Page 41 - The Handbook for Quality Management a Complete Guide to Operational Excellence

28 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 29

the product that is on trial and not the manufacturer. There are several
areas in which engineering and management are vulnera ble, including
design; manufacturing and materials; packaging, installation, and appli-
cation; and warnings and labels.
Designs that create hidden dangers to the user, designs that fail to
comply with accepted standards, designs that exclude necessary safety
features or devices, or designs that don’t properly allow for possible
unsafe misuse or abuse that is reasonably foreseeable to the designer are
all suspect. Quality control includes design review as one of its major
elements, and all designs should be carefully evaluated for these short-
comings. As always, the concept of reason ableness applies in all its
ambiguity.
The application of quality control principles to manufacturing, materi-
als, packaging, and shipping is probably the best protection possible
against future litigation. Defect prevention is the primary objective of
quality control and the defect that isn’t made will never result in loss or
injury. Bear in mind, how ever, a defect in quality control is usually defined
as a non-conformance to requirements. There is no such definition in the
law. Legal definitions of a defect are based on the concept of reasonable-
ness and the need to consider the use of the product.

Environmental Issues Relating to the Quality Function

The primary connection between environmental issues and the quality
function is the ISO 14000 standard, which covers six areas:

1. Environmental management systems
2. Environmental auditing
3. Environmental performance evaluation
4. Environmental labeling
5. Life-cycle assessment
6. Environmental aspects in product standards
The 14000 series standard mirrors the ISO 9001 quality standard in requir-
ing a policy statement, top-down management com mitment, document
control, training, corrective action, management review, and continual
improvement. Plans call for integrating ISO 9000 and ISO 14000 into one
management standard that will also include health and safety. It is possi-
ble that eventually a single audit will cover both ISO 9000 and ISO 14000.
ISO 14001—the environmental management system (EMS) specifica tion—
is intended to be the only standard establishing requirements against
which companies will be audited for certification. The standard does not
set requirements for results, only for the continuous improvement of a

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