ML20085J011
| ML20085J011 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2020 |
| From: | Yamir Diaz-Castillo NRC/NRR/DRO/IQVB |
| To: | |
| Diaz-Castillo Y | |
| Shared Package | |
| ML20098E004 | List: |
| References | |
| CN 20-020 | |
| Download: ML20085J011 (5) | |
Text
NRC INSPECTION MANUAL IQVB INSPECTION PROCEDURE 43003 REACTIVE INSPECTIONS OF NUCLEAR VENDORS PROGRAM APPLICABILITY: IMC 2507 43003-01 INSPECTION OBJECTIVES 01.01 To obtain additional information about reported problems involving vendors supplying basic components. Verify that vendors supplying basic components have taken adequate corrective actions to preclude recurrence of significant conditions adverse to quality. Verify that vendors supplying basic components identified the root or apparent cause(s) of a reported deficiency, including evaluation of the adequacy and effectiveness of the vendor's 10 CFR Part 21 program as well as appropriate aspects of the 10 CFR Part 50, Appendix B, quality assurance (QA) program. Verify that vendors supplying basic components have evaluated the deficiency for potential generic implications. Problems may be identified through 10 CFR Part 21 reports, 10 CFR 50.55(e) reports, 10 CFR 50.72 reports (immediate notifications), 10 CFR 50.73 reports (licensee event reports), allegations, and requests from the regional offices or other branches within the NRC.
This procedure is to be used in combination with the following inspection procedures, when applicable: Inspection Procedure (IP) 36100, Inspection of 10 CFR Part 21 and Programs for Reporting Defects and Noncompliance, or 36100.01, Inspection of 10 CFR 50.55(e) Programs for Reporting Defects and Noncompliance During Construction, and IP 43004, Inspection of Commercial-Grade Dedication Programs.
43003-02 INSPECTION REQUIREMENTS 02.01 Review the vendors nonconformance and corrective action programs to verify that the vendor has identified and evaluated significant conditions adverse to quality (SCAQ) or conditions adverse to quality (CAQ) that have potentially affected basic components supplied by the vendor.
02.02 Verify that the root or apparent causes of SCAQs have been adequately identified, including identification of weaknesses in the QA program that contributed to the significant condition adverse to quality.
02.03 Verify that actions taken to correct both the specific SCAQs and the causal factors are adequate to preclude recurrence.
02.04 Review the vendors implementation of corrective actions for outstanding items identified during previous inspections and/or pending issues, as applicable.
02.05 When applicable, and in accordance with IP 36100 or 36100.01, verify that the QA program provides adequate controls for evaluating and reporting defects and failures to comply.
Issue Date: 04/08/20 1 43003
02.06 When applicable, and in accordance with IP 43004, verify that commercial-grade products or services procured for use in safety-related applications are adequately dedicated through the implementation of a suitable commercial-grade dedication program.
02.07 When directed by the Allegations Review Board (ARB), follow-up on potentially safety significant allegations to determine their validity, and, if valid, evaluate the vendor's corrective actions taken to resolve the matter.
02.08 Assess whether the circumstances and/or behavior of the inspected party should be subject to evaluation and possible investigatory measures by the Office of Investigations (OI).
02.09 When applicable, a qualified vendor inspector also qualified as a safety culture assessor, should participate when safety culture and/or safety conscious work environment issues (SCWE) need to be evaluated.
43003-03 INSPECTION GUIDANCE Inspection Manual Chapter 2507 will be followed for additional guidance.
General Guidance. Reactive inspections will be conducted at vendor facilities in response to unexpected situations that could affect the quality of the basic components supplied to assess the vendors corrective actions related to the reported problem. Problems may be identified through 10 CFR Part 21 reports, 10 CFR 50.55(e) reports, 10 CFR 50.72 reports (immediate notifications), 10 CFR 50.73 reports (licensee event reports), allegations, NRC operating experience community reports, information provided by vendors, applicants, and licensees, and requests from the regional offices or other branches within the NRC.
The lead inspector will prepare an inspection plan in accordance with established guidelines.
The inspection plan should provide the scope and basis for the inspection; describe the proposed evaluation of the vendors activities, including the QA program procedures and its implementation, and identify the work assignments for each inspector. Reactive inspections may be unannounced as determined by the ARB or the Quality Assurance and Vendor Inspection (IQVB) Branch Chief. Guidance on developing inspection plans is contained in IMC 0617, Vendor and Quality Assurance Implementation Inspection Reports.
The inspectors will evaluate the effectiveness of the vendor's QA program and procedures, as it relates to the reported problem, using a graded approach with emphasis in the guidance described below.
03.01 Review the vendor's nonconformance and corrective action processes and their implementation to verify if the SCAQs or CAQs were evaluated and causal factors identified.
Examine vendor's records to determine if the SCAQ or CAQ is repetitive, and, if so, determine why previous corrective actions were ineffective. In the event that other vendor products are affected, verify that corrective actions and notifications have taken place, as applicable.
Issue Date: 04/08/20 2 43003
03.02 Verify that the vendor has performed an adequate root or apparent cause analysis of depth as applicable to the issue or problem significance, including an evaluation of the vendor's QA program to identify potential programmatic deficiencies that may have led or contributed to the SCAQ. Verify that the identified root or apparent causes and programmatic deficiencies are being or have been corrected.
03.03 Verify that the vendors compensatory measures and corrective actions are adequately documented and sufficient to prevent recurrence. Evaluate the adequacy of the corrective actions to preclude recurrence as well as the timeliness of their implementation.
03.04 Verify that the vendor's corrective actions on previously identified inspection findings have been adequately implemented consistent with its QA program requirements. Identify and document issues of a generic nature.
03.05 Refer to IP 36100, 36100.01, and/or IP 43004, as applicable, for additional guidance.
03.06 If applicable, through interviews and observations, gather the information necessary to either substantiate the alleger's claims or provide reasonable assurance that the claims are unfounded. Some of the information provided by vendor employees, contractors, or other individuals during the inspection may be considered allegations. This information needs to be addressed in conformance with NRC Management Directive (MD) 8.8, "Management of Allegations."
03.07 Evaluate the information obtained during the inspection to determine if potential wrongdoing has occurred. If potential wrongdoing has been identified, it must be considered an allegation and should immediately be reported to the inspectors management and the Office Allegation Coordinator, for possible referral to the Office of Investigations, or other appropriate action.
03.08 If applicable, and when dealing with SCWE and/or safety culture issues, utilize the questions from Appendix A of IP71152, Problem Identification and Resolution, as it applies to vendors.
03.09 Discuss the licensees oversight activities with the vendor and review licensee audit reports to gauge the adequacy of the licensees oversight. If inadequacies in the licensees oversight are identified, discuss the issues with the IQVB Branch Chief, who may forward the information to regional management or the Nuclear Procurement Issues Corporation for additional action, as appropriate.
43003-04 NOTIFICATION TO AFFECTED LICENSEES The lead inspector will provide input to the NRC generic communications process to determine the need for wider distribution of information obtained during the inspection.
43003-05 RESOURCE ESTIMATE This inspection procedure is used for reactive inspections of vendors providing basic components to licensees. The resource estimate for this inspection procedure is approximately 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of direct inspection effort.
Issue Date: 04/08/20 3 43003
43003-06 REFERENCES Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products."
GL 91-05, "Licensee Commercial-Grade Procurement and Dedication Programs."
Information Notice 86-21 and supplements, "Recognition of ASME Accreditation Program for N Stamp Holders."
Inspection Manual Chapter 2507, Vendor Inspections.
Inspection Procedure (IP) 43002, Routine Inspections of Nuclear Vendors.
IP 43004, Inspection of Commercial-Grade Dedication Programs.
IP 36100, Inspection of 10 CFR Part 21 and 50.55(e) Programs for Reporting Defects and Nonconformance.
IP 71152, Problem Identification and Resolution.
IP 36100.01, Inspection of 10 CFR 50.55(e) Programs for Reporting Defects and Noncompliance During Construction.
NRC Management Directive 8.8, "Management of Allegations."
END
Attachment:
Revision History for IP 43003 Issue Date: 04/08/20 4 43003
ATTACHMENT 1 Revision History for IP 43003 Commitment Accession Number Description of Change Description of Comment Resolution and Tracking Issue Date Training Closed Feedback Form Number Change Notice Required Accession Number (Pre-and Completion Decisional, Non-Public Date Information)
N/A 10/03/07 Researched commitments for 4 years N/A N/A CN 07-030 and found none.
Initial issuance N/A ML110871939 Revised Inspection Procedure to refer N/A N/A 04/25/11 to Manual Chapter 2507. Added CN 11-007 Manual Chapter 2507 to the references.
This revision is in response to OIG audit (OIG-10-A-02 (ML103020267)).
N/A ML13248A332 Revised Inspection Procedure to create N/A ML13248A333 10/03/13 one reactive vendor inspection CN-13-024 procedure. The requirements from IP 43001, Reactive Inspection of Nuclear Vendors, have been moved to IP 43003, Reactive Inspections of Nuclear Vendors. Upon issuance of this version of IP 43003, IP 43001 will be deleted.
N/A ML15323A153 Added a pointer to IP 71152 and added N/A ML15323A154 12/14/15 guidance on qualified safety culture CN 15-029 assessors.
N/A ML20085J011 Revised Manual Chapter to reflect the N/A N/A 04/08/20 new organization based on the merger CN 20-020 of NRR and NRO, and made some editorial changes.
Issue Date: 04/08/20 Att1-1 43003