ML20005F006
| ML20005F006 | |
| Person / Time | |
|---|---|
| Site: | 07100277 |
| Issue date: | 06/20/1979 |
| From: | ALLIED-SIGNAL CORP. |
| To: | |
| Shared Package | |
| ML20005F004 | List: |
| References | |
| NUDOCS 9001120172 | |
| Download: ML20005F006 (29) | |
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QUALITY ASSURANCE PROGRAM.-
URANIUM HEXAFLUORIDE CYLINDERS Engineered Materials Allied signal t
1 Metropolis Works Metropolis, Illinois License No. SUB-526 June 20, 1979
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L V4-L Table of Contents
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.Section Page Introduction 1-
. Appendix""E" Criteria p
1.
Organization 2 and.3 2.
Quality Assurance Program 4 and 5 3.-
Design Control-6
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Procurement Document Control 7
.5.
cInstructions, Procedures and Drawings 8
6.
Document Control-9 7.
. Control of Purchased Materials, 10 Parts.and' Components
- 8. -Identification and Control of Materials, 11 Parts, and' Components 9.
Control of Special Processes 12
- 10. Inspection-13
- 11. Test Control 14
.12.' Control ofl Measuring and Test Equipment 15
- 13. Handling, Storage, and Shipping 16
'14. Inspection, Test and Operating Status 17
- 15. Non-conforming Materials, Parts, or 18 Components
- 16. Corrective Action 19
- 17. Quality Assurance Records 20
- 18. Audits 21
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l r-APPENDIX-Page Exhibit A Divisional Organization Chart 22' Exhibit B Metropolis Works Quality 23
~ Assurance Organizational Chart v
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INTRODUCTION The purpose of the Quality-Assurance Program is to assure that the quality of materials, components and' packages procured and used by~ Allied Signal Corporation's Metropolis Works for shipment of uranium hexafluoride are adequate to protect the health and safety of'the public and complies with those specifications recognized by the Nuclear Regulatory Commission (NRC).
The Quality Assurance (QA) Program applies to the design, fabrication, assembly, testing, inspection, use, maintenance,-and repair of all vessels-and components used for the storage and shipment of low specific activity, sourcefmaterial (containing 0.711% or less U-235) uranium hexafluoride (UF )-
6 Allied Signal will delegate some responsibilities contained in the Quality Assurance Program.with the understanding that the responsibilities will not be relinquished.
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Appendix "E" Criteria 1.
Organization Allied Signal shall retain and exercise responsibility for.
the Quality Assurance Program.
Allied Signal will delegate, bdt not relinquish some responsibilities to fabricators,-
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contractors, or subcontractors.
Those activities to be
-delegated will vary on a case by case basis, depending greatly on the competence available and to be applied.
Delegated activities will be audited by Allied Signal.
The Metropolis Works Quality Assurance organization.shall perform or delegate to other organizations all the functions necessary to assure that appropriate elements of 10 CFR Part 71, Appendix "E" will be implemented.
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l Job. descriptions and qualifications shall be available for each job function shown on the organizational chart in Exhibit "B".
overall authority and responsibility for the Quality j
Assurance Program has been assigned by Division Management j
i to the Plant Manager.
The Plant Manager of the Metropolis Plant is responsible for direction of the overall plant operations.
With regards to the Quality Assurance Program, the Plant Manager is responsible for developing and R1 directing an organization which will establish and 1
administer a program in accordance with Appendix "E",
10 CFR
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4-Part 71.
TheEPlant Manager is responsible for assurance i
that such programs are implemented and enforced within the framework of corporate policies and philosophies.
The Plant
-Manager delegates authority to the organizational structure-r, as outlined in Exhibit "B"
for execution, control and audit of the Quality Assurance Program.
In relation to the Quality Assurance Program, the qualifications of t he1 Plant Manager are such to assure that good management practices are implemented.
The Plant R1 4
Manager is educated both formally and through experience such as to be familiar and' technically knowledgeable of the Quality Assurance Program.
The current qualifications of 5
the Plant Manager include a college education with a working-knowledge of chemical plant operations and a minimum of five (5) years of related management experience.
Allied Signal Divisional management has delegated in writing, the authority and responsibility for the L
implementation of the Quality Assurance Program to the l-Metropolis Works Technical department.
The Technical L
Department has the authority to stop unsatisfactory work and control further processing, delivery, discard or 1.
l installation of non-conforming material.
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2.
Quality Assurance Program The Quality Assurance-Program is established and administered:in'accordance with Appendix "E",110 CFR Part 71.
The NRC' approved Quality Assurance Program will be followed by Allied Signal's Metropolis Works to assure that all UF6 cylinders meet the provisions of the approved
-Quality Assurance Program as a minimum.
The Plant-Manager has issued instructions that the above is corporate policy and compliance'is mandatory.
Metropolis Works management will routinely evaluate the Quality Assurance-Program to assure that the program is being~ effectively administered within the intent of 10 CFR Part'71, Appendix "E" Criteria and this program.
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The distribution of controlled Quality Assurance manuals shallibe recorded on a distribution sheet.
Any additions or deletions of distributed copies shall be noted on the distribution sheet.
Any revisions to the Quality Assurance manual will be communicated to all copyholders.
Holders of controlled manuals shall be required to return superseded pages.
Suppliers and contractors shall have an acceptable Quality Assurance Program that is in compliance with this Quality Assurance Program..
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The design, purchase, fabrication, inspection, testing, f
maintenance, repair, and shipmenta of UF6 cylinders; the t
purchase, inspection, testing and installation of UF6 cylinder valves; the purchase, inspection and installation R1 of UF6 cylinder pluge; and the calibration, inspection and meintenance of the UF6 cylinder scales shall be controlled by the Quality Assurance Program.
Any quality-related disputes shall be resolved by Metropolis i
Works management without sacrifice of safety standards.
Personnel performing quality-related activities shall be properly indoctrinated and trained to assure competent implementation of the Quality Assurance procedures.
The method of training and the names of those individuals that have been trained to perform various quality-related activities shall be documented.
The Quality Assurance procedures shall specify special equipment and environmental conditions where applicable, for "I
the performance of quality-related activities.
Inspection and tests shall not be performed until all specified prerequisites have been satisfied.
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Design Control The design of UF6 cylinders and safety related components shall be performed in accordance with approved engineering t
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standards or shall be proven adequate by test.
Quality standards shall be specified in the design documents.
L Measures shall be established to correctly translate the applicable regulatory requirements and design basis into R1 specifications, drawings, written procedures, and instructions.
Design conditions and materials specified shall not be altered unless approved by Metropolis Works management.
Design changes shall be based on documented evidence that such changes will not diminish any safety-related aspect of the cylinder and are subject to the same design contro1r that were applicable to the original design.
Design dotails incorporated in an NRC Certificate of Compliance will not be altered without prior NRC approval.
The design shall be reviewed to assure that the design characteristics can be controlled, inspected and tested, and that inspection and test criteria are identified.
The proper. selection and accomplishment of design verification or checking processes such as design reviews alternate calculations, or qualification testing shall be performed.
The individuals or groups responsible for design l'
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verification shall be different form the original designer and his immediate supervisor.
Test programs shall be R1 performed with a prototype unit under design conditions.,
The personnel or groups responsible for design reviews and h
verification activities and their authority and responsibility shall be identified and controlled by written procedures.
l Corrective action shall be taken to prevent repetition of design errors and deficiencies affecting safety-related items and such action shall be documented.
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Procurement Document Control Procedures shall be established to assure that procurement documents are properly prepared, reviewed, approved and controlled to assure that procurement functions are accomplished in accordance with specified codes, standards, drawings and specifications.
The procurement document shall identify the applicable 10 CFR Part 71, Appendix "E" requirements which must be R1 complied with and described in the supplier's Quality Assurance Program.
Quality Assurance personnel shall review all procurement documents to determine that the procurement document is in accordance with the Quality Assurance Program requirements.
-The procurement document shall contain or reference the i
design based technical requirements including applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
l The procurement document shall specify documentation such as drawings, specifications, personnel qualifications, inspection and test records, and/or other procedures necessary for Allied Signal's review and approval.
A record of qualified suppliers shall be maintained.
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t All procurement documents (or copies thereof) shall be i
retained for the life of the cylinder (s) to which they apply.
The procurement document shall identify those records that i
are.to be delivered to Allied Signal prior to completion of f
the contract and that Allied Signal personnel shall have the right of access to supplier's facilities and records for source inspection and audit.
Any changes or revisions to procurement documents are subject to at least the same review and approval as the original document.
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Instructions, Procedures and Drawings Those activities necessary to assure the quality of UF 6 cylinders shall be performed in accordance with written instructions, procedures or drawings.
The preparation, review, approval and control of quality-related instructions, procedures and drawings shall be performed in a prescribed manner.
Qualified Quality Assurance personnel shall review and concur with inspection plans, tests, calibrations,-and special process procedures, drawings and specifications.
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Document Control t
All documents concerning the design, fabrication, inspection, operating and maintenance instructions, j
procurement, and Quality Assurance procedures must be approved by qualified Quality Assurance personnel,and Metropolis Works management before the activities described L
in the documents are pursued.
This control applies to the activities affecting the quality of existing UF6 cylinders, as well as those affecting new cylinders.
Applicable and
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current documents shall be available at the location where t
the work is being performed.
Any approved modifications to instructions, procedures, drawings, or specifications shall be added to the documents prior to implementation and superseded documents disposed of (one copy shall be kept as a historical record).
All revised documents shall require the same reviews and approvals as the original document.
Appropriate record management shall be maintained to prevent the inadvertent usa of obsolete documents.
A master list shall be established to identify the current revision numbers for instructions, procedures, specifications, drawings and procurement documents, s
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Control of Purchased Materials, Parts and Components Qualified personnel shall evaluate suppliers to assure that they are capable of providing acceptable quality services and products.
This evaluation will be based on the suppliers -(1) capability to comply with applicable elements of 10 CFR Part 71, Appendix "E" and this program, (2) provisions, records, and performance relating to the same or similar articles or (3) a survey of supplier's facilities and Quality Assurance Programs.
The results of supplier evaluations shall be documented and retained.
Qualified personnel shall audit suppliers and/or inspect procured materials or equipment during fabrication, inspection, testing, and shipment as necessary to assure conformance to the purchase order requirements.
The supplier shall furnish documentary evidence that purchased material or equipment conforms to the procurement specifications.
The supplier shall identify any procurement i
specifications which were not met together with a description of those nonconformances and shall promptly notify Allied Signal.
Inspection records or certificates of conformance attesting I'
to the acceptance of material or components shall be available prior to installation or use.
Items accepted and released for use shall be identified by tags or other acceptable means of identification.
Nonconforming items
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has been made to avoid the inadvertent use of non-conforming material, components or equipitent.
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Identification and Control of Materials, P a ;: : s, and Components i
Measures shall be established for the identification and control of safety-related materials, parts and components, including partially fabricated assemblies.
Identification shall be maintained either on the item or on records traceable to the item to preclude use of incorrect or i
defective items.
The method of identification shall not affect the fit, function, or quality of the item being identified.
Measures shall be established for tracing safety-related materials. parts and components to appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
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Correct identification of materials, parts, and components shall be verified and documented prior to release for fabrication, assembling, installation, or use.
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Control of Special Processes Procedures shall be established to assure that special L
' processes such as welding, heat treating, nondestructive testing, and cleaning are performed by qualified personnel and in accordance with applicable codes, standards, and specifications.
I Qualification records of procedures, equipment and personnel associated with special processes shall be established as i.
L required, filed and kept current.
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Inspection
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An inspection program shall be established, documented, and accomplished in accordance'with written and controlled procedures to assure conformance of quality-affecting activities.
All modifications, repairs, and replacements shall be inspected in accordance~with the original design and inspection requirements, or approved alternatives.
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inspection procedures shall identify any required mandatory inspection hold points for witness by an inspector.
Inspection personnel shall be qualified in accordance with applicable codes, standards, and company training programs, i
and shall be independent from the individuals performing the activity being inspected.
The inspector's qualifications shall be kept current.
Indirect control bf monitoring shall be provided when direct control by inspection is not practical.
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Test Control Written controlled procedures shall be established for test programs that will demonstrate that safety-related items and components are constructed in accordance with design specifications.
The procedures shall include testing instructions, qualifications, equipment, testing conditions, and limits, as applicable.
Modifications, replacements and repairs shall be tested in accordance with original design and testing requirements, or approved alternatives.
Test results shall be documented, evaluated and their acceptability determined by a qualified, responsible individual.
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Control of Measuring and Test Equipment i
Measuring and test equipment used in activities affecting quality shall be calibrated at specified intervals based on required. accuracy, degree of usage, purpose, and other characteristics and conditions affecting measurements.
Calibrations shall be made using known or national standards whenever possible.
If known or national standards are not l
available, documented calibration procedures describing techniques, frequency and course of action shall be applied.
Measures shall be taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
Measuring and test equipment shall be identified and traceable to the calibration test date.
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Handling, Storage, and Shipping Procedures shall be established for the handling, storage, cleaning, packaging, shipping, preservation and inspection of material and equipment to prevent and/or detect damage or deterioration.
The work and inspection shall be performed by trained personnel.
Shipments shall not be made unless all necessary tests, inspections, certifications, and approvals have been performed to assure the safe transportation of the package and that the package complies with applicable NRC and DOT regulations.
Shipping papers shall be prepared prior to shipment.
The departure, arrival time, and destination of a package shall be established and monitored to a degree consistent R1 with the safe transportation of the package.
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Inspections, Test and operating Status Measures shall be established for communicating methods of identification of inspection, test and operating status to the necessary organizations.
The application and removal of inspection and test status-indicators and departure from requirements for inspection, l
testing, or other critical operations shall be procedurally controlled.
Nonconforming, inoperative, or malfunctioning packages or components shall be identified and segregated to prevent inadvertent use pending disposition.
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Nonconforming Material, Parts, or Components Materials, parts, or components which do not conform to requirements shall be marked, tagged, or disposed of to prevent their inadvertent use or installation.
Procedures shall be established for the identification, documentation, segregation, review, disposition, and prompt notification to i
affected organizations of nonconforming materials, parts, or components which are likely to jeopardize the safe use or I
operation of such items.
Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked according to documented procedures.
The acceptability of reworked or repaired materials, parts,
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or components shall be verified by reinspection and retesting using the original inspection and testing procedures, or an equally approved alternative.
l Documentation shall identify the nonconforming item, nature 1
- of nonconformance, inspection requirements, and disposition or corrective action.
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Corrective Action All conditions that are adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances shall be promptly corrected.
9 Measures shall be taken by responsible personnel to assure that the cause of significant conditions adverse to quality is determined and corrective action taken to preclude repetition.
The identification of a condition adverse to quality, cause of the condition, and the corrective action taken shall be documented.
Inspection procedures shall be revised, as necessary, for prompt identification of conditions that are adverse to quality.
Follow-up reviews shall be conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
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Quality Assurance Records Identifiable and retrievable records shall be maintained to provide documentary evidence of the quality and safety of items covered by this program and the activities affecting quality and safety.
Quality Assurance records shall contain applicable information and documentation such ast results of reviews, i-inspections, tests, audits, and material analyses; l
qualification of personnel, procedures, and equipment; i
drawings, specifications, procurement documents, calibrating procedures and reports; nonconformance reports; and corrective action reports, i
A list of the required records, retention times and their storage locations shall be maintained.
Design-related records shall be maintained for the life of shipping packages.
Inspection and test records shall contain the following where applicable:
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A description of the type of observation.
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Evidence of completing and verifying a manufacturing, inspection, or test operation.
3.
The date and results of the inspection or test.
4.
Information related to conditions adverse to quality.
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Inspector or data recorder identification.
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Evidence as to the acceptability of the results..
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Audits i
t Audits shall be performed in accordance with pre-established written procedures or check lists and conducted by personnel not directly responsible in the areas being audited.
Audits of the Quality Assurance Program shall be performed at least biennially based on the safety significance of the R1 activity being audited.
The frequency shall change according to the number of faults, deviations, or noncompliances discovered during inspections, tests, or audits.
Audit results shall be documented and reviewed with management in the area being audited.
Responsible management shall take the necessary action to correct deficiencies revealed by an audit.
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Plant
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l Manager Piant Manager Manager Manager Production Controller Process Maintenance &
Regulatory Technology Plant Engineerin Af f airs m
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l Coordinator l
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Proc Engrs OA Inspectort -;-------------
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l Production Purchasing Accountability Maintenance Plant Reliability OA Related OA Related Engineering Engineering i
OA Related og peggggg Shippin9 Repairs &
OA Related OA Related Operations &
Procurement '
Accounting &
Inspections
' Design &
Tests 8 inspections Documentatior Specification inspections l
1 EXHIBIT B 12/15/8 9 j
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