ODDS Company's FDA QSR Design Controls Training/Consulting Services
(Six Free Introductory Tutorials)


ODDSCO assists medical device manufacturers in automating auditable compliance with 21 CFR 820.30, FDA Quality System Regulation (QSR, nee cGMP) Design Controls requirements via the Integrated Product/Process Team (IPPT) approach used during provision of Consulting Services that apply the practitioner level methods and use of ancillary tools taught in the offered Training Seminars.


Why is that needed and how is it done?

ODDS Company is particularly useful to medical device manufacturer organizations that either must become auditably compliant with FDA 21 CFR 820, the Quality System Regulation, or remain so through periods of change. Because all business organizations seeking to gain or improve profitability via 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, with the various regulatory constraints on medical devices development, such solutions generally are not obvious to the improvement team members (who normally are thought most likely to find them).

Accordingly, to evaluate probable worth of ODDSCO Training and Consulting services with regard to accomplishing their planned objectives, potential clients should comprehend FDA QSR Design Controls provisions and the Integrated Product/Process Team (IPPT) approach sufficiently, plus know a bit about classical Systems Engineering (such as it not being the same as engineering systems). A few first-time visitors, such as classical Systems 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 for the majority of first-time site visitors.

Why so much free information?

ODDSCO provides the public service of free educational tutorials to its website visitors for one selfish reason:
Unless basic knowledge of any claimed area of expertise is understood, the value of offered consulting and training services will not be apparent and likelihood of sales is small. But, if the free basic training is perceived as useful and indicative of the ODDSCO consultant's knowledge, that likelihood should improve.
In other words, when equipped with the basic knowledge, a visitor whose organization desires to virtually automate effective QSR Design Controls compliant medical devices development with minimal resources and schedule impact could become a highly qualified client.


Tutorials List:

    1. Automating FDA QSR Design Controls Compliance [An approach that integrates proven elements of the below tutorials into embedded systems medical devices development]

    2. Integrated Product/Process Team, Concurrent Engineering, and Systems Engineering [Related approaches to effective complex systems development and leveraging team capability, with an extensive additional (seventh) free tutorial on the defense/aerospace approach]

    3. The Continuous Improvement Process (CIP) and Total Quality Management (TQM) [Methods in these umbrella names for associated approaches to improving effectiveness of operational processes]

    4. Knowledge Support Systems (KSS) and Tools [Fundamental and additional support for the other operational processes]

    5. An IPPT Supporting Decision Process [A low tech, easily understood, and simple to use but robust business decision making method, fully disclosed]

    6. Project Risk Assessment [Evaluation of Project Technical, Schedule, and Cost Risk (rather than the medical device human safety related Risk Analysis explained in Tutorial 1) integrated with the Tutorial 5 Decision Process]


About ODDSCO: [All have returns to here]:

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ODDS Company:

The ODDSCO Co. Logo<br> (A stylized duck).<br>

Optants Documented Decision Support Co.
(ODDSCO)
297 Casitas Bulevar
Los Gatos, CA 95032-1119
(408) 379-6448

ODDSCO was founded in 1991 as a sole proprietership modeled on the approach used by 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. That is, 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.

A first product was to be a robust, but easily understood decision assisting PC based program for automating much of the decision process presented in Tutorial 5. Even then, however, this author was dissatisfied with software manuals that stated only what to do, without explaining why to do it. Then, experimenting with a popular spreadsheet program led to the key finding: Thomas 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 writing shifted toward business related decision making and research expanded into new domains.

While working to comprehensively describe processes supported by related decision and risk assessment methods, this author developed and presented the 1994 and 1995 National Council on Systems Engineering (NCOSE) Symposia Proceedings Papers which are the essence of Tutorials 6 and 5. Then, a drop in Silicon Valley defense/aerospace work resulted in some extended unemployment and redirection of effort toward renewal of a primary earnings source. That employment was as a software tester with a medical device manufacturer, which led to the observation that adapting some proven defense industry practices was more than appropriate. However, Integrated Product/Process Team (IPPT) and classical Systems Engineering processes simply were not understood by that organization (the latter was thought to simply mean 'engineering systems' by the engineering staff, which naturally occurs) and, therefore, such labels were less than welcome. Accordingly, stealthy implementation of many process improvements was required to obtain their value. Pride of authorship was internalized as the product developments became smoother. This author's experiences then, and continued 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 was reworked to provide a medical systems development emphasis to match the extensive revisions to this website.

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ODDSCO's Training Courses

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

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ODDSCO's Consulting Services

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 alng with the not invented here (NIH) factor.)

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) or process champions, 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 major management consultants that work to expand the perceived need for ever more consulting services).

To pursue this approach, click on ODDSCO Consulting.

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ODDSCO's Product Descriptions

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.

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ODDSCO E-mail contacts list

Tutorials Author: jonesjh@optants.com
Consulting/products: consult@optants.com

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About the Tutorial's Author

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.

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Associated useful links list

Associated Resources, other useful links that are indirectly related to the tutorial subjects.

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