Académique Documents
Professionnel Documents
Culture Documents
Lynn Torbeck
In theory there is no difference between theory and practice, but in practice there is.
Yogi Berria
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X Axis Y Axis 1 Y Axis 2 Y Axis 3 X Axis 2 Y Axis 4 10.0 8.04 9.14 7.46 8 6.58 8.0 6.95 8.14 6.77 8 5.76 13.0 7.58 8.74 12.74 8 7.71 9.0 8.81 8.77 7.11 8 8.84 11.0 8.33 9.26 7.81 8 8.47 14.0 9.96 8.10 8.84 8 7.04 6.0 7.24 6.13 6.08 8 5.25 4.0 4.26 3.10 5.39 19 12.5 12.0 10.84 9.13 8.15 8 5.56 7.0 4.82 7.26 6.42 8 7.91 5.0 5.68 4.74 5.73 8 6.89
12.00
10.00
8.00
6.00 4.00
y = 0.5001x + 3.0001
2.00
0.00 0.0 2.0 4.0 6.0 8.0 X 10.0 12.0 14.0 16.0
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14.00 12.00 10.00 8.00 6.00 4.00 2.00 0.00 0.0 2.0 4.0 6.0 8.0 X 10.0 12.0 14.0 16.0
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14 12 10 8 6 4 2 0 0 5 10 X2 15 20
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12.00
10.00
8.00
6.00 4.00
2.00
0.00 0.0 2.0 4.0 6.0 8.0 X 10.0 12.0 14.0 16.0
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Histogram of UV Assay
9 8 7 6
Frequency
90
95
100
105
110
Histogram of UV Assays
14 12 10
Frequency
90
95
100
105
110
8 6 4 2 0
80
85
90
95 UV Assays
100
105
110
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Histogram of Retests
90 3.0 2.5 2.0 1.5 1.0 0.5 0.0 95 100 105 110
Frequency
88
92
96
100 Retests
104
108
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out of specifications. The cans accepted are just as bad or good as the cans rejected. 45% of the values are OOS The product was taken off the market. A personal story
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Shipping Decision
3 2.5
Number of Complaints
Outside Temperature
apt to impress the imagination as the wonderful form of cosmic order expressed by the Law of Frequency of Error.
Francis Galton in Natural Inherence, 1888
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18 16 14
Frequency
distribution. Gotten close a couple of times. There are no real Normal distributions Its a theoretical fiction that is useful part of the time. We must separate reality from theory.
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Normal Distribution
-6
-3
Mean
+3
+6
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Normal Facts
In theory, the tails of the distribution
stretch from minus infinity to plus infinity, but there are real physical limits. It is unique in that it is fully described by just its mean, mu, , and its standard deviations, sigma, , which are almost never actually known for certain. Probabilities are represented by areas.
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Church contributions
Floods
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Watch Out!
The tails are the most volatile and unstable
But, that is often the area of most interest! Difficult to tell if data are normally
distributed by looking at a small sample. Crude rule is that we need at least 100 representative data values to determine if it is even approximately normal.
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additional tool to assist the scientist in making scientific interpretations and conclusions and not an end in itself.
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Differences
A scientific analysis often takes the form
of looking for significant differences. Is drug A different from drug B? Is the increase in yield significantly better with the new centrifuge? A difference can be significant in two ways, practical and statistical.
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Practical Significance
Practical significance comes form
comparing a difference to an absolute reference or absolute truth. How big a difference can you accept for:
Number of seconds of tooth pain? Number of phone rings before hanging up? How long will you wait for a bus? How big your next raise is?
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Statistical Significance
Statistical significance testing is one of the
great tools of statistics and science. Statistical significance comes from comparing a difference, a signal, to a relative reference of random variability or the best estimate of noise in the data.
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Practical vs.Statistical
Practical Significance always wins and
takes precedence over statistical significance! In most applications, statistical significance should not be tested until practical significance is found.
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Barb
100.2 100.5
99.7
Xbar=99.1 Spec= 90.0 to 110.0
100.8
Xbar=100.5 Two Sided t, P=0.04
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Signal to Noise
All statistical significance testing is only a
comparison of the signal to the noise. If the signal can be shown to be larger than the noise, than we would expect by chance variation alone, we say it is significant. Bigger signal more significant. Smaller noise more significant.
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Significance?
Practical / Statistical
NO
Nothing going on here it seems.
1. Small noise 2. Large sample size. What does it mean?
YES
1. 2.
NO YES
Why Do It To It?
The primary purpose of statistical tests of significance is to prevent a us from accepting an apparent result as real when it could be just due to random chance. Statistical significance without practical significance could in some circumstances be a lead to finding new relationships. What if the spec was changed to 98.0 to 102.0? We may want to find out why different
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solution that is quick, simple, understandable and absolutely wrong! More grief has been perpetuated by this formula than any in statistics.
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3 will bracket
99.73% of the area under the normal cures. Note that this assumes we know the true values for the mean mu, , and standard deviation, sigma, , which we never do of course. We have to estimate them with the small samples we take. Thus, there is uncertainty in the estimates.
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Side Line
Did you hear about the statisticians wife
who said her husband was just average? She was being mean.
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wrench and apply it to all of your statistical questions. Use the right tool for the job. Use Confidence Intervals to bracket the unknown mean. Use Tolerance Intervals to bracket a given percentage of the individual data values.
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Control Charts
Having just told you not to use Xbar3S, I
now have to tell you that is how control charts define the control limits. This is an artifact of history. Control charts were developed by Dr. Walter Shewhart in 1924 while working at Western Electric in Cicero Ill.
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Control Chart
Add Xbar 3S limits to a line plot. A chart for the response.
A chart for the
I and MR Chart for Yield %
103.5
Individual Value
UCL=103
Mean=100
LCL=97
Subgroup 4
Moving Range
UCL=3.686
3 2 1 0 R=1.128 LCL=0
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probability statements. They dont take into account the number of samples in the data set for the limits. They are intended as early warning devices and not accept/reject decision tools. Dont use for large $$ decisions.
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You did what to set the specification criteria for your million dollar product?
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Setting Specifications
A specification is a document that contains
Million $$ Decisions?
Regulatory Limits - External
Release: accept/reject - Internal Action limits Alert
Warning limits Trend limits Validation limits
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Alert Action
Accept / Reject
Regulatory
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Calculating Criteria
Dont use Confidence Intervals, they
shrink toward zero with large sample sizes. Dont use X bar 3 S. They are too narrow for small sample sizes Use Tolerance Intervals, preferably 99%/99%. This will take into consideration the sample size and uncertainty of the average and the standard deviation.
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vary and widen the Tolerance Limits For accept/reject limits, add a further allowance for stability. Consider the clinical results when possible as part of the justification for limits.
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Drunken Teachers
Did you know that there is a positive
correlation between alcohol consumption and High School teachers salaries? That there is a negative correlation between average students test scores for a state and the distance of the state capital from the Canadian boarder?
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relationship to see if this works? Should we just ask people what they think? No causation without manipulation. Gold Standard is double blind clinical trial.
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in the lab last year? How many manufacturing deviations were investigated last year? How many lots were rejected last year? How many of your quality problems would go away if there were no variation?
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Misconceptions of variability
We have variability because the equipment
needs to be replaced with new technology. We do too many tests. Variability exists because some idiot didnt do their job correctly. Variability is an inherent fact of life and there isnt a darn thing we can do about it except to live with it. Its cost of business.
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single source. Use CAPA to solve it. Common Cause variation is the result of multiple small sources all contributing to the sum total. CAPA will not work for common cause We need a culture change to address common cause variation
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Sources of Variation:
Common cause variation:
People Materials Methods Measurement Machines Environment
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with X bar 3 S illustrates common cause variation. A value that is larger than would be expected by chance alone is assumed to be due to a special cause.
UCL=103
Mean=100
LCL=97
Observation Number
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Demings Message
Dr. W. Edwards Deming was the very
famous statistician that taught statistical quality control to the Japanese in the 50s.
If I had to reduce my message for
management to just a few words, Id say it all had to do with reducing variation.
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Demings Message
If you reduce variability, you will reduce
scrap, rejects and rework. You can then make a better product at less cost. You will capture a larger market share. Your people will be employed and you will prosper.
Paraphrase of Demings message
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New Technology
Continuous and forever improvement
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plans just suck the common sense right out of peoples brains. Normal, logical and rational people suddenly become willfully and terminally stupid. Many myths and misconceptions about what sampling plans can and can not do.
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good lot of product will be rejected. Called the Producers Risk, usually 5%. There is a small but real probability that a bad lot will be accepted. Consumers Risk, usually 5% or 10% Most common plan is ANSI/ASQ Z1.4.
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worst tolerable process average . The acceptance of a lot is not intended to provide information about lot quality. The standard is not intended as a procedure for estimating lot quality or for segregating lots.
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the economic and psychological pressure of lot non-acceptance, to induce a supplier to maintain a process average at least as good as the specified AQL while at the same time providing an upper limit on the consideration of the consumers risk of accepting occasional poor lots.
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Misunderstandings
Double and multiple sampling plans are
not testing into compliance. It is not possible to have an AQL=0.0 Accept on zero, reject on one is not always the best plan for critical defects. If the lot size is ten times or more than the sample size, then the lot size doesnt matter.
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Summary
one day be as necessary for efficient citizenship as the ability to read and write.
H. G. Wells
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References
NIST online statistics textbook
http://www.itl.nist.gov/div898/handbook/inde x.htm
References
Torbeck, Lynn.,Using Statistics to Measure
and Improve Quality, DHI Publishing 2004. De Muth, James (1999). Basic Statistics and Pharmaceutical Statistical Applications, Marcel Dekker.
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