Dental Lab Quality Management Flashcards
7 cards from real CDT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Dental Lab Quality Management flashcards as text
Which document serves as the primary reference for establishing a dental laboratory quality management system in the United States?
Answer: ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system for organizations involved in the design and manufacture of medical devices, including dental prosthetics.
A dental lab receives a crown back from the dentist because the margin is open. Which corrective action step should come FIRST?
Answer: Document the nonconformance in the complaint log
Documenting the nonconformance is the first step in any corrective action process to ensure traceability and proper root cause analysis.
What is the purpose of a 'design history file' (DHF) in a dental laboratory producing custom appliances?
Answer: To document the design and development process for regulatory compliance
A design history file documents the design and development process to demonstrate that the device was developed in accordance with the approved design plan.
A technician notices that a batch of alloy from a new supplier has inconsistent color after casting. What QMS tool should be used to identify the root cause?
Answer: Fishbone (Ishikawa) diagram
A fishbone diagram systematically maps potential causes across categories such as materials, methods, machines, and manpower to identify root causes.
Under FDA regulations, which type of dental prosthetic is classified as a Class II medical device requiring 510(k) clearance?
Answer: Removable partial denture frameworks
Removable partial denture frameworks are classified as Class II devices under 21 CFR Part 872 and require 510(k) clearance before marketing.
Which statistical process control (SPC) chart is BEST suited for monitoring the proportion of defective units in a dental lab production run?
Answer: p-chart
The p-chart (proportion defective chart) monitors the fraction of nonconforming units in subgroups and is ideal for attribute data such as pass/fail inspection.
When a dental lab undergoes an FDA inspection, which record must be available to demonstrate control of nonconforming products?
Answer: Nonconformance reports with disposition records
FDA 21 CFR Part 820.90 requires documented procedures for control of nonconforming product, including identification, documentation, evaluation, and disposition.