Hi Doug,

This isn't what you were asking for, but you might find it interesting. In
2015, Health Canada commissioned a survey of various international
regulatory agencies on risk assessment and risk management practices.
Report here
<https://www.oecd.org/sti/consumer/Report%20on%20International%20Consumer%20Product%20Safety%20Risk%20Assessment%20Practices.pdf>
.

On Wed, Jun 17, 2020 at 8:21 AM Pete Perkins <
00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> wrote:

> Doug et al,
>
>
>
>                Risk assessment methodology exploded in the (60s and 70s)
> early days of the aerospace program as there were a myriad of new problems
> coming out of this bleeding edge technology being implemented.
>
>
>
>                Willie Hammer’s classic training manual covered all of the
> methodologies; he gave a presentation to our professional staff in the
> 1980s.  It all seemed to be more invasive than we were wanting to go in
> those days; we depended upon the standards developers to assess the risks
> and provide adequate provisions in the safety standards to cover them.
>
>
>
>                Working with machinery later opened the doors to diving
> deeper into the hazards and risks associated.  Risk assessment became a
> routine process and a well oiled process was introduced to get design teams
> to quickly evaluate them and rank them; I have my own procedure and
> worksheets for this.  Yes, there are options as to the details of the
> methods used; these are being refined and consolidated with time.
>
>
>
>                More recently I worked with a clever engineer on a project
> for which he developed a comprehensive spreadsheet which collected the risk
> assessment inputs and quickly developed any of a number of ‘standardized
> risk reports’.  It is proprietary today; perhaps is will be publicly
> discussed and/or made available in the future.
>
>
>
> :>)     br,      Pete
>
>
>
> Peter E Perkins, PE
>
> Principal Product Safety & Regulatory Affairs Consultant
>
> PO Box 1067
>
> Albany, ORe  97321-0413
>
>
>
> 503/452-1201 <(503)%20452-1201>
>
>
>
> IEEE Life Fellow
>
> IEEE PSES 2020 Distinguished Lecturer
>
> p.perk...@ieee.org
>
>
>
> Entropy ain’t what it used to be
>
>
>
> *From:* Ruth Shapira <rshap...@tauex.tau.ac.il>
> *Sent:* Wednesday, June 17, 2020 1:48 AM
> *To:* EMC-PSTC@LISTSERV.IEEE.ORG
> *Subject:* Re: [PSES] Risk Assessment question
>
>
>
> *Hi Douglas,*
>
> *A list of Risk Management and Functional Safety Standards you can find in
> pag.124 of the book “Electrical Product Compliance and Safety Engineering”
> published at Artech House in 2017.*
>
> *Also an analysis of RM  and Methods for Failure Analysis is presented on
> the same book in Chapters 6 and 5.*
>
> *I hope that above info can help you.*
>
>
>
> *Best Regards and be safe,*
>
> *Steli*
>
>
>
>
>
>
>
> *Steli Loznen*, M.Sc., SM-IEEE
>
> VP for Technical Activities and Member of BoG IEEE-PSES
>
> Convener IEC 62A/MT29+MT 62354
>
> 17-3 Shaul HaMelech Blvd.
>
> Tel Aviv 6436719
>
> Israel
>
> Tel:+972-3-6912668
>
> Fax:+972-3-6913988 <+972%203-691-3988>
>
> Mobile:+972-54-4818816 <+972%2054-481-8816>
>
> e-mail: *sloz...@ieee.org <sloz...@ieee.org>*
>
>
>
> *From:* Douglas Powell <doug...@gmail.com>
> *Sent:* Wednesday, June 17, 2020 1:49 AM
> *To:* EMC-PSTC@LISTSERV.IEEE.ORG
> *Subject:* [PSES] Risk Assessment question
>
>
>
> All,
>
>
>
> Over the past several years, nearly all safety standards have
> incorporated Risk Assessment (RA) as a part of their requirements. I did an
> informal search and found that the assessment methods are used in a wide
> range of disciplines from electrical products to machinery, robotics,
> safety software controls, medical equipment, medical procedures,
> automotive, aerospace, traffic control and even tree removal
> in municipalities. It is very clear that safety professionals worldwide
> really do like this method and I think it lends a certain comfort to a
> safety engineer's angst in marginal situations. I probably shouldn't say it
> but in my personal opinion this is a huge CYA exercise (cover your anatomy)
> for all involved.
>
>
>
> Usually the product RA goes before construction review, testing and
> certification. It is often used to identify areas not covered well by the
> body of the standard and where additional testing may be required.
> Virtually all standards describing the use of RA mention the scheme found
> in FMEA/FMECA of identifying a tasks, operations, or events and assigning
> numerical values to the parameters of interest, followed by the product of
> these values to identify level of risk. Commonly these parameters are
> severity, frequency of exposure, and possibility of avoidance. Today the
> use of FMEA goes far beyond design, manufacturing, and processes.
>
>
>
> Often times, a particular standard will say something like "*documents
> that can be used as guidance for the safety analysis include...*"
> followed by a short list of standards from IEC, EN, ISO, ANSI, MIL STD and
> so on. Notable to me is the use of the word "can" or "may" which implies
> the user has some leeway in selecting which document they prefer.
> Additionally, further guidance is often given for "active" protection
> devices and software/firmware controls for safety function (i.e. safety
> integrity levels and performance levels). Once again, using the methodology
> of FMEA as a way of assigning risk levels.
>
>
>
> So after all that, here is my question. Given wide-ranging product types
> and use models, the long list of risk assessment standards, has anyone
> produced a comprehensive list or matrix correlating products to applicable
> standards? I believe a list such as this would be very helpful.
>
>
>
> Stay safe and stay frosty all,
>
>
>
> Doug
>
>
>
> --
>
>
>
> Douglas E Powell
>
> Laporte, Colorado USA
>
> doug...@gmail.com
> http://www.linkedin.com/in/dougp01
>
>
>
>
>
> -
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-- 
Scott Aldous | Regulatory Compliance Manager | scottald...@google.com |
 650-253-1994

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