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 document must be established for each type of device and include or refer to the device specifications and production processes?
Answer: Device Master Record (DMR)
The Device Master Record (DMR) must be established and maintained for each type of device and includes all specifications and procedures required for production.
A medical device manufacturer discovers that a nonconforming product was inadvertently distributed. According to 21 CFR Part 820, this event most likely triggers which procedure?
Answer: Recall and field action procedure
Distribution of nonconforming product requires activation of recall and field action procedures under 21 CFR Part 820.100 and related sections.
Which 21 CFR Part 820 requirement mandates that manufacturers establish procedures to ensure that purchased or received product conforms to specified requirements?
Answer: Purchasing controls (§820.50)
Purchasing controls under §820.50 require that manufacturers evaluate and select suppliers and establish procedures to ensure incoming materials meet specified requirements.
According to 21 CFR Part 820, how long must a manufacturer retain the Device History Record (DHR) after the last date of manufacture?
Answer: 2 years or the expected life of the device, whichever is greater
21 CFR §820.180 requires that records be retained for a period equivalent to the expected life of the device or 2 years from the date of release, whichever is greater.
Management review under 21 CFR Part 820 must be conducted with sufficient frequency to ensure that the quality system is:
Answer: Suitable and effective for its stated purposes
§820.20 requires management review to be conducted with sufficient frequency to ensure the quality system remains suitable and effective.
Under 21 CFR Part 820, which entity has primary responsibility for establishing, implementing, and maintaining the quality system?
Answer: Management with executive responsibility
§820.20 places responsibility for establishing and maintaining the quality system on management with executive responsibility.
A manufacturer's internal audit reveals that sterilization validation records are incomplete for a finished device. Under 21 CFR Part 820, this finding is best classified as:
Answer: A nonconformance to be addressed through CAPA
Incomplete validation records represent a quality system nonconformance that must be addressed through the CAPA process per §820.100.