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Diagnostic testing for the companion animal, livestock and poultry veterinarian,
water (coliforms) and dairy (antibiotics) industries
We manufacture and sell chemistry, hematology, xray and other test instruments
and consumables
We manufacture and sell rapid assay tests and Elisa plate assays
We provide diagnostic laboratory services
We develop and sell practice management software for veterinarians

Power tools go beyond the typical t-test and ANOVA (which are really just
significance tests for differences in means)
They are more complex than the fundamental one factor tests, full factorials and
fractional factorials that are typically taught.
They may incorporate split plots, blocking, chunk-type factors and other special
design elements, but they are study designs in their own right.

Powerful tools are those that are:


Versatile in their use; applicable to many diverse situations
Easy to use
Intuitively insightful; do not rely on statistical summaries, p values, etc.
Compelling in their results

5-Whys on statistical engineering steroids

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Some causal systems will use hybrids of the 3 primary split categories

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Whats Wrong: The most common approach and works well with simple Problems
and obvious (easily observed) causes.
Whats Changed: The weakest question. It requires that the cause was known,
measured and recorded. It is also prone to post hoc, ergo propter hoc* errors.
Whats Different: Involves determining the differences between the diagnostic
pairs. When used with a convergent elimination strategy it is highly effective.
What s Happening: This is the strongest question.
Whats
question It includes the other three
questions as appropriate and when coupled with a convergent elimination strategy
is the most effective approach for highly complex problems

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Independence and replication are cousins of each other in statistical analyses.

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Critical to Quality = Critical to the Customer. Only the Customer knows this.
CTQs are typically performance characteristics. These can include visual or
cosmetic characteristics and reliability based times.

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Definition of a Problem: "An undesired situation whose cause is unknown".


What is wrong with What? Object, Defect
State The Problem in terms of effects, not causes!
To determine effects

$$

To isolate causes

Define the Business Case: Why is important to solve The Problem?


Importance may be measured by:
Cost to The Company
Cost to the Customer (may not be able to assign $)
Customer Satisfaction
Time (delays, time or effort to resolve or repair)
Quantity or number of occurrences
Safety

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The fuel lid supplier (who welded the spring to the fuel lid) had very wide
specifications for the weld distance. Once the specification on location was
tightened and communicated the Problem was eliminatedthe problem of too large
an opening distance was also eliminated.

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The materials could have lost potency from the time of the initial qualification testing
to the final release testing due to an inherent instability of the materials, stress or
other mechanism independent of the process steps.
The quickest way to split process from time was to determine if the cause lay with
the process or not.

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Anewlotoftheantibodycoatingandtheconjugateareusedforthisexperiment.

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The best results occur whenever the second operation (Blocking) is performed
using the hand process.

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Again new lots of materials are used

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This experiment like any experiment may not work.


But its relatively easy, quick and cheap, so failure will teach us something
The only way to determine if an experiment will work is to do the experiment; we
cannot answer the question thru intellectual debate.
At this point some members of the team saw the blot step used in the hand coating
and were sure that it was the causal difference. This is known as a squirrel or shiny
object

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Note that with these new materials the machine step does pass. However there is
still a difference between the hand and machine steps.
Two lots had passed in the previous year so an occasional passing lot is to be
expected.
In Problem Solving, pass-fail status doesnt matter; distinctive differences do.

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The hand blotting vs. machine aspirate didnt seem to matter, but the nature of the
machine vs. hand wash did. The machine wash was doing something destructive to
the assay.

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The science of the surfactant is to enable the Ab coating to be more receptive to


capturing the positive sample and conjugate.
One new Ab coating lot and two new conjugate lots were used
The full standard hand and machine coating processes were used as internal
controls

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Notice the use of both controls and replication across multiple levels of all other
factors is used consistently throughout the diagnostic process. This provides
protection against other factor changes and ensures our results are conclusive and
compelling

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In general the term independence refers to the individual data points in a sample.

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Measurement error is best determined using a crossed study. One of the exercises
in this section will show the pitfalls of trying to determine measurement error using a
standard observational multi-vari study.
Inferences about the effect of measurement error can sometimes be made from a
properly designed nested study.
See the manual on Measurement Systems Analysis for MSA study designs and
analysis.

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