ML19242D080
| ML19242D080 | |
| Person / Time | |
|---|---|
| Site: | 07100241 |
| Issue date: | 06/03/1979 |
| From: | Gregg B UNITED NUCLEAR CORP. (SUBS. OF UNC, INC.) |
| To: | |
| Shared Package | |
| ML19242D078 | List: |
| References | |
| QAP-001, QAP-1, NUDOCS 7908140479 | |
| Download: ML19242D080 (15) | |
Text
unc UnC OUALITY ASSURANCE PROGRAM e.
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SHIPPING CCN %INERS 1.0 purpose This document describes the quality assurance program of UNC Recovery Systems (UNC-RS) for the procurement, inspection and use of shipping containers for radioactive materials, in ecopli-ance with 10CFR71.51.
2.0 Scope The application of this program is limited to the extent of the requirements of 10CFR71.51 and Appendix E to 10CFR71.
Cnly unirradiated uranium-bearing special nuclear material, source material or small sealed radioactive sources are involved in shipments by UNC-RS.
Packages and conditions for shipment of irradiated fuel, high level waste and pluto-nium are specificaly excluded.
Based on the simplicity of the standard design containers used by UNC-RS, and their significant record of acceptable fabrication and safe use, this program does not involve extensive use of formal, detailed procedures in providing the degree of quality assur-ance necessary for compliance.
3.0 Organization 3.1 Corporate Organization UNC's management structure for shipment of radioactive material begins at the divisien level and, therefore, no corporate organization is presented.
The General Manager reports directly to corporate management and is responsible for all activities at CNC-RS.
3.2 Site Organization The General Manager for UNC-RS is responsible for the everall management of the plant.
The Manager, Cuality Assurance (CA) reports directly to the General Manager and is responsible for the planning, administration, and control cf quality assurance programs for UNC-RS.
He has che responsibility and authority, delineated in writing, to stop work in any aspect of the operation which is net in compliance with the Cuality Assurance program.
An organization chart depicting the management structure for UNC-RS, desicned specifically to identify all the j
s units which have responsibilities associated with quality assurance programs, is shown in Figure 1.1.
This organization structure provides the separation of x
functions and independence of acticns necessary for prcper quality assurance.
Figure 1.2 describes t g. 3
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so e '" ' RADIOACTIVE MATERIAL New 2 of 1 3 SHIPPING CONTAINERS Q A P-001 f unctions normally performed by each operational unit, relative to this QA Program.
Although aspects of this program may be delegated to other organizations or individuals, UNC-RS retains and exercises overall respun-sibility.
4.0 Cuality Assurance Program Quality Assurance comprises all necessary actions to provide adequate confidence that a transportation package will per-form satisfactorily in service.
The UNC-RS QA Program insures that a package and its use have the reliability for which the safety and performance cf the package were evaluated.
4.1 Management Assessment UNC-RS management, independent of the Quality Assurance Cepartment, regularly assesses the scope, status, imple-mentation, and effectiveness cf the QA Program to assure that it is adequate and ccmplies with 10CFR Part 71, Appendix E criterit.
4.2 QA Manual Control Any QA manuals prepared in support of this QA Program shall have controlled distribution.
Revisions thereto shall similarly be controlled.
4.3 QA Program Implementation Provisions are established for comnunicating to all re-sponsible organizations and individuals that quality policies, QA manuals, and precedures are mandatory requirements which must be implemented and enforced.
4.4 QA Program Applicability This program is applicable to all radioactive material shipping containers and shipments, except those which are exempt under the provisions of 49CFR.
4.5 Resolution of Disputes Dis,.utes involving quality, arising from a difference of opinien between QA personnel and other departments shall be resolved in such a manner as to assure com-pliance with saf ety and regulatory requirements.
4.6 Indcctrination and Training Personnel performing quality-related activities are provided with indoctrination and training to the degree necessary to assure an adequate lesel of knowledge and pro ficiency.
When deemed necessary, such personnel are retrained in these activities wherein weakness has been detected.
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s. ' RADIOACTIVE MATERIAL O A P- 001 SHIPPING CCNTAINERS 4.7 Performance of Cuality-Related Activities When specified by procedure, quality related activities are performed with specified equipment under suitable environmental conditions.
Specified prerequisites are satisfied prior to inspection and test.
5.0 Desien Control Under norma' conditions, UNC-RS uses only standard design D.O.T.
approved containers or is a registered user of USNRC approved containers.
Therefore, this section of 10CFR71, Appendix E is not applicable.
Should UNC-RS beccme involved in the design of radicactive material shipping containers, the following items will be implemented.
5.1 Desicn Activities Measures will be established to carry out design activ-ities in a planned, controlled, and orderly manner.
5.2 Requirements Translation Measures will be established to correctly translate the applicable regulatory requirements and design bases into specificaticns, drawings, written procedures, and instructions.
5.3 Specification of Quality Standards Quality standards will be specified in the design documents, and deviations and changes from these quality standards will be controlled.
5.4 Design Review Designs will be reviewed to assure that (1) design characteristics can be centrolled, inspected and tested and (2) inspection and test criteria are identified.
5.5 Design verificaticn Proper selection and accceplishment of design verifica-tien or checking processes such as by design reviews, alternate calculations, or qualification testing will be performed.
When a test program is used to verify the adequacy of a design, a qualification test of a proto-type unit under design conditions will be used.
Individuals or groups responsible for design verificaticn will be other than the original designer and the designer's immediate supervisor.
Positions or groups responsible for design reviews and other design verification activities and their authority and responsibility will be identified and centrolled by written documents.
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sa'*" RADIOACTIVE MATERIAL New 4 of la SHIPPING CCNTAINERS O A P-ool 6.0 Procurement Cccurent Centrol To the extent necessary, UNC-RS will implement the follcw-ing aspects of procurement dccument control.
Under normal operating conditions, UNC-RS procurement of shipping con-tainers is limited to D.O.T.
17-H's and 6-M's (55 gallen drums), and only minor aspects of procurement document con-trol are required.
6.1 Procedures Procedures are established that delineate the sequence of acticns to be accc=plished in the preparation, review, approval and control of procurement documents.
6.2 Procurement Document Contents Documents for the procurement of radioactive material shipping containers will include or reference the following information, when applicable.
6.2.1 The applicable 10CFR Part 71, Appendix E require-ments which must be cceplied with and described in the supplier's QA program.
6.2.2 The design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, draw-ings, specifications, codes and industrial stand-ards, test and inspection requirements, and special process instructions.
6.2.3 The documentation (e.g.,
drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, perscnnel and proce-dures qualifications, and chemical and physical test results of material) to be prepared, main-tained, and submitted to CNC-RS for review and approval.
6.2.4 Identification of those records to be retained, controlled, and maintained by the supplier, and those delivered to CNC-RS prior to use or installation of the hardware.
6.2.5 UNC-RS's right of access to supplier's facilities and records for source inspection and audit.
6.3 Procurerent Document Revisicn Changes and revisiens to procurement documents are sub-ject to at least the same review and approval as the original document.
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RADICACTIVE MATERIE new 5 oflJ O A P-001 surppisc ctvTAINEas 7.0 Instructions, Procedures, and Drawings When considered applicable by UNC-ES, the following items are implemented.
7.1 Activities Affecting Quality Activities affecting quality are prescribed and accom-plished in acccrdance with documented instructions, procedures, or drawings.
7.2 Sequence of Ac:icns Provisions are established which clearly delineate the sequence of actions to be accceplished in the prepara-tion, review, approval, and control of instructions, procedures, and drawings.
7.3 Ouality Assurance Reviews Quality Assurance reviews and concurs with inspection plans: test, calibration, and special process procedures; drawings and specifications; and changes thereto.
8.0 Document Centrol UNC-RS will implement the follcWing items when such action is considered to be applicable and appropriate.
8.1 Document Adequacy The review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
8.2 Chance Review and Implementation Changes to documents are reviewed and approved by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by P.he applicant.
Approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.
S.3 Cocument Availability Cccurents are available at the location where the activ-ity will be performed prior to cctmencing the work.
8.4 Decument Master Lists A master list, or equivalent, is establic.hed to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
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$ of 13 RADIOACTIVE MATERIAL O A P-ool e n m o r e e-ccm Twuc 9.0 Control of Purchased Materials, Parts and Ccmponents UNC-RS determines the need for performance of the following activities, and implements them as needed.
9.1 Supplier Evaluation 9.1.1 Qualified personnel evaluate the supplier's capability to provide acceptable quality serv-ices and products.
9.1.2 The evaluation of suppliers is based en one or more of the follcwing:
(1)
The supplier's capability to ccmply with the elements of Appendix E to 10CFR Part 71 that are applicable to the type of material, equip-ment, or service being procured.
(2)
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
(3)
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufactur-ing, and quality requirements.
9.1.3 The results of supplier evaluations are documented and filed.
9.2 Supplier Surveillance If required, surveillance of suppliers during fabrica-tion, inspection, testing, and shipment of materials, equipment and components is planned and performed in accordance with written precedures to assure conformance to the purchase order requirements.
9.3 Supplier Records As a minimum, the supplier furnishes the follcwing records to UNC-ES:
(1)
Cocumentation that identifies the purchased material or equipment and the specific procurement require-ments (e.g.,
codes, standards, and specifications) met by the items.
(2)
Cocumentaticn that identifies any procurement requirements which have not been met,together with a description of those nonconformances dispositioned
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RADICACTIVE MATERIAL New 7 of 13 SHIPPING CCNTAINERS O A P- 0 01 9.4 Receiving Inspection Receiving inspection of the supplier-furnished material, equipment, and services is performcd to assure:
(1)
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
(2)
Material, components, equipment, and acceptance records are inspected and j udged acceptable in accordance with predetermined inspection instruc-tions, prior to installation or use.
(3)
Inspection records or certificates of conformance attesting to the acceptance of material and compo-nents are available prior to installation or use.
(4)
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.
10.0 Identification and Control of Materials, Parts, and Components when considered necessary and applicable by UNC-RS, the following items are implemented.
10.1 Identification and Centrol Procedure Procedures are established to identify and control materials, parts, and components including partially f abricated subassemblies.
The identification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incor-rect or defective items.
10.2 Traceability Identificaticn of materials and parts important to the f unction of safety-related systems and compcnents can be traced to the apprcpriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection dccuments, deviation reports, and physical and chemical mill test reports.
10.3 Identification Lccation and Methed The locaticn and the method of identification do not affect the fit, f un ction, or quality of the item being identified.
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10.4 Verification and Documentation Correct identification of materials, parts, and compo-nents is verified and dccumented prior to release for fabrication, assembling and installation.
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b RADIOACTIVE MATERIAL New 3 of 13 SHIPPING CCNTAINERS Qu4 P. 001 11.0 Control of Special Processes Special processes are controlled when such centrol is consi-dered to be necessary to the proper functicning of die compo-nente 11.1 Procedural Control Special processes such as welding, heat treating, non-destructive testing, and cleaning are procedurally con-
- trolled, 11.2 Qualifications Procedures, equipment, and personnel connected with special processes are qualified in accordance with appli-cable codes, standards, and specifications.
Qualification records of procedures, equipment, and per-sonnel associated with special processes are established, filed, and kept current.
12.0 Inspection UNC-RS reviews the need for the following inspection controls, and implements them as necessary and applicable.
12.1 Inspection Proc?dures An inspection program'which verifies conformance of quality-affecting activities with requirements is esta-blished, documented, and accomplished in accordance with written and controlled procedures.
12.2 Inspection Personnel Inspection personnel are independent frem the individuals performing the activity being inspected.
Inspectors are qualified in accordance with applicable codes, standards, and company training prcgrams; and their qualifications and certifications are kept current.
12.3 Inspection of Modifications, Repairs, and Replacements Mcdifications, repairs, and replacements are inspected in accordance with the original design and inspecticn requirements or acceptable alternatives.
12.4 Inspection Hold Points Provisions are established that identify mandatory inspection hold points for witness by an inspector.
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. c.iw so. m RADICACTIVE MATERIAL Q A P 001 SHIPPING CCNTAINERS 13.0 Test Control When applicable, UNC-RS provides the following test controls.
13.1 Test Procedures A test pr im to demonstrate that the item or component will perft satisf actorily in service is established, docurented, and accomplished in accordance with written contrc' led procedures.
13.2 Testing of Modifications, Repairs, and Replacements Modifications, repairs, and replacements are tested in accordance with the original design and testing require-ments or acceptable alternatives.
13.3 Test Results Test results are documented, evaluated, and their accept-ability determined by a qualified, responsible individual or group.
14.0 Control of sgasuring and Test Equipment When reasure.nsnt and testing of shipping packages by UNC-RS is determined to be necessary, the following controls will be provided for.
14.1 Calibration Measuring and test instruments are calibrated at speci-fied intervals based on the required cccuracy, purpose, degree of usage, stability characteristics, and other conditions cffecting the measurement.
14.2 Identification and Traceability Measuring and test equipment is identified and traceable to the calibration test data.
14.3 Validity of Previous Inspections Measures are taken and documented to determine the validity of previous inspections performed when measur-ing and test equipment is found to be out of calibration.
14.4 Standards Reference and transfer standards are traceable to nationally recognized standards: or, where national standards do not e:cis t, provisions are established to docurent the basis for calibration.
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s,.. c UDC New 1 0 of la RADICACM MRIAL O A P- 001 FHIPPING CCNTAINERS 15;0 Handling, Storage, and Shipping UNC-PS provides the following controls to the degree deter-mined to be necessary and applicable.
15.1 Work and Inspection Instructions Special handling, preservation, storage, cle anin g,
packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
15.2 NRC and CCT Conditions All conditions (operations, tests, inspections, speci-fications, etc.) of the NRC package approval and the U.S.
Department of Transportation shipping requirements are satisfied prior to shipmenL.
15.3 Shipping papers All necessary shipping papers will be prepared, as required.
15.4 Shipment Monitoring Departure, arrival time and destination of a package will be established and monitored to a degree consistent with tne safe transportation of the package.
16.0 Inspection, Test, and Operating Status When applicable, UNC-RS implements the following controls.
16.1 Identification of Status Identification of the inspection, test, and operating status of packages and components is kncwn by affected organizations.
16.2 Control cf Status Indicators The application and removal of inspection and Nelding stamps and status indicators such as tags, markings, labels, and stamps are procedurally controlled.
16.3 Control of Cperational Bypasses Bypassing of required inspections, tests, and other critical operations is procedurally centrolled.
16.4 Status of Unacceptable packages The status of nonconforming, inoperative, or malfunction-ing packages or components is identified to prevent inadvertent use.
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' RADICACTIVE.%\\TERI AL UnC New 1 of 1 i SnippINo CCNTAINERS O A P- 0 01 17.0 Nanconforming Material, Parts, or Ccmponents UNC-PS ',ill control nonconforming items by techniques suit-able for :cauring that they are not utilized until their acceptability is established and documented.
Such techniques may include the following elements.
17.1 Procedural Controls The identification, documentation, segregation, review dispositien, and notifi':ation to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.
17.2 Cocumentation Documentation identifies the nonconforming item; describes the nonconformance, the dispositicn of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
17.4 Segregation and Identification Nonconforming items are segregated from acceptable items and identified as discrepant until properly dispositioned.
17.5 Acceptance of Rework and Repair Acceptability of rework or repair of materials, parts, ccmponents and systems is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
13.0 Corrective Action When appropriate to the circumstances, UNC-RS tukes the follcwing steps relative to corrective action.
18.1 Corrective Action Evaluation Evaluation of conditions adverse to quality (such as noncen fo rmances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
19.2 Initiation of Cr tve Action Corrective action
, protect against recurrence is initiated following the determination of a condition adverse to quality and the need for such action.
18.3 Follow-up Reviews Follow-up reviews are conducted to verify proper imple-mentation of corrective actions and to closecut the corrective action documentation.
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CCNTAINERS Q A P-001 19.0 Quality Assurance Records Appropriate records will be kept by UNC-RS, as required else-where by this program, and maintained in a manner consistent with applicable regulatory requirements.
Sufficient records are maintained to provide documentary evidence of the quality and safety of items and the activities affecting quality and safety.
When applicable, the following records and controls will be utilized, 19.1 Types of Records QA records include operati.'q logs; results of reviews, inspections, tests, audits, and materisl analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; an s. corrective action reports.
19.2 Records Control and Retention A list of the required records and their storage locations will be maintained.
The records will be identifiable and retrievable.
Design related records (e.g., drawings, calculations, etc.) are maintained for the life of the shipping package and all other records are maintained for a minimum of two years.
19.3 Contents of Inspection and Test Records Inspection and tost records contain the following where applicable:
(1)
A description of the type of cbservation.
(2)
Evidence of completing and verifying a manufactur-ing, inspection, or test operation.
(3)
The date and results of the inspection er test.
(4)
Information related to conditions adverse to quality.
(5)
Inspector or data reccrder icentificaticn.
(6)
Evidence as to the acceptability of the results.
20.0 Audits Audits will be carried out by UNC-RS to verify ccmpliance with all aspects of this Quality Assurance Program and to determine the effectiveness of the program.
Elements of these audits include the following.
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O A P. 001 SHIPPING CONTAINERS 20.1 Audit Pe r fo rmance Audits are performed in accordance with preestablished written procedures or check lists and conducted by personnel not having direct responsibilities in the areas being audited.
20.2 Documentation, Review, and Corrective Action Audit results are documented and then reviewed with management having responsibility in the area audited.
Responsible manageme7t then takes the necessary action to correct the deficiencies revealed by the audit, 20.3 Reauditing Deficient areas are reaudited on a timely basis to verify implementation of corrective actior s which minimize recurrence cf deficiencies.
20.4 Audit Frec,ue ncy Audits of the CA program are perfcmed at least annually based on the safety significance of the activity being audited.
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UnC New 1 of 2 O A P- 001 RADIOACTIVE MATERIAL SHIPPING CONTAINERS APPENDIX FIGUPE 1.1 FUNCTIONAL ORGANIZATION CHART UNC RECOVERY SYSTEMS GENERAL MANAGER A
- MANAGER, MANAGER, QUALITY FUEL
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ASSURANCE RECOVERY C
PURCHASING PRODUCTION C
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ENGRNG NUCLEAR MA'"E RI AL CONTROL NUCLEAR AND INDUSTRIAL SAFETY s"
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New 2 of 2 SHIPPING CONTAINERS O A P-ool APPENDIX FIGURE 1.2 JOB FUNCTICNS 1.
General Manager Responsible for overall management of UNC-RS.
2.
Manager, Finance and Administration Responsible for purchasing and procurement of shipping con-tainers and shipping services.
3.
Manager, Quality Assurance Responsible for overall planning, administration, and control of Shipping Quality Assurance Program.
4.
Quality Assurance Engineering Responsible, when applicable, for training, documentation and document control, control of purchased materials, parts and ccmponents, identification, control of special processes, inspection, test control, measuring and test equipment control, status control, control of non-conforming items, corrective action programs, quality assurance records, and audits.
5.
Nuclear Material Control Responsible, when applicable, for shipping document preparation and control.
6.
Nuclear and Industrial Safety Responsible, when applicable, for safety analyses, and inspec-tion and preparation for shipment.
7.
Manager, Fuel Recovery Respcnsible, when applicable, for handling and storage of shipping containers and components, repair of shipping con-tainers, inspection and preparation for shipment.
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