The Art of Documentation

New concerns on complying with federal regulations may also affect certain aspects of the dentist’s Rx. One key to complying with many of these standards is audit logging of all changes to Rx information. In some cases, a full electronic signature system is required for rigorous tracking of materials and design changes to Rx information.

The exponentially growing volume of CAD/CAM scan and design data created in laboratories and dental offices has pushed manufacturing software vendors to pay more attention to how their software handles electronic data exchanges. Attention must be paid to how scan input and design output data of a dental prosthesis is managed, how dentists’ scan data is imported and exported, and how mobile technology integrates with the manufacturing software.

The following procedure applies to the control of the Rx—including those that are electronic and external. It involves requirements affecting quality such as methods, regulations, procedures, and instructions pertaining to the dental prosthesis Quality Management System (QMS).

Dental laboratories should clearly control each of the following:

1. The dentist’s work order, or Rx, by reviewing the product selected by the dentist and its compatibility with manufacturer-recommended prep design and product indications. A qualified laboratory technician then determines if there is need for an alternative product or modification of the current design. Once the modifications have been agreed upon, a Document Change Request (DCR) order is generated for dentist approval.

2. The extra elements received from the dentist that are essential to case planning success— ie, multiple impressions, study models, face-bow, etc. Such elements must be inventoried upon receipt of the case and controlled throughout the manufacturing process to ensure that they are used as required by the dentist.

3. All dentist-supplied raw materials and parts—ie, implant parts, attachments, alloys, etc. These will be inventoried at the time of receipt as to the quantities received of each type, lot number, batch number, and expiration date (if any). The inventory list should accompany the case throughout the manufacturing process, then be transferred to the final document (invoice) accompanying the finished product.

4. The steps taken in authorizing the design before initiating the manufacturing process. It is recommended that the laboratory develop a multipoint check system before the manufacturing of the product begins. The laboratory may consider validating and approving:

• the information supplied by the dentist (Rx)
• the design elements requested
• raw materials supplied by the dentist

All stages of quality control must be carried out by a skilled person who is also authorized to initiate a Document Change Request (DCR) form if needed. According to the FDA, since 1984, the major cause of device remakes and failures has been identified as a lack of quality controls.

5. All changes requested or made to the original work information (Rx) originally provided by the dentist. The recommended changes may be due to a poor impression, unclear margins, etc., but once agreed upon and approved, a Document Change Request (DCR) form will be established with the dentist’s approval and signature, along with that of the processing party who initiated the DCR form. The DCR form is a vital tool to ensure the following: that only necessary changes are made; that these changes are communicated to all affected parties (dentist, laboratory technician, and administrative staff); and that approved changes are actually carried out as agreed. 
If amendments to prescriptions are not controlled, the case schedule and budget will be destroyed before the laboratory and dentist recognize that anything has happened.

6. The outsource protocol for a complete product, or just the stage of the manufacturing process for this product when outsourced to a third-party/outsource facility. Such a protocol should include:

• the transfer of information and case design elements to the third-party or outsource facility
• the quality control measures that are in place at the third-party or outsource facility during the manufacturing process
• the quality checkpoints required once production at the third-party or outsource facility is completed and the product is returned to the originating laboratory
• the protocol to deal with rejected products that are received from the third-party facility due to nonconformity

7. The invalid or obsolete work information Rx/document to assure against unintended use. The obsolete or invalid document should be marked as “Uncontrolled” and should be segregated or disposed of as state and or federal law permits. Any obsolete documents that are kept for either legal, reference, or other purposes must be clearly identified through markings, separate storage areas, or other means, and should be marked as “Archived.”

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.

Here are some suggested metrics on how to measure the performance of your document control process, which can ultimately help determine how to drive continual improvements into your entire QMS.

User satisfaction—Periodically survey your employees regarding the usability of your documentation. Use the results to improve the format of your documents and training of your authors.

Document errors—Track the number of document revisions due to information mistakes in your documentation. Results will often reveal weaknesses in your review and proofreading processes.

Up-to-date—Count the number of document revisions or audit discrepancies stemming from a document that is out-of-date. This will tell you whether your periodic document reviews or obsolete document provisions are effective.

Cycle time—Measure the time it takes a document to be developed or revised from initial draft to release. Work to improve the efficiency of your document control process as you would any other business process.

Cost—Consider tracking the costs associated with your documentation including developing, revising, storing, retrieving, distributing, filing, auditing, reviewing, approving, etc. Of these potential costs, document retrieval is often an expensive hidden cost generated when individuals must search endlessly for a document because of inadequate indexing, organization, storage, or training.

The metrics cited above were first seen in Scott Dawson’s article on 4.2.3 Document Control, which can be found at dentalaegis.com/go/idt364