In this weeks lecture Dr. Simon mentions design review meetings which happen at the end of every design stage in order to be able to move to the next stage. In this class we have also learned that staying on track with the timeline is crucial in project management. For those of you who work/have worked in industry. Have you ever had any instances were during one of the design review meetings it is agreed to move on to the next stage (in order to stay on time) even though the previous phase was not completed yet?
I personally do not have any first hand experience with this situation. However, based on what I have learned in this class, I can imagine that if this were to happen, it could cause a variety of problems within the development process. Staying on track in product development is very important, but maintaining a high standard for the work done and ensuring every step along the path is completed to the full extent is the most essential. If the verdict of a design review meeting it to move onto the next stage of development without successful completion of the prior phase, it will inevitably cause delays. For that reason, I think that in exception of extreme situations, it should be ensured that all prior tasks have been successfully completed before continuing to the next step.
No first hand experience here, but I'd have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process groups, but it would be pretty impossible to move on to the next stage if the proper documents weren't able to be completed and approved. When your closing out a project you will be looking back and making sure all the details are correct and complete and if they aren't then you will have to go back and fix/finish, and if you do encounter a problem then depending on its severity or the changes that would need to happen in order to fix the problem you could end up derailing the whole project. The monitoring and controlling process group that happens all throughout the project is the main line of defense against this type of scenario.
I do not have experience with industrial projects, however I have been on a surgical research team. While on this team we went over the DDP of the project, and covered all tasks required. While working on our project it was crucial to complete each task before moving onto the next. There were many steps in the project the first being the acquisition of human blood, then separation of the fluid, then testing, etc. Although I was never actually pressed for time as much as I am sure industrial projects are, I do not believe that it would be possible to have completed the project by skipping steps or just moving on. The only time a step could be skipped were if it was something so insignificant that no bad outcome could possibly be a result. Skipping stages is dangerous as it could result in a higher cost variance in the long term. Each stage of the project feeds into the next, and skipping one could cause a snowball effect of issues. This would eventually result in more resources being required to fix these issues, thus raising the overall cost of the project.
I currently work at a project-based clinical research company where I process and manufacture cell-based infusion products for the treatment of conditions that are not easily treatable (myelomas, melanoma, renal carcinomas, etc). We hold daily meetings at the start of each shift to discuss the plans/processes that are to take place for the day as well as any changes that are implemented (mainly in SOPs). Since the design meetings occur with members from all departments, changes that are department-specific are not openly discussed and are instead disclosed shortly prior to processing to ensure that the new information will be immediately remembered and applied. One downside to the meetings at my company is that certain important topics are brought up at the meeting rather than being distributed to the team members prior. As mentioned in lecture, one of the most important aspects when presenting a document in a meeting is to provide each participant with a handout of the designated document. This form of communication will allow each team member to adequately review the contents of an executed change so that it can be efficiently discussed and approved while everyone is together in the same location.
Meeting minutes are normally stored in the DHF and are commonly completed as a 1 page document. This document contains entries such as the attendees, topics on the agenda, a brief summary of the discussion following each task on the agenda, and the action items that addresses each task at hand along with their designated deadlines. A second page is usually recommended for acquiring the signatures of all attendees that states that they approved of the aforementioned items. How are non-approvals handled in meetings (i.e. meeting extensions, reschedules)? Are there other change-related documents that can be handed out during design meetings? Are meeting minutes required by the FDA? If a design team is able to communicate entirely via email/skype, then can meeting minutes be omitted from a DHF?
While I do not have any industry experience in design review meetings, I think it is crucial to finish the previous step before moving on to the next. Even if you are on a strict timeline, it is irrational to move onto the next step if you aren't fully prepared for it. For example, if the planning process is rushed, the team can grossly overestimate or underestimate some important spec/parameters. The product can be developed using the wrong blueprint, and then tested under incorrect settings. All this time will be wasted when the team realizes the errors and is forced to go back to the first step and restart the whole process. This delay will be even greater than if the team spent adequate additional time to complete the first step. It also depends on how far along the team is in the design control process, and how much the incomplete step will impact future steps.
I may not be as experienced as other people in this class so I can only speak as to what I've seen. I've never seen a phase skipped over to start the next before the completion of the previous. I don't think it's possible from a regulation standpoint. I don't think it possible from a timeline standpoint either. Unless the phase end is internal paperwork that will be completed, but the company allows the next stage to proceed, I don't see that happening. Everything has an order for a reason, because one step relies on some if not all the steps before it. Unless I misunderstood your question, I don't think this happens often if at all.
I do not have much of industry experience but I don't think it's possible to skip on to the next phase just to be on track with the pace of the project as it is necessary to complete all the previous stage to its fullest and then move on to the next, as the next stage might depend on the previous stage's output.
I personally feel the previous stage has to be completed first and then we should proceed with the next once its finished as there needs to be a certain flow and doing two stages at once might as well disturb it, what if one person is involved in both the stages, he has two tasks to take care of and is prone to make more mistakes.