Risk are generally analyzed by a given history and test ran on vaccines before giving them to patients. We generally also ask for patient history to understand if there are any type of adverse reactions to vaccines if so diphenhydramine is given in order to mitigate risk. After administration vaccines are administered and patients are monitored for the next couple of days in order to watch all signs of ailment.
Risk identification is the process of listing project risk and their characteristics and document it. This information is used for risk analysis, which in turn will support creating risk response. Risk identification can be also represented in a risk breakdown structure, a hierarchical structure used to categorize potential project risk by source. The ultimate purpose of risk identification is to minimize the negative impact of project and maximize the positive impact of project opportunities.
Risk identification is the first step in risk management process. To carry out risk analysis, we have to list the possible threats that we encounter and then estimate the likelihood that these threats would materialize. FMEA methods are implemented to analyze the risk factors. Brainstorming, Fish bone diagram for finding the root cause of the possible failures are also taken in consideration. Document review is one of the important aspects in risk identification process. It is carried out in reviewing the project, plans, project files and identifying the areas of inconsistency or lack of clarity.
Risk management is the process of analyzing, identifying and responding to risk factors. Managing risks early is the best way to avoid issues later on. Throughout the R&D stage, 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. Risk identification determines which risks are likely to affect the project, which includes reviewing the lists of possible risk sources against a team’s experiences and knowledge. Then risks are categorized and prioritized based on their impact and how much financially it would affect the product/company. If you have experience, how are risks identified and prioritized in your company?
Risks are typically identified and prioritized based on the critical quality attributes (CQAs) of the device. CQAs are the most important features of a device. If these features are manufactured out of spec/tolerance, that could potentially lead to a failure of a particular function of the device during its use. For example, the saw blade that's used to make the bone cuts during a total knee replacement procedure needs to be extremely flat to ensure a flat, even cut is being made, since the implant needs to fit flush against the bone. If the flatness of the saw blade is uneven, that could lead to uneven bone cuts being made, which could lead to malpositioning of the implant, which could lead to a number of failures of the implant (loosening, insufficient range of motion, etc.). The flatness of the saw blade would be identified as a CQA since there is such a high risk associated with this feature, and this would clearly be documented within the DFMEA and Risk Table.
Risk management is a vital part of any company as it is the practice of protecting the company from anything that can damage its image or get it in legal trouble. In my life I have witnessed these practices in a healthcare consulting company I interned for while in my undergrad. Since we were using data that was classified under HIPAA, our company had multiple people in charge of identifying risks. The regular risks were just getting employees certified and trained. To manage data leaking risks, we used an email extension and data protection service called Virtru. Basically, it was just implemented to make sure that there weren't and documents with patient data getting emailed outside of the company.
The company i worked in had a similar approach like mentioned by @cef that for risk identification a design matrix is very crucial all the cqa are determined and then the critical development parameters were determined and studied how the risk parameters could affect the cqa also we used to brainstorm all the possible risks and give them ratings we also performed SWOT analysis as you know its sometimes difficult to mitigate all the risks involved but we always ensured to mitigate most of the risks involved and ensure the product was safe and passed the FDA standards.
I am currently working in a university setting rather than an industry setting. Therefore, we will have a different approach however the main fundamental idea is the same. For lab settings, we do a more concentrated dive in literature and talk with senior members of our team to get some guidance. In addition, we try to have 2 Ph.D. students with similar interests to collaborate this way they are able to confirm each other work increasing the validity of each work. In addition, we report to our PI who additionally checks if there are problems or risks within our projects. In addition, we use statistics a lot to make sure that the results are significant and follow the guidelines. We also keep a log of what possible risks came about which was not expected before hence it may be applicable for a future projects of similar nature.
Quantifying risk in product development is incredibly important for the project to stay on track successfully. This is not always an easy task, which is why there are methods like the SWOT analysis method. This takes an in depth look at the strengths, weaknesses, opportunities and risks in order to identify and analyze seen and unforeseen risks involved in the development process.
The way I have seen be effective in quantifying the risk involved in development is to separate every potential risk into probability and intensity. This involves quantifying specific things like how likely the scenario is to happen, and if it occurs, how much of a delay it will cause or how many people it will effect. By doing this a clear picture of risk can be drawn about a project.
Many of the technologies described above are used by my firm to identify and manage risk. Risk can be connected with the device's design as well as its production, as the professor also stated. Risk can also be linked to the manner in which the gadget will be utilized. The QA department does a functional analysis, which involves looking at each individual step in the surgical procedure and identifying any potential hazards. As a result of the functional analysis, a risk table is created. In terms of design, QA collaborates with R&D to analyze engineering drawings in order to discover any critical quality characteristics (CQA) associated with the design. We also conduct dFMEAs to identify design failure modes and their consequences, as well as pFMEAs with our suppliers to identify failure modes and impacts of all process (manufacturing) related activities. So, at my firm, we approach and identify hazards from a variety of perspectives.
I currently work in R&D and we are constantly assessing risk factors before we put a new product on the market, or upgrade our current product or assays. We assess risk first by identifying the potential flaws of the device, weighing from potential machine failure or human error. We then put all these factors into a protocol and stress the machine. SO if the machine is suppose to work without fail for 8 hours, we operate on the machine for 10. If the machine needs 50ml to work, we use both 40ml and 60ml, this accounts for possible human error. Basically, any risk factor we predict, we over test to assure the product or assay can with stand those risks.
In my own company, the way I have identified risk is by evaluating and trouble shooting what my customers may need or any problems they may be having. This can be financially, medically, or personal. For example, my customer may have issues with payment and prices. Owning my own fitness business, this can become a huge risk I have to face because it’s how my business runs efficient. It become a priority to fix so that my customer and I both benefit. To reiterate, my identification of risk management comes from my customers and their satisfaction. Also, in the gym I work in! There are so many liabilities in the gym that have to be identified, assessed, and fixed!
I work in research administration. My company has set in place numerous checks and balances to manage risks. For instance, whenever a grant proposal is getting ready to be submitted it, it must go through numerous departments and personnel to receive approval.
My submission would go to the PI to verify that all of the information is accurate. After it leaves the PI, it goes to my bosses, then it heads to the chairs of the departments involved. After it leaves the departments, it is sent to the officials in the office of sponsored programs. Throughout the approval process, reviewers might send a notice for corrections to be made. Those corrections must occur before the proposal goes to the next reviewer. Systems like this ensures we are putting our best foot forward when submitting the proposal.
Also, we have various submission systems, such as eRA Commons, that will notify you when errors or warnings are found throughout your proposal application. These tools are very useful.
Working at a bakery was a unique experience that came with risks that I was unaware of prior to starting. Health was always a first priority, risks can come from cross contamination and foodborne illness. To prevent these risks, the government has certain standards in place for food safety management, such as the Good Manufacturing Practices (GMP), Good Hygiene Practices (GHP), and the Food Legislation.
Hello,
While I don't have personal industry experience, I can share common practices in risk identification and prioritization. In many companies, the process begins with a thorough risk assessment during the project planning phase. Cross-functional teams, comprising members with diverse expertise, collaborate to identify potential risks by drawing on their collective experiences and knowledge. This may involve reviewing historical data, lessons learned from previous projects, and industry benchmarks. Risk identification tools such as brainstorming sessions, SWOT analysis, and Failure Modes and Effects Analysis (FMEA) are often employed. Once risks are identified, they are categorized based on their nature, whether they are technical, operational, regulatory, or external. Following categorization, risks are then prioritized by assessing their potential impact on the project's objectives and the financial implications for the product or company. This prioritization helps focus resources on addressing the most critical risks first, ensuring a targeted and effective risk management strategy throughout the life of the project. Regular reassessment and updates are conducted as the project progresses to adapt to evolving circumstances and newly identified risks.
