ML21244A498
| ML21244A498 | |
| Person / Time | |
|---|---|
| Site: | FitzPatrick  |
| Issue date: | 09/03/2021 |
| From: | David Lew NRC Region 1 |
| To: | |
| References | |
| EA-20-138 IR 2021090 | |
| Download: ML21244A498 (5) | |
See also: IR 05000333/2021090
Text
ENCLOSURE 1
NRC RESPONSE TO INFORMATION PROVIDED IN THE EXELON LETTER
DATED JUNE 3, 2021
As discussed below, the NRC Independent Review Team (IRT) revie wed the information
provided by Exelon Generation Company, LLC (ExGen) and determined that the characterization
of the finding remains of low-to-moderate safety significance ( White). The IRT determined that
the violations of 10 CFR 50, Appendix B, Criterion VII, Control of Purchased Mat erial,
Equipment and Services, and Criterion XV, Nonconforming Mater ials, Parts or Components,
were not sufficiently supported as written. As a result, the C riterion VII violation has been
withdrawn and the Criterion XV violation has been revised. The violation of TS 3.5.1 remains
unchanged. However, the IRT determined that a violation of 10 CFR Part 50 Appendix B,
Criterion V, is warranted.
Regarding the contested 10 CFR Part 50 Appendix B, Criteria VII and XV violations, the IRT
determined that neither 10 CFR Part 21, nor any associated NRC guidance, requires a
licensee to evaluate an incoming component for the existence of a Part 21 notification.
FitzPatrick, as required by 10 CFR 21.31 1, appropriately invoked the requirements of Part 21
by its inclusion in the purchase order. Part 21 does not repre sent a receipt inspection
characteristic for the procurement of a structure, system, comp onent, or service. Rather, its
inclusion in the purchase order places the supplier on notice t hat the requirements of Part 21
must be met. Accordingly, given that no additional information was presented in the inspection
report regarding a failure to comply with procurement documents (i.e., the purchase order), the
IRT determined the assertion, that Fitzpatrick failed to ensure purchased material, equipment,
and services, whether purchased directly or through contractors and subcontractors, conform
to the procurement documents, was not supported as stated in t he subject inspection report.
In reviewing the licensees response and the body of informatio n available to support the
inspection outcome, the staff determined that FitzPatrick faile d to comply with its procurement
and receipt procedures which resulted in ExGens failure to ade quately identify and control
items to prevent the use of a defective item as specified in Se ction 6, Identification and Control
of Items, of FitzPatricks Quality Assurance Program Manual (QAPM). Thus, the staff
determined that FitzPatricks failure to accomplish procurement activities as prescribed by
ExGens quality assurance procedures resulted in a noncomplianc e with 10 CFR 50, Appendix
B, Criteria V and XV. The revised finding and Notice of Violation (NOV) are described in
Enclosures 2 and 3.
SUMMARY OF EXGEN COMMENT - Ability to Identify Part 21 Information
ExGen disputed NRCs basis for determining that the violations were reasonably foreseeable
and preventable because the act of clearing an unrelated shelf- life hold did not provide an
opportunity for either the Limerick Generation Station (Limeric k) material handler, or the
FitzPatrick qualified receipt inspector (QRI), to identify the Part 21 information. The Part 21
information was documented in an Issue Report (IR) located in t he component database and
was also documented in ExGens Corrective Action Program (CAP) database.
1 10 CFR 21.31, Procurement documents, states, Each individual, corporation, partnership, dedicating
entity, or other entity subject to the regulations in this part shall ensure that each procurement document
for a facility, or a basic component issued by him, her or it on or after January 6, 1978, specifies, when
applicable, that the provisions of 10 CFR Part 21 apply.
2
NRC RESPONSE
The IRT considered the violation in the context of 10 CFR 21 (i .e., Part 21) as used (or implied)
in the contrary to statements for the issued 10 CFR 50 Append ix B, Criterion VII and Criterion
XV violations. The IRT concluded that this aspect of the viola tions should be withdrawn.
SUMMARY OF EXGEN COMMENT - Archived, Descriptive and Readily Available
With respect to the shelf life hold, ExGen contends the NRC has mischaracterized this
archived and descriptive information as readily available to both the Limerick material
handler and the FitzPatrick quality receipt inspection quality receipt inspection.
NRC RESPONSE
As a point of clarification, the hold that was presented was a user-hold. In order to identify the
reason for a user-hold, the licensees staff would need to furt her review and disposition the
concern as appropriate. As described in ExGens June 3, 2021 r esponse, the manipulation of
the Passport system requires some degree of user familiarity an d skill of the craft. As the
licensee states in their response, descriptive information in t he component tracking database
can be provided in several panels. After a review of the infor mation and steps to manipulate the
Passport system, the NRC maintains that this information was re adily available, and as a result
represented a reasonable opportunity to foresee and prevent the installation of the
nonconforming PCV.
SUMMARY OF EXGEN COMMENT- Requirements to Research
Although ExGen provided information in the response to the AV - demonstrating that there was
no regulatory requirement to research information unrelated to the shelf life hold, as well as
explaining why the non-conformance would not have reasonably be en identified by the Exelon
Business Services Corporation (BSC) staff in 2017 - there is no indication in the issued NOV
that this information was considered.
NRC RESPONSE
The IRT assessed this information during its deliberations. Th is information, in part, is
addressed in the NRC Response to EXGEN Comments pertaining to10 CFR Part 50 Appendix
B, Criterion VII. The NRC agrees that there was no regulatory requirement to research
information unrelated to the user hold. Accordingly, the revis ed NOV does not cite a failure to
perform this level of research. Instead, the IRT recommended a performance deficiency (PD)
and violation associated with failures to follow ExGens proced ural provisions and the availability
of the subject information. Ultimately, the staff determined t hat it was reasonable for ExGen to
foresee and prevent the installation of the nonconforming PCV d uring receipt inspection;
however, the failure of personnel to adhere to procedural requi rements resulted in a failure to
identify that the diaphragm in the PCV required replacement.
SUMMARY OF EXGEN COMMENT- Limerick Criterion XV
The NRC staff acknowledged that the Criterion XV violation that occurred at Limerick in 2010
could not have been prevented by the ExGen staff in 2017. Howev er, when recharacterizing the
3
Criterion XV violation as having occurred in 2017, the NRC did not explain how Criterion XV
was violated that year.
NRC RESPONSE
NRC staff identified that information about the Part 21 notific ation was readily available in the
database and could reasonably be identified by a qualified proc urement engineer when
performing a review of available information to address the ho ld'. As determined by the IRT,
the basis for the issued Criterion XV violation was underpinned by the Criterion VII violation. As
described above, the IRT found Criterion VII to be unsupported. As a result of the IRT review of
this matter, NRC determined that the Criterion XV violation was not sufficiently supported as
stated in the issued Notice; the IRT documented a revised Crite rion XV violation that was based
on a procedural deficiency in lieu of a Part 21 procurement def iciency.
SUMMARY OF EXGEN COMMENT- Clearing the User Hold
The licensee stated that the shelf-life hold was actually clear ed by the Limerick MH after the
existence of the hold had been communicated to the FitzPatrick buyer; and, that the FitzPatrick
buyer engaged the FitzPatrick Procurement Engineer (PE) who app ropriately reviewed the
original vendor documentation and determined that the shelf-lif e could be extended - which was
subsequently communicated to the FitzPatrick buyer and the Fitz Patrick QRI. Per the licensee,
at no time did the FitzPatrick buyer, the FitzPatrick QRI, or t he FitzPatrick PE have any reason -
nor was there any regulatory requirement - to access the compon ent tracking database or the
ExGen CAP system to investigate the reason for the shelf-life h old. ExGen stated that clearing
the hold was the responsibility of the Limerick warehouse staff as the custodian of the
component.
NRC RESPONSE
The NRC recognizes that the specific facts of the procurement incident are impacted by the
amount of time that has elapsed since the 2017 transfer, person nel retirements, and the lack of
documentation. However, in response to the comments above, the NRC reviewed action
request (AR) 04348906 - originated on June 6, 2020, by FitzPatr ick - to inform our decision on
the sequence of events and the actions of the involved individu als. Specifically, per the AR, (1)
the PCV was put on user hold at Limerick on October 20, 2017, d ue to the self-life expiring
within 5 days, (2) the valve was transferred to Fitzpatrick on December 15, 2017, with the shelf-
life indicating expired in Passport, and (3) the Fitzpatrick quality receipt package inspection
identified, reviewed and dispositioned the shelf-life issue wit h FitzPatricks Procurement
Engineering prior to releasing the PCV for installation in the HPCI system.
Procedure SM-AA-102, Warehouse Operations, Rev 23, Attachment 1 , step 1.10.6, specifies, in
part, that for items on hold to be released to another facility , the receiving facility must create an
action item to track the resolution before the transfer occurs. FitzPatrick, the receiving facility,
did not create an action item to track the dispositioning of th e hold which should have resulted in
the component being returned to user-hold status and tagged unt il dispositioning had occurred.
Based on the IRT assessment of the supporting information, the team concluded that there
were a number of procedural adherence issues at both the Limeri ck and FitzPatrick stations
with respect to procurement practices. Similar conclusions wer e arrived by ExGen as
documented in the Corrective Action Program Evaluation (CAPE) C harter for Condition Report
Number 04334315, dated June 24, 2020, when addressing both Lime ricks and FitzPatricks
shortcomings in the total chain of events.
4
SUMMARY OF EXGEN COMMENT- Clearing the User Hold
The licensee asserted that the NRC incorrectly stated that IR 1 086768 had not been resolved at
the time the PCV was sold to, and accepted at, FitzPatrick. ExG en had previously explained in
their response to the AV, that all actions associated with IR 1 086768 have been in
COMPLETE status since 2010. However, the NRC did not acknowl edge this fact in the NOV
and inaccurately stated that the IR remained unresolved.
NRC RESPONSE
The NRC acknowledges that actions associated with IR 1086768 ha ve been in COMPLETE
status since 2010. The actions of concern were taken to COMPLE TE by generating M Codes
which directed the replacement of the diaphragm prior to instal lation. Specifically, in the
component identification (CID) facility-specific section in Pas sport Panel D202, it stated, Need
to replace diaphragm 116-0013 prior to use in the plant refer I R 1086768. The IRT determined
that if prescribed procedures were followed as described above, it would have been reasonable
for the FitzPatrick procurement staff to identify that the acti on to replace the diaphragm was not
completed. Furthermore, it was reasonable for procurement engi neers to review Passport
Panel D202 during the receipt process regardless of whether a h old was placed on the
component.
SUMMARY OF EXGEN COMMENT- Unresolve Part 21s
ExGen specifically informed the NRC that there is no reference to the Part 21 in the component
tracking database. Furthermore, if a search of the referenced IR would have been required,
which ExGen continues to stress was NOT required, it would have indicated to the Limerick MH
and the FitzPatrick QRI that there were no open ATIs associated with that IR and therefore, they
would have concluded that the IR was dispositioned correctly an d closed. In order for any BSC
or ExGen staff to identify that there was an unresolved Part 21 concern associated with the
PCV, the individual would have had to arbitrarily decide to aud it the closures of each of the ATIs
associated with IR 1086768, despite having no cause or regulato ry requirement to do so.
NRC RESPONSE
As stated above, Part 21 does not represent a receipt inspectio n characteristic for the
procurement of an structures, systems and components (SSC).
SUMMARY OF EXGEN COMMENT- Part 21 and Closed Action Tracking It ems (ATIs)
Assuming the BSC staff had reason to look for any open ATIs ass ociated with older Part 21
notifications in 2017, which they did not, the BSC staff would have determined that appropriate
actions were put in place and subsequently completed to address the 2010 Part 21 notification.
NRC RESPONSE
As stated above, Part 21 does not represent a receipt inspectio n characteristic for the
procurement of a SSC.
5
SUMMARY OF EXGEN COMMENT - Descriptive Information
The issue report (IR) number associated with the 2010 Part 21 r esponse was not documented
in the status field, but instead was documented in a hidden de scriptive information field along
with 63 other line items of descriptive information.
NRC RESPONSE
The IRT disagreed with ExGens characterization that the releva nt descriptive information
concerning the deficient PCV diaphragm was not readily availabl e. Specifically, information was
clearly available in Passport panel D202. Procurement Engineer s operate in accordance with
procedure SM-AA-300-1001, Procurement Engineering Process, an d other procedures.
Section 4.29 describes how additional comments and basis for si te applicability may be entered
using CID specific panel D202. The IRT determined that, when c learing the user-hold for the
PCV, it would have been reasonable for procurement engineers to access this descriptive
information, which was readily available and required no more t han a few minutes to review.
From this descriptive information, it would have been reasonabl e for the licensee to identify that
the defective diaphragm in the PCV required replacement. Furth ermore, it was reasonable for
procurement engineers to review Passport Panel D202 during the receipt process regardless of
whether a hold was placed on the component.