” Risk /rɪsk/, noun
the possibility that something unpleasant or unwelcome will happen.
Synonyms: chance, uncertainty, unpredictability, instability, riskiness…”
We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy day…or planning a project without a proper risk management plan…
Unknowingly you are doing Risk assessment in everyday life!
Take a rain (hazard) for instance… Before you leave home in the morning you turn on the news to determine if rain is likely or not. This is uncertainty. What are the chances that it will rain that day (likelihood), where (location), when (timeliness), and what the intensity of rain is expected (severity)?
From this uncertainty information, you can make a decision based as to the risk as to whether you will get wet, high or not, and whether you need an umbrella that day. By reducing the uncertainty through some knowledge you can determine whether the risk of acting or not acting on the residual uncertainty.
Work, tasks, projects can also include some uncertainty and as a result some risks.
Creating something new, starting a new project always brings excitement, but enthusiasm is short living when problems start to occur. The questions appear: Is the project progressing in the right way? Will we be done by the due date? Are we going to stay within the planned budget?
"...The questions appear: Is the project progressing in the right way?"
These questions create concern or uncertainty amongst project leaders and members. If the answers to these questions are YES, then there is little uncertainty and essentially, the project is progressing in the right direction. But if only one of them is NO or DON’T KNOW YET, then an element of uncertainty remains and we should start thinking about what can go wrong and what kind of impact could that have on the project. That casts a shadow of uncertainty, with the angst of risk, on the whole project.
So, what is the difference between Risk and Uncertainty? And how can we apply to a project and Risk Analysis?
In both cases, we don’t know what is going to happen next. However, in case of the risk we have measurable probabilities of outcomes; that we don’t have in the case of uncertainty.
Simply, uncertainty is generally not measurable, because future based events are unpredictable and the outcome information is deficient.
Risk is something that can be predicted and calculated by observing the frequency of events to deduce probabilities.
What makes the recognition and mitigation of possible risks easier?
For every possible risk or hazard, there is a solution or a way to put it under control, especially when we talk about projects. Risk management has become a whole separate branch of management science and offers a lot of options on how to pull a project out from the clutches of uncertainty.
qmsWrapper has a Risk assessment process for projects. Team members can identify and record the risks which appear in their part of the job, and it’s up to the Risk manager to evaluate and mitigate them according to the given information.
From one perspective, planning a project which is flexible enough and has realistic targets makes the recognition and mitigation of possible risks easier. In that way, the risk mitigation has been already being built-in by addressing known possible uncertainties.
"...From one perspective, planning a project which is flexible enough and has realistic targets makes the recognition and mitigation of possible risks easier."
Also, if we are aware of consequences or know the possible outcomes of certain hazards, we can prepare or plan solutions for them that can lead the project to more certain success without any uncertainty. In the case when we are not aware of all, or some, of the possible outcomes, then we can talk about uncertainty.
qmsWrapper with its implemented risk assessment module prepares the team to deal with any kind of risk/hazard in their project, and manage them, address them, in a systematic way. Risks, will not be ignored!
Risks and their hazards don’t need to mean something wrong or something that could handicap the project.
Look at them from another perspective: they can help identify things that were simply not thought of, or identified, at the time the original requirements were written and as such, they can help to improve the product. By highlighting any weak points or deficiencies in the project or the subject of the project, it can be a positive impetus leading to good development.
Risk as a part of QMS is also important because Compliance demands that you record and document any possible hazard or risk in each project that might be subject to or related to compliance whether ISO or FDA. The QMS Manager needs to have documented proof about the identification, mitigation and evaluation methods for each hazard.
"...Compliance demands that you record and document any possible hazard or risk in each project that might be subject to or related to compliance whether ISO or FDA."
When risks are identified, evaluated, mitigated and documented (i.e. put under control), you can be sure that risk won’t be a synonym for uncertainty in your project, but rather a step to improvement.