Quality Control & Industry Standards Flashcards
7 cards from real CDC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Control & Industry Standards flashcards as text
What is the primary purpose of a Certificate of Conformance (CoC) accompanying dental materials from a supplier?
Answer: To document that the supplied lot meets specified quality requirements
A Certificate of Conformance declares that a specific lot of material meets all agreed-upon quality and specification requirements.
In dental ceramics manufacturing quality control, 'firing curve validation' ensures that:
Answer: Time-temperature profiles produce ceramics with target physical properties
Firing curve validation confirms that the specific time-temperature profile used will consistently produce ceramic with the desired strength, translucency, and fit.
Which standard provides the framework for quality management systems in medical device manufacturing that a dental ceramic producer might follow?
Answer: ISO 13485
ISO 13485 specifies quality management system requirements specific to medical devices, making it the applicable standard for dental ceramic manufacturers.
A dental laboratory notices a pattern of porcelain chipping on posterior PFM restorations from a specific technician. The FIRST quality control step should be:
Answer: Conduct a failure analysis to identify the specific cause of chipping
Failure analysis must precede corrective action to determine whether the cause is technique, material, design, or another factor.
Color measurement using a spectrophotometer in a dental laboratory quality program provides which advantage over visual shade matching?
Answer: Objective, repeatable numerical color data independent of observer variability
Spectrophotometric measurement produces objective numerical L*a*b* values that are reproducible regardless of lighting conditions or observer differences.
What is 'metamerism' in the context of dental ceramic quality control?
Answer: A phenomenon where two colors match under one light source but differ under another
Metamerism occurs when two objects appear to match under one illuminant but look different under another, a critical issue for verifying dental ceramic shade accuracy.
In a quality audit of a dental ceramic laboratory, 'objective evidence' refers to:
Answer: Documented information that can be verified as true based on facts
Objective evidence consists of verifiable data such as records, measurements, and observations — not opinions or claims — that confirm quality system compliance.