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{{#Wiki_filter:Closure of PRA Peer Review Facts and ObservationsRegulatory Information ConferenceTechnical Session TH35Adrienne Driver, Reliability and Risk Analyst March 14, 2018  
{{#Wiki_filter:Closure of PRA Peer Review Facts and Observations Regulatory Information Conference Technical Session TH35 Adrienne Driver, Reliability and Risk Analyst March 14, 2018


==Background:==
==Background:==
New Process for closure of F&Os Industry Guidance and ProcessesPRA Processes for Regulatory ReviewOverview of Appendix X: Closure of F&Os ProcessIndustry Pilots and Staff ObservationsStaff Acceptance of Appendix XPost Acceptance ObservationsNRC Audits: Crediting F&O ClosureProposed Staff Endorsement in RG 1.200, Revision 3  
New Process for closure of F&Os Industry Guidance and Processes PRA Processes for Regulatory Review Overview of Appendix X: Closure of F&Os Process Industry Pilots and Staff Observations Staff Acceptance of Appendix X Post Acceptance Observations NRC Audits: Crediting F&O Closure Proposed Staff Endorsement in RG 1.200, Revision 3
*


==Background:==
==Background:==
The Risk Informed Steering Committee (RISC) identified several high-priority issues to foster an environment conducive to achieving the full benefit of risk-informed regulation.-Common theme was difficulty associated with evaluation of Probabilistic Risk Assessment (PRA) technical acceptability in review of risk-informed licensing applications
The Risk Informed Steering Committee (RISC) identified several high-priority issues to foster an environment conducive to achieving the full benefit of risk-informed regulation.
*Working Group 1 Issue 2 Objective: Improve process for documentation and closure of Peer Review Facts and Observations (F&Os)
      - Common theme was difficulty associated with evaluation of Probabilistic Risk Assessment (PRA) technical acceptability in review of risk-informed licensing applications
ASME/ANS PRA Standard
* Working Group 1 Issue 2 Objective: Improve process for documentation and closure of Peer Review Facts and Observations (F&Os)
*Provides standards for peer review of a PRA to be used in risk-informed decisions for commercial nuclear power plants.
ASME/ANS PRA Standard                       NEI 05-04/07-12/12-16
*Defines PRA upgrades and stipulates when a peer review should be performed.
* Provides standards for peer review of
*Peer Review
* Guidance for Peer Review Process a PRA to be used in risk-informed            -Assessment of the Capability decisions for commercial nuclear            Category (CC) of the Supporting power plants.                                Requirements (SR), CC-I, CC-II, CC-III
*Inherently establishes PRA model-of-record (MOR)
* Defines PRA upgrades and stipulates
NEI 05-04/07-12/12-16
* Full Scope when a peer review should be
*Guidance for Peer Review Process-Assessment of the Capability Category (CC) of the Supporting Requirements (SR), CC-I, CC-II, CC-III
* Focused Scope performed.
*Full Scope  
* Gap Assessment to RG 1.200
*Focused Scope
* Peer Review
*Gap Assessment to RG 1.200
* Defines levels of F&Os
*Defines levels of F&Os
* Inherently establishes PRA                -   Findings model-of-record (MOR)                    -  Observations
-Findings-Observations
                                              -   Best Practices Peer Review W/
-Best Practices No F&O Closure Gap Assessment to RG 1.200 Disposition of F&O to Risk App.Peer Review PRA UpgradesPeer Review W/New F&Os Closure of F&OClosure of F&O 2Independent ReviewersDocumentationAssessment of Upgrade or UpdateQualifications for Independent ReviewerConcurrent Focused Scope Peer ReviewNote: The final Appendix X process is documented in ADAMS Accession No. ML17095A252.NRC Closure Independent AssessmentPeer ReviewFull Scope Simplified process compared to the alternative process in the ASME/ANS PRA Standard for peer reviewsIA Team has direct access to model of record (MOR) and supporting documentation.IA Team has access to Peer Review Report(s) including text of the original F&O.Process appears suitable for closure of F&Os addressing:
PRA New F&Os Upgrades Disposition of F&O to Risk App.
*Documentation issues  
No F&O Closure Gap Assessment to RG 1.200 Peer Review Closure Closure of of F&O F&O NRC Closure                                  Independent Peer Review Assessment Qualifications for   Concurrent      Full Scope Documentation                            Independent     Focused Scope Reviewer        Peer Review 2 Independent Reviewers                  Assessment of Upgrade or Update Note: The final Appendix X process is documented in ADAMS Accession No. ML17095A252.
*Individual modelling and method errors
Simplified process compared to the alternative process in the ASME/ANS PRA Standard for peer reviews IA Team has direct access to model of record (MOR) and supporting documentation.
*Incorrect F&O's When using both webinar and teleconference (shared screen, and voice connectivity) performing a limited scope IA remotely, appeared to be a suitable and capable manner to support IA reviewers role and responsibilities.The IA provides guidance for closure of the F&Os to be documented with a pedigree for retention during auditing and inspection purposes.
IA Team has access to Peer Review Report(s) including text of the original F&O.
Plant A*IA Team (Vendor)Plant B*IA Team (Vendor)*Concurrent Focused Scope*Remote reviewer participationPlant C*IA Team (Vendor)*Concurrent Focused Scope*Reliance on SR met at CC-II*No justification for upgrade or update
Process appears suitable for closure of F&Os addressing:
*Incomplete documentation for closureNote: The NRC staff observation report is documented in ADAMS Accessions No. ML17095A252.
        *Documentation issues
The NRC staff accepted the final version of the Appendix X guidance in a letter to NEI May 3, 2017 with the following conditions of acceptance (ADAMS Accession No. ML17079A427).Conditions of Acceptance:1)Independent Assessment process does not include review of the closure of F&Os that include PRA upgrades: Focused scope peer review still required for PRA upgrades. 2)The licensee should adhere to the guidance in Appendix X in its entirety to obviate the need for an in-depth review and/or submittal of F&Os in licensing actions
        *Individual modelling and method errors
: 1. NEI 05-04, Appendix X, Section X.1.3: Use of Remote ReviewersParticipation of remote independent reviewers was not planned and scheduled.
        *Incorrect F&Os When using both webinar and teleconference (shared screen, and voice connectivity) performing a limited scope IA remotely, appeared to be a suitable and capable manner to support IA reviewers role and responsibilities.
: 2. NEI 05-04, Appendix X, Section X.1.3: Host Utility Preparation
The IA provides guidance for closure of the F&Os to be documented with a pedigree for retention during auditing and inspection purposes.
*A written assessment and justification of explaining why each finding was either a PRA upgrade or maintenance update was not performed.
Plant
*Scope of F&Os included in the review and provided to the independent assessment team not clearly understood.3. NEI 05-04, Appendix X, Section X.1.3: Close Out of F&Os by IA
* IA Team (Vendor)
*Unclear independence between review teams and work originators
* Reliance on SR met at A
*IA team did not review MOR with changes incorporatedNote: Note: The NRC staff observation report is documented in ADAMS Accessions No. ML17265A812.  
CC-II
*Staff review of LARs and closure reports identified incomplete information for a streamlined review across regulatory guidelines (i.e., RG 1.200, RG 1.174, and SRP 19.1):
* No justification for
-Scope of IA review (e.g., F&Os, self-assessment findings)
* IA Team (Vendor) upgrade or update                        Plant
-Concurrent focused scope performed
* Concurrent Focused Scope
-Timeline of peer reviews and IA performed
* Incomplete documentation for                            B
-Written justification for if closure of F&O constituted an upgrade or maintenance update
* Remote reviewer participation closure Plant
-IA team assessment of the closure of F&Os against the SR for Met at CC-II  
* IA Team (Vendor)
*IA F&O closure process has (so far) resulted in 60 -80% reduction in number of open F&Os
* Concurrent Focused C      Scope Note: The NRC staff observation report is documented in ADAMS Accessions No. ML17095A252.
*RG 1.200 guidance for open F&Os still applicable. LAR should include:
The NRC staff accepted the final version of the Appendix X guidance in a letter to NEI May 3, 2017 with the following conditions of acceptance (ADAMS Accession No. ML17079A427).
-discussion of resolution of applicable F&Os OR-Justification that demonstrates accident sequences or contributors significant to application decision not adversely impacted Endorsement of Appendix X in RG 1.200, Revision 3
Conditions of Acceptance:
*Endorsement of Closure of F&Os will further address:1.Summary of information to be provided in the LAR when crediting Appendix X for closure of F&Os2.Defined Terms for:Model of Record Base Model3. Conditions of Acceptance
: 1) Independent Assessment process does not include review of the closure of F&Os that include PRA upgrades: Focused scope peer review still required for PRA upgrades.
*Audits and Acceptance of F&O Closure processNRC staff will continue to perform audits and observations to provide continued monitoring and oversight of the Appendix X process.
: 2) The licensee should adhere to the guidance in Appendix X in its entirety to obviate the need for an in-depth review and/or submittal of F&Os in licensing actions
*Appendix X Process should be standardized for reliance to:Foster efficiency in staff reviews.Improve adherence to guidance and staff endorsement of the Standard.Establish pedigree for training materials and qualifications.Promote consistency across guidance documents  
: 1. NEI 05-04, Appendix X, Section X.1.3: Use of Remote Reviewers Participation of remote independent reviewers was not planned and scheduled.
*Facts and Observations (F&Os)
: 2. NEI 05-04, Appendix X, Section X.1.3: Host Utility Preparation
*Independent Assessment (IA)
* A written assessment and justification of explaining why each finding was either a PRA upgrade or maintenance update was not performed.
*Probabilistic Risk Analysis (PRA)
* Scope of F&Os included in the review and provided to the independent assessment team not clearly understood.
*American Society of Mechanical Engineers (ASME)
: 3. NEI 05-04, Appendix X, Section X.1.3: Close Out of F&Os by IA
*American Nuclear Society (ANS)
* Unclear independence between review teams and work originators
*Regulatory Guide (RG)
* IA team did not review MOR with changes incorporated Note: Note: The NRC staff observation report is documented in ADAMS Accessions No. ML17265A812.
*Nuclear Energy Institute (NEI)
* Staff review of LARs and closure reports identified incomplete information for a streamlined review across regulatory guidelines (i.e., RG 1.200, RG 1.174, and SRP 19.1):
*Internal Events (IE)
  - Scope of IA review (e.g., F&Os, self-assessment findings)
*Internal Flood (IF)
  - Concurrent focused scope performed
*Seismic Probabilistic Risk Analysis (SPRA)*Model of Record (MOR)
  - Timeline of peer reviews and IA performed
*Fire Probabilistic Risk Analysis (FPRA)*Capability Category (CC)
  - Written justification for if closure of F&O constituted an upgrade or maintenance update
*Risk-informed Completion Time (RICT)*Integrated Risk-Informed Leak Rate Testing (ILRT) }}
  - IA team assessment of the closure of F&Os against the SR for Met at CC-II
* IA F&O closure process has (so far) resulted in 60 -
80% reduction in number of open F&Os
* RG 1.200 guidance for open F&Os still applicable.
LAR should include:
  - discussion of resolution of applicable F&Os OR
  - Justification that demonstrates accident sequences or contributors significant to application decision not adversely impacted Endorsement of Appendix X in RG 1.200, Revision 3
* Endorsement of Closure of F&Os will further address:
: 1. Summary of information to be provided in the LAR when crediting Appendix X for closure of F&Os
: 2. Defined Terms for:
Model of Record Base Model
: 3. Conditions of Acceptance
* Audits and Acceptance of F&O Closure process NRC staff will continue to perform audits and observations to provide continued monitoring and oversight of the Appendix X process.
* Appendix X Process should be standardized for reliance to:
Foster efficiency in staff reviews.
Improve adherence to guidance and staff endorsement of the Standard.
Establish pedigree for training materials and qualifications.
Promote consistency across guidance documents
* Facts and Observations (F&Os)
* Capability Category (CC)
* Independent Assessment (IA)
* Risk-informed Completion Time
* Probabilistic Risk Analysis (PRA)      (RICT)
* American Society of Mechanical
* Integrated Risk-Informed Leak Rate Engineers (ASME)                        Testing (ILRT)
* American Nuclear Society (ANS)
* Regulatory Guide (RG)
* Nuclear Energy Institute (NEI)
* Internal Events (IE)
* Internal Flood (IF)
* Seismic Probabilistic Risk Analysis (SPRA)
* Model of Record (MOR)
* Fire Probabilistic Risk Analysis (FPRA)
                                      }}

Latest revision as of 07:51, 3 February 2020

3/14/2018 - Regulatory Information Conference (RIC) 2018 - Session TH35 - Driver Slides - Closure of PRA Peer Review Facts and Observations
ML18087A372
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Issue date: 03/14/2018
From:
Office of Nuclear Reactor Regulation
To:
References
Download: ML18087A372 (14)


Text

Closure of PRA Peer Review Facts and Observations Regulatory Information Conference Technical Session TH35 Adrienne Driver, Reliability and Risk Analyst March 14, 2018

Background:

New Process for closure of F&Os Industry Guidance and Processes PRA Processes for Regulatory Review Overview of Appendix X: Closure of F&Os Process Industry Pilots and Staff Observations Staff Acceptance of Appendix X Post Acceptance Observations NRC Audits: Crediting F&O Closure Proposed Staff Endorsement in RG 1.200, Revision 3

Background:

The Risk Informed Steering Committee (RISC) identified several high-priority issues to foster an environment conducive to achieving the full benefit of risk-informed regulation.

- Common theme was difficulty associated with evaluation of Probabilistic Risk Assessment (PRA) technical acceptability in review of risk-informed licensing applications

  • Working Group 1 Issue 2 Objective: Improve process for documentation and closure of Peer Review Facts and Observations (F&Os)

ASME/ANS PRA Standard NEI 05-04/07-12/12-16

  • Provides standards for peer review of
  • Guidance for Peer Review Process a PRA to be used in risk-informed -Assessment of the Capability decisions for commercial nuclear Category (CC) of the Supporting power plants. Requirements (SR), CC-I, CC-II, CC-III
  • Defines PRA upgrades and stipulates
  • Full Scope when a peer review should be
  • Focused Scope performed.
  • Peer Review
  • Defines levels of F&Os
  • Inherently establishes PRA - Findings model-of-record (MOR) - Observations

- Best Practices Peer Review W/

PRA New F&Os Upgrades Disposition of F&O to Risk App.

No F&O Closure Gap Assessment to RG 1.200 Peer Review Closure Closure of of F&O F&O NRC Closure Independent Peer Review Assessment Qualifications for Concurrent Full Scope Documentation Independent Focused Scope Reviewer Peer Review 2 Independent Reviewers Assessment of Upgrade or Update Note: The final Appendix X process is documented in ADAMS Accession No. ML17095A252.

Simplified process compared to the alternative process in the ASME/ANS PRA Standard for peer reviews IA Team has direct access to model of record (MOR) and supporting documentation.

IA Team has access to Peer Review Report(s) including text of the original F&O.

Process appears suitable for closure of F&Os addressing:

  • Documentation issues
  • Individual modelling and method errors
  • Incorrect F&Os When using both webinar and teleconference (shared screen, and voice connectivity) performing a limited scope IA remotely, appeared to be a suitable and capable manner to support IA reviewers role and responsibilities.

The IA provides guidance for closure of the F&Os to be documented with a pedigree for retention during auditing and inspection purposes.

Plant

  • IA Team (Vendor)
  • Reliance on SR met at A

CC-II

  • No justification for
  • IA Team (Vendor) upgrade or update Plant
  • Concurrent Focused Scope
  • Incomplete documentation for B
  • Remote reviewer participation closure Plant
  • IA Team (Vendor)
  • Concurrent Focused C Scope Note: The NRC staff observation report is documented in ADAMS Accessions No. ML17095A252.

The NRC staff accepted the final version of the Appendix X guidance in a letter to NEI May 3, 2017 with the following conditions of acceptance (ADAMS Accession No. ML17079A427).

Conditions of Acceptance:

1) Independent Assessment process does not include review of the closure of F&Os that include PRA upgrades: Focused scope peer review still required for PRA upgrades.
2) The licensee should adhere to the guidance in Appendix X in its entirety to obviate the need for an in-depth review and/or submittal of F&Os in licensing actions
1. NEI 05-04, Appendix X,Section X.1.3: Use of Remote Reviewers Participation of remote independent reviewers was not planned and scheduled.
2. NEI 05-04, Appendix X,Section X.1.3: Host Utility Preparation
  • A written assessment and justification of explaining why each finding was either a PRA upgrade or maintenance update was not performed.
  • Scope of F&Os included in the review and provided to the independent assessment team not clearly understood.
3. NEI 05-04, Appendix X,Section X.1.3: Close Out of F&Os by IA
  • Unclear independence between review teams and work originators
  • IA team did not review MOR with changes incorporated Note: Note: The NRC staff observation report is documented in ADAMS Accessions No. ML17265A812.
  • Staff review of LARs and closure reports identified incomplete information for a streamlined review across regulatory guidelines (i.e., RG 1.200, RG 1.174, and SRP 19.1):

- Scope of IA review (e.g., F&Os, self-assessment findings)

- Concurrent focused scope performed

- Timeline of peer reviews and IA performed

- Written justification for if closure of F&O constituted an upgrade or maintenance update

- IA team assessment of the closure of F&Os against the SR for Met at CC-II

  • IA F&O closure process has (so far) resulted in 60 -

80% reduction in number of open F&Os

  • RG 1.200 guidance for open F&Os still applicable.

LAR should include:

- discussion of resolution of applicable F&Os OR

- Justification that demonstrates accident sequences or contributors significant to application decision not adversely impacted Endorsement of Appendix X in RG 1.200, Revision 3

  • Endorsement of Closure of F&Os will further address:
1. Summary of information to be provided in the LAR when crediting Appendix X for closure of F&Os
2. Defined Terms for:

Model of Record Base Model

3. Conditions of Acceptance
  • Audits and Acceptance of F&O Closure process NRC staff will continue to perform audits and observations to provide continued monitoring and oversight of the Appendix X process.
  • Appendix X Process should be standardized for reliance to:

Foster efficiency in staff reviews.

Improve adherence to guidance and staff endorsement of the Standard.

Establish pedigree for training materials and qualifications.

Promote consistency across guidance documents

  • Facts and Observations (F&Os)
  • Capability Category (CC)
  • Independent Assessment (IA)
  • Risk-informed Completion Time
  • Probabilistic Risk Analysis (PRA) (RICT)
  • American Society of Mechanical
  • Integrated Risk-Informed Leak Rate Engineers (ASME) Testing (ILRT)
  • American Nuclear Society (ANS)
  • Regulatory Guide (RG)
  • Nuclear Energy Institute (NEI)
  • Internal Events (IE)
  • Internal Flood (IF)
  • Seismic Probabilistic Risk Analysis (SPRA)
  • Model of Record (MOR)
  • Fire Probabilistic Risk Analysis (FPRA)