Nuclear Plant Journal, September-October 2014 NuclearPlantJournal.com
35
Washington, D.C.: 2005
program
and scope of accreditation.
NEI
submitted
NEI
14-05,
Plant Engineering: Guideline for the
Acceptance
of
Commercial-Grade
Design and Analysis Computer Programs
Used
in
Nuclear
Safety-Related
Applications: Revision 1 of 1025243,
3002002289
to the NRC on April 29,
2014. This document contains guidance
on application of ILAC accreditation
for commercial nuclear facilities. One
objective of NEI 14-05 is to provide
an acceptable approach for procuring
commercial grade testing services as
well as calibration services. Another is to
enable the use of laboratories accredited
by international accrediting bodies as
well as U.S.-based accrediting bodies.
3.
How are the characteristics
necessary to perform “safety functions”
measured?
Methods that can be used to verify
a critical characteristic depend upon
the characteristic itself. For example,
a dimensional characteristic would
typically be verified using a measuring
or test device appropriate for the type of
measurement and required tolerances.
Characteristics associated with
material could be measured by testing
physical properties such as tensile
strength, yield strength, and hardness
or by analysis of chemical composition
such as Fourier transform infrared
spectrometer (FTIR) for elastomers or
optical emission spectrographic analysis
for metals.
Characteristics associated with
services are typically accepted either
by examination of the item upon which
the service was performed (to verify the
service produced acceptable results) or
by verification that the service provider
has appropriate controls in place to assure
the service is performed correctly.
4.
What is the progress in identifying
fraudulent items in the last year?
On July 30, 2014, EPRI published
updated guidance on prevention of
counterfeit and fraudulent items. EPRI
3002002276,
Plant Support Engineering:
Counterfeit and Fraudulent Items—
Mitigating the Increasing Risk, Revision
1 of 1019163
is available to the public for
download at epri.com.
With respect to the EPRI Suspect
Counterfeit and Fraudulent Item (SCFI)
database, three additional incidents have
been reported so far in 2014. Two are
confirmed to be fraudulent, and the third
ended up being an authentic item with
non-standard identification markings.
5.
Can IEEE 323 and IEEE 344
seismic and environmental qualification
requirements be met just by a dedication
program?
One of the basic premises related
to commercial grade dedication is that
the design process must be complete
before dedication can begin. As defined
in 10CFR Part 21, dedication is an
acceptance process (not a design process).
Acceptance is based upon establishing
reasonable assurance that the item being
dedicated is capable of performing its
intended safety function(s). Seismic and
environmental qualification are part of
the design process. These qualification
methods are used to establish suitability
of design by proving that a component is
capable of withstanding and functioning
during and after exposure to seismic
activity and harsh environmental
conditions. Seismic and environmental
qualification (and the rest of the design)
must be completed before dedication
begins.
When an item is being dedicated for
use in an application or component that
is seismically and/or environmentally
qualified, the dedication must include
critical characteristics that establish
reasonable assurance that the item is
capable of performing its intended safety
function during and after exposure to
seismic activity and harsh environmental
conditions.
6.
What is the applicability of legacy
10CFR50, Appendix B-compliant QA
programs in current day and age?
Supplier can still use a 10CFR50,
Appendix B-compliant QA program
to deliver a basic component to the
marketplace without using any dedication
at all. The option for a supplier to design
and manufacture (control) and sell
basic components under an Appendix
B-compliant QA program still exists.
In this scenario, the supplier uses
quality controls to ensure that all design
requirements applicable to the item are
met.
Some suppliers have opted to
produce certain items outside of their
Appendix B-compliant QA programs. For
example, they may manufacture certain
parts in a different facility that operates
under a commercial QA program. If a
nuclear facility orders a commercial item
for safety-related use, the supplier would
have to dedicate the commercial grade
item before providing it to the facility as
a basic component. If the supplier owns
and is knowledgeable about the original
design that was accepted by the nuclear
facility, they can dedicate the item based
on the original design requirements. In
this case, the item’s design parameters
and allowables become the critical
characteristics and acceptance criteria
used in the dedication. An important point
is that all design requirements are verified
to ensure that the item will perform its
intended function.
If the supplier does not have
access to the original design or is not
knowledgeable about the original design,
the dedication would have to be based
upon the intended safety-related function
of the item and critical characteristics
identified
though
a
documented
engineering analysis (such consideration
of the item’s failure modes).
7.
Has the updated EPRI guidance been
accepted by US NRC and the industry?
Throughout
the
development
process, the EPRI technical advisory
committee that developed the updated
guidance
(3002002289)
had
the
opportunity to work closely with the
NRC staff members experienced in
commercial grade dedication. Several
of them have been following dedication
since the term was first introduced in the
1970s. The team members, including
NRC staff, worked hard to ensure that
the guidance is consistent with the NRC’s
regulatory requirements and expectations.
We believe the guidance is aligned with
both the current version of 10CFR Part
21 and currently proposed changes to the
dedication requirements in 10CFR Part
21.
It is our understanding that the NRC
is preparing a draft regulatory guide (DG-
1292,
US NRC Draft Regulatory Guide,
Dedication of Commercial Grade Items
)
that will include guidance on commercial
grade dedication. An important objective
throughout the development effort
