Guest Column | January 13, 2021

Avoiding ISO 14971 Mistakes — Do You Really Understand The Term "Hazard"?

By Naveen Agarwal, Ph.D., principal and founder, Creative Analytics Solutions, LLC

Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a  medical device. Yet, these terms are often misunderstood and misapplied in the industry. As a result, there is a lot of confusion and inconsistency in the implementation of risk management systems to meet the requirements of ISO 14971.

In this first part of a three-part series, we will review the term “hazard” in detail, highlight a few areas of confusion, and illustrate a few examples to facilitate a better understanding and its application in risk analysis.

ISO 14971:2019 defines a hazard as a potential source of harm. What does that mean? Is it a thing, an action, or an activity?

Well, it could be anything that could result in harm. A hazard doesn’t always lead to harm, but it can.

Fire is a hazard because it can cause a severe burn. Driving is a hazardous activity because it can lead to injury or death from a crash. Surgery is also inherently hazardous because it can lead to many different complications, either during or after a procedure.

A medical device and its use present many different hazards to patients and medical personnel. It is important to identify and clearly define these hazards, especially in the early phase of product development, so they can be appropriately controlled to minimize the risk of harm.

A common practice in the medical industry utilizes the failure mode effects analysis (FMEA) tool to identify potential device failures, failure modes, and their causes and effects. Another commonly used tool is fault tree analysis (FTA), which traces all the potential causes and faults to a topline event of significance, such as a harm or a hazardous situation.

Although these are highly useful tools for engineering analysis, they are not sufficiently effective in analyzing risks of harm from the perspective of ISO 14971. While device failures or faults may lead to a hazardous situation, where one or more hazards may be active, this is not always the case. Harm can occur even when there is no device failure.

This is why understanding the term “hazard” and how it differs from a fault, failure, or failure mode is important. Watch this video for a deeper analysis of this key concept and share your questions or comments below.

Click here for Part 2: Avoiding ISO 14971 Mistakes — Are You Accurately Defining "Hazardous Situations"?

About The Author:

NaveenNaveen Agarwal began his consulting practice in 2017, with the goal of helping medical companies build safe products through quality systems that are not only compliant to regulatory requirements but also focused on the needs of patients and physicians. He has 20 years of industry experience in leadership roles ranging from R&D to product quality and business analytics. As a result, he has a broad and deep expertise in all of the core functions involved in the lifecycle of medical products. His consulting practice focuses on problem-solving in the areas of risk management, quality systems, customer experience, and quality culture. You can view other videos by Agarwal on his YouTube channel, email him at, and connect with him on LinkedIn.