ML20212H495
| ML20212H495 | |
| Person / Time | |
|---|---|
| Site: | Paducah Gaseous Diffusion Plant |
| Issue date: | 09/24/1999 |
| From: | UNITED STATES ENRICHMENT CORP. (USEC) |
| To: | |
| Shared Package | |
| ML20212H491 | List: |
| References | |
| NUDOCS 9910010161 | |
| Download: ML20212H495 (11) | |
Text
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.r GDP 99-0149 11 Pages Total United States Enrichment Corporation (USEC)
Certificate Amendment Request Paducah Gaseous Diffusion Plant Letter GDP 99-0149 i
Removal / Insertion Instructions Remove Page Insert Page Volume 3 Quality Assurance Program Quality Assurance Program 9/10,15/16,19/20, A-11/A-12 9/10,15/16,19/20,20a/20b, A-11/A-12 9910010161 990924 PDR ADOCK 0700 0 1 C
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Quality Assurance Program - GDPs December 13, 1998 Rev. 33 ~
2.3.3.5 Design Changes Procedures for design change control are established to ensure the following:
i 1.
Changes to final designs, field changes, modifications, and nonconforming items dispositioned "use-as-is" or " repair" are justified, documented, and evaluated against criteria established by the Engineering Manager; 1
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 is found to be necessary because of an incorrect design, the design process and verification i
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 defm' ed; and 3.
Design information transmitted across interfaces is documented and controlled in accordance with Supplement 3S-1, Section 6 of NQA-1,1989.
1 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 maintained in accordance with Supplement 3S-1, Section 7 of NQA-1,1989 and Section 2.l~'i+f this QAP.
l 2.4 PROCUREMENT DOCUMENT CONTROL 2.4.1 General 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 _ document control system ensures that applicable regulatory requirements, technical requirements, and QAP requirements are included or referenced in procurement documents for the 9
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Quality Assurance Program - GDPs PROPOSED September 24,1999 RAC 99C048 (RO) l 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 responsible 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 that define these activities, including the criteria for developing the necessary technical and quality requirements for procurement.
1 The Central Procurement Director is responsible for purchasing activities and for ensuring that items are procured from approved suppliers on the approved suppliers list.
2.4.3 Requirements The requirements of Section 2.4.3.1 apply only to non-commercial grade items and services. Sections 2.4.3.2 and 2.4.3.3 apply to both commercial grade and non<ommercial grade items and services.
1 2.4.3.1 Procurement Document Contents Procedures governing procurement document content are established te ensure the following:
1.
Procurement documents shall contain a statement of work as appropriate.
2.
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.
3.
Procurement documents, for non-commercial grade items, require that the supplier implement a documen'ed quality assurance program that is equivalent to the requirements of ASME-NQA 1,1989.
The procurement 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.
4.
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.
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Quality Assurance Program - GDPs PROPOSED September 24,1999
- RAC 99C048 (RO) evaluations of the suppliers technical and quality capabilities or history of satisfactory performance or the evaluation of the suppliers current quality records as determined and approved by the Engineering Manager
- and the Safety, Safeguards and Quality Manager. The Safety, Safeguards and Quality Manager is also msponsible for developing and implementing procedures which meet the requirements of this section of the 1
- QAP.
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The Production' Support Manager provides suppoit functions such as source verification or surveillance, mceipt inspections, installation inspections, and review of procurement documents during receipt inspections. This manager is also responsible for developing and implementing procedures which meet the requirements of this section of the QAP.'
The Engineering Manager is responsible for evaluation of suppliers' technical capabilities and for determining the methods of acceptance to be applied to purchased items and services. The Engineering Manager is also responsible for the approval of dispositions and technical evaluations for supplier-generated nonconformances for items and services. The Engineering Manager is also responsible for providing measures which ensure the proper selection, application, methods of acceptance, and use ofitems.
The Central Procurement Director is responsible for purchasing activities and ensuring that items are procured from approved suppliers on the approved suppliers list when required.
2.7.3 Requirements Sections 2.7.3.1 through 2.7.3.8 apply to non-commercial grade items and services. Section 2.7.3.9 applies to commercial grade items and Section 2.7.3.10 applies to commercial grade services.
2.7.3.1 Procurement Planning Procedures are established to ensure the following:
1.
Procurement activities are plarmed and documented to assure a systematic approach to the procurement process.
2.
Procurement planning results in the documented identification of procurement methods and organizational msponsibilities.
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 a potential supplier and are in accordance with an evaluation ofits capability to provide items or services in accordance with the requirements of procurement documents. An assessment of the potential supplier's technical and quality capability is performed in accordance with one or more of the following:
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Quality Assurance Program - GDPs August 15,1998
~ Rev. 26 '
1.
~An evaluation of the potential supplier's history of providing an identical or similar product which performs satisfactorily in actual use.
2.
.The potential supplier's ctrrent quality records supported by documented qualitative and quantitative information that can be objectively evaluated.
3.
The potential supplier's technical and quality capability as determined by a direct evaluation of his j
facility and personnel and the implementation of the potential supplier's quality assurance program.
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 Supplement 7S-1 to ASME NQA-1,1989 are met prior to award of the contract.
2.7.3.4 Supplier Evaluation-
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Procedures governing interface with the supplier are established and conducted as early as practicable which provide measures to verify the supplier's performance. The purchaser's verification g
activities, however, shall not relieve the supplier of his responsibilities for verification of quality
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achievement. 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 fot exchange of information with the supplier.
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Establishing the extent of source surveillance and inspection activities.
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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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' Quality Assurance Program - GDPs August 15, 1998 Rev.261 4.
Verification of the implementation of the disposition.
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5.
Maintenance d records of supplier submitted nonconformances.
3 2.7.3.9 Commercial Grade Items Procedures are established governing the application and use of conunercial grade items:
- 1. -
Methods for determining whether an item can be purchased as commercial grade and dedicated for i
use in a Q application. A commercial grade item is an item satisfying all of the following:
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Not subject to design or specification requirements that are unique to the nuclear facility.
a.
1 b.
Used in applications other than nuclear facilities.
i c.
Is to be ordered from the manufacturer / supplier on the basis of a specification set forth in the manufacturer's published product description (e.g., catalog).
2.
The criteria and methods for identifying the critical characteristics that are essential to ensure that
- the item will perform its intended Q function.-
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. The criteria for determining the type and depth of product acceptance and the criteria for j
determining the point of dedication at which time USEC assumes the responsibility for reportability.
Dedication of a commercial grade item occurs after receipt when that item is designated for use in a Q application.
4.
' Methods used to accept (dedicate) commercial grade items are receipt inspection as required by 2.7.3.9.10 or one or more of the following as determined by engineering:
a.
Special test
- b.
'. Commercial grade survey of supplier c.
' Source verification
' d.
' Acceptable supplier and item performance record i
5.
The selection of the method or combination of methods in 4. above is based on the following:
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Selected critical characteristics b.
Available supplier information c.'
- Quality history -
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Quality Assurance Program - GDPs PROPOSED September 24,1999 RAC 99C048 (RO) d.
Degree of standardization e.
Importance to safety and complexity of the item 6.
Altemate commercial grade items are allowed provided the Engineering Manager provides verification that the alternate commercial grade item will perform its intended Q function.
7.
Source evaluation and selection, where determined necessary by the engineering based on complexity and importance to safety, shall be in accordance with the requirements of Section 3.1 of Supplement 7S-1 of ASME NQA-1,1989.
8.
Procurement documents are issued and controlled in accordance with the requirements of Sections 2.4.3.2 and 2.4.3.3 of this QAP.
9.
Commercial grade items are identified in the purchase order by the manufacturer's published product description.
10.
Receipt inspections are performed to determine that damage was not sustained during shipment, that the item received is the item ordered, and that inspection and testing are performed as required, to ensure confonnance with manufacturer's published requirements; and to ensure that required documentation is mceived and is acceptable.
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The requirements of other sections of this QAP apply once a commercial grade item is dedicated and
' determined acceptable for use in a Q application.
2.7.3.10 Commercial Grade Services 1.
Methods for determining whether a service can be purchased as commercial grade and dedicated for use in a Q application are established and implemented. A commercial grade service is a service satisfying all of the following:
- a.
Not subject to design or specification requirements that are unique to GDP facilitiu or activities, b.
Used in applications other than GDP facilities or activities, and c.
Is to be ordered from the manufacturer / supplier on the basis of a specification set forth in the manufacturer's published product description (e.g., catalog) or other appropriate documents.
2.
The criteria and methods for identifying the critical characteristics (critical controls) for acceptance are established. The critical characteristics (critical controls), which once selected to be verified, provide reasonable assurance that the service provided meets specified requirements.
3.
In selecting the critical controls, the impact of the activities associated with the service on the safety function of plant equipment is considered.
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Quality Assurance Program - GDPs PROPOSED September 24,1999 I
RAC 99C048 (RO) '
4.
If there are no critical controls that impact the safety functica of the plant equipment that can be applied to the service, then administrative controls for the service may be applied such as controls over the process or qualification of personnel.
5.
' Methods of acceptance of commercial grade services are established and include any one or combination of the following:
a.
Special tests and inspections b.
Commercial grade survey c.
Source verification d.
Acceptable supplier service performance history 6.
Dedication of a commercial grade service occurs when that service is accepted in accordance with 2.7.3.10.5 above.
7.
Source evaluation and selection, where deemed necessary by engineering based on complexity and importance to safety, is in accordance with the requirements of Section 2.7.3.2.
8.
Procurement documents are issued and controlled in accordance with the requirements of Sections 2.4.3.2 and 2.4.3.3 of this QAP.
9.
Commercial grade services are identified in the purchase order by the manufacturer's published product description or other appropriate documents.
2.8 IDENTIFICATION AND CONTROL OF ITEMS 2.8.1 General A system is established for the identification and control of Q items within the scope of the QAP as described in Section 2.2. The requirements for the identification and control of such items are in accordance with Basic Requirement 8 and Supplement 8S-1 of ASME NQA-1,1989. This system establishes the requirements for the identification and control of such items and associated materials, consumables, parts, spare parts, components, and sub-assemblies.
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.o Quality Assurance Program -GDPs PROPOSED September 24,1999 RAC 99C048 (RO) 2.8.2 Responsibilities The Engineering Manager is responsible for specifying requirements for identification methods, traceability, shelf life, and operating life of items when required by codes, standards, or specifications.
Engineering specifies these requirements during the generation of specifications, drawings, procurement documents, or other documents appropriate to the circumstances.
i The Production Support Manager is responsible for verifying that items are correctly identified through receipt inspection, storage, installation, and use as required.
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Quality Assurance Program - GDPs PROPOSED September 24,1999 RAC 99C048 (RO) 2.7.3 Requirements AQ items are procured in accordance with the requirements of this section. AQ services shall be in accordance with the requirements of Section 2.7.3.10 of the Q program.
2.7.3.1 Changes to Procurement Documents The requirements of Section 2.4.3.3 are followed when changes to procurement documents are made.
1
- 2.7.3.2 Application, Use and Methods of Acceptance for items Procedures are established which govern the application, use and acceptance of items. Engineering specifies the use, acceptance criteria and method of acceptance for procured items and is in accordance with the following:
1.
Engineering specifies methods used to accept items. Methods include one or more of the j
following:
a.
Receipt inspection (done for all items) b.
Post-installation test c.
Supplier survey d.
Source verification e.
Acceptable supplier and item performance record f.
Certificate of Compliance g.
Special test 2.
The selection of the method or combination of methods in 1. above is based on the following:
a.
Importance to safety and complexity of the item, b.
Selected critical characteristics, c.
Available supplierinformation, i
d.
Quality history, e.
Degree of standardization.
3.
Alternate items are allowed provided the Engineering Manager provides verification that the alternate item will perform its intended AQ function.
4.
Procurement documents are issued and controlled in accordance with the requirements of
)
Section 2.4 of this Appendix.
5.
Receipt inspections determine that damage was not sustained during shipment, that the item received is the item ordered, and that inspection and testing are performed as required, to ensure conformance with manufacturer's published requirements; and to ensure that required documentation is received and is acceptable.
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--. Quality Assurance Program - GDPs August 15,1998
~ Rev.- 26' 2.8 : Identification and Control of items 1
2.8.1 General A system is established for the identification and control of AQ items within the scope of the
' Appendix'as described in Section 2.2 of this Appendix. The requirements for the identification and control of such items are in accordance with Basic Requirement.8 and Supplement 8S-1 of ASME NQA-1,1989. This system establishes the requirements for the identification and control of such items and associated materials, consumables, parts, spare parts, components, and sub-assemblies.
2.8.2 Responsibilities The Engineering Manager is responsible for specifying requirements for identification methods, traceability, shelf life, and operating life of items when required by codes, standards, or specifications.
Engineering specifies these requirements during the generation of specifications, drawings, procurement
' documents, or other documents appropriate to the circumstances.
Organization Managers are responsible for maintaining and implementing identification, traceability, shelf life and operating life requirements for items under their jurisdiction.
The Materials Management Manager is responsible for receipt, delivery, storage, identification, traceability, and control of materials.
2.8.3 Requirements 2.8.3.1 Identification of items Procedures are established to ensure that items are identified from initial receipt and fabrication of the items up to and including installation and use to assure that only correct and accepted items are used or installed. Where physical identification to control the item is either impractical or insufficient, physical separation, procedural controls, or other means are employed. When markings are used, measures are
- established to ensure that the markings are clear, legible and do not have a detrimental effect on the function or service life of the item._ Markings are transferred to each part of an identified item when subdividing and are not to be obliterated or hidden by surface treatments or coatings unless other means of identification are provided.
2.8.3.2 Traceability of items Procedures are established for the traceability of items, when specified by codes, standards or
. specifications.
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