ML20205R406
| ML20205R406 | |
| Person / Time | |
|---|---|
| Site: | Portsmouth Gaseous Diffusion Plant |
| Issue date: | 04/16/1999 |
| From: | Toelle S UNITED STATES ENRICHMENT CORP. (USEC) |
| To: | Paperiello C NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| GDP-99-0057, GDP-99-57, TAC-L32109, NUDOCS 9904220331 | |
| Download: ML20205R406 (11) | |
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USEC A Global Energy Company April 16,1999 GDP 99-0057 Dr. Carl J. Paperiello Director, Oflice of Nuclear Material Safety and Safeguards Attention: Document Control Desk U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Portsmouth Gaseous Diffusion Plant (PORTS)
Docket No. 70-7002 Certificate Amendment Request - Proposed Changes to the Quality Assurance Program Description - Response to NRC Request for Additional Information (TAC No. L32109)
Dear Dr. Paperiello:
The purpose of this letter is to respond to the NRC's March 18,1999 request for additiona information (Reference 1) on USEC's February 12,1999 Certificate Amendment Request (CAR) regarding proposed changes to the Quality Assurance Program (QAP) Description (Reference 2).
USEC's response to the NRC information request is provided in Enclosure I to this letter. The proposed QAP pages have been revised as described in our question responses and are included in. These revised QAP pages are replacement pages for those previously provided in fI Reference 2.
l USEC has reviewed Enclosure 1 (Detailed Description of Change) and Enclosure 3 (Significance Determination) in our February 12,1999 CAR and has determined that the conclusions of these ghy enclosures remain valid.
i Any questions related to this subject should be directed to Steve Routh at (301) 564-3251. There are no new commitments contained in this submittal.
Sincerely, 21 s. 9.' L Steven A.Toelle Nuclear Regulatory Assurance and Policy Manager 9904220331 990416 PDR ADOCK 07007002 PDR C
6903 Rockledge Drive, Bethesda, MD 20817-1818 Telephone 301-564-3200 Fax 301-564-3201 http://www.usec.com Offices in Livermore, CA Paducah, KY Portsmouth, OH Washington, DC
i Dr. Carl J. Paperiello Ap,ril 16,1999 GDP 99-0057, Page 2
References:
- 1. Letter from Yawar Faraz (NRC) to Mr. James N. Adkins (USEC),"Paducah and Portsmouth Gaseous Diffusion Plant: Quality Assurance Program Change--
Request for Additional Infonnation (TAC Nos. L32108 and L32109)," March 18, 1999.
- 2. Letter from Steven A. Toelle (USEC), to Dr. Carl J. Paperiello (NRC),
"Portsmouth Gaseous Diffusion Plant (PORTS), Docket No. 70-7002, Certificate Amendment Request - Proposed Changes to the Quality Assurance Program Description," USEC Letter No. GDP 99-0009, February 12,1999.
Enclosures:
- 1. United States Enrichment Corporation, Portsmouth Gaseous Diffusion Plant, Certificate Amendment Request, Proposed Changes to the Quality Assurance Program Description, Response to March 18,1999 NRC Request for Additional Information (TAC No. L32109)
- 2. Oath and Affirmation, Revised Quality Assurance Program Description Pages cc: Mr. Robert C. Pierson (NRC)
NRC Region III Office NRC Resident inspector - PGDP NRC Resident inspector - PORTS
GDP 99-0057 Page1of3 United States Enrichment Corporation Portsmouth Gaseous Diffusion Plant Certificate Amendment Request Proposed Changes to the Quality Assurance Program Description Response to March 18,1999 NRC Request for AdditionalInformation (TAC No. L32109) 1.
The first sentence in Section 2.43.1, Item 2 has a proposed change that adds the words "or alternatives as described in Section 2.73.2" at the end of the sentence that
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addresses NQA-1-1989. Basic Requirement 4 of NQA-I-1989 requires: "To the extent nece=sary, procurement documents shall require Suppliers to have a quality assurance program consistent with the applicable requirements of this Standard."
Section 2.7.3.2, Items 3 through 6 provide acceptable alternatives. However,it is not clear that the reference to Section 2.73.2 in Section 2.4.3.1, Item 2 does not include Section 2.7.3.2, Items 1 and 2 that are not acceptable alternatives. Clarify.
Resnonse The proposed change to QAP Section 2.4.3.1.2 has been revised to read as follows:
"2.
Procurement documents, for non-commercial grade items, require that the supplier implement a documented quality assurance program that is equivalent to the -
requirements of ASME-NQA-1-1989 or alternatives as described in Sections 2.7.3.2.3 through 2.7.3.2.6. The procurement documents..."
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The proposed changes to Section 2.183.2, Item 3.h of the QA Program and Section 2.18.3.2, Item 4.b of the Appendix of the QA Program, which delete the term "onsite,"is acceptable. However,it is not clear how "USEC supervision" will be provided for services
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performed both on-site and off-site. Clarify.
Resnonse A contracted supplier may provide nuclear (Q, AQ, and AQ-NCS) services to USEC under either the supplier's USEC-approved quality assurance (QA) program or the USEC QA program.
When a supplier is contracted to perform work under the USEC QA program, USEC ensures that supplier personnel are adequately trained to perform the work. As a minimum, supplier j
personnel are trained to the USEC QA program and the USEC implementing procedures that
a GDP 99-0057 Page 2 of 3 are applicable to the scope of work. Training on other USEC procedures such as security, safety and health, work control, etc. is also provided as necessary for performing the work.
When a supplier is contracted to perform work under the USEC QA program and USEC implementing procedures, that work will normally be conducted at either the Paducah or Portsmouth site or at USEC headquarters, in these cases, USEC personnel will control the supplier's work using the same methods used to control USEC employees.
In some circumstances, the particular capabilities of a supplier can best be utilized at their own facilities or at a combination of their facilities and USEC's facilities. When this is the case and l
the work is being performed under the USEC QA program and implementing procedures, specific controls are prv.ided in procurement documents (specifically, the Statement of Work) that describe how the contracted work will be controlled by USEC personnel. Depending on the nature and duration of the work, these controls will include one or more of the following:
Periodic visits to the supplier's site by USEC personnel to assess progress made and conformance of the supplier to the USEC QA program and procedures.
Visits by supplier personnel to USEC's facilities to demonstrate progress achieved at key milestones in the work.
I Periodic communications between supplier personnel and USEC personnel using phones, fax machines, electronic mail, or other methods as appropriate for the intended purpose.
j Periodic surveillances of supplier activities by the USEC quality assurance organization to ensure compliance with the USEC QA program and procedures.
l In addition to the above methods used during the performance of work, formal methods are also required for accepting supplier work products and documenting that acceptance, l
As part of the implementation of this Certificate. Amendment Request, the applicable USEC procedures will be revised to include the above supervisory / oversight controls.
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GDP 99-0057 Page 3 of 3 E1. Section 2.7.3.2, Items I and 2 have changed " potential supplier's" to " supplier's." Section 2.7.3.2, Item 3 has the same change in the second line but not in the first line. For consistency, consider making the same change in the first line.
Resnonse The proposed change to QAP Sectica 2.7.3.2.3 has been revised to read as follows:
"3.
The supplier's technical and quality capability is determined by a direct.. "
E2. The organization referred to as "NIAC" in Section 2.7.3.2, Item 4 should be better identified.
Resnonse The proposed change to QAP Section 2.7.3.2.4 has been revised to read as follows:
"4.
USEC reviews... audits (i.e., third party audits such as the Nuclear Industry Assessment Committee (NIAC), etc.). The review.. "
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GDP 99-0057 Oath and Affirmation and Revised Quality Assurance Progam Description Pages (4 pages total) f
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OATH AND AFFIRMATION I, Steven A. Toelle, swear and affirm that I am the Nuclear Regulatory Assurance and Policy Manager of the United States Enrichment Corporation (USEC), that I am authorized by USEC to sign and file with the Nuclear Regulatory Commission these revised Quality Assurance Program Description pages in support of a Certificate Amendment Request for the Portsmouth Gaseous Diffusion Plant, as described in USEC Letter GDP 99-0057, that I am familiar with the contents thereof, and that the statements made and matters set forth therein are true and correct to the best of my knowledge, information, and belief.
/l S. A.
I Steven A.Toelle l
On this 16th day of April,1999, the person signing above personally appeared before me, is j
known by me to be the person whose name is subscribed to within the instrument, and acknowledged that he executed the same for the purposes therein contained.
In witness hereofI hereunto set my hand and official seal.
I
'd Robi D. Johnson,Notpublic Sta of Maryland, Montgomery County h' y commission expires June 1,2002
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Quality Assurance Program - GDPs May 31,1996 Rev.3 2.
Design documents, including changes thereto, are controlled in accordance with Section 5 of Supplement 3 S-1 to NQA-1,1989 and Section 2.6 of this QAP. When a significant design change l
is found to be necessary because of an incorrect design, the design process and verification procedure are reviewed and modified as necessary; and 3.
Changes to the plant are evaluated and processed in accordance with the provisions of 10 CFR 76.68.
2.3.3,6 Design Interfaces Procedures for design interface control are established to ensure the following:
1.
Internal and external design interfaces are identified and controlled and design efforts are coordinated among participating organizations; 2.
The responsibilities for the preparation, review, approval, release, distribution, and revision of documents involving design interfaces are defined; and 3.
Design information transmitted across interfaces is documented and controlled.
2.3.3.7 Design Documentation and Records Design documentation and records that provide evidence that the design and design verification processes were performed in accordance with this section are collected, stored, and maintamed in accordance with Section 2.17.
2.4 PROCUREMENT DOCUMENT CONTROL 2.4.1 General t
A procurement document control system is established for Q items and related activities and services within the scope of this QAP as identified in Section 2.2. The procurement document control system is in accordance with ASME NQA-1,1989, Basic Requirement 4, and Supplement 4S-1. The procurement l
document control system ensures that applicable regulatory requirements, technical requirements, and QAP requirements are included or referenced in procurement documents for the procurement of items and services. This system also establishes provisions for the preparation, review, approval, and control of procurement documents, including changes thereto.
2.4.2 Responsibilities The Engineering Manager is resportsible for the preparation and maintenance of design specifications (including specifications for spare and replacement parts) and for identifying the technical and quality requirements necessary to ensure item acceptability. These specifications are subject to the requirements of Section 2.3 of this QAP. The Engineering Manager is also responsible for development of procedures 9
.o Quality Assurance Program-GDPs PROPOSED April 16,1999 RAC 98X0041 (RI) that define these activities, including the criteria for developing the necessary technical and quality requirements for procurement.
The Central Procurement Director is responsible for purchasing activities and for ensuring that items are procured from approved suppliers on the approved suppliers 1.st.
2.4.3 Requirements The requirements of Section 2.4.3.1 apply to non-commercial grade items. The requirements of Section 2.7.3.9 apply to commercial grade items.
2.4.3.1 Procurement Document Contents Procedures governing procurement document content are established to ensure the following:
1.
Technical requirements are specified in procurement documents by specific reference to drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto, that describe the items or services to be furnished. These procurement documents also are required to provide identification of any special instructions and requirements for designing, fabricating, cleaning, erecting, packaging, shipping, handling, storing, testing, inspecting, and accepting.
2.
Procurement documents, for non-commercial grade items, require that the supplier implement a documented quality assurance program that is equivalent to the requirements of ASME-NQA-1, 1989 or alternatives as described in Sections 2.7.3.2.3 through 2.7.3.2.6. The procurement l
documents also require the supplier to extend the applicable requirements of the procurement documents to the supplier's subtier procurement documents. The extent of the program required is dependent upon the importance to safety, type, and use of the item or service being procured.
3.
Procurement documents, for non-commercial grade items, provide for access to the selected supplier's facilities and records for inspection or audit by the purchaser, its designated representative, and/or other authorized parties.
4.
Procurement documents identify the documentation required to be submitted for information, review, or approval. Requirements for the supplier to maintain specific quality assurance records, j
l the retention times, and disposition are also identified. Record requirements for the supplier to collect, store and maintain specific quality assurance records are identified in applicable procurement documents and as required by Section 2.17.3.9 of this QAP. Procurement documents establish the requirements for reporting and approving disposition of nonconforming items and services. The identification of appropriate spare and replacement parts or assemblies and the identification of the technical ind quality requirements equal to or better than the original requirements are provided for ordering replacement parts or assemblies.
2.4.3.2 Procurement Document Review Procedures for the review of procurement documents are established to ensure the following:
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i Quality Assurance Program - GDPs PROPOSED April 16,1999 RAC 98X0041 (RI)
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2.7.3 Requirements The requirements of Sections 2.7.3.1 through 2.7.3.8 apply to services and non-commercial grade items. For commercial grade items, the requirements of Section 2.7.3.9 apply.
2.7.3.1 Procurement Planning Procedures are established to ensure the following:
1.
Procurement activities are planned and documented to assure a systematic approach to the procurement process.
2.
Procurement planning results in the documented identification of procurement methods and organizational responsibilities.
3.
Planning activities meet the requirements of Section 2 of Supplement 7S-1 to ASME NQA-1,1989.
2.7.3.2 Supplier Selection Procedures are established for the selection of suppliers. This selection shall be based ort the evaluation of their capability to provide items or services in accordance with the requirements of procurement documents. Measures for evaluation and selection of procurement sources, and the results therefrom, shall be documented and shall include one or more of the following:
i 1.
Evaluation of the supplier's history of providing an identical or similar product which performs satisfactorily in actual use. The supplier'c history shall reflect current capability.
2.
The supplier's current quality records supported by documented qualitative and quantitative l
information that can be objectively evaluated.
3.
The supplier's technical and quality capability is determined by a direct evaluation of his facility and personnel and the implementation of the supplier's quality assurance program. As an alternative to supplier quality assurance programs satisfying the applicable criteria of ASME NQA-1,1989, supplier quality assurance programs that satisfy the applicable criteria of 10 CFR 50, Appendix B, are acceptable.
4.
USEC reviews and approves the audit results of recognized industry shared supplier audits (i.e.,
third party audits such as the Nuclear Industry Assessment Committee (NIAC), etc.). The review ensures that the requirements of 2.7.3.2.3 above have been met.
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-5.
The supplier has an applicable valid " Certificate of Accrediation" issued by the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology (NIST). When using this method, an implementation audit shall be performed in accordance with
- 2. I 8.3.2.5.b.
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Quality Assurance Program - GDPs PROPOSED February 12,1999 RAC 98X0041 (RO) 6.
The supplier implements an NRC accepted quality assurance program. When using this method, an implementation audit shall be performed in accordance with 2.18.3.2.5.b.
Upon an acceptable evaluation using any of the above methods, the supplier may be placed on the Approved Suppliers List (ASL).
2.7.3.3 Bid Evaluation Procedures are established which provide measures for the performance of bid evaluations. These procedures ensure the requirements of Section 4 of Sul pement 7S-1 to ASME NQA-1,1989 are met prior to award of the contract.
2.7.3.4 Supplier Evaluation Procedures governing interface with the supplier are established which provide measures to verify the supplier's performance. The measures include:
1.
Establishing an adequate understanding between Purchaser and Supplier of the provisions and specifications of the procurement documents.
2.
Requirements for the supplier to identify the methods and processes to be used by the supplier in fulfilling the requirements of the procurement.
3.
Reviewing the supplier documents generated or processed during activities fulfilling procurement requirements.
4.
Identifying and processing necessary change information.
5.
Establishing methods for exchange of information with the supplier.
6.
Establishing the extent of source nirveillance and inspection activities.
The above verification activities are based on the importance to safety, complexity, and quantity of the items or services provided and are performed by personnel assigned to check, inspect, audit, or witness the activities of the supplier. These personnel meet the qualification requirements of Section(s) 2.10 or 2.18 of this program. Activities performed to verify conformance to requirements of procurement documents such as source surveillance and inspections, surveys, audits, receiving inspections,'nonconformances, dispositions, and corrective actions are documented and/or recorded in accordance with procedures.
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2.7.3.5 Control of Supplier Documents and Changes to Procurement Documents
- Procedures are established to determine the acceptability of supplier-generated documents. These measures assure that submittal of these documents is accomplished as required by the procurement 16 l
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