Quality Management System
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.
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.
Quality Gurus
There are several individuals
widely recognized for their
contributions to quality.
W. Edwards Deming
Joseph M. Juran
Phil Crosby
Tools Used to Monitor and
Improve Quality
One of their purposes is
quality control in
manufacturing.
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.
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
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