Change to a project can have different effects on the overall project. When considering change, it must remain within the project scope. Changes cannot be made if it changes the project to the extent that it no longer meets the needs of customer, stakeholder, and business. If change requests are within the project scope, changes must be considered within the limitation of resources and time. If a project has progressed months and a change will effectively take it back to the beginning, then there becomes a balance between the risk factors in time required to make the change and in the harm if the change isn't made. There can be severe costs suffered from a company by making changes to a large project, but if making a change can also save the company heavy costs that may result from future product recalls. A financial analysis must be performed to guide the course of action, while ethical management will ultimately determines the imperatives of allowing change to take effect or not.
The first thing that should be done when looking at change requests is the reason behind them. We receive a lot of change requests on projects we work on. Some of these requests are unnecessary because one parameter was overlooked somewhere. It is critical to evaluate these change requests and make sure that they are actually needed. To do so, you have to have an overall idea of the project. Another necessary component of processing change requests is to think of alternative ways to go about solving them. Because sometimes the requests might propose an impractical or inefficient way of solving the problem. It is important to look back at them and make sure that there isn't any other more efficient way of doing things. Lastly, change requests should be looked at by multiple people to get different perspectives. This will help in the correct evaluation of the request.
If the change involves the device or the manufacturing of the device, the technical aspects of the change have to be reviewed. The most important factor will be making sure that patient health and safety will not be impacted in any way. The justification for change has to be established by evaluating the potential risks of incorporating the change, cost changes and downtime are also important aspects to be reviewed. A group of people from manufacturing, quality assurance, engineering, regulatory department, and sales must provide their views to the management regarding the proposed change. As everyone above has discussed in summary it is all about analyzing the reason for the change and the justification for it. An impact assessment can be carried out by an appointed sub-group if necessary.
When evaluating a change request, the monitor and control team should consider the nature of the change and the long-term effects of this change if it were to be approved. Would the change benefit the patient if it is a product design change? Would an alteration of the material used during manufacturing benefit the overall budget, or would it require a significant increase? There is also the risk of making too many changes to the point where the project is not recognizable to the initial scope. Changes requests should be approved if they benefit the project as a whole, they remain in scope, and they satisfy the consumer's needs.
