ML18047A195

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IMC 1245, Appendix C8, Vendor Inspector Technical Proficiency Training and Qualification Journal
ML18047A195
Person / Time
Issue date: 07/30/2018
From: Alexander Schwab
NRC/NRR/DIRS/IRGB
To:
Schwab A
Shared Package
ML18047A106, ML18211A122 List:
References
CN 18-023, DC 18-011
Download: ML18047A195 (21)
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Text

NRC INSPECTION MANUAL IRGB INSPECTION MANUAL CHAPTER 1245, APPENDIX C8 VENDOR INSPECTOR TECHNICAL PROFICIENCY TRAINING AND QUALIFICATION JOURNAL Effective Date: 07/30/2018

Table of Contents Introduction ................................................................................................................................. 1 Vendor Inspector Technical Proficiency Individual Study Activities.............................................. 2 (ISA-VI-1) Vendor Quality Assurance Program ................................................................ 3 (ISA-VI-2) 10 CFR Part 21 Reporting .............................................................................. 6 (ISA-VI-3) Commercial-Grade Dedication ........................................................................ 8 Vendor Inspector Technical Proficiency On-the-Job Activities ................................................... 10 (OJT-VI-1) Preparing for a Vendor Inspection ............................................................. 11 (OJT-VI-2) Conducting a Vendor Inspection ................................................................ 13 (OJT-VI-3) Writing a Vendor Inspection Report ........................................................... 15 Vendor Inspector Technical Proficiency Level Signature Card and Certification ........................ 17 Form 1: Vendor Inspector Technical Proficiency Level Equivalency Justification ..................... 18 : Revision History Sheet ................................................................................ Att1-1 Issue Date: 07/30/18 i 1245 Appendix C8

Introduction The inspector training and qualification program requires a candidate to complete a variety of assignments. Each assignment has been selected to help the candidate learn information or practice a skill that will be important to performing the job of a Vendor Inspector. After completing the entire qualification process, a candidate will have demonstrated proficiency in each of the competencies that describe a successful Vendor Inspector.

Do not begin the activities or complete the courses in this qualification journal until you have completed the Basic Inspector Certification Journal. You may complete the General Proficiency requirements contained in Appendix B together with the Technical Proficiency requirements outlined in this journal.

Issue Date: 07/30/18 1 1245 Appendix C8

Vendor Inspector Technical Proficiency Individual Study Activities Issue Date: 07/30/18 2 1245 Appendix C8

Vendor Inspector Technical Proficiency Individual Study Activity TOPIC: (ISA-VI-1) Vendor Quality Assurance Program PURPOSE: The purpose of this activity is to familiarize the candidate with the documents necessary to provide the NRC inspector with the bases and guidance required to support vendor inspection activities.

COMPETENCY AREAS: INSPECTION LEVEL OF EFFORT: 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />

REFERENCES:

1. 10 CFR Part 50, Appendix B (Appendix B), Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants
2. American National Standards Institute (ANSI) 45.2, Quality Assurance Requirements for Nuclear Power Plants
3. Regulatory Guide 1.26, Quality Group Classification and Standards for Water, Steam, and Radioactive-Waste-Containing Components of Nuclear Power Plants, Revision 4, March 2007
4. Regulatory Guide 1.28, Quality Assurance Program Requirements (Design and Construction), Revision 4, June 2010
5. Regulatory Guide 1.33, Quality Assurance Program Requirements (Operation), Revision 2, February 1978
6. American Society of Mechanical Engineers (ASME) Standard NQA-1 (1994, 2008, NQA-1a 2009 addenda Editions), Quality Assurance Program for Nuclear Facilities
7. NRC Standard Review Plan (SRP) 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants
8. Regulatory Issue Summary (RIS) 2000-18, Guidance on Managing Quality Assurance Records in Electronic Media
9. International Standards Organization (ISO) Q9001-2000, Quality management systems - Requirements
10. SECY-03-0117, Approaches for adopting more widely accepted international quality standards
11. The current version of the Vendor Inspection Program Plan (VIPP):

http://www.nrc.gov/reactors/newreactors/oversight/quality-assurance/vendor-insp.html Issue Date: 07/30/18 3 1245 Appendix C8

EVALUATION:

CRITERIA: At the completion of this activity, the candidate should be knowledgeable in the following areas:

1. How the Appendix B criteria applies to vendors and how the criteria are used during vendor inspections.
2. Methods acceptable to the NRC staff for complying with the Commission's regulations with regard to overall quality assurance program requirements and implementation as described in NRC Regulatory Guides.
3. Understand how the ANSI and ASME standards specify requirements for the establishment and execution of quality assurance programs for the siting, design, construction, operation, and decommissioning of nuclear facilities that meet the requirements of Appendix B.
4. The criteria used by the NRC specified in the SRP to evaluate a quality assurance program description provided by an applicant for a design certification, combined license, early site permit, construction permit or an operating license.
5. Understand NRC guidance on managing quality assurance records in electronic media.
6. Understand how vendors, particularly international vendors, attempt to implement an ISO Q9001-2000 program in lieu of an Appendix B program.
7. Understand how the VIPP is applied to the NRC vendor inspection organization.

TASKS: 1. Review Appendix B and discuss the application to vendors with a qualified vendor inspector.

2. Review the specified industry guidance and discuss how the guidance meets the requirements of Appendix B with a qualified vendor inspector.
3. Review the specified Regulatory Guides and RIS and discuss their application to vendors with a qualified vendor inspector.
4. Review SRP 17.5 and discuss its application to vendors with a qualified vendor inspector.
5. Review ISO Q9001-2000 and discuss its similarities with, and differences from, 10 CFR Part 50 Appendix B with a qualified vendor inspector.

Issue Date: 07/30/18 4 1245 Appendix C8

6. Meet with your supervisor or a qualified vendor inspector to discuss any questions that you may have as a result of this activity and to demonstrate that you can meet the evaluation criteria listed above.
7. Review and discuss the VIPP with a qualified vendor inspector.

DOCUMENTATION: Obtain your supervisors signature in the line item for Item ISA-VI-1 in the Vendor Inspector Technical Proficiency Level Signature Card and Certification Form.

Issue Date: 07/30/18 5 1245 Appendix C8

Vendor Inspector Technical Proficiency Individual Study Activity TOPIC: (ISA-VI-2) 10 CFR Part 21 Reporting of Defects and Noncompliance.

PURPOSE: The purpose of this activity is to familiarize the candidate with the procedures, guidance and activities applicable to the Reporting Requirements of 10 CFR Part 21, and defect reporting bases and guidance.

COMPETENCY AREAS: INSPECTION LEVEL OF EFFORT: 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />

REFERENCES:

1. 10 CFR Part 21 (Part 21), Reporting of Defects and Noncompliance
2. Section 206, Noncompliance of the Energy Reorganization Act of 1974
3. NUREG-0302, Remarks Presented (Questions/Answers Discussed) at Public Regional Meetings to Discuss Regulations (10 CFR Part 21) for Reporting of Defects and Noncompliance, Revision 1, July 1977
4. 10 CFR 50.55(e)
5. LIC-403, Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR Part 50.55(e))

EVALUATION CRITERIA: After completing this study, the candidate should be able to:

1. Discuss the requirements of Part 21, its legal basis and applicability to licensees and vendors.
2. Understand the differences between a deviation and a defect and the vendors responsibility toward both.
3. Identify the attributes you will be looking for compliance with Part 21 during a plant tour of the vendors facilities.
4. Understand the differences between Part 21 and 50.55(e).
5. Identify the records that the vendor should have to demonstrate compliance with this regulation.
6. Understand how the need for performance of a vendor inspection may be identified through NRC staff review of Part 21 notifications.

Issue Date: 07/30/18 6 1245 Appendix C8

TASKS: The activities listed below shall be performed under the guidance of a qualified vendor inspector. Discuss the evaluation criteria with your supervisor for documentation on signature card:

1. Review the references to understand the principles discussed in the evaluation criteria.
2. Discuss the general requirements of Part 21 with your supervisor or qualified vendor inspector.
3. Gain a general understanding of a vendors Part 21 Program through discussions with a qualified vendor inspector. If possible, review a vendors Part 21 implementing procedure and discuss your observations with a qualified vendor inspector.
4. Meet with your supervisor or a qualified vendor inspector to discuss any questions that you may have as a result of this activity and demonstrate that you can meet the evaluation criteria listed above.

DOCUMENTATION: Obtain your supervisors signature in the line item for Item ISA-VI-2 in the Vendor Inspector Technical Proficiency Level Signature Card and Certification Form.

Issue Date: 07/30/18 7 1245 Appendix C8

Vendor Inspector Technical Proficiency Individual Study Activity TOPIC: (ISA-VI-3) Commercial Grade Dedication PURPOSE: The purpose of this activity is to familiarize the candidate with the procedures, guidance and activities applicable to the commercial-grade dedication process. The candidate should develop an understanding of how a commercial item can be used as a basic component through a dedication process. In all cases, the dedication process must be conducted in accordance with the applicable provisions of Appendix B to 10 CFR Part 50.

COMPETENCY AREAS: REGULATORY FRAMEWORK INSPECTION LEVEL OF EFFORT: 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br />

REFERENCES:

1. 10 CFR Part 21, Reporting of Defects and Noncompliance
2. GL 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products
3. GL 91-05, Licensee Commercial-Grade Procurement and Dedication Programs
4. EPRI NP-5652, Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications (NCIG-07)
5. EPRI Report NP-6406, Guidelines for the Technical Evaluation of Replacement Items in Nuclear Power Plants (NCIG-11)
6. NRC Inspection Procedure (IP) 38703, Commercial Grade Dedication
7. NRC IP 43004, Inspection of Commercial-Grade Dedication Programs
8. Regional or Office guidance on handling of Part 21 reports
9. EPRI NP-7218 Guideline for the Utilization of Sampling Plans for Commercial Grade Item Acceptance (NCIG-19)

EVALUATION CRITERIA: Use the references above and/or sections of the references above to answer the Evaluation Criteria. At the completion of this activity, you will be asked to demonstrate your understanding of the Vendor Inspectors role with regard to commercial grade dedication by successfully discussing the following:

Issue Date: 07/30/18 8 1245 Appendix C8

1. State the purpose of commercial grade dedication.
2. State the four acceptable methods of accepting commercial grade items. Be able to describe key characteristics of each method.
3. Describe what is meant by critical characteristics and their importance to the commercial grade dedication process.
4. Define like-for-like replacement and describe when it can be used.
5. Describe the three characteristics of effective procurement and dedication programs.
6. Describe EPRI guidance on sampling.

TASKS: The activities listed below shall be performed under the guidance of a qualified vendor inspector. Discuss the evaluation criteria with your supervisor for documentation on signature card:

1. Review the references to understand the principles discussed in the evaluation criteria.
2. Review Enclosure 1 to GL 91-05 for specifics of inspection findings related to commercial grade dedication programs.
3. Discuss the evaluation criteria with a qualified vendor inspector or with your Supervisor.

DOCUMENTATION: Obtain your supervisors signature in the line item for Item ISA-VI-3 in the Vendor Inspector Technical Proficiency Level Signature Card and Certification Form.

Issue Date: 07/30/18 9 1245 Appendix C8

Vendor Inspector Technical Proficiency On-the-Job Activities Issue Date: 07/30/18 10 1245 Appendix C8

Vendor Inspector Technical Proficiency On-the-Job Activity TOPIC: (OJT-VI-1) Preparing for a Vendor Inspection PURPOSE: The purpose of this activity is to provide the candidate with experience in the actions and research required to adequately prepare to perform a vendor inspection.

COMPETENCY AREAS: INSPECTION LEVEL OF EFFORT: 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br />

REFERENCES:

1. NRC Inspection Manual Chapter (IMC) 2700, Vendor Inspection Program
2. Inspection Procedure (IP) 43001, Reactive Inspection of Nuclear Vendors
3. IP 38703, Commercial Grade Dedication
4. IP 43004, Inspection of Commercial-Grade Dedication Programs
5. IP36100, Inspection of 10 CFR Parts 21 and 50.55(e) Programs for Reporting Defects and Noncompliance EVALUATION CRITERIA: At the completion of this activity, a candidate should be able to:
1. State the actions required to be taken prior to the performance of a vendor inspection.
2. State the areas to be researched and reviewed prior to a vendor inspection.
3. State the goals of the vendor inspection.

TASKS: 1. Attend a telephone call with a vendor to announce the upcoming inspection and to obtain confirmation on the inspection dates.

2. Explain how to obtain a vendor inspection docket number.
3. Prepare an Announcement Letter which formally informs the vendor of the upcoming inspection and documents the dates.
4. Identify the goals of the inspection and to allow for the preparation of an Inspection Plan. The research should include the review of any current documentation (e.g. allegations), and review of Part 21 reports and the vendor docket file for information related to the Issue Date: 07/30/18 11 1245 Appendix C8

specific areas to be inspected.

5. Prepare the inspection plan for the vendor inspection.
6. Prepare entrance meeting notes.
7. Meet with your supervisor or a qualified vendor inspector to discuss any questions that you may have as a result of this activity and demonstrate that you can meet the evaluation criteria listed above.

DOCUMENTATION: Obtain the supervisors signature in the line Item OJT-VI-1 of the Vendor Inspector Qualification Signature Card.

Issue Date: 07/30/18 12 1245 Appendix C8

Vendor Inspector Technical Proficiency On-the-Job Activity TOPIC: (OJT-VI-2) Conducting a Vendor Inspection PURPOSE: The purpose of this activity is to provide the candidate with experience in the actions and activities required to successfully perform a vendor inspection.

COMPETENCY AREAS: INSPECTION LEVEL OF EFFORT: Varies

REFERENCES:

See OJT-VI-1, Preparing for a Vendor Inspection EVALUATION CRITERIA: At the completion of this activity, a candidate should be able to:

1. State the actions required to be taken during the performance of a vendor inspection.
2. State examples of the protocol required to be adhered to during the performance of the vendor inspection.
3. State the key points to be made to the vendor during the entrance and exit meeting.
4. State how the goals of the vendor inspection were achieved by the activities performed during the inspection.

TASKS: During the preparation or performance of a vendor inspection, discuss the required protocol during the performance of the vendor inspection with a qualified inspector or supervisor.

1. Discuss NRC guidelines for sharing written notes or other information with a vendor.
2. Discuss how inspection findings are to be characterized during an inspection exit meeting.
3. Discuss how allegation-related information should be handled and/or addressed during the inspection.
4. Discuss the proper handling of vendor proprietary information and copying and removal of vendor documents.
5. Attend an inspection entrance meeting.
6. Perform inspection tasks assigned which may include: (1) the review of documents, (2) observation of activities, (3) inspection of Issue Date: 07/30/18 13 1245 Appendix C8

equipment, material, and product, and (4) interviewing of vendor personnel.

7. Attend an inspection exit meeting.
8. Meet with your supervisor or a qualified vendor inspector to discuss any questions that you may have as a result of this activity and demonstrate that you can meet the evaluation criteria listed above.

DOCUMENTATION: Obtain your supervisors signature in the line Item OJT-VI-2 of the Vendor Inspector Technical Proficiency Level Signature Card and Certification Form.

Issue Date: 07/30/18 14 1245 Appendix C8

Vendor Inspector Technical Proficiency On-the-Job Activity TOPIC: (OJT-VI-3) Writing a Vendor Inspection Report PURPOSE: The purpose of this activity is to provide the candidate with experience in the actions and research required to document the results of an inspection conducted at a vendor.

COMPETENCY AREAS: INSPECTION LEVEL OF EFFORT: 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />

REFERENCES:

1. IMC 0617, Vendor and Quality Assurance Implementation Inspection Reports
2. OJT-VI-1, Preparing for a Vendor Inspection EVALUATION CRITERIA: At the completion of this activity, a candidate should be able to:
1. State the steps taken and the information used to prepare vendor inspection report input.
2. State the attributes to look for in an inspection report input to verify that the goals of the inspection have been accomplished and adequately verified.
3. State the steps that are required to assemble the inspection report into its final form and prepare the cover letter that transmits the report to the vendor.

TASKS: 1. Prepare inspection report input based on the task(s) assigned during an inspection. Sources of information will be notes taken during the inspection and review of vendor documents (both on and off-site).

2. Prepare a Notice of Nonconformance (NON) or Notice of Violation (NOV), if identified during the course of the vendor inspection.
3. Draft the cover letter which will transmit the vendor inspection report and any NOVs or NONs to the vendor.
4. Draft the ADAMS Document submission sheet (Form NRC-665) which is required to be submitted with the vendor inspection report.
5. Meet with your supervisor or a qualified vendor inspector to discuss any questions that you may have as a result of this activity and demonstrate that you can meet the evaluation criteria listed above.

Issue Date: 07/30/18 15 1245 Appendix C8

DOCUMENTATION: Obtain your supervisors signature on the line Item OJT-VI-3 on the Vendor Inspector Technical Proficiency Level Signature Card and Certification Form.

Issue Date: 07/30/18 16 1245 Appendix C8

Vendor Inspector Technical Proficiency Level Signature Card and Certification Employee Supervisors Inspector Name: ______________________ Initials / Date Signature /

Date Required Training Courses None identified Individual Study Activities ISA-VI-1 Vendor Quality Assurance Program ISA-VI-2 10 CFR Part 21 Reporting ISA-VI-3 Commercial-Grade Dedication On-the-Job Activities OJT-VI-1 Preparing for a Vendor Inspection OJT-VI-2 Conducting a Vendor Inspection OJT-VI-3 Writing a Vendor Inspection Report Supervisors signature indicates successful completion of all required courses and activities listed in this journal and readiness to appear before the Oral Qualification Board.

Supervisors Signature: _______________________________ Date: _____________

Issue Date: 07/30/18 17 1245 Appendix C8

Form 1: Vendor Inspector Technical Proficiency Level Equivalency Justification Identify equivalent training and experience for which the inspector Inspector Name: ______________________ is to be given credit Required Training Courses None identified Individual Study Activities ISA-VI-1 Vendor Quality Assurance Program ISA-VI-2 10 CFR Part 21 Reporting ISA-VI-3 Commercial-Grade Dedication On-the-Job Activities OJT-VI-1 Preparing for a Vendor Inspection OJT-VI-2 Conducting a Vendor Inspection OJT-VI-3 Writing a Vendor Inspection Report Supervisors Recommendation: Signature / Date: ______________________

Division Directors Approval: Signature / Date: ______________________

Copies to: Supervisor, Inspector, and Human Resources Issue Date: 07/30/18 18 1245 Appendix C8

Revision History Sheet Attachment 1 Commitment Accession Description of Change Description of Comment Tracking Number Number Training Resolution and Issue Date Required and Closed Feedback Change Notice Completion Date Form Accession Number N/A 01/10/08 Appendix C-8 was extensively revised to update the None ML073510727 CN 08-001 content and format of the document. Completed 4 year historical CN search.

N/A ML12248A339 This revision updates references in ISA-1 and ISA-3, None ML12290A180 12/19/12 adds Evaluation Criteria 6 to ISA-3, and adds new CN-12-029 knowledge requirements (a reference, evaluation criteria, and task) regarding the vendor inspection program plan to ISA-1.

N/A ML18047A195 This revision updates the references in OJT-3 to ML18065A657 07/30/18 account for the creation of IMC 0617. Closed FF:

CN 18-023 1245C8-2266 ML18134A021 Issue Date: 07/30/18 Att1-1 1245

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