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.
The following five steps can be followed to ensure that your risk assessment is carried out correctly:
*Source: https://www.hseblog.com
The two types of risk assessment are:
*Source: https://www.hseblog.com
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
Learn how to perform proper risk assessment and management evaluation and other necessary steps to ensure your organization manufactures compliant medical device products.