Dental Lab Quality Management Flashcards

Which type of validation is required when a dental lab introduces a new CAD/CAM milling process for producing zirconia copings?

Answer: IQ, operational qualification (OQ), and performance qualification (PQ)

A complete validation protocol for new manufacturing processes requires IQ, OQ, and PQ to confirm that equipment is installed correctly, operates within parameters, and consistently produces conforming products.

What is the primary purpose of calibration records for dental laboratory instruments such as articulators and firing furnaces?

Answer: To provide evidence that measurements are traceable to recognized standards and accurate

Calibration records provide documented evidence that measuring instruments produce accurate results traceable to national or international measurement standards.

A complaint is received stating that an implant-supported bar overdenture does not seat properly. After root cause analysis, the lab finds the digital scan file was corrupted. Under CAPA, what must be done next?

Answer: Implement a corrective action to prevent recurrence of scan file corruption in production

After identifying the root cause, the CAPA process requires implementing a corrective action to eliminate the cause and prevent recurrence, followed by verification of effectiveness.

What distinguishes a 'corrective action' from a 'preventive action' in dental lab quality management?

Answer: Corrective actions address existing nonconformances; preventive actions address potential ones

Corrective actions eliminate the cause of an existing nonconformance, while preventive actions eliminate the cause of a potential nonconformance before it occurs.

Which work instruction element is MOST critical for ensuring consistent quality when multiple technicians fabricate the same restoration type?

Answer: Step-by-step procedural details including materials, equipment settings, and acceptance criteria

Detailed work instructions with materials specifications, equipment settings, and acceptance criteria ensure that all technicians produce restorations that meet the same quality standard regardless of individual variation.

A dental laboratory is required to maintain records for a minimum of how many years for custom medical devices under FDA regulations?

Answer: 2 years

FDA 21 CFR Part 820 requires that device history records, including those for custom devices, be retained for a period of at least 2 years from the date of release for distribution.

What is the role of a 'supplier qualification' program in a dental laboratory quality system?

Answer: To evaluate and approve suppliers based on their ability to meet quality and regulatory requirements

A supplier qualification program evaluates suppliers' quality systems, certifications, and track records to ensure purchased materials and services meet the lab's quality requirements.