ML18319A017
| ML18319A017 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/2018 |
| From: | Joe Golla NRC/NRR/DLP/PLPB |
| To: | |
| Golla J, NRR/DLP, 415-1002 | |
| References | |
| Download: ML18319A017 (11) | |
Text
Example of Audits and Inspection Activities for a Modification Performed Under the ISG-06, Rev. 2 Alternate Review Process Draft ISG-06, Rev. 2 NRC Inspection Workshop November 15, 2018
Example Purpose To identify the types of LAR Review Audits and Post-LA NRC Inspection Activities that would be performed in relation to an ISG-06 Alternate Review Process License Amendment Request (LAR).
The example is based on the Oconee RPS/ESFAS digital instrumentation and controls (DI&C) Modification using the Alternate Review Process.
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Reference Material Oconee License Amendment (with Safety Evaluation): ML100220016 Oconee Audit Reports:
- July 23, 2008: ML081900197
- November 12, 2008: ML083080453 Note: June 11, 2009 and June 22, 2009 audit reports are proprietary Oconee Recommended Inspection Items: See Section 3.14 of the Safety Evaluation Oconee Inspection Reports:
- March 0, 2012: ML12069A088 Vendor Oversight Plan (VOP) Description Example: Provided by NEI 3
Alternate Review Process Licensing and Oversight Activities Timeline Modification Concept High Level System Detailed HW & SW Design Test Activities, Post FAT Licensee and Phase 0 Implementation Design, Planning and Fabrication including FAT Reports Activities, SAT Meeting(s)
LAR Submitted LA Issued All Information to meet Regulatory Requirements Available NRC: NRC: NRC:
LAR Review and Regional/Vendor Inspections Regional Inspections Regulatory Audit(s) of Implementation and Test Activities of Site Activities
- Electronic Audit(s)
- Plant Site
- Plant Site
- Vendors Facility
- Vendors Facility Audit(s)
- Site Audit(s)
Note: Audit and Inspection Teams would be composed of the following staff:
- I&C Technical Reviewers
- Regional Inspectors
- Vendor Inspectors 4
LAR Review Audit(s)
Electronic Audit(s):
- Audit of non-docketed material in response to open items*
Audit(s) at the Vendors Facility and/or Plant Site:
- Audit of non-docketed material in response to open items
- Application Configuration Management
- Application Secure Development and Operational Environment
- Vendor Quality
- Licensee Vendor Oversight
- Closure of the open items will determine if the audited material needs to be submitted to the docket in response to Request for Additional Information 5
Post-License Amendment Inspections:
Regional/Vendor Inspections May Include the Following:
- Licensee Vendor Oversight
- Requirements Traceability
- FAT Test Coverage and Results
- Time Response
- Configuration Management
- Secure Development and Operational Environment
- Vendor Quality
- Site Acceptance Testing
- Installation
- Procedures, Plans and Training 6
Post-License Amendment Inspections:
Regional/Vendor Inspections
- Verify what vendor oversight activities the licensee is performing, per the VOP
- Includes inspections of VOP Reports at the plant
- Verify how the licensee and the vendor are performing those activities
- Includes inspections at the vendor facility
- Verify site installation and testing 7
NRC Perspectives on Vendor Oversight Activities Key Elements
Design Implementation
- Confirmation that the plans have been followed by the software developer.
- Evidence of Implementation to be reviewed should include the following:
- Safety Analysis Reports
- Verification and Validation Reports
- Configuration Management Reports
- Testing Activity Reports Example: The acceptance criterion for software safety analysis implementation is that the tasks in that plan have been carried out in their entirety. Documentation exists to show that the safety analysis activities have been successfully accomplished for each life cycle activity group and that the proposed digital system software is, in fact, safe.
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Design Outputs
- Confirmation that Design Outputs are acceptable.
- Design Outputs to be reviewed should include the following:
- Software Requirements Specification
- Software Architecture Description
- Software Design Specification
- Code Listings
- System Build Documents
- Installation Configuration Tables
- Operations Manuals
- Software Maintenance Manuals
- Software Training Manuals Example: Review Guidance for SRSs - Each requirement should be traceable to one or more safety system requirements, and the requirements traceability matrix should show where in the software the required action is being performed. The requirements traceability matrix should also show where the particular requirement is being tested.
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NRC Perspectives and Questions on VOP Summary
- 1. Scope and depth of VOP Summary provided in the LAR
- 2. Reference to specific licensee oversight activities
- 3. Reference to IEEE 1012 or other standards
- 4. Scope and depth of licensee vendor oversight reports
- 5. Schedule of application life cycle development and vendor oversight activities 11