QS/GMPs - Purchasing Controls

The combination of this past month'­s release by the media of information regarding a dental appliance contaminated with lead and FDA'­s inspection of a number of U.S. dental laboratories has stirred domestic dental laboratories to ensure that their quality management program provides the assurance to their dental clients that they have met the requirements set forth by FDA'­s Title 21, Chapter I, Subchapter H - Medical Devices, Part 820 Quality System Regulation.  DAMAS certified laboratories and ISO registered laboratories should be pleased with their decisions to go the extra mile to undergo third-party scrutiny.

Under the above-referenced FDA regulation, a dental laboratory must establish a Quality System/Good Manufacturing Practices (QS/GMPs). The components of QS/GMP'­s include:

    * Determination of applicability and FDA registration.
    * Assignment of management responsibility.
    * Competency and training of personnel.
    * Defining of purchasing controls.
    * Identification and traceability of patient contact materials.
    * Production and process controls.
    * Acceptance of final product.
    * Review of non-conforming product.
    * Corrective and prevention action procedures.
    * Control of labeling and packaging.
    * Handling, storage, distribution and installation of materials and finished items.
    * Records retention and control

The quality topic this month is purchasing controls which includes:

    * Qualified suppliers, subcontractors and consultants.
    * Specifications: expected output from suppliers, subcontractors and consultants.
    * Complaints.
    * System for purchasing and receipt of materials.
    * Checking expiration dates; first-in, first out.
    * Traceability of lot numbers.
    * Environmental controls.

It is recognized that the product is the sum total of all parts and labor combined. A major component of continuous improvement is prevention of a defective/non-conforming product. Thus, one of the best controls is to ensure that the materials that make up your product meet your quality expectations. To that end, suppliers will be informed of the required specifications of the materials they provide and they will be qualified to provide them.

Subcontractor/Supplier Approval

You will want to provide each of your suppliers and subcontractors a method for assuring you that they can meet your specifications. Subcontractors and suppliers that supply materials and provide services to you must be qualified to perform them prior to hire via the selection process that is a part of the quality system. The laboratory should send a questionnaire to each vendor regarding quality issues such as length of time in business, how returns are handled, existence of a quality system, etc. Subcontractors and suppliers should agree to notify you of changes in the product or service so that you may determine whether the changes may affect the quality of a finished dental appliance.

Subcontractors, both domestic and foreign, must meet all FDA requirements including the completion of an FDA inspection of the foreign facility for the purpose of determining compliance.

A list of approved subcontractors and suppliers and the reason for doing business with each one is a part of the quality system. Information from FDA indicates that stating the reason for doing business as historical relationship is not acceptable. It is recommended that you re-quality each supplier and subcontractor every two years at a minimum. This list must be made available to FDA or a third-party certifier upon request. This list should include UPS, FedEx, DHL, private couriers, etc. because the timely delivery of the appliance is a part of most laboratories'­ quality system and service to their dental clients.

You must have a system for evaluation of the performance of your suppliers and subcontractors. Records must be maintained to document any non-conformances. This information may be recorded on a supplier complaint form.  These records will be reviewed at a minimum annually by the management review committee.

Verification of Purchased Materials

You must have procedures for acceptance of incoming materials. Upon receipt of patient contact materials for processing, each item received from a supplier and subcontractor must be verified to be conforming to the original purchase order requirements. You must have a system for recording any lot or batch number for any patient contact materials, i.e. alloys, porcelain, denture teeth, acrylic, implant components, zirconia blocks/cylinders, etc. Remember that you must track lot and batch numbers to the patient appliance as closely as possible. In the event there is a recall of a lot or batch, you must be able to trace the materials back to the patient.

 An inventory rotation system (first in, first out rule) should be utilized for storage and use of products and materials. Where the quality of the material affects the finished product, it will not be used until deemed acceptable. Material failing to meet the required specifications will be placed in quarantine. Thus, the purchasing department will label and segregate the nonconforming or unacceptable product that is held in quarantine until proper disposition is handled. Dated materials determined not usable must be removed from inventory.

Your due diligence to ensure that the materials used in the manufacture of your dental appliances is an important part of your quality system. If a subcontractor or supplier can'­t provide you with sufficient information to meet this requirement, you can be jeopardizing your liability by using those materials. Insist on a statement of assurance from each supplier and subcontractor and request the re-confirmation of the information annually.