The Practical Difference Between

Ppk and Cpk

Mark DiMartino
Director Quality Engineering
Amgen Inc.
Agenda

• Overview of Performance/Capability Indices

• What is Statistical Control?
• Types of Variation and the impact on Cpk/Ppk
• Examples

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 Four Indices are Typically Used in Industry to
Measure Process Performance

Potential Performance Actual Performance

Measure Measure

Assumes
Process Performance
Centered Process Capability (Cp)
(Pp)
Process

Accounts for Process Capability Process Performance

Process Adjusted for Process Adjusted for Process
Average Shift (Cpk) Shift (Ppk)

ASTM E22821 Standard Practice for Process and Measurement Capability Indices

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Each Index is a Measure of Process
Performance Relative to a Specification
The output is an index standardized to a ±3 SD range, meaning a
Ppk/Cpk of 1.0 indicates that there are 3 SDs between the mean and
the closest specification range. Cp/Pp use the center of the
specification (i.e., the target) in lieu of the mean.
Specification Limits

Process Mean
LSL X USL

Process and Target

Measurement
Variability

3 SDs Ppk = 1.0

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What Does This Performance Measure
Mean?
The performance measure can be converted to the probability of
observing an out of specification (OOS) result. The higher the
Index, the lower the probability of an
2007
OOS*
1.60

1.50

1.40

1.30

1.20
Ppk

1.10

1.00

0.90

0.80

0.70
0 5000 10000 15000 20000 25000 30000

Estimated OOS (ppm)

2700 ppm
*This interpretation applies to all process performance and process capability indices
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 The Index Value Is Driven by a Combination of
the Mean, SD, and Specification Limits
0 bias, acceptable variability Bias, low variability
LSL Target USL LSL Target USL

Slight bias, low variability Large bias, very low variability

LSL Target USL LSL Target USL

Cpk/Ppk = 1.0 for each instance

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What is the Distinction Between Pp/Ppk and
Cp/Cpk?

• Per ASTM E2281:

• Process capability indices (Cp/Cpk) compare the variability of a
process quality measure against product specifications or
tolerances and assume the process is in a state of statistical
control.
• Process performance indices (Pp/Ppk) are useful in situations
when the process in not in a state of statistical control.

• Mathematically:
• Cp/Cpk uses short term variation, for batch processes with a
subgroup n=1 it is based on the average distance between
adjacent points.
• Pp/Ppk uses long term variation which is the normal “Excel”
standard deviation calculation.

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What is Statistical Control?

• Statistical control or process “stability” is a state in

which only common cause variation is evident.
• Common cause variation is the normal expected
variation in a process that is:
• Due to the process itself
• Produced by interactions of variables within that process
• Present in all processes
• “In statistical control” (stable) provided it is the only
variation present
• Predictable

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What Does it Mean to be Out of
Statistical Control?

• A process that is out of statistical control or “unstable”

demonstrates evidence of special cause variation.
• Special Cause Variation is...
• Due to a specific, assignable cause
• Caused by special circumstances not inherent in the
process.
• Generally easier to detect than common causes.
• Not predictable

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 How Do I Determine if Special Cause
Variation is Present?
• Statistical Process Control (SPC) techniques are used to determine
the state of statistical control.
• The individuals control chart is the most typical SPC approach, with
tests applied to identify special cause variation.
Individuals Chart Moving Range Chart
1 6 in a row increasing 800
UCL=714.02
700
11000
or decreasing 600
UCL=10713.72
3 500
10500

Moving Range
400

of Value
Value

22 300
Avg=10132.57
10000 Avg=218.59
200
100
9500 LCL=9551.42
0 LCL=0.00
-100
3 6 9 12 15 18 21 24 27 30 3 6 9 12 15 18 21 24 27 30

Sample Sample

Single point above the UCL

Single Point outside 9 in a row above or
for the MR chart
3 sigma limits below centerline

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How Does Statistical Control Relate to
Cpk/Ppk?

• Cp/Cpk provides an estimate of potential process

performance or capability
• How the process would perform in the absence of special cause
variation.

• Pp/Ppk provides the actual process performance given

all of the variance that is currently present in the
process
• Pp/Ppk is generally <= Cp/Cpk

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But of Course it is Not That Simple

• There is a third type of variation that is often present,

especially when considering batch processing
• Some statisticians call this Long term common cause
variation
• Long term common cause variation is:
• Variation that a control chart may consider special cause, but is
expected and generally tolerated in manufacturing
• Also called autocorrelation, where observations that are close
together in time tend to look more similar than observations that
are further apart in time.

• Cp/Cpk generally underestimates the standard

deviation in these situations, thereby overestimating
performance.
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Examples of Long Term Common Cause
Variability

• Campaign based manufacturing

• Same raw material lot used over multiple batches
• Equipment within a lab
• Analyst within a lab
• Column Packing
• Critical Reagents used over a long period of time
• Multiple purification lots from a single harvest lot

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 Example 1: Common Cause Variation

• Example 1: Parameter demonstrates statistical control,

all values exhibit random noise
Individuals Chart Moving Range Chart
130 40
UCL=125.42 UCL=36.14
35
120
30
110

Moving Range of Result

25
100 20
Result

Avg=96.00
90 15

10 Avg=11.06
80
5
70
LCL=66.59 0 LCL=0.00
60 -5
3 6 9 12 15 18 21 24 27 30 33 3 6 9 12 15 18 21 24 27 30 33

Sample Sample

Cpk Ppk
-3s Mean +3s -3s Mean +3s Cp Cpk Pp Ppk
LSL Target USL LSL Target USL 1.00 0.88 0.99 0.87
60 80 100 120 140 60 80 100 120 140

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 Example 2: Special Cause Evident

• Special cause variation leads to a discrepancy in

Cpk/Ppk
Individuals Chart Moving Range Chart
0.40
1.1 UCL=1.091 0.35

0.30
1.0

Moving Range of Result

0.25
Avg=0.954
0.20
Result

0.9 UCL=0.1678
0.15
LCL=0.818 0.10
0.8
0.05 Avg=0.0514

0.7 0.00 LCL=0.0000

-0.05
3 6 9 12 15 18 21 24 27 30 33 36 39 3 6 9 12 15 18 21 24 27 30 33 36 39

Sample Sample

Cpk Ppk
-3s Mean +3s -3s Mean +3s
Cp Cpk Pp Ppk
LSL Target USL LSL Target USL

0.6 0.8 1 1.2 0.6 0.8 1 1.2

1.46 1.07 0.94 0.69

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 Example 3: Long Term Common Cause

• Long term common cause variation leads to a

discrepancy in Ppk/Cpk
Individuals Chart Moving Range Chart
1000

11000
UCL=10854.71 800 UCL=816.07

Moving Range of Value

10500 600
Value

Avg=10190.50 400
10000
Avg=249.83
200

9500 LCL=9526.29
0 LCL=0.00

0 1 2 3 4 5 6 7 8 9 11 13 15 17 19 21 23 25 27 29 0 1 2 3 4 5 6 7 8 9 11 13 15 17 19 21 23 25 27 29
Sample Sample

Cpk Ppk
-3s Mean +3s -3s Mean +3s
Cp Cpk Pp Ppk
LSL Target USL LSL Target USL

9000 10000 11000 9000 10000 11000

1.51 1.22 1.06 0.86

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Summary

• Ppk and Cpk are both useful measures in assessing

how a particular parameter is performing vs
specification.
• The concept of long term common cause variation
needs to be taken into account when assessing
statistical control.
• Understanding the nature of the underlying data is
critical when interpreting Cpk or Ppk.

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THANK YOU!

Any Questions?

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