Re: [PSES] Risk Assessment question

[Doug Nix]

In general I agree with your summary, but there is one point that really sticks 
badly for me: Use of FMEA/FMECA for risk assessment. In my opinion, this is a 
fundamental mistake that is often made because the tools have superficial 
similarity with OHS/machinery/product risk assessment tools. Bear with me here.

Similarities
Both RA and FMEA tools use consequence and probability parameters.
Both RA and FMEA tools develop a “score” that is intended to represent the 
magnitude of the analyzed situation.

Differences
FMEA is intended to analyze the impact on the performance of a 
function/provision of a feature by the product. It is focused on Failure Modes 
(that’s in the title). The consequence parameter is not scaled in terms of 
injury, but in terms of loss or impact on performance.

FMEA probability parameters are scaled differently than RA probability 
parameters.

FMEA is inconsistent with the requirements laid down by ISO 12100.

RA is focused on injury to people. The consequence parameter (severity of 
injury) is focused on the injury to people, not loss of function. The outcome 
of the tool is risk, not likelihood of failure/loss of function.

The RA probability parameter is focused on three critical aspects of human 
interaction with the product: Frequency AND Duration of Exposure, Probability 
of the Hazardous Event, and the Probability of Avoiding or Limiting Harm. 

These tools are structured to be consistent with ISO 12100.

These may seem inconsequential differences but they are not. IMO use of 
FMEA/FMECA for human risk assessment is a serious error and one I strongly 
counsel against making.

Doug Nix
d...@ieee.org
+1 (519) 729-5704

> On 16-Jun-20, at 18:49, Douglas Powell  wrote:
> 
> 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 
> 
> 
> -
> 
> This message is from the IEEE Product Safety Engineering Society emc-pstc 
> discussion list. To post a message to the list, send your e-mail to 
> mailto:emc-p...@ieee.org>>
> 
> All emc-pstc postings are archived and searchable on the web at: 
> http://www.ieee-pses.org/emc-pstc.html 
> 
> Attachments are not permitted but the IEEE PSES Online Communities site at 
> http://product-compliance.oc.ieee.org/ 
>  can be used for graphics (in 
> well-used formats), large files, etc.
> 
> Website: http://www.ieee-pses.org

Re: [PSES] Risk Assessment question

[Douglas Powell]

Pete,

I also have a number of spreadsheets and have toyed with the idea of
automatically adapting them to various product types. Not sure I have the
energy for such a project as it would have to be on my own time.

Best,  Doug





On Wed, Jun 17, 2020 at 9:21 AM Pete Perkins <
0061f3f32d0c-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
>
>
>
> IEEE Life Fellow
>
> IEEE PSES 2020 Distinguished Lecturer
>
> p.perk...@ieee.org
>
>
>
> Entropy ain’t what it used to be
>
>
>
> *From:* Ruth Shapira 
> *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
>
> Mobile:+972-54-4818816
>
> e-mail: *sloz...@ieee.org *
>
>
>
> *From:* Douglas Powell 
> *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, 

Re: [PSES] Risk Assessment question

[Scott Aldous]

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 <
0061f3f32d0c-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 
> *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 *
>
>
>
> *From:* Douglas Powell 
> *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

Re: [PSES] Risk Assessment question

[Pete Perkins]

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

 

IEEE Life Fellow

IEEE PSES 2020 Distinguished Lecturer

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

Entropy ain’t what it used to be

 

From: Ruth Shapira  
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

Mobile:+972-54-4818816

e-mail: sloz...@ieee.org <mailto:sloz...@ieee.org> 

 

From: Douglas Powell mailto:doug...@gmail.com> > 
Sent: Wednesday, June 17, 2020 1:49 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto: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 li

Re: [PSES] Risk Assessment question

[Ruth Shapira]

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
Mobile:+972-54-4818816
e-mail: sloz...@ieee.org

From: Douglas Powell 
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<mailto:doug...@gmail.com>
http://www.linkedin.com/in/dougp01


-


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This message is from the IEEE Product Safety Engineering Society emc-pstc 
discussion list. To post a message to the list, send your e-mail to 


All emc-pstc postings are archived and searchable on the web at:
http://www.ieee-pses.org/emc-pstc.html

Attachments are not permitted but the IEEE PSES Online Communities site at 
http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used 
formats), large files, etc.

Website:  http://www.ieee-pses.org/
Instructions:  http://www.ieee-pses.org/list.html (including how to unsubscribe)
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For help, send mail to the list a

Re: [PSES] Risk Assessment question

[Douglas Powell]

Thanks, I'll check them out.

On Tue, Jun 16, 2020, 8:25 PM MIKE SHERMAN  wrote:

> Doug --
> Good summary!
> Bruce Main of Design Safety Engineering has published a couple of overview
> books on risk assessment; you can find them on his web site. If you can't
> get the Table of Contents somewhere, I can scan them for you. In my
> recollection, it's more of an overview of what standards are used in what
> industries, vs. which risk assessment standards are specifically called out
> in which product safety standards.
> Mike Sherman
> Graco Inc.
>
> On 06/16/2020 5:49 PM Douglas Powell  wrote:
>
>
> 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
>
>
> -
> 
>
> This message is from the IEEE Product Safety Engineering Society emc-pstc
> discussion list. To post a message to the list, send your e-mail to <
> emc-p...@ieee.org>
>
> All emc-pstc postings are archived and searchable on the web at:
> http://www.ieee-pses.org/emc-pstc.html
>
> Attachments are not permitted but the IEEE PSES Online Communities site at
> http://product-compliance.oc.ieee.org/ can be used for graphics (in
> well-used formats), large files, etc.
>
> Website: http://www.ieee-pses.org/
> Instructions: http://www.ieee-pses.org/list.html (including how to
> unsubscribe) 
> List rules: http://www.ieee-pses.org/listrules.html
>
> For help, send mail to the list administrators:
> Scott Douglas 
> Mike Cantwell 
>
> For policy questions, send mail to:
> Jim Bacher 
> David Heald 
>
>

-

This message is from the IEEE Product Safety Engineering Society emc-pstc 
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Re: [PSES] Risk Assessment question

[MIKE SHERMAN]

Doug --
Good summary!
Bruce Main of Design Safety Engineering has published a couple of overview 
books on risk assessment; you can find them on his web site. If you can't get 
the Table of Contents somewhere, I can scan them for you. In my recollection, 
it's more of an overview of what standards are used in what industries, vs. 
which risk assessment standards are specifically called out in which product 
safety standards.
Mike Sherman
Graco Inc.

> On 06/16/2020 5:49 PM Douglas Powell  wrote:
> 
> 
> 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 mailto:doug...@gmail.com
> http://www.linkedin.com/in/dougp01
> 
> 
> -
> 
> 
> This message is from the IEEE Product Safety Engineering Society emc-pstc 
> discussion list. To post a message to the list, send your e-mail to 
> mailto:emc-p...@ieee.org >
> 
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> well-used formats), large files, etc.
> 
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formats), large files, etc.

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[PSES] Risk Assessment question

[Douglas Powell]

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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