ML102800306

Request for Additional Information (Enclosure)

ML102800306
Person / Time
Site:	07007016
Issue date:	10/20/2010
From:	Office of Nuclear Material Safety and Safeguards
To:	GE-Hitachi Global Laser Enrichment
References
Download: ML102800306 (9)

Text

Enclosure Request for Additional Information General Electric-Hitachi Quality Assurance Program Description QAPD-1 Acronym Section Please clarify the use of brackets following definitions provided in the acronyms section of the Quality Assurance Program Plan (QAPD); do the bracketed referenced indicate that a definition was cited verbatim from the reference or was the definition derived from the reference document and modified as needed to suit the intent of the QAPD? Also, please provide specific references where multiple document versions may be relevant (i.e., American Society of Mechanical Engineers (ASME) NQA-1-2004 instead of ASME NQA-1).

QAPD-2 Acronym Section In the QAPD, a Basic Component is defined as: A structure, system, or component (SSC) designated as an item relied on for safety (IROFS), or part thereof that affects the IROFS function, that is directly procured by the licensee of a facility or activity subject to the regulations in 10 CFR 70 and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the U.S. Nuclear Regulatory Commission (NRC) would create a substantial safety hazard Please clarify the use of the phrase, would create a substantial safety hazard, in lieu of the wording used in Title 10 of the Code of Federal Regulations (10 CFR) Part 21, which uses the phrase could create a substantial safety hazard.

Also, in the QAPD, Dedication is defined as: An acceptance process undertaken to provide reasonable assurance that a commercial-grade item or service to be used as a basic component will perform its intended item relied on for safety (IROFS) function and, in this respect, is deemed equivalent to an item designed and manufactured under a 10 CFR 50, Appendix B, Quality Assurance Program. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted in accordance with the applicable provisions of 10 CFR 50, Appendix B. The process is considered complete when the item is designated for use as a basic component.

Please clarify the references to Appendix B to 10 CFR Part 50 since the proposed facility will not implement an Appendix B Quality Assurance (QA) Program.

Please ensure consistency of these definitions, if revised, with those identified in the License Application (LA).

2 QAPD-3 Section 2 If applicable, please identify the interrelationships and areas of responsibility and authority for any external organizations performing activities relied on for safety, including principal contractors (such as architect/engineer, constructor, construction manager, and operator).

Also, please clarify that persons or organizations responsible for ensuring that appropriate QA has been established and for verifying that activities affecting quality have been correctly performed have sufficient authority, access to work areas, and organizational independence to carry out their responsibilities. The QAPD states that the QA and Infrastructure Program Manager will have sufficient authority, access to work areas, and organizational independence to carry out his or her responsibilities; however, these provisions are not defined for the other key QA personnel identified in Section 2.

QAPD-4 Figure 1 Figure 1 of the QAPD identifies the Global Laser Enrichment Project Design and Construction Phase Organization Chart. Please identify what organizational relationships will be applied during facility operation and decommissioning. Also, please identify how the organization will be structured and executed when construction and operations are performed concurrently.

QAPD-5 Section 2.5 Section 2.5 of the QAPD states that:

The Global Laser Enrichment (GLE) Projects Manager reports to the GLE President and CEO.

The GLE Projects Manager is responsible for managing the design, construction, initial startup, and procurement activities. In addition to managing contracts, the GLE Projects Manager also manages a group of Project Managers and the Project Controls Manager. The Project Managers are responsible for Procurement, Construction, Engineering, Project Engineering, Project Controls, and Startup.

Please identify the responsibilities of the Project Controls Manager, and, if applicable, any minimum qualification requirements applicable to the Project Managers and the Project Controls Manager.

QAPD-6 Section 2.7 Section 2.7 of the QAPD states that, Changes to the facility or to activities of personnel that require prior NRC approval are reviewed and approved by the EHS Manager or designee.

Please identify any controls that will be applied at the proposed facility with respect to designation authority to ensure that persons who perform QA activities as designees have sufficient qualifications, knowledge, and experience to appropriately perform such activities.

Also, if applicable, please identify any documentation requirements applicable to designation authority, such as that a memorandum will be prepared and maintained on file as a QA record for persons who are granted signature authority for other persons.

3 QAPD-7 Section 2.8 and Figure 1 Please identify why the GLE Procurement Manager, who reports operationally to the GLE President and CEO, is not shown on the Organization Chart provided as Figure 1 of the QAPD.

Also please clarify if the Procurement Manager is the GLE Procurement Manager or if it is the General-Electric Hitachi Procurement Manager.

QAPD-8 Section 3.2.3 Section 3.2.3 of the QAPD states that, The specific application of training and qualifications, consistent with the general descriptions provided in GLE LA Section 11.3, are driven by a task analysis that addresses human factors elements, complexity of the safety function carried out, and basic knowledge of the individuals involved.

Regarding the phrase basic knowledge of the individuals involved, please clarify if the task analysis considers the existing level of knowledge of individuals who will be involved in the task, the level of knowledge or skill needed for the personnel, or both.

QAPD-9 Section 4 Section 4, Design Control, of the QAPD uses the term design management. Please verify that this term is equivalent in intent to design control. Also, Paragraph 2 of Section 4 states the following:

Design management includes the following:

Organizations in which the Design Control System is to be implemented; Design interface responsibilities between internal and external organizations; Exchange of technical information between internal and external organizations; Use of implementing design policies, plans, and/or procedures; Establishment of technical requirements and design standards; Selections and performance of design practices, to include review methods; Preparation of design documents; Extent of design reviews, to include technical reviews, peer reviews, modeling, and alternate calculations, as appropriate; Design output document control, to include review, approval, release status identification, distribution, and revision of documents; Determination and specification of acceptance criteria, required tests and inspections, and program requirements for records; Maintenance and retention of design documents; and Controls for design change.

Please provide clarification as follows regarding this list:

1.

Please identify the intent of the above list. It is the staffs understanding that the list describes functions and responsibilities within the scope of the design control

[management] organization at the proposed facility.

4

2.

For the bullet that reads, Organizations in which the Design Control System is to be implemented, please clarify the intent of this statement. That is, is the statement saying that the design control function includes all GLE Organizations in which design control activities are performed? Is it saying that the QAPD design control requirements will be applied to all GLE Organizations in which design control activities are performed? What is the design control system?

3.

For the bullet that reads, Design interface responsibilities between internal and external organizations, please clarify the intent of this statement. That is, is the statement saying that the design control [management] function is responsible for controlling design interfaces between internal and external organizations? Or is it saying that establishing the responsibilities of internal and external organizations with respect to design interface is a design control [management] function?

4.

For the bullet that reads, Extent of design reviews, to include technical reviews, peer reviews, modeling, and alternate calculations, as appropriate, please clarify the intent of this statement. That is, is the statement saying that the design control [management]

organization will determine the extent of design reviews required for design control activities in order to provide reasonable assurance of the acceptability of the design?

5.

For the bullet that reads, Controls for design change, please clarify the intent of this statement. That is, is the statement saying that the design control [management]

organization is responsible for establishing appropriate controls, such as policies and procedures, to control design changes?

QAPD-10 Section 4 Section 4, Design Control, of the QAPD states that, Design output documents for IROFS such as specifications, system descriptions, and drawings contain requirements for appropriate inspections, testing, and maintenance.

Please provide further description of the requirements that will be identified in design output documents. Will the requirements be high level or will they contain specific details of the inspections, testing, and maintenance to be performed? Will design output documents also contain any relevant acceptance criteria? Will this guidance be supplemented by written procedures or work instructions?

QAPD-11 Section 5 Section 5, Procurement Control, of the QAPD identifies the information that will be included in procurement documents for Quality Level-1 (QL-1) items. Please identify what information will be identified in QL-2 procurement documents.

QAPD-12 Section 5 Section 5, Procurement Control, of the QAPD states that procurement documents for QL-1 items will include, Requirements for the control of nonconformances and changes, including provisions to control and report nonconformance and changes to products being delivered.

Please clarify what is meant by, products being delivered. Do the nonconformance reporting requirements applicable to suppliers apply to fabrication, the time between fabrication and delivery to the facility (when facility formally takes ownership of the item, typically via receipt

5 inspection), or after delivery occurs (such as if the vendor identified a nonconformance in an identical item after delivering it to the facility)?

QAPD-13 Section 5 Section 5, Procurement Control, of the QAPD states that changes to the procurement documents will be subject to the same degree of control as was utilized in the preparation of the original procurement document. Does this include review and approval at the same level of staff/management as the original procurement document?

QAPD-14 Section 6 Section 6 of the QAPD describes controls for facility instructions, procedures, and drawings.

Please describe the review and approval requirements for changes to instructions, procedures, and drawings. Should temporary procedure changes be allowed by the facility, please describe the provisions for implementing such changes to facility documents.

QAPD-15 Section 7 Section 7, Document Control, of the QAPD states that policies, plans, and procedures are maintained under revision control. Does this provision only apply to policies, plans, and procedures, or does it extend to any other facility documents that fall under the scope of the document control program (i.e., documents prescribing or specifying quality requirements or activities affecting the availability or reliability of IROFS such as drawings, work instructions, etc.)?

QAPD-16 Section 8 Section 8, Control of Purchased Items and Services, of the QAPD states that the design function is responsible for determining specific methods of acceptance to be applied to purchased items and reviewing the specific method of acceptance to be applied to services.

Please identify which function within the facility organization will be responsible for identifying the specific method of acceptance to be applied to services.

QAPD-17 Section 8 Please identify circumstances that will allow the conditional release of nonconforming items, and any conditions applicable to the approval and use of conditional releases.

QAPD-18 Section 9 Please identify provisions in Section 9, Identification and Control of Materials, Parts, and Components, of the QAPD that will be implemented at the facility to provide reasonable assurance that incorrect or defective items are not used or identify where such guidance may be found in the QAPD.

QAPD-19 Section 11 Section 11, Inspection, of the QAPD states that the planning of inspection activities, methods, and attributes will be based on, among other things, the importance of the item or activity to be

6 inspected. Please clarify if the importance is the items importance to safety or if a different type of importance is intended.

QAPD-20 Section 12 Section 12, Test Control, of the QAPD identifies the information that will be contained in test policies, plans, and procedures. However, it does not specify that tests required for items or computer programs (i.e., IROFS) will be planned and executed in accordance with these test policies, plans, and procedures. Please provide the commitment to perform testing in accordance with written and approved testing guidance or codes and standards, as applicable.

QAPD-21 Section 12 Please clarify the following statement from Section 12, Test Control, of the QAPD:

Test policies, plans, and/or procedures contain the following information, as appropriate: [] Adequate instrumentation is available and suitable environmental conditions are maintained.

Is the intent of the statement to say that test policies, plans, or procedures will contain provisions to ensure that adequate/appropriate instrumentation is available and suitable environmental conditions are maintained for testing?

QAPD-22 Section 12 The list identifying the information to be contained in test policies, plans, or procedures identifies that policies, plans, and procedures will contain provisions for documenting and evaluating the test results for conformance with acceptance criteria. Please clarify where the acceptance criteria for test will be identified (i.e., will they be included in the test policies, plans, and/or procedures?)

QAPD-23 Section 17 Section 17, Corrective Actions, of the QAPD discusses the actions that will be taken in response to conditions adverse to quality and significant conditions adverse to quality.

However, neither Section 17 nor the Acronyms section of the QAPD define the terms, condition adverse to quality or significant condition adverse to quality. Please define these terms in accordance with how they will be used at the facility.

QAPD-24 Section 17 Section 17, Corrective Actions, of the QAPD states that, Significant conditions, their causes, and corrective actions are documented. Please clarify if information associated with conditions adverse to quality will be documented.

Section 17, Corrective Actions, of the QAPD also states that, Approved written policies, plans, and/or procedures specify requirements for identification and classification of conditions adverse to quality, trending of significant conditions adverse to quality, criteria for determining trends, and follow-up action to be taken to verify implementation of corrective action.

7 Please identify if approved, written policies, plans, or procedures will also specify requirements for: (1) determining and performing corrective actions for conditions adverse to quality and significant conditions adverse to quality; (2) documenting information associated with corrective actions; and (3) making notifications to management when significant conditions adverse to quality are identified. Please note that Chapter 17 of the QAPD does contain commitments to perform action (2) for significant conditions adverse to quality ONLY (not for conditions adverse to quality) and action (3) above; however, it is unclear if these actions will be performed in accordance with written and approved guidance documents.

QAPD-25 Section 18 Section 18, QA Records, of the QAPD states that GLE produced QA records that furnish documentary evidence of quality shall be specified, prepared, and maintained in accordance with applicable regulatory requirements and approved written policies, plans, and procedures.

Please describe the measures that will be implemented for QA records not produced by GLE, such as supplier furnished documents and externally generated test reports that furnish documentary evidence of quality.

QAPD-26 Section 18.2 Section 18.2 of the QAPD states that, Documents are considered valid records only if authenticated (e.g., stamped, initialed, or signed and dated by authorized personnel).

Section 18.2 also states that, Lifetime records are entered into record storage after receipt or validation.

Please clarify the following aspects of the statement that lifetime records will be entered into records storage after receipt and validation:

1.

How does validation differ from authentication?

2.

As described in the QAPD, documents that will be lifetime records have to be authenticated prior to becoming a record; therefore, please describe the chronology to be applied to receipt, validation, and authentication of documents that will become lifetime records.

QAPD-27 Section 18.2 Section 18.2 of the QAPD states that, Temporary storage in approved containers is provided until records are entered into lifetime storage. Please describe where the criteria for identifying approved containers will be designated and identify if there are any time limitations on temporary storage of lifetime records.

QAPD-28 Section 18.2.1 Section 18.2.1 of the QAPD states that, Lifetime records are defined in accordance with ASME NQA-1-1994, Supplement 17S-1, Section 2.7.1, Supplementary Requirements for Quality Assurance Records. The applicable document that specifies the record indicates those to be forwarded for lifetime storage. In the case of specified records produced by supplier, an agreement for records turnover is established.

8 Please clarify the following:

1.

What is meant by the statement that lifetime records are defined in accordance with NQA-1 Supplement 17S-1; is this a commitment to comply with the provisions of ASME NQA-1-1994, Supplement 17S-1, Supplementary Requirements for Quality Assurance Records? If this is a commitment, please ensure that it is referenced as such in applicable portions of the LA and the QAPD and that sufficient guidance and criteria is included in the QAPD to provide reasonable assurance that the provisions of 17S-1 of NQA-1-1994 will be met.

2.

As described in the QAPD, documents that will be lifetime records have to be authenticated prior to becoming a record. Given this statement, please describe the process applied to supplier-furnished documents. Specifically, will documents be received as records or will documents furnishing objective evidence of quality be received from the supplier, authenticated, then designated as records?

QAPD-29 Section 18.3 Section 18.3 of the QAPD states that, Hard copy or microfilm storage facilities shall meet the requirements of ASME NQA-1-1994, Supplement 17S-1, Section 4.4, Supplementary Requirements for Quality Assurance Records.

Please clarify if this is a commitment to meet the provisions of Supplement 17S-1 of NQA 1994. If this is a commitment, please ensure that it is referenced as such in applicable portions of the LA and the QAPD and that sufficient guidance and criteria is included in the QAPD to provide reasonable assurance that the provisions of 17S-1 of NQA-1-1994 will be met.

QAPD-30 Section 18.3 Section 18.3 of the QAPD states that, For electronic storage, backups or duplicate files are generated. Please describe how backup or duplicate files will be maintained and stored.

QAPD-31 Section 19 Section 19 of the QAPD states that, Follow-up action is taken to verify the implementation and effectiveness of the corrective action and to determine if repetitive problems require further corrective action. Please identify if this follow up action is part of the verification performed by the QA Organization or if this action is performed by the audited organization.

QAPD-32 Section 19 Section 19 of the QAPD states that, Audit records include audit plans, audit reports, written responses to the audit findings, and the record of completion of corrective action. Please identify if the documented verification of corrective action, which is performed by the QA organization, is an audit record.

QAPD-33 Section 19 Please identify if any provisions have been established for incorporating the status of audit findings and recommendations in management reports.

9 Liability Insurance Provide proof of liability insurance for the proposed uranium enrichment facility as required under 10 CFR 140.13b.

The regulations in 10 CFR 140.13b require that each holder of a uranium enrichment facility license have and maintain liability insurance. In addition, proof of liability insurance must be filed with the Commission as required under 10 CFR 140.15 before issuance of a license.

On October 4, 2010, you provided a letter from the American Nuclear Insurers (ANI) stating that ANI expects to write nuclear liability insurance for the proposed uranium enrichment facility in Wilmington, North Carolina. In addition, ANI said it currently has a liability insurance policy in place for $200 million for the fuel manufacturing facilities in Wilmington. ANI also stated that ongoing coverage for the proposed uranium enrichment facility is subject to a satisfactory engineering evaluation of the facility. Regardless of the expectation that liability insurance for the enrichment facility will be provided sometime in the future, you will need to submit proof of insurance for the uranium enrichment facility prior to a license being issued. Preferably, proof of insurance should be provided by November 30, 2010, so that this is not carried as an open item in the Safety Evaluation Report.