NIEP Evaluation PO&A “How-to” Guide and Issue Classification Rob Seipel Senior Manager, Corporate QA Tennessee Valley Authority

“How-to” Guide Similar to Document 11 used by NUPIC Front section will contain general guidelines Each checklist will have a specific section that provides amplifying information associated with completion of the checklist items

“How-to” Guide

NIEP Issue Classification For 2014 through 2016, there has been one Significant Deficiency identified from all NIEP evaluations (54) combined The current definition appears to be subjective to the point where Significant Deficiencies are not identified Based on feedback, there are two main drivers: The use of the term “Significant” The subjectivity of the term “significant impact”

NIEP Issue Classification Current Definition of Significant Deficiency: Any element of the approved QA Program is found to be in non-conformance with, or is inadequately implementing, a regulatory or licensing basis requirement (bolded Attribute). The issue has led, or has the potential to lead, to significant impact.

NIEP Issue Classification A review of all NIEP Deficiencies from 2015 and 2016, by the NIEP Sub-committee identified ten that appear to meet the definition of Significant Deficiency, but were classified as Deficiencies

NIEP Issue Classification Example 1: Two Security audits (two different sites) exceeded a 12 month regulatory and procedurally required frequency by completing the audit in 13 months. The utility’s Master Audit Schedule inappropriately allowed three month grace period for Security audit performance. The issue with the grace period was previously identified during the May 2015 NIEP Audit at another site from the same utility, with corrective actions targeted for 12/31/15 completion.

NIEP Issue Classification Example 2: The apparent cause evaluation for missing/inadequate objective evidence did not adequately document the validation details to support that all regulatory required audit objectives were met for a 2015 Emergency Preparedness (EP) Audit. The audit package for the 2015 audit identified that approximately 25% of the audit scope was statused as not performed. This was based upon the utility’s inability to locate documented objective evidence. This was identified by the NOS organization during a self-assessment performed after the audit and entered into the Corrective Action Program (CAP). The Apparent Cause report stated that this did not invalidate the audit results and no additional audit would be required with NOS management concurrence. The technical basis for this decision is not documented in the Apparent Cause investigation.

NIEP Issue Classification Example 3: A formal qualification tracking process did not exist for the Plant Operations Review Committee (PORC) Members or Alternates. As a result, required PORC and 10CFR50.59 procedure reviews; training; and Regulatory Guide 1.8 Radiation Protection Manager qualifications for Health Physics personnel are not readily available or known by some station personnel based on review of procedures, training records, memos, or via interviews. These fundamental behaviors challenge the ability of PORC to meet quorum, present a potential challenge to past decisions and approvals made by PORC, and a knowledge gap by some PORC Members or Alternates.

NIEP Issue Classification Example 4: A review of Plant Operations Committee (POC) Meeting Minutes indicates that three meetings were conducted where the minimum quorum requirements were not met in that the meeting was conducted with the Chair (or Vice Chair) and only three other members. Specific meetings not meeting quorum requirements were POC Meetings 14-08, 14-16, and 14-16.01. Requirement OQAPD, Appendix III, Rev. 47, Section 2.1.5 states that "the quorum of the POC necessary for the performance of the POC responsibility and authority provision of these requirements shall consist of the Chair or Vice Chair and four members including alternates."

NIEP Issue Classification Example 5: The procedure for Quality Control Inspection did not list or reference the specific inspection attributes required. Inspection personnel relied on Maintenance procedures, drawings, and other site standards to provide guidance on the required inspection attributes. This was identified during previous NIEP audits and the Pre-NIEP audit conducted by the utility in 2015. The resolution to this issue is untimely. This was first identified in 2011 and there has been no change in QC to address this issue. The QC Supervisor has an assignment for a change management plan to correct the issue.

NIEP Issue Classification Significant Deficiency changed to QA Program Deficiency

NIEP Issue Classification Significant Deficiency: Any Element of the approved QA Program is found to be in non-conformance with, or is inadequately implementing, a regulatory or licensing basis requirement (bolded attribute). The issue has led, or has the potential to lead, to significant impact.

NIEP Issue Classification QA Program Deficiency (proposed): A condition that represents a failure to develop, document, or implement effectively any element of the approved QA Program that results in a NIEP Compliance Element being rated as Effective with Concerns, or Ineffective.

NIEP Issue Classification Deficiency (proposed): A condition which renders an Attribute within a NIEP Compliance Element as “Not Acceptable”. For issues below the level of the two NIEP issue classifications above, the Team Manager should communicate them to the Host Utility Manager for consideration and disposition within their internal processes – e.g. CAP, procedure revision request process, etc.

Questions 16