By Design: To Do No Harm

My duties included designing products and following them on into production. Getting the product produced taught me the importance of getting the part design right before releasing the product for manufacturing. These early experiences gave me a respect for the design process that has continued to the present.

I have now been observing the design and development process for over 50 years. In my opinion many of the new products now being marketed leave much to be desired. There are many gorgeous products available today. However, there are an increasing number of products that do not perform as required.

In 2000 the American National Highway Traffic Safety Administration recalled 24.3 million vehicles for inspection or repair. Another 13.3 million were recalled in 2001.

At about the same time a survey among engineers regarding maintenance problems with their own personal cars credited 52% of those problems as failures in design. Manufacturing defects accounted for 41% and dealer faults were 7%. General Motors budgeted $1 billion to pay for product liability litigation in 2007 and again in 2008.

Theoretically the quality of cars and trucks is improving; however, there were 16.4 million recalls in 2010. Product failures are not new and they are not limited to automobiles. The unreliability of the M-16 assault rifles issued at the start of the Vietnam conflict contributed to the death of American soldiers. In an after-the-event test of 2000 M-16s, 384 failed, an unacceptable rate for a life-and-death-determining product.

Decline in manufacturing standards

The Consumer Product Safety Commission's records indicate an annual increase in the number of products being recalled from 2003 through 2008. These include, among other things, infant highchairs, cribs, beds, playpens, and collapsing strollers with pinch points that severed the fingers of at least 12 children. Failure to comply with Federal safety requirements resulted in the recall of more than 160,000 lawn mowers with blades that continued to rotate after the user released the "power on" handgrip.

Recently Claudio Celata, speaking in his role as chairman of the EuropeanCommittee CEN/TC 145 within Euromap, the trade association of European plastics machinery manufacturers, said the group had tested 100 plastics and rubber processing machines imported from China into Europe. Ninety of those machines failed European safety standards. Some problems were corrected locally. Others required returning the machines to China.

In the healthcare field there have been highly publicized failures of pacemakers, hip implants, and cataract lens. The Tylenol recall was said to have cost Johnson & Johnson over $900 million in lost sales. Another report claimed that in 2010 Boston Scientific lost $1 billion to declining sales of defibrillators and stents due to recalls and related legal expenses.

Who is at fault?

I find it difficult to understand the large number of current product failures and recalls. Over the past 20 years we have seen the introduction of sophisticated computer-aided-engineering and simulation programs. In the same time period Deming and his disciples provided us with elaborate quality control systems. We are being told that there is an ongoing improvement in the quality of products manufactured in America. In spite of these claims the recalls continue. I surmise that the source of these problems has more to do with management than with technology.

Original Equipment Manufacturers (OEM) have now decreed that quality is a given and it must be handled by their suppliers. Upper management's primary concern now is to reduce cost in order to compete with low-cost imports. This is actually a euphemism for increasing the corporate profits that are so near and dear to CEOs.

Many of today's corporate managers have little understanding of the complex technology now being used to design and manufacture products. One of the ways these uninformed managers reduce cost is by hiring newly graduated, desperate-for-a job, low-cost, engineers to replace more costly, experienced engineers who had learned how to do things right the first time.

Some of the current product failures undoubtedly result from not allowing enough time to design, develop, and test new products. Non-technical managers believe they can save time and cost by eliminating the important step of building prototype molds and testing actual molded parts.

Today OEMs and their suppliers are fighting major increases in the cost of plastic materials. It is now a common practice to change from one material supplier to another or to an imported material in a desperate attempt to maintain profit margins. In many cases these changes are made on the fly with no time set aside to thoroughly evaluate the new material or provide for life testing.

The same situation exists with efficiency improvements in the manufacturing process. Hot-runner molds are more efficient than cold-runner molds. Hot-runner molds subject the plastic material to a different heat history. This change justifies a thorough reevaluation of the molded parts. Regrettably those tests are not always performed.

During my ten years at Abbott Laboratories we had our share of product failures and recalls. I can say with confidence, however, that none of these failures were the result of cutting costs or introducing products without thorough short and long term testing. Part of that was due to Abbott Laboratories being in the over-regulated healthcare industry. However, there was more to it than that.

We had managers who understood the market, the product design function, and the manufacturing processes. Abbott Laboratories was a profit-making company. The managers wanted to maximize profits and get to market as soon as practical. These desires were, however, held in check by the mantra to "do no harm to the customer." In my opinion there would be fewer product recalls if more corporate managers adopted that philosophy.