.09
100
9
Inspected Total
Defectives #
p CL
p
p
p
= = = =
= + = + =
= =
=
= = = =
Solution:
40
P CONTROL CHART
41
CCHART EXAMPLE: THE NUMBER OF WEEKLY CUSTOMER COMPLAINTS ARE
MONITORED IN A LARGE HOTEL USING A CCHART. DEVELOP THREE SIGMA CONTROL
LIMITS USING THE DATA TABLE BELOW.
Week Number of
Complaints
1 3
2 2
3 3
4 1
5 3
6 3
7 2
8 1
9 3
10 1
Total 22
0 2.25 2.2 3 2.2 c c LCL
6.65 2.2 3 2.2 c c UCL
2.2
10
22
samples of #
complaints #
c
c
c
= = = =
= + = + =
= = =
z
z
Solution:
42
C CONTROL CHART
43
The ability of a process to meet product design/technical specifications
Assessing capability involves evaluating process variability relative to
preset product or service specifications
Process Capability Cp and Cpk
Cp assumes that the process is centered in the specification range
Cpk helps to address a possible lack of centering of the process
PROCESS CAPABILITY
6
LSL USL
width process
width ion specificat
Cp
= =

.

\

=
3
LSL
,
3
USL
min Cpk
44
GRAPHING THE TOLERANCE AND A MEASUREMENT
Its useful to see the tolerance and the part measurement on a graph.
Suppose that:
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
45
GRAPHING THE TOLERANCE AND A MEASUREMENT
Its useful to see the tolerance and the part measurement on a graph.
Suppose that:
the tolerance is .515
Specification
Limit MIN
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
46
GRAPHING THE TOLERANCE AND A MEASUREMENT
Its useful to see the tolerance and the part measurement on a graph.
Suppose that:
the tolerance is .515 to .525
Specification
Limit MAX
Specification
Limit MIN
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
47
GRAPHING THE TOLERANCE AND A MEASUREMENT
Its useful to see the tolerance and the part measurement on a graph.
Suppose that:
the tolerance is .515 to .525
and an individual part is measured at .520.
Specification
Limit MAX
Specification
Limit MIN
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
X
48
GRAPHING THE TOLERANCE AND MEASUREMENTS
Suppose we made and measured several more
units, and they were all EXACTLY the same!
We wouldnt have very many part problems!
Specification
Limit MAX
Specification
Limit MIN
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
X
X
X
X
49
GRAPHING THE TOLERANCE AND MEASUREMENTS
In the real world, units are NOT EXACTLY the same.
Everything VARIES.
The question isnt IF units vary.
Its how much, when, and why.
Specification
Limit MAX
Specification
Limit MIN
.512 .513 .514 .515 . 516 .517 .518 .519 .520 .521 .522 .523 .524 .525 .526 .527 .528
XX
XXX
XXXXX
XXXXXXX
50
The normal bell curve
Widths, heights, depths, thicknesses, weights, speeds, strengths,
and many other types of measurements, when charted as a
histogram, often form the shape of a bell.*
A perfect bell, like a perfect circle, doesnt occur in nature, but
many processes are close enough to make the bell curve useful.
(*A number of common industrial measurements, such as flatness and straightness, do NOT tend
to distribute in a bell shape; their proper statistical analysis is performed using models other than
the bell curve.)
XX
XXX
XXXX
XXXX
XXXXX
XXXXX
XXXXXX
XXXXXX
XXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXXXXX
XX
XXX
XXXX
XXXX
XXXXX
XXXXX
XXXXXX
XXXXXX
XXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXXXXX
51
What is a standard deviation?
If we measure the DISTANCE from the CENTER of the bell
to each individual measurement that makes up the bell curve,
we can find a TYPICAL DISTANCE.
The most commonly used statistic to estimate this distance is the
Standard Deviation (also called Sigma).
Because of the natural shape of the bell curve, the area of +1 to 1
standard deviations includes about 68% of the curve.
XX
XXX
XXXX
XXXX
XXXXX
XXXXX
XXXXXX
XXXXXX
XXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXXXXX
XX
XXX
XXXX
XXXX
XXXXX
XXXXX
XXXXXX
XXXXXX
XXXXXXX
XXXXXXXX
XXXXXXXXX
XXXXXXXXXXX
Typical distance
from the center: +1
standard deviation
Typical distance
from the center: 1
standard deviation
52
How much of the curve is included in how many standard
deviations?
From 1 to +1 is about 68% of the bell curve.
From 2 to +2 is about 95%
From 3 to +3 is about 99.73%
From 4 to +4 is about 99.99%
(NOTE: We usually show the bell from 3 to +3 to make it easier to draw, but in
concept, the tails of the bell get very thin and go on forever.)
6 5 4 3 2 1 +1 +2 +3 +4 +5 +6 0
53
A
B
What is Cpk? It is a measure of how well
a process is within a specification.
Cpk = A divided by B
A = Distance from process mean to closest spec limit
B = 3 Standard Deviations (also called 3 Sigma)
A bigger Cpk is better because fewer units will be beyond spec.
(A bigger A and a smaller B are better.)
Specification
Limit
Specification
Limit
Cpk =
A divided by
B
54
A
B
Process Capability is the ability of a process
to fit its output within the tolerances.
a LARGER A
and a SMALLER B
means BETTER Process Capability
Specification
Limit
Specification
Limit
Cpk =
A divided by
B
55
A
B
An Analogy
Analogy:
The bell curve is your automobile.
The spec limits are the edges of your garage door.
If A = B, you are hitting the frame of your garage door with your car.
Specification
Limit
Specification
Limit
Cpk =
A divided by
B
56
A
B
How can we make Cpk (A divided by B) better?
1. Design the product so a wider tolerance is functional (robust design)
2. Choose equipment and methods for a good safety margin (process capability)
3. Correctly adjust, but only when needed (control)
4. Discover ways to narrow the natural variation (improvement)
Specification
Limit
Specification
Limit
Cpk =
A divided by
B
57
A
B
What does a very good Cpk do for us?
This process is producing good units with a good safety margin.
Note that when Cpk = 2, our process mean is 6 standard deviations from
the nearest spec, so we say it has 6 Sigma Capability.
Specification
Limit
Specification
Limit
This Cpk is
about 2.
Very good!
Mean
58
A
B
What does a problem Cpk look like?
This process is in danger of producing some defects.
It is too close to the specification limits.
(Remember: the bell curve tail goes further than B
we only show the bell to 3sigma to make it easier to draw.)
Specification
Limit
Specification
Limit
This Cpk is just
slightly greater
than 1. Not good!
59
A
B
What does a very bad Cpk look like?
A significant part of the tail is hanging out beyond the spec limits.
This process is producing scrap, rework, and customer rejects.
Notice that if distance A approaches zero
the Cpk would approach zero, and
the process would become 50% defective!
Specification
Limit
Specification
Limit
This Cpk is less
than 1. We desire
a minimum of 1.33
and ultimately we
want 2 or more.
60

Q & A
61
MEASUREMENT SYSTEM ANALYSIS (MSA)
An MSA is a statistical tool used to
determine if a measurement system
is capable of precise measurement.
What is It?
Objective or Purpose
To determine how much error is in
the measurement due to the
measurement process itself.
Quantifies the variability added by
the measurement system.
Applicable to attribute data and
variable data.
When to Use It
On the critical inputs and outputs
prior to collecting data for analysis.
For any new or modified process in
order to ensure the quality of the
data.
Measurement System Analysis is
an analysis of the measurement
process, not an analysis of the
people!!
IMPORTANT!
Who Should be Involved
Everyone that measures and makes
decisions about these measurements
should be involved in the MSA.
MEASUREMENT SYSTEM ANALYSIS (MSA)
Process
Variation
Measurement
System
Variation
Observed
Variation
The observed variation in
process output
measurements is not
simply the variation in the
process itself; it is the
variation in the process
plus the variation in
measurement that results
from an inadequate
measurement system.
Conducting an MSA reduces the likelihood of
passing a bad part or rejecting a good part
MEASUREMENT SYSTEM ANALYSIS (MSA)
Process
Variation
Measurement
System
Variation
Observed
Variation
The output of the process
measured by:
Cycle time
Dimensional data
Number of defects
and others
Observed
Variation
Process
Variation
Measurement
System
Variation
Reproducibility
Precision
(Variability)
Linearity
Bias
Stability
Resolution
Repeatability
Accuracy
(Central
Location)
OBSERVED VARIATION
Calibration addresses accuracy
Measurement System Analysis (MSA)
MEASUREMENT SYSTEM ERRORS
Accuracy: difference between the observed
measurement and the actual measurement.
Precision: variation that occurs when
measuring the same part with the same
instrument.
MEASUREMENT SYSTEM ERROR
Precise but not
accurate
Accurate but not
precise
Not accurate or
precise
Accurate and
precise
ACCURACY OF MEASUREMENT
Broken down into three components:
a.Stability:
The consistency of measurements over time.
b.Bias:
A measure of the amount of partiality in the system.
c.Linearity:
A measure of the bias values through the expected
range of measurements.
OBSERVED VARIATION
Observed
Variation
Process
Variation
Measurement
System
Variation
Precision
(Variability)
Linearity
Bias
Stability
Resolution
Repeatability
Reproducibility
Accuracy
(Central
Location)
Calibration Addresses Accuracy
Lets take a closer look at
Precision
Measurement System Analysis (MSA)
Measurement System Analysis (MSA)
Error in Resolution
The inability to detect small
changes.
Possible Cause
Wrong measurement device
selected  divisions on scale
not fine enough to detect
changes.
Resolution
MEASUREMENT SYSTEM ANALYSIS (MSA)
Error in Repeatability
The inability to get the same
answer from repeated
measurements made of the
same item under absolutely
identical conditions.
Possible Cause
Lack of standard operating
procedures (SOP), lack of
training, measuring system
variablilty.
Repeatability
Equipment Variation
MEASUREMENT SYSTEM ANALYSIS (MSA)
Error in Reproducibility
The inability to get the same
answer from repeated
measurements made under
various conditions from
different inspectors.
Possible Cause
Lack of SOP, lack of training.
Reproducibility
Appraiser Variation
VARIABLE MSA GAGE R&R STUDY
Gage R&R is the combined estimate of
measurement system Repeatability and
Reproducibility
Typically, a 3person study is performed
Each person randomly measures 10 marked parts per trial
Each person can perform up to 3 trials
There are 3 key indicators
EV or Equipment Variation
AV or Appraiser Variation
Overall % GRR
1. Select 10 items that represent the full range of longterm process variation.
2. Identify the appraisers.
3. If appropriate, calibrate the gage or verify that the last calibration date is valid.
4. Open the Gage R&R worksheet in the PPAP Playbook to record data.
5. Have each appraiser assess each part 3 times (trials first in order, second in reverse order, third
random).
6. Input data into the Gage R&R worksheet.
7. Enter the number of operators, trials, samples and specification limits
8. Analyze data in the Gage R&R worksheet.
9. Assess MSA trust level.
10. Take actions for improvement if necessary.
VARIABLE MSA GAGE R&R STEPS
Step 1
Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9
Step 10
Step 2
STEPS 1 AND 2: VARIABLE MSA  GAGE R&R
Select 10 items that represent
the full range of longterm process
variation.
Step 1
Identify the appraisers.
Should use individuals that actually do the
process being tested.
Can also include other appraisers
(supervisors, etc.).
Should have a minimum of 3 appraisers.
Step 2
STEPS 3 AND 4: VARIABLE MSA GAGE R&R
If appropriate, calibrate the gage
or verify that the last calibration
date is valid.
Step 3
Enter the data Gage R&R worksheet
Step 4
STEP 5: VARIABLE MSA GAGE R&R
Step 5
Have each appraiser assess each item 3 times.
Each appraiser has to work independently.
Items should be evaluated in random order.
After each appraiser completes the first evaluation of
all items repeat the process at least 2 more times.
Do not let the appraisers see any of the data during
the test !!
STEPS 6 AND 7: VARIABLE MSA GAGE R&R
Collect data into the Gage R&R
worksheet
Enter the number of operators, trials,
samples and specification limits in
same work sheet
Step 6
Step 7
STEPS 8 AND 9: VARIABLE MSA GAGE R&R
Assess MSA Trust Level.
Red: > 30% (fail)
Yellow: 1030% (marginal)
Green: < 10% (pass)
Step 9
Step 8
Calculate & Analyze data in the Gage R&R worksheet
% Tolerance*
10%
30%
STEP 10: VARIABLE MSA GAGE R&R
If the Measurement System needs improvement:
Brainstorm with the team for improvement solutions.
Determine best practical solution (may require some
experimentation).
Pilot the best solution (PDSA)
Implement best solution train employees.
Rerun the study to verify the improvement.
Step 10
GAUGE R & R FORMULAS
81
Repeatability  Equipment Variation (EV) = (R bar bar) X K1
Reproducibility Appraiser Variation(AV) = Sqrt{(X bar diff X K2)2
(EV/[(# parts) X (# Trials)]}
Repeatability & Reproducibility (GRR) = Sqrt((EV2) +(AV2))
Part Variation (PV) = Rp X K3
Total Variation(TV) = Sqrt{(GRR2) + (PV2)}
% Equipment Variation(%EV) = 100(EV/TV)
% Appraiser Variation(%AV) = 100(AV/TV)
% Gauge R & R(%GRR) = 100(GRR/TV)
% Part Variation(%PV) = 100(PV/TV)
SAMPLE EXCERCISE
Sample for Gauge R & R
82
Important: An MSA is an analysis of the process, not an analysis of the people. If
an MSA fails, the process failed.
A Variable MSA provides more analysis capability than an Attribute MSA. For this
and other reasons, always use variable data if possible.
The involvement of people is the key to success.
Involve the people that actually work the process
Involve the supervision
Involve the suppliers and customers of the process
An MSA primarily addresses precision with limited accuracy information.
Tips and Lessons Learned
FINALLY
84