Sounding off to the previous posts. I think that R&D and Quality Assurance/Compliance conflicts in most cases due to the differences in the role they play and the overall objective they need to meet. Quality assurance/compliance dictates whether each or several procedures/processes are within company or regulatory agency guidelines to ensure that the product is doing what its suppose to do and safe. On the other hand, R&D is set on innovation and improving current technology and meet certain deadlines on each phase of R&D. This might mean innovating procedures and processes as well to get there; and this is when the problem arises between the two. They might disagree on these subjects because quality assurance/compliance has to set new checks for it in addition to existing regulations to ensure that its safe and won't cause any problems in the future.
Ultimately the difference between quality and R&D comes down to who each group answers to. Quality is responsible to the FDA, whereas R&D is responsible to the business. R&D strives to find innovation and solutions for products, services, and devices. Quality strives to ensure that all endeavors meet with FDA regulations. Ultimately, both groups are interested in keeping the company or business doing well and progressing, but they approach it from different perspectives. My previous job was doing R&D for a small medical device company, but worked directly with the Quality manager. It often resulted in difficulty when trying to solve problems, because my solution from an R&D perspective may not meet the quality requirements. While this was very frustrating, it was important in making sure the "solution" was correct.
I have no experience in this matter but, from product development cycle, I can pull out few points. R&D and QA may have major conflicts are during revisions of features while prototyping a deceive. R&D's duty is to innovate and bring about a competitive edge to the company and keep the company in business. However, while in the stage of development, R&D doesn't fully understand the risk associated with the end user. Furthermore, QA must identify such risks and highlight them during discussions and get a revision of these designs. Hence striking the right balance and compromising on design may serve as a major obstacle between R&D and QA departments.
R&D and Quality control are two different sectors which are dependent on each other. Even though research of a particular product would inititate the development of a product, the application of the particular product into the real world would never be processed without QC. As in the QC, the pros and cons of product and the utility and necessity of the product is taken as a main concern. Only if the product has a product quality evaluation it is validated to apply into the real world population. Quality deals with the well being of the population which is the ultimate goal of research. Only if QC has a proper results then R&D had evaluated.
R&D and quality are the two different departments of the company. R&D helps the business to have a competitive edge over its competitors whereas the quality department ensures that the product or services adhere to a defined set of quality criteria or meets the customers. R&D department which involves developing products or services and to improve the existing product or services. R&D differs from institution to institution where engineers are staffed and tasked with directly developing new products. Quality department comes with following procedures and maintaining the compliance. Quality department involves the safety of the customers whereas in R&D involves developing new products. Quality department involves ensuring that the product developed meets the standard safety. R&D is focused on developing new innovative products whereas quality ensures that the products developed meet the standards also the company is protected from litigation and recalls.
I believe that both departments are necessary and need each other in order to work. Quality is very important because it helps with FDA regulations and making sure that the company and the employees do not get sued or fired for not following regulations and not following the management process correctly. R&D works with making the products that the Quality department looks over so the R&D group is extremely essential as they put out the final products that will make the company money and allow them to hire more experienced Quality personnel so as to improve the overall company. The main conflict comes from R&D pushing their ideas and agenda through with scientific backing that the Quality department then has to shut down or regulate. R&D may fully believe that their ideas or products are safe and meet the desired requirements of the scope but Quality is there to make sure that legally these ideas will not come back to hurt the company. Also, quality is important so that R&D can focus on their research and not have to worry about looking up FDA regulations or testing and measuring all of the finished products. If R&D had to do their job and the job of Quality there would be a increased chance of mistakes and in the medical device industry that can lead to some major consequences. Both are essential and need each other and it is common for both groups to argue with each other since both jobs directly affect the other ones work.
The issue behind Quality is that there is an assumption that the procedures that have too be followed will optimize results. Compliance and quality assurance are important but it's important to acknowledge that having procedures and strict standards can curb innovation and creativity. In other words, R&D cannot pursue new techniques or develop new products if their endeavor conflict with established standards of quality. This is very important because companies have to constantly compete with each other and one way to get ahead is to come up with some brand new and better. There also lies the assumption that if there were very few rules and boundaries, that companies will use this to lower costs by introducing poor quality products. However, competition keeps quality high and is what protects the consumer because if a company sells poor products, then consumers will go to another business to purchase what they need. Quality and compliance hinders R&D in many ways because the rules introduce limitation as to what R&D can pursue and without R&D, companies cannot compete and will not last long.
I think there should be a intermediator who can talk between and has fair amount of the knowledge on both side to help them agree to a somehow acceptable level. That being said, everyone needs to compromise for whatever the goal they need to accomplish. There is always a gap between the "radical" theoretical world and the "conservative" industrial world, even though a research accomplishment has been discovered recently and everybody is eager to apply that to the industry. But that is always a long way to go. And chances are there will be too many production process or too costly on just fitting this new technique. Then the quality control must be reassessed because of its huge expense. Anyway, it is a fine art to meet with the lowest acceptable line of the product being produced the way FDA will approve and a happy solution for both sides, but it is solvable with good communication and an expert who can serve as an intermediator.
I think both departments relay in each other in order to work and I believe that both ending up with the same goal.I agree with my classmate's opinions that R&D and quality often seem to be fighting one another. I believe that R&D and Quality Assurance/Compliance conflicts in most cases due to the differences in the role they play and the overall objective they need to meet. However, as mentioned I believe that both company striving for the same goal. Both groups are interested in keeping the company or business doing well and progressing, but they approach it from different perspectives. Quality is necessary because it helps with FDA regulations and making sure that the company and the employees do not get sued or fired for not following regulations. R&D works to make the products that the Quality department check over. Quality and compliance hinders R&D in many ways because the rules introduce limitation as to what R&D can pursue.
While R&D and Quality both want as many products to be shipped out as possible, Quality has the added responsibility of making sure that all the products meet all of the regulations. While their overall goal is the same, it is the added responsibility that causes R&D and QA to constantly butt heads. R&D wants to ship out as many products as they can but the extra responsibility in Quality prevents that from happening. It is a quite literal case of quality vs. quantity and there is no way to optimize one without sacrificing the other.
R&D mainly focuses on being able to advance technology to develop a better products for a company while the area of quality makes sure that the product being made will be safe. In the end both sections value the making of the best product possible
I am currently working as an R&D Engineer for a medical device company, and have been for the past 6 years. As an R&D engineer I do have a lot of experience working with the Quality departments (QA, QC, etc.). As our professor has pointed out a numerous times in this week’s lecture, it is very common to encounter situations where the engineer (scientist) have conflicts with the Quality department. I have personally been in many situations where scientific, statistical, and practical knowledge has conflicted with our internal quality procedure; which then leads to lengthy debates between R&D and Quality about how to pursue the matter at hand. R&D generally comes from the side of science, practical knowledge, and the need to get stuff done and keep the project moving forward. While the Quality department usually comes from the side of following procedures and maintaining compliance. What are some of you opinions on this very extremely common dynamic between the R&D and Quality department.
Having worked in R&D New product development, I have also noticed disagreements between the Quality engineers and R&D Engineers. The biggest disagreement I've noticed comes with Test Method Validation and the statistical approach that the Quality engineers want to use. Quality engineers tend to push for the use of %P/t which is precision-to-tolerance ratio and takes upper and lower bounds into account during the analysis. In some cases, you want a product to fall within a certain "goldilocks" range of a test, not too high but not too little, and %P/T can be a great tool in this instance. In other cases, where you only have a lower spec/bound to clear with no upper limit for example, can cause problems with %P/T and lead to results that indicate that the test is not validated even if the product clears the spec consistently by a large amount.
A different statistical approach to use would be gauge R&R which is a way to access the differing types of variability within an experiment and can also be used to validate a test method.
I would be interested if there were any quality engineers that could explain their process for selecting their statistical approaches when it comes to test method validation?
Thanks.
Matt
Within the company, I like to think of the quality department as the government because essentially what they're doing is making sure the citizens (employees) are following the laws. I think with Engineering departments in general not just R&D they're always going back and forth with quality because they want to get the job done and the ball rolling. With R&D as you mentioned there's the science, practical knowledge, and ultimately research with other industries and types of engineers they are dealing with customers directly to deliver a product. Quality is the buffer that stands between them and delivering. However, as much as it is a love-hate relationship essentially Quality is a necessary evil and without engineering there is no product to begin with. As you mentioned it's a dynamic relationship and one of the better things about QC as opposed to QA is they're actually on the floor, lab etc. working side by side operators and engineers so they're a bit more proactive when it comes to compliance. I think that as long as Quality gives the engineers the room to breathe and do the engineering while keeping just lane bumpers up so they don't go too crazy it'll keep them in check without compromising their innovativeness.
I recently started working at R&D. I worked for manufacturing for the last 3 years. Therefore, I have extensively seen how quality can be important. Working at R&D makes me realize how quality could be a little bit annoying when it comes to conducting a research. R&D is heavily based on the scientific theories and knowledge, experiments and findings, feasibility of studies etc. A research can be time consuming and so people would want to do everything as quickly as possible hopefully without harming the experiment. People could be tempted to overlook the systems and regulations, get done with their studies and move on to the next one and meet the next deadline. Therefore, there are chances that people could come up with shortcuts which may or may not be good for the product quality. And that's when quality comes handy as their job is to ensure that the company is following the FDA guidelines before launching a product. It is very much based on the procedure and guidelines of preparing a product since its initial period. Also for instance, FDA can appear anytime for an audit and so a company has to be fully prepared. Quality comes handy when it comes to preparing a company for the audit by spreading the knowledge of FDA regulations and requirements. R&D and Quality do not agree in many matters as there are many stringent guidelines of FDA comes into play in between them. however, they both work for the success of the company's products, business and reputation.
While R&D and quality do have the "bigger picture" goal in common, they individually do have drastically different goals. R&D's work to create new innovations, technologies and processes whereas quality is there to make sure all of these things are appropriate to carry out. Often times R&D engineers will feel like quality is there to "police" and create many obstacles and hindrances in their pursuits. Whereas quality will feel like R&D engineers are not thinking within their bounds. There is understandable tension between the two departments, however this should not always be seen as a bad thing. It shows that they are all committed and dedicated to their jobs despite their differences. A possible solution could be possible having a middle person or team to serve as a liaison, someone that can try to help R&D's meet the concerns raised by quality. A team of these people could work to mediate between the two and also be active in helping R&Ds and quality agree on something ensuring that time isn't wasted and that everyone is working proactively.
