ML19305C556
| ML19305C556 | |
| Person / Time | |
|---|---|
| Site: | 07100244 |
| Issue date: | 02/14/1980 |
| From: | NL CHEMICALS (USA), INC. |
| To: | |
| Shared Package | |
| ML19305C554 | List: |
| References | |
| 15554, NLQ-63, NLQ-63-R1, NUDOCS 8003310046 | |
| Download: ML19305C556 (26) | |
Text
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NLQ-63 O
QUALITY ASSURANCE PROGRAM FOR COMPLIAt4CE WITil APPENDIX "E" OF 10 CFR PART 71 NLQ-63 REV. 1 FEllRUARY 14, 1980 NUCLEAR DIVISION NL INDUSTRIES, INC.
P.O.
I0X 2046 WILMINGTON, DELAWARE 15554 8003 31 (6g
NLQ-63 RETENTION RECORD REV. LEVEL REV. DATE DESCRIPTION OF REVISION APPROVAL QA/QC BfANAGER Rev. 0 12/21/78 Initial Issue Rev. 1 2/14/80 Complete re-write to comply with NRC letter of 8/29/79.
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NLQ-63 REV. 1 2/14/80 TABLE OF CONTENTS Introduction Page 4 Quality Assurance Program 8
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NLQ-63 REV. 1 2/14/80 INTRODUCTION The following NL Industries, Inc., quality assurance program has been structured to satisfy the requirements of 10 CFR Part 71, Appendix E.
The quality assurance program (Hereafter referred as NLI's Commercial Nuclear Quality Manual) is provided by NL Industries, Inc.,
Nuclear Division, to assure effective application of the effort and resources necessary to meet the quality objectives for cask design, fabrication and operation.
The overall quality obj ective is to provide a shipping package whose safety related systems, structures and components will perform their required functions in the predicted manner over their intended service life.
NLI's Commercial Nuclear Quality Manual has been designed to assure that quality related elements are identified and controlled and that documented records are provided which will demonstrate attainment of quality objectives in accordance with the require-ments of Appendix E, 10 CFR Part 71.
The program includes l
directly or by reference the written policies, procedures and instructions for the execution of all quality related activities applied to the design, purchasing, fabrication, assembly, testing, use, repair, handling, inspecting, modifying and maintenance of the shipping package.
The quality assurance program will be applied to all component parts, subassemblies, assemblies and/or systems which are critical in meeting performance requirements.
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NLQ-63 REV. 1 2/14/80 in the following systems.
Reactivity Control
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Containment of Radioactive Material 1
l Radiation Shiciding Decay lleat Dissipation Carriage on and attachment to vehicle
.I Cask lifting gear i
The above requirements are not applicable to commercially available vehicle running gear (rail car truck and draft gear) and other commercially available components required in auxiliary i
systems.
NLI Nuclear Division, as licensee, has the responsibility 4
for development, implementation and execution of the overall 4
quality assurance program.
Certain delegations of responsibility are made to support groups within the NL organization, approved 4
subvendors or clients for implementation of individual elements in the overall quality assurance plan, llowever, responsibility for the adequacy of procedures by which these delegated responsi-1 bilities are implemented is retained by the Nuclear Division, NL Industries, Inc.
Specific responsibilitics are as follows:
(a)
The Engineering Manager and QA Manager shall be responsible for indentifying the specific levels of quality required for each safety related component in the cask system.
1 (b)
The QA Department is responsible for review and approval of design drawings, purchase specifications, fabrication procedures and other pertinent prepared design media.
NLQ-63 REV. 1 2/14/80
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These reviews are for the purpose of determining if the media adequately assures conformance of the item to the design basis and safety criteria.
All design changes 1
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Department.
(c)
The Purchasing Department is responsible for such procure-f ment documentation with internal review and approval pro-l cedures provided to assure adequacy of quality provisions.
Final approval of QC provision is by the Manager, Quality Assurance or his delegate.
(d)
The quality assurance department is responsible for establish-ing and carrying out programs for qualification and control of all subvendors.
(e)
The QA Department is responsibic for preparation and appli-cation of a documented quality control plan for safety 4
related equipment and components in accordance with ULI's Commercial Nuclear Manual.
Responsibility for preparation and control of this document is assigned to the Manager, Quality Assurance.
Internal review procedures are utilized to assure adequacy and consistency with project quality obj e ctives.
(f)
In those instances where engineering development work is required in support of. design to assure equipment safety, responsibility for direction is with the NTD Manager.
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NLQ-63 REV. 1 2/14/80 Included within this responsibility is the evaluation of results and the subsequent application to those areas where quality requirements standards and controls are affected.
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NLQ-63 REV. 1 2/14/80 QUALITY ASSURANCE PROGRAM 1.
Organization The Nuclear Transportation Department of NL Industries, Inc.,
Nuclear Division, has the responsibility and authority for the design of the shipping packages for radioactive materials and is responsible for all procurement, manufacturing, testing, use, repair, maintenance, modification and quality assurance aspects related to the shipping packages for radioactive mate-rials.
Lines of responsibility and authority are shown on the attached Organization Chart.
(Refer to Attachment 1).
The QA/QC Manager of the Nuclear Transportation Department (NTD) has full responsibility for establishing QA policies, goals, objectives, and authority for assuring complete implementation and maintenance of the Quality Assurance program.
The Quality Assurance Department has the organizational freedom to identify quality problems, to initiate, recommend or provide solutions; and to verify implementation of solutions.
The QA/QC Department has the authority to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material.
-NLQ-63 REV. 1 a
2/14/80 2.
Quality Assurance Program Appendix E of 10 CFR 71 Quality Assurance Criteria for packaging of radioactive materials for transport and ASME Code Section III I
(NA-4000) has been selected as the governing standards to assure that the required Quality standards are attained during the design, engineering, procurement, manufacturing, and acceptance testing of.the NLI shipping packages for radioactive materials.
Comprehensive documentation of the overall quality assurance program to be carried out throughout the life of the shipping packages for radioactive materials have been initiated. Struc-tures, systems and components the quality of which will. affect f
attainment of program safety objectives and criteria have been identified through analysis of operating and potential accident conditions.
Documented program plans and procedures provide
-control, verification and maintenance of quality by means appro-priate to each of the successive program phases, including
-necessary qualifications'and indoctrination of personnel execu-ting the program.
T The actual verification for conformance to established require-j
-ments=shall be accomplished by individuals or groups who do not have. direct responsibility for performing the work being verified.
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NLQ-63 REV. 1 2/14/80 3.
Design Control Measures have been established for the design phase of the Spent Fuel Shipping Cask program to assure that regulatory requirements, design bases and safety criteria are correctly implemented in the final design drawings, specifications, instructions, etc.
These measures include NTD review and approval of all design media pertaining to safety significant systems, components and structures as well as periodic design safety reviews by teams of qualified individuals not directly associated with the design program.
The scope and timing of such reviews have been such as to permit assessment of basic program concepts, safety assurance procedures and implementation of safe ~y ob-c jectives and requirements in cask detail design.
By establishing policies and procedures, reports of review findings are directed to line organization management for review and documented res-ponse.
Design control measures also require that design changes be prepared, reviewed and approved by the organizations performing these functions on the original design.
Procedures by which design media are issued for review and approval, for revision, for release to fabrication and for accumulation of reference files have been established among participating organizations.
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NLQ-63 REV. 1 2/14/80 4.
Procurement Document Control Detailed Quality Control Procedures are established and clearly identify the sequence of actions to be taken in the preparation, review, approval and control of procurement documents and all revisions thereto.
f As a minimum, the procurement documents shall specify the follow-l ing:
(a)
The applicable Sections of 10 CFR 71 Appendix E which must be complied with and so described in the suppliers QA Pro-gram which must be submitted and approved by NL Industries.
(b)
The design basis technical requirements including the applicabic regulatory requirements, material and component identification requirements, drauings specifications, codes and industrial standards, test and inspection requirements and special process requirements.
(c)
All documentation which must be prepared, maintained and/
or submitted to NL Industries for review and/or approval.
(d)
Identification of those records which must be retained, controlled or delivered to NLI prior to use or installa-tion of the hardware.
'(e)
A statement that permits NL Industries and others access L
to the supplier's facility for the purpose of inspection and audit.
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Instructions, Procedures and Drawings As with the control of design and procurement, such instruc-1
-tions, procedures and supplementary information as may be necessary for control of other activities affecting quality are documented to include quantitative or qualitative accept-ance criteria for determining that important operations have been satisfactorily accomplished.
Examples are operating and testing instructions, equipment maintenance procedures, etc., as required to implement the overall quality assurance i
program and/or specific quality control plans.
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Document Control Written procedures exist which specifically delineates the sequence of actions taken in the preparation, review, approval and control of procedures, drawings (manufacturing and design),
procurement documents, design specifications, special process procedures and manufacturing /QC procedures, and all revisions thereto.
As a minimum the review and approval will be by Engineering and QC Departments.
All such documents and changes thereto are initiated and approved prior to implementation of same.
The aforementioned procedure also provides instructions for the control of obsolete or superseded documents.
NLQ-63 REV. 1 2/14/80 7.
Control of Purchased Material, Equipment & Services Detailed Quality Assurance / Control Procedures have been developed and as a minimum include the following:
(a)
Pre-award evaluation and documentation of same by QA Depart-ment Personnel with assistance from others when so requested by the QA Manager.
The pre-award evaluation may consist of one or more of the following:
1.
Per-award audit for compliance to applicable Sections of 10 CFR 71 Appendix E.
2.
A review of previous records and performance of sup-pliers who have provided similar articles of the type being procured.
(b)
The provision for surveillance, if deemed necessary by the QA Department, during fabrication, inspection, testing and shipment to assure compliance with procurement documents.
(c)
The requirement for records which shall be fully traceable to each component /part and provided to the Purchaser.
(d)
The provision for handling nonconforming items.
(c)
The provision for material identification and traceability.
(f)
Receiving inspection by the Purchaser's QC Department for those components / parts / materials not previously inspected and accepted at the source..L
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NLQ-63 REV. 1 2/14/80 l
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Identification and Control of Materials Parts & Components Established quality control plans and implementing procedures include provisions for assuring identification and traceability of materials, parts, subassemblies and components from acquisi-tion through final application as required to prevent use of i
incorrect, defective or uncontrolled items and complete trace-ability to all associated records.
These include measures for assuring that treatment during shipping, handling, storage, etc., does not impair the quality of such items and that special protective conditions as required in certain cases are documented and p'rovided.
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NLO-63 REV. 1 2/14/80 I
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9.
Control of Special Processes I
Special-processes such as welding, heat treating, non-i destructive testing, cleaning, visual inspection are pro-cedurally controlled.
Where required all such procedures and personnel shall be qualified in accordance with applica-j ble standards and/or
!es prior to implementation.
Records I
of all such qualifications shall be maintained and kept current.
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NLQ-63 REV. 1 2/14/80 1
10.
Inspection Requirements for in-process and final inspection of activities 4
affec"ng the quality of purchased or fabricated components or j
modification, repair and replacements thereto are delineated in approved and controlled design and procurement documenta-tion and/or in applicabic quality control plans and procedures.
Specification of the level and type of inspection is based on the particular conditions, e.g. material control and in-process monitoring where non-destructive testing of finished items can-not provide complete demonstration of quality.
Use is e~le of i
h mandatory hold points where required to assure compliance with I
designs and specifications.
Inspection and NDE personnel are independent of the personnel performing the activity being inspected.
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NLQ-63 REV. 1 2/14/80 11.
Test Control Measures have been established for assuring that checkout and i
acceptance of those Spent Fuel Shipping Cask components and structures including any modification, repair or replacement thereto having safety significance are fully utilided to demon-strate attainment of requisite quality.
Test requirements and acceptance limits will be defined in documented procedures which will contain provisions for assuring that tests are pro-perly performed (adequate and correctly calibrated instrumenta-tion and test devices, under suitable environmental conditions) and that test results are documented and evaluated to verify
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attainment of requisite quality.
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NLO-63 REV. 1 2/14/80 12.
Control of Measuring and Test Equipment An established tool and gage calibration procedure which has been developed in accordance with MIL-STD-120 and MIL-C-45662 that all test and measuring equipment has been cali-assures brated and is acceptabic for use during the inspection and testing phase of the program.
s, NLO-63 REV. 1 2/14/80 13.
Ilandling, Storage & Shipping When deemed necessary, specific procedures for cleaning, handling, storage, preservation and shipping are developed and made a part of the shipping package program. -
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NLQ-63
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REV. 1 2/14/80 t
14.
Inspection, Test and Operating Status i
f As with procurement and fabrication quality control plans, Spent Fuel Shipping Cask pre-operational testing and equipment opera-1 j
ting procedures will establish specific measures for maintaining identification and records as to the quality status (e.g. com-4 pliance with inspection and test requirements) or individual i
components and of operating equipment.
The application and removal of inspection and test status indicators shall be con-trolled by the QC Department.
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NLQ-63 REV. 1 2/14/80 1
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Nonconforming Material, Parts or Components Established quality control plans and procedures include appro-i priate measures to prevent inadvertent use of iastallation of material, parts or components which do not conform with approved i
drawings and specifications.
Requirements are documented for identification, segregation and disposition of such items and for necessary notification and record documentation.
Disposition requirements include specific procedures by which non-conforming
' items are to be reviewed for acceptance, rej ec tion, r'ework or i
repair and by which ultimate disposition is to be documented.
Provisions are made to review noncanformance reports periodically 4
to show quality trends and the results are reported to management.
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NLQ-63 REV. 1 2/14/80 16.
Corrective Action In addition to control of defective items during procurement and fabrication, Spent Fuel Shipping Cask pre-operational testing and operating procedures will provide measures to assure that all conditions adverse to quality are promptly identified and reported to appropriate levels of management; also that the cause of the adverse condition is determined and corrected.
NLQ-63 REV. 1 2/14/80 17.
Quality Assurance Records A basic requirement of the Spent Fuel Shipping Cask Quality i
Assurance Program and its implementing quality control plans and procedures is to provide a documented record of quality related activities which will (a) demonstrate that the cask has been built in accordance with approved plans and specifica-tions, and (b) provide sufficient information on the quality status of the as-built cask to permit critical requirements and standards to be met or improved throughout operation, maintenance and modification (if required).
This requires 1
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accumulation of quality record files for all components and structures identified as contributing to attainment of safety I
objectives and criteria covering each operation, tests and inspection previously identified (in established specifications, plans and procedures) as necessary for assurance of requisite q uality.
For effective use in program management, it is required that record documents identify the activity, the results obtained and the action taken (e.g. accepted, rejected or corrected) and provide evidence that the activity was performed and/or approved by authorized individuals.
Also, provisions are included for pre-paration of referenta files, for recording location of detailed data and-supporting information and for ratention of detailed
'information to meet applicabic regulatory requirements.
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NLQ-63 REV. 1 2/14/80 18.
Audits To provide additional control of program effectiveness, pro-cedure for independent audit and review of quality assurance activities are extensively utilized in the Ouality Assurance program.
Auditing shall be performed by personnel not having direct responsibility in-the area being audited.
Furthermore, audits will be performed to insure that activities are being I
performed in compliance with the appropriate regulations.
i Audit requirements are appropriately documented and include provisions for assuring management review of audit findings and recommendations and for implementing follow-up action where indicated.
Audit indications of nonconformance with the approved QA plan form the basis for discontinuance of fabrication or operations pending resolution.
Management shall regolarly assess through auditing (by persons outside the QA organization) the scope, status, implementation, and effectiveness of the QA program.
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NL INDUSTRIES, INC.
NUCLEAR DIVISION General Manager w
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Manager g
Nuclear i
Transportation Albany Plant QA/QC Engineering Procurement
& Contracts Administration d
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