Latest DAMAS News - Dental Appliance Manufacturers Audit Scheme

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!

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 1^st 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 10^th March 2015 – in this case we would need to review your records from 10^th 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 1^st April 2015.

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

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

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

Yours sincerely,

The DLA team

Many laboratories are currently implementing DAMAS and undergoing their first DAMAS audit. 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.