ML21244A497
| ML21244A497 | |
| Person / Time | |
|---|---|
| Site: | FitzPatrick  |
| Issue date: | 09/03/2021 |
| From: | David Lew NRC Region 1 |
| To: | Rhoades D Exelon Generation Co |
| Erin Carfang | |
| Shared Package | |
| ML21244A495 | List: |
| References | |
| EA-20-138 IR 2021090 | |
| Download: ML21244A497 (14) | |
See also: IR 05000333/2021090
Text
.
September 3, 2021
Mr. David P. Rhoades
Senior Vice President
Exelon Generating Company LLC
President and Chief Nuclear Officer, Exelon Nuclear
4300 Winfield Road
Warrenville, IL 60555
SUBJECT:
JAMES A. FITZPATRICK NUCLEAR POWER PLANT - RESPONSE TO
CONTESTED VIOLATION AND FINAL WHITE FINDING AND REVISED
NOTICE OF VIOLATION - INSPECTION REPORT 0500333/2021090
Dear Mr. Rhoades:
This letter provides you the response to your letter dated June 3, 2021, contesting the
Notice of Violation (NOV) issued by Nuclear Regulatory Commission (NRC) letter dated April
20, 2021 (ML21105A543). In summary, Exelon Generation Company, LLC (ExGen) did not
agree that the violation constituted a Performance Deficiency as the staff at James A.
FitzPatrick Nuclear Power Plant (FitzPatrick) could not have reasonably been able to identify
and prevent a nonconforming component (pressure control valve) from being installed and
therefore, contested the characterization of the 10 CFR 50 Appendix B, Criterion VII and XV
violations. On June 25, 2021, the NRC acknowledged receipt of this letter (ADAMS Accession
ML 21176A005) and informed you that we would evaluate your response and provide the
results of our evaluation.
In your letter dated February 26, 2021 (ADAMS Accession ML 21057A190), ExGen
acknowledged that the failure to control a defective part and prevent its use occurred at the
Limerick Generating Station (LIM) in 2010; and, as a result the staff at LIM failed to
communicate the deficiency to Fitzpatrick prior to selling the defective part to FitzPatrick.
ExGen further acknowledged that the sale of the defective part from Limerick to FitzPatrick in
2017, and its subsequent installation, resulted in a failure of the FitzPatrick high pressure
coolant injection system (HPCI) in 2020.
The NRC conducted a detailed review of your response and the applicable regulatory
requirements, in accordance with Part I, Section 2.4.4, of the NRC Enforcement Manual. The
NRC team that performed the review were not involved with the original inspection effort.
Based on the totality of the information, including the inspection report with referenced
documents, your response to the apparent violation, and your response contesting the final
violation; the review team determined that the violations referencing 10 CFR 50, Appendix B
Criterion VII, Control of Purchased Material, Equipment and Services, and Criterion XV,
Nonconforming Materials, Parts or Components, were not sufficiently supported as stated in
D.P. Rhoades
- 2 -
the issued Notice. The Criterion VII violation has been withdrawn and the Criterion XV violation
has been revised.
The review team confirmed the validity of the issued Technical Specification violation and
recommended a revised performance deficiency concerning FitzPatrick staffs failure to
adequately follow its procurement and receipt procedures. The team determined that these
failures, which substantially contributed to the installation of a defective part into the high
pressure coolant injection system, was reasonably foreseeable and preventable. The
circumstances of the performance deficiency were determined to constitute violations of 10 CFR
50 Appendix B, Criterion V, Instructions, Procedures, and Drawings (hereafter referred to as
Criterion V) and Criterion XV. The noncompliance with Criterion V is newly identified, and the
noncompliance with Criterion XV, with changes, is confirmed. The bases for these
determinations, which include the withdrawal of the Criterion VII violation are detailed in the
enclosures to this letter. The enclosed Notice (i.e., revised) supersedes the Notice issued on
April 20, 2021. The revised Notice includes violations (i.e., Criterion V, Criterion XV and
Technical Specification 3.5.1) that are categorized collectively as a problem associated with a
finding.
Due to the change in the characterization of the performance deficiency, a review of the
previously issued risk assessment was also performed (Enclosure 2). This review concluded
that the underlying assumption and methodology were not altered by the revised performance
deficiency and that the performance deficiency supports a finding of White significance.
You are not required to respond to this letter. If you have additional information that you believe
the NRC should consider, you should follow the instructions in the Notice. The details of the
NRC's evaluation of a reply to the Notice of Violation, as well as the re-stated Notice, are
contained in the enclosures to this letter. In accordance with Title 10 of the Code of Federal
Regulations (10 CFR) 2.390, "Public inspections, exemptions, requests for withholding," a copy
of this letter and its enclosure will be made available electronically for public inspection in the
NRCs ADAMS, accessible from the NRC Web site http://www.nrc.gov/readinq-rm/adams.html.
Should you have any questions regarding this matter, please contact Ms. Erin E. Carfang, Chief,
Projects Branch 1, Division of Reactor Projects in Region I, at 610-337-5120.
Sincerely,
David C. Lew
Regional Administrator
Docket No. 50-333
License No. DPR-59
cc: Distribution via ListServ
David C. Lew
Digitally signed by David C. Lew
Date: 2021.09.03 08:37:46 -04'00'
SUNSI Review
Non-Sensitive
Sensitive
Publicly Available
Non-Publicly Available
OFFICE
RI/DRSS
RI/RA
NAME
CCahill
CMiller
MLombard
DLew
DATE
09/2 /21
09/ 2 /21
09/3 /21
09/ 3 /21
ENCLOSURE 1
NRC RESPONSE TO INFORMATION PROVIDED IN THE EXELON LETTER
DATED JUNE 3, 2021
As discussed below, the NRC Independent Review Team (IRT) reviewed 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 Material,
Equipment and Services, and Criterion XV, Nonconforming Materials, Parts or Components,
were not sufficiently supported as written. As a result, the Criterion 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 21.311, appropriately invoked the requirements of Part 21
by its inclusion in the purchase order. Part 21 does not represent a receipt inspection
characteristic for the procurement of a structure, system, component, or service. Rather, its
inclusion in the purchase order places the supplier on notice that 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 the subject inspection report.
In reviewing the licensees response and the body of information available to support the
inspection outcome, the staff determined that FitzPatrick failed to comply with its procurement
and receipt procedures which resulted in ExGens failure to adequately identify and control
items to prevent the use of a defective item as specified in Section 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 noncompliance 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 (Limerick) 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 the 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 Appendix B, Criterion VII and Criterion
XV violations. The IRT concluded that this aspect of the violations 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 further review and disposition the
concern as appropriate. As described in ExGens June 3, 2021 response, the manipulation of
the Passport system requires some degree of user familiarity and skill of the craft. As the
licensee states in their response, descriptive information in the component tracking database
can be provided in several panels. After a review of the information and steps to manipulate the
Passport system, the NRC maintains that this information was readily 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 been 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. This 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 revised 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 procedural provisions and the availability
of the subject information. Ultimately, the staff determined that it was reasonable for ExGen to
foresee and prevent the installation of the nonconforming PCV during receipt inspection;
however, the failure of personnel to adhere to procedural requirements 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. However, 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 notification was readily available in the
database and could reasonably be identified by a qualified procurement engineer when
performing a review of available information to address the hold'. 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 Criterion XV violation that was based
on a procedural deficiency in lieu of a Part 21 procurement deficiency.
SUMMARY OF EXGEN COMMENT- Clearing the User Hold
The licensee stated that the shelf-life hold was actually cleared 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 appropriately reviewed the
original vendor documentation and determined that the shelf-life could be extended - which was
subsequently communicated to the FitzPatrick buyer and the FitzPatrick QRI. Per the licensee,
at no time did the FitzPatrick buyer, the FitzPatrick QRI, or the FitzPatrick PE have any reason -
nor was there any regulatory requirement - to access the component tracking database or the
ExGen CAP system to investigate the reason for the shelf-life hold. 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, personnel 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 FitzPatrick - to inform our decision on
the sequence of events and the actions of the involved individuals. Specifically, per the AR, (1)
the PCV was put on user hold at Limerick on October 20, 2017, due 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 with 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 the hold which should have resulted in
the component being returned to user-hold status and tagged until 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 Limerick and FitzPatrick stations
with respect to procurement practices. Similar conclusions were arrived by ExGen as
documented in the Corrective Action Program Evaluation (CAPE) Charter for Condition Report
Number 04334315, dated June 24, 2020, when addressing both Limericks 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 1086768 had not been resolved at
the time the PCV was sold to, and accepted at, FitzPatrick. ExGen had previously explained in
their response to the AV, that all actions associated with IR 1086768 have been in
COMPLETE status since 2010. However, the NRC did not acknowledge this fact in the NOV
and inaccurately stated that the IR remained unresolved.
NRC RESPONSE
The NRC acknowledges that actions associated with IR 1086768 have been in COMPLETE
status since 2010. The actions of concern were taken to COMPLETE by generating M Codes
which directed the replacement of the diaphragm prior to installation. Specifically, in the
component identification (CID) facility-specific section in Passport Panel D202, it stated, Need
to replace diaphragm 116-0013 prior to use in the plant refer IR 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 action to replace the diaphragm was not
completed. Furthermore, 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.
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 and 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 audit the closures of each of the ATIs
associated with IR 1086768, despite having no cause or regulatory requirement to do so.
NRC RESPONSE
As stated above, Part 21 does not represent a receipt inspection characteristic for the
procurement of structures, systems and components (SSC).
SUMMARY OF EXGEN COMMENT- Part 21 and Closed Action Tracking Items (ATIs)
Assuming the BSC staff had reason to look for any open ATIs associated 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 inspection 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 response was not documented
in the status field, but instead was documented in a hidden descriptive information field along
with 63 other line items of descriptive information.
NRC RESPONSE
The IRT disagreed with ExGens characterization that the relevant descriptive information
concerning the deficient PCV diaphragm was not readily available. Specifically, information was
clearly available in Passport panel D202. Procurement Engineers operate in accordance with
procedure SM-AA-300-1001, Procurement Engineering Process, and other procedures.
Section 4.29 describes how additional comments and basis for site applicability may be entered
using CID specific panel D202. The IRT determined that, when clearing 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 than a few minutes to review.
From this descriptive information, it would have been reasonable for the licensee to identify that
the defective diaphragm in the PCV required replacement. Furthermore, 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.
ENCLOSURE 2
REVISED FINDING IN RESPONSE TO CONTESTED VIOLATION
Defective Part Results in High Pressure Coolant Injection System Pressure Control Valve
Failure
Cornerstone
Significance
Cross-cutting
Aspect
Report
Section
Mitigating
Systems
White NOV 05000333/2020012-01
Open
[H.1] -
Resources
The inspectors documented a self-revealed White finding and related violation of FitzPatrick
Technical Specifications (TS 3.5.1). The finding included failures to comply with Title 10 of
the Code of Federal Regulations (10 CFR) Part 50, Appendix B, Criterion V, Instructions,
Procedures and Drawings and Criterion XV, Nonconforming Materials, Parts, or
Components. Exelon Generation, LLC (ExGen) did not adequately implement quality-related
procedures which contributed to FitzPatricks failure to identify a nonconforming component,
which was verified as acceptable for use. Subsequently, FitzPatricks maintenance staff
installed the nonconforming component which caused the inoperability of the HPCI system on
April 10, 2020.
Description:
The HPCI system at FitzPatrick provides an emergency source of water following a transient
or accident. This high pressure source of coolant is delivered from two water sources using
steam generated from the reactor to drive the associated turbine and pump. The HPCI
system pump can deliver up to 4,250 gallons per minute and may be operated across a wide
range of reactor pressures. The HPCI system pump and turbine are supported by an oil
system designed to lubricate bearings and provide adequate pressure to control the steam
turbine stop and control valves.
During a HPCI maintenance window in December 2017, an emergent need arose for a
replacement pressure control valve (PCV). ExGen did not have a replacement PCV on site at
the time, and subsequently located a replacement PCV at Limerick. On December 16, 2017,
ExGen issued purchase order (P.O.) 637326 to move the HPCI system PCV from the
Limerick warehouse to FitzPatrick during a planned HPCI system maintenance window. Due
to the emergent demand, the purchase order was issued in parallel with a document review
by FitzPatrick. Per issue report (IR) 04348906, originated on June 6, 2020, the PCV was put
on user hold at Limerick on October 20, 2017, due to the shelf-life expiring within 5 days.
This IR states the valve was transferred to FitzPatrick on December 15, 2017, with an expired
shelf-life annotated in Passport (the licensees component tracking database). Additionally,
the IR states that prior to releasing the PCV for installation, Fitzpatricks quality receipt
inspection identified, reviewed, and dispositioned the shelf-life issue with FitzPatrick
Procurement Engineering.
Procedure SM-AA-300-1001, Section 4.10.2, specified that when the requesting facility
(FitzPatrick) is not a specific user of the procured component that the existing Catalogue
Identification (CID) at the target site (Limerick) shall be reviewed by the requesting site. The
purpose of this review is to ensure that quality and technical requirements of the component
are adequate for the requesting facilitys need; and, that the review shall be performed by a
procurement engineer (PE) for a safety-related component. The CID was not in a ready state
2
at the time of request, as a user hold existed in Passport for a shelf-life concern. The
document package associated with P.O. No. 011466532 included electronic correspondence
documenting that appropriate Fitzpatrick staff reviewed the document package for P.O. No.
0011466532 and found it to be acceptable. FitzPatricks review did not identify discrepant
information located within Exelons equipment database (e.g., the CID facility-specific section
in Passport panel D202).
The FitzPatrick procurement staff authorized Limerick to transfer a component in hold status
in the Passport system without initiating a new hold upon receipt of the component at the
destination site (FitzPatrick). These actions were not in accordance with the requirements of
procedure SM-AA-102, Warehouse Operations, Rev. 23. Procedure SM-AA-102, specified
that items released on hold shall be tracked by a respective Action Request (AR) assignment,
Work Order task or Issue report with respective assignments to track the released material.
Specifically, the licensee failed to ensure that a component released on hold was adequately
tracked by a respective AR assignment, work order task or issue report with respective
assignments to ensure requisite component quality, and the Catalogue ID (CID) for this
component was set to READY. Additionally, a hold tag was required to be attached to the
component upon receipt of the transfer at the receiving site and entered into the sites hold
tag log. These actions were not performed. The failure to initiate a hold upon receipt of the
PCV or initiate tracking documents resulted in opportunities for FitzPatrick to identify the
discrepant information located within the equipment database. The formal actions to
disposition the hold, as required per SM-AA-102, provided a reasonable opportunity, under
these specific circumstances, for FitzPatrick to identify that the PCV was nonconforming.
Descriptive information relating to the nonconforming condition was readily available in
several panels in the licensees component tracking data base. For example, panel D202
included a readily available note which stated need to replace diaphragm 116-00134 prior to
use in plant.
The review of P.O. No. 011466532 did not identify the discrepant information located within
the CID facility specific section in Passport panel D202. The document package associated
with the P.O. included electronic correspondence (i.e., a one-line email) documenting that a
senior procurement engineer reviewed the document package for the P.O. and found it to be
acceptable. The use of panel D202 is described in Section 4.29 of SM-AA-300-1001,
Procurement Engineering Process and Responsibility, Rev 24. Specifically, the procedure
states Additional comments and the basis for site applicability may be added under the CID
facility specific section in Passport panel D202, AAA route list, D201 panel OLE field, or BOM
NOTES, as appropriate. The guidance in Procedure SM-AA-300-1001, combined with the
failures to follow procedural requirements for applying hold tags and initiating tracking
documentation further inform the agencys conclusion that reasonable opportunities existed to
foresee and prevent the installation of the nonconforming PCV.
Consequently, without identifying adverse information concerning the PCV, procurement staff
verified a nonconforming component as acceptable for use. As a result of the nonconforming
part installation, on April 10, 2020, at 1:15 AM, while conducting monthly technical
specification surveillance testing of the HPCI auxiliary oil system, operators identified an oil
leak on 23PCV-12 as a result of a tear in the subject diaphragm. Ultimately, the HPCI system
was declared inoperable and placed the station into a higher licensee-established risk
category (Yellow). ExGen notified the NRC of the inoperability per 10 CFR Part
50.72(b)(3)(v)(D) via Event Notification 54647. The 23PCV-12 valve was replaced and the
HPCI system restored to operable status on April 10, 2020, at 8:02 PM.
3
Corrective Actions: ExGen performed immediate corrective actions to replace the
nonconforming HPCI system PCV. ExGen also performed a fleet-wide stand down for
procurement staff to conduct additional training. Additionally, ExGen created a separate
action for each ExGen site to validate that a similar condition does not exist regarding other of
nonconforming materials, parts, or components within their inventory tracking database.
Furthermore, ExGen revised its warehouse and procurement procedures, adding steps
pertaining to items subject to 10 CFR Part 21 notifications and items with holds.
Corrective Action References: IR 4334315, IR 4348906
Performance Assessment:
Performance Deficiency: The inspectors determined that FitzPatricks did not comply with the
requirements and guidance of quality-related procurement procedures, which contributed to
ExGens failure to adequately identify and control a nonconforming item.
Procedure SM-AA-102, Warehouse Operations, Rev 23, states items that are on hold at one
site can be released to another site while on hold only if an action item is created at the
receiving site to track resolution of the item before the transfer occurs, and the item is added
to the receiving sites hold tag log. Additionally, a hold tag shall be attached to the item upon
receipt of the transfer at the receiving site.
On December 16, 2017, FitzPatrick failed to follow SM-AA-102. Adherence to the
requirements of this procedure, as well as using guidance provided in SM-AA-300-1001,
would have presented a reasonable opportunity for FitzPatrick to identify and assess readily
available information that was within the licensees Catalogue ID database and also linked to
the ExGen corrective action program. Consequently, without reviewing readily available
adverse information concerning the PCV, procurement staff verified a nonconforming
component as acceptable for use. Subsequently, FitzPatricks maintenance staff installed the
nonconforming component which caused the inoperability of the HPCI system.
Screening: The inspectors determined the performance deficiency was more than minor
because it was associated with the Equipment Performance attribute of the Mitigating
Systems cornerstone and adversely affected the cornerstone objective to ensure the
availability, reliability, and capability of systems that respond to initiating events to prevent
undesirable consequences. Specifically, the HPCI system was unavailable to perform its
safety function as a result of the failed PCV.
Significance: The performance deficiency was assessed by a Region I Senior Reactor
Analyst (SRA) and NRR Senior Risk Analysis and determined that prior risk assessment was
still valid for the failed HPCI system. The finding was determined to be of low to moderate
safety significance (White). The risk important core damage sequences were dominated by
internal events, primarily loss of condenser heat sink and loss of main feedwater. The
dominant core damage sequence is loss of condenser heat sink, failure of high-pressure
injection (HPI), and failure to manually depressurize the reactor. See Enclosure 1 to this final
determination report and the Attachment, HPCI Oil PCV Failure Detailed Risk Evaluation, to
the preliminary determination report (ADAMS Accession Number: ML21020A108) for a
detailed review of the quantitative and qualitative criteria considered in the final risk
determination.
4
The inspectors assessed the significance of the finding using Appendix A, The Significance
Determination Process (SDP) for Findings At-Power. The inspectors reviewed Inspection
Manual Chapter (IMC) 0609, Attachment 4, Initial Characterization of Findings, and
determined the finding affects the mitigating system cornerstone. The inspectors evaluated
the significance of this finding using Inspection Manual Chapter (IMC) 0609, Appendix A, The
Significance Determination Process (SDP) for Findings at Power, Exhibit 2 - Mitigating
Systems Screening Questions. The inspectors determined that the finding represented a loss
of the PRA function of a single train, the HPCI system, for greater than its technical
specification (TS) allowed outage time and required a detailed risk evaluation (DRE).
A Region I Senior Reactor Analyst (SRA) performed a detailed risk evaluation. The finding
was determined to be of low to moderate safety significance (White). The risk important core
damage sequences were dominated by internal events, primarily loss of condenser heat sink
and loss of main feedwater. The dominant core damage sequence is loss of condenser heat
sink, failure of high-pressure injection (HPI), and failure to manually depressurize the reactor.
This final determination report and the Attachment, HPCI Oil PCV Failure Detailed Risk
Evaluation, to the preliminary determination report provide a detailed review of the
quantitative and qualitative criteria considered in the final risk determination (ADAMS
Accession Number: ML21020A108).
Cross-Cutting Aspect: H.1 - Resources: Leaders ensure that personnel, equipment,
procedures, and other resources are available and adequate to support nuclear safety. The
cause of the finding was determined to be associated with a cross-cutting aspect of
Resources in the Human Performance area because ExGen staff failed to identify and
address a nonconformance during verification of the quality of the HPCI system PCV.
Specifically, the inspectors determined there were multiple ways for ExGen to reasonably
identify a nonconformance associated with the PCV diaphragm which had not been
addressed. Furthermore, procurement implementing procedures did not provide adequate
guidance to ensure that procedure users would identify and resolve this issue. Having
comprehensive steps within the relevant procedure would likely have prevented installation of
the defective part at FitzPatrick.
ENCLOSURE 3
Exelon Generation Company, LLC Docket No. 50-333
James A. FitzPatrick Nuclear Power Plant License No. DPR-59 EA-20-138
During an NRC review in response to a contested violation conducted from June 3, 2021,
through September 3, 2021, violations of NRC requirements were identified. In accordance with
the NRC Enforcement Policy, the violations are listed below:
Title 10 CFR Part 50, Appendix B, Criterion V, Instructions, Procedures, and Drawings, states,
in part, that activities affecting quality shall be prescribed by documented instructions,
procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished
in accordance with these instructions, procedures, or drawings.
Title 10 CFR Part 50, Appendix B, Criterion XV, Nonconforming Materials, Parts, or
Components, states, in part, that measures shall be established to control materials, parts, or
components which do not conform to requirements in order to prevent their inadvertent use or
installation. These measures shall include, as appropriate, procedures for identification,
documentation, segregation, disposition, and notification to affected organizations.
Exelon Procedure SM-AA-102, Warehouse Operations, Revision 23, prescribes activities
affecting quality and measures to control nonconforming components. Procedure SM-AA-102,
Attachment 1, step 1.10.6, states Items that are on hold at one site can be released to another
site while on hold only if an action item is created at the receiving site to track resolution of the
item before the transfer occurs, and the item is added to the receiving sites hold tag log. A hold
tag shall be attached to the item upon receipt of the transfer at the receiving site.
FitzPatrick Technical Specification (TS 3.5.1) requires, in part, that the HPCI system be
operable in Modes 1, 2 and 3 with reactor steam dome pressure >150 psig. If the HPCI system
is determined to be inoperable, it shall be returned to an operable status within 14 days. If not
restored to an operable status, the unit shall be shut down and in Mode 3 within 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />.
Contrary to the above, from December 16, 2017, to April 10, 2020, activities affecting quality
were not accomplished in accordance with procedures for controlling a nonconforming
component and a nonconforming component was not controlled in accordance with documented
procedures. Specifically, Exelon failed to initiate an action item at FitzPatrick to track resolution
of a nonconforming Pressure Control Valve (PCV) before its transfer occurred, did not add it to
the receiving sites hold tag log, and did not attach a hold tag upon receipt. As a result, on
December 16, 2017, Exelon did not identify that the PCVs diaphragm required replacement and
installed the nonconforming PCV in the High Pressure Coolant Injection (HPCI) system.
Consequently, the HPCI system was rendered inoperable prior to April 10, 2020, for a period
longer than its TS allowed outage time, and the unit was not shut down and placed in Mode 3
within 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> in accordance with requirements.
These violations are categorized collectively as a problem and are associated with a White
Significance Determination Process finding.
2
No response to this Notice of Violation is required since the NRC previously received adequate
responses as documented in a letter dated February 26, 2021 (ML21057A190). If you wish to
provide additional information for the NRC to consider, you should notify the Region I Regional
Administrator verbally within 10 days of receipt of this Notice of Violation, followed by a written
response submitted within 30 days of the date of the verbal notification to the U.S. Nuclear
Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555-0001, with a
copy to the Regional Administrator, Region I, and a copy to the NRC Resident Inspector at the
facility that is the subject of this Notice. This reply should be clearly marked as a "Reply to a
Notice of Violation; EA-20-138".
Your response, if made, will be made available electronically for public inspection in the NRC
Public Document Room or from the NRCs document system (ADAMS), accessible from the
NRC Web site at http://www.nrc.gov/reading-rm/adams.html, to the extent possible, it should not
include any personal privacy, proprietary, or safeguards information so that it can be made
available to the public without redaction. If personal privacy or proprietary information is
necessary to provide an acceptable response, then please provide a bracketed copy of your
response that identifies the information that should be protected and a redacted copy of your
response that deletes such information. If you request withholding of such material, you must
specifically identify the portions of your response that you seek to have withheld and provide in
detail the bases for your claim of withholding (e.g., explain why the disclosure of information will
create an unwarranted invasion of personal privacy or provide the information required by
10 CFR 2.390(b) to support a request for withholding confidential commercial or financial
information). If safeguards information is necessary to provide an acceptable response, please
provide the level of protection described in 10 CFR 73.21.
In accordance with 10 CFR 19.11, the licensee may be required to post this Notice within two
working days of receipt.
Dated this 3rd day of September 2021.