Tools for Normal and Fault Conditions

adir88

Starting to get Involved
#1
There's been endless (but meaningful) discussion on how FMEA does not meet ISO 14971 requirements since the latter requires identification of hazards and hazardous situations in both normal and fault conditions.

It's pretty clear that a design FMEA (and HA and FTA) are good tools to incorporate with a risk management process to cover off fault conditions.

What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions? Is including usability engineering process per IEC 62366-1 within a risk management process considered sufficient to address this requirement?

Many thanks ~
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Is including usability engineering process per IEC 62366-1 within a risk management process considered sufficient to address this requirement?
I tend to say no, but you'd have to clarify which requirement you refer to in "this requirement".
The usability engineering process focuses on misuse/use errors. A device might pose a risk not due to a technical failure (FMEA) or misuse (usability), e.g. simply due to a bad design. Among other things, risk management is intended to weed out design flaws.
 

adir88

Starting to get Involved
#3
Thanks for your response...

I tend to say no, but you'd have to clarify which requirement you refer to in "this requirement".
I meant the requirement for identifying hazards and hazardous situations for normal conditions.

The usability engineering process focuses on misuse/use errors. A device might pose a risk not due to a technical failure (FMEA) or misuse (usability), e.g. simply due to a bad design. Among other things, risk management is intended to weed out design flaws.
I can see how risk management as part of usability engineering may not be sufficient. This leaves my first question still unanswered: What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions?

Many thanks ~
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I meant the requirement for identifying hazards and hazardous situations for normal conditions.
Then my previous answer becomes a confident no.
What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions?
Other than those already mentioned, the ones I know are good old brainstorming and involving diverse specialists in the process (designers, engineers, application specialists / clinicians and anyone else who seems relevant and reasonably accessible).
 

Tidge

Involved In Discussions
#5
This leaves my first question still unanswered: What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions?
A simple tool to address this need is to create a generalized questionnaire which covers "all the bases" relative to hazards and circumstances of use. For example, the questionnaire can include general questions about hazards (does the device use electricity, is it connected to the mains, does it use battery power) and also about user classes/locations (is it used in a home environment, is it used by surgeons).

You can generate the first version of your questionnaire based on the (device) consensus standards that you consider for your device families. For example, if you worry about sterility, questions about infection (as a hazard) would be on the questionnaire. You can pretty much walk through 60601-1 for medical electrical devices to get a sense of the 'basic safety' hazards to consider. It might be easier to use the second edition of 60601 as a starting point because the second edition was only concerned with basic safety; the third edition's introduction of essential performance may confuse things... this is not to say that you can avoid essential performance in your risk management process, just that the foundation of risk management is basic safety. The third edition just makes it explicit that ME devices need to actually be safe in their use as well as not starting fires, pinching users, etc.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
A simple tool to address this need is to create a generalized questionnaire which covers "all the bases" relative to hazards and circumstances of use. For example, the questionnaire can include general questions about hazards (does the device use electricity, is it connected to the mains, does it use battery power) and also about user classes/locations (is it used in a home environment, is it used by surgeons).
...which reminds me that ISO 14971 actually has such a questionnaire...
 

adir88

Starting to get Involved
#7
A simple tool to address this need is to create a generalized questionnaire which covers "all the bases" relative to hazards and circumstances of use. For example, the questionnaire can include general questions about hazards (does the device use electricity, is it connected to the mains, does it use battery power) and also about user classes/locations (is it used in a home environment, is it used by surgeons).

You can generate the first version of your questionnaire based on the (device) consensus standards that you consider for your device families. For example, if you worry about sterility, questions about infection (as a hazard) would be on the questionnaire. You can pretty much walk through 60601-1 for medical electrical devices to get a sense of the 'basic safety' hazards to consider. It might be easier to use the second edition of 60601 as a starting point because the second edition was only concerned with basic safety; the third edition's introduction of essential performance may confuse things... this is not to say that you can avoid essential performance in your risk management process, just that the foundation of risk management is basic safety. The third edition just makes it explicit that ME devices need to actually be safe in their use as well as not starting fires, pinching users, etc.
Thanks! We already use the list in ISO 14971 so looks like we're covered for the most part. We make sure more items are added for the type of device etc.
 

indubioush

Quite Involved in Discussions
#9
Some other activities that help to determine hazards and hazardous situations in the normal condition:
- Review the instructions for use from a competitor device. Determine whether the adverse events listed are applicable to your device.
- Review literature for the condition your device is treating and for information on adverse outcomes for similar devices.
- Obtain physician/clinician input.
- Review clinical protocols and informed consent documents for similar devices on clinicaltrials.gov.
 
Last edited:

sagai

Quite Involved in Discussions
#10
There's been endless (but meaningful) discussion on how FMEA does not meet ISO 14971 requirements since the latter requires identification of hazards and hazardous situations in both normal and fault conditions.

It's pretty clear that a design FMEA (and HA and FTA) are good tools to incorporate with a risk management process to cover off fault conditions.

What are some tools that might be included within a risk management process to identify hazards and hazardous situations related to normal conditions? Is including usability engineering process per IEC 62366-1 within a risk management process considered sufficient to address this requirement?

Many thanks ~

Hi Adir and All,
I am in the process to put all the thoughts I have on these together into a kind of comprehensive material and to training.
One diagram that might be useful as regards to methodology tools we have for risk management I have kindly attached.

SafetyAnalysis.jpg

Kind Regards
Saby
 
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