Will DAMAS Make My Laboratory Too Fat?

I get asked all the time if having a DAMAS certification will cause there to be too much paperwork, documentation and general overhead and expense to justify it. Here is a real world snapshot of what DAMAS, or any other GMP program, will be like once it’s been implemented in your laboratory.

Because GMP's are about process control, and not about product control, everything boils down to employee orientation and training, proper control of, and use of materials, establishing manufacturing procedures, and equipment and facilities controls. Of course customer feedback, failure reporting and management response to this information play an important role in adjusting or modifying these processes for further refinement or corrective action.

Employee Impact
Every employee should receive a proper orientation and understanding of GMP's, and their importance in the total quality process. This includes understanding company and employee responsibilities, job descriptions and training and CE expectations.
Every employee should have documented records showing that they are qualified for the job they are performing, or in a training situation that provides performance expectations and company procedure manuals (or appropriate manufacturer instruction manuals if applicable.) Any subsequent training should be documented, as should any performance reviews.

Those in positions where customer contact and feedback are recorded, should understand reporting procedures, and attend meetings and participate in data analysis. Minutes and follow up actions should be properly recorded and archived.

Case Control and Trace-ability
From the moment a custom made appliance or restoration is received by the laboratory, it should be traced from it's arrival, inspection, infection control and every stage of manufacture. Only those with demonstrated and documented qualifications should be permitted to perform those tasks. In the event of failures or contamination, some method of tracking these cases back must be in place.

Laboratory management software such as Jenmar and others can record the history or possession of a case once the case arrives, has been inspected and accepted, and can even limit the technicians who are a permitted to work on, and barcode individual tasks performed on the case.

Customer feedback and failure reporting
Customer feedback, both for quality control purposes and for tracking material failures should be made easily accommodated and facilitated and recorded, whether received orally or in writing. This can be done with simple quality control questionnaires, such as those used by many laboratories, and supplemented with a complaint log to document complaints or feedback received telephonically or by other means.

In our laboratory, we enter the feedback from the QC questionnaires into a spreadsheet to generate statistical trends and analysis, and hold bi-weekly customer service meetings to analyze entries in the complaint logs and remake and touch up reports from sales reports and production information. Of course minutes of these meetings are kept and action lists and followed up on subsequent meetings.

Equipment and facilities maintenance
Because so many of the things we do in the dental laboratory can be affected by the equipment we use, whether it is the furnaces we fire our ceramics in, to the casting machines, or acrylic processing equipment, it is very important that they are properly maintained and calibrated.

Equipment maintenance logs should be created with all critical equipment properly identified, and it's maintenance and calibration history documented. Specialized testing, certification and equipment is not necessary unless specified by the manufacturer, provided materials processed in that equipment are performing as indicated.

Cleanliness and prevention of cross contamination are all critical to accurate process control, and safety in the dental laboratory, and is therefore, an important component in maintaining good manufacturing practices. In our laboratory, each department has a posted cleaning schedule those details daily, weekly and monthly cleaning and sanitation requirements that must be met and initialed by either department heads or maintenance personnel. 

Standard operating procedures and technical instructions
FDA GMP's do not specify how a particular product or material is manufactured, but that the process is documented and monitored. For this reason, every laboratory is free to develop any system they desire, provided the steps are repeatable and documented. For those laboratories who have very specialized and highly personalized techniques, and who may use multiple, and possibly incompatible, or even contraindicated combinations of materials or procedures, this may open them up to potential liability issues in the event of post operative material failures.

This also increases the burden of the laboratory owner or manager to keep up the procedure manuals and documentation as new or different techniques, materials or processes are implemented.

For this reason, in our laboratory utilizes only the individual manufacturer instructions for each material or product that we process. This not only reduces the administrative burden of the laboratory management, but also ensures that if we experience material failures, those patients, prescribing dentists and manufacturers are protected from the possibility of potential adulteration of the material or processes used in our laboratory.

Material use and traceability
At the current time, the FDA does not regulate domestic dental appliance manufacturers, but rather the materials they use. For this reason, all laboratories must use approved materials for their intended application. Laboratories may only order materials from designated, approved vendors, and inspected and approved upon receipt by qualified individuals. In order to avoid potential contamination or adulteration by non-approved materials, a system for identification, rejection and return of these items must be established and documented.

One critical component of this system is also the traceability of potentially contaminated or recalled materials. Most laboratories use a "just in time" inventory system that places any new material received into production virtually upon receipt and acceptance.

Consequently, if a manufacturer were to notify a laboratory that they may have received a batch of recalled materials, it should be relatively easy to identify and notify any customer who may have been exposed to these materials.

In this particular case, I am making some very generalized assertions, and the FDA GMP's require a much more definitive system for material tracking, but this may give some comfort to those who fear they need an extremely intrusive system. It's also important materials are not mixed or used in a manner contraindicated by the manufacturer.

Product packaging and material disclosure
Regardless of what the GMP's may specify, I happen to believe we have an ethical obligation to our dentists and their patients to give proper material disclosure, manufacturer contact information and indications and contraindications. We take this one step further by providing customers with preparation guidelines, cementation and bonding instructions, and in the case of laboratory customers recommendations for approved veneering materials. This can be done quickly and easily on the laboratory invoice, or by using specialized packaging inserts in crown boxes or denture bags and labels.

Administrative Impact
Once the GMP system has been put in place, maintaining and auditing it become second nature. New employees will need the proper orientation and training, and systems and procedures are audited annually, but because we have bi-weekly meetings for customer service and laboratory supervisors, it seems that the annual audit is almost unnecessary, though mandated.

I'm sure there are a lot of holes in here, and this is not meant to be a super detailed discussion, but a realistic overview of what really happens here with regard to GMP's.

I don't think anyone will argue that any of these items are a waste of time. They certainly have tightened up this ship, and we run more efficiently, more professionally, and certainly more consistently.