December 14, 2009 at 5:31 am #53028
why QMS focus only on product ???0December 14, 2009 at 1:18 pm #187508
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Elements of QMSOrganizational Structure
Concept of quality – historical backgroundThe concept of quality as we think of it now first emerged out of
the Industrial Revolution. Previously goods had been made from
start to finish by the same person or team of people, with
handcrafting and tweaking the product to meet ‘quality criteria’.
Mass production brought huge teams of people together to work
on specific stages of production where one person would not
necessarily complete a product from start to finish. In the late
1800s pioneers such as Frederick Winslow Taylor and Henry Ford
recognized the limitations of the methods being used in mass
production at the time and the subsequent varying quality of
output. Taylor established Quality Departments to oversee the
quality of production and rectifying of errors, and Ford emphasized
standardization of design and component standards to ensure a
standard product was produced. Management of quality was the
responsibility of the Quality department and was implemented by
Inspection of product output to ‘catch’ defects.
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. Over this period,
few other disciplines have seen as many changes as the quality
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 system for medical devicesQuality System requirements for medical have been internationally
recognized as a way to assure product safety and efficacy and
customer satisfaction since at least 1983, and were instituted as
requirements in a final rule published on October 7, 1996. The U.S.
Food and Drug Administration (FDA) had documented design
defects in medical devices that contributed to recalls from 1983 to
1989 that would have been prevented if Quality Systems had been
in place. The rule is promulgated at 21 CFR 820.
According to current Good Manufacturing Practice (GMP), medical
device manufacturers have the responsibility to use good judgment
when developing their quality system and apply those sections of
the FDA Quality System (QS) Regulation that are applicable to their
specific products and operations, in Part 820 of the QS regulation.
As with GMP, 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
The 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. These elements include:
personnel training and qualification;
controlling the product design;
product identification and traceability at all stages of production;
controlling and defining production and process;
defining and controlling inspection, measuring and test equipment;
controlling nonconforming product;
instituting corrective and preventive action when errors occur;
labeling and packaging controls;
handling, storage, distribution and installation;
all overseen by Management Responsibility and Quality Audits.
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 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
Code of Federal Regulations: 21 CFR 211. However, the FDA has
instituted new policies requiring QS for pharmaceuticals.
Quality management organizations and awardsThe International Organization for Standardization’s ISO 9001:2008
series describes standards for a QMS addressing the principles and
processes surrounding the design, development and delivery of a
general product or service. Organizations can participate in a
continuing certification process to ISO 9001:2000 to demonstrate
their compliance with the standard, which includes a requirement
for continual (i.e. planned) improvement of the QMS.
(ISO 9000:2005 provides information the fundamentals and
vocabulary used in quality management systems. ISO 9004:2009
provides guidance on quality management approach for the
sustained success of an organization. Neither of these standards
can be used for certification purposes as they provide guidance,
The Malcolm Baldrige National Quality Award is a competition to
identify and recognize top-quality U.S. companies. This model
addresses a broadly based range of quality criteria, including
commercial success and corporate leadership. Once an
organization 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 Malcolm
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.0December 14, 2009 at 4:25 pm #187510
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Stan………..Are you feeling OK?0December 14, 2009 at 5:29 pm #187516
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wrong!0December 14, 2009 at 8:44 pm #187523
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