The risk identification on the project is one of the most important processes in a project. For this purpose, all the team members should be aware of the project completely. Also, all the members must brainstorm over the risks that can occur while executing the project. These risks can be listed down and then can be classified according to the severity of the risks. Previous documents regarding the projects can also be referred just in case we need some more ideas regarding the risks. The risk file is the most important file for the project. It has all the previous data recorded regarding the old projects which will help for future projects.
When identifying and analyzing risks, there are tools that can be used such as brainstorming, failure mode effects analysis (FMEA), fish bone diagrams etc. to help lay out why the risk is present, how failures can occur, the probability of it, root cause analysis of failures, and even the relationship between parts. All of this should be considered when trying to identify risks. In terms of prioritization of risks, the probability of occurrence and severity to the end user are the key factors in determining risk classification. Usually, risk classification is based on a scale from low to high and is understood through a chart that takes into account the two key factors mentioned previously. It is important to accurately name these risks into their corresponding classifications, because that is than what will be considered in the managing phase of the risk management process. For instance, it is unlikely that risks classified as low would be a high priority to avoid or mitigate. But for risks that are classified as high, this may be the make or break to a products development if the reward does not outweigh the high risk being taken.
Risk must be identified during the planning stage of the project development process. This way the risks can be strategically observed and categorized. It also gives the team a chance to find methods to avoid risks that aren't necessary for the project. The time taken to manage the risks is what ultimately determines the quality of the final product.
Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management tools early on and all the way through the life of the project will ensure that risks are aggressively managed.
Aspect of Project Risk Management:
Risk Identification: Likely to affect the project
Risk Quantification: Evaluation of risk to assess the range of possible outcomes
Risk Response Development: Planning response and mitigation
Risk Respond Control: Responding to changes in risk over the course of the project
Risk identification determines which risks are likely to affect the project. This aspect of Project Risk Management includes reviewing the lists of possible risk sources as well as the project team’s experiences and knowledge. Then risks are categorized and prioritized.How do you identify and prioritize the risks you want to include?
I don't think that managing risks for a project is as simple as managing them from high to low and then addressing the higher ones first. I think it's important to prospectively look at risk and identify their potential for affecting various parts of the project life cycle. To do this, I would first identify the risk impact, then identify the likelihood of it happening. I would prioritize it based on those factors and have them managed on an individual-based and micromanaged on a team basis. Similar to a check and balance approach.
Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management tools early on and all the way through the life of the project will ensure that risks are aggressively managed.
Aspect of Project Risk Management:
Risk Identification: Likely to affect the project
Risk Quantification: Evaluation of risk to assess the range of possible outcomes
Risk Response Development: Planning response and mitigation
Risk Respond Control: Responding to changes in risk over the course of the project
Risk identification determines which risks are likely to affect the project. This aspect of Project Risk Management includes reviewing the lists of possible risk sources as well as the project team’s experiences and knowledge. Then risks are categorized and prioritized.How do you identify and prioritize the risks you want to include?
I currently do not work in the medical device field, so I do not have to entertain risk management from that vantage point, but I have had to work through the process of risk management in other areas of my life. I am a teacher and a planner. So what do either of those have to do with risk management.
I teach biomedical lab sciences on the high school level. Even though they tend to be more mature than the lower grades, there are still instances where they can make mistakes that could potentially lead to harmful situations. If I worked in a typical business, I think a team should be involved in risk management, but in the classroom, I am the beginning and end when it comes to safety for my students. I constantly review lab safety protocol before and during labs. I reinforce the need for them to review lab procedures before moving on to subsequent steps and outline procedures for clean-up. If accidents do happen, my students know how to proceed.
When planning events on the school level or with other organizations for which I have been involved, I take safety very seriously. I always try to entertain the worst case scenario and plan for that with the hope that nothing ever happens.
In order to identify the risk you must brainstorm and predict the risk before they occur. You must evaluate the safety and effectiveness of the device. This will help you or a team identify the risk. You may also compare the risk of equivalent devices or test the device in clinical trials to identify the risk. Lastly you can use the risk management tools that are available. These tools will also help with the improvement of the device, and ensure the safety. You prioritize the risk based on the severity of harm or occurrence. Therefore the end result will have more benefits than risk.
@zbw2 spoke on a good system to use when considering risks. They mention that during the brainstorming part of the process, priority should be put on risks associated with the most critical parts of the device that can’t be avoided, followed by risks that can be mitigated, and risks that can be accepted. I also like the additional detail the the entire team should be part of the risk identification. This allows for other minds to work and ideally pick up on things that could have been overlooked.
There are numerous ways to identify risks, such as brainstorming, the Delphi Technique, Pre-mortem, and the Cause and Effect Diagram. Depending on the nature of your project, project managers may use two or more of these methods during a project. There are numerous ways to identify risks. Project managers may want to use a combination of these techniques. The project team may review a checklist in one of their weekly meetings and check assumptions in a subsequent meeting
@dbonanno1 exactly, agreed with what you stated here!
I think its also important to note that the question of "What could go wrong with this product" should be applied to the SME's. The SME's are the subject matter experts of a process or technology. They along quality and the rest of a project team should be included in developing the FMEA, the Brainstorming session, or whatever other tool that company may utilize to identify risk. I've noticed many people have stated that quality should be involved--but it goes beyond that and several perspectives and expertise should be involved in the process to get the best-most rounded results for risks involved.