RAC Quality System Regulation 2 — Questions and Answers
Question 1: 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?
- Device Master Record (DMR) (Correct answer)
- Device History Record (DHR)
- Quality System Record (QSR)
- Design History File (DHF)
Correct 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.
Question 2: 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?
- CAPA procedure
- Complaint handling procedure
- Corrective action procedure only
- Recall and field action procedure (Correct answer)
Correct 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.
Question 3: Which 21 CFR Part 820 requirement mandates that manufacturers establish procedures to ensure that purchased or received product conforms to specified requirements?
- Design controls (§820.30)
- Purchasing controls (§820.50) (Correct answer)
- Production and process controls (§820.70)
- Acceptance activities (§820.80)
Correct 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.
Question 4: According to 21 CFR Part 820, how long must a manufacturer retain the Device History Record (DHR) after the last date of manufacture?
- 2 years or the expected life of the device, whichever is greater (Correct answer)
- 3 years after product discontinuation
- 5 years from the date of manufacture
- The record must be retained indefinitely
Correct 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.
Question 5: Management review under 21 CFR Part 820 must be conducted with sufficient frequency to ensure that the quality system is:
- Profitable and cost-efficient
- Suitable and effective for its stated purposes (Correct answer)
- Compliant with ISO 13485 requirements
- Approved by a third-party notified body
Correct 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.
Question 6: Under 21 CFR Part 820, which entity has primary responsibility for establishing, implementing, and maintaining the quality system?
- The FDA district office
- Management with executive responsibility (Correct answer)
- The quality assurance department
- Third-party auditors
Correct answer: Management with executive responsibility
§820.20 places responsibility for establishing and maintaining the quality system on management with executive responsibility.
Question 7: 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:
- A product defect requiring immediate recall
- A nonconformance to be addressed through CAPA (Correct answer)
- An adverse event requiring MDR submission
- A design verification failure
Correct 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.
RAC Quality System Regulation 2
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?