Risk management, from my understanding, is the act of ensuring your device is free from unacceptable harm. I believe the first step in any risk management plan is to determine your potential sources of harm that are directly related to the medical device. For example if you have a medical device that emits an electrical output, one hazard to the patient can be electrical shock. The first step in an effective risk management plan is to determine these types of hazards and then the next step would be to manage/mitigate the potential situations that would expose us to that harm. That would be done by first assessing the level risk associated with the hazard and then implementing effective measures against those hazards that have been deemed to have too high of a risk. Such mitigation steps could include encasing the battery which provides voltage to prevent exposure to the patient or by using strong adhesive to ensure the patient cannot have access to the internal circuit board that controls the device.
Through my work experience, I have worked with two different methods such as FMEA’s and biocompatibility test. Most recently more so with FMEA with suppliers that provides critical finished devices to us for a top level kit. This was not the only means for risk management performed, just the only portion in which I was involved. FMEAs are comprehensive approaches to determining multiple avenues of failure associated with a medical device then assigning severity, detection, and occurrence values to form an RPN value. Additionally controls are introduced with the FMEA to help mitigate those potential causes of failure and additional controls can be implemented as additional mitigation measures if need be dependent on the calculated RPN value.

To add on to what aij5 has said, there is also legal liabilities that companies should make sure that they have covered. If a product goes out to market with known risks and they have made sure that the public knows about them and have warning labels and such on the product, they are less liable for legal action against them. If a drug goes to market with side effects goes to market after FDA approval, they limit the risk for legal action against them if the public knows the risks involved with taking the drugs and the patient assumes responsibility for his/her actions.

Hi, so here we are talking about two different kinds of Risk Managment Plans. In project management the Risk management plan is how we identify risk throughout the project. At the start of the project the project team will identify potential risks and how that would impact the cost, timeline, or quality of the overall project. They can then create a plan to mitigate risks. For example, if the project included and FDA submission a risk might be that the FDA does not accept the first submission and asks for additional information. What is the likelyhood of that happening? How would this impact cost? timeline? How can we mitigate that risk? Project Risk management plan should be updated throughout the project as new risks are identified.

The second type of Risk Management we are discussing here is product risk management and 14971 is specific to risk management of medical devices. This is a process that will identify risks in the design, process and use of the devices and how these risks would potentially impact a patient. These risks need to be brought down to an acceptable level to reduce the impact to the patient. These risks can be reduced by improving a design or process, implementing quality control procedures, or creating instruction for use to the physician/patient. These risk managment documents which usually include a Risk Managment Plan, PFMEA, DFMEA, AFMEA, and Hazards lists, should also be updated throughout the life of the product and whenever a new risk or failure mode is identified.

Risk management planning is important process how you do risk identification, risk analysis, risk responses, risk monitoring and control. Risk is not always bad, when we think about risk we always think about the negative impact of risk .But we have to think about the risk and the rewards. An example, you identified a risk and you know that if it happens it will cause you 25000 $ and there is a 60% chance that risk is going to happen. And now you also know that you can spend 10000 $ and that risk will go away. Are you willing to spend 10000$ and make that risk completely go away or do you take that 60 % of chance and let go that 25000$?
In risk management planning we consider the stakeholder tolerance for risk, the basic concept is higher is the project priority is more willing is the organization to spend money to eliminate risk. In Planning meeting and analysis, we need project manger, project team, stakeholders. we need to consider cost elements, schedule activities and risk management plan.

Risk management means to have a set plan to follow based on the possible scenarios that could go bad. Your team needs to be a master on the design and production process so that they can anticipate areas of concern and develop a plan to follow if that problem does occur. It also takes adjusting as nothing will go perfectly every time. Being able to adjust to unanticipated problems is of major importance and it is needed to keep a project running. Risk management needs to have consistent communication with all members of the project as it is important to keep update and not let any issues remain unnoticed. Issues that take longer to figure out will take longer to find a solution as the project is moving forward and now the team must go back and repeat its task to solve their risk problem. Risk management should first start with assigning guidelines that each department must follow based on the project and testing protocol. ISO 14970 determines that risk management must set up guidelines and a strategic plan to evaluate, control and then review each specification so as to maintain constant monitoring.

From reading all the response I did some research and found that there are 6 categories involved with Risk Management. They are Risk Identification, Risk Responsibilities, Risk Assessment, Risk Response, Risk Mitigation and Risk Contingency Planning. A Risk Management Plan can be considered a program that is done indefinitely with a company. It tends to stay through the duration of a project(s). Risk assessment is the topic Ill speak on and allow anyone else to speak on them more in depth. Basically, Risk assessment is determining the probability that risk can occur. With that one wants to know as well the impact of that potential risk. There are charts that display a definition of a risk i.e.( frequent, likely,…) these risk categories have a meaning associated with them. Afterwards, the value of 1 being the least and 5 the highest are evaluated using i.e(1,2,3,4,5) for the five. A risk management might have the words catastrophic appear which have many synonyms associated with it below to describe this risk assessment. With the other Risk Management categories listed, one may be able to define them?

To add on to what everyone said above, the intent of the Risk Management Plan is to “Differentiate most critical product features related to safety/harm, Quantify and determine acceptability of risk, Provide focus and priority for product development and lifecycle activities (such as V&V, CAPA, etc.)”. The Risk Management Plan includes: assignment of responsibilities and authorities, risk acceptability criteria, risk verification, production and post production activity data collection and review. As some people stated above, risk is not necessarily very bad but it is the level of the risk that is important. The Risk Management Plan helps identify these risk and the level of it to determine the course of action.

More information on this can be found at pda.org under risk management

A risk to the product is something that every company faces, may it be a startup or a large established company. Risk management is something how the company or the firm tackles the risk.Risk Management is the process of identifying, analyzing and responding to risk factors throughout the life of a project and in the best interests of its objectives.
Risk management is done to
- Identify possible Risks.
- Reduce the Risk.
- Provide a rational basis for a better decision making regarding the risk.
- And then plan Accordingly.

There are many risk management plans for different backgrounds. In the medical device industry we base our risk management plans on ISO 14971. Every time we mention risk management I think of ISO 14971, because the medical devices companies have to be comply with ISO 14971. In this industry of design, manufacturing, research and development, the ISO 14971 process must be followed, it is the bread and butter to the risk management plan. This plan covers everything from potential hazard to the severity to an adverse event that can take place. It really important especially in the medical device industry. Any device has a potential liability, the plan is to find and state the potential issues.

The risk management plan is a document prepared by project manager to foresee risks and methods to either minimize or eliminate their negative impact on project . An ideal risk management plan can solve any unexpected problem coming while executing the project because all the scenarios that can go wrong has been taken into consideration while planning . and it also decrease the level of problem affecting the project. The risk management plan should include budget, work breakdown structure, roles and responsibilities , risk register ,reporting structure,risk categories and process that will be adopted. The Risk management plan is referred to frequently throughout the project, to ensure that all risks are mitigated as quickly as possible. For a project to be successful ensure that risk management plan is maintained.

Risk management plan is method to reduce any risk a company can suffer. It is a way that the company can avoid/ minimize being sued or even harming the public. Last year I took medical device development and the way we dealt in starting our risk management plan is by shooting any risk idea that happen and from there we would solve them. If any new risk arises we added to the list and solve them. ISO 14971 standard is basic application of risk management for medical devices which we had to include in our risk management plan. It help identify and analysis any potential risk that medical device an inflict.

A risk management plan is a crucial step in a project. It helps to identify risks and implement a plan to reduce them. It helps the members to foresee risks, identify actions to prevent them from occurring and reducing their impact. It also mentions the risk based on ranking and priority, and the process of tracking the risks. Throughout the project, risks plan are managed closely because it could change the stated delivery and if issues occur then it will give chances to boost success.

If I have a project to finish by a specific due date or an exam to study for, taking remedial measures at the very beginning of my work will help give a head-start as well as avoiding any issue that might bump in the way. It is the same case with bug projects, where an individual needs to make some measures ahead before starting with the project to save running into risks, which can completely throw the plan away. Project management plans can identify, anticipate, and employ solutions in case of running into issues/problems. A good project risk management plan is the one that can face the unexpected problems that might arise because the plan from the beginning has taken into consideration all the possible scenarios that can go wrong while executing the project. Some of the attributes of a good project risk management plan are a process, budget, work breakdown structure, risk register, roles and responsibilities, reporting structure and risk categories. During my last internship at United Healthcare, I followed this project risk management plan for the project I worked on.

A risk is an event or condition that, if it occurs, could have a positive or negative effect on a project’s objectives.
Risk Management is defined as the process of recognizing, classifying, evaluating, responding to and managing risks that could appear in any project. This plan is usually created by the project manager. The team members including the project manager and the project sponsor are responsible for what is included in this plan. This plan is normally prepared by the project manager. This plan would make it easier for the team to keep track of any predicted risk project, and to determine the risk impacts and classify it whether it is high (impact project cost/plan/achievement), medium (slight impact), or low (relatively little impact).

ISO 14971 is a required standard by the regulatory authorities for all medical device companies to ensure the risk management process. This standard would assist the risk management process in a medical device company in identifying hazards, and in estimating the risk.

I found these few key definitions on greenlight.guru useful to learn:

"RISK - combination of the probability of occurrence of harm and the severity of that harm
HAZARD - potential source of harm
HAZARDOUS SITUATION - circumstance in which people, property, or the environment are exposed to one or more hazard(s)
HARM - physical injury or damage to the health of people, or damage to property or the environment
SEVERITY - measure of the possible consequences of a hazard
RISK ANALYSIS - systematic use of available information to identify hazards and to estimate the risk
RISK ESTIMATION - process used to assign values to the probability of occurrence of harm and the severity of that harm
RISK EVALUATION - process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
RISK ASSESSMENT - overall process comprising a risk analysis and a risk evaluation
RISK CONTROL - process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels
RESIDUAL RISK - risk remaining after risk control measures have been taken"