CY-05-152, Proposed Change to Revision 5 of the Connecticut Yankee Quality Assurance Program

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Proposed Change to Revision 5 of the Connecticut Yankee Quality Assurance Program
ML051750533
Person / Time
Site: Haddam Neck File:Connecticut Yankee Atomic Power Co icon.png
Issue date: 06/20/2005
From: Bourassa J
Connecticut Yankee Atomic Power Co
To:
Document Control Desk, NRC/FSME
References
CY-05-152, RG-7.010, Rev. 2
Download: ML051750533 (218)
v • d • e


Text

  • 3CONNECTICUT YANKEE ATOMIC POWER COMPANY HADDAM NECK PLANT 362 INJUN HOLLOW ROAD

U. S. Nuclear Regulatory Commission Attention: Document Control Desk Washington, D. C. 20555-0001 Haddam Neck Plant Proposed Change to Revision 5 of the Connecticut Yankee Quality Assurance Program (CYQAP)

The purpose of this letter is to request a change, in accordance with 10 CFR 50.54(a), to Revision 5 of the Connecticut Yankee Quality Assurance Program (CYQAP) for the Haddam Neck Plant (HNP). The proposed change involves elimination of commitments to ANSI Standards and Regulatory Guides in various sections. On March 30, 2005, all spent fuel and GTCC Waste was removed from the Spent Fuel Pool and transferred to the Independent Spent Fuel Storage Installation at the HNP site. All safety-related Structures, Systems, and Components (SSCs) have been removed from service and have undergone or are undergoing demolition. Therefore, the current commitments to various ANSI standards and Regulatory Guides are no longer necessary. The only SSCs that remain subject to the CYQAP are ISFSI related. The SSCs related to the ISFSI are categorized as important to safety and are subject to the guidance of Regulatory Guide 7.10, Revision 2, "Establishing Quality Assurance Program for Packaging Used in the Transportation of Radioactive Material". This guidance will be utilized to satisfy the criteria of Appendix B to 10 CFR 50 and the Quality Assurance requirements of 10 CFR 71 and 10 CFR 72.

Since the proposed change involves a reduction in commitment to the current CYQAP, Connecticut Yankee Atomic Power Company (CYAPCO) hereby requests NRC review and approval of the proposed change to the CYQAP.

Attachment 1 provides a detailed description and justification of the proposed change including a comparison matrix of Regulatory Guide 7.10. The comparison matrix demonstrates that the provisions included in Regulatory Guide 7.10 have been adequately addressed in the CYQAP and implementing procedures. Attachment 1 also includes a comparison of the eighteen criteria of 10 CFR 71, Subpart H to the CYQAP to demonstrate that these criteria are adequately addressed. Attachment 2 includes a marked-up version of Revision 5 to the CYQAP and a summary of changes. Attachment 3 includes the proposed retyped version of Revision 6 to the CYQAP.

Q 00

Document Control Desk CY-05-152 / Page 2 In accordance with 10 CFR 50.54(a), CYAPCO will implement proposed Revision 6 to the CYQAP upon approval by the NRC or after 60 days from the date of this letter.

Similar changes have been proposed and approved at the Yankee Atomic Rowe Plant, as documented in letters from the USNRC to Yankee Atomic dated June 20, 2000, and September 27, 2004.

There are no regulatory commitments contained within this letter.

If you should have any questions regarding this submittal, please contact Mr. G.

P. van Noordennen at (860) 267-3938.

Sincerely, b( LI' 05 J F. B urassa Date Director of Nuclear Safety/Regulatory Affairs Attachments:

1. Description and Justification of the Proposed Change to the CYQAP Including a Comparison Matrix of Regulatory Guide 7.10.
2. A Marked-up Version of Revision 5 to the CYQAP and Summary of Changes.
3. A Retyped Version of Proposed Revision 6 to the CYQAP.

cc: Mr. S. J. Collins, NRC, Region 1 Administrator Ms. M. T. Miller, Chief, Decommissioning Branch, NRC Region 1 Mr. T. B. Smith, NRC, Project Manager Dr. E. L. Wilds Jr., CT DEP, Director, Radiation Division

CY-05-1 52 Docket No. 50-213 Attachment 1 Haddam Neck Plant Proposed Chanae to Revision 5 of the Connecticut Yankee Quality Assurance Program Description and Justification of the Proposed Change to the CYQAP Including a Comparison Matrix of Regulatory Guide 7.10 June 2005

CYQAP CR 05-02 10CFR50.54(a) Evaluation Purpose Evaluate the changes to the CYQAP proposed under Revision 6, CR 05-02, to the Program to determine if these changes require prior NRC approval pursuant to the requirements of 10CFR50.54(a).

Discussion As transfer of all spent fuel to the ISFSI has been completed, there is no longer a need to maintain quality requirements or Quality Assurance Program applicability to the previously defined scope of the CY Quality Assurance Program (CYQAP).

All plant safety-related systems, structures and components have been reclassified as non-safety-related. All applicable Limiting Conditions for Operation (LCOs), surveillances and administrative requirements, previously found in the Technical Specification Safety Manual, have been transferred to the CYQAP in accordance with License Amendment 201. Activities previously identified in the CYQAP as Augmented Quality activities are now controlled in accordance with applicable programs and procedures.

The quality related activities remaining are those required for decommissioning and activities related to the safe storage of spent fuel and GTCC at the ISFSI.

The CYQAP will remain applicable to these activities.

Similar changes have been proposed and approved at the Yankee Atomic Rowe Plant, as documented in letters from the USNRC to Yankee Atomic dated June 20, 2000, and September 27, 2004.

Evaluation of changes shall be presented on a "Section by Section" basis.

Page 1 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Evaluation Table of Contents Changes to this Section are editorial in nature to support the proposed changes within the CYQAP. These changes include changing the name of individual parts of the CYQAP from "Chapter" to "Section" and renaming of certain Appendices.

Determination of Impact 10 CFR 50.54(a)(3) does not consider quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, as reductions in commitment. Therefore, the proposed changes may be made without prior approval of the USNRC.

No adverse impact to the CYQAP will result due to these changes.

Abstract No changes have been made to this section.

Policy Statement These changes are virtually identical to those which were approved by the USNRC for the Yankee Decommissioning Quality Assurance Program (YDQAP).

In accordance with 10CFR50.54(a)(3)(ii). The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility, is acceptable for implementation without prior USNRC approval.

These changes do not constitute a reduction in commitment and may be implemented without prior USNRC approval.

Determination of Impact No adverse impact to the CYQAP will result due to these changes.

Page 2 of 15

CYQAP CR 05-02 10CFR50.54(a) Evaluation Chapter 1 - Organization Significant changes to this Chapter include:

  • Deletion of the Industry Experience Program
  • Deletion of Director of Nuclear Safety/Regulatory Affairs and UnitIISFSI Manager responsibilities for the Fire Protection Program
  • Transfer of responsibility for Site Closure activities from the Director of Decommissioning to the Director of Project Support Other changes to this section include title changes, typographical corrections, editorial changes and changes in responsibilities or lines of communication.

Determination of Impact The requirements for maintaining an Industry Experience Program are found in 10 CFR 50. The purpose for this Program, as described in regulation, are to ensure that important lessons learned from industry experience are promptly and effectively communicated to those personnel actively engaged in plant design and construction, monitoring and establishing goals for the Maintenance Rule Program, characterizing the functional importance of SSCs, and maintenance of training programs subject to 10CFR50.120 requirements. Connecticut Yankee no longer maintains any safety-related SSCs or engages in the design, construction or monitoring of safety-related SSCs. The requirements of 1OCUR 50.120 are for the training and qualification of nuclear power plant personnel.

Although Connecticut Yankee continues to maintain the Part 50 license for the Haddam Neck Plant, a certification of permanent cessation of operations has been issued to the USNRC. All remaining instrumentation associated with the plant and ISFSI is categorized as either non-safety-related or Important to Safety Category C. There are no safety-related or Important to Safety Category A or B SSCs for which periodic or corrective maintenance is required. Similarly, there are no chemistry parameters to be maintained. Any industry experience which might be of value to health physics personnel would be communicated to Connecticut Yankee by the Certificate of Compliance holder for the NAC-MPC system or by the NRC through generic communications. Therefore, the reasons for maintaining an Industry Experience Program are no longer applicable to the Haddam Neck Plant or ISFSI. The deletion of the Industry Experience Program from the CYQAP; however, constitutes a reduction in commitment and may not be implemented except in accordance with the provisions of 10 CFR 50.54(a)(4)(iv).

The Fire Protection Program is controlled in accordance with ISFSI procedures and was considered an Augmented Quality Program in previous revisions to the CYQAP. With the deletion of the applicability of the CYQAP to Augmented Quality Programs in Change Request CR-05-01 to the CYQAP, this change is Page 3 of 15

CYQAP CR 05-02 10CFR50.54(a) Evaluation considered editorial in nature. Under the provisions of 10CFR50.54(a)(3), these changes do not constitute a reduction in commitment.

Changes in responsibilities or lines of communication are necessary to properly position the organization for transition from wet to ISFSI storage and complete decommissioning. These changes still reflect appropriate independence where required and the appropriate level of management involvement in quality related activities. These changes do not constitute a reduction in commitment and may be implemented without prior USNRC approval.

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. These changes may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 2 - Quality Assurance Program Significant changes to this Chapter include:

  • Deletion of applicability of the CYQAP from Plant safety-related SSCs and related programs
  • Deletion of applicability of the ASME Code and related regulatory guides and standards
  • Decrease in the frequency of the management assessment of the Quality Assurance Program from annually to biennially Other changes to this section include title changes, typographical corrections, and editorial changes.

Determination of Impact With the elimination of all safety-related SSCs, changes associated with the applicability of the ASME Code and related regulatory guides are no longer appropriate. The requirements for maintenance, monitoring and design of the ISFSI are contained in the NAC-MPC Certificate of Compliance and SAR.

Applicability to these SSCs remains as specified in Appendix A of the CYQAP.

These changes, however, constitute a reduction in commitment and may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

The purpose of the annual management assessment is to assess the effectiveness of the QA Program. Past assessments have not had significant findings and have found the QA Program to be adequate and effective in ensuring that activities affecting quality are performed in accordance with programs and Page 4 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation procedures which have been reviewed and approved in accordance with the CYQAP. In light of these positive assessments and the continual oversight of activities affecting quality provided by the Independent Review and Audit Committee, it is not anticipated that any adverse impact would result by extending the period between management assessments to 24 months. This change, however, constitutes a reduction in commitment and may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

Among the corrections is the deletion of the statement in paragraph 2.2.3 that Important to Safety SSCs are listed in the CY UFSAR. Important to Safety SSCs are no longer listed in the CY UFSAR since all spent fuel and GTCC waste has been transferred to the ISFSI. In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. These changes may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 3 - Design Control All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 4 - Procurement Document Control Significant changes made to this Section relate to the deletion of reference to endorsed Codes and Standards.

All other changes to this Section are editorial in nature.

Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have Page 5 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of IOCFR50.54(a)(4)(iv).

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 5 - Procedures, Instructions and Drawings Significant changes made to this Section relate to the deletion of reference to endorsed Codes and Standards.

All other changes to this Section are editorial in nature.

Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter 6 - Document Control Significant changes to this Chapter include the deletion of "functions" from the scope of applicability found in paragraph 6.1.

Page 6 of 15

CYQAP CR 05-02 I OCFR50.54(a) Evaluation All other changes to this Section are editorial in nature.

Determination of Impact By stating that controlled distribution of documents is pertinent to Quality Activities affecting the Important to Safety functions of SSCs is inappropriately limiting. By rewording the statement to eliminate "functions", increases the scope of applicability of the Quality Assurance Program. An increase in scope does not constitute a reduction in commitment, therefore, this change may be implemented without prior USNRC approval.

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. These changes may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 7 - Control of Purchased Material, Equipment and Services Significant changes to this Chapter include the deletion of commitment to the requirements of Regulatory Guide 1.123, Regulatory Guide 1.144 and ANSI N45.2.1 3.

Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

No adverse impact to the CYQAP will result due to these changes.

Chapter 8 - Identification and Control of Materials, Parts and Components All changes to this Section are editorial in nature.

Page 7 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Determination of Impact Inaccordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter 9 - Control of Special Processes Significant changes made to this Section relate to the deletion of reference to endorsed Codes and Standards.

All other changes to this Section are editorial in nature.

Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter 10 - Inspection Significant changes made to this Section relate to the deletion of reference to endorsed Codes and Standards.

All other changes to this Section are editorial in nature.

Page 8 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter I1 - Test Control All changes to this Section are editorial in nature.

Determination of Impact In accordance with IOCFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter 12 - Test Control All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

Page 9 of 15

CYQAP CR 05-02 iOCFR50.54(a) Evaluation No adverse impact to the CYQAP will result due to these changes.

Chapter 13 - Handling, Storage and ShipPing Significant changes made to this Section relate to the deletion of reference to endorsed Codes and Standards.

All other changes to this Section are editorial in nature.

Determination of Impact The Codes and Standards referenced in previous revisions of the CYQAP were pertinent to operating plants and the HNP while safety-related SSCs were still maintained. With the completion of transfer of all spent fuel to the ISFSI and the resultant elimination of all safety-related SSCs, compliance with all previously endorsed Codes and Standards is no longer appropriate. Similar actions have been taken in a revision to the Yankee Decommissioning Quality Assurance Program. As deletion of reference to previously endorsed Codes and Standards constitutes a reduction in commitment, this change may not be implemented except in accordance with the provisions of 10CFR50.54(a)(4)(iv).

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 14 - Inspection, Test and Operating Status All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Page 10 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Chapter 15 - Nonconforming Materials, Parts, Components or Services All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chanter 16 - Corrective Actions All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Chapter 17 - Qualitv Assurance Records All changes to this Section are editorial in nature.

Determination of Imnact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Page 11 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Chanter 18 - Audits All changes to this Section are editorial in nature.

Determination of Impact These changes still reflect appropriate independence where required and the appropriate level of management involvement in quality related activities. In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Appendix A No Changes were made to this Appendix.

Appendix B All changes to this Section are editorial in nature.

Determination of Impact In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

No adverse impact to the CYQAP will result due to these changes.

Appendix C Significant changes to this Appendix include the endorsement of NUREG/CR-6407 "Classification of Transportation Packaging and Dry Fuel Storage System Components According to Importance to Safety" (February 1996) and the deletion of commitment to the following regulatory guides and standards:

Regulatory Guide 1.28 - 2/79 - Quality Assurance Program Requirements (Design Page 12 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation and Construction) Endorses ANSI N45.2-1977.

  • Regulatory Guide 1.94 - Quality Assurance Requirements for Installation, Inspection and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plant - 4/76 - Endorses ANSI N45.2.5 -

1974 and Section 6.11 of ANSI N45.2.5-1978.

  • Regulatory Guide 1.152- uCriteria for Digital Computers in Safety Systems of Nuclear Power Plants," January 1996- Endorses IEEE-ANS 7.4.3.2 - 1993.

Editorial changes to this Appendix are minor in nature and serve to clarify the contents of this Appendix.

Determination of Impact These changes still reflect appropriate independence where required and the appropriate level of management involvement in quality related activities. In accordance with 10 CFR 50.54(a)(3), editorial or title changes do not constitute a reduction in commitment. This change may be implemented without prior USNRC approval.

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment.

No adverse impact to the CYQAP will result due to these changes.

Page 13 of 15

CYQAP CR 05-02 IOCFR50.54(a) Evaluation Appendix D Significant changes to this Appendix include the deletion of the quality assurance term: "Nuclear Grade," and changing the applicability of 'Material Requests" from "Nuclear Grade" to "Important to Safety" procurements.

Editorial changes to this Appendix are minor in nature and serve to correct typographical errors.

Determination of Impact Upon completion of transfer of all spent fuel and GTCC to the ISFSI and the subsequent reclassification of safety-related SSCs to non-safety related status, there will be no value in defining the term "Nuclear Grade". Further, without safety-related SSCs, there is no reason to continue its use. Upon reclassification of SSCs and cancellation of the program, there is no reason to carry this definition or reference to "safety-related" in the CYQAP. The deletion is, therefore, considered editorial in nature. As such, in accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment.

No adverse impact to the CYQAP will result due to these changes.

Appendix E Appendix E is the approved exceptions to Regulatory Guides and standards and is deleted in its entirety in this revision to support deletion of related commitments.

Determination of Impact The deletion of these exceptions would require full compliance with the remaining commitments. As such, there is no reduction in commitment by the deletion.

No adverse impact to the CYQAP will result due to these changes.

Appendix F Significant changes to this Appendix include the deletion of the Independent Review and Audit Committee responsibility to review and assess the Fire Protection Program.

Page 14 of 15

CYQAP CR 05-02 10CFR50.54(a) Evaluation Editorial changes include the renaming of Appendix F to Appendix E following deletion of the old Appendix E and correction of numbered paragraphs to correspond to changes to the CYQAP made necessary by the deletion of paragraphs referencing the Fire Protection Program Determination of Impact The Fire Protection Program is controlled in accordance with ISFSI procedures and was considered an Augmented Quality Program in previous revisions to the CYQAP. With the deletion of the applicability of the CYQAP to Augmented Quality Programs in Change Request CR-05-01 to the CYQAP, this change is considered editorial in nature. Under the provisions of 10CFR50.54(a)(3), these changes do not constitute a reduction in commitment.

In accordance with 10CFR50.54(a)(3), editorial or title changes do not constitute a reduction in commitment.

No adverse impact to the CYQAP will result due to these changes.

Conclusion Based on the results of this evaluation, some of the changes proposed for Revision 6 reduce the level of commitment in the CYQAP and may not be implemented except in accordance with 10CFR50.54(a)(4)(iv) which states, Changes to the quality assurance program description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.

Page 15 of 15

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

1. GUIDANCE ON § 71.103, QUALITY ASSURANCE ORGANIZATION 1.1 Structure and Authority Section 1, An organizational chart is provided in Section 1 of CYQAP, For each function, the structure of the organization and the Figure 1 Figure 1 assignment of responsibility should ensure that:

-The formal organization structure is documented on organization charts that identify each organizational element that functions under the QA program,

-The required authority and organizational freedom, including 1.4.10 1.4.10 states that the Nuclear Safety Manager is sufficient independence from influences of cost and schedule, responsible to ensure that the Quality Assurance are provided, Organization has the organizational freedom and authority to: identify problems; to initiate, recommend or provide solutions through designated channels; verify implementation of solutions; and stop unsatisfactory work.

-The specified quality requirements are achieved and 2.2.3 2.2.3 states, maintained by those who have been assigned the responsibility "For systems, structures and components and regulatory for performing the work, commitments, procedures describe the measures taken to assure that the quality assurance requirements are met.

The degree of control over activities affecting quality systems, structures, and components is consistent with their importance to safety. The CYQAP provides controls that include the use of appropriate equipment; establishment of suitable controls over special processes and skills necessary to attain the required quality; and the need for verification of quality by inspection and test."

1 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

-Measures are established to provide adequate control over 2.2.3 2.2.3 states, activities important to safety (e.g. inspecting, cleaning, 'Applicable organizations jointly determine and identify the purchasing, preparing the packaging for extent of quality assurance controls are to be applied to delivery), and quality structures, systems, and components. The quality assurance controls are in conformance with this CYQAP, which complies with 10 CFR 50 Appendix B, 10 CFR71 Subpart H and 10 CFR 72 Subpart G."

-Conformance to established requirements is verified by 10.1 10.1 states, individuals and groups not directly responsible for performing Inspection of activities to verify the quality of systems, the work. structures and components, which are performed by or for Note: If, because of limited personnel, multiple functions CY are executed in accordance with the CYQAP and including QA are performed by the same individuals, measures appropriate procedures, instructions and drawings by should be established to ensure that the designated individuals qualified personnel independent from the individual or when performing QA and QC functions have the responsibility group performing the activity being inspected."

and authority to stop unsatisfactory work, stop delivery or installation of nonconforming material, and have direct access to management levels that can ensure that QA procedures important to safety have been accomplished.

The duties and qualifications required for (1) the individual who 1.4.2 For Item (1), 1.4.2 states, has overall authority and responsibility for the QA program as 'The President reports to the CEO and has the necessary well as (2) other personnel performing QA and QC functions, authority and overall responsibility for developing, and those individuals should have the written endorsement of maintaining, and implementing the CYQAP at the HNP and top management. ISFSI and in providing support services to the staff."

2.2.5 For Item (2), 2.2.5 states,

'A program is established and maintained for quality assurance indoctrination and training which provides confidence that the required level of personnel competence and skill is achieved and maintained in the performance of quality activities. Quality procedures delineate the requirements for an indoctrination program to assure that personnel responsible for performing quality activities are instructed in the purpose, scope, and implementation of 2 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement quality procedures and instructions and that compliance to these documents is mandatory. CY Management is responsible for ensuring appropriate indoctrination and training of assigned personnel performing quality activities.

Training Programs shall be developed and implemented to provide training for individuals performing quality activities associated with the HNP or ISFSI. Additional guidance is established in procedures.

Implementing procedures describe the program requirements which assure that:

  • Documentation of formal training and qualification programs includes the objective, content of the program, attendees, date of attendance, and examination results, as applicable;
  • Proficiency of personnel performing and verifying activities affecting quality is established and maintained. Personnel proficiency is established and maintained by training, examination/testing, and/or certification based upon the requirements of the activity. Acceptance criteria, as appropriate, are developed to determine if individuals are properly trained and qualified; and

. Certificates or other documentation of qualification clearly delineate the specific functions personnel are qualified to perform and the criteria used to qualify personnel in each function."

Appendix B For both parts (1) & (2), Appendix B contains the 3 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement qualification requirements for the Quality Assurance Manager and other plant personnel performing quality activities.

1.2 Top Management Endorsement of a QA Program Section 1 Item (1) is addressed in the Policy Statement and Section 1 Top management should maintain a continuing involvement in 2.2.2 and 2.2.2.

QA matters in order to ensure that the QA program is effective. 2.2.6 To ensure the commitment of top management, the 18.2.1 Item (2) is addressed in Sections 2.2.6 and 18.2.1.

company/corporate president or chief executive officer should establish a written policy stating that it is company/corporate policy to perform work on items important to safety in accordance with the requirements of Subpart H, as described in Policy Statement The Policy Statement and Section 1 address all aspects of the QA program plan and implemented in the QA program & Section 1 Para. 1.2.

implementing documents. The policy statement should also identify the functions and positions who have delegated authority for the following tasks:

  • Implement and revise the provisions of the described QA program.
  • Regularly assess the scope, status, implementation, and effectiveness of the QA program.
2. GUIDANCE ON §71.105, "QUALITY ASSURANCE CYQAP The CYQAP has been previously approved by the NRC PROGRAM" and is allowed to be used per 10CFR71.101(f).

2.1 General Guidance on QA Programs In its program description submittal, the QA program user should identify to the NRC how each of the regulations in Subpart H of 10 CFR Part 71 applies to its particular situation and how it will be satisfied. The information supplied for NRC review will vary as a function of the nature of activities in which the QA program user is involved. For example, an individual or organization using a general license solely for transportation of radioactive material in packages purchased or leased for that purpose would be expected to address regulations governing activities such as procurement, shipment, and handling. By contrast, someone who designs and fabricates packaging 4 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement would be expected to address criteria for design and testing, as well as material procurement activities. Elements common to all QA program descriptions include the quality organization and program, corrective action, QA records, and audits. In developing its programs, prospective QA program users can refer to the NRC's guidance in this regulatory guide, as well as the additional guidance on graded QA in NUREG/CR-6407 (Ref. 2).

In developing its program, QA program users should apply each of the applicable Subpart H regulations in a graded approach (i.e., to an extent that is consistent with its importance to safety).

Following the NRC staffs technical review and determination that the QA program submittal meets regulatory requirements, the Commission issues a QA Program Approval. The approval expires on the last day of the month stated on the approval form and may be renewed (at the request of the QA program user and in accordance with 10 CFR 71.38) not less than 30 days prior to expiration.

All changes to the approved QA program description require NRC approval. Therefore, before implementing any change in the QA program description that was used as the basis for NRC approval, the QA program user should submit the proposed change for NRC review and approval. Requests for review and approval of such changes are handled through amendments to the QA Program Approvals and do not affect the renewal dates.

The only exception to the requirement for NRC approval of any change relates to QA programs that the NRC staff approved under Appendix B to 10 CFR Part 50, which was subsequently accepted under 10 CFR 71.101(f). This exception allows a nuclear power plant licensee to change such a QA Program to 5 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement the extent permitted under 10 CFR 50.54(a)(3).

Based on NRC approval of its QA program description submittals, a QA program user will translate the regulations discussed in its submittals into lower-level (working-level) implementing procedures that govern the conduct of QA activities that are important to safety.

If the NRC staff reviews a QA program submittal and finds that it inadequately describes how the requirements will be met or fails to specifically address some Subpart H regulation(s), the staff will ask the QA program user to submit additional information to correct the deficiencies.

2.2 Scope of QA Program The QA program user should establish measures for identifying Appendix A For item (1), Appendix A addresses all SSCs to which the (1) the components, structures, and systems to be covered by CYQAP is applicable.

the QA program, and (2) the approach for verifying that the applicable components, structures, and systems meet design CYQAP For item (2), various sections of the CYQAP identify the objectives. Although 10 CFR Part 71 allows the development approach for verifying that the applicable components, of a 'graded" QA program, this does not preclude the structures, and systems meet design objectives.

alternative of defining a program based on maximum controls if such a program is deemed necessary to attain the confidence Sections 5, 7, 9, For bullet 1, Sections 5, 7, 9, 10, 10, 12, 13, & 14 identify needed for meeting design objectives. In particular, the QA 10, 10, 12, 13, 14 the controls and practices necessary to ensure that program user should establish measures to ensure that the activities important to safety are performed using specified following requirements are fulfilled: equipment and under suitable environmental conditions.

  • Activities important to safety are performed using specified equipment and under suitable environmental conditions. CYQAP For bullet 2, all sections of the CYQAP specify the
  • QAIQC manuals specify the designated QA and QC designated QA and QC responsibilities for implementation responsibilities for implementation of activities important to of activities important to safety.

safety.

  • The QA program user has established indoctrination and 2.2.5, 9.9.2, For bullet 3, Sections 2.2.5, 9.9.2, & 10.2.3 establish the training programs to ensure that personnel performing activities 10.2.3 requirements for established indoctrination and training important to safety are trained and qualified to perform those programs to ensure that personnel performing activities 6 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 XA Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement activities. important to safety are trained and quali ed to perform those activities.

2.3 Applicability of QA Program Measures covered by the QA program should be compatible Abstract, The Abstract and Appendix A of the C QAP address the with and emphasize characteristics identified in the Appendix A applicability of the CYQAP, including I SSCs. In Appendix manufacturer's QA program. The QA program user should A, the NAC-MPC Final Safety Analysis Repor(FSAR) and establish the rationale to Identify items that are classified as associated NAC specifications, NAC Storage Transport important to safety and subject to the user's QA program. Cjask STC) Safety Analysis Report and associated NAC specifications and NUREG/CR-6407 are identified as input references for determining Important to Safety classifications.

2.4 Documentation The QA program user should ensure that (1) written procedures Section 5 Section 5 of the CYQAP states, and instructions describe all activities that are important to 'The CYQAP provides measures for the preparation, safety and applicable to the design, procurement, fabrication, Master Document review, approval, control and distribution of procedures, and testing of packaging, and (2) those procedures and Index instructions and drawings of activities affecting quality instructions will be in place before the QA program user systems, structures and components during maintenance, engages in those activities. modification, and decommissioning of the HNP and ISFSI.

The documents include appropriate quantitative and With respect to anticipated activities important to safety that the qualitative acceptance criteria which specify the activity to QA program user has not yet initiated, the user should identify be performed; the methods of construction and testing to the implementing procedures by title and procedure number, be employed; material, equipment or parts to be used; a and should provide a brief description of the content of those sequence of operation and the required documentation."

procedures with an estimated date for their completion. The following table shows a suitable format for listing procedures to (The Quality Assurance Criterion to Implementing demonstrate implementation of a documented QA program. Procedure Matrix is contained in Attachment 1)

(Table I omitted.)

2.5 Controlled Conditions 5.1 Paragraph 5.1 states, Measures should be established to ensure that activities 11.2.1 "The CYQAP provides measures for the preparation, important to safety are accomplished using appropriate 11.2.3 review, approval, control and distribution of procedures, production and test equipment, suitable environmental 11.2.4 instructions and drawings of activities affecting quality conditions, applicable codes and standards, and proper work systems, structures and components during maintenance, instructions. The assignment of responsibility for each task and modification, and decommissioning of the HNP and ISFSI.

7 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement method used to verify conformance to these quality The documents include appropriate quantitative and requirements should be documented. qualitative acceptance criteria which specify the activity to be performed; the methods of construction and testing to be employed; material, equipment or parts to be used; a sequence of operation and the required documentation."

Section 11.2.1 states,

'Test requirements to determine or to verify the capability of an item to meet specified requirements in accordance with engineering/design documents, Safety Analysis Reports (SAR), technical specifications, procedures or procurement documents, as appropriate, are accomplished by subjecting the item to a set of physical, chemical, environmental or operating conditions. Retest following repair, replacement or modification is performed in accordance with the original design requirements or acceptable alternatives and is performed when original test results are invalidated."

Section 11.2.3 states,

'CY procedures provide the criteria for determining when a test is required and the accuracy requirements of test equipment.

The following steps are taken in the control of test equipment:

a. Test instrumentation is checked and calibrated in accordance with CY procedures to ensure accuracy;
b. Plant and ISFSI instrumentation used in testing is calibrated. It is maintained in calibration at regular intervals in accordance with surveillance and/or preventative maintenance procedures; and 8 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement Where special instrumentation is required for testing, the requirements are stated in the procedures. Instrument characteristics, including accuracy requirements, are equivalent to or better than those specified by the vendor."

Section 11.2.4 states, "The documented test results are evaluated against the predetermined acceptance criteria by an individual or group having appropriate qualifications. The acceptance status of the test is documented. Deficiencies noted during the evaluation are documented and dispositioned in accordance with approved procedures."

3. GUIDANCE ON §71.107, "PACKAGE DESIGN CONTROL" 3.1 Section 3.1 assigns responsibility to the Director of Project Essential elements of adequate design control are (1) good Support for control of design activities which include relationships among those responsible for preparing design identification of the design basis and correctly translating disclosures, (2) conducting independent design analyses, (3) these requirements into specifications, drawings, coordinating interfaces, and (4) maintaining lines of procedures, and instructions; controlling design interfaces communication. To ensure an adequate commitment to control among participating organizations; and controlling design of design activities, applicants should consider the three changes to ensure control measures commensurate with principal areas of (1) control of the design process, (2) control those applied to the original design.

of design input, and (3) control of design verification, as defined in regulatory positions 3.1 - 3.3. The last paragraph of Section 3.1 specifically states that the application of design controls does not include SSCs for Since users of packaging do not normally perform design radioactive material transportation packages and dry spent activities, this section of Subpart H should not be applicable to fuel storage components utilized under the provisions of a users of packaging. However, users should establish and verify General License pursuant to 10 CFR 71 and 10 CFR 72. The that the packaging was designed under the control of an NRC- NAC MPC System and the NAC STC System have received approved QA program. Certificates of Compliance from the NRC.

Computer-aided design (CAD) is extensively used in current 3.2.4 Section 3.2.4 provides requirements for the use of design applications. Designs developed using CAD methods computer codes and calculations in the design process.

are prepared and stored electronically. Thus, applicable QA procedures that address software verification/validation, 6.2.1 Section 6.2.1 establishes quality requirements for computer 9 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement management of electronic records, and quality control of codes used in the design, maintenance or modification of electronic data should address the control of electronic data in quality related SSCs.

design applications to ensure authenticity and technical accuracy. The Nuclear Information and Records Management Association (NIRMA), American National Standards Institute (ANSI), and the Electric Power Research Institute (EPRI) provide guidance for use in developing QA programs for managing electronic data. In addition, NRC Generic Letter 88-18, 'Plant Record Storage on Optical Disks" (Ref. 5), and Regulatory Information Summary 00-18, 'Guidance on Managing Quality Assurance Records in Electronic Media" (Ref. 6), provides guidance on the use of optical disc document imaging systems for retrieving record copies of QA records.

3. GUIDANCE ON §71.107, "PACKAGE DESIGN CONTROL" 3.1 Section 3.1 assigns responsibility to the CY Director of Essential elements of adequate design control are (1) good Project Support for control of design activities which include relationships among those responsible for preparing design identification of the design basis and correctly translating disclosures, (2) conducting independent design analyses, (3) these requirements into specifications, drawings, coordinating interfaces, and (4) maintaining lines of procedures, and instructions; controlling design interfaces communication. To ensure an adequate commitment to control among participating organizations; and controlling design of design activities, applicants should consider the three changes to ensure control measures commensurate with principal areas of (1) control of the design process, (2) control those applied to the original design.

of design input, and (3) control of design verification, as defined in regulatory positions 3.1 - 3.3. Section 3.1 and Appendix A to the CYQAP specifically Since users of packaging do not normally perform design 3.1 state that the CYQAP design control process shall not be activities, this section of Subpart H should not be applicable to CYQAP, used to change or modify the affected components which users of packaging. However, users should establish and verify Appendix A are provided under the Certificate Holder's NRC-approved that the packaging was designed under the control of an NRC- Quality Assurance Program.

approved QA program.

Computer-aided design (CAD) is extensively used in current 7.2.1 Section 7.2.1 requires audits and surveillances of vendors design applications. Designs developed using CAD methods as necessary to verify a vendor's ability to comply with the are prepared and stored electronically. Thus, applicable QA applicable criteria of 10CFR50 Appendix B. 10CFR17 10 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement procedures that address software verification/validation, Subpart H, or 10CFR72 Subpart G.

management of electronic records, and quality control of electronic data should address the control of electronic data in design applications to ensure authenticity and technical 3.4 Section 3.4 requires the use of suitable means for verifying accuracy. The Nuclear Information and Records Management or checking the adequacy of a design meeting identified Association (NIRMA), American National Standards Institute Implementing design objectives.

(ANSI), and the Electric Power Research Institute (EPRI) Procedure provide guidance for use in developing QA programs for AD-24, Implementing Procedure AD-24 provides requirements for managing electronic data. In addition, NRC Generic Letter 88- 'Computer any software whose output is used in quality applications.

18, 'Plant Record Storage on Optical Disks" (Ref. 5), and Software Control" Regulatory Information Summary 00-18, "Guidance on Managing Quality Assurance Records in Electronic Media" (Ref. 6), provides guidance on the use of optical disc document imaging systems for retrieving record copies of QA records.

3.1 Control of Design Process Measures such as "classification of characteristics" should be 3.4 Section 3.4 requires the use of suitable means for verifying established to ensure that packaging designs are reviewed to or checking the adequacy of a design meeting identified emphasize critical parameters that can be controlled by design objectives.

inspections or tests and to identify test and inspection criteria and quality standards.

Recognized engineering practices such as prescribing drafting 3.2.3 Section 3.2.3 requires use of written procedures to control room standards, checking methods, review and approval design interfaces that include appropriate measures for the requirements, issuance and distribution requirements (including review, approval, release, distribution, and revision of revisions to them), maintaining current "as-built" configurations, design documents and storage and control of original and master copies should be established to control the preparation of drawings and specifications.

3.2 Control of Design Input 3.2.1 Section 3.2.1 requires procedures for the identification and Measures should be established to ensure that appropriate incorporation of appropriate quality standards in design codes and standards are used in the design of the packaging. documents and controlling deviations from these In the absence of such codes and standards for formulation of standards.

11 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement the design activities, alternative approaches should be identified.

Section 3.2.1 requires procedures for the selection and Measures should be established to ensure (1) that all design 3.2.1 review for suitability of application materials, parts, parameters, e.g., criticality physics, cooling, and 3.2.4 equipment, and processes that are essential to the safety decontamination of an item, have been properly considered, function of SSCs that are classified as Safety Related or reviewed, and approved by the responsible design organization Important to Safety. Section 3.2.1 also requires suitable and that the parameters are in accordance with the applicable design controls to activities such as seismic, stress, performance codes, standards, and regulatory requirements thermal, hydraulic, radiation, and accident analyses; and (2) that maintenance, repair, in-service inspection, compatibility of materials; and accessibility for inservice handling, storage, and cleaning requirements are specified in inspection, maintenance and repair. Section 3.2.4 requires design documents. independent verification of design activities for validation of design activities.

3.3 Control of Design Verification 3.2.4 Section 3.2.4 requires use of suitable means for verifying or Methods to be used In verifying the adequacy of the design checking the adequacy of a design in meeting identified (e.g., qualification testing, design review, or alternative design objectives. These means shall be conducted in calculations, including use of computer programs) should be accordance with procedures and may include design established. Technically qualified individuals or groups reviews, alternate or simplified calculation methods or by a responsible for design verification should not be in the suitable testing program. If a test program is used, then a administrative line of authority of the original designer. The qualification test of a prototype unit under the most adverse designer's immediate supervisor may perform the verification design conditions shall be used. The responsibilities and provided: qualification of the verifier, the areas and features to be

_ The supervisor is the only technically qualified individual, verified, the pertinent considerations to be verified, the

_ The need is documented and approved in advance by the acceptance criteria and the extent of documentation to be supervisor's management, and generated shall be identified in procedures.

_ The QA audits cover the effectiveness of the use of supervisors as design verifiers to guard against abuse of this practice.

During the sequence of design verification, changes to the final 3.2.2 Section 3.2.2 requires that changes to design and design may result; consequently, measures should be 3.1 specifications are subject to the same design controls and established for ensuring that drawina and specification changes CYQAP, approvals that were applicable to the original design unless 12 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement are reviewed and approved by the same individuals or Appendix A delegated in writing to another responsible organization.

organizations that reviewed and approved the original Section 3.1 and Appendix A to the CYQAP specifically documents. Changes in design that could result in conditions state that the CYQAP design control process shall not be different from those prescribed on the CoC should be approved used to change or modify the affected components which by NRC prior to implementation. are provided under the Certificate Holder's NRC-approved Quality Assurance Program.

Design verification, if other than by qualification testing of a 3.2.4 Section 3.2.4 requires use of suitable means for verifying or prototype or lead production unit, should be satisfactorily checking the adequacy of a design in meeting identified completed prior to (1) release for procurement or fabrication design objectives. These means shall be conducted in and (2) release to other organizations for use in other design accordance with procedures and may include design activities except when this timing cannot be met. In these reviews, alternate or simplified calculation methods or by a cases, design verification may be deferred provided the suitable testing program. If a test program is used, then a justification for this action is documented and the unverified qualification test of a prototype unit under the most adverse portion of the design output documents are appropriately design conditions shall be used. The responsibilities and identified and controlled. When a test program is used to verify qualification of the verifier, the areas and features to be the adequacy of a design, the prototype should be subjected to verified, the pertinent considerations to be verified, the the most adverse design conditions. acceptance criteria and the extent of documentation to be generated shall be identified in procedures.

4. GUIDANCE ON §71.109, 4.1 Section 4.1 states, "PROCUREMENT DOCUMENT CONTROL" The procurement of materials, equipment, parts and/or The QA program user should establish measures to control the services required during the maintenance and modification o r w of quality systems, structures and components at the HNP preparation, review, concurrence, and approval of all and ISFSI is performed in a controlled manner which procurement documents.assures compliance with applicable regulatory requirements, procedures, quality assurance standards and regulations affecting procurement documents. Changes to procurement documents are subject to the same degree of control as utilized in the preparation of the original documents.

13 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 4.1 Content of Procurement Documents 4.2.1 Scope, design basis technical requirements, right of access The QA program user should establish measures to ensure that 4.2.2 to vendors, required documentation and applicability of include the following information (as

.documents 7 2.4 Subpart H requirements is contained in section 4.2.2.

procurement 17.2 applicable): Implementing Section 4.2.1 requires that applicable QA requirements be

  • the scope of work to be performed by the prospective supplicr Procedure imparted upon vendors engaged in quality activities.
  • the design-basis technical requirements (or references AD-19, ISFSI thereto), including applicable regulatory requirements, Records Section 7.2.4 requires vendors to furnish documentation of material and component identification requirements, Program" nonconformances dispositioned "accept as is" or 'repair.

drawvings, specifications, codes and standards, special process instnictions, and test and inspection requirements Section 4.2.2 provides requirements for documentations

  • applicable Subpart H requirements that should be complied which must be submitted retained or dispositioned by the with and described in the supplier's QA program (Qualified supplier.

QA personnel from the purchaser's organization should Section 17.2 states, review and concur in the stipplier's QA program or portions "CY procedures define the documentation requirements for thereof before the purchaser initiates activities affected by the inspection and test records, as appropriate."

program. Also, if sub-tier suppliers are involved, the QA program user should specify the QA provisions appropriate to Procedure AD-19, 'ISFSI Records Program," provides those procurements. The extent of the supplier's and sub-tier requirements and guidance on records formats and for supplier's QA programs will depend on the particular item or maintaining software necessary for the retrievability of service being procured.) records.

  • pennission to gain access to the supplier's and sub-tier supplier's plant facilities and records for inspection and audit purposes (Procurement documents should identify the type of verification activities required of any sub-tier suppliers for supplied materials, as well for any design, fabrication, assembly, testing, maintenance, and repair services or activities supplied.)
  • identification of the documentation (e.g., drawvings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure 14 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement qualifications, results of chemical and physical tests on material) that the supplicr(s) must prepare, maintain, and submit to thc purchaser for approval

  • requirements for reporting and approving disposition of nonconformnances
  • identification of records that the supplier must retain, control, and maintain, as well as those records that the supplier must deliver to the purchaser prior to installation of hardware

[These records should include the pertinent documentation to be furnished vith the procured materials or services (e.g.,

CoC, as-built drawings, photographs, sketches, use and maintenance manuals). If the pertinent documentation is in an electronic formnat, the QA program user should specify the software system that must be used to prepare and deliver the documentation.]

4.2 Replacement Part Procurement Measures should be established to require that procurement of 4.2.1 Section 4.2.1 states, replacement parts important to safety be reviewed by QA 'The procurement of spare or replacement parts for quality personnel to ensure that appropriate technical and QA systems, structures, or components is subject to the requirements are included in purchase orders and that the controls of the CYQAP and implementing procedure purchase orders are placed with suppliers previously qualified requirements. The spare or replacement parts are subject during fabrication of the packaging. If replacement parts are to controls equivalent to original or subsequent codes and purchased from suppliers not previously identified as qualified standards."

sources, the QA program user must assure himself or herself that the replacement parts meet requirements at least as stringent as the original criteria.

4.3 Review and Changes to Procurement Documents The QA program user should establish measures to ensure that 4.2.1 Section 4.2.1 states, review and approval of procurement documents are recorded 'Changes to procurement documents are subjected to the 15 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement prior to release, and that changes and revisions to those same degree of control as that utilized in the preparation of documents are subject to at least the same review and the original document."

approval as the original documents.

5. GUIDANCE ON §71.111, "INSTRUCTIONS, PROCEDURES, AND DRAWINGS" 5.1 Quality Assurance Program Procedures The QA program user should establish measures to ensure that the following requirements are fulfilled:
  • Activities important to safety are prescribed and 5.2.1 Section 5.2.1 states, accomplished in accordance with current documented Implementing 'Procedures and instructions for activities affecting quality instructions, procedures, or drawings that have been Procedure are prepared, reviewed, and approved in accordance with approved by appropriate levels of management. AD-4, 'ISFSI written procedures and instructions."

Procedure Control Program" Procedure AD-4, 'ISFSI Procedure Control Program,"

describes the process for development, review approval and revision of procedures, including the review and approval by appropriate levels of management.

  • Instructions, procedures, and drawings specify the methods CYQAP The CYQAP, in various sections including the Abstract and for complying with each of the applicable sections of Subpart Policy Statement, invokes compliance with 10CFR71 H of 10 CFR Part 71. Subpart H and 10CFR72 Subpart G which satisfies all of this section.
  • All work activities are coordinated with QA personnel to 5.2.1 Section 5.2.1 states, in part, ensure that the work controlling documents incorporate 'CY Quality Assurance reviews and concurs with quality appropriate inspection and hold points to verify that initial procedure and special process manuals and procedures.

work, planned work, effective repairs, or rework have been The criteria for documents requiring CY review are defined performed satisfactorily. in CY administrative procedures to ensure that:

a. Administrative procedures which implement the 16 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement CYQAP are reviewed for compliance with the CYQAP and applicable Appendix C requirements, and

b. Work Procedures/Work Documents used to perform quality activities are reviewed to assure appropriate quality assurance controls have been specified."

Section 5.2.3 states, "5.2.3 ACCEPTANCE CRITERIA

  • Instructions, procedures, and drawings include quantitative 5.2.3 acceptance criteria (e.g., dimensions, tolerances, and Review and approval of departmental procedures, operating limits) and qualitative acceptance criteria (e.g. instructions and drawings is described in CY procedures to workmanship samples) to verify that activities important to ensure the inclusion of adequate quantitative and safety have been satisfactorily accomplished. qualitative acceptance criteria for determining satisfactory work performance and quality compliance. These criteria apply to quality activities as defined in the CYQAP."

17.2 Section 17.2 states, Implementing "Procedures and instructions establish the responsibilities

  • Written procedures address the use, management, storage, Procedure and requirements for the maintenance, identification, and protection of electronic records and data. The QA AD-19, 'ISFSI retention and retrievability of records pertaining to program user should also maintain information on the specific Records materials, equipment, parts, processes or operations software applications and storage or computing hardware. Program" relating to systems, structures and components which when founded on observations, measurements or tests can be fully verified, and documented by cognizant personnel."

Procedure AD-19, "ISFSI Records Program," Identifies the types of acceptable storage media and associated acceptance and maintenance criteria for each.

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Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 5.2 QA Review and Concurrence 5.2.3 Section 5.2.3 contains the requirements for review and 10.2.5 concurrence of quality related procedures, inspection plans; The QA program user should establish measures to ensure that test, calibration, and special process procedures the QA organization reviews and concurs in inspection plans; test, calibration, and special process procedures; and Section 10.2.5 states, in part, specifications as well as any changes thereto. Prior to 'Mandatory hold and notification points, as required, are fabrication of an item, the QA organization should review and identified in procurement documents and work concur in the related manufacturing plans, as they relate to procedures/documents. Purchase Order/Contracts and scheduled witness and hold points during fabrication. work procedures/documents are subject to the review and concurrence for adequacy of inspection, notification and/or mandatory hold controls by CYAPCo and Quality Assurance, respectively."

6. GUIDANCE ON §71.113, "DOCUMENT CONTROL" 6.1 Controlled Documents 6.2.1 Section 6.2.1 states that CY procedures and instructions The QA program user should maintain each of the documents delineate the measures for controlling documents including under the control of the QA program to reflect the current direction for the review for adequacy, approval by status. As a minimum, the QA program user should exercise authorized personnel, distribution of controlled documents control over the following: and verification that changes are promptly incorporated and
  • design documents (e.g., drawings, specifications, and implemented.

computer codes)

  • procurement documents Procurement documents, nonconformance reports and
  • QA and QC manuals corrective action reports are not controlled documents at
  • operating, maintenance, and modification procedures Connecticut Yankee. They function as QA records rather
  • inspection and test procedures than controlled documents.
  • nonconformance reports
  • design change requests
  • corrective action reports 6.2 Control of Document Generation and Issuance 6.1, 6.2 Section 6.1 and 6.2 require review and approval of all The QA program user should establish controls to ensure that Implementing changes, and inclusion of the changes in the document all documents and changes thereto are adequately reviewed Procedure prior to placing the system in operating status.

and approved prior to their issuance. These controls should AD-3, ISFSI include measures (e.g., the use of a master document list) to Document Section 6.2.1 states that the provisions for control of 18 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement ensure that current issues of applicable documents are Control Program documents shall be contained in implementing procedures available at the location where the activity is being performed to Procedure AD-3, "ISFSI Document Control Program,"

preclude use of obsolete or superseded documents. The QA requires the ISFSI Manager to designate those documents program user should also check all packaging affected by which will be controlled through the use of a master design changes to verify that it is in accordance with the document list. The procedure also provides for distribution appropriate revision. In addition, the QA program user should of controlled documents through the use of the Controlled identify (by function or position) the individuals or groups Document Distribution List.

responsible for reviewing, approving, and issuing documents and revisions thereto. Section 6.1 requires distribution of controlled documents to effected work locations to preclude the use of outdated or unapproved documents.

6.3 Control of Document Changes 6.1 Section 6.1 requires review and approval of document The QA program user should establish measures to ensure that changes by the same organizations or by other responsible changes to documents are reviewed and approved by the same organizations as described in implementing procedures.

organization that performed the original review and approval and the changes are in accordance with established configuration control procedures.

6.4 Control of Electronic Documents 6.0 The CYQAP provides appropriate controls for quality If the documents are stored electronically, the QA program user documents, regardless of the media and calls for specific should establish controls over access to the documents to Implementing controls to be contained in implementing procedures.

ensure that the latest versions of the documents are available Procedure Implementing Procedure AD-3 provides requirements for and changes to the documents are properly authorized and AD-3, -ISFSI control of documents of all types of media.

implemented. The software and hardware systems used to Document store electronic information should be reliable to avoid Control Program" alteration or corruption of the information.

7. GUIDANCE ON §71.115, "CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES" The QA program user should establish measures in the areas identified below to ensure that materials, equipment, and 19 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement services conform to procurement documents.

7.1 Procurement Document Planning CYQAP The CYQAP (as delineated below) establishes the The QA program user should establish procurement planning measures necessary to assure that purchased material, procedures that describe each procurement step leading to Implementing equipment, and services, whether purchased directly or contract award for items and services. These procedures Procedures through contractors or subcontractors, conform to the should identify the organizations responsible for each AD-13, requirements of the procurement documents. These procurement step. "Requisitioning measures shall be specified in implementing procedures.

Material, For ISFSI quality related procurements, Procedure AD-13 Equipment & assigns responsibility for implementation to the ISFSI Services for the Manager. For other quality related procurements, ISFSI" Procedure MPM 1.1-01 assigns responsibility for implementation to the Procurement Manager MPM 1.1-01,

'Procurement and Control of Items and Services for the Decommissioning Project" 7.2 Selection of Procurement Sources 7.1 Section 7.1 establishes measures for the control of The QA program user should establish measures for evaluating procured material, equipment, parts and services by or for and selecting procurement sources, including the extent of QA CY related to or classified as Important to Safety for the and engineering involvement. Specifically, the QA program HNP or ISFSI to ensure conformance to procurement user should consider establishing the following provisions (if documents. These measures include provisions for source applicable): evaluation and selection, submission of objective evidence by the contractor or subcontractor, inspection at the vendor source and examination of items upon delivery.

  • the supplier's capability to comply with applicable sections of 7.2.1 To ensure that vendors employ a quality assurance Subpart H program that conforms to applicable portions of the
  • results of the survey of the supplier's facility and QA program CYQAP, which commits to the requirements of 10CFR71, 20 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement review of the supplier's previous records and performance. Subpart H, evaluations of vendors by one or more of the following methods Is required:

. Audits

  • ASME N, NA, NPT, NV, or MM/ MS Certificate of Authorization;

. Commercial grade surveys and/or coordinated review of a potential vendor utilizing one or more departments, (i.e., Engineering, Operations and/or Purchasing); or

. Vendor inspection/surveillance.

The determination of vendor approval is based on such factors as prior performance, quality performance data, audits, commercial grade surveys, surveillances and evaluations of the supplier's quality assurance program.

7.3 Bid Evaluation and Award 7.2 Section 7.2 requires that the evaluation and selection of The QA program user should establish measures to ensure that vendors is to be performed in accordance with procedures, designated individuals or organizations evaluate proposed which specify that procurement source evaluation and suppliers, as applicable to the type of procurement, based on selection measures are performed to determine vendor technical considerations, conformance to QA requirements, capability and delineate responsibilities of qualified production capability, and past performance. personnel involved in the evaluation and selection process.

Prior to contract award, the QA program user should resolve (if 18.2.3 Section 18.2.3 assigns responsibility to the follow-up of possible) all unacceptable conditions identified during the bid audit findings to the auditing organization, as necessary, to 21 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement evaluation. If any unacceptable conditions cannot be resolved verify that appropriate actions have been taken to resolve prior to contract award, the QA program user should obtain the audit findings.

supplier's commitment that the conditions will be resolved at a mutually agreeable date during the contract period. Implementing Purchasing implementing procedures MPM 1.1-01 and AD-Procedures 13 require review and approval of Purchase Order AD-13, Requests by the Quality Assurance Group.

'Requisitioning Material, Equipment &

Services for the ISFSI" MPM 1.1-01,

'Procurement and Control of Items and Services for the Decommissioning Project" 7.4 Supplier Performance Control The QA program user should establish measures for pre- and 7.2.2 Section 7.2.2 requires surveillance of vendor's to verify post-award activities, such as meetings and other 10.2.5 compliance with quality requirements specified in communications, to ensure that the supplier understands procurement documents. Section 10.2.5 assigns the QA procurement requirements, including, if applicable, 'hold points" Organization responsibility for incorporation of mandatory (i.e., pre-established inspection points in the manufacturing inspection notification/hold points for vendor activities.

process that require inspection approval and release by the QA organization prior to further processing) during manufacturing and testing and before shipment.

22 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 7.5 Verification Activities 7.2.2 Section7.2.2 states:

The QA program user should establish the extent to which source surveillance will be performed during fabrication, 'CYAPCo is responsible for the performance of source assembly, maintenance, modification, repair, inspection, inspections at suppliers' facilities to ensure that the testing, and shipment to ensure conformance with the purchase requirements of a Purchase Order/Contract have been order requirements. The source surveillance should cover the met.

following aspects:

  • instructions specifying characteristics or processes to be Source inspections are performed in accordance with witnessed, inspected, or verified procedures which provide for the method of inspection, the
  • the documentation required extent of documentation required, and those responsible for
  • identification of those responsible for implementing source implementing those instructions.

surveillance Inspection of items occurs either when verifications of procurement requirements cannot be determined upon receipt or the vendor's QA program has not been accepted by CYAPCo."

The QA program user should also establish the extent to which 7.2.3 7.2.3 states:

inspection will be performed upon receipt of supplier-furnished 11.2.1 'Receipt inspection of vendor-furnished material and hardware to ensure that items are properly identified and equipment is performed to assure that material, correspond with procurement documentation. When components, equipment and acceptance records are acceptance of an item is contingent on tests after installation in examined in accordance with predetermined inspection the package, the QA program user and item supplier should instructions prior to acceptance, installation and operation.

mutually establish the relevant acceptance documentation prior Receipt inspections include, as appropriate:

to its use.

a. Measures for verifying that the shipment is complete, properly identified, undamaged and corresponds with the required documentation.
b. Measures for inspection of the item and review of supporting documentation (e.g., mill test reports, NDE reports) as required by the purchase documents; 23 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

c. Measures for inspection and acceptance of items in accordance with predetermined methods;
d. Measures for identifying and controlling acceptable items including identification of inspection status prior to release from the receipt inspection area;
e. Measures for identifying, segregating and handling nonconforming items;
f. Measures to ascertain that inspection records or certificates of conformance are acceptable prior to release for installation; and/or
g. In cases involving procurement of services, the project engineer or department head shall designate the means by which services may be accepted, and is given the authority to accept services in accordance with methods defined in CY procedures.

11.2.1 states:

Test requirements to determine or to verify the capability of an item to meet specified requirements in accordance with engineering/design documents, Safety Analysis Reports (SAR), technical specifications, procedures or procurement documents, as appropriate, are accomplished by subjecting the item to a set of physical, chemical, environmental or operating conditions. Retest following repair, replacement or modification is performed in accordance with the original design requirements or acceptable alternatives and is performed when original test results are invalidated.

24 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement CY procedures are written and approved to delineate the methods and responsibilities for controlling, accomplishing and documenting testing during maintenance and modification of the HNP and ISFSI.

In addition, the QA program user should take appropriate 7.2.1 Section 7.2.1 requires CYAPCO to perform evaluations measures (such as source surveillance and audits of records) ensure that vendors employ a quality assurance program to ensure that the supplier performed the design and fabrication that conforms to applicable portions of the CYQAP.

of packaging under the control of an NRC-approved QA program.

7.6 Controlling Nonconformances 7.2.4.b Section 7.2.4.b requires vendors to provide documentation The QA program user should establish measures to ensure the that Identifies any procurement requirements which have proper disposition of items or services that do not meet not been met, together with a description of those procurement requirements. These measures should include nonconformances dispositioned "accept as is" or 'repair."

evaluation of nonconforming items categorized by the supplier, along with technical justification and recommended disposition (e.g., 'use as is" or 'repair").

7.7 Records 7.2.4 Section 7.2.4 requires vendors to provide certifications or The QA program user should establish measures to ensure that documentation provided by the supplier which attests to the supplier furnishes to the purchaser the following records (as conformance to procurement document requirements, a minimum): identifies that all the specific procurement requirements

  • documentation that identifies material or equipment and the have been met (either by reference to the purchase order specific procurement requirements (e.g., codes, standards, and or by delineation) and the following documents, as a specifications met by the items) minimum:
  • documentation that identifies any procurement requirements that have not been met, a. Documentation that identifies the purchased material or alongi with a description of those nonconformances designated equipment and the specific procurement requirements 25 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

.use as is" or 'repair" (e.g., codes, standards and specifications) which have

  • documentation that the supplied material and equipment been met by the items; and, meets the applicable procurement requirements prior to installation or use b. Documentation that identifies any procurement
  • appropriate documentation, as identified in the purchase requirements which have not been met, together with a order, that will accompany the NRC-approved packaging during description of those nonconformances dispositioned transport and be received at the destination by the user. .accept as is"or 'repair."

Such documents should (1) be referenced in the CoC, (2) relate to the use and maintenance of the packaging, and (3) identify necessary actions to be taken prior to delivery of the licensed material to a carrier for transport. If the pertinent documentation is in an electronic format, the QA program user should specify the software system that must be used to prepare and deliver the documentation.

The QA program user should retain the documentation at the 17.1 In Section 17.1, the CYQAP provides for the maintenance, facility or site of material or equipment use. 17.3 identification, retention and retrieval of records to furnish evidence of activities affecting quality during maintenance and modification of the HNP and ISFSI. The records include but are not limited to:

a. Operating logs and the results of reviews;
b. Inspections;
c. Tests;
d. Audits;
e. Monitoring of work performance; and
f. Material analyses.

26 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement The records also include closely related data such as qualifications of personnel, procedures and equipment.

Inspection and test records contain as a minimum but are not limited to: identification of inspector or data recorder; and, the acceptability and the action taken in connection with any deficiencies and reportable occurrences noted. Procedures establish requirements concerning record retention such as duration, location and assigned responsibility.

Quality assurance records shall also include these records required by 10 CFR 71.135 and 10 CFR 72.174. Records subject to the provisions of 10 CFR 71.135 shall be retained for 3 years beyond the date of the final transportation activity subject to the controls of this Quality Assurance Program. Records subject to the provision of 10 CFR 72.174 shall be retained until the NRC license to store spent nuclear fuel at the ISFSI is terminated.

Section 17.3 requires review and acceptance of vendor documentation by a responsible qualified individual.

8. GUIDANCE ON §71.117, "IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS" The QA program user should establish measures to ensure that 8.1 In Section 8.1, the CYQAP provides measures for the materials, parts, and components, including partially fabricated identification and control of material, parts and components, assemblies, are adequately identified to preclude the use of Implementing including partially fabricated assemblies, during incorrect or defective items. These measures should provide Procedures maintenance and modification to the HNP and ISFSI. To the means for physical identification (e.g., stamping, tags, AD-13, ensure that each item can be traced to associated labels, or lot-follower cards) and traceability to appropriate 'Requisitioning documentation, the identification of the item is maintained documentation (e.g., mill reports, drawings, or specifications) Material, by heat number, lot number, part number, serial number, or throughout fabrication, installation, and use. Also, when Equipment & other appropriate methods, and is physically marked on the 27 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement replacement of limited-life items is specified, the QA program Services for the item and/or on records traceable to the item.

user should establish measures to preclude use of items for ISFSI" which the shelf life or prescribed operation time has expired. Procedure MPM 1.1-01, 'Procurement and Control of Items MPM 1.1-01, and Services for the Decommissioning Project," and

'Procurement Procedure AD-13, "Requisitioning Material, Equipment &

and Control of Services for the ISFSI," require identification of shelf life, Items and when applicable, during the requisition of items.

Services for the Decommissioning Project" In addition, the QA program user should establish measures to 8.2 Section 8.2 requires that CY procedures establish the facilitate continued processing when required inspections or responsibilities and requirements for the identification and tests have not been completed In order to maintain physical control of materials, parts and components. The identity and control over affected materials. procedures assure that Identification and control is maintained throughout fabrication, receipt, handling, storage and installation of items.

9. GUIDANCE ON §71.119, "CONTROL OF SPECIAL PROCESSES" Special processes are not normally performed by the user of 9.1 Section 9.1 states:

packaging. However, if packaging maintenance requires the 9.2 'The CYQAP provides measures to assure control of use of special processes (e.g., welding or heat treating) or special processes associated with quality systems, nondestructive testing, or if special processes are required to structures and components by the use of qualified meet CoC requirements, the QA program user should establish procedures, equipment and personnel during maintenance measures to ensure that the special processes are controlled in and modification of applicable the HNP and ISFSI SSCs."

accordance with the following requirements:

  • Procedures, equipment, and personnel are qualified in Section 9.2 requires that during maintenance and accordance with applicable codes, standards, and modification of the HNP or ISFSI, CY Management ensures specifications. that special process data and documentation is reviewed;
  • The operations are performed by qualified personnel and vendor's special process procedures used at the HNP or accomplished in accordance with written process or procedure ISFSI are qualified and approved; and that personnel and sheets that direct the recording of evidence of verification. equipment utilizing special processes are properly qualified prior to the start of work.

28 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

  • Qualification records of procedures, equipment, and personnel 9.2.2 Section 9.2.2 requires that codes, standards and CYAPCo are established, filed, and kept current. procedures specify personnel qualification/certification requirements. Personnel responsible for the performance and verification of special processes are trained, tested, and certified as required by applicable specifications, codes and standards. Requirements for the period of certification, retesting, and recertification of personnel are also specified.

Vendors qualify personnel and maintain records of qualified personnel in accordance with applicable codes, standards, specifications, and vendor Purchase Order/Contract requirements. The department that Is contracting services is responsible for the review of records of qualified personnel, equipment and procedures associated with special processes.

10. GUIDANCE ON §71.121, "INTERNAL INSPECTION" 10.1 The QA program user should establish measures to ensure that the following requirements are fulfilled:
  • Inspection procedures, instructions, or checklists are available 10.1 Section 10.1 requires that inspection of activities to verify for each work operation, where necessary to ensure quality. the quality of systems, structures and components, which are performed by or for CY are executed in accordance with the CYQAP and appropriate procedures, instructions and drawings by qualified personnel independent from the individual or group performing the activity being inspected.
  • Documents developed include methods for identifying 10.2.2 Section 10.2.2 states, characteristics and activities to be inspected, acceptance and Documented inspection plans may be either a separate rejection criteria, and the individuals or groups responsible for document or an integral part of work instruction documents.

performing the inspection. The plans are based on design specifications, procurement documents, drawings, other specifications, or previous experience, as appropriate.

During the performance of CY work activities, procedures 29 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement provide criteria for the determination of accuracy requirements of inspection equipment and when inspections are required. These procedures describe requirements for the preparation of surveillance and/or inspection plans."

  • Objective evidence of inspection results is recorded. 10.2.4.a Section 10.2.4.a states that required inspection or surveillance activities are performed and documented in accordance with procedures and/or checklists.
  • Hold or witness points are identified. 10.2.5 Section 10.2.5 assign responsibility for incorporation of hold points and notification points, as required.
  • The appropriate personnel approve data to ensure that all 10.2.3 Section 10.2.3 provides that inspections are performed by inspection requirements have been satisfied. 10.2.6 individuals other than those who performed or directly supervised the activity being inspected. Inspection personnel are qualified and/or certified in accordance with appropriate codes, standards, and/or training programs.

Section 10.2.6 requires that evaluations are to be performed by the responsible personnel who are qualified in accordance with the appropriate commitments listed in Appendix C to the CYQAP.

  • The prerequisites to be satisfied prior to inspection are 10.2.4 Section 10.2.4 identifies the required scope and content of identified, including operator qualification and equipment inspection plans including operator qualification and calibration. Where sampling is used to verify acceptability of a Implementing equipment calibration. Sampling requirements are group of items, the standard used as the basis for acceptance Procedure specified in Implementing Procedure MPM 1.1-01.

should be identified. MPM 1.1-01, "Procurement and Control of Items and Services for the Decommissioning Project" 30 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 10.2 Inspections 10.2.1 Receiving Inspections 7.2.3 Section 7.2.3 requires receipt inspections of vendor The QA program user should establish measures to ensure that furnished material/services, in accordance with items that are important to safety (i.e., the features of a predetermined instructions.

structure, component, or system under control of the QA program and necessary to ensure the integrity of the packaging and its capability to prevent or mitigate the consequences that could result from release of radioactive material) meet the requirements specified on the purchase order when the items are received at the plant.

The QA program user should establish the criteria for 7.2.3 Section 7.2.3 states, acceptance of each of these inspections, as well as the action "Receipt inspection of vendor-fumished material and to be taken if noncompliance is encountered. These visual equipment is performed to assure that material, inspections should include the following aspects: components, equipment and acceptance records are

  • surface conditions examined in accordance with predetermined inspection
  • weld and structural integrity instructions prior to acceptance, installation and operation.
  • the condition of flange faces or sealing areas, gaskets, seals, Receipt inspections include, as appropriate:

gauges, rupture disks, valves, and pressure relief devices

  • the condition of tie-down members (if applicable) a. Measures for verifying that the shipment is complete, llabeling and marking properly identified, undamaged and corresponds with the
  • leak-tightness of the packaging required documentation.

In addition, the QA program user should establish provisions to control accepted items until they are placed in stock or released b. Measures for inspection of the item and review of for use, as well as provisions for the proper disposition of supporting documentation (e.g., mill test reports, NDE rejected items. reports) as required by the purchase documents;

c. Measures for inspection and acceptance of items in accordance with predetermined methods;
d. Measures for identifying and controlling acceptable items including identification of inspection status prior to release from the receipt inspection area; 31 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

e. Measures for identifying, segregating and handling nonconforming items;
f. Measures to ascertain that inspection records or certificates of conformance are acceptable prior to release for installation; and/or
g. In cases involving procurement of services, the project engineer or department head shall designate the means by which services may be accepted, and is given the authority to accept services in accordance with methods defined in CY procedures."

10.2.2 In-Process Inspections 10.1 Section 10.1 States, The QA program user should establish measures to ensure that Inspection of activities to verify the quality of systems, process specifications and their supporting documentation structures and components, which are performed by or for provide for indirect control by monitoring processing methods, CY are executed in accordance with the CYQAP and equipment, and personnel if direct inspection is impractical. appropriate procedures, instructions and drawings by qualified personnel independent from the individual or group performing the activity being inspected. If inspection is impossible or disadvantageous, indirect controls by monitoring processing methods, equipment and personnel are provided. Inspection notification and hold points are identified, as required, in the applicable documents.

32 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 10.2.3 Final Inspections 10.2.4.c For (1), Section 10.2.4.c requires that modification, repair, The QA program user should establish measures to ensure that replacement or rework items are inspected in accordance (1) final inspections provide for resolution of nonconformances with original inspection requirements or approved identified in earlier inspections, (2) the inspected item is alternatives.

identifiable and traceable to specific records and is adequately protected from physical or environmental damage, and (3) 8.1 For (2), Section 8.1 states, supervisors review inspection records to verify that all 8.2 'The CYQAP provides measures for the identification and inspection requirements have been satisfied. control of material, parts and components, including partially fabricated assemblies, during maintenance and modification to the HNP and ISFSI. To ensure that each item can be traced to associated documentation, the identification of the item is maintained by heat number, lot number, part number, serial number, or other appropriate methods, and is physically marked on the item and/or on records traceable to the item. Documentation associated with material, equipment, and components delineated that these items have been designed, fabricated, manufactured, tested and/or inspected in accordance with the specified requirements."

Section 8.2 states,

'CY procedures establish the responsibilities and requirements for the identification and control of materials, parts and components. The procedures assure that identification and control is maintained throughout fabrication, receipt, handling, storage and installation of items."

10.2.1 Section 10.2.1 states, For packaging use, the QA program user should establish Implementing "Quality Assurance personnel shall perform inspections of checklists to ensure that inspections are performed to verify the Procedure modification and maintenance activities on systems, following: GPP-GGGR- structures, and components governed by the CYQAP. The a Packaqes are properly assembled. R0031-000, criteria used to determine when CY Quality Assurance 33 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

  • Moderators and neutron absorbers are present, if applicable. 'Radioactive inspections shall be required for these activities and for the
  • Valves through which primary coolant flows are protected Material Shipping preparation of inspection plans shall be identified in against tampering. Program (RPM appropriate procedures. Quality Assurance personnel shall
  • Valves are set to specifications. 3.10-0)" be responsible for ensuring the inspection function which includes:
a. Identification of inspection personnel;
b. Review of work procedures and work documents to identify QA 'hold" points associated with the work;
c. Preparation and approval of inspection plans ensuring that the necessary inspection requirements, methods, and acceptance criteria have been identified; and
d. Documentation of inspection results.

Implementing Procedure GPP-GGGR-R0031-000,

'Radioactive Material Shipping Program (RPM 3.10-0),"

contains specific requirements for consideration of elements listed in Reg. Guide 7.10, section 10.2.3

  • All shipping papers are properly completed. 5.2 Section 5.2 requires development of implementing
  • Packages are conspicuously and durably marked as required Implementing procedures for all activities effecting quality.

by the regulations set forth by the U.S. Department of Procedures Transportation (DOT). GPP-GGGR- Implementing procedure GPP-GGGR-R0031-000,

  • Measures are established to ensure that appropriate R0031 -000, 'Radioactive Material Shipping Program (RPM 3.10-0)."

personnel designated by the package user sign the shipping 'Radioactive details the programmatic requirements and responsibilities tags or indicators prior to authorization for shipping. Material Shipping for shipment of radioactive material.

Program (RPM 3.10-0)" Implementing Procedure GPP-GGGR-R3803-001, "Hazardous Waste Manifest Preparation and Copy GPP-GGGR- Distribution," contains the specific guidance for shipping 34 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement R3803-001, paper generation and distribution, including the transmittal

'Hazardous of completed documents to Nuclear Waste Manifest Records.

Preparation and Copy Various other Waste Management implementing Distribution" procedures detail the requirements for shipment of radioactive material, depending upon the type of material and the destination. These requirements include ensuring that radioactive material is properly prepared, packaged, marked, labeled, loaded onto a vehicle, inspected and is in proper condition for transport.

Implementing procedures GGGR-R0031-000 and GPP-GGGR-R3803-001 require that only qualified and authorized personnel sign shipping documents.

10.2.4 Maintenance Inspections The QA program user should establish measures for an 10.2.1 Section 10.2.1 of the CYQAP establishes these inspection program to ensure adequate maintenance of requirements, as stated above, for Reg. Guide 7.10, section packaging. This inspection program should identify the items to 10.2.3.

be maintained, criteria for acceptability or replacement, and the frequencies of inspection assigned to each item.

10.2.5 Inspectors The QA program user should establish measures to ensure that 10.2.3 Section 10.2.3 requires that inspections are performed by (1) inspectors are qualified in accordance with applicable individuals other than those who performed or directly codes, standards, and company training programs; (2) such supervised the activity being inspected. Inspection qualifications and certifications are kept current; and (3) personnel are qualified and/or certified in accordance with inspection personnel are independent from all individuals appropriate codes, standards, and/or training programs.

performing the activity being inspected.

10.2.6 Inspection Documentation 35 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement The QA program user should maintain inspection records as 17.1 Section 17.1 identifies inspections as quality assurance QA records to document performance of inspection activities. records.

11. GUIDANCE ON §71.123, "TEST CONTROL" 11.1 Requirements 11.1 Section 11.1 states, The QA program user should establish measures to ensure that 'A documented test control program is established by the applicable test programs, including prototype qualification tests, CYQAP for systems, structures and components to ensure production tests, proof tests, and operational tests, are that they will perform satisfactorily in service and that test accomplished in accordance with written procedures. The QA results are documented in accordance with 10 CFR 50 program user should also establish measures to ensure that Appendix B, 10 CFR 71 Subpart H, 10 CFR 72 Subpart G, modifications, repairs, and replacements are tested in and other pertinent regulatory and/or technical requirements.

accordance with the original design and testing requirements.

The test control program identifies the systems, structures and components to be tested, method of conducting tests, evaluation of tests and documentation of tests by qualified personnel to assure requirements have been satisfied.

The test control program is systematic and includes proof tests prior to installation, construction tests, operational tests, surveillance tests, and retest following repairs, replacements, preventative maintenance or modifications."

11.2 Procedures The QA program user should establish measures to ensure that 11.2.1 Section 11.2.1 states, test prerequisites identified in the appropriate design "Test requirements to determine or to verify the capability of disclosures (e.g., instrument calibrations, monitoring to be an item to meet specified requirements in accordance with performed, mandatory hold points, suitable environmental engineering/design documents, Safety Analysis Reports conditions to be maintained, condition of the test equipment, (SAR), technical specifications, procedures or procurement methods for physical identification of test specimen, methods documents, as appropriate, are accomplished by subjecting for documenting or recording test data, and criteria for the item to a set of physical, chemical, environmental or acceptance) are properly translated into test procedures. operating conditions. Retest following repair, replacement or modification is performed in accordance with the original 36 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement design requirements or acceptable alternatives and is performed when original test results are invalidated."

11.3 Acceptance Tests 5.2 Section 5.2 requires development of implementing The QA program user should establish measures, as procedures for all activities effecting quality.

appropriate, to ensure that acceptance tests are conducted prior to delivering packages for transport to a carrier. These 10.2.4 Section 10.2.4 requires inspections to be performed in measures should identify the basis for acceptance criteria (e.g., accordance with written procedures or checklists which CoC, maintenance and operational manuals furnished by the identify appropriate acceptance criteria.

packaging manufacturers). Tests should typically include the following considerations: 11.2.2 Section 11.2.2 requires that tests on quality related SSCs

  • structural integrity are to be conducted in accordance with written procedures
  • leak-tightness (on containment vessel as well as auxiliary which incorporate or reference the requirements and equipment and shield tanks) acceptance criteria in the applicable design and
  • component performance for valves, gaskets, and fluid procurement documents.

transport devices

  • shielding integrity Implementing Implementing procedure GPP-GGGR-R0031-000,
  • thermal integrity Procedure 'Radioactive Material Shipping Program (RPM 3.10-0)."

GPP-GGGR- details the programmatic requirements and responsibilities R0031-000, for shipment of radioactive material, including direction of

'Radioactive inclusion of the requirements listed in Reg. Guide 7.10 Material Shipping during procedure development for specific waste transport Program (RPM containers.

3.10-0)"

11.4 Maintenance Tests 5.2 Section 5.2 requires development of implementing The QA program user should establish maintenance test procedures for all activities effecting quality.

programs to ensure that packages remain usable and free of excessive radiation and contamination. These test programs 10.2.4 Section 10.2.4 requires inspections to be performed in should include measures to ensure that qualified and accordance with written procedures or checklists, which responsible individuals document, evaluate, and assess the identifies appropriate acceptance criteria.

acceptability of all test results.

11.2.2 Section 11.2.2 requires that tests on quality related SSCs 37 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement are to be conducted in accordance with written procedures which incorporate or reference the requirements and acceptance criteria in the applicable design and procurement documents.

Implementing Implementing procedure GPP-GGGR-R0031-000, Procedure 'Radioactive Material Shipping Program (RPM 3.10-0)."

GPP-GGGR- details the programmatic requirements and responsibilities R0031 -000, for shipment of radioactive material, including direction of

'Radioactive inclusion of the requirements listed in Reg. Guide 7.10 Material Shipping during procedure development for specific waste transport Program (RPM containers.

3.10-0)"

Implementing Various procedures have been developed and Procedures for implemented in accordance with the CYQAP for the ISFSI Operations operation and maintenance of fuel storage canisters at the OP-1, "ISFSI ISFSI to ensure that design parameters are maintained in Temperature accordance with the NAC-MPC Certificate of Compliance.

Monitoring Such Implementing Procedures include:

Program" OP-2, "ISFSI OP-1, 'ISFSI Temperature Monitoring Program" Routine OP-2, 'ISFSI Routine Surveillances" Surveillances" OP-5, 'Procedure for the Touch-Up of Metal Coatings on OP-5, 'Procedure the NAC-MPC Vertical Concrete Casks" for the Touch-Up OP-7, "VCC and ISFSI Pad Inspection Program" of Metal Coatings OP-8, 'ISFSI Preventative Maintenance and Surveillance on the NAC-MPC Program" Vertical Concrete Casks" OP-7, "VCC and ISFSI Pad 38 of 54

I Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement Inspection Program" OP-8, 'ISFSI Preventative Maintenance and Surveillance Program" 11.5 Results The QA program user should establish measures to ensure that 10.2.6 Section 10.2.6 states, test results are documented, evaluated, and maintained as QA 'Inspection results are evaluated for acceptability in records. These records should be readily available if questions accordance with procedures which identify the responsible arise concerning operational aspects of the packages. In organization.

addition, a qualified individual or group should determine the acceptability of the records. The evaluations are performed by the responsible personnel who are qualified in accordance with the appropriate commitments listed in Appendix C (of the CYQAP)."

11.2.4 Section 11.2.4 requires the documentation of test results.

17.1 Section 17.1 identifies test results as quality assurance records.

12. GUIDANCE ON §71.125, "CONTROL OF MEASURING AND TEST EQUIPMENT" 12.1 Calibration Control The QA program user should establish measures to ensure that 12.1 Section 12.1 provides the following requirements:

measurement and test equipment (e.g., gauges, fixtures, 12.2.2 reference standards, and devices used to measure product Periodic calibration and adjustment of measuring and test characteristics) is calibrated, adjusted, and maintained at equipment is performed and controlled to assure accuracy prescribed intervals or prior to use. Such equipment should be is maintained within limits necessary to verify that design 39 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement labeled or tagged to indicate the planned date of its next and operating condition requirements have been met.

calibration, and the calibration records should be identified, traceable, and maintained as QA records. The QA program Section 12.2.2 requires that measuring and test equipment user should also establish measures to ensure that in-house shall be permanently marked or tagged with a unique reference or transfer standards used in calibrating measuring identification number and the date calibrated and next and test equipment are traceable to nationally recognized calibration date indicated on the M&TE. Section 12.2.2 standards. Calibrating standards should have known valid further requires that CY procedures describe the measures relationships to nationally recognized standards. If no known taken to assure that reference and transfer standards are recognized standard exists, the QA program user should traceable to nationally recognized standards and that, document the basis for calibration. where national standards do not exist, provisions are established to document the basis for calibration.

12.2 Out-Of-Calibratlon Equipment 12.2.3 Section 12.2.3 requires conducting and documenting an When test and measuring equipment is found to be out of evaluation to determine the validity of previous inspections calibration, the QA program user should take measures to or test results when measuring and test equipment is found validate previous inspection and test results up to the time of to be out of calibration.

previous calibration. In addition, the QA program user should repair or replace any measuring equipment that is consistently out of calibration.

13. GUIDANCE ON §71.127, "HANDLING, STORAGE, AND SHIPPING CONTROL" 13.1 Preservation The QA program user should establish measures to ensure that 13.1 Section 13.1 states, cleaning, handling, storage, and shipping are accomplished in 13.2 accordance with design requirements to preclude damage or 'Measures are established by the CYQAP using deterioration by environmental conditions such as temperature procedures, instructions and procurement documents to and humidity. When necessary, the QA program user should ensure proper handling, storage, shipping, cleaning and also establish provisions for the use of special handling, lifting, preservation of material, equipment and parts. These or storage devices (e.g. cranes, shock absorbers, or special measures are imposed during maintenance and markings) to adequately identify and preserve packaging modification activities in order to preclude damage, loss or components or assemblies. In addition, the QA program user deterioration of materials, equipment and parts."

should ensure that conditions identified in the CoC are adhered Section 13.2 requires that procedures, instructions and 40 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement to when unloading packaging. procurement documents define the requirements and responsibilities for the handling, storage, shipment, cleaning and preservation of material, equipment, and parts required for implementation of established design and specification requirements.

Implementing Implementing Procedure GPP-GGGR-R0031-000, Procedure 'Radioactive Material Shipping Program (RPM 3.10-0)."

GPP-GGGR- details the programmatic requirements and responsibilities R0031-000, for shipment of radioactive material, including direction of

'Radioactive inclusion of the requirements listed in Reg. Guide 7.10 Material Shipping during procedure development for specific waste transport Program (RPM containers.

3.10-0)"

13.2 Preparation, Release, and Delivery to Purchaser 13.1 Section 13.1 requires the packaging, handling and storage The QA program user should establish measures to ensure that of quality related SSCs in accordance with written a final pre-release review has been completed. This review procedures.

should ensure that packaging (1) is prepared for delivery to the purchaser in accordance with approved drawings, Implementing Implementing Procedure GPP-GGGR-R0031-000, specifications, and government regulations; (2) has passed all Procedure 'Radioactive Material Shipping Program (RPM 3.10-0)."

applicable inspections and tests; (3) is properly identified by GPP-GGGR- details the programmatic requirements and responsibilities physical markings or tags; and (4) contains operating manuals, R0031 -000, for shipment of radioactive material, including direction of maintenance manuals, and generic procedures relating to its "Radioactive inclusion of the requirements listed in Reg. Guide 7.10 use. Material Shipping during procedure development for specific waste transport Program (RPM containers. These requirements include independent In addition, the QA program user should establish measures to 3.10-0)" verification of packaging and shipping activities.

ensure that the following requirements are fulfilled:

- Cavities within gas-cooled package containments have been adequately dried, and cavities within liquid-cooled packages have been drained to allow adequate void space.

41 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

  • All conditions (including specified operations, inspections, and tests) have been completed prior to delivery to a carrier.
  • All NRC and DOT requirements have been satisfied prior to delivery to a carrier.
  • All necessary shipping papers have been prepared as required and reviewed by qualified personnel to verify completeness and accuracy.
14. GUIDANCE ON §71.129, "INSPECTION, TEST, AND OPERATING STATUS" The QA program user should establish measures to ensure that 14.0 All of Section 14 for section 14.1 of Reg. Guide 7.10 is the status of inspections, tests, and operating conditions applicable to ensuring that the guidance found in section 14 (including maintenance of items) is known by organizations of Reg. Guide 7.10 is considered Section 14.1 provides responsible for ensuring quality. General Requirements for indication status of items undergoing Inspections and tests (tags, labels, logs, data-The OA program user should also establish measures to sheets, etc.) to prevent unintentional bypass of required control the application and removal of status indicators (e.g., inspection and tests, including operation as well. Section tags, markings, stamps) and to ensure that bypassing a 14.2 provides implementation requirements for all required inspection or test or any other required operation is responsible parties and requires procedural controls and procedurally controlled under the cognizance of the GA records to accomplish the requirements.

organization.

15. GUIDANCE ON §71.131, "NONCONFORMING MATERIALS, PARTS, OR COMPONENTS" An acceptable program for controlling nonconforming items 15.0 Section 15.0 provides requirements for identification, should include the following principal elements: disposition, inspection and segregation of nonconforming
  • proper identification items, services, or activities, including associated
  • segregation of discrepant or nonconforming items documentation.
  • disposition of the nonconforming items
  • evaluation of the nonconforming items
16. GUIDANCE ON §71.133, "CORRECTIVE ACTION" 16.1 Reporting The GA program user should establish measures to ensure that 16.0 All of Section 16.0 must be considered for section 16 of 42 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement the causes of conditions detrimental to quality (e.g., those Reg. Guide 7.10. In Section 16, measures are established resulting from failures, malfunctions, deficiencies, deviations, or to ensure that conditions adverse to quality are identified defective material and equipment) are promptly identified and and reported to management. Section 16 also requires reported to appropriate levels of management. In addition, the significance determination and causal evaluations to QA program user should establish measures to obtain establish appropriate corrective actions and to prevent corrective actions from suppliers and ensure that followup recurrence. Those responsible for implementation are actions are documented to verify that the corrective actions identified. Adverse conditions are tracked for identification were implemented and effective. of adverse trends. Follow-up is addressed by periodic audits to verify proper implementation.

16.2 Closeout, Retrieval, and Disposition of Records The QA program user should establish measures to ensure that corrective actions designated by cognizant individuals have been implemented to preclude recurrence. In addition, the QA program user should identify (by function or position) the individuals or organizations responsible for closing out corrective actions and documenting their resolution.

17. GUIDANCE ON §71.135, "QUALITY ASSURANCE RECORDS" 17.1 General QA records should furnish documentary evidence of the 17.1 Section 17.1 states that quality assurance records shall activities that affect quality and should provide sufficient include, but not limited to; applicable plant history, information to allow each record to be identified with the items operating logs, principal maintenance, design change or activities to which it applies. As a minimum, QA records activities, reportable occurrences, nonconformance reports, should include the following information: results of reviews, inspections, tests, audits, material
  • design, procurement, manufacturing, and installation records analyzed, monitoring of work performance, qualification of
  • supplier evaluations personnel, drawings, specifications, procurement
  • nonconformance reports documents, calibration documents and reports, corrective
  • results of inspections and tests action reports, and other applicable decommissioning and
  • failure analyses spent fuel storage records.
  • as-built drawings and specifications
  • qualification of personnel, procedures, and equipment
  • calibration procedures
  • training and retraining records 43 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

  • corrective action reports
  • records demonstrating evidence of operational capability
  • records verifying repair, rework, and replacement
  • audit plans, audit reports, and corrective actions
  • records that are used as a baseline for maintenance In addition, the QA program user should retain records that 17.1 Section 17.1 states those records required by show evidence of package delivery to a carrier and proof that 10CFR71.135 shall be retained for three years beyond the all NRC and DOT requirements have been satisfied (with their date of the final transportation activity subject to the retention times identified). controls of this Quality Assurance Program.

Where applicable, inspection and test records should contain 11.2.1 Section 11.2.1 requires written test documents with the following information: consideration for:

  • a description of the observation
  • Requirements and acceptance limits contained in
  • evidence of completion of the inspection or test operation applicable design and procurement documents
  • results of inspections or tests with appropriate data . Instructions for performing the test
  • conditions that are detrimental to quality
  • Test prerequisites
  • names of inspectors, testers, or data recorders
  • Mandatory inspection hold points requiring
  • evidence of acceptability witnessing by the owner, contractor or inspector, when applicable
  • Acceptance and rejection criteria
  • Method of documenting test data and results 17.2 Generating Records The QA program user should establish measures to ensure that 17.2 Section 17.2 requires implementation of an established methods employed to generate and manage documents that Implementing process, which provides for administration, receipt, storage, are designated as QA records result in information that is Procedure preservation, safe keeping, retrieval, and final inspection of retrievable, intelligible, and reliable. Such records should reflect AD-19, 'ISFSI records. Implementing Procedure AD-19 provides for the the work accomplished and should be stored in a manner that Records storage of all media types avoids unnecessary delay when the record is needed. In Program" addition, procedures for generating QA records should address both hard copy records and electronic information.

44 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 17.3 Indexing and Classification Records 17.1 Section 17.1 provides requirements for 10CFR71 records The QA program user should classify QA records as either retention.

'lifetime' or'nonpermanent":

  • Lifetime records include those pertaining to package 17.3 Section 17.3 provides requirements for records fabrication and those associated with a particular item while it is classification as 'lifetime" or "nonpermanent."

installed in the packaging or stored for future use. These records demonstrate the capability for safe operation; provide Implementing Implementing Procedure AD-19 provides specific guidance evidence of repair, rework, replacement, or modification; aid in Procedure for records classification, retention and indexing.

determining the cause of an accident or malfunction of an item; AD-19, -ISFSI and provide a baseline for inservice inspection. Records

  • Nonpermanent records are those that show evidence that an Program" activity has been performed but do not meet the criteria for lifetime records. Records pertaining to use of a package should be retained for a period of 3 years after the shipment.

17.4 Receipt, Retrieval, and Disposition of Records 17.3 Section 17.3 provides requirements and responsibilities for The QA program user should establish measures to provide a the collection, control, maintenance and disposition of receipt control system, including identification of functions or records.

positions in each organization responsible for receiving records and assessing the current status of records in their possession. Implementing Implementing Procedure AD-19 delineates responsibilities The QA program user should also establish measures to Procedure AD- for processing records into permanent storage including ensure that records that are maintained in-house or at other 19, 'ISFSI collection, storage, and retrieval requirements for in-house locations are identifiable and retrievable, and are not disposed Records as well as storage facility activities. Provisions are made of until prescribed conditions are satisfied. For electronic Program" for all types of records media.

records the software systems employed to image and store information should be compatible with new hardware as current technologies are implemented. In addition, before installing any new hardware systems, the QA program user should have a procedure in place to ensure that the new systems can reliably store and retrieve information from existing software systems.

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Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 17.5 Storage, Preservation, and Safekeeping 17.3 Section 17.3 requires that storage facilities shall prevent The QA program user should establish measures to ensure that Implementing destruction of the records by fire, flooding, theft, and the following requirements are fulfilled: Procedure AD- deterioration by environmental conditions, such as

  • Facilities used to store records should be constructed to 19, "ISFSI temperature and humidity minimize the risk from damage or destruction by severe natural Records conditions, such as wind, flood, fire, temperature, humidity, Program" Implementing Procedure AD-19 provides guidance on the mold, or infestation by insects or rodents. proper storage and preservation of all media types.
  • Records should be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets. Implementing Procedure AD-19 provides guidance for
  • Electronic records should be maintained in facilities that access control, dual storage of records and replacement or minimize or eliminate the potential for destruction of information modification of records.

as a result of demagnetization.

  • Electronic records should be backed up daily to eliminate the potential for loss of information as a result of equipment failure or human error.
  • If dual storage facilities are used to ensure the record integrity, the storage facilities should be sufficiently remote from each other to preclude a single event (such as a fire or flood) from damaging both facilities.
  • The QA program user should take measures to protect special records (e.g., radiographs and microfilm) from excessive light, electromagnetic fields, and temperature.
  • The QA program user should take measures to prevent unauthorized personnel from entering record storage areas.
  • Electronic Information storage systems should be accessible only through security measures such as passwords, and the number of personnel who have authorized access should be limited. In addition, personnel who have authorized access should have Identified privileges, such as 'read only" or 'read and add only."
  • The QA program user should establish measures to ensure prompt replacement of a record that is lost or damaged.

46 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 1- 1

18. GUIDANCE ON §71.137, "AUDITS" 18.1 Elements of an Audit Program A comprehensive audit program should include the following 18.1 Section 18.1 requires that a comprehensive system of elements: planned and periodic audits shall be carried out to verify compliance with the CYQAP during the maintenance and modification of the HNP or ISFSI.
  • assurance of the authority and organizational independence of 1.4.10 Section 1.4.10 states the Quality Assurance Manager is the auditors responsible for the implementation of the Quality Assurance Program which has sufficient organizational freedom and authority, independent of costs and schedule.
  • a commitment to adequate manpower, funding, and facilities 1.4.2 Section 1.4.2 states the President is responsible for to implement the audit maintaining an organization and providing support to ensure the proper implementation of the CYQAP.
  • identification of audit personnel and their qualifications 18.2.1 Section 18.2.1 states the audits are performed by Implementing appropriately trained and qualified personnel.

Procedure Implementing Procedure QA-1 provides the training and QA-1, 'Quality qualification requirements for audit personnel.

Program Administration"

  • provisions for reasonable and timely access of audit personnel 4.2.2.d Section 4.2.2.d requires that procurement documents to facilities, documents, and qualified personnel necessary for 17.3 include requirements for the right of access to the vendor's performing audits facilities and records for the purposes of audit, surveillance or inspection. Section 17.3 Identifies the Nuclear Records as having responsibility to ensure control of retrievability of records.

47 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement

  • use of established procedures and checklists 18.1 Section 18.1 requires the use of checklists or procedures for audit performance.
  • methods for reporting audit findings to responsible 18.2.2 Section 18.2.2 requires audit reports are issued to the management of both the audited and auditing organizations Implementing appropriate management of the area audited to ensure Procedure appropriate and/or timely corrective action is taken to QA-2, 'Quality address any audit issues. Implementing Procedure QA-2 Assessments" requires periodic meeting with the audited organization management to discuss audit progress and issues.
  • provisions for the audit team to gain access to levels of 1.4.10 Section 1.4.10 states that the Manager - Quality Assurance management that have responsibility and authority for has direct communication with the CY Staff, the Director of corrective action Quality Assurance/Regulatory Affairs, the President, and the CEO and provides the daily interaction on matters affecting quality, nuclear safety, and nuclear related activities. This ensures access to appropriate levels of management for all quality activities.
  • methods for verifying that effective corrective action has been 18.2.3 Section 18.2.3 states the QA Organization is responsible accomplished on a timely basis for follow-up of audit findings, as necessary, to verify that appropriate actions have been taken to resolve audit findings.

The QA program user should also establish and maintain a list Appendix E, This section of CYQAP specifies the areas to be audited to reflect the current status of the activities important to safety Paragraph 1.2.g and the frequency for each area.

that are to be audited and the frequency at which each quality criterion is to be audited. The frequency of audits should be based on each activity's importance to safety; however, each 48 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement quality criterion should be audited at least once each year.

The QA program user should also establish measures to 7.2.1 Section 7.2.1 requires audits to verify a vendor's ability to ensure that packaging manufacturers are audited to assess the comply with the applicable criteria the CYQAP, which extent of their compliance with purchase orders and to verify includes applicable requirements of 10CFR50 Appendix B, that their work is controlled under an NRC-approved QA 10CFR71 Subpart H, 10CFR72 Subpart G, and other program. quality program baselines.

In addition, the QA program user should also identify (by 18.2.2 Section 18.2.2 states that audit reports are issued to the function or position) the individuals or groups that have the 18.2.3.a management of the audited organization to ensure responsibility and authority to ensure that corrective actions appropriate andlor timely corrective action is taken to resulting from audit findings are accomplished on a timely address any audit issues. Section 18.2.3.a states that the basis. The QA program user should re-audit deficient areas management of the audited organization is required to take on a timely basis to verify implementation of corrective actions. the necessary action to addresses any findings identified by the audit.

18.2 Scheduling of Audits 2.2.6 Section 2.2.6 requires a biennial independent management The QA program user should establish schedules for internal assessment of the Quality Assurance Program. Other audits, external audits, and audits performed by management. CYQAP, internal audits are addressed in Appendix E.

These schedules should ensure that key activities of the QA Appendix E program (e.g., design, fabrication) receive priority consideration.

For audits performed by management, the schedules should 2.2.6 Section 2.2.6 requires a biennial independent management identify the level of management (usually from the corporate assessment of the Quality Assurance Program. Other office or another division) designated to assess the overall CYQAP, internal audits are addressed in Appendix E.

effectiveness of the implementation of the described inhouse Appendix E QA program. The QA program user should also identify the activities important to safety (e.g., procurement, training of personnel) that should be included in the audit program.

49 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement Management audits should be conducted at least once every 12 months.

For internal audits, the schedules should ensure that applicable CYQAP, Internal audits, requirements and schedules are addressed elements of the QA program are audited annually or at least Appendix E in Appendix E.

once within the life of the activity, whichever is shorter. For external audits, the schedules should ensure that all elements 7.2.1 Section 7.2.1 provides requirements for external audits.

of a major supplier's (or major contractor's) QA programs are audited on a triennial basis. The 3-year period should begin Implementing Additional requirements for External audits, including re-with performance of an audit when sufficient work is in progress Procedure audit schedules not to exceed three (3) years is contained to demonstrate implementation of a QA program that has the QA-2, 'Quality in Implementing Procedure QA-2.

required scope for purchases placed during the 3-year period. Assessments""

18.3 Team Selection 18.2.1 Section 18.2.1 states the QA Organization is responsible The QA program user should establish the qualifications of the for training and qualification of audit personnel. Additional lead auditor and audit team members and specify their Implementing guidance and requirements for audit team selection, respective responsibilities with respect to evaluating and Procedure including the use of technical specialists is contained in issuing audit reports. QA-2, 'Quality Implementing Procedure QA-2.

Assessments" The auditing organizations should have the responsibility to establish qualifications for prospective audit personnel and the requirements for use of technical specialists to accomplish auditing activities that are important to safety. The QA program user should select the lead auditor and audit team members from personnel who do not have direct responsibility in the areas being audited.

Specific guidance for determining qualifications for the lead auditor and individual audit team members may be obtained from ANSI/ASME NQA-1 (Ref. 1).

50 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 18.4 Pre-Audit Conference Implementing Implementing Procedure QA-2 provides guidance on the Prior to an audit, the QA program user should specify the Procedure conduct of audits, including development of audit plans.

nature and scope of the pre-audit conference between QA-2, 'Quality management of the organizations being audited and the team Assessments" conducting the audit.

The purpose of the pre-audit conference should be to meet counterparts, confirm the audit scope and dates, establish channels of communication, discuss the sequence and duration of the audit, prepare an agreed-upon agenda for the audit, and set the time for the post-audit conference.

Implementing Implementing Procedure QA-2 provides guidance on the 18.5 Post-Audit Conference Procedure conduct of audits, including the conduct and purpose of The QA program user should establish measures to conduct a QA-2, 'Quality audit exit meetings.

post-audit conference between management of the Assessments" organizations being audited and the team conducting the audit to present the results and clarify any misunderstandings that may arise.

18.6 Reporting and Response Implementing Implementing Procedure AD-2 requires audit report The QA program user should establish measures to identify Procedure issuance within 30 days. Condition Reports initiated as a time constraints imposed for issuing audit reports and the QA-2, "Quality result of the audit will be processed in accordance with requested date for a corrective action response by the audited Assessments" implementing procedure AD-7, "Corrective Action organization. The response should clearly state the corrective Program," which ensures that problems are evaluated to action taken to prevent recurrence of nonconformances. If Implementing the depth necessary to determine the cause and that corrective action cannot be taken immediately, the response of Procedure appropriate and timely corrective actions are taken to the audited organization should include scheduled dates for AD-7, 'Corrective prevent recurrence.

initiation and completion of the corrective action. Action Program" 51 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 Regulatory Guide 7.10 Revision 2 Corresponding CYQAP Comments QA Program Requirement 18.7 Followup Action 18.2.3 Section 18.2.3 states the QA Organization is responsible The audit team leader should verify that (1) the audited for follow-up of audit findings, as necessary, to verify that organization provides a timely response to the audit report, (2) Implementing appropriate actions have been taken to resolve audit the response is adequate, and (3) the corrective action has Procedure findings.

been accomplished within the prescribed schedule. QA-2, 'Quality Assessments" Implementing Procedure AD-2 requires inclusion into the audit plan of a follow-up of previous audit issues.

52 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 10 CFR 71, Subpart HI Quality Assurance Criterion to Implementing Procedure Matrix Criterion # Implementing Procedure # and Title 71.103 AD-1, ISFSI Management Organization And Responsibilities and Independent Review Quality Assurance QA-1, Quality Program Administration Organization 71.105 QA-1, Quality Program Administration Quality Assurance Program 71.107 EF-1, ISFSI Engineering Evaluations and Design Control Program Design Control AD-24, Computer Software Control 71.109 AD-13, Requisitioning Material, Equipment & Services for the ISFSI Procurement Document Control 71.111 AD-4, ISFSI Procedure Control Program Instructions, Procedures, And Drawings 71.113 AD-3, ISFSI Document Control Program Document Control EF-2, ISFSI Drawing Control 71.115 AD-13, Requisitioning Material, Equipment & Services for the ISFSI Control Of Purchased AD-14, Receipt, Identification, Handling and Storage of Material, Equipment and Services for the Material, Equipment, ISFSI And Services QA-2, Quality Assessments QA-3, Quality Inspections 71.117 AD-13, Requisitioning Material, Equipment & Services for the ISFSI Identification And AD-14, Receipt, Identification, Handling and Storage of Material, Equipment and Services for the Control Of Materials, ISFSI Parts, And Components 71.119 AD-5, ISFSI Work Control Program Control Of Special OP-5, Procedure for the Touch-Up of Metal Coatings on the NAC-MPC Vertical Concrete Casks Processes 53 of 54

Comparison of CYQAP to Regulatory Guide 7.10 Revision 2 71.121 QA-3, Quality Inspections Internal Inspection 71.123 AD-5, ISFSI Work Control Program Test Control EF-1, ISFSI Engineering Evaluations and Design Control Program OP-1, ISFSI Temperature Monitoring Program OP-2, ISFSI Routine Surveillances OP-7, VCC and ISFSI Pad Inspection Program OP-8, ISFSI Preventative Maintenance and Surveillance Program 71.125 AD-5, ISFSI Work Control Program Control Of Measuring AD-13, Requisitioning Material, Equipment & Services for the ISFSI And Test Equipment 71.127 AD-13, Requisitioning Material, Equipment & Services for the ISFSI Handling, Storage, AD-14, Receipt, Identification, Handling and Storage of Material, Equipment and Services for the And Shipping Control ISFSI 71.129 AD-14, Receipt, Identification, Handling and Storage of Material, Equipment and Services for the Inspection, Test, And ISFSI Operating Status 71.131 AD-23, Nonconformance Reporting Nonconforming AD-12, Evaluation of Component or Equipment Failure or Deviation for IOCFR21 Reportability Materials, Parts, Or Components 71.133 AD-7, Corrective Action Program Corrective Action 71.135 AD-19, ISFSI Records Program Quality Assurance AD-20, Program for Electronic Storage of Records Records 71.137 QA-1, Quality Program Administration Audits QA-2, Quality Assessments 54 of 54

CY-05-1 52 Docket No. 50-213 Attachment 2 Haddam Neck Plant Proposed Change to Revision 5 of the Connecticut Yankee Quality Assurance Program A Marked-up Version of Revision 5 to the CYQAP and Summary of Changes June 2005

Mark-up of the Effected Pages Of CYQAP, Revision 5, CR-05-01 Showing the Changed Areas For CYQAP, Revision 6 (CR-05-02)

TABLE OF CONTENTS CONNECTICUT YANKEE OUALITY ASSURANCE PROGRAM (CYOAP)

HADDAM NECK PLANT Abstract Policy Statement Quality Assurance Program Sections QAP 1.0 Organization QAP 2.0 Quality Assurance Program QAP 3.0 Design Control QAP 4.0 Procurement Document Control QAP 5.0 Procedures, Instructions and Drawings QAP 6.0 Document Control QAP 7.0 Control of Purchased Material, Equipment and Services QAP 8.0 Identification and Control of Materials, Parts and Components QAP 9.0 Control of Special Processes QAP 10.0 Inspection QAP 11.0 Test Control QAP 12.0 Control of Measuring and Testing Equipment QAP 13.0 Handling, Storage, and Shipping QAP 14.0 Inspection, Test, and Operating Status QAP 15.0 Nonconforming Materials, Parts, Components, or Services QAP 16.0 Corrective Action QAP 17.0 Quality Assurance Records QAP 18.0 Audits Appendices A. Important-to-Safety Systems, Structures and Components CR 05-01 B. Qualification and Experience Requirements C. Regulatory Commitments of Assurance Terms L E. Pogram xceptionsL mF e Controls G. Position Cross Reference CR 05-01 TABLE OF CONTENTS i CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 1.0 ORGANIZATION

1.1 INTRODUCTION

This section describes the organizations involved with the Haddam Neck Plant and ISFSI. In addition, this section describes the responsibilities governed by the CYQAP. Qualifications for the key personnel are found in the Appendices to this Quality Assurance Program. CR 05-01 1.2 PROGRAM RESPONSIBILITY 1.2.1 The CEO reports to the CYAPCo board of Directors and has ultimate responsibility for the Haddam Neck Plant and ISFSI.

1.2.2 The President has overall responsibility for the CYQAP for the Haddam Neck Plant and ISFSI. While retaining full responsibility and overall authority, the President has delegated corporate authority for the preparation and administration of the CYQAP to the Director of Nuclear Safety/Regulatory Affairs. (See Figure 1-1) 1.2.2.1 The President maintains contact with the quality assurance activities through meetings with Director of Nuclear Safety/Regulatory Affairs nd~the receipt of various documents, such as: periodic progress reports, tReview Committe eeting notes and audits related to the implementation of programs at the Haddam Neck Plant and ISFSI.

CR 05-01 1.2.2.2 The President resolves all disputes related to the implementation of the CYQAP for which resolution is not achieved at the appropriate organizational levels within the nuclear organization.

1.3 GENERAL RESPONSIBILITIES 1.3.1 The head of each department performing quality activities is responsible for:

a. Administering those activities within their organization which are required by the CYQAP;
b. Ensuring implementation of the CY Quality Assurance Program;
c. Establishing and clearly defining the duties and responsibilities of personnel within their organization who perform quality activities;
d. Planning, selecting, and ensuring that personnel are trained to meet the 1

QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

requirements of the CYQAP; and

e. Performing and coordinating quality activities within their organization and interfacing with the CY Quality Assurance Personnel organization as required in program implementation.

1.3.2 Each individual performing or verifying activities affecting quality is responsible to conduct those activities in accordance with the requirements of the CYQAP and implementing procedures.

1.3.3 Lines of authority, responsibility, and communication shall be established and defined for the highest management levels through intermediate levels to and including all operating organization positions. These relationships shall be documented and updated, as appropriate, in the form or organization charts, functional descriptions of departmental responsibilities and relationships, and job descriptions for key personnel positions, or in equivalent forms of documentation.

1.4 ORGANIZATION CONNECTICUT YANKEE AT THE HADDAM NECK PLANT 1.4.1 CEO The CEO reports to the CYAPCo Board of Directors. He ha d responsibility for the Haddam Neck Plant and ISFSI (See Figure 1-1).

1.4.2 President P ient reports to the CEO and has the necessary authority and sgne esponsibility for developing, maintaining, and implementing the The President has the overall responsibility to implement the CYQAP at the HNP and ISFSI and in providing support services to the staff.

The President is responsible for the safe operation of the HNP and ISFSI and has control over those support activities necessary for decommissioning of the plant. These responsibilities include: CR 05-01

  • Direction of the CY Quality Assurance Program.
  • Implementation of policies and procedures.
  • Verifications through planned audits, surveillances, and inspections to assure compliance with 10 CFR50 Appendix B and other regulatory requirements.
  • Implementation of the CYQAP requirements.

The President has delegated these responsibilities to the Director of Nuclear Safety/Regulatory Affairs, the Director of Project Support, the Director of Decommissioning, the Regulatory Affairs Manager, the Unit/ISFSI Manager 2

QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

and the Executive Director of Business Operations (Procurement issues only). CR 04-02, CR 04-05, CR 04-01 The iden is onsible for appointing members of th1ndepeynden view uncton specified in Attachment F. CR 04-04 1.4.3 Director o ucear Re gulatory Affairs The Director of Nuclear Safety/Regulatory Affairs (NS/RA) reports to the President and is responsible for the following:

  • Direction for developing and maintaining the CYQAP.

&I~ impemetaton ireti an f te inusty eperenc prog ra m) imhCR 05-01

  • Direction and administration of operation, surveillance and maintenance of the systems, structures, and components required for safe storage of spent fuel at the Independent Spent Fuel Storage Facility (ISFSI)

CR 05-1

  • Direction and administration of th Independent Review function (ISR) described in Appendix F -0
  • Administration and support for implementation of the security program
  • Administration and support for implementation of the training program a o :or imple n of theFire Protec
  • Administration of the Health Physics Program CR 04-02 Rning operat 1.4.4 Director of Project Support The Director of Project Support reports to the President and is responsible for the following:
  • Direction and administration of engineering activities CR 05-01
  • Direction and implementation of project planning
  • Administration and execution of project scheduling
  • Administration of the records management

. Nirection and administration of document control 1.4.5 Director of Decommissioning The Director of Decommissioning reports to the President and is responsible for the following:

3 QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

g Dirctio andadmiistration of Integrated Site Closure activities 2

  • Direction and administration of activities necessary for the safe decommissioning of the plant
  • Direction and administration of the Waste Management Program CR 04-02, CR 04-05
  • Direction and administration of Industrial Safety CR 05-01 1.4.6 Director of Project Support The Director of Project Support reports to the President and is responsible for the following:
  • Direction and administration of engineering activities
  • Direction and implementation of project planning
  • Administration and execution of project scheduling
  • Administration of the records management
  • Direction and administration of document control CR 04-05, CR 05-01 1.4.7 Regulatory Affairs Manager The Regulatory Affairs Manager reports to the Director of Nuclear Safety/Regulatory Affairs. The Regulatory Affairs Manager is responsible for the direction and administration of:
  • Planning and coordination of decommissioning licensing activities
  • Correspondence and communications with regulatory agencies
  • Coordination of NRC inspections
  • Existing and proposed regulatory requirements as they apply to decommissioning.
  • End state activities to reach project completion with regulatory agencies including property transfer CR 05-01 1.4.8 Unit/ISFSI Manager The Unit/ISFSI Manger reports to the Director of Nuclear Safety/Regulatory Affairs. The Unit/ISFSI Manager is responsible for the direction and administr ion of the ISFSI Operations and Decommission Site Training, irrt ond rn Planning. Th unction (ISR), descried in ppendixFreports to the Unit/ISFSI Manager i ao anc cments. CR 05-01 4

QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

1.4.9 Executive Director of Business Operations (Procurement issues only)

The Executive Director of Business Operations reports to the President and is responsible for the following:

  • Direction and administration procurement activities including materials inventory
  • Direction and administration of contract administration
  • Management and coordination of project control functions including financial rti CR 04-02, CR 05-01 1.4.10 Manager-The Manager reports to the Director o u ea Regulatory Affairs and is responsible for audit, surveillan tion activities of the HNP and ISFSI. The Manager Sa rvides management with objective evidence of the activities affecting quality, independent of the individual or group directly responsible for performing the specific activity. This individual has the authority and organizational freedom to verify activities affecting quality. This is performed independent of undue influences and responsibilities for schedules and costs. The Manager N Safet as the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming materials. The individual also has the responsibility and authority to identify quality problems, to recommend or provide solutions, and to verify their implementation.

The Manager uclear Safety esponsibilities include:

  • Administerin uogram for audits, surveillances and inspections
  • Verifying the implementation of the CYQAP requirements
  • Evaluating performance and identification of strengths and weaknesses
  • Providing recommendations for improving nuclear performance at the HNP and ISFSI
  • Serving as the primary C ,Nuclear Safe management interface with HNP and ISFSI management
  • Stopping unsatisfactory work
  • Administering the Nonconformance and Corrective Action Programs CR 05-01 The Manager -u Safetis i an active participant on the CY Independent 5

QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

eview Committee I defined in Append( 3 CR 04-04 The Manager Nuclear Safety has direct communication with the CY Staff, the Director o uclear Safe egulatory Affairs, the President, and the CEO and provides the nteraction on matters affecting quality, nuclear safety, and nuclear related activities.

1.4.11 Radiation Protection Manager The Radiation Protection Manager carries out Health Physics func ions and reports to the Director o lrS-af-eRegulatory Affairs. The Radiation Protection Manager fulfills the position qualifications required by Appendix4>

Section 3.2. Radiation Protection includes those activities established to protect personnel from radiological hazards. CR 05-01 6

QAP 1.0 CYQAP Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

CONNECTICUT YANKEE ATOMIC POWER COMPANY ORGANIZATION CHART CHIEF EXECUTIVE OFFICER 1 (CEO) l INDEPENDENT SAFETY I REVIEW (IRAC) CR 04.04 PRESIDENT I

-I I DIRECTOR DIRECTOR DIRECTOR OF EXECUTIVE DIRECTOR OF I PROJECT SUPPORT I OF a

RE1UA~YAFAIRSl d IR DECOMMISSIONING BUSINESS OPERATIONS (Procurement Issues only)

CR-04-02, CR 05-01 I

NUIC LEAR SAFE (Note 1) uality Assurance

  • SITE CLOSURE
  • SCHEDULING
  • PROJECT CONTROLS Quality Control CR 05-01
  • PLANNING
  • PROCUREMENT Corrective Action
  • WASTE
  • ENGINEERING Nonconformances CR 05.01 MANAGEMENT
  • PROJECT
  • CONTRACTS

. ISFSI/OPERATIONS/MAINTENANCE CR 04.02, CR 04-05 ADMINISTRATION CR 0501

  • INDUSTRIAL SAFETY
  • DOCUMENT Independent Review Function (ISR) CR 05.01 CONTROL CR 04.04
  • EMERGENCY PLANNING
  • DECOMMISSIONING
  • RECORDS
  • TRAINING OPERATIONS MANAGEMENT CR 05-01 IRE PROTECTION_
  • SEUITY
  • HEALTH PHY CS (Radiation Protection Manager)
  • REGULATORY, GOVERNMENT AND PUBLIC AFFAIRS CR 05-01 Note 1: The Nuclear Safety Manager has a fine of communication with the President.

6 FIgure 1-1 QAP - 1.0, Rev: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 2.0 QUALITY ASSURANCE PROGRAM 2.1 GENERAL REQUIREMENTS CYAPCo has established the CYQAP for the HNP and ISFSI which complies with the criteria of 10 CFR 50, Appendix B, and follows the guidance referred to in Appendix C and Appendix E, herein. The quality assurance requirements set forth herein, supplemented by Site and ISFSI Procedures provide the primary basis of the Program with regard to quality assurance. This program is established for the HNP and ISFSI in a manner intended to accomplish the required level of quality for applicable plant and ISFSI activities. It includes quality activities during the maintenance, modification and operation of the Independent Spent Fuel Storage Installation and some activities associated with Radioactive Material Transportation. This program also satisfies the requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G. CR 05-01 The CYQAP applies to activities affecting th safe functions of systems, structures and components. Such activities are quality activities as defined in Appendix A herein. The level of CY QAP applicability is delineated in established administrative documents.

CR 05-01 The requirements of this Program are implemented by CYAPCo, who operate the HNP and ISFSI, and their vendors performing activities affecting quality systems, structures, and components. CR 05-01 Procedures define the required indoctrination and training of personnel performing activities affecting quality, as necessary, to assure that suitable proficiency is achieved and maintained.

Training sessions are documented. The content is described, attendees and attendance date(s) indicated, and the results of the training session(s) (e.g., satisfactory examination results) recorded.

A periodic program review of the status and adequacy of the CYQAP is accomplished by:

  • audits, surveillances and inspections;
  • CY dependent Review Committeeviews; and
  • Independent Assessment of the CYQAP Audit Program.

Vendors are required to review the status and adequacy of that part of the Quality Assurance Program for which they have designated responsibility.

QAP 2.0 8 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Analysis Reports (SARs). Important-to-Safety systems, structures, and components ACppeindix &o e A S~dent fed the in U CY Fa aressScin 3.2.1 of NRC R euaoGuide) 1.70. ference Appendix sance wth Y adminstrative proceures and QAP 5.0). CR 05-01 For systems, structures and components, covered by the ASME Code, procedures describe the measures taken to assure that the quality assurance requirements contained in the code are supplemented by the specific guidance of the applicable regulatory guides listed in Appendix C of this Program.

/ or systems, structures and components, regulatory commitments and procedures

> describe the measures taken to assure that the quality assurance requirements are tmet.

(The degree of control over activities affecting quality systems, structures, and components is consistent with their importance to safety. The CYQAP provides controls that include the use of appropriate equipment; establishment of suitable controls over special processes and skills necessary to attain the required quality; and the need for verification of quality by inspection and test.

Applicable organizations jointly determine and identify the extent of quality assurance controls are to be applied to quality structures, systems, and components.

The quality assurance controls are in conformance with this CYQAP, which complies with 10 CFR 50 Appendix B, 10 CFR71 Subpart H and 10 CFR 72 Subpart G. CR 05-01 2.2.4 PARTICIPATING ORGANIZATIONS CYAPCo requires that its vendors invoke upon their subcontractors, via Purchase Orders/Contracts, requirements for a quality assurance program to meet the applicable criteria of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H or 10 CFR 72 Subpart G, including the applicable elements of the Regulatory Guides and their endorsed Standards identified in Appendix C herein. However, CY retains overall responsibility for the implementation of the QA Program. The specific quality activities performed by these organizations are specified in the procurement documents. CY is responsible for the review and approval of vendor quality assurance programs prior to initiation of contracted activities. The object of the review is to verify that the vendors have an adequate quality assurance program to meet applicable requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G as applicable.

In addition to the initial review, CY Management is responsible for the subsequent performance, as appropriate, of audits, surveillances, and inspection QAP 2.0 10 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

of a vendor's quality assurance program to assure continued implementation of quality requirements.

uclear Sa lso performs on-site audits, surveillances, and inspections, as appropiate, of e vendor activities.

Vendors may be delegated the execution of quality assurance functions by contract. These contracts are reviewed and approved in accordance with program requirements.

2.2.5 INDOCTRINATION AND TRAINING A program is established and maintained for quality assurance indoctrination and training which provides confidence that the required level of personnel competence and skill is achieved and maintained in the performance of quality activities. Quality procedures delineate the requirements for an indoctrination program to assure that personnel responsible for performing quality activities are instructed in the purpose, scope, and implementation of quality procedures and instructions and that compliance to these documents is mandatory. CY Management is responsible for ensuring appropriate indoctrination and training of assigned personnel performing quality activities.

Training Programs shall be developed and implemented to provide training for individuals performing quality activities associated with the HNP or ISFSI.

Additional guidance is established in procedures. CR 05-01 Implementing procedures describe the program requirements which assure that:

Documentation of formal training and qualification programs includes the objective, content of the program, attendees, date of attendance, and examination results, as applicable;

  • Proficiency of personnel performing and verifying activities affecting quality is established and maintained. Personnel proficiency is established and maintained by training, examination/testing, and/or certification based upon the requirements of the activity. Acceptance criteria as appropriate are developed to determine if individuals are properly trained and qualified; and CR 05-01
  • Certificates or other documentation of qualification clearly delineate the specific functions personnel are qualified to perform and the criteria used to qualify personnel in each function.

2.2.6 MANAGEMENT OVERSIGHT OF THE QUALITY ASSURANCE PROGRAM QAP 2.0 11 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

The President ensures M janagement review of the CY Quality Assurance Program is conductecf~ntiual1 assess the effectiveness of the QA Program. This is accomplished by performing an independent assessment of the program. In addition, thittee (IRA= described in Appendixe performs oversig t o the program in accordance with the approved charter.

CR 04-04 Results of the assessments and reports are forwarded to the President for corrective action, as necessary. CR 04-04 QAP 2.0 12 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

The independent design verification should not dilute or replace the responsibility of the supervisors for the quality of work performed under their supervision. Where changes to previously verified designs have been made, design verifications are required for the change, including evaluation of the effects of those changes on the overall design. Design verification may be accomplished by testing. Tests to demonstrate adequacy under adverse design conditions shall comply with the requirements of QAP 11.0, "TEST CONTROL."

Design errors and deficiencies which adversely affect quality systems, structures and components in design process are documented, and appropriate corrective action is taken.

These design errors and deficiencies are documented in accordance with design change procedures or as defined in QAP 16.0, "Corrective Action."

Application of design controls does not include SSCs for radioactive material transportation packages and dry spent fuel storage components utilized under the provisions of a General License pursuant to 10 CFR 71 and 10 CFR 72. Additional guidance is contained in Appendix A.

3.2 IMPLEMENTATION The CY Director of Project Support is responsible for ensuring design, design review, engineering approval of design changes, design evaluation and design control are adequately performed at the HNP and ISFSI. The function may be delegated to other organizations to perform the design activity, or any part thereof, but the responsibility for overall design remains with the CY Director of Project Support. In all cases, final engineering decisions and ultimate design control of systems, structures and components related to the ISFSI are the responsibility of the CY Director of Project Support. CR 04-05, CR 05-01 ue Sart ment performs audits, surveillances, and inspections, to verify that Departments are effectively complying with the CYQAP and procedural requirements for design control.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections, to verify that vendors are effectively complying with the CYQAP and procedural requirements for design control.

4 as appropriate, on-site audits, surveillances, and inspections of these venor activities. CR 05-01 3.2.1 DESIGN PROCESS Design control measures are applied to design analyses, such as: stress, thermal, hydraulic, nuclear radiation, accident and seismic analyses; compatibility of materials; accessibility for required inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and test. Measures established to control design documents are described in QAP 6.0, "Document Control."

QAP 3.0 14 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Program procedures and instructions define the method of implementing design control measures. These measures require that applicable design requirements, such as, design bases, regulatory requirements, codes and standards, are translated into specifications, drawings, procedures or instructions. Instructions further require that appropriate quality standards are specified and included in design documents. All materials, equipment, parts and processes, including standard "off the shelf' commercial or previously approved items essential to the quality functions, are selected and reviewed for suitability of application.

The basis for selection may include industry standards, material and prototype hardware testing programs, and design review.

CY procedures assure that a documented check is performed to verify the accuracy and completeness of design drawings and specifications before release for use.

Design drawings and specifications issued for design changes are reviewed for completeness and accuracy before being released to operations, in accordance with CY procedures.

CY procedures describe the provisions to assure that design drawings and specifications are prepared, reviewed and approved in accordance with company procedures, and that the documents contain the necessary quality assurance requirements, such as inspections and test requirements, acceptance requirements, and the extent of documenting inspection and test results.

3.2.2 DESIGN CHANGE CONTROL Procedures and instructions govern design change control during modifications to the HNP and ISFSI. Control of discrepant or deficient design conditions, and reported unsatisfactory performance, provide for the identification of design changes and a documented method to control these changes. Design and specification changes are subject to design control measures commensurate with those applied during the original design.

An independent review and approval of design changes is performed by the organization that conducted the original design reviews, unless another qualified organization is designated to perform this function.

Proposed design change modifications are sub an ement for processing an view. This review includes thIndependent Revie required by Appendi he In ers (IS vise e S1 Manager on maers reaiii l Comosition, responsibilities, and authority of the committee are defined in AppendiCf the CYQAP. If the proposed change involves a quality system structure or component, the change will be reviewed by qualified engineering personnel for technical adequacy.

Reviews of the 10 CFR 50.59 and 10 CFR 72.48 evaluations ss ted with design changes are performed by th CC).

QAP 3.0 15 CYQAP IZEV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 GENERAL REOUIREMENTS The procurement of materials, equipment, parts and/or services required during the maintenance and modification of quality systems, structures and components at the HNP and ISFSI is performed in a controlled manner which assures compliance with applicable regulatory requirements, procedures, quality assurance standards and regulations affecting procurement documents. Changes to procurement documents are subject to the same degree of control as utilized in the preparation of the original documents.

4.2 IMPLEMENTATION 4.2.1 PROGRAM Material and service requests are reviewed for technical adequacy and verification of the quality designation. The appropriate engineering management reviews and approves material and service requests, as applicable.

CYAPCo is responsible for ensuring performance of a procurement engineering evaluation to ensure the inclusion and adequacy of technical and quality assurance requirements prior to the issuance of the Purchase Order. Material for which technical and quality assurance requirements have been previously established are procured without additional procurement engineering evaluation.

Vendors utilized in the maintenance and modification of the HNP and ISFSI are responsible to implement measures for control of procurement documents associated with quality material, equipment, parts and services to ensure applicable requirements including quality assurance requirements are specified.

CYAPCo is responsible for ensuring the performance, as appropriate, of off-site audits, surveillances, and inspections to ensure that vendors are effectively complying with the requirements for the control of procurement documents.

CYu af erforms, as appropriate, on-site audits, surveillances, and inspections of t ese vendor activities.

Changes to procurement documents are subjected to the same degree of control as that utilized in the preparation of the original document. The procurement of spare or replacement parts for quality systems, structures, or components is subject to the controls of the CYQAP and implementing procedure requirements.

The spare or replacement parts are subject to controls equivalent to original or subsequent codes and standards. The use of subsequent codes and standards are controlled in accordance with the design change control requirements in QAP 3.0, "Design Control."

QAP 4.0 18 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

CYAPCo ensures the performance of procurement engineering evaluations of quality related material and service requests by personnel to ensure that:

a. Adequate technical requirements are specified;
b. The quality assurance requirements are correctly stated, auditable and controllable; and
c. There are adequate acceptance and rejection criteria.

4.2.2 PROCUREMENT DOCUMENT PROVISIONS Procurement documents are prepared, reviewed and approved in accordance with procedures of the issuing organization or department and are available for verification. These procedures require that procurement documents consist of the following, as necessary:

a. The scope of work to be performed;
b. Technical requirements (specified or referenced) including the applicable components and materials identification requirements, drawings, specifications, procedures, instructions, codes and regulations, and the identification of applicable test, inspection and acceptance requirements, or special process instructions;
c. CYQAP requirements to be imposed on contractors which include the applicable requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G and the Regulatory Guides and their endorsed ANSI Standards listed in Appendix C, herein; CR 05-01
d. Right of access which provides, as appropriate, for access to contractor facilities and records for inspection or audit by CYAPCo or its designated representative; and provides access for events such as those requiring notification of hold points; and/or
e. The documentation required to be prepared, maintained, and/or submitted to CYAPCo or its representative for review, approval or historical record. The time of submittal of this documentation and the retention and disposition of quality assurance records which are not submitted to CYAPCo is prescribed, as applicable, fob§bIerhmdej procurements.

4.2.3 SELECTION OF PROCUREMENT SOURCES The function of procurement source selection is the responsibility of CYAPCo.

QAP 4.0 19 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 5.0 QPROCEDURES. INSTRUCTIONS. AND DRAWVINGS 5.1 GENERAL REQUIREMENTS The CYQAP provides measures for the preparation, review, approval, control and distribution of procedures, instructions and drawings of activities affecting quality systems, structures and components during maintenance, modification, and decommissioning of the HNP and ISFSI. The documents include appropriate quantitative and qualitative acceptance criteria which specify the activity to be performed; the methods of construction and testing to be employed; material, equipment or parts to be used; a sequence of operation and the required documentation.

5.2 IMPLEMENTATION Q endures provide direction for personnel performing quality functions. CY Safety eviews and concurs with CY quality procedures as defined in the CY administr control procedures. Comments concerning compliance with the CYQAP and regulatory requirements are resolved prior to issuance of the procedure.

Vendors utilized in the maintenance and modification of the HNP and ISFSI. may be delegated responsibility for preparing, 'maintaining, issuing and verifying the implementation of program documents which are selectively reviewed/approved by the appropriate Manager.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the quality assurance programs to ensure the vendors are effectively complying with the requirements for procedures and instructions.

CYuclear Safe erforms, as appropriate, on-site audits, surveillances, and inspections of these y ivies. Vendor programs are required to clearly delineate the actions to be accomplished in the preparation, review and control of procedures, instructions and drawings and the methods for complying with 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and/or 10 CFR72 Subpart G. CR 05-01 5.2.1 PROCEDURES AND INSTRUCTIONS Procedures and instructions for activities affecting quality are prepared, reviewed, and approved in accordance with written procedures and instructions.

QAP 5.0 21 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

The appropriate CY Manager ensures that any veuidors utilized in the maintenance and modification of the HNP and ISFSI, implement quality assurance programs which contain written instructions for preparation, review and approval of procedures and instructions affecting quality. In addition, vendor's site ity Edures and quality control inspection procedures are reviewed by C Safe to assure compliance with the vendor's QA Program.

The CY line organization is responsible for the preparation, review and approval of plant and ISFSI quality procedures. The procedures include test procedures and overall site and ISFSI administrative procedures which implement the requirements of the CYQAP.

CY r Safe reviews and concurs with quality procedure and special process nd procedures. The criteria for documents requiring CY review are defined in CY administrative procedures to ensure that:

a. Administrative procedures which implement thjCYQAP are for comfha ce with the CYQAP an appble Appendix f~Cguies and st~andard~san
b. Work Procedures/Work Documents used to perform quality activities are reviewed to assure appropriate quality assurance controls have been specified.

5.2.2 DRAWINGS The design control and verification measures described in QAP 3.0, are applicable for the review and approval of drawings. Review and approval of newv drawings or changes to existing drawings are described in CY procedures. The originating organization may delegate to other organizations or departments the work of design and review activities, or any part thereof, but retains responsibility for this work.

The measures taken to assure the preparation of as-built drawings and related documentation in a timely manner to accurately reflect the plant and ISFSI are described in CY procedures. Drawings critical to the maintenance of the long term fuel storage are updated prior to system turnover to operation and are available to the operating personnel.

5.2.3 ACCEPTANCE CRITERIA Review and approval of departmental procedures, instructions and drawings is described in CY procedures to ensure the inclusion of adequate quantitative and qualitative acceptance criteria for determining satisfactory work performance and quality compliance. These criteria apply to quality activities as defined in the CYQAP.

QAP 5.0 22 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 6.0 DOCUMENT CONTROL 6.1 GENERAL REQUIREMENTS The CYQAP provides measures to assure controlled distribution of documents pertinent to Quality Activities affecting3Imrln' i iit to Sstructures, systems, and components in accordance with CY quality procedures and 10 CFR 50 Appendix B, 10 CFRq7l Subpat H and 10 ICER72 SubjiifG. CR 05-01 Documents such as procedures, instructions, drawings, specifications and reports are prepared, reviewed for appropriate qualitative and quantitative acceptance criteria, and approved by authorized personnel in the affected organization. Approved controlled documents are distributed to affected locations in accordance with a controlled distribution list. Changes to controlled documents are reviewed and approved by the same organization which performed the original review and approval, unless otherwise specified in the implementing procedures. Measures are provided for controlling documents to preclude the possibility of the use of outdated documents.

6.2 IMPLEMENTATION 6.2.1 RESPONSIBILITY CY procedures and instructions delineate the measures for controlling documents including direction for the review for adequacy, approval by authorized personnel, distribution of controlled documents and verification that changes are promptly incorporated and implemented. iThe ec'ntroi-mea pply toiapplicable documes ffeeting syste s;.8tirctuies and.components-fortho eim enance and modificati6~oIf theiSFSIsu'h

§ ' - CR 05-0'

a. Design Specifications;.
b. Design, Manufacturing, Construction and Installation Drawings;
c. As-Built Documents;
d. QuaalityK i iiri Proce ures and iinicions; CR 05a'h1
e. Manufacturing, Inspection and Testing Instructions;
f. Test Procedures;
g. Calculations;
h. Design Basis Documentation; QAP 6.0 23 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01
h. Design Basis Documentation;
i. Final Safety Analysis Reports;
j. Procurement Documents;
k. Design Change Records;
1. CY Quality Assurance Program;
m. Nonconformance Reports; and
n. Computer Codes.

CY procedures describe the measures taken for the control of documents to assure review and concurrence, as necessary, with regards to quality assurance aspects.

The requirements for control of procurement documents are contained in QAP 4.0, "Procurement Document Control." During all phases of plant and ISFSI life, it is the responsibility of each organization issuing controlled documents to employ document control procedures. The issuing organization is additionally responsible for distribution of the documents to appropriate locations. There shall be provisions to assure that approved changes are included in instructions, procedures, drawings and other documents prior to implementation of the changes.

Vendors utilized by CY in the maintenance and modification of the HNP or ISFSI are responsible for implementing measures for review, approval, control and distribution of controlled documents, to ensure they are effectively complying with the requirements for document control.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the vendors to verify compliance with their approved quality assurance programs.

C erfo rm s, as appropriate, on-site audits, surveillances, and inspections of these vendor activities.

6.2.2 DISTRIBUTION OF CONTROLLED DOCUMENTS CY procedures specify in what manner controlled documents and revisions thereof, are distributed to appropriate locations prior to commencing the work.

6.2.3 DRAWING CONTROL QAP 6.0 25 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

CYAPCo is responsible to implement a program for the retention and retrieval of drawings and records submitted by cognizant CY personnel. CYAPCo maintains a drawing status file which includes drawings (newly issued or revised) with the latest revision and current status.

The vendors utilized during the maintenance and modification of the HNP or ISFSI may be delegated the function of drawing control and must furnish periodic status reports listing the revisions of applicable drawings issued.

N e s responsible for the performance of off-site audits, surveillances, and inspections of vendors to verify they are effectively complying with their programs for document control of drawings.

performs, as appropriate, on-site audits, surveillances, and inspectionso vendor activities.

6.2.4 INSTRUCTION AND PROCEDURE CONTROL erforms audits, surveillances, and inspections of departments and, as appropriate, any on-site vendors utilized in maintenance and modification to the HNP or ISFSI to ensure they are effectively complying with their QA program for control of procedures and instructions.

The originating department is responsible for establishing adequate control over quality procedures and instructions issued by the vendor. The responsible organization also issues status reports or revised indices listing the latest revision of applicable controlled documents issued by the vendor. Procedures identify requirements for assuring controlled documents are available at the work location prior to commencing work.

QAP 6.0 26 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

7.2.5 COMMERCIAL DEDICATION CYAPCo procedures address the measures taken to assure that commercial grade items, where specific quality assurance controls for nuclear applications cannot be imposed in a practicable manner, that special dedication requirements are

( established and implemented.

These measures follow the guidance in Regulatory Guide 1.144, paragraph C. 3. b (1) and Regulatory Guide 1.123 and applicable paragraphs of Section 10 of ANSI (N45.2.13.X These measures include appropriate requirements for special categorization and identification within the procurement document, receipt inspection, and additional controls during the installation and testing process to be performed by the CY organization and/or other appropriate groups.

QAP 7.0 30 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

b. Controls to assure that the correct identification of an item is verified and documented prior to release for fabrication, assembly, shipping or installation,
c. Requirements which assure that the method or location of markings do not affect the function or quality of an item, or
d. Establishment of identification requirements in purchase orders, contracts, specifications, drawings, procedures or instructions.

During the maintenance and modification of the HNP or ISFSI, CY may delegate any portion of the implementation of the identification and control program to a vendor contracted to perform related quality activities. If delegated, contracts require that the vendor establish an identification and control program which meets the CYQAP requirement.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the vendor's quality assurance program, to ensure they are effectively complying with the requirements for identification and control of material, equipment and components.

Cas appropriate, on-site audits, surveillances, and inspections of the vendor activities.

Receipt inspections are performed to verify that materials, equipment and components are properly identified in accordance with procurement requirements. CYAPCo is responsible for assigning and applying permanent identification to the items in accordance with procedures. If the application of a serial number is not practical, other means of identification are implemented to assure proper identification and traceability.

In the event that the equipment, material or component is nonconforming or the identification becomes lost or illegible, the items are considered nonconforming and are identified and controlled in accordance with QAP 15.0, "Nonconforming Materials, Parts, Components, or Services."

QAP 8.0 32 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 9.0 CONTROL OF SPECIAL PROCESSES 9.1 GENERAL REQUIREMENTS The CYQAP provides measures to assure control of special processes associated with quality systems, structures and components by the use of qualified procedures, equipment and personnel during maintenance an oof the P and ISFSI Special processes are performed under controlled conditions in accordance with special requirements and may include, but are not limited to: welding, cleaning, heat treating, and nondestructive examination and/or testing.

9.2 IMPLEMENTATION During maintenance and modification of the HNP or ISFSI, CY Management ensures that special process data and documentation is reviewed; vendor's special process procedures used at the HNP or ISFSI are qualified and approved; and that personnel and equipment utilizing special processes are properly qualified prior to the start of work.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections to ensure the vendors are effectively complying with their quality assurance program requirements for control of special processes.

fas appropriate, on-site audits, surveillances, and inspections of the vendor activities.

CY special process procedures utilized during maintenance and modification of the HNP or ISFSI are prepared, reviewed and approved in accordance with procedures as specified in QAP 5.0, "Procedures, Instructions, and Drawings."

9.2.1 PROCEDURE QUALIFICATION AND CONTROL CYAPCo procedures specify that written process control documents are utilized and qualified, as required, in accordance with the applicable specification, codes or standards.

9.2.2 PERSONNEL QUALIFICATION AND CERTIFICATION Codes, standards and CYAPCo procedures specify personnel qualification/certification requirements. Personnel responsible for the performance and verification of special processes are trained, tested, and certified as required by applicable specifications, codes and standards. Requirements for the period of certification, retesting, and recertification of personnel are also specified. Vendors qualify personnel and maintain records of qualified personnel in accordance with applicable codes, standards, specifications, and vendor QAP 9.0 33 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Purchase Order/Contract requirements. The department that is contracting services is responsible for the review of records of qualified personnel, equipment and procedures associated with special processes.

Nuclear Safety performs as appropriate, audits, and surveillances of the ica rocess.

/ The CY Nuclear Safety Department is responsible for ensuring that the training, testing, and certification of NDE personnel at the HNP and ISFSI is in accordance with the requirements of Regulatory Guide 1.58 (Rev. 1, 9/80) and ASNT Recommended Practice No. SNT-TC- 1A.

9.2.3 SPECIAL PROCESS RECORDS Records provide objective evidence that special processes were performed in accordance with procedures, by qualified personnel, and that when required by procedures, specifications, and codes, such performance was verified. Results of nondestructive examinations are recorded in accordance with applicable specifications, codes and standards. These records are retained by the vendor or supplied to CY as required by contract or purchase order. If records are to be retained by the supplier, the contract or purchase order specifies the retention period and instruction for final disposition of records.

Special process documentation such as special process procedures, qualifying data, and personnel and equipment qualification records associated with the performance of special processes at nuclear power plants, are kept current and maintained in appropriate CY files, with final disposition to the CY record facility.

QAP 9.0 34 CYQAP REV: 05, CR 04-0 1, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 10.0 INSPECTION 10.1 GENERAL REQUIREMENTS Inspection of activities to verify the quality of systems, structures and components, which are performcd by or for CY are executed in accordance with the CYQAP and appropriate procedures, instructions and drawings by qualified personnel independent from the individual or group performing the activity being inspected. If inspection is impossible or disadvantageous, indirect controls by monitoring processing methods, equipment and personnel are provided. Inspection notification and hold points are identified, as required, in the applicable documents.

10.2 IMPLEMENTATION 10.2.1 INSPECTION RESPONSIBILITIES During maintenance and modification of the HNP or ISFSI, procedures shall define the need for inspections (e.g., receipt inspections, installation, and product acceptance).

C lar Safe shall ensure procedural requirements are met by means of audits and surveillances as defined in CY Department procedures.

inspections of modification and maintenance activities on systems, structures, mponents governed by the CYQAP. The criteria used to determine whe nspections shall be required for these activities and for of inspection plans shall be identified in appropriate procedures. uclear Safety hall be responsible for ensuring the inspection function which inuds

a. Identification of inspection personnel;
b. Review of work procedures and work documents to identify QA "hold" points associated with the work;
c. Preparation and approval of inspection plans ensuring that the necessary inspection requirements, methods, and acceptance criteria have been identified; and
d. Documentation of inspection results.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections to verify that any vendor utilized in the maintenance and modification of the HNP or ISFSI are effectively complying with their quality assurance program requirements for inspection and for QAP 10.0 35 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

performing/witnessing inspections at "hold" or "notification" points identified in procurement documents.

N Sfety as appropriate, on-site audits, surveillances, and inspections of vendor activities.

10.2.2 INSPECTION PLANS Documented inspection plans may be either a separate document or an integral part of work instruction documents. The plans are based on design specifications, procurement documents, drawings, other specifications, or previous experience, as appropriate.

During the performance of CY work activities, procedures provide criteria for the determination of accuracy requirements of inspection equipment and when inspections are required. These procedures describe requirements for the preparation of surveillance and/or inspection plans.

The inspection criteria, including the use of inspection equipment and their accuracy requirements, are specified in the surveillance/inspection plans.

10.2.3 INSPECTION PERSONNEL AND INSPECTION DOCUMENT ACCESS Inspections are performed by individuals other than those who performed or directly supervised the activity being inspected. Inspection personnel are qualified and/or certified in accordance with appropriate codes, standards, and/or training programs.

Inspections are performed bgy YNuclear Safety personnel or qualified contract personnel. The on-site QA inspection services shall review the acceptability of vendor personnel/equipment certification prior to the initiation of the activity.

When vendors are contracted to perform inspection se stheir inection plans/procedures are reviewed and concurred upon byY Nuclear Safe in accordance with QAP 5.0, "Procedures, Instructions, and Drawings".

Access to drawings, procedures, specifications or other documented criteria necessary for the performance of inspections is provided prior to performing the inspection activity.

QAP 10.0 36 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

10.2.4 INSPECTION PROCEDURES (a) Required inspection or surveillance activities are performed and documented in accordance with procedures and/or checklists.

Inspection procedures, plans or checklists contain the following:

(1) Identification of characteristics to be inspected; (2) Identification of the individual or groups responsible for performing the inspections; (3) Requirements for the necessary measuring and test equipment and the required accuracy of this equipment; (4) Acceptance criteria; (5) A description of the method of inspection when other than direct visual examination using the unaided eye; (6) A record of the results of the inspection; and/or (7) Record of inspector or data recorder.

(b) Procedures specify surveillance of processing methods or testing and operation of equipment when inspection is impossible, inaccessible or not applicable.

(c) Modification, repair, replacement or rework items are inspected in accordance with original inspection requirements or approved alternatives.

10.2.5 MANDATORY HOLD AND NOTIFICATION POINTS Mandatory hold points are utilized when an inspection/operation must be performed or witnessed and signed off by the responsible personnel before work can proceed.

are used to identify the operations or completed processes that Nrepresentatives may elect to witness and/or inspect during the manufacturing or installation process. Mandatory hold and notification points, as required, are identified in procurement documents and work procedures/documents. Purchase Order/Contracts and work procedures/documents are subject to the review and concurrence for ade of ins tn, notification and/or mandatory hold controls by CYAPCo an respectively.

QAP 10.0 37 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

10.2.6 INSPECTION RESULTS EVALUATION Inspection results are evaluated for acceptability in accordance with procedures which identify the responsible organization.

The evaluations are performed by the responsible personnel who are qualified in accordance with the appropriate Regulatory Guide/ANSI Standard commitments listed inApedx.

performs audits and surveillances to assure that inspections are performed per the requirements of applicable CY procedures.

QAP 10.0 38 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

c. Where special instrumentation is required for testing, the requirements are stated in the procedures. Instrument characteristics, including accuracy requirements, are equivalent to or better than those specified by the vendor.

11.2.4 EVALUATION OF TEST RESULTS The documented test results are evaluated against the predetermined acceptance criteria by an individual or group having appropriate qualifications. The acceptance status of the test is documented. Deficiencies noted during the evaluation are documented and dispositioned in accordance with approved procedures.

The evaluation of test results may also be delegated to vendors. When delegated, contracts require the vendor to assure the use of qualified personnel, evaluate the data against predetermined criteria and document the results of the evaluation and acceptance status of the test.

CYAPCo is responsible for the performance of off-site audits, surveillances, and inspections, as appropriate, to verify that these vendors are effectively complying with their quality assurance program requirements for test control.

cear afe erforms on-site audits, surveillances, and inspections, as approprate, of e activities.

QAP 11.0 41 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 12.0 CONTROL OF MEASURING AND TESTING EQUIPMENT 12.1 GENERAL REQUIREMENTS The CYQAP provides measures for the control of measuring and testing equipment (M&TE) used as the basis for acceptance in activities affecting quality during inspection, testing and measurement of materials, equipment and parts. Periodic calibration and adjustment of measuring and test equipment is performed and controlled to assure accuracy is maintained within limits necessary to verify that design and operating condition requirements have been met. Documentation is retained such that all items of M&TE are traceable to their calibration records.

12.2 IMPLEMENTATION 12.2.1 GENERAL Procedures delineate the methods and responsibilities for the control, maintenance and calibration of M&TE including portable and temporarily installed test instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment.

Documentation associated with M&TE is maintained in appropriate files, with eventual incorporation into the records system. When the information for the control, use, and calibration of M&TE is in electronic form, this information is controlled and protected in accordance with procedures. CR 05-01 The calibration program is implemented in accordance with the requirements defined in CY procedures which describe the measures utilized to maintain M&TE. Functional groups are responsible for implementing these procedures which comply with the requirements contained in specifications and drawings.

M&TE administrative procedures related to the M&TE calibration program are independently reviewed and approved as described in Appendix F.

CYAPCo or the appropriate M&TE Custodian, as delineated by the Purchase Order, is responsible for verifying that receipt of calibrated equipment is in coormance with the requirements of procurement documents. CYAPCo and erafet responsible for the calibrated M&TE used during their inspections, respectively.

QAP 12.0 42 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

D eartpervisore responsible to ensure that M&TE equipment is cahrated, issued, and controlled in accordance with the requirements of the procedures. The "activity" Supervisor shall ensure that the users of the M&TE are properly instructed in the use and control of the M&TE. HNP and ISFSI Departments are responsible for calibrating M&TE within the required interval or removing the M&TE from service until the required calibration can be performed.

CY departments are also responsible for reviewing calibration data associated with M&TE calibration by outside vendors in accordance with the procedures.

CY 3 performs audits, surveillances, and inspections to verify implementation of the M&TE program.

Vendors utilized in the maintenance and modification of the HNP or ISFSI are responsible for implementing measures for the control of M&TE to ensure they are properly calibrated, adjusted and maintained at specified intervals in order to maintain accuracy within required limits.

CYAPCo is responsible for the performance of off-site audits, surveillances, and inspections, of the quality assurance programs of vendors to verify that they are effectively complying with their requirements for control of M&TE.

Sfe on-site audits, surveillances, and inspections, as fvendor activities.

12.2.2 CALIBRATION STANDARDS Measuring and test equipment is calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement. Measuring and test equipment shall be permanently marked or tagged with a unique identification number and the date calibrated and next calibration date indicated on the M&TE.

CY procedures describe the measures taken to assure that reference and transfer standards are traceable to nationally recognized standards and that, where national standards do not exist, provisions are established to document the basis for calibration.

QAP 12.0 43 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 13.0 HANDLING, STORAGE AND SHIPPING 13.1 GENERAL REQUIREMENTS Measures are established by the CYQAP using procedures, instructions and procurement documents to ensure proper handling, storage, shipping, cleaning and preservation of material, equipment and parts. These measures are imposed during maintenance and modification activities in order to preclude damage, loss or deterioration of materials, equipment and parts.

13.2 IMPLEMENTATION 13.2.1 GENERAL Procedures, instructions and procurement documents define the requirements and responsibilities for the handling, storage, shipment, cleaning and preservation of material, equipment, and parts required for implementation of established design and specification requirements.

Handling, storage, cleaning and preservation requirements of material, equipment and parts is conducted in accordance with procedures and procurement documents.

Vendors utilized in the maintenance and modification to the HNP and ISFSI are responsible for implementing measures for handling, storage, shipping, cleaning and preserving materials, equipment and parts to preclude damage, loss or deterioration.

CYAPCo is responsible for off-site audits, surveillances, and inspections, as appropriate, to verify that vendors are effectively implementing and complying with the approved procedures and instructions for handling, storage, shipping, cleaning and preservation of materials, equipment and parts.

CY Nuclear Safetye sn-site audits, surveillances, and inspections, as appropriate, 0+/- the activities.

13.2.2 ESTABLISHMENT OF SPECIAL HANDLING. STORAGE. SHIPPING, CLEANING AND PRESERVATION REQUIREMENTS Special or additional handling, storage, shipping, cleaning and preservation requirements are to be identified and implemented as specified in procurement documents and approved procedures. These established requirements are consistent with the regulatory positions of the NRC Regulatory Guides and their endorsed ANSI Standards listed in C, Appendix C herein, or specifications and/or vendor technical manuals, and will be CY procedures describe the measures taken for the storage of chemicals, reagents (including control of shelf life), lubricants, and other consumable materials.

QAP 13.0 45 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

procedures and instructions, to prevent inadvertent operations of systems, structures and components.

CY procedures describe the measures taken to control the altering of the sequence of required tests, inspections and other operations. The review and approval for these actions is subject to the same control as taken during the original review and approval of tests, inspections and other operations.

uclear Safety performson-site audits, surveillances, and inspections, as appropritoh activtes.

14.2.2 STATUS IDENTIFICATION AND CONTROL Procedures and instructions describe control of the application and removal of markings such as stamps, tags, labels, and other suitable means to indicate the status of systems, structures and components to prevent inadvertent operation, and to preclude omission of inspections, tests or other critical operations. These procedures and instructions delineate the requirements, methods and responsibilities for indicating the status of the affected items. The complete status of all items under the calibration system is recorded and maintained.

Records associated with status identification are maintained in accordance with procedures.

QAP 14.0 47 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

a. Impact on nuclear safety; CR 05-01
b. Safety of personnel;
c. Suitability of material or items in the "as is" condition, i.e., probability of eventual satisfactory resolution of the nonconforming without repair, rework or replacement;
d. Accessibility of material or items after release;
e. Cost of removal and repair or replacement should material or items eventually have to be removed, repaired, or replaced; and
f. Effect on the orderly progress of work.

Items repaired are verified by reinspecting the items as originally inspected or by a documented method which is equivalent to the original inspection method.

Items reworked may require reinspection as defined in procedures. CR 05-01 6CY Nuclear Safety performs~udits and surveillances to verify that dispositions fnonforming conditions are adequate.

QAP 15.0 49 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 16.0 CORRECTIVE ACTION 16.1 GENERAL REQUIREMENTS The CYQAP requires that an effective corrective action program be established for CY and their vendors to ensure that conditions adverse to quality are promptly identified and corrected as soon as practicable and documented in accordance with approved procedures.

These procedures include measures for determining the cause and corrective action to preclude recurrence for conditions identified as significant conditions adverse to quality.

16.2 IMPLEMENTATION 16.2.1 PROGRAM Procedures define personnel responsibilities and establish various measures for identification, documentation, evaluation/review, disposition and correction of conditions adverse to quality and significant conditions adverse to quality.

Reporting mechanisms are available to station personnel.

16.2.2 CORRECTIVE ACTION AND FOLLOW-UP Procedures describe the measures taken to evaluate if conditions adverse to quality exist and to determine the need for immediate corrective action or disposition. The Director oft Regulatory Affairs is responsible for ensuring that the assigned personnel and their vendors working at HNP or ISFSI comply with the corrective action program and for ensuring that corrective action is adequate and properly implemented in a timely manner at the HNP and ISFSI.

CY Management is responsible for ensuring that conditions adverse to quality are promptly identified and corrected in accordance with approved procedures.

Audits and surveillances to verify that organizations working at the HNP and ISFSI comply with the corrective action program and that corrective action is adequate and properly implemented in a timely manner.

The President has the final authority in the event that agreement on the action to be taken is not reached at the appropriate organization levels within the CY organization. CR 04-04 QAP 16.0 50 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

16.2.3 RECURRENCE CONTROL Procedures provide responsibility and the process for determining appropriate significance based on actual or potential consequences for conditions adverse to quality and requirements for evaluation and corrective action.

Procedures also establish the responsibilities and measures taken to accomplish these actions.

An analysis of conditions identified as adverse to quality is developed and adverse trends are periodically reported to management by the organization responsible for controlling the problem reporting program. Trends concerning specific vendor performance shall be reported to the affected contractor for resolution, if appropriate.

Audis and surveillances to verify that the corrective action program is adequate and controlled in accordance with procedures.

QAP 16.0 51 CYQAP REVI: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Vendors utilized in the maintenance and modification of the HNP or ISFSI are responsible to implement measures for identification, maintenance, retention, retrieval and turnover of records to CY personnel which contain objective evidence of quality, as specified in Purchase Order/Contracts.

CYAPCo is responsible for off-site audits, surveillances, and inspections, of vendors, as appropriate, to verify they are effectively complying with their program for quality assurance records.

o on-site audits, surveillances, and inspections, as appropriate, of these activities.

Quality Assurance records are identified controlled and maintained in appropriate files and are identifiable to specific systems, structures and components at HNP and ISFSI. When identification to a specific system, structure or component is not practical, records are filed by category (e.g. specification, nonconformance reports, audits, etc).

17.3 RETENTION CY quality assurance records are ssified as life records or nonlife records as delineated by the Nuclear Records Program f records are those documents that are maintained for a specific period of time other than the lifetime of the in-service nuclear power plant, ISFSI or the particular component or part. Life records are those documents that are maintained for the lifetime of the in-service nuclear power plant, ISFSI or for the life of the particular component or part. Life records are those which would be of significant value in meeting

-one or more of the following criteria:

a. Demonstrating capability for safe operations;
b. Maintaining, reworking, repairing, replacing or modifying the item;
c. Determining the cause of an accident or malfunction of an item; or
d. Providing required base line data for in-service inspection.

Records are reviewed and approved by the cognizant qualified personnel and vendors as appropriate, and are transmitted to Nuclear Records. The responsibility of Nuclear Records upon receipt of records is to maintain and provide controlled retrievability of records affecting the HNP or ISFSI in such a manner as to prevent destruction of records by fire, flood, theft, and environmental conditions, such as temperature or humidity, as delineated in procedures. CR 05-01 QAP 17.0 53 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

QAP 18.0 AUDITS 18.1 GENERAL REQUIREMENTS The CYQAP requires that a comprehensive system of planned and periodic audits shall be carried out to verify compliance with the CYQAP during the maintenance and modification of the HNP or ISFSI.

Audits are conducted in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited.

Audit results are documented and reviewed by management having responsibility in the area audited and the responsible management takes the necessary action to address any audit findings revealed by the audit.

18.2 IMPLEMENTATION 18.2.1 PROGRAM The audit program requires audits of corporate, HNP and ISFSI quality activities under the oversight by the CY Independent Review Committee (IRAC) as described in Appendix F. Audits are performed on activities where the requirements of 10 CFR 50, 10 CFR 71 and 10 CFR 72, and the CYQAP are being implemented. CR 05-01 Audits are regularly scheduled on the basis of the status and safety importance of the activities being performed. Regularly scheduled audits are supplemented by audits for one or more of the following conditions:

a. When significant changes are made in functional areas of the quality assurance program, such as significant reorganization or procedure revisions;
b. When it is suspected that the quality of the item is in jeopardy due to deficiencies in the quality assurance program;
c. When a systematic, independent assessment of program effectiveness is considered necessary; and / or
d. When necessary to verify implementation of required corrective action.

Schedules f the audit of CY activities are originated and maintained by6 3 Nuclear Safety. Schedules are approved by thanager.

QAP 18.0 54 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Audits are performed as specified in CY Nuclear Safety procedures by qualified personnel, using a pre-established written audit plan prepared by the auditing organization. Audits may include evaluation of the work areas, activities, processes, items, and review documents and records to determine the effectiveness of implementation and conformance to the CYQAP. CR 05-01 Approved vendors utilized in the maintenance and modification activities to the HNP or ISFSI are responsible for developing and implementing a system of planned and periodic audits to verify compliance with the effectiveness of all aspects of their quality assurance programs.

CYAPCo is responsible for verifying the acceptability of vendor audit programs and for the performance of subsequent off-site audits, as appropriate, to verify compliance with the effectiveness of all aspects of their quality assurance programs. CR 04-01 CY Nuclear Safety performs audits/surveillances of on-site vendors, as ay etivene ss of appropriate aspects of their quality assurance programs In addition to the audits, other methods, such as surveillances, and inspections are used to ensure that quality activities are in compliance with the CYQAP.

18.2.2 REPORTING OF AUDIT RESULTS Audit results are reviewed, approved, and reported in accordance witl nd/or approved vendor procedures, as applicable. The Bit reports are issued to the appropriate management of the area audited to ensure appropriate and/or timely corrective action is taken to address any audit issues. In addition, audit data and reports are included as part of the review for quality trends and assessed in accordance with QAP 16.0, "Corrective Action."

18.2.3 REVIEW, ACTION, AND FOLLOW-UP OF AUDIT FINDINGS Audit findings are reviewed and investigated by the management having the responsibility for the area audited. The responsible management is required to:

a. Take the necessary action to addresses any findings identified by the audit;
b. Report the results of such reviews and investigations;
c. Take the necessary actions to correct problems reported; and
d. Report the completion of corrective actions within specified time QAP 18.0 55 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

frames.

Follow-up of audit findings is performed by the auditing organization, as necessary, to verify that appropriate actions have been taken to resolve audit findings. Actions on audit findings which cannot be resolved by affected management and the Director Ne gulatory Affairs are submitted for resolution t sd 18.2.4 RECORDS/REPORTS OF AUDITS Audit records, reports, and associated documentation pertinent to audits are dispositioned to Nuclear Records, as specified in procedures.

QAP 18.0 56 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

APPENDIX B CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM QUALIFICATION AND EXPERIENCE REQUIREMENTS CR 05-01 This Appendix consolidates specific qualification and experience requirements for several key positions within the CYAPCO organization.

1.0 The Manager b a S l satisfy the following requirements:

Graduate of a four-year accredited engineering or science college or university, plus fifteen (15) or more years of industrial experience including five years in positions of leadership, such as lead engineer, project engineer, audit team leader, etc. At least two years of this experience should be associated with nuclear Quality Assurance Activities, and at least one year of this experience is in a Quality Assurance Organization. A master's degree in engineering or business management is considered equivalent to two years of experience.

NOTE The education and experience requirements should not be treated as absolute when similar training or an outstanding record will provide reasonable assurance that a person can perform the required tasks.

2.0 As stated in Appendix C, education and experience requirements for the Haddam Neck Plant personnel will use Regulatory Guide 1.8 - I-R - 5/77 - Personnel Selection and Training (which endorses ANSI N18.1 - 1971) as general guidance for facility positions.

CR 05-01 APPENDIX B 60 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

APPENDIX C

<z CQNNEMCjjU)ANKEE!2UALITY ASSURANCE PROGRAM

'REGULATORY GUZDE AN-D AN~SI sTAN-D-AlN NSmif l '

NOTE The CYQAP is committed to utilize the guidance obtained from the following regulatory documents and their endorsed standards. Exceptions to these positions are listed in Appendix E, herein.

10 CFR 50, Appendix B- Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.

10 CFR 50, Section 50.54, Condition of Licenses.

10 CFR 71, "Packaging and Transportation of Radioactive Material" CR 04-01 10 CFR 72, "Licensing Requirements for the independent Storage of Spent Nuclear Fuel, High Level Radioactive Waste, and Reactor-Related Greater than Class C Waste" 10 CFR 72, Subpart G- Quality Assurance Criteria for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste3, and Greater Than Class C Waste Regulatory Guide 1.8 - I-R - 5/77 - Personnel Selection and Training - Endorses ANSI N18.1 - 1971.

,Regulatory Gutde 1.28 - 2/79 - Quality Assurance Program Requireet Dsg n osrcin Deleted CR 05-01 Deleted CR 05-01 Deleted CR 05-01 BYRgulatory Guide 1.38 - Quality Assurance Requirements for Packaging, Shipping, Receiving, Deleted and Handling of Items for Water-Cooled Nuclear Power Plants, 5/77 - Endorses (Storage CRANSI) 05-Ol Deleted CR 05-01 Regulatory Guide 1.58 - Qualification of Nuclear Power Plant Inspection, Examination, and Testing L

( Personnel, Rev. 1, 9/80 - Endorses ANSI N45.2.6-1978.

t uid 1.4 -

Reulaory ualty ssurnceReqirements for the Design of Nuclear Power Plants, APPENDIX C 61 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

z;/76 - Endorses ANSI N45.2.1 1-1974. A Regulatory Guide 1.70 - "A Guide for the Organization and Content of Safety Analysis Reports" Revision 2, September, 1975 was utilized for CY, however, certain revised sections of the CY UFSAR are written to the Revision 3 format. No new analyses have been performed which would be required by Revision 3.

Regulatory Guide 1.88 - Collection, Storage, and Maintenance of Nuclear Power Plant Quality an Pn/ ANSI N45.2.9-1974.9 Assurance Records -oe Endorses Regulatory Guide 1.94 - Quality Assurance Requirements for Installation, Inspection and Testing ofR t Stuctual Cncree ad Structural Steel During the Construction Phase of Nuclear Power Plant -

41 -9Endorses ANSI N45.2.5 - 1974 and Section 6.11 of ANSI N45.2.5-1978.

Deleted CR 05-01 Regulatory Guide 1.123 - Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants - 7/77 - Endorses ANSI N45.2.13-1976.

Regulatory Guide 1.144 - Auditing of Quality Assurance Programs for Nuclear Power Plants - Rev.i

.1 - 9/80 Endorses ANSI N45.2.12 - 1977.

7 Regulatory Guide 1.146 - Qualification of Quality Assurance Program Audit Personnel For Nuclear

)7 Power Plants - 8/80 Endorses ANSI N45.2.23-1978.

Regulatory Guide 1.152 - "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," January 1996 - Endorses IEEE-ANS 7.4.3.2 - 1993.

Regulatory Guide 7.10, Revision 1 (6/86), "Establishing Quality Assurance Programs for Packaging Used in the Transportation of Radioactive Material".

APPENDIX C 62 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Identification - A means by which material, equipment and parts can be traced to their associated documentation through the use of heat numbers, lot numbers, part numbers, serial numbers, or other appropriate means.

Important-To-Safety - Important-to-Safety systems, structures and components (SSCs) means those features of the ISFSI, Monitored Retrievable Storage (MRS) Installation and spent fuel casks (10CFR7I/2) whose functions are:

a. To maintain the conditions required to store spent fuel or high level radioactive waste safely.
b. To prevent damage to the spent fuel or the high-level radioactive waste container during handling and storage.
c. To provide reasonable assurance that spent fuel or high-level radioactive waste can be received, handled, packaged, stored, and retrieved without undue risk to the health and safety of the public.

rIndependent Reviewer) An individual not having direct responsibility for the work function under rhevieev 'regadIe whether they operate as part of an organizational unit or as an individual staff member.

ISFSI - Independent Spent Fuel Storage Installation (ISFSI) means a complex designed and constructed for the interim storage of spent nuclear fuel, solid reactor-related GTCC waste, and other radioactive materials associated with spent fuel and reactor-related GTCC waste storage.

Item - Any level of unit assembly, including structures, systems, subsystems, subassembly, component, part or material.

Lnspection - A phase of quality control which, by means of examination, observation, or measurement, determines the conformance of material, supplies, components, parts, appurtenances, systems, processes, structures, or services to predetermine quality requirements.

Inspection Status - Identification of material, equipment, and parts that have completed inspection, either acceptable or unacceptable.

Maintenance and Modifications - Refers to the required functions for design, construction, testing, maintenance, operation, and modification of facilities at the HNP during decommissioning activities.

Material Request - The format used for identifyGdmaterial and services to be procured.

Measuring and Test Equipment - Those instruments, gages, tools, fixtures, reference and transfer standards, nondestructive test equipment, and measuring devices used during inspection and testing to determine that the measuring and test parameters comply with appropriate requirements in APPENDIX D 65 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

specifications and drawings.

Monthly - At least once per 31 days. CR 05-01 NAC MPC Certificate of Compliance - A certificate issued by the NRC pursuant to 10 CFR Part 72 that constitutes the USNRC approval of the NAC Multi Purpose Canister Storage system for the storage of spent nuclear fuel. The Certificate of Compliance includes the Technical Specifications and the approved contents and design features for the NAC MPC system. The NAC MPC system is described in the NAC MPC Final Safety Analysis Report (NAC MPC FSAR), which is a supporting licensing document for the NAC MPC Certificate of Compliance.

NAC STC Certificate of Compliance - A certificate issued by the NRC pursuant to 10 CFR Part 71 that constitutes the USNRC approval of the NAC Storage Transport Cask for the transport of spent nuclear fuel. The Certificate of Compliance includes the construction/assembly requirements, approved contents and description of design features for the NAC STC. The NAC STC is described in the NAC STC Final Safety Analysis Report (NAC STC FSAR), which is a supporting licensing document for the NAC STC Certificate of Compliance.

Nonconformance - A deficiency in characteristic documentation or procedure which renders the quality of an item unacceptable or indeterminate.

Nuclear Grade - The procurement classification applied to all materials and services intended for items listed as Cat. I in the MEPL or other approved processes. These may require validating documentation such as Certificate of Material Test Report, Certificate of Conformance, Certificate of Compliance, Personnel Qualifications, etc., as specified by codes or standards, and have been designed/qualified for a nuclear application. Nuclear Grade items are manufactured/qualified under a program that satisfies 10 CFR 50, Appendix B, IOCFR71, Subpart H or 10CFR72, Subpart G, as applicable, with the vendor responsible for the reporting requirements of 10CFR2 1. The vendor should be approved and listed in the Decommissioning Vendor's List.

Nuclear Records - The organization responsible for maintaining CY records.

Deleted CR 05-01 Approved Suppliers List - A list identifying the approval status of the quality assurance programs of vendors; commonly referred to as the Approved Vendors List Obiective Evidence - Any statement of fact, information, or record, either quantitative or qualitative, pertaining to the quality of an item or service based on observation, measurements, or tests which can be verified.

Preservation - Those actions performed to maintain an item in its original and usable condition.

APPENDIX D 66 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Procedures and Instructions - Documents that specify how an activity is to be performed. They may include methods to be employed; material, equipment, or parts to be used; and a sequence of operations.

Procurement Documents - Purchase requisitions/material requests, purchase orders, contracts, drawings, specifications or instructions used to define requirements for purchase.

Product Acceptance Test - Activities conducted as part of the receiving or source inspection process to verify acceptability of one or more critical characteristics of the item being inspected.

Deleted CR 05-01 Deleted CR 05-01 Purchase Order/Contract - The document which provides the contractual basis for vendor material and services provided in accordance with CYQAP requirements.

Purchased Service - Services provided by a vendor or consultant on a QA requisition when activities are performed under a quality assurance program other than the CYQAP.

Quality Assurance Records - Any record pertaining to the quality of material, equipment, parts, processes, or operations relating to systems, structures and components which are founded on observations, measurements, or tests which can be fully checked or verified. Such statements may be recorded on a written or preprinted document or tag. The statements are authorized with a signature or stamp identifiable to the person making the statement of fact.

Quality Activities - Activities governed by this CYQAP are those that affec a re ate functions of structures, systems, and components; these activities include designing, analyzing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, and modifying. Quality Activities also include activities associated with computer software used in implementing the CYQAP and Augmented Quality items as defined herein.

Ouality Procedures - Quality Assurance procedures and other department procedures which implement the requirements of the CYQAP.

Quarterly - At least once per 92 days. CR 05-01 Repair - A disposition applied to nonconforming material, equipment, and parts that are unsuitable for their intended purpose which are modified by the use of additional operations and/or processes so that they are suitable for their intended purpose but may not meet all specified requirements.

Retest - A test conducted prior to operation following installation inspections of work associated with maintenance and refueling to verify that systems, structures, and components will function satisfactorily when in operation. A retest may also be performed when original test results are APPENDIX D 67 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

\~ APPENDIX E CONNECTICUT YANKEE OUALITY ASSURANCE PROGRAM PROGRAM EXCEPTIONS

1. \NSI N45.2.9, states in part, "structure, doors, frames, and hardware should be Class A e-related with a recommended four-hour minimum rating." The three record storage vau s at NNECO have a two-hour rating and the record vault door and hardware at CYA 0 has a three hour rating.

Both NNE 0 and CYAPCo's vaults are used for storage of documentation that is unsuitable foilming or awaiting filming.

A records organi ion exists along with written procedures addressing the control of quality assurance re rds.

2. Deleted CR 05-01
3. ANSI N45.2.9-1974, paragrapha.4, definition of "Quality Assurance Records" states in part: "For the purposes of this sta ard, a document is considered a quality assurance record when the document has been ompleted."

CYAPCo has developed the following temative definition to provide guidance during the interim period from the time a document completed until it is transmitted to Nuclear Records:

"A record is considered a working document u il it is transmitted to Nuclear Records at which time it is designated as a Quality Assuranc Record. The following maximum time limits are established for the transmittal of working ocuments to Nuclear Records:

Operations Documents - Documentation gene ed during Plant or ISFSI Operations may be maintained, as needed, by opeting plant departments, for up to one year.

New Construction or Betterment Documents - Docu nts which evolve during new construction or betterment projects shall be transmitted o Nuclear Records within 90 days of completion of a new construction project or over of a betterment project or plant operations.

Procurement Documents - Inspection/Surveillance/Audit Rep rts generated during vendor oversight activities which are used to maintain vendor s tus for current and future procurements may be maintained, as needed, by CYAPCo or up to three years.

All Other Working Documents - All other working documents shall b transmitted APPENDIX E 69 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

>ei)e PX to Nuclear Records within 6 months of their receipt or completion."

The requirements of ANSI N45.2.9-1974 do not apply to these "working documents" based n paragraph 1.1 of the ANSI standard which states:

"It (SI N45.2.9) is not intended to cover the preparation of the records nor to include workin ocuments not yet designated as Quality Assurance Records." CR 05-01

4. Deleted Re torv Guide 1.64 - 6/76, the Regulatory position states, in part, "It should not be construed th tvsuch verification constitutes the required independent design verification." CYA Co has developed the following alternative to allow for adequate independent design v fication:

This review may be perfo ed by the originator's Supervisor, only if the Supervisor /

Manager:\

Did not specify a singu a esign approach; Did not establish the design* puts or did not rule out certain design considerations; Is the only individual in the o anization competent to perform the review.

Where the Supervisor/ Manager performsi e design review, the next level of management shall fulfill the responsibilities of the Supe or / Manager.

5. ANSI N45.2.13 - 1976, paragraph 10.3.4, statesi part, "Post-Installation Test requirements and acceptance documentation (shout) shall be mutually established by the

-purchaser and supplier." Involvement by the suppli in establishing Post-Installation Test requirements and acceptance documentation is request d only when it is deemed necessary and proper by the responsible engineering organization.

CYAPCo no longer has any nuclear plants under constructio As a result, most procurements are made for spare parts from suppliers who are ot the original equipment manufacturer. In these cases, the supplier may have little or no u derstanding or knowledge of either the operation of the system the component is t be installed in, or applicable Post-Installation Test requirements and acceptance docu ntation. As such, CYAPCo assumes responsibility for establishing Post Installation Test equirements and acceptance documentation.

6. Deleted ANSI N45.2.2-1972, paragraph 1.2, states in part that, "The requireients of this standard apply to the work of any individual or organization that participates ithe packaging, shipping, receiving, storage, and handling of items to be incorporate into nuclear power plants."

APPENDIX E 70 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

Since a portion of CYAPCo procurement activities involve commercial suppliers which do n ly comply with the requirements of ANSI N45.2.2, CYAPCo verifies through source inspecti receipt inspection, and/or survey activities that the quality of the materials, items, compon or equipment is preserved by those suppliers to the extent that packaging, shipping,s e and handling methods are employed which are commensurate with the nature of the produc.

7. Deleted CR 05-01
8. Deleted CR 05-01
9. Deleted CR 05-01 N

erles F-1>

APPENDIX E 71 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

APPENDIX CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM ADMINISTRATIVE CONTROLS 1.0 REVIEW AND AUDIT 1.1 INDEPENDENT SAFETY REVIEW An Independent Safety Review shall be a thorough review conducted by one or more qualified Independent Safety Reviewers. Persons performing these reviews shall be knowledgeable in the subject area being reviewed. Independent Safety Reviews must be completed prior to implementation of proposed activities.

a. Independent Safety Reviewers shall be individuals without direct responsibility for the performance of these activities under review. These reviews may be from the same functionally cognizant organization as the individual or group performing the original work.
b. Independent Safety Reviewers shall have at least 5 years of professional experience and either a Bachelor's Degree in Engineering or the Physical Sciences or shall have equivalent qualifications in accordance with ANSI 18.1-1971. The Unit/ISFSI Manager (or designee) shall document the appointment of Independent Safety Reviewers.
c. The following subjects shall be independently reviewed by a qualified Independent Safety Reviewer:
1. Evaluations for changes in the facility or ISFSI as described in the Updated Final Safety Analysis Report (UFSAR) or NAC-MPC FSAR. Changes in procedures as described in the UFSAR or NAC-MPC FSAR, and tests or equipment not described in the UFSAR or NAC-MPC FSAR to verify that such actions do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10CFR50.59 or 10CFR72.48, and CR 05-01
2. Proposed changes to the programs required by the CYQAP in Section 4.0 of this Appendix to verify that such changes do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10CFR50.59 or IOCFR72.48 CR 04-04, CR 05-01 APPENDIX F 72 CYQAP REV: 06
g. The IRAC's responsibility shall include an Audit Program. IRAC audits shall be performed at least once per 24 months in accordance with appropriate administrative procedures and shall encompass:
1. The conformance of unit and ISFSI operation to provisions contained within the Technical Specifications and applicable license conditions;
2. The training and qualifications of the staff;
3. The implementation of programs required by CYQAP Appendix F Sections 4 and 5;

>4. The Fire Protection Program and implementing procedures

5. The fire protection equipment and program implementation utilizing either a <

( qulifid ofsit liense fire protection engineer or an outside independent fr

6. Actions taken to correct deficiencies occurring in equipment, structures, systems, components, or method of operation that affect nuclear safety; and
7. Other activities and documents as requested by the President.
h. Written records or reviews and audits shall be maintained. As a minimum, these records shall include:
1. Results of the activities conducted under the provisions of CYQAP Appendix F Sections 4 and 5;
2. Recommendations to the management of the audited organization;
3. An assessment of the safety significance of review or audit findings;
4. Documentation of reviews conducted under CYQAP Appendix F Sections 4 and 5; and
5. Determination of whether each item considered under CYQAP Appendix F Sections 4 and 5 require prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48. CR 04-04, CR 05-01 RECORDS Written records of reviews and audits shall be maintained. As a minimum, these records shall include results of the activities conducted under the provisions of APPENDIX F 75 CYQAP REV: 05, CR 04-01, CR 04-02, CR 04-04, CR 04-05, CR 05-01

CONNECTICUT YANKEE ATOMIC POWER COMPANY QUALITY ASSURANCE PROGRAM Summarv of Chanees GENERAL DESCRIPTION OF CHANGE Section/Appendix Table of Paragraph No. N/A Rev. No. 6 Contents Section/Appendix 1.0 Paragraph No. 1.2.2.1, 1.4.1, 1.4.2, Rev. No. 6 1.4.3, 1.4.5, 1.4.6, 1.4.8, 1.4.10,1.4.11, Figure 1.1 Section/Appendix 2.0 Paragraph No. 2.1, 2.2.3, 2.2.4, Rev. No. 6 2.2.6 Section/Appendix 3.0 Paragraph No. 3.2, 3.2.2 Rev. No. 6 Section/Appendix 4.0 Paragraph No. 4.2.1, 4.2.2.c & e Rev. No. 6 Section/Appendix 5.0 Paragraph No. 5.2, 5.2.1 Rev. No. 6 Section/Appendix 6.0 Paragraph No. 6.1, 6.2.1, 6.2.3, Rev. No. 6 6.2.4 Section/Appendix 7.0 Paragraph No. 7.2.5 Rev. No. 6 Section/Appendix 8.0 Paragraph No. 8.2 Rev. No. 6 Section/Appendix 9.0 Paragraph No. 9.1, 9.2, 9.2.2 Rev. No. 6 Section/Appendix 10.0 Paragraph No. 10.2.1, 10.2.3, Rev. No. 6 10.2.5, 10.2.6 Section/Appendix 11.0 Paragraph No. 11.2.4 Rev. No. 6 Section/Appendix 12.0 Paragraph No. 12.2.1 Rev. No. 6 Section/Appendix 13.0 Paragraph No. 13.2.1, 13.2.2 Rev. No. 6 Page I of 2

Summary of Changes (con't.)

Section/Appendix 14.0 Paragraph No. 14.2.1 Rev. No. 6 Section/Appendix 15.0 Paragraph No. 15.2.3 Rev. No. 6 Section/Appendix 16.0 Paragraph No. 16.2.2, 16.2.3 Rev. No. 6 Section/Appendix 17.0 Paragraph No. 17.2, 17.3 Rev. No. 6 Section/Appendix 18.0 Paragraph No. 18.2.1, 18.2.2, 18.2.3 Rev. No. 6 Section/Appendix B Paragraph No. 1.0 Rev. No. 6 Section/Appendix C Paragraph No. Title, 7, 11, 13, 14, Rev. No. 6 15, 16, 17, 19, 20, 21, 22, 23 (newv), 24 Section/Appendix D Paragraph No. Ind. Reviewer, Rev. No. 6 Material Request, Nuclear Grade, Quality Activities Section/Appendix E Paragraph No. Deleted Rev. No. 6 Section/Appendix F Paragraph No. Title, 1.2.g.4 & 5 Rev. No. 6 Section/Appendix G Paragraph No. All (New Appendix) Rev. No. 6 PURPOSE OF CHANGE:

This revision reflects changes made based upon all spent fuel being transferred to the ISFSI and re-orientation of the Quality Assurance Program for dry fuel storage and decommissioning activities.

This revision also incorporates changes similar to those previously made to the Yankee Decommissioning Quality Assurance Program involving the deletion of commitments to codes and standards which are no longer relevant to dry fuel storage and decommissioning activities.

This revision does constitute a reduction in commitments to the previously USNRC approved Quality Assurance Program and may not be implemented except in accordance with the provisions of 10 CFR 50.54(a)(4)(iv).

Page 2 of 2

CY-05-1 52 Docket No. 50-213 Attachment 3 Haddam Neck Plant Proposed Change to Revision 5 of the Connecticut Yankee Quality Assurance Program A Retyped Version of Proposed Revision 6 to the CYQAP June 2005

Connecticut Yankee Quality Assurance Program for the Haddam Neck Plant

TABLE OF CONTENTS CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM (CYOAP)

HADDAM NECK PLANT Abstract Policy Statement Quality Assurance Program Sections QAP 1.0 Organization QAP 2.0 Quality Assurance Program QAP 3.0 Design Control QAP 4.0 Procurement Document Control QAP 5.0 Procedures, Instructions and Drawings QAP 6.0 Document Control QAP 7.0 Control of Purchased Material, Equipment and Services QAP 8.0 Identification and Control of Materials, Parts and Components QAP 9.0 Control of Special Processes QAP 10.0 Inspection QAP 11.0 Test Control QAP 12.0 Control of Measuring and Testing Equipment QAP 13.0 Handling, Storage, and Shipping QAP 14.0 Inspection, Test, and Operating Status QAP 15.0 Nonconforming Materials, Parts, Components, or Services QAP 16.0 Corrective Action QAP 17.0 Quality Assurance Records QAP 18.0 Audits Appendices A. Important-to-Safety Systems, Structures and Components B. Qualification and Experience Requirements C. Regulatory Commitments D. Glossary of Quality Assurance Terms E. CYQAP Administrative Controls F. Position Cross Reference

- Deleted: 03 TABLE OF CONTENTS i CYQAP l REV: f06, CR 05-02

CONNECTICUT YANKEE ATOMIC POWER COMPANY HADDAM NECK PLANT ABSTRACT Connecticut Yankee Atomic Power Company (CYAPCo) has developed and is implementing a comprehensive Quality Assurance Program for the Haddam Neck Plant (HNP) to assure conformance with established regulatory requirements as set forth by the Nuclear Regulatory Commission (NRC). The participants in this Quality Assurance Program assure that the applicable quality activities for the Haddam Neck Plant and ISFSI are performed in a safe and effective manner.

This Connecticut Yankee Quality Assurance Program (CYQAP) complies with the requirements set forth in 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G), and is responsive to the NRC Regulatory Guide 1.70, that describe the information required to be presented in the Quality Assurance Section of the SARs for nuclear power plants.

This CYQAP applies to the safety functions of systems, structures, and components and are I considered quality activities as defined in the CYQAP. Snmortant-to-Safetv Systems, Structures . - -( Deleted: Safety and Components are discussed in Appendix A herein. Applicability of Appendix A to the CY Updated Final Safety Analysis Report (UFSAR) is addressed by the specific design bases and licensing commitments.

This CYQAP is committed to utilize the guidance obtained from the regulatory documents and their endorsed standards as referenced in Appendix C.

I--- - - - -- - - - - - - -- - - - -- - - - -- - - - -- - - -- - - - - -- - -- - . -- Detd: 03 I ABSTRACT ii CYQAP I REVI: 06, CR 05-02

POLICY STATEMENT OUALITY ASSURANCE PROGRAM CYAPCo has established a Quality Assurance Program for the Haddam Neck Plant and ISFSI.

This QA program has been developed to achieve quality assurance in applicable activities affecting the safe decommissioningloperation of the Haddam Neck Plant (HNP) and the ISFSI.

The program described herein is the Connecticut Yankee Quality Assurance Program for the Haddam Neck Plant and ISFSI. The policies, requirements and tasks contained in this program description have been developed to achieve a recognized need for quality assurance for applicable HNP and ISFSI activities to ensure that adequate quality requirements are being complied with to safeguard employees (CYAPCo and contract) and the public.

CY procedures which implement the program at the Haddam Neck Plant and ISFSI are developed and approved in accordance with Connecticut Yankee administrative procedures.

The CYQAP is responsive to applicable codes, Nuclear Regulatory Commission regulatory requirements, accepted industrial standards and revisions thereto. Provisions are established to update the CYQAP in accordance with revisions to codes, standards and regulatory requirements and to inform cognizant personnel to implement appropriate actions to assure that the highest standard of quality is achieved for applicable systems, structures, components and services for the HNP and ISFSI.

The controls which implement the actions identified in the CYQAP are station and departmental procedures and instructions which delineate actions and steps necessary to accomplish quality requirements. Procedures and instructions are written by company groups, divisions, departments, branches, or sections, which have the responsibility for implementing actions assigned to them as delineated by the CYQAP.

Thc Chief Evcvutive Officcr has the uitiniatc responsihilitv for the Haddarn Neck Plant and ISFS1.

The overall responsibility for this Quality Assurance Program lies with the President. Corporate _ I Deleted: development and l authority is delegated to the Director of Quality Assurance/Regulatory Affairs for the preparation . Deleted: Chairman, Chief Executive Officer and I and administration of the Connecticut Yankee Quality Assurance Program (CYQAP). The Director of Quality Assurance/Regulatory Affairs, Director of Decommissioning, Director of I Project Support and Executive Director of Business Operations .1re responsible for the - ( Deleted: are I implementation of the Quality Assurance Program within their Departments.

..- *tDeleted: 03 l POLICY STATEMENT iii CYQAP I REV: 06, CR 05-02

QAP 1.0 ORGANIZATION

1.1 INTRODUCTION

This section describes the organizations involved with the Haddam Neck Plant and ISFSI. In addition, this section describes the responsibilities governed by the CYQAP. Qualifications for the key personnel are found in the Appendices to this Quality Assurance Program.

1.2 PROGRAM RESPONSIBILITY 1.2.1 The CEO reports to thie CYAPCo board oCDirectors and hai ultimate -- - Formatted: Bullets and Numbedng I rersponsihilitv for the Haddam Neck Plant and ISFSI I _21,ThePresident has overall responsibility forjhe CYQAP for the Haddam . - Deleted: 1.2.1.

Neck Plant and ISFSI. While retaining full responsibility and overall Deleted: ChAtrman, CEO and puthorityjthe President has delegated corporate authority for the preparation -Deleted: the development of and administration of the CYQAP to the Director of Quality ;Deleted:

Assurance/Regulatory AffairskJee Figure I-) '------

Deld theChairman, CEO :nd 1.2.2.1 The President maintains contact with the quality assurance activities ' ,

through meetings with Director of Quality Assurance/Regulatory Affairs (Deleted:.

and the receipt of various documents, such as: periodic progress reports, Independent Review and Audit Committee (IRAC) meeting notes and audits related to the implementation of programs at the Haddam Neck Plant and ISFSI.

1.2.2.2 The President resolves all disputes related to the implementation of the CYQAP for which resolution is not achieved at the appropriate organizational levels within the nuclear organization.

1.3 GENERAL RESPONSIBILITIES 1.3.1 The head of each department performing quality activities is responsible for:

a. Administering those activities within their organization which are required by the CYQAP;
b. Ensuring implementation of the CY Quality Assurance Program;
c. Establishing and clearly defining the duties and responsibilities of

-personnel within their orgaiza~tion who perform quality ativities; - (---

.Deleted: 03 QAP 1.0 CYQAP REV: 416, CR 05-02

d. Planning, selecting, and ensuring that personnel are trained to meet the requirements of the CYQAP; and
e. Performing and coordinating quality activities within their organization and interfacing with the CY Quality Assurance Personnel organization as required in program implementation.

1.3.2 Each individual performing or verifying activities affecting quality is responsible to conduct those activities in accordance with the requirements of the CYQAP and implementing procedures.

1.3.3 Lines of authority, responsibility, and communication shall be established and defined for the highest management levels through intermediate levels to and including all operating organization positions. These relationships shall be documented and updated, as appropriate, in the form or organization charts, functional descriptions of departmental responsibilities and relationships, and job descriptions for key personnel positions, or in equivalent forms of documentation.

1.4 ORGANIZATION CONNECTICUT YANKEE AT THE H-ADDAM NECK PLANT 1.4.1 CEO The CEO reports to the CYAPCo Board of Directors. He has ultimate responsibility for the H-addam Neck Plant and ISFSI (See Figure 1-1).

1.4.2 President The President reports to the CEO and has the necessary authority and overall responsibility for developing, maintaining, and implementing the CYQAP at the HiNP and ISFSI and in providing support services to the staff. The President is responsible for the safe operation of the H{NP and ISFSI and has control over those support activities necessary for decommissioning of the plant. These responsibilities include:

  • Direction of the CY Quality Assurance Program.
  • Implementation of policies and procedures.
  • Verifications through planned audits, surveillances, and inspections to assure compliance wvith 10 CFR50 Appendix B and other regulatory requirements.
  • Implementation of the CYQAP requirements.

-- '(Deleted: 03 QAP 1.0 CYQAP IREV: 116, CR 05-02

The President has delegated these responsibilities to the Director of Quality Assurance/Regulatory Affairs, the Director of Project Support, the Director of Decommissioning, the Regulatory Affairs Manager, the Unit(ISFSI Manager and the Executive Director of Business Operations (Procurement issues only).

The President is also responsible for appointing members of the Independent Review and Audit Committee (IRAC) as specified in Attachment F.

1.4.3 Director of Quality Assurance/Regulatory Affairs The Director of Quality Assurance/Regulatory Affairs (NS/RA) reports to the President and is responsible for the following:

  • Direction for developing and maintaining the CYQAP.
  • Direction and implementation of Regulatory, Government and Public Affairs activities
  • Direction and implementation of the audit program
  • Direction and administration of operation, surveillance and maintenance of the systems, structures, and components required for safe storage of spent fuel at the Independent Spent Fuel Storage Facility (ISFSI)
  • Administration and support for implementation of the security program
  • Direction and administration of the Independent Review Function described in Appendix E through the use of Independent Safety Reviewers (ISR)
  • Administration and support for implementation of the training program
  • Administration of the Health Physics Program 1.4.4 Director of Project Support The Director of Project Support reports to the President and is responsible for the following:
  • Direction and administration of engineering activities
  • Direction and implementation of project planning
  • Administration and execution of project scheduling
  • Administration of the records management
  • Direction and administration of document control

.- IDeleted: 03 3

QAP 1.0 CYQAP l REV: 116, CR 05-02

1.4.5 Director of Decommissioning The Director of Decommissioning reports to the President and is responsible [ Formatted: Bullets and Numbering for the following:

  • Direction and administration of activities necessary for the safe decommissioning of the plant
  • Direction and administration of the Waste Management Program
  • Direction and administration of Industrial Safety
  • Direction and implementation of Decommissioning operations 1.4.6 Director of Project Support The Director of Project Support reports to the President and is responsible for the following:
  • Direction and administration of engineering activities
  • Direction and implementation of project planning
  • Administration and execution of project scheduling
  • Administration of the records management
  • Direction and administration of document control
  • Direction and administration of Integrated Site Closure activities 1.4.7 Regulatory Affairs Manager The Regulatory Affairs Manager reports to the Director of Quality Assurance/Regulatory Affairs. The Regulatory Affairs Manager is responsible for the direction and administration of:
  • Planning and coordination of decommissioning licensing activities
  • Correspondence and communications with regulatory agencies
  • Coordination of NRC inspections
  • Existing and proposed regulatory requirements as they apply to decommissioning.
  • End state activities to reach project completion with regulatory agencies including property transfer 1.4.8 Unit[ISFSI Manager The UnitIlSFSI Manger reports to the Director of Quality Assurance/Regulatory Affairs. The Unit/lSFSI Manager is responsible for the
  • direction and administration of the ISFSI Operations and Decommissioning -. Deleted: 03 4

QAP 1.0 CYQAP RE': 16, CR 05-02

Site Training, Security, and Emergency Planning. Independent Safety Reviewers, performing the Independent Review Function described in Appendix E, report to the Unit/ISFSI Manager in accordance with licensing requirements.

1.4.9 Executive Director of Business Operations (Procurement issues only)

The Executive Director of Business Operations reports to the President and is responsible for the following:

  • Direction and administration procurement activities including materials inventory
  • Direction and administration of contract administration
  • Management and coordination of project control functions including financial reporting 1.4.10 Manager- Quality Assurance The Manager- Quality Assurance, reports to the Director of Quality Assurance/ Regulatory Affairs and is responsible for audit, surveillance and inspection activities of the HNP and ISFSI. The Manager - Quality Assurance provides management with objective evidence of the performance of activities affecting quality, independent of the individual or group directly responsible for performing the specific activity. This individual has the authority and organizational freedom to verify activities affecting quality.

This is performed independent of undue influences and responsibilities for schedules and costs. The Manager - Quality Assurance has the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming materials. The individual also has the responsibility and authority to identify quality problems, to recommend or provide solutions, and to verify their implementation.

The Manager - Quality Assurance, responsibilities include:

  • Administering the Quality Assurance Program for audits, surveillances and inspections
  • Verifying the implementation of the CYQAP requirements
  • Evaluating performance and identification of strengths and weaknesses
  • Providing recommendations for improving nuclear performance at the HNP and ISFSI p -- Serving as the primary Quality Assurance management interface with.- - Deleted 03 _

5 QAP 1.0 CYQAP l REV: 016, CR 05-02

HNP and ISFSI management

  • Stopping unsatisfactory work
  • Administering the Nonconformance and Corrective Action Programs The Manager - Quality Assurance/Designee is an active participant on the CY Independent Review and Audit Committee (IRAC) defined in Appendix E.

The Manager - Quality Assurance has direct communication with the CY Staff, the Director of Quality Assurance/Regulatory Affairs, the President, and the CEO and provides the daily interaction on matters affecting quality, nuclear safety, and nuclear related activities.

1.4.11 Radiation Protection Manager The Radiation Protection Manager carries out Health Physics functions and reports to the Director of Quality Assurance/Regulatory Affairs. The Radiation Protection Manager fulfills the position qualifications required by Appendix E, Section 3.2. Radiation Protection includes those activities established to protect personnel from radiological hazards.

. - Deleted: 03 6

QAP 1.0 CYQAP I REX': 416, CR 05-02

CONNECTICUT YANKEE ATOMIC POWER COMPANY ORGANIZATION CHART EXECUTIVE DIRECTOR OF BUSINESS OPERATIONS (Procurement Issues only

  • PROJECT CONTROLS i Fornatted: luf1ets and Numben.g!
  • PROCUREMENT
  • CONTRACTS Note1: The ManagerWOuafty Asswwance hasa line of communtcalon wih the President I 7 .. Delted:

-I 63l Figure 1-1 I QAP -1.0, REV: 016CR 05-02

QAP 2.0 QUALITY ASSURANCE PROGRAM 2.1 GENERAL REQUIREMENTS CYAPCo has established the CYQAP for the HNP and ISFSI which complies with the criteria of 10 CFR 50, Appendix B, and follows the guidance referred to in Appendix C and Appendix E, herein. The quality assurance requirements set forth herein, supplemented by Site and ISFSI Procedures provide the primary basis of the Program with regard to quality assurance. This program is established for the HNP and ISFSI in a manner intended to accomplish the required level of quality for applicable plant and ISFSI activities. It includes quality activities during the maintenance, modification and opermion of the Indncendcent Deleted:sto orage of spent fuel at the Sontn Fuc! Sti norw Iisullation and swme activities as.ociatcd with RaNiP Ctivc Material I Transrortaiionl. This program also satisfies the requirements of I QCFR7 1, Subpart H and Deleted::

10CFR 72, Subpart G.

\

I The CYQAP applies, activities affecting the important to safety functions of systems, - Deleted: in structures and components. Such activities are quality activities as defined in Appendix Deleted: its entiret I I A herein. The level of CY QAP applicability is delineated in established administrative e p documents.

The requirements of this Program are implemented by CYAPCo, who operate the HNP and ISFSI, and their vendors performing activities affecting quality systems, structures, and components.

Procedures define the required indoctrination and training of personnel performing activities affecting quality, as necessary, to assure that suitable proficiency is achieved and maintained.

Training sessions are documented. The content is described, attendees and attendance date(s) indicated, and the results of the training session(s) (e.g., satisfactory examination results) recorded.

A periodic program review of the status and adequacy of the CYQAP is accomplished by

  • audits, surveillances and inspections;
  • CY Independent Review and Audit Committee reviews; and
  • Independent Assessment of the CYQAP Audit Program. - ( Deleted: 03 i Vendors are required to review the status and adequacy of that part of the Quality Assurance Program for which they have designated responsibility.

QAP 2.0 8 CYQAP I REV: 06, CR 05-02

2.2 IMPLEMENTATION 2.2.1 GOALS AND OBJECTIVES The goals of the CYQAP are to maintain quality levels in an effective and efficient manner and to assure a high degree of functional integrity and reliability of quality systems, structures and components. To meet this goal, the following objectives of the CYQAP have been defined:

a. Define through documented procedures, the quality activities that apply to the maintenance, modification and operation of the HNP and ISFSI;
b. Establish, assign, and document the responsibilities for the conduct of those activities affecting quality systems, structures and components;
c. Establish confidence that:
  • The maintenance, modification and operation of the applicable HNP and ISFSI activities are performed in a manner consistent with CY Policies, and
  • Quality activities are performed by responsible personnel, and are verified through a system of audits, surveillances, and inspections of those organizations with quality responsibilities;
d. Apprise the President of unresolved problems and trends which could have a significant effect on nuclear safety.

2.2.2 PROGRAM DOCUMENTATION The CYQAP defines the CY nuclear goals and objectives and is used as guidance for the development of the various implementing procedures. Revisions to the CYQAP will be made as needed to reflect current requirements and descriptions of activities prior to implementation. These revisions will be made in accordance with 10 CFR 50.54 (a)(3) and CY procedures.

Quality procedures are developed, reviewed and approved by the departments performing quality activities. Quality Assurance reviews are performed for quality procedures to verify compliance with the CYQAP and concurs on such procedures.

Changes to procedures are subjected to the same degree of control as that utilized in the preparation of the original document.

Deleted: 03 2.2.3 SYSTEMS. STRUCTURES. AND COMPONENTS The requirements of the CYQAP shall apply, as a minimum, to all Jmnnortanr-n- - [iDeleted- safetyrlaied Saety systems, structures, and components, as addressed in the applicable Safety QAP 2.0 9 CYQAP l REV: 06, CR 05-02

Analysis Reports (SARs). lniiortani-to-Safvti systems, structures, and components I Deleted: Safety tS`;-Cs) are identified in Appendix A of the CYQAP. Process changes will be performed in accordance with CY administrative procedures and QAP 5.0.

For systems, structures and components and regulatory commitments, procedures describe the measures taken to assure that the quality assurance requirements are met. The degree of control over activities affecting quality systems, structures, and components is consistent with their importance to safety. The CYQAP provides controls that include the use of appropriate equipment; establishment of suitable controls over special processes and skills necessary to attain the required quality, and the need for verification of quality by inspection and test.

Applicable organizations jointly determine and identify the extent of quality assurance controls are to be applied to quality structures, systems, and components.

The quality assurance controls are in conformance with this CYQAP, which complies with 10 CFR 50 Appendix B, 10 CFR71 Subpart H and 10 CFR 72 Subpart G.

2.2.4 PARTICIPATING ORGANIZATIONS CYAPCo requires that its vendors invoke'upon their subcontractors, via Purchase Orders/Contracts, requirements for a quality assurance program to meet the applicable criteria of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H or 10 CFR 72 Subpart G, including the applicable elements of the Regulatory Guides and their endorsed Standards identified in Appendix C herein. However, CY retains overall responsibility for the implementation of the QA Program. The specific quality activities performed by these organizations are specified in the procurement documents. CY is responsible for the review and approval of vendor quality assurance programs prior to initiation of contracted activities. The object of the review is to verify that the vendors have an adequate quality assurance program to meet applicable requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G as applicable.

In addition to the initial review, CY Management is responsible for the subsequent performance, as appropriate, of audits, surveillances, and inspection of a vendor's quality assurance program to assure continued implementation of quality requirements.

QA personnel also perform on-site audits, surveillances, and inspections, as appropriate, Deleted: 03

-- - of he' ve dor activities ---------------------------------------------

Vendors may be delegated the execution of quality assurance functions by contract. These contracts are reviewed and approved in accordance with program requirements.

QAP 2.0 10 CYQAP l REV: 06, CR 05-02

2.2.5 INDOCTRINATION AND TRAINING A program is established and maintained for quality assurance indoctrination and training which provides confidence that the required level of personnel competence and skill is achieved and maintained in the performance of quality activities. Quality procedures delineate the requirements for an indoctrination program to assure that personnel responsible for performing quality activities are instructed in the purpose, scope, and implementation of quality procedures and instructions and that compliance to these documents is mandatory. CY Management is responsible for ensuring appropriate indoctrination and training of assigned personnel performing quality activities.

Training Programs shall be developed and implemented to provide training for individuals performing quality activities associated with the HNP or ISFSI.

Additional guidance is established in procedures.

Implementing procedures describe the program requirements which assure that:

  • Documentation of formal training and qualification programs includes the objective, content of the program, attendees, date of attendance, and examination results, as applicable;
  • Proficiency of personnel performing and verifying activities affecting quality is established and maintained. Personnel proficiency is established and maintained by training, examination/testing, and/or certification based upon the requirements of the activity. Acceptance criteria, as appropriate, are developed to determine if individuals are properly trained and qualified; and
  • Certificates or other documentation of qualification clearly delineate the specific functions personnel are qualified to perform and the criteria used to qualify personnel in each function.

2.2.6 MANAGEMENT OVERSIGHT OF THE QUALITY ASSURANCE PROGRAM The President ensures that a management review of the CY Quality Assurance Program is conducted biennially to assess the effectiveness of the QA Program.

This is accomplished by performing an independent assessment of the program. In addition, the Independent Review and Audit Committee (IRAC), described in - Deleted: 03 Appendix E, peffoims oversight of the program in accordance withl the approved charter.

Results of the assessments and reports are forwarded to the President for corrective action, as necessary.

QAP 2.0 11 CYQAP l REV: 06, CR 05-02

-( Deleted: 03 l QAP 2.0 12 CYQAP I REV': 06, CR 05-02

QAP 3.0 DESIGN CONTROL 3.1 GENERAL REOUIREMENTS CY Director of Project Support is responsible for ensuring design work, design control activities (including design interface), and design modifications for quality systems, structures and components are adequately implemented as described in QAP Section I "Organization".

The CYQAP for design control is established to assure that the applicable design requirements, such as design bases, regulatory requirements, codes, technical standards and quality standards are identified in design documents which are reviewed, approved and controlled in accordance with established procedures. Such controls include a review for suitability of application of materials, equipment, parts and processes that are essential to the functions of the systems, structures and components. Changes to, and deviations from, specified requirements are identified, documented and controlled.

The responsibility for design control processes rests with the CY Director of Project Support.

The division of responsibilities and jurisdictional boundaries for program implementation are set forth in the appropriate administrative procedures. Although other organizations may be delegated the task of establishing and executing the design control program or any part thereof, the CY Director of Project Support will retain the ultimate responsibility for the program. The applicable requirements of the CYQAP will be imposed on other organizations delegated the task of establishing or executing the program in accordance with QAP 4.0, "Procurement Document Control" and QAP 7.0, "Control of Purchased Material, Equipment and Services,"

herein.

The interface controls, both internal and external, for organizations performing design work for quality systems, structures and components are identified and implemented in accordance with documented procedures. This identification includes those organizations providing criteria, designs, specifications and technical direction.

Measures are applied to verify the adequacy of design. The extent of design verification is specified and documented by the responsible organization. The individuals performing design verification should not:

(1) have immediate supervisory responsibility for the individual performing the design; (2) have specified a singular design approach; (3) have ruled out certain design considerations; or (4) have established the design inputs for the particular design aspect being verified.

The independent design verification should not dilute or replace the responsibility of the {DeIeted: 03 supervisors for the quality of worlkperformed under their supervision. "Where changes to - -

previously verified designs have been made, design verifications are required for the change, including evaluation of the effects of those changes on the overall design. Design QAP 3.0 13 CYQAP l REV: 06, CR 05-02

verification may be accomplished by testing. Tests to demonstrate adequacy under adverse design conditions shall comply with the requirements of QAP 11.0, "TEST CONTROL."

Design errors and deficiencies which adversely affect quality systems, structures and components in design process are documented, and appropriate corrective action is taken.

These design errors and deficiencies are documented in accordance with design change procedures or as defined in QAP 16.0, "Corrective Action."

Application of design controls does not include SSCs for radioactive material transportation packages and dry spent fuel storage components utilized under the provisions of a General License pursuant to 10 CFR 71 and 10 CFR 72. Additional guidance is contained in Appendix A.

3.2 IMPLEMENTATION The CY Director of Project Support is responsible for ensuring design, design review, engineering approval of design changes, design evaluation and design control are adequately performed at the HNP and ISFSI. The function may be delegated to other organizations to perform the design activity, or any part thereof, but the responsibility for overall design remains with the CY Director of Project Support. In all cases, final engineering decisions and ultimate design control of systems, structures and components related to the ISFSI are the responsibility of the CY Director of Project Support.

The Quality Assurance department performs audits, surveillances, and inspections, to verify that Departments are effectively complying with the CYQAP and procedural requirements for design control.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections, to verify that vendors are effectively complying with the CYQAP and procedural requirements for design control.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of these vendor activities.

3.2.1 DESIGN PROCESS Design control measures are applied to design analyses, such as: stress, thermal, hydraulic, nuclear radiation, accident and seismic analyses; compatibility of materials; accessibility for required inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and test. Measures established to control design documents are described in QAP 6.0, "Document Control."

Deleted: 03 QAP 3.0 14 CYQAP l REV: 0l6, CR 05-02

Program procedures and instructions define the method of implementing design control measures. These measures require that applicable design requirements, such as, design bases, regulatory requirements, codes and standards, are translated into specifications, drawings, procedures or instructions. Instructions further require that appropriate quality standards are specified and included in design documents. All materials, equipment, parts and processes, including standard "off the shelf" commercial or previously approved items essential to the quality functions, are selected and reviewed for suitability of application.

The basis for selection may include industry standards, material and prototype hardware testing programs, and design review.

CY procedures assure that a documented check is performed to verify the accuracy and completeness of design drawings and specifications before release for use.

Design drawings and specifications issued for design changes are reviewed for completeness and accuracy before being released to operations, in accordance with CY procedures.

CY procedures describe the provisions to assure that design drawings and specifications are prepared, reviewed and approved in accordance with company procedures, and that the documents contain the necessary quality assurance requirements, such as inspections and test requirements, acceptance requirements, and the extent of documenting inspection and test results.

3.2.2 DESIGN CHANGE CONTROL Procedures and instructions govern design change control during modifications to the HNP and ISFSI. Control of discrepant or deficient design conditions, and reported unsatisfactory performance, provide for the identification of design changes and a documented method to control these changes. Design and specification changes are subject to design control measures commensurate with those applied during the original design.

An independent review and approval of design changes is performed by the organization that conducted the original design reviews, unless another qualified organization is designated to perform this function.

Proposed design change modifications are submitted to management for processing and review. This review includes the Independent Review Function required by Appendix E. The Independent Safety Reviewers (ISR) advise the CY Unit/lSFSI Manager on matters relating to nuclear safety. If the proposed change involves a quality system structure or component, the change will be reviewed by qualified engineering personnel for technical adequacy. Reviews of the 10 CFR Deleted:_03

- 50.59 and 10 CFR 72.48 evaluations associated with design changes are - - -. Deleted 03 performed by the Independent Review and Audit Committee (IRAC). The QAP 3.0 15 CYQAP l REV: 06, CR 05-02

sequence of the Independent Review Function depends upon the determination of whether License Amendment is required.

The combination of these independent reviews by the ISR and IRAC are performed to assure that:

a. The adequacy of the proposed change is substantiated;
b. The need to obtain NRC approval prior to implementing a change, test or, experiment that has been identified and dispositioned per 10 CFR 50.59 or 10 CFR 72.48; and
c. Nuclear safety requirements have been addressed.

Errors and deficiencies in design, including the design process, that could adversely affect quality structures, systems, and components are documented and corrective action is taken in accordance with QAP 16.0, "Corrective Action."

Notification of design changes are transmitted to responsible plant personnel as part of the design package close out. CY procedures describe this notification which assures that personnel are made aware of design change modifications.

3.2.3 DESIGN INTERFACE CONTROL The CY Director of Project Support is responsible for review, coordination and documentation of design interfaces. Procedures provide for the method for identifying design interfaces, changes, and modifications affecting drawings and design documents.

3.2.4 INDEPENDENT DESIGN VERIFICATION Design changes are reviewed for adequacy and the sign-off performed by a person other than the originator of the design. Design verification is documented in accordance with procedures or instructions. Simplified calculations or computer programs may be utilized as alternate means of design verification. When design verification is performed by testing, the tests are performed using approved procedures, which specify the authority and responsibility of design verification personnel. Ultimate responsibility for design adequacy and evaluation is retained by the CY Director of Project Support.

Design verification (if other than by qualification testing) is normally completed prior to release for procurement, manufacturing, and construction, or to another Deleted: 03

.- - organization for use inmother design activities. Forrthose cases where design . . - ...

verification cannot be completed prior to release for procurement, manufacturing, QAP 3.0 16 CYQAP l REV: 106, CR 05-02

and construction, procedures ensure that design verification is completed prior to the point when the installation is declared operational.

CY procedures describe the requirements which assure the following when testing is considered as an alternate method of design verification:

a. Specifications or procedures provide criteria that specify when verification should be by test.
b. Prototype, component or feature testing is performed as early as possible prior to installation of plant equipment, or prior to the point when the installation is declared operational.
c. Verification by test performed under conditions that simulate the most adverse conditions as determined by analysis.

Particular emphasis is placed on assuring that designs are in conformance with applicable codes, and on selecting the proper design verification or checking method. Procedures and instructions provide the requirements and necessary controls for design verification. These controls include a review to assure that design characteristics can be controlled, verification that there is adequate accessibility for inspection or test, and that inspection and test acceptance criteria are incorporated. Documentation of reviews is provided.

CY procedures include requirements which identify the responsibility of design verifiers, the areas and features to be verified, and the extent of the documentation.

CY procedures assure that procedural control is established for design documents that reflect the commitments of the CY Updated Final Safety Analysis Report (UFSAR) or the NAC MPC Certificate of Compliance. These procedural controls vary for design documents which receive formal design verification by several disciplines or organizations, and those which can be reviewed by a single individual. The specific design documents and specialized reviews are determined and used as required by the design changes and modifications.

CY procedures are established to assure that verified computer programs are certified for a specific use.

The CY Director of Project Support is responsible for assuring that design documents provided by vendors are adequately approved and maintained.

lDeleted: 03 QAP 3.0 17 CYQAP l REV: 1j6, CR 05-02

QAP 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 GENERAL REOUIREMENTS The procurement of materials, equipment, parts and/or services required during the maintenance and modification of quality systems, structures and components at the HNP and ISFSI is performed in a controlled manner which assures compliance with applicable regulatory requirements, procedures, quality assurance standards and regulations affecting procurement documents. Changes to procurement documents are subject to the same degree of control as utilized in the preparation of the original documents.

4.2 IMPLEMENTATION 4.2.1 PROGRAM Material and service requests are reviewed for technical adequacy and verification of the quality designation. The appropriate engineering management reviews and approves material and service requests, as applicable.

CYAPCo is responsible for ensuring performance of a procurement engineering evaluation to ensure the inclusion and adequacy of technical and quality assurance requirements prior to the issuance of the Purchase Order. Material for which technical and quality assurance requirements have been previously established are procured without additional procurement engineering evaluation.

Vendors utilized in the maintenance and modification of the HNP and ISFSI are responsible to implement measures for control of procurement documents associated with quality material, equipment, parts and services to ensure applicable requirements including quality assurance requirements are specified.

CYAPCo is responsible for ensuring the performance, as appropriate, of off-site audits, surveillances, and inspections to ensure that vendors are effectively complying with the requirements for the control of procurement documents.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of these vendor activities.

Changes to procurement documents are subjected to the same degree of control as that utilized in the preparation of the original document. The procurement of spare or replacement parts for quality systems, structures, or components is subject to the controls of the CYQAP and implementing procedure requirements.

The spare or replacement parts are subject to controls equivalent to original or - Deleted: 03 subsequent codes and standards. The use of subsequent codes and standards are controlled in accordance with the design change control requirements in QAP 3.0, QAP4.0 18 CYQAP l REV: 06, CR 05-02

"Design Control."

CYAPCo ensures the performance of procurement engineering evaluations of quality related material and serv ice requests by personnel to ensure that:

a. Adequate technical requirements are specified;
b. The quality assurance requirements are correctly stated, auditable and controllable; and
c. There are adequate acceptance and rejection criteria.

4.2.2 PROCUREMENT DOCUMENT PROVISIONS Procurement documents are prepared, reviewed and approved in accordance with procedures of the issuing organization or department and are available for verification. These procedures require that procurement documents consist of the following, as necessary:

a. The scope of work to be performed;
b. Technical requirements (specified or referenced) including the applicable components and materials identification requirements, drawings, specifications, procedures, instructions, codes and regulations, and the identification of applicable test, inspection and acceptance requirements, or special process instructions;
c. CYQAP requirements to be imposed on contractors which include the applicable requirements of 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G and the NRC regulatory requirements listed in Appendix C, herein;
d. Right of access which provides, as appropriate, for access to contractor facilities and records for inspection or audit by CYAPCo or its designated representative; and provides access for events such as those requiring notification of hold points; and/or
e. The documentation required to be prepared, maintained, and'or submitted to CYAPCo or its representative for review, approval or historical record. The time of submittal of this documentation and the retention and disposition of quality assurance records which are not submitted to CYAPCo is prescribed, as applicable, for Important to Safety procurements. ( Deleted: 03 4.2.3 SELECTION OF PROCUREMENT SOURCES QAP 4.0 19 CYQAP l REV: 06, CR 05-02

The function of procurement source selection is the responsibility of CYAPCo.

Purchasing verifies that the procurement document has been reviewed and approved, and that the vendor has been approved for procurement prior to issuing the purchase order for the material, equipment, parts and services.

Purchase Orders/Contracts may be issued to organizations with unapproved quality assurance programs. These procurement documents to unapproved organizations contain detailed supplementary quality assurance requirements and/or witness/hold points to verify CY requirements.

Material requisitions are reviewed to ensure appropriate quality assurance requirements are specified. These requirements, included in the procurement document, as necessary, include acceptance criteria, audits, surveillances and/or inspections at the vendor's facilities with scheduled witness/hold points during the fabrication process and/or prior to shipment of the procured item. Acceptance inspections and tests determined by CYAPCo shall be performed after receipt at the HNP or ISFSI, but prior to operability.

- t Deleted:03 I QAP 4.0 20 CYQAP I REX': 06, CR 05-02

QAP 5.0 PROCEDURES. INSTRUCTIONS. AND DRAWINGS 5.1 GENERAL REQUIREMENTS The CYQAP provides measures for the preparation, review, approval, control and distribution of procedures, instructions and drawings of activities affecting quality systems, structures and components during maintenance, modification, and decommissioning of the HNP and ISFSI. The documents include appropriate quantitative and qualitative acceptance criteria which specify the activity to be performed; the methods of construction and testing to be employed; material, equipment or parts to be used; a sequence of operation and the required documentation.

5.2 IMPLEMENTATION Quality procedures provide direction for personnel performing quality functions. CY Quality Assurance reviews and concurs with CY quality procedures as defined in the CY administrative control procedures. Comments concerning compliance with the CYQAP and regulatory requirements are resolved prior to issuance of the procedure.

Vendors utilized in the maintenance and modification of the HNP and ISFSI. may be delegated responsibility for preparing, maintaining, issuing and verifying the implementation of program documents which are selectively reviewvedapproved by the appropriateAj1snangae - Deleted: Director CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the quality assurance programs to ensure the vendors are effectively complying with the requirements for procedures and instructions.

CY Quality Assurance performs, as appropriate, on-site audits, surveillances, and inspections of these vendor activities. Vendor programs are required to clearly delineate the actions to be accomplished in the preparation, review and control of procedures, instructions and drawings and the methods for complying with 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and/or 10 CFR72 Subpart G.

5.2.1 PROCEDURES AND INSTRUCTIONS Procedures and instructions for activities affecting quality are prepared, reviewed, and approved in accordance with written procedures and instructions.

Deleted: 03 QAP 5.0 21 CYQAP l REV: 06, CR 05-02

The appropriate CY- 1\jan.auc. ensures that any vendors utilized in the maintenance

  • Deleted: Director i and modification of the HNP and ISFSI, implement quality assurance programs which contain written instructions for preparation, review and approval of procedures and instructions affecting quality. In addition, vendor's site quality procedures and quality control inspection procedures are reviewed by CY Quality Assurance personnel to assure compliance with the vendor's QA Program.

The CY line organization is responsible for the preparation, review and approval of plant and ISFSI quality procedures. The procedures include test procedures and overall site and ISFSI administrative procedures which implement the requirements of the CYQAP.

CY Quality Assurance reviews and concurs with quality procedure and special process manuals and procedures. The criteria for documents requiring CY review are defined in CY administrative procedures to ensure that:

a. Administrative procedures which implement the CYQAP are reviewed for compliance with the CYQAP and applicable Appendix C requirements, and
b. Work Procedures/Work Documents used to perform quality activities are reviewed to assure appropriate quality assurance controls have been specified.

5.2.2 DRAWINGS The design control and verification measures described in QAP 3.0, are applicable for the review and approval of drawings. Review and approval of new drawings or changes to existing drawings are described in CY procedures. The originating organization may delegate to other organizations or departments the work of design and review activities, or any part thereof, but retains responsibility for this work.

The measures taken to assure the preparation of as-built drawings and related documentation in a timely manner to accurately reflect the plant and ISFSI are described in CY procedures. Drawings critical to the maintenance of the long term fuel storage are updated prior to system turnover to operation and are available to the operating personnel.

5.2.3 ACCEPTANCE CRITERIA Review and approval of departmental procedures, instructions and drawings is described in CY procedures to ensure the inclusion of adequate quantitative and - Deleted: 03 qualitative acceptance criteria for determining satisfactory work performance and quality compliance. These criteria apply to quality activities as defined in the CYQAP.

QAP 5.0 22 CYQAP I REV: 06, CR 05-02

QAP 6.0 DOCUMENT CONTROL 6.1 GENERAL REOUIREMENTS The CYQAP provides measures to assure controlled distribution of documents pertinent to Quality Activities affecting Important to Safety structures, systems, and components in accordance with CY quality procedures and 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G.

Documents such as procedures, instructions, drawings, specifications and reports are prepared, reviewed for appropriate qualitative and quantitative acceptance criteria, and approved by authorized personnel in the affected organization. Approved controlled documents are distributed to affected locations in accordance with a controlled distribution list. Changes to controlled documents are reviewed and approved by the same organization which performed the original review and approval, unless otherwise specified in the implementing procedures. Measures are provided for controlling documents to preclude the possibility of the use of outdated documents.

6.2 IMPLEMENTATION 6.2.1 RESPONSIBILITY CY procedures and instructions delineate the measures for controlling documents including direction for the review for adequacy, approval by authorized personnel, distribution of controlled documents and verification that changes are promptly incorporated and implemented. These control measures apply to applicable documents affecting systems, structures and components for the maintenance and modification of the ISFSI, such as:

a. Design Specifications;
b. Design, Manufacturing, Construction and Installation Drawings;
c. As-Built Documents;
d. Quality Assurance Program Procedures and Instructions;
e. Manufacturing, Inspection and Testing Instructions;

f. Test Procedures; -- Deleted: 03

g. Calculations;
h. Design Basis Documentation; QAP 6.0 23 CYQAP l REV: 06, CR 05-02
i. Final Safety Analysis Reports;
j. Procurement Documents;
k. Design Change Records;
1. CY Quality Assurance Program;
m. Nonconformance Reports: and
n. Computer Codes.

CY procedures describe the measures taken for the control of documents to assure review and concurrence, as necessary, with regards to quality assurance aspects.

The requirements for control of procurement documents are contained in QAP 4.0, "Procurement Document Control." During all phases of plant and ISFSI life, it is the responsibility of each organization issuing controlled documents to employ document control procedures. The issuing organization is additionally responsible for distribution of the documents to appropriate locations. There shall be provisions to assure that approved changes are included in instructions, procedures, drawings and other documents prior to implementation of the changes.

Vendors utilized by CY in the maintenance and modification of the HNP or ISFSI are responsible for implementing measures for review, approval, control and distribution of controlled documents, to ensure they are effectively complying with the requirements for document control.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the vendors to verify compliance with their approved quality assurance programs.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of these vendor activities.

6.2.2 DISTRIBUTION OF CONTROLLED DOCUMENTS

-- - CY-procedures specify in-what manner controlled documents and revisions - Deleted: 03 thereof, are distributed to appropriate locations prior to commencing the work.

QAP 6.0 24 CY'QAP l REV: 06, CR 05-02

6.2.3 DRAWING CONTROL CYAPCo is responsible to implement a program for the retention and retrieval of drawings and records submitted by cognizant CY personnel. CYAPCo maintains a drawing status file which includes drawings (newly issued or revised) with the latest revision and current status.

The vendors utilized during the maintenance and modification of the HNP or ISFSI may be delegated the function of drawing control and must furnish periodic status reports listing the revisions of applicable drawings issued.

Quality Assurance personnel are responsible for the performance of off-site audits, surveillances, and inspections of vendors to verify they are effectively complying with their programs for document control of drawings.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of vendor activities.

6.2.4 INSTRUCTION AND PROCEDURE CONTROL Quality Assurance personnel perform audits, surveillances, and inspections of departments and, as appropriate, any on-site vendors utilized in maintenance and modification to the HNP or ISFSI to ensure they are effectively complying with their QA program for control of procedures and instructions.

The originating department is responsible for establishing adequate control over quality procedures and instructions issued by the vendor. The responsible organization also issues status reports or revised indices listing the latest revision of applicable controlled documents issued by the vendor. Procedures identify requirements for assuring controlled documents are available at the work location prior to commencing work.

--- --. . Deleted: 03 QAP 6.0 25 CYQAP l REV: 06, CR 05-02

QAP 7.0 CONTROL OF PURCHASED MATERIAL. EOUIPMENT, AND SERVICES 7.1 GENERAL REOUIREMENTS Measures for the control of procured material, equipment, parts and services by or for CY related to or are classified as Important to Safety for the HNP or ISFSI, are established and imposed by the CYQAP during maintenance and modification to the HNP or ISFSI to ensure conformance to procurement documents. These measures include provisions for source evaluation and selection, submission of objective evidence by the contractor or subcontractor, inspection at the vendor source and examination of items upon delivery. Control of quality by vendors and subcontractors is assessed for effectiveness at intervals consistent vith the importance, complexity and quantity of the product or service.

7.2 IMPLEMENTATION The evaluation and selection of vendors is performed in accordance with procedures, which specify that procurement source evaluation and selection measures are performed to determine vendor capability and delineate responsibilities of qualified personnel involved in the evaluation and selection process.

7.2.1 VENDOR OUALIFICATIONS CYAPCo utilizes one or more of the following methods in evaluating the qualifications of a potential vendor:

a. Audits and/or coordinated review of a potential vendor utilizing CY personnel and/or contracted personnel;
b. Other utility vendor audits and evaluations;
c. Nuclear Procurement Issues Committee (NUPIC) audits;
d. ASME N, NA, NPT, NV, or MM/ MS Certificate of Authorization;
e. Commercial grade surveys and/or coordinated review of a potential vendor utilizing one or more departments, (i.e., Engineering, Operations and/or Purchasing); or
f. Vendor inspection/surveillance.

Evaluations ensure that vendors employ a quality assurance program that Deleted: 03 conforms to applicable portions of the CYQAP.-

CYAPCo is responsible for maintaining documented evidence of the evaluation and QAP 7.0 26 CYQAP l REV: 06, CR 05-02

acceptance of the vendor's quality assurance program. The determination of vendor approval is based on such factors as prior performance, quality performance data, audits, commercial grade surveys, surveillances and evaluations of the supplier's quality assurance program.

Vendor Certificates of Conformance are periodically evaluated by audits, commercial grade surveys, surveillances, independent inspections and tests, to assure the vendor processes are valid. This verification of the process is documented.

7.2.2 SOURCE INSPECTION CYAPCo is responsible for the performance of source inspections at suppliers' facilities to ensure that the requirements of a Purchase Order/Contract have been met.

Source inspections are performed in accordance with procedures which provide for the method of inspection, the extent of documentation required, and those responsible for implementing those instructions.

Inspection of items occurs either when verifications of procurement requirements cannot be determined upon receipt or the vendor's QA program has not been accepted by CYAPCo.

CYAPCo has contracted the performance of some vendor source inspection activities to an approved vendor. CY has accepted the vendor's QA process on audits performed to accept the vendor's process.

7.2.3 RECEIPT INSPECTION CYAPCo ensures the performance of receipt inspections. Receipt inspection for procured items is performed in accordance with quality procedures which delineate requirements and responsibilities necessary to perform inspection functions. Contractual obligation fulfillment and specified requirements are verified during receipt inspections.

Receipt inspection of vendor-furnished material and equipment is performed to assure that material, components, equipment and acceptance records are examined in accordance with predetermined inspection instructions prior to acceptance, installation and operation. Receipt inspections include, as appropriate:

a. Measures for verifying that the shipment is complete, properly identified, undamaged and corresponds with the required documentation.
b. Measures for inspection of the item and review of supporting documentation (e.g., mill test reports, NDE reports) as required by the purchase documents; - Deleted: 03
c. Measures for inspection and acceptance of items in accordance with QAP 7.0 27 CYQAP REV: 06, CR 05-02

predetermined methods;

d. Measures for identifying and controlling acceptable items including identification of inspection status prior to release from the receipt inspection area;
e. Measures for identifying, segregating and handling nonconforming items;
f. Measures to ascertain that inspection records or certificates of conformance are acceptable prior to release for installation; and/or
g. In cases involving procurement of services, the project engineer or department head shall designate the means by which services may be accepted, and is given the authority to accept services in accordance with methods defined in CY procedures.

7.2.4 VENDOR FURNISHED RECORDS Records required to be furnished by the vendor are specified in the procurement document. Certifications or documentation provided by the supplier which attests to conformance to procurement document requirements, identifies that all the specific procurement requirements have been met (either by reference to the purchase order or by delineation).

The vendor must furnish the following records as a minimum:

a. Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards and specifications) which have been met by the items; and,
b. Documentation that identifies any procurement requirements which have not been met, together with a description of those nonconformances dispositioned "accept as is" or "repair."

CYAPCo is responsible for ensuring reviews for acceptability, those documents which pertain to the requirements in the procurement document, in accordance with the CYQAP and its applicable procedures.

The Department that is contracting on-site QA services shall be responsible for the review and acceptability of vendor personnelVequipment certifications prior to the start of work. CY Quality Assurance will provide oversight of these activities via audit, surveillance, or inspection.

  • Deleted: 03 7.2.5 'COMMERCIAL DEDICATION CYAPCo procedures address the measures taken to assure that commercial grade QAP 7.0 28 CYQAP REV: 06, CR 05-02

items, where specific quality assurance controls for nuclear applications cannot be imposed in a practicable manner, that special dedication requirements are established and implemented.

These measures follow the applicable guidance defined in Appendix C These measures include appropriate requirements for special categorization and identification within the procurement document, receipt inspection, and additional controls during the installation and testing process to be performed by the CY organization and/or other appropriate groups.

. - f Deleted: 03l QAP 7.0 29 CYQAP I REV: 06, CR 05-02

--- I- -

QAP 8.0 IDENTIFICATION AND CONTROL OF MATERIALS.

PARTS AND COMPONENTS 8.1 GENERAL REQUIREMENTS The CY organization assures that the identification of inspections, tests, and operation status of structures, systems, and components is known by affected organizations.

The CYQAP provides measures for the identification and control of material, parts and components, including partially fabricated assemblies, during maintenance and modification to the HNP and ISFSI. To ensure that each item can be traced to associated documentation, the identification of the item is maintained by heat number, lot number, part number, serial number, or other appropriate methods, and is physically marked on the item and/or on records traceable to the item. Documentation associated with material, equipment, and components delineated that these items have been designed, fabricated, manufactured, tested and/or inspected in accordance with the specified requirements. The object of these controls is to prevent the use of incorrect or defective materials, parts and components, in accordance with 10 CFR 50 Appendix B, 10 CFR 71 Subpart H and 10 CFR 72 Subpart G.

8.2 IMPLEMENTATION CY procedures establish the responsibilities and requirements for the identification and control of materials, parts and components. The procedures assure that identification and control is maintained throughout fabrication, receipt, handling, storage and installation of items. Provisions include:

a. Requirements for traceability to appropriate documentation, such as:
  • Purchase orders/contracts,
  • Manufacturing documents,
  • Drawings,
  • Specifications,
  • Certifications,
  • Inspection and test records, and
  • Nonconformance reports.

.. Deleted: 03

b. Controls to assure that the correct identification of an item is verified and documented prior to release for fabrication, assembly, shipping or installation, QAP 8.0 30 CYQAP REX: 06, CR 05-02
c. Requirements which assure that the method or location of markings do not affect the function or quality of an item, or
d. Establishment of identification requirements in purchase orders, contracts, specifications, drawings, procedures or instructions.

During the maintenance and modification of the HNP or ISFSI, CY may delegate any portion of the implementation of the identification and control program to a vendor contracted to perform related quality activities. If delegated, contracts require that the vendor establish an identification and control program which meets the CYQAP requirement.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of the vendor's quality assurance program, to ensure they are effectively complying with the requirements for identification and control of material, equipment and components.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of the vendor activities.

Receipt inspections are performed to verify that materials, equipment and components are properly identified in accordance with procurement requirements. CYAPCo is responsible for assigning and applying permanent identification to the items in accordance with procedures. If the application of a serial number is not practical, other means of identification are implemented to assure proper identification and traceability.

In the event that the equipment, material or component is nonconforming or the identification becomes lost or illegible, the items are considered nonconforming and are identified and controlled in accordance with QAP 15.0, "Nonconforming Materials, Parts, Components, or Services."

j Deleted: 03 QAP 8.0 31 CYQAP REV': 06, CR 05-02

QAP 9.0 CONTROL OF SPECIAL PROCESSES 9.1 GENERAL REQUIREMENTS The CYQAP provides measures to assure control of special processes associated with quality systems, structures and components by the use of qualified procedures, equipment and personnel during maintenance and modification of applicable the HNP and ISFSI SSCs.

Special processes are performed under controlled conditions in accordance with special requirements and may include, but are not limited to: welding, cleaning, heat treating, and nondestructive examination and/or testing.

9.2 IMPLEMENTATION During maintenance and modification of the HNP or ISFSI, CY Management ensures that special process data and documentation is reviewed; vendor's special process procedures used at the HNP or ISFSI are qualified and approved; and that personnel and equipment utilizing special processes are properly qualified prior to the start of work.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections to ensure the vendors are effectively complying with their quality assurance program requirements for control of special processes.

Quality Assurance personnel, as appropriate, on-site audits, surveillances, and inspections of the vendor activities.

CY special process procedures utilized during maintenance and modification of the HNP or ISFSI are prepared, reviewed and approved in accordance with procedures as specified in QAP 5.0, "Procedures, Instructions, and Drawings."

9.2.1 PROCEDURE QUALIFICATION AND CONTROL CYAPCo procedures specify that written process control documents are utilized and qualified, as required, in accordance with the applicable specification, codes or standards.

9.2.2 PERSONNEL QUALIFICATION AND CERTIFICATION Codes, standards and CYAPCo procedures specify personnel qualification/certification requirements. Personnel responsible for the performance and verification of special processes are trained, tested, and certified as required by applicable specifications, codes and standards. Requirements for Deleted: 03 the period of certification, retesting, and recertification of personnel are also specified. Vendors qualify personnel and maintain records of qualified personnel in accordance with applicable codes, standards, specifications, and vendor QAP 9.0 32 CYQAP l REV: 06, CR 05-02

Purchase Order/Contract requirements. The department that is contracting services is responsible for the review of records of qualified personnel, equipment and procedures associated with special processes.

The evaluations are performed by the responsible personnel who are qualified in accordance with the appropriate commitments listed in Appendix C.

CY Quality Assurance performs, as appropriate, audits, and surveillances of the personnel qualification process.

9.2.3 SPECIAL PROCESS RECORDS Records provide objective evidence that special processes were performed in accordance with procedures, by qualified personnel, and that when required by procedures, specifications, and codes, such performance was verified. Results of nondestructive examinations are recorded in accordance with applicable specifications, codes and standards. These records are retained by the vendor or supplied to CY as required by contract or purchase order. If records are to be retained by the supplier, the contract or purchase order specifies the retention period and instruction for final disposition of records.

Special process documentation such as special process procedures, qualifying data, and personnel and equipment qualification records associated with the performance of special processes at nuclear power plants, are kept current and maintained in appropriate CY files, with final disposition to the CY record facility.

Deleted: 03 QAP 9.0 33 CYQAP l REX': 06, CR 05-02

QAP 10.0 INSPECTION 10.1 GENERAL REQUIREMENTS Inspection of activities to verify the quality of systems, structures and components, which are performed by or for CY are executed in accordance with the CYQAP and appropriate procedures, instructions and drawings by qualified personnel independent from the individual or group performing the activity being inspected. If inspection is impossible or disadvantageous, indirect controls by monitoring processing methods, equipment and personnel are provided. Inspection notification and hold points are identified, as required, in the applicable documents.

10.2 IMPLEMENTATION 10.2.1 INSPECTION RESPONSIBILITIES During maintenance and modification of the HNP or ISFSI, procedures shall define the need for inspections (e.g., receipt inspections, installation, and product acceptance).

Quality Assurance personnel shall ensure procedural requirements are met by means of audits and surveillances as defined in CY Department procedures.

Quality Assurance personnel shall perform inspections of modification and maintenance activities on systems, structures, and components governed by the CYQAP. The criteria used to determine when CY Quality Assurance inspections shall be required for these activities and for the preparation of inspection plans shall be identified in appropriate procedures. Quality Assurance personnel shall be responsible for ensuring the inspection function which includes:

a. Identification of inspection personnel;
b. Review of work procedures and work documents to identify QA "hold" points associated with the work; C. Preparation and approval of inspection plans ensuring that the necessary inspection requirements, methods, and acceptance criteria have been identified; and
d. Documentation of inspection results.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, Deleted: 03 surveillances, and inspections to verify that any vendor utilized in the maintenance and modification of the HNP or ISFSI are effectively complying with their quality assurance program requirements for inspection and for QAP 10.0 34 CYQAP REV: 06, CR 05-02

performing witnessing inspections at "hold" or "notification" points identified in procurement documents.

Quality Assurance personnel perform, as appropriate, on-site audits, surveillances, and inspections of vendor activities.

10.2.2 INSPECTION PLANS Documented inspection plans may be either a separate document or an integral part of work instruction documents. The plans are based on design specifications, procurement documents, drawings, other specifications, or previous experience, as appropriate.

During the performance of CY work activities, procedures provide criteria for the determination of accuracy requirements of inspection equipment and when inspections are required. These procedures describe requirements for the preparation of surveillance and/or inspection plans.

The inspection criteria, including the use of inspection equipment and their accuracy requirements, are specified in the surveillance/inspection plans.

10.2.3 INSPECTION PERSONNEL AND INSPECTION DOCUMENT ACCESS Inspections are performed by individuals other than those who performed or directly supervised the activity being inspected. Inspection personnel are qualified and/or certified in accordance with appropriate codes, standards, and/or training programs.

Inspections are performed by Quality Assurance personnel or qualified contract personnel. The on-site QA inspection services shall review the acceptability of vendor personnel/equipment certification prior to the initiation of the activity.

When vendors are contracted to perform inspection services, their inspection plans/procedures are reviewed and concurred upon by Quality Assurance personnel in accordance with QAP 5.0, "Procedures, Instructions, and Drawings".

Access to drawings, procedures, specifications or other documented criteria necessary for the performance of inspections is provided prior to performing the inspection activity.

j Deleted: 03 QAP 10.0 35 CYQAP l REV: 06, CR 05-02

10.2.4 INSPECTION PROCEDURES

a. Required inspection or surveillance activities are performed and documented in accordance with procedures and/or checklists.

Inspection procedures, plans or checklists contain the following:

1. Identification of characteristics to be inspected;
2. Identification of the individual or groups responsible for performing the inspections;
3. Requirements for the necessary measuring and test equipment and the required accuracy of this equipment;
4. Acceptance criteria;
5. A description of the method of inspection when other than direct visual examination using the unaided eye;
6. A record of the results of the inspection; and/or
7. Record of inspector or data recorder.
b. Procedures specify surveillance of processing methods or testing and operation of equipment when inspection is impossible, inaccessible or not applicable.
c. Modification, repair, replacement or rework items are inspected in accordance with original inspection requirements or approved alternatives.

10.2.5 MANDATORY HOLD AND NOTIFICATION POINTS Mandatory hold points are utilized when an inspection/operation must be performed or witnessed and signed off by the responsible personnel before work can proceed.

Notification points are used to identify the operations or completed processes that Quality Assurance personnel or their representatives may elect to witness andlor inspect during the manufacturing or installation process. Mandatory hold and notification points, as required, are identified in procurement documents and work procedures/documents. Purchase Order/Contracts and work procedures/documents are subject to the review and concurrence for adequacy of inspection, notification and/or mandatory hold controls by CYAPCo and Quality Assurance, respectively.

Deleted: 03 QAP 10.0 36 CYQAP l REV: 06, CR 05-02

10.2.6 INSPECTION RESULTS EVALUATION Inspection results are evaluated for acceptability in accordance with procedures which identify the responsible organization.

The evaluations are performed by the responsible personnel who are qualified in accordance with the appropriate commitments listed in Appendix C.

Quality Assurance personnel perform audits and surveillances to assure that inspections are performed per the requirements of applicable CY procedures.

.. - { Deleted: 03 QAP 10.0 37 CYQAP I REV: 06, CR 05-02

QAP 11.0 TEST CONTROL 11.1 GENERAL REQUIREMENTS A documented test control program is established by the CYQAP for systems, structures and components to ensure that they will perform satisfactorily in service and that test results are documented in accordance with 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, 10 CFR 72 Subpart G, and other pertinent regulatory and/or technical requirements.

The test control program identifies the systems, structures and components to be tested, method of conducting tests, evaluation of tests and documentation of tests by qualified personnel to assure requirements have been satisfied.

The test control program is systematic and includes proof tests prior to installation, construction tests, operational tests, surveillance tests, and retest following repairs, replacements, preventative maintenance or modifications.

11.2 IMPLEMENTATION 11.2.1 TEST PROGRAM Test requirements to determine or to verify the capability of an item to meet specified requirements in accordance with engineering/design documents, Safety Analysis Reports (SAR), technical specifications, procedures or procurement documents, as appropriate. are accomplished by subjecting the item to a set of physical, chemical, environmental or operating conditions. Retest following repair, replacement or modification is performed in accordance with the original design requirements or acceptable alternatives and is performed when original test results are invalidated.

CY procedures are written and approved to delineate the methods and responsibilities for controlling, accomplishing and documenting testing during maintenance and modification of the HNP and ISFSI.

Vendors utilized in the maintenance and modification of the HNP and ISFSI are responsible for implementing measures for the control of tests to ensure that materials, equipment and parts will perform satisfactorily.

CYAPCo is responsible for the performance, as appropriate, of off-site audits, surveillances, and inspections of selected proof tests when hold points have been identified in Purchase Order/Contracts of vendors to verify they are complying with their quality assurance program requirements for test control. - - Deleted: 03 CY Quality Assurance performs, as appropriate, on-site audits, surveillances, and inspections of the vendor activities.

QAP 11.0 38 CYQAP l REV: 06, CR 05-02

Proof tests, product acceptance tests, retests, and periodic surveillance tests are conducted by qualified personnel in accordance with procedures. Personnel performing tests ensure that calibrated equipment and instrumentation utilized are within the calibration interval specified. Documentation including test procedures and data sheets are maintained in appropriate files.

11.2.2 TEST PROCEDURE PREPARATION AND TEST PERFORMANCE Testing is accomplished in accordance with test procedures which incorporate or reference the requirements and acceptance criteria in the applicable design and procurement documents. The test procedure or test program documents include the following as a minimum:

a. Instructions for the testing method used;
b. Required test equipment and instrumentation;
c. Test requirements, such as acceptance and rejection criteria;
d. Hold, notification, inspection and data collection points;
e. Test prerequisites, such as: calibrated instrumentation; trained, qualified, and licensed or certified personnel; preparation, condition and completeness of the item to be tested; and/or suitable and controlled environmental conditions;
f. Methods for documenting or recording test data and results; and
g. Provisions for data collection and storage.

11.2.3 TEST EQUIPMENT CY procedures provide the criteria for determining when a test is required and the accuracy requirements of test equipment.

The following steps are taken in the control of test equipment:

a. Test instrumentation is checked and calibrated in accordance with CY procedures to ensure accuracy,
b. Plant and ISFSI instrumentation used in testing is calibrated. It is (Deleted: 03 maintained in calibration at regular intervals in accordance with surveillance and/or preventative maintenance procedures; and QAP 11.0 39 CYQAP l REV: 06, CR 05-02
c. Where special instrumentation is required for testing, the requirements are stated in the procedures. Instrument characteristics, including accuracy requirements, are equivalent to or better than those specified by the vendor.

11.2.4 EVALUATION OF TEST RESULTS The documented test results are evaluated against the predetermined acceptance criteria by an individual or group having appropriate qualifications. The acceptance status of the test is documented. Deficiencies noted during the evaluation are documented and dispositioned in accordance with approved procedures.

The evaluation of test results may also be delegated to vendors. W\'hen delegated, contracts require the vendor to assure the use of qualified personnel, evaluate the data against predetermined criteria and document the results of the evaluation and acceptance status of the test.

CYAPCo is responsible for the performance of off-site audits, surveillances, and inspections, as appropriate, to verify that these vendors are effectively complying with their quality assurance program requirements for test control.

Quality Assurance personnel perform on-site audits, surveillances, and inspections, as appropriate, of the activities.

.. { Deleted: 03 I QAP 11.0 40 CYQAP l REV: 06, CR 05-02

QAP 12.0 CONTROL OF MEASURING AND TESTING EQUIPMENT 12.1 GENERAL REOUIREMENTS The CYQAP provides measures for the control of measuring and testing equipment (M&TE) used as the basis for acceptance in activities affecting quality during inspection, testing and measurement of materials, equipment and parts. Periodic calibration and adjustment of measuring and test equipment is performed and controlled to assure accuracy is maintained within limits necessary to verify that design and operating condition requirements have been met. Documentation is retained such that all items of M&TE are traceable to their calibration records.

12.2 IMPLEMENTATION 12.2.1 GENERAL Procedures delineate the methods and responsibilities for the control, maintenance and calibration of M&TE including portable and temporarily installed test instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment.

Documentation associated with M&TE is maintained in appropriate files, with eventual incorporation into the records system. When the information for the control, use, and calibration of M&TE is in electronic form, this information is controlled and protected in accordance with procedures.

The calibration program is implemented in accordance with the requirements defined in CY procedures which describe the measures utilized to maintain M&TE. Functional groups are responsible for implementing these procedures which comply with the requirements contained in specifications and drawings.

M&TE administrative procedures related to the M&TE calibration program are indcrxelnf;lv revicwed and apnroved as described in Appendix E.

CYAPCo or the appropriate M&TE Custodian, as delineated by the Purchase Order, is responsible for verifying that receipt of calibrated equipment is in conformance with the requirements of procurement documents. CYAPCo and Quality Assurance personnel are responsible for the calibrated M&TE used during their inspections, respectively.

Implementing personnel are responsible to ensure that M&TE equipment is- - Deleted: 03 calibrated, issued, and controlled in accordance with the requirements of the procedures. The "activity" Supervisor shall ensure that the users of the M&TE are properly instructed in the use and control of the M&TE. HNP and ISFSI Departments are responsible for calibrating M&TE within the required interval or QAP 12.0 41 CYQAP l REV: 06, CR 05-02

removing the M&TE from service until the required calibration can be performed.

CY departments are also responsible for reviewing calibration data associated with M&TE calibration by outside vendors in accordance with the procedures.

Quality Assurance personnel perform audits, surveillances, and inspections to verify implementation of the M&TE program.

Vendors utilized in the maintenance and modification of the HNP or ISFSI are responsible for implementing measures for the control of M&TE to ensure they are properly calibrated, adjusted and maintained at specified intervals in order to maintain accuracy within required limits.

CYAPCo is responsible for the performance of off-site audits, surveillances, and inspections, of the quality assurance programs of vendors to verify that they are effectively complying with their requirements for control of M&TE.

Quality Assurance personnel perform on-site audits, surveillances, and inspections, as appropriate, of vendor activities.

12.2.2 CALIBRATION STANDARDS Measuring and test equipment is calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement. Measuring and test equipment shall be permanently marked or tagged with a unique identification number and the date calibrated and next calibration date indicated on the M&TE.

CY procedures describe the measures taken to assure that reference and transfer standards are traceable to nationally recognized standards and that, where national standards do not exist, provisions are established to document the basis for calibration.

Calibration of this equipment should be against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated. When this is not possible, the standards shall have an accuracy that assures the equipment being calibrated will be within required tolerance and the basis of acceptance is documented and authorized by the manager of the applicable group.

In addition, the calibrating standards shall have greater accuracy than secondary standards being calibrated. Calibrating standards with the same accuracy may be

- - - - -used if they can be shown to be adequate for the requirements and the basis of - - -4 Deleted 03 acceptance is documented.

12.2.3 "OUT OF TOLERANCE" CONTROL QAP 12.0 42 CYQAP l REV: 06, CR 05-02

M&TE and reference standards when found out of tolerance are so identified and removed from service. A timely review is conducted to determine the validity of previous inspection or test results gained through use of the instrument, and of the acceptability of items previously measured or tested.

_ Deleted: 03 )

QAP 12.0 43 CYQAP I REV: 06, CR 05-02

QAP 13.0 HANDLING. STORAGE AND SHIPPING 13.1 GENERAL REQUIREMENTS Measures are established by the CYQAP using procedures, instructions and procurement documents to ensure proper handling, storage, shipping, cleaning and preservation of material, equipment and parts. These measures are imposed during maintenance and modification activities in order to preclude damage, loss or deterioration of materials, equipment and parts.

13.2 IMPLEMENTATION 13.2.1 GENERAL Procedures, instructions and procurement documents define the requirements and responsibilities for the handling, storage, shipment, cleaning and preservation of material, equipment, and parts required for implementation of established design and specification requirements.

Handling, storage, cleaning and preservation requirements of material, equipment and parts is conducted in accordance with procedures and procurement documents.

Vendors utilized in the maintenance and modification to the HNP and ISFSI are responsible for implementing measures for handling, storage, shipping, cleaning and preserving materials, equipment and parts to preclude damage, loss or deterioration.

CYAPCo is responsible for off-site audits, surveillances, and inspections, as appropriate, to verify that vendors are effectively implementing and complying with the approved procedures and instructions for handling, storage, shipping, cleaning and preservation of materials, equipment and parts.

Quality Assurance personnel perform on-site audits, surveillances, and inspections, as appropriate, of the activities.

13.2.2 ESTABLISHMENT OF SPECIAL HANDLING. STORAGE. SHIPPING.

CLEANING AND PRESERVATION REOUIREMENTS Special or additional handling, storage, shipping, cleaning and preservation requirements are to be identified and implemented as specified in procurement documents and approved procedures. These established requirements are consistent with the applicable commitments listed in Appendix C herein, or specifications and/or vendor technical manuals, and will be consistent with accepted industry standards.

CY procedures describe the measures taken for the storage of chemicals, reagents Deleted: 03 (including control of shelf life), lubricants, and other consumable materials.

QAP 13.0 44 CYQAP l REV: 06, CR 05-02

QAP 14.0 INSPECTION. TEST AND OPERATING STATUS 14.1 GENERAL REOUIREMENTS The CYQAP provides measures for indication, by the use of marking such as stamps, tags, labels or other suitable means, the status of tests and inspections of material, equipment and parts throughout the maintenance and modification of the HNP or ISFSI to preclude the inadvertent bypassing of inspection and test requirements. These measures provide for the identification of items which have satisfactorily passed required inspections and tests.

Measures are also established for indicating the operating status of systems, structures and components to prevent inadvertent operation.

14.2 IMPLEMENTATION 14.2.1 GENERAL Vendors utilized in the maintenance and modification of the HNP or ISFSI are responsible for implementing approved measures for the identification of inspection and test status of material, equipment and parts to preclude the bypassing of requirements.

CYAPCo is responsible for the performance of offsite audits, surveillances, and inspections of vendors, as appropriate, to verify that they are effectively complying with their requirements for identification of inspection and test status, in compliance wvith procedures and instructions.

Elements of this system require that vendors have a controlled manufacturing and test operation, in order to preclude the inadvertent bypassing of process inspections or tests, and to provide a positive identification of component status throughout all phases of manufacturing, testing, and inspection by means of tagging, routing cards, stamping, manufacturing or test reports, labeling or other appropriate methods.

When Receipt Inspections are performed, CYAPCo ensures that traceability is maintained for acceptable materials, equipment and parts, to indicate conformance to Purchase Order/Contract requirements. Material used at CY that requires traceability to be maintained is delineated in the appropriate CY procedure.

Nonconforming materials, equipment and parts are identified in accordance with QAP 15.0, "Nonconforming Materials, Parts, Components, or Services" and/or QAP 16.0, "Corrective Action."

During tests and inspections of operating systems required to support the storage

-lDeleted:.03 !

of the spent fuel, a status tagging system is implemented, as per approved procedures and instructions, to prevent 'inadvertent operations of systems, QAP 14.0 45 CYQAP l REV: 06, CR 05-02

structures and components.

CY procedures describe the measures taken to control the altering of the sequence of required tests, inspections and other operations. The review and approval for these actions is subject to the same control as taken during the original review and approval of tests, inspections and other operations.

Quality Assurance personnel perform on-site audits, surveillances, and inspections, as appropriate, of the activities.

14.2.2 STATUS IDENTIFICATION AND CONTROL Procedures and instructions describe control of the application and removal of markings such as stamps, tags, labels, and other suitable means to indicate the status of systems, structures and components to prevent inadvertent operation, and to preclude omission of inspections, tests or other critical operations. These procedures and instructions delineate the requirements, methods and responsibilities for indicating the status of the affected items. The complete status of all items under the calibration system is recorded and maintained.

Records associated with status identification are maintained in accordance with procedures.

  • -Deleted: 03 I QAP 14.0 46 CYQAP I REV: 06, CR 05-02

QAP 15.0 NONCONFORMING MATERIALS. PARTS. COMPONENTS. OR SERVICES 15.1 GENERAL REOUIREMENTS The CYQAP requires that documentation and control of nonconforming materials, parts, components, or services utilized in systems, structures and components during maintenance and modification of the HNP or ISFSI be performed in accordance with procedures in order to prevent inadvertent use or installation. These procedures include appropriate requirements for identification, documentation, segregation and disposition of nonconforming items, and notification to affected organizations.

15.2 IMPLEMENTATION 15.2.1 PROGRAM Procedures define personnel responsibilities and establish various measures for identification, documentation, segregation, review and disposition of nonconforming item reports. Report mechanisms are available to all CY and contractor personnel.

15.2.2 DOCUMENTATION Documentation of nonconforming items requires identification of the items, description of the nonconformance, disposition of the nonconformance, inspection requirements and signature approval of the disposition.

Tagging systems are utilized to physically identify nonconforming items prior to installation. CYAPCo utilizes tags for received material, parts and components.

15.2.3 EVALUATION AND DISPOSITION Evaluations are performed to determine the impact on system, structures and component operability and to determine the disposition of nonconforming items and services. The evaluation determines whether an item or service is to be used as is, returned to vendor, repaired, or scrapped. An engineering evaluation is performed, if necessary, prior to the resolution of nonconformances. These evaluations assure that the final condition does not adversely affect safety, operation or maintenance of the item or service, or of the component or system.

Reports involving deviation from design bases such as "use as is" or "repair" are forwarded to the appropriate engineering organization for review, and disposition.

Applicable information is accumulated and records are maintained. - Deleted: 03 The need to release/use nonconforming materials, parts or components shall be based on such considerations as:

QAP 15.0 47 CYQAP I REV: 06, CR 05-02

a. Impact on nuclear safety,
b. Safety of personnel;
c. Suitability of material or items in the "as is" condition, i.e., probability of eventual satisfactory resolution of the nonconforming without repair, rework or replacement;
d. Accessibility of material or items after release;
e. Cost of removal and repair or replacement should material or items eventually have to be removed, repaired, or replaced; and
f. Effect on the orderly progress of work.

Items repaired are verified by reinspecting the items as originally inspected or by a documented method which is equivalent to the original inspection method. Items reworked may require reinspection as defined in procedures.

Quality Assurance personnel perform audits and surveillances to verify that dispositions for reports documenting nonconforming conditions are adequate.

  • - Deleted: 03 QAP 15.0 48 CYQAP l REV: 06, CR 05-02

QAP 16.0 CORRECTIVE ACTION 16.1 GENERAL REOUIREMENTS The CYQAP requires that an effective corrective action program be established for CY and their vendors to ensure that conditions adverse to quality are promptly identified and corrected as soon as practicable and documented in accordance with approved procedures.

These procedures include measures for determining the cause and corrective action to preclude recurrence for conditions identified as significant conditions adverse to quality.

16.2 IMPLEMENTATION 16.2.1 PROGRAM Procedures define personnel responsibilities and establish various measures for identification, documentation, evaluation/review, disposition and correction of conditions adverse to quality and significant conditions adverse to quality.

Reporting mechanisms are available to station personnel.

16.2.2 CORRECTIVE ACTION AND FOLLOW-UP Procedures describe the measures taken to evaluate if conditions adverse to quality exist and to determine the need for immediate corrective action or disposition. CY Management is responsible for ensuring that the assigned personnel and their vendors working at HNP or ISFSI comply with the corrective action program and for ensuring that corrective action is adequate and properly implemented in a timely manner at the HNP and ISFSI.

CY Management is responsible for ensuring that conditions adverse to quality are promptly identified and corrected in accordance with approved procedures.

Quality Assurance personnel perform audits and surveillances to verify that organizations working at the HNP and ISFSI comply with the corrective action program and that corrective action is adequate and properly implemented in a timely manner.

The President has the final authority in the event that agreement on the action to be taken is not reached at the appropriate organization levels within the CY organization.

  • Deleted: 03 !

QAP 16.0 49 CYQAP l REV: 0)6, CR 05-02

16.2.3 RECURRENCE CONTROL Procedures provide responsibility and the process for determining appropriate significance based on actual or potential consequences for conditions adverse to quality and requirements for evaluation and corrective action.

Procedures also establish the responsibilities and measures taken to accomplish these actions.

An analysis of conditions identified as adverse to quality is developed and adverse trends are periodically reported to management by the organization responsible for controlling the problem reporting program. Trends concerning specific vendor performance shall be reported to the affected contractor for resolution, if appropriate.

Quality Assurance personnel perform audits and surveillances to verify that the corrective action program is adequate and controlled in accordance with procedures.

. - l Deleted: 03 I QAP 16.0 50 CYQAP I REV: fl6, CR 05-02

QAP 17.0 QUALITY ASSURANCE RECORDS 17.1 GENERAL REQUIREMENTS The CYQAP provides for the maintenance, identification, retention and retrieval of records to furnish evidence of activities affecting quality during maintenance and modification of the HNP and ISFSI. The records include but are not limited to:

a. Operating logs and the results of reviews;
b. Inspections;
c. Tests;
d. Audits;
e. Monitoring of work performance; and
f. Material analyses.

The records also include closely related data such as qualifications of personnel, procedures and equipment. Inspection and test records contain as a minimum but are not limited to:

identification of inspector or data recorder; and, the acceptability and the action taken in connection with any deficiencies and reportable occurrences noted. Procedures establish requirements concerning record retention such as duration, location and assigned responsibility.

Quality assurance records shall also include these records required by 10 CFR 71.135 and 10 CFR 72.174. Records subject to the provisions of 10 CFR 71.135 shall be retained for 3 years beyond the date of the final transportation activity subject to the controls of this Quality Assurance Program. Records subject to the provision of 10 CFR 72.174 shall be retained until the NRC license to store spent nuclear fuel at the ISFSI is terminated.

17.2 IMPLEMENTATION Procedures and instructions establish the responsibilities and requirements for the maintenance, identification, retention and retrievability of records pertaining to materials, equipment, parts, processes or operations relating to systems, structures and components which when founded on observations, measurements or tests can be fully verified, and documented by cognizant personnel.

CY procedures define the documentation requirements for inspection and test records, as 4 Deleted: 03

'appropriate.

Vendors utilized in the maintenance and modification of the HNP or ISFSI are QAP 17.0 51 CYQAP REV: 06, CR 05-02

responsible to implement measures for identification, maintenance, retention, retrieval and turnover of records to CY personnel which contain objective evidence of quality, as specified in Purchase Order/Contracts.

CYAPCo is responsible for off-site audits, surveillances, and inspections, of vendors, as appropriate, to verify they are effectively complying with their program for quality assurance records.

Quality Assurance personnel perform on-site audits, surveillances, and inspections, as appropriate, of these activities.

Quality Assurance records are identified controlled and maintained in appropriate files and are identifiable to specific systems, structures and components at HNP and ISFSI. When identification to a specific system, structure or component is not practical, records are filed by category (e.g. specification, nonconformance reports, audits, etc).

17.3 RETENTION CY quality assurance records are classified as life records or nonlife records as delineated by the Nuclear Records Program. Non-life records are those documents that are maintained for a specific period of time other than the lifetime of the in-service nuclear power plant, ISFSI or the particular component or part. Life records are those documents that are maintained for the lifetime of the in-service nuclear power plant, ISFSI or for the life of the particular component or part. Life records are those which -wouldbe of significant value in meeting one or more of the following criteria:

a. Demonstrating capability for safe operations;
b. Maintaining, reworking, repairing, replacing or modifying the item;
c. Determining the cause of an accident or malfunction of an item; or
d. Providing required base line data for in-service inspection.

Records are reviewed and approved by the cognizant qualified personnel and vendors as appropriate, and are transmitted to Nuclear Records. The responsibility of Nuclear Records upon receipt of records is to maintain and provide controlled retrievability of records affecting the HNIP or ISFSI in such a manner as to prevent destruction of records by fire, flood, theft, and environmental conditions, such as temperature or humidity, as delineated in procedures.

] Deleted: 03 QAP 17.0 52 CYQAP l REX': 06, CR 05-02

QAP 18.0 AUDITS 18.1 GENERAL REQUIREMENTS The CYQAP requires that a comprehensive system of planned and periodic audits shall be carried out to verify compliance with the CYQAP during the maintenance and modification of the HNP or ISFSI.

Audits are conducted in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited.

Documented audit results are reviewed by management having responsibility in the area audited and who takes the necessary action to address any audit findings revealed by the audit.

18.2 IMPLEMENTATION 18.2.1 PROGRAM The audit program requires audits of corporate, HNP and ISFSI quality activities under the oversight by the CY Independent Review and Audit Committee (IRAC) as described in Appendix E. Audits are performed on activities where the requirements of 10 CFR 50, 10 CFR 71 and 10 CFR 72, and the CYQAP are being implemented.

Audits are regularly scheduled on the basis of the status and safety importance of the activities being performed. Regularly scheduled audits are supplemented by audits for one or more of the following conditions:

a. When significant changes are made in functional areas of the quality assurance program, such as significant reorganization or procedure revisions;
b. When it is suspected that the quality of the item is in jeopardy due to deficiencies in the quality assurance program;
c. When a systematic, independent assessment ofprogram effectiveness is considered necessary and / or
d. When necessary to verify implementation of required corrective action.

Schedules for the audit of CY activities are originated and maintained by Quality - Deleted: 03 Assurance personnel. Schedules are approved by the Quality Assurance Management.

QAP 18.0 53 CYQAP l REV: 06, CR 05-02

Audits are performed as specified in CY procedures by qualified personnel, using a pre-established written audit plan prepared by the auditing organization. Audits may include evaluation of the work areas, activities, processes, items, and review documents and records to determine the effectiveness of implementation and conformance to the CYQAP.

Approved vendors utilized in the maintenance and modification activities to the HNP or ISFSI are responsible for developing and implementing a system of planned and periodic audits to verify compliance with the effectiveness of all aspects of their quality assurance programs.

CYAPCo is responsible for verifying the acceptability of vendor audit programs and for the performance of subsequent off-site audits, as appropriate, to verify compliance with the effectiveness of all aspects of their quality assurance programs.

Quality Assurance personnel perform audits/surveillances of on-site vendors, as appropriate, to verify the effectiveness of appropriate aspects of their quality assurance programs In addition to the audits, other methods, such as surveillances, and inspections are used to ensure that quality activities are in compliance with the CYQAP.

18.2.2 REPORTING OF AUDIT RESULTS Audit results are reviewed, approved, and reported in accordance with Quality Assurance and/or approved vendor procedures, as applicable. The audit reports are issued to the appropriate management of the area audited to ensure appropriate and/or timely corrective action is taken to address any audit issues. In addition, audit data and reports are included as part of the review for quality trends and assessed in accordance with QAP 16.0, "Corrective Action."

18.2.3 REVIEW. ACTION. AND FOLLOW-UP OF AUDIT FINDINGS Audit findings are reviewed and investigated by the management having the responsibility for the area audited. The responsible management is required to:

a. Take the necessary action to addresses any findings identified by the audit;
b. Report the results of such reviews and investigations;
c. Take the necessary actions to correct problems reported; and Deleted: 03
d. Report the completion of corrective actions within specified time frames.

QAP 18.0 54 CYQAP l REV: 06, CR 05-02

Follow-up of audit findings is performed by the auditing organization, as necessary, to verify that appropriate actions have been taken to resolve audit findings. Actions on audit findings which cannot be resolved by affected I management are submitted for resolution to th, Senior Management. j Deleted: Chairman. CEO and I 18.2.4 RECORDS/REPORTS OF AUDITS Audit records, reports, and associated documentation pertinent to audits are dispositioned to Nuclear Records, as specified in procedures.

.. Deleted: 03 QAP 18.0 55 CYQAP I REV: 06, CR 05-02

APPENDIX A CON NF.CTICUT V'XANiIT Y UMALITY ASSURANC' PROGRAM IMPORTANT- TO-SAFETY SYSTEMS.

STRUTTIC iURES. AND) COMP ON'FNT S Thezialitvassuranccreoutrenients pe'-tinent of 11)CFR 50. Apnendix R, 10 CFR71 Subpart H and 10 CFR 72 Subpart G will be applied. as a minimun, to all cualitv activitics aft;atingft the Important-to-Safetv S-stenis. StructuLis, a-idComnonentslS.'s) assciated witnt ite storare and transportation.

NOTF The safcrv classification of svstcrn. structurcs and components (SSCsLoK)_f thle JST Facility mav be revised lilsed on enemecrintz evzaluations and a revision to the CY' UFSAR. dutinn [Ile decotnmissioning pnroess. These moditicattionn are controlled in accordance with the C'Y Dcsi-mn Control rooccss and are not cnor.sidered a reduction in the cornminntmcs to th_ C(YAP.

Thoe ttalitv classiiication otNPC Licensed ISFS1 Drv Fuel Storage Commonentl and Transportation Paclaaes mav not he revised usina the CY Desicn Control process. T-hese modliflCations mutis lbc made hv the NRCp C'ertificate Holdler (NAC lntrnI.jtionial The Ce'rtificge_ M-oldcr is resporsitile for rlign an icensing,controls for these conn.ss undcr their NRC aoprrcived Oualitv Assurance Proerrmn. CY utilizes these tyPes ofcounpolnenis tlnder tIle trovisions of a NRC General License for Radioactive Material Transpotiation Packac!es (10ncFR 71 and Snpent Fuel Storatic 110 CFR 72).

,n adtdition to tl cse SSCs. ierls and service;% associa-edwith Radioactive Material Trattspor Packaees as described in 10(FR 71 . and Spent Fuel Storace aS described in ------

1 (0CFR 72 will also fall under the renuirmenenis ofthe CYOAP.

Iltnorui-nt-to-Safery SSCs associated with snent fuel storJge and radioactive matertal transpIt3tation packaues are defined below:

IMPORTANT-TO-SA:ETY AS DEFINED BY II CFR. 71 A.ND It) CFR 72 A. Storaneof Snent Fuel (0i CF1 72) . - - i Formatted: Bullets and Numbering

,- - - The ISFS Svstems. Structurcs and Component.: SSCs) that re. 'Important-to-Safetv" _ _ -

I Deleted: 03 1 and the associated dllality cateuotv in accordance wjith 10 CFR 72,Remulatory Guide 7.1I and NUF FGI -R-6407:

APPENDIX A 56 CYQAP I REV: 16, CR 05-02

SWC Oialihv Catenfyrv Tran-ortable Stauce CanilStcr and 1ucl A Basket Assembliv Vertieal (:nn~cr tc hwk: R Transfer Cask and Adanter Plate B Rccoilfw-ured Fuxe Assenibliv A ISFSI P'adi C Liffinu Yoke B Daniaetd Fuel Can A B. Transport of Snent Fuel and GTCC Waste ((1 CFR 71) - -- - { Formatted: Bullets and Numbering I The ISFSI SSC; that are "Important to Salftv' and the associated qualitv calegory in accordance wvith 10 CFR 71 and NIJRFEGC(R-6407 are as follows:

SSC O(ltitv Cateor-v Transporntablo S;torane (c3nisters A And Fuel 13askict Asscmblv Recorfiured FRel Assembly A Storaawz Transport Cask A Transportable Storaee Canister and Basket A Asscini.!v for GTCC Waste Containers Damaced Fuel C;n A C. Radioactive Material Transport Packatges (10 CFR 71) . - -

  • I Formatted: Bullets and Numbering )

Radioactive Material Transpo)rt Packavws subject to the nrovisions of It) CFR 71 Subpart C. (Gieneral Licenses< are "Important-to-Saretv" and subject to the applicable rctuircinonts nof CY(Talitv Aisurance Proerran.

.. - -iDeleted: 03 I APPENDIX A 57 CYQAP I REV': 06, CR 05-02

1. S ~N'C-\f PC Final Satieiv Analv-iis Report il->AR) and ai.swociated NAC Prezifceations ir additional classification.

Io. Sec N\r-AG(. Stora-c Trmirilo! (';ssk (fSTC)d;  ; .AnalvsisReport ;anlIssO C *dVC

- - Formatted: Bullets and Numbering sMecificiautions for additional detail.

3R. NIJRlB 'R-6:40 tatcs that tli iSFSI concrete nad is (7itlcnrvC for (N'APCO.

1 For the delinition SkQiualitv Cat A. 13. anti C. refer to NURI3G.'R-6'407.

Atirics

  • iDeleted: 03 APPENDIX A 58 CYQAP I REV: 06, CR 05-02

APPENDIX B CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM QUALIFICATION AND EXPERIENCE REQUIREMENTS This Appendix consolidates specific qualification and experience requirements for several key positions within the CYAPCO organization.

1.0 The Manager - Quality Assurance Personnel shall satisfy the following requirements:

Graduate of a four-year accredited engineering or science college or university, plus fifteen (15) or more years of industrial experience including five years in positions of leadership, such as lead engineer, project engineer, audit team leader, etc. At least two years of this experience should be associated with nuclear Quality Assurance Activities, and at least one year of this experience is in a Quality Assurance Organization. A master's degree in engineering or business management is considered equivalent to two years of experience.

NOTE The education and experience requirements should not be treated as absolute when similar training or an outstanding record will provide reasonable assurance that a person can perform the required tasks.

2.0 As stated in Appendix C, education and experience requirements for the Haddam Neck Plant personnel will use Regulatory Guide 1.8 - I-R - 5/77 - Personnel Selection and Training (which endorses ANSI N 18.1 - 1971) as general guidance for facility positions.

f Deleted: 03 I APPENDIX B 59 CYQAP I REV: 06, CR 05-02

APPENDIX C CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM REGULATORY AND STANDARD COMMITMENTS NOTE The CYQAP is committed to utilize the guidance obtained from the following regulatory documents and their endorsed standards. Exceptions to these positions are listed in Appendix E, herein.

10 CFR 50, Appendix B- Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.

10 CFR 50, Section 50.54, Condition of Licenses.

10 CFR 71, "Packaging and Transportation of Radioactive Material" 10 CFR 7 1, Subpart H - "Quality Assurance" 10 CFR 72, "Licensing Requirements for the independent Storage of Spent Nuclear Fuel, High Level Radioactive Waste, and Reactor-Related Greater than Class C Waste" 10 CFR 72, Subpart G- Quality Assurance Criteria for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Wastc3, and Greater Than Class C Waste Regulatory Guide 1.8 - l-R - 5/77 - Personnel Selection and Training - Endorses ANSI NI 8.1 -

1971.

Deleted Deleted Deleted Deleted Deleted Deleted Deleted Deleted

-1 Deleted: 03)

APPENDIX C 60 CYQAP l REV: 06, CR 05-02

Regulatory Guide 1.70 - "A Guide for the Organization and Content of Safety Analysis Reports" Revision 2, September, 1975 was utilized for CY, however, certain rcvised sections of the CY UFSAR are written to the Revision 3 format. No new analyses have been performed which would be required by Revision 3.

Deleted Deleted Deleted Deleted Deleted Deleted Deleted Reeultry Guide 7. 10 Rviion 2 (March, 2005). "Establishing OualitV Absurance Programs for PaclkaLinv1Used in the Trurisnortation of Radioacfive Mnaerial".

IiJ KIFG(;:(!'R-6407, "Classification of Transportation Packaging and Dry Fuel Storage System Components According to Importance to Safety" (February 1996)

{ Deleted: 03 l APPENDIX C 61 CY'QAP I REV: 06, CR 05-02

APPENDIX D CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM GLOSSARY OF QUALITY ASSURANCE TERMS Accept As Is - (also known as "Use-As-Is") A disposition which may be imposed for a nonconformance when it can be established that the discrepancy will result in no adverse conditions and that the item under consideration will continue to meet all engineering functional requirements including performance, maintainability, fit and safety.

Annuallv or Yearly- At least once per 366 days (as pertains to the performance of surveillances or tests).

Approved Vendors - Contractors, suppliers, and engineering service organizations who have been approved to provide quality related material, equipment, parts, and services, or computer software to the CY under their QA Program.

As Built Documents - Documents which accurately describe the condition actually achieved in a system, structure, or component. These documents include: material certification and test data; reports of inspections, examinations, and test results; drawing, specifications, procedures, and instructions; and records of nonconformance and their resolution.

Audit - A formal, documented activity performed in accordance with written checklists or procedures to verify by evaluation of objective evidence that a quality assurance program has been developed, documented, and implemented in accordance with applicable requirements.

Deleted Calibration - The process by which measuring and test equipment are checked against standards of known higher accuracy and adjusted as necessary to ensure their compliance with designated specifications.

Deleted Deleted Cleaning - Those actions performed to maintain an item in accordance with cleanness requirements.

Commercial Grade Item (CGI) - A commercial grade item per 10 CFR 21 is a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item Deleted-_03 cannot be verified). - - Deleted: 03 APPENDIX D 62 CYQAP REV: 06, CR 05-02

Commercial Grade Survev - Activities conducted by the purchaser to ascertain and verify that a supplier, or manufacturer of commercial grade items, controls the technical and quality characteristics determined to be critical for satisfactory performance of specifically designated commercial grade items, as a method to accept those items for safety-related use.

Condition Adverse to Quality - Failures, malfunctions, deficiencies, deviations, defective materials and equipment, and nonconformances.

Deleted Contractor - Any organization under contract for furnishing items or services. Itincludes the terms Vendor, Supplier, Subcontractor, Fabricator and subtier levels of these where appropriate. The Nuclear Steam Supply System (NSSS) Supplier is included in this category.

Corrective Action - Action taken to correct identified conditions adverse to quality.

Decommission - Means to remove (as a facility) safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use and termination of license. (10 CFR 50.2)

Deficiencies - Departures from specified requirements.

Department - The use of the word department, throughout the CYQAP, can refer to any portion of the CY organization or support organizations.

Desizn - Technical and management processes which lead to and include the issuance of design output documents such as drawings, specifications, and other documents defining technical requirements of systems, structures, and components.

Desien Chances - Changes in drawings and specifications that define the design of systems, structures, and components of nuclear plants.

Design Documents - The drawing, calculation, specification, or other document(s) that define the Technical requirements of systems, structures, or components.

Everv 9 months - At least once per 276 days.

Handling - An act of physically moving an item by hand or by mechanical machinery, but not including transport modes.

HNP - Haddam Neck Plant is used throughout this document to define the Connecticut Yankee plant site. Deleted: 03 APPENDIX D 63 CYQAP l REX': 06, CR 05-02

Identification - A means by which material, equipment and parts can be traced to their associated documentation through the use of heat numbers, lot numbers, part numbers, serial numbers, or other appropriate means.

lniportant-To-Safetv- Important-to-Safety systems, structures and components (SSCs) means those features of the ISFSI, Monitored Retrievable Storage (MRS) Installation and spent fuel casks (IOCFR71/72) whose functions are:

a. To maintain the conditions required to store spent fuel or high level radioactive waste safely.
b. To prevent damage to the spent fuel or the high-level radioactive waste container during handling and storage.
c. To provide reasonable assurance that spent fuel or high-level radioactive waste can be received, handled, packaged, stored, and retrieved without undue risk to the health and safety of the public.

Independent Safety Reviewer - An individual not having direct responsibility for the work function under review regardless of whether they operate as part of an organizational unit or as an individual staff member.

ISFSI - Independent Spent Fuel Storage Installation (ISFSI) means a complex designed and constructed for the interim storage of spent nuclear fuel, solid reactor-related GTCC waste, and other radioactive materials associated with spent fuel and reactor-related GTCC waste storage.

Item - Any level of unit assembly, including structures, systems, subsystems, subassembly, component, part or material.

Inspection - A phase of quality control which, by means of examination, observation, or measurement, determines the conformance of material, supplies, components, parts, appurtenances, systems, processes, structures, or services to predetermine quality requirements.

Inspection Status - Identification of material, equipment, and parts that have completed inspection, either acceptable or unacceptable.

Maintenance and Modifications - Refers to the required functions for design, construction, testing, maintenance, operation, and modification of facilities at the HNP during decommissioning activities.

Material Request - The format used for identifying Nuclear Grade or Important to Safety material and services to be procured.

Measuring and Test Equipment - Those instruments, gages, tools, fixtures, reference and transfer standards, nondestructive test equipment, and measuring devices used during inspection and testing t l APPENDIX D 64 CYQAP REV: 06, CR 05-02

to determine that the measuring and test parameters comply with appropriate requirements in specifications and drawings.

Monthl] - At least once per 31 days.

NAC MPC Certificate of Compliance - A certificate issued by the NRC pursuant to 10 CFR Part 72 that constitutes the USNRC approval of the NAC Multi Purpose Canister Storage system for the storage of spent nuclear fuel. The Certificate of Compliance includes the Technical Specifications and the approved contents and design features for the NAC MPC system. The NAC MPC system is described in the NAC MPC Final Safety Analysis Report (NAC MPC FSAR), which is a supporting licensing document for the NAC MPC Certificate of Compliance.

NAC STC Certificate of Compliance -A certificate issued by the NRC pursuant to 10 CFR Part 71 that constitutes the USNRC approval of the NAC Storage Transport Cask for the transport of spent nuclear fuel. The Certificate of Compliance includes the construction/assembly requirements, approved contents and description of design features for the NAC STC. The NAC STC is described in the NAC STC Final Safety Analysis Report (NAC STC FSAR), which is a supporting licensing document for the NAC STC Certificate of Compliance.

Nonconformance - A deficiency in characteristic documentation or procedure which renders the quality of an item unacceptable or indeterminate.

Deleted Nuclear Records - The organization responsible for maintaining CY records.

Deleted Approved Suppliers List - A list identifying the approval status of the quality assurance programs of vendors; commonly referred to as the Approved Vendors List Obiective Evidence - Any statement of fact, information, or record, either quantitative or qualitative, pertaining to the quality of an item or service based on observation, measurements, or tests which can be verified.

Preservation - Those actions performed to maintain an item in its original and usable condition.

Procedures and Instructions - Documents that specify how an activity is to be performed. They may include methods to be employed; material, equipment, or parts to be used; and a sequence of operations.

Procurement Docunients - Purchase requisitions/material requests, purchase orders, contracts, drawings, specifications or instructions used to define requirements for purchase. Deleted: 03 APPENDIX D 65 CYQAP l REV: 06, CR 05-02

Product Acceptance Test - Activities conducted as part of the receiving or source inspection process to verify acceptability of one or more critical characteristics of the item being inspected.

Deleted Deleted Purchase Order/Contract - The document which provides the contractual basis for vendor material and services provided in accordance with CYQAP requirements.

Purchased Service - Services provided by a vendor or consultant on a QA requisition when activities are performed under a quality assurance program other than the CYQAP.

Qualitv Assurance Records - Any record pertaining to the quality of material, equipment, parts, processes, or operations relating to systems, structures and components which are founded on observations, measurements, or tests which can be fully checked or verified. Such statements may be recorded on a written or preprinted document or tag. The statements arc authorized with a signature or stamp identifiable to the person making the statement of fact.

Qualitv Activities - Activities governed by this CYQAP are those that affect Important to Safety functions of structures, systems, and components; these activities include designing, analyzing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, and modifying. Quality Activities also include activities associated with computer softwvare used in implementing the CYQAP and Augmented Quality items as defined herein.

Quality Procedures - Quality Assurance procedures and other department procedures which implement the requirements of the CYQAP.

Ouarterly - At least once per 92 days.

Repair - A disposition applied to nonconforming material, equipment, and parts that are unsuitable for their intended purpose which are modified by the use of additional operations and/or processes so that they are suitable for their intended purpose but may not meet all specified requirements.

Retest - A test conducted prior to operation following installation inspections of work associated with maintenance and refueling to verify that systems, structures, and components will function satisfactorily when in operation. A retest may also be performed when original test results are invalidated.

Return to Vendor - A disposition applied to nonconforming material, equipment, and parts that are unsuitable for their intended purpose but which are feasible to repair or rework at a vendor's facility.

. Deleted: 03 APPENDIX D 66 CYQAP REV: 06, CR 05-02

Semiannuallv or every 6 months - At least once per 184 days.

Deleted Special Processes - Processes for which the desired level of quality can only be assured through the use of additional process controls, and where control through direct inspection alone is inadequate, impossible, or disadvantageous. These processes are performed under controlled conditions in accordance with special requirements utilizing qualified procedures, equipment, and personnel. These special processes may include, but are not limited to welding, brazing, soldering, cleaning, heat treating, and nondestructive testing.

Storze- The act of holding items at the HNP or in an area other than its permanent location in the plant or ISFSI.

Surveillance- A documented record of the observation of work operations performed at CY or a vendor's site to assure compliance with applicable codes, standards, specifications, procedures, drawings, and procurement documents. Surveillances are not performed to a preplanned checklist.

Test and Operating Status - Identification of material, equipment, and parts that are ready for test or operation, or an existing stage of a test operation.

Testina - The determination or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.

Vendor - Organizations that provide material, equipment, parts, and services, or computer software.

Weckly- At least once per 7 days

. Deleted: 03 APPENDIX D 67 CYQAP REV: 06, CR 05-02

APPENDIX E CONNECTICUT YANKEE QUALITY ASSURANCE PROGRAM ADMINISTRATIVE CONTROLS 1.0 REVIEW AND AUDIT 1.1 INDEPENDENT SAFETY REVIEW An Independent Safety Review shall be a thorough review conducted by one or more qualified Independent Safety Reviewers. Persons performing these reviews shall be knowledgeable in the subject area being reviewed. Independent Safety Reviews must be completed prior to implementation of proposed activities.

a. Independent Safety Reviewers shall be individuals without direct responsibility for the performance of these activities under review. These reviews may be from the same functionally cognizant organization as the individual or group performing the original work.
b. Independent Safety Reviewers shall have at least 5 years ofprofessional experience and either a Bachelor's Degree in Engineering or the Physical Sciences or shall have equivalent qualifications in accordance with ANSI 18.1-1971. The Unit/ISFSI Manager (or designee) shall document the appointment of Independent Safety Reviewers.
c. The following subjects shall be independently reviewed by a qualified Independent Safety Reviewer:
1. Evaluations for changes in the facility or ISFSI as described in the Updated Final Safety Analysis Report (UFSAR) or NAC-MPC FSAR. Changes in procedures as described in the UFSAR or NAC-MPC FSAR, and tests or equipment not described in the UFSAR or NAC-MPC FSAR to verify that such actions do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in 10CFR50.59 or IOCFR72.48, and
2. Proposed changes to the programs required by the CYQAP in Section 4.0 of this Appendix to verify that such changes do not involve a change to the Technical Specifications or will not require prior NRC approval as defined in I OCFR50.59 or IOCFR72.48.

APPENDIX E 68 CYQAP REV: 06

1.2 INDEPENDENT REVIEW AND AUDIT COMMITTEE (IRAC)

The IRAC is responsible for reviewing, auditing, and advising the President (or a designee) on matters related to the safe storage of irradiated fuel. This review and audit function is independent of line organization responsibilities.

a. The IRAC shall include a minimum of five members. Alternates may be substituted for regular members. The licensee shall designate in writing the chairman, the members, and alternates for the IRAC. The Chairman shall not have management responsibilities for, or report to, the lines organizations responsible for operation or maintenance of the fuel storage facility.
b. The IRAC shall collectively have experience and knowledge in the following functional areas:

I. fuel handling and storage (including the potential for criticality),

2. chemistry and radiochemistry,
3. engineering,
4. radiation protection, and
5. quality assurance.

If necessary, individuals with knowledge and experience in other functional areas may be utilized to provide advice to the IRAC.

c. As a minimum, the IRAC shall hold at least one meeting per quarter.
d. A quorum shall consist of three regular members or their duly appointed alternates.

Those members representing the line organizations responsible for the operation and maintenance of the facility or ISFSI shall not constitute a majority of the quorum. At least one member of the quorum shall be the Chairman or the Chairman's designated alternate.

e. As a minimum, the IRAC shall perform the following functions:
1. Advise the President (or a designee) on all matters related to safe storage of irradiated fuel.
2. Advise the management of the audited organization and the President (or a designee) of audit results as they relate to safe storage of irradiated fuel.
3. Recommend to management of the audited organization, and its management, any corrective action to improve the safe storage of irradiated fuel. Deleted: 03 APPENDIX E 69 CYQAP l REV: 06, CR 05-02
4. Notify the President (or a' designee) of any safety significant disagreement betwveen the IRAC and Site Management within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
f. The IRAC shall be responsible for reviewing:
1. The evaluations for procedures, and changes thereto, completed under the provisions of 10 CFR 50.59 or 10 CFR 72.48 to verify that such actions do not require prior NRC approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This review maybe completed after implementation of the affected procedure;
2. Changes to structures, systems or components important to safe storage of irradiated fuel to verify that such changes do not require prior NRC approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This review may be completed after implementation of the change;
3. Test or experiments involving the safe storage of irradiated fuiel to verify that such tests or experiments do not require prior NRC approval or a license amendment as defined in 10 CFR 50.59 or 10 CFR 72.48. This reviewv may be completed after performance of the test or experiment;
4. Proposed changes to the Haddam Neck Technical Specifications or the license;
5. Violations of codes, regulations, orders, license requirements, or internal procedures/instructions having nuclear safety significance;
6. Indications of unanticipated deficiencies in any aspect of design or operation of structures, systems, or components that could affect safe storage of irradiated fuel;
7. Significant accidental, unplanned, or uncontrolled radioactive releases.

Including corrective action(s) to prevent recurrence;

8. Significant operating abnormalities or deviations from normal'and expected performance of equipment that affect safe storage of irradiated fuel;
9. The performance of the corrective action system; and
10. Internal and external experience information related to the safe storage of irradiated fuel that may indicate areas for improving facility safety.

Reports or records of these reviews shall be forwarded to the President within 30 days after completion of the reviewv.Detd:3 APPENDIX E 70 CYQAP IREV: 06, CR 05-02

g. The IRAC's responsibility shall include an Audit Program. IRAC audits shall be performed at least once per 24 months in accordance with appropriate administrative procedures and shall encompass:
1. The conformance of unit and ISFSI operation to provisions contained within the Technical Specifications and applicable license conditions;
2. The training and qualifications of the staff;
3. The implementation of programs required by CYQAP Appendix E Sections 4 and 5;
4. Actions taken to correct deficiencies occunring in equipment, structures, systems, components, or method of operation that affect nuclear safety; and
5. Other activities and documents as requested by the President.
h. Written records or reviews and audits shall be maintained. As a minimum, these records shall include:
1. Results of the activities conducted under the provisions of CYQAP Appendix E Sections 4 and 5;
2. Recommendations to the management of the audited organization;
3. An assessment of the safety significance of review or audit findings
4. Documentation of reviews conducted under CYQAP Appendix E Sections 4 and S; and
5. Determination of whether each item considered under CYQAP Appendix E Sections 4 and 5 require prior NRC approval as defined in 10 CFR 50.59 and 10 CFR 72.48.

RECORDS Written records of reviews and audits shall be maintained. As a minimum, these records shall include results of the activities conducted under the provisions of Section 1.2.

2.0 RECORD RETENTIONDetd:0 APPENDIX E 71 CYQAP IREV: 06, CR 05-02

2.1 In addition to the applicable record retention requirements of Title 10, Code of Federal Regulations, the following records shall be retained for at least the minimum period indicated.

2.2 The following records shall be retained for at least 5 years:

a. Records and logs of facility and ISFSI operations;
b. Records and logs of principal maintenance activities, inspections, repair, and replacement of principal items of equipment related to nuclear safety;
c. ALL REPORTABLE EVENTS;
d. Records of surveillance activities, inspections, and calibrations required by Section 4;
e. Records of surveillance activities, inspections, and calibrations required by the NAC MPC Certificate of Compliance or the NAC STC Certificate of Compliance;
f. Records of test and experiments;
g. Records of changes made to the procedures required by Section 4 of this Appendix or by the NAC MPC Certificate of Compliance or the NAC STC Certificate of Compliance;
h. Records of radioactive shipments;
i. Records of sealed source and fission detector leak tests and results;
j. Records of annual physical inventory of all sealed source material of record; and 2.3 The following records shall be retained for the duration of the facility Operating License:
a. Record and drawing changes reflecting facility design modifications made to systems and equipment described in the FSAR;
b. Records of new and irradiated fuel inventory, fuel transfers, and assembly burnup histories;
c. Records of facility radiation and contamination surveys; -_Deleted

. 03 j APPENDIX E 72 CYQAP l REV: 06, CR 05-02

d. Records of radiation exposure for all individuals entering radiation control areas;
e. Records of gaseous and liquid radioactive material released to the environs;
f. Records of transient or operational cycles of the reactor vessel;
g. Records of training and qualification for current members of the facility staff;
h. Records of inservice inspections performed under previous amendments to the HNP Technical Specifications;
i. Records of quality assurance activities required by the Quality Assurance Manual not listed in paragraph 2.2;
j. Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments pursuant to 10 CFR 50.59 or 10 CFR 72.48;
k. Records of Independent Safety Reviews (ISR) and IRAC meetings;
1. Records for Environmental Qualification;
m. Records of reviews performed for changes to the Radiological Effluent Monitoring and Offsite Dose Calculation Manual (REMODCM) and the Process Control Program;
n. Records required by 10 CFR Part 72, Subpart D.

3.0 Facility Staff Qualifications 3.1 Each member of the facility staff shall have sufficient qualifications to perform their assigned duties. Regulatory Guide 1.8 - I-R - 5/77 will be used as guidance for assessing qualifications.

3.2 The position of Radiation Protection Manager shall meet the following minimum qualifications:

a. Academic degree in an engineering or science field or equivalent as per paragraph c, below. ( Deleted: 03 APPENDIX E 73 CYQAP l REV: 06, CR 05-02
b. Minimum of five years professional technical experience in the area of radiological safety, three years of which shall be in applied radiation work in a nuclear facility dealing with problems similar to those encountered in a nuclear power reactor.
c. Technical experience in the area of radiological safety beyond the five year minimum may be substituted on a one-for-one basis towards the academic degree requirement (four years of technical experience being equivalent to a four year academic degree).
d. Academic and technical experience must total a minimum of nine years.

4.0 Procedures and Proarams 4.1 Written procedures shall be established, implemented, and maintained covering the activities referenced below:

a. The procedures applicable to the safe storage of spent fuel.
b. All programs specified in Section 5 of this Appendix.
c. Fire Protection Program implementation.
d. Quality controls for effluent monitoring.
e. The use or operation of Radwaste Treatment Systems utilizing the guidance provided in the REMODCM.

4.2 Each procedure of Section 4.1 and programs of Section 5, and changes thereto, shall be independently reviewed in accordance with administrative procedures and approved by the designated manager or designee prior to implementation.

4.3 Temporary changes to procedures of Section 4.1 may be made provided:

a. The intent of the existing procedure is not altered;
b. The change is approved by 2 members of the plant management staff; and
c. The change is documented, reviewed and approved by the designated manager or designee within 14 days of implementation.

5.0 Proerams and Manuals

'5.1 - - -Radiation Protection Proeram- - ----- Deleted: 03 APPENDIX E 74 CYQAP REV: 06, CR 05-02

A program for personnel radiation protection shall be prepared consistent with the requirement of 10 CFR 20 and shall be approved, maintained, and adhered to for all operations involving personnel radiation exposure.

5.2 Process Control Proeram (PCP)

The PCP shall contain the current formulas, sampling, analyses, tests, and determinations to be made to ensure that processing and packaging of solid radioactive wastes will be accomplished to ensure compliance with 10 CFR Parts 20, 61, and 71; state regulations; burial ground requirements; and other requirements governing the disposal of solid radioactive waste.

Changes to the PCP:

a) Shall be documented and records of reviews shall be retained. This documentation shall contain:

1. sufficient information to support each change, together with the appropriate analyses or evaluations to justify the change; and
2. a determination that each change maintains the overall conformance of the solidified waste product to existing requirements of Federal, State, or other applicable regulations; and b) Shall become effective after the change is independently reviewed in accordance with administrative procedures and approved by the designated manager or designee.

5.3 Radiolocical Effluent Monitorine and Offsite Dose Calculation Manual (REMODCM)

The REMODCM shall contain the methodology and parameters used in the calculation of offsite doses resulting from radioactive gaseous and liquid effluents, in the calculation of gaseous and liquid effluent monitoring alarm and trip setpoints, and in the conduct of the Radiological Environmental Monitoring Program.

The REMODCM shall also contain the Radioactive Effluent Controls and Radiological Environmental Monitoring Program required by Sections 5.4 and 5.5, respectively, and descriptions of the information that should be included in the Annual Radiological Environmental Operating and Radioactive Effluent Release Reports required under Sections 5.6.1 and 5.6.2. Deleted: 03 APPENDIX E 75 CYQAP l REV: (16, CR 05-02

Changes to the REMODCM:

a) Shall be documented and records of review shall be retained. This documentation shall contain:

1. sufficient information to support each change, together with the appropriate analyses or evaluations to justify the change; and
2. a determination that each change maintains the levels of radioactive effluent control required by 10 CFR 20.1302,40 CFR Part 190, 10 CFR 50.36a, and 10 CFR 50, Appendix I and that the change will not adversely impact the accuracy or reliability of effluent, dose, or setpoint calculations; b) Shall become effective after the change is independently reviewed in accordance with administrative procedures and approved by the designated manager or designee.

c) Shall be submitted to the NRC in the form of a complete legible copy of the entire REMODCM as a part of or concurrent with the Radioactive Effluent Release Report for the period of the report in which any change was made to the REMODCM. A summary of each change shall be included.

Each change shall be identified by markings in the margin of the affected pages, clearly indicating the area of the page that was changed, and shall indicate the date (i.e., month and year) the change was implemented.

5.4 Radioactive Effluent Controls Proaram This program conforms to 10 CFR 50.3 6a for the control of radioactive effluents and for maintaining the doses to MEMBERS OF THE PUBLIC from radioactive effluents as low as reasonably achievable. The program shall be contained in the REMODCM, shall be implemented by procedures, and shall include remedial actions to be taken whenever the program limits are exceeded. The program shall include the following elements:

a) Limitations on the functional capability of radioactive liquid and gaseous monitoring instrumentation, including surveillance tests and setpoint determinations, in accordance with the methodology described in the REMODCM; b) Limitations on the concentrations of radioactive material released in liquid effluents to unrestricted areas, conforming to the pre-1994 concentration values in 10 CFR Part 20, Appendix B (to 20.1 to 20.602), Table II, Column 2;

- IDeleted: 03 APPENDIX E 76 CYQAP IREV: 06, CR 05-02

c) Monitoring, sampling and analysis of radioactive liquid and gaseous effluents in accordance with 10 CFR 20.1302 and with the methodology and parameters described in the REMODCM.

d) Limitations on the annual and quarterly doses or dose commitment to a MEMBER OF THE PUBLIC from radioactive materials in liquid effluents released from the facility to unrestricted areas, conforming to 10 CFR Part 50, Appendix I; e) Determination of cumulative dose contributions from radioactive effluents for the current calendar quarter and current calendar year in accordance with the methodology and parameters described in the REMODCM performed at least every 92 days. A determination of projected dose contributions from radioactive effluents in accordance with the methodology in the REMODCM performed at least very 92 days; f) Limitations on the functional capability and use of the liquid and gaseous effluent treatment systems to ensure that appropriate portions of these systems are used to reduce releases of radioactivity when the projected doses in a period of 31 days would exceed 2% of the guidelines for the annual dose or dose commitment, conforming to 10 CFR Part 50 Appendix I; g) Limitations on the dose rate resulting from radioactive material released in gaseous effluents from the site to areas at or beyond the SITE BOUNDARY shall be as follows:

1. for noble gases: < a dose rate of 500 mrem/yr to the total body and

< a dose of 3000 mremlyr to the skin; and

2. for tritium and all radionuclides in particulate form with half-lives >

8 days: < to a dose rate of 1500 mrem/yr to any organ; h) Limitations on the annual and quarterly air doses from noble gases released in gaseous effluents from the unit to areas beyond the SITE BOUNDARY, conforming to 10 CR Part 50, Appendix I; i) Limitations on the annual and quarterly doses to a MEMBER OF THE PUBLIC from tritium and all radionuclides in particulate form with half-lives

> 8 days in gaseous effluents released from each facility to areas beyond the SITE BOUNDARY, conforming to 10 CFR Part 50, Appendix I;and j) Limitations on the annual dose or dose commitment to any MEMBER OF THE PUBLIC at points beyond the SITE BOUNDARY due to releases of D e

' . radioactivity and to radiation from uranium fuel cycle sources, conforming to-l-l APPENDIX E 77 CYQAP l REV: 06, CR 05-02

40 CFR Part 190.

5.5 Radiological Environmental Monitoring Program This program monitors the radiation and radionuclides in the environs of the facility. The program shall provide representative measurements of radioactive materials in the highest potential exposure pathways, verification of the accuracy of the effluent monitoring program, and modeling of environmental exposure pathways. The program shall be contained in the REMODCM and shall include the following:

a) Monitoring, sampling, analysis, and reporting of radiation and radionuclides in the environment in accordance with the methodology and parameters described in the REMODCM: and b) Participation in an Interlaboratory Comparison Program to ensure that independent checks on the precision and accuracy of the measurements of radioactive materials in environmental monitoring.

5.6 Reporting Requirements 5.6.1 Annual Radioloeical Environmental Operating Report The Annual Radiological Environmental Operating Report covering the activities of the facility during the previous calendar year shall be submitted prior to May I of each year. The Report shall include summaries, interpretations, and analyses of the trends of the results of the Radiological Environmental Monitoring Program for the reporting period. The material provided shall be consistent with the objectives outlined in the Radiological Effluent Monitoring and Offsite Dose calculation Manual (REMODCM).

The Annual Radiological Environmental Operating Report shall include the results of analyses of all radiological environmental samples and of all environmental radiation measurements taken during the period pursuant to the locations specified in the tables and figures in the REMODCM, as well as summarized and tabulated results of these analyses and measurements. In the event that some individual results are not available for inclusion with the report, the submitted report shall note and explain the reasons for the missing results.

The missing data shall be submitted in a supplementary report.

5.6.2 Annual Radioactive Effluent Release Report The Radioactive Effluent Release Report covering the operation of the facility shall be submitted in accordance with 10 CFR 50.36a. The Report shall include a _ 03

__Deleted:

-summary of the quantities of radioactive liquid and gaseous effluents and solid APPENDIX E 78 CYQAP l REV: 06, CR 05-02

waste released from the facility. The material provided shall be consistent with the objectives outlined in the REMODCM and Process Control Program.

The Radioactive Effluent Release Report covering the activities during the previous calendar year shall be submitted by May I of each year.

The Annual Radioactive Effluent Release Report shall include licensee-initiated changes to the REMODCM during the period of the report as described in Section 5.4.

5.7 Hieh Radiation Area 5.7.1 High Radiation Areas x ith Dose Rates Not Exceedine 1.0 rem/hour at 30 Centimeters from the Radiation Source or from anv Surface Penetrated by the Radiation a) Each entryway to such an area shall be barricaded and conspicuously posted as a high radiation area. Such barricades may be opened as necessary to permit entry or exit of personnel or equipment.

b) Access to, and activities in, each such area shall be controlled by means of Radiation Work Permit (RWP) or equivalent that includes specification of radiation dose rates in the immediate work area(s) and other appropriate radiation protection equipment and measures.

c) Individuals qualified in radiation protection procedures and personnel continuously escorted by such individuals may be exempted from the requirement for an RWP or equivalent while performing their assigned duties provided that they are otherwise following plant radiation protection procedures for entry to, exit from, and work in such areas.

d) Each individual or group entering such an area shall possess:

1. A radiation monitoring device that continuously displays radiation dose rates in the area; or
2. A radiation monitoring device that continuously integrates the radiation dose rates in the area and alarms when the device's dose alarm setpoint is reached, with an appropriate alarm setpoint, or
3. A radiation monitoring device that continuously transmits dose rate and cumulative dose information to a remote receiver monitored by radiation

..... protection personnel responsible for.controlling personnel radiation I Deleted 03 APPENDIX E 79 CYQAP l REV: 06, CR 05-02

exposure within the area, or

4. A self-reading dosimeter (e.g., pocket ionization chamber or electronic dosimeter) and, (i) Be under the surveillance, as specified in the RWP or equivalent, while in the area, of an individual qualified in radiation protection procedures, equipped with a radiation monitoring device that continuously displays radiation dose rates in the area; who is responsible for controlling personnel exposure within the area, or (ii) Be under the surveillance as specified in the RWVP or equivalent, while in the area, by means of closed circuit television, of personnel qualified in radiation protection procedures, responsible for controlling personnel radiation exposure in the area, and with the means to communicate with individuals in the area who are covered by such surveillance.
e. Except for individuals qualified in radiation protection procedures, or personnel continuously escorted by such individuals, entry into such areas shall be made only after dose rates in the area have been determined and entry personnel are knowledgeable of them. These continuously escorted personnel will receive a pre-job briefing prior to entry into such areas. This dose rate determination, knowledge, and pre-job briefing does not require documentation prior to initial entry.

5.7.2 High Radiation Areas with Dose Rates Greater than 1.0 rem/hour at 30 Centimeters from the Radiation source or from any Surface Penetrated by the Radiation, but less than 500 rads/hour at 1 Meter from the Radiation Source or from any Surface Penetrated by the Radiation

a. Each entryway to such an area shall be conspicuously posted as a high radiation area and shall be provided with a locked or continuously guarded door or gate that prevents unauthorized entry, and, in addition:
1. All such door and gate keys shall be maintained under the administrative control of the shift supervisor, radiation protection manager, or his or her designee.
2. Doors and gates shall remain locked except during periods of personnel or equipment entry or exit.
b. Access to, and activities in, each such area shall be controlled by means of an

. RWP or equivalent that includes specification of radiation dose rates in the Deleted: 03 APPENDIX E 80 CYQAP l REV: 06, CR 05-02

immediate work area(s) and other appropriate radiation protection equipment and measures.

c. Individuals qualified in radiation protection procedures may be exempted from the requirement for an RWP or equivalent while performing radiation surveys in such areas provided that they are otherwise following plant radiation protection procedures for entry to, exit from, and work in such areas.
d. Each individual or group entering such an area shall possess:
1. A radiation monitoring device that continuously integrates the radiation rates in the area and alarms when the device's dose alarm setpoint is reached, with an appropriate alarm setpoint or
2. A radiation monitoring device that continuously transmits dose rate and cumulative dose information to a remote receiver monitored by radiation protection personnel responsible for controlling personnel radiation exposure within the area with the means to communicate with and control every individual in the area, or
3. A self-reading dosimeter (e.g., pocket ionization chamber or electronic dosimeter) and, (i) Be under the surveillance, as specified in the RWP or equivalent, while in the area, of an individual qualified in radiation protection procedures, equipped with a radiation monitoring device that continuously displays radiation dose rates in the area; who is responsible for controlling personnel exposure within the area, or (ii) Be under the surveillance as specified in the RWP or equivalent, while in the area, by means of closed circuit television, of personnel qualified in radiation protection procedures, responsible for controlling personnel radiation exposure in the area, and with the means to communicate with and control every individual in the area.
4. In those cases where options (2) and (3), above, are impractical or determined to be inconsistent with the "As Low As is Reasonably Achievable" principle, a radiation monitoring device that continuously displays radiation dose rates in the area.

e) Except for individuals qualified in radiation protection procedures, or personnel continuously escorted by such individuals, entry into such areas shall be made only after dose rates in the area have been determined and entry Deleted: 03

- - personnel are knowledgeable of them.- These continuously escorted personnel - De:

APPENDIX E 81 CYQAP l REV: 06, CR 05-02

will receive a pre-job briefing prior to entry into such areas. This dose rate determination, knowledge, and pre-job briefing does not require documentation prior to initial entry.

f) Such individual areas that are within a larger area where no enclosure exists for the purpose of locking and where no enclosure can reasonably be constructed around the individual area need not be controlled by a locked door or gate, nor continuously guarded, but shall be barricaded, conspicuously posted, and a clear visible flashing light, shall be activated at the areas as a warning device.

NOTE The FREQUENCY specified for the performance of inspection and testing requirements shall correspond to the intervals defined in Appendix D. Each of the inspections and/or tests shall be performed within the specified FREQUENCY with a maximum allowable extension not to exceed 25% of the specified FREQUENCY.

5.8 Sealed Source Contamination 5.8.1 Limitine Condition for Operation Each sealed source containing radioactive material either in excess of 100 micro Curies of beta and/or gamma emitting material or 5 microCuries of alpha emitting material shall be free of greater than or equal to 0.005 microCurie of removable contamination.

Applicability At all times.

Action Each sealed source with removable contamination in excess of the above limits shall be immediately withdmrwn from use and either:

1. Decontaminate and repair the sealed source, or
2. Dispose of the sealed source in accordance with Commission Regulations.

{ Deleted: 03 I APPENDIX E 82 CYQAP I REV: 06, CR 05-02

5.8.2 Inspection and Testing Requirements

1. Test Requirements - Each sealed source shall be tested for leakage and/or contamination by:
a. The licensee, or
b. Other persons specially authorized by the Commission or an Agreement State.
2. Test frequencies - Each category of sealed sources (excluding startup sources and fission detectors previously subjected to core flux) shall be tested at the frequency described below.
a. Sources in use - At least once per 6 months for all sealed sources containing radioactive materials:
1) With a half-life greater than 4\30 days (excluding Hydrogen 3), and
2) In any form other than gas.
b. Stored sources not in use - Each sealed source and fission detector shall be tested prior to use or transfer to another licensee unless tested within the previous 6 months. Scaled sources and fission detectors transferred without a certificate indicating the last test date shall be tested prior to being placed into use; and
c. Startup sources and fission detectors - Each sealed startup source and fission detector shall be tested following repair of maintenance to the source.
3. Reports - A report shall be prepared and submitted to the Commission on an annual basis if sealed source or fission detector leakage tests reveal the presence of greater than 0.005 microCurie of removable contamination.

5.8.3 Bases The limitations on removable contamination for sources requiring leak testing, including alpha emitters, is based on 10 CFR 70.39(a)(3) limits for plutonium.

This limitation will ensure that leakage from Byproduct, Source, and Special Nuclear Material sources will not exceed allowable intake values.

I Deleted: 03 APPENDIX E 83 CYQAP REV: 06, CR 05-02

Sealed sources are classified into three groups according to their use, with Surveillance Requirements commensurate with the probability of damage to a source in that group. Those sources which are frequently handled are required to be tested more often than those which are not. Sealed sources which are continuously enclosed within a shielded mechanism (i.e., sealed sources within radiation monitoring or boron measuring devices) are considered to be stored and need not be tested unless they are removed from the shielded mechanism.

l Deleted: 03 I APPENDIX E 84 CYQAP I REV: 06, CR 05-02

APPENDIX F POSITION CROSS REFERENCE I QAP Appendix E Section I QAP Identified Position I Station Organization Position I Facility Qualifications 3.2 I Health Physics Manager I Radiation Protection Manager Procedures and Programs 4.2 l Designated Manager I Unit/ ISFSI Manager 4.3 I Designated Manager I Unit / ISFSI Manager l Programs and Manualss 1 5.2 I Designated Manager I Unit / ISFSI Manager I REMODCNI 1 5.3 I Designated Manager I Unit/ ISFSI Manager

.. t Deleted: 03 APPENDIX F 85 CYQAP I REV: 06, CR 05-02

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