211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether
any changes to the established process are warranted...
Process variability should be periodically assessed and monitoring adjusted accordingly.
We recommend that the quality unit meet periodically with production staff to evaluate data, discuss possible trends or undesirable process variation, and coordinate any correction or follow-up actions by production.
Data gathered during this stage might suggest ways to improve and/or optimize the process by altering some aspect of the process or product, such as the operating conditions (ranges and setpoints), process controls, component, or in-process material characteristics. A description of the
planned change, a well-justified rationale for the change, an implementation plan, and quality unit approval before implementation must be documented (? 211.100). Depending on how the proposed change might affect product quality, additional process design and process qualification activities could be warranted.19
the point is, regulations expect you to assess same periodically ( the frequencyand criteria shall suit the purpose of the product - process - etc)