Analyzing Risk Before and After Sale

Originally developed in the 1950s in connection with the U.S. missile program, risk assessment and related engineering evaluations have, since that time, been a part of the design and manufacturing process. But, for many manufacturers, it was an informal process with little documentation.

More recently, however, pre-sale risk assessment has become a topic of discussion in legal and manufacturing circles. Industries and standards groups in the United States and Europe have turned their attention to risk assessment and developed specific methodologies for their industries or specific products.

In addition, risk assessment is now being used by manufacturers and government entities to assist in making decisions about post-sale responsibilities, including whether a product should be reported to a government agency and recalled.

This article will discuss risk assessment techniques before and after sale and some of the legal and practical implications arising from their use.

Why the Increased Interest in Risk Assessment?

Although risk assessment methods have existed in various forms for many years, interest has increased over the last 15 years for several reasons including:

• Costs—Significant opportunities exist for productivity gains and cost efficiencies.
• International influences—The CE mark is an identifying symbol and certification that a product meets the applicable European standards and is in fact safe and is required for most products sold in the European Union (EU). The first step in obtaining the CE mark is to complete a risk assessment.

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