Quality System Regulation Flashcards
7 cards from real RAC 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 System Regulation flashcards as text
Under 21 CFR Part 820, which procedure must address the disposition of nonconforming product, including the use of concessions (use-as-is decisions)?
Answer: Nonconforming product procedure
§820.90 requires manufacturers to establish procedures for nonconforming product, including how use-as-is or rework decisions are made and by whom.
A manufacturer uses contract manufacturers to produce subassemblies. Under 21 CFR Part 820, the primary manufacturer's obligation regarding these contractors is to:
Answer: Establish and maintain procedures to ensure they meet specified requirements
§820.50 requires establishing procedures to ensure contractors meet specified requirements; the primary manufacturer retains full responsibility for quality system compliance.
Design validation under 21 CFR Part 820 must be performed under which conditions?
Answer: Simulated or actual use conditions
§820.30(g) requires design validation to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents, using simulated or actual use conditions.
Under 21 CFR Part 820, which record tracks the production history of a specific finished device unit or lot?
Answer: Device History Record (DHR)
The Device History Record (DHR) demonstrates that each device was manufactured in accordance with the DMR and documents the production history of each unit or lot.
Finished device acceptance activities under 21 CFR Part 820 require that devices be released for distribution only after:
Answer: A designated individual reviews and approves the DHR
§820.80(d) requires that finished devices be reviewed and approved for release by a designated individual who reviews the DHR to ensure the device was manufactured in accordance with the DMR.
According to 21 CFR Part 820, environmental controls are required when environmental conditions could adversely affect product quality. Which environment typically triggers this requirement?
Answer: Cleanrooms used during assembly of sterile devices
§820.70(c) requires environmental controls where environmental conditions — such as temperature, humidity, or contamination — could have adverse effects on product quality, as in sterile device assembly.
Under 21 CFR Part 820, which of the following best describes a 'critical device'?
Answer: A device that is life-sustaining, life-supporting, or substantially important to the prevention of health impairment
§820.3(e) defines a critical device as one that is intended to be used in humans to support or sustain life, or whose failure to perform when used as intended could result in serious injury.