In my view, the Risk Assessment should never be treated as a 'get out of
jail' card or panacea. Instead, it is only a starting point for a safe
design and should be done near the beginning of a project, not the end. I
agree with what Rich says, I've seen a lot of subjective assessments by
cross-functional teams, with variability based on personal risk tolerance
or risk aversion.  There are any number of articles pointing to why humans
are not very good at assessing risk (Google search
<https://www.google.com/search?q=humans+are+not+very+good+at+assessing+risk>
).

When using FMEA for risk assessment, I always stress that the RPN factors
of probability of occurrence, severity, and detection be quantified
separately without regard to the other factors, not an easy task. There is
also the problem of RPN vs Criticality (severity x occurrence).  If using
the RPN, there is the possibility that Detection can dilute the RPN number
to a point below the threshold for action. So in my view, Criticality alone
should be used to trigger action.

Kenneth Ross wrote a very good article last month on Navigating the Safety
Hierarchy; for me, it was an excellent refresher on how I should use
risk assessment more effectively (
https://incompliancemag.com/article/navigating-the-safety-hierarchy/).

-Doug

Douglas E Powell
Laporte, Colorado USA

(UTC -07:00) Mountain Time (US-MST)


On Fri, Feb 11, 2022 at 11:52 AM Richard Nute <ri...@ieee.org> wrote:

>
>
>
>
> I would say “…risk assessment WILL have variants…”
>
>
>
> The risk assessment process is subjective.  If you perform a risk
> assessment on an ordinary extension cord, you can find that it is
> marginally safe.
>
>
>
> Rich
>
>
>
> *From:* scott...@gmail.com <scott...@gmail.com>
> *Sent:* Friday, February 11, 2022 9:14 AM
> *To:* EMC-PSTC@LISTSERV.IEEE.ORG
> *Subject:* Re: [PSES] EN 62368-1 : 2020 Ed 3
>
>
>
> Hi Charlie,
>
>
>
> It is pity.  The risk assessment may have variants and inconsistence
> amongst test engineers and make the compliance more difficult.
>
>
>
> Regards,
>
>
>
> Scott
>
>
>
>
> -
> ----------------------------------------------------------------
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-- 

-Doug

Douglas E Powell
Laporte, Colorado USA
doug...@gmail.com
http://www.linkedin.com/in/dougp01

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