Training as a risk control for ISO 14971

Ronen E

Problem Solver
Staff member
Moderator
#11
Some people are just "un-trainable".:lol:
This is usually an indication that there’s something inherently wrong with the process. A good process doesn’t require a lot of training, and can be followed successfully by its target population.
 
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TWA - not the airline

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#12
This is usually an indication that there’s something inherently wrong with the process. A good process doesn’t require a lot of training, and can be followed successfully by its target population.
So true. I would even argue that setting up a good process for training can be done under design control (i.e. with design input from risk management, design output being the documented training process with all the training documents and procedures, verification against the requirements specs and usability validation...) and then would actually qualify as safety by design. :D
 

Mark Meer

Trusted Information Resource
#13
This thread is very enlightening.

I was operating under the assumption that, based on the idea that information provided was generally unreliable as a risk control (it can easily be forgotten, lost, or simply not read/consumed at all), that this was not considered an acceptable risk mitigation (at least according to the EN version).

Prior to reading this thread that was my interpretation of the deviation. :eek:

However, I'm now struggling to grasp what is "information about residual risk", and what is "information for safety".

For example, consider the following hazardous situation:
"Enclosure cracks, exposing user to sharp edge."

In the accompanying documentation, there could be any of the following statements:
1. "Cracked enclosure can result in exposure to sharp edges."
2. "Do not use if enclosed is cracked. Cracked enclosure can expose user to sharp edges"
3. "Inspect enclosure prior to use. Do not use if enclosure is cracked."

In this example, (1) would qualify as informing of residual risk, whereas (2) & (3) could qualify as risk-mitigations? Do I have this correct?
 

Peter Selvey

Staff member
Super Moderator
#14
I think in practice there three types of "information for safety":

(1) Stating the obvious - this is where operation manuals include a bunch of warnings which a reasonable person or qualified professional ought to know. These warnings are then included as risk controls

(2) Lazy risk analysis - this is where the true risk control is a physical feature, protection or inherent design, but the analysis shows a warning as the risk control.

(3) Important information for safety - this is special training material for the individual device which can be expected to be studied by the user and reinforced by training as appropriate to the situation

For areas (1) and (2), the warnings are not the real world risk control. So, of course they don't reduce the risk and it would be difficult to prove they are effective (e.g. usability).

To protect against spurious claims of product liability, manufacturers might want to keep a lot of warnings related to (1) and (2). But the important point is not to refer to these in the risk management file.

An example for case (2) I came across in training seminar years ago, was ECG with a thermal printer. The risk management file had an line item indicating risk of burns from the printer head, with a "hot surface" sticker as a risk control.

We took that as an example to dig deeper. A whole lot of issues came up, but in the end we realised the printer head never got hot enough to burn in the first place, unless the user deliberately left there finger there for 30s or more (which any reasonable person would not do). The sticker was probably for product liability. The true risk control was a temperature limiting circuit in the printer head.
 
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