ML20302A239
| ML20302A239 | |
| Person / Time | |
|---|---|
| Issue date: | 10/27/2020 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | Chris Miller NRC/NRR/DRO |
| Sakadales A | |
| References | |
| Download: ML20302A239 (9) | |
Text
October 27, 2020 MEMORANDUM TO: Christopher G. Miller, 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 2020 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 23, dated September 2020 (Agencywide Documents Access and Management System Accession No. ML20268B275).
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. Miller 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 2020, the VIP met 10 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. Miller
SUBJECT:
VENDOR INSPECTION PROGRAM ANNUAL SELF-ASSESSMENT REPORT FOR FISCAL YEAR 2020 Dated: October 27, 2020 DISTRIBUTION NRR_DRO_IQVB RFelts THipschman ADAMS Accession No.: ML20302A239 *via email NRR-106 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB NAME YDiaz-Castillo* ASakadales* KKavanagh*
DATE 10/22/2020 10/27/2020 10/27/2020 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.
Goals: Effective, Open FY 2020 Inspections Vendor Inspections 14 Analysis: DROs Operating Plan directed the vendor inspection staff to perform a minimum of 20 inspections during fiscal year (FY) 2020. The vendor inspection staff completed a total of 14 vendor inspections during FY 2020. In addition, the vendor inspection staff observed one Nuclear Procurement Issues Corporation (NUPIC) audit and one Korea Institute of Nuclear Safety (KINS) inspection.
Therefore, this represents a score of 70%.
Metric Criteria Met: No Corrective Actions: The vendor inspection staff noted that the root cause for being unable to perform the minimum vendor inspection requirement of 20 was due to the travel restrictions and mandatory lockdowns associated with the COVID-19 global pandemic. The vendor inspection staff has reprioritized the vendor inspection schedule for FY 2021 to include the delayed FY 2020 vendor inspections.
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 Criterion IX 40.00%
Criterion III 60.00%
Analysis: The NRC issued a total of five NONs against vendors during FY 2020. The decrease in the total number of NONs issued from FY 2019 to FY 2020 follows a similar decrease from FY 2018 to FY 2019, during a time of a decreasing number of vendor inspections. Regarding 10 CFR Part 21, no NOVs were issued to vendors during FY 2020, as was the case during FY 2019. The reduced number of vendor inspections performed in FY 2020 is largely due to the COVID-19 global pandemic. All five NONs cited against Appendix B to 10 CFR Part 50 were not indicative of any industry trend considering that this is one year performance and the reduced number of vendor inspections performed.
However, more focus will be placed in these two criteria during future vendor inspections. 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. The NRC received positive feedback from the vendors on 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 13 notifications of inspection completed in FY 2020, all were within the VIP timeliness goal, which represents a score of 100%.
Although 14 total inspections were conducted in FY 2020, one announcement letter was captured in the FY 2019 metrics, two inspections were unannounced, and two Announcement Letters pertained to inspections that will be conducted in FY 2021.
Metric Criteria Met: Yes 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.
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 14 inspection plans completed in FY 2020, all were completed within the VIP timeliness goal, which represents a score of 100%.
Although a total of 14 inspections were conducted in FY 2020, one inspection plan was captured in the FY 2019 metrics, and one inspection plan pertained to an inspection that will be conducted in FY 2021.
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 12 inspection reports issued in FY 2020, all but one was completed within the VIP timeliness goal, which represents a score of 91.67%. Although 14 total inspections were conducted in FY 2020, one inspection report was issued for an inspection that was captured in the FY 2019 metrics and three inspection reports will be issued in FY 2021.
Metric Criteria Met: Yes 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.
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 five vendor NON responses received in FY 2020, all acknowledgement letters were issued within the VIP timeliness goal, which represents a score of 100%. During FY 2020, six vendor NON responses were required. However, one vendor has not yet responded, so this will be captured in the FY 2021 metrics.
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 two NONs contested by a stakeholder during FY 2020. However, after an independent assessment, there were no retracted NONs during FY 2020, 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 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 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.
Analysis: The vendor inspection staff supported 52 allegation actions during FY 2020. Of those allegations, two resulted in reactive inspections 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 2020, no vendor inspector completed their qualification. However, there were three trainees undergoing the qualification process at the end of FY 2020.
All three are on track to qualify 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 February 2020.
Therefore, this represents a score of 100%.
Metric Criteria Met: Yes