A defect could be the result of a manufacturing or production error, or
it could result from the design of, or the materials used in, the
product. A defect could also occur in a product's contents,
construction, finish, packaging, warning, and/or instructions.
Not all products that present a risk of injury are defective. A kitchen
knife is one such example. The fact that the blade is sharp to allow
the consumer to cut or slice food is the very reason why the product was
created; the knife's cutting ability is certainly not a produce defect,
even though some consumers may cut themselves while wielding the knife.
In determining whether a product's risk of injury is the type that could
make the product defective, the Commission considers the following:
1. What is the utility of the product? What is it supposed to do?
2. What is the nature of the injury that the product might cause?
The kitchen knife is supposed to have a handle so you can use the knife
safely; if the knife has no handle and you have to grip the cutting edge
to use the knife, this would constitute a possible defect.
3. What is the need for the product? Could you possibly cut food
without a knife?
4. What is the population exposed to the product and its risk of
5. What is the Commission's experience with the product?
6. Finally, what other information sheds light on the product and
its pattern of consumer use?
If the information available to the company does not reasonably support
the conclusion that a defect exists, the firm need not report to the
Commission. However, since a product may be defective even if it is
designed, manufactured, and marketed exactly as intended, the company
should report if it is in doubt as to whether a defect exists.
If the information obtained by the company supports a conclusion that
the product has a defect, the company must then consider whether the
defect is serious enough that it could create a substantial product
hazard. Generally, a product presents a substantial number of units or
if the possible injury is serious or is likely to occur. Because most
companies seldom know the extent of public exposure or the severity of
the injury when a product defect first comes to their attention, the
company should report to the Commission even if they don't know whether
a substantial product hazard exists.
Section 15 lists the statutory criteria for determining a substantial
product hazard, including the pattern of defect, the volume of defective
products distributed in commerce, and the severity of the risk to
consumers. Any one of the following factors could indicate the
existence of a substantial product hazard:
1. Pattern of defect. The defect may stem from the design,
composition, content, construction, finish, packaging, warnings and/or
instructions accompanying the product. Or, conditions may exist under
which the defect presents itself.
2. Number of defective products distributed in commerce. A single
defective product could be the basis for a substantial product hazard
determination if an injury is likely or could be serious. By contrast,
a few defective products posing no risk of serious injury and having
little chance of causing even minor injury, ordinarily would not be
considered to present a substantial product hazard.
3. Severity of risk. A risk is considered severe if the injury
that might occur is serious or likely to occur. Likelihood of injury is
determined by considering the number of injuries which have occurred,
the intended or reasonably foreseeable use or misuse of the product, and
the population group exposed to the product, (such as children, the
elderly, and the handicapped).
A substantial product hazard may exist when a product does not comply
with an applicable consumer product safety rule, provided this lack of
compliance creates a substantial risk of injury to consumers.
A. Company Reports
A company is considered to have knowledge of product safety information
when such information is received by an employee or official of the firm
who may reasonably be expected to be capable of appreciating the
significance of that information. Under ordinary circumstances, five
(5) days is the maximum reasonable time for that information to reach
the chief executive officer or other official assigned responsibility
for complying with the reporting requirements. Weekends and holidays
are not counted in that timetable.
The Commission will valuate whether or when a firm should have reported.
This evaluation will be based, in part, on what a reasonable person,
acting under the circumstances, knows about the hazard posed by the
product. Thus, a firm shall be deemed to know what it would have known
if it had exercised due care ascertaining the accuracy of complaints or
A company should report to the Commission under section 15 within 24
hours of obtaining information which reasonably supports the conclusion
that a product does not comply with a product safety rule or contains a
defect which possibly could create a substantial risk of injury to the
public. The company may report a substantial product hazard to the
Commission even while its own product investigation is continuing.
If the company is uncertain as to whether the information is reportable,
the firm may elect to spend a reasonable time investigating the matter,
but no evaluation should exceed then (10) days unless the firm can
demonstrate that a longer timetable for the investigation is reasonable.
If a firm elects to conduct an investigation to decide whether it has
reportable information, the Commission will deem that, at the end of ten
(10 ) days, the firm has received and considered all information which
would have been available to it had a reasonable, expeditious, and
diligent investigation been undertaken.
B. Information To Be Reported
A company calling the Commission (301- 504-0608) to report a potentially
defective product should be prepared to provide some general and
background information; however, no company should delay its report
because some of the vital information has not been complied. The
following information should be transmitted to the Commission by
a. Description of the product.
b. Name and address of your company, whether you are a
manufacturer, distributor, importer or retailer.
c. Nature and extent of the possible product defect.
d. Nature and extent of injury associated with the product.
e. Name, address and telephone number of the person informing the
f. To the extent such information is reasonably available, the data
specified in Section 1115.13(d) of the Commission's regulations
interpreting the reporting requirements.
C. Retailer and Distributor Reporting
Retailers and distributors may satisfy their reporting obligations under
section 15 either by telephone (301-504-0608) or by writing the Division
of Corrective Actions, Directorate for Compliance, U.S. Consumer Product
Safety Commission, Washington, D.C. 20207. Alternatively, the retailer
or distributor may transmit a letter to the manufacturer or importer
describing the defective or non-complying product and forward a copy of
that letter to the Division of Corrective Actions at the address listed
above. Retailers and distributors also must report information received
from another firm about a defective or non-complying product handled by
the retailer or distributor. Similarly, a distributor or retailer
receiving product hazard information from a manufacturer or importer
should report to the Commission unless the manufacturer/importer advises
that the CPSC has already been notified.
from the CORRECTIVE ACTION HANDBOOK
U.S. Consumer Product Safety Commission
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