IJCA - Volume I - Flipbook - Page 58
58 The International Journal of Conformity Assessment
3) Identification and Traceability
The organization should identify the product with
appropriate means, if applicable, throughout all
stages of product realization. The organization
shall identify the condition of the product
in relation to monitoring and measurement
requirements. If traceability is a requirement, the
organization must manage and record the unique
identification of the product.
4) Customer Assets
The organization should pay attention to customer
assets that are under its control or use. The
organization must identify, verify, protect, and
maintain customer assets used as products or
provided for making products. If a customer asset
is found to be lost, damaged, or inappropriate to
use, it should be recorded and reported to the
customer.
5) Preservation of Products
The organization must ensure that product
suitability is maintained during the internal
process as well as until the product is delivered
to a designated destination. This should include
identification, handling, packaging, storage, and
protection. This should also apply to product
components.
6. Overview of Product Liability Measures for Small
and Midsize Enterprises.
It is necessary to establish an appropriate system
that can respond to product responsibility in the
company from an enterprise-wide perspective, and
to improve consciousness that is required from top
management to all employees, including lines and
staff.
To this end, by introducing the ISO 9001 system,
the company’s quality management system will be
improved to the next level. As a result, it is possible
to establish a system that can supply reliable and
safe products to the market.
In other words, adopting and implementing ISO
9001 helps to maintain a quality management
system that produces products with high stability.
Furthermore, product liability measures cannot be
considered without introducing such a system. The
obvious difference between the two is that ISO 9001
is an arbitrary system, while product liability has
compulsory power by law. Therefore, management
by ISO 9001 is an important means until a product
liability problem occurs. Once a lawsuit is filed for
2022 | Volume 1, Issue 1
a defective product, countermeasures based on the
product liability law are required.
In particular, it is essential to perform tasks based
on the product liability concept from the design
stage, which is the initial stage of the product. To
prevent design defects, the latest legal standards
and technical information of each country should be
obtained and adapted.
Companies should also re-review all in-house
product safety standards (i.e., design standards,
stability evaluation standards). This includes experts
in charge of product safety, such as those in charge
of product safety propulsion or the stability of the
check predecessors that are assigned. At the same
time, allow an assuming sense of responsibility by
clarifying the duties of the relevant sector.
The design method used by the majority of industry
professionals should be adopted, and the reasons
for design adoption and change should be carefully
reviewed to avoid risks that can occur according to
product liability. The design should be evaluated
from the viewpoint of stability and the stability
should be tested to ensure the results are reflected.
Because evaluation result data and test result data
are essential matters in litigation, they should be
sufficiently checked and managed. Above all, the
focus should be on the safety design considering
human engineering.
To prevent manufacturing defects, safety design
should be done. Safety designs incorporate several
important steps—including purchase, manufacturing
process, inspection, shipment, distribution, end use,
and disposal.
Technology for safety improvement should be
researched and developed and an independent
department for quality control and stability
management should be established.
Safety audits also should be conducted and
encompass every aspect of safety management.
Best practices in safety management should
be informed by data collected during design,
development, and manufacturing and by interlocking
with the ISO 9001 system.
In addition, the full management of test and
inspection equipment such as measurement
equipment, and the management system of
production equipment, should be re-reviewed to
ensure that functions are possible with a focus on
safety management.
The fundamental methodology to prevent
product liability problems hinges on building and
implementing a comprehensive system that can
respond rapidly and effectively.
At present, many companies are ISO 9001-certified.
Even with an ISO 9001 certificate, it does not mean
a company’s liability is exempted in the event of
a problem caused by product liability. However, if
a quality management system or documentation
of the quality system is already prepared, and if
the work is carried out accordingly, it will be a
very important means in implementing measures
according to product liability.
Conducting a product liability audit allows a
company to gauge whether its organization or
quality system is suitable for preventing product
liability. Through professional diagnosis by an
audit team consisting of lawyers and technicians
specializing in product liability, it is possible to
learn about product liability prevention and system
improvement in preparation for litigation.
Diagnosis will be conducted focusing on whether
the product liability organization has been properly
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maintained, whether its operation functions
organically and smoothly, and whether it is familiar
with the types and formats of documents.
Responding to the Product Liability Act using
the PDCA (plan-do-check-act) concept, which
is based on the above methodologies, is
ultimately considered a safer and more effective
countermeasure for small and midsize enterprises.
Author Bio:
Gilbert Gong, Ph.D., serves as president of the
Institute of Global Certification (IGC) and as
president of Global Personnel Certification Co.,
Ltd. (GPC), a management system and personnel
certification body in Seoul, South Korea. He is also
a professor at Inha University in Incheon, South
Korea, and an ISO lead auditor and QMS inspector
for medical devices. Dr. Gong, who has authored
several books and journal articles, received
his doctorate in chemistry from the Technical
University of Berlin in Germany and a degree in
chemical engineering from Chung-Ang University
in Seoul.
