If someone has not asked all stakeholders to identify potential risks then their project could be have a disadvantage. They would only have the points of view of engineers and others on the project team. In order to try and supplement the points of view they don't have would be to conduct substantial due diligence to find similar aspects and figure out the risks that were present when those projects were being completed. You could also look at past projects that your company has done and see if risks that have happened in previous projects could occur with what you're working on. This way you could look at more detailed reports and could try and prevent them before they happen. It would be best to try and involve stakeholders and get as many points of view as you can but if not you might have to continue on and deal with the risks and vulnerabilities as they come.

During the development process, identified potential risks can come from a variety of sources. In my experience, most of the risks identified were from our engineering teams working on the project and from previous experiences on past projects. Some risks were identified by mechanical, some by electrical, quality, and so on. During development we would give each other feedback based on the items or changes each team wanted to implement into the product. Sometimes there were no problems, while others something electrical would want to do would causes issues with what mechanical would develop. Vendors have sometimes voiced concerns about our designs and how during manufacturing problems could arise. They have never told us about rival companies because vendors are confidential with their clients and never give out info to other companies. Customers too have come forward and say that based on what we came up with in our design, what kind issues they think will happen. So identifying risks can come a lot of different sources.

In addition to doing a strong stakeholder analysis and getting input from those stakeholders into the risk planning process, it is important to make sure that risk management is done throughout the project cycle. The project manager. In terms of project risk, the risk management plan should include what happens if a risk is identified during the project. For example of a critical team member leaves the company or goes on unexpected leave or a supplier is falling behind in production, that risk needs to be communicated effectively and the risk documentation needs to be updated. For product related risks, anytime a new risk or patient harm is identified the product risk management documents need to be updated.

In my experience with suppliers, they are always open to providing suggestions for process monitoring, potential avenues of future risk, and additional cleaning steps to ensure the safety of the product. This can come in handy with risk management because not only would they have seen how your product of design is being manufactured, they would also see how others do things as well. That insight could prove to be valuable, especially from a supplier perspective if it results in additional money coming in. Customer surveys and routine checkups can prove to be valuable as well. They can disclose any issues they are experiencing which can be incorporated into the next iteration of a design.

Another source to use to identify risks is with complaint analysis. When your product reaches a customer and the product that they receive is not satisfactory, they will file a complaint. For example, it is possible that the product was damaged during transport. When the product is returned to the company, it can be examined and the ways in which it was damaged can be identified. The extent of the damage would be assessed, and you would be able to determine how the product was effected. Then you can try try calculate the risk of it happening again and the risk to the end user if the product was used instead of returned. Finally, you could manage the risk of it happening again by improving the design of the product or the design of the packaging.

I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked on a project where the team leader main concern was the qualification behind the equipment. I work with the conversion of some of our labs to GMP labs and the risk management was surrounded around time line that were set by manufacturing for dosing of the first patent for a new product. We found a solution be spitting the work and priorities into two separate groups that would be manages by different members of the team. The people that prioritized a specific risk monument ideal worked on the parts of the project that would add support. In the end the project leader monitored the progress and we had many meeting were we exchanged different ideas and updates. At some point the project began to come together and at that point there were more aligned with what the risk were and how we would handed it.

The role of project stakeholders is very valuable since there is always potential for positive and negative influence of one stakeholder over another. The greater the potential influence, the greater the risk reach project goals. Knowing the weight of each stakeholder can help in focusing on the stakeholders' needs, avoid risks, promote good relations between stakeholders, and keep integral stakeholders engaged in the project from start to finish. It's important to ask questions about the role of each stakeholder at the inception of the project. It's also important to really sit down and map out the contributions of each stakeholder and their potential impact to the project. When trying to evaluate and manage risks within a project, it should be noted that a lot of negative outcomes can be avoided by learning about what worked/did not work for another project in the past.

The process of identification and evaluating risks starts in the planning phase of the project and continues through out the project. It is important to determine each risk likelihood to occurring as well as its effect on the overall project .The earlier the risks can be identified, earlier plans can be made to mitigate risks. Qualitative risk analysis focus on high impact risk for which proper mitigation responses can be planned while Quantitative risk analysis evaluate effect of identified risk on overall project , decision can be made with reduced uncertainty . However interview with colleagues and stakeholder with relevant experience can garner a lot of ideas and information. It is important to look up organization historic data to search for risk and then evaluate them, reports from the previous project can be a huge asset. The other methods to identify risk are checklist analysis, diagramming techniques , SWOT analysis.

It is a very important aspect of the planning phase for the team to ensure they have covered all the ground and assessed possible risk from every stakeholder. There will be varying opinions about possible risk from all departments, and getting a broad range of views to asses is imperative in order to not oversee any glaring risk of the project. Failure to do so, resulting in inaccurate risk management could result in attempting to operate on a project that was doomed from the start due to aggressive risk, and causing the company to lose a large amount of money, along with additional problems.

The stakeholders should be involved from the beginning of the planning phase. Each stakeholder will have valuable information in the subject matter that they have expertise in. Involving them too late could result in resistance at different aspects of the project, and (depending on who the stakeholder is) can cause delays.

As learned in lecture, stakeholders can be a wide variety of individuals ranging from patients to the financial investors that support the project. This goes to state that risk can come in many forms and can actually become more prominent as a project progresses. One method to identify risk is to generate a risk matrix, which associates a risk's likelihood of occurrence with the severity should it occur. The resulting product will decide if a project factor has low, medium, or high risk, which in turn should determine how the risk will be handled. Another technique for assessing risk is through FMECA (failure mode effects and criticality analysis), which asks "how" something can fail, along with its probability of occurring and its severity. The risks determined using FMECA can even possibly be used to generate the risk matrix.

Risk management is initiated during the planning phase and is carried out for the remainder of a project (ideally). Once the potential risks are measured, they can be handled through a means of avoidance, mitigation, transferance, or acceptance. What is the difference between transferance and acceptance? How might these methods be applied to a hip stem that demonstrates a risk of cytotoxicity a few months post-implantation? How might an early detection of risks affect a project's life cycle? Who is ultimately responsible for deciding how risks will be handled?

Asking all stakeholders to identify potential risks is quite important. As said before, different stakeholders from different parts of the stream offer varying perspectives of the industry. While it's important to include all potential stakeholders from the start, it is also very important to continue the conversation about risk throughout the life of the project. Just because a FMECA (pFMECA,dFMECA, etc) is done at a certain point does not mean that every single risk has been taken into account. It is completely possible for a risk to slip through, and often times it is that which turns into a non-conformance or CAPA. Therefore in order to mitigate this, continuing conversations about risk is important in order to capture the full breadth of it. A time this happened was in a design change project to change the on label shelf life of a product. The main risks were thought to have been determined, however when we continued to talk about the project, more and more risks were identified. The biggest one was identified only more recently: reducing the on label shelf life may trigger the risk of having a massive recall of product that has the old shelf life on it (this is major!). It was only because we were continuing the conversation on risk that we were able to identify this. Had we not done so, it may have been identified at a time where it would hurt us a lot more.

Communicating with stakeholder's through out the project life cycle is important to the success of the project. Communication between stakeholder's and the project manager/team helps build support for risk management efforts and increase transparency. If stakeholder's are not incorporated in the risk management phase, as described in the initial post, it is important that the project conducts a strong and thorough risk assessment to identify any and all potential risks the project may face. A thorough risk assessment involves brainstorming with the project team, reviewing historical project data, or consulting with subject matter experts. After identifying potential risks, it is good practice to categorize risks into different types, such as technical, schedule, budget, and external risks. Categorizing risks can help identify areas where the project is most vulnerable and help the team avoid these vulnerable areas. By taking these two measures of identification and categorization, the project manager can help reduce the impact of these risks on the project and increase the likelihood of successful project outcomes.