ODDS Company is an educational and consulting company that deals with product and process
improvements at all levels (from Executive Management to engineering support staff).
ODDSCO is particularly useful to medical device manufacturer organizations that always must
remain auditably compliant with FDA 21 CFR 820, the Quality System Regulation, when making
any change. Organizations seeking to accomplish Continuous Improvement eventually find that
the "low hanging fruit" has been harvested (the law of diminishing returns has
become apparent). Then, cost-effective solutions to the problems of further improvement are
required. However, many such solutions will not be obvious to the improvement teams.
Accordingly, potential customers and/or clients should comprehend FDA QSR Design Controls,
the Integrated Product/Process Team (IPPT) approach, and Systems Engineering methods
sufficiently to evaluate probable worth of ODDSCO Training and Consulting services with
regard to accomplishing their planned objectives. A few first-time visitors, such as
classical System Engineers with experience in both defense/aerospace systems and medical
devices development, may already know over sixty percent of the provided introductory
tutorials content. Extremely rare, however, is anyone who already knows over
ninety percent of the provided information (at the detail level). The integrated set of
comprehensive tutorials is provided to address the probable knowledge gaps.
Return to Top of the Tutorials List
ODDSCO was founded in 1991 as a sole proprietership modeled on the approach used by the
many university professors who write and consult in a specialty, thus needing a means
to keep the income from products and services separate from their teaching salaries
and to deduct the legitimate business expenses. In other words, ODDSCO was a side business
at inception, allowing only part-time writing, consulting, and teaching. Still, much was
accomplished despite that constraint, permitting increased proportion of time for developing
training materials and performing seminars.
The first product was to be a robust, but easily understood decision assisting computer
program for automating much of the decision process presented in Tutorial 5. Even then, this
author was dissatisfied with software manuals that stated only what to do, without explaining
why to do it. Accordingly, the text was expanded to provide that added value.
Meanwhile, during translation of the source code from compiled BASIC to the more structured
Pascal language, a "bug" surfaced in the Pascal compiler and one of the affected
computers was loaned to Borland International to assist their troubleshooting.
Until a workaround was found, experimentation with a popular spreadsheet program was begun.
The key finding: Saaty's Analytic Hierarchy Process for priority weighting with consistency
feedback (an eigenvalue and eigenvector computation in matrix algebra) could be implemented
for up to nine decision criteria within the limit of cell formulas length. Because virtually
everyone with a personal computer could have a reasonably capable spreadsheet, this meant a
much larger potential audience for the decision process. The intended book content shifted
to business decision making and research expanded.
While revising the book to comprehensively describe processes supported by the decision
and risk assessment methods, this author developed and presented the 1994 and 1995 National
Council on Systems Engineering Symposia Proceedings Papers which are the essence of Tutorials
6 and 5. Next, a drop in Silicon Valley defense/aerospace work resulted in some extended
unemployment and redirection of effort toward primary earnings source renewal. That employment
was as a software tester with a medical device manufacturer, which led to the observation that
adapting some defense industry practices was more than appropriate. However, the Integrated
Product/Process Team and classical Systems Engineering processes simply were not understood by
that organization and, therefore, such labels were less than welcome. Accordingly, stealthy
implementation to show the value of their results was required to obtain the process
improvements. The author's experiences then, and later as a working Systems Engineering
Manager with another medical device developer, were convincing of need for an IPPT approach in
the QSR domain for more than just those two organizations. The training and consulting work
expanded and the book was again undergoing extensive rework to provide the medical systems
development emphasis to match this website.
The above listed tutorials are excerpts from that seemingly forever evolving book, so they
provide indications of its intended depth and breadth of coverage. (If the book development
tasks can spend enough time near the front of the work, learning, methods application,
consulting, training, and research queue, its completion finally will become possible.)
Featured ODDSCO Training reinforces and builds upon the primary tutorials provided knowledge.
Comprehensive training on using an Integrated Product/Process Team approach to implement
automatic compliance with FDA QSR Design Controls is the obvious primary seminar. Training is
offered for the supporting elements of the other tutorials as well, when specific gaps in the
requisite knowledge are recognized. Further, all the primary tutorials may be customized to
emphasize selected areas with expanded detail.
To view descriptions of the current set of in-house training seminars, click on ODDSCO Training
When you must compress the cycle to obtaining cost-effective solutions, ODDSCO Consulting
teaches the recommended processes while assisting in addressing specific identified
problems. The emphasis is on the adaptable proprietary knowledge within your organization,
because therein awaits the source of most rapid adoption. Usually, the experienced workers
soon recognize that application of specific methods to existing approaches is mostly just
targeted tailoring and thereby is acceptable. (Stubborn resistance usually arises from a
perception of radical change.)
Proprietary knowledge remains with you, of course, because each client will develop unique
solutions based on differences from as well as similarities to general practices provided
in the training. Learning (beyond the free introductory tutorials content) while solving
your own problems on the job with the working consultant can transform you or some designated
person(s) into the local consultant(s), which soon can make ODDSCO Consulting assistance
redundant. A reputation for quickly training competent replacements while implementing the
integrated processes is the goal of ODDSCO (unlike the management consultants that work to
expand the perceived need for ever more consulting services).
To pursue this approach, click on ODDSCO Consulting.
ODDSCO Products complement the
tutorial provided knowledge with supporting tools (spreadsheet Weighting Template,
Documentation, and Example Decision Model Template) for the Decision Process described in
Tutorials 5 and 6 and in their pdf versions.
Tutorials Author: jonesjh@optants.com
Consulting/products: consult@optants.com
James H. Jones received his B.S. in Business Administration from College of Notre Dame at
Belmont, CA, and his M.S. in Industrial and Systems Engineering from San Jose State
University, CA. During an economic recession, he performed contract work in avionics System
Engineering for the ongoing application of experience gained during U.S. Navy and in both
major and minor aerospace corporation employment as industrial electronic technician,
industrial engineer, system test engineer, logistics specialist, and staff system engineer.
Subsequently, he performed embedded system medical devices R&D requirements management with
emphasis on formal verification and implementation of FDA QSR (cGMP requlation) design
controls compliance. Therefore, he teaches and writes from in-depth experience and exposure
as well as extensive research into the processes set forth in the above set of tutorials.
Associated Resources, other
useful links that are indirectly related to the tutorial subjects.