Hello all,
Chances are the audits of components and/or component assemblies are based
on individual entity's (the NRTLs) requirements and not OSHA's (in my
opinion). If you want a given mark, you must dance to their tune.
Regards, Art Michael
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============================================================================
On Tue, 6 Sep 2005, Brian O'Connell wrote:
> Mr. Barrows makes a good point: get the requirements from the donkey's mouth.
>
> Should have put this URL in my original msg:
>
> http://www.osha-slc.gov/dts/otpca/nrtl/nrtlregs.html
>
> which is only says that "adequate controls" for "conducting follow-up
inspections of the
> actual production of items to evaluate conformance with test standards" and
"conducting field inspections to assure proper use of its marks or labels...".
>
> But this provides more detail on when an NRTL may accept 3d party test data
(which is what they are doing when they accept your test data on the
out-sourced component):
>
> http://www.osha-slc.gov/pls/oshaweb/o
adisp.show_document?p_table=FEDERAL_REGISTER&p_id=13454
>
> But, it does NOT say that the NRTL "shall" accept any 3d party test data; so
the agency can require any out-sourced mfr to comply with the same FUS audits
performed at the end-use mfr.
>
> luck,
> Brian
>
> -----Original Message-----
> From: Scott Barrows [mailto:[email protected]]
> Sent: Tuesday, September 06, 2005 7:00 AM
> To: Brian O'Connell; Jon Griver; [email protected]
> Subject: Re: NRTL Factory Inspection Question ...
>
> Hi All,
> For a clarification of the NRTL requirements for Factory inspections. Go to
the OSHA website and look it up. It is a interesting place and defines the
guidelines that all of the NRTL's must follow.
>
> Subject to interpretation of course, but if you want to argue a point that
may save you money or aggravation, give it a shot - it is the law, I believe.
>
> Scott
>
> ----- Original Message -----
> From: Brian O'Connell
> To: Jon Griver ; [email protected]
> Sent: Tuesday, September 06, 2005 9:27 AM
> Subject: RE: NRTL Factory Inspection Question ...
>
>
> CENELEC requirements do not necessarily pertain to NRTL requirements; which
are driven by United States OSHA requirements...
>
> When acting as an NRTL, I've yet to see any two agencies perform a FUS audit
using the same procedure, having the same requirements.
>
> If a safety-critical component does not bear a mark that would indicate that
it is an NRTL recognized component, then most NRTLs will require that the mfr
be audited.
>
> If your company has an approved quality-control process, and can demonstrate
that your receiving performs 100% test IAW the scoped standard, then they
would probably accept the component if the report specifies the mfr and test
requirements in the construction details.
>
> luck,
> Brian
>
>
> > -----Original Message-----
> > From: [email protected] [mailto:[email protected]]On Behalf
> > Of Jon Griver
> > Sent: Sunday, September 04, 2005 10:32 PM
> > To: [email protected]
> > Subject: Fw: NRTL Factory Inspection Question ...
> >
> >
> > Doug,
> >
> > CENELEC has a document, CCA-201, "Factory Inspection Procedures, CCA
> > Harmonized Requirements", which defines the manufacturer's
> > premises/factory
> > location as "the location where the final assembly and/or testing of
> > certified products normally takes place and the
> > Certification Mark is
> > applied".
> >
> > The document also defines sub-contractors and out-workers,
> > but states that
> > inspecting them is the manufacturer's responsibility.
> >
> > In my experience the European Test Houses use this document
> > as guidelines
> > for their own procedures. I don't know if the document is
> > used by NRTL's.
> > but at least the NRTL's with European main offices should
> > know of the
> > document.
> >
> > In my experience, labelling the certified product is
> > literally a symbolic
> > act. The substantive act is final assembly and testing,
> > particularly safety
> > testing (hipot, etc.) if this is necessary for the product,
> > and this defines
> > where inspection should take place.
> >
> > Regards,
> >
> > Jon Griver
> > http://www.601help.com
> > The Medical Device Designer's Guide to IEC 60601-1
> >
> >
> >
> >
> > > Recently, I had a discussion with an NTRL regarding
> > product factory
> > > inspections.
> > > I was under the impression that where the label was
> > applied, that was
> > > where
> > > the factory inspection would occur. And, if the contract
> > noted a different
> > > company where the manfacturing was done and being that was
> > typically
> > > (not always) where the lable was applied, that was
> > inspections would
> > > happen.
> > >
> > > Not so, according to these people. This was in response to
> > a hypothetical
> > > situation I gave them to consider.
> > >
> > > For instance, say your company has sells a product in your
> > companys name.
> > > But, you have assembly done at any number of contractors.
> > And the NRTL
> > > label is applied at your company. Even if the contractors
> > aren't on the
> > > contract with the NRTL for whatever reason, the factory
> > inspector will
> > > inspect as much as possible the product at your site, then
> > inspect the
> > > contractor site even though it is not on the contract.
> > Basically at their
> > > discretion.
> > >
> > > The result of this is ... if say your company has ten
> > contractors on a
> > > list
> > > of approved vendors with which do business (just as an
> > example for the
> > > sake of argument) for possible assembly contracts and at
> > any time you
> > > do business with just one of those contractors, this all
> > really means you
> > > must inform the NRTL of all ten 'posible' manufactoring
> > locations and
> > > all ten, including your own company, are to be inspected
> > on a quarterly
> > > basis and thus increase your factory inspection cost by a
> > factor of 10.
> > >
> > > For some reason, this all sounds a little unreasonable to me.
> > >
> > > What say you?
> > >
> > > Regards, Doug McKean
>
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