There are several types of changes within the Monitoring and Controlling Phase of a project:
1. Non-Essential Design Change (NDC): Change to a design control document while product is still in design control
2. Design Change Number (DNC): Major change to device's Bill of Materials or other manufacturing document while device is still in design controls
3. Engineering Change Order (ECO): Change to a device after design controls are finished. Sometimes is can be the project itself.

Each of these changes can affect a project differently. Some are done while the design controls are being created and some can create impact afterwards.

Changes can be made to design control documents, SOPs, DMR, BOM, DID, DDP, DSD, verification/validation protocols, and the risk management plane. Changes will go through a design review process during which documents are reviewed, changes are made if necessary, and documents are approved. Once the document is approved, a controlled copy is updated and released.

The comments above really touched upon the different types of changes in the monitoring and controlling phase. Within larger companies typically what I have noted is that ECOs are much more common than NDCs or DNCs. With my current position there are quite a bit of ECO's that come my way through or that I generate post market data or complaints. These changes generally help the product there are some instances where the change can impact 510k submissions and a new 510k needs to be submitted.

The different kinds of changes made during the monitoring and controlling phase include non essential design changes, design change numbers, and engineering change order.
Non essential design changes involve a change to the design control document while the product is still in the design controls. Design change numbers are a major change to the device's bill of materials or another document while the device is still in design controls. An engineering change order is a change made after design controls have finished.

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.

The types of changes noted in this week’s lecture vary based on what phase of design controls the project is in. Ordering them from beginning stages to completion would be: 1. Non-essential design change (NDC), 2. Design change number (DCN), 3. Engineering change order (ECO).

Both NDC and DCN are for when the project is in the design controls phase, but NDC is used to change the design control document and DCN is to change manufacturing documents. ECO is implemented if the project has completed design controls. I would imagine ECO is much harder to go through compared to NDC or DCN.

Does anyone have experience with implementing one of these changes?