The different kinds of changes, as mentioned in previous posts, are Non-Essential Design Change (NDC), Design Change Number, and Engineering Change Order. Each one of these carry a workload in order to implement the change. All of them require following company procedures, although some such as engineering change order may also impact regulatory filings which might require following regulatory agencies processes and timelines. The regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Effective change control activities (e.g., quality planning and control of revisions to specifications, process parameters, procedures) are key components of any quality system. There are regulatory guidances that explain changes and in these guidances change is discussed in terms of creating a regulatory environment that encourages change towards continual improvement. This means a manufacturer is empowered to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle.