Risk management is important because you never know how projects may turn out amongst the many sectors that are involved. To avoid uncertainties and minimizing possible occurrences, creating a Risk Management Plan is a necessity. A Risk Management Plan (RMP) is prepared by a project manager to address risks, their potential impact on a program, and consists of ways to reduce these risks. The first thing you should do at the beginning of a RMP is identify risks. Taking chances on running a project involves risks in many platforms such as risk sources, risk categories, probability of risk occurrence, risk impact, risk exposure, risk occurrence timeframe, and risk events. Prior to this weeks discussion I did not know much about ISO 14971 standard, but I learned that it defines the international requirements of risk management systems for medical devices and defines the best practices throughout the entire life cycle of a device. It is a nine part standard which first establishes a framework for risk analysis, evaluation, control, and review and also specifies a procedure for review and monitoring during production and post-production. As a current employee at the FDA, I took out the time to investigate on our website a more in depth description of the RMP along with detail about the ISO 14971 standard. The following link is a PowerPoint on how the FDA operates!
According the PMBOK Guide, risk management is a, “systematic process of identifying, analyzing, and responding to project risks”. PMI express that in order to be able to apply the process to of risk management, one must understand that risk is events or conditions that are spontaneous and may either cause a positive or negative effect. PMI emphasis that "risk" is not an event, but more as a "probable happening".
Risk management is the process of identifying possible risks, problems or disasters before they happen. This allows business owners to set up procedures to avoid the risk, minimize its impact, or at the very least help cope with its impact. Risk management is recognized as an integral component of good management and governance. It is an iterative process consisting of steps, which, when undertaken in sequence, enable continual improvement in decision making.
https://marineagency.com/reasons-why-every-company-should-implement-a-risk-management-plan/
https://www.careersinaudit.com/article/the-importance-of-risk-management-in-an-organisation/
Every organization irrespective of its size and type may undergo various types of uncertain incidents that might include natural disasters, fire accidents, and human-made events such as data breaches, etc. So, it is necessary for each organization to implement a risk management plan in their project life cycle. Risk management refers to the way the organization is going to face or handle risk and eventually have a risk response plan for uncertain events ranging from natural disasters to data breaches. Usually, a risk management document has certain possible potential risks to the organization at each level and appropriate solutions to them or to keep those risks at the base or acceptable level. In an organization, various types of risk management plans tackle different risks. In general, a risk management plan is developed or designed by the organization’s stakeholders that include department managers, senior management, and compliance officers to address or solve strategic and high-level risks, and when one is dealing with the project management plan, then the project manager must deal with the project team to develop a risk management plan to solve risks related to the project. I strongly believe that implementing a risk management plan in the organization does not solve or eliminate all types of risks in the workplace, but it helps in establishing a best practice or actions to enhance the cost-benefit connection between risk elimination and the usage of organization resources. ISO 14971 is also a risk management plan but it deals with medical device risk management and mostly it comprises software as in vitro diagnostic medical devices and medical devices
