According to the QSR, which requirement is NOT included in the record of complaint investigation?

The correct answer highlights the omission concerning changes in procedures that correct quality problems when it comes to recording complaint investigations under the Quality System Regulation (QSR).

According to QSR guidelines, documentation related to a complaint investigation must include the nature and details of the complaint, the dates and results of the investigation, and any communication made to the complainant. While the QSR emphasizes the importance of addressing and documenting complaints thoroughly, it does not specifically mandate that records must include details about changes made to procedures as a result of the investigation.

This focus is primarily on understanding the complaint itself and how it was handled rather than detailing remedial actions taken afterward. Therefore, including changes in procedures does not fall under the immediate requirements for documenting a complaint investigation, making it the correct choice in this context. Documentation practices may certainly include updates from investigations, but they are not explicitly required in the formal record of the complaint investigation itself.