ML19249B846
| ML19249B846 | |
| Person / Time | |
|---|---|
| Site: | 07100277 |
| Issue date: | 06/20/1979 |
| From: | Phillips D ALLIED CHEMICAL CORP. |
| To: | |
| Shared Package | |
| ML19249B847 | List: |
| References | |
| NUDOCS 7909050521 | |
| Download: ML19249B846 (26) | |
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REVISIC'i SHEET Revision Date of Description Number Revision of Revision Signature O
6/20/79 First issue
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TABLE CF CONTENTS Section Face Introduction 1
Appendix "E" Criteria 1.
Organication 2
2.
Quality Assurance Program 3
3.
Design Control 4
4.
Procurement Document Control 5
5.
Instructions, Procedures and Drawings 6
6.
Document Control 7
7.
Centrol of Purchase Materials, Parts and Ccepenents 8
8.
Identification and Centrol of Material, Parts and Ccepenents 9
9.
Control of Special Processes 10 10.
Inspection 11 11.
Test Control 12 12.
Control of Measuring and Test Equipment 13 13.
Handling, Storage and Shipping 14 14.
Inspection, Test and Cperating Status 15 15.
Ncnconforming Materials, Parts, or Components 16 16.
Corrective Action 17 17.
Quality Assurance Records 18 18.
Audits 19 3.
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APPENDIX Page Exhibit A Divisional Crganization Chart 20 Exhibit B Metropolis Works Quality Assurance Organizational Chart 21
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INTRODUCTION The purpose of the Quality Assurance Program is to assure that the quality of materials, compenents and packages precured and used by Allied Chemical Corporation's Metropolis Works for shipment of uranium hexafluoride are adequate to protect the health and safety of the public and cceplies with those specifications recognized by the Nuclear Regulatory Commission (NRC).
The Quality Assurance (QA) Program applies to the design, fabrication, assembly, testing, inspection, use and main-tenance of all vessels and components used for the storage and shipment of low specific activity, source material (containing 0.711% or less U-235) uranium hexafluoride (UF 6*
Allied Chemical will delegate scme responsibilities contained in the Quality Assurance Program with the understanding that the responsi-bilities will not be relinquished.
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s t.Lew 3, APPENDIX "E" CRITERIA 1.
Orcanization Allied Chemical shall retain and exercise responsibility for the Quality Assurince Program. Allied Chemical will delegate, but not relinquish some responsibilities to fabricators, contractors, or sub-contractors. 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 Chemical.
Metropolis Works Quality Assurance organization shall perform or delegate to other organizations all the functions necessary to assure that appropriate elements of Appendix "E" will be implemented.
Job descriptions and qualifications shall be available for each jcb function shown on the organizational chart in Exbibit "B".
Overall authority and responsibility for the Qualit/ Assurance Program has been assigned by Division management to the Plant Manager.
Allied Chemical Divisional management has delegated in writing the authority and responsibility for the implementation of the Quality Assurance Program to the Metropolis Works Technical repartment.
The Technical Department has the authority to stcp unsatisfactory work and control further processing, delivery, discard or installation of ncn-conforming material.
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2.
Quality Assurance Procram The Quality Assurance Program is established and administered in accordance with Appendix "E",
The tIRC-approved Quality Assurance Program will be followed by Allied Chemical's Metropolis Works to assure that all UF y
rs meet the provisions of the approved 6
Quality Assurance Program as a minimum. The Plant Manager has issued instructions that the above is Corporate policy and compliance is man-datory.
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.
The distribution of controlled Quality Assurance manuals shall be recorded on a distribution sheet. Any additions or deletiens of dis-tributed 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.
The fabrication and maintenance of UF, shipping containers and O
safety related equipment shall be centrolled by the Quality Assurance Program.
Any quality-related disputes shall be resolved by Metrcpolis Works management without sacrifice of safety standards.
Personnel performing quality-related activities shall be prcperly indoctrinated and trained to assure ccmpetent implementatien of quality assurance precedures. The methed of training and the names of those individuals that have been trained to perform various quality-related activities shall be dccumented.
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Design Control The design of UF y
rs and safety related compenents shall be 6
performed in accordance with approved engineering standards or shall be proven adequate by test.
Quality standards shall be specified in the P
design documents.
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 controls that were applicable to the original design.
Design details incorporated in an :TRC Certificate of Compliance will not be altered without prior NRC approval.
The design shall be reviewed to assure that the design charac-teristics can be controlled, inspected and tested, and that inspection and test criteria are identified.
Verification of design, calculations or processes relating to safety items shall be performed by an independent crganization or individual. Test programs shall be performed with a prototype unit under design conditions.
The personnel or groups respcnsible for design reviews and veri-fication activities and their authority and respcnsibility shall be identified and controlled by written procedures.
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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4.
Precurement Document Centrol Procedures shall be established to assure that procurement docu-ments are p roperly prepared, reviewed, approved and controlled to assure that procurement functions are accceplished in accordance with specified codes, standards, drawings and specifications.
Cuality 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 design basis technical requirements including applicable regulatory require-ments, material and ccmponent identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
The procurement document shall specify documentation such as drawings, specifications, personnel qualifications, inspection and test records, and/or other procedures necessary for Allied Chemical's review and approval. A record of qualified suppliers shall be maintained.
All procurement dccuments (or copies therenf) shall be retained for the life of the cylinder (s) to which they apply.
The procurement document shall identify these records that are to be delivered to Allied Chemical prior to ccmpletion of the centract and that Allied Chemical perscnnel shall have the right of access to supplier's facilities and records for source inspection and audit.
Any changes cr revisions to precurement documents are subject to at least the same review and approval as the original document.
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5.
Instructions, Procedures and Drawings Those activities necessary to assure the cuality of UF. cylinders O
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, test, calibratien, and special process procedures, drawings and specifications.
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Document Control All documents concerning the design, fabrication, inspection, operating ano maintenance instructions, procurement, and Quality Assurance pcocedures must be approved by qualified Quality Assurance personnel and Metropolis Works management before the activities described in the dccuments are pursued. This control applies to the activities affecting the quality of existing UF cylinders, as aell as t.50se affecting new 6
cylinders. Applicable and current documents shall be available at the location where the work is being performed.
Any approved modifications to instructions, procedures, drawings, er specifications shall be added to the dccuments 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 use of obsolete documents.
A master list shall be established to identify the current revision numbers for instructicns, procedures, specifications, drawings and pro-curement documents.
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Centrol of Purchased Materisis, Parts and Ccrpenents 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 Program. The results of supplier evaluations shall be documented and retained.
Cualified personnel shall audit suppliers and/or inspect prccured materials or equipment during f abricatien, inspection, testing, and shipment as necessary to assure conformance to the purchase order requirements.
The supplier shall furnish documentary evidence that purchased material cr equipment conforms to the procurement specifications.
The supplier shall identify any procurement specifications which were not met together with a description of these noncenformances dis-positioned " accept as is", " repair", or " discard", and shall prceptly so notify Allied Chemical.
Inspection records or certificatc.. conformance attesting to the acceptance of material or ccmpenents shall be available pricc to installation or use.
Items accepted and released for use shall be identified by tags or other acceptable means of identification.
Ncn-conforming items shall be identified and centrciled until final disposition has been made to avoid the inadvertent use of non-cenferring material, ccmponents or equipment.
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Identific1 tion and Control of Materials, Parts, and Components Measures shall be established for the identification and control of safety-related materials, parts and cceponents, including partially fabricated assemblies.
Identification shall be maintained either on the i:2m or en records traceable to the item to preclude use of in-correct er defective items.
The methed 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 apprcpriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
Carrect identification of materials, parts, and components shall be verit ' ed and documented prior to release for fabrication, assembling, installation, or use.
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Centrol of Special Processes procedures shall be established to assure that special processes such as welding, heat treating, nondestructive testing, and cleaning are per-formed by qualified personnel r_nd in accordance with applicable ccdes, standards, and specifications.
Cualification records of procedures, equipment and personnel asscciated with special processes shall be established as required, filed and kept current.
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Inspection An inspection program shall be established, dccumented, and accomplished in accordance with written and controlled procedures to assure conformance of quality-affecting activities. All =cdi-fications, repairs, and replacements shall be inspected in accor-dance with the original design and inspection requirements, or approved alternatives. The 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, and shall be independent from the individuals performing the activity being inspected. The inspector's qualifications shall be kept current.
Indirect control by =cnitoring shall be provided when direct control by inspection is not practical.
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Test Con *.rol Written controlled precedures shall be established for test prograns that will demonstrate that safety-related items and ccaponents are in accordance with design specifications. The procedures shall include testing instructions, qualifications, equipment, testing condi-tiens, and limits, as applicable.
Mcdifications, replacements and repairs shall be tested in accer-dance with original design and testing requirements, or approved alternatives.
Test results shall be documented, evaluated and their acceptability determined by a c,.alified, responsible individual.
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12.
Centrol of Measuring and Test Equiccent Measuring and test equipment used in activities affeccing quality shall be calibrated at specified intervals based on required accuracy, degree of usage, purpcse, and other characteristics and conditions affecting measurements.
Calibrations shall be made using known or naticnal standards when-ever possible.
If known or national standards are not available, dccumented calibration procedures describing techniques, frequency and course of action shall be applied.
Measures shall be taken and documented to determine the validity of previcus 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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Handline, Storage, and Shippinc Procedures shall be established for the handling, storage, cleaning, packaging, shipping, preservation and inspection of material and equip-ment to prevent and/cr detect damage or deterioration. The work in-spection 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 DCT regulations. Shipping papers shall be prepared prior to shipment.
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Inscections, Test and Operatin: Status Measures shall be established for communicating methods 02 identification of inspection, test and operating status tc the necessary organizations.
The application and removal of inspection and test status in-dicators and departure from requirements for inspection, testing, or other critical crerations shall be procedurally controlled.
Ncnconforming, incperative, or malfunctioning packages or ccc-ponents shall be identified and segregated to prevent inadvertent use pending dispcsition.
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Noncenforminc Material, Parts, or Components Materials, parts, or cceponents 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 affected organizations for noncenforming materials, parts, or ccepcnents which are likely to jecpardize the safe use or 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, or components shall be verified by reinspection and retesting using the original inspection and testing procedures, or an equally approved alternative.
Documentation shall identify the nonconforming item, nature of nonconformance, inspection requirements, and disposition or corrective action.
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16.
Corrective Acticn All conditions that are adverse to quality, such as deficiencies, deviatior.s, defective material and equipment, and ncnconformances shall be prceptly corrected.
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 conditicn adverse to quality, cause of the condition, and the corrective action taken shall be documented.
Inspection procedures shall be revised, as necessary, for prcmpt identification of conditions that are adverse to quality.
Fellow-up reviews shall be conducted to verify proper implementation of corrective actions and to close cut the corrective action documentaticn.
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Quality Assurance Records Identifiable and retrievable records shall be maintained to pro-vide documentary evidence of the quality and safety of items covered by this program and the _ activities af fecting quality and safety.
Quality ; surance reccrds shall contain applicable information and documenta'.io. such as; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; drawings, specifications, procurement documents, calibrating procedures and reports; nonconformance reports; and correc-tive action reports.
A list of the required records, retention times and their storage locations shall be maintained. Design-related records shall be mair-tained for the life of shipping packages.
Inspection and test records shall contain the follcwing where applicable:
1.
A description of the type of observation.
2.
Evidence of completing and verifying a manufacturing, inspection, or test operation.
3.
The date and results of the inspection er test.
4.
Information related to conditiens adverse to quality.
5.
Inspector er data recorder identification.
6.
Evidence as to the acceptability of the results.
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Audits Audits shall be performed in accordance with pre-established written procedures or check lists and conducted by perscnnel not directly re-spensible in the areas being audited.
The frequency of audits shall be based on the relationship of the audit to safety. The frequency shall change acccriing to the number of faults, deviations, or ncncompliances 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 b';
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s> 4 I s' p w N #i PRESIDE!JT Di re ct. Res[>ons i b i l i t.y Si't:CI ALTY CllEMICALS DIVISIOti l
i Ativ i sory Available line of conununica t. ion ort VICE PRES.-MFG. & EllGR.
DIRECTOR IJUCLFAR Qua1ity Assurance SI'ECI ALTY CllEMICALS
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REGUIATORY & GOVE RtJ-DIVISIO!1 ME!JTAL AFFAIRS DIRECTOR - OPERATIOtJS -
TECllllICAL - IJUCLEAR ACTIVITIES lieavy 1ined boxes indi ca t e lirianary responsibility for cylinder Quality PIAf4T MAIJAGER Assurance.
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