Text

Reduction in Commitment to the Columbia Operation Quality Assurance Program Description
	ML20139A225
Person / Time
Site:	Columbia
Issue date:	05/18/2020
From:	Hettel W; Energy Northwest
To:	; Document Control Desk, Office of Nuclear Reactor Regulation
References
	GO2-20-076
	Download: ML20139A225 (13)
	v • d • e

ENERGY William G. Hettel Columbia Generating Station NORTHWEST P.O. Box 968, PE23 Richland, WA 99352-0968 Ph. 509.377.8311 l F. 509.377.4674 wghettel@energy-northwest.com May 18, 2020 GO2-20-076 10 CFR 50.54(a)

U. S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001

Subject:

COLUMBIA GENERATING STATION, DOCKET NO. 50-397 REDUCTION IN COMMITMENT TO THE COLUMBIA OPERATIONAL QUALITY ASSURANCE PROGRAM DESCRIPTION

Dear Sir or Madam:

Pursuant to 10 CFR 50.54(a)(4), Energy Northwest hereby requests approval of a revision to the Columbia Generating Station (Columbia) Operational Quality Assurance Program Description (OQAPD) that results in a reduction of commitment to the previously accepted quality assurance program. The change provides an alternative to current approved methods to perform vendor surveillance under certain stated conditions.

The proposed change provides the ability to perform remote vendor surveillance typically used to verify successful completion of certain fabrication and testing activities related to equipment that is complex, expensive, or designated for use in nuclear safety-related applications. The use of this method of verification will only be applicable when a pandemic or similar state of emergency has been declared restricting access or travel to and/or from those locations affected by the declaration.

The Enclosure provides Energy Northwests basis for concluding that the revised program continues to satisfy the criteria of 10 CFR 50 Appendix B and provides an adequate level of quality control. Attachments 1 and 2 provide markup and clean affected pages of the Columbia OQAPD, respectively.

Included in the basis for the change is an outline of the method to be used by Energy Northwest procurement and quality personnel to screen certain vendor surveillance activities to assure an acceptable means of documenting the activity and providing necessary objective evidence.

GO2-20-076 Page 2 of 2 No commitments are being made to the NRC by this letter. Approval of the change is requested within the 60 days identified in 10 CFR 50.54(a)(4). The OQAPD will be revised within 10 business days of approval to support station activities. Should you have any questions, please contact Richard M. Garcia at (509) 377-8463.

I declare under penalty of perjury that the foregoing is true and correct.

18 Executed this ______ day of May, 2020.

Respectfully, r DocuSigned by:

L~=8E~

W. G. Hettel Vice President Nuclear Generation, Chief Nuclear Officer

Enclosure:

As stated Attachments: As Stated cc: NRC RIV Regional Administrator NRC NRR Project Manager NRC Senior Resident Inspector CD Sonoda - BPA EFSECutc.was.gov - EFSEC E Fordham - WDOH R Brice - WDOH L Albin - WDOH

GO2-20-076 Enclosure Page 1 of 7 1.0 Description of the Change The proposed change will add a remote performance option to the Columbia Generating Station (Columbia) Operational Quality Assurance Program Description (OQAPD) when vendor surveillance is required. The proposed change does not apply to the vendor audits or surveys and specifically addresses the vendor surveillances portion of source verification activities identified in the OQAPD. The change will provide guidance for the application of video and other real-time communication technologies for the successful performance of remote vendor surveillance. The use of this method of verification will only be applicable when a pandemic or similar state of emergency has been declared restricting access or travel to and/or from those locations affected by the declaration.

2.0 Reason for the Proposed Change Columbia has experienced relatively low impact due to the current pandemic travel restrictions. However, inability to perform quality assurance activities such as audits, commercial grade surveys, and vendor surveillances at suppliers facilities is impacting plant maintenance operations.

The worldwide pandemic caused by the COVID-19 virus has impacted the ability for utilities such as Energy Northwest to perform necessary and sometimes regulatory required verification activities at vendor locations. Columbia currently has the need to perform a vendor surveillance to complete a purchase of test equipment required to perform preventive maintenance testing. The declaration of various stay-at-home orders as a result of the COVID-19 pandemic prevents Energy Northwest personnel from traveling to the vendors location to complete an on-site surveillance. In addition, the specific Proclamation 20-25 issued by the Governor of the State of Washington remains in effect with only limited exceptions imposing a Stay Home - Stay Safe order throughout Washington State.

The following process description is based on Remote Source Verification During a Pandemic or Similar State of Emergency: Screening Criteria and Process Guidance,

[Electrical Power Research Institute] EPRI, Palo Alto, CA: 2020. 3002019436. The Energy Northwest definitions differ from those used in the EPRI document in that Source Verification at Energy Northwest includes Vendor Surveillance, Inspections and Audits. This submittal uses the Energy Northwest term Vendor Surveillance in place of the EPRI term Source Verification to be consistent with our existing program terminology. The function described by the two terms is the same.

The proposed change will provide an alternate method of performing remote vendor surveillances under certain conditions. Typically, a vendor surveillance is used to verify successful completion of certain fabrication and testing activities related to equipment that is complex, expensive, or designated for use in nuclear safety-related applications. The use of this method for vendor surveillance will only be applicable when a pandemic or similar state of emergency has been declared restricting access or travel to and/or from those locations affected by the declaration. The

GO2-20-076 Enclosure Page 2 of 7 proposed change will not apply to other quality assurance activities such as vendor audits or surveys used to qualify a vendors quality assurance program.

3.0 Basis for Concluding that the Revised Program Continues to Satisfy the Criteria of 10 CFR 50, Appendix B and the Previously Accepted Quality Assurance Program Commitments.

The Columbia OQAPD provides a consolidated overview of the quality program controls which govern the operation and maintenance of Energy Northwest's quality related items and activities. The OQAPD serves as a written charter to describe the quality assurance organizational structure, functional responsibilities, levels of authority, and interfaces. The methods of implementation of the requirements of the OQAPD are commensurate with the item's or activity's importance to safety. The applicability of the requirements of the OQAPD to other items and activities is determined on a case-by-case basis. The OQAPD implements 10 CFR 50 Appendix B.

The OQAPD is implemented through the use of approved procedures (i.e., policies, directives, procedures, instructions, or other documents) which provide written guidance for the control of quality-related activities and provide for the development of documentation to provide objective evidence of compliance.

During the development of the following regulatory documents which provide the basis for the Columbia OQAPD, availability of real-time communication technologies for remote source verification is not discussed. Therefore, the existing regulatory language provided below implies source verification (vendor surveillance) is conducted in-person at the source location and any changes to the regulatory framework would require prior approval.

Criterion VII of 10 CFR 50, Appendix B includes clear language relating to the use of source verification to accept a basic component for use without commercial grade dedication.

VII. Control of Purchased Material, Equipment, and Services Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that material and equipment conform to the procurement requirements shall be available at the nuclear powerplant or fuel reprocessing plant site prior to installation or use of such material and equipment. This documentary evidence shall be retained at the nuclear powerplant or fuel reprocessing plant site and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and

GO2-20-076 Enclosure Page 3 of 7 quantity of the product or services. [Emphasis added]

Additionally, NRC Inspection Manual Inspection Procedure 43004 Issued April 25, 2011 states the following in Section 03.04 Definitions.

m. Source Verification: Activities witnessed at the supplier's facilities by the purchaser or its agent before releasing the CGI from the vendor or test laboratory facility to confirm by direct observation that the selected critical characteristics are verified by the vendor. [Emphasis added]

ANSI N45.2.10 endorsed by NRC Regulatory. Guide 1.74 defines source surveillance as:

A review, observation, or inspection for the purpose of verifying that an action has been accomplished as specified at the location of material procurement or manufacture. [Emphasis added]

The performance of a remote vendor surveillance contains limitations as it does not permit the same flexibility as an in-person witnessing of an activity would provide such as:

The ability to review the actual documents and procedures as well as preparations, equipment, personnel, and other things going on in the vicinity of the activity.

Added difficulty to ask questions during the process, request adjustments, double-check measurements, and so forth.

The verifiers field of vision and ability to observe and verify is limited by the frame of the camera or video screen.

The ability to verify is also limited to the capabilities of the video equipment and individuals operating the video equipment.

As a result, remote vendor surveillance may not be an effective alternative for the full range of source verification activities. Therefore, Energy Northwest proposes a screening of the specific source verification be performed to determine if remote vendor surveillance is appropriate for the activities being verified prior to conducting the activity remotely. Energy Northwest proposes to screen the required vendor surveillance for eligibility by using an industry developed approach that employs the following six attributes:

1. Is it possible to do on-site surveillance?

If it is possible for the individual(s) performing the surveillance to be on-site, the activity is not eligible for remote vendor surveillance. If it is not possible for the individual(s) performing the surveillance to be on-site, the answer is no and the reason that surveillance cannot be performed should be documented and screening may proceed.

GO2-20-076 Enclosure Page 4 of 7 The intent is to limit remote vendor surveillance to situations where an on-site presence is not possible due to restrictions imposed by authorities (such as stay-at-home orders) that are related to the safety of individuals performing the vendor surveillance. A no answer shall not be based on cost savings, expediting, ordinary unavailability of personnel, etc.

2. Is the activity an assessment?

Remote vendor surveillance is not intended to be used to conduct quality assessments such as audits or commercial grade surveys. If the answer is yes, the activity is not eligible for remote vendor surveillance. If the activity can be adequately verified remotely, the screening can proceed.

3. Can the activity be adequately surveilled remotely?

The intent of this question is to determine if the activity is one that can be adequately performed using remote surveillance. If the answer is no, the activity is not eligible for remote surveillance. If the answer is yes, proceed with screening.

Certain types of activities and special processes may require in-person inspection. An example might be an inspection that is highly dependent on visual examination or requires very close inspection such as a weld inspection. Examples of activities that could be adequately verified remotely would include witnessing a calibration or acceptance test.

Another consideration when determining if an activity can be adequately surveilled remotely is the confidence in the ability of the organization performing the activities being surveilled to understand the objectives and be willing to enable successful completion of the surveillance activities. Factors to consider include:

Previous experience with the supplier

The suppliers capability and willingness to conduct the surveillance remotely

Complexity of the activity being performed

Ability to implement controls to ensure successful completion and documentation of the surveillance activities

4. Can progress and results be captured and communicated in real time?

The intent of this question is to determine if technology can be used to capture the progress and results of the activity remotely, in real time (while the activity occurs), with two-way communication. Considerations may include the ability of cameras to capture all important aspects of the activity, the ability of the person doing the surveillance to have an appropriate level of control over the process, and so on. For example, the remote surveillance cannot be based on previously recorded video. The verifier must be able to communicate with the entity performing the activity while it is being performed.

GO2-20-076 Enclosure Page 5 of 7 If the answer is no, the activity is not eligible for remote surveillance. If the answer is yes, screening may proceed.

5. Can a maintainable record be created for objective evidence?

The purpose of this question is to determine if the verifier can document the activity in a format the verifier can maintain and control as objective evidence in a quality record. If the answer is no, the activity is not eligible for remote surveillance. If the answer is yes, screening may proceed. Another consideration is the ability to uniquely identify the item so that traceability to the surveillance results can be ensured.

6. Does initiating entity concur with use of remote surveillance?

This question applies when the entity performing the screening is different than the organization or individual that originally requested the traditional vendor surveillance. It is intended to determine whether the original requestor agrees the activity can be successfully accomplished remotely.

This ensures the original requestor does not object to use of remote surveillance after the surveillance is completed. It also provides the original requestor with an opportunity to identify an alternative acceptance method. For example, if the vendor surveillance activity was to witness a pressure test, the original requestor might determine the purchaser could do the pressure test after delivery instead.

If the answer is no, the activity is not eligible for remote surveillance. If the answer is yes, screening is complete, and the activity is eligible for remote surveillance.

Once it is determined that the activity is eligible for remote vendor surveillance, a plan for performing the remote vendor surveillance will be developed and approved by the Energy Northwest organizations responsible for not only verifying the items quality attributes, but also those providing the communication tools and the security and confidentiality associated with the remote vendor surveillance activity.

Development and Limitations of a Remote Vendor Surveillance Plan Many factors will affect the specific communication tools and the platform used in each remote vendor surveillance plan. Therefore, a specific communication tool or platform is not discussed in this proposal. The selection will be based on history of use, compatibility with involved organizations, standardization, stability, versatility, timestamping requirements, video capture, etc.

Energy Northwest will develop a vendor surveillance plan that will include attributes such as:

Determining if the scope or objectives of the vendor surveillance plan need to be adjusted to account for additional activities and resources needed to accomplish the

GO2-20-076 Enclosure Page 6 of 7 vendor surveillance remotely

Identifying and testing communication tools and platforms to be used during the remote vendor surveillance

Developing a plan for accomplishing the vendor surveillance objectives in real-time during the remote vendor surveillance

Discussing the activity with the affected stakeholders to ensure that they concur with the use of remote vendor surveillance and that the remote vendor surveillance plan addresses their objectives

Establishing a contingency plan to include the primary and secondary form of communication during the activity - means of signaling/recovering if communication fails

Establishing method of documenting the activity and results

Working with the supplier, perform a trial run to verify primary and contingency equipment works as expected

Establishing the scheduled date and time for the vendor surveillance

Conducting and then confirming that the vendorsurveillance activities included in the remote vendor surveillance plan are complete and satisfactory prior to release Upon receipt, additional inspections may be added.

4.0 Conclusion Although remote vendor surveillance cannot fully replace the ability to observe and verify activities at the source, as discussed above the use of modern communication technologies approved by Energy Northwest Information Services (IS) and Corporate Information Technology (IT), a remote vendor surveillance verification plan can be developed and implemented that will continue to satisfy the criteria of Appendix B to 10 CFR Part 50 providing an equivalent, and therefore acceptable, level of quality control. As stated above, the proposed change will only apply to vendor surveillance activities that can be justified by applying the above questions. The proposed change does not impact any other attributes of the Columbia OQAPD.

5.0 References

1. U.S. Code of Federal Regulations, Title 10, Chapter 1, Part 50, Domestic Licensing of Production and Utilization Facilities. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, D.C.

2. Nuclear Regulatory Commission Inspection Procedure 43004Inspection of Commercial-Grade Dedication Programs. NRC Inspection Manual. U.S. Nuclear Regulatory Commission, Government Printing Office, Washington, D.C.: January 2017.

3. ANSI N45.2.10, Quality Assurance Requirements Terms and Definitions, American National Standards Institute, Washington, D.C.: 1973.

4. Regulatory Guide 1.74, Quality Assurance Terms and Definitions, U.S. Nuclear Regulatory Commission, Washington, D.C.: February 1974.

GO2-20-076 Enclosure Page 7 of 7

5. OQAPD-01, Columbia Operational Quality Assurance Program Description, Major Revision 055, Minor Revision 0 Effective Date September 16, 2019

6. Remote Source Verification During a Pandemic or Similar State of Emergency, Screening Criteria and Process Guidance, EPRI 3002019436 dated April 2020

GO2-20-076 Attachment 1 Revised Pages of the Columbia Operational Quality Assurance Program Description

Number: OQAPD-01 I Use Category: INFORMATION Major Rev: 055 Minor Rev: N/A

Title:

Operational Quality Assurance Program Description (EN-QA-004) Page: 18 of 54

c. A survey of the vendor's facilities and QA program to determine their capability to supply a product, which meets the design, manufacturing, and quality requirements.

d. Suppliers of commercial-grade calibration or testing services from a laboratory holding accreditation by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) and a documented review of the supplier's accreditation by Energy Northwest may be used in lieu of audit, survey, inspections, or tests following delivery, or in-process surveillances during performance of the service.

7.2.5 Source verification (vendor surveillance, inspection and audit) shall be commensurate with the relative importance, complexity, and quantity of the items or service procured and the vendor's quality performance. In-process and final surveillance requirements of vendor products shall be determined in advance and performed to assure conformance with procurement document requirements.

Source verification is not required to be performed where the quality of the item can be verified by review of test reports, inspection upon receipt, or other means.

Source verification activities shall include evaluation of vendor furnished Certificates of Conformance and/or vendor's Certification System. Remote vendor surveillance is acceptable as a dedication process when a pandemic or similar state of emergency has been declared restricting access or travel to and/or from vendor locations affected by the declaration. The remote vendor surveillance will be screened for eligibility, planned, and then performed using real time video and documented.

7.2.6 Receiving inspection of vendor furnished items shall be performed to assure that:

a. The item is properly identified and corresponds to the identification on the procurement document and the receiving documentation.

b. The item and the acceptance records satisfy the inspection instruction prior to relying upon the item to perform its safety function.

c. Specified inspection, test, and other records are complete and available at the site prior to relying upon the item to perform its safety function.

d. Inspection status of accepted items is identified prior to their being released for storage, use or further work.

7.2.7 Documentary evidence that the vendor furnished items conform to the procurement requirements shall be retained by Energy Northwest for the life of the items.

GO2-20-076 Attachment 2 Retyped Pages of the Columbia Quality Assurance Program Description