According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the:

The correct focus on documenting the re-testing and re-evaluation of nonconforming devices after rework activities in the Device history record aligns with the requirements of the Quality System Regulations (QSR). The Device history record is a compilation of records that pertains to a specific device batch or lot, capturing all manufacturing, inspection, and testing information, as well as any deviations and corrective actions taken. This ensures traceability and accountability for each device.

In the context of rework, when a device is found to be nonconforming, any subsequent testing or evaluation performed to verify its conformance post-rework must be meticulously documented in this record. This documentation is critical—it provides evidence that the device meets the necessary regulatory and quality standards before it can be released for distribution.

The Device master record, while important, contains information related to the specifications, manufacturing processes, and instructions for producing the device, but it does not encompass the transactional history of individual devices. The Quality manual serves as a high-level document that outlines the overall quality policies of an organization rather than focusing on specific product records. The Design history file pertains to the design controls and documentation related to the design and development of a device, which would not typically include post-manufacturing activities like re-testing