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Copyright © 2007
by the NADL
Journal of Dental
Technology.
All rights reserved.
January 2007
WHAT IS DAMAS ?
Part
1 of 12
By
David G Lawrence
The answer to the question what is quite simple, DAMAS is a GMP system. This leads to the next question, what is a GMP system? GMP means Good Manufacturing Processes.
Most laboratory owners and technicians will immediately reply, “we have good manufacturing process systems.” In most cases this is absolutely correct. A laboratory could not survive in this very competitive field without disciplined processes.
The next question is, why then do I need a GMP system?
Firstly
because the U.S. Food and Drug Administration has legislated that every dental
laboratory within the
DAMAS is the only GMP system that is prepared solely for the dental laboratory industry. It was originated and written by laboratory owners and technicians for the specific purposes of satisfying the legislative requirements and, more importantly, to offer a system that produces an economic return to the laboratories that adopt its principles.
It is also the only laboratory specific GMP system that is certified by an internationally accredited independent certification authority .
The FDA has inspected several laboratories in order to assess their compliance to the GMP requirements. In most cases the results of those visits have not been the happiest of experiences. Because DAMAS-approved laboratories are certified and therefore have proven system controls it is almost certain that future FDA inspections will concentrate on non-DAMAS certified laboratories.
There is another international certified system available namely ISO9001:2000, however this is a general standard applicable to all from manufacturing industry to accountants, lawyers etc. Many of the requirements for certification are over and above those required to satisfy the GMP. It is also far more expensive .
DAMAS concentrates on the actual hands-on processes within the laboratory. The activities are written into a series of procedures without being too prescriptive. A good technician does not need a detailed procedure telling him or her step-by-step how to fabricate the work, the procedure does indicate the basic steps involved.
The procedures also cover areas such as maintenance, customer complaints/returns and purchasing. It has been proven time and again that if you analyze the cause of returns, complaints, vendor problems, reason for maintenance etc. great economic and manpower savings can result. There are many instances where, even in very small laboratories, the DAMAS system has recovered its cost within the first 12-month period and continues to bring savings.
DAMAS
has proven to be so successful in the
In summary: DAMAS is a GMP system that satisfies the FDA legislation also bringing the additional benefits of:
q
Certification by an independent international registration authority.
q
Improved
efficiency and productivity.
q
Reduce
waste of materials and manpower.
q
Application
of good management disciplines.
q
Increased
customer confidence.
q
Insight
into company operation form different perspective.
q
Help
to meet customers’ needs.
q
Provides
competitive edge.
q
Potential
for increased profitability.
q Reduce risk and liability.
After leaving college with a BSc metallurgy, David G Lawrence spent many years in the laboratory and manufacturing and aerospace industries culminating in nine years as director responsible for quality, technical and laboratory issues within a large organisation with branches throughout Europe and the far East involved in medical device, engineering and aerospace manufacturing. In 1993, he formed his own business as consultant for management systems with particular emphasis on medical device issues within Europe and