I worked on several projects for R&D which always got delayed due to disagreements with the quality department. One major product that we produce is an intra-aortic balloon which is a class two device. Based on a CAPA that the manufacturing department received, we had to test 300 samples of a particular IAB for a leak test. If one of the three hundred IABs failed then 1500 IABs would need to be tested. The quality and engineering departments disagreed on this issue for days because the engineers had a realistic approach while the quality department wanted to follow the methods documented from the FDA. The engineers had to abide by the standards that the quality department demanded. Luckily, none of the IABs failed and the CAPA was closed. This is one out of hundreds of instances when the quality department and engineers in R&D or manufacturing disagreed on how to approach an issue.

In industry, there will always be a situation where departments will not be in the same page and this is because they have different objectives. In this case where the production of a new medical device is hindered by the questioning of QA, it is important to understand that QA's job is to ensure the safety of the customer, sure the thought process of the two departments are not the same and are striving for different objectives. R&D is interested in producing new products on time based on the timeline provided by management and QA's job is to run all checks and balances to ensure all products produced by the company meets the safety standard, sure projects will be delayed because of point of views and practicality. The important thought to keep in mind is that both departments must always meet in the middle and reach a win-win situation, both that satisfies everyone, at the end of the day both departments can make or break the company, a single error on either side can cost the company everything. As an engineer's mindset and oath, their work is to ensure the safety of the general public and always strive for a resolution without cutting corners.

I agree with @asimbana, both departments have different objectives, which is why you'd find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be conflicting when it comes to the actual production and finalizing of products. These are the types of situations that should be better understood between both departments. R&D should focus more on making sure that their design and product is to detail, rather than trying to rush so that when sent to quality, they don't have to worry about dealing with the Quality department. Quality department has a job, and that's to make sure that products are safe and are functioning accordingly. Although it may seem troublesome for the development process, its something that should be done to ensure medical products are safe for consumers.

R&D as well as quality comes with there own set of goal. Goal of R&d is to develop and innovate new or current technology in order to strength the position of company in the market. While quality has a goal to get the products developed by R&D to be approved and certified by as many regulatory bodies as possible in order to increase the trust of the consumer in the product. I believe that there is nothing quality department can do to help R&D department in terms of testing or in terms of number of test to be done because ultimately what quality people are asking is something which specified by the regulatory body. Its is not something specified m=by the quality department so I think if R&D department co-operates with the quality department there is no issue in it.

Quality is put in place to police R&D and other departments to ensure that effectiveness and suitability of processes are maintained across all levels. With that being said, both departments are crucial to the business. I believe that at the end of the day both departments must reach a consensus in order to continue progress. One cannot strive without the other. R&D should understand the goals associated with the Quality department but act in favor of compliance in order to keep the FDA in good hands. Quality should advise R&D the right measures and keep them informed of such changes in standards such as ISO 13485 to ensure that everything is being kept up to par so once again FDA is not concerned. Regardless, this dynamic needs to be a collaborative effort to maintain a win/win situation.

In my company, looking at the overall big picture, I would say quality and R&D both have the same end goal. We are devoted to developing quality products to make healthcare better. However, the method of reaching that goal is what causes the distinction between R&D and quality. I agree with most people's opinion that R&D and quality often seem to be fighting one another. While a robust quality system is very critical, sometimes it can swing way too far to the conservative side, and sometimes it can go way too far on the liberal side. It really needs to be somewhere in the middle to ensure that it does not kill innovation. One observation I would make is that in my industry we often see very innovative products being developed by very small, startup companies. The larger companies tend to just have larger portfolios of various products and their "innovations" are usually just tweaks to their existing product lines or acquisitions of the small companies with the innovative products rather than coming up with some new game-changing technology internally. What is the reason for this? The innovative products never would have made it through the quality system of the larger company, whereas the small company with a skeleton quality system were able to develop and launch the product.

Quality and R&D are sections of a company that have different goals. R&D focuses on the advancement of the technology to develop a better product for a company while Quality ensures that the product being made will be safe. However, both parties value the production of the best product possible. However, the method of achieving this is different. R&D looks to feed innovation for the company while Quality ensures that the product is in its best possible capacity and also protects the company from liability and recalls for the product. In order to progress efficiently, both sides of the company must reach an agreement to how they will approach the development. Quality is important to have because R&D must have regulation or else there may be some deviation in the goal of the group.

The dynamic between the research and development and quality department is understandable. They are almost an oxymoron, one is a more creative entity using scientific skills for innovation and discovery, where the other department is in place to follow procedures and guidelines and play with the legal aspects that can somewhat hinder the creativity. In terms of business, the two departments are essential. The R&D departments are in charge of the continuing relevance of the company, the department in charge of producing a reason for the company to be on the map due to their product. On the other hand, the quality depart is what keeps the company afloat. There have been many instances that failure in products has shut down businesses, decreased confidence in shareholders and company value. Wiithout the quality departments, issues like these would be unavoidable. Even though the two groups have a heated relationship, they provide a system of checks and balances that keep the company moving forward.

I think the main issue is the ego the R&D department thinks they know every thing and what ever they do is 100% right, so in a situation when the quality people comes and tell them according to rules you have perform this test 3000 times not 300 times to test the device then at that point they R&D start explaining theories to quality people and at that point the debate starts. I think goal of both department is same is to grow the company, but the difference is sometimes R&D is over confidence they start following their own rules and that point the quality has to step in and try to explain them that we have do everything by book. I think sometimes R&D forgets how the things can go wrong no matter how accurate and good your work is and they neglect the risk factors but the quality knows what can go wrong and how to avoid them. And that is why quality people are their to make sure that the product does not have any problems and is follows the FDA standards before it goes out in the market.

I feel as though both sides have valid concerns in how a project should proceed. On the R&D hand, you have legitimate data and statistic to prove that the project is good to continue. Quality on the other hand have standards that they have assure the project meets; otherwise, it can spell trouble for the company early on. As mentioned in other post, QA is something can potentially save on a lawsuit or worse down the line. Although scientists have full faith in their data, if does not reach standards set forth by organizations whom standards come from multiple research endeavors then it is technically not safe or prudent to continue with the said project. R&D are there to develop the project while quality is there to assure the validity of it and save the company trouble down the line, which in my opinion, is what a company should be more concerned with.

I have worked in an R&D company before. I was in the R&D lab. The most things that I did is researching, doing experiments and writing the report. And there is an independent apartment for Quality. Every product has to go there after the manufacturing. I don't know exactly what they did for every kind of product, but it always takes time to evaluate the product. And there are many people in their apartment, they did different things. Our company has ten years history and nothing awful happened. I think that the quality apartment made a big sense.

R&D department works on advancement of technolgy to give a product which would help people. Quality department monitors the safety of the product before reaching the people. Quality department sees all the department as to whether the quality requirements and standards are being maintained throughout the product development. Both the departments should understand the roles of each department and support each other in their tasks so that the company can give safe and reliable product to customers.

The dynamic is interesting and I have a middle ground perspective between the two fields. As a Process Engineer in my companies manufacturing and science technology group my role deals in bridging the gap between R&D and manufacturing, therefore I deal with both departments on various issues. From my experience quality simply follows the guidelines that are created to the letter and does not stray from the directives that are created. This is where the tension rises in certain projects between R&D, there are many times where new products are put on an accelerated path however quality is where the slow down occurs because you cannot cut corners. R&D may be able to adjust the timelines they have for an accelerated path to market and attempt to use statistics and science to convince quality but this does not usually work as I stated before quality is stringent, and rightfully so on following the directives that they have.

I searched about this title and found that there is the potential for misalignment and conflict when the quality function and the R&D function are divided in two separate organizations, often with different objectives and performance measures. The danger comes when R&D folks start to see themselves as less responsible for product quality as they assume that the Quality organization exists to ensure that warranty cost and customer satisfaction goals are met. In these environments many R&D teams forget their own role in achieving quality, beginning with early system design and architecture and including daily decisions made by individual development engineers. When customer-reported quality issues occur, there’s a tendency in these businesses to blame the Quality organization for failing to detect issues or failing to effectively advocate for design changes late in the development lifecycle.