ML19259A883
| ML19259A883 | |
| Person / Time | |
|---|---|
| Site: | 07100250 |
| Issue date: | 12/29/1978 |
| From: | Goldmann K TRANSNUCLEAR, INC. |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| E-1473, NUDOCS 7901110117 | |
| Download: ML19259A883 (25) | |
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December 29, 1978 g
o S 5, '.. ::. M;CH Director; Office of Nuclear Material Safety and Safeguards Nuclear Regulatory Commission Washington, D.C.
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Subject:
Quality Assurance Program for Shipping Packages Transnuclear, Inc. herewith submits its Quality Assurance Progran for Design, Manufacture, Test, Use, Maintenance and Repair of Packaging 3 for Transport of Radioactive Materials.
This submittal is intended to be in compliance with the requirements of 10 CFR 71.51 for filing such a program with your office.
He are awaiting your acceptance of this program before implementing it.
In the meantime, we shall continue to operate under our existing QA programs.
Very truly yours, l/) &W -
J Kurt Goldmann Chief Engineer
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Transnuclear, Inc. E-1473, Original Issue 12/28/78
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QUALITY ASSURANCE PROGRAM FOR DESIGN, MANUFACTURE, TEST, USE, MAINTENANCE AND REPAIR OF PACKAGINGS FOR TRANSPORT OF RADIOACTIVE MATERIALS e
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Approved Description 0
12/28/78 [M%
Original Issue F
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T TABLE OF CONTENTS Page Introduction 1
1.
Organization 3
2.
Quality Assurance Program 8
3.
Design Control 10 4.
Procurement Document Control 12 5.
Instructions, Procedures and Drawings 12 6.
Document Control 13 7.
Control of Purchased Material, Equipment and Services 14 8.
Identification and control of Materials, Parts and Components 15 9.
Control of Special Processes 15 5'L 10.
Inspection 16 11.
Test Control 16 12.
Control of Measuring and Test Equipment 17 13.
Handling, Storage and Shipping 18 14.
Inspection, Test and Operating Status 18 15.
Nonconforming Materials, Parts or Components 19 16.
Corrective Action 20 17.
Quality Assurance Records 20 18.
Audits 22 0
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m INTRODUCTION "he Code of Federal Regulations, Title 10, Part 71 (10 CFR 71) " Packaging of Radioactive Material for Trans-port and Transportation of Racioactive Material Under Certain Conditions", requires in paragraph 71.51 that a licensee establish, maintain and execute a quality assurance program (QA program) satisfying each of the applicable criteria specified in Appendix E of 10 CFR 71.
A licensee is a person or organization that delivers licensed material in an approved packaging to a carrier for transport.
The licensee is required to assure himself and the Nuclear Regulatory Commission that the QA program, on which approval of the packaging is based, has been implemented.
The present document describes how Transnuclear, Inc. (TNY), as a licensee, l'
intends to satisfy these requirements, w
As a licensee, TNY has QA responsibility for all phases of design, manufacture, test, use, maintenance, and repair of any packaging which TNY delivers to a carrier for transport of licensed material.
This QA responsibility exists whether TNY has contractual responsibility for each of the individual phases or not.
For example, if TNY intends to transport material in a packaging which was designed and fabricated by others without TNY involvement, TNY shall assure itself that these activities were performed where applicable in accord with the quality assurance requirements of 10 CFR 71, Paragraph 71.51.
On the other hand, if a packaging is design-ed and fabricated by TNY or under contract to TNY, TNY shall assure that the QA program, as described herein, 1i
e is implemented during these phases.
Organizations that perform such work under direct contract to TNY are identified herein as major participating organizations.
They may provide hardware, services or both.
The present document describes TNY's generic QA program for the design, manufacture, test, use, main-tenance and repair of packagings in accordance with 10 CFR 71, Paragraph 71.51.
Additionally TNY's appli' a-tions for NRC package approval shall also contain speci-fic provisions, as required.
These specific provisions shall consider the complexity and the proposed use of the packaging and its components.
Supplemental requirements may be added or the applicability of certain of the 18 criteria of Appendix E of 10 CFR 71 may be deleted.
T' The organization of this document follows that of
^
Appendix E, 10 CFR 71, in that sections are numbered and titled the same as the corresponding 18 criteria of Appendix E.
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1.
ORGANIZATION
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The organizational structure which has been set up at TNY to establish and implement its QA program is shown in Fig. 1.
The authority and duties of the personnel per-forming activities affecting the safety related functions of packagings are described below.
The Chief Engineer is the person responsible for establishing the QA program.
He reports directly to the President of..TNY.
The President shall approve the QA pro-gram and any revisions thereto.
The Chief Engineer shall approve corporate QA procedures and any revisions thereto.
For each project one person from the TNY organization shall be assigned the QA functic for that Project.
This person may be the Chief Engineer.
Any other person who is assigned to the QA function for a particular pre 4ect shall have no other responsibilities on that Project.
He shall be functionally independent of any group or in-dividual directly responsible for the activities which he monitors.
He shall have the authority and organizational freedom to enforce QA requirements, to identify problem areas, to recommend or provide solutions to QA problems, and to verify the effectiveness of the solutions.
As shown by the solid line in Fig. 1, he can communicate directly with the President.
He has the following typical responsibilities:
a.
Prepare TNY's QA Program Plans and QA procedures for specific projects.
b.
Verify that major participating organizations have approved QA Programs, as required.
c.
Approve QA Program Plans of participating organizations for a Project for which he has been assigned the QA function.
3
PRESIDENT GENERAL CHIEF MANAGER ENGINEER OF OPERATIONS i
PROJECT QUALITY MANAG/3R ASSURANCE FIG.1 TNY ORGANIZATION CHART s'
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Verify that major participating organizations have QA procedures, as required.
e.
Perform audits to Jerify that QA requirements are being met.
f.
Stop unsatisfactory work and control further processing, delivery or installation of non-conforming material.
He may delegate the performance of_one or more of these functions to other qualified individuals at TNY or from contractor organizations.
A Project Manager or Project Engineer shall be re-sponsible to the Chief Engineer for all technical aspects of a Project including issuing of procurement documents, preparation of licensing documents, fabrication and j
delivery of the packaging and use of the packaging.
TNY's General Manager of Operations or his designee shall be responsible for all transport operations after delivery of a packaging to TN'f.
During the design and pro-curement phases, he reviews and provides input on transport and operations requirements.
A.possible interrelationship between TNY and another major participating organization is show in Fia. 2.
The other organization could_be a design agent, packaging manu-facturer, supplier, sub-contractor or user.
The chart is provided to establish that any organization performing functions affecting quality must have a QA position with the required authority and organizational freedom as well as direct access to upper levels of management.
The chart also shows the requirement for direct communication between Quality Assurance of TNY and the other organization.
As licensee, TNY shall retain overall responsibility for the QA 6
program.
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4 Specific organization charts of major participating organizations shall be detailed in their respective QA documents, and shall be in full compliance with the QA requirements of 10 CFR Part 71, Ah*
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s PRESIDENT I
CHIEF GENERAL ENGINEER MANAGER OF OPERATIONS PROJECT QUALITY MANAGER ASSURANCE TNY
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PROJECT QUALITY MANAGEMENT ASSURANCE OTHER PARTICIPATING ORGANIZATION 8
FIG. 2 TYPICAI OVERALL ORGANIZATIONAL CHART 7
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2.
QUALITY ASSURANCE PROGRAM The program described herein is a general QA pro-gram which shall be implemented by TNY as a licensee who delivers a package to a carrier for transport of radioactive materials.
It is intended to be in full compliance with the requirements of 10 CFR 71 and addresses the 18 quality assurance criteria of Appendix E for the design, manufacture, test, use, manitenance and repair of packagings for transport of radioactive materials.
Preparation of and subsequent revisions to this QA program are the responsibility of the Chief Engineer.
The program and any revisions thereto shall be approved by the President of TNY.
The status and adequacy of the pro-gram shall be reviewed annually by a group of cognizant per-
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sonnel chaired by the President.
The Chief Engineer shall record the results of these reviews which shall include a list of follow-up action items, designating responsibilities and schedules for implementation.
Safety related items shall be identified for each specific design and shall be submitted with an application for package approval.
The complexity and importance of these items shall be defined and any special requirements shall be described.
Major organizations participating in a p oject shall have approved quality assurance programs and shall prepare written proceduren and instructions to implement their respective programs.
Their programs, procedures and instructions shall be in full com-pliance with 10 CFR 71.
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- TNY shall perform audits and/or overchecks to assure that these programs and procedures are properly implemented by the participating organizations.
Details for implementing TNY's QA program.shall be described in QA plans and procedures.
Generally applicable corporate QA procedures shall be approved and distributed by the Chief Engineer.
QA plans and procedures for a specific project shall be approved and distributed by the individual who has
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responsibility for the QA function:of: that project.
That~ individual is responsible'for verifying that for that project all activities on safety-related systems, structures and components are controlled by the QA program.
In case of disputes with the Project j-Manager or others over quality matters, he can request resolution by TNY's President.
TNY and major participating organizations shall provide suitable conditions, environment and equip-ment for activities affecting quality.
Special con-trols, tools, equipment, etc. shall be provided to attain the appropriate level of quality.
Inspections, tests and other controls shall be implemented to assure that the appropriate levels of quality are attained.
Personnel performing activities affecting quality shall be properly trained and indoctrinated to assure proficiancy for the tasks which they are to perform.
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3.
DESIGN CONTROL TNY shall establish measures to assure that regu-latory requirements and packaging design have been or are correctly translated into drawings, specifications, procedures and instructions.
The design shall consider, but shall not be limited to the following design aspects:
criticality, shielding, stresses, thermal and hydraulic performance, accident conditions, compatibility of materials, accessibility for in-servicd inspection, maintenance and. repair.
Written instructions, procedures and/or plans shall identify the methods of control for the design of the packaging.
These documents shall' identify the safety related items, regulatory requirements, applicable codes T~'
or standards, design criteria and measures for coordination 6
and control of design interfaces and appropriate quality standards.
Deviations from applicable codes and standards shall be identified and controlled.
Designrcalculations and drawings shall be prepared and checked in accord with approved procedures..
The adequacy of the design may be. verified by test of a prototype or scale model.
In addition, the design shall be formally reviewed by individuals or groups, other than those who performed the original design.
These reviews shall be in the form of Design Review Meetings for packaging designs which are devel-oped by TNY.
For such designs, the Project Manager shall schedule and chair rsview meetings.
These meetings shall confirm that various aspects of the design have be held r
been pioperly considered, including conformance to license requirements when applicable, and to assure that there has been and is appropriate coordination between 10
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organizations. participating in the design, quality assurance, fabrication, and testing.
TNY shall assure that measures are established and implemented to verify that the fabrication and assembly drawings, prepared by the Manufacturer are consistent with design documents.
For packagings of TNY designs, TNY shall review all fabrication drawings, approve design changes and establish pr,ocedures for the documentcry control of design changes.
All design changes, including field changes, shall be subject to the same or equivalent design control measures as are applicable to the original design.
TNY shall establish measures to assure that the approved
~f design and operating conditions are not changed unless the
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effect of the changes on the design are evaluated and approved.
For any change which affects the basis for the Certificate of Compliance of a packaging, approval for the change shall be obtained from the Nuclear Regulatory Com-mission, prior to its use under the modified conditions.
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%L 4.
PROCUREMENT DOCUMENT CONTROL Procurement documents shall be prepared which clearly define all design requirements including quality assurance requirements, and shall reference all applicable docu-ments, including codes, standards, regulatory require-ments and the package design, as specified in the appli-cation for approval.
These documents shall serve as the principal technical documents for the procurement of materials, sparee parts, components, equipment or services to be used in the manufacture, test, use, maintenance or repair of the packaging.
These documents may be prepared by TNY or by one or more major participating organization, e.g. Design jp Agent, Manufacturer, etc.
Each of these organizations i'
shall have a documented, approved quality assurance pro-gram which shall be supplemented by detailed procedures and instructions as required to assure adequate control for preparing and changing procurement documents.
These programs shall also include measures to qualify / accept the quality assurance programs of their suppliers and subcontractors for safety related equipment, materials or services.
Procurement documents shall also address the applicability of the provisions of 10 CFR 21, Report-ing of Defects and Noncompliance.
5.
INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities affecting quality during design, manufacture, test, use, maintenance and repair shall 12
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be described in instructions, procedures and/or drawings.
They shall be prepared, reviewed, approved and controlled in accord with written document control procedures.
These instructions, procedures and drawings shall.
include quantitative and/or qualitative acceptance criteria to permit verification that activities affecting quality have been satisfactorily accomplished.
The QA tunction on a Project shall review and approve Project instructions, procedures and drawings which are prepared by TNY.
These documents may include, but are not limited to specifications, drawings, special process, calibration, test, operating, maintenance and repair instruc-tions and procedures and any changes thereto.
c.
4, 6.
DOCUMENT CONTROL TNY shall establish and implement procedures to control the issuance of TNY documents which prescribe activities affecting quality.
These procedures shall define document control measures to assure adequate review, approval, release and distribution of original documents and subsequent revisions.
These documents may include, but are not limited to design specifications, drawings, procurement documents, special process, test and operating procedures.
Major participating organizations shall establish and implement document control procedures in accord with their approved QA program.
Changes to documents shall be reviewed and approved by the same organizations that performed the original 4
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A review and approval unless otherwise delegated by TNY or a major participating organization.
The Project Manager shall be responsible for the control of Project documents which are issued by TNT.
He shall also be responsible for the receipt and dis-tribution of Project documents to and from participating organizations.
He shall maintain an up-to-date file of all Project records.
For certain types of documents which are issued by TNY, the Project Manager shall maintain Master Lists to identify current revisions.
He shall update and distribute these lists to responsible personnel to preclude the use of superseded documents.
Major parti-cipating organizations shall utilize the same or equiva-
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lent measures.
7.
CONTROL OF PURCHASE MATERIAL, EQUIPMENT AND SERVICES Measures shall be established and implemented to assure that allppurchased material, equipment and services conform to procurement documents.
Source evaluations shall be performed to confirm that any organization providing safety-related equipment, materiais or services has the willingness and capability to supply these items in accord with the Project's design, quality assurance and procurement requirements.
TNY shall inspect and audit contractors and sub-contractors at suitable intervals to verify that they 14
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2L comply with quality requirements and to assess the effectiveness of their QA programs.
Suppliers shall provide objective evidence that packagings and associated items, including repaired or spare parts, meet all quality requirements.
All items shall be properly identified.
Appropriate records shall be available prior to use or inst'llation to permit a
verification of conformance with procurement documents.
These records shall be retained accessi,bly (See Section 17).
8.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS g-Measures shall be established and implemented to
'i identify and control materials, parts, and components.
These measures shall assure identification of an item by an appropriate means during the fabrication, install-ation and use of the item and shall prevent the inadvertent use of incorrect or defective items.
The identification and control of safety-related items shall be traceable through procurement, fabri-cation, inspection and test records.
9.
CONTROL OF SPECIAL PROCESSES Measures shall be established and implemented for tne control of special processes used in the manufacture and repair of packagings.
These proce les include welding, non-destructive testing and other processes special to a specific packaging as identified in the application for packaging approval.
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PL Special processes shall be performed in accordance with approved written procedures.
Personnel who perform special processes shall be formally trained and qualified in accordance with applicable codes, standards or specifications.
Qualification records of procedures and personnel shall be filed and kept current by the organization which performs the special process.
10.
INSPECTION Measures shall be established and implemented to inspect materials, parts, processes or other activities affect-ing quality to verify conformance with documented ir ttuctions, procedures, specifications, drawings, or other procurement c
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documents.
These inspections shall be performed by personnel other than those who performed the activity being inspected.
These inspections shall be performed in accord with approved, written instructions and procedures which identify methods and controls for indirect inspections when direct inspection is impossible.
The instructions and procedures shall address acceptance criteria.
Mandatory hold points shall be established for inspections or witnessing, as required.
Work shall not proceed beyond a hold point without the consent of the designated inspector.
11.
TEST CONTROL A program shall be established and implemented to perform required proof, acceptance and operational tests, as identi-16
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fied in procurement documents and the application for package approval.
The tests shall be performed by qualified personnel in accordance with approved, written instructions or procedures.
The test procedures shall identify test equipment, calibrated instrumentation, and conditions for each test.
Test results shall be documented and evaluated.
They shall demonstrate that acceptance criteria have been met.
Acceptance of test results for a specific project shall be acknowledged by the TNY Project Manager for that project or his designee.
12.
CONTROL OF MEASURING AND TEST EQUIPMENT y
Measures shall be established and implemented to 4'
assure that tools, gages, instruments and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated and adjusted to maintain accuracy within necessary limits.
These measuring devices shall be calibrated at scheduled intervals against certi-fied standards having known, valid relationships to national standards.
All calibrations shall be performed in accordance with approved written procedures.
Test equipment shall be subjected to a proof test to demonstrate that it performs its intended function prior to its use for testing packaging components or the complete packaging.
Operational checks shall be performed on test equip-ment, as required to assure that the equipment is still functioning properly, prior to actual testing of packaging components or the complete packaging.
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g 13.
HANDLING, STORAGE AND SHIPPING Measures shall be established and implemented to assure that all materials, components, assemblies, spare parts, special tools, equipment and the packaging itself are handled, stored,; packaged and shipped in a manner which prevents damage, loss of identity or deterioration.
These activities shall be carried out in accordance with written approved procedures.
When necessary, storage procedures shall address special requirements for environmental protection such as inert gas atmospheres, moisture, temperature levels, etc.
Shipping procedures shall assure that all conditions of the Certificate of Compliance are satisfied prior to delivery du of radioactive material to a carrier for transport in an approved package.
14.
INSPECTION, TEST AND OPERATING STATUS Measures shall be established and implemented to assure that the status of required inspections and cests of packagings and associated items are clearly indicated by some suitable means, e.g. tags, labels, cards, form sheets, check lists, etc.
The status of nonconforming items is of particular concern (see Section 15).
Where appropriate, the operating status of components of the packaging, e.g. valves, switches, etc. shall be indi-cated to prevent inadvertent operation.
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The application and removal of status indicators shall be in accord with approved written instructions and proce-dures.
15.
NONCONFORMING MATERIALS, PARTS OR COMPONENTS Measures shall be established and implemented to control materials, parts, and components which do not conform to requirements so as to,. prevent their inadvertent use in sub-sequent manufacturing operations or during service.
.These measures shall be described in approved written instructions and procedur'es.
The nonconforming items shall include items which do not meet specification or drawing requirements, as well as items which are not fabricated or r
1.
tested in accordance with approved written procedures or by qualified processes or by qualified personnel, where the use of such pre dures, processes or personnel is required by the fabrication, test, inspection or quality control documents.
l'onconforming items shall be identified and segregated to pre 7ent their inadvertent use.
Nonconformance reports shall be utilized for the procedural control of nonconformances.
They shall describe the nonconformances and provide for their disposition.
They shall be utilized to notify other affected organizations.
Items which are not in conformance with TNY approved documents shall be reviewed by TNY's Project Manager and QA function.
Their disposition shall be approved by TNY's QA function.
Nonconformances with documents such as fabri-cation details, which may not require TNY approval, may be resolved without TNY approval by major participating organi-zations, as appropriate, in accord with their approved QA programs.
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Nonconformance reports shall be made part of the inspection records.
They shall also be reviewed periodically to identify quality trends.
The results of these reviews shall be reported to management for their assessment.
Procedures shall be established and implemented to report defects and noncompliances in accord with the provisions of 10 CFR 21.
16.
CORRECTIVE ACTION Measures shall be established and Unplemented to assure that conditions adverse to quality are promptly identified and corrected to preclude repetition.
7 Personnel responsible for quality assurance shall e
periodically review nonconformance reports and operating re-ports relating to failures, malfunctions and deficiencies to assess the need for corrective actions.
They shall advise their respective managements of such needs, document decisions and appropriate courses of action, and perform the 2ecessary follow up to verify that the corrective actions have been taken.
17.
QUALITY ASSURANCE RECORDS A program shall be established and implemented to assure that sufficient written records are maintained to furnish evidence of activities affecting quality.
These records include, bi.t are not limited to design records, records of 20
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use and the results of reviews, inspections, tests, audits, monitoring of work performance, materials analyses and related procedures such as qualifications of personnel and equipment.
The program shall be based on ANSI N45.29 Require-ments for Collection, Storage, and Maintenance of Quality Assurance Records for Nuclear Power Plants.
Quality assurance records shall be collected by the originating organization as the documents are completed.
They shall be stored by thero organiz& tion (s) until delivery of the packaging.
The program shall identify which types of records shall be transmitted to TNY for retention at TNY and which ones shall be retained by the originating organiza-k tion.
" Lifetime records shall be retained by TNY.
Duplicate record storage may be utilized to prevent loss.
The records shall be identified, indexed.and stored in accessible locations.
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Maintenar.ce of records at TNY shall be in accord with written approved procedures.
These procedures shT11 address duration of storage, responsibilities for safekeeping, preservation and disposition of nonpermanent records.
Main-tenance of records at participating organizations shall be in accord with their approved program.
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e-L 18.
AUDITS A comprehensive program of planned and periodic audits shall be established and implemented by TNY and major partici-pating organizations to verify compliance with all aspects of the QA program and to determine its effectiveness.
The program shall describe the areas to be audited, such as design activities, fabrication, testing, use, maintenance and repair of packagings.
The schedule for such audits shall be based upon the safety importance of the activities being audited.
The audits shall be performed by quafified personnel not having direct responsibilities in the areas being au_ed.
The audits shall be conducted in accord with written, ap_ coved e
'l procedures and/or check lists.
AQdits results shall be documented and shall be reviewed with personnel having responsibility for the area audited.
Agreements on correc-tive actions and schedules for impleacntation shall be established and recorded.
Reaudits of deficient areas shall be scheduled on a timely basis to verify implementation of agreed upon correctivg actions.
Audit reports shall be distributed to management.
The reports shall be reviewed for indications of adverse trends which could affect quality.
If the results of such assessments so indicate, pertinent sections of the QA program shall be revised.
Audits of areas for which TNY has direct responsibility shall be performed by TNY's QA function, except for audits of TNY's quality assurance activities.
The latter shall
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be performed by qualified personnel, nominated by TNY's President, who have no responsibility for the activities being audited.
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