7 Experts insights to know

about “Human error”

EU MDR COMPLIANCE
Take control of medical device compliance | Templates & guides | Practical solutions for immediate
implementation
If your root cause analysis ends with 'human error,' you're only halfway there

'Human failures' can be divided into two broad categories:

1. Errors (Skill-based errors)

→ A human error is an action or decision that was not intended, that involved a deviation from an
accepted standard, and that led to an undesirable outcome. (Skill-based errors or mistakes)

Examples of human error:

1. Errors of omission ...more

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In 2024, I posted this:
→ ‘HUMAN ERROR’ is not a valid root cause!
→ 2,833 reaction; + 60 comments & +550 reposts
→ The best-performing post on my linkedin

Additional value? ↴

The experts comments below this post are gold nuggets!

Here's a review of the most liked comments!

I love it when the comments become more interesting

than the post.

Today I've decided to share them with you!

 1/7: Ekaterina Potemkina

Ekaterina Potemkina
Quality StepChanger | Auditor who is on Your side | ISO Certifications | Enterprise-
wide Quality Systems | Quality Profession Guide & Coach

To be fully fair, at the end all issues are rooted in human factor - since it is
Humans who develop processes, supposed to maintain systems, provide
trainings, follow up on effectiveness, perform audits, conduct
investigations and so on.

The shopfloor worker who caused the conveyor failure wasn't trained
properly by someone, who did provide insufficient knowledge... and so
on..

You can look both ways at the topic

But I personally wouldn't exclude a pure human factor due to laziness,

lack of attention to details and disengagement... process works just find,
equipment doesn't malfunction.. it's just this guy

But again - how "this guy" ended up here? Another human hired him 😁
81

To keep in mind:
→ Ultimately, all issues stem from human factors—people design processes,
maintain systems, train others, and conduct audits.
→ While laziness or disengagement can be a factor, it often traces back to
gaps in training, hiring, or oversight.
 2/7: Georg Digel

Georg Digel
Get clarity (back) into your CAPA process | On a mission to help medical device quality
leaders improve their CAPA program | Sharing insights about the journey

If most of your investigations reveal human error as root cause, I know it's
a shallow or lazy investigation.

In order to uncover more insights, try:

- looking at processes and systems

- interviewing the involved personnel
- understanding whether monitoring is in place

Often, people are so stressed and processes so weak that there is almost
no chance to NOT cause issues "due to human error".

If you peel back layers, you'll see that people already have proposals for
improvement, but no one listens to them.

Be the first one to start listening.

31

To keep in mind:
→ 'Human error' as a root cause often signals a shallow investigation—analyze
processes, people, and monitoring.
→ Weak processes and stress drive errors; listen to employees for
improvement ideas.
 3/7: Frauke Schuurkamp

Frauke Schuurkamp
Managing Human Factors Specialist at UL

All humans who use devices will make mistakes when using these
devices. After all, we’re not robots . 🤖
Mistake are related to using the device though, so a “use error”.

Many people probably blame themselves for these use errors, saying “I
wasn’t paying enough attention” or “I was just tired”.

We have to look many levels deeper and dig into what the actual root
cause was, because in real life people are sometimes just tired and don’t
always pay attention to things.

In such cases medical devices should also be used in a safe and effective
way, so we should always be looking into design-related root causes from
my point of view, because that’s what manufacturers can change (I know,
changing people would be the easy solution, but not possible)!

16

To keep in mind:
→ Humans will make mistakes when using devices—these are 'use errors,' not
just lapses in attention or fatigue.
→ Instead of blaming users, focus on design-related root causes, as
manufacturers can improve device safety and usability.
 4/7: Edward Ball

Edward Ball
Medical device specialist: Risk management, product safety, design & development,
quality management, regulatory affairs, post-market surveillance

As said in other comments...none of these should be your root cause, and

only one of these terms should show up in your analysis at all:

❌ Human error (not the preferred term)

❌ Operator error (not the preferred term)
❌ User error (not the preferred term)
✔ Use error (preferred)
Why is the latter preferred? It describes the act rather than attributing
the blame. If we lay blame, then honesty and transparency are affected
and information is not shared, then we cannot learn and improve things.
8

To keep in mind:
→ Use 'use error' instead of 'human,' 'operator,' or 'user error' to describe
actions without assigning blame.
→ Focusing on actions fosters transparency, encourages information sharing,
and drives improvements.
 5/7: Amandine Broussier

Amandine Broussier
🌟 Je vous accompagne dans le processus d’aptitude à l’utilisation de votre dispositif
🩺💉

It’s too easy to attribute every errors to humans instead of searching

ways to improve the usability of the device.

I think that’s why we now use the term use errors rather than human
errors to avoid systematically blaming the user.

To keep in mind:
→ It's easy to blame humans for errors instead of improving device usability.
→ The term 'use errors' replaces 'human errors' to shift focus from users to
design improvements.
 6/7: Steve Gompertz

Steve Gompertz
Experienced Leader in Quality Systems Implementation & Management (CMQ/OE,
CMDA, RAC-US, CMIIC)

The key is to remember that root cause is almost never found near the
point of observation.

To keep in mind:
→ Root cause is rarely found at the point of observation—look deeper into
underlying factors.
→ Effective RCA requires tracing issues beyond the immediate symptoms.
 7/7: Tibor Zechmeister

Tibor Zechmeister
Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of
Regulatory and Quality @ Flinn.ai | Notified Body Auditor | MedTech Entrepreneur |
Software Solutions for Regulatory Automation with AI

Human error can never be the endpoint.

What I see during audits is that after determining human error as a root-
cause, the main solution is "retraining".

Then they show me some random evidence that somebody had a

meeting with someone.

This might seem like a quick-fix, but it will create an endless loop of new
issues and meaningless retraining without effectiveness.

To keep in mind:
→ Human error should never be the final root cause—retraining alone is a
superficial fix (it’s not a valid corrective action).
→ Without addressing underlying issues, retraining leads to recurring
problems and lacks real effectiveness.
What the experts say (compilation) :

→ Problems often come from human factors—people design, maintain, train,

and audit systems. Weak processes, stress, and lack of oversight contribute to
errors.

→ Calling something "human error" is often a sign of shallow investigation.

Look deeper into processes, people, and monitoring instead of stopping at the
surface. Root causes are rarely found where the problem is observed.

→ Effective root cause analysis (RCA) means going beyond immediate

symptoms.

→ Simply “retraining” people is not a real solution—it’s a short-term fix that

doesn’t address deeper issues. Instead of blaming "human error," focus on
methods and processes.

→ Errors with devices are often "use errors," not just mistakes caused by
fatigue or inattention. Blaming users is easy, but the real focus should be on
improving device design and usability to prevent mistakes.

→ Using "use error" instead of "human error" promotes transparency,

encourages information sharing, and drives improvements. It shifts the focus
from blaming people to improving systems and design.