Greetings fellow members,
I am looking for any volunteers to join the IEEE PSES Risk Assessment
Technical Committee.
It would only take a few hours of your valuable time out of every month at
most.
One of the main functions of this Technical Committee is to promote
activities in our field
AM
*To:* Richard Nute
*Cc:* EMC-PSTC@LISTSERV.IEEE.ORG
*Subject:* Re: [PSES] Risk assessment versus HBSE
Hi Rich,
Your points are well taken.
There are some good ISO standards that relate to exposure to hot
and cold temperatures. These standards take the type
Access=true
>
>
>
> Best regards,
>
> Rich
>
>
>
>
>
> *From:* Douglas Nix
> *Sent:* Wednesday, February 23, 2022 8:57 AM
> *To:* Richard Nute
> *Cc:* EMC-PSTC@LISTSERV.IEEE.ORG
> *Subject:* Re: [PSES] Risk assessment versus HBSE
>
>
>
> Hi Rich,
>
&
Hi Doug:
See:
https://www.tandfonline.com/doi/pdf/10.1080/01446193.2016.1274418?needAccess=true
Best regards,
Rich
From: Douglas Nix
Sent: Wednesday, February 23, 2022 8:57 AM
To: Richard Nute
Cc: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Risk assessment versus
data or studies regarding impact with children.
>
> Thanks,
>
> Mark
>
>
>
>
>
>
> Hi Doug:
>
>
>
> Thanks for your comments.
>
>
>
> What bothers me about risk assessment is that the committees that have
> written the standards requirin
about risk assessment is that the committees that have
written the standards requiring risk assessment have not critically
evaluated the risk assessment process. If they had done so, we would
not have the process as we know it today.
Actually, I do not fully agree with the Gibson finding that ener
think that we need both approaches,
that is HBSE and “conventional” risk assessment. The issue is always this: what
do you do when you don’t have any data? Practitioners must start with what they
know, and that usually means starting with qualitative risk assessments. This
is especially true
qu...@listserv.ieee.org
> <mailto:0bb8ff993b10-dmarc-requ...@listserv.ieee.org>> wrote:
> Hi Rich,
>
> I have to admit that I’ve been thinking about your reply all weekend.
>
> As you know, I teach machinery risk assessment and consult in this area
> regularly
ain Time (US-MST)
On Mon, Feb 14, 2022 at 1:45 PM Douglas Nix <
0bb8ff993b10-dmarc-requ...@listserv.ieee.org> wrote:
> Hi Rich,
>
> I have to admit that I’ve been thinking about your reply all weekend.
>
> As you know, I teach machinery risk assessment and consult in this
Hi Rich,
I have to admit that I’ve been thinking about your reply all weekend.
As you know, I teach machinery risk assessment and consult in this area
regularly. I want to stipulate that there are some significant issues with risk
assessment the way it is most commonly applied in industry, see
Hello Rich
I am somewhat alarmed by a paragraph in your email!! In it you indicated
that:
"When I evaluate a product, I look for the physical energy sources, *and
then determine if the energy sources are hazardous or no*t. Unlike Risk
Assessment, this is easy and repeatable and not subje
I don’t like the Risk Assessment process because it is highly subjective and
not very repeatable.
When I was with Hewlett Packard, three of us developed “Hazard Based Safety
Engineering,” HBSE. The basis for HBSE was James J. Gibson’s (Cornell
University) research into child injury
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
d0c-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 t
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%20Internatio
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
-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
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 Con
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
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
When going for a RED certificate from a Notified Body, have you received a
risk assessment template to fill in or do you supply with your own self-made
risk document? (Maybe based on CENELEC guide 32 . )
Best regards
Amund
All,
Realize IEC 60601-1, ed. 3.0 or 3.1 requires a process under ISO 14971, per
sub-clause 4.2.2, so doesn’t matter what you think you need.
Here is the first sentence of 4.2.2 “A RISK MANAGEMENT PROCESS complying with
ISO 14971 shall be performed"
So, sorry but ISO 14971 MEDICAL DEVICE risk
“… does a palliative involve an interchange of energy?
Yes, chemical energy. But, no injury.
Rich
-
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a
I knew someone would come back with that reply.
Technically, it may or may not be correct (does a palliative involve an
interchange of energy?) but in practice it stretches the original assertion
beyond any useful application.
As ever, real life is more complex than it is possible to express
“Injuries to a living organism can be produced only by some energy interchange.”
Not all risk are of energetic nature:
Risk is never a function of energy interchange. Risk is the “combination of
the probability of occurrence of harm and the severity of that harm.”
Injury is a function
Life is consist of risk assessments!
If you cross a road, you quickly assess the risk of safely getting to
the other side.
What you call a scientific method, is a risk assessment based on
physical hypotheses , but the hypothesis might be wrong tomorrow, or in
another place. But the chance
If the device transfers energy, but the energy proves ineffective, that
is still an 'energy interchange'. If the device fails to transfer
energy, there is no 'cause' to produce an 'effect', so any injury is not
due to the device but to some other energy interchange.
Do we rename the list
In the medical device context, no this is not correct because the failure of
the device to provide the claimed medical benefit can be a cause of ‘injury’.
Nick.
> On 17 Apr 2018, at 20:17, Richard Nute wrote:
>
>
>
> Do you agree or disagree with James Gibson’s
“… well understood risk management process provides a quite scientific and
systematic method for identification of safety related issues in the
construction…”
I don’t agree that the risk management process “provides a scientific… method…”
ISO 14971 requires identification of the
Thanks for the explanations. However, I still think that at some point
risk assessment is inevitable.
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2018-04-17 00:22, Richard Nute wrote:
… how do you test *objectively* the adequacy
… how do you test objectively the adequacy of a symbol like the ! in a triangle…
The ! is not a safeguard. Ultimately, the safeguard is some prescribed
behavior on the part of a person. The manufacturer of equipment can only
describe the desired behavior. The behavior can be tested to
. It was 'considered' that the probability of two coinciding
pinholes was acceptably low. If that isn't a risk assessment, I'm not
writing this message. This is just an example of 'test the adequacy of
the safeguards'. Many others spring to mind rather readily; how do you
test *objectively
West London, UK
From: Richard Nute [mailto:ri...@ieee.org]
Sent: 16 April 2018 21:48
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Medical device risk assessment - faulty chargers
I don’t like “risk assessment.” It is highly subjective and not scientific.
Read ISO 14971 or any
… 2 Means of Patient Protection (dielectric and spacings requirements)…
I trust this statement is a slip-up. Spacings i.e., clearances, are an indirect
measure of dielectric strength. They do not constitute two independent means
of patient protection.
Note that creepage distances
lt;ari.honk...@sesko.fi
<mailto:ari.honk...@sesko.fi>>
*To: *"EMC-PSTC" <EMC-PSTC@LISTSERV.IEEE.ORG
<mailto:EMC-PSTC@LISTSERV.IEEE.ORG>>
*Sent: *Wednesday, April 11, 2018 5:20:35 AM
*Subject: *Re: [PSES] Medical device risk assessment - faulty chargers
is an unstated background to this discussion.
>
> Mike Sherman
> Graco Inc.
>
> From: "Ari Honkala" <ari.honk...@sesko.fi>
> To: "EMC-PSTC" <EMC-PSTC@LISTSERV.IEEE.ORG>
> Sent: Wednesday, April 11, 2018 5:20:35 AM
> Subject: Re: [PSES] Med
: "Ari Honkala" <ari.honk...@sesko.fi>
To: "EMC-PSTC" <EMC-PSTC@LISTSERV.IEEE.ORG>
Sent: Wednesday, April 11, 2018 5:20:35 AM
Subject: Re: [PSES] Medical device risk assessment - faulty chargers
My first thought: what has the origin of the charger has to do with i
...@conformance.co.uk]
Sent: tiistai 10. huhtikuuta 2018 19:21
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Medical device risk assessment - faulty chargers
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical products
Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2018-04-10 17:21, Nick Williams wrote:
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical products.
With the increased used of universal USB power
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical products.
With the increased used of universal USB power as a source for battery
charging, it’s easy for the risk assessment to identify use
, September 19, 2016 09:43
But what type of Fault Testing or Risk assessment needs to be done regarding
the filter? With the filter removed, the instrument passes the construction
requirements for a Fire Enclosure. But with the filter installed and because of
its close proximity to the fan/blower;
1
lecom.com
From: Kunde, Brian [mailto:brian_ku...@lecotc.com]
Sent: Monday, September 19, 2016 12:43 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Risk Assessment of Air Filter
I seek advice and opinions from fellow safety minded people.
Our typical product has a metal chassis which is
ing/maintaining it will be relatively
"intelligent" and will suitably trained in how to perform those tasks
correctly, and that includes use of the correct replacement parts during
user maintenance.
John E Allen
W.London, UK
From: Kunde, Brian [mailto:brian_ku...@lecotc.com]
Sent:
[PSES] Risk Assessment of Air Filter
I seek advice and opinions from fellow safety minded people.
Our typical product has a metal chassis which is constructed as a Fire
Enclosure (laboratory equipment 61010-1). On the back is a cutout for a
cooling fan/blower mounted in the cutout. The fan is
Blocked Vent and Stalled
Fan tests to insure no hazards are caused from the rise in internal
temperatures.
But what type of Fault Testing or Risk assessment needs to be done regarding
the filter? With the filter removed, the instrument passes the construction
requirements for a Fire Enclosure
In message
e79b96282e4f9f43baf7c6d3d578acde0907f...@ca1exclv07.adcorp.kla-tencor.co
m, dated Thu, 14 Jun 2012, Crane, Lauren
lauren.cr...@kla-tencor.com writes:
I wonder how to decide if John's view (the hazard is exposed to
personnel) or my view (personnel are exposed to the hazard) is the
I'm seeking a clearer definition of what the term, Probability of Exposure
means in regards to IEC 61010-1 3rd Ed. In table 12. There are two choices;
Exposure is not intended during Normal Use
And
Exposure is intended during Normal Use.
What I have is a pinch hazard which exceeds the
Brian
Compared with Severity issues, the Probability issue is always a difficult
subject to address in risk assessment because it can be, and often is, far
more subjective, especially where it involves human behaviour - human error
being one of the greatest causes of accidents
In message
64D32EE8B9CBDD44963ACB076A5F6ABB0261F219@Mailbox-Tech.lecotech.local,
dated Thu, 14 Jun 2012, Kunde, Brian brian_ku...@lecotc.com writes:
Would this be considered intended or not intended exposure?
If properly drafted, a standard must confine its provisions to those
: Thursday, June 14, 2012 3:21 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Risk Assessment: Probability of Exposure
In message
64D32EE8B9CBDD44963ACB076A5F6ABB0261F219@Mailbox-Tech.lecotech.local,
dated Thu, 14 Jun 2012, Kunde, Brian brian_ku...@lecotc.com writes:
Would this be considered
Fellow listers,
I am pleased to announce that CSA's new OHS Risk assessment standard, CSA
Z1002, is out for public review and comment as of today. When published this
year, Z1002 will become a Canadian National Standard and will have influence
on other standards in the CSA Catalog
Dear Colleagues,
Teradyne is seeking the services of a Principal Mechanical Engineer, who is
also a licensed PE to provide the guidance and leadership required to
complete a thorough product review for Risk Assessment.
This individual should possess the following skill sets and/or experiences
Dec 11. 2000
To all of you that took time out to help me.
Thank you , Thank you.
Thank you so much for all the help that you have provided me.
All responses had very good information in them.
Sincerely
Stig W. Jorgensen
jorgen...@skyskan.com
---
This
mailto:alan.brews...@novellus.com
--
From: Stig Jorgensen [SMTP:jorgen...@skyskan.com]
Sent: Thursday, December 07, 2000 12:25 PM
To: emc-p...@ieee.org
Subject: Risk assessment
Hi Group, Dec 07,2000
Hi Stig,
One of my side jobs is in the Army National Guard Field Artillery. We
perform a risk assessment at each firing point we pull into using an Army
manual, FM 100-14 (Risk Management). I was surprised to see how closely
their documentation parallels EN 1050 in many aspects.
Here's
This is also the Risk Assessment matrix that all military services and several
other government agencies used in program/product development.
It is included in Mil-Std-882D, DOD Standard Practice for System Safety -
released February 2000.
System Safety is generally the equivalent to Product
Deep within a very interesting paper on EMC and Functional Safety by the
IEE at
http://www.iee.org.uk/PAB/EMC/core.htm
in section 13.5 (page 49 on my copy) are pretty classic descriptions of
probability and severity. These probably are descendents of MILSTD1442, and
are probably also treated
Facsimile : +61 2 9663 1412
Mobile : 0418 464 016
-Original Message-
From: Stig Jorgensen [mailto:jorgen...@skyskan.com]
Sent: 8 December 2000 7:25
To: emc-p...@ieee.org
Subject:Risk
Hi Stig:
I believe you are interested in severity of injury,
not potential for injury, or risk of injury.
Here is a numerical assignment for severity of injury
that I found in my files. I have no idea of its
source.
10 Death
9 Long-term or permanent coma
8 Full body
Hi Group, Dec 07,2000
I am in the process of establishing the potential for an injury from a
hazard.
I can get a reasonable 'expression' to describe the potential for a hazard
to turn into an accident (event). I am looking for the words that
classifies the
Has anyone attended a seminar which they would recommend on
hazard analysis and or risk assessment?
Sandy
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