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 quality metric would BEST measure the overall effectiveness of a dental laboratory's quality management system over time?
Answer: First-time quality rate (percentage of cases accepted without remake or adjustment)
The first-time quality rate measures the percentage of cases that meet specifications on the first attempt, directly reflecting the effectiveness of the lab's quality processes.
Under FDA oversight, what distinguishes a 'medical device report' (MDR) from a routine customer complaint in a dental lab?
Answer: MDRs are required when a device malfunction could cause or contribute to serious injury or death
MDRs are mandatory reports to the FDA when a device malfunction could cause or contribute to a serious injury or death if it were to recur.
A dental lab conducts a gauge repeatability and reproducibility (GR&R) study. What does this study assess?
Answer: The variability contributed by measuring instruments and technicians to overall measurement variation
A GR&R study quantifies how much of the total observed variation in measurements is due to the measurement system (gauge repeatability) versus operator differences (reproducibility).
Which practice BEST demonstrates 'quality by design' in the development of a new type of dental prosthetic at a laboratory?
Answer: Identifying critical quality attributes and design controls early in the development process
Quality by design means systematically identifying critical quality attributes and incorporating design controls early so that quality is built into the product rather than tested in afterward.
A dental lab's SOPs have not been reviewed or updated in four years. Which ISO 13485 requirement is most likely being violated?
Answer: Document control requirements for periodic review and updating of documents
ISO 13485 requires that documents be reviewed and updated as necessary to ensure they remain current, accurate, and appropriate for their intended use.
When performing final inspection on a fixed partial denture, which acceptance criterion is most directly tied to patient safety?
Answer: The restoration is free of voids, cracks, or sharp edges that could injure tissues
Structural defects such as voids, cracks, or sharp edges pose direct risks of tissue injury, fracture, or restoration failure, making them the highest-priority safety acceptance criteria.
A dental laboratory implements a 'quality manual.' What is the primary purpose of this document?
Answer: To describe the scope of the quality management system and how its elements are implemented in the lab
A quality manual describes the scope of the QMS, references relevant procedures, and explains how the organization meets applicable quality system requirements.