ML20212H519
| ML20212H519 | |
| Person / Time | |
|---|---|
| Site: | Portsmouth Gaseous Diffusion Plant |
| Issue date: | 09/24/1999 |
| From: | UNITED STATES ENRICHMENT CORP. (USEC) |
| To: | |
| Shared Package | |
| ML20212H516 | List: |
| References | |
| NUDOCS 9910010170 | |
| Download: ML20212H519 (11) | |
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4 GDP 99-0164 11 Pages Total United States Enrichment Corporation (USEC)
Certificate Amendment Request Portsmouth Gascous Diffusion Plant Letter GDP 99-0164 Removal / Insertion Instructions Remove Page Insert Page Volume 3 Quality Assurance Program Quality Assurance Program 10a/10b,15/16,19/20, A-11/A-12 10a/10b,15/16,19/19a,19b/20, A-11/A-12 l
l 9910010170 990924 PDR ADOCK 07007002 C
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- Quality Assurance Program - GDPs September 24,1999 p
RAC 99-X0042 (RO)
L PROPOSED 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 2.43.1 apply only to non commemial grade items and services. Sections 2.43.2 and 2.433 apply to both commercial grade and non-commercial grade items and services.
2.4.3.1 Procurernent Docuenent Contents Procedures goveming procurement document content are established to ensure the following:
l 1.
Procurement documents shall contain a statement of work as appropriate.
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2.
Technical requirements are specified in procurement documents by specific reference to drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto, I
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.
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3.
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.
The procurement documents also require the supplier to extend the applicable requirements of the procureraent 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.
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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 l-other authorized parties.
l 5.
Procurement documents identify the documentation required to be submitted for information, review, l
or approval. The time of submittal shall be established. Requirements for the supplier to maintain specific quality assurance records, the retention times, and disposition are also identified. Record L
requirements for the supplier to collect, store, and maintain specific quality assurance records are identified in applicable procurement documents and as required by Section 2.173.9 of this QAP.
l Procurement documents establish the requirements for reporting and approving disposition of j.
nonconforming items and services. The identification of appropriate spare and replacement parts or assemblies and the identification of the technical and quality requirements equal to or better than the original requirements are provided for ordering replacement parts or assemblies.
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. 2.43.2 Procurement Document Review
' Procedures for the review of procurement documents are established to ensure the following:
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Quality Assurance Program - GDPs April 14,1999 Rev.31 Blank Page L'
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Quality Assurance Program - GDPs September 24,1999 RAC 99-X0042 (RO)
PROPOSED 2.7.3 Requirements Sections 2.73.1 through 2.73.8 apply to non-commercial grade items and services. Section 2.73.9 applies to commercial grade items and Section 2.7.3.10 applies to commerical grade services.
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 responsibihties.
3.
Planning activiies meet the requirements of Section 2 of Supplement 7S-1 to ASME NQA-1,1989.
i 2.7.3.2 Supplier Selection 1
Procedures are established for the selection of a potential supplier and are in accordance with an evaluation of its 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:
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 suppliefs current 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 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 Procedures governing interface with the supplier are established and conducted as early as practicable which provide measures to verify the suppliefs performance. The Purchaser's verification activities, however.
shall not relieve the Supplier of his responsibilities for verification of quality achievement. The measures include:
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Quality Assurance Program - GDPs April 14,1999 Rev.31
- 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 ofinformation with the supplier.
6.
Establishing the extent of source surveillance and inspection activities.
The above verification activities are based on the importance to safety, complexity, and quantity of the items or services provided and am 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.
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 mquired by the procurement documents.
These procedures provide measures for the acquisition, processing, and recorded evaluation of technical, inspection, and test data against acceptance criteria. Procedures also are established for the control and documentation of changes to procurement documents. The requirements of Section 2.4.3 are followed when changes to procurement documents are made.
2.7.3.6 Methods of Acceptance for Items Procedures are established which govern the acceptance of items. Prior to offering the item for acceptance, the supplier shall verify that the item being fumished complies with the procurement requirements.
Where required by code, regulation, or contract requirement, documentary evidence that items conform to procurement documents shall be available at the facility site prior to installation or use. Any one or more of the following methods of acceptance are used:
1.
Certificate of Conformance - When this method is utilized, the following minimum criteria are met:
The certificate identifies the purchased material or equipment.
a.
b.
The certificate identifies the specific procurement requirements met.
c.
The certificate identifies any procurement requirements that were not met.
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Quality Assurance Program - GDPs.
September 24,1999 RAC 99-X0042 (RO)
PROPOSED L
c.
Source verification d.
Acceptable supplier and item performance record
' 5.
The selection of the method or combination of methods in 4. above is based on the following:
a.
Selected critical characteristics b.
Available supplierinformation c.
Quality history
. d.
Degree of standardization e.
Importance to safety and complexity of the item 6.
Alternate commercial grade items aie allowed provided the Engineering Manager provides verification that the alternate commercial grade item will perform its intended Q function.
7.
Soun:e 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.
j 8.
Procurement documents are issued and controlled in accordance with the require.nents of Sections 2.4.3.2 and 2.4.3.3 of this QAP.
j 9.
Commercial grade items are identified in the purchase order by the manufacturer's published product i
description.
I 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 e
ensure conformance with manufacturer's published requirements; and to ensure that required documentation is received and is acceptable.
i i1.
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 COMMERICAL GRADE SERVICES 1
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:
Not subject to design or specification requirements that are unique to GDP facilities or a.
activities' l
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.6 Quality Assurance Program - GDPs September 24,1999 RAC 99-X0042 (RO)
PROPOSED 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.
4.
If there are no critical controls that impact the safety function 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 quJification 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 19a i
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4 Quality Assurance Program - GDPs September 24,1999 RAC 99-X0042 (RO)
PROPOSED Blank Page 19b
Quality Assurance Program - GDPs April 14,1999 Rev.31 establishes the requirements for the identification and control of such items and associated materials, consumables, parts, spare parts, components, and sub-assembhes.
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2.8.2 Responsibilities The Engineereg Manager is responsible for specifying requirements for identification methods, j
traceability, shelf life, ara 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 document: appropriate to the circumstances.
The Production Support Manager is responsible for verifying that items are correctly identified through receipt inspection, storage, installation, and use as required.
Organization Managers are n sponsible for maintaining and implementing identification, traceability, and shelf life and operating life requirements for items under theirjurisdiction.
The Materials Management Manager is responsible for receipt, delivery, storage, traceability, identification, and control of materials.
2.83 Requirements 2.83.1 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 as required by applicable codes, standards, or specifications. Identification shall relate an item to an applicable design or other pertinent specifying document. Physical identification shall be used to the maximum extent possible. 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.
2.83.2 Traceability of Items Procedures are established for the traceability of items, when specified by codes, standards or specifications.
2.833 Limited Life items Procedures are established to ensure that items which have a limited operating life or shelf-life are identified and controlled to preclude use of items whose operating life or shelf-life has expired. These procedures also establish the requireraents for the identification and control of items such as chemicals and reagents.
2.83.4 Maintaining Identification of Stored Items Procedures are established for the control of item identification consistent with the planned duration and conditions of storage such as (1) provisions for maintenance or replacement of markings and identification records due to damage duiing handling or aging, (2) protection of identifications on items subject to excessive deterioration due to environmental exposure, t.nd (3) provision of updating existing plant records.
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'. <3 0 Quality Assurance Program - GDPs September 24,1999 RAC 99-X0042 (RO)
PROPOSED 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.
l 2.7.3.1 Chang (s to Procurement Documents The mquimments of Section 2.4.2.3 are followed when changes to procurement documents are made.
2.7.3.2 Application, Use and Methods of Acceptance for items Procedures are established which govern the application, use and acceptance ofitems. 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 following:
a.
Receipt inspection (done for all items) b.
Post-installativa test c.
Supplier sun'ey d.
Source verification e.
Acceptable supplier and item performance record f.
Certificate of Compliance g.
Special test 2.
The se!ection 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, 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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Quility Assurance Program - GDPs May 31,1996 Rev.3 2.8 Identification and Control of items 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 ideatification 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 specificnions.
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 theirjurisdiction.
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 teceipt and fabrication of the items up to and including installation and use to assure that only correct and accepted items are used or j
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 j
specifications.
2.8.3.3 Limited Life Items Procedures are established to ensure that items which have a limited operating life or shelf-life are identified and controlled to preclude use of items whose operating life or shelf-life has expired. These A-12