Ways to abide to procedure for all departments can be to collaboratively implement a procedure which all voices partake in the creation of such procedure. That way, upper management involved can hear each others opinions and reach a consensus. Quality and regulatory compliance should have the final say as the goal for medical devices is to be safe and effective which is to be achieved through the compliance of standards within processes and procedures. A department has to abide by procedure or FDA will notice and issue problematic statements and fines. It should be in everyone's mind to keep FDA content with all decisions made in the company to avoid the company from have external auditors, companies, fines, closure, etc. Furthermore, the document control personnel within quality say what changes are allowed to be made and what needs to be changed so if procedure is not being followed, nothing will get done until it is corrected.

I think there could be many ways to overcome the bad relations that the quality department often has with other departments such as R&D. One way could be to ensure that the quality representative or team that is involved in an R&D project is included from the beginning of the project and is kept up to date with any project changes that are being made. Having quality included very early on and being up to date prevents procedures from being missed during the course of the project, which would then cause the R&D team major timeline setbacks in order to go back and fulfill these requirements. Another way is for both departments to truly act as a team, and be flexible and understanding to the needs of each department. R&D should not also be on the defense looking to cut corners to get the project done, and quality should not be trying to ensure that every last detail of a quality procedure is followed. Both departments need to work together to come to resolutions that makes sense and satisfies the necessary procedural standards. There are often other ways to satisfy quality procedures other than long term testing or other items that take a long of time. The quality department should be more open to these types of solutions and base their acceptance on risk and practicality.

I believe that the quality department, at the most successful and consistent companies, runs deep within the structure of the organization. By this I mean that although there is a designated quality department, there has to be a great emphasis on the integration of these employees and their procedures within each facet of the company. For example, within each R&D meeting, ideally, there is also an individual from the quality team present to identify potential compliance issues before they develop a faulty idea. By catching these potential errors early on in the development process, time, money, and intercompany relationships are put under less duress. This example of integration should also be applied to every other department within the company as well to ensure that marketing, manufacturing, etc. all are within FDA regulation and abide by the companies own compliance goals. If a procedure is not followed, I believe that it would be most effective for the quality department to not only point out the offending issue, but show the erroneous party how to fix the mistake. Ideally, this would be done in person to more effectively communicate the corrective actions and avoid most misunderstandings that could put unnecessary strain on the intercompany relationships.

I agree with dbonanno1 and dag56 on the integration of R&D and quality. by having R&D Engineers work in conjunction with Quality during the design process, delays can be minimized as procedures can be done properly the first time. it should be the goal of every department to maintain compliance as it is necessary for the existence of the company.

and in response to dbonanno1's comment, As someone who is yet to work in the medical device industry, I don't understand this notion of cutting corners. while i understand how long projects can be lengthened because of fine details that can be annoying, isn't the goal to not just release a product but to release the best product? cutting corners sounds like a fast track to getting a product recalled and getting fired.

I have several suggestions that I believe could improve the relationship between R&D and quality. First, R&D tends to be quite ignorant when it comes to what the quality procedures are all about. They just see them as dragging out and holding back the development of their product. There needs to be more collaboration between the departments, where R&D gets some insight into where these procedures came from and understand the purpose of the procedure. Also, quality needs to make sure when they put a procedure in place that it will be compatible with all products they are developing and may develop in the future, and be careful about being too specific. In general, having better collaboration between the R&D and quality departments during the development of a product rather than always fighting each other would be beneficial. Having knowledge-sharing events periodically such as every quarter would be one way a company may be able to foster better collaboration between these departments.

Based on my experience, the quality department in my company has to deal with all other departments so the relations between the quality department and all other departments are not bad. In my company, the quality department attends every meeting to make sure that we are on the same page and that no work has to be redone for any quality issues. THe quality department has to make sure that the parts go through all the testings and that it meets all the requirements, and it has to deal with customer complains. So the only reason to have bad relations between the quality department and the others is to have issues with the part itself, which should have been considered from the beginning, so it is not their faults which leaves us with no reason to have bad relations. But the quality department has to consider that if the issues are let's say 0.02% of all the parts produced then it should be ignored because it is a really small portion of production.

I always made friends with the QA people because they had such large control over your job/project. I think them having so much power improved their relationship with other departments because if you piss them off, your job/project will probably get delayed. As I wrote in another post this week, they can stop/slow down jobs if they see a problem and there may or may not be an actual problem. Usually the QA person on back shift disagrees with the QA person on front so again, everyone just waits until backshift and the
"problem" is not a problem anymore. I'm not sure anyone knows who is right. Again, this is a problem in itself and I would recommend they fix this somehow. In conclusion, QA is a necessary evil but because most things are so subjective they can stop/slow down a job for any reason they can think of so it is in your best interest to have a good working relationship.

I believe that conflicts between R&D and Quality departments can be significantly reduced if both functions understand their role. For example, the R&D department considers itself responsible for quality of the product and the Quality department feels equally responsible for designing the product right. These departments focus on their role and at the same time making one another successful. When a problem arises, team members assume accountability and strive to resolve it in the best way possible first ensuring patient safety and second taking into account of what is the best for the company as a whole (it is not about either departments). Establishing this level of collaborative teamwork will be likely reduce conflicts between these two departments.

I think if every department follows rules and regulations then there should not be any conflict. ALthough, this is not possible in real world because there will be something or other that will go wrong either in data or device or just in documentations. The way for departments to work together and calmly accept the fault and make sure it does not happen will definitely improve the relations. Noone is perfect and there can not be 100% accuracy, if people just accept that we are humans and are allowed to make mistakes, all departments will be happily ever.

I think that there are several methods to overcome the bad relationship. The most important is the quality member follow the R&D research at the very beginning. When searching the information, the quality member can already give their thoughts for the future research. If they think the product will face kinds of problems, the experiment can stop at that time maybe. Or during the experiments, the quality members can come up with ideas to optimize the method, which will make sense in the future. They have both experiences in experiment and quality, their thought will be more valuable.

The bad relationship or conflicts between R&D department and quality department can be tried to sorted by involving the quality department into other teams, meetings and discussions from the beginning of the project. Team representatives from quality department should be involved in the discussions during the development of the ideas for the project so that they can also discuss about the quality check requirements in the beginning itself.

I don't really have any experience with company and what goes on in the company, but from what I learned from the slides and the lecture video, I think the biggest arguments that the Quality Engineers have is with R&D department. It could potentially be with every other departments as well, because they are basically in charge of making sure that everything is done by the rules and everyone is following the rules. That is why, every company needs Quality engineers because it is potentially the most important job out there.

When we observe the hierarchy of the government it is clear that a system of checks and balances keeps the three branches running in agreement. However, this is not always the case in an industrial setting where various departments influence the outcome of a company's product. Quality departments seemed to have established a sort of tyranny over the other factions of a company. The lists of regulations enforced by quality tend to have a demeaning effect on departments such as R&D and technology. The role Quality plays of ensuring the rules of a workplace and research are followed are sometimes very limiting. For departments such as R&D, these rules prevent the growth and success of many projects and ideas. However, having a firm understanding of the overall goal or mission statement of the company can help overcome this obstacle.

I think the best way for quality teams to work with R&D teams would be to have both teams syncing up with each other on a consistent basis, so that they can discuss and resolve any difficulties, misunderstanding, or confusions between teams. Involving team members from different teams in other meetings or calls can help keep all teams in loop with each other so everyone knows whats going on. Members of the quality team can better ensure that other departments are under compliance and let them know right away of any violations etc the more integrated the other between all other cross-functional teams.