FREE RAC Quality System Regulation Questions and Answers

Question 1

A medical device manufacturer discovers a recurring nonconformity during in-process testing of a Class II device.
According to 21 CFR 820.100, which of the following is the MOST appropriate initial step in the Corrective and Preventive Action (CAPA) process?

Accepted Answer

Analyzing all relevant quality data to identify the root cause of the nonconformity.

Answer

Implementing a production-wide change to the manufacturing process.

Answer

Disseminating information about the quality problem to all production staff.

Answer

Immediately scrapping all affected lots of the device.

Question 2

Which of the following records serves as the comprehensive 'recipe' or set of instructions for manufacturing a specific medical device, containing all procedures and specifications for a finished device?

Accepted Answer

Device Master Record (DMR)

Answer

Design History File (DHF)

Answer

Device History Record (DHR)

Answer

Quality System Record (QSR)

Question 3

Under 21 CFR 820.30, Design Controls are required for which of the following categories of medical devices?

Accepted Answer

All Class II, Class III, and certain specified Class I devices.

Answer

All Class I devices.

Answer

Class II and Class III devices only.

Answer

All Class I, II, and III devices.

Question 4

A manufacturer of sterile surgical kits needs to validate a new packaging sealer. According to the Quality System Regulation, this activity falls primarily under which subsystem?

Accepted Answer

Production and Process Controls (P&PC)

Answer

Design Controls

Answer

Corrective and Preventive Action (CAPA)

Answer

Acceptance Activities

Question 5

During an FDA inspection, an investigator asks to see the records demonstrating that a specific lot of a finished device was manufactured in accordance with its approved specifications. Which of the following documents should the manufacturer provide?

Accepted Answer

The Device History Record (DHR)

Answer

The Device Master Record (DMR)

Answer

The Design History File (DHF)

Answer

The Quality System Audit reports

Question 6

Which of the following is a key responsibility of management with respect to the Quality System, as outlined in 21 CFR 820 Subpart B?

Accepted Answer

Ensuring that the quality policy is established and that adequate resources are provided for the quality system.

Answer

Personally performing all internal quality audits.

Answer

Authoring every standard operating procedure (SOP) for the facility.

Answer

Reviewing and approving every individual complaint file.