I support @bb254's description of the process of design review meetings. While I am not yet an engineer, as a co-op I am often tasked with preparing the data and materials before an engineer's design review meeting. For example I was responsible for testing samples for a protocol that they would be presenting for the design review meeting. The design review meeting is important for each phase of the meeting.
In Capstone I and II, I participate in my team's weekly design review meeting along with our advisor. During design review meetings, my team and I would start it off by discussing the milestones we've accomplished and missed; These milestones were set at the beginning of the project. During these meetings we give and get inputs from everyone about their respective responsibilities and we run design changes with everyone to make sure that one's design change will not alter or make the other person's work altered drastically. We make sure that everyone is on the same page with the design and on schedule. If one had fallen behind, we discuss possible contingency plans to not delay the project as a whole.
During a design review, at least within the bounds of our senior project, we would evaluate our project step by step with our customer and group members. Usually, during this time, problems were pointed out and points were clarified by the group members. This is a constructive meeting that allows the group to track progress and ensure that everything checks out okay. If there are issues that arise during the review, it is important not to take them personally and to leave the changes for after the review.
Design review takes place multiple times during the development process and is a milestone in the product development process and the meetings themselves are very long tedious. During this meeting, good meeting notes must be taken on what is said and who says it. At the end of the meeting, everyone present must sign the document confirming that everything is correct. This is a chance for everyone involved directly and indirectly in the project to review all details regarding the project, project status, risks, issues, plans, and solutions.
In my experience with design reviews during my undergrad capstone we had weekly meetings with an advisor and a customer to discuss progress made in the past week and any new concerns. The meetings themselves typically started out by going through a status report that as prepared before the meeting that addresses any milestones meet or missed in the week, progress on upcoming milestones, objectives for the next week, any issues ran into, and how we expected to progress in the future compared to our schedule of milestones. The meetings were a good way to stay on track of our schedule.
As you near the verification process the design review meetings become very important as they are a great opportunity for coworkers, management, or even document control to realize an issue in your verification before it is initiated. Once initiated and alteration of the verification severely increases the time frame for completion. The design review meeting can be as easy as hey that doesn't seem like its going to work or as detailed as citing specific wording to change to help make the verification repeatable. The downfall of any company can come quickly if there is a lack of communication.
Although I've never attended a design review meeting, I think it's safe to say these meetings are crucial to get every member of the team and even sponsors and consumers on the same page. It would be the perfect platform for outlining the details of the design and receiving constructive criticism and approval on the various design phases. These meetings are also a medium to outline any upcoming objectives and the critical paths that will determine the longevity of the project and updates on when important milestones will be reached.
I agree with you that design meetings facilitate communication between the parties involved such as management, design team, and the customer. Although I don’t have experience with design review meetings, I understand, from research, that they are critical for the members to review their progress and discuss a way forward. When evaluating a design against the requirements, a number of means such as physical tests, walk-through examinations, and engineering simulations may be used. Although the design meetings happen at the end of each stage of the product development, their timing is important. It is imperative that these meetings are held when every member of the team and participants are present. The team members ought to be notified in advance of the intention to hold the design review meetings. In design review meetings, the contribution of every member is important, and thus no member should be left out.
Most of the design reviews I've witnessed were mostly informal during project meetings. From what I've seen, initial designs are subject to many changes throughout the course of a project. The reasons for such changes often occur to minimize testing costs, lower material consumption, and of course to pass the testing phases if the original design fails to meet standards. I find it very important and logical to have design reviews very often and even informally because failure to discuss every small concern during smaller meetings may lead to complications in the future. However, I also find it equally important to involve everyone on the team when any changes are made so that everyone is aligned and can agree on the changes, as well as be aware of them for their own reference as they continue their role.
While I myself have never been a part of a design review meeting, i still feel that such meetings are very important in the production process of a product. As a new idea is being developed, it goes through many changes in order to comply with any and all new restrictions that appear after the initial approval. Having such a meeting after all the changes is a great way to catch everyone that's a part of the project, from the customer to the project manager, up and verify that all the needs and restrictions are being met. It gives an opportunity to fix any issues that may arise before they have a chance to arise in the verification process, which would just slow the entire project down. Most importantly, it reassures everyone whether or not the product is meeting the requirements of the customer even after changes have been made, and if not, they are able to identify which issues need to be fixed before moving on to the next stage.
Working in industry, I am aware of design review meetings which happen almost weekly. One of the many engineers will have some sort of change which affects the inputs or outputs of the process or product, and this needs to be approved through design review meetings. These are very formal events which require an agenda, proposal, well prepared project lead, and attendance by managers from all applicable departments. This could include regulatory, quality, research, manufacturing engineering, and operations representatives among others. Basically anyone who may be affected needs to be in the loop and have the chance to give any feedback before the potential change is approved and implemented. It also requires several phases and various reports throughout the design change process. This is understandable since it is a step in the FDA Design Controls and that means you will need a lot of paperwork as evidence that supports your claim that the change will not introduce elevated levels of risk or failure.
I have participated in 1 design review at my co-op, and whilst it occurred similarly to what others here have mentioned I think some more specifics would help people understand them a bit better. The one I was in was to review a new pain relieving lotion. due to the way my department functions, it was not exactly the same as the way one functions at a medial device review, but none the less it was still informative. There we representatives from R&D, Marketing, and management. Since this was a later stage review the product was in blank packaging. The review started with talking about the documents and making sure that we were still on track to meet the deadlines. Then we reviewed the actual product. We tested the objective characteristic of did it numb the area it was applied to, but we also tested some subjective things like does it have an appealing scent, is the application a pleasant experience, and does it leave the user feeling like the product is working. Now this is different than a medical device as this is a consume product, but the review was still a good insight into how these function. It also helped to show what marketing and management were looking for in the product and the project as a whole.
I do not have experience in a design review meeting at a company but I do believe that these meetings are very important. In the beginning of the project/design, there are meetings to discuss what is necessary for the product and how that will be accomplished. These meetings are after each stage is complete which helps to keep track of where the product is on the timeline, what needs to be fixed, how much more time is necessary, and see if there are other problems that occurred that haven’t been addressed earlier. These meetings help to modify the product so that there aren’t any issues later down the road or at the end when the product is finished. These meetings also help with what the customer wants and if it’s going in the right track. Agendas are required so that each meeting is facilitated properly and every point is covered. For my senior design project, we would have meetings with our advisor to see where we were on our project and he would help us try to figure out any solutions to our problems. If it wasn’t a group meeting with our advisor, we would have our group leader talk to our advisor and keep them updated on the project as a more informal design review meeting. These meetings helped us decide how to go forward with our project and if we were on the correct timeline. I believe at companies, there are walkthroughs and meetings to make sure everything is on track and to address issues that arise. These meetings are usually with the managers of each department.
The company that I work for carries out clinical research involving the processing of auto/allogeneic cell-based products for therapeutic purposes. Each project team is required to hold meetings at the start of each shift to go over what processing has to be done, what deviations need to be addressed from prior processing, and the implementation of any design changes. Design changes most frequently occur within the manufacturing/production protocols, such as adding/removing certain steps, rewording a procedure for simplicity, or simply correcting a typo.
The meetings we hold are more informal than formal in the sense that although all issues that are brought up get addressed, we do not necessarily record the context or the duration of the meeting under any official document. The probable reason for this is because the extra documentation is perceived as excessive and tedious due to the lack of an electronic QMS, which has yet to be developed because our products are still in the clinical phase of development. In a more formal setting however, a GDP-based document will be used to indicate the meeting name, purpose, attendees, the number of tasks on the agenda and who is scheduled to carry out each task as well as a signature section for all of the attendees to confirm that they acknowledge the content of the meeting.
Some meetings may take place via skype or over the phone due to its participants being in different locations, which can complicate the use of formal documents. Should a regulatory document be required for each meeting of a design/development process if the product being worked on is a tongue depressor? What about for an implantable pacemaker?
As most medical devices go through phase-gated activities, a design review meeting is very important. It basically landmarks when the next phase can be conducted and ensures that the project team is kept up-to-date about the project. The project team can bring up any concerns about moving on to the next stage. Having the meeting also documents that the members of the project team acknowledge their responsibilities moving on to the next phase.
Additionally, Having the input of each department involved is very useful when going through the stages. For example, the team responsible for determining the design input, usually R&D engineers, can get good insight from the verification and validation team members (clinical, test engineers, etc.). They will be able to give their opinions based on experience on whether these design inputs are unreasonable or can even be met.
ih37, I don't think there is a concern for remote users with formal documentation on the design review meetings. I understand that you may not have a formal electronic system but creating an email that gets sent out after the meeting wouldn't be too difficult. It doesn't necessarily have to be written like formal meeting minutes but just having documented proof of what was discussed allows the team to refer back to something and use them in later meetings.
