While I'm sure it is incredibly frustrating for R&D to be delayed by the Quality department's need to follow and enforce compliance, it is a necessary delay. If a project moves forward at any point and the procedure(s) is not within regulation, it could further delay a project more than if the Quality department rectifies it earlier on in the process. R&D's momentum may be disrupted, but Quality's involvement forces them to double-check their tests and procedures in order to create a more viable product or obtain more valuable data.
Both R&D and Quality have there own set of agenda and goals. In the past have had the opportunity to work with R&D and their goal is always get things out as soon as possible, however the goal of quality is to ensure that product going out the door is in accordance with standards and quality procedures. Quality is only ensuring that product is in accordance to procedures provided by regulatory department. Both departments just need to come to agreement that they are both part of the same team.
At my company I have worked with R&D on many issues which Quality was also involved. As stated by @dbonanno1, R&D and Quality had very different opinions on how to handle most situations, R&D coming from a view of practicality and statistics and Quality from compliance and FDA regulation. This project involved a testing a new Intra-Aortic Balloon during a design verification build. While testing, for design verification, the product should have all of the components, but none of the packaging and labeling components were ready when the build was occurring, so the labeling and packaging from a similar product that was already released was used. Quality did not want to allow this and wanted to build a new 600 pieces for Design Verification so they could represent all of the components of the new product. While I understand Qualities point of view, the labeling and packaging components where the same as the current product and posed no risk to the testing. Inevitably, management sided with R&D on this because the money had already been spent and it would have been a huge waste of material and time. It often feels like Quality knows they are over reacting to situations, but are to scared of the FDA and any possible consequences to side with engineering.
At my former job I worked as a R&D scientist along with four others. I have the privilege to work in quality as well and there is a big difference in the two.While my time as a R&D scientist we did numerous research project to keep the production going strong and new advances we may come across. Quality is different but similar in goal within the company.While working in quality I have had the chance to oversee to make sure everything and everyone stays in compliance with the regulation the company must follow.The way that I see the two is very different but we need both to have continue growth within the company.But to sum it up R&D is the science and research of the company while quality if the compliance control over everything.
In every industry, there will be instances where departments are not on the same page because they have different goals. Like we learnt in the lecture, the objectives of a department can be very dynamic. They might not be the same every year. It is very important for management to make sure the work of both departments compliments each other.
From the comments above I would say that R&D should be given a more priority as all the company policies and mission statements tend to build on the results.
I will give an example of this from my own working time. Although my company does not manufacture a medical device, the processes for quality control during production are similar. In companies, quality control departments are often seen as "fault finders." Because you worked in another department, lets say you are working in the research and development department, and you designed a shaft and it would go into a bearing. You designed the system and sent it to production. But it the system does not work because you select the necessary tolerances wrong and materials does not pass into each other as desired. They are called "fault finders" because it is generally the quality department that ensures that these and similar errors are found and corrected. As a general comment, although it may seem like a bad thing for you to find your mistakes, finding and debugging before the product is released poses extreme problems for both the company and the users of the product. Therefore, the R&D department and the quality control departments should work in harmony, and the QC departments should do their best to find faults and prevent a future problem, no matter how few mistakes the R&D department makes.
A different approach from what has been said so far that can be taken to evaluate this relationship is to understand that this relationship happens in other businesses involving other job functions. I have worked in a more commercial role that is not part of a medical device company and the relationship between our sales/marketing team and the legal team is very similar to the situation that was described. Many times, it was the sales/marketing team that has their ideas and wants to implement them, but at the same time, the legal team is checking to make sure all the guidelines are being followed. It is important to acknowledge that each of these teams is doing its job and not trying to impede the other. I have heard that it can be frustrating to work with legal, as I am sure it can be frustrating to work with QA and QC. At the end of the day, it needs to be known that they are just doing their job and making sure that the company does not get sued or violate any major guidelines as that would cause even further implications. It is important to have a good relationship between the two teams as the dynamic is very important for the company to get things done.
R&D comes with long stretches of time whereas Quality is a fixed amount of stretch job with certainty more monetary benifit. If the company is into mass manufacturing quality is requires big quality staff although work is monotonous in nature. R&D can be interesting but again it ends up similar as working in clinical labs with not quick promotion and requiring highest degree which requires a person to spend 25+ years of life in education. On other hand QC is quick to get in with fairly good amount of salary with just 20 years of education.
Quality department and R&D are two sections of company that have different goals. R&D focuses on research and advancement of technology to create a better product, whereas quality ensures that the product being made is safe, have high quality, and satisfies customers' need. However, both department works to produce best products.
This is an interesting topic that is very prevalent in medical device and pharmaceutical companies. I too have experience in the medical device industry and have witnessed the challenges that quality personnel tend to face when interacting with their R&D counterparts. I have worked in both Quality Control as a Chemist and Quality Assurance in multiple roles. There is often a perception that R&D is “too lax” or Quality is “too uptight” when it comes to completing tasks. However, it is my belief that personnel in both areas are simply relying on their academic knowledge and working experience to justify how they handle certain situations in their perspective areas. It is critical, though, that personnel in both areas adapt to the necessary requirements to ensure they can work interdependently while maintaining compliance for the company’s sake. I will say that in most cases, it is up to those in the quality and/or regulatory departments that ensure compliance is maintained across all employees in the company, including those in R&D – not because they are strict, but because the company has regulations to abide by. So, it is up to everyone to understand the requirements and be held accountable to them. “Quality” overall, is every employee’s responsibility. So, the idea of “Quality” should be considered a positive cultural outlook for companies, not an overburdening act or policing group of employees.
R&D is the organized and inventive activity performed to add to the existing body of information, such as the body of knowledge about people, industry, and civilization, and to come up with new ways to use the understanding that already exists. In order to avoid quality problems and preserve the authenticity of the product throughout its development, quality assurance is a quality management process that entails the establishment of regulations and processes. An organization can manage all areas of quality management, including quality planning, quality assurance, quality control, and quality improvement, using a quality management system, which is a collection of techniques and tools.
Both departments should have a symbiotic relationship. Yes, their departments have different scopes of work but they are working towards the same goal. If QA and R&D are not working together then the whole project will fail.
The relationship between R&D and Quality departments is critical for the success of a medical device company. R&D focuses on developing new products and features, while the Quality department is responsible for ensuring that these products meet regulatory requirements and are safe for use by patients. These two departments often have different priorities and approaches, which can lead to tension and disagreements. To minimize conflict and ensure a smooth collaboration between the two departments, it is important for both sides to communicate effectively and understand each other's perspectives. R&D needs to understand the importance of quality and regulatory compliance, while Quality needs to appreciate the need for innovation and speed in product development. Cross-functional team meetings and training can help bridge the gap between these two departments and foster a culture of collaboration and respect. In summary, while there may be tensions and disagreements between R&D and Quality departments, it is important for both sides to work together and communicate effectively to ensure the successful development and launch of safe and effective medical devices.
Research and development (R&D) includes activities that companies undertake to innovate and introduce new products and services. It is often the first stage in the development process. The goal is typically to take new products and services to market and add to the company's bottom line. The term is widely linked to innovation both in the corporate and government sectors. It allows a company to stay ahead of its competition. Meanwhile quality control is a process through which a business seeks to ensure that product quality is maintained or improved. Quality control requires the company to make an environment where management and employees strive for perfection.
R&D cooperation has become a core aspect of the innovation strategy of R&D-performing organizations over the last three decades. Globalization has increased the imperative to organize these cross-border, inter-firm agreements efficiently, and this has led to a cross-fertilization of ideas from a variety of fields, including international business, management, geography, and, more recently, psychology. The breadth of the academic discussion has evolved towards a general consensus on governance choice decisions, motives for collaboration, partner selection decisions, and performance implications.
I think it is a constant battle. R&D might want to make a product like how they envision. The engineers need to make it come to life. However, there is usually a big gap just there. The second thing is that quality might think there might be a a lot of challenges from their realm to make sure everything is good from their perspective. I think it is just the nature of the business.