Forum

Notifications
Clear all

Changes to Products in Production

7 Posts
7 Users
0 Reactions
184 Views
(@vthampi)
Posts: 75
Estimable Member
Topic starter
 

Once a project closes and it is ready for production, all documents necessary for making the product are handed over to manufacturing and the product goes into production. However, does this mean that the project manager and project team has no more involvement with the product? Would they be considered subject matter experts (SME) on the product and sought out for any problems with it? Or would any member of their department suffice? For example, if a regulatory change to a product already in production is being made, would the initiator need the approval of the original regulatory member of the project team, or would any member of the regulatory department suffice?

I imagine that any member of the department would suffice, but it would be beneficial to have the approval of the original project team, since they have so much knowledge. On the other hand, they might have a narrow view of the project and might not agree with the change based on unintentional bias. Is it better to have approvals made by t original project team member who would have a wealth of knowledge specifically pertaining to the product, or the fresh eyes of someone who has no biases for the product?

 
Posted : 18/03/2024 11:24 pm
(@ma2726)
Posts: 73
Trusted Member
 

Even after a project is completed and sent into production, the project team's engagement does not necessarily cease there. While they provide paperwork for manufacturing, their experience might still be useful in addressing changes or concerns that arise during the product's lifecycle.

The original project team members frequently have extensive insights into the product's creation, making them subject matter experts (SMEs). Their awareness of the product's complexities and history might help them make informed decisions about improvements or regulatory changes.

However, it is equally vital to consider new perspectives. Involving people from different departments or stakeholders can bring fresh perspectives and allow a more thorough assessment of proposed changes.

In practice, a balanced approach that includes both original team members and external stakeholders can result in more informed decisions about post-production alterations.

 
Posted : 19/03/2024 9:53 am
(@bs725)
Posts: 31
Eminent Member
 

This is an interesting point and it wasn't completely clear. However, I think in larger/more established organizations naturally have short-term goals, but they also have long-term goals that can extend out decades. So in this scenario, the project team would be briefed on the next project goal and the project development/management process would start all over again. Simultaneously, this would keep much of the informational knowledge in the organization, especially if something went wrong with the product in production and their expertise is needed.

In the case that certain developers would need to be "let go" at the closing stage of a project, I think this is also fairly normal and is common with a lot of CRO work or contracted work. However, I don't think that the original person is needed for further approval of the product either. I believe that their contract would stipulate their work was contracted and the rights of ownership/intellectual property belong to the company in exchange for monetary compensation. If this is not the case, the person may be needed as a contact throughout the remainder of the process.  

 
Posted : 22/03/2024 3:44 pm
 SAM
(@afshinsadri)
Posts: 34
Eminent Member
 

In my opinion, I should first mention that when a project reaches the production stage, all the relevant documents, including the company and factory standards, the production process, and the necessary product standards, must be transferred to the higher authorities. However, this does not mean that managers have a greater role in the production process. Yes, they are considered subject matter experts (SMEs) because of their experiences and knowledge, and it is their experiences and knowledge that are valuable during problems. Additionally, the skills of other members cannot be denied or ignored. In the scenario mentioned regarding changes in product regulations, we can ask how significant the change is. Some changes, such as optimizing the production rules of a product in the medical equipment industry, often involve a re-examination of the 510K rules. However, in general, changes to product regulations that are already in production must first be approved by the main supervisory member of the project team and provide several advantages. These individuals in this position have a better understanding of the manufactured product, but conflicts may arise from some minor changes, either in the product or in the production rules, according to experience, which sometimes result in significant conflicts.

 
Posted : 22/03/2024 6:32 pm
(@archishak)
Posts: 72
Trusted Member
 

The project manager/team may still be involved with the product even if the project is closed and is being transitioned into production. This is because they may provide valuable expertise or knowledge regarding the product and serve as SMEs. The project manager/team may be consulted for their insights when dealing with complex problems that may arise with production. When it comes to regulatory changes, the regulatory expertise may involve the project manager/team to assess the impact of the proposed changes. All in all, the main goal is to involve appropriate individuals in the decision-making processes to ensure proper quality, regulatory compliance, and project success are met. 

 
Posted : 22/03/2024 8:54 pm
(@jo277)
Posts: 69
Trusted Member
 

Once a product reaches the end of its developmental life cycle, where all associated documents and paperwork are formalized and finalized, I would assume that two things would happen. First, the original core team that was instrumental in the product launch may be assigned to different projects/assignments to lend their skillset and knowledge to while also maintaining a partial role in the product's followup team, where they may be asked to continue following up on the product's market release and continuation of success. Depending on the significance of the individual's role/talents, they may either be on standby or help train and development the next team to take care of post-product launch activities.

The second assumption/route that I think that the core team would take is the development/improvement on the first product launch in order to continue providing enhancements and improvements to the second iteration of the product. This may be an ongoing thing straight from launch, where they got the core deliverables out with the first product launch, but would want to address other quality of life or considerable improvements that might not have been launched in the first product but is significant enough to call for its own "next generation" iteration.

 
Posted : 23/03/2024 10:18 am
(@ms2768)
Posts: 76
Trusted Member
 

While all the documentation in the DHF and other company based paperwork is transferred at the end of a project's lifecycle, the members of the project would still be contacted if there are any issues moving forward with the project afterwards. I believe this is a large reason why all documentation is officially signed off by the project members that are leading/representing their respective departments throughout the project. Thus, if there are any issues after the closing stage such as a regulatory issue that comes up later on, the regulatory member that signed off on the relevant documents would be contacted for their experience and expertise on the original project. It's important to note that this can be problematic because these people may have left the company or moved on when these questions arise and this leaves it up to the new members to make decisions based off what they already know. 

 
Posted : 23/03/2024 9:00 pm
Share: