ML21298A142
| ML21298A142 | |
| Person / Time | |
|---|---|
| Issue date: | 10/28/2021 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Christopher Regan NRC/NRR/DRO |
| Sakadales A | |
| References | |
| Download: ML21298A142 (9) | |
Text
October 28, 2021 MEMORANDUM TO: Christopher Regan, Acting Director Division of Reactor Oversight Office of Nuclear Reactor Regulation FROM: Kerri A. Kavanagh, Chief /RA/
Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
SUBJECT:
VENDOR INSPECTION PROGRAM ANNUAL SELF-ASSESSMENT REPORT FOR FISCAL YEAR 2021 The Vendor Inspection Program (VIP) verifies that reactor applicants and licensees are fulfilling their regulatory obligations with respect to providing effective oversight of the nuclear supply chain. It accomplishes this through limited scope, targeted inspections of vendor quality assurance programs, communicating relevant vendor information to stakeholders, and supporting allegation response activities. In addition, the VIP addresses interactions with nuclear consensus standards organizations, industry and external stakeholders, and international constituents.
The VIP also includes objectives and associated performance metrics to demonstrate that the overarching goals are being supported. The VIP performance metrics are assessed to ensure successful implementation and continuous improvement of the VIP. These performance metrics use objective measures and predetermined criteria to monitor the performance of the VIP as described in the Vendor Inspection Program Plan, Revision 25, dated September 2021 (Agencywide Documents Access and Management System Accession No. ML21243A311).
The performance metrics are based on input from various sources, including, but not limited to, inspection reports and vendor inspection staff comments. The vendor inspection staff collects data quarterly and uses pre-established success criteria to analyze the data. In most cases, success is defined as a steady or improving trend and achieving the goals of the program performance metrics. Performance metrics have been established for each of the following VIP objectives:
CONTACT: Antoinette Sakadales, NRR/DRO/IQVB 301-415-6441
C. Regan 2
- VIP O-1: Verify that applicants and licensees are fulfilling their regulatory obligations with respect to providing effective oversight of the supply chain for operating reactors and reactor design and construction through a strategic sample of vendor inspections.
- VIP O-2: Effectively communicate with internal and external stakeholders.
- VIP O-3: Perform timely and adequate allegation follow up and closure.
- VIP O-4: Ensure that vendor inspectors have the necessary knowledge and skills to successfully implement the VIP.
Each objective has a set of performance metrics associated with it in order to establish the overall success of the VIP.
The results of the vendor inspection staff analysis are enclosed. The vendor inspection staff found that for fiscal year 2021, the VIP met 11 out of 11 performance metrics by meeting the criteria defined in Appendix D, Vendor Inspection Program Performance Metrics, to the Vendor Inspection Program Plan.
Enclosure:
Vendor Inspection Program Performance Metrics
C. Regan
SUBJECT:
VENDOR INSPECTION PROGRAM ANNUAL SELF-ASSESSMENT REPORT FOR FISCAL YEAR 2021 Dated: October 28, 2021 DISTRIBUTION NRR_DRO_IQVB RFelts KMorgan-Butler PMcKenna ADAMS Accession No.: ML21298A142 *via email NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME YDiaz-Castillo* ASakadales* KKavanagh*
DATE 10/27/2021 10/27/2021 10/27/2021 OFFICIAL RECORY COPY
VENDOR INSPECTION PROGRAM PERFORMANCE METRICS VIP-O-1A Accomplish DROs (Division of Reactor Oversight) Established Number of Inspections per Fiscal Year1 Definition: Accomplish DROs established number of inspections per fiscal year to capture a reasonable perspective of industry performance (per NUREG-1100, Performance Budget/Congressional Budget Justification).
Criteria: Expect DRO to perform the required number of inspections established at the beginning of the fiscal year (FY).
Goals: Effective, Open FY 2021 Inspections Audits Multinational Inspection Vendor Inspections Parallel Inspection Region II Assist Observations Analysis: DROs Operating Plan directed the vendor inspection staff to perform a minimum of 20 inspections during FY 2021. In FY 2021, the DRO metric was modified to include licensing audits, observations, and regional inspection support to the definition of inspections. As such, the vendor inspection staff completed a total of 21 inspections/audits/observations: 10 vendor inspections, four observations of Nuclear Procurement Issues Committee (NUPIC) audits, one observation of a French Nuclear Safety Authority (ASN) inspection, one parallel vendor inspection with ASN and one multinational vendor inspection under the Multinational Design Evaluation Program, three licensing audits, and one Region 2 assist. Therefore, this represents a score of 100%.
Metric Criteria Met: Yes 1
This metric is counted based on the FY of the entrance date of the inspection. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
Enclosure
VIP-O-1B: Completion of Annual Assessment of the Number of Notices of Violations (NOV) and Notices of Nonconformance (NON)2 Definition: Perform an annual assessment of NONs and NOVs to identify generic industry issues and take corrective actions as necessary. Corrective actions may include discussions at the vendor workshop, issuance of generic communications, and other activities.
Criteria: Expect industry attendance at vendor workshops and industry outreach meetings and through generic communications.
Goals: Objective, Open, Risk-Informed FY 2021 NOVs and NONs Criterion XVI 100.00%
Analysis: The NRC issued one NON against a vendor during FY 2021. The decrease in the total number of NONs issued from FY 2020 to FY 2021 is indicative of the implementation of the more than minor guidance in Inspection Manual Chapter (IMC) 0617. Therefore, this represents a score of 100%.
Metric Criteria Met: Yes 2
This metric is counted based on the FY of when the inspection report is issued. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
VIP-O-2A Obtain Feedback from Vendors After the Vendor Inspection3 Definition: The Branch Chief will solicit feedback from vendors on such aspects as the immediate inspection effort, vendor oversight, or NRC requirements and guidance.
Criteria: Expect stable or increasingly positive perception over time.
Goals: Effective, Open, Understandable Analysis: This metric requires that the vendor Branch Chief solicit feedback from the vendors management on such aspects as the immediate inspection effort, vendor oversight, or NRC requirements and guidance. In FY 2021, IQVB solicited feedback from 14 vendors. Out of the 14, eight vendor responses were received. All but one was positive. This feedback was discussed with staff. The remainder of the feedback that was received spoke to the thoroughness of the inspections and the professionalism of the NRC staff. Therefore, this represents a score of 100%.
Metric Criteria Met: Yes VIP-O-2B Notification of Inspection4 Definition: Obtain data on the total number of inspections that were notified to the vendor within the timeliness goals stipulated in Section 10 of the Vendor Inspection Program (VIP) plan.
Criteria: Expect 90 percent of inspections to be announced to the vendor within the VIP timeliness goals.
Goals: Effective, Open, Predictable Analysis: The metric for notifying the vendors of an NRC inspection is no less than 30 calendar days from the start date of the inspection unless the inspection is unannounced. In cases where the need for the inspection arises (i.e., allegation, testing schedule, and/or specific vendor activity) less than 35 days before the inspection start date, issue the Announcement Letter within five calendar days of being notified of the need for the inspection. In cases where the need for the inspection arises less than five calendar days, issue the Announcement Letter prior to inspection. Out of the 11 notifications of inspection completed in FY 2021, 10 were within the VIP timeliness goal, which represents a score of 90%.
Although 21 total inspections were conducted in FY 2021, seven announcement letters were captured in the FY 2020 metrics, audits and observations are not announced by the US NRC, and three announcement letters pertained to inspections that will be conducted in FY 2022.
3 This metric is counted based on the FY of the exit date of the inspection. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
4 This metric is counted based on the FY of the first announcement of the inspection to the vendor if applicable. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
Metric Criteria Met: Yes VIP-O-2C Inspection Plans are Timely5 Definition: Obtain data on the total number of inspection plans issued within the timeliness goals stipulated in Section 10 of the VIP plan.
Criteria: Expect 90 percent of inspection plans to be issued within the VIP timeliness goals.
Goals: Effective, Open, Predictable Analysis: The metric for issuing inspection plans is no less than seven calendar days from the start date of the inspection. In cases where the need for the inspection arises (i.e., allegation, testing schedule, and/or specific vendor activity) less than seven calendar days before the inspection start date, issue the inspection plan prior to the inspection. Out of 11 inspection plans completed in FY 2021, all were completed within the VIP timeliness goal, which represents a score of 100%.
Although a total of 21 inspections were conducted in FY 2021, five inspection plans were captured in the FY 2020 metrics, audits and observations do not require an inspection plan, and one inspection plan pertained to an inspection that will be conducted in FY 2022.
Metric Criteria Met: Yes VIP-O-2D Inspection Reports are Timely6 Definition: Obtain data on the total number of inspection reports issued within the timeliness goals stipulated in Section 10 of the VIP plan and Inspection Manual Chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, dated February 2020.
Criteria: Expect 90 percent of inspection reports to be issued within the VIP timeliness goals.
Goals: Effective, Open, Predictable Analysis: The metric for issuing inspection reports is no later than 45 calendar days after the exit meeting, extended until the next business day if the 45 days end on a weekend or a Holiday. Out of the 13 inspection reports issued in FY 2021, all were completed within the VIP timeliness goal, which represents a score of 100%. Although 21 total inspections were conducted in FY 2021, it should be noted that one inspection report was issued for an inspection that was captured 5
This metric is based on the FY of when the inspection was announced to the vendor. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
6 This metric is based on the FY of when the inspection report was issued to the vendor. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
in the FY 2020 metrics and the US NRC does not issue inspection reports for audits or observations.
Metric Criteria Met: Yes VIP-O-2E Acknowledgment Letters Are Timely7 Definition: Obtain data on the total number of acknowledgement letters issued within the timeliness goals stipulated in Section 10 of this plan.7 Criteria: Expect 90 percent of acknowledgement letters to be issued within the VIP timeliness goals.
Goals: Effective, Open, Predictable Analysis: The metric for issuing acknowledgement letters is no later than 30 calendar days after the vendors last communication is entered into the Agencywide Documents Access and Management System (ADAMS). Out of the three vendor NON responses received in FY 2021, all acknowledgement letters were issued within the VIP timeliness goal, which represents a score of 100%. During FY 2021, two vendor NON responses were from findings issued in FY 2020 and one response was for the NON issued in FY 2021.
Metric Criteria Met: Yes VIP-O-2F Inspection Results Accepted by Stakeholders Definition: Track the total number of NOVs and NONs contested by vendors.
Criteria: Retract less than 10 percent of NOVs and NONs because they are successfully contested by the stakeholders.
Goals: Effective, Objective, Open, Predictable Analysis: There were no contested NONs by a stakeholder during FY 2021, which represents a score of 100%.
Metric Criteria Met: Yes VIP-O-3 Allegation Support Definition: Achieve the timely submittal of allegation response documents.
Criteria: Conduct all support within the Allegation Program timeliness requirements.
Support includes, but is not limited to, providing input for Allegation Review Board (ARBs) materials, attending ARBs, providing input to requests for 7
This metric is based on the date that the vendors correction actions are received by ADAMS and the date that the staff acknowledges receipt of the vendors corrective actions. Therefore, other metrics associated with this inspection could be captured in a different FYs assessment.
information, participating in phone calls with the Concerned Individual(s),
providing input for closure and response after closure letters, etc.
Goals: Effective, Objective, Risk-Informed Analysis: The vendor inspection staff supported 49 allegation actions during FY 2021. Of those allegations, one resulted in reactive inspection based on the outcome of the ARB. All input provided to the Headquarters Allegation Team was submitted within the Allegation Programs timeliness requirements, which represents a score of 100%.
Metric Criteria Met: Yes VIP-O-4A Assessment of Trainee Qualifications Definition: Branch Chiefs assess inspectors in training for progress in achieving qualifications at least quarterly.
Criteria: Expect 90 percent of trainees to qualify in two years.
Goals: Effective, Predictable, Understandable Analysis: In FY 2021, two vendor inspectors completed their qualification within the two-year qualification timeline, which represents a score of 100%.
Metric Criteria Met: Yes VIP-O-4B Assessment of Inspector Proficiency Definition: Maintain proficiency for all qualified inspectors.
Criteria: Maintain annual proficiency for all qualified inspectors in accordance with the guidance set forth by the VIP for refresher and continuing training.
Goals: Effective, Predictable, Understandable Analysis: All qualified vendor inspectors met the annual proficiency requirements as stated in Section 12 of the VIP plan and Section C-8 of Appendix D1 to Inspection Manual Chapter 1245, Maintaining Qualifications, dated June 2020. Therefore, this represents a score of 100%.
Metric Criteria Met: Yes