What is NOT a requirement of the QSR for manufacturers of finished devices?

The correct choice indicates that "audit operations annually" is not a specific requirement within the Quality System Regulation (QSR) for manufacturers of finished devices.

Under FDA regulations, while manufacturers are required to conduct internal audits to ensure compliance with established quality system requirements, there is flexibility regarding the frequency of these audits. The regulations do not explicitly mandate that these audits must occur on an annual basis; instead, they emphasize the effectiveness of the quality system and that audits should be conducted in a manner that best ensures ongoing compliance and risk management.

The other options reflect elements that are indeed aligned with QSR requirements. For instance, audits must be conducted by qualified individuals who are independent from the operations being audited to maintain objectivity. Furthermore, documenting the dates and results of audits is essential for traceability and accountability, as is having findings reviewed by management, which ensures that necessary corrective actions are taken in a timely manner.

Therefore, while regular auditing is important, the specific requirement to perform these audits annually is not stated in the QSR, making this the correct answer to the question.