As risk management has made its way to the center stage of quality management over the last eight years, due to the updates made to ISO 9001 and many other standards, it is critical to ensure that our comprehension of the subject matter becomes a focal point as well. As defined by ISO 31000 - Risk Management — Guidelines, risk is "the effect of uncertainty on objectives." In the simplest sense, risk is not limited to negative conceptualization built into the layman understanding. Instead, risk is something that can be either a negative or positive outcome because of actions taken.

Think of risk as two sides of a coin. On one side we have our negative risk, while the other side would be defined as an opportunity. No matter what the scenario is, there are both negative and positive possibilities that could arise depending on the actions taken. Due to risk having both a negative and positive aspect, we want to ensure that when identifying risks, we properly identify how to approach them to minimize or address negative factors while promoting positive factors.

In the world of risk analysis and management, there are a plethora of different tools at one’s disposal to use. Organizations can utilize tools such as Failure Modes Effect Analysis (FMEA), pareto charts, fishbone diagrams, and even the Delphi method. Each methodology offers a potentially different perspective. However, regardless of the methodology you use, brainstorming is a core concept utilized in each.

Brainstorming can be used to explore a risk, problem, process, or topic in a deeper sense than initially understood. It can also be used to gain a better understanding of the potential risks at hand, both positive and negative.

How to Conduct a Constructive Brainstorm

Before you begin brainstorming, open the challenge up to others who will bring diverse perspectives. When an individual looks at a scenario, risk, or problem for the first time, bias is something that may cloud judgements on the routes or actions to take. However, brainstorming with others or in a collaborative setting helps ensure that a wide variety of ideas are introduced, minimizing biases while promoting a problem-solving mindset.

When brainstorming, be sure to also think about the different personnel, processes, and products risk might impact. Risk is dynamic, meaning that our understanding of risk should not be compartmentalized down to a singular idea or area, but those surrounding it as well.

For example, an organization’s quality system is managed through a Laboratory Information Management System (LIMS) which logs its records and documentation into one secure system. Within the LIMS, SOPs are listed and made accessible to the appropriate parties. Within the last three months, it was determined the SOP associated with processing calibration reports was to be updated.

To update the SOP for processing calibration reports, brainstorming will ensure there is a more comprehensive scope of what areas may be impacted by updating this particular SOP.

Start by asking simple questions such as who, what, when, where, why, how, and how much. If you update this SOP, who will be impacted by the changes? What aspects must be updated when processing the update? When must the SOP be updated by? What other SOPs will be impacted by the update? How much of a positive impact will this change have?

Through this dialogue, you will gain a better understanding of the other factors that need to be accounted for to ensure success moving forward.

In updating an SOP, there may be other SOPs that reference it which now will need to be updated as well. In processing these changes, training may need to be provided for impacted staff and implementation periods may need to be set up.

When brainstorming is utilized, especially in a collaborative manner, comprehension of the dynamic nature of risk becomes clearer. Keep an open mindset throughout the process and allow for all types of ideas to be brought up. Having a large group of ideas for addressing risks helps set oneself up for success when trying to address them before they occur and can even be utilized as a response to issues arising. Taking the time to understand risks associated with a process, product, or problem means that there will always be resources to return to if necessary.