Quality System Regulation Flashcards

Under 21 CFR Part 820, which of the following is a key difference between corrective action and preventive action (CAPA)?

Answer: Corrective action addresses existing nonconformances; preventive action addresses potential nonconformances

§820.100 distinguishes corrective action (eliminating causes of existing nonconformances) from preventive action (eliminating causes of potential nonconformances).

A manufacturer identifies a trend in field complaints suggesting a component is failing at an elevated rate. Under 21 CFR Part 820, the most appropriate initial response is to:

Answer: Initiate a CAPA investigation to determine root cause

§820.100 requires that quality data sources, including complaints, be analyzed to identify existing and potential causes of nonconforming products, triggering a CAPA investigation.

Under 21 CFR Part 820, labeling and packaging operations must include controls to prevent which specific risk?

Answer: Mislabeling and mix-ups during labeling operations

§820.120 requires procedures to prevent mislabeling and labeling mix-ups, including inspection of labeling for accuracy before distribution.

Which of the following best describes the role of statistical techniques in 21 CFR Part 820?

Answer: Should be established where appropriate to verify acceptability of process capability and product characteristics

§820.250 requires manufacturers to establish and implement procedures for identifying valid statistical techniques where appropriate for process control and product acceptance.

A manufacturer wants to make a change to an approved production process. Under 21 CFR Part 820, which step is required before implementing the change?

Answer: Following documented change control procedures including verification or validation as appropriate

§820.70(b) requires that changes to production processes be documented and reviewed, with verification or validation as appropriate before implementation.

Under 21 CFR Part 820, which of the following is NOT required to be included in a complaint investigation?

Answer: The name of the FDA investigator assigned to the complaint

§820.198 specifies that complaint investigations must determine device conformance, MDR reportability, and corrective action needs — there is no requirement to document an FDA investigator's name.

Under 21 CFR Part 820, traceability requirements for implantable devices must ensure that each device can be traced to:

Answer: The specific patient implanted, where required

§820.65 requires that implantable devices be traceable to the patient who received them, to support effective field corrections and recalls.