: (8.3.4d)
❖ validation activities are conducted to
ensure that the resulting products and
services meet the requirements for the
specified application or intended use;
Review, Verification & Validation

Validation activities are

Reviews are conducted to
evaluate the ability of the conducted to ensure that the
results of design and
development to meet
requirements
Verification activities are
conducted to ensure that the
resulting products and services
design and development
meet the requirements for the
outputs meet the input
specified application or
requirements;
intended use;
 Predictive and Preventive Maintenance
❖ Both types of maintenances are actions
which extend the life of equipment and
avoid unnecessary failures.
❖ Preventive: planned and scheduled
❖ Predictive: condition based, reduces
unnecessary maintenance, but needs
initial investment.
 Predictive and Preventive Maintenance
❖ Benefits:
❖ Reduced total cost of maintenance
❖ Stable work force requirement
❖ Reduced damage to equipment
❖ Less breakdowns and interruptions
❖ Less need for high priority unscheduled
work
❖ Better management of spare parts
Predictive and Preventive Maintenance

Preventive
Regular maintenance to lessen
the chance of failure
Example: Car service, oil change Example: regular vibration
Triggered by time, meter or
event
Predictive
Determined by the condition of
equipment
monitoring, oil analysis, thermal
imaging to discover trends.
Triggered by condition
Cost effective but needs initial
investment
 Reliability
❖ The probability that an item will perform
a required function without failure under
stated conditions for a stated period of
time.
 Reliability
❖ Why do products fail?
❖ Design might not be capable to perform the
intended function (wrong assumption,
design defect)
❖ Manufacturing Defects
❖ Lack of controls such as inspection
❖ Components overstressed
❖ Variation in components
❖ Wear out, Poor maintenance
 Reliability
❖ Measuring or quantifying Reliability
❖ MTTF
MTTF – Mean Time to Failure
❖ MTBF MTBF – Mean Time Between Failures
MTTR – Mean Time to Repair
❖ MTTR
❖ Availability

❖ Failure: When system does not meet the

desired objective.
❖ Repairable (car) and Non-repairable
systems (bulb)
 Mean Time To Failure (MTTF)
❖ Basic measure of reliability for non-
repairable systems.
❖ It is the mean time expected until the first MTTF – Mean Time to Failure
MTBF – Mean Time Between Failures
failure of a piece of equipment. MTTR – Mean Time to Repair

MTTF

Start First Begin End Second

Failure Repair Repair Failure
 Mean Time To Failure (MTTF)
❖ MTTF is a statistical value and is meant to
be the mean over a long period of time and
a large number of units.
Reliability

MTBF
MTTF MTTR

Start First End Second

Failure Repair Failure

MTTF – Mean Time to Failure

MTTR – Mean Time to Repair
MTBF – Mean Time Between Failures
 Mean Time Between Failures (MTBF)
❖ Basic measure of reliability for repairable
systems.
❖ It is the mean time between two failures.
❖ MTBF = Total operating hours / Number of
units failed.
❖ Failure Rate (λ) = 1 / MTBF
MTBF
MTTF MTTR

Start First End Second

Failure Repair Failure
 Mean Time Between Failures (MTBF)
❖ If you tested 100 items for 10,000 hours, 5 items MTTF = Total operating
failed at 5,000 hours during this time. What is hours / Total number of
the MTTF? units
❖ (95*10,000+5*5,000)/100 = 9,750 hours

❖ If you tested 100 items for 10,000 hours, 5 items

failed at 5,000 hours during this time. What is MTBF = Total operating
the MTBF? hours / Number of units
❖ (95*10,000+5*5,000)/5 = 195,000 hours
failed.

❖ Failure Rate = 1/MTBF = 1/195,000 failures/hr.

 Mean Time Between Failures (MTBF)
❖ MTBF follows exponential distribution
during constant failure rate period.

❖ Probability that an item will be operational

at a time t is
❖ P(t) = e^(-t/MTBF)

❖ Probability that an item will be operational

at time equal to MTBF is e^(-1) = 0.3677

❖ Chance of surviving the MTBF is less than

50% (actually 36.77%)
 Mean Time To Repair Failure (MTTR)
❖ Mean Time To Repair (MTTR)
❖ It is the mean time needed to repair a failed
system.

MTBF
MTTF MTTR

Start First End Second

Failure Repair Failure
 Availability
❖ A = MTBF / (MTBF+MTTR)
❖ A = (Uptime) / (Uptime + downtime)

MTBF
MTTF MTTR

Start First End Second

Failure Repair Failure
 Reliability Models
❖ IIIE-3 Identify, define, and distinguish
between the basic elements of reliability
models such as exponential, Weibull,
and bathtub curve.

❖ Bathtub curve
❖ Exponential
❖ Weibull
 Year Units Working
0 1000
1 950
2 910
3 880
Reliability 4 860
Test
5 840
6 820
7 800
8 750
9 690
 1200

1000

800

Reliability 600

Test
400

200

0
0 1 2 3 4 5 6 7 8 9
 Year Units Working Hazard Rate
0 1000
1 950 0.05
2 910 0.04
3 880 0.03
4 860 0.02
5 840 0.02
6 820 0.02
7 800 0.02
8 750 0.06
Reliability 9 690 0.08 The hazard function is the
instantaneous rate of failure at a given
Test time.

Hazard Function
1200 0.09
0.08
1000
0.07
800 0.06
0.05
600
0.04
400 0.03
0.02
200
0.01
0 0.00
0 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9
 Hazard Functions
❖ The hazard function is the instantaneous
rate of failure at a given time.
Hazard Function
❖ Three functions and associated 0.09
0.08

distribution 0.07
0.06

❖ Decreasing hazard function 0.05

0.04

❖ Constant hazard function 0.03

0.02

❖ Increasing hazard function 0.01

0.00
1 2 3 4 5 6 7 8 9
 Bathtub Curve
❖ Pattern of failure over time for non-
repairable items (Hazard rate vs time)
❖ Three types of hazards:
❖ Decreasing hazard rates are observed in items
which become less likely to fail as their
survival time. (Burn-in)
❖ A constant hazard rate is characteristic of
failures which are caused by the application of
loads in excess of the design strength, at a
constant average rate.
❖ Wearout failure modes follow an increasing
hazard rate
 Bathtub Curve
❖ Pattern of failure over time for
repairable items (Failure Rate vs time)
❖ Three types of hazards:
❖ Repairable systems can show a decreasing
failure rate when reliability is improved by
progressive repair, as defective parts which
fail relatively early are replaced by good
parts.
❖ A constant hazard rate is characteristic of
failures which are caused by the application of
loads in excess of the design strength, at a
constant average rate.
❖ Wearout failure modes follow an increasing
hazard rate
 Hazard Functions
❖ Three functions and associated 0.09
Hazard Function

distribution 0.08

❖ Decreasing hazard function: Weibull

0.07
0.06

distribution with a shape parameter (k) less 0.05

0.04
than 1 0.03

❖ Constant hazard function: Exponential 0.02

0.01
distribution/ Weibull distribution with k = 1 0.00
1 2 3 4 5 6 7 8 9

❖ Increasing hazard function: Weibull

distribution, with k > 1 More on Weibull and
❖ Weibull distribution: k (kappa) is the other distributions later …
shape parameter, λ (lamba) is the scale
parameter Lets learn some
basic probability first.
 Back to Basics - Probability
❖ Will be covered in Section VI.B.3 in
detail.
❖ What is the probability of failure at any
point of time in this example?
1200

1000

800

600

400

200

0
0 1 2 3 4 5 6 7 8 9
 Back to Basics - Probability
❖ Simple example of probability - Venn
Diagram
❖ Joint Probability:
❖ Union: Probability that events A or B occur:
P(A ∪ B)
❖ Intersection: Probability that events A and B
occur: P(A ∩ B)
 Probability
❖ Mutually Exclusive Events: When two
events cannot occur at the same time

❖ Independent Events: The occurrence of

Event A does not change the probability
of Event B

❖ Complementary Events: The probability

that Event A will NOT occur is denoted
by P(A').
 Probability
❖ Rule of Addition
The probability that Event A or Event B occurs
=
Probability that Event A occurs
+
Probability that Event B occurs
-
Probability that both Events A and B occur

P(A ∪ B) = P(A) + P(B) - P(A ∩ B)

 Probability
❖ Rule of Multiplication:
The probability that Events A and B both occur
=
Probability that Event A occurs
x
Probability that Event B occurs, given that A has
occurred

P(A ∩ B) = P(A) P(B|A)

 Reliability
❖ Reliability is defined as the probability
that a device will perform its intended
function during a specified period of
time under stated conditions.
 Reliability
❖ The reliability of a missile is 0.80. If two
missiles is fired, what is the probability
of at least one hit? (Assume both
missiles are independence)
❖ Approach 1:
❖ P(A ∪ B) = P(A) + P(B) - P(A ∩ B)
❖ P(A ∩ B) = P(A) P(B|A)
❖ Approach 2: Tree diagram
 Reliability
❖ The reliability of a missile is 0.80. If two
missiles is fired, what is the probability
of at least one hit? (Assume both
missiles are independence)
❖ Approach 1:
❖ P(A ∪ B) = P(A) + P(B) - P(A ∩ B)
❖ P(A ∩ B) = P(A) P(B|A)
❖ Approach 2: Tree diagram
 System Reliability
❖ Series R1=0.90 R2=0.80
❖ System works if all components work
❖ R series = R1 x R2 x R3 …. Rn
❖ If a system has 200 components in series
with reliability of 0.99. What is the
reliability of the system
❖ (0.99)200 = 0.1339
❖ What will be reliability when
components are reduced by 50%?
(0.366)
 System Reliability
❖ Parallel
❖ System works if any one components
works R1=0.90
❖ R parallel = 1 – (1 - R1 ) x (1 - R2) x (1 - R3)….
(1 – Rn) R2=0.80

R parallel = 1 – (1 – 0.90 ) x (1 – 0.80)

❖ Reducing components in series
increases the reliability. However R parallel = 1 – 0.10 x 0.20
reducing components in parallel R parallel = 1 – 0.02 = 0.98
decreases the probability.
 System Reliability
❖ Calculate the reliability of the below
system: R5=0.90

R2=0.90 R6=0.90
R1=0.80 R4=0.50
R3=0.90 R7=0.20
R2,3 = 1 – (1 – 0.90 ) x (1 – 0.90)

R2,3 = 1 – 0.01 = 0.99

R8=0.50
R5,6,7,8 = 1 – (1 – 0.90 ) x (1 – 0.90) x (1 – 0.20) x (1 – 0.50)
R5,6,7,8 = 1 – 0.1 x 0.1 x 0.8 x 0.5
R5,6,7,8 = 1 – 0.004 = 0.996
R = 0.80 x 0.99 x 0.50 x 0.996 = 0.3944
 System Reliability
❖ Calculate the reliability of the below system if 3 out of 4
should be working for the system to work?
R1=0.90 Probability of zero failures
P(0) = 0.90 x 0.90 x 0.90 x 0.90 = 0.65
R2=0.90 P(1) = 0.10 x 0.90 x 0.90 x 0.90 x 4 = 0.29

R3=0.90
Reliability = 0.65 + 0.29 = 0.94
R4=0.90
Probability for parallel components
R5,6,7,8 = 1 – (1 – 0.90 ) x (1 – 0.90) x (1 – 0.90) x (1 – 0.90) = 0.9999
 Weibull Distribution
❖ It’s a continuous variable distribution.
(Just like Normal distribution is)
❖ Probability Density Function

❖ Cumulative Density Function

❖ k (kappa) is the shape parameter, λ

(lamba) is the scale parameter
 Hazard Functions
❖ The hazard function is the instantaneous
rate of failure at a given time.
❖ Three functions and associated
distribution
❖ Decreasing hazard function: Weibull
distribution with a shape parameter (k) less
than 1
❖ Constant hazard function: Exponential
distribution/ Weibull distribution with k = 1
❖ Increasing hazard function: Weibull
distribution, with k > 1
 Weibull Distribution
❖ k (kappa) is the shape parameter,
❖ k = 1 for constant hazard. At k = 1 Weibull
distribution reduces to Exponential
Distribution
❖ P(t)= ⅇ−𝑡Τ𝑀𝑇𝐵𝐹
❖ λ (lamba) is the scale parameter.
❖ Failure Rate (λ) = 1 / MTBF
 Mean Time Between Failures (MTBF)
❖ For constant rate of failure MTBF follows
exponential distribution

❖ Probability that an item will be operational

at a time t is
❖ P(t)= ⅇ−𝑡Τ𝑀𝑇𝐵𝐹 = 𝑒 −𝜆𝑡

❖ Probability that an item will be operational

at time equal to MTBF is 𝑒 −1 = 0.3677

❖ Chance of surviving the MTBF is less than

50% (actually 36.77%)
 Weibull Distribution
❖ Question: My car has a constant failure rate of 10-4 per hr. What is
the probability of driving 1000 hr without failure.

❖ Constant rate means k = 1 and Weibull distribution reduces to

Exponential Distribution.
❖ Failure Rate (λ) = 1 / MTBF (but we already have the value of λ as 10-4 per
hr.
❖ MTBF = 1/ λ = 104 hrs = 10,000 hrs

10 −4𝑡 10−4𝑥 1000

❖ P(t)= ⅇ−𝑡Τ𝑀𝑇𝐵𝐹 = 𝑒 −𝜆𝑡 = 𝑒 − = 𝑒 − = 𝑒 −0.1 = 0.904
 Weibull Distribution
❖ Question: At 1000 hr. my car has the reliability of 0.904. Assuming
the reliability to follow the exponential distribution, what is the
MTBF?

❖ P(t)= ⅇ−𝑡Τ𝑀𝑇𝐵𝐹
❖ 0.904 = ⅇ−1000Τ𝑀𝑇𝐵𝐹
❖ ln(0.904) = -1000/MTBF
❖ -0.100 = -1000/MTBF
❖ MTBF = 1000/0.1 = 10,000
 Weibull Distribution
❖ Question: The MTTF for a computer mouse is 500 hrs. What
percent of mouse will survive 1500 hrs of service? Assume
constant rate of failure (or exponential distribution)

❖ t = 1500 hrs, MTBF = 500 hrs

❖ P(t)= ⅇ−𝑡Τ𝑀𝑇𝐵𝐹 = 𝑒 −𝜆𝑡
❖ P(t) = ⅇ−1500Τ500 = 𝑒 −3 = 0.0497
 Assessment Tools
❖ Reliability / Safety / Hazard Assessment Tools:
❖ Failure Mode and Effects Analysis (FMEA)
❖ Failure Mode Effects and Criticality Analysis
(FMECA)
❖ Fault Tree Analysis (FTA)
 FMEA
❖ Failure Mode and Effect Analysis:
❖ The FMEA is a design tool used to
systematically analyze potential failures
and identify their effects.
❖ Identify
❖ Prioritize
 FMEA Concept
FMEA

Design FMEA Process FMEA

Identifies failures associated Identifies failures associated
with: with:

•Product malfunctions •Product quality Design FMEA Process FMEA

•Product life •Process reliability
•Safety hazards •Customer dissatisfaction
FMEA
Concept
FMEA

Design Process
FMEA FMEA

- System
Production Assembly
- Subsystem
FMEA FMEA
- Component
FMEA
- System - System
- Subsystem - Subsystem
- Component - Component
FMEA FMEA
 FMEA
❖ Failure Mode and Effect Analysis:
❖ It is proactive tool (Before the problem
happens / not the after effect analysis)
❖ It is a living document
 FMEA
Process / Failure Mode Failure Severity Cause(s) of Occurrence Current Detection R Recommende
Requirement Effect (1-10) failure mode (1-10) Controls (1-10) P d actions
(KPIVs) N
Perfume (1-10) • Unclear (1-10) • Review and 4 96
Making • Inconsistent specificatio 3 approve
quality 8 n specification
• Receiving • Wrong by design
ingredients
• Substandard 6 • Third party 4 192
material certification
supplied by • In house test
supplier lab
• Mixing
 FMEA
❖ Risk Priority Number (RPN)
❖ Severity (1-10) x Occurrence (1-10) x
Detection (1-10)

❖ Severity
❖ Severity 1 – No effect/ client might not
even notice it
❖ Severity 10 – Serious safety hazard
without warning
 FMEA
❖ Occurrence
❖ Occurrence 1 – Rare event, no data of such
type of failure in past
❖ Occurrence 10 – Failure almost inevitable
❖ Detection
❖ Detection 1 – Current system almost
certainly detect the problem (automation)
❖ Detection 10 – Current system can not
detect the problem
 FMEA
❖ Identify key process steps
❖ Identify failure mode
❖ Identify failure effects/severity
❖ Identify causes/occurrence
❖ Identify controls /detection
❖ Calculate Risk Priority Number (RPN)
❖ Prioritize by RPN – Higher RPN first
❖ Determine action plan
❖ Recalculate RPN
 FMEA
❖ Update FMEA when there is plan to
change / actual change of :
❖ Design
❖ Application
❖ Material
❖ Process

❖ FMEA is a living document

 FMECA
❖ FMEA and FMECA are basically similar.
❖ FMECA extends FMEA by including a
criticality analysis.
 Fault Tree Analysis
❖ Most common gates are AND , OR gates

OR gate AND gate

Image from Wikipedia

 Fault Tree Analysis
❖ AND gate
❖ Output occurs if all inputs occur.
❖ If any of the inputs fail, the system fail. OR gate AND gate
❖ represents series connection.
R1=0.90 R2=0.80

❖ R series = R1 x R2 x R3 …. Rn

Image from Wikipedia

 Fault Tree Analysis
❖ OR gate
❖ Output occurs if any inputs occur.
❖ If all of the inputs fail, the system fail. OR gate AND gate
❖ represents parallel connection.
R1=0.90

R2=0.80

❖ R parallel = 1 – (1 - R1 ) x (1 - R2) x (1 - R3)….

(1 – Rn)
Image from Wikipedia
 Fault Tree Analysis
❖ Find the reliability of this system,
assuming the reliability of each input as
0.9
OR gate AND gate

0.9 0.9 0.9 0.9 0.9 0.9

Image from Wikipedia 0.9

0.9
 Fault Tree Analysis
❖ Find the reliability of this system,
assuming the reliability of each input as
0.9
0.9999948
OR gate AND gate

0.99 0.729 0.981

0.81

0.9 0.9 0.9 0.9 0.9 0.9

Image from Wikipedia 0.9

0.9
2022 – Changes in the BoK – 3E

From Analyze to Apply

From Evaluate to Analyze

2022 – Changes in the BoK – 3E
❖ Topics removed from the BoK
❖ None
❖ Topics added to the BoK
❖ FMEA - > dFMEA, pFMEA, uFMEA
❖ Fault Tree Analysis - > Hazard Analysis
dFMEA, pFMEA, uFMEA
❖ dFMEA = Design FMEA
❖ pFMEA = Process FMEA
❖ uFMEA = Use FMEA
dFMEA, pFMEA, uFMEA
❖ Design FMEA is used by Design Engineers to assure that
the design related causes or failure mechanisms have been
considered and addressed. This could include system,
subsystem or component level FMEAs
dFMEA, pFMEA, uFMEA
❖ Process FMEA is used to assure that the potential failures
during manufacturing, assembly and logistics have been
addressed. For example, process variation, defects during
production etc.
dFMEA, pFMEA, uFMEA
❖ Use FMEA is used to assure that the use-related risks are
considered and mitigated to an acceptable level.
❖ Some examples of use “Failure Modes”
❖ Window blinds with string pose a risk of child strangulation.
❖ Drawer Chests Tip-Over and Entrapment Hazards
❖ Medicines - Failure to Meet Child Resistant Packaging Requirement
Hazard Analysis
Risk vs Hazard
❖ "Hazard" is the harm that something can cause.
❖ The harm may be physical injury, damage to health, property and/or the environment.
Hazard is an intrinsic or "built-in" characteristic.

❖ "Risk" is the likelihood that a hazardous material will cause harm to

people, property or the environment.
HACCP
Hazard Analysis and Critical Control Points, or HACCP
❖ HACCP is a systematic preventive approach to food safety from biological,
chemical, and physical hazards in production processes that can cause the
finished product to be unsafe and designs measures to reduce these risks to
a safe level. (Wikipedia)
❖ The focus of HACCP is the prevention of hazards.
HACCP
Hazard Analysis and Critical Control Points, or HACCP
❖ The first step (principle) of HACCP is to conduct a Hazard Analysis.
❖ Plan to determine the food safety hazards and identify the preventive measures
the plan can apply to control these hazards.
❖ A food safety hazard is any biological, chemical, or physical property that may
cause a food to be unsafe for human consumption
HACCP
Hazard Analysis and Critical Control Points, or HACCP
❖ Hazard: A biological, chemical, or physical agent that is reasonably likely to
cause illness or injury in the absence of its control.
❖ Hazard Analysis: The process of collecting and evaluating the information
on hazards associated with the food under consideration to decide which are
significant and must be addressed in the HACCP plan.
HACCP
Hazard Analysis and Critical Control Points, or HACCP
❖ When performing hazard analysis (for food processing facility) consider
these factors:
❖ Ingredients (microbiological, physical or chemical hazards)
❖ Processing (cooking, pasteurizing)
❖ Facility and equipment being used
❖ Sanitization
❖ Storage and Packaging
❖ etc.