Quality System Regulation Flashcards

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?

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

According to 21 CFR 820.100(a), the CAPA process requires manufacturers to establish procedures for analyzing various sources of quality data to identify existing and potential causes of nonconforming product. Investigating the cause of the nonconformity is a critical first step before implementing any corrective actions, ensuring that the action taken is effective and appropriate.

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?

Answer: Device Master Record (DMR)

The Device Master Record (DMR), as defined in 21 CFR 820, is a compilation of records containing the procedures and specifications for a finished device. It includes device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications. The DHF describes the design history, and the DHR provides evidence that a specific batch was made according to the DMR.

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

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

21 CFR 820.30(a) specifies that design controls apply to all Class II and Class III medical devices. It also applies to a specific list of Class I devices, such as those automated with computer software and surgeon's gloves. Therefore, not all Class I devices are subject to design controls.

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?

Answer: Production and Process Controls (P&PC)

Production and Process Controls (P&PC), covered in Subpart G of 21 CFR 820, require that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. Sealing, especially for sterile products, is a classic example of a special process that requires validation to ensure it consistently meets specifications.

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?

Answer: The Device History Record (DHR)

The Device History Record (DHR), as required by 21 CFR 820.184, contains the production history for a specific batch, lot, or unit. It includes dates of manufacture, quantity manufactured, and acceptance records demonstrating the device was produced in accordance with the Device Master Record (DMR).

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

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

21 CFR 820.20, Management Responsibility, requires that executive management establish its policy and objectives for quality, and ensure the quality policy is understood, implemented, and maintained. Management is also responsible for providing adequate resources, including trained personnel, to implement and maintain the quality system. While they must review the suitability of the quality system, they are not required to perform all audits or approve every single record personally.