Section 5

A
Basic Quality and Problem-solving

Tools
B
Process Improvement Techniques
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Change Control and Configuration
Management
G
Verification and Validation
H
Risk Management Tools
01
Pareto Charts
5A 02
Cause and effect diagrams
Basic Quality 03
Flowcharts
04
Statistical Process Control (SPC)
Tools and 05
Check Sheets
Problem-solving 06
Scatter Diagrams
Tools 07
Histograms
08
Root Cause Analysis
09
Plan-do-check-act (PDCA)
Pareto Chart
What?
❖ A bar chart where the bars are arranged in
descending order of magnitude.
Why?
❖ To prioritize actions needed to solve complex
problems.
❖ To sort out the “vital few” from the “trivial
many.”
❖ To separate important from unimportant
causes contributing to a problem. 1. Pareto Chart
5. Check sheet
Pareto Chart - Defects during water bottle

Defect manufacturing
Defect Scratch Loose Cap Label Volume Leakage Frequency 120.0
100.0
Frequency %
Capacity 80.0
60.0
40.0
300 ml. || || |||| | | 11
20.0
500 ml. ||| |||| || | | 12 0.0

Loose Wrong
Scratch Leakage Volume
Cap Label
1000 ml. |||| |||| | | | 13 Percentage 50.0 22.2 13.9 8.3 5.6
Cummulative 50.0 72.2 86.1 94.4 100.0
Sum 5 18 8 2 3 36 percentage
Defect
1. Pareto Chart Slide 4

Cause-and-effect Diagrams
What?
❖ A tool used to graphically display the
relationship between an effect (e.g., a problem
statement) and the its causes.
Why?
❖ To identify the various causes affecting a
problem.
❖ Helps a group reach a common understanding
of a problem. 2.
Cause-and-effect
Diagrams
Cause-and-effect Diagrams
❖ Important tools for Root Cause Analysis

(Tool # 8 of this section)
Also called as:
❖ Ishikawa Diagram
❖ Fishbone Diagram
2.
Cause-and-effect
Diagrams
Typical top level
causes:
•Man (people)
•Machine
•Material
•Methods
•Measurement
•Mother Nature
(Environment)
2. Cause-and-effect Diagrams Slide 7

Flowchart
What?
❖ Shows the processes as boxes connected by
arrows and decision boxes.
Why?
❖ Helps in understanding the process flow and
interrelationships between processes.
3. Flowcharts
3. Flowcharts Slide 9
• Cross Functional
Flowchart
• Swimlane Flowchart
3. Flowcharts Slide 10
Statistical Process Control
What?
❖ A line graph of the measurements of a product
or process over time that has statistically based
control limits placed on it.
Why?
❖ To display and manage variation in process
output over time.
❖ To identify when a process changes.
❖ To distinguish special from common causes of
variation.
4. Statistical
❖ To tell the operator when to take and when not Process Control
to take the action and just let the system run.
(SPC)
Reaching Time
6.50 UCL
6.40
• Understand the
Time
6.30 MEAN
variation because of: 6.20
6.10
• Common Causes 6.00
LCL
• Special Causes 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Day
4. Statistical Process Control (SPC) Slide 12

COMMON CAUSES SPECIAL CAUSES
Many Causes Few Causes

Each Having minimum Impact Each Having Significant Impact
Un-economical to eliminate Economically viable to eliminate
Also Called: Also Called:

Random, Chance, Signal, Systematic,
Non-assignable Assignable

Variables / Measurements
❖ I-MR or X-MR chart (Individual, Moving
Range)
❖ X bar - R chart (Average – Range)
Control Chart ❖ X bar - s chart (Average – Standard
Selection deviation)
Attributes / Counts
❖ np Chart (Number of defectives)
❖ p Chart (Proportion defectives)
❖ c Chart (Number of defects)
❖ u Chart (Number of defects per unit)

Rule Pattern Probable Cause
1 1 point more than 3 Stdev from CL New person, wrong setup
2 9 (or more) points in a row on same side of CL Setup change, process change, prolonged bias
3 6 (or more) points in a row all increasing or all decreasing Trend, Tool wear
4 14 (or more) points in a row alternating up and down Over control, tempering
5 2 (or 3) out of 3 points more than 2 Stdev from CL (same side) New person, wrong setup
6 4 (or 5) out of 5 points more than 1 Stdev from CL (same side) New person, wrong setup
7 14 points in a row within 1 Stdev from CL (either side) Process change
8 8 points in a row more than 1 Stdev from CL (either side) Process change

Check sheets
What?
❖ A data-collection form used to manually tally
and record the number of observations or
occurrences of certain events during a
specified time period.
Why?
❖ To collect and display the data.
❖ To detect patterns.
❖ Solving a problem.
5. Check sheets
Defect
Defect Scratch Loose Cap Label Volume Leakage Frequency
• Check sheet is used for
data collection Capacity
• Checklist is a mistake- 300 ml. || || |||| | | 11

proofing aid or reminder 500 ml. ||| |||| || | | 12
tool.
1000 ml. |||| |||| | | | 13
Sum 5 18 8 2 3 36
5. Check sheets Slide 18

Scatter Diagram
What?
❖ A plot of one measured variable against
another. Paired measurements are taken on
each item and plotted on a standard X-Y graph.
Why?
❖ To study the possible relationship between one
variable and another.
6. Scatter
Diagrams
Travelling time from home to office
25
20
Travelling time in Minutes

15
10
0
6.00 6.05 6.10 6.15 6.20 6.25
Time I started from my home
6. Scatter Diagrams Slide 20

Travelling time from home to office
25
• X axis – Independent Variable

• Y axis – Dependent Variable
20
Travelling time in Minutes

15
10
0
6.00 6.05 6.10 6.15 6.20 6.25
Time I started from my home
6. Scatter Diagrams Slide 21

Histogram
What?
❖ A bar chart that displays the distribution of
individual measurements
❖ Also called a frequency distribution
Why?
❖ To quickly visualize the center, variation
(spread), and shape of the distribution of
measurements.
❖ Provides clues to reducing variation and causes
of problems. 7. Histogram
7. Histogram Slide 23
Root Cause Analysis
What?
❖ RCA is a structured process to identify root
causes of an event that resulted in an
undesired outcome and develop corrective
actions.
Why?
❖ To identify and eliminate the root cause of the
problem so that the problem is not repeated.
8. Root Cause
Analysis
5 Whys Cause and
Effects Analysis
Oil spill on Leakage from
floor pump
Gasket Sub standard

damaged gasket
Policy of
ordering to
lowest bidder
8. Root Cause Analysis Slide 25

Plan-do-check-act (PDCA)
What?
❖ Iterative approach of improvement
❖ Deming popularized PDSA Cycle ( Shewhart
Cycle) and later changed it to PDCA cycle
Why?
❖ Systematic approach of improvement
9. PDCA/PDSA
Cycle
Act Plan Act Plan
Check Do Study Do
9. PDCA/PDSA Cycle Slide 27

A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
5B
Process 01
Six Sigma
Improvement 02
Lean
Techniques
Six Sigma
❖ Six Sigma history
❖ Understanding Six Sigma in layman’s terms
❖ Overview of Six Sigma – Three approaches
❖ Defect level vs Sigma number
❖ DMAIC and DMADV approach
❖ Six Sigma belts
Six Sigma
1985 Dr. Mikel J Harry wrote a paper relating early failures
to quality
1987 Motorola
1992 Allied Signal
1995 General Electric
History of Six Sigma Slide 31

Plane Landing
If pilot always lands

within half the landing
strip width, we can say
that the pilot has Six
Sigma capability.
HALF Width of Landing Strip
Width of Landing Strip
Pilot’s Six Sigma Performance Slide 32

Tool Process Philosophy
Six Sigma as a
Statistical
Tool
Six Sigma as Six Sigma
a Process as a
Philosophy 33
Overview of Six Sigma Slide 33

Sigma DPMO (Defects Per
Number Million DPMO (Defects Per Million Opportunities)
Opportunities) 600,000
Defects Per Million Opportunities

1.5 s 500,000
500,000
2.0 s 308,300
400,000
2.5 s 158,650
3.0 s 67,000 300,000
3.5 s 22,700 200,000
4.0 s 6,220
100,000
4.5 s 1,350
5.0 s 233 0
0 1 2 3 4 5 6 7
5.5 s 32 Sigma Number
6.0 s 3.4
Defects Level vs Sigma Slide 34

DEFINE MEASURE ANALYZE IMPROVE CONTROL
Define the problem. Measure the current Analyze the problem Improve the process Maintain the gain
state of the process based on facts and
figures
Six Sigma Process - DMAIC Slide 35

DEFINE MEASURE ANALYZE DESIGN VERIFY
Define the goal. Quantify the needs of the Analyze the options Design a new process Verify the ability to meet
customer. based on facts the target
Six Sigma Process - DMADV Slide 36

Master Black Belt
White Yellow Green Black
Belt Belt Belt Belt
Management Beginners Part time Full time
Stakeholders Team members Lead small projects Lead projects
Basic terminology Support projects Mentor Yellow Belts Mentor Green Belts
SSWB SSYB SSGB SSBB
Six Sigma Belts Slide 37

5B
Process 01
Six Sigma
Improvement 02
Lean
Techniques
Benefits of Lean
• Reduce Waste
• Improved Quality/Customer
Satisfaction
• Reduced Inventory
• Reduced Cycle Time
• Flexible Manufacturing
• Safe Workplace Environment
• Improved Employee Morale
Lean Philosophy
1. Identify 2. Map 3. Create 4. Pull 5. Seek
Value the Value Flow Perfection
Stream
Specify what creates value Identify all the steps along Make the value process flow Make only what is needed Strive for perfection by
from the customer’s the process chain by the customer continually attempting to
perspective. produce exactly what the
customer wants
Value Stream Maps
❖ Type of Flow Chart showing how value
flows through the organization
❖ Flow of material
❖ Processes to transform raw material to
finished good
❖ Flow of information
Value Stream Maps
Source: SigmaXL software

Value Stream Maps
Frequency
Company
Supplier / Customer Production Control External Shipment
Operator Work Cell Inventory Store

Value Stream Maps
Maximum Quantity
Push Arrow FIFO Lane
Manual Information Flow Electronic Information Flow

Value Stream Maps
Typical Process Information
C/T = Cycle Time

C/O = Changeover Time
Batch = Batch Size
% Uptime = % Uptime
FPY = First Pass Yield

Value Stream Maps
❖ Used to analyze waste
Current Lean Future

State Principles State
Waste Elimination
01
Understanding types of wastes
5B2 02
Eliminating waste (techniques)
Lean • Pull system

• Kanban
• 5S
• Standard work
• Poka-yoke
Waste - Philosophy
❖ Waste exist in all processes at all levels
in the organization.
❖ Waste elimination is the key to
successful implementation of lean.
❖ Waste reduction is an effective way to
increase profitability.
Waste elimination
Muda
An activity that is wasteful and
doesn't add value or is
unproductive
Mura
Any variation leading to
unbalanced situations.
Muri
Any activity asking
unreasonable stress or effort 3 Categories of
from personnel, material or Waste
equipment.
Muda
❖ Muda is a traditional Japanese term for
an activity that is wasteful and doesn't
add value or is unproductive
❖ Type I Muda: (Incidental Work)
❖ Non-value-added tasks which seam to be
essential. Business conditions need to be
changed to eliminate this type of waste.
❖ Type II Muda: (Non-Value-Added Work)
❖ Non-value-added tasks which can be
eliminated immediately. 3 Categories of
Waste
Mura
❖ MURA: Any variation leading to
unbalanced situations.
❖ Mura exists when
❖ workflow is out of balance
❖ workload is inconsistent
3 Categories of
Waste
Muri
❖ MURI: Any activity asking unreasonable
stress or effort from personnel, material
or equipment.
❖ For people, Muri means too heavy a mental
or physical burden.
❖ For machinery Muri means expecting a
machine to do more than it is capable of or
has been designed to do.
3 Categories of
Waste
Transportation Over Processing
Unnecessary movement of Processing beyond the demand
people or parts between from the customers.
processes.
Inventory Over Production

Materials parked and not having Producing too much, too early
value added to them. and/or too fast.
8 Types
of Wastes Defects
Motion
Unnecessary movement of Sorting, repetition or making
people or parts within a process. scrap
Wait Time Under Utilized Staff

People or parts waiting for a Failure when it comes
work cycle to finish. to exploiting the knowledge and
talent of the employees.
Eight Types of Muda Slide 53

Transportation
Unnecessary movement of
people or parts between
8 Types
processes. of Wastes

Inventory
Materials parked and not
having value added to
8 Types
them. of Wastes

Motion
Unnecessary movement of
people or parts within a
8 Types
process. of Wastes

Wait Time
People or parts waiting for a
work cycle to finish.
8 Types
of Wastes

Over Processing
Processing beyond the
demand from the
8 Types
customers. of Wastes

Over Production
Producing too much, too
early and/or too fast.
8 Types
of Wastes

Defects
Sorting, repetition or
making scrap
8 Types
of Wastes

Under Utilized Staff
Failure when it comes
to exploiting the knowledge
8 Types
and talent of the employees. of Wastes

Eliminating waste
(techniques)
• Pull system
• Kanban
• 5S
• Standard work
• Poka-yoke Waste elimination
Pull Systems
❖ Pull:
❖ Produce based on demand
❖ Providing product or service when
required by customer or the next
process.
❖ Push:
❖ Produce to stock
❖ Based on demand forecast
Pull System
Pull Systems
❖ Pull:
❖ Limits the Work In Progress and
Inventory.
❖ Kanban cards
Pull System
Kanban
❖ Kanban means Signboard (or billboard)
in Japanese.
❖ Kanban is an inventory-control system
❖ Taiichi Ohno developed it as a part of JIT
Kanban
Kanban
• Three bin system for supplied parts
• One bin is on the factory floor (the initial
demand point),
• One bin is in the factory store (the inventory
control point), and
• One bin is at the supplier.
• The bins usually have a Kanban card.
Kanban
5S
❖ The 5S’s are simple but effective
methods to organise the workplace.
❖ It however, goes beyond this simple
concept, and is concerned with
making orderly and standardized
operations the norm, rather than the
exception.
5S
5S
❖ The 5S’s are simple but effective
methods to organise the workplace.
❖ It however, goes beyond this simple
concept, and is concerned with
making orderly and standardized
operations the norm, rather than the
exception.
5S
Seiri Seiton Seison Seiketsu Shitsuke
Sort Set in order Shine Standardize Sustain
Remove all of Organize in an Clean up the Ensure Ensure that 5S

the clutter from efficient and entire area standard ways principles are
the work place ergonomic removing all of working for part of the
manner. dirt the first three culture
stages.
5S Summary Slide 69
5S
1. Seiri (Sort)
Remove all of the clutter from the work
place
❖ This requires the classifying of items into
two categories, necessary and
unnecessary, and storing or removing
the latter.
5S
5S
2. Seiton (Straighten)
Organize in an efficient and ergonomic
manner.
• Arrange items to minimise search time and
effort.
• Each item should have a designated place
A place for everything and everything in its
place.
5S
5S
3. Seison (Shine)
Clean up the entire area removing all
dirt
❖ Seison means cleaning the working
environment.
❖ It can help in the spotting of
potential problems as well as
reducing the risk of fire/injury by
cleaning away the potential causes of
accidents.
5S
5S
4. Seiketsu (Standardize)
Ensure standard ways of working for the
first three stages.
❖ It can also be viewed as the
continuation of the work carried out
in Seiri, Seiton, and Seison.
5S
5S
5. Shitsuke (Sustain)
Ensure that 5S principles are part of the
culture
❖ Shitsuke means self-discipline.
❖ The 5 S’s may be viewed as a philosophy,
with employees following established and
agreed upon rules at each step.
❖ By the time they arrive at Shitsuke they will
have developed the discipline to follow the
5 S’s in their daily work. 5S
Sort Set in order Shine Standardize Sustain
Remove all of Organize in an Clean up the Ensure Ensure that 5S

the clutter from efficient and entire area standard ways principles are
the work place ergonomic removing all of working for part of the
manner. dirt the first three culture
stages.
5S Summary Slide 75
Standard Work
❖ Doing work in a standard way
❖ All people do one work in one way only
❖ Improvement made in the process leads
to revised standard work
Standard Work
Poka-yoke
❖ Poka-yoke (pronounced "POH-kah YOH-
kay") was invented by Shigeo Shingo in
the 1960s.
❖ The term "poka-yoke" comes from the

Japanese words "poka" (inadvertent
mistake) and "yoke" (prevent).
Poka-yoke
Types of Poka-yoke
❖ Eliminates the cause of an error at
the source;
❖ Detects an error as it is being made;
❖ Detects an error soon after it has

been made but before it reaches the
next operation.
Waste elimination
Types of Poka-yoke
❖ Prevention.
❖ engineers the process so that it is impossible
to make a mistake.
❖ remove the need of correction.
❖ Detection.
❖ signals the user when a mistake has been
made.
❖ they do not enforce the correction.
Waste elimination
A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
5C
01
Measures of central tendency
Basic Statistics 02
Measures of dispersion
03
Qualitative and quantitative
analysis
Statistics
Statistics
Descriptive Inferential
Descriptive
Statistics
Statistics
Measurement
Measurement
of Central
of Dispersion
Tendency
Measurement
of Central
Tendency
Statistics
Mean Median Mode
Mean = Average
Mean of
(104+98+90+104+104) / 5
104, 98, 90, 104, = 100
104
Median = middle value when arranged
Median of Arrange in ascending order

90, 98, 104, 104, 104
104, 98, 90, 104,
104 Median = 104
Median = middle value when arranged
Median of Arrange in ascending order

85, 90, 98, 104, 104, 104
104, 98, 90, 85,
104, 104 Median = (98+104)/2 = 101
Mode = most occurring
Mode of
104, 98, 90, 85, Mode = 104
104, 104
5C
01
Basic Statistics 02
03
analysis
Measurement
of Dispersion
Statistics
Standard
Range Variance
Deviation
Range = highest – lowest value
Range of
Range = 104-85
104, 98, 90, 85,
104, 104
= 19
Standard Deviation
Standard Deviation First find the

of mean
104, 98, 90, 104, 104 Mean = 100
Standard Deviation
How far each item is from Distance from

mean
mean
(104-100), (98-100), (90-
100), (104-100), (104-100) 4, -2, -10, 4, 4
Standard Deviation
Take square of the

distance from
mean 16, 4, 100, 16,
(4)^2, (-2)^2, 16
(-10)^2, (4)^2,
(4)^2
Standard Deviation
Take the mean of

these squares This is Variance
(16+4+100+16+16)/ 30.4
5
Standard Deviation
Standard
Square root of Deviation
variance is the
Standard Deviation Sqrt(30.4) =
5.51
5C
01
Basic Statistics 02
03
analysis
Qualitative vs Quantitative
❖ Qualitative: data are measures of 'types’.

❖ Example: Profession, model type, color
❖ Quantitative: data are measures of
values or counts.
❖ Example: Height, Weight, number of defects.
Data Types
Data
Qualitative Data Quantitative Data
Continuous
Discrete
Mode Mean, Median
Data Types Slide 99

DEFECTS
❖ Pie Chart Scratch Loose Cap Label Volume
❖ Bar Chart 15%
❖ Line Chart
Data
46%
23%
Visualization for
16%
Trends TOTAL DEFECTS

7
DEFECTS
20
6
15 5
4
10 3
2
5 1
0
0
Scratch Loose Cap Label Volume
2 3 4 5 6 7 8 9 10 11 12 13
Defects
TOTAL DEFECTS
Trends Slide 100

DEFECTS
❖ Pie Chart Scratch Loose Cap Label Volume
❖ Bar Chart 15%
❖ Line Chart
Data
46%
23%
Visualization for
16%
Trends 8
DEFECTS
6
4
2
0
Scratch Loose Cap Label Volume
Defects
Trends Slide 101

TOTAL DEFECTS
❖ Pie Chart
20
15
❖ Bar Chart 10
❖ Line Chart
Data 5
Visualization for
0
2 3 4 5 6 7 8 9 10 11 12 13
Trends
TOTAL DEFECTS
TOTAL DEFECTS
20
15
10
0
2 3 4 5 6 7 8 9 10 11 12 13
TOTAL DEFECTS
Trends Slide 102

A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
5D
01
Common and Special Cause
Process Variation 02
Process Performance Metrics
03
Outliers
❖ Understanding the variation
❖ Finding the trend

❖ Too early
❖ Too late
❖ Key factor is the cause of variation:

Common Cause or Special Cause
Variation
❖ Common Cause or Special Cause
❖ Help us in understanding when and when
not to take action.
Variation
COMMON CAUSES SPECIAL CAUSES
Many Causes Few Causes

Each Having Each Having
minimum Impact Significant Impact
Economically
Un-economical viable to
to eliminate eliminate
Also Called: Also Called:

Random, Chance, Non-assignable Signal, Systematic, Assignable
Common and Special Cause Slide 107

5D
01
03
Outliers
❖ Cp= Process Capability
❖ Cpk= Process Capability Index
❖ Pp= Process Performance
❖ Ppk= Process Performance Index
Cp, Cpk
Pp, Ppk
Process Capability
❖ Ratio of the spread between the process
specifications to the spread of the
process values, (6 process standard
deviations) .
❖ Voice of customer / Voice of process > 1
Cp, Cpk
Pp, Ppk
Process Capability
❖ Voice of Customer:
❖ LSL – Lower Specification Limit
❖ USL - Upper Specification Limit
❖ Voice of Process:
❖ LCL – Lower Control Limit
❖ UCL - Upper Control Limit
Cp, Cpk
Pp, Ppk
Process Capability: Cp
❖ Specification for film thickness: 50 plus
minus 3 microns
❖ Sample of 100 thicknesses measured
show the mean as 50 microns and
standard deviation as 0.4 microns.
𝑼𝑆𝐿 − 𝐿𝑆𝐿
𝐶𝑝 =
6 × 𝜎𝒘𝒊𝒕𝒉𝒊𝒏
53−47
𝐶𝑝 =
6×0.4
= 2.5 Cp, Cpk
Pp, Ppk
Process Capability: Cp
❖ Specification for film thickness: 50 plus
minus 3 microns
❖ Sample of 100 thicknesses measured
show the mean as 50 microns and
standard deviation as 0.4 microns.
𝑼𝑆𝐿 − 𝐿𝑆𝐿
𝐶𝑝 =
6 × 𝜎𝒘𝒊𝒕𝒉𝒊𝒏
53−47
𝐶𝑝 =
6×0.4
= 2.5 Cp, Cpk
What would be the Cp value when the mean is Pp, Ppk
52 microns instead of 50 microns?
Process Capability Index: Cpk
𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐌𝐞𝐚𝐧 − 𝐿𝑆𝐿
𝐶𝑝𝑳 =
𝟑 × 𝜎𝒘𝒊𝒕𝒉𝒊𝒏
𝑼𝑺𝑳 − 𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐌𝐞𝐚𝒏
𝐶𝑝𝑼 =
𝟑 × 𝜎𝒘𝒊𝒕𝒉𝒊𝒏
Cpk = Min (CpU, CpL )
Cp, Cpk
Pp, Ppk
σ within
❖ Short term standard deviation
❖ Used for Cp and Cpk
σ overall
❖ Long term standard deviation
❖ Used for Pp and Ppk Cp, Cpk
Pp, Ppk
Process Capability Index: Cpk
❖ Acceptable value of Cpk
❖ >1.33 (Good – Equivalent to 4 sigma in terms of
6 Sigma)
❖ 2 (Excellent – equivalent to 6 Sigma)
❖ 1 (just capable)
❖ <1 (process is not capable to meet specification)
Cp, Cpk
Pp, Ppk
Cp, Cpk Cases:
❖ Cp = 1.33, Cpk = 2.00
❖ Something wrong with calculation. Cpk can not
be more than Cp.
❖ Cp = 1.33, Cpk = 0.80
❖ Process is capable but needs to be centered.
❖ Cp = 0.80, Cpk = 0.80
❖ The process is centered, but the variation is high
and needs to be reduced to meet specification.
Cp, Cpk
Pp, Ppk
5D
01
03
Outliers
Outliers
❖ Extreme values
❖ Abnormally different from other
observations
❖ This is related to special cause in case of
process control
❖ Example: Time to travel from home to
office in minutes: 10, 11, 10, 8, 12, 11,
65, 9, 11.
Outliers
A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
5E
01
Acceptance Sampling Plans
Sampling 02
Types of Sampling
Methods 03
Sampling Terms
❖ Because of the cost and time
involved in studying the entire
population.
Why Sampling?
❖ Probability Samples
❖ Everyone in the population has an
equal chance of being selected
❖ Non-Probability Samples
❖ Where the probability of selection
can't be accurately determined.
❖ Sample may not be (generally isn’t)
representative of the general
population
Types of
Sampling
Simple Random Sampling
Systematic Random Sampling

Probability
Stratified Random Sampling

Sampling
Cluster Sampling
Accidental / Convenience Sampling

Non Probability
Judgemental Sampling
Sampling
Quota Sampling Types of

Sampling
❖ Each item in the population has an equal

chance of being selected.
❖ Examples: Using random tables, Random
draw of lot (lottery)

Types of
Probability

Sampling
Cluster Sampling Sampling

❖ Select elements at regular intervals through

that ordered list.
❖ Example: Checking every 6th piece produced
by the machine.

Types of
Probability

Sampling

❖ Used to ensure that sub-groups within a

population are represented proportionally
in the sample.
❖ Example: If 10 people are drawn to
represent a country, 5 of them are male and
5 females to avoid the sex bias.

Types of
Probability

Sampling

Cluster Sampling
❖ Sometimes it is more cost-effective to select
respondents in groups ('clusters'). Sampling
is often clustered by geography, or by time
periods.
❖ Example: Survey all customers visiting
particular stores on particular days.

Types of
Probability

Sampling

Convenience Sampling
❖ The researcher selects whomever is
convenient. The samples are being drawn
from that part of the population which is
close to hand
❖ Example: A researcher at the mall selects
the first five people who walk by to get
their opinion of a product.

Non Probability
Judgemental Sampling Types of

Sampling
Quota Sampling Sampling

Judgmental Sampling
❖ The researcher chooses the sample based
on who they think would be appropriate for
the study.
❖ Example: Auditor selects a sample based on
the concerns he/she had in the earlier audit

Non Probability

Sampling

Quota Sampling
❖ A quota is established and auditor are free
to choose any sample they wish as long as
the quota is met.
❖ Example: 2% of the calibration records.

Non Probability

Sampling

5E
01
Sampling 02
Types of Sampling
Methods 03
Sampling Terms
1000 pieces
Accept the lot if 3 or less
Check 80 pieces
are defective
Reject the lot if 4 or more
are defective
Standards
Attribute Sampling MIL-STD-105 (withdrawn)
ANSI/ASQ Z1.4
Pass/Fail Dodge-Romig
Variable Sampling MIL-STD-414 (withdrawn)

ANSI/ASQ Z1.9
Dimension
Acceptance Sampling Standards Slide 133

Attribute Sampling
❖ You need to decide
❖ Level (e.g. I, II, III, S1, S2, S3 or S4)
❖ AQL (Acceptable Quality Limit) – e.g. 1.5%
❖ Single, Double or Multiple Sampling Plan
❖ Reduced, Normal or Tightened inspection
Acceptance
Sampling Plans
Attribute Sampling
❖ You need to decide
❖ Level (e.g. I, II, III, S1, S2, S3 or S4)
❖ AQL (Acceptable Quality Limit) – e.g. 1.5%
❖ Single, Double or Multiple Sampling Plan
❖ Reduced, Normal or Tightened inspection
Attribute Sampling
Example
• Lot size : 1,000, General inspection level
II
• Acceptable Quality Limit(AQL): 1.5%
• Take 80 random samples:
• Accept the lot if 3 or less are
rejected.
• Reject the lot if 4 or more rejected.
5E
01
Sampling 02
Types of Sampling
Methods 03
Sampling Terms
Actual Lot Condition
Good Lot Bad Lot
Correct Type II Error

Accept the Lot
Conclusion Conclusion (Buyer’s Risk)
Based on
Sampling Type I Error Correct
Reject the Lot
(Producer’s Risk) Conclusion
Sampling Terms Slide 138

Level of Significance
Type I error (alpha) Type II error (beta)
or Type I Error:
Name Producer’s risk/ Consumer’s risk
α = 1 – C (0.10, 0.05, Significance level
0.01) 1 minus error is
called
Confidence level Power of the test
Example of Fire False fire alarm leading Missed fire leading to

Alarm to inconvenience disaster
Confidence Level: Effects on Unnecessary cost Defects may be produced
process increase due to frequent
C = 0.90, 0.95, 0.99 changes
(90%, 95%, 99%) Simple definition Innocent declared as Guilty declared as innocent
guilty
Sampling Terms Slide 139

A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
Why Change?
❖ Change request could be generated by
the organization, client or supplier for
the following reasons (typically)
❖ Correction, fixing a bug
❖ Performance improvement
❖ Cost reduction
❖ Safety or reliability improvement
❖ New technology or client needs
❖ Regulatory requirement changes
Change Control
Change to the QMS
❖ When the organization determines the
need for changes to the quality
management system, the changes shall
be carried out in a planned manner.
❖ The organization shall consider:
a) the purpose of the changes and their
potential consequences;
b) the integrity of the quality management
system;
c) the availability of resources;
d) the allocation or reallocation of
responsibilities and authorities. Change Control
ISO 9001:2015 - 6.3 Planning of changes
Document Changes
❖ Documented information required by the
quality management system and by this
International Standard shall be controlled to
ensure:
a) it is available and suitable for use, where and when
it is needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).
❖ For the control of documented information, the
organization shall address the following
activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of
legibility;
c) control of changes (e.g. version control); Change Control
d) retention and disposition.
ISO 9001:2015 - 7.5.3 Control of documented information
Document Changes
❖ Version control
❖ Hard copy approach
❖ Electronic version control
Change Control
Configuration Management
❖ ISO 10007 Quality management
systems — Guidelines for configuration
management is to assist organizations
applying configuration management for
the technical and administrative
direction over the life cycle of a product.
Configuration management can be used
to meet the product identification and
traceability requirements specified in
this International Standard. Change Control
Configuration
❖ Functional and physical characteristics
of existing or planned hardware,
firmware, software or a combination
thereof as set forth in technical
documentation and ultimately achieved
in a product.
Configuration
Management
❖ The process of systematically handling
changes to a system in a way that it
maintains integrity over time.
ISO 10007:2017 definition:
❖ coordinated activities to direct and
control the interrelated functional and
physical characteristics of a product [as]
defined in the requirements for product
design, realization, verification, Configuration
operation and support.
Management
ISO 10007:2017 - Quality management –
Guidelines for configuration management –
Key steps:
❖ Configuration identification
❖ Change control
❖ Configuration status accounting
❖ Configuration audit
Configuration
Management
A simplified version related to document
control (change control)
Product version A:
Part GA, rev 0
Part GB, rev 1
Part GC, rev 7
Product version B:
Part GA, rev 0
Part GB, rev 2
Part GC, rev 7 Configuration
Management
A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
Definitions per ISO 9000:2015
Verification:
❖ confirmation, through the provision of
objective evidence, that specified
requirements have been fulfilled
Verification and
Validation
Definitions per ISO 9000:2015
Validation:
❖ confirmation, through the provision of
objective evidence, that the
requirements for a specific intended use
or application have been fulfilled
Verification and
Validation
Verification Validation
confirmation, through the

confirmation, through the provision of provision of objective evidence,
objective evidence, that specified that the requirements for a
requirements have been fulfilled specific intended use or
application have been fulfilled
Typically external process

Typically internal process
(meeting client needs)
Involves checking documents, code, Involves testing and validating the

design final product
Verification vs Validation Slide 153

A
Tools
B
5 C
Basic Statistics
Quality Tools and D

Process Variation
Techniques E
Sampling Methods
F
Management
G
H
1
Understanding and Managing Risk
5H
Risk Management 2
FMEA, PFMEA, and DFMEA
Tools 3
Hazard Analysis and Critical Control
Points (HACCP)
4
Critical to Quality (CTQ) Analysis
Risk: Definition (ISO 9000:2015)
❖ effect of uncertainty
❖ An effect is a deviation from the expected
— positive or negative.
❖ Risk is often expressed in terms of a
combination of the consequences of an
event and the associated likelihood of
occurrence.
❖ The word “risk” is sometimes used when
there is the possibility of only negative
consequences.
Risk Management
Opportunity
❖ Positive risks is called opportunities.
❖ You would like to take maximum

advantage of these positive risks.
Risk Management
Issue
❖ Risk is associated with future event,
which has not happened yet.
❖ A risk which has already occurred is

considered as an “issue”.
Risk Management
Why Take Risk?
❖ There is a balance between risk and
rewards.
❖ Generally more risks lead to more

rewards. But that is not true always.
❖ You want more rewards with less risk
Risk Management
Risk Management
❖ Risk management is the identification,
assessment, and prioritization of risks
(positive or negative) followed by
coordinated and economical application
of resources to minimize, monitor, and
control the probability and/or impact of
unfortunate events or to maximize the
realization of opportunities.
Risk Management
❖ Risk management is the identification, assessment, and prioritization of
risks (positive or negative) followed by coordinated and economical
application of resources to minimize, monitor, and control the
probability and/or impact of unfortunate events or to maximize the
realization of opportunities.
minimize monitor control
Identification
of risks probability and/or impact of unfortunate
events
Assessment
of risks Resources
maximize
realization of opportunities
Prioritization
of risks
Risk Management Slide 161

Plan Risk Plan Risk Monitor and
Identify Risks Analyze Risks
Management Response Control Risks
Risk Management Steps Slide 162



1. Plan Risk Management
❖ Define risk related terms
❖ Define roles and responsibilities
❖ Tools and template for risk management
❖ Planning includes how to:
❖ Identify risks
❖ Analyze risks
❖ Plan risk responses
❖ Monitor and control risks
1. Plan Risk
Management

2. Identify Risks
❖ Risk identification is systematic, and
methodic process.
❖ It is best done in a group environment.
❖ Wide number of people participate in
this process including
❖ Management, Employees, Customer, Other
stake holders
2. Identify Risks
2. Identify Risks
❖ Tools Used:
❖ Brainstorming is the most common
approach.
❖ Other tools include:
❖ Ishikawa Diagram (Cause and Effect)
❖ Flow Diagram
❖ SWOT Diagram (Strengths, Weaknesses,
Opportunities and Threats)
❖ FMEA (Failure Mode and Effects Analysis)
2. Identify Risks
2. Identify Risks
Risk Register
❖ Output of Identify Risks process is a risk
register.
❖ This lists down all the risks identified
❖ In the next process these risks are
prioritised and action plan is created to
address these risks.
2. Identify Risks

3. Analyze Risks
❖ Risks are analyzed to set priority
❖ Sets focus on high priority risks
3. Analyze Risks
Quantitative Risk
Qualitative Risk Analysis
Analysis
Quick and easy to Detailed and time

perform consuming
Subjective Analytic
Expected Monitory Value Analysis

Probability and Impact Matrix Monte Carlo Analysis
Decision Tree
3. Analyze Risks Slide 172

3. Analyze Risks
Probability and Impact Matrix
❖ This is a qualitative risk analysis tool

❖ This evaluates
❖ Likelihood (probability) that a particular
risk will occur
❖ Potential impact on an objective if it
occurs
3. Analyze Risks
3. Analyze Risks
Failure Mode and Effects Analysis (FMEA)
❖ Risk Priority Number (RPN) is the
multiplication of:
❖ Severity
❖ Probability
❖ Detection

❖ Combination of:
❖ Probability 3. Analyze Risks
❖ Impact (similar to severity)
3. Analyze Risks
❖ Each risk is analyzed for probability and
Impact and is assigned
❖ a nine point rating: a score between 1 to 9
❖ a five point rating: Very Low, Low, Medium,
High, Very High
❖ or a score of 1 to 5
❖ a three point rating: Low, Medium, High
❖ or a score of 1 to 3
❖ Risk score = Probability x Impact 3. Analyze Risks
3. Analyze Risks
Probability and Impact Matrix Example
❖ If the risk has low probability and is

assigned a score of 1
❖ If the impact is significant and is
assigned an Impact value of 9
❖ Risk score = Probability x Impact = 1 x 9

=9 3. Analyze Risks
Sample Probability Table
Probability Probability Description

Category Number
Very High 9 Risk event expected to occur

High 7 Risk event more likely than not to occur
Probable 5 Risk event may or may not occur
Low 3 Risk event less likely than not to occur
Very Low 1 Risk event not expected to occur
Decision Tree

Sample Impact Table
Project Objective Very Low Low Moderate High Very High
1 3 5 7 9
Cost Insignificant cost < 10% cost 10-20% cost 20-40% cost > 40% cost
impact impact impact impact impact
Schedule Insignificant < 5% schedule 5-10% schedule 10-20% schedule > 20% schedule
schedule impact impact impact impact impact
Scope Barely noticeable Minor areas Major areas Changes Product becomes
impacted impacted unacceptable to effectively
client useless
Quality Barely noticeable Minor functions Client must Quality reduction Product becomes
impacted approve quality unacceptable to effectively
reduction client
useless
Decision Tree

1 3 5 7 9
Probability
9 9 27 45 63 81
7 7 21 35 49 63
5 5 15 25 35 45
3 3 9 15 21 27
1 1 3 5 Expected7Monitory Value
9 Analysis
Decision Tree
Impact

Very Low Medium High Very
Low High
Very Medium Medium High High High

Probability High
High Low Medium Medium High High
Medium Low Medium Medium Medium High
Low Low Low Medium Medium Medium
Very Low Low Low Expected

LowMonitory Medium
Value Analysis
Probability
Low and Impact Matrix Monte Carlo Analysis
Decision Tree
Impact


4. Plan Risk Response
Responding to Risks
❖ How to decrease the possibility of

❖ Negative risk affecting the objectives
❖ How to increase the possibility of
❖ Positive risk helping the objective
4. Plan Risk
Response
Negative Risk Positive Risk
Avoid Exploit
Mitigate Enhance
Transfer Share
Accept Accept
Decision Tree
4. Plan Risk Response Slide 183

Avoid the risk
Negative Risk
Examples:
• Plan is changed to avoid the risk
Avoid
• Adopting a proven approach instead of a Mitigate
new approach
Transfer
• Improving team communication
Accept
Decision Tree

Reduce the probability and/or impact of the
risk
Negative Risk
Examples: Avoid
• Simplify the processes Mitigate
• Develop prototype
Transfer
• Additional inspections
• Lessons Learned from past Accept
Decision Tree

Transfer the risk to a third party
Negative Risk
Examples:
• Insurance
Avoid
• Performance warranty Mitigate
• Subcontract Transfer
Accept
Decision Tree

Accept the risk if:
• no action is feasible or
• the probability and/or impact is too small. Negative Risk
Avoid
• Two types of acceptance:
Mitigate
• Passive Acceptance: No plan created to deal
with these Transfer
• Active Acceptance: Contingency plan is Accept
created and risks are monitored Expected Monitory Value
Monte Carlo Analysis
Analysis
Decision Tree

Exploit: Make sure that positive risk happens
and make best use of the opportunity
Positive Risk
Examples: Exploit
• Put best team members and more resources Enhance
Share
Accept
Decision Tree

Enhance: Increase the probability and/or
impact of the risk
Positive Risk
Examples: Exploit
• Put best team members and more resources Enhance
Share
Accept
Decision Tree

Share the opportunity with a third party
Positive Risk
Examples:
• Forming team, Joint Venture or a company Exploit
with a third party. Enhance
Share
Accept
Decision Tree

Accept the opportunity when it happens but
not actively pursuing it
Positive Risk
Examples: Exploit
• Probability and rewards are not attractive. Enhance
Share
Accept
Decision Tree


5. Monitor and Control Risks
❖ Regularly review the identified risks
and ensure that these are still relevant
❖ Identify new risks
❖ Remove risks that are not relevant
❖ Risk audits may be conducted to
ensure that the plan is being
implemented and is effective.
5. Monitor and
Control Risks
1
5H
Risk Management 2
Tools 3
Points (HACCP)
4
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
Design FMEA Process FMEA FMEA
Identifies failures associated Identifies failures associated
with: with:
•Product malfunctions •Product quality

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

Slide 196
Concept
FMEA
Concept
FMEA
Design Process
FMEA FMEA
Production Assembly
- System
FMEA FMEA
- Subsystem
Design FMEA Process FMEA - Component
- System - System
FMEA
- Subsystem - Subsystem
- Component - Component
FMEA FMEA

Slide 197
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
Failure Mode and Effects Analysis (FMEA) Slide 199

Risk Priority Number (RPN) = Severity (1-10) x Occurrence (1-10) x Detection (1-10)
Severity Occurrence Detection

❖ Severity 1 – No ❖ Occurrence 1 – ❖ Detection 1 –
Rare event, no Current system
effect/ client might almost certainly
not even notice it data of such type detect the
of failure in past problem
❖ Severity 10 – ❖ Occurrence 10 – (automation)
Serious safety Failure almost ❖ Detection 10 –
hazard without inevitable Current system
warning can not detect the
problem
Failure Mode and Effects Analysis (FMEA) Slide 200

❖ 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

Slide 201
FMEA
❖ Update FMEA when there is plan to
change / actual change of :
❖ Design
❖ Application
❖ Material
❖ Process
❖ FMEA is a living document
FMEA
1
5H
Risk Management 2
Tools 3
Points (HACCP)
4
Hazard Analysis and Critical
Control Points
❖ HACCP is an internationally recognized
system used to enhance food safety
throughout the food chain.
❖ The development of a HACCP system involves:
❖ identifying potential hazards
❖ implementing control measures at specific
points in the process
❖ monitoring and verifying that the control
measures are working as intended
HACCP
❖ HACCP plans follow seven core
principles.
❖ 1. Conduct a Hazard Analysis
❖ 2. Determine the Critical Control Points
❖ 3. Establish Critical Limits
❖ 4. Establish Monitoring Procedures
❖ 5. Establish Corrective Actions
❖ 6. Establish Verification Procedures
❖ 7. Establish Record-Keeping and
Documentation Procedures
Hazard Analysis and Critical Control Points (HACCP)

Slide 205
1
5H
Risk Management 2
Tools 3
Points (HACCP)
4
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)
CTQ
❖ VOC’s can be vague and difficult to

define, that’s where CTQ’s 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 to Measure Easy
Critical to Quality (CTQ)

Slide 209

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A

Basic Quality and Problem-solving

Quality Tools and D

Pareto Chart - Defects during water bottle

Defect Scratch Loose Cap Label Volume Leakage Frequency 120.0

500 ml. ||| |||| || | | 12 0.0

1. Pareto Chart Slide 4

❖ Important tools for Root Cause Analysis

2. Cause-and-effect Diagrams Slide 7

4. Statistical Process Control (SPC) Slide 12

Many Causes Few Causes

Un-economical to eliminate Economically viable to eliminate

Also Called: Also Called:

4. Statistical Process Control (SPC) Slide 13

4. Statistical Process Control (SPC) Slide 14

4. Statistical Process Control (SPC) Slide 16

• Checklist is a mistake- 300 ml. || || |||| | | 11

5. Check sheets Slide 18

Travelling time in Minutes

6. Scatter Diagrams Slide 20

• X axis – Independent Variable

Travelling time in Minutes

6. Scatter Diagrams Slide 21

Gasket Sub standard

8. Root Cause Analysis Slide 25

9. PDCA/PDSA Cycle Slide 27

Quality Tools and D

1992 Allied Signal

1995 General Electric

History of Six Sigma Slide 31

If pilot always lands

HALF Width of Landing Strip

Width of Landing Strip

Pilot’s Six Sigma Performance Slide 32

Overview of Six Sigma Slide 33

Defects Per Million Opportunities

3.5 s 22,700 200,000

Defects Level vs Sigma Slide 34

Six Sigma Process - DMAIC Slide 35

Six Sigma Process - DMADV Slide 36

Management Beginners Part time Full time

Stakeholders Team members Lead small projects Lead projects

SSWB SSYB SSGB SSBB

Six Sigma Belts Slide 37

Source: SigmaXL software

Supplier / Customer Production Control External Shipment

Operator Work Cell Inventory Store

Source: SigmaXL software

Push Arrow FIFO Lane

Manual Information Flow Electronic Information Flow

Source: SigmaXL software

C/T = Cycle Time

Source: SigmaXL software

Current Lean Future

Lean • Pull system

Inventory Over Production

Wait Time Under Utilized Staff

Eight Types of Muda Slide 53

Eight Types of Muda Slide 54

Eight Types of Muda Slide 55

Eight Types of Muda Slide 56

Eight Types of Muda Slide 57