What is Risk Assessment?

Risk Assessment Definition

ISO 14971 defines risk as the probability of occurrence of harm and the severity of that harm. Risk assessment covers risk analysis and risk evaluation as separate tasks, that when combined, comprise risk assessment. Risk management seeks to identify, evaluate, analyze, assess, and mitigate potential product risks or issues.


What is the five step process of risk assessment?

The following five steps can be followed to ensure that your risk assessment is carried out correctly:

  1. Identify the hazards
  2. Determine who might be harmed and how
  3. Evaluate the risks and decide on control measures
  4. Record your findings
  5. Review your assessment and update if necessary

*Source: https://www.hseblog.com

What are the two types of risk assessment?

The two types of risk assessment are:

  • Quantitative Risk Assessment – Data analysis is used to determine the likelihood of an event happening and the severity of the outcome. A numerical value is typically assigned to the risk to compare it against others and decide how it should be managed.
  • Qualitative Risk Assessment – Personal judgement is used to define a risk as either high, medium, or low. This helps prioritize when further action is needed.

*Source: https://www.hseblog.com

How do you do a risk assessment?

One of the most important aspects of a risk analysis is risk assessment. Risk analysis is a multi-step process that aims to discover and analyze all potential risks and concerns that could be harmful to the company. This is a continuous process that is updated as needed. These ideas are intertwined and can be utilized separately. The process of exchanging information and opinions about risk with those who are affected is known as risk communication. The proactive control and evaluation of hazards and risks in order to avoid accidents, uncertainties, and errors is known as risk management. These are all critical factors that, when combined with risk assessment, aid in making educated decisions such as risk mitigation.

*Source: https://safetyculture.com

Strategies for Managing Compliance

Learn how to perform proper risk assessment and management evaluation and other necessary steps to ensure your organization manufactures compliant medical device products.