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ISPE Statistical Method PDF
ISPE Statistical Method PDF
COM
Statistical Method
Jakarta, 29-30 March,2016
Speaker: Heru Purnomo
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FITHRUL FARMASIINDUSTRI.COM
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
FITHRUL FARMASIINDUSTRI.COM
PART 1:
Introduction
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• 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
FITHRUL FARMASIINDUSTRI.COM
?
FITHRUL FARMASIINDUSTRI.COM
Reference
Shingo, Shigeo (1986). Zero Quality Control: Source Inspection and the Poka-yoke System. Productivity
Press, Cambridge, Massachusetts.
FITHRUL FARMASIINDUSTRI.COM
• 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.
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Lower Upper
Spec Spec
Limit Limit
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Target
Smaller the Better Upper
Spec
Limit
• microbial level
• particulate level
• contamination level
Target
Lower Upper
• Vial fill volume Spec Spec
• Potency, Assay Limit Limit
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• Mistake Proofing
Reducing Variation
W. Edward Deming
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Statistical Variation
The differences, no matter how small, between ideally identical units
of product.
2.3 ml
DIFFERENCES
0.9 ml 1.4 ml
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Displaying Variation
5
Number Measured
0
21.6 22.4 23.2 24.0
Cap Removal Force in PSI
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We use the Normal Curve to Model systems having expected outcomes or goals….
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• Total Area = 1
-3 -2 -1 1 2 3
Standard Deviations from the Mean
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A STABLE PROCESS
Total
Variation
Slide 20
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AN UNSTABLE PROCESS
• Total
Variation
Slide 21
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A CAPABLE PROCESS
CAPABLE
Spec
Limits
NOT
CAPABLE
Slide 22
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Objective of SPC
To consistently produce high quality
products by achieving stable and
capable processes.
Slide 23
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WHY
REDUCE
VARIATION?
Slide 24
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GOOD GOOD
PRODUCT PRODUCT
Slide 25
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Slide 26
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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
$0
Slide 27
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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
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Slide 29
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Benefits of SPC
• Fewer Defects
• Wider Operating Windows
• Higher Customer Value
• Better Management
• Maximize Process Capability
Slide 30
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PART 2:
Capability Studies
Slide 31
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Slide 32
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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
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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)
Very little variation Virtually all of output meets High index value
costumer requirements (Cpk > 1.5)
(Process sigma 6 or better)
Slide 34
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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
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-3σ +3σ
Process Width
LSL T USL
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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
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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
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20
e
m
Ti
Slide 41
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Slide 42
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Total
Variation
Between Subgroup
Variation
Within Subgroup
Variation
Slide 43
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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.
USL − LSL
Cp =
6σ
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USL − x x − LSL
C pk = Min or •Where σ is “within”
3σ 3σ rather than pooled
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• 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
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6σ 6σ
Cp = 1 Cp = 1
Cpk = 1 Cpk < 1
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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
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Cpm *
StDev(Overall).
598 599 600 601 602
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PART 3:
Cp, Cpk and Six Sigma
Slide 51
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Process ShouldFARMASIINDUSTRI.COM
be Stable before Checking Capability
UCL
LCL
LCL
A Stable Process
Slide 52
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-3.0σ 0.135%
-2.5σ 0.6%
-1.5σ 6.7%
-1.0σ 15.8%
-0.5σ 30.9%
0.0σ 50%
Slide 53
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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
Slide 54
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Cp = 1
±1.5σ
LSL USL
6.75%
Defective
• -3σ • 3σ
• 3 – Sigma Process
Slide 55
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Cp = 1.5
±1.5σ
LSL USL
1350
Defects/Million
-4.5σ 4.5σ
4.5 – Sigma Process
Slide 56
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Cp = 2.0
±1.5σ
•LSL •USL
3.4
Defects/Million
-6σ 6σ
6 – Sigma Process
Slide 57
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What has Changed?
±1.5σ
LSL USL
• 3 – Sigma Process
-3σ 3σ
±1.5σ
LSL USL
-4.5σ 4.5σ
±1.5σ
LSL USL
6 – Sigma Process
-6σ 6σ
Slide 58
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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
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Cp = 2
LSL USL
-6σ 6σ
Slide 60
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Determine Cpk
Distance from X to the nearest Spec
Cpk =
3S
X
LSL
3S
Average - LSL
Slide 61
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Cpk = 1
USL
Cp = 1
LSL
Slide 62
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Cpk = 2
USL
• Cp = 2
LSL
Slide 63
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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
Slide 64
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Interpreting Cpk
Table below gives the corresponding defect level of
various Cpk’s with Cp = 2.0:
1 1350 dpm
0.83 0.6%
0.5 6.7%
Slide 65
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PART 4:
Use of Capability Studies
Slide 66
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Slide 67
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Slide 71
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PART 5:
Technical Considerations
Slide 73
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• 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
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Slide 75
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Slide 76
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Slide 77
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PART 6:
Use of Control Charts
Slide 78
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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
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When To Use:
• Track performance over time
• Evaluate progress after process changes/improvements
• Focus attention on process behaviour
• Separate “signals” from “noise”
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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?
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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
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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
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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
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Count Classification
Defects or Defectives or
Nonconformance Nonconforming Units
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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
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PART 7:
Use of Control Charts
Slide 98
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• Evaluation
• Improvement
• Maintenance
Slide 99
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• Improvement
• Maintenance
Slide 100
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• Evaluation
• Maintenance
Slide 101
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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
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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
Slide 103
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Slide 104
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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
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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
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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
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PART 8:
Minitab Exercise
Slide 108
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Menu bar
Toolbars
Session
window
Data window
Project
Manager
window
(minimized)
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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)
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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
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Example 1
Tools
• Dotplot
• Time Series Plot
• Graphical Summary
• Display Descriptive Statistics
• Layout Tools
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Open Project
1. Choose File > Open project
2. Choose ISPE_Example 1.MPJ.
3. Click open.
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Creating Dotplots
• Choose Graph > Dotplot
• Complete the dialog as shown below, then click OK
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• Press [DELETE]
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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
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Graphical Summary
• Choose Stat > Basic Statistic > Graphical Summary
• Complete the dialog as shown below
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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
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I-MR
• Open ISPE_Example 2.MPJ
• Choose Stat > Control Charts > Variable Charts for
Individuals > I-MR
• Complete the dialog box as shown below
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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
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Next Step
Remove mean then replot the I-MR Chart
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Example 3
Problem
With previous data analyse normality and capability process
Tools
Probability
Capability Six Pack
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Probability Plot
• Open ISPE_Example 2.MPJ
• Choose Grap > Probability Plot > Single
• Complete the dialog box as shown below
• Complete dialog as shown below
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Normality Check
• Check normality data (P>0.05)
60
50
40
30
20
10
5
0.1
1130 1140 1150 1160 1170 1180 1190 1200
Fill Weight
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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
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Capability Analysis
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
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
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Summary
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