The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Manufacturing, Service, and Business Systems Processes > Human Factors and Ergonomics in Engineering
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

What is the typical industry standard for documenting Usability Risk? - Page 2


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related Topic Tags
iec 62366 - medical device usability engineering, usability risk
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 15th April 2015, 08:31 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,896
Re: What is the typical industry standard for documenting Usability Risk?

Also, it?s important to note some differences between the ISO 14971 process and the risk management required by IEC 62366 (and IEC 62366-1).

The "full" risk management from ISO 14971 requires the analysis, evaluation and control of risks, and risk needs to be analyzed, as the definition, based on severity and probability.

Another important aspect is use error. Use error is a kind of "failure". Failures are not a problem in itself, they lead to a problem. Speaking in ISO 14971 terms, failures are part of the sequence of events that leads to a hazardous situation (but are never the hazard situation itself). Use errors follow the same principles (although, in the case of use errors, some may be a hazardous situation).

Going back to the differences, there?s no known method to estimate the probability of use errors. So it?s not possible to estimate the probability of the hazardous situation (P1), and thus the usability engineering process do not require that the probability of the risk (which is P1xP2) to be estimated, only the severity. Also, there?s no need to evaluate the risk. The rationale is that, as we cannot predict the probability of use error, it?s better to treat (control) all use errors that led to hazardous situation.

So, the requirement is that, for any safety-related use error, the user interface design has to include requirements related to them.

Which means, in practice, that you only perform part of the full ISO 14971 RM process for user error-related risk management.

This can be seen in the comparison table between ISO 14971 and IEC 62366 that in the annex of the standards

Last edited by Marcelo Antunes; 15th April 2015 at 08:50 AM.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!

Sponsored Links
  Post Number #10  
Old 15th April 2015, 10:00 AM
kreid

 
 
Total Posts: 35
Re: What is the typical industry standard for documenting Usability Risk?

We have a User Risk Assessment that considers the risks that may come from using the product (we also have process and design risk assessments). We then use our usability testing/study to help validate some of the mitigations we arrived at from our risk assessments.
Thank You to kreid for your informative Post and/or Attachment!
Sponsored Links

  Post Number #11  
Old 15th April 2015, 07:42 PM
Ronen E

 
 
Total Posts: 2,953
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

there?s no known method to estimate the probability of use errors.
...with the exception of devices that are already in use for a statistically-significant length of time, by a statistically-significant population. In such cases the probability can be estimated based on actual incidents with a certain factor to account for unreported incidents.

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

Also, there?s no need to evaluate the risk. The rationale is that, as we cannot predict the probability of use error, it?s better to treat (control) all use errors that led to hazardous situation.
To me, this is a weird concept. It should still depend on severity of the potential harm. If the harm is minimal, and the mitigation complex / costly / lengthy (in D&D terms) / results in other risks - is it still better?...
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #12  
Old 15th April 2015, 08:53 PM
Mark Meer

 
 
Total Posts: 513
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

...there?s no known method to estimate the probability of use errors. So it?s not possible to estimate the probability of the hazardous situation...
I would agree that, with few exceptions (see Ronen's post), estimating the probability of use errors is not feasible.

However, I would disagree that it is therefore not possible to estimate the probability of hazardous situations. If you assume user error to be inevitable, then estimation of the probability of a hazardous situation comes down to asking "given the user error, what is the probability that this error results in a hazardous situation?".
Thank You to Mark Meer for your informative Post and/or Attachment!
  Post Number #13  
Old 15th April 2015, 09:10 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,896
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
...with the exception of devices that are already in use for a statistically-significant length of time, by a statistically-significant population. In such cases the probability can be estimated based on actual incidents with a certain factor to account for unreported incidents.
You are right, in fact you "can" estimate even for newer devices, but it?s really more difficult to estimate (when comparing, for example, with component failures).

Quote:
Quote:
Also, there?s no need to evaluate the risk. The rationale is that, as we cannot predict the probability of use error, it?s better to treat (control) all use errors that led to hazardous situation.

To me, this is a weird concept. It should still depend on severity of the potential harm. If the harm is minimal, and the mitigation complex / costly / lengthy (in D&D terms) / results in other risks - is it still better?...
It does, but not on the old version of the standard (and sorry, I was thinking about the old version, not the newer one).

In IEC 62366-1, we fixed this problem by including item 5.5 * Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION, in which the manufacturer either uses all HAZARD-RELATED USE SCENARIOS or a subset based on severity, but in this latter case there?s need to be a summary and rationale on the selection process.

Last edited by Marcelo Antunes; 15th April 2015 at 09:26 PM.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #14  
Old 15th April 2015, 09:24 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,896
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
However, I would disagree that it is therefore not possible to estimate the probability of hazardous situations. If you assume user error to be inevitable, then estimation of the probability of a hazardous situation comes down to asking "given the user error, what is the probability that this error results in a hazardous situation?"
You are more or less right (and again I was thinking about the old standard, not the newer one), in fact the question should be something like: given the use error (and it?s use, not useR), what is the sequence of events that can lead to a hazardous situation, and is it possible to estimate the probability of the events in the sequence? If so, you could estimate the probability of the hazardous situation (this is the same problem that happened in the "100% failure" in IEC 62304).

The newer standard (and even more so, IEC 62366-2) tries to correct a lot of misconceptions on the common use of risk management in the usability engineering process. For example, experience showed that one of the problems was that usability engineering professionals did not focus on the risk as defined by ISO 14971, but only on the use error itself.

So, a lot of clarifications were included in IEC 62366-1 (and a lot more discussion on this is being written on IEC 62366-2) so people can apply the correct ISO 14971 risk management concepts.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #15  
Old 16th April 2015, 08:12 AM
ryannh

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

Marcelo,
Are you on the committee for ICE62366-2? If so do you have any idea when it may go out for comment or be available in draft form? We have worked on our assessment of 62366:2007 vs 62366-1 but are getting hung up on a couple of items that will hopefully be cleared up with -2.
  Post Number #16  
Old 16th April 2015, 02:42 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,896
Re: What is the typical industry standard for documenting Usability Risk?

Quote:
Marcelo,
Are you on the committee for ICE62366-2? If so do you have any idea when it may go out for comment or be available in draft form? We have worked on our assessment of 62366:2007 vs 62366-1 but are getting hung up on a couple of items that will hopefully be cleared up with -2.
I am. A draft of IEC 62366-2 has already been circulated as a CD for all National Committees.

The comments are being discussed this week in a meeting in France (unfortunatelly, I?m not participating in this meeting).

After the resolution of comments is finished and the draft is updated, a CDV will be circulated.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Manufacturing, Service, and Business Systems Processes > Human Factors and Ergonomics in Engineering

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Link between Risk Management, Usability Engineering and R&D in Medical Devices Marcelo Antunes ISO 14971 - Medical Device Risk Management 2 8th March 2015 09:20 PM
What are typical Acceptable Quality Levels (AQL) adopted in Food industry? sabrinalim Food Safety - ISO 22000, HACCP (21 CFR 120) 1 19th April 2013 11:02 PM
IEC 62366:2007 - Is FDA Usability Engineering Standard a Requirement in Canada? melaniewalls Canada Medical Device Regulations 5 4th February 2013 09:46 AM
Usability standard IEC 60601-1-6 in the Medical Device Industry Sanne IEC 60601 - Medical Electrical Equipment Safety Standards Series 4 10th July 2007 07:26 AM
Standard Causes of Registration Audit Nonconformances and Typical Failure Modes TownDawg IATF 16949 - Automotive Quality Systems Standard 5 22nd July 2004 05:18 PM



The time now is 02:21 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies" - A Peachfarm Internet Property