. Rewards for Information on Incident. Rewards
usually lead to information as to the identity of the
violator and result in ending further incidents.
. Fees for Packaging Consultants. Since it is impossi-
ble for every company to have employees who are
experts on every contingency, outside consultants
will be required to assist in meeting the challenge.
. Cost of Legal Counsel to Respond to Litigation. Self-
explanatory.
. Damage Awards Where Determined in Court. See
above.
The list can go on. Many of these costs will be incurred
even in false claims of possible product tampering.
When compared to the potential expense for defending
a single claim of tampering, the cost of effective tamper-
evident packaging becomes insignificant. Some in the
industry will take the moral position that we have an
obligation to protect the consumer and they are right.
Beyond the moral position is the reality that many firms
simply cannot afford the cost of responding to product
tampering claims, especially if the firm is a small, with a
very limited product line where the reputation of the
entire product line can be affected by adverse publicity
on one item in the product line. Liability insurance cannot
restore lost-customer confidence.
A recent incident, later determined to be suicide, al-
most caused a household name brand to go out of business
because of the high cost of produced recall and package
redesign, even though the product and company were
linked to the incident only by circumstance.
In considering cost, the cost associated with responding to
one claim of product tampering far exceeds the cost of
incorporating tamper-evident features in the package de-
sign. Would you want to explain to your boss how your
companycouldnotaffordthepennyortwoformakingeach
package tamper-evident, and how you can afford the 10
million dollars or more your company is spending on defend-
ing a claim of possible product tampering? Who can put a
value on human life that would justify not using effective
tamper-evident packaging? The reality is, tamper-evident
packaging should be utilized if it will provide any protection
for your product, regardless of government regulation.
SELECTING WHICH FEATURE TO USE
Everyone has a preference for one type of package over
another. This preference has been developed by either the
products we manufacture or our experience with various
types of packaging in our everyday living. Selecting which
feature to use should not be affected by these preferences, but
by objective testing during the package development stage.
During the design stage, the package engineer should
consider the function of the product and how the consumer
intends to use it. Next, each TE feature that is usable on
the package should be tested to determine which feature
will offer the greatest protection to the consumer. The test
used should be objective, consistent, and replicable. Re-
cords of the test results should be retained indefinitely. If a
feature selected for use achieves a lower value than others
that were rejected, reasons for the selection should be
recorded and retained with the test results. Remember,
cost cannot be a factor in selecting which feature to use.
You would not want to be questioned by attorneys for the
other side as to why you were willing to accept less
effectiveness to save a few pennies and to compare those
few cents to the value of injury to a consumer.
One form of testing the effectiveness of tamper-evident
packaging is the Rosette Protocol, which measures the
degree of difficulty in violating a specific package and
restoring it to a nearly original condition. The Protocol
also measures increases in effectiveness through the use of
multiple features. The value for a specific combination of
features is not equal to the sum of each feature. Some
factors cover the combination, rather than each feature
separately. For example, the knowledge factor is applied
once, regardless of the number of features in the combined
package, and only one knowledge level was required. Time
is cumulative; if it takes 20 min to violate each feature, the
time required is not the value for 20 min multiplied by the
number of features used on the package. In this example
the time factor is the value for 1 h. Only one category of
equipment may be required if all tools or equipment
required to violate the different features in the combination
are in the same class. The feature visibility values for all
used on multiple feature packages are multiplied; even the
use of multiple features that are not shelf-visible increases
the effectiveness of the package. The feature material is
added for each feature replaced or reused to determine the
feature material value. The value of the feature, used with
the specific package components, on the specific product
and form of product tested, is the sum of all the factors.
The FDA and the Non-prescription Drug Manufac-
turers Association have expressed concern that the in-
dustry would gravitate to the feature achieving the
highest score in any testing procedure. In reality,
the value for a specific feature will vary, depending on
the exact product and all other packaging components
used in a specific package. The same feature from different
manufacturers may achieve different values, because
there
are slight variations
in design and manufacture,
even though the features may appear to be identical. If a
value were to be established at 20 on a scale of 0–50 for a
single feature, the value of 20 could be attained through
the use of multiple features if necessary. This would
preclude any single feature from becoming the industry
mandated method to provide protection. The above value
of 20 is for illustration purposes only; prior testing has
shown the minimum design for FDA acceptance to be
around 11, with some minimum values for approved
features scoring much higher. A standard requiring 20
as the minimum value would require most packages to be
improved before the package would meet the standard.
The use of multiple features can result in a value higher
than 50. While the Rosette Protocol has been tested and in
use for several years, there are others that may be as
objective and in use by other companies.
Certain tamper-evident features in use today, and
approved for use by the FDA, are at best window dressing.
Such features can be violated without the use of tools of
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