Person Comparing FMEA and HTM

FMEA vs Hazard Traceability Matrix in ISO 14971

by | Apr 9, 2021 | Regulations

It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019.

Especially since nothing prevents a company from using these terms interchangeably or using different terms entirely.

You are technically allowed to call each of these tables whatever you wish.

Although, using the correct terminology can prevent prolonged discussions about what your company means by using a term as opposed to how the term is defined in the standard.

In this article we will cover:

This post is not a comprehensive guide to risk management but a simplified comparison of two risk management tools. Always follow the standards applicable to you and your company.

What is FMEA?

Failure Mode and Effects Analysis (FMEA) stands for a group of systematized processes meant to identify and evaluate the potential failure(s) of a process or a product and its effect before identifying and documenting activities that could reduce or eliminate the occurrence of the potential failure.

When to Use FMEA?

FMEA in IEC 60812 is typically used for the design or redesign of a product, process, or service. It is a useful tool when your main focus is on system reliability and/or performance.

What Is a Hazard Traceability Matrix (HTM)?

Hazard Traceability Matrix (HTM) is a tool used in the process of risk management to ensure good traceability of risk controls as it pertains to ISO 14971. It typically includes risk analysis, evaluation, control (including proof of its implementation), and residual risk evaluation.

Although the ISO 14971 does not require you to refer to this tool as the Hazard Traceability Matrix, the matrix is a commonly accepted solution to map the requirements listed in ISO 14971. Thus, you’re free to call this table whatever makes the most sense to you and your company.

For clarity, we will refer to the tool that maps the requirements in ISO 14971 as the Hazard Traceability Matrix in this post.

When to Use Hazard Traceability Matrix (HTM)?

Practical use of the Hazard Traceability Matrix within ISO 14971 lies in mapping the requirements of ISO 14971 into a traceable format (including verifying the implementation of risk controls, which ensures that the risks have been reduced).

Importantly, the HTM includes harm whereas the FMEA only focuses on system reliability.


The below infographic can help give you a robust overview of the differences between the two.

Failure Mode and Effects Analysis (FMEA) VS Hazard Traceability Matrix (HTM)
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Applicable International Standard

For Failure Mode and Effects Analysis (FMEA), the applicable International Standard is IEC 60812:2018.

The standard defines how Failure Mode and Effects Analysis (FMEA), and Failure Modes, Effects, and Criticality Analysis (FMECA) variation:

  • planned
  • performed
  • documented
  • executed

On the other hand, ISO 14971:2019 is an applicable standard for what we here choose to call the Hazard Traceability Matrix (HTM). This ISO standard explains the application of risk management to medical devices.

Main Purpose

The purpose of Failure Mode and Effects Analysis (FMEA) is to improve the reliability of a design component or a process step. However, the Hazard Traceability Matrix manages all risks that could arise in any lifecycle phase of your medical device.

The Basis for Severity Evaluation

In Failure Mode and Effects Analysis (FMEA), the severity evaluation is based on system performance. In contrast, the severity evaluation in the Hazard Traceability Matrix is based on harm to the end-user or patient.

Technically, according to the ISO 14971:2019, harm also includes damage to property or environment, but these are seldom focused on in practice.

Does it Include Harm?

If you need to map your risks to any potential harm, choosing the Hazard Traceability Matrix is the obvious choice. Failure Mode and Effects Analysis (FMEA) does not consider harm.


Failure Mode and Effects Analysis (FMEA) only looks at the fault condition – how components fail (the name is a big clue).

In contrast, both fault and normal conditions are taken into consideration in the Hazard Traceability Matrix.

Does it Require a Mature Design?

A mature design (knowledge of detailed process steps and components) is required in Failure Mode and Effects Analysis (FMEA).

However, when using Hazard Traceability Matrix, a mature design is not needed. Usually, the Hazard Traceability Matrix starts with hazard identification, and an early approved draft is frequently used as a design input (often in the product requirement specification).

When Should You Start Relative to the Project?

Given that a preliminary Hazard Traceability Matrix is often used as design input, drafting and filling out the HTM should start quite early relative to the project.

In contrast, filling out the Failure Mode and Effects Analysis (FMEA) usually takes place later relative to the project due to needing a more mature design.

Control Your Risk Documentation With Ease

SimplerQMS allows you to manage your risk management documentation, as well as any other file digitally. Our cloud-based Quality Management System (eQMS) aligns with the latest version of the ISO 14971:2019 and will help bring your medical device to the market faster.

See a quick overview of what SimplerQMS has to offer!

If you are very serious about your document control efforts, we would suggest you see SimplerQMS in action!

Final Thoughts

In this article, you have seen the major differences between the Failure Mode and Effects Analysis (FMEA) according to IEC 60812 and the ISO 14971 Risk Management tool – here referred to as the Hazard Traceability Matrix.

If your company needs to meet the requirements of ISO 14971:2019, you should know that using only FMEA is not enough.

However, if the system performance and reliability of the device are high on your priority list, it can be a powerful addition to your risk management toolset.

If you want to know more, Peter Sebelius at MedicalDeviceHQ has multiple comprehensive courses for Risk Management.

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