RAC Quality System Regulation 3 — Questions and Answers
Question 1: Under 21 CFR Part 820, the Design History File (DHF) must contain or reference which of the following?
- All records necessary to demonstrate that the design was developed in accordance with the approved design plan (Correct answer)
- Only the final design output specifications
- Manufacturing records for the first production lot
- Post-market surveillance data only
Correct answer: All records necessary to demonstrate that the design was developed in accordance with the approved design plan
§820.30(j) requires the DHF to contain or reference all records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of Part 820.
Question 2: Which 21 CFR Part 820 section specifically addresses the requirement to identify, document, validate, and monitor software used as part of production or quality systems?
- §820.30 — Design controls
- §820.70(i) — Automated processes (Correct answer)
- §820.40 — Document controls
- §820.250 — Statistical techniques
Correct answer: §820.70(i) — Automated processes
§820.70(i) requires validation of software used in production or quality systems, including establishing protocols for changes to that software.
Question 3: When a manufacturer transfers a design to production, 21 CFR Part 820 requires which activity to ensure the device can be produced using the approved design?
- Design review
- Design verification
- Design transfer (Correct answer)
- Design validation
Correct answer: Design transfer
§820.30(h) requires design transfer procedures to ensure that the device design is correctly translated into production specifications.
Question 4: A manufacturer receives a complaint that a device caused patient injury. Under 21 CFR Part 820, the complaint file must include all of the following EXCEPT:
- Date the complaint was received
- Identity of the complainant
- Name and address of the manufacturer's CEO (Correct answer)
- Results of the investigation
Correct answer: Name and address of the manufacturer's CEO
§820.198 requires complaint files to include the complaint date, complainant identity, device identification, investigation results, and corrective action — the CEO's identity is not required.
Question 5: Under 21 CFR Part 820, which type of device is EXEMPT from design control requirements?
- Class I devices that are not life-sustaining or life-supporting and have no substantial risk (Correct answer)
- Devices manufactured in quantities fewer than 1,000 units per year
- Class II devices with a 510(k) clearance already in place
- Class III devices manufactured by small businesses
Correct answer: Class I devices that are not life-sustaining or life-supporting and have no substantial risk
§820.30(a) exempts certain Class I devices — specifically those not life-sustaining or life-supporting, not for a use substantially important to health, and not presenting a risk of serious injury — from design control requirements.
Question 6: Under 21 CFR Part 820, corrective actions must be verified or validated to ensure they are effective. This verification must be:
- Performed by the quality manager only
- Documented (Correct answer)
- Completed within 30 days of identifying the nonconformance
- Approved by the FDA prior to implementation
Correct answer: Documented
§820.100 requires that the activities related to corrective action, including verification of effectiveness, be documented.
Question 7: A manufacturer's calibration program must include which of the following according to 21 CFR Part 820?
- Calibration intervals, calibration standards traceable to national standards, and out-of-calibration records (Correct answer)
- Daily calibration of all equipment regardless of use frequency
- Calibration by a FDA-certified third party only
- Calibration logs reviewed quarterly by FDA inspectors
Correct answer: Calibration intervals, calibration standards traceable to national standards, and out-of-calibration records
§820.72 requires calibration procedures, calibration intervals, traceable standards, and documentation of calibration activities including out-of-calibration findings.
RAC Quality System Regulation 3
Under 21 CFR Part 820, the Design History File (DHF) must contain or reference which of the following?