Statistical Method

Jakarta, 29-30 March,2016

Speaker: Heru Purnomo

1
Module Outline

• PART 1: Introduction
• PART 2: Capability Studies
• PART 3: Cp, Cpk and Six Sigma
• PART 4: Use of Capability Studies
• PART 5: Technical Considerations
• PART 6: Control Charts
• PART 7: Use of control chart
• PART 8: Overview of Statistic Application
 PART 1:

Introduction
What is Statistical Process Control?

• A tool that allows us to manufacture products per our customer’s

requirements on a consistent basis. This is achieved by preventing
defects at each stage of the manufacturing process.

• By itself will not insure our products, processes and services meet our
customer’s expectation. Therefore, we assume that all initial work has
been done to meet those requirements such as:
– Establishment of specification
– Process Characterization
– Standards and SOPs
– Validation
– Training
Where should we use SPC?

• Use as a Method for Preventing Defects

• Use With the Assumptions that Requirements Have

Already Been Established:
– Customer
– Process
– Product
So, how do we prevent defects, and build products,
processes and provide services with consistently good
quality?

To answer this question, we will use a hypothetical filling

operation to illustrate various methods of preventing defects.
How Does One Prevent Defects?

?
Two Possible Causes

Cap Fell Off Due

to Low Cap Never Put
Removal Force Onto Vial
CAP NEVER PLACED ONTO VIAL

• This is an Error in the form of an Omission.

• Errors are Prevented by Mistake Proofing.

• Mistake Proofing means ensuring that the defects either

cannot occur or cannot go undetected.

Reference
Shingo, Shigeo (1986). Zero Quality Control: Source Inspection and the Poka-yoke System. Productivity
Press, Cambridge, Massachusetts.
Low Removal Forces

• Removal Force is Affected by Many Factors.

• Having low removal forces is an Optimization (Targeting) and Variation

Reduction problem.

• Low removal forces are prevented by identifying and controlling the key
inputs and establishing proper targets and tolerances.

Reference
Taylor, Wayne A. (1991). Optimization and Variation Reduction I Quality. McGraw-Hill, New York and
ASQC Quality Press, Milwaukee.
Optimization & Variation Reduction
(O.V.R)
Target

Lower Upper
Spec Spec
Limit Limit
Typical O.V.R Problems
Larger the Better
Lower
Spec
Limit

Target
Smaller the Better Upper
Spec
Limit
• microbial level
• particulate level
• contamination level

Closer to the target the Better

Target
Lower Upper
• Vial fill volume Spec Spec
• Potency, Assay Limit Limit
Two Approaches to Preventing
Defects

• Mistake Proofing

• Optimization and Variation Reduction

Reducing Variation

“ If I had to reduce my message for management to

just a few words, I’d say it all had to do with
reducing variation.”

W. Edward Deming
Tools for SPC

• SPC provides two tools for reducing variation:

1) Control Charts
2) Capability Study

• The primary tool for managing variation is the capability

study.

• An effective program for reducing variation must also

incorporate many other tools including:
 Design Experiments
 Variation Decomposition Methods
 Taguchi’s Methods
Statistical Variation
The differences, no matter how small, between ideally identical units
of product.

2.3 ml

DIFFERENCES

0.9 ml 1.4 ml
Displaying Variation

Histogram of Removal Force of the cap cover of Sterile Injection

5
Number Measured

0
21.6 22.4 23.2 24.0
Cap Removal Force in PSI
The Bell-Shaped Curve
Normal
Curve

21.6 22.4 23.2 24.0

We use the Normal Curve to Model systems having expected outcomes or goals….
The Standard Normal Curve
• Contains an Area equal to One
• Corresponds to 100% of ALL possible Outcomes in a Stable System.
• Has a Mean = 0, and SD = 1

• Total Area = 1

-3 -2 -1 1 2 3
Standard Deviations from the Mean
A STABLE PROCESS
Total
Variation

Slide 20
AN UNSTABLE PROCESS
• Total
Variation

Slide 21
A CAPABLE PROCESS
CAPABLE

Spec
Limits

NOT
CAPABLE

Slide 22
Objective of SPC
To consistently produce high quality
products by achieving stable and
capable processes.

Slide 23
 WHY
REDUCE
VARIATION?

Slide 24
 Reducing Variation Reduces Defects

Lower Upper Lower Upper

Spec Spec Spec Spec
Limit Limit Limit Limit

GOOD GOOD
PRODUCT PRODUCT

•Defective Product •No Defective Product

Slide 25
 Reducing Variation Widens
Operating Windows

Lower Upper Lower Upper

Spec Spec Spec Spec
Limit Limit Limit Limit

Initial Operating Window Wider Operating Window

Slide 26
 Reducing Variation Improves
Customer Value
Target Upper
Lower
$20 Spec
Spec
Limit Limit

L
O GOOD Bad
Bad
S $10 PRODUCT Product
Product
S

$0 •Taguc
hi’s
Target
Lower Loss
$20 Upper
Spec
Spec
Limit
Limit

L
O
S $10

S Loss equals value

$0

Slide 27
 Better Management
• Provides facts on process performance to allow:
 Prioritized improvement projects
 Tracking progress
 Demonstrating results
• Provides data on process capability required in
product design.
• Better management of suppliers.

Slide 28
 Maximize Process Capability
• Replace existing equipment only if necessary.
• Improve capability make new product feasible.

Slide 29
 Benefits of SPC
• Fewer Defects
• Wider Operating Windows
• Higher Customer Value
• Better Management
• Maximize Process Capability

Slide 30
 PART 2:
Capability Studies

Slide 31
Variation Reduction Tools

• There are many tools that help to achieve

stable and capable processes:
 Scatter Diagrams
 Screening Experiments
 Multi-Vari Charts
 Analysis of Means (ANOM)
 Response Surface Studies
 Variation Transmission Analysis
 Component Swapping Studies
 Taguchi Methods
 Control Charts & Capability Studies

Slide 32
 Capability Study
• Determines if a Process or System is Stable and
Capable i.e., can it consistently make good product.
• Can Measures the Progress and Success achieved
after changes or improvement
Pre-Capability
Study

Variation
Reduction Tool

Post Capability
Study

Slide 33
 Capability Study
Process capability measures statistically summarize
how much variation there is in a process relative to
costumer specifications.

Too much variation Hard to produce output within Low index value
costumer requirement (e.g. Cpk < 0.5)
(specification) (Process sigma between 0 and 2)

Moderate Variation Most output meets costumer Middle index value

requirement (Cpk between 0.5 and 1.2)
(Process sigma between 3 and 5)

Very little variation Virtually all of output meets High index value
costumer requirements (Cpk > 1.5)
(Process sigma 6 or better)

Slide 34
Short-Term vs Long Term Sigma
Long-Term Sigma
This is the variation is due to both common and special
causes. This variation is calculated based on all of
individual readings (population). Used for Pp and Ppk
calculations

Short-Term Sigma
This variation is due to common causes only. This
variation is estimated from the control chart data. Used for
Cp and Cpk calculations

35
Cp and Cpk vs. Pp and Ppk
• These metrics are calculated the same way, but they
use a different way to estimate standard deviation
• Cp and Cpk are considered “short-term” measures
R
 The estimated StDev (Within) is average of d 2 for
each subgroup
• Pp and Ppk are considered “long-term” measures
 The estimated StDev (Overall) is calculated using
the standard deviation (n-1) for all the data set
points
The conservative approach is to report whichever set of statistics is
smaller. Typical data sets are usually too small to be able say with
certainty that one metric is better than the other.

36
 Process Capability Ratio – Cp (Cont.)
Allowed variation (spec .) USL - LSL
Cp = •or Cp =
Normal variation of the process 6σ
Where σ is “within”
rather than pooled
99.73% of values

-3σ +3σ

Process Width

LSL T USL

37
Subgroup Measured Values Average Std. Dev.
1 52.0 52.1 53.0 52.3 51.7 52.22 1.3
2 51.7 51.5 52.0 51.7 51.3 51.64 0.7
3 51.7 52.2 51.9 52.6 52.5 52.18 0.9
4 51.3 52.2 51.8 52.5 51.4 51.84 1.2
5 50.8 50.9 51.7 51.8 51.4 51.32 1.0
6 52.6 51.4 52.9 52.6 52.4 52.38 1.5
7 53.0 52.9 52.5 52.5 51.8 52.54 1.2
8 52.5 52.7 51.2 53.7 51.3 52.28 2.5
9 51.9 51.6 51.6 52.7 51.7 51.90 1.1
10 52.2 52.7 52.3 51.8 53.2 52.44 1.4
11 52.4 52.6 52.1 51.8 51.9 52.16 0.8
12 51.3 51.2 51.9 53.1 52.9 52.08 1.9
13 51.7 51.6 51.4 51.4 51.1 51.44 0.6
14 51.8 51.0 52.4 51.2 51.6 51.60 1.4
15 52.0 51.7 52.6 51.8 52.7 52.16 1.0
16 52.0 52.3 51.8 52.0 51.5 51.92 0.8
17 51.8 51.8 51.8 51.9 52.0 51.86 0.2
18 52.0 51.9 51.4 51.8 53.3 52.08 1.9
19 51.5 52.6 52.8 52.4 52.0 52.26 1.3
20 51.5 51.8 50.8 51.3 52.5 51.58 1.7
51.99 1.22

38
 Is the process Stable?
Control Chart for Average and Range
53.0 UCL=53.043

52.5
Individual Value

_
52.0 X=51.994

51.5

51.0 LCL=50.945
1 3 5 7 9 11 13 15 17 19 21
Observation

UCL=1.289
1.2

0.9
Moving Range

0.6
__
MR=0.394
0.3

0.0 LCL=0
1 3 5 7 9 11 13 15 17 19 21
Observation

Slide 39
Is the process Capable?
Histogram of H1

20
• LS • US
L L
15
Frequency

10

0
50 51 52 53 54 55
H1

Potential
Capability Cp = 1.55

Actual
Capability Cpk = 1.23

Slide 40
 Calculating the Grand Average
• If Χ1,Χ2,… ,Χ20 are the subgroup averages, the
grand average is:
X = Χ1+Χ2+… +Χ20 Grand
Average

20

e
m
Ti

Slide 41
 Calculating the Average Range
• If R1,R2,… ,R20 are the subgroup ranges, the
average range is:
R = R1+R2+… +R20
20
• Estimates the average within the subgroup
variation.

Slide 42
 Between and Within Subgroup Variation

Total
Variation

Between Subgroup
Variation
Within Subgroup
Variation

Other names for within subgroup variation:

• Noise
• Unexplained
• Inherent
• Error

Slide 43
Process Capability Ratio – Cp
• Ratio of total variation allowed by the specification to the total
variation actually measured from the process
• Use Cp when the mean can easily be adjusted (i.e., plating,
grinding, polishing, machining operations, and many
transactional processes where resources can easily be added
with no/minor impact on quality) AND the mean is monitored
(so operator will know when adjustment is necessary – doing
control charting is one way of monitoring)
• Typical goals for Cp are greater than 1.33 (or 1.67 if of
considerable importance)

If Cp < 1 then the variability of the process

is greater than the specification limits.

44
Different Levels of Cp
LSL USL
The Cp index reflects the
Cp = 1
potential of the process if
the mean were perfectly
centered between the
specification limits.

Cp > 1 The larger the Cp index, the better!

USL − LSL
Cp =
6σ

For a Six Sigma Process,

Cp < 1
Cp = 2

45
Process Capability Ratio – Cpk
This index accounts for the dynamic mean shift in the
process – the amount that the process is off target.

USL − x x − LSL 
C pk = Min  or  •Where σ is “within”
 3σ 3σ  rather than pooled

Calculate both values and report the smaller number.

Notice how this equation is similar to the Z-statistic.

46
 Process Capability Ratio – Cpk (Cont.)
• Ratio of the distance to the closest spec to ½ of the estimated process variation
• Use when the mean cannot be easily adjusted (i.e., stamping, casting,
plastics molding)
• Typical goals for Cpk are greater than 1.33 (or 1.67 if of considerable
importance)
• For sigma estimates use:
• R/d2 [short term] (calculated from X-bar and R chart) – use with Cpk

• s = Σ (xi -x) 2 [ “longer” term] (calculated from (n-1) data points) – use
with Ppk
n-1
• “Longer” term: When the data has been collected over a sufficient time period
that over 80% of the process variation is likely to be included

47
 Actual Process Performance (Cpk)
Unlike the Cp index, the Cpk index takes into account off-centering of the
process. The larger the Cpk index, the better.

LSL USL LSL USL

6σ 6σ

Cp = 1 Cp = 1
Cpk = 1 Cpk < 1

48
 Calculating Cp, Cpk and Pp, Ppk
How did Minitab calculate these values?
•Process Capability Analysis for Supp1
LSL USL
Process Data
USL 602.000
Within
Target *
LSL 598.000 Overall
Mean 599.548
Sample N 100
StDev (Within) 0.576429
StDev (Overall) 0.620865

Potential (Within) Capability Cp and Cpk values are calculated based on estimated
Cp
CPU
1.16
1.42
StDev(Within).
CPL
Cpk
0.90
0.90
The minimum of CPU (capability with respect to USL) and
Cpm *
CPL
598 (capability 599 with respect
600 to LSL) 601 is the Cpk 602.

Overall Capability
IfObserved
a target is entered,
Performance
then Cpm, Taguchi’s
Exp. "Within" Performance
capability index,
Exp. "Overall" Performance
Pp 1.07 is <also
PPM LSL calculated.
10000.00 PPM < LSL 3621.06 PPM < LSL 6328.16
PPU 1.32 PPM > USL 0.00 PPM > USL 10.51 PPM > USL 39.19
PPL 0.83 Cp and Cpk values are considered to be “short term.”
PPM Total 10000.00 PPM Total 3631.57 PPM Total 6367.35
Ppk 0.83

49
Cp, Cpk vs. Pp, Ppk
How did Minitab calculate these values?
If the Cp and Pp values are significantly different this is an
•Process Capability Analysis for Supp1
Process Data
indication
LSL of an out of control process. USL
USL 602.000
Within
Target *
LSL 598.000 Overall
Mean 599.548
Sample N 100
StDev (Within) 0.576429
StDev (Overall) 0.620865

Potential (Within) Capability

Cp 1.16
CPU 1.42

Pp and Ppk values are calculated based on estimated

CPL 0.90
Cpk 0.90

Cpm *
StDev(Overall).
598 599 600 601 602

Overall Capability The

Observedminimum
Performance of Ppu
Exp. (capability
"Within" Performance with Exp. respect to USL) and
"Overall" Performance
Pp
PPU
1.07
1.32
P pl (capability
PPM < LSL
PPM > USL
10000.00
0.00
with respect
PPM < LSL
PPM > USL
to LSL)
3621.06
10.51
is the
PPM < LSL
PPM > USL
P pk . 6328.16
39.19
PPL
Ppk
0.83
0.83
Pp and Ppk values are considered to be “longer term.”
PPM Total 10000.00 PPM Total 3631.57 PPM Total 6367.35

50
 PART 3:
Cp, Cpk and Six Sigma

Slide 51
 Process Should be Stable before Checking Capability

UCL

LCL

NOT a Stable Process

UCL

LCL

A Stable Process
Slide 52
 Stable Process are Predictable!
Distance from Average
Percentage out of Spec.
(d)

LSL -5.0σ 0.3/million

d
-4.5σ 3.4/million
Individuals
Distribution -4.0σ 31/million
Percent out of
Spec -3.5σ 233/million

-3.0σ 0.135%

-2.5σ 0.6%

-3σ -2σ -1σ 0 1σ 2σ 3σ -2.0σ 2.3%

-1.5σ 6.7%

-1.0σ 15.8%

-0.5σ 30.9%

0.0σ 50%

Slide 53
Cp
Compares the Specification Range to
the Width of the Process, (±3σ each
side of the mean):
Cp = USL-LSL
6S
USL

Cp = 0.5
Cp = 1 Cp = 1.5
Cp = 2

Cp Does Not Consider Centering LSL

Slide 54
 Cp = 1
±1.5σ
LSL USL

6.75%
Defective

• -3σ • 3σ
• 3 – Sigma Process

Allows a ±1.5σ operating window, worse case

is 6.7% defective.

Slide 55
 Cp = 1.5
±1.5σ
LSL USL

1350
Defects/Million

-4.5σ 4.5σ
4.5 – Sigma Process

Allows a ±1.5σ operating window, worse case

is 1350 defects per million.

Slide 56
 Cp = 2.0
±1.5σ
•LSL •USL

3.4
Defects/Million

-6σ 6σ
6 – Sigma Process

Allows a ±1.5σ operating window, worse case

is 3.4 defects per million.

Slide 57
 What has Changed?
±1.5σ
LSL USL

• 3 – Sigma Process

-3σ 3σ
±1.5σ
LSL USL

4.5 – Sigma Process

-4.5σ 4.5σ
±1.5σ
LSL USL

6 – Sigma Process

-6σ 6σ

Slide 58
Operating Windows
• Don’t forget to include them in your
process design.
• Stable process can hold a ±1.5σ operating
window.
• Automated processes may be able to hold
a ±1.0σ operating window.
• If a process is not stable, a ±1.5σ window
may not be enough room for the average.
Why?
UCL, LCL = X ± 3σ/√n
When, n = 5
then,
±3σ/√n = ±3σ/√5 = ±1.34σ

Slide 59
Cp Does Not Consider Centering

Cp = 2
LSL USL

-6σ 6σ

Slide 60
Determine Cpk
Distance from X to the nearest Spec
Cpk =
3S

X
LSL

3S

Average - LSL

Slide 61
Cpk = 1
USL

Cp = 1

LSL

Slide 62
Cpk = 2
USL

• Cp = 2

LSL

Slide 63
 Cpk When Cp = 2

USL
• Cpk = 1/2
Cpk = 1
• Cpk = 1.5
• Cpk = 2.0
• Cpk = 1.5
Cpk = 1
Cpk = 1/2

LSL
Fix the variability, then move the average

When the process is perfectly centered,

Cpk = Cp.

Slide 64
Interpreting Cpk
Table below gives the corresponding defect level of
various Cpk’s with Cp = 2.0:

Cpk Defect Level

1.5 3.4 dpm

1.167 233 dpm

1 1350 dpm

0.83 0.6%

0.5 6.7%

Slide 65
 PART 4:
Use of Capability Studies

Slide 66
 Uses of Capability Study
• Identifying processes needing improvement.
• Tracking process performance.
• Verifying the effectiveness of fixes.
• Determining the ability of suppliers to consistently make
good product.
• Qualifying new equipment.
• Determining the manufacturability of new product.

Slide 67
 Identifying Processes Needing Improvement
• Unstable processes of processes with poor Cp’s and/or
Cpk’s are target for improvements.
• If the process is unstable it is a good candidate for control
chart.
• If the process is stable, but not capable, one should first
look for obvious sources of variation.
• If no obvious sources exist, then you should perform
designed experiments to uncover them.

Slide 68
Verifying Effectiveness of Fixes
• Use a capability study to demonstrate the
effectiveness of fixes.
• New estimates of Cp and Cpk should be at least
15% greater than the pre-fix estimates.
• True changes are unlikely when pre and post
capability estimates are within ± 15% of each
other.

Slide 69
Assessing the performance of Suppliers
• Materials and components from our suppliers make up one
or more inputs in our manufacturing process.
• Our final quality is only as good as our supplier’s quality.
• All suppliers need to provide good product on a consistent
basis.
• “Consistency” requires a stable process of manufacturing.
• If the process is not stable, the products produced will not
be stable in quality.
• “Stability” can only be assessed by looking at time ordered
samples.
Slide 70
Qualifying New Equipment
• Want to demonstrate the equipment can
consistently make good products.
• Should use a capability study to demonstrate
“consistency”.
• Consider requesting a capability study when
purchasing a new equipment.

Slide 71
Determining the Manufacturability of New
Product
• Capability studies measure the match between
product specifications and process variation.
• A process may be capable of manufacturing one
product, but not another.
• For new products, use capability studies to
determine how well the product design adapts to
the manufacturing process.
Slide 72
 PART 5:
Technical Considerations

Slide 73
 The Normality Assumption
• Common Misconception:
“The data has to be normally distributed to be
control charted”

• Control charts work well even when the data are not
normally distributed.
• The normality assumption was originally introduced from the
control chart constants, i.e. d2, A2, D4, etc,
• Even the control chart constants do not change appreciably
when the data are non-normal*.

Slide 74
Why 3 Standard Deviation Limits?
• Not established solely on the basis of probability theory.
• Outcomes in most stable processes generally occur
between ±3 S.D.’s from the average.
• Originally designed to minimize the time looking
unnecessarily for shifts in the process average.
• Additionally concerned with missing an actual process shift
as it occurs.

Slide 75
Rational Sub grouping
• Organizing the data into rational subgroups allows
us to answer the right questions.
• The variation occurring within the subgroups is
used to set the control limits.
• The control chart uses the within subgroup
variation to place limits on how much variation
should naturally exist between subgroups.

Slide 76
Rational Sub grouping
Some Guidelines:
• Try not to place unlike things together into the same
subgroups.
• Organize in a way that produces the lowest variation within
each subgroup.
• Maximize the opportunity to observe the variation between
subgroups.

Slide 77
 PART 6:
Use of Control Charts

Slide 78
Control Charts
Control charts are one of the most commonly
used tools in our Lean Six Sigma toolbox
• Control charts provide a graphical picture of the
process over time
• Control charts are both practical and easy-to-use
• Control charts help us establish a measurement
baseline from which to measure improvements

79
What Do Control Charts Tell Us?
• When the process location has shifted
• When process variability has changed
• When special causes are present
• Process not predictable
• A learning opportunity
• When no special causes are present
• Process is predictable
• No clues to improvement available; may need to
introduce a special cause to effect a change
Control charts tell you when, not why

80
 Why Use a Control Chart?
• Statistical control limits are another way to separate common cause and
special cause variation
• Points outside statistical limits signal a special cause
• Can be used for almost any type of data collected over time
• Provides a common language for discussing process performance

When To Use:
• Track performance over time
• Evaluate progress after process changes/improvements
• Focus attention on process behaviour
• Separate “signals” from “noise”

81
Control Chart Selection
• Control chart selection should be based
upon:
• Data type
• Number of observations
• Sample size
• Subgrouping
• The primary determinant in control chart
selection is Data Type

82
Data Types
• There are many different types of data
• Each type of data has its own unique control chart
• The basic format and underlying concepts are the same
across the entire family of control charts
• A basic understanding of the different data types is
important to increase the successful use of control charts
• How many different types of data are there?

83
Two General Kinds of Data
• Attribute – The data is discrete (counted).
Results from using go/no-go gages, or from the
inspection of visual defects, visual problems,
missing parts, or from pass/fail or yes/no
decisions
• Variable – The data is continuous (measured).
Results from the actual measuring of a
characteristic such as diameter of a hose,
electrical resistance, weight of a vehicle, etc.

84
Continuous Data
• Continuous data is a set of numbers that can potentially take on any
value
• Also known as variable data
• Examples: 0.1, 1/4, 20, 100.001, 1,000,000, -3.26, -10,000
• Common Applications
• Dimensions (lengths, widths, weight, etc)
• Time (seconds, minutes, hours, etc)
• Finance (mills, cents, dollars, etc)
• Distribution Types
• Normal
• Uniform
• Exponential
• Because continuous data has more discrimination, go for continuous
data whenever possible

85
Control Charts for Individual Values
Time ordered plot of results (just like time plots)
Statistically determined control limits are drawn on the plot.
Centerline calculation uses the mean

53.0 UCL=53.043
LCL= X + 2.66mR

52.5
Centerline = X
52.0 Avg=51.99

UCL= X + 2.66mR
51.5

51.0
LCL=50.945

2 4 6 8 10 12 14 16 18 20
Index

86
 Attribute Data
• Attribute data has two main subsets, Binary data and Discrete
Data
• Binary Data is a characterized by classifying into only two
outcomes
• Examples: Pass/Fail, Agree/Disagree, Win/Loss,
defective/conforming
• Common uses: Proportions and ratios
• Distribution: Binomial
• Key assumptions
• Events are independent of each other
• Mutually exclusive outcomes
• Number of trials and outcomes of each trial is known

87
Attribute Data (Cont.)
• Discrete Data is a set of finite outcomes, usually
integers, and is measured by counting
• Also known as Ordinal data
• Common uses and examples:
• Number of product defects per item
• Number of customer requirements per order
• Number of accounting errors per invoice
• Distribution: Poisson
• Poisson characteristics and assumptions
• Unlimited number of defects per item
• Constant probability of defect per item
• Probability of defect per unit is low
• Defects are independent of each other

88
 Control Chart Selection Tree
TYPE OF DATA

Count or Classification Measurement

(Attribute Data) (Variable Data)

Count Classification

Defects or Defectives or
Nonconformance Nonconforming Units

Fixed Variable Fixed Variable Subgroup Subgroup Subgroup

Opportunity Opportunity Opportunity Opportunity Size of 1 Size < 9 Size > 9

C Chart U Chart NP Chart P Chart I -m R X-bar R X-bar S

PoissonDistribution
•Poisson Distribution BinomialDistribution
•Binomial Distribution Normal
•Normal Distribution
Distribution

89
Individuals and Moving Range
Charts
• Display variables data when the sample subgroup size is
one (And in certain situations, attribute data)
• Variability shown as the difference between each data
point (i.e., moving range)
• Appropriate Usage Situations:
• When there are very few units produced relative to the opportunity for process
variables (sources of variation) to change
• When there is little choice due to data scarcity
• When a process drifts over time and needs to be monitored

• I-mR is a good chart to start with when evaluating

continuous data
90
Calculations for Individuals Charts
1. Determine sampling plan
2. Take a sample at each specified interval of time
3. Calculate the moving range for the sample. To calculate each moving
range, subtract each measurement from the previous one. There will be
no moving range for the first observation on the chart
4. Plot the data (both individuals and moving range)
5. After ‘30' or more sets of measurements, calculate control limits for moving
range chart
6. If the Range chart is not in control, take appropriate action
7. If the Range chart is in control, calculate limits for individuals chart
8. If the Individuals chart is not in control, take appropriate action

91
Why Use Subgroups?

It allows us to examine both within

sample variation and between sample
variation

92
 X-Bar & R Chart
• The X-bar & R chart is the most commonly used control chart due to its use of
subgroups and the fact that it is more sensitive than the ImR to process shift
• Consists of two charts displaying Central Tendency and Variability
• X-bar Chart
• Plots the mean (average value) of each
subgroup
• Useful for identifying special cause changes
to the process mean (X)
• X-bar control limits based on +/- 3 sigma
from the process mean are calculated
using the Range chart
• R Chart
• Displays changes in the "within" subgroup dispersion of the process
• Checks for constant variation within subgroups

93
 Calculations for X-Bar & R Charts
1. Determine an appropriate subgroup size and sampling plan
2. Sample: (Take a set of readings at each specified interval of time)
3. Calculate the average and range for each subgroup
4. Plot the data. (Both the averages and the ranges)
5. After ‘30' or more sets of measurements, calculate control limits for the
range chart
6. If the range chart is not in control, take appropriate action
7. If the range chart is in control, calculate control limits for the X-bar chart
8. If the X-bar chart is not in control, take appropriate action

94
 Rational Subgrouping
• An important consideration in using the X-bar & R (and X-bar & S) chart
is the selection of an appropriate subgroup size
• Rational Subgrouping is the process of selecting a subgroup based
upon “logical” grouping criteria or statistical considerations
• Subgrouping Examples
• “Natural” Breakpoints:
• 3 shifts grouped into 1 day;
• 5 days grouped into 1 week,
• 10 machines grouped into 1 dept
• Wherever possible, both natural breakpoints and homogenous group
considerations should be combined together in selecting a sample size

95
Attribute Control Charts
• Attribute control charts are similar to variables
control charts, except they plot proportion or count
data rather than variable measurements
• Attribute control charts have only one chart which
tracks proportion or count stability over time
• Chart Types
• Binomial: P chart, NP chart
• Poisson: C chart, U chart

96
Attribute Control Charts
• Binomial Distribution Charts
• Use one of the following charts when comparing a product to a
standard and classifying it as being defective or not (pass vs. fail):
• P Chart – Charts the proportion of defectives in each subgroup
• NP Chart – Charts the number of defectives in each subgroup

• Poisson Distribution Charts

• Use one of the following chart when counting the number of defects
per sample or per unit
• C Chart – Charts the defect count per sample (must have the same
sample size each time)
• U Chart – Charts the number of defects per unit sampled in each
subgroup (using a proportion so sample size may vary)

97
 PART 7:
Use of Control Charts

Slide 98
Uses of Control Charts

• Evaluation

• Improvement

• Maintenance

Slide 99
Uses of Control Charts

• Evaluation: Determine if the process is both stable

and capable, as part of a capability study.

• Improvement

• Maintenance

Slide 100
Uses of Control Charts

• Evaluation

• Improvement: Identify changes to the process so

that the causes may be investigated and
eliminated.

• Maintenance

Slide 101
Improvement
• Control Charts search for differences over time.
• Observing a change on the control charts means a key
input variable has changed.
• The pattern observed on the control chart provides clues
about the key variable that changed:
• Timing of the change
• Shape or pattern
• Trends
• Jumps or shifts

Slide 102
Maintenance
• Control charts can help us to decide when to make
adjustments to the process.
• Using control charts we can make better decisions, and
minimize the chance of making two possible errors:.
• 20% - Failing to adjust when the process needs adjustments
• 80% - adjusting when the process does not need adjustment

• When maintaining processes using control charts, try to

center the average around the desired target.

Slide 103
 Statistical Step to Establish Control Limit
1. Collect the data 30 or more
2. Prepare Individual moving range chart (I-MR) using appropriate
statistical software
3. Review the moving range chart, if any data point beyond are beyond
the UCL, the data the data point must be evaluated and excluded if
there is an assignable cause, then replot the moving range chart.
4. Review the individual chart, if any data point beyond are beyond the
UCL and LCL, the data the data point must be evaluated and excluded
if there is an assignable cause, then replot the individual chart.

Slide 104
Real Time Evaluation
Rule 1 The data outside of control limit: One point of outside the
control limit

56

55

54

53 UCL=53.043

52 Avg=51.99

51 LCL=50.945

2 4 6 8 10 12 14 16 18 20
Index

105
Real Time Evaluation
Rule 2 Trend Shift: 8 consecutive point on same side of center line

UCL=53.043
53.0

52.5

52.0 Avg=51.99

51.5

51.0
LCL=50.945

3 6 9 12 15 18 21 24 27
Index

106
Real Time Evaluation
Rule 3 Trend drift: 6 consecutive points that trend in the same
direction (all increasing or all decreasing)

53.0 UCL=53.043

52.5

52.0 Avg=51.99

51.5

51.0
LCL=50.945

3 6 9 12 15 18 21 24
Index

107
 PART 8:
Minitab Exercise

Slide 108
 Opening a new project in Minitab

Menu bar

Toolbars
Session
window

Data window
Project
Manager
window
(minimized)

109
Overview of Minitab
Worksheet
• Each Minitab worksheet can contain up to 4,000
columns, each column is identified by a number
• The letter after the column number indicates the
data type:
D : date / time
T : text (alphanumeric)

If no letter appears, the data are numeric

110
Example 1

Problem
Supervisor of medical company is preparing a sales report for a
new line of facial cream that the company intends to distribute
nationally. In a pilot launch, the company sold facial cream at
various stores in Jakarta and Bandung for three months.

Data Collection
The supervisor recorded the daily revenue for two locations
during the three months and stored them in minitab project

111
Example 1

Tools
• Dotplot
• Time Series Plot
• Graphical Summary
• Display Descriptive Statistics
• Layout Tools

112
Open Project
1. Choose File > Open project
2. Choose ISPE_Example 1.MPJ.
3. Click open.

113
Creating Dotplots
• Choose Graph > Dotplot
• Complete the dialog as shown below, then click OK

• In graph variable, enter ‘Jakarta Sales’ and ‘Bandung Sales’

by highlighting them and double clicking each variable, then
click OK

114
Interpreting your result
The graph shows the sales data during the three month period
for both location. On average, Bandung sales appear higher
than Jakarta sales.

115
Correcting the Outlier
After checking with the person who entered the data, your
discover that the sales information for data n=20 is missing.
Instead of entering 0, you should enter an asterisk (*) to indicate
that the value is missing.
• Click project manager toolbar
• In the Bandung column, highlight the cell in column 3 and
row 20 as show below.

• Press [DELETE]

116
Updating a graph
• To choose the dotplot, click in the project manager toolbar
• Click the graph to make it the active window
• Choose Editor > Update > Update graph now

117
Time Series Plot
• Choose Graph > Time Series Plot
• Choose Multiple, then click OK
• In series, enter ‘Jakarta Sales’ ‘Bandung Sales’
• Click Time / Scale
• Complete the dialog as shown below

118
119
Graphical Summary
• Choose Stat > Basic Statistic > Graphical Summary
• Complete the dialog as shown below

120
121
Display Descriptive Statistic
• Choose Stat > Basic Statistic > Display Descriptive
Statistics.
• In variable, enter ‘Jakarta Sales’ ‘Bandung Sales’
• Click statistics
• Complete the dialog box as shown below, then click OK

122
123
Creating a multiple graph
• Click graph folder, then click the dotplot in the project
manager. Click the graph to make it the active window.
• Choose Editor > Layout tool
• Double click all graph have been created to place the graph
in the layout window.

124
125
Example 2
Problem
The validation supervisor want to evaluate the consistency of
the fill weight for hydrocortisone cream. The cream is packed in
tube. The target weight is 1150grams. The specification limit are
1100 and 1200 grams.
Earlier evidence indicate this process is stable with a mean of
1150 grams and a standard deviation of 8.6 grams

Tools
I-MR

126
I-MR
• Open ISPE_Example 2.MPJ
• Choose Stat > Control Charts > Variable Charts for
Individuals > I-MR
• Complete the dialog box as shown below

127
I-MR
• Click Scale, under X scale, choose stamp
• Under Stamp columns, enter date/time. Click OK
• Click I-MR Options.
• In Mean, type 1150; in standard deviation type 8.6, then click
OK

128
Individual chart shows that the process is clearly not in
statistical control also process operated consistently above the
mean.

129
Next Step
Remove mean then replot the I-MR Chart

130
Example 3
Problem
With previous data analyse normality and capability process

Tools
Probability
Capability Six Pack

131
Probability Plot
• Open ISPE_Example 2.MPJ
• Choose Grap > Probability Plot > Single
• Complete the dialog box as shown below
• Complete dialog as shown below

132
Normality Check
• Check normality data (P>0.05)

Probability Plot of Fill Weight

Normal - 95% CI
99.9
Mean 1164
Normal Data
99
StDev 8.576
N 60 P > 0.05
AD 0.293
95 P-Value 0.591
90
80
70
Percent

60
50
40
30
20
10
5

0.1
1130 1140 1150 1160 1170 1180 1190 1200
Fill Weight

133
Capability Analysis
• Open ISPE_Example 2.MPJ
• Choose Stat > Quality Tools > Capability Analysis
• Complete the dialog box as shown below
• Complete dialog as shown below

134
Capability Analysis

• Cp/Cpk > 1.33

Process Capability Report for Fill Weight

LSL USL
Process Data Overall
LSL 1100 Within
Target *
USL 1200 Overall Capability
Sample Mean 1163.58 Pp 1.94
Sample N 60 PPL 2.47
StDev(Overall) 8.57554 PPU 1.42
StDev(Within) 8.34686 Ppk 1.42
Cpm *
Potential (Within) Capability
Cp 2.00
CPL 2.54
CPU 1.45
Cpk 1.45

1110 1125 1140 1155 1170 1185 1200

Performance
Observed Expected Overall Expected Within
PPM < LSL 0.00 0.00 0.00
PPM > USL 0.00 10.81 6.39
PPM Total 0.00 10.81 6.39

135
Summary

• Understand basic principle statistic

• Know important parameter
• Know variation and trending
• Know proper tools for data evaluation
• Combine data statistic and product
knowledge

136
137