In a situation like this, I believe any previous data collected should be used to help determine the most efficient way to verify the new device. However, I think the altered instrument should be fully verified before moving forward. Although it would initially cause a greater negative CV, if the instrument is not fully verified and there is a failure or problem further along, it could result in a much more significant cost than if it were initially verified. 

In this case, validation would be sufficient to move forward with the implementation of the new instrument. In any change control process, each function has a representative that assesses the change and determines what is needed. When other factors play a role into deciding the requirements, then a meeting would have to be scheduled to inform the team about the situation. Based on the information provided, I feel that process and design validation can be sufficient to move forward with the new instrument; if the manufacturing line has a 100% acceptance, meaning there is inspection after each lot made and any product with defects would be disregarded, then it shouldn't be a problem. If in the future, it is determined that the waste increased then another optimization tools have be implemented. In an ideal world, where we only care about expecting the worst case to have a successful project, a full set of testing would be needed, however, sometimes it does not make sense.

Based on the presented situation I would definitely have the new instrument be verified again. This change in design could result in issues later down the line that could cost much more than just verifying that there is no issue immediately. For verification testing you can utilize the same as the previous design. A project also may not even make it to the field if it requires FDA approval without proper verification of the current design, which would most likely cost more time and money than just verifying the project beforehand.

Change control is a methodology used to manage any change requests that impact the baseline of your project. It’s a way to capture that change from the point where it’s been identified through every step of the project cycle. That includes evaluating the request and then approving, rejected or deferring it.

The purpose of this process is to make sure that you’re not changing things in the project that don’t need to be changed. The last thing you want to do is disrupt the project for no good reason, wasting valuable time and resources. Any changed that is approved is then documented. The change control process is part of the larger change management plan.

What Is Change Control in Project Management? (projectmanager.com)

@tt239 Your point is valid and very detailed, I like how you explained your points of view this case!

When faced with a change control request for an instrument that is based on a previous design but has a slight change that may create an uneven loading situation, and the project has a negative cost variance, the question arises whether to leverage the previous data and risk the instrument breaking in the field, which would require corrective action, or to spend more to ensure the instrument is fully verified, but causing an even greater negative cost variance. In such a scenario, the decision ultimately depends on the risk appetite of the project team and stakeholders. If patient safety is a top priority, it may be more prudent to spend more to ensure the instrument is fully verified, even if it results in a greater negative cost variance. If the risk is deemed acceptable and the project team is confident in the previous data, leveraging it may be a viable option.

When considering the decision of whether to leverage previous testing data or to spend more to ensure full verification of a slightly modified instrument, it's important to weigh the risks and benefits of each option. While leveraging previous data may be more cost-effective in the short term, it could result in the instrument breaking in the field, potentially leading to corrective actions and higher costs in the long run. On the other hand, spending more to ensure full verification may result in a greater negative cost variance upfront but could ultimately prevent future issues and reduce costs in the long term. Ultimately, the decision should be based on a thorough risk analysis and a consideration of the potential impact on patient safety and product quality

Change control is a mechanism used to handle any requests for changes that affect the project's baseline. It is a method of documenting that change from the time it is identified through each stage of the project cycle. The request is evaluated as part of the change control process, after which it is either approved, rejected, or deferred. Effective change management is essential to finishing your project on schedule and on budget. Yet change control also has some unanticipated advantages. It enhances teamwork, for starters. Your team has the chance to collaborate on a solution to the change request when it comes to change. The collaborative nature of change control can boost the project's overall productivity. Change management enhances your team's capacity to collaborate more effectively, and the good benefits trickle down to increase productivity. Naturally, it complements teamwork perfectly. But the more you involve your team in change control, the better they get at finding quick solutions to issues. Naturally, this aids in the transition, but it also increases your team's efficiency across the board.