Quality Management Tools and Techniques 2014 Part 1 ST - Ver.

QUALITY
MANAGEMENT
January 2014
Quality Management
Part 2
Tools and Techniques used in Total
Quality Management
January 2014
Quality Management
Tools and Techniques used in Total

Quality Management
Tools and Techniques
Product and Process Improvements
January 2014
Quality Management
Part 2.1
Tools and Techniques
January 2014
Quality Management
Introduction
One of the basic principles of Total Quality is
management by facts
It requires that each decision, each solution to a
problem is based on relevant data and
appropriate analysis
Collecting and analyzing data can be difficult
Use of Total Quality tools and techniques ensure
better decision making, better solution to
problems, improvement in productivity, products
and services
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Quality Management
Overview of Total Quality Tools

Basic 7 tools:
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The Pareto Chart

Cause-and-Effect Diagrams
Check Sheets
Histograms
Scatter Diagrams
Stratification
Run Charts and Control Charts
Quality Management

Other tools:
January 2014
Statistical Process Control (SPC)

5S
Flowcharts
Input-output diagram
Failure mode and effects analysis
Design of Experiments (DOE)
Quality Management
Overview of Total Quality Techniques
Process Capability
Quality Loss Function and Robust Engineering
Risk Assesment
Problem Solving and Decision Making
PDCA
8D
Kepner Traego
Six Sigma
January 2014
Quality Management
Pareto chart
Pareto charts are useful for separating the important from the
trivial. Pareto charts are important because they can help an
organization decide where to focus limited resources
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Quality Management
Pareto Chart
The purpose is to separate the vital few from the trivial many.
The number of production interruptions, and the reasons for the interruption, at
an injection molding plant are recorded for one month.
Machine
Breakdown and
Defective
Production are the
biggest
contributors to
production
interruption.
What
Frequency of
Type of Interruption information do
we Occurrence
see from
Machine Breakdown the Pareto?
180
Defective Production
135
No Material
63
Change-over
56
Tool Breakdown
27
Defective Material
23
Maintenance
14
No Labor
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Pareto chart
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Cause and Effect Diagram

The purpose of the cause-and-effect diagram
( Ishikawa of fishbone) diagram is to help
identify and isolate the causes of problems
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Example of problem:
Contamination of product with iron.
Possible (primary) causes of contamination:
Measurement
Material
Methods
Environment
Manpower
Machines
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5M+E
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Measurements
Materials
Methods
Iron in
product
Environment
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Manpower
Machines
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Measurements
Lab error
Analyst
Improper calibration Calculation
Solvent contamination
In laboratory
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At supplier
15
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Can be used in any function of an organization
Example from Human Resources
Employee turnover
Possible (primary) causes of turnover:
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Economy
Performance of the Organization
Organizational Culture
Job Characteristics
Unrealisic Employee Expectations
Personal Reasons
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Check sheet
Check sheets make it easy to collect data for specific purposes and
to present it in a way that automatically converts it into useful
information
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Histogram
Histograms have to do with variability. A histogram is a measurement scale
across one axis and a frequency of measurements on the other.
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Histogram
Adds to 100%
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Scatter diagram
Scatter diagram is used to determine the
correlation between two variables.
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What is a Correlation?
A correlation exists between two variables when

they are related to one another in some way.
Project
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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Time
(Days)
14
29
26
10
18
11
34
26
24
21
Cost
($k)
80
111
76
27
55
51
150
140
80
120
QUESTION:
What is the relationship between Project
time and Cost?
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Scatter Diagram
A scatter diagram is the graphical
representation of paired (x,y) data.
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Cost
($k)
80
111
76
27
55
51
150
140
80
120
T ime vs . C os t of P rojec ts
150
C os t ($ k)
Project
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Time
(Days)
14
29
26
10
18
11
34
26
24
21
100
50
10
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20
T im e (D a ys )
30
24
Scatter Diagram
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Cost
($k)
80
111
76
27
55
51
150
140
80
120
150
C os t ($ k)
Project
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Time
(Days)
14
29
26
10
18
11
34
26
24
21
100
50
10
20
T im e (D a ys )
30
As the project time increases,

so does the cost.
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Types of Relationships
Positive Correlation
Strong Positive
Perfect Positive
Negative Correlation
Strong Negative
Perfect Negative
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No Correlation
Nonlinear Correlation
26
Correlation Coefficient
The correlation coefficient, r,
is a statistical measure of the strength of the
linear relationship between two variables.
r is always between -1 and 1 (inclusive).

When r is close to zero, no linear relationship
is present.
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Correlation Coefficient
Cost
($k)
80
111
76
27
55
51
150
140
80
120
1 50
C os t ($ k)
Project
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Time
(Days)
14
29
26
10
18
11
34
26
24
21
1 00
50
10
20
T im e (D a ys )
30
r = 0.82
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Correlation Coefficient - Examples

r = 0.52
Positive Correlation
r = - 0.73
Negative Correlation
r = 0.85
Strong Positive
r = - 0.89
Strong Negative
r = 1.0
Perfect Positive
r = - 1.0
Perfect Negative
r = 0.09
No Correlation
r@0
Nonlinear Correlation
Note: r 0 means no linear relationship.

The variables might be related, just not in
a linear fashion.
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Correlation Coefficient Discussion
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1.

is approximately (select one):
a.) 0.50
b.) 0.85
c.) 0.05
2.

is approximately (select one):
a.) 0.00
b.) 0.70
c.) -0.70
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Stratification
Stratification is a tool used to investigate the cause of a problem by grouping
data into categories. Grouping of data by common elements or characteristics
makes it easier to understand the data and to draw insights from it.
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Run chart
The run chart records the output results of a process over time
For this reason, the run chart is sometimes called a trend chart
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Run charts and Control charts

The weakness of the run chart is that it
does not tell whether the variation is
the result of common causes or special
causes.
This weakness gave rise to the control
chart.
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Control Chart
Common Cause Variation
Routine, inherent process variation the steady
state variation that persists over time
Common-cause variation is the noise within the
system.
Common cause variation describes variability in a
process that is inherent in the design of the
process
Reduction of common cause variation requires
(usually) a redesign of the process
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Control Chart
Special Cause Variation
Variation that demonstrates a deviation from the
process steady state.
Special-cause variation always arrives as a
surprise. It is the signal within a system
Special cause variation is a variability that comes
from some extraordinary event
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Control Chart
Two different sorts of data:
Data collected by counting:
Attribute/discrete data charts
Number of wrong invoices received per day
Data collected by measurements:

Variable/ continue data charts
Percentage of alcohol in beer
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Control Chart
Two different control charts:
The p-chart is used to monitor the number of
(non) conforming units in a sample
The x and R chart is used to monitor a
variable's data when samples are collected at
regular intervals from a business or industrial
process.
Range of a set of data is the difference between
the largest and smallest values
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Run (p) chart

Each week, n=500 invoices are sampled.
The percentage of invoices needing correction is
plotted for 20 weeks.
P Chart of Rejcted Invoices
0.10
0.09
0.08
0.07
Proportion
Wk 1 4%
Wk 2 5,2%
Wk 3 5,3%
Wk 4 4,9%
Wk 5 2,5%
Etc.
UCL=0.06839
0.06
0.05
Average
= 0,04126
P=0.0416
0.04
0.03
0.02
LCL=0.01481
0.01
2
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10
12
Week
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16
18
20
38
Control Chart
On Control chart, data are plotted just
as they are on a run chart, but a lower
control limit, an upper control limit,
and a process average are added.
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Control Chart
Control limits are statistical bounds that
define the region within which the process
naturally varies.
These bounds are computed from the data.
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Upper and Lower Control Limit

(UCL & LCL) for p chart
UCL/LCL =
p = average of all p values: (0,04+0,052+0,053+0,049+0,025)/5
UCL=0.0416+3
0.0416 ( 1 0.0416)
500
= 0,04126 + 0,02679= 0,06839
LCL=0.0416 0,02679 = 0, 01481
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Control (p) Chart

P Chart of Rejcted Invoices
0.10
Upper Control
Limit
0.09
0.08
Within
Control
Limits
Proportion
0.07
UCL=0.06839
0.06
0.05
_
P=0.0416
0.04
Lower Control
Limit
0.03
0.02
LCL=0.01481
0.01
2
10
12
Week
14
16
18
20
When the process randomly fluctuates within the control limits, it is impacted
only by common causes of variation and considered stable, or in statistical control.
If the process is in control , 99.73% of all the points will fall between the control
limits.
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Control (p) Chart

.
Special Cause
Variation
Variation that
demonstrates a
deviation from the
process steady
state.
P Chart
of Rejected
Invoices
P Chart
of Rejcted
Invoices
0.10
0.09
0.08
Proportion
0.07
Common Cause
Variation
Routine, inherent
process variation the
steady state variation
that persists over time.
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UCL=0.06839
0.06
0.05
_
P=0.0416
0.04
0.03
0.02
LCL=0.01481
0.01
2
10
12
Week
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14
16
18
20
43
Run (x) Chart
Range
Range of Daily Production Cost per Week
Week Number
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Control Chart
To construct a Control chart, we need
to establish a lower control limit, an
upper control limit, both for the
process averages (x) and for the
ranges (R)
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Control (x R) Chart
UCL = 8.9
10.0
UC L
8.0
X
chart
Compute and plot the control

limits for the Averages chart.
6.0
4.0
2.0
LCL
0.0
LCL = 1.1
16.0
R
chart
UC L
12.0
8.0
4.0
LCL
0.0
Sample #
1
2
3
4
5
Average
Range
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8:00
10.0
1.0
4.0
9.0
8.0
6.4
9.0
8:30
7.0
4.0
10.0
2.0
8.0
6.2
8.0
9:00
5.0
2.0
6.0
2.0
3.0
3.6
4.0
9:30 10:00 10:30 11:00

9.0
2.0
2.0
5.0
3.0
4.0
4.0
6.0
7.0
2.0
8.0
4.0
3.0
6.0
8.0 10.0
1.0
1.0
6.0
3.0
4.6
3.0
5.6
5.6
8.0
5.0
6.0
7.0
Quality Management
UCL
UCL
LCL
LCL
x
x
x
x
= X + A2 R
= 5 .0 + ( 0 .577 6 .7 ) = 8 .9
= X - A 2R
= 5 .0 - ( 0 .577 6 .7 ) = 1 .1
Subgroup
Size (n)
2
3
4
5
A2
1.880
1.023
0.729
0.577
D3
0.000
0.000
0.000
0.000
D4
3.267
2.574
2.282
2.114
46
Control (x R) Chart
UCL = 8.9
10.0
UC L
8.0
X
chart
Compute and plot the control

limits for the Range chart.
6.0
4.0
2.0
LCL
0.0
LCL = 1.1
16.0
UCL = 14
UC L
12.0
R
chart
8.0
4.0
LCL = 0
0.0
Sample #
1
2
3
4
5
Average
Range
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8:00
10.0
1.0
4.0
9.0
8.0
6.4
9.0
8:30
7.0
4.0
10.0
2.0
8.0
6.2
8.0
9:00
5.0
2.0
6.0
2.0
3.0
3.6
4.0
LCL = D3R
LCL = 0 x 6.7 = 0
UCL = D4R
UCL = 2.114 x 6.7 = 14
LCL
9:30 10:00 10:30 11:00

9.0
2.0
2.0
5.0
3.0
4.0
4.0
6.0
7.0
2.0
8.0
4.0
3.0
6.0
8.0 10.0
1.0
1.0
6.0
3.0
4.6
3.0
5.6
5.6
8.0
5.0
6.0
7.0
Quality Management
Subgroup
Size (n)
2
3
4
5
A2
1.880
1.023
0.729
0.577
D3
0.000
0.000
0.000
0.000
D4
3.267
2.574
2.282
2.114
47
Control Chart
As long as the variation is the result of
common causes such as statistical variation
only, the plotted data stays between the
upper control limit and lower control limit
while varying about the center line or average.
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Other tools:
January 2014

5S
Flowcharts
Input-output diagram
Failure mode and effects analysis
Design of Experiments (DOE)
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Overview of Total Quality Techniques
Process Capability
Quality Loss Function and Robust Engineering
Risk Assesment
PDCA
8D
Kepner Traego
Six Sigma
January 2014
Quality Management
50

Traditionally, in mass-manufacturing,
traditionally, the quality of a finished article is
ensured by end of line inspection of the
product.
Each article (or a sample of articles from a
production lot) may be accepted or rejected
according to how well it meets its design
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In contrast, SPC use statistical tools to observe
the performance of the production process in
order to predict significant variations which may
result in the production of a sub-standard article.
An advantage of SPC over end of line inspection is
that it allows early detection and prevention of
problems, rather than the correction of problems
after they have occurred
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Statistical Process Control (SPC) is a statistical
method of separating variation resulting from
special causes from natural variation in order
to eliminate the special causes.
It is used to monitor processes and indicate
when they get out of control
It can be applied to any process
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Collecting Data for an SPC Chart

At least 20 subgroups of about n=5 data are
required.
The data within a subgroup should be collected
close together in time (for example, 5 consecutively
produced parts)
Longer time intervals are used between subgroups.
(Depending on the process and purpose of the
study, these time intervals could be 15 min., 30
min., 1hr., 2 hr., or longer).
Use a sampling frequency that captures normal
changes in the process (changes in material,
operators, etc.).
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Collecting Data for an SPC Chart

Measure
1
Time
08:00
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
2
09:00
3
10:00
4
11:00
5
12:00
6
13:00
x
R
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7
14:00
.........
20
03:00
x=
R=
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Creating a SPC Chart

Calculate the UCL and LCL
In case of variable data also for the Range
Create a SPC chart with time intervals on the horizontal
axis and x or p on the vertical axis
In case of variable data create additional chart for
Range
Plot the UCL and LCL on the chart
Start collecting data from the process
Generally, the average and range are monitored
simultaneously, so that the entire system can be
evaluated
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SPC (X Bar and R) Chart

X Bar Control Chart Average Daily Production Costs by Week
Range of Daily Production Cost per Week
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Interpretation of SPC charts
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Out of Control Conditions:
If one or more points falls outside of the upper control limit
(UCL), or lower control limit (LCL). see section A
If two out of three successive points fall in the area that is
beyond two standard deviations from the mean, either
above or below - see section B
If four out of five successive points fall in the area that is
beyond one standard deviation from the mean, either
above or below - see section C
If there is a run of six or more points that are all either
successively higher or successively lower - see section D
If eight or more points fall on either side of the mean - see
section E
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SPC and Process Capability

Does it mean that if all results on an SPC chart are
within Control limits at least 99,73% of the products
are good?
No, it only means that the process is under statistical
control
To determine if the process is producing only good
products we need to understand the relation between
control limits and product specification
A specification is an explicit set of requirements to be
satisfied by a material, design, product, or service
=> PROCESS CAPABILITY

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Normal Distribution
The central limit theorem states that under certain
(fairly common) conditions, the sum of many random
variables will have an approximately normal
distribution
U p p e r C o n tr o l L im i t
L o w e r C o n tr o l L im i t
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Properties of the Normal Distribution
68% of parts will fall

between
+/- 1 standard deviations
from the mean
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95% of the parts will fall

between
from mean
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99.73% of the parts will fall

between
from mean
63
Standard deviation (Sigma)
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Standard deviation (Sigma)
The standard deviation of a statistical

population is the square root of its variance
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Example
Consider a population consisting of the following eight values:
2 4 4 4 5 5 7 9
These eight data points have the mean (average) of 40:8 =5
To calculate the population standard deviation, first compute the
difference of each data point from the mean, and square the result of
each:
Next compute the average of these values, and take the square root:
This is the population standard deviation; it is equal to the square root of
the variance.
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Population vs sample standard

deviation
The formula is valid only if the eight values we
began with form the complete population.
If they instead were a random sample, drawn
from some larger, "parent" population, then
we should have used 7 (which is n 1) instead
of 8 (which is n) in the denominator of the
formula, and then the quantity thus obtained
would have been called the sample standard
deviation
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Process capability
Process capability shows the relationship
between the natural process limits (the
control limits) and specifications
Process in (statistical) control vs. Capable
process
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Specification Limits
LCL
UCL
Specification Limits are

applied to individual
measurements.
LSL
USL
Specification limits are decided by people.

Control limits are determined by the data
(voice of the process).
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Process Capability Improvement

Cut Dimension (mm)
Histogram of Dimension B
Initial State:
POOR
CAPABILITY
25
Frequency
20
15
10
0.0
0.5
1.0
1.5
LSL
2.0
2.5
USL
Cut Dimension (mm)

Histogram of Dimension B (m.m.)
20
Frequency
15
10
After Modified
Collision Sensor
Installed
BETTER CAPABILITY
0.0
0.5
1.0
LSL
1.5
2.0
A fter
2.5
USL
Cut Dimension (mm)

Histogram of Dimension B (m.m.)
16
14
After Auto Clamp

Installed
HIGH PROCESS
CAPABILITY!
12
Frequency
10
8
6
4
2
0
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0.0
0.5
1.0
1.5
2.0
2.5
70
LSL
USL
Cp Index Demonstrates Potential

Capability
Cp = (USL LSL)/ 6s
Cp = 1
3s
LSL
USL
3s
Cp is the ratio of Total

Tolerance to the 6s
Process Spread.
It shows how capable the
process would be if it were
perfectly centered.
Cp =1.33
Cp = Potential Capability
USL
4s
LSL
4s
Cp = 2
6s
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6s
This is a
Six Sigma
process.
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USL Avg.
Cpk =
3s
USL
LSL
Cpk Index Demonstrates Actual

Capability
Cp = 2
Cpk = 1.33
Cp = 2
Cpk = 2
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Cpk takes into

account any offcentering that actual
occurs.
When process is
centered, Cp = Cpk.
72
Process Sigma Level - Table

PPM
Sigma Level
3.4
233
6210
66807
308538
691462
Six Sigma thinking employs a 1.5 sigma shift.
For example: if a process exhibits 4 Sigma capability in the

short term, it would probably exhibit 2.5 Sigma capability in
the long term.
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Process Performance Index

(Pp and Ppk)
Process Performance Index basically tries to
verify if the sample that you have generated
from the process is capable to meet the
requirements
It differs from Process Capability (Cp & Cpk) in
that Process Performance only applies to a
specific batch of material.
An example of this is for a short preproduction run.
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Process Control and Capability
Examples of process control and capability

Three different production processes
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Process In Control (Stable)
Xbar-R Chart of Nugget Diameter
U C L=1.4127
Sample Mean
1.40
1.35
_
_
X=1.3022
1.30
1.25
1.20
LC L=1.1916
3
12
15
Sample
18
21
24
27
30
U C L=0.4053
Sample Range
0.4
0.3
_
R=0.1917
0.2
0.1
0.0
LC L=0
3
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12
15
Sample
18
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21
24
27
30
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Process Is Capable (Cpk > 1.67)
Process Capability of Nugget Diameter
LSL
P rocess D ata
LS L
0.80000
Target
*
USL
*
S ample M ean
1.30220
S ample N
150
S tD ev (Within)
0.08320
S tD ev (O v erall) 0.08138
W ithin
Ov erall
P otential (Within) C apability
Cp
*
C PL
2.01
C PU
*
C pk
2.01
C C pk 2.01
O v erall C apability
Pp
PPL
PPU
P pk
C pm
0.90
O bserv ed P erformance
P P M < LS L 0.00
PPM > USL
*
P P M Total
0.00
January 2014
1.08
E xp. Within P erformance

P P M < LS L 0.00
PPM > USL
*
P P M Total
0.00
1.26
1.44
1.62
*
2.06
*
2.06
*
1.80
E xp. O v erall P erformance

P P M < LS L 0.00
PPM > USL
*
P P M Total
0.00
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Process In Control (Stable)
Xbar-R Chart of Preform Length
U C L=730.85
Sample Mean
730.0
727.5
_
_
X=725.25
725.0
722.5
720.0
LC L=719.64
2
10
12
14
Sample
16
18
20
22
24
20
Sample Range
U C L=17.55
15
10
_
R=7.69
5
0
LC L=0
2
January 2014
10
12
14
Sample
16
Quality Management
18
20
22
24
78

Process Is Not Capable (Ppk < 1.67)
Process Capability of Preform Length
Calculations Based on Weibull Distribution Model
LSL
USL
P rocess Data
LS L
700.00000
Target
*
USL
720.00000
S ample M ean 708.21482
S ample N
120
S hape
1.67064
S cale
7.84297
Threshold
701.20479
O v erall C apability
Pp
0.83
PPL
1.22
PPU
0.69
P pk
0.69
E xp. O v erall P erformance
P P M < LS L
0.0
P P M > U S L 13481.4
P P M Total
13481.4
O bserv ed P erformance
P P M < LS L
0.00
P P M > U S L 8333.33
P P M Total
8333.33
700
January 2014
704
708
712
716
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720
724
79

Process Not In Control (Not Stable)
Xbar-R Chart of Strip Caster Thickness
Special Cause
Sample M ean
0.031
0.030
U C L=0.029480
0.029
_
_
X=0.028057
0.028
0.027
LC L=0.026634
2
10
12
14
Sample
16
18
20
22
24
0.0060
Sample Range
U C L=0.005218
0.0045
0.0030
_
R=0.002468
0.0015
0.0000
LC L=0
2
January 2014
10
12
14
Sample
16
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18
20
22
24
80

Process Is Not Capable
(Cpk will be calculated after special cause is eliminated.)
Histogram of Strip Caster Thickness
20
Frequency
15
LSL=
0.024
10
USL=
0.030
0
0.020
January 2014
0.022
0.024
0.026
0.028
Thickness
Quality Management
0.030
0.032
0.034
81

Determine what to measure, and verify measurement
system
Determine appropriate sub grouping, and collect data in
time order.
Create control chart and assess stability.
If special cause(s) present, then remove the special
cause(s), collect new data.
(Apply problem solving: KT, 8D, etc.)
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Once stable, evaluate process capability.
Make histogram.
Check for normality.
Compute Cpk or Ppk, PPM.
If not capable, then reduce variation (conduct DOE if
needed), and collect new data.
(Note: Cpk/Ppk > 1.67 is often the goal.)
Establish preventive maintenance
(needed to maintain stable & capable condition).
January 2014
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A process is in statistical control when it is stable
over time, and therefore predictable
Common Capability Indices:
Cp, Cpk (used when data is
normal and process is in control)
Pp, Ppk (used for non-normal data, and for processes
that have not yet been stabilized).
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If we produce a product in a stable and
capable process it means that almost all parts
are produced within the tolerance limits
(99,9777% with Cpk of 1,67)
Does that mean that all those products have
same quality?
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Quality Loss Function (Taguchi)

Taguchi showed that "loss" in capabilities did not
begin only after exceeding these tolerances, but
increased as described by the Taguchi Loss
Function at any condition exceeding the nominal
condition
The customer wants a target value
=> any deviation will cause loss
The quality loss function attempts to measure

quality as loss due to deviation from target
Highest quality system is the one which has the
least functional variability
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Quality Loss Function

The quality loss function is quantitative evaluation of
loss caused by functional variation of a product
LSL
January 2014
USL
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Quality Loss Function

Quality Loss Function approach aims at
improving Quality by reducing the functional
variation of a product.
Another approach
Robust Engineering
January 2014
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Robust Engineering
Robustness is the state where technology,
product or process performance is minimally
sensitive to factors causing variability (in
users environment and manufacturing) at the
lowest cost.
January 2014
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89
Robust Engineering
Robust Engineering is
prevention.
Robust Engineering focuses
on
How to prevent failures,
How to reduce
variability in product
function,
How to reduce cost.
January 2014
Quality Management
Applicable in:
Electronic
Mechanical
Chemical
Software
Engineering
Systems
90
Robust Engineering
All failures and defects are caused by 3 types of noise:
Various usage conditions
End-user/ Environmental conditions
Neighboring subsystems
Deterioration or wear (degradation over time)
Individual difference (manufacturing
imperfections)
How can we prevent problems due to these types of

noise factors?
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Robust Engineering
Countermeasures against Noise
1. Ignore
2. Control/ eliminate Noise (reactive)
(standardization, control charting, Error Proofing,
Tolerance design)
3. Compensate effect of Noise
(feedback control, feed-forward control)
4. Minimize effect of Noise (proactive)
(Robust optimization Parameter Design)
$$$
The more we can do #4, the less money we spend on the

others.
January 2014
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Quality Loss Function vs. Robust

Engineering
Quality Loss Function approach aims at
improving Quality by reducing the functional
variation of a product.
while
Robust Engineering approach aims at

improving Quality by minimizing the
sensitiveness of a product to factors causing
variability (noise)
January 2014
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93
Quality Loss Function vs. Robust

Engineering
Quality Loss
Function
Quality Loss
Robust
Engineering
Value
Target
January 2014
Quality Management
94
5S
5S is the name of a workplace organization
methodology
It describes how to organize a work space for
efficiency and effectiveness by identifying and
storing the items used, maintaining the area
and items, and sustaining the new order.
January 2014
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5S
(Seri, Seiton, Seiso, Seiketsu, Shitsuke)
1S - Separate and Scrap

Sort useful form useless
2S Straighten
Everything in its place
3S Scrub
Workplace and equipment clean
4S Standardize
Select the best practice
5S Sustain
Make sure rules are followed
By organizing the workplace, unstable or wasteful situations
become visible earlier, allowing for a quick, effective response.
January 2014
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Purpose of 5S
A structured system to make
abnormalities stick out
These abnormalities can then

be addressed
January 2014
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5S example
January 2014
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Flowchart
A flowchart is a picture of the separate steps of a process in
sequential order
High level flowchart
January 2014
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Flowchart
Detailed flowchart
January 2014
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100
The Input-Process-Output (IPO)

Diagram
IPO Diagrams are high-level process maps.
Input: Substance(s) that enter the system.
Process: Actions taken upon or using the
input.
Output: Tangible item(s) that result from
the processing, and exit the process.
January 2014
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101
IPO - High Level Process Maps

Hire Employee
INPUTS
PROCESS
OUTPUTS
Post Position
Personnel Request Form
Candidates for the
position
Resumes
Review Resumes
Select Candidates
Person placed in position

Rejected candidates
Closed-out PR Form
Interview
Make Offer
January 2014
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102
Risk Assessment
Risk assessment is the determination of
quantitative or qualitative value of risk related
to a concrete situation and a recognized threat
Quantitative risk assessment requires
calculations of two components of risk (R):,
the magnitude of the potential loss (L), and
the probability (p) that the loss will occur
Total Risk: R = L x p
January 2014
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Risk Assessment
Important problem of products are risks which
are caused by bad or insufficent quality. In the
first line these are safety risks (danger to
human life, health, property). Both in the
production phase and usage phase
Producer and/or distributor has a moral and
legal responsibilty for the risks in usage phase.
.
January 2014
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Risk Assessment
Damage
occurence
Area of extreme
risks
often
possible
seldom
not
probable
small
January 2014
medium
big
Quality Management
catastrop
hic
Potential
damage
105
Product liability
Product liability is the area of law in which
manufacturers, distributors, suppliers,
retailers, and others who make products
available to the public are held responsible for
the injuries those products cause.
Although the word "product" has broad
meaning, product liability as an area of law is
traditionally limited to products in the form of
tangible personal property.
January 2014
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Product liability
Types of liability:
Manufacturing defect,
Manufacturing defects are those that occur in the
manufacturing process and usually involve poor-quality
materials or poor workmanship
Design defect,
Design defects occur where the product design is inherently
dangerous or useless (and hence defective) no matter how
carefully manufactured
Failure to warn
Failure-to-warn defects arise in products that carry inherent
nonobvious dangers which could be mitigated through adequate
warnings to the user, and these dangers are present regardless
of how well the product is manufactured and designed for its
intended purpose.
January 2014
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Product liability
European Union:
European Union Directive 85/374/EEC
Czech Republic
Zkon . 59/1998 Sb. o odpovdnosti za kodu
zpsobenou vadou vrobku
January 2014
Quality Management
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Risk management
In design and development
DFMEA
Design verification
Design validation
Prototyping and testing
In production
PFMEA
SPC
Poka Yoke
Final product inspection / Product audit
(Quick) Problem Solving
January 2014
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FMEA
Failure modes and effects analysis (FMEA) is a
step-by-step approach for identifying all possible
failures in a design, a manufacturing or assembly
process, or a product or service.
Failure modes means the ways, or modes, in
which something might fail. Failures are any
errors or defects, especially ones that affect the
customer, and can be potential or actual.
Effects analysis refers to studying the
consequences of those failures.
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FMEA
The purpose of the FMEA is to take actions to
eliminate or reduce failures, starting with the
highest-priority ones.
Failure modes and effects analysis also
documents current knowledge and actions about
the risks of failures, for use in continuous
improvement.
FMEA is used during design to prevent failures.
Ideally, FMEA begins during the earliest
conceptual stages of design and continues
throughout the life of the product or service.
January 2014
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FMEA
Failures are prioritized according to
how serious their consequences are
(severity)
how frequently they occur

(occurrence)
how easily they can be detected

(detection).
January 2014
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112
Occurrence
Rating
1
2/3
4/5/6
7/8
9/10
Meaning
No known occurrences on similar products or processes
Low (relatively few failures)
Moderate (occasional failures)
High (repeated failures)
Very high (failure is almost inevitable
Severity
Rating
1
2
3
4/5/6
7/8
9/10
Meaning
No effect
Very minor (only noticed by discriminating customers)
Minor (affects very little of the system, noticed by average customer)
Moderate (most customers are annoyed)
High (causes a loss of primary function; customers are dissatisfied)
Very high and hazardous (product becomes inoperative; customers angered; the failure may result unsafe
operation and possible injury)
Detection
Rating
1
2
3
4/5/6
7/8
9/10
January 2014
Meaning
Certain - fault will be caught on test
Almost Certain
High
Moderate
Low
Fault will be passed to customer
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113
FMEA process
RPN (Risk Priority Number) = S x O x D
January 2014
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FMEA example
January 2014
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115
FMEA example
January 2014
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FMEA cycle
January 2014
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117
Types of FMEA
Process: analysis of manufacturing and assembly processes
Design: analysis of products prior to production
Concept: analysis of systems or subsystems in the early
design concept stages
Equipment: analysis of machinery and equipment design
before purchase
Service: analysis of service industry processes before they
are released to impact the customer
System: analysis of the global system functions
Software: analysis of the software functions
January 2014
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Design of Experiments
Design of experiments (DOE) is a sophisticated
method for experimenting with complex
processes for the purpose of optimizing them.
DOE allows multiple factor adjustments
simultaneously
It reduces the number of tests needed to find
an optimal situation by factor 10
It also shows which factors are critical and
which are not
January 2014
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119

A problem is a situation in which what exists does
not match what is desired or, put another way, the
discrepancy between the current and the desired
state of affairs.
Problem solving in a total quality setting is not
about putting out fires. It is about continual
improvement.
January 2014
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Securing reliable information is an important
part of problem solving and decision making.
Recommended tools:
January 2014
Cause-and-effect diagrams
Flowcharts
Pareto charts
Run charts
Histograms
Control charts
Scatter diagrams
Quality Management
121
PDCA
Identify and analyze the problem. Set a
measurable goal . Identify root cause(s) of the
problem
Request corrective actions on

significant differences between actual
and planned results . Standardize the
solutions
January 2014
Develop and implement the solution
Evaluate the actual results (measured and

collected in "DO" above) and compare against
the expected results (targets or goals from the
"PLAN") to ascertain any differences
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8D methodology (TOPS)
January 2014
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8D methodology
D0: Problem Awareness:
Plan for solving the problem and determine the
prerequisites.
D1: Team:
Establish a team of people with product/process
knowledge.
D2: Defining the Problem:

Specify the problem by identifying in quantifiable
terms the who, what, where, when, why, how, and
how many (5W2H) for the problem.
January 2014
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8D methodology
D3: Contain :
Define and implement containment actions to isolate
the problem from any customer
Verify effectiveness of actions
D4: Diagnose (Define and verify root causes) :

Identify all applicable causes that could explain why
the problem has occurred.
Identify why the problem has not been noticed at the
time it occurred.
All causes shall be verified or proved by
experimentation and statistical data, not determined
by fuzzy brainstorming.
January 2014
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8D methodology
D5: Action (Choose and verify permanent corrective
actions)
Verify that the correction will actually solve the problem
Evaluate the degree of problem reduction or elimination
D6: Verify
Verify the effectiveness of the corrective actions
D7: Prevent (Take Preventive Measures):

Modify the management systems, operation systems,
practices, and procedures to prevent recurrence of this
and all similar problems.
D8: Closure:
Recognize the collective efforts of the team.
January 2014
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8D and FMEA
The Failure Modes in a FMEA are equivalent
to the problem statement or description in an
8D.
Causes in a FMEA are equivalent to potential
causes in an 8D.
Effects of failure in a FMEA are problem
symptoms in an 8D.
January 2014
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Diagnose the problem

Basic 5 times Why
The intent of asking "Five times Why is to assure that the root causes and
not symptoms are corrected.
The "Five-Why Process" was introduced at Toyota to find solution to
manufacturing problems, but this approach can be applied to any other area
as well.
Ask "Why this problem happened?" to discover its underlying problem then
ask "Why?" again to go deeper by another level until you reach the root cause.
Continuous
January
2014 Improvement
Quality Management
128
5 times Why
Why did the machine stop?
A fuse in the machine has blown
Why did the fuse blow?
Circuits overloaded
Why did the circuit overload?
The bearings have been damaged and locked up
Why have the bearings been damaged?
There was insufficient lubrication
Why was there insufficient lubrication?
The oil pump on the machine is not circulating enough oil
Why is the pump not circulating enough oil?
Pump intake is clogged with metal shavings
Why is the intake clogged with metal shavings?
There is no filter on the pump intake
Asking "why" repeatedly, possibly more than five times, directs the focus towards real
causes, so problems can be solved permanently.
Continuous
January
2014 Improvement
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D4 Use Problem Solving Tools to Diagnose

the probable Root Cause
Problem Analysis (PA) is used to find the true cause of a positive or

negative deviation.
When people, machinery, systems or processes are not performing as
expected, problem analysis provides a structured process to identify and verify
the cause.
The PA process describes the problem with a clear Problem Statement and
Problem Specification (IS / IS NOT).
Continuous
January
2014 Improvement
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130
IS / IS NOT
Continuous
January
2014 Improvement
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131
Six Sigma
The most complex and sophisticated
methodology, within Total Quality, for
problem solving and process improvements is
Six Sigma
January 2014
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QUALITY

Tools and Techniques used in Total

Overview of Total Quality Tools

The Pareto Chart

Overview of Total Quality Tools

Statistical Process Control (SPC)

Overview of Total Quality Techniques

Cause and Effect Diagram

Cause and Effect Diagram

Cause and Effect Diagram

Cause and Effect Diagram

Improper calibration Calculation

Cause and Effect Diagram

Cause and Effect Diagram

Cause and Effect Diagram

A correlation exists between two variables when

As the project time increases,

r is always between -1 and 1 (inclusive).

Correlation Coefficient - Examples

Note: r 0 means no linear relationship.

Correlation Coefficient Discussion

The correlation coefficient, r,

The correlation coefficient, r,

Run charts and Control charts

Data collected by measurements:

Run (p) chart

Upper and Lower Control Limit

= 0,04126 + 0,02679= 0,06839

LCL=0.0416 0,02679 = 0, 01481

Control (p) Chart

Control (p) Chart

Run (x) Chart

Range of Daily Production Cost per Week

Compute and plot the control

9:30 10:00 10:30 11:00

Compute and plot the control

9:30 10:00 10:30 11:00

Overview of Total Quality Tools

Statistical Process Control (SPC)

Overview of Total Quality Techniques

Statistical Process Control (SPC)

Statistical Process Control (SPC)

Statistical Process Control (SPC)

Collecting Data for an SPC Chart

Collecting Data for an SPC Chart

Creating a SPC Chart

SPC (X Bar and R) Chart

Interpretation of SPC charts

Interpretation of SPC charts

Interpretation of SPC charts

SPC and Process Capability

=> PROCESS CAPABILITY

Properties of the Normal Distribution

68% of parts will fall

95% of the parts will fall

99.73% of the parts will fall

Standard deviation (Sigma)

Standard deviation (Sigma)

The standard deviation of a statistical

Population vs sample standard

Specification Limits are

Specification limits are decided by people.

Process Capability Improvement