We learned this week that often times the people who make up the risk management team are also on the project team. When/why would this not be ideal?
Hypothetically, if you have a project team who is really pushing to get their product on the market or are pressured by deadlines in industry, having them also be the risk management team can be non-ideal as there can be conflicts of interest. The project team may take shortcuts or incorrectly categorize risks during their risk assessments in order to further push their product to market sooner. Having another team handle the risk management will keep the project team accountable and ensure that the product is safe and of high quality before going to market.
We learned this week that often times the people who make up the risk management team are also on the project team. When/why would this not be ideal?
This can affect both teams positively or negatively, but there are different scenarios. For example, if the risk management team is having a hard time with their work, it would be great for the project team to help them. However, if the project team is also having a hard time, it would not be ideal for them to work together since it can cause an interruption to both assignments at hand. However, suppose they work together and help each other out systematically. In that case, it can be an excellent idea for them to work together since it will allow more people to figure out solutions for each other. Leading to faster work being accomplished and more views toward each problem.
I would agree with @njq3 on the potential conflict of interest by sharing personnel with the project team, especially if the project team is incentivized for completion of the project. I think the hardest component of this conflict of interest to overcome would be in the subjective realm of risk severity and risk probability. When between 2 categories, it can be hard to be conservative with the probability of an occurrence. To me, not including the perspective of end users and manufacturing may be the largest liability. Their experience with working with the manufacturing and use of similar products typically elucidates risks unknown to the rest of the group, and generally have first hand experience with the problem and how often it occurs.
In a perfect world, this would not be an issue. However, the personal convictions and motivations of the risk management team can affect the validity of their results. In order to keep the risk management team as unbiased as possible, it is best to bring them in from another division or even company. As much as we all like to pretend we are extremely professional and unwavering in our convictions in engineering; it is highly likely that a team of risk managers who are also developing a device will have a risk management style less centered in reality. This is not to say that such an arrangement is impossible, just that strong oversight might be necessary in those scenarios.
Conflict of interest is the main factor as to why it wouldn't be ideal to have people who make up the risk management team also be on the project team. While having a member of the project team would provide valuable insight on the inner workings of the product and how it is manufactured which could help in the determinations of potential risk that could occur while the product is in use, the potential for bias is very high. A person who is also part of the project team would likely view the product that they worked hard on to be of the utmost quality and also would want it to reach to market as soon as possible. However, an outside person who is not part of the project team would have a completely unbiased opinion of the product and would be able to properly categorize the different potential risks and determine potential risk levels.
In my opinion, I think the ideal risk management team would consist mainly of individuals who are not part of the project team but also have at least one (maybe more depending on the scale of the project) member from the project team. This would allow for the risk management team to be mainly unbiased when evaluating the product in question, but also allow the project team to give input and insight into the product in question. Their insight would help the risk management to better understand the product and hence better categorize the risks and risk levels.
As mentioned by my peers, conflict of interest would most certainly be the biggest issue with the risk management team being made up of members of the project team. If its a company that lacks morals, perhaps something like Theranos, then members who are under pressure to release the product under any circumstance may cut some corners. And, as mentioned above by a peer, if there is an overwhelming amount of work to be done, then the risk management or design tasks may be completed improperly as the necessary resources would not have been devoted to them. Ideally, I think that risk management should be made up of people outside of the design team. This would remove potentially overwhelming responsibilities from the project team and would ideally also be more unbiased.
There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our project. We knew the project all the way through since we developed the idea, pitched it, brainstormed multiple ideas, implemented design inputs, specifications, verification, and validation testing, including different protocols written by us. The pros of having this is that we have better knowledge about the project than anyone else. The only inputs and feedback we received about the risks were from our advisor and it allowed us to make better decisions and judgement on the device. Now that was academic-wise and a prototype for a class. We knew our project device inside and out. We were able to list as many risks as we could due to our planning and careful analysis on what we are planning to build. Yes, you may know all about your project you are intending to build for the healthcare world, but you will run into the case of bias or you can miss something crucial or even something simple. It is best to have another team to assess the risk of the device since they have a broader view and a fresh perspective on your device. You are meeting with the risk management team, and they do not know your project, and you have to explain it to them. From their perspective and intel, they can provide a really good guidance for your device. They can provide important information that the project team may have missed entirely or failed to consider. It is best to identify as many risks, hazards, or hazardous events as possible rather than miss any. This allows for accurate identification purposes.
Medical devices have all types of risks, some having higher risk compared to others. Companies are selling these devices to people to use for their well-being. Sometimes project teams are more focused on creating the device to be functional and working. They also want their devices to pass the difficult time-consuming tasks of verification and validation to meet deadlines and such. Once testing is done, they believe the device is all good to go and that nothing else needs to be done. Risk management, as we learned, is done from the beginning of the product to beyond the finishing of the product after placing it on the market. It is also not ideal for the project team to be risk management after the product is on the market and they are monitoring the results of use. Again, there would be bias where they believe the device is full-proof and will not fail or pose any risks to others since they had already mitigated the risk and done all the work with testing. Another thing about this is, as I mentioned, that the project team is more focused on completing the project within the time frame given as in the industry, projects are deadline oriented and money driven. If the project team is the risk management team, then it could lead to huge issues. With their extreme focus on completion, they may fail to realize the risks present or would potentially believe that taking the time to do a risk assessment, analysis, estimation, and evaluation would jeopardize their time frame and budget.
I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that are on the project team are working with the product everyday and are either designing the product, brainstorming intended uses, and guidelines to properly use the product. If anything, they are the most familiarized with the project and in theory could produce potential risks associated with improper use of the product or risks associated, with proper use for that matter, of the product. Where I think this becomes an issue is if the project team intentionally or not neglects some potential risks that that may not have been considered which of course could lead to patients being harmed by the product if the risk were to arise. I think it is crucial to have some individuals who's jobs specialize in risk management in order to balance out the project team in order to ensure that all risks are being accounted for and that regulatory ISO risk management standards are being met. In this way both teams can collaborate and come together to create a comprehensive risk mitigation and management plan that draws upon their combined efforts and expertise.
It's not idea when the project team also handles risk management in cases where the device introduces new technology or unfamiliar clinical use. When engineers are very close to the design, they tend to see the product through the same assumptions, which can cause them to miss real-world risks. An independent or cross-functional risk team brings a fresh perspective and can catch issues the project team is too immersed to notice. For example, engineers may design something perfectly according to specs, but a clinician, manufacturing engineer, etc. might immediately spot risks related to workflow, maintenance, or user interaction that the project team would never think of.
The project team and the risk management team shouldn't necessarily be the same individuals because this might lead to heavy bias and/or blind spots. When you build a device, of course you would want it to function, which may cause you to ignore some risks or downplay how serious they are. A separate risk management team brings in new perspectives from individuals who are not emotionally invested in the design and are better able to question things you wouldn't. For high-risk devices or where design choices have a significant impact on safety, this would be very important. Independent reviewers are able to identify problems that the project team may have overlooked. Slowing down the team isn't intentional, it's about ensuring that all risks are actually addressed because the same team is attempting to meet deadlines and evaluate its own work which could prove dangerous.
There are a few conflicts that could arise when it comes risk management and the project team being involved in the same tasks. One is the distribution workload for the project. Having the same group work on two different sectors within a project could create unnecessary risks and increased times for deliverables and tasks to be completed. So having two separate teams working on their own accord without having to dabble in either department would not only create a less stressful environment, but also increase productivity.
The second issue that comes to mind is how the team views the project at hand. While the project team is trying to create and push the device out, the risk management team should be cross checking and challenging the mindset of the project team. By combining the departments, it creates unnecessary risk and even temptation to cut corners. Additionally, the project team should be thinking on how the system or device should be used while the risk management team will be thinking on how it would be used on the worst day or in a worst case scenario.
