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Inside Dental Technology

February 2013, Volume 4, Issue 2
Published by AEGIS Communications


Finding Competitive Edges

Become DAMAS-certified to build confidence in current and future customers

By Nick Azar

All dental technicians are confident about their skills and know they provide excellent service to their clients while also assuring compliance with the law. But how can they make both existing and potential customers aware of the many benefits they have to offer?

The dental laboratory is the glue for the delivery of quality dental care. Without the skillset of the dental technicians in the laboratory, where would dentistry be today? The requirements set forth in the Dental Appliance Manufacturer Audit System (DAMAS) are based upon the sound quality system management principles specified in ISO (International Organization for Standardization), but they are geared specifically for the dental laboratory setting.1

Why DAMAS?

Becoming a DAMAS-certified laboratory will give your customers peace of mind and can be the crucial deciding factor for those choosing a laboratory. The DAMAS specifications can be a great asset to your laboratory by:

Improving workflow and efficiency
Improving customer service and management disciplines
Providing a competitive edge (less than 1% of laboratories in North America are DAMAS certified)
Reducing labor inefficiencies and material waste
Reducing risk and liability
Provide traceability throughout the whole manufacturing process
Most importantly, improving the ability to increase profitability and save time

The standards required by DAMAS closely mirror the FDA’s Quality System/Good Manufacturing Practice (QS/GMP) specifications, which are required of all dental laboratories conducting business in the United States. By complying with the DAMAS requirements, you demonstrate that you can manufacture patient-specific dental appliances in compliance with the US Code of Federal Regulations.1

What are the management system requirements?

The following management system requirements are aimed at achieving dental client satisfaction by preventing nonconformity at all stages of dental appliance manufacture. It is also aimed at providing sources of objective evidence that will allow a third party to assess the dental laboratory’s conformity with the specification requirements.

Who should comply?

Any person who designs, manufactures, fabricates, assembles, or processes any medical device that is suitable for use or capable of functioning—whether it is packaged, labeled, or sterilized—should comply, by defining, documenting (in writing or electronically), and implementing a Quality Management
System (QMs).

How Can I Implement the DAMAS System?

There is obviously some work for the laboratory to undertake, but this will be minimal and generally consist of gathering information, for example, on suppliers and subcontractors.

A laboratory can hire a DAMAS-approved trainer/consultant to train the laboratory and its personnel on how to fully integrate the system into your daily operations. Once your laboratory has integrated the processes, the laboratory must go through a third-party audit to ensure compliance with the DAMAS specification standards. This gives your laboratory outside verification that the business is doing what it intends to do relative to quality assurance.1

If you are looking to improve your laboratory’s efficiency, reduce waste, improve customer service, provide a competitive edge, reduce risk, increase profitability, and—most importantly—provide a formal process to help meet FDA QS/GMP requirements, you are encouraged to go through DAMAS-compliance requirements. Certification of your quality system proves to your existing customers that you are meeting a recognized standard, and DAMAS certification can certainly be used to attract new ones.

References

1. National Association of Dental Laboratories. DAMAS: Dental Appliance Manufacturers Audit System. Available at: www.nadl.org/DAMAS.cfm. Accessed December 18, 2012.

Nick Azar is a DAMAS consultant, business strategist, executive coach, and founder of Azar & Associates. For inquiries, Nick can be reached at nick@azarandassociates.com.

DAMAS REQUIREMENTS

Management Responsibility
The laboratory shall define and document its commitment with a formal public quality policy and objective statement. The laboratory shall appoint a management representative to ensure that the requirements are maintained.

Management System
The laboratory shall establish, document, and maintain a dental appliance manufacturing system. It shall retain copies of US Code of Federal Regulations, and shall be registered as a DAMAS participating dental laboratory with the National Association of Dental Laboratories (NADL).

Review of Client’s Requirements
The laboratory shall ensure that dental clients’ requirements are defined and documented.

Patient Contact Materials
The laboratory shall identify and maintain a record of patient oral cavity materials selected by the laboratory for use in the manufacture of dental appliances. The laboratory shall evaluate and select subcontractors/suppliers on their ability to supply the materials selected, and the laboratory shall maintain a documented procedure for purchasing those selected materials to ensure that incoming purchased materials conforms to the purchase order description and that is not damaged.

Defined Manufacturer Processes
The laboratory shall document the dental appliance manufacturing processes ensuring the appliance is manufactured by a suitable competent person, and patient contact materials are processed in compliance with the supplier’s instructions.

Training
The laboratory shall establish and maintain procedures for identifying training needs, and personnel shall be verified as competent to carry out assigned work.

Maintenance and Calibration of Equipments
The laboratory shall ensure that equipments and measuring devices are suitably maintained and calibrated where appropriate.

Cleanliness
The laboratory shall establish and maintain suitable procedures for daily, weekly, and monthly cleaning of the facility and equipment.

Documented Review of Final Product
The laboratory shall ensure that each appliance is given a final inspection by a competent person to complete the evidence of conformance with the client’s specified requirements.

Defined Handling and Packaging
The laboratory shall establish and maintain procedures for handling, storage, packaging, preservation, and delivery of finished dental appliances.

Control of Records
The laboratory shall establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records.

Statement
The laboratory shall draw up a Statement of Conformity.

Labeling
The laboratory shall ensure that each dental appliance is suitably labeled as specified in US Code of Federal Regulations.

Complaints
The laboratory shall establish and maintain a documented system for the effective handling of customer complaints and report of dental appliance nonconformities.

Internal Audits/Management Review
The management system shall be internally audited to ensure compliance with planned arrangements. The laboratory shall annually review the dental appliance manufacturing system to ensure continuing suitability and effectiveness in satisfying the requirements
of the laboratory management specifications.

For more information on DAMAS, visit: dentalaegis.com/go/idt332


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