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What is the typical industry standard for documenting Usability Risk?


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iec 62366 - medical device usability engineering, usability risk
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  Post Number #1  
Old 14th April 2015, 07:12 AM
ryannh

 
 
Total Posts: 14
Question What is the typical industry standard for documenting Usability Risk?

With the recent release of IEC 62366-1 what is the typical industry standard for documenting usability risk? Are companies starting to turn towards using the FMEA process? Other than the IEC 62366 are there any good resources for ensuring that you are capturing everything?

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  Post Number #2  
Old 14th April 2015, 08:10 AM
kreid

 
 
Total Posts: 37
Re: What is the typical industry standard for documenting Usability Risk?

We use 14971 and 62366.

In my opinion 62366 is well written and therefore usable. The -1 draft also looks like a good improvement which we will adopt.
Thank You to kreid for your informative Post and/or Attachment!
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  Post Number #3  
Old 14th April 2015, 08:12 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 5,958
Re: What is the typical industry standard for documenting Usability Risk?

Welcome to the Cove!

The addition of risk management in IEC 62366-1 is also happening in ISO 9001:2015 and similar questions are being asked.

In both standards there is no default format for documenting risk assessment. I often suggest FMEA because there is a great deal of documentation and instruction on that format. If applying the FMEA format I would consider not limiting to three existing factors (severity, occurrence and detection) but would add more factors and change the occurrence and detection to suit your needs. I suggest including a column for regulation and make this a default for Significant status; the Severity factor, which I would keep, could also trigger Significant status.

The most comprehensive and usable examples I have seen added columns to list applicable regulation(s), one for applicable operational control procedure(s), one for monitoring method(s). An additional set of columns could be added to show the effect on risk by actions taken to mitigate through improved operational controls. It is especially important to be able to point to the engineering changes done to lower Severity. I would add a Date column showing when it was done, and/or a reference number/name of a record for the applicable project to lower the risk.

I hope this helps!
Thanks to Jen Kirley for your informative Post and/or Attachment!
  Post Number #4  
Old 14th April 2015, 08:13 AM
ryannh

 
 
Total Posts: 14
Re: What is the typical industry standard for documenting Usability Risk?

KReid, Thanks for the response. I think I should have been more clear in my question. Do you do a usability risk analysis along with product/process risk analysis or is it built into the product/process risk analysis?
  Post Number #5  
Old 14th April 2015, 08:28 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 5,958
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
In Reply to Parent Post by ryannh View Post

KReid, Thanks for the response. I think I should have been more clear in my question. Do you do a usability risk analysis along with product/process risk analysis or is it built into the product/process risk analysis?
If using Excel, an additional column could be used to indicate usability/process and sorted when the user wants to only view usability risk analysis.
Thanks to Jen Kirley for your informative Post and/or Attachment!
  Post Number #6  
Old 14th April 2015, 08:46 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 5,958
Re: What is the typical industry standard for documenting Usability Risk?

I would also add that automotive uses a Design FMEA, in which Severity criteria are specific to usability. Other factors might also be different, as appropriate for usability.
Thanks to Jen Kirley for your informative Post and/or Attachment!
  Post Number #7  
Old 14th April 2015, 12:27 PM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,070
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
In Reply to Parent Post by ryannh View Post

KReid, Thanks for the response. I think I should have been more clear in my question. Do you do a usability risk analysis along with product/process risk analysis or is it built into the product/process risk analysis?
Usability analysis is separate from process and product risk. Both are usually documented in the risk file, but risk assessment based on 14971 alone is not enough. Another document to look at is ANSI/AAMI HE75:2009
Thanks to Statistical Steven for your informative Post and/or Attachment!
  Post Number #8  
Old 14th April 2015, 05:05 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,959
Re: What is the typical industry standard for documenting Usability Risk?

A table such as the one in the attached document is what ISO 14971 (and IEC 62366) requires (I include the sequence or combination of events which is not formally required but makes sense in including)

If you use any hazard analysis technique such as FMEA, FTA, etc, you need to use the result of those to populate the ISO 14971 summary (as they do not have all the information required by ISO 14971).
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File Type: pdf Risk management summary example.pdf (38.7 KB, 348 views)
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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