ML20196G554

Declaration of Jg Thorgersen.* Supports Motion of Summary Disposition of Utah G.With Certificate of Svc

ML20196G554
Person / Time
Site:	07200022
Issue date:	06/28/1999
From:	Thorgersen J AFFILIATION NOT ASSIGNED, WISCONSIN ELECTRIC POWER CO.
To:
Shared Package
ML20196G530	List: ML20196G528 ML20196G554
References
ISFSI, NUDOCS 9907010197
Download: ML20196G554 (101)

Text

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UNITED STATES OF AMERICA '

NUCLEAR REGULATORY COMMISSION Before the Atomic Safety and Licensing Board In the Matter of

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PRIVATE FUEL STORAGE L.L.C.

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Docket No. 72-22

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(Private Fuel Storage Facility)

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DECL.ARATION OF JOHN G. THORGERSEN John G. Thorgersen states as follows under penalties of perjury:

1.

I am currently employed by Wisconsin Electric Power Company

("WEPCo"). Prior to April 1999 (when I began training, to become an Operating Super-visor), I served as the Manager-Quality Verification at the Point Beach Nuclear Plant (PBNP). In this position, I was responsible for the oversight of PBNP's Quality Assur-ance (QA) activities. My responsibilities included coordinating QA oversight activities for the construction of WEPCo's independent spent fuel storage installation (ISFSI), off-site fabrication of storage casks for the ISFSI, and onsite loading of dry fuel storage con-tainers for storage at the ISFSI. I also served as the Chairman of the QA Committee for Private Fuel Storage, L.L.C. (PFS)(and its predecessor, Mescalero Fuel Storage, L.L.C.)

from its formation in 1996 through the Spring of 1997. I am providing this declaration in support of a motion for summary disposition of Contention Utah G in the above cap-tioned proceeding to show that PFS's QA program for the Private Fuel Storage Facility (PFSF) satisfies the requirements of Subpart G of 10 C.F.R. Part 72.

2.

My professional and educational experience is summarized in the cur-riculum vitae attached as Exhibit I to this declaration. By virtue of being Manager-Quality Verification at PBNP and my previous positions as Senior Project Engineer for 9907010197 990628 PDR ADOCK 07200022 C

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Quality Assurance at PBNB and Quality Assurance Auditing Supervisor at the Kewaunee l

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Nuclear Power Plant, I am knowledgeable of the NRC requirements for QA plans, in-cluding 10 C.F.R. 50 Appendix B and 10 C.F.R. Part 72, Subpart G, as well as applicable industry QA standards.

I 3.

As the Chairman of the PFS QA Committee through the Spring of 1997, I am knowledgeable of PFS's QA Program and the QA procedure; that implement the pro-gram. By letter dated November 3,1995 (attached as Exhibit 2 to this declaration), the NRC approved a Quality Assurance Program Description (QAPD) that had been submit-ted by PFS's predecessor, the Mescalero Fuel Storage, L.L.C.; the NRC concluded that the QAPD satisfied the requirements of 10 C.F.R. Part 71, Subpart H and indicated that it could also be used to satisfy the requirements of 10 C.F.R. Part 72, Subpart G, since the requirements are substantively the same. In August 1996, PFS submitted to the NRC a revised version of the Mescalero QAPD which the NRC approved by letter dated Sep-tember 16,1996 as meeting the requirements of 10 C.F.R. Part 71, Subpart H. The August 1996 QAPD is attached as Exhibit 3 to this declaration and the NRC's September 16,1996 approval is attached as Exhibit 4. The current version of the PFS QAPD, dated May 1999, is attached as Exhibit 5 to this declaration. It contains only minor revisions from the August 1996 QAPD, primarily concerning organizational changes, none of which reduce any commitments made in the August 1996 QAPD. Exhibits 6,7, and 8 to this declaration are updated SAR Figures 9.1-1,9.1.-2, and 9.1-3 (which will be filed as part of the next PFS License Amendment) showing the PFS organization for the three phases of the project - pre-licensing, construction and operation.

4.

In the bases for Contention G, as admitted by the Licensing Board, the State alleges that PFS's QA Program is inadequate to satisfy the requirements of 10 C.F.R. Part 72, Subpart G, in that 1) the PFS QA Program Description (QAPD) lacks suf-ficient detail (basis 1), and 2) the QA organization lacks adequate independence (basis 4).

I have reviewed these claims and believe that they have no merit.

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s-5.

The State's claim that the QAPD lacks sufficient detail reflects a funda-

. mental misunderstanding of the purpose of a QAPD in the context of an overall QA pro-L gram. Section 72.24(n) of 10 C.F.R. Part 72, which is the provision of the NRC regula-tions that covers what must be filed as part of a license application, requires that "[a] de-scription of the quality assurance program that satisfies the requirements of subpart G" be included as part of any ISFSI license application. Subpart G of Part 72, specifically 10 C.F.R. G 72.140(c), describes what an applicant must submit regarding its QA program:

"Each [ applicant] shall file a description ofits quality assurance program, including a discussion of which requirements of[Subpart G] are applicable and how they will be sat-isfied...." Thus, NRC regulations do not require an applicant to provide as part of a license application the detailed means or procedures by which a QA program is to be l

implemented, which appears to be the basis of the State's claim.

i 6.

In accordance with well established NRC requirements, the PFS QA pro-gram consists of a hierarchy of documents extending down from 10 C.F.R. Part 72 Sub-part G to the PFS QAPD and its various implementing procedures. Each layer in the hi-

. erarchy is intended to provide more detail as to the requirements to be followed. Subpart O establishes the basic requirements for a QA program. The PFS QAPD provides more specific details as to how the PFS intends to satisfy these requirements, while the proce-dures provide the detailed methodology for implementing these requirements.

7.

The level of detail required for the QA program description in a Part 72 ISFSI license application can be inferred from the level of detail required for an applica-tion for a reactor construction permit (10 C.F.R. G 50.34(a)(7)), an application for an op-erating license (10 C.F.R. 50.34(b)(6)(ii)), or the QA program described or referenced in the FSAR for a licensed commercial nuclear power plant (10 C.F.R. { 50.54(a)).

Those regulations require an applicant or a licensee to describe the quality assurance pro-gram applicable to the reactor under the requirements of 10 C.F.R. Part 50, Appendix B, which are almost identical to the requirements of 10 C.F.R. Part 72, Subpart G. Recctor license applications do not contain detailed procedures implementing the QA program 3

but normally consist of general descriptions of how the applicants will satisfy QA pro-gram requirements. Therefore, the PFS QAPD is to reflect PFS's commitment as to how it will implement the QA program required by the NRC for the PFSF. Indeed, as quoted above,10 C.F.R 72.140(c) requires an ISFSI license applicant to " file a description of its quality assurance program, including... how (the applicable requirements of Subpart G) will be satisfied."

8.

The NRC's focus on the commitments in a QAPD is also apparent from the regulations that govem the shanges that reactor licensees may make to their QA pro-grams without prior NRC approval. Those regulations do not focus on the licensees' QA procedures. Section 50.54(a)(3) of 10 C.F.R. Part 50, as amended effective April 26, 1999, states that a licensee is free, without prior approval from the NRC, to make changes j

to a previously accepted QAPD that do not reduce the commitments the QAPD contains.

The April 26,1999 amendment to Section 50.54(a)(3) designated certain types of changes that might have previously been considered to be reductions in commitment to be allowable without prior NRC approval based on the NRC's conclusion that they are "of minor safety significance." Therefore, because reactor and ISFSI QAPD require-ments are very similar, the NRC's focus with respect to QAPDs for ISFSI licensees is also on commitments rather than procedures.

9.

In my professional opinion, based on the NRC's review and acceptance of the PFS QA program as satisfying the requirements of 10 C.F.R. Part 71, Subpart H, my review of the QA Program as Chairman of the PFS QA Committee, and my familiarity with the QA plans of other nuclear facilities, the description of the QA program provided in Chapter 11 of the SAR and in the PFS QAPD (which is referenced in SAR Section 11.1) describes the PFS QA Program to a level of detail adequate to satisfy 10 C.F.R. Q 72.24(n) and 72.140(c). The SAR and the QAPD contain the commitments that form the basis of the PFS QA program. Specifically, SAR Chapter 11, Sections 11.1.1 through 11.1.18, and the PFS QAPD, Sections 1.0 through I8.0, describe the 18 sections of the PFS QA Program and how PFS will meet the individual requirements of 10 C.F.R. Q 4

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72.142-72.176. In the QAPD (at page 2), PFS commits further that "the QA [ Program]

l and implementing procedures shall be designed and administered to meet the 18 criteria of 10 C.F.R. 71, Subpart H and 10 C.F.R. 72, Subpart G." These commitments are suffi-cient to satisfy the requirements of 10 C.F.R. Part 72, Subpart G.

10.

In basis 1 for Utah G, the State claims that PFS must "descri[be] the

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means by which quality assurance will be achieved." In my professional opinion, this is not an accurate statement of the NRC's regulatory requirements. Under 10 C.F.R.

l 72.140(c), a description of the QA program must include a " discussion" of which re-quirements of Subpart G are applicable and how they will be " satisfied." The "means" by which quality assurance will be achieved is reflected in the QA program implementing procedures, which are not required to be submitted with the license application (but which PFS has committed to developing and administering so as to meet the criteria of 10 j

C.F.R. Part 71, Subpart H and Part 72, Subpart G).

11.

The State also claims in basis I that the description of the PFS QA Pro-gram is " utterly inadequate" to provide sufficient detail for the NRC staff to determine the plan's sufficiency. On the contrary, as indicated in paragraphs 5-9 above, based on my review of the QA Program and my familiarity with the QA programs of other appli-cants and licensees, the PFS QA Program contains more than enough detail for the NRC Staff to conduct a thorough review and the Staff has done so in approving the Program under 10 C.F.R. Part 71, Subpart H.

12.

The State also claims in basis 1 that the QA Program does not provide suf-ficient information to show that PFS's design control will satisfy the NRC requirements.

In my professional opinion, this is incorrect. Section 11.1.3 of the SAR and Section 3.0 of the PFS QAPD adequately describe how the QA Program will ensure that the nearly identical requirements of 10 C.F.R. 71.107 and 10 C.F.R. 72.146 are satisfied. As Section 3.0 of the PFS QAPD clearly describes, the QA program will assure that the de-sign of all structures, systems and components meet applicable regulatory requirements, codes and standards. The QA Program will establish written procedures to ensure that 5

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"[d]esign input and criteria are [ properly] translated into specifications, drawings, proce-l' dures, calculations, instructions and procurement documents prepared and reviewed by qualified personnel." Exh. 5 at 5. In addition, these procedures will describe and control the design and any changes throughout the project's design and construction, will identify and control the design interfaces, and will provide for coordination between participating design organizations. However, as stated above, these detailed implementing procedures are not required to be included in a description of the QA program.

13.

In basis 1 of Utah G, the State also claims that the plan is inadequate be-cause it does not state how design reviews will be conducted and by whom. This is in-correct; the PFS QA Program does describe how design reviews will be performed and by whom. Section 3.0 of the PFS QAPD states in part: " The procedure shall provide for a design review by qualified personnel other than those performing the design." This adequately describes how PFS will satisfy the requirement of 10 C.F.R. 72.146(b) m that verification of the design be performed by " individuals or groups other than those who were responsible for the original design." The procedures by which the actual de-sign review will be conducted and by which individuals is a level of detail normally

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found in the implementing procedures and is not required to be included in the descrip-tion of the QA program.

14.

The State also claims in basis 1 that the QA Program is inadequate be-cause it does not specify the type of and the level of training for QA employees or iden-tify what training will be provided as a QA measure to all personnel. This type ofinfor-mation, however, is not required in the license application; it is normally supplied in the implementing procedures. Furthermore, the State's assertion is simply wrong. Section 2.0 of the QAPD states:

Training and/or evaluation of personnel qualifications are required for all Quality Assurance functions in accordance with written procedures. The training program requires that all employees who participate in the QA Program will receive a level of classroom and on-the-job training com-mensurate with their involvement in the licensed activities.

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5 When required by applicable codes and standards, qualified personnel shall be appropriately certified in accordance I

with approved procedures.

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Exh. 5 at 4. In my opinion, this description adequately describes the training to be pro-vided to QA employees and other employees as a quality assurance measure. Any addi-tional level of detail regarding QA training would be described in imniementing proce-dures, which are not required to be included in the description of the Quality Assurance program. Furthermore, the adequacy of PFS's overall training program, including that for QA, is described in the declaration of Michael Ladd, the Training Process Manager at the Prairie Island nuclear plant.

15.

The State also claims in basis 1 that "while the QAPD... states that the QA program will be reviewed at established intervals, it does not specify the minimum review intervals nor does it define what will trigger an earlier review...." The State's claim is immaterial and incorrect. First, NRC regulations,10 C.F.R. { 72.144(d), require a licensee to review its QA program "at established intervals" but do not require any par-ticular interval. The review interval is normally included in QA implementing proce-dures. Indeed, PFS Quality Assurance Procedure 6.1 5.3 provides that the PFS Quality Assurance Program is to be reviewed periodically "or at a minimum interval of two years." Second, the events that would trigger early review are also normally included in '

the implementing procedures, but nevertheless, QAPD @ 18.0 indicates that in the event of the discovery of a deficiency or nonconformance during a QA audit,"[f]ollow-up ac-tions, including a reaudit, shall be performed to verify that corrective actions have been taken."

16.

The State claims in basis 4 of Utah G that the PFS QA program is defi-cient because it fails to adequately demonstrate the independence of the PFS QA organi-zation. This claim is meritiess. NRC regulations,10 C.F.R. @ 72.142(b), require that:

The persons and organizations performing quality assur-ance functions must have sufficient authority and organiza-tional freedom to identify quality problems; to initiate, rec-7 l

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ommend, or provide solutions; and to verify implementa-tion of solutions The persons and organizations performing quality assur-ance functions shall report to a management level that en-sures that the reqzired authority and organizational free-dem, including sufficient independence from cost and schedule considerations when these considerations are op-posed to safety considerations, are provided.

j The PFS QAPD shows that the QA organization will have sufficient independence to en-i sure that the QA program has been effectively implemented.

17.

In order to ensure the independence of the QA organization, the standard industry practice in the case of a licensed commercial nuclear power plant is for the QA organization to report to the level above the Plant Manager (e.g., to the Site Vice Presi-dent) or higher (e.g., to the Senior Vice President or Chief Nuclear Officer), which is a level above the management position that has direct responsibility for production. In the case of a vendor, the QA organization usually reports to the highest level at the facility.

The top quality position is also at the same level as most department heads in the line or-ganization. This ensures that the quality organization is independent of production con-siderations (i.e., it has organizational freedom from cost and schedule considerations) and provides a level playing field (authority) to verify that the QA program has been devel-oped, documented, and is being effectively implemented. Irrespective of the organiza-tional structure, the persons and organizations assigned the quality assurance functions must have direct access to the levels of management necessary to perform these func-tions.

18.

In my professional opinion, the description of the PFS QA organization provided in Section 11.1.1 of the SAR satisfies the requirements for 10 C.F.R. & 72.142 and meets industry standards for independence of the organization. The pre-licensing organization (Exhibit 6 - SAR Figure 9.1-1) shows the PFS QA Committee reporting di-rectly to the Board of Managers, which is the highest level in the organization. The li-8

censing and construction organization for the construction phase (Exhibit 7 - SAR Figure 9.1-2) shows the QA organization reporting to the Project Director with an interface (dashed line) to the Board of Managers. This interface provides sufficient independence in that it provides direct access to the Board of Managers so that the QA organization can regularly report on the status and adequacy of the QA program and have the organiza-tional freedom to report any concems to the Board of Managers, as described in Section 1.0 of the PFS QAPD. As stated there," Quality Assurance shal' be independent from other organizations and shall have direct access to the Board of Managers." Exh. 5 at 3.

Further, both the SAR and the PFS QAPD expressly provide the QA organization with the necessary authority to act to ensure that the PFS QA program is being effectively im-plemented. Section 0.0 of the QAPD (Exh. 5 at 2) provides that " Quality Assurance has the authority and resources to maintain oversight and initiate management action to limit further processing on items ofindeterminate quality, to initiate management action to re-solve any deficiencies, and to assure that satisfactory resolutions have been achieved prior to authorizing further processing," as does Section 11.1.1 of the SAR in similar lan-guage.

19.

The operational organization (Exhibit 8 - SAR Figure 9.1-3) shows the QA organization reporting to the General Manager / Chief Operating Officer with an inter-face (dashed line) to the Board of Managers and the Safety Review Committee. This is similar to a vendor organization in that the QA organization reports to the highest level of managem'ent at the facility. Further, similar to the construction phase of the project, the interface with the Board of Managers provides QA direct access to the Board so that the QA organization can regularly report on the status and adequacy of the QA program and can have the organizational freedom both to report any concems to the Board of Manag-ers and to ensure the effective implementation of the QA program in accordance with Sections 0.0 and 1.0 of the PFS QAPD and Section 11.1.1 of the SAR. Similarly, the in-terface with the Safety Review Committee provides QA direct access to this important Committee which provides additional oversight as to the status and adequacy of the QA program. Finally, the QA organization is represented on the Operations Review Com-9 l

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mittee, which acts in an advisory role to the General Manager / Chief Operating Officer.

Thus, the PFS QA organization will have sufficient independence to ensure that the PFS QA program is being effectively implemented.

20.

In basis 4, the State claims that PFS " fails to describe the interrelationship between the Architect / Engineer group and the QA Committee and how the relationship enhances OA " ihe first part of the State's assertion is wrong; PFS does describe the relationship between the Architect / Engineer and the PFS QA organization. The Archi-tect/ Engineer is a qualified vendor that provides services to PFS under its own QA pro-gram, which is separate from PFS's QA Program, but subject to review and auditing by the PFS QA Committee. As described in SAR Sections 11.1.1 and 11.1.7, and Section 7.0 of the PFS QAPD, the Architect / Engineer QA program has been reviewed and ap-proved by the PFS QA Committee in order to allow for the provision of A/E servicer. In addition, as described in Sections 11.1.1 and 11.1.7 of the SAR, and Section 7.0 of the PFS QAPD, the PFS QA organization performs audits and surveillance of the services provided by vendors and suppliers, including the Architect / Engineer, to ensure that these services are provided in accordance with the reviewed and approved QA programs of the vendors / suppliers. Further, the SAR specifically provides that the QA organization has "the authority to 'stop work' where project activities are not in compliance" with project requirements or "when the quality of Structures, Systems and Components... are inde-terminate," SAR at 11.1-2, as does the QAPD, Exh. 5 at 2-3. The Architect / Engineer QA program must also satisfy the requirements of 10 C.F.R. Part 72, Subpart G (and the QA program of Stone & Webster has in fact been approved by the NRC under 10 C.F.R. Part 50, Appendix B (SAR at 11.1-4)). As such, the Architect / Engineer is required to review the status and adequacy ofits own QA program at established intervals (10 C.F.R. 72.144(d)), and to carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects ofits QA program and to determine the effectiveness of the program (10 C.F.R. 72.176). Therefore, both the Architect / Engineer's QA or-ganization and the PFS QA organization are verifying the quality of the services provided by the Architect / Engineer under its QA program.

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l 21.

Thus, PFS has described the relationship between the Architect / Engineer and the PFS QA organization and that relationship comports with the requirements of 10 C.F.R. Part 72, Subpart G. There is no requirement to describe "how the relationship en-i hances QA," such as claimed by the State. The description of the relationship between l

the two entities and the described responsibilities of each adequately set forth how QA will be maintained.

22.

In basis 4 the State also claims that "the SAR fails to identify who is re-l sponsible for pre-licensing ' day-to-day activities, costs, or schedules' and how the or-ganizational structure ensures QA in quality-and safety-related activities." This claim has no foundation. The SAR shows that the QA Committee, which is the responsible QA entity during the pre-licensing phase, "is an independent organization" reporting to the Board of Managers that "shall not be responsible for day to day activities, costs, or schedules." SAR at 11.1-2; Figure 9.1-1. Thus, the PFS QA Committee has no direct j

responsibilities in those areas which it audits (as required by 10 C.F.R. Q 72.176).

l Moreover, Section 1.0 of the QAPD indicates that the Project Director is responsible for "the day-to-day direction of all aspects associated [with PFS), including licensing activi-ties and enforcement actions," and that the Architect / Engineer is responsible for " project

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design, preparation oflicense applications and any other activities as directed by the Project Director." Exh. 5 at 3.

23.

Further, the discussion in SAR Section 11.1.1, various parts of SAR Sec-tion 9.1, and the PFS QAPD describe the responsibilities of the Board of Managers, the l

QA Committee and other project participants, such as the Architect / Engineer, for ensur-l ing QA in the performance of quality-and safety-related activities. For example, the 1

l Board of Managers is responsible for ensuring the proper establishment and the effective implementation of the QA program. SAR Sections 9.1.1.1 and 11.1.1; QAPD Section 1.0. The Quality assurance Committee is provided the organizational independence and authority for implementing the quality assurance program as described in Sections 9.1.1.2 and 11.1.1 of the SAR and Sections 0.0 and 1.0 of the QAPD. The Architect / Engineer, 11

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subcontractors and cask vendors are required to perform work under approved quality assurance programs, subject to oversight and audit by PFS QA and other PFS committees l

. and staff as described in' Sections 9.1.1.3 and 11.1.1 of the S AR and Section 7.0 of the QAPD.

l 24.'

Thus, PFS's organization for pre-licensing activities clearly describes the general functional responsibilities of the various organizations, makes clear that QA is not to have responsibilities for day-to-day activities and cost and schedule, and describes L

how the QA'of quality-and saiety-related activities is to be ensured. Any further level of detail is not required at the license application stage. Section 72.142 requires the licensee L

to clearly establish and delineate in writing the authority and duties of persons and or-1 ganizations performing the functions associated with attaining quality objectives and the quality assurance functions.~ Section 72.144(a) also requires the licensee to identify the major organizations participating in the program, and the designated functions of these organizations. The discussion in SAR Sections 9.1.1 and 11.1.1 and Sections 0.0,1.0 and 7.0 of the PFS QAPD, along with SAR Figure 9.1-1 provide sufficient detail to describe l

how the above requirements are satisfied in the pre-licensing phase of the project.

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25.

The State also claims in basis 4 that the SAR " fails to provide any mean-ingful description of the licensing and construction, and operational functional responsi-bilities,' interrelationships, and various authority for performing quality and safety related activities." This claim is simply wrong. As discussed above in paragraphs 18-19, the PFS QAPD and SAR describe how PFS's organizational structure maintains the neces-l sary independence of the QA organization throughout the PFS project. In addition, the SAR describes the functions and interrelationships of the other PFS organizations in all phases of the project. The interrelationships during the pre-licensing phase have been described in paragraphs 20-24 above. Further, SAR Sections 9.1.1.1 and 9.1.1.2.2 (and l

l Fig. 9.1-2) similarly describe the PFS organizational and functional responsibilities and interrelationships for the construction phase; SAR Sections 9.1.1.1 and 9.1.1.2.3 (and Fig.

9.1-3) describe the same for the operational phase; and SAR Sections 9.1.1.3 and 9.1.4 12

describe the functional responsibilities and relationships with outside contractors, suppli-ers and vendors. In both phases, the QA organization is responsible for establishing and verifying the effective implementation of the QA Program, as reflected in those sections of the SAR as well as Section 11.1.1 of the SAR and the QAPD. Other PFSF functions are performed by other PFS organizations as described in the cited SAR provisions.

Further, as indicated above, the PFS QAPD and SAR expressly provide that the PFS QA organization shall be an " independent" organization" that "shall have direct access to the Board of Managers" and "shall not be responsible for day to day activities, costs, or schedules." QAPD at 3; SAR at i1.1-2.

26.

Finally, in basis 4, the State, citing QA Docket 71-0829 (the PFS QAPD) at page 4, alleges that "[a]Ilowing responsible individual organization management to determine the adequacy of the QA over their own programs does not allow independent oversight nor objectivity in establishing QA procedures." The State's claim is misplaced.

To support its allegation, the State quotes Section 2.0 of the QAPD, which states that

"[m]anagement of other organizations participating in the Quality Assurance program shall regularly review the status and adequacy of that part of the program which they are execming." Contrary to the State's claim, however, the QAPD statement does not impermissibly allow responsible individual organization management to determine the adequacy of the QA of their own programs. The QAPD statement is almost a verbatim recitation of the regulatory language of 10 C.F.R.72.144(d) which requires that

"[m] anal;2 ment of other organizations participating in the quality assurance program shall regularly review the reatus and adequacy of that part of the quality assurance program which they are executing." Hence, this commitment represents the realization by PFS, and the NRC, that each organization within PFS must work to ensure the quality and safety of the project's design, construction and operation. The PFS QA organization will independently audit the implementation of the QA Program by other PFS organizations g

and determine the adequacy of the implementation of the QA Program. But, as reflected

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in 10 C.F.R. 72.144(d) and QAPD 2.0, other organizations are to review the status and adequacy of thit part of the program they are executing in light of the QA audit results, 13 L

l and take appropriate action as may be necessary. Thus, the section of the QAPD quoted by the State does not reflect a lack ofindependence of the PFS QA organization, but the proper manner in which other organizations are to ensure the proper implementation of l

QA requirements.

l 27.

. In its responses to PFS's first discovery requests, the State raised a number ofissues which it asserts relate to its QA contention but which in fact do not concern or indicate the inadequacy of the PFS QA program description in the license application.

First, the State claims that PFS has not provided sufficient quality assurance design or operational information with its application, in that Chapter 4 of the SAR (Facility De-sign) does not provide sufficient detail to show that PFS has complied with all regulatory and industry code requirements. The State asserts that licensing under 10 C.F.R. Part 72 requires the submission of" detailed design information" that PFS has not provided. This assertion has nothing to do with the adequacy of the PFS QA program description, which is the subject of Contention Utah G. Specifically, it is unrelated to either basis 1 " Lack of detail" or basis 4 " Failure to Demonstrate Independence of QA Organization."

28.

Second, the State asserts in its discovery responses that QA problems with a storage cask vendor and its subcontractors " indicate the clear need for a comprehensive and detailed quality assurance program for PFS." Indeed, the PFS QA program descrip-tion in the license application must satisfy and does satisfy the requirements of 10 C.F.R. Part 72, Subpart G, in particular the level of detail required by the NRC's regulations as discussed above. Nevertheless, the fact that a storage cask vendor may have had QA 1

problems in the past does not implicate the PFS QA program, nor does it alter the NRC's regulatory requirements concerning the level of detail required as part of the QAPD.

Moreover, PFS will audit its vendors to ensure that they are implementing all necessary QA practices:

The QA program shall be reviewed at established intervals j

to assure that it is being effectively implemented and is adequate. All QA program requirements shall be required of subcontractors and suppliers and translated within pro-14

cedures, instructions, purchase orders, contracts, specifica-tions, plans, and drawings.

To the extent necessary to assure quality, procurement documents shall require suppliers of material, equipment, and services to have a QA program complying with the pertinent provisions of 10 CFR 71, Subpart H or 10 CFR 72, Subpart G.

SAR at i1.1-4, -5. PFS QA procedures will include criteria for the performance of sup-plier audits and supplier performance evaluations will be performed on a periodic basis.

-QAPD 7.0, Exh. 5 at 9.

29.-

Third, the State asscrts in its discovery responses that because the PFS project consists of a large number ofindependent utilities handling half the nation's spent fuel, the project presents a " major problem with respect to verifying the construction of each of the 4,000 [ spent fuel) casks" and "PFS must verify the integrity of the irradiated fuel that is put inside the cask, the loading of the fuel, and the welding of the canister."

First, the State's claim has nothing to do with the adequacy of the PFS QA program de-scription that is the subject of Contention Utah G, specifically, the level of detail in the PFS QAPD or the independence of the QA organization. Second, the State's assertion rests on faulty premises. The loading of the spent fuel canisters and spent fuel transpor-tation casks will take place at reactor sites under the NRC-approved QA programs of the reactor licensees. Thus, it will be unnecessary for PFS to verify the quality of those ac-j tivities (although PFS will inspect the spent fuel shipping casks and canisters when they arrive at the PFSF). Moreover, the PFS QAPD expressly states that " Design and fabrica-tion of shipping casks shall not be conducted under this Quality Assurance Program."

= QAPD at 1. PFS does, however, ensure as discussed in paragraph 28 above, that cask vendors have an approved quality assurance program and PFS will conduct supplier audits and performance evaluations on a periodic basis 15

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30.

In summary, the PFS QA Program satisfies applicable NRC requirements.

The QA Program contains an adequate level of detail to satisfy 10 C.F.R. 72.24(n) re-quirements for a " description" of the QA program. The QA Program also ensures the independence of the QA organization through all phases of the design, construction and operation of the PFS facility to satisfy 10 C.F.R. 72.142.

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

Executed on June 24,1999 l

ohn Thorgersen/

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4 RESUME OF JOHN GREGORY THORGERSEN

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JOHN GREGORY THORGERSEN j

EDUCATION:

Bachelor of Science - Nuclear Engineering University of Wisconsin - Madison (1980)

Coursework toward a Masters in Management Cardinal Stritch College - Milwaukee (1984 - 1985)

EXPERIENCE:

Wisconsin Electric Power Company 4/5/99 - Present Nuclear Power Business Unit Operating Supervisor Trainee 4

Operations Section

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Currently enrolled in a Senior Reactor Operator license training program at the Point Beach Nuclear Plant.

6/1/98 - 4/5/99 Nuclear Power Business Unit Manager - Quality Verification Nuclear Assurance Section Primary responsibilities include the intemal and supplier QA assessment programs, including QA oversight of major projects.

4/12/93 - 6/1/98 Nuclear Power Business Unit Senior Project Engineer Quality Assurance Section Primary responsibilities included the internal and supplier QA assessment programs, QA oversight of major projects and maintenance of the safety classification list (Q-List) for QA scope structures, systems and components.

Wisconsin Public Service Corporation 9/1/86 - 4/12/93 Nuclear Power Department Quality Assurance Auditing Supervisor Quality Assurance Auditing Group Primary responsibilities included the internal QA assessment program.

7/1/81 - 9/1/86 Nuclear Power Department Nuclear Engineer

7-i Nuclear Licensing & Systems Group 1/26/81 - 7/1/81 Nuclear Power Department Associate Engineer Nuclear Licensing & Systems Group Primary engineering responsibilities included the design analysis. and operation of systems and equipment installed at an operating Nuclear Power Plant and associated licensing activities. Responsible Project Manager for Equipment Qualification Program Pressurizer Safety / Relief Valve Qualification and Analysis of the Discharge Piping, and Upper Plenum Injection / Emergency Core Cooling System Analysis. Also served 4.5 years as a Certified Shift Technical Advisor.

MEMBER American Nuclear Society Tau Beta Pi Phi Kappa Phi CERTIFICATION 1.

Certified Shift Technical Advisor at the Kewaunee Nuclear Power Plant, a PWR (1982 - 1986) 2.

Cenified Lead Auditor to ANSI N45.2.23-1978 (1987 - Present)

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THORGERSEN Exhibit 2 l

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UNITED STATEL Wi' !

NUCLEAR REGULATORY COMMISSION 7

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W ASHINGTON. O C. 2055 Moot Nove.oer 3, 1995 Mescalero Fuel Storage, Limited Liability Company ATTN:

Mr. Jchn D. Parkyn Chairman Board of Directors P.O. Box C4010 Lacrosse, WI 54602-4010

Dear Mr. Parkyn:

In your letter dated August 28, 1995, you requested Nuclear Regulatory Commission approval of your Quality Assurance (QA) Program for meeting the requirements of 10 CFR Part 71, Subpart H, and 10 CFR Part 72, Subpart G.

.In response to your request regarding 10 CFR Part 71, we have enclosed QA Program Approval for Radioactive Material Packages No. 0829, Revision No. O.

This Approval satisfies the requirements of 10 CFR f 71.12(b) for a QA Program approved by the Commission.

Please note the conditions in the Approval. This Approval will remain in effect until the expiration date, indicated in Block No. 3.

Termination of any other NRC licenses you may obtain in the future will not cause this Approval to be automatically terminated.

If you wish to renew, amend, or terminate this Approval, please request it in

-writing.

Concerning 10 CFR Part 72, an application for a license to store spent fuel in an independent spent fuel storage installation under 10 CFR Part 72 must include a description of the QA Program that satisfies Subpart G of 10 CFR Part 72 in accordance with 10 CFR i 72.24(n).

Prior to issuiag a license, the Commission must, among other things, find under 10 CFR S 72.40(a)(7) that the applicant's QA Program complies with Subpart G of 10 CFR Part 72.

In connection with each license application under 10 CFR Part 72, the Commission will provide an opportunity for a hearing as provided in 10 CFR f 72.46(a).

I Generally, t..a y,.equirements in 10 CFR Part 72, Subpart G, are comparable to the requirements in 10 CFR Part 71, Subpart H.

Hence, if you file a license application under 10 CFR Part 72, you could propose in the application to use your approved 10 CFR Part 71 QA Program to satisfy the requirements of 10 CFR Part 72, Subpart G.

Further, use of your approved 10 CFR Part 71 QA Program for 10 CFR Part 72 pre-application activities would be appropriate.

With respect to a potential future application for a license under 10 CFR Part 72, the Commission will provide an opportunity for hearing. At that time, any person whose interest may be affected and who desires to participate as a party may file an intervention petition, and may seek to challenge your

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license application including the QA Program described in the application.

l RECORD SEQ. NO I

l FAC2 I OF3 I

Mr. John D. Parkyn 2

This letter also serves as a reminder that if you are using or planning to use an NRC-approved packaging for transportation, you must be registered for use of that packaging with NRC.

Registration for use of NRC-approved packagings should be made pursuant to 10 CFR s 71.12(c)(3).

If you have any questions regarding this matter, please contact Stephen O'Connor of my staff at 301/415-7878.

Sincerely, bu l 5%

ohn P. J nkovich, Section Leader Containment and Storage Inspection Section-Office of Nuclear Material Safety and Safeguards Docket No. 71-0829

Enclosure:

As stated m

l RECORD SEQ. NO

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PAGE E OF 0 l

05680 l

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' NRC roRu m U. S. NUCLEAR REGULA

.Y COMMISSION j 1. A PPROVAL NUMBF &

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QUALITY ASSURANCE PROGRAM APPROVAL cs:9 FOR RADIOACTIVE MATERIAL PACKAGES RE W580N NweEn L

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Pweswant to one A tomic Energy Act of 1954. as amended. the Energy Reor3.nita' tion Act of 1974, as m* ended, and Thie 10 Code et Federas Regulet.ons. Chaofer 1. Part

71. and en res ance on staterments and reorosentations meretofore made an 8 tem 5 or ene person am s

the Owahey Asswrence Progre identi.ed en stem $ es meteov approved. Thes aDoroval as issued to satisfy the reoverements of Sect f

i of to CFR Part 71. TNs approval is suosect to all acchcacie rules. regulations and orders of the Nweiear Regulatory Comm as.on

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hereafter en ef fect and to any condit nas soecihed colouv.

2. N AME

3. EXPIR ATION DATE

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Mescalern ruel Storage, Limited Liability Company STREET ADDRESS November 30, 2000

• 5 P.O.

Box C4010

4. OOCxE T NUMBER CIT Y STATE ZIP CODE g

Lacrosse WI 54602-4010 t

71-0829

5. QUALITY ASSURANCE PROGRAM APPLICATION OATEfS)

August 28 and 29, 1995 and October 18, 1995 l

6. CONOs TsONS iF:

,1 lE Activities conducted under applicable criteria of Subpart H of 10 CFR Part 71 l!

to be executed with regard to transportation packagings.

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.i RECORD SEQ, NO /

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FOR THE U.S. NUCLEAR REGULATORY COesestssioN P

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>h J n P. J ovich, Ph.D.

November 3, 1995 e d eo -.--

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L PPJVATE FUEL STORAGE L.L.C.

l QUALITY ASSURANCE PROGRAM DESCRIPTION August 1996

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l TABLE OF CONTENTS

- Section Page Statement of Quality Assurance Policy 1

O.0 Introduction 2

1.0 Organization 3

2.0 Quality Assurance Program 4

3.0 Design Control 5

- 4.0 Procurement Document Control 6

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5.0 Instructions, Procedures and Drawings 7

6.0 Document Control 8

7.0 Control of Purchased Material Equipment and Services 9

8.0 Identification and Control of Material, Parts and Components 10 9.0 Control of Special Processes 11' 10.0 Inspection 12 j

11.0 Test Control 13 12.0 Control of Measuring and Test Equipment 14 13.0 Handling, Storage and Shipping 15 14.0 Inspection, Test and Operating Status 16 j

15.0 Non-Conforming Materials, Parts or Components 17

-l 16.0 Corrective Action 18'

'17.0 Quality Assurance Records 19 18.0 Audits 20 Figure 1 Organization Chart 21 4

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l PRIVATE FUEL STORAGE LLC-Issue!

QUALITY ASSURANCE PROGRAM DESCRIPTION l

PRIVATE FUEL STORAGE llc STATEMENT OF OUALITY ASSURANCE POLICY l

l The Quality Assurance Program described herein has been developed by Private Fuel Storage LLC (PFSLLC) to assure safe and reliable operation of facilities for independent spent nuclear fuel storage, high level radioactive waste storage, and the use of radioactive shipping packaging.

The Program is designed to meet the requirements of Title 10 of the Code of Federal Regulations (CFR), Part 71, Subpart H and Part 72, Subpart G.

The Quality Assurance Program applies to all activities affecting quality and includes design, operation. documentation, procurement, repair, material. fabrication, inspection, testing, equipment operation and use, maintenance, modification inventory, shipment and records retention.

Design and fabrication of shipping casks shall not be conducted under this Quality Assurance Program.

Quality Assurance is responsible for the establishment of the Quality Assurance Program which meets the requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpan G, and assuring

_ implementation of the Program.

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irman, Board of DiMetors k M w) $D,iO96 Date

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U l PRIVATE FUEL STORAGE LLC

!ssue1 OUALITY ASSURANCE PROGRAM DESCRIPTION 0.0 Introduction This Quality' Assurance Program Description (QAPD) has been developed to ensure that necessary controls are in place to assure the quality of all materials and processes used for the independent storage of spent nuclear fuel and high level radioactive waste as well as

'l the use of radioactive shielding, casks, containers and other equipment pertaining to shipping packaging for radioactive materials.

The QAPD delineates requirements and procedures necessary to exercise control over design, operation, documentation, procurement. material, fabrication, inspection.

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' operational testing, equipment operation and use, maintenance, repair, modification.

inventory, shipment and quality records retention.

The QAPD and implementing procedures shall be designed and administered to meet the 18 criteria of 10 CFR 71, Subpan H and 10 CFR 72, Subpan G.

The QAPD contains a statement of policy and authority, signed by the Chairman of the Board which defmes the QAPD as the Corporation's policy related to quality. The QAPD states the policies, assigns the responsibilities, and describes and summarizes the procedures governing the design, procurement, construction, testing and operations of safety important components, systems and structures as defined by contract in compliance with applicable licensing / certification regulations.

The policies described in the QAPD implement the requirements of Title 10, CFR Pan 71, Subpan H; and Part 72, Subpart G as well as additional requirements of ANSI, ASME, regulatory guides, and military standards as applied to organizations performing design, procurement, construction, testing and operational activities for nuclear applications to the extent specified by contract and licensing / certification regulations.

The statement of policy and authority includes provision to specify that attainment of l

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- quality objectives is the responsibility of all personnel of the PFSLLC. It also states that i

compliance with the Quality Assurance Program as described in the QAPD is mandatory l

for all PFSLLC personnel whose activities affect quality.

Quality Assurance, reporting to the Board of Directors, is given full responsibility for maintaining the QA Manual and for assuring uniform implementation of the Quality Assurance Program requirements. Quality Assurance has the authority and resources to maintain oversight and initiate management action to limit further processing on items of indeterminate quality, to initiate management action to resolve any deficiencies, and to assure that satisfactory resolutions have been achieved prior to authorizing further processing.

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1 l PRIVATE FUEL' STORAGE LLC

!ssue:

r QUALITY ASSURANCE PP.OGRAM DESCRIPTION l

1.0 Organization l

The PFSLLC Organization (see Figure 1) consists of a Board of Managers. Quality Assurance. Business Services Unit. Project Manager. NRC Liaison. Public Relations Director, Architect Engineer. Human Resources Development Group, and Administrative Group who have responsibilities as follows:

Board of Managers are responsible for budget approval, financial oversight, planning, utility liaison, and business development as well as assuring the effective and efficient implementation of this program.

Quality Assurance is responsible for establishing this program as well as determining the effective implementation by performing audits. Quality Assurance has the authority to stop fabrication, construction, installation or testing of components systems or structures which do not conform to applicable regulatory requirements, codes and standards and specifications or procedures.

Quality Assurance shall be independent from other organizations and shall have direct access to the Board of Directors.

Business services Unit is responsible for accounts payable, accounts receivable, payroll, l

and other business related services associated with the operation of the PFSLLC.

Project Manager is responsible for the day-to-day direction of all aspects associated with l

the creation of the PFSLLC.

l Licensing Manager is responsible for all contacts associated with licensing activities or enforcement actions.

l Public Relations Director is responsible for all public information.

Architect Engineer is responsible for project design, preparation oflicense applications and any other activities as directed by the Project Manager.

l liuman Resource Develonment is responsible for employment and training.

Administrative Groun supplies all clerical needs and on-site record controls to support the project.

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QUALITY ASSURANCE PROGRAM DESCRIPTION 1

2.0 Ouality Assurance Program l

The QA Program described herein sets forth the requirements for the control of quality in the design. fabrication. operation and maintenance ofindependent spent fuel storage l

installations / monitored retrievable storage facilities (ISFSIs and MRSs) and the use of shipping containers for nuclear products.

The QA Program shall be comprised of the Quality Assurance program Description (QAPD) and Quality Assurance Procedures which contain detailed implementing l

instructions.

L The QA Program is designed to provide control of activities affecting quality in systems, structures and components that involve approved package design or facility licensing requirements that are important to safety.

Training and/or evaluation of personnel qualifications are required for all Quality Assurance functions in accordance with written procedures. The training program requires that all employees who participate in the QA Program will receive a level of classroom and on-the-job training commensurate with their involvement in the licensed activities. When required by applicable codes and standards, qualified personnel shall be appropriately certified in accordance with approved procedures.

The QA program shall be reviewed at established intervals to assure its adequacy and status and the program is being effectively implemented. Management of other organizations participating in the Quality Assurance program shall regularly review the status and adequacy of that part of the program which they are executing.

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j PRIVATE FUEL' STORAGE LLC issue 1 QUALITY ASSURANCE PROGRAM DESCRIPTION 3.0 Desien Control This section establishes the requirements to assure that structures. systems and

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components are designed. added. deleted or modified in accordance with applicable regulatory requirements, codes and standards.

The design control process shall be implemented in accordance with written procedures.

Design input and criteria are translated into specifications. drawings, procedures.

calculations, instructions and procurement documents prepared and reviewed by qualified personnel. Design inputs include the design basis, regulatory requirements, applicable codes and standards and quality assurance requirements.

Design control procedures shall be prepared to describe and control the design and any changes from inception through final approval, release, distribution and implementation.

The procedure shall provide identification and control of design interfaces and for coordination among participating design organizations. The procedures shall provide for the review ofitems such as: stress, hydraulic, thermal, criticality physics, radiation, shielding, and accident analyses; compatibility ofinaterials; accessibility for inspection.

maintenance and repair; features to facilitate decontamination; and delineation of acceptance criteria for inspections and tests. The procedure shall provide for a design review by qualified personnel other than those performing the design.

Any design change or field change shall be subjected to the same design control measures as specified for the original design.

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QUALITY ASSURANCE PROGRAM DESCRIPTION i

l 4.0 Procurement Document Control l

l-This section establishes the measures to assure that procurement documents covering material, equipment, and services specify appropriate quality requirements. The i

l procurement documents shall specify or reference the applicable requirements, design bases, codes, and standards to assure quality.

'All procurement activity shall be performed in accordance with written procedures delineating requirements for preparation, review, approval and control of procurement documentation. Revisions to procurement documentation shall be reviewed and approved by the same cognizant groups as the original.

1 Supplier evaluation and selection, objective evidence of supplier quality, assignment of quality requirements to procurement documents, including related design documents, and source, in-process and receiving inspection shall be administered and controlled in accordance with approved procedures.

j Purchase orders shall include specifications which contain all the information necessary to assure that material, equipment, and services are of adequate quality. Documentation i

required to provide evidence that materials, equipment, and services are of adequate

. quality shall be clearly delineated in purchase orders.

To the extent necessary, procurement documents shall require suppliers of material, j

equipment, and services to have a quality assurance program complying with the pertinent provisions of 10 CFR 71, Subpart H or 10 CFR 72, Subpan G. Suppliers will be required to provide access to their facilities and records for inspection and audit, as i

required, to determine compliance with provisions of purchase orders. These requirements shall extend to lower tier procurements, as determined by management.

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QUALITY ASSURANCE PROGRAM DESCRIPTION 5.0 Instructions. Procedures and Drawines This section establishes the measures to assure that activities affecting quality are

. performed in accordance with approved instructions. procedures and drawings.

All instructions, procedures and drawings are to be developed, reviewed. approved.

utilized and controlled in accordance with the requirements of approved procedures.

l Changes to instructions, procedures and drawings shall be developed reviewed, approved, utilized and controlled using the same requirements as applied to the original documents.

Procedures shall be developed and implemented for those operations that affect cpality.

Procedures define the manner in which quality objectives will be attained, such as criteria for workmanship to comply with standards, inspections, tests and verification activities.

Documented work instructions define suitable equipment, working environments, work processes r.nd approvals. Work instructions include methods to measure performance against established technical and quality requirements. Procedures and instnx.tions shall be established and maintained to ensure that sufficient records are specified, reflect the quality of the work performed and comply with appropriate codes, standards and regulatory requirements.

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QUALITf ASSURANCE PROGRAM DESCRIPTION 6.0 Document Control This section describes the system to control the issue. use. review. approval, distribution and revision of quality related documents.

Procedures shall be developed to identify individuals / organizations responsible for control, review.' approval and issuance of documents.

Documents, including revisions, that are to be controlled shall be prepared. reviewed and approved by qualified personnel using document control procedures. Procedures shall be implemented specifying required reviews and approvals and distribution of documents.

Documents shall be distributed to and used at the location where the activity prescribed by the document is performed.

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. l PRIVATE FUEL STORAGE LLC.

Issue 1

. QUALITY ASSURANCE PROGRAM DESCRIPTION 7.0 '

Control of Purchased Material. Eauinment and Service-This section establishes the requirements to assure that purchased material. equipment and services. whether purchased directly or through contractors and subcontractors.

i conform to the procurement documents.

Procedures shall be implemented and used for determining supplier selection and evaluation. Procedures shall include criteria for the performance of supplier audits. This would include items such as: the supplier's capability to comply with codes and standards. supplier performance and review of the supplier's QA program and facility operation.

Suppliers of radioactive shipping packaging shall be evaluated to ensure that the design and fabrication of packaging are performed under the control of an NRC-approved QA

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Program.

Supplier performance evaluations shall be performed on a periodic basis. The time intervals shall be established based on the importance, complexity and quantity of the product or services.

I Receipt inspection consistent with importance and complexity shall be performed using approved procedures to assure:

a.

The material, component or equipment is properly identified and corresponds with the identification of the applicable receiving documentation.

b.

Material, components, equipment and acceptance records are inspected and are acceptable in accordance with inspection instructions, prior to installation or use.

1 c.

Inspection records and/or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.

d.

Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.

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Issue i QUALITY ASSURANCE PROGRAM DESCRIPTION 8.0 identification and Control of Materials. narts and Comnnnents This section establishe's the requirements for the identification and control of material.

parts and components from receipt through installation or use.

Approved instructions and procedures shall be implemented for the identification and control of materials. parts and components. An identification system shall be established using purchase ~ order numbers, heat numbers, part numbers, serial numbers or other means to identify and control materials,' parts and components.

Specifications shall require that materials parts and components are identified by some means and shall require that documentation have identification providing traceability to

' the item.

A means of physical identification should be used to the maximum extent possible for relating an item at any time to applicable documentation. Identification shall be either on the item or records traceable to the item. Where physical identification is impractical, physical separation procedural control, or other appropriate means shall be employed.

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PRIVATE FUEL STORAGE LLC issue!

3 QUALITY ASSURANCE PROGRAM DESCRIPTION 9.0 Control of Snecial Processes This section establishes the measures to assure that special processes, including welding, heat treating. radioactive waste processing, and non-destructive testing. are controlled and accomplished by qualified personnel using qualified procedures in accordance with 1 applicable codes, standards, specifications, criteria, and other special requirements.

Special processes shall be planned through items such as: documented work instructions.

defining the sequence of operations, special environments, suitable equipment and criteria for workmanship standards. process controls shall be established to ensure characteristics are maintained within specified requirements.

Each special process shall be performed in accordance with instructions, procedures, drawings, checklists, or other appropriate means. Measures will be taken to ensure process parameters are controlled and that environmental conditions such as temperature, humidity, and cleanliness are maintained. The written procedures for special processes shall specify the qualifications of personnel, the proper equipment to be used. and control of materials and supplies.

Equipment used for accomplishing special processes shall be calibrated, maintained, stored, handled and issued in accordance with applicable procedures.

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Personnel shall be qualified to ensure proficiency in the special skills required for the process. The knowledge and capabilities required of personnel performing special i

processes shall be delineated in written instructions, including requirements for periodic i

evaluations of continuing proficiency.

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QUALITY ASSURANCE PROGRAM DESCRIPTION 10.0 Insnection This section establishes a program for inspection of activities affecting quality to serify conformance with approved procedures. drawings and specifications.

Approved procedures shall be implemented delineating inspection methods.

characteristics and documentation. Inspections shall be performed by qualified personnel other than those who performed or supervised the work being inspected.

Mandatory inspection hold points, which require witnessing or inspecting of an activity before processing, shall be indicated in the appropriate procedures or specifications. The inspection shall be documented to indicate approval and release prior to continuation of the activity.

Inspection requirements shall apply to all activities whether performed by company personnel or contractor personnel, and shall require that inspection procedures and instructions are provided with necessary drawings prior to commencing inspection activities.

Inspection req tirements goveming modifications, repairs and replacement shall be in accordance e 4 'he original design and inspection requirements or as amended by approved chaigs to the original design.

Where direct ir;,pections of processed material or products cannot be called out, indirect controls will be utilized to control quality.

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i QUALITY ASSURANCE PROGRAM DESCRIPTION 11.0 Test Control This section establishes the requirements for a test program to demonstrate that structures. systems and components will' perform satisfactorily in service.

A program shall be established to assure that all testing required to demonstrate that structures, systems and components will perform satisfactorily in service is identified and documented.

Testing shall be performed in accordance with approved test procedures which incorporate or reference the requirements and acceptance criteria contained in applicable design documents and specifications.

Test procedures shall incorporate. but not be limited to, requirements for such items as:

hold points, witness points, caution notes, and emergency requirements.

Test results shall be documented and evaluated to ensure that test requirements have been satisfied.

Test results which fail to meet the requirements and acceptance criteria shall be properly noted and appropriate corrective action taken.

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, PRIVATE FUEL STORAGE LLC issue 1 QUALITY ASSURANCE PROGRAM DESCRIPTION 12.0 Control of Measuring and Test Eauinment This section establishes the requirements for the control. calibration. and periodic adjustment of tools, gauges. instruments. and other measuring and test equipment used to verify conformance to established requirements.

Inspection, test and work procedures shall include provisions to assure that tools, gauges.

instruments, and other inspection, measuring, and test equipment and devices used in activities affecting quality are of the proper range, type, and accuracy to verify conformance to established requirements and test parameters.

To assure equipment accuracy, inspection. measuring, and test equipment shall be controlled. calibrated, adjusted, and maintained periodically, or prior to use. Calibrations are performed against certified measurement standards that are traceable to nationally recognized standards. Where national standards do not exist, provisions will be established to document the basis for calibration.

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QUALITY ASSURANCE PROGRAM DESCRIPTION l

13.0 Handling. Storage and Shipping This section establishes the measures to control the handling, storage, shipping, cleaning.

packaging. and preservation of material and equipment to prevent damage. deterioration.

or loss through shipment. installation or use.

Approved procedures and instructions shall be implemented delineating the requirements for handling. storage, shipping, cleaning and preservation of materials and equipment.

When required, procedures shall describe special equipment to be used, protective environments and coatings, or other protective measures. Documentation such as records ofinspections or maintenance or required shipping documentation shall also be specified in procedures and instructions.

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QUALITY ASSURANCE PROGRAM DESCRIPTION

' 14.0. Insnection. Test and Oneratine Status This section describes the system for indicating the inspection, test and operating status of components and systems.

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Approved procedures shall be implemented that include measures to preclude bypazing ofinspections and tests,' or prevent the operation of equipment or systems until authorized by designated personnel.

The operating status of systems and components shall be controlled through the use of -

tags secured to appropriate valves, switches, or control mechanisms. The use of tags and authorization for application and removal shall be specified in approved procedures. The use of status indicators shall be utilized on systems or components when operation, or

' removal from operation, would adversely affect performance of the system. constitute an operational safety or environmental hazard, or violate statutory / regulatory compliance requirements.

The status ofinspections and test. shall be indicated on the item to the extent possible, or in documents traceable to the item. The status is identified by the use of tags, markings, stamps, or other means to ensure required inspections or tests are not bypassed. Status indicators shall be specified in approved procedures.

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-l PRIVATE FUEL' STORAGE LLC issueI QUALITY ASSURANCE PROGRAM DESCRIPTION 15.0 Non-Conformine Materials. Parts or Comnonents This section establishes the measures to control materials, parts or components which do q

not conform to specified requirements in order to prevent their inadvertent use or installation.

Approved procedures shall be implemented to provide requirements for identifying, j

segregating, reporting discrepancies and dispositioning of non-conforming items as well j

as notification to affected organizations.

Materials, parts, or components which do not conform to requirements shall be identified and placed in a hold status. Nonconforming items shall remain in a segregated area as

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appropriate until approved disposition has been received, l

l The disposition of nonconformances shall be evaluated and approved by appropriate l

personnel in accordance with approved procedures. Nonconforming items shall be centrolled until final disposition is approved by authorized personnel.

Disposition of a nonconformance involving repair or rework shall include provisions to retest or reinspect to the original acceptance criteria. Any changes to design require the same design control as those applied to the original design.

Nonconformances shall be closed by qualified personnel in accordance with wTitten i

procedures. Closure activities include verification that the corrective action was l

adequate, complete and documented appropriately.

Approved procedures shall identify methods for reporting adverse quality conditions in accordance with 10 CFR Part 21 requirements. Nonconformances are evaluated by appropriate personnel to determine reporting requirements.

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. PROGRAM DESCRIPTION 16.0 Corrective Action-This section establishes measures to assure that conditions adverse to quality, such as failures, malfunctions. deficiencies. deviations. defective material and equipment and nonconformances are promptly identified and corrected.

Conditions adverse to quality, such as failures. malfunctions, deficiencies, deviations and defective material and equipment, shall be identified and reported to appropriate personnel using approved procedures. For significant conditions adverse to quality, the cause of the condition and corrective action necessary to prevent recurrence shall be I

identified. implemented and then followed-up to verify corrective action effectiveness using approved procedures.

Appropriate levels of management will be notified of significant conditions adverse to quality and the disposition of these conditions.

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!ssue1 QUALITY ASSURANCE

. PROGRAM DESCRIPTION

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i 17.0 Ouality Assurance Records This section establishes measures for maintaining records of activities affecting quality.

Approved procedures shall be developed and implemented to establish controls for the identification, receipt, storage, preservation. safekeeping, traceability. retrieval and disposition of records.

Records to be maintained would include, but not be limited to, design, engineering, procurement. manufacturing, construction. inspection and test, installation, operations, maintenance, modification calibration, audit. personnel qualifications, and procedures.

Inspection and test records shall identify as applicable: inspection type; evidence of completion and verification of manufacturing, inspection on test operation; date and results ofinspection or test; information relating to noted discrepancies; inspection or data recorder; evidence of acceptance.

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Records shall be maintained in facilities designed o prevent their loss or deterioration and shall comply with one of the following: 1) two sets ofidentical records are maintained at separate storage locations, or 2) the official copy of QA records is maintained in approved fireproof files or vaults at a single location.

l A system shall be established to identify all documents and record retention for the project. At a minimum, records penaining to the design, fabrication, erection, testing, maintenance and use of structures, systems and components important to safety shall be 1

maintained until termination of the license.

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l PRIVATE FUEL STORAGE LLC issue 1

. QUAllP/ ASSURANCE PROGRAM DESCRIPTION 18.0 Audits This section establishes the requirements for a system of planned and documented audits to verify compliance with all aspects of the Quality Assurance Program and to assess the effectiveness of the program. The system provides for the reporting and review of audit results by appropriate levels of supervision and management.

Audits shall be performed in accordance with written procedures or checklists by -

appropriately trained personnel having no direct responsibilities in the area audited.

Audits and surveillance results shall be documented and reviewed with supervision responsible for the area audited who shall take necessary action to correct reported deficiencies.

Audit results shall be documented and reported to the management having responsibility in the area audited.

i Deficiencies or nonconformances uncovered during an audit shall be documented and brought to the attention of the appropriate management personnel. Follow-up actions, including a reaudit, shall be performed to verify that corrective actions have been taken to correct the deficiencies or nonconformances.

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THORGERSEN Exhibit 4 l

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UNITED STATES I' kff E

NUCLEAR REGULATORY COMMISSION l

f 5TI ME WASHtNGTON, D.C. 20565m01 t n y# /

september 16, 1996 Mr. John D. Parkyn, Chairman Board of Managers Private Fuel Storage Limited Liability Company P.O. Box C4010 Lacrosse, WI 54602-4010

Dear Mr. Parkyn:

i Enclosed is Quality Assurance Program Approval for Radioactive Material Packages

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No. 0829, Re"ision No. 1, a: amended. Thi; Approval satisfie; the requirements of 10 CFR f 71.12(b) for a Quality Assurance Program approved by the Commission.

Please note the conditions in the Approval.

This Approval will remain in effect until the expiration date, indicated in Block No. 3.

Termination of your materials license does not cause this Approval to be automatically terminated.

If you wish to renew, amend, or terminate this Approval, please request it in writing.

This letter also serves as a reminder that if you are using or planning to use an NRC-approved packaging, you must be registered for use of that packaging with NRC. Registration for use of NRC-approved packagings should be made pursuant to 10 CFR 6 71.12(c)(3).

Sincerely,

$4 f cHA J n P. J nkovich, Section Chief Transportation and Storage Inspection Section Spent Fuel Project Office, NMSS Docket Nos. 71-0829

Enclosure:

As stated SEP 201996

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V. 5 NUCLEAR REGULAfo:V cousissiON i

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QUALITY ASSURANCE PROGRAM APPROVAL 1.AfuovAtsvueTg

' 9 FO? CADICACTIVE MATERIAL, PACKAGES E VlSION NVMBE A y

l Pursuant to ene Atomic Energy Act of 1954 Aegutanons, Chapter 1. Part 71, ano in rel ance on statements anc representaoons heretofo ees the Owalaty Alswrence Progre ioentified in item 5 is hereoy aooroveo mee in item 5 Dy me persca nameo en item 2 r

of 10 CFR Part 71. This aooroval s sucieet to att econcacie rules.

rais acorosat is mwee to satisfy the reovirements of section 71 aerestier in et+eet ano to any cono.oons soeca.eo oeiow.

egwlations. ano orcers of tme Nuclear meguratorv Comm,n on am 3, l

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2. N A M E l

Private Fuel Sterne *. nited Liability Comeany

3. E ) PIR A flO*J C A TE STREET ADOAEss p' '

P.O. "Ox C4010

[ 5eptember 30. 2001 p,

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a. DOCx E T NuveE A STATE

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Lacrosse ZIP COOE WI 54602-4010 71-0829

5. QUALtTY A$$UR ANCE PROGRAM -APPLICA TION D ATEtSi August 28 and 29, 1995. Oc tO'aer 19, 1995, and August 30, 1906

6. CONOITIONS 1.

Activities authorized by this approval:

I procurement, maintenance, repair, and use to be executed with regard to transportation packagings. All other activities (i.e.,

design, fabrication,

assembly, testing, and modification) shall be satisfied by obtaining certifications from l

packaging suppliers that these activities were conducted in accordance with an NRC-approved Quality Assurance Program.

It shall remain the i

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responsibility of the Quality'Aisurance Program holder that all transportation activitiesfeel the req'uirements of 10 CFR { 71.101.

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2.

Records shall be ma@t'ained in accordance wibf.the provisions of 10 CFR s

t Part 71.

Specifically:

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b Recordsofeachship).nent of licensed material shall be maintained for three years aftWXhat shipment [10 CFR { 71.91(a)).

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Records pr$idinglevi

f. pack (ging qual 1ty shall be maintained for three years M,fet t g

, :of the packaging (10 CFR 6 71.91(c)]

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RecordsdesE.lbin klNec,tinggbkagingqualityshallbe I

maintained faf three ' years'.'after,Sthis.

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Approval is ter(Jnated (10MFR~ 5 71.135)pDality Assurance Program

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FOR THE U.S. NUCLEAR REGULATORY COMMISSION g

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September 16, 1996 g.

Jo/m P. Jadifovich Section Chief oATE g

TRANSPORTATION AND, STORAGE INSPECTION sEC'nON j

g SPENT PUEL. PROJECT OFFICE t - - _ _ _ _ _ _ _ _ _ _,_.. N MSS

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THORGERSEN Exhibit 5 l

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PRIVATE FUEL STORAGE L.L.C.

QUALITY ASSURANCE PROGRAM May 1999 l

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TABLE OF CONTENTS Section Pane Sentement of Onnlity Assurance Poliev 1

1 0.0 Introduction 2

1.0 Oranni7ation 3

2.0 Onnlity Assurance Proaram 4

j 3.0 Desien Control 5

4.0 Prneurement Document Control 6

5.0 Inctructions. Procedures and Drawinac 7

6.0 Document Control 8

7.0 Control of Purchneed Material. Eauinment and Services 9

8.0 identifientinn and Control of Material. Parts and Comannents 10 9.0 Control of Snecial Prnce==*e 11 10.0 Inenection 12 11.0 Test Control 13 12.0 Cnntrol of Measurina and Test Eauinment 14 13.0 Handline. Storane and Shinnina 15 14.0 Inenection. Test and Oneratine Starne 16 15.0 Non-Conformine Materinic. Parts or Comnonents 17 16.0 Corrective Actinn 18 17.0 Ounlity A=enenace Decards 19

) 8.0 Audits 20 Firure 1 Orennivatinn Chart 21 L

PRIVATE FUEL STORAGE LLC

. QUALITY ASSURANCE Issue 2 PROGRAM PRIVATE FUEL STORAGE LLC I

STATEMENT OF OUAI ITY ASSURANCE POLICY 1

The Quality Assurance Program described herein has been developed LLC (PFSLLC) to assure safe and reliable operation of facilities for indepen fuel storage, high level radioactive waste storage, and the use of radioactiv packaging. The Program is designed to meet the requirements of Title 10 of the Co Federal Regulations (CFR), Part 71, Subpart H and Part 72, Subpart G.

The Quality Assurance Program applies to all activities affecting quality an operation, documentation, procurement, repair, material, fabrication, inspectio equipment operation and use, maintenance, modification, inventory, shipment and r retention.

i Design and fabrication of shipping casks shall not be conducted under this Qualit Program.-

Quality Assurance is responsible for the establishment of the Quality Assuranc which meets the requirements of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G assuring implementation of the Program.

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, Board of Man 2gers Ed.c/9 9 Date l

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I PRIVATE FUEL STORAGE LLC Issue 2 l

' QUALITY ASSURANCE PROGRAM l

0.0 -

Introduction i

This Quality Assurance Program (QAP) has been developed to ensure that necessary controls are in place to assure the quality of all materials and processes used for the independent storage of spent nuclear fuel and high level radioactive waste as well as the use of radioactive shielding, casks, containers and oth:r equipment pertaining to shipping packaging for radioactive materials.

The QAP delineates requirements and procedures necessary to exercise control over design, operation, documentation, procurement, material, fabrication, inspection, operational testing, equipment operation and use, maintenance, repair, modification, inventory, shipment and quality records retention.

The QAP and implementing procedures shall be designed and administered to meet the 18 criteria of 10 CFR 71, Subpart H and 10 CFR 72, Subpart G.

The QAP contains a statement of policy and authority, signed by the Chairman of the Board which defines the QAP as the Corporation's policy related to quality. The QAP states the policies, assigns the responsibilities, and describes and summarizes the procedures governing the design, procurement, construction, testing and operations of safety important components, systems and structures as defined by contract in compliance with applicable lic6nsing/ certification regulations.

The policies described in the QAP implement the requirements of Title 10, CFR Part 71, Subpart H; and Part 72, Subpart G as well as additional requirements of ANSI, ASME, regulatory guides, and military standards as applied to orgamzations performing design, procurement, construction, testing and operational activities for nuclear applications to the extent specified by contract and licensing / certification regulations.

The statement of policy and authority includes provision to specify that attainment of quality objectives is the responsibility of all personnel of the PFSLLC. It also states 3

that compliance with the Quality Assurance Program as is mandatory for all PFSLLC personnel whose activities affect quality.

- Quality Assurance, reporting to the Board of Managers, is given full responsibility for maintaining the QA Manual and for assuring uniform implementation of the Quality Assurance Program requirements. Quality Assurance has the authority and resources to maintain oversight and initiate management action to limit further processing on items of indeterminate quality, to initiate management action to resolve any de6ctencies, and to assure that satisfactory resolutions have been achieved prior to authorizing further processing.

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE-FROGRAM 1.0 Orsanianden The PFSLLC Organization (see Figure 1) consists of a Board of Managers, Quality Assurance, Business Services Unit, Project Manager, Licensing Manager, Public Relations Director, Architect Engineer, Human Resources Development Group, and Administrative Group and Technology Committee who have responsibilities as follows:

i Board of Managers are responsible for budget approval, financial oversight, planning, utility liaison, and business development as well as assuring the effective and efficient implementation of this program.

l Ounlity Assurance is responsible for establishing this program as well as determining l

the effective implementation by performing audits. Quality Assurance has the authority l

to stop fabrication, construction, installation or testing of components, systems or j

l structures which do not conform to applicable regulatory requirements, codes and standards and specifications or procedures.

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E Quality Assurance shall be independent from other organizations and shall have direct access to the Board of Managers.

1 Business Services Unit is responsible for accounts payable, accounts receivable, l

payroll, and other business related services associated with the operation of the PFSLLC.

Proiect Director is responsible for the day-to-day direction of all aspects associated with the creation of the PFSLLC, including licensing activities and enforcement actions.

Project Manager is responsible for all public information and government relations.

Architect Engmeer is responsible for project design, preparation of license applications i

and any other activities as directed by the Project Manager.

l Admini=trative Groun supplies all clerical needs and on-site record controls to support L

the project.

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM 2.0 Onauty Assur==ce Prorr==

The QA Program described herein sets forth the requirements for the control of quality in the design, fabrication, operation and maintenance of independent spent fuel storage installations / monitored retrievable storage facilities (ISFSIs and MRSs) and the use of shipping containers for nuclear products.

The QA Program shall be implemented through Quality Assurance Procedures which contain detailed implementing instructions.

The QA Program is designed to provide control of activities affecting quality in systems, structures and components that involve approved package design or facility licensing requirements that are important to safety.

Training and/or evaluation of personnel qualifications are required for all Quality Assurance functions in accordance with written procedures. The training program requires that all employees who participate in the QA Program will receive a level of classroom and on-the job training commensurate with their involvement in the licensed activities. When required by applicable codes and standards, qualified personnel shall be appropriately certified in accordance with approved procedures.

The QA program shall be reviewed at established intervals to assure its adequacy and status and the program is being effectively implemented. Management of other orgamzations participating in the Quality Assurance program shall regularly review the status and adequacy of that part of the program which they are executing.

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7 PRIVATE FUEL STOfdGE LLC Issue 2 QUALITY ASSURANCE PROGRAM l

3.0 Design Control This section establishes the requirements to assure that structures, systems and components are designed, added, deleted or modified in accordance with applicable regulatory requirements, codes and standards.

The design control process shall be implemented in accordance with written procedures. Design input and criteria are translated into specifications, drawings, procedures,' calculations, instructions and procurement documents prepared and reviewed by qualified personnel. Design inputs include the design basis, regulatory requirements, applicable codes and standards and quality assurance requirements.

Design control procedures shall be prepared to describe and control the design and any changes from inception through final approval, release, distribution and implementation.' The procedure shall provide identification and control of design interfaces and for coordination among participating design organizations. The procedures shall provide for the review of items such as: stress, hydraulic, thermal, criticality physics, radiation, shielding, and accident analyses; compatibility of materials; accessibility for inspection, maintenance and repair; features to facilitate decontamination; and delineation of acceptance criteria for inspections and tests. The procedure shall provide for a design review by qualified personnel other than those performing the design.

Any design change or field change shall be subjected to the same design control measures as specified for the original design.

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PRIVATE FUEL STORAGE LLC

!ssue 2 QUALITY ASSURANCE PROGRAM i

4.0 Procurement Document Control This section establishes the measures to assure that procurement documents covering material, equipment, and services specify appropriate quality requirements. The procurement documents shall specify or reference the applicable requirements, design bases, codes, and standards to assure quahty.

All procurement activity shall be performed in accordance with written procedures delineating requirements for preparation, review, approval and control of procurement documentation. Revisions to procurement documentation shall be reviewed and approved by the same cognizant groups as the original.

Supplier evaluation and selection, objective evidence of supplier quality, assignment of quality requirements to procurement documents, including related design documents, and source, in-process and receiving inspection shall be administered and controlled in accordance with approved procedures.

Purchase orders shall include specifications which contain all the information necessary to assure that material, equipment, and services are of adequate quality.

Documentation required to provide evidence that materials, equipment, and services are of adequate quality shall be clearly delineated in purchase orders.

To the extent necessary, procurement documents shall require suppliers of material, equipment, and services to have a quality assurance program complying with the pertinent provisions of 10 CFR 71, Subpart H or 10 CFR 72, Subpart G. The requirements of 10CFR Part 21 shall be specified on procurement documents as applicable. Suppliers will be required to provide access to their facilities and records for inspection and audit, as required, to determine compliance with provisions of purchase orders. These requirements shall extend to lower tier procurements, as determined by management.

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- QUAUTY ASSURANCE PROGRAM 5.0 lastructions. Procedures and Drawings This section establishes the measures to assure that activities affecting quality are performed in accordance with approved instructions, procedures and drawings.

All instructions, procedures and drawings are to be developed, reviewed, approved, utilized and controlled in accordance with the requirements of approved procedures.

Changes to instructions, procedures and drawings shall be developed, reviewed, approved, utilized and controlled using the same requirements as applied to the original documents.-

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Procedures shall be developed and implemented for those operations that affect quality.

Procedures define the manwr in which quality objectives will be attained, such as criteria for workmanship tc comply with standards, inspections, tests and verification activities. Documented work instructions define suitable equipment, working environments, werk processes and approvals. Work instructions include methods to measure performance against established technical and quality requirements.

Procedures and instructions shall be established and maintained to ensure that sufficient records are specified, reflect the quality of the work performed and comply with appropriate codes, standards and regulatory requirements.

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1 PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM r

6.0 I)ocument Control This section describes the system to control the issue, use, review, approval, distribution and revision of quality related documents.

Procedures shall be developed to identify individuals /orgamzations responsible for control, review, approval and issuance of documents.

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Documents, including revisions, that are to be controlled shall be pr: pared, reviewed j

and approved by qualified personnel using document control procedures. Procedures shall be implemented specifying required reviews and approvals and distribution of

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documents.

Dwanents shall be distributed to and used at the location where the activity prescribed by the document is performed.

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j PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE

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PROGRAM j

7.0 Control of Purch=M M* rial. Eauine=*=* and Services This section establishes the requirements to assure that purchased material, equipment and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents.

Procedures shall be implemented and used for determining supplier selection and evaluation. Procedures shall include criteria for the performance of supplier audits.

This would include items such as: the supplier's capability to comply with codes and standards, supplier performance and review of the supplier's QA program and facility operation.

Suppliers of radioactive shipping packaging shall be evaluated to ensure that the design and fabrication of packaging are performed under the control of an NRC-approved QA Program.

Supplier performance evaluations shall be performed on a periodic basis. The time intervals shall be established based on the importance, complexity and quantity of the product or services.

Receipt inspection consistent with importance and complexity shall be performed using l

approved procedures to assure:

a.

The material, component or equipment is properly identified and corresponds with the identification of the applicable receiving documentation.

b.

Material, components, equipment and acceptance records are inspected and are acceptable in accordance with inspection instructiors, prior to installation or use.

c.

Inspection records and/or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.

d.

. Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work, i

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM J

l 8.0.

I?=M- =F

=d C "ml of Macd=l== Parts and Comac= =:

This section establishes the requirements for the identification and control of material, parts and components from receipt through installation or use.

l, Approved instructions and procedures shall be implemented for the identification and control of materials, parts and components. An identification system shall be established using purchase order numbers, heat numbers, part numbers, serial numbers, or other means to identify and control materials, parts and components.

Specifications shall require that materials, parts and components are identified by some l

means and shall require that documentation have identification providing traceability to the item.

l A means of physical identification should be used to the maximum extent possible for relating an item at any time to applicable documentation. Identification shall be either I

on the item or records traceable to the item. Where physical identification is impractical, physical separation, procedural control, or other appropriate means shall be employed.

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM 9.0 Control of Special Processes This section establishes the measures to assure that special processes, including welding, heat treating, radioactive waste processing, and non-destructive testing, are controlled and accomplished by quailfied personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria,'and other special requirements.

Special processes shall be planned through items such as: documented work instructions, defining the sequence of operations, special environments, suitable equipment, and criteria for workmanship standards. process connols shall be established to ensure characteristics are maintained within specified requirements.

Each special process shall be performed in accordance with instructioni,, procedures, drawings, checklists, or other appropriate means. Measures will be taken to ensure process parameters are controlled and that environmental conditions such as temperature, humidity, and cleanliness are maintained. The written procedures for special processes shall specify the qualifications of personnel, the proper equipment to be used, and control of materials and supplies.

Equipment used for accomplishing special processes shall be calibrated, maintained, stored, handled and issued in accordance with applicable procedures.

Personnel shall be qualified to ensure proficiency in the special skills required for the process. The knowledge and capabilities required of personnel performing special processes shall be delineated in written instructions, including requirements for periodic evaluations of continuing proficiency.

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE

' PROGRAM 10.0 Inspection This section establishes a program for inspection of activities affecting quality to verify conformance with approved procedures, drawings and specifications.

Approved procedures shall be implemented delineating inspection methods, characteristics and documentation. Inspections shall be performed by qualified personnel other than those who performed or supervised the work being inspected.

Mandatory inspection hold points, which require witnessing or inspecting of an activity before processing, shall be indicated in the appropriate procedures or specifications.

The inspection shall be documented to indicate approval and release prior to continuation of the activity.

Inspection requirements shall apply to all activities whether performed by company personnel or contractor personnel, and shall require that inspection procedures and instructions are provided with necessary drawings prior to commencing inspection activities.

Inspection requirements governing modifications, repairs and replacement shall be in accordance with the original design and inspection requirements or as amended by approved changes to the original design.

Where direct inspections of processed material or products cannot be called out, indirect controls will be utilized to control quality.

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' PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE 1

PROGRAM l-11.0 Test. Control This section establishes the requirements for a test program to demonstrate that structures,' systems and components will perform satisfactorily in service.

A program shall be established to assure that all testing required to demonstrate that structures, systems and components will perform satisfactorily in service is identified and documented.

Testing shall be performed in accordance with approved test procedures which incorporate or reference the requirements and acceptance criteria contained in applicable design documents and specifications.

Test procedures shall incorporate, but not be limited to, requirements for such items as:

hold points, witness points, caution notes, and emergency requirements.

Test results shall be documented and evaluated to ensure that test requirements have been satisfied.

Test results which fail to meet the requirements and acceptance criteria shall be properly noted and appropriate corrective action taken.

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p PRIVATE FUEL STORAGE LLC Issue 2 l

QUALITY ASSURANCE PROGRAM l

12.0 Control of Merine and Test Eauirunent This section establishes the requirements for the control, calibration, and periodic adjustment of tools, gauges, instruments, and other measuring and test equipment used to verify conformance to established requirements.

Inspection, test, and work procedures shall include provisions to assure that tools, gauges, instruments, and other inspection, measuring, and test equipment and devices used in activities affecting quality are of the proper range, type, and accuracy to verify conformance to established requirements and test parameters.

To assure equipment accuracy, inspection, measuring, and test equipment shall be controlled, calibrated, adjusted, and maintained periodically, or prior to use.

Calibrations are performed against certified measurement standards that are traceable to nationally recognized standards. Where national standards do not exist, provisions will be established to document the basis for calibration.

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PRIVATE FUEL STORAGE LLC Issue 2 QUAllTY ASSURANCE PROGRAM 13.0 Handlina. Storsqre and Shinping This section establishes the measures to control the handling, storage, shipping, cleaning, packaging, and preservation of raaterial and equipment to prevent damage, deterioration, or loss through shipment, installation or use.

Approved procedures and instructions shall be implemented delineating the requirements for handling, storage, shipping, cleaning and preservation of materials and equipment.

When required, procedures shall describe special equipment to be used, protective environments and coatings, or other protective measures. Documentation such as records of inspections or maintenance or required shipping documentation shall also be specified in procedures and instructions.

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r PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM 14.0 i== Man. Test==d Oneraine Semene i

This section describes the system for indicating the inspection, test and operat ng status of components and systems.

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4 Approved procedures shall be implemented that include measures to preclude bypassing of inspections and tests, or prevent the operation of equipment or systems until authorized by designated personnel.

The operating status of systems and components shall be concoiled through the use of tags secured to appropriate valves, switches, or control mechanisms. The use of tags and authorization for application and removal shall be specified in approved procedures. The use of status indicators shall be utilized on systems or components when operation, or removal from operation, would adversely affect performance of the system, constitute an operational safety or environmental hazard, or violate statutory / regulatory compliance requirements.

The vatus of inspections and tests shall be indicated on the item to the extent possible, or in documents traceable to the item. The status is identified by the use of tags, markings, stamps, or other means to ensure required inspections or tests are not bypassed. Status indicators shall be specified in approved procedures.

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PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM 15.0 Non-Conforming Materials. Parts or Components This section establishes the measures to control materials, parts or components which do not conform to specified requirements in order to prevent their.nadvertent use or installation.

Approved procedures shall be implemented to provide requirements for identifying, segregating, reporting discrepancies and dispositioning of non-conforming items as well as notification to affected organizations.

Materials, parts, or components which do not conform to requirements shall be identified and placed in a hold status. Nonconforming items shall remain in a segregated area as appropriate until approved disposition has been received.

The disposition of nonconformances shall be evaluated and approved by appropriate personnel in accordance with approved procedures. Nonconforming items shall be controlled until final disposition is approved by authorized personnel.

Disposition of a nonconformance involving repair or rework shall include provisions to i

retest or reinspect to the original acceptance criteria. Any changes to design require the same design control as those applied to the original design.

Nonconformances shall be closed by qualified personnel in accordance with written procedures. Closure activities include verification that the corrective action was adequate, complete and documented appropriately.

Approved procedures shall identify methods for reporting adverse quality conditions in accordance with 10 CFR Part 21 requirements. Nonconformances are evaluated by appropriate personnel to determine reporting requirements.

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p PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE l

PROGRAM l

l 16.0 Correcdve Acdon l

This section establishes measures to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment and nonconformances are promptly identified and corrected.

l Conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations i

and defective material and equipment, shall be identified and reported to appropriate personnel using approved procedures. For significant conditions adverse to quality, the L

cause of the condition and corrective action necessary to prevent recurrence shall be identified, implemented and then followed-up to verify corrective action effectiveness using approved procedures.

Appropriate levels of management will be notified of significant conditions adverse to quality and the disposition of these conditions.

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I PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM

- 17.0 Opality Assurance Records This section establishes measures for maintaining records of activities affecting quality.

Approved procedures shall be developed and implemented to establish controls for the identification, receipt, storage, preservation, safekeeping, traceability, retrieval and l

disposition of records.

Records to be maintained would include, but not be limited to, design, engineering, procurement, manufacturing, construction, inspection and test, installation, operations, maintenance, modification, calibration, audit, personnel qualifications, and procedures.

Inspection and test records shall identify as applicable: inspection type; evidence of completion and verification of manufacturing, inspection on test operation; date and results of inspection or test; information relating to noted discrepancies; inspection or data recorder; evidence of acceptance.

Records shall be maintamed in facilities designed to prevent their loss or deterioration and shall comply with one of the following: 1) two sets of identical records are maintained at separate storage locations, or 2) the official copy of QA records is maintained in approved fireproof files or vaults at a single location.

A system shall be established to identify all documents and record retention for the project. At a minimum, records pertaming to the design, fabrication, erection, testing, maintenance and use of structures, systems and components important to safety shall be maintained until termination of the license.

19

PRIVATE FUEL STORAGE LLC Issue 2 QUALITY ASSURANCE PROGRAM 18.0 Audits This section establishes the requirements for a system of planned and documented audits to verify compliance with all aspects of the Quality Assurance Program and to assess the effectiveness of the program. The system provides for the reporting and I

review of audit results by appropriate levels of supervision and management.

Audits shall be performed in accordance with written procedures or checklists by appropriately trained personnel having no direct responsibilities in the area audited.

Audits and surveillance results shall be documented and reviewed with supervision responsible for the area audited who shall take necessary action to correct reported deficiencies.

Audit results shall be documented and reported to the management having responsibility in the area audited.

Deficiencies or nonconformances uncovered during an audit shall be documented and brought to the attention of the appropriate management personnel. Follow-up actions, including a reaudit, shall be performed to verify that corrective actions have been taken to correct the deficiencies or nonconformances.

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EXCERPTS FROM DEPOSITION OF MARVIN RESNIKOFF i

p 72 1

there is not an issue concerning safety, the State 2

is not going to push issues that are imaginary.

3 Q-All I am saying is is there any reason to 4

believe the crane would not be designed to properly 5

hold'the cask?

Do you have any reason to believe 6

that?

That's what I am asking you.

7 A

It is a sizeable object that has to be 8

lifted.

You know, we have concerns about dropping 9

one of these casks, concerns about the effect on 10 welds, so we have some concerns about the safety of 11 the crane.

12 MR. GAUKLER:

Anything else before I go on 13 to G?

14 MR. TURK:

No.

l 15 BY MR. GAUKLER:

l 16 Q

What, going to Utah contingent G, quality l

17 assurance -- what did you do today to prepare with l

18 respect to Utah Contingent G?

19 A

I reviewed the contention and I reviewed 20 the NRC regulations.

l 21 Q

What documents have you had a hand in 22 preparing relating to Utah G?

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1

'A Well, I have reviewed the discovery 2

documents, the discovery documents that we-have.

l 3

Q I think you misunderstood my question.

My 4

question was what documents have you had a role in 5

developing or preparing with respect to Utah 6

Contention G?

7

~A Well, the contention itself.

8 Q

Any others?

l 9

A Together with, as I mentioned, Mr. Ben =,

10 Ed Benz.

11 Q

He also played a role in preparing the 12 contention?

13 A

Yeah.

He worked with Lawrence White.

14 Q

And what role did you play in preparing 15 the contention?

16 A

It is hard to know where one ended, since 17 documents were passed back and forth, you know, 18 before they were finalized, but my general role was 19 to compare the regulations and the application.

20 Q

And what was Mr. Benz's role in preparing 21 Utah G?

22 A

It was similar, similarly.

We had similar ANN RILEY & ASSOCIATES, LTD.

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roles.

I think as I remember the process I was one 2

of the last ones,-technical persons to actually look 3

at and make sure everything waa okay when it was 4

handed over to the lawyers.

5 Q

So you reviewed Mr. Benz's draft?

j i

6 A

Also did my.own and reviewed his, made 7

sure it all fit together.

8 Q

Was there a particular part of the Utah G 9

that you drafted versus Mr. Benz?

l 1

10 A

I have to say I don't remember who drafted 11 which part.

I also reviewed this quality assurance.

12 program description, which was filed, you know, by 13 well, for the Mescaleros sometime ago, 1996.

14 Q

You are referring to the Private Fuel 15 Storage L.L.C. quality program description,-August 16 1996?

Is that the date?

17 A

Yes.

18 Q'

What exposure or background do you have 19 with respect to nuclear quality assurance?

/

20 A

As it relates to this issue, the dry 21 storage facility, I have reviewed the inspection 22 reports and correspondence with Consumer Power ANN RILEY & ASSOCIATES, LTD.

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concerning the Palisades. storage facility, 2

particularly the VSC 24 cask and the welding 3

problems that had occurred, and the certification of 4

welders.

So that was another different proceeding.

5 Q

Excuse me, you said in a different 6

proceeding?

7 A

That was the issue of storage facility at 8

Palisades.

I mean, it was a dry storage facility, 9

but not PFS's.

10 Q

So you are saying those inspection reports 11 were involved in a different proceeding?

12 A

No.

They were all -- the inspection 13 reports were all done as an overview of Palisades, 14 the Consumer Power operation at Palisades.

15 Q

So you reviewed these inspection reports?

16 A

Yes.

17 Q

Any other exposure or background with 18 respect to quality assurance as it relates to 19 nuclear facilities?

20 A

I can't remember any more off the top of 21 my head.

22 Q

You don't have any training in nuclear l-i r

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76 1

quality assurance?

2 A

I don't have specific training concerning 3

quality assurance.

4 Q

Do you have any publications concerning 5

nuclear quality assurance?

I 6

A No.

7 Q

Have you ever reviewed the adequacy of a l

8' quality assurance program for a nuclear facility?

9 A

As I said, only the problems as they 10 related to.the Palisades reactor.

11 Q

And that was you reviewed the inspection 12 reports; is that it?

13 A

And an inspection of the cask designers 14 and the' cask manufacturers all the way down the i

15 chain involved in the construction of those dry 16 storage casks at Palisades.

17 Q

Have you ever testified before concerning 18 a quality assurance program for a nuclear facility?

19 A

I do' remember -- yes is the answer to 12 0 that.

And that involved hearings before the Public 21 Service Commission in Wisconsin concerning the Point 22 Beach reactors in which these issues involving ANN RILEY & ASSOCIATES, LTD.

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quality assurance were raised, the issues at 2

Palisades were raised.

3 Q

What issues are raised in that proceeding 4

specifically?

5 A

Concern about the quality -- concern about 6

the safety of these, the dry storage system.

7 Q

When were those hearings in Wisconsin 8

held?'

9 A

Say that again.

10 Q

When were those hearings in Wisconsin 11 held, approximately?

12 A

I would say within the past three years.

13 Q

Now, the inspection reports that you 14 referred to with respect to Palisades, those were 15 inspection reports concerning the vendors' quality

{

16 assurance program; is that correct?

17 A

Yes.

Well, the vendors, but also we went 18 further back to the manufacturers of casks, both 19 quality assurance of the welds, how well the casks 20 were welded together, it involved issues about 21 unloading.

These were inspection reports also of 22 the utility involving the ability to unload these --

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1 it was more than inspection reports.

It was 2

meetings held with NRC-staff and contractors, 3

correspondence that went back and forth.

4-Q And for what purpose did you do this 5

review of the inspection reports and the associated 6

documents?

What was the purpose of that review?

7 A

To investigate this for this Wisconsin PSC 8

hearing.

I also looked into it for the Prairie 9

Island Indian community concerning the Prairie 10 Island reactors, as far as unloading the casks were 11 concerned, that issue.

12 Q

The hearing involved at the PSC in 13 Wisconsin, did it not involve the licensing of an 14 independent storage installation?

Isn't that 15 correct?

16 A'

That's right.

It involved rate 17 proceedings.

18 Q.

Rate proceedings?

19 A

Yes.

20 Q

The State claims that the QA program as 21-submitted by PFS lacks adequate detail.

What is 22 your opinion as to the level of detail required in a I

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1 quality assurance program?

2 A

Well, my answers could be the same as the 3

last one I gave for F&P that we talked about earlier 4

today, which is the process that I.would undertake, 5

which is I.would look at the QA program for.the 6

utilities and see and compare it to the PFS quality 7

assurance program, which was developed under part 8

71, not part 72.

9 So I can't give you specific examples 10 other than that right now.

11.

Q So you don't have an opinion right now in 12 terms of what the level of detail is in terms of the 13 quality assurance program?

14 A

Right now I don't, not as we sit here.

i 15 All the issues, you know, appear in the petition.

16 And I haven't yet done that review to --

17 Q

You have not reviewed any applications of 18 other nuclear facilities in terms of --

4 E19 A

Not yet.

20 Q

-- what level of detail they have for the 21 quality assurance program?

22 A

That's right, not yet.

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Q' Okay.

So you don't know at this point in L

2 time-what the appropriate division is between the 3

' level of detail in the quality. assurance program and 4

that which appears in the procedures in planning the 5

' program?

6 A

'As we sit here, no.

7 Q

.The State also alleges that the quality 8

assurance program, especially the_ structure of the 9

quality assurance' program, is not -- strike that.

.c

~10 The State also alleges that the quality 11-assurance' organization for PFS is not sufficiently 12 independent.

What is the basis of that assertion?

13 A-The basis is the following:

It makes it

<14

'different from.the standard dry storage proposals-15.

that utilities have, in which you have a utility L16 responsible for those d27 storage containers which i

17

. set /out.on'its pad.

You have PFS essentially owning 18 the. casks, but you have the utilities actually 19.

filling the casks and sealing the casks so'that PFS R20 depends on some-other entity to do the work, depends 21 on many'different' entities, many different welders, 22 many differentlQA programs.

i i

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And PFS essentially has the responsibility 2

of1-- well, is essentially responsible then for the 3

storage of these -- for transporting these 4

containers and storing them at its site while

)

5 someone else was responsible for actually loading up 6

the containers and sealing them.

And in that sense 7

it is different, different from the standard utility 8

approach which the NRC has licensed.

9 So we have concerns.

That's the basis for 10 our concern and'why the QA program is so important.

.11 MR. GAUKLER:

Right nok does he have the 12

. contention there, counsel?

13 MS, CURRAN:

Yeah.

Just let me take a 14 break for a second.

15 (Counsel confers with the witness.)

16 THE WITNESS:

Okay, I have been to the 17 woodshed again.

1 18 BY MR. GAUKLER:

19 Q

Do you have anything to add with respect 20 to the last question and answer?

21 A

Well, counsel pointed out to me that 22 though all the points I raised were well taken, they ANN RILEY & ASSOCIATES, LTD.

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82-

1 related to a part of-the contention that had been l-2

' tossed.

3 Q.

.That had been dismissed by the board, 4

right?

C 5.

A Yes, that's,a more kindly.way'to put.it.

6 Q

I would like to have you focus on the --

7-do you have the contention in front of you there 8'

'now?-

9 A

I do.

The question that you raised 10 relates to this failure to demonstrate independence j

11 of'QA organization.

12 Q

Correct, which is page 50 of the 13

' contention.

14

.A Yes..

15-Q.

What is: the basis, as you understand it, 16' for that: concern?

s

17

.A

~ I don't think I have anything to add, 18 other than what appears in that contention, which is 19 questioning the independence of~the QA committee.

l

- 20

-Q.

If the QA committee had access to the 21 chairman of the board,' would that alleviate your

~

22.

-concerns?

In other words, if there was an i:

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)

1 organizational access to the chairman of the board?

2 A

That would give me more confidence, yes.

3.

Q That they would have an avenue beyond the 1

4 manager to go up to the board to express their QA 5

concerns, correct?

6 A

That would give me more confidence, you 7

know, and there are some other issues that are also 8

included in the petition that are indicated.

9 Q

Have you ever reviewed previously the 10 organizational structure for a company or group of 11 people operating a nuclear facility to evaluate the 12 independence of the quality assurance organization 13 within the organizational structure?

14 A-Not really, not really.

I see the 15 importance of the issue but 16 Q

You have not evaluated other 17 organizational structures with respect to whether 18 the quality assurance organization within that 19 structure was sufficiently independent to meet the 20 NRC requirements; is that correct?

21 A

Not really.

'22 MR. GAUKLER:

I have no further questions ANN RILEY & ASSOCIATES, LTD.

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84

'l on G.

2-MR. TURK:

I have a few follow-up 3

questions.

4-EXAMINATION 5

BY MR. TURK:

6 Q'

Are you_ aware of any'NRC, regulatory' 7.

guidance that would apply to the independence of a 8

'QA organization?

9 A

No, I am not.

Similar to F&P, I haven't 10 reviewed any, if any exists.

i

- 11 Q

What is your understanding of how a QA 12 program has to be structured in order to satisfy NRC 13 requirements?

14 -

A My understanding is the following:

The QA has to be set up so that if there are problems that 1

16 arise, it can call a halt to operations.

It has to 17 have that independence and that connection with the l

18 manager of the organization.

That's a general gut 19-feeling that I have about what has to be done with 20 the QA' program.

21 Q

I am not sure I understood what your point i

22 was.

The manager of QA has to have -- what did you l

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i say he has to have?

2 A

The manager of the QA program has to be 3

able -- must have the independence to call a halt to 4-operations.if~there is some failure and has to have 5

the connections to the board of managers to be able 6

to have the board of managers call a halt to the 7

operations.

8' Q

In terms of --

9 A

That's why it has to be independent.

It 10 can't be just part of the operation but has to be 11 able to have a check role.

.12 Q

In terms of the program itself, do you 13 understand what the program elements are?

For 14

' instance, is there supposed to be a plan, a quality 15

' assurance plan?

16 A

It is my understanding.

17 Q

Are there any other elements of a program, 18 other than the plan itself?

19 A'

Well, yeah, the guts of the plan.

That 20 is, the plan is just a piece of paper, the personnel 21' who are responsible for it and procedures.

22 Q

Have you ever looked at the procedures of ANN RILEY & ASSOCIATES, LTD.

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any other quality assurance organization?

2 A

No.

3 Q

Have you ever looked at the quality 4

assurance plan of any organization, other than PFS?

5 A

Other than PFS?

6 Q

Yes.

7 A

No.

As I said, only as concerns the VSC 8

storage cask and its construction of the Palisades 9

reactor.

10 0

But you didn't look at the QA plan or QA 11 procedures of any organization involved with the VSC 12 cask, did you?

13 A

I didn't.

I just looked at 14 Q

You did not?

15 A

I did not.

Rather, I looked at the 16 license -- the inspection reports that discussed the 17 QA procedures and the fact that they weren't 18 satisfactory.

19 MR. TURK:

That's all I have.

20 MS. CURRAN:

I need a consult, and then I 21 may have a question.

22 (Counsel' confers with the witness.)

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MS. CURRAN:

I don't have any questions.

)

2 EXAMINATION i

3-BY MR. GAUKLER:

4 Q

Dr. Resnikoff, I would like to turn to 1

5 Utah Contention K next.

What did you do today, what 6

did you do to prepare for today's deposition with 7

respect to Utah Contention K?

)

8 A

I reviewed the contention.

I reviewed 9

some of the responses, the RAI responses.

I 10 reviewed some of the discovery materials that -- is 11 it General Cole?

Is that the right term?

12 Q

Yes.

13 A

-- has developed, has obtained.

I 14 reviewed that file, 15 Q

Did you review any other discovery 16 documents, other than those that General Cole had 17 obtained?

i 18 A

Some maps that I reviewed, a map of the j

19 Utah testing range.

l I

20 Q

Of the Utah Testing Training Range?

l 1

21 A

Yes..

I had a discussion with General 22.

Matthews.

1 l

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