Making Creativity More Productive

As my company starts production, we have a parallel effort to establish the policies and procedures to enable us to get the various ISO and FDA credentials necessary to
sell products beyond the borders of the United States and as a medical device company in the U.S.

The bad news is that the process is tedious. There is a lot of work and paperwork necessary to go through the process and to get ready for review by a notified body. The good news is that it has to be done only once and, when completed, will help us do more than sell our products; it will help engineers do their job better and more efficiently.

I realize that many engineers, especially the creative ones, will ask, "How can process and procedures, paperwork and controls help us do our job better?"

Essentially, there are certain disciplines that will make the job of being creative more productive. When used properly, they are the tools that will focus creativity, allowing engineers to identify the final goal more quickly. Once the goal or goals are identified, you will be able to confirm that you are on the correct path to a solution.

Two important elements of this process are the development of detailed functional specifications and risk analysis. The functional specifications should tell you what you want the final product to do, and how it is going to do it. The functional specification does not give you details of the design, but does elaborate on the device's theory of operation.

Risk analysis comes in two forms. One is a top-down hazard analysis looking at what could happen if the device is used improperly or malfunctions. The second is failure methods effects analysis, or FMEA.

FMEA looks at each system element or part to determine how it could fail and the results of the failure. When they're combined, these two methods of analyzing the system will help engineers find solutions to problems before they occur and design robust products more effectively.

The rest of the standard operating procedures developed to qualify for ISO 9000 or ISO 13485 will help the design engineer use the tools of functional specifications and the risk analysis more effectively.

But it is important to mention what is typically called the "Nigeria Letter Scam." In 1997, the U.S. State Department's Bureau of International Narcotics and Law Enforcement Affairs prepared a 33-page report warning Americans about this scam. A copy of the report can be found on the Web at www.state.gov/www/regions/africa/naffpub.pdf. I have gotten more than a dozen versions of this scam letter in the last seven years.

The letter requests assistance in getting a large sum of money, from $250,000 to $40 million, out of a developing country because you are a trusted business professional. In return for your assistance, a percentage of these funds, typically 20 to 30 percent, will be received. After responding to the initial letter, you will learn that your expenses will be 10 percent of the money to be received. If you are willing to help and send the 10 percent, you will never see it again. At least one person has been killed trying to recover their lost money.

The most recent letters have been coming through my ASME address. They are from Lagos, but the text is virtually unchanged from the original text I remember from several years ago.

If you are seen as a business leader, which you will be as an entrepreneurial engineer, you will receive letters like this from time to time. Delete and ignore them. Remember, if it looks too good to be true, it most likely is.

— Niel Leon
Committee on Engineering
Entrepreneurship
leonn@asme.org

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