ML18319A015

From kanterella
Jump to navigation Jump to search
General Roles and Responsibilites -November 15, 2018 Inspection Workshop
ML18319A015
Person / Time
Issue date: 11/15/2018
From: Joe Golla
Research and Test Reactors Licensing Projects Branch
To:
Golla J, NRR/DLP, 415-1002
References
Download: ML18319A015 (15)
v • d • e


Text

Draft ISG-06, Revision 2 NRC Inspection Workshop November 15, 2018

Outline

  • Alternate Review Process Summary (10 mins)
  • NRC Activities Related to DI&C Modifications
  • I&C Technical Reviews (5 mins)
  • Division of Inspection and Regional Support (10 mins)
  • Vendor Inspections (10 mins)
  • Regional Inspections (10 mins) 2

DI&C-ISG-06, Rev. 2, Alternate Review Process Summary

DI&C-ISG-06 Purpose and Scope

  • Defines the licensing process used to support license amendment request (LAR) reviews associated with safety-related DI&C equipment modifications in operating plants and in new plants once they become operational
  • Provides guidance for activities performed before LAR submittal and during LAR review. The NRC staff uses the process described in ISG-06 to evaluate compliance with NRC regulations
  • ISG-06 makes reference to, and is to be used in conjunction with SRP Chapter 7 (NUREG-0800) 4

Comparison of Licensing and Oversight Activities Timeline Tier 1, 2, and 3 Review LA Issued Process (Rev. 1 and 2)

LAR Submitted NRC: LAR (Phase 1) and Phase 2 Review, and Regulatory Audit(s) NRC:

Phase 1 Information Regional Inspections Available of Site Activities Tier 1, 2, and 3 Licensee Activity:

Licensee Activities Producing and Submitting Phase 2 Supplement Info (Not applicable to the Alternate Review Process)

Modification Concept High Level Implementation and Detailed HW & SW Design and Phase 0 System Design, Test Activities, Post FAT Licensee Activities, SAT and Fabrication Meeting(s) Planning including FAT Report Alternate Review Process LA Issued (Rev. 2)

NRC:

LAR Submitted LAR Review and NRC: NRC:

All Information to meet Regional/Vendor Regional Inspections Regulatory Audit(s)

Regulatory Requirements Inspections of Site Activities of Implementation Available

& Test Activities Timeline 5

Characteristics of a License Amendment Request (LAR) using the Alternate Review Process

  • The LAR provides the necessary and sufficient design information to demonstrate regulatory compliance
  • The LAR describes the licensees Vendor Oversight Plan that ensures the vendor executes the project consistent with the LAR, and ensures the vendor uses, as a reference, the 2015 version of ASME NQA 1, Part II Subpart 2.7 on Quality Assurance Requirements for Computer Software for Nuclear Facility Applications
  • The LAR includes appropriate commitments to complete plant- specific actions that are included in the referenced topical report
  • The LAR includes appropriate commitments to complete lifecycle activities under the licensees QA program 6

Alternate Review Process: Licensee Committments and License Conditions

  • The Alternate Review Process relies on the LAR containing licensing information and additional regulatory commitments to implement remaining development phases by the licensees QA program, after the license amendment is issued
  • The NRC staff may likely translate some of the regulatory-significant commitments into license conditions, as part of the approval (e.g., factory acceptance testing) 7

NRC Activities Related to DI&C Modifications (General Roles and Responsibilities)

I&C Technical Reviews DI&C Modification Responsibilities:

  • Topical Report Reviews
  • LAR Safety Evaluations
  • Regulatory Audits
  • Inspection Support
  • Regional Support Applicable Guidance:
  • Draft ISG-06, Rev. 2 - Licensing Process

I&C Technical Reviews (contd.)

Regulatory Audits

  • A regulatory audit is a planned, license or regulation-related activity that includes the examination and evaluation of primarily non-docketed information.
  • A regulatory audit is conducted with the intent to gain understanding, to verify information, and/or to identify information that will require docketing to support the basis of the licensing or regulatory decision.

10

Division of Inspection and Regional Support (DIRS)

  • Provides centralized management of the Reactor Oversight Program and support for regional and resident inspector-based inspection activities consistent with the NRC's mission of protecting the health safety of the public and environment.
  • Responsible for leading, guiding and coordinating the agency activities associated with inspecting and assessing licensee performance at commercial nuclear power plants; evaluating plant operational data and communicating lessons learned to cognizant groups.
  • Coordinates the implementation of all these activities and develops recommendations for program changes.

11

Vendor Inspections DI&C Modification Responsibilities:

  • Inspections at vendor shops are conducted principally to examine whether the vendor has been complying with Appendix B to 10 CFR Part 50, as required by procurement contracts with licensees.

- Notices of Nonconformances or Notices of Violations are issued to vendors for failures to meet quality commitments or the requirements of 10 CFR Part 21, "Reporting of Defects and Noncompliance," respectively.

  • The vendor inspection program (VIP) verifies that reactor applicants and licensees are fulfilling their regulatory obligations with respect to providing effective oversight of the supply chain.

- It accomplishes this through limited scope, targeted inspections of vendor quality assurance (QA) programs, communicating relevant vendor information to stakeholders, and supporting allegation response activities.

  • Vendor Inspectors provide audit support to the technical reviewers.

12

Vendor Inspections (contd.)

Vendor Inspection procedures may be developed in consideration of the following:

- Criterion II, Quality Assurance Program, as it relates to unique aspects of software project management and organizational processes; software quality assurance (QA) processes; software verification and validation processes; and software configuration management processes.

- Criterion III, Design Control, as it relates to activities that should be specified in design documents, and the design control measures for verifying or checking the adequacy of the design that are unique to software;

- Criterion V, Instructions, Procedures, and Drawings, as it relates to guidance for I&C activities affecting quality that may warrant specific documented procedures and guidance on the control of I&C documents that prescribe activities affecting quality specific to software;

- Criterion XI, Test Control, as it relates to aspects of the testing program specific to software; and Criterion XVI, Corrective Action, as it relates to identifying and correcting failures, malfunctions, and anomalies throughout the software lifecycle.

13

Regional Inspections DI&C Modification Responsibilities:

  • Ensure that the licensee is in compliance with their commitments in accordance with the plant specific licensing basis.
  • To verify that the licensee has ensured the development of a DI&C system as committed in the licensing basis.
  • To confirm by inspection that the licensee has adequately developed and implemented the DI&C development process to yield a system that meets the licensing basis.

- Including: Planning, Requirements, Design & Implementation, Integration, Validation & Test, Installation, Operation, and maintenance

  • Regional Inspectors provide audit support to the technical reviewers.

14

Regional Inspections (contd.)

Inspection procedures for the Region may be developed in consideration of the following:

Retrieved from "https://kanterella.com/w/index.php?title=ML18319A015&oldid=1919542"