In today’s rapidly changing global business environment, U.S. manufacturers must develop an efficient and cost effective strategy to satisfy regulatory compliance requirements. But in many cases, it’s not easy.

With few exceptions, most companies operate as quickly as possible in order to beat competitors to market. This generally means squeezing every single unnecessary delay out of the product development process. Unfortunately, this often results in commitments to very challenging — if not impossible — product release deadlines.

Let the Problems Begin

If not anticipated and adequately addressed from the start of the product development program, regulatory compliance hurdles can represent a significant risk to new product introduction and result in a devastating impact to your company’s business interests. Risks can include the delay or halt of product introductions, as well as civil and criminal penalties for the organization and/or individuals involved.

Initiate a Tracking Function

Manufacturers are wise to put a function in place that is responsible for tracking all regulatory compliance directives and standards applicable to target foreign markets. And to support this effort, manufacturers should have an in-house database that provides a clear understanding of global compliance and certification processes. Importantly, manufacturers also should have a regulatory compliance manager on staff whose responsibility is to insure that the compliance effort is performed in a seamless, effective and efficient manner.

Testing and More Testing

To verify the product compliance, manufacturers typically are required to perform a series of inspections and tests along with an analysis effort. The effort must be conducted in a well thought out, well organized manner, and should not be dealt with as an afterthought.

To this end, the compliance effort should start at the beginning of each product’s conceptual design stage and continue throughout the product’s life cycle. Importantly, the product design team must keep in mind that the product’s functional design factors, reliability, quality attributes and regulatory compliance design considerations are very closely interrelated to each other. This can help prevent design factors that negatively impact other design factors.

More Compliance Requirements

In our era of globalization, manufactured products are increasingly being subjected to new foreign regulatory compliance requirements. The sooner American manufacturers recognize and address this fact, the better off American manufacturers will be.

The Costs on Non Compliance

I was consulting on behalf of a medium size electronics manufacturer who required various certifications for its products. The design department staff assured me that the firm had implemented high speed digital circuit design rules and that the products should meet radiated emissions certification requirements. My role in this compliance effort was to act as an electromagnetic compatibility (EMC) and product safety consultant responsible for managing the certification effort.

The product failed tests with several frequencies significantly above the maximum emissions limits. I conducted a quick EMC review of the product’s digital circuit design and determined that some practices were correctly applied in the design — but failed in others. In my opinion, this was tantamount to attempting to plug a few holes in a sieve.

The result: a product EMC redesign was required, including a new layout of the product’s printed circuit board. This added large costs and resulted in severe shipment delays.

Impact to the Bottom Line

In a second case, a client required a CE Mark certification for its machinery that was to be shipped to German customer. In haste, as well as in bad judgement, the firm made the decision to apply the self-certification method in order to verify conformity. Unfortunately, the firms had little experience in this matter. Six months later my firm was asked to review compliance documentation.

When I completed my review, I determined that the firm’s documentation was totally inadequate and of little value. The manufacturer had completely misunderstood the requirements imposed by the self-certification process.

The manufacturer was then faced with a difficult situation: the machine shipment date was at hand but the pre-paid product could not be shipped. The lost sale had a significant negative impact to the small firm’s bottom line.

Regulatory Compliance Needs To Be Part of the Process

Global business is not getting any easier. As a result, it is essential to effectively deal with known issues, saving time for the unknown problems.

Consequently, manufacturers who integrate aspects of regulatory compliance into their product designs from the start will be ahead of the curve.

Who Is Responsible for Tainted Imports Entering the United States?

U.S. exporters face a multitude of product standards and regulations when entering foreign markets. But what are foreign firms faced with when exporting to the U.S.?

There is a multi-tiered responsibility involved in insuring that imported products are safe for American consumers. However, the prime responsibility rests with the importing organization or agent.

In exercising this responsibility, the importing organizations or agent are wise to verify that all imported products are manufactured to documented specifications and evaluated under strict quality assurance specifications. This is essential from a legal, reputational and moral stand point.

A second tier of responsibility is on the United States Consumer Protection Agency (CPSC). It has the responsibility of insuring that unsafe consumer products are not placed in the U.S. marketplace, whether they are made domestically or imported. Unfortunately, CPSC is both underfunded and understaffed.

Responsibility of Foreign Exporters

Product manufacturers in exporting countries, no doubt, have an obligation to see that their products produced are safe. However, there are a number of factors that often limit sound measures. Plus, cutting corners to reduce costs and forcing production through the pipeline are not uncommon.

Lastly, the foreign exporter’s government has some degree of responsibility to ensure that products made in its country are safe. In many cases, however, surveillance efforts are minimal and not very effective.

Tony DiBiase is president of Spec-Hardened Systems, an EMC and Product Safety consulting firm. He is a graduate of the Rochester Institute of Technology and holds a BSEE degree. Tony can be contacted at (585) 225-2857 or This email address is being protected from spambots. You need JavaScript enabled to view it. . This article appeared in Impact Analysis, November-December 2007.

Anthony DiBiase
About The Author Anthony DiBiase
Tony DiBiase is president of Spec-Hardened Systems, an EMC and Product Safety consulting firm. He is a graduate of the Rochester Institute of Technology and holds a BSEE degree.

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