Will DAMAS Force Me to Run My Laboratory Like Someone Else's Laboratory?

This is the question most frequently asked with regard to DAMAS. The answer is very definitely no. DAMAS does not in any way attempt to regulate how you work

DAMAS does meet the FDA requirement for GMP systems within dental laboratories. (Editor's Note: DAMAS seeks to follow and closely mirror FDA QS/GMP standards. The FDA as a government body will not formally endorse any quality assurance process from the standpoint that it meets FDA standards. The rationale of the FDA is that its up to the business to implement the standard so the standard itself does not warrant formal recognition. However, a dental laboratory in Arkansas passed its FDA inspection earlier this year with good response and the FDA inspector cited the DAMAS system as the reason why it did so well.) However, the methods to achieve those requirements are many and varied.

The implementation process for DAMAS begins with the basic assumption that each laboratory has its own tried and proven working practices based upon individual preferences and experience. Also, that any laboratory trading successfully and profitably must in general terms be doing it right. It is unnecessary and unrealistic to try to change these established working practices.

There is no such thing within the dental laboratory industry as one size fits all. 

The FDA requirement stipulates a number of criteria that are required to be met within dental laboratories. Also, it stipulates that each of these must be described in written procedures. The DAMAS consultant ensures that these criteria are present within your system and will prepare the documented procedures in the required format based upon your working practices.

But DAMAS offers far more than that; the consultant will examine the working practices and then suggest additions or make recommendations for improvement to the various existing systems using his or her experience with many other laboratories and industries. If these suggestions are accepted and approved by the laboratory owner, the consultant  will assist in their development and implementation. These suggestions usually produce substantial rewards in the form of working time, materials management, financial savings, etc.

DAMAS does not attempt to control or change the actual manufacturing processes. How the technicians produce the device is, and must be, an individual process.   Technicians are highly skilled and work to a similar high standard to produce the product, each of which is a one off custom-made device requiring individual techniques.

In a similar way, the method of achieving the stipulated FDA GMP requirement for other activities is individual to each laboratory. As an example, the FDA GMP requires a written procedure describing purchasing and vendor selection. Once again, each laboratory has its own method of selecting vendors, placing orders, etc. 

During the implementation of the DAMAS system these purchasing methods are written as a descriptive procedure by the consultant who, having seen so many variations on a theme, can offer those worthwhile, cost saving recommendations. This does not mean that you have change what you are presently doing. 

It really is surprising how very differently laboratories of a similar size control the daily management of the essential activities. 

DAMAS concentrates on your working activities to produce a system which is individual to your laboratory based upon your existing methods.  

The consultant observes very strict rules of confidentiality; your methods are yours and will not be made known to other laboratories.