Whenever risk is identified whether it is part of a process or the design of a product, mitigation of the risk needs to occur. Risk mitigation is the process of reducing risk, this includes reducing the severity of the risk and the probability of the risk occurring.[1] Both the severity and probability play a part in determining the level of the risk; low, medium, or high. The level of the risk will in turn affect the mitigation that is used to reduce the risks down to acceptable levels. A low-level risk will need less intense mitigation while a high-level risk will need intense mitigation. The activities involved in risk mitigation vary widely.

Risk mitigations activities can include the creation of new processes. For example, if a risk is identified in the overall manufacturing process where the safety of the product is brought into question, introducing a sub-process to check the product for safety against strict standards may be effective enough to reduce the risk to an acceptable level. Alternatively, multiple processes may be what is necessary to reduce the risk. If a new process cannot be created to reduce the risk then altering an existing process may be what is necessary.

If the risk is identified as part of the design of the product, then altering the design of the product may ultimately be what is needed. This is a difficult mitigation to undertake as it will involve extensive planning and going through the design control processes in order to ensure that any changes to the design are acceptable. Unfortunately, there are some situations where altering the design is the only mitigation available to reduce the risk.  

Alternatively, the inherent design of the product or process may be all that is needed to reduce the risk. The design or process may have been done in such a way that it inherently mitigates the risk just by itself. These types of situations normally occur at the beginning of design and development when risk is identified before the final design or processes are put into place. This means that the design or process can be created with those risks in mind and thus be made in such a way that the risk is reduced.

Risk mitigation is tricky. There is also the need to be careful with whatever risk mitigation is put into place as those mitigations might create more risks themselves. EMMA International can help with risk mitigation and with the entire risk management process. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (April 2020) Q9 Quality Risk Management, retrieved 03/26/2022 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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