DAMAS Inspections – What to expect

Date posted: May 12, 2016

 

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!

 

 

DAMAS Registrations

Date posted: May 9, 2016

 

DAMAS registrations continue to increases across the UK, with the number of DAMAS registered laboratories reaching an all-time high of 420.

So what does this equate to nationally?

 

Location Number of DAMAS Registered Labs in each area
WALES 13
CORNWALL, DEVON & SOMERSET 29
WILTSHIRE, DORSET, HAMPSHIRE & ISLE OF WIGHT 21
SURREY, SUSSEX & KENT 27
GREATER LONDON 29
NORFOLK, CAMBS & SUFFOLK 17
NORTHANTS, OXFORD, BERKS, BUCKS & BEDS 18
AVON, GLOS, HEREFORD & WORCS 18
SHROPSHIRE, STAFFS & WEST MIDLANDS 39
LEICESTER, NOTTINGHAM, DERBY & LINCS 44
MANCHESTER, CHESHIRE & MERSEYSIDE 51
YORKSHIRE & HUMBERSIDE 46
LANCS & CUMBRIA 23
DURHAM, CLEVELAND & NORTHUMBERLAND 21
SCOTLAND 18
NORTHERN IRELAND 6

 

Size of DAMAS Laboratories:

Laboratory size based on number employees Number of DAMAS Registered Labs in each group
1-2 110
3-5 120
6-10 102
11-14 38
15-24 33
25-49 15
50-99 2
100-149 0
150-199 0
200-249 0
250 + 0

 

For more information on DAMAS including how to become DAMAS registered contact the DLA office on 0115 9254888.

DAMAS Internal Audits, when do these need to be undertaken?

Date posted: April 5, 2016

 

If you are already a registered DAMAS laboratory, you will know that as part of the system you need to conduct Internal Audits.

The frequency of the Internal Audits is up to you, they need to be conducted, as a minimum, annually, a little before your External Audit is due. Some laboratories choose to undertake Internal Audits quite frequently, and certainly for bigger laboratories, this can make it easier to keep on top of the system.

The purpose of the Internal Audit:

Conducting the Internal Audit gives the laboratory an accurate view and understanding of whether the DAMAS Compliance System is running effectively within the lab, and if it isn’t, why this is.

Once you have been through the Internal Audit process and recorded the findings on the internal audit format, the next thing to do is to undertake a Management Review.

The Purpose of the Management Review:

The Management Review is usually, conducted by more than one individual and follows on from the Internal Audit. The purpose is to assess the findings that arose during the Audit, and to see if any corrective action is required. If there are any issues uncovered, then a corrective action plan(s) can be formulated using this form.

 

DAMAS numbers continue to grow!

Date posted: March 10, 2016

 

The number of new labs becoming DAMAS registered continues to grow, It’s not surprising then that it is becoming the ever more popular and straightforward way for prescribers to choose which new laboratories to try out.

As ever we are travelling the length and breadth of the country to visit new and existing clients from Inverness to Cornwall, and East Yorkshire to Belfast. The number of Welsh labs alone has doubled in a little over a year!

Looking ahead we can see more and more new laboratories coming onboard, with both bookings for initial audits and DAMAS in a day Consultancy visits on the rise.

For more information about DAMAS call us on 0115 925 4888, or email us at info@damas.co.uk.

DAMAS – Hints & Tips

Date posted: November 2, 2015

 

Storing Records

As you will know, it is a requirement that laboratories retain and store their prescriptions (and many other records) for a minimum of five years.  As technology moves on and with storage space becoming more limited for some labs, new methods for storing this data effectively are becoming more common. Dentists are choosing to store and communicate more of their records electronically, with the scanning of models and more recently online prescribing methods becoming more popular.

Some laboratories are beginning to look to similar space saving ideas, one method for labs to save on storage space and reduce the risk of their records deteriorating over time, is to scan in and save their prescriptions, this enables earlier appropriate disposal of these records, thus freeing up more space in-house!

Two important things to remember for anyone thinking of going down this route is firstly to ensure the scanned in documents are clearly readable, and secondly to ensure they are adequately backed up, to avoid any losses if there are any unexpected problems such as electricity cuts, computer viruses etc.

 

 

DAMAS – HINTS & TIPS

Date posted: October 26, 2015

 

MHRA Registration – Ensuring you are up to date!

We find as we visit laboratories around the country, that sometimes their details need updating with the MHRA.

Have you moved address?

Have you changed your trading name?

If the answer is yes then you need to inform the MHRA – www.mhra.gov.uk

It is also advisable that you check that you are listed on the MHRA register as many laboratories details have been archived following the 2008 live publishing of the register.

The MHRA now has now introduced an easier access search option on their website, making it quicker and easier for you to not only check your own status and details, but also those of other laboratories. Now rather than searching alphabetically there is also the option to type in the name or MHRA number (if known) of the company you want to check, simply by clicking on the new ‘Search Registration’ tab at the top, right hand side of the page:

http://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200

Registration with the Medicines & Healthcare products Regulatory Agency (MHRA) is a legal requirement as all dental laboratories are required to comply with the Medical Devices Directive and Medical Devices Regulations.