I don't entirely agree, but the term is certainly vague and subjective.
The trouble is, it's embedded in step 4 of your procedure. I think we
have moved on from it now, but you will surely remember the requirement
for two layers of plastic film or insulation, in case one layer had a
pinhole. 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* the adequacy of a symbol like the ! in a triangle,
meaning, well, I think it has had more than one meaning over the years?
I do wish there was a way of eliminating it, but I don't see one.
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2018-04-16 21:47, Richard Nute wrote:
I don’t like “risk assessment.” It is highly subjective and not
scientific. Read ISO 14971 or any treatise on risk assessment.
I use the “energy transfer model.” This is not subjective and highly
scientific.
It was first proposed by James J. Gibson in 1961:
“Injuries to a living organism can be produced only by some energy
interchange.”
The first step is to identify the energy sources within a product.
The second step is to class the energy sources as capable of causing
injury or not. The third step is to provide the energy sources
capable of causing injury with one or more safeguards to prevent the
transfer of energy to a body part. The fourth step is to test the
adequacy of the safeguards.
Easy and straight-forward. Not subjective.
Rich
-
----------------------------------------------------------------
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 <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/
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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org>>
Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org>>
For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org>>
David Heald <dhe...@gmail.com <mailto:dhe...@gmail.com>>
-
----------------------------------------------------------------
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 <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>
For policy questions, send mail to:
Jim Bacher: <j.bac...@ieee.org>
David Heald: <dhe...@gmail.com>
