ML19259A843
| ML19259A843 | |
| Person / Time | |
|---|---|
| Site: | 07100247 |
| Issue date: | 12/28/1978 |
| From: | Mertz R IRT CORP. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 7901110070 | |
| Download: ML19259A843 (15) | |
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AI I U. S. Nuclear Regulatory Cormission Attn:
Mr. Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards Washington, D.C. 20555
Dear Sir:
In accordance with your letter of June 28, 1978, IRT Corporation submits seven (7) copies of IRT's " Quality Assurance Program for the Use and Maintenance of Shipping Packages for Certain Special Form Radioactive Materials", IRT 4511-003.
Yours truly, I
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[ Robert L. iert:
President Encl.
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7650 Convey Ccc:t
- P.O. Scx EOS17
- San D ego. Caldemia 92133 711/ 565 7171
- Te ex: 69-5412
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3 IRT 0511 003 QUAUTY ASSURANCE PROGRAM FOR THE USE AND MAINTENANCE OF 3 HIPPING PACKAGES FOR CERTAIN SF.01AL FORM RADIOACTIVE MATERIALS I
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1RT Corporation i
I IRT Corporation P. O. Box S0817 San Diego, California 92133 l
(714) 565-717i l
I Revision Number Issue Date_
December 23. 1973 Authorization and Approval:
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TABLE OF CONTENTS 1.
IN TRO D U C TIO N...........................
I 2
2.
O RG A NI Z A TIO N...........................
2 2.1 Quality Assurance Manager....................
2 2.2 Engineeri.ng and Manufacturing Department.
2 2.3 Purchasing Department......................
2 2.4 Shipping Department.......................
6 2.5 Radiation Safety Office.....................
6 2.6 5ecurity Office 7
3.
QU ALITY ASSUR ANCE PROGR AM...................
7 3.1 Scope 7
3.2 Training 7
3.3 Purpose 7
3.4 Program Revisions........................
8 4.
DOCUM ENT CONTROL........................
8 4.1 Scope 8
4.2 Applicability 8
4.3 R esponsibility..........................
9 5.
H ANDLING, STORAGE, AND SHIPPING.................
9 5.1 Scope 9
5.2 Purpose 9
5.3 Responsibilities........
6.
INSPECTING TEST AND OPERATING ST TUS..............
10 10 6.1 Scope 10 6.2 Purpose 10 6.3 Responsibility..........................
11 7.
QU ALITY ASSURANCE RECORDS...................
7.1 Scope 11 11 7.2 Purpose 11 7.3 Responsibilities.........................
3.
AU DITS..............................
12 12 8.1 Scope 12 S.2 Purpose 12 S.3 Respon sibilities.........................
iii
- 1. INTRODUCTION IRT Corporation recognizes the need and desirability of establishing routine methods to ensure that radioactive materials are packaged and transported in a safe manner in compliance with applicable Nuclear Regulatory Commission or other licensing authority and the Department of Transportation regulations.
This document is intended to satisfy the requirements of the Nuclear Regulatory Commission with respect to quality assurance as applied to shipping activities pursuant to Title 10 Code of Federal Regulations Section 71.51 and is applicable to the shipment of those materials and packages identified in 10CFR Section 71.12 herein referred to as package (s).
It is not intended to cover the design, manufacture, or test of those identified specification containers or licensed packages, nor is it intended to cover major repair of these packages. Maintenance means replacement of damaged or worn parts such as bolts, gaskets, and retainers. IRT is a small (150 person) company with a relatively low shipment activity of the types of materials and containers covered by this program. For this reason it is not practicable to maintain an established full-time inspection and quality-assurance department. Quality assurance duties are assigned on a part-time basis to various personnel. When acting in this capacity, those people report to and are directly responsible to the Quality Assurance (Q/A) Manager.
1
- 2. ORGANIZATION The Quality Assurance Manager reports directly to the President of the company.
He is assisted by the Radiation Safety Office on matters concerning radio!cgical safety licensing, packaging, and requirements fer shipping of radicactive materials. Figure I shows IRT Ccrperation's present organization chart. Figure 2 gives the interrelation-ship of the quality assurance function, and Figure 3 is a respensibility matrix.
2.1 QUALITY ASSURANCE MANAGER The quality assurance furction ultimately is the responsibility of the President of the corporation.
The Q/A Manager, acting for the President, har the authority, respensibility, and crganizational freedom to identify quality centrol problems and to initiate, recommend, and provide solutions thereto. He is responsible for the interpre-tation, enforcement, and revisien of the Quality Assurance Program.
2.2 ENGINEERING AND MANUFACTURING DEPARTMENT The Engineering and Manuf acturing Depanment is respon,ible for inspection, maintenance, and repair of packages and appropriate document control.
2.3 PURCHASING DEPARTMENT The Purchasing Department is respensible for procurement of packages, replace-the parts, and all necessary documentation and certification showing that ment container was manufactured under a Nuclear Regulatory Commissien approved quality assurance program if applicable.
2.4 SHIPPING DEPARTMENT The Shipping Department is responsible to assure that certificatien of all necessa y tests, inspections, and licensing requirements have been cbtained price to releasing packages for shipment.
2
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PGES!?!%T RESPONSIBLE FOR APPROVAL AC IMPLEWENTATION OF QUALITY A55L8tA%CE ACTIVITY AUDITOR RESPONSIELE FOR AUDITIN3 0F DROGRAw QUALITY AssuRA%:E MANA;Es RADIATION SAFE *Y OFr!CE RESP 0%5IBLE FOR LICEN5!%3. PACKAGE RESPCNSIBLE FOR OVERALL QUALITY ASSURANCE PROGRAu IMPLEWE%TATION, CERTIFICATION, U ECIAL PERWITS, OPERATION, AND TRAIN!%3 A%D %RC Com?tIANCE SHIpp!N3/PECEIVING DEPARTWENT RESPONSISLE FOR PACGGE ANO RESPON5! ELE FOR PACKA3!N3, STORA3E, cy;;;7;;27;os 3nd"ug%TS.
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Figure 3. Quality assurance responsibility matrix 5
2.5 RADIATION SAFETY OFFICE The Radiation Safety Office is responsible for assuring that the package meets the appropriate requirements for the material, that the material is packaged according to applicable NRC/ DOT regulations, and that all licensing provisions are satisfied.
2.6 SECURITY OFFICE The Security Office is responsible for assuring that any required safeguard measures applicable to the shipment are in effect.
6
- 3. QUALITY ASSURANCE PROGRAM 3.1 SCOPE IRT Corporation, in accordance with this document, will establish and implement a Quality Assurance Program relevant to the use, and maintenance of packages for certain special form radioactive materials.
3.2 TRAINING All personnel designated by the Q/A Manager to perform these quality assurance functions will be specifically trained for the purpose r will have adequate knowledge of the required task to be technically competent to perform the task.
3.3 PURPOSE This program is instituted to make certain that applicable quality control, engineering, manufacturing, shipping, procurement, and specific procedures associated with a particular package are followed.
This program is directed toward the procurement of packages with written certification of manufacture under NRC-approved quality assurance programs, the control of safety related characteristics, and the compliance with specified procedures, testing, and use of licensed packages.
3.4 PROGRAM REVISIONS The Quality Assurance Program may be revised as necessary by the Q/A Manager in cooperation with affected departments; revisions will not become effective until such time as they are approved by the President of IRT Corporation and the U. S.
Nuclear Regulatory Commission.
7
- 4. DOCUMENT CONTROL 4.1 SCOPE Document control is established to assure that all documents pertaining to quality assurance for a particular package are controlled and retrievable. These documents include vendor-supplied quality assurance certifications, results of inspections tests and maintenance, and specific instructions for licensed packages.
4.2 APPLICABILITY The document control applies to all necessary quality assurance documents required for a particular package and other information regarding the use and disposition of the package.
4.3 RESPONSIBILITY Document control is the responsibility of the Q/A Manager and Operations (Department) Managers. Procedures pertaining to document control are the responsi-bility of individual departments concerned with the various aspects of the quality assurance program and must be approved by the Q/A Manager. These departments include, but are not limited to, Purchasing, Engineering and Manuf acturing, Radiation Safety Office, Security Office, and Shipping Department.
All document changes relating to quality assurance of packages will be in accordance with departmental procedures with approval of the Q/A Manager.
S
- 5. HANDLING, STORAGE, AND SHIPPING 5.1 SCOPE The quality assurance function is established to cover all phases of handling, storage, and shipping of packages of certain special form radioactive materials.
5.2 PURPOSE The purpose is to assure that all affected packages are handled, stored, and shipped in accordance with procedures designed to satisfy all applicable safety restrictions, NRC/ DOT rules and regulations, and all licensing requirements.
5.3 RESPONSIBILITIES The Shipping Department is responsible for assuring that all documents pertaining to certification testing and inspection are in order and complete prior to releasing the package for shipment, and for establishing specific work instructions if required.
The Engineering and Manufacturing Department is responsible for the physical safety of all operations involved in the handling, storage, and shipping of packages. He is also responsible for establishing specific written work instructions as needed for these operations and for assuring that established safety restrictions are followed.
The Radiation Safety Office is responsible for all aspects of radiation safety associated with these operations and specific written work instructions as required; certifying the package as ready for shipment with respect to packaging, marking, and labeling in accordance with applicable NRC/ DOT regulations; and assuring that all operations involving the handling, storage, and shipping of the package are in compliance with applicable licenses and/or special permits.
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- 6. INSPECTING TEST AND OPERATING STATUS 6.1 SCOPE The Q/A function is established to provide for inspection, testing, and specifica-tion of the operational status of packages for certain special form radioactive material.
6.2 PURPOSE The purpose is to assure that these specific packages and/or replacement parts have been inspected and tested in accordance with established procedures or in accordance with those specific instructions required by a specific license, regulation, and/or permit and to provide a method for identifying the status of packages and/or parts.
6.3 RESPONSIBILITY The Engineering and Manufacturing Department is responsible for inspecting, testing, and status determination of a shipping container or replacement parts accord-ing to established or designated procedures.
The designated inspector is responsible for recording the results of inspections and/or tests by identifying tags, labels, marks or other records at established within overall company quality assurance procedures for manufacturing.
The Radiation Safety Office is responsible for assisting the Engineering and Manufacturing Department and in establishing those procedures specified by applicable licenses and/or permits. !t is also responsible for control of nonconforming parts and packages to assure they are removed from service.
10
- 7. QUALITY ASSURANCE RECORDS 7.1 SCOPE Quality assurance actions are recorded for all phases of operations affecting quality. These include, but are not limited to, inspection test and review results, certification, operating logs, shipment records, and personnel qualifications.
7.2 PURPOSE The purpose is to:
1.
Maintair. a system of records of actions relating to quality assurance in sufficient detail to provide assurance that all activities affecting quality of specified packages cre recorded and that these records are retrievable.
2.
Provide information concerning personnel, types of tests, or actions taken.
7.3 RESPONSIBILITIES Each department involved in the quality assurance program is responsible for maintaining quality assurance records according to their established procedure. These records are to be identifiable and retrievable for a period of no less than two years.
The records are to be maintained in an active file for no less than one year and in a recorded location for the remaining time.
The Q/A Manager is responsible for maintaining a central file of Q/A records in the form of copies of records or a listing of available records and their location.
The Radiation Safety Office is responsible for maintaining a file of shipments and certifications for shipment and all license documents asseciated with a particular package.
11
A
- 8. AUDITS 8.1 SCOPE Audits are provided by qualifiec persennel not directly related ic the quality assurance operation to review each phase cf the program. Audits will be performed en an annual basis or more frequently, dependent upon the amount of activity.
8.2 PURPOSE The program audit is performed to critically review each phase of the quality assurance operation such that its effectiveness can be evaluated and any deficiencies corrected.
3.3 RESPONSIBILITIES The Auditor, designated by the President of the company, is responsible for performing the timely audi of each function providing written procedures and report of his findings to the Q/A Manager and President. He is also responsiSte for fellow-up audits of functions fcund deficient and/or lacking to assura that corrective acticn is taken. The Auditer will maintain a written reccrd of the results of the audits and corrective action; these records are also a part of the quality assurance records.
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