Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
- From: "McQuaid, Paul" <paul.mcquaid@xxxxxxxxxxxxxxxxxxxxxx>
- To: "foxboro@xxxxxxxxxxxxx" <foxboro@xxxxxxxxxxxxx>
- Date: Thu, 19 Mar 2015 10:45:49 -0500
If it helps.........I did Validation for a manufacturer supplying equipment
into some Pharmaceutical sites in the UK a while back so this might be old
information, but for Hardware at least the Phrase "FORM,FIT or FUNCTION" was
the test used to define the need for re-validation, so In my view, and this was
sometimes tested with customers, auditors, (successfully back then at least),
as long as it doesn't change the way a validated process is functioning then is
does not require re validation. In the case of my sites The manufacturer
supplied a document that there was no change to the form fit or function and
that was acceptable to the auditors.....
i.e. if a Microprocessor is updated through lack of availability as long as it
does exactly the same job then it is acceptable.
BUT I also know many sites where as far a Software is concerned a software
version MUST remain the same, as there is in, their (auditors) opinion no proof
that it does EXACTLY the same thing without re validation :-(
I suppose its fair to say that the Auditors decision, will be the rule, and
that may differ dependant on the site and potentially the person, and possibly
whether his/her partner was nice to them last night :-)
Best Regards
Paul McQuaid
-----Original Message-----
From: foxboro-bounce@xxxxxxxxxxxxx [mailto:foxboro-bounce@xxxxxxxxxxxxx] On
Behalf Of Landry, Scott
Sent: 19 March 2015 11:44
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
Ken is correct in that this information is conveyed internally through a
Engineering Release/Revise/Cancel Notice.
Many reasons for a ERN, example , a component is no longer available from
ManufacturerA so a compatible component
from ManufacturerB is used in its place and the Hardware Revision letter is
changed to reflect this.
Regards,
Scott
________________________________________
From: foxboro-bounce@xxxxxxxxxxxxx [foxboro-bounce@xxxxxxxxxxxxx] On Behalf Of
Joseph M. Riccardi [Joe@xxxxxxxxxxxxx]
Sent: Wednesday, March 18, 2015 8:13 PM
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
Scott,
I appreciate that explanation but the unknown factor is still what changed from
the REV-0L to the REV-0P level. In other words, how does the certifying
authority know that the differences in the hardware/software will have no
impact on final product?
I am still hoping Ken's suggestion holds water...
Joseph M. Riccardi
386-451-7607 Cell
Joe@xxxxxxxxxxxxx
"To give real service you must add something that cannot be bought or measured
with money; and that is sincerity and integrity." - Donald A. Adams
-----Original Message-----
From: foxboro-bounce@xxxxxxxxxxxxx [mailto:foxboro-bounce@xxxxxxxxxxxxx] On
Behalf Of Landry, Scott
Sent: Wednesday, March 18, 2015 5:39 PM
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
Revision Level typically only makes a difference when it is below the
suggested field usable Revision Level.
Foxboro also has what we call a minimum shippable Revision Level, which is
usually higher than the min. field useable
level but always at least at the min. field useable level. Hardware that
is in the Mature and Lifetime Lifecycle phase and
comes from MEP or Repair or NOS stock is typically revised up to the latest
Revision Level if possible.
Regards,
Scott
________________________________________
From: foxboro-bounce@xxxxxxxxxxxxx [foxboro-bounce@xxxxxxxxxxxxx] On Behalf Of
Joseph M. Riccardi [Joe@xxxxxxxxxxxxx]
Sent: Wednesday, March 18, 2015 6:51 PM
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
Ken,
I presented your position to the engineer responsible and he bought it
soooooo...
Thanks for the advice.
Joseph M. Riccardi
386-451-7607 Cell
Joe@xxxxxxxxxxxxx
"To give real service you must add something that cannot be bought or measured
with money; and that is sincerity and integrity." - Donald A. Adams
-----Original Message-----
From: foxboro-bounce@xxxxxxxxxxxxx [mailto:foxboro-bounce@xxxxxxxxxxxxx] On
Behalf Of Ken Heywood
Sent: Wednesday, March 18, 2015 12:14 PM
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
Maybe it has not been an issue. If the part is replaced with the same part
number, revision level should not make a difference to a certifying authority.
Especially so if Foxboro did not change the specifications according to the PSS
sheet. Typically, Foxboro issued a new part number if the functionality and/or
specifications changed.
Thank You,
Ken Heywood
Calibration Laboratory Manager
PROCESS CONTROL SERVICES, INC.
Established in 1983
http://www.processcontrolservices.com
mailto:KHeywood@xxxxxxxxxxxxxxxxxxxxxxxxxx
Telephone: 734-453-0620
Wireless: 508-241-2040
===============================================
-----Original Message-----
From: foxboro-bounce@xxxxxxxxxxxxx [mailto:foxboro-bounce@xxxxxxxxxxxxx] On
Behalf Of Joseph M. Riccardi
Sent: Wednesday, March 18, 2015 2:36 PM
To: foxboro@xxxxxxxxxxxxx
Subject: Re: [foxboro] "Like for Like" kind FBM100 series REV-0L
It's never a good sign when you get no responses. The subject must be taboo.
:-(
Going once, going twice,...
Joseph M. Riccardi
386-451-7607 Cell
Joe@xxxxxxxxxxxxx
"To give real service you must add something that cannot be bought or measured
with money; and that is sincerity and integrity." - Donald A. Adams
-----Original Message-----
From: foxboro-bounce@xxxxxxxxxxxxx [mailto:foxboro-bounce@xxxxxxxxxxxxx] On
Behalf Of Joseph M. Riccardi
Sent: Monday, March 16, 2015 10:40 AM
To: foxboro@xxxxxxxxxxxxx
Subject: [foxboro] "Like for Like" kind FBM100 series REV-0L
Folks,
We recently had an FBM01 REV-0L fail and replaced it with a REV-0P version.
In the Nuclear, Pharma, and I am sure other industries that require validation,
the documentation required to support replacement parts of a "Like for Like"
kind is simpler. I cannot find any reference in the GCS web site that would
point me to documentation for the various hardware revision levels that would
support this "Like for Like" kind. Does one exist? What do other Nuclear,
Pharma, and other industries that require validation do in this case?
Thanks
Joseph M. Riccardi
386-451-7607 Cell
Joe@xxxxxxxxxxxxx <mailto:Joe@xxxxxxxxxxxxx>
"To give real service you must add something that cannot be bought or measured
with money; and that is sincerity and integrity." - Donald A. Adams
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This mailing list is neither sponsored nor endorsed by Invensys Process Systems
(formerly The Foxboro Company). Use the info you obtain here at your own risks.
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If you have received it in error, you are on notice of its status. Please
notify the sender immediately by reply e-mail and then delete this message from
your system. Please do not copy it or use it for any purposes, or disclose its
contents to any other person.
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Systems (formerly The Foxboro Company). Use the info you obtain here at
your own risks. Read http://www.thecassandraproject.org/disclaimer.html
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