The Benefits of becoming a DAMAS registered laboratory.

Date posted: May 3, 2016

 

What is DAMAS?

The Dental Appliance Manufacturers Audit Scheme (DAMAS) is a quality assurance management system, similar to systems such as ISO 9001, but has been simplified and tailored specifically towards the dental industry. It provides the opportunity for laboratories to become certified as a laboratory that is in compliance with the law.

There are many benefits to being able to call yourself a DAMAS laboratory:

Retaining clients:

As more and more clients, (particularly bigger corporate clients) look for a straightforward way to select their labs, some are now specifying that they will only use labs with such proven registrations (DAMAS).

The potential to attract new clients:

As the number of DAMAS laboratories continues to grow, when seeking out new laboratories to try, clients will know at a glance that you have proven your labs compliance to the law and a commitment to quality.

Promotion for your laboratory:

Once registered your laboratory will be published on the DAMAS website, making it easier for people to find you.

Peace of mind:

Knowing that your laboratory is in conformity with the requirements of the MDD and MDR, for you and your clients.

A simple to follow management system:

A simple system to help ensure the smooth day-to-day running of your business.

CPD:

After having implemented the system and passed your first external       audit, you and your staff will be eligible to receive verifiable CPD.

Becoming DAMAS Registered:

There are a few routes that you can take to start the process:

Using the DAMAS Specification as a guide implement your own system.

Buy in the DLA DAMAS Implementation System and follow the guidance provided to implement the system.

If you have already bought the DAMAS folders from the DLA, but feel you do not have the time to implement the system yourself or would like more support, a DAMAS Consultant can come into your laboratory and implement your system for you.

For more information on any areas about becoming DAMAS registered or for more details on the amount of CPD you could claim as a DAMAS laboratory please feel free to contact the DAMAS office, via the DLA on 0115 925 4888 or email to info@damas.co.uk

 

The importance of effective purchasing

Date posted: March 29, 2016

 

All laboratories, need some kind of purchasing system in place to keep on top of their ordering. Maintaining an effective purchasing system can make a huge difference to the smooth running of your laboratory.

There are many ways of recording your purchasing, as DAMAS laboratories will know, recording what you order on one of the provided formats can make this process much simpler.

In order to keep track of what you have ordered, some form of purchase order record will be required.

A good purchase order form will allow you to easily record the following:

Opening the order:

– Which supplier you are ordering from

– What it is you are ordering

– When you have placed the order

– How you placed the order

After the order has been placed:

– Whether the order was received

– When the order was received

– Whether it was complete (or had things on back order for example)

– Whether items have been substituted for other items

– Whether any items need chasing up

When orders are received having a purchase order to make additional notes on is always very useful for traceability purposes, recording of lot and invoice numbers.

Evaluating new materials or processes?

Date posted: March 22, 2016

 

Are you thinking of introducing a new material or process such as CAD CAM or Flexible Dentures into your lab?

It is a good idea, regardless of whether you are a DAMAS laboratory or not, that you take time to effectively evaluate new materials and processes, before fulling implementing them.

New materials:

Common reasons for introducing new materials:

– Recommendations

– A favourite material has been discontinued

– A new process or technology requires specific materials

New processes:

Common reasons for introducing new processes:

– A new technique to make an existing process easier

– A modern, time saving technology

– The expansion of laboratory product lines

– The expansion of the laboratory as a whole

– Frequent requests for a certain type of appliance have made the introduction worthwhile

Apart from doing research before committing, conducting thorough evaluations is key to ensuring that the new process or material will work within your laboratory.

An important thing to remember is that you should (and already will, if you are a DAMAS lab) maintain lists of approved materials and suppliers. If at any point the new product is included in an appliance for a genuine patient case, the material must be added to the approved materials list. There is a material / process evaluation form provided with the DAMAS system for you to fill out as part of your evaluation process.

So what is the DAMAS Consultancy Service?

Date posted: March 8, 2016

 

Some laboratories may find the idea of setting up the DAMAS system themselves a daunting task, or they may simply feel that they do not have the time to do it.

The first and most efficient step to becoming a DAMAS laboratory is buy the system folders from the DLA. Once you have received your folders, you can either choose to implement the system yourself, before booking your initial external audit, or have one of our consultants implement it for you.

A typical DAMAS Consultancy:

If you choose to have a consultant come in to your lab to help set up your system, it takes typically the same length of time as an initial audit, but this can vary depending on a number of factors, for example the size of the lab, number of staff, number of manufacturing areas undertaken.

Consultants will require a tour of your laboratory, information about your current materials, suppliers, subcontractors and staff members, as well as what your current procedures are.

Our team are all well practiced at implementing these systems, so shouldn’t need to take up too much of your time, the real advantages are having peace of mind that the system is set up correctly and not having to spend a lot of your own time away from the business yourself to do it. As well as implementing the system for you, a guide as to how to use the system fully will be provided and the consultant will be available, during and after the implementation if you have any queries.

DAMAS in a day helps prospective labs get the system started and of to a flying start.

If your lab isn’t yet DAMAS registered, why not contact us for more information?

You can contact us about any aspect of DAMAS by calling us on 0115 925 4888, or emailing us at info@damas.co.uk.

 

DAMAS – What to expect from you laboratory audit

Date posted: March 23, 2015

 

The prospect of having your systems inspected can be quite daunting so to try and allay your fears below is a brief overview of what you can expect to happen on your DAMAS inspection day.

Most laboratories are choosing to purchase an off the shelf system from the DLA which guides you through the implementation stages. It is very important that your laboratory procedures comply with each clause of the DAMAS Specification and it is important to remember that simply buying the ‘DAMAS Implementation System’ from the DLA is not enough to prove compliance.

Once you have implemented all of the procedures to comply with DAMAS you need to check that it actually satisfies the requirements. This check is called internal auditing. What you may find by undertaking this internal audit is that not everything is being done correctly – this is called a nonconformity. Don’t worry about getting nonconformities just fix them and make sure they don’t happen again. Once you have one internal audit under your belt, you should carry out a management review which should determine if your system has been compromised by the number of nonconformities found.

When you are satisfied that your system meets the requirements of DAMAS, and you have a minimum of three months records, you may then apply to have your audit.

On the day of the assessment, the assessor will explain what will happen during the day. They will then assess your system for conformity with the DAMAS requirements. This will be done by examining samples of your records and assessing if these are sufficient to demonstrate conformity. The assessor will need a tour of your laboratory to look how your processes are undertaken which will include amongst other things, booking in, booking out and final inspection.

The assessor will take lots of notes and ask different questions about all different aspects of your manufacturing processes. Don’t worry about this. The assessor has to make records of their assessment so that random checks may be made to ensure that assessors are doing the job correctly!

When the assessor has finished, they will confirm any nonconformities they have found. It is up to you to fix nonconformities. In some instances, the assessor will guide you in the right direction but there are limitations on what guidance they can give. In all circumstances the assessor will let you know how to complete any paperwork which puts right any nonconformities that are identified.

In most cases, the assessor will find nonconformities of a minor nature that can be quickly fixed and that are not a cause for concern. The assessor will advise you that, in their opinion, your system meets the DAMAS requirements and that they will be recommending your registration as a DAMAS laboratory.

The DLA will confirm your DAMAS registration in writing and provide a copy of the DAMAS logo which may be used to promote your DAMAS status and on your lab stationery and lab tickets. It is also worthwhile writing to your clients to tell them about your success and that you now have independent proof that you are complying with the law, namely the Medical Devices Regulations and Medical Devices Directive. This is principally what DAMAS is about!

 

 

Oasis Dental Care

Date posted: December 19, 2014

 

It has come to the attention of the DLA that if you are an accredited supplier of Oasis Dental Care you may have received a letter from Oasis stating that you need to become a British Bite Mark member and either a DAMAS UK or ISO 9001 accredited member.

We wanted to let you know the easiest way to become DAMAS accredited, and inform you of the auditing time period which is required by DAMAS, as well as how simple it is to become a British Bite Mark member.

DAMAS

Firstly, becoming DAMAS accredited. The Oasis letter stipulated a deadline of 1st April  2015 to become DAMAS accredited. In order to meet this deadline you will need to look at implementing DAMAS now, as the DAMAS auditors require a 10-12 week auditing period. For instance, say we audited your laboratory on 10th March 2015 – in this case we would need to review your records from 10th December  2014.

The DLA is aware that many laboratories, although wishing to implement the DAMAS system, often struggle to put the basics in place. Therefore the DLA has designed a DAMAS Implementation System that is much easier and less time consuming in the initial stages to implement. This system has been designed for lab owners by lab owners and has been successfully implemented by hundreds of dental laboratories.

As with all quality systems, there will still be work to do to meet the DAMAS requirements, but the main bulk of the system will be set up for you in advance. The DAMAS Procedures Manual, which is the main area of the system, is already compiled for you – all you need to do is fine-tune it to ensure it describes what happens in your laboratory.

The ‘DAMAS Implementation System’ consists of:

  •  DAMAS Procedures Folder
  •  DAMAS Records Folder
  •  DAMAS CD
  •  DAMAS Procedures Implementation Checklist
  •  DAMAS Record Keeping Checklist
  •  DAMAS Ongoing Work Checklist
  •  Booklet – DAMAS Explained
  •  Booklet – MDD Explained

 

As well as having all the information you need to hand, included as part of the package is unlimited telephone and email support from the DLA office. 

It is our advice to book your DAMAS audit in as soon as possible for March/April, as DAMAS audit dates will be allocated on a first come first served basis. In order to meet the oasis deadline you need to have had your audit on or before the 1st April 2015. 

Please allow at least 10 weeks’ notice to book your DAMAS audit.

The DLA office is closed for Christmas on 21st December at 12.30pm and re opening on 5th January at 9am .

If you decide that you want to be DAMAS accredited, please give the DLA office a ring on 0115 9254888 and they can talk you through the different options.

The British Bite Mark

Secondly, it is very simple to become a British Bite Mark member. The idea of the British Bite Mark was of a logo that identified custom made dental appliances manufactured in Britain. According to ‘Made in Britain’ research carried out in 2011, the British public was confused about which products were made in the UK. The DLA felt this was equally true for dental patients in the UK, who were receiving complex dental treatment without knowing where the appliances in their mouth had come from and to what standards they had been manufactured.

Therefore the DLA launched the British Bite Mark as a trademark that would help patients and professionals easily recognise that their custom made dental appliances had been manufactured in Britain to a set of high standards.

In terms of becoming a British Bite Mark member, this is FREE to all DLA members assuming you meet the criteria below:

I hereby certify that all custom made medical devices manufactured by the above named business are compliant with the rules of the Medical Devices Directive and the General Dental Council and that we are member of the Dental Laboratories Association.

In addition I accept that all products manufactured at this address meet the requirements of the British Bite Mark meaning that they have been wholly manufactured on site or have been subject to a substantial change at this site in the last phase of manufacturing.

The DLA office is closed for Christmas on 21st December at 12.30pm and re opening on 5th January at 9am .

If you have any further questions, give the DLA office a ring on 0115 9254888.

Yours sincerely,

The DLA team