The process of putting a strategic plan of managing identified threats and exploiting opportunities into action is called the implementation of the risk management plan. Such a process may take many forms. What methods and tools you are going to choose to implement your risk management plan?
There are many tools that can be used to mitigate the risks. Some of them are being discussed in risk management lectures. Mainly three tools have been mentioned. Among them first one was FMEA. FMEA stands for failure mode effects analysis. It looks at how things can go wrong and its probability and severity. Along with that, brainstorming and fish bone diagram are also discussed as risk management tools.
Proactive Risk Management provides a unique approach that models the scalability of risk to any size project or program and easily deployable into any product development or project management life cycle. It offers methods for identifying drivers (causes) of risks so you can manage root causes rather than the symptoms. In order to implement this the following steps should be taken:
- Define what you expect to gain from the plan.
- Understand the different frameworks, risks, and previous experiences available.
- Take stock of the resources available. T
- Review the plan.
- Target the implementation in a controlled way.
- Consistently report on progress.
Smith, P. G., & Merritt, G. M. (2020). Proactive risk management. productivity press.
Brainstorming is a good method to use to develop a risk management plan. The goal of brainstorming in risk identification is to gain a thorough list of risks. To gain a comprehensive list of risks it is important to involve the right stakeholders in the brainstorm. This would normally be the project team itself with aid of external experts, who have relevant insight. Using a facilitator or lead who has brainstorming experience is beneficial as they can help motivate the team members during the thinking process. The brainstorm should produce a broad range of more or less unorganized ideas for risks depending on the brainstorming technique. The ideas need to be categorized, grouped and connected to be useful for the further risk analysis. This can be done either as a part of the brainstorming session or by the facilitator.
A tool used to mitigate risks is the fish bone diagram. These diagrams are a visual way to look at cause and effect. There are essentially 4 main steps to using a fish bone diagram.
1. Write the main problem in a box on the left side of a paper and draw a horizontal line across the page from the box.
2. Identify as many factors that may be part of the problem as possible. Draw a line of the horizontal line for each factor and label each line. (The figure should start looking like a fish skeleton)
3. For each factor brainstorm possible causes of the problem that are related to the factor. Draw these causes as lines coming off the factor lines. If a cause is large or complex, break it down into sub-causes and draw them as lines coming off each cause line.
4. At this point the diagram should have all the possible causes of the problem that you can brainstorm of. Using this diagram you can start investigating the most likely causes and start finding solutions.
The "Bow-Tie" method for risk assessment is one way we can implement our risk management strategies. This is a visual diagram that resembles a bow tie and is used to differentiate proactive and reactive responses to the immediate threat/ risks to the device in development. Additionally, you can make this diagram specific to the different types of hazard you warrant can come of the device being dealt with.
From what I have read a standard risk management plan consists of five factors: definitions, presumptions, detailed structure of risk breakdown, impact, and cost. Definitions help with clarification on identifying potential risks, presumptions are planning ahead of time for potential risks.With the risk breakdown structure include categories of potential risks and the cost component is shown through statistical analysis. I believe if companies added a risk register an increase in improvements will be seen. Risk registers navigate potential risks in new projects, using this will allow companies to prepare and respond effectively to challenges.
The Risk Management Process has a variety of different tasks that are encompassed within it. The Analysis portion that is involved includes a good amount of brainstorming where any risks that may involve a product should be listed, and their levels of risk be categorized accordingly. When Evaluating these risks, we must include the probabilities that they will actually occur, as well as the impact they can have to patient/user safety. One way of doing this is by generating a Risk Matrix where the occurrences and severities of a risk are related in that their avoidance and impact can be directly referenced by all parties involved in the design. From here, it is all about managing these errors, which is more of the damage control session to act on these risks if they were to occur and mitigate the damage. Then Evaluate the plan that you have currently put forth. Is it good at handling risks when they occur? Were there new risks that developed that weren't initially brought up during the brainstorming? Is there a risk that is occurring more frequently than we thought? All of these are things to add to your current plan to keep improving it's quality to approach a more perfect Risk Management Plan.
