Lawrence Hall Consultants - Specialists in DAMAS consultancy
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DAMAS questions and answers as published in the JDT Online

 

What is DAMAS?

How can Damas help me manage my laboratory better?

How can Damas help me save money?

How can Damas improve my relationship with my dentist/clients?

Will Damas force me to run my laboratory like someone else's laboratory?

What are the top three reasons why I should become a Damas laboratory?

How much does it cost to become a Damas laboratory and what return will I see on my investment?

I've heard becoming a Damas laboratory will mean the FDA will inspect my laboratory, is that true?

Can Damas improve my productivity?

What steps are involved in becoming a Damas lab?

How has DAMAS impacted laboratories in the United Kingdom?

How will Damas improve quality at my laboratory?

 

 

What is DAMAS?

The answer to the question “what is Damas” 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 FDA have legislated that every dental laboratory within the USA must operate such a system.  In order to comply with this legislation the system elements should be in written procedure form.

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 purpose 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 have inspected several labs 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 lab, the activities are written into a series of procedures without being too prescriptive. A good technician does not need a detailed procedure telling him step by step how to fabricate the work, the procedure does however 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 by analyzing 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 labs, 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 UK that many labs operating the system receive a 30% discount on their annual liability insurance.

In summary :What is Damas”  it is a GMP system that satisfies the FDA legislation also bringing the additional benefits of

    1. Certification by an independent international registration authority
    2. Improved efficiency and productivity
    3. Reduce waste of materials and manpower
    4. Application of good management disciplines
    5. Increased customer confidence
    6. Insight into company operation form different perspective
    7. Help to meet customers needs
    8. Provides competitive edge
    9. Potential for increased profitability
    10. Reduce risk and liability

  

How can DAMAS help me manage my laboratory better?

Like any GMP system Damas is designed for two main purposes, firstly to satisfy national or local regulatory requirements and secondly, and perhaps more importantly, to provide definite benefits to the laboratory. Damas was devised by laboratory owners and technicians who understand all aspects of this competitive industry.

Damas places the focus on hands-on activities within the laboratory and suggests methods of improving or streamlining them. A general description of the lab’s activities is described in procedures and encourages the investigation of the causes of problems.

For instance remakes; we are all aware that remakes are unavoidable, time consuming and, therefore, expensive.  Damas suggests and provides a simple system for the recording of remakes and an investigation into the most common causes.

If you can eliminate just one remake a week, that could save you thousands of dollars a year. Damas provides the means to accomplish this in even the smallest of laboratories without creating mounds of paperwork or time consuming input.

Once a common cause has been established Damas provides the means to take corrective and preventive actions which result in economic savings to the lab in both materials and manpower.

Damas will also enable you to reduce the time in dealing with complaints and their causes, by an active approach to preventive action, providing you with more time to actually run your laboratory. A satisfied customer is a happy customer.

The same Damas philosophy applies to all other areas of the lab functions.  In an article written by Mark Jackson of Precision Ceramics Dental Laboratory in Montclair, Calif. Mark states that after implementing Damas he is saving from $300 to $500 per month on his maintenance costs.

By addressing common causes of problems that may occur within the laboratory, Damas ensures that, overall, a better product is consistently produced and problems become highlighted at an early stage.

Damas also encourages active participation by all laboratory employees, creating an atmosphere of shared responsibility.   It never ceases to surprise us how enthusiastically most technicians embrace the Damas concept and how valuable their input and observations prove to be.

Damas provides the means for labs, whatever size, to control all processes, also to easily gather and process the necessary data to ensure a more efficient, cost effective and therefore more profitable operation without excessive paperwork or manpower input.

Damas is re-certified on a yearly basis and a certificate showing compliance is issued to the laboratory.  Each certified lab is able to display the Damas logo on documentation and web sites as evidence of its commitment to excellence and customer care.

 

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How can DAMAS help me save money?

This is the $64,000 question.  I wish we could say this is the amount Damas will save you each year!  It could depending upon the size of your lab, customer base and application of the system

Realistically the savings to be made by adopting the Damas system are more modest, but, none the less, quite substantial. Each laboratory is different and not every lab will find a saving from the same place.

Damas focuses on the working practices within the lab and identifies those activities that can be improved and those where savings can be made. This improvement may mean changing the method of manufacture, materials used, the level of expertise of the technician, or other factors. Damas examines all processes and, where necessary, provides the means for more efficient production

The system also ensures that what is now called “ownership” is introduced.  Basically this means that each technician accepts responsibility for the work he does. This really does encourage the concept of “right first time”, thereby reducing the number of minor adjustments or rework required during the manufacturing process.  The cost savings based on materials and time are more than significant

The Damas system also concentrates on returns and remakes from the dentist.  By investigating returns and identifying the most common causes vast savings can be made.  The simple reduction of a few remakes each month can save you thousands of dollars a year.

The same principles apply throughout all lab functions, from receipt of the work through to packaging and dispatch including administration, purchasing and maintenance of equipment. Damas provides simple systems that have been proven time and again to produce significant savings. Problems are identified at an early stage enabling prompt and less costly resolutions

As a GMP system Damas also ensures that the lab can be seen to be operating Good Manufacturing Processes; this not only meets the obligatory FDA requirement for dental laboratories but also assures the dentist that his confidence in the lab is fully justified. A lab that can show evidence of certification to a universally recognized GMP will attract a larger number of customers

In the UK many Damas certified laboratories enjoy a 30% reduction in their liability insurance premiums; this in itself represents a substantial sum

You may own a smaller lab and feel that much of the above does not apply.  I can assure you that even in 2 to 3 person labs the Damas system has produced very significant savings and smoother working practices

Whatever the size of your lab the Damas system can produce major savings in time and money. 

Better use of management time allows you to focus on the real ways forward.

 

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How can DAMAS improve my relationship with my dentist clients?

What is good client relationship based upon?  From the client’s point of view there must be many factors involved in the answer to this question; some of these surely include trust, consistent quality of product, easy and honest communication, reliable delivery times, prompt and concerned action regarding complaints/remakes and, of course, cost.

The Damas system considers all of these in a manner that is relevant to each individual laboratory.   What is right or the best system in one laboratory may not be applicable in another. The whole purpose of Damas is to create an efficient, quality conscious, reliable production and management system, whatever the size of the laboratory. This does not mean vast amounts of paperwork or time within the laboratory.

The first step of Damas implementation is the examination and review of existing systems and practices with the purpose of improving the efficiency, smooth running and profitability of the business.   An example of this is the handling of client complaints and returns.

Over a period of time complaints and returns are analyzed and the most common causes identified.   These may be found to be the fault of the laboratory or, perhaps, the unjustified criticism of an unduly critical or awkward client (I am sure most of us have examples of these).

Where the problem is found to be the fault of the laboratory actions are taken to eliminate or correct the cause.  The cause may be quite simple or may result in actions such as re-sourcing process materials, replacing/refurbishing laboratory equipment or providing a technician with more training.   It may mean an honest face-to-face discussion with the client.

Whatever the cause, once it has been resolved the beneficiaries are the client and the laboratory owner.  If the laboratory was found to be responsible the client will be assured that he receives a consistent quality of product from this point forward with far fewer reasons for complaint or return.  If the client was found to be over critical the face-to-face discussion will, hopefully, result in a better understanding and an improvement on his part.

Does the laboratory continually miss “due by” dates?  Is an unacceptable amount of work returned for adjustment?  If so, why?  These are matters that are irritating to the client leading to a loss of good client relationship. 

The Damas system ensures that every aspect of the laboratory’s processes are reviewed from the receipt of  work,  administration, manufacturing, through to packaging and delivery, resulting in a system that provides a reliable and consistent service;  a service in which the client can confidently place his trust.

A Damas laboratory can show its Certificate and use the Damas logo on all paperwork as visible evidence to the client that the laboratory has been independently certified thereby demonstrating professionalism, reliability and assured quality.  What better basis for first class client relationships?

I am sure we all agree that client confidence is of paramount importance and value.  Such confidence is so difficult to build and even easier to lose.  A client’s confidence is worth possibly thousands of dollars a year.

 

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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. 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.   It also 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 experience of 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 to 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.

 

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What are the top three reasons why I should become a DAMAS laboratory?

There are so many reasons why a dental laboratory should become Damas certified that it is difficult to select the top three, however in my opinion three very important reasons are listed below.

The first or top reason in my opinion is to introduce a system which has proven time and again to bring economic benefit to the labs that adopt it.

Damas was developed by laboratory owners and technicians specifically for dental labs. It focuses on the really pertinent issues within each lab with the intention of bringing savings in all areas including manufacturing time, use of materials, basic systems and, as a result, dollars.

It has been proven so many times that laboratories certified to the Damas system benefit from economic savings, this has been shown to be true of labs of all sizes within the USA, Canada, the UK and Europe. In many cases the resulting cost savings are very significant.

In the UK Damas certified labs have been able to obtain a 30% reduction in their insurance premiums.  In the USA a lab in California has reported in the JDT that savings of $300 to $500 per month are being made since the introduction of Damas, in another large lab, a saving of over $100,000 was achieved in the first year.

The second reason is that, because Damas certification is issued by an international certification authority, your professionalism, commitment to excellence and quality of work is proven for all to see

At the time of certification the lab is presented with a Damas certificate and is also able to display the Damas logo on all paperwork , the certification process is undertaken by an international certification authority. 

Confidence in the laboratory, the quality of work and the relationship with the lab are perhaps the most important aspects in the dentists mind at the time of placing his work. Of course cost is also one of his considerations.

If he knows that, his concerns or complaints are handled in a professional caring and efficient manner and that the quality of work is of paramount importance to all involved, he is far more likely to select that lab. All of these are proven to him by the Damas certification

The third reason must be the fact that Damas meets the obligatory requirements of the FDA GMP regulations for dental laboratories.  This regulation means that all laboratories must be able to show that they have systems with written procedures covering the relevant sections of the FDA GMP specification CFR Part 820

Damas satisfies the FDA GMP requirement in the least painful most efficient way by identifying the relevant sections,  including them within the system and also presenting them in the required format

Systems other than Damas can satisfy the FDA GMP requirement but Damas is the only industry produced system that can be certified by an independent international certification authority.  ISO:9001 can be certified but is a system produced to cover all types of industry and businesses, it is very dictatorial, requires a great deal of time to maintain and is far more expensive

Damas doe not tell you how to run your lab or how to manufacture the product, it does lead to financial benefits.

 

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How much does is cost to become a DAMAS laboratory and what return will I see on my investment?

There are three basic charges involved in the Damas certification process.

The first cost is $150 which is the application to the NADL.  In return for this you will receive the Damas information pack.

The second cost is the consultation fee.   As a general rule this is set at $4000 for the larger sized labs;  however, Lawrence-Hall Consultants Ltd realize that in many instances, especially in the smaller labs, this is a major sum and we are therefore more than happy to discuss individual terms with each lab. This can result in staggered payments or reduced base charges.

We also run small lab training sessions.   Basically this means that if a group of labs in any one area are each prepared to send a representative to attend 3 or 4 separate one day training sessions over a period of time, the charge can be greatly reduced.  The consultants will explain the DAMAS system in detail and spend one on one time with each representative.

The third charge is to the independent certification authority, AJA Registrars, situated in Orlando, Florida.  Their charges are also dependant upon the size of the lab.  An estimate of the charge can be obtained from Mr Ray Kirton, Registrar, at 407/306-8193 or by fax at 407/306-8189.

In the case of lab groups, both the consultancy and certification fees are negotiable dependent upon the number of labs within the group. 

The returns on your investment come from many directions.   Every laboratory is different, but the majority of those seen by consultants have said that they very quickly covered the DAMAS costs by the savings they made.

Mark Jackson of Precision Ceramics Dental Laboratory - Montclair, CA has stated within the JDT that he has made actual savings of $300 to $500 per month since DAMAS certification.  In the UK, DAMAS many certified laboratories enjoy a 30% reduction in insurance premiums. 

One of the aspects of the DAMAS system is to encourage the lab to concentrate on the cause of problems.   As an example consider remakes - a saving of $100 a week on remakes will return $5000 a year, this has easily been achieved in many labs. By controlling material usage and keeping waste to a minimum vast savings can be realized.

The DAMAS consultant does not tell you how to run your lab, but he does have the responsibility, using the knowledge and experience gained over many years in labs and other industry worldwide, to advise on the different methods of approaching various tasks.

It is surprising how in any circumstance in or out of working life, because we are so familiar with current practices/methods, we miss an opportunity for change or improvement;.   An outside view is, more often than not, beneficial.

I cannot tell you exactly how much return you will see on your investment.  I can tell you however, that whatever size your lab if Damas is applied correctly you will see a substantial return.

 

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I've heard becoming a DAMAS laboratory will mean the FDA will inspect my laboratory, is that true?

This is most definitely not true.  Every laboratory, whether based within the USA or off shore, producing dental appliances for the USA market must satisfy the relevant sections of the obligatory FDA Good Manufacturing Processes (GMP) requirements, these are detailed in the FDA document CFR Part 820. All dental laboratories are liable to be subjected to an FDA inspection.

There is no more reason why the FDA should select a Damas certified laboratory than any other laboratory for an inspection, in fact the reverse is most probably the case.  The Damas system meets the requirements of the FDA GMP, the laboratory can show evidence of satisfying this requirement by means of their registration as a Damas certified organization.

Damas certification is undertaken by an internationally accredited registration authority, namely AJA Registrars. This 3rd party certification which is commonly known as a systems audit, is conducted according to strict international guidelines by qualified and registered auditors. The same auditing rules also apply to any labs having achieved ISO9001 certification.

Once certified to Damas the lab is presented with a certificate of registration. Both AJA Registrars and the NADL hold a record of all Damas certified laboratories.

When one considers the large number of dental labs within the USA it becomes obvious that for the FDA to inspect them all is a massive task. I would suggest that any lab demonstrating compliance to the FDA GMP requirement by means of 3rd party certification would be the least likely to be included into the FDA inspection program.

Of course, should a laboratory, whether Damas certified or not, show just cause for an FDA inspection by for instance, malpractice, then an FDA inspection would be mandatory. One of the advantages of Damas certification is that systems are in place to ensure that such a circumstance should not arise.

Should the FDA prove my assumption incorrect by selecting a Damas certified lab for inspection, the systems needed to meet the GMP requirement are not only in place but are proven by the 3rd party audit to be satisfactory. 

The only labs that have to worry about an FDA inspection are those who do not have a proven GMP system and do not meet the obligatory GMP requirement.

 

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Can DAMAS help me improve productivity?

The answer to this question is yes it most certainly can.  Will it? is entirely dependent upon the individual laboratory and their application of the system. Like every other tool Damas is as good as the person or persons using it allow it to be.  When applied correctly the Damas system is proven to improve most areas of your business                                                                                                       

Damas is a GMP (Good Manufacturing Processes) system, it is based upon tried and proven quality systems with the added benefit of being adapted specifically for dental laboratories. It was originated by laboratory owners and technicians for the purpose of meeting obligatory regulatory requirements and, more importantly, bringing value and financial advantage to the laboratory

During the implementation of the Damas system the consultant reviews all of the working practices, he will, where applicable, offer advice with regard to improvements or modifications to the existing systems and assist in the implementation of these

Damas does not become involved in the actual method of manufacturing; each device is unique, no two patients are identical and therefore the actual manufacturing process of their device is also unique. The technicians are highly skilled with far more hands-on knowledge than the consultant, however, the general flow of work through each department and the managerial controls involved follow a set pattern, this pattern in many instances can be beneficially improved.

Working with you and your technicians the consultant will review the controls, the documentation and the workflow and offer constructive recommendations for streamlining present systems.  The Damas system also puts in place systems to identify and reduce the main causes of problems such as those resulting in remakes and rework. By reducing the number of remakes and in-house rework the technician is able to increase the amount of billable work per day.

The same is true of all other activities within a laboratory from the receipt of the Rx and associated work, the booking-in process through to delivery of the final product, including purchasing of materials, handling customer concerns, returns, packaging, to upkeep and maintenance of equipment.

By refining methods in all areas of the laboratory the employee has more time to devote to other meaningful activities.  By improving managerial controls the lab owner frees up his valuable time allowing greater time for more productive activities or possibly, an extra round of golf.

 Every minute saved results in greater productivity and therefore financial reward. Just 10 minutes saved per technician each day equals 50 manufacturing minutes per technician each week, taken over a year this represents a great deal of time and money.

Generally in all aspects of life, what has always been done becomes established as what will always be done.  Often it takes an outside viewpoint to identify better options or methods.   All the consultants have years of experience working with dental laboratories and a wide range of other industries enabling them to offer practical and meaningful advice. Working with you they produce a system that is based on your existing methods with the refinements necessary to increase productivity.  

 

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What steps are involved in becoming a DAMAS laboratory?

There are 3 steps involved in becoming a Damas certified laboratory as explained in the following paragraphs.  Step 2 assumes that you choose to use the services of a consultant,  you may however attempt to prepare your own system, this is of course possible, however, experience shows that achieving compliance in this way is usually very long, time consuming, expensive, frustrating and usually unsuccessful: the consultant knows the “ ins and outs”.

One of the 3 main reasons for achieving Damas certification as stated in an earlier question and answer, is to satisfy the obligatory FDA GMP detailed in the FDA document CFR Part 820.  Once again the consultant has the necessary knowledge to ensure these requirements are fully satisfied.

The first step in becoming a Damas Certified laboratory is to contact the NADL and request an information pack.

The second step is to contact Lawrence-Hall Consultants Ltd to arrange a convenient date for a consultant to visit your lab. The consultant will work with you and the relevant people in the lab for 1 or 2 days, of course in larger labs the consultancy will cover a greater period of time.

The consultant will ask for a guided walk through the lab with the owner or a technician able to explain in very general terms the processes involved, this is followed by an explanation of both the Damas system and the FDA regulation. From this point on he will want to talk to various people for the purpose of preparing the Damas system.

At various times the consultant will discuss with the relevant people recommendations for amendments or modifications to the existing systems, whether these are accepted is of course your decision.  If modified systems are introduced the consultant will assist in their implementation including any staff training that may be required.  After the on-site visit of he may ask to contact you for further information etc. by telephone or email.

The consultant will prepare the final system as a hard copy quality manual together with a procedure manual including the detailed system requirements necessary to achieve certification, these will also be sent to you as a computer disc. The consultant will be prepared to visit you again at your convenience to ensure the systems are satisfactory and running smoothly. He can always be contacted and will be ready and willing to offer further help and advice.

Lawrence-Hall Consultants Ltd also run small lab training sessions; basically this means that instead of an on site visit should a group of labs in any one area be each prepared to send a representative to attend 3 or 4 separate one day training sessions over a period of time charges can be reduced.  The consultants will explain the Damas system in detail and spend one on one time with each representative.

The third step is to contact the registration authority to make application for certification, this occurs once the system has been in place for a minimum period of 3 months. The consultant can arrange this for you.  The registration authority arrange for their representative to visit you,  he will spend a day checking the contents of the system and verifying its effectiveness. Once again, should you request,  the consultant can be present to assist at this time. You then receive a certificate of registration that confirms your status as a certified Damas laboratory.

 

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How has DAMAS impacted laboratories in the United Kingdom?

Damas was introduced into the United Kingdom in 1994, the system was originated by dental laboratory owners and technicians for 2 reasons.  The first being the introduction of legislation which stated that each dental laboratory had to register with the MDA ( the medical device agency) A requirement of registration was, and still is, that the lab must show that they had in place a GMP (quality system). covering the relevant sections of the European Medical Device Regulations)  This GMP was to be in writing and available for inspection at any time. The Damas system was prepared in a manner that ensured these MDA requirements were met

The second reason was to ensure that, because labs were obliged by legislation to introduce a GMP system, there should be some material benefit for doing so.  Damas was designed to cover all aspects of the laboratory functions and offer means of improving them, the objective being to increase the efficiency, productivity and profit margins of participating labs whilst ensuring that the lab owner was not told how to run his business

An alternative route to meeting the MDA  GMP requirement was to adopt ISO9000, this was followed by a number of labs, but because it is a general standard for all industry it did not produce the additional benefits outlined in paragraph 2, it is far more expensive to implement and importantly did, and still does, tell the company how to perform certain aspects of their business

A measure of the success of the Damas system is that the labs who have adopted it in the UK are able to obtain very substantial discounts on their insurance premiums, up to 30% in many cases, also, hospitals who place work with dental laboratories, and there a large number of these,  will only select those that are certified. A leading pharmacy chain in the UK offers dentistry on the high street, this group also adopt a similar selection policy for the placement of work.

The UK has a private health care section and a national health care service (NHS) , once again the majority of dentists in the private section select certified labs for dental work.  It is possible to give many other examples of this type of benefit relating to certified dental laboratories; the certification indicates their commitment to quality, excellence and customer care

As all good and workable systems should, Damas has evolved over the 12 years it has been in existence, it has been amended several times as the industry changes, it has been proven time and again
to bring financial reward based upon the improvements the system introduces into the laboratory. 

Because there are other ways of meeting the MDA GMP requirement labs are not compelled to adopt the Damas system, and those that have done so have the option of leaving the Damas certification system or adopting an alternative such as ISO9000.  This has not happened, the benefits of Damas are so real that lab owners are more than happy to be to display the Damas Certified certificate and logo and enjoy the resulting rewards

 

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How will DAMAS improve quality at my laboratory?

There is no direct answer to this question, this is because the manufacture of each device is a unique “hands on” operation, therefore the quality of the final device is dependent upon the skill and experience of the technicians involved in its manufacture, Damas provides systems that not only support the manufacturing processes but also identifies those processes and supporting services that can be improved

Improvement may involve the selection of materials used in manufacture, information supplied to the technician, the equipment used, work flow, environment or even individual skill issues

A technician can only work within the boundaries placed upon him, if for instance, a particular manufacturing material is not quite the best for the job, then the resulting work is also not the best. Just because a material has always been used does not mean that there is nothing better. A piece of equipment may have been in use for a long while, does it still perform to its original specification?

Has the technician been provided with sufficient details?, is the work flow and scheduling well planned? are there too many rush jobs resulting in lower quality? is the technician totally familiar with current technology?.  All of these and many others are issues to be considered when evaluating the quality of work produced. The Damas system considers all aspects of the laboratory operations and offers solutions to them, In some cases DAMAS enhances what is already in place and takes what may at this time be an occasional process and makes it part of the normal working practice.

The administration and support staff play an important role in the whole process from booking in to final invoicing including purchasing, control of inventory and maintenance of equipment, if these functions are managed in a satisfactory and timely manner the work flow becomes smoother resulting in less pressure on the technicians and more productive working time

There is no quality or GMP system that can guarantee the quality of each individual product for the reasons stated in the first paragraph.   I have often been asked, then why Damas and not ISO9000?  

ISO9000 is a general standard applicable to all industries from high volume manufacturing to service industries such as lawyers, accountants etc. it is a management control system and dictates that certain management functions must take place. It is
true that some of the ISO9000 requirements are also in Damas.  But because ISO:9000 is a general standard aimed at such a wide audience it cannot focus on specific laboratory issues

The Damas system is the only quality system that is specific to the dental laboratory industry, it is a system that builds on a range of good practices gained from the experiences of many labs worldwide, all of which are available to assist the technicians who are drawn into the Damas process at all times. Damas concentrates on specific dental laboratory issues, those that not only lead to quality of product but also to economic returns

This sophisticated management and production system will build quality assurance into every facet of your day-to-day operations enabling you to maintain consistent quality standards.

 

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