Page 37 - The Handbook for Quality Management a Complete Guide to Operational Excellence

24 B u s i n e s s - I n t e g r a t e d Q u a l i t y S y s t e m s T h e Q u a l i t y F u n c t i o n 25

simply a conformance requirement. The quality professional’s primary
role is the creation of systems for the prevention and detection of safety
prob lems caused by nonconformance to established requirements, and
development of systems for controlling the traceability of products that
may have latent safety problems that might be discovered at a future date,
or that may develop these problems as the result of unanticipated product
usage.
There are a myriad of government agencies that are primarily con-
cerned with safety, including the Consumer Product Safety Commission
(CPSC), which deals with the safety of consumer products; the Defense
Nuclear Facilities Safety Board Office of Environment, Safety, and Health;
the Center for Food Safety and Applied Nutrition; the Mine Safety and
Health Administration; the Occupational Safety and Health Administra-
tion (OSHA); the Office of System Safety; and the Defense Nuclear Facilities
Safety Board, among others.

Regulatory Issues
For many years the fastest growing “industry” in the United States has
been federal regulation of business. The U.S. Small Business Administra-
tion estimated that compliance with federal regulations alone con sumed
$1.75 trillion dollars in 2008 (Crain and Crain, 2010), or approximately
13 percent of 2008 GDP. Each year over 150,000 pages of new regulations
are issued by government agencies. The quality manager will almost cer-
tainly be faced with regulatory compliance issues in his or her job. In some
industries, compliance may be the major component of the quality man-
ager’s job.

Product Liability
The subject of quality and the law is also known as product liability. While
the quality manager isn’t expected to be an expert in the subject, the qual-
ity activities bear directly on an organization’s product liability exposure
and deserve the quality manager’s attention. To understand product lia-
bility, one must first grasp the vocabulary of the subject. Table 2.2 presents
the basic terminology (Thorpe and Middendorf, pp. 20–21).
There are three legal theories involved in product liability: breach of
war ranty, strict liability in tort, and negligence. Two branches of law deal
with these areas, contract law and tort law.
A contract is a binding agreement for whose breach the law provides a
rem edy. Key concepts of contract law relating to product liability are those
of breach of warranty and privity of con tract.
Breach of warranty can occur from either an express warranty or an
implied warranty. An express warranty is a part of the basis for a sale: the
buyer agreed to the purchase on the reasonable assumption that the
prod uct would perform in the manner described by the seller. The seller’s

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