From Wikipedia,
the free encyclopedia
A Quality Management System
(QMS) is a system that outlines
the policies and procedures
necessary to improve and control
the various processes that will
ultimately lead to improved
business performance. One of their
purposes is
quality control in
manufacturing.
Although it may seem obvious
that quality systems are
necessary, many small or start-up
companies function, or attempt to
function, with only some areas
covered. A survey performed in
1988 indicates the breadth of the
systems established within the
biopharmaceutical industry. The
table below summarizes the systems
and the percentages of the
respondent companies that had
established these systems. The age
of the company and the industry
had some effect on the
extensiveness of the quality
function activities . It is clear
that testing is the primary
emphasis. This supports the
observation that testing or QC is
perceived, at least in the
beginning, as the emphasis of the
quality function.
In manufacturing industries,
statistical process control is
a vitally important methodology
used to control quality. This is
important in the
Six Sigma quality management
scheme, pioneered by
Motorola.
Concept of Quality - A Historical
Background
The concept of quality evolved
from inspection, measurement, and
testing, which had been in
practice for many, many years.
Long ago, an artist or a sculptor
took pride in his work and as a
result always tried to excel in
what was created. Mass production
systems brought the concept of
inspection by someone other than
the craftsman in the first half of
the 20th century.
Application of statistical
control came later as a result of
World War production methods.
Quality Management Systems are the
outgrowth of work done by
W. Edwards Deming, a
statistician, after whom the
Deming Prize for
quality is named.
Quality, as a profession and
the managerial process associated
with the quality function, was
introduced during the second-half
of the 20th century, and has
evolved since then. No other
profession has seen as many
changes as the quality profession.
The quality profession grew
from simple control, to
engineering, to systems
engineering. Quality control
activities were predominant in the
1940s, 1950s, and 1960s. The 1970s
were an era of quality engineering
and the 1990s saw quality systems
as an emerging field. Like
medicine, accounting, and
engineering, quality has achieved
status as a recognized profession.
Current Good Manufacturing
Practice
According to Current
Good Manufacturing Practice (cGMP)
medical device manufacturers
should use good judgment when
developing their quality system
and apply those sections of the
Food and Drug Administration
(FDA) Quality System (QS)
Regulation that are applicable to
their specific products and
operations,
21 CFR 820.5 of the QS
regulation. Operating within this
flexibility, it is the
responsibility of each
manufacturer to establish
requirements for each type or
family of devices that will result
in devices that are safe and
effective, and to establish
methods and procedures to design,
produce, and distribute devices
that meet the quality system
requirements.
FDA has identified in the QS
regulation the essential elements
that a quality system shall embody
for design, production and
distribution, without prescribing
specific ways to establish these
elements. Because the QS
regulation covers a broad spectrum
of devices and production
processes, it allows some leeway
in the details of quality system
elements. It is left to
manufacturers to determine the
necessity for, or extent of, some
quality elements and to develop
and implement specific procedures
tailored to their particular
processes and devices. For
example, if it is impossible to
mix up labels at a manufacturer
because there is only one label to
each product, then there is no
necessity for the manufacturer to
comply with all of the GMP
requirements under device
labeling.
Drug manufactures are regulated
under a different section of the
CFR:
21 CFR 211.
Quality Management
Organizations and Awards
The
International Organization for
Standardization's
ISO 9000 series describes
standards for a QMS addressing the
processes surrounding the
design,
development and delivery of a
general
product or
service. Organisations can
participate in a continuing
certification process to
demonstrate their compliance with
the standard.
The
Malcolm Baldrige National Quality
Award is a competition to
identify and recognise top-quality
U.S. companies. This model
addresses a broadly based range of
quality criteria, including
commercial success and corporate
leadership. Once an organisation
has won the award it has to wait
several years before being
eligible to apply again.
The
European Foundation for Quality
Management's
EFQM Excellence Model supports
an award scheme similar to the
Malcom Baldrige Award for European
companies.
In Canada, the
National Quality Institute
presents the 'Canada
Awards for Excellence' on an
annual basis to organisations that
have displayed outstanding
performance in the areas of
Quality and Workplace Wellness,
and have met the Institute's
criteria with documented overall
achievements and results.
The Alliance for Performance
Excellence is a network of state,
local, and international
organizations that use the
Malcolm Baldrige National Quality
Award criteria and model at
the grassroots level to improve
the performance of local
organizations and economies.
NetworkforExcellence.org is
the Alliance web site; browsers
can find Alliance members in their
state and get the latest news and
events from the Baldrige
community.
Reference
ICH1 Guidance E6: Good Clinical
Practice: Consolidated guideline
