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| {{#Wiki_filter:ENCLOSURE 1 | | {{#Wiki_filter: |
| NRC RESPONSE TO INFORMATION PROVIDED IN THE EXELON LETTER
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| DATED JUNE 3, 2021
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| As discussed below, the NRC Independent Review Team (IRT) reviewed the information
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| provided by Exelon Generation Company, LLC (ExGen) and determined that the characterization
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| of the finding remains of low-to-moderate safety significance (White). The IRT determined that
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| the violations of 10 CFR 50, Appendix B, Criterion VII, Control of Purchased Material,
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| Equipment and Services, and Criterion XV, Nonconforming Materials, Parts or Components,
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| were not sufficiently supported as written. As a result, the Criterion VII violation has been
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| withdrawn and the Criterion XV violation has been revised. The violation of TS 3.5.1 remains
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| unchanged. However, the IRT determined that a violation of 10 CFR Part 50 Appendix B,
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| Criterion V, is warranted.
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| Regarding the contested 10 CFR Part 50 Appendix B, Criteria VII and XV violations, the IRT
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| determined that neither 10 CFR Part 21, nor any associated NRC guidance, requires a
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| licensee to evaluate an incoming component for the existence of a Part 21 notification.
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| FitzPatrick, as required by 10 CFR 21.311, appropriately invoked the requirements of Part 21
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| by its inclusion in the purchase order. Part 21 does not represent a receipt inspection
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| characteristic for the procurement of a structure, system, component, or service. Rather, its
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| inclusion in the purchase order places the supplier on notice that the requirements of Part 21
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| must be met. Accordingly, given that no additional information was presented in the inspection
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| report regarding a failure to comply with procurement documents (i.e., the purchase order), the
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| IRT determined the assertion, that Fitzpatrick failed to ensure purchased material, equipment,
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| and services, whether purchased directly or through contractors and subcontractors, conform
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| to the procurement documents, was not supported as stated in the subject inspection report.
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| In reviewing the licensees response and the body of information available to support the
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| inspection outcome, the staff determined that FitzPatrick failed to comply with its procurement
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| and receipt procedures which resulted in ExGens failure to adequately identify and control
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| items to prevent the use of a defective item as specified in Section 6, Identification and Control
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| of Items, of FitzPatricks Quality Assurance Program Manual (QAPM). Thus, the staff
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| determined that FitzPatricks failure to accomplish procurement activities as prescribed by
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| ExGens quality assurance procedures resulted in a noncompliance with 10 CFR 50, Appendix
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| B, Criteria V and XV. The revised finding and Notice of Violation (NOV) are described in
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| Enclosures 2 and 3.
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| SUMMARY OF EXGEN COMMENT - Ability to Identify Part 21 Information
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| ExGen disputed NRCs basis for determining that the violations were reasonably foreseeable
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| and preventable because the act of clearing an unrelated shelf-life hold did not provide an
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| opportunity for either the Limerick Generation Station (Limerick) material handler, or the
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| FitzPatrick qualified receipt inspector (QRI), to identify the Part 21 information. The Part 21
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| information was documented in an Issue Report (IR) located in the component database and
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| was also documented in ExGens Corrective Action Program (CAP) database.
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| 1 10 CFR 21.31, Procurement documents, states, Each individual, corporation, partnership, dedicating
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| entity, or other entity subject to the regulations in this part shall ensure that each procurement document
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| for a facility, or a basic component issued by him, her or it on or after January 6, 1978, specifies, when
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| applicable, that the provisions of 10 CFR Part 21 apply.
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| 2
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| NRC RESPONSE
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| The IRT considered the violation in the context of 10 CFR 21 (i.e., Part 21) as used (or implied)
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| in the contrary to statements for the issued 10 CFR 50 Appendix B, Criterion VII and Criterion
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| XV violations. The IRT concluded that this aspect of the violations should be withdrawn.
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| SUMMARY OF EXGEN COMMENT - Archived, Descriptive and Readily Available
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| With respect to the shelf life hold, ExGen contends the NRC has mischaracterized this
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| archived and descriptive information as readily available to both the Limerick material
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| handler and the FitzPatrick quality receipt inspection quality receipt inspection.
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| NRC RESPONSE
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| As a point of clarification, the hold that was presented was a user-hold. In order to identify the
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| reason for a user-hold, the licensees staff would need to further review and disposition the
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| concern as appropriate. As described in ExGens June 3, 2021 response, the manipulation of
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| the Passport system requires some degree of user familiarity and skill of the craft. As the
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| licensee states in their response, descriptive information in the component tracking database
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| can be provided in several panels. After a review of the information and steps to manipulate the
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| Passport system, the NRC maintains that this information was readily available, and as a result
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| represented a reasonable opportunity to foresee and prevent the installation of the
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| nonconforming PCV.
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| SUMMARY OF EXGEN COMMENT- Requirements to Research
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| Although ExGen provided information in the response to the AV - demonstrating that there was
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| no regulatory requirement to research information unrelated to the shelf life hold, as well as
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| explaining why the non-conformance would not have reasonably been identified by the Exelon
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| Business Services Corporation (BSC) staff in 2017 - there is no indication in the issued NOV
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| that this information was considered.
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| NRC RESPONSE
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| The IRT assessed this information during its deliberations. This information, in part, is
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| addressed in the NRC Response to EXGEN Comments pertaining to10 CFR Part 50 Appendix
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| B, Criterion VII. The NRC agrees that there was no regulatory requirement to research
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| information unrelated to the user hold. Accordingly, the revised NOV does not cite a failure to
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| perform this level of research. Instead, the IRT recommended a performance deficiency (PD)
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| and violation associated with failures to follow ExGens procedural provisions and the availability
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| of the subject information. Ultimately, the staff determined that it was reasonable for ExGen to
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| foresee and prevent the installation of the nonconforming PCV during receipt inspection;
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| however, the failure of personnel to adhere to procedural requirements resulted in a failure to
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| identify that the diaphragm in the PCV required replacement.
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| SUMMARY OF EXGEN COMMENT- Limerick Criterion XV
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| The NRC staff acknowledged that the Criterion XV violation that occurred at Limerick in 2010
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| could not have been prevented by the ExGen staff in 2017. However, when recharacterizing the
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| 3
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| Criterion XV violation as having occurred in 2017, the NRC did not explain how Criterion XV
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| was violated that year.
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| NRC RESPONSE
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| NRC staff identified that information about the Part 21 notification was readily available in the
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| database and could reasonably be identified by a qualified procurement engineer when
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| performing a review of available information to address the hold'. As determined by the IRT,
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| the basis for the issued Criterion XV violation was underpinned by the Criterion VII violation. As
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| described above, the IRT found Criterion VII to be unsupported. As a result of the IRT review of
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| this matter, NRC determined that the Criterion XV violation was not sufficiently supported as
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| stated in the issued Notice; the IRT documented a revised Criterion XV violation that was based
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| on a procedural deficiency in lieu of a Part 21 procurement deficiency.
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| SUMMARY OF EXGEN COMMENT- Clearing the User Hold
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| The licensee stated that the shelf-life hold was actually cleared by the Limerick MH after the
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| existence of the hold had been communicated to the FitzPatrick buyer; and, that the FitzPatrick
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| buyer engaged the FitzPatrick Procurement Engineer (PE) who appropriately reviewed the
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| original vendor documentation and determined that the shelf-life could be extended - which was
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| subsequently communicated to the FitzPatrick buyer and the FitzPatrick QRI. Per the licensee,
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| at no time did the FitzPatrick buyer, the FitzPatrick QRI, or the FitzPatrick PE have any reason -
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| nor was there any regulatory requirement - to access the component tracking database or the
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| ExGen CAP system to investigate the reason for the shelf-life hold. ExGen stated that clearing
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| the hold was the responsibility of the Limerick warehouse staff as the custodian of the
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| component.
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| NRC RESPONSE
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| The NRC recognizes that the specific facts of the procurement incident are impacted by the
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| amount of time that has elapsed since the 2017 transfer, personnel retirements, and the lack of
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| documentation. However, in response to the comments above, the NRC reviewed action
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| request (AR) 04348906 - originated on June 6, 2020, by FitzPatrick - to inform our decision on
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| the sequence of events and the actions of the involved individuals. Specifically, per the AR, (1)
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| the PCV was put on user hold at Limerick on October 20, 2017, due to the self-life expiring
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| within 5 days, (2) the valve was transferred to Fitzpatrick on December 15, 2017, with the shelf-
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| life indicating expired in Passport, and (3) the Fitzpatrick quality receipt package inspection
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| identified, reviewed and dispositioned the shelf-life issue with FitzPatricks Procurement
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| Engineering prior to releasing the PCV for installation in the HPCI system.
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| Procedure SM-AA-102, Warehouse Operations, Rev 23, Attachment 1, step 1.10.6, specifies, in
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| part, that for items on hold to be released to another facility, the receiving facility must create an
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| action item to track the resolution before the transfer occurs. FitzPatrick, the receiving facility,
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| did not create an action item to track the dispositioning of the hold which should have resulted in
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| the component being returned to user-hold status and tagged until dispositioning had occurred.
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| Based on the IRT assessment of the supporting information, the team concluded that there
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| were a number of procedural adherence issues at both the Limerick and FitzPatrick stations
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| with respect to procurement practices. Similar conclusions were arrived by ExGen as
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| documented in the Corrective Action Program Evaluation (CAPE) Charter for Condition Report
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| Number 04334315, dated June 24, 2020, when addressing both Limericks and FitzPatricks
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| shortcomings in the total chain of events.
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| 4
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| SUMMARY OF EXGEN COMMENT- Clearing the User Hold
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| The licensee asserted that the NRC incorrectly stated that IR 1086768 had not been resolved at
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| the time the PCV was sold to, and accepted at, FitzPatrick. ExGen had previously explained in
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| their response to the AV, that all actions associated with IR 1086768 have been in
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| COMPLETE status since 2010. However, the NRC did not acknowledge this fact in the NOV
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| and inaccurately stated that the IR remained unresolved.
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| NRC RESPONSE
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| The NRC acknowledges that actions associated with IR 1086768 have been in COMPLETE
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| status since 2010. The actions of concern were taken to COMPLETE by generating M Codes
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| which directed the replacement of the diaphragm prior to installation. Specifically, in the
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| component identification (CID) facility-specific section in Passport Panel D202, it stated, Need
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| to replace diaphragm 116-0013 prior to use in the plant refer IR 1086768. The IRT determined
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| that if prescribed procedures were followed as described above, it would have been reasonable
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| for the FitzPatrick procurement staff to identify that the action to replace the diaphragm was not
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| completed. Furthermore, it was reasonable for procurement engineers to review Passport
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| Panel D202 during the receipt process regardless of whether a hold was placed on the
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| component.
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| SUMMARY OF EXGEN COMMENT- Unresolve Part 21s
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| ExGen specifically informed the NRC that there is no reference to the Part 21 in the component
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| tracking database. Furthermore, if a search of the referenced IR would have been required,
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| which ExGen continues to stress was NOT required, it would have indicated to the Limerick MH
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| and the FitzPatrick QRI that there were no open ATIs associated with that IR and therefore, they
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| would have concluded that the IR was dispositioned correctly and closed. In order for any BSC
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| or ExGen staff to identify that there was an unresolved Part 21 concern associated with the
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| PCV, the individual would have had to arbitrarily decide to audit the closures of each of the ATIs
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| associated with IR 1086768, despite having no cause or regulatory requirement to do so.
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| NRC RESPONSE
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| As stated above, Part 21 does not represent a receipt inspection characteristic for the
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| procurement of an structures, systems and components (SSC).
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| SUMMARY OF EXGEN COMMENT- Part 21 and Closed Action Tracking Items (ATIs)
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| Assuming the BSC staff had reason to look for any open ATIs associated with older Part 21
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| notifications in 2017, which they did not, the BSC staff would have determined that appropriate
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| actions were put in place and subsequently completed to address the 2010 Part 21 notification.
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| NRC RESPONSE
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| As stated above, Part 21 does not represent a receipt inspection characteristic for the
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| procurement of a SSC.
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| 5
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| SUMMARY OF EXGEN COMMENT - Descriptive Information
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| The issue report (IR) number associated with the 2010 Part 21 response was not documented
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| in the status field, but instead was documented in a hidden descriptive information field along
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| with 63 other line items of descriptive information.
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| NRC RESPONSE
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| The IRT disagreed with ExGens characterization that the relevant descriptive information
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| concerning the deficient PCV diaphragm was not readily available. Specifically, information was
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| clearly available in Passport panel D202. Procurement Engineers operate in accordance with
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| procedure SM-AA-300-1001, Procurement Engineering Process, and other procedures.
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| Section 4.29 describes how additional comments and basis for site applicability may be entered
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| using CID specific panel D202. The IRT determined that, when clearing the user-hold for the
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| PCV, it would have been reasonable for procurement engineers to access this descriptive
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| information, which was readily available and required no more than a few minutes to review.
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| From this descriptive information, it would have been reasonable for the licensee to identify that
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| the defective diaphragm in the PCV required replacement. Furthermore, it was reasonable for
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| procurement engineers to review Passport Panel D202 during the receipt process regardless of
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| whether a hold was placed on the component.
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| }} | | }} |
