A Risk Assessment is yet another powerful tool in a professional’s arsenal that, if used effectively, can greatly help identify and reduce risks associated with a product or process. Risk assessments are conducted by identifying hazards and then conducting “the analysis and evaluation of risks associated with exposure to those hazards.”[1] This may seem like a daunting task at first, but the truth is that with proper planning a Risk Assessment does not need to be all that challenging.

A risk assessment centers around a few simple questions:

  1. What could go wrong?
  2. What is the likelihood of that occurring?
  3. How bad will it be if it does occur?1

Besides those three questions, it is also important to consider how the hazard can cause something to go wrong, as well as, what the actual harm of it going wrong might be. In addition, what caused the hazard in the first place should also be identified.

Focusing on those questions and approaching a potential hazard from all possible angles is key to conducting a good risk assessment. One hazard can result in multiple things going wrong with varying probabilities of occurring and varying severities if they do occur. Having that need to approach a single hazard from all possible hazards is why it is important to have a team comprised of individuals from all over an organization when conducting a risk assessment. Failing to do so leaves the possibility of overlooking a potential outcome of a hazard.

The identified hazards will be tied back to the design of the product by being tied to design inputs. Risk mitigation activities will eventually be conducted based on those initially identified hazards. The activities will then play into the design outputs of the product.

As stated earlier, conducting a risk assessment seems challenging, but with proper planning and a well-made team, it does not have to be. EMMA International can help put the systems in place needed to conduct a risk assessment and even help with conducting a risk assessment as well as all other risk management activities. 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 03/06/2022 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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