ML20125B851
| ML20125B851 | |
| Person / Time | |
|---|---|
| Issue date: | 03/12/1979 |
| From: | Dircks W NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NEWARK BETH ISRAEL MEDICAL CENTER, NEWARK, NJ |
| Shared Package | |
| ML20125B114 | List: |
| References | |
| FOIA-92-93 NUDOCS 9212100179 | |
| Download: ML20125B851 (14) | |
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UZlTED S?ATES imCLEAR REGULATORY COMMISSION 3 -
yg W ASHINGTON. D. C. 20553 e
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March 12, 1979 NEnARK HETH ISRAEL MEDICAL CENTER f
NUCLEAR MEDICINE DEPARTMENT j
201 LYOfiS AVENUE I
NEWARK NJ 07112 L
29=00102-05 TO ALL MEDICAL LICENSEES l
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The attached order amends certain medictl licenses to:
(a) Require the perfomance.of molybdenum-99 breakthrough tests prior to administration of technetium-99m to patients.
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(b) Prohibit the use of technetium-99m containing greater than specified levels of molybdenum-99.
l (c) Require the establistnent of written procedures and training for performing the tests.
l (d) Require that certain records be kept.
Since this order becomes effective immediately, and its provisions must be implemented within 10 days after the date of this order, it is important that you transmit this information to personnel in your nuclear medicine.
facility as quickly as possible and retain this order with your license records.
William J. Dircks, Director Office of Nuclear Material Safety and Safeguards i
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' Mr. Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS U. S. Nuclear Regulatory Commission
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Dear Mr. MacDonald:
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In accordance with your April 23, 1980 letter, enclosed please find sevQ copies of Revision 3 of the Quality Assurance Program for Nedtronbduous, Inc. (NPI).
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EP Attached to this letter is a sumary that addresses item by item t$ request-for additional information which you transmitted with your April 23 letter.
Items 2, 5, and 14 of the request for additional infomation were addressed by directly modifying the QA program. These changes are underlined.
If there are any questions regarding this submittal, plesse feel free to contact me at 301/428-9819.
Sincerely, NEITTROI4 PRODUCTS, INC.
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Camine Smedira Quality Assuranco Manager Enclosures CS/bms 1ss7s M'
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L UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERI ALS, SAFETY, AND SAFEGUARDS WASHINGTON, D.C.
2055S ORDER MODIFYING LICENSES (EFFECTIVE IMMEDI ATELY1 I
A recent investigation revealed the possibility of greater than normal quantities of molybdenum-99 contamination in the technetium-99m from processes involving the elution or extraction of technetium-99m from molybdenum-99.
The presence of the molybdenum-99 serves no diagnostic purpose.
It could result in a radiation dose to a critical _ organ of one or more rems and should such doses occur in large populations of patients, they would be unacceptable from a public health and safety standpoint.
Approximately five to six thousand generators are shipped weekly presenting a potential for exposure of large numbers of persons from contaminated technetium-99m. There has been no estimate made of the numbers of licensees using technetium-99m from other sources.
Tests for the presence of molybdenum-99 in technetium-99m for human use should be performed on each elution or extraction.
Information obtained during NRC inspections indir.ates that not all licensees routinely perform such tests. There are no uniform requirements in licenses, regulations, or package labeling for the performance of tests to determine the amount of molybdenum-99 present in the technetium-99m prior to administration to patients. The Nuclear Regulatory Comission (NRC) considers it necessary that, whenever feasible, steps be taken to minimize radiation exposure of patients and personnel.
Radiation exposures from abnormal levels of molybdenum-99 in technetium-99m for human use are unnecessary and preventable.
II From the foregoing, breakthrough tests
- as described below are necessary to prevent unnecessary radiation exposures to patients and personnel as a result of the presence of molybdenum-99 in technetium-99m administered to patients. Accordingly, the Director, Office of Nuclear
- In this context, the phrase " breakthrough test" refers to the detection and quantitation of molybdenum-99 in any separated technetium-99m, whether from a generator elution or other extraction process.
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1 i Materials, Safety and Safeguards has found pursuant to 10 CFR 2.204 of the Commission's regulations that the public health, safety or interest requires that this Order be made effective innediately.
III In view of the foregeing and pursuant to the Atomic Energy Act of 1954, as amended, and the regulations in 10 CFR Parts 2, 30, and 35, IT IS HEREBY ORDERED THAT:
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Effective immediately, any license which authorizes possession and use of molybdenum-99/ technetium-99m generators and any license which authorizes extraction or separation of technetium-99m from molybdenum-99 not contained in generators is amended to add the j
following conditions:
(1) Be91nning as soon as feasible but within ten (10) days of the date of this order, molybdenum-99 breakthrough tests shall be l
perf ormed prior to the administration of technetium-99m to patients.
(2) Beginning as soon as feasible but within ten (10) days of the date of this order, technetium-99m containing more than one i
(1) microcurie of molybdenum-99 per millicurie of technetium-99m or more than five (5) microcuries of molybdenum-99 per dose of technetium-99m shall not be administered to patients. The limits for molybdenum-99 contamination represent maximum values and molybdenum-99 contamination should be kept as low as reasonably achievable below these limits.
(3) Beginning as soon as feasible but within ten (10) days of the date of this order, the licensee shall establish written procedures for personnel performing molybdenum-99 breakthrough tests including all necessary calculations and steps to be taken if quantities of molybdenum-99 in excess of the above specified limits are detected.
(4) Personnel performing molybdenum-99 breakthrough tests : hall be given specific training in performing these tests prior to conducting such tests.
(6) The licensee.shall maintain for inspection by the Nuclear Regulatory Commission records of the results of each molybdenum l breakthrough-test performed and records of training given to l
personnel performing the molybdenum-99 breakthrough-tests.
l (6)
Records described in item (5) shall be maintained for two (2) years following performance of the tests.
I IV Any licensee to whom this Order applies may, within 20 days.from the receipt of this Order, request a hearing.
Any request for such hearing shall be filed with Mr. R. Cunningham, Director, Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555.
Such a request for a hearing SHALL NOT STAY THIS ORDER.
V In the event a hearing is requested within the time specified, the issues to be considered at such a hearing shall be:
(1) Whether the circumstances described in section I above existed, and (2) Whether on the basis of such circumstances, this ORDER should be sustained as regards the licensee.
'FOR THE NUCLEAR REGULATORY COMMISSION
,.r William J. Dircks, Director Office of Nuclear Material Safety and Safeguards Dated at Bethesda, Maryland this/ / day of March, 1979.
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'..'utron ?radu::u, Inc. heraby nubmits a request for an ntenCnent to Co..:plianca :: umber 5364 to allow the chipment of lart;e Cur:iticate e quau ti. ries a C c.,5 alt-60 uhich r.aetc the r:pecial fore require:nents of 10 c' 71. /.
.:d a's CF:: 17 3. M S.
All ccbalt-60 chipped in this cash chall maat tiie special fora require-w.nts of these ctions either as rolid fern r.aterial or as encapsulated caterial.
All otaer terms, ccaditicas, and previsions of the certificate re ain un O,.13ns ea.
Enclosed please find a chech for $150.00 na payment of th: appropris..te administrative fees.
Sincerely,
!!EUTRON PP.CDUCTS, 150.
D,:.: nue f a,la Carnina Eredra Quality /.ssuranca 'Anagar 3 ?,*;> h,;...- -.s ~%
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Fursuant to the requircraants of 10 CFil 71.12, I*eutron Products, Inc., as holdars c2 State of Maryland License :1D-31-025-01, triahes to register as a user of the Chen.--Fuc1 car Syetens, Inc. CNSI 15-1603 radieactite interiuls shi pina cask.
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NPI Rcsponso to Additionti Information Requested by NRC With Respect to NPI QA The NPI QA program states that "The Quality Assuranco Manager must have a 1.
sufficiently broad education and experience to be able_ to interpret the re-quirements of all regulatory agencies to all aspects of the company's opera-The implementing criteria used by NPI management in the' selection tions."
of QA managers are:
reasonably extensive nuclear project experience; (a)
(b) some experience in dealing with regulatory or safety require-ments; and, (c) demonsttated writing skills.
While To date, NPI QA managers have been degreed engineers or scientists.
we do not intend to make a degree a requirement, most people who meet the above criteria art degreed.
The present QA Manager is a degreed nuclear engineer with 12 years of nucicar The majority of his time in the last year has been de-project experience. voted to trying to assure that company activities are in complian State of Maryland, Nuclear Regulatory Commission, Department of Transpor-tation, Food and Drug Administration, and other regulatory and safety re-quirements.
2.
See QA plan modification page 40.
Safety related systems, structures and components controlled by the QA 3.
program:
(a) All NPI shipping containers for radioactive materials (b)
Customer teletherapy units serviced by NPI Dickerson I and Dickerson II irradiators (c)
(d) Customer laminar flow equipment serviced by NPI Under the interpretation that a prototype unit is a full scale, full-feature component of a system or structure to be put-into service, NPI does not build 4.
Instead of prototype units, the actual system or structure prototype units.
has been built and prcof tested before being placed in service.
5.
See QA plan modification page la.
Consquently NPI identifies and controis NPI does not manufacture equipment.
materials, parts and components used in manufacturing through control of 6.
procurements (see Procurement Document Control, Control of Purchase and Material, Equipment, Services, Etc. in each subplan of the overall QA progra:s).
We believe this is covered in Section 17 of each subplan of the overall QA 7.
progrmn.
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'NPI Rzsponse to Additicns1 Information' _
-R qussted by NRC With Rcspcct to NPI_ QA y-Page Two -
In view of the re'1'ative simplicity of materials and: parts. important to-the
- 8. - functionLof _ safety related systems and components ' associated with NPI activ-ities,-'NPI does not maintain complete documentation of the actual' materials:
and_ parts used in-safety-systems.
Instead, the adequacy of the materia, s 1
and parts used is usually.readily ascertained;while in service or under a Documentation of the required functions' of: safety systems routine inspection.
is maintained. _ For example, safety systems-on _NPI _irradiators make extensive use of limit switches and relays whose performance is routinely checked.
.We do not verify the materials used in manufacturing the relayL and switches.
We have documented the required performance of these systems.
9.
NPI management recognizes the role that good judgement-of responsible,em-ployees plays in making a QA program successful. Consequently, we do.not --
have a statement in our QA program to the effect that the method. of ident-
'ifying an item should not affect the fit, function, or quality of the _ item.
To date, this has not been a problem. -
The comment we made with respect to item 6 above would appear to be. appro-10.
priate here also.
Section 11 of each subplan of the overall QA plan covers special
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11, 12, 13.
processes appropriate to that aspect of NPI operations. _ These: subsections require procedural controls and personnel qualification as appropriate.
Section VI of the plan states that NPI shall maintain Personnel Qualifi-cation Approval and Certification records.
- 14. - See QA plan modification page 41.
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Introduction Neutron Products, Inc. (NPI) was established in 1959 to commercially.
produce radioisotopes.
Activities of the company have grown to in-clude the production of radioactive sources for. medical and industrial applications, the sterilization of hospital supplies and the radiation processing of chemicals to change their chemical and physical-proper-ties.
NPI has, and will continue, to provide quality products and services to its customers.
Efforts to improve the safety of company personnel, the public, the local environment, and when possible, the users of NPI products will continue and are closely coupled to the company's Quality Assurance Program.
NPI operates under the regulatory scope of the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the Depart-ment of Transportation (DOT), and the State-of Maryland.
In the interest of'public and occupational health and safety, regulations have been established with respect to quality assurance.
Execation of the Quality Assurance Program presented in this document, nftich has been written to comply with all appropriate regulations and is part of a continuing effort to provide high quality services at reasonable costs to our customers, is.the sole responsibility of NPI.
II.
Comuany Organization A company organization chart is indicated in Figure 1.
Mr. J. A.
Ransohoff, President of the company, is responsible for overall management and operation. -Mr. M. M. Turkanis is the Vice President directly responsible for cobalt-60 production, marketing, and dis-tribution.
Mr. D. G. Woodard is the Vice President directly respon-
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sible for the radiatien processing and radiation testing operations of the company.
Mr. C. Smedira is the Quality Assurance Manager. As such, he will be responsible for the company's QA program. The QA Manager has the authority to stop any company operation which he has_ reason-to believe is proceeding in an unsatisfactory fashion. The QA Manager reports directly to the President and has.the au.thorlty to identify ptablents, to initia.te, recomend, or ptooide solutions, and.to veri-fy.the implementation of solution.s.
The Quality Assurance Manager mast haue a sufficiently broad educa -
tion and experience to be able.to interpret tJte requirements of all.
regulatory-agencies to all aspects of the company's operations.
The OA organization reviews and concurs with-inspection plans, tost,.
calibration, and special process procedures; drawings and specifica-
.tions; and changes thereto.
Because of-the relatively small size of the company, some personnel, among them the QA Manager, have been assigned multiple responsibilities.
The specific QA/QC functions tchich are to be performed by the NPI QA organization are listed in Section V of.this document.
Corporate fbtance and adnbtistration occur under.the ~ direction of the.
The Corporate Secre-Corporate Treasurer and Secretary, respectively.
.tary also nanages.the compantfs Lambtar Floto Technology activities.
From time to time, special projects are undertaken under the direct ~When.th supervision of the President of the company.techn.ical manager, as QA Manager, utill be given the responsibility.to execute the project.
The P.tesident and the QA Manager shall confer at.the initiation of any such ptojcet.to determine an approptiate QA apptoach for the ptoject.
Personnel assignments and responsibilities are presented in more detail in each of the specific quality control programs presented in Sc tion V.
The President of NPI tciLE, ~at least once each year, communicate to all the QA ptogram and ptocedures are manda. tory and
.the QA Manager saith.the responsibility.to implement and enforce these The P.tesident of the company sh1LL be responsible for.
requttements.the resolution of all disputes involving quality arising from a. dif-ference of opinion betxeen the QA Manager and other line ma in the company.
Lishing an htdoctrination and Ltahting ptogram such.that:
Pstsonnel responsible for perfornting quality related 1.
activities are htsttucted as.to.the purpose, scope, and implementation of the QA program, inst:uctions, and ptocedures.
Personnet perfornting quality affecting activities are.
2.
tnained and qualified in the pthiciple and. techniques of the activity being performed.
The scope, the objective, and.the method of implement-3.
ing the h1doctrination and training ptagnam are docu-mented.
Proficiency of personnet performing quality affeeling 4.
activLties is maintabted by retrag, rcexanining, andfor recertifying.
N.
. III. Company Operations This section presents a listing and brief description of the present and anticipated products and services of NPI.
1.
Cobalt-60 Irradiation Sources The company is engaged in the business of selling cobalt-60 sources for teletherapy, intercavity, and industrial appli-cations. Toward this end, company activities include cobalt-59 target design, procurement, transportation, and irradiation, as well as cobalt-60 transportation, process-ing, encapsulation, delivery, installation, maintenance, and replacement.
2.
bhintenance of Teletherapy Units The company is engaged in the business of repairing and reconditioning cobalt-60 teletherapy units currently in use.
3.
Radiation Processing The company uses evbalt-60 irradiators to process materials to achieve desired biological, chemical, and physical pro-perties and in conjunction WLtit a citemical mix plant, to produce a group of polymeric products largely based on acrylamide.
Irradiators are also used for testing to deter-mine the effect of radiation on chemical and physical pro-perties of substances and to determine the performance of equipment used in radiation environments during normal and off-normal conditions.
4.
Laminar Flow Testing The company provides inspection, testing, and routine main-tenance services for horizontal and vertical laminar flow hoods used in hospitals, pharmacies, and in other clean room applications.
5.
Product Marketiim The company markets the following products of other manu-facturers:
Block and Wedge Holder - This attachment to teletherapy units allows finer collimation of the radiation beams during therapy.
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NEUTRON PRODUCTS, INC.
BOARD OF DIRECTORS
-J. Ransohoff, M. Turkanis,-D.=Woodard-Office of the President Special Projects' J. Ransohoff, President R. Demory D. Culler D. Repp Laminar Flow Technology.
F. Kreysa
. Acting Manager Finance and Administration Quality Assurance-
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F. Kreysa, Secretary 3
p-D. Lewis, Treasurer C. Smedira, Manager-l l'
Radiation Processing Sources and Systems D. Woodard H. Turkanis Vice President Vice President Figure 1 W '
Kadiation Detectors - The company sells the Primalert-10 Radiation. Level Monitor and the optional Primalarm remote signal unit.
Simulators - The company plans to market a new radiation therapy simulator, a device used in the localization of tumors and for planning radiation treatments.
IV.
General Ouality Assurance Approach 10 CFR 50, Appendix B, and 10 CFR 71, Appendix E, provides 18 guidelines for establishing and implementing a quality assurance program for some types of nuclear activities. 21 CFR 5 provides nine guidelines for the establishment of " Good Manufacturing Practices" for medical devices.
The NPI Quality Assurance Program is committed to complying with these 27 guidelines (not all of which are different).
This QA plan represents NPI's application of these guidelines to company activities. The formal QA approach presented in this document consists of the following key elements:
Planning - what to do to provide quality Judgement - to determine what should be verified and/or documented Execution - of the plans established Documentation - of the execution and verifications Inspecting and Auditing - to see if activities are performed and documented correctly At NPI the line organi:ation has the responsibility for the planning, judgement, execution, and documentation activities.
The QA Manager participates and concurs in these activities and has the responsibility for auditing tasks.
In view of NPI's size, maximum use of line indi-viduals has been made.
Line individuals will be qualified to check, verify, test, and inspect independent actions of other line individuals.
The QA Manager will continue to assess the effectiveness of the overall program and be responsible for program change, indoctrination and,t, rain-ing, monitoring, and coordination.
Because of the diverse nature of the.various operations "of the company, separate subplans for quality assurance have been generated for each operation. The intent of.each of these subplans follows from Section I of this document, the organization in each of these subplans follows from Section II, and the basic approach is consistent with the genecial intention of this section.
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compiles with att applicable regulatiosts, at least 400 times a year.'.
The-QA tfanager will continue.to assess the effectiveness of the overall:.
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- Each subplan follows this outline:
l Scope 1.
Organi:ation 2.
Quality Assurance Definitions 3.
Buildings 4.
Equipment 5.
Design Control 6.
Procurement Document Control 7.
Instructions, Procedures, and Drawings 8.
Document Control 9.
Control of Purchased Material, Equipment, and Services 10.
Identification and Control of Materials, Parts, and Components 11.
Special Processes 12.
Inspection
- 13. Test Control 14.
Control of Measuring and Test Equipment IS.
Handling, Storage, Distributing; Shipping, and Installation 16.
Evaluation, Inspection, Test, and Operating Str+.us.
'17.
Nonconforming Materials, Parts, and Components 18.
Corrective Action 19.-
Packaging and Labeling
' Where a particular section is not appropriate to a specific subplan, it is so statod.
V.
Special Quality Assurance Programs The specific 'subplans which are contained in this section are:
1.
Cobalt-60 Irradiation Sources 1.1 Reactor Target Assemblies 1,2 Radioactive Source Inventory Control 1.3 Radioactive Source Fabrication 1.4 Radioactive Materials Transportation 1,5 P.adioactive Source Transfcr 2.
Teletherapy Unit Reconditioning 3.
Radiation Processing 3.1 Dose Control Irradiations 3.2 Physical and Chemical Properties Irradiations 3.3 Polyacrytamide Production
-3.4-Other Irradiations 4.
Laminar Flow Testing-
-5.
Product Marketing n
-S-1.1 Reactor Target Assemblies 1.1.1 Organization Design, fabrication, transportation, and irradiation of cobalt-60 reactor targets is the responsibility of the Vice President for Sources and Systems. He will be assisted by other company person-nel as appropriate.
A definite distribution of responsibilities between NPI, other contractors, and the reactor operator will be' established for each enatract and the procedures, specifications,. and criteria of a contractor which shall be approved by NPI will be documented in the contract agreement.
1.1.2 Definitions Reactor target assemblies - completed rods, herein called targets, ready for loading into a reactor.
Capsule - a sealed stainless steel' tube containing. cobalt-59 material. This tube is contained inside the target assembly.
Quality - a quality target is one which has the purity and:
integrity of composition to withstand the necessary handling, irradiation, and transportation without the release of cobalt to any reactor system or the environment and perform its in-tended neutron absorbing function within the reactor.
1.1.3 Buildings Targets and target components will be fabricated and handled in NPI existing buildings and in other facilities. - Adequate space shall be provided to facilitate cleaning,' prevent mixups, and assure the orderly handling of incoming material,' rejected material, _ material in the fabrication process, and testing and measuring equipment.
Adequate lighting, ventilation, and tem-perature and humidity control shall be provided. ' Airborne con-tamination shall be monitored and kept within appropriate limits.
Inspections of the building condition shall be periodically per-formed and the results of these inspections shall be recorded.
The NPI and contractor quality assurance organizations shall be responsible for the performance and documentation of these -inspec-tions in their respective facilities. No less than two inspec-tions per year will be performed.
The line organization shall be responsible for cleaning the buildings. Adequate sanitary facilities will be provided.
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1.1.4 Eauiprent Nondisposable equipeent use'd in the manufacturing process of target components and assemblies shall be cleanable and, if necessary, adj ustabic. _Equiprent shall be stored in such a manner to reduce contamination by dust or dirt or radioactivity. Equipment will be clean when used.
Equipment which requires periodic adjustment shall have allowable tolerances posted Where~the equipment is stored or used.
Materials used in the manuf acturing process and _not desired in the final product will be recoved and such removal shall be documented.
1.1.5 Design Control The Vice President for Sources and Systems shall establish and imple-cent methods for controlling design activities to assure that appli-cable design criteria, codes, standards, practices,'and requirements for targets are defined and correctly translated into specifications, drawings, procedures, and instructions. He shall also establish and implement a method for coordinating and Laterfacing with other organ-izations, contractors and the reactor operator to assure compliance with these requirecents. A design review to assure that he design meets the design criteria shall be conducted. Representatives of other organizations (such as the reactor operator) may participate in this review. Only parts, materials, and processes Which have been proven to be acceptable for targets will be used.
Specifications, drawings, instructions, and other engineering documents which may be necessary to describe the design, materials, fabrication, instal-larion, testing, inspection, packaging, shipping and storage require-ments of the targets will be prepared at NPI and at other contractor organizations. A specific definition of responsibilities for.all documentation shall be made.
A cethod shall be established to define and control design inter-faces between NPI and the reactor operator. Design changes, includ-ing field changes, shall be subject to design control measures com-mensurate with those applied to the original design.
1.1.6 -Procurement Document Control Vendors supplying target material and/or capsule material shall comply uith NPI Specifications, P-2, Specifications, Procedures, and Quality Control Plan for Tube Type Cobalt Targets, and P Specifications, Procedures, and Quality Control Plan for Clad Wire Type Cobalt Targets.
e 3.1.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings necessary to assure quality in the fabrication of targets and capsules _ vill be listed in NPI Specification F-6, Quality Control Plan and Outline of Fabrication Procedures for Cobalt Target Rod Assembly and in the approved specifications'of a contractor as appropriate. Periodi-cally, audits shall be conducted to check for confornance. -
1.1.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Vice Pac 4ident for Sourcea and Sy4tema and by con-tractors, as appropriate. These documents shall be submitted to-the QA Managcr for approval. Changes to any of these docu=er-shall also require his approval.
1.1.9 Control of Purchased Material, Equipment, and Services
-Independent enterials testing and _ examination of each and every -
target and capsule shall be performed and the results documented.
1.1.10 Identification and Control of Materials, Parts, and Components The Vi.cc Prcaident for Soureca and Sy6tema shall establish a con-trol area in which all targets and capsules are stored and labeled.:
Access to this area shall be limited. Vendors supplying target and/or capsule materials shall comply with NPI 9pecifications P-2 and P-3.
1.1.11 Special Processes Any individual performing a velding, heat treating, or_nondestruc-tive examination of target components-or a forming or melting opera-tion of the components shall be certified by the appropriate.deAignce of.the Vice Prc6ident for Source 4 and Systema or by the contractor's organization. Nondestructive examination of target components shall be in conformance to NPI Specifications Q-4, X-Ray.Inspectien' (Hollow),
Q-5, X-Ray Inspection (Solid),'Q-6, Helium Mass Spectrography In-..
spection, and Q-7, Dypenetrant Inspection, or those of a contractor approved by NPI.
1.1.12 Inspection Contractor inspection requirements for targets and capsules shall be in accordance with NPI Specifications P-2 and P-3.
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.. ' Periodically, NPI personnel will witness these. inspections.
Inspections to be performed by NPI personnel will periodi-cally be witnessed by the Quality Assurance hhnager or his Edesignee.
1.1.13 Test Control Helium leak testing of assembled targets and capsules shall be in accordance with NPI Specification Q-6 or by a NPI contractor procedure approved by NPI.
1.1.14 Control of Measurine and Test Ecuipment t
Equipment used to examine targets and capsules shall be con-trolled, calibruted, adjusted, and maintained. Calibrations shall be recorded. Each calibration record shall show the name of the-person who performed the calibration, the date on which it was done, and the=next date on which a calibra-tion should be performed.
1.1.15 Handling, Storage, Distributine, Shirping, and Installation Targets and_ component materials shall be handled and stored in accordance with NPI Procedures R 2003, General-Procedure for In-Pool Source Operations, NR 2005, Procedure for Decanning Cobalt-60 Sources from Zircaloy Tubes, and NR 2008, Pro,cedure for Placing and Unloading Casks in Main Storage Pool.
Target installation in a reactor shall be in accordance with-the appropriate technical specifications of the reactor opera-tor.
1.1.16 Evaluation, Insnection, Test, and Ocerating Status
-Target operating status shall be ascertained by the raactor operator via= flux level indicators, flowmeters, and thermo-couples. Acceptable flux and temperature' levels for each target shall be specified prior to irradiation.-
Upon receipt of the irradiated-target, NPI personnel shall ascertain the' condition of the target in accordance with Section 1.2 of this plan.
1.1.17 Nonconforming Parts-Incoming target or capsule material identified as nonconform-ing to any NPI specification shall be tagged accordingly,
. Nonconforming material shall be stored physica11yfapart from acceptable material and a list of nonconforming items shall be prepared by the Vice President for Sources and Systems or by contractors and provided on a weekly basis to the Quality-Assurance' Manager.
The Vice President for Sources e.nd Systems shall make recommendations for appropriate disposition for nonconforming materials. The approval of the QA Hanager is required for any. disposition of nonconforming material. Such disposition shall be documented.
1.1.18 Corrective Action The Vice President for Sourcca and Systems -shall document the cause for nonconformance of any items so labeled. He shall also document recommendations for suggested corrective actions.
1.1.19 Packaging and Labeling All targets and capsules shall be uniquely labeled.
1.2 Radioactive Source Inventory Control 1.2.1 Organization The responsibility for the characterization and maintenance of has been delegated to all radioactive source material inventory ! Under the Vice-the Vice President for Sources and-Systems President, the responsible individual is the Section Manager for Source Production, Mr. J. Corun.
Mr. Corun vill be assisted by other company personnel as appropriate.
1.2.2 Definitions Inventory quality control program - one which (1) continually and accurately records the identity, location, and activity of all individual source material; (2) is conducted in com-pliance with the NPI Radiation Protection Program; and, (3) does not result in releases of radioactive cobalt to the local environment.
Target sources - cobalt 'O sources contained in target rod assemblies.
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. Teletherapy sources - singly or doubly encapsulated cobalt-60 teletherapy slugs. Teletherapy sources acquired from cus-tomers or other suppliers may contain cobalt-60 pellets.
Teletherapy slugs - cobalt-60 sources prepared by a melting process.
Industrial sources - doubly encapsulated rods and/or springs of solid cobalt-60.
Rod sources - singly encapsulated cobalt-60 rods.
Spring sources - singly encapsulated cobalt-60 springs.
Check sources - cobalt-60 or cesium-137 sources used for cali-bration or checking of radiation monitors.
1.2.3 Buildings Inventory control facilities shall have adequate space and storage equipment to prevent mixups and to assure the accurate handling of all incoming cobalt-60 sources, regardless of form, and to enable the operator to unload and store all incoming shipments, Space shall also be adequate for equipment to assure the quality of source activity calibrations.
1.2.4 Eauipment Nondisposable equipment used in the handling and calibrating process' shall be cleanable and, E necessary, adjustable. Equipment shall be stored in such a canner to reduce contamination-by dust or dirt.
Equipment will be clean when used.
Equipme.t which requires periodici adjustment shall have allowable tolerances posted where the equip-ment is stored.
1.2.5 Design Control Not applicable 1.2.6 Procurement Document Control
-Not applicable 1.2.7 Instructions, Procedures, and Drawings After target rod sources have.been removed from an incoming shipping cask and documented as'to their position in the pool storage tank, they shall be calibrated.- After calibration, the target rods:shall-
. be cut open and the contained individual rod and spring sources.
shall be removed and documented as to their holder and holder positions. The sources shall be calibrated on an individual basis and then-returned.to their holders. The holders shall be placed in the pool storage tank and their positions documented.
1.2.8 Document Control For each target or source calibrated, a calibration trace shall be -
generated. This trace shc11 contain information as to target number, source number, source type, date of calibration, activity, date of After areas have activity, and source holder number and position.
been run on these traces and activities calculated, the traces shall be stored in notebooks by holder numbers.
Changes to these traces can be made only at.the direction of the persans originating the "
After sources have been sold, the traces for that source traces.
shall be removed from the inventory file, identified as to'encapsu-lated source number, and placed in the customer's. file.
1.2.9 Control of Purchased Material, Eouiument, and Services Not applicable 1.2.10 : Identification and Control of Paterials, Parts, and Components As each rod is removed from the shipping cask, its identifying number shall be documented and the position in the pool storage tank noted.
1.2.11 Special Processes Each individual source shall be calibrated 'and the results.docu-mented.
All rod and spring sources :shall be calibrat~ed.by the underwater pool calibrator or by the hot cell-calibrator (in; bothL of these the' source is passed under-a shielded collimated detector and the output reading plotted; the readings are compared to a known standard to determine curie activity). Teletherapy sources shall be rated by direct output dose rate by measurement in the hot cell.
1.2.12 Inspection periodic inspections shall be conducted to assure that the pool operator can locate a particular source.. The soure.e shall be pulled from the holder and calibrated and the resulting trace shall be compared with the trace already existing for that source.
A record of such inspections shall be maintained by the Quality Assurance Manager.
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1.2.13 Test Control Not applicable 1.2.14 Cont,rol of Measuring and Test Eouipment The industrial source calibrators shall be periodically tested by measurement of standard industrial sources. The dose rate meter shall be periodically tested by measurement of a standard teletherapy source. The calibrator and planimeter shall be tested periodically.
Records of such testing and the results shall be kept.
1.2.15 Handling, Storage, Distributing, Shipping, and Installation All incoming target rods shall be handled in accordance with NPI Procedures NR 2001, Procedure for Loading and Removal of Radio-active Shipping Containers from the Main Storage Pool; R 2007, Calibratinn by Area Method; R 5002, Opening Hot Cell Door After Processing Single and Double Encapsulated Cobalt-60; R 5004, Transfer of Sources Between Hot Cell and Canal Tanks; R 5005, Loading of Encapsulated 3ources in Transfer and Shipping Con-tainers from Hot Call; and, NR 5007, Processing Exposed Cobalt-60.
The rods shall be stored in the main storage pool. -Rod and spring sources and industrial-sources shall be stored in the main storage pool. Teletherapy sources shall be stored in canals.
1.2.16 Evaluation, Inspection, Test, and Operating Status once a quarter the Vice President for Sources and Systems and the QA Manager shall spot review the source inventory log records. Pool operating temperatures shall be inspected by
.the Source Production bbnager or appointee at'least once a day _
and a graph of pool temperature as a function of time shall be provided on a weekly basis to the Vice President for Sources and Systems.
1.2.17 Nonconforming Parts Encapsulated sources which fail leak tests or are damaged or otherwise defective shall be stored separately from all others and held for disposal, d
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1.2.18 Corrective Action Each noncorforming source all be evaluated on a case-by-case basis to decide if salvage or disposal is warranted.
1.2.19 Packsging and Labeling All sources shall be uniquely labeled.
1.3 Source Fabrication 1.3.1 Organization Source design and fabrication and equipment and facilities for fabrication, testing, and calibration is the overall responsi-bil a of the Vice Prssident for Sources and Systems. He has dele 346ed this responsibility to the Section Manager for Source
-Production.
1.3.2 Definitions Quality source fabrication - the process of transforming irradiated cobalt-60 target material into calibrated, encapsulated sources for specific end use, in accordance with NPI Radiation Protection and Radioactive Respiratory Protection Programs and in accordance witt. all applicable Federal and state regulations.
Teletherapy sources - sources designed specifically for use in medical teletherapy units.
Industrial sources - sources designed specifica ?y for indus-trial use.
Other sources - sources designed for use other than above'.
Hot cell - the shielded enclosure in.nich the esfority of source fabrication operations are performed.
Pool - a pool of dimeneralized water used for storage of-cobalt-60 sources and for certain fabrication operations.-
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1.3.3 Buildings Sources are fabricated and handled in a hot cell and pool until transferred to a shipping cask.
Both cell and pool shall have adequate space for operations and storage of all sources including as received, in work, and finished product. Adequate Jighting, ventilation, and temperature control shall be provided to assure the safety of operations, containment of contamination, and inte-grity of the product.
1.3.4 Equipment All eq'Pnment used in the fabrication process and unique building service; shall be designed, maintained, and operated to provide safe and functional working conditions, to minimize the spread of radioactive contamination, and to provide a high degree of reli-ability and reproducible accuracy as required.
1.3.5 Design Control Not applicable 1.3.6 Procurement Document Control Vendors supplying source encapsulation materials shall supply manufacturer's test reports and certifications for these materials.
This control shall be the responsibility of the Source production Section Manager and periodically checked by the Quality Assurance Manager or appointee in accordance with NPI Specification P-4, Procedure for Encapsulation of Teletherapy Sources.
1.3.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings required to fabricate sources will be provided in NPI Specification M-1, Specification for Scamless Stainless Steel Tubing for Encapsulation of Radio-active Sources and Specification P-4 1.3.8 Document Control Documents relating to source fabrication shall be maintained by the Source Production Section Manager. These shall have the approval of the Vice President of Sources, and Systems.
1.3.9 Control of Purchased Material, Eouipment, and Services The Source Production Section Manager will.init ste and approve all purchases and maintain records of the source inventory.
. 1.3.10 Identification and Control of Materials, Parts, and Components The Source Production Section Manager shall establish a control area where all encapsulation materials are ntored and identified.
1.3.11 Special Processes Fabrication of sources is a special process which will be performed in accordance with NPI Specifications P-2, P-3, and P-4 Changes to these specifications require the approval of the Vice President for Sources and Systems and the Quality Assurance Manager.
1.3.12 Inspection Inspection of all critical operations will be in accordance with I'PI Specification P-1, Specifications, Procedures, and Quality Control for Scaled Cobalt-60 Sources.
1.3.13 Test Control All sources shall be tested for quality and integrity in secordance with NPI Sper.ification P-1.
1.3.14 Control of Measuring and Test Eauipment Equipment for calibrating and measuring shall be in accordance with NPI Procedure R 2007.
1.3.15 Handling and Storage Source hand'ing and storage shall be in accordance with NPI Procedure R 2003.
1.3.16 Evaluation, Insnection, Test, and Operating Status Not applicable 1.3.17 Nonconfornine Materials All nonconforming sturce encapsulation materials shall be disposed of by physical removal from encapsulation material storage and
" written off" the inventory records.
All sources encapsulated or otherwise in-work found to be nonconforming shall be set aside in a segregated area for disposal and so documented.
1.3.18 Corrective Action Nonconforming encapsulated sources will be reviewed by the Vice President of Sources and Systems for a determination retarding disposal or salvage on a case-by-case basis.
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. 1.3.19 Packaging and Lab g;nyq All finished telethe ~i sources shall be uniquely identifiable.
Packaging for shipt t thall be in accordance with Sect ton 1.4 of this document-1.4 Radinetive Matcicials Transportation 1.4.1 Oraanization Design, fabrica, tion, and maintenance of radioactive material sftipping contalncrs and transportAtton of radioactive shipments is the respon-sibility of the Vice President for Sources and Systems. He shall be assis.ted by other compant) personnel as appropriate.
1.4.2 Defhtitions the-landing of radioactive materials in an NP1 Quality packaging ion's shipping contalnch for shipment in con-or other organi:at formance leith applicable regt tatory requirements, and completion of the docwentation of thLs activity rn accordance seith the reoninements of this section.
Off s te Location - a location other than Dickcrson at schich a radioantive shipmestt controlled by NPI may origina,te.
Quallty transportation - the safe and efficient carrying of radio-active materials from one site to another in accordance. scibt applicable requirements and the comptction of docwnentation of tJtis activity.
Radioactive ma,terials shipping container - herein caged container, is one complying seith the applicable regulations of the 90T and NRC.
1.4.3 Buildings Buildings in tehich shipping containers are stored.or handled shall have adequate space for etcaning, maintaining, and orderly handling.
of incoming and outgoing shipments. Airborne contanination shall be minimized and monliored in facilitics to:,ich have encapsulated radioactive materials.
Tnspcetions of the. building conditions.
sh1LL be performed periodicallt) and the results recorded.
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. 1.4.4 feuirment W% cut used in handling and vcitietes used for transpod.ing con-takets statt be Moted in such a mannch as to mainia.in an adequate condition for use.
Shipping containers, overpacks, special handling eqtdpmertt, inst?urents, and tools toilt be maintained by the Tele-thcrapy Schvices Section htnager.
Equipment needed to perforn quality rciated aciivilles shalt be spccified prior to use, as shati the en-vironmentrl conditicas ttnder which the equipment is to bc operated.
1.4.5 Desian Contro!..
The Vice Pruident for Sources and SyMers is responsible for the design of contaken and handling equipment.
When additional trans-portation equipment design is required, he shalt establish ptocedurcs to a.ssure tha.t applicable design criteria, Mandards, practices, and-rcautatory requLterents are dcfined and trautstated b.to spccifica-tions, drawings procedures, and instructions.
He shalt es.tablish and leptcrent a method for coordinating with other organizations and con-tractors. A dc. sign revice shall be conducted to assure that (1).the desinn meets the design criterin; (2) design characteristles can be controllcd, inspectcd, and tested: and, (3) inspestion and. test cri-tcria are identifLed. The indLvidual resportsibte for the dcsign re-vice shall be other than the cdainal designer and the designer's immediate supervisor.
Design an'd specification clanges shall be subject to the same design costtrols and approvals tha.t were appli-cable to the original design.
For cach design activity for a trans-poMation package, specific crgani::M.lonal responsibilitics shall be established.
1.4.6 Procurcrent Docurestt Control Vcndou or contractou supptging shipping costtaincrs, handling eqtap-ment, and parts shalt comptu scith NP1 Specification E-1, Equipment Specification for a Lead Sitictded Shippkg Cask or other appropdate specification.
Conttol of procuterent documents shall be the rc.spon-sibility cf.the Vice President for Sources and Systens. He shall be responsible to (1) ptepare as appropriate, procedurcs or instructions thM clenniy delincMe.the sequence of actions to be accomplished in the preparation, review, approvat, and control of permanent documents; (2) identify in all appropriate ptocurement documents, the applicable 10 CFR Part 71, Appendix E requirements which rust be complied tolth and described in.the supplier's CA ptogram; (3) regtdre that procurcmertt docurcutto cotstain or ref erence the design basis techstical reqldxcrestts including the applicable regula. tory requircrents, materlat and com-ponent identification requircrestts, drateings, specifications, codes
-. _.. - ~ _ _ _ _ _. _ _
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. i and industrial standuds, test and inspection recaircrent.s, and spechte ptocess instructiosu; and tIutt thet) specily the documen-tation (e.g., draicings, speci?ications, ptocedurcs, inspection and fabdccAion plosu, inspection and test records, personnel and procedurc.s qualificaticia, and chcrical and phy.sical test results o f r.aterlat).to be ptcp=1cd, nzintained, and subritted.to NP1 for i
revice and approval; (4) specify.those accords to be retained, con-1 Ltattcd, and raiittained by the supplich, and.ihose dclivered to NP1 ptiot to use or installation of the hardntte; and, (S) require NPI's richt of access to supplich's facilitics and records for inspection
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and audit.
Cisnges and revisions to procacecott doctrents dall have at least i
the same revice and ii at cA the oM pinat doeurent.
i 1.4.7 instructions, Precc s,~qy fp See Sec. tion 1.4. 8.
Pe w 'l M L4 to chech for conforrance to these docurents teiLL be concacted bi.the CA "anager or his designce.
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DCcumCttt tonirol Instructions, ptocedures, draicings, and specifitaticns fo.t containers, container handling, packaging and sitipping arc listed in and shan compitt teith NPI QC P.tocedure 1C01.
Pesponsibilitics for the. istitia-tion, revicte, approvat, and issuance of.these documents are specified
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in this procedure and no changes to thcsc docurertts shan be made.
teithou.t the approvat of the same people v+n initiaut) apptoved.these j
doeureatts. Approved changes in htstructions, procedura, drawings, and other docurestts shad be made ptior to.the irplcncriation OV such changes.
The QA "anagcr shall be rcsponsible for~ assuring that the sequence of actions requited by Proccdure 1001 for the ptcpa-ration and revicw of requited documentation is fattowed..
Apptopriate documents shall be available at att unrk tocztions ptior to commencenerst of work. The L' ice President for Sources and Systems shall have and raintain a master LLst schich identifics the current revision nurber of l>utructions, ptocedures, specifications, draw-ings, and procurcrent documents.
1.4.9 Cont 10% of Purclased,"atetial. Eouicmentt, and Services The Vice Prc.sideri for Sources and Systems shall have an evaluation done of att supplichs to asscss their capability.to ptovide acceptable
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3 q ualit y l e~.vic es nd p teduct s.
Tiis evaluaticn shall be bzsed en sutecy cf the v:<!1et's lacilities and CA ptcg' tar to dctcAninc
- lis capabliity it supply a ptccht vhich rects the design, manu-f actuting, and cuality tcqu.i?.cr:cnts.
Ali supplier cualuations shali L c !ccurented and ?iled.
"hcn tcquir cd, HP1 surecillance cf suppilets du~1q !abric.ztien, inscection, tcsting, and sitiprent of raterials, equierent, and ccercucnts shaEL be perfotred io assure con!ctrance to the pwtchase c det t e quitcrents.
All supplicrs sh1LL be requlted to furnish the follcrina recetds as a rinirur to the purchasc:
1.
Tocumentation that identifies tho. purchased ratcrial
~
cr equipecnt and the specific procurcrent requirements (c.g., ccdes, standatds, and.spccificaticns ) re.t bij the iters.
2.
Docurentation il1t identifies any precurcrent requite-rents schich have net lccn rc.0 together telth a descrip-tien cf those nonconferrance.s dispositioned " accept as is" or "rcpai?.."
Pccciving inspection of the supplict-furnished ratetial, equipecnt, y
and sc:.cices shall be performed to assute:
b 1.
The raterial, ccepcnents, er equipecnt is ptopcrty identified and costcs;: ands teith the identification on ~.ccciving decurentatien.
2.
Hxtetial, cc~ponents, cquir~ent, and acceptance records arc inspceted and judged acceptable in acccrdance teith predetetr.incd inspecticn insttuc-ticus prict ic installatien er use.
3.
In!pection rccctds or cestificate.s of conformance aticsting.tc the acceptance of ratetial and com-poncnts c.rc available prior to installation or use.
1 Itcrs accepted and relcased arc identificd as to theit inspcotion status peler to forvrading.ther
.to a contr. cited stetage arca cr rcicasing ther fct futt er c:cah.
- 1. '.10 Tdentilication and Cent ct os "atcrials, Pasts, and Components The Vice Ptcsident for Scurces and Suster.s sh1LL be responsible for the ptcyc? identificction and centtal of ratc?.lats, parts, and ccm-ponents associated teith the fab?.i. cation of radicactive shipping containers.
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1.4.11 Special Processes Lcadhtg and unloadir.g containers for radioactive sMpmerts are special processes.
These slwlt be performed in accordance talth HP1 CC Proarer 10:3, Pachage loading Procedce (cr Radioactive Hatcrials and CC Prcgrar 1C:4, Pachage Unloading Procedure for P.adioactive Matcriah.
1.4.12 inspection Trupection of all qualittj conformance activitics slutti be performed under.the responsibility of tne CA l'anager in accordance talth QC Proccdure QC 1006.
Inspecilon personnel seilt be htdependent from l
those perfornhtg these ac.tivitics.. Thcse htspectors shall be.
qualified bt acco.tdar.cc scLth.the company's trahting program and sehen other quallficaticns and certifica.tlons are required they shall be kept currert.
Ifodifications, repairs, and replaccments for shipping cashs shall be hupected in.tecordance teith the origh,at design and htspection requirements, :>r acceptabte atternativcs.
Cperating and QC procedurcs teilt identify, schere applicabtc, manda. tory htspection hold poirts for. seitness by an inspector.
1.4.13 Test Control The Vice President of sources and Systens slad.t be responsible for shipping cash test corirol.
A tcst procedure for demonstrat-ing tlutt sMpping casks scill perform satisfactoriitj in scruice is estcbtished and docueen.ted.
This procedure is a checklist performed tn accordance seith CC Procedure 1006.
Ant) modifications, repaLu, or replaccrents to-shipping casks shall be tested in accordance seith.the original design and tes.t requirements or acceptable altcAnatives.
Test results are documented, evaluated, and their acceptability detchnined by the Section 1%nagcr responsible for.the radiation shipment.
1.4.14 Control of l'eascing and Test Eaulsetnt All measuring and test hatturents shalt be.catibrated at specific -
intervals to assure accuract) for intended ' purposes.
Calibration test data for.tncsc hist twents siclL be idertifiable and traceab?e.
.Whencuer tcst equipr.cnt is found to be out of cetibra. tion, previous tests teLCL be investigated for validity and so documented.
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Where applicabic, as b: the case of radiation measuring butrumentts, the b.1 sis for cailbtcticn teilt be traccabic to nationaltij recopstized standards.
1.4.15 Handling, Storaac, and Shecht; i
All operations concerning handlb:g, storage, and sMpping of radio ~
active sMpping cashs skli be in accordance seith NPT QC Procedure 1005, Handling, Storage, and SMpping Procedure for Radioactive Ifatcrials.
Spccial handling, prescrvation, storage, etcaning, and sMpping reqaircretts are esL1blished h1 tMs pro-packaging,hese are accomplished by Ltained, specificalig designated cedure. T qualificd individuals in accordance seith the above procedure.
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AU conditions of I.TC package approvat and U. S, DOT sMpping re-quircrents shall be satisfied prior to antf sMpment.
All necessary i
shippina papers shall be properly prcpared. Departure and arrivat une and destination of cach package slutti be established and moni-i
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tored to a degree couaient icith safe transpor.tauon of the package.
1.4.16 Evaluation,1stspection, Tcst, and Opchating Stattu Tnspection, testing, and oper.ating statna of au sMpping pachagcs and companc>tts sh LL be in accordance telth HP1 QC Procedure 1006, Inspecuan, Tcst, and Operating Statta Procedure for Radioactive Ifatcrials, identification, test, u.d cperating status of all packages and components shaLL be 610 tat by all af fec.ted sections.
Application and renoval of htspection tag markhtgs, and shipping or other labets shall be contratted in accordance telth QC Proccdwte 1006. By-passing of required tnspections, tests, and other critical operations, requires the. prior approval of the Vice President for Sources and the QA !.anager.
The status of nonconforring, h: operative, or malfuncuoning packages or corponents shall be clearly identified to prevent htadvertent us e.
s 1.4.17 Nonconforring Parts Any nonconforcing parts vill be so identified and segregated for disposal or renovat from the container or shipping arcas.
Honcon-forxing ratcrials, parts, components, and scruices shall be con-
. trotted in accordance tcith HP1 QC Procedurcs 1005 and 1006 teMeh require the. identification, documentation, segregation of noncon-forning iter.s and the notification of _affccted individuals.
Desig -
nations of h1dividuals responsible for the revicw and disposition of.the ratchicts are made b: these yzocedurcs..
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l Vccuro:taticr, shall idctii!y the nonconfowing item, state its l
inspection requiac.-cvAs, desc?Jbe the nonconforrance, and iden-tify final disposiucn.
Signatute approvat of the Vice Presidott i
for Scurces and Syncrs is requiAed for final disposition.
l Acceptability of rewod or repair shall be verified by acirtspec-tjen and actesting, as required, and as originally istspected or I
i by an equal nethod.
1.4.18 Coraective Action l
The QA Manager shall ccnduct an cualuation, in conjunc. tion seith
.the Vice President for Sources and Systems, of ant conditions dctchmined to be adverse to quality (such as nonco)nformances, failures, malfunctions, deficiencies, deviations, and defective matc?lats and equiprert) te dctcmine the need for cortective action.
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Perodr or replacemert of nonconforming parts or.the correction of o.ther deficiencies shall be recommended by the Soutce Produc-tion Scction Managcr, the Hanagcr for UtlLLzation, TaclLities, and Equipmerl, or the Health Physics Technician, and nust be approved by the Vice President for Sounces and Systers.
To.the cdent possible, correctlve ac. lions shall attempt to preclude recurrence of.the aduchse condition.
Toltcwup revicics shatt be conducted by the Q* Hanager to ycrlfy 7
the prcycr irplementation of corrective action.s and to close out the corrective action documentation.
1.4.19 Pachapina and Labelina Att NP1 radioactive shipments shall be packaged and labcLed in accordance sci.th NPI QC Program 1003.
1.5 Radioactive Source Transfer 1.5.1 Orcanization The Vice President for_ Sources and Systems has the overall respon-sibility for radioactive source transfers.
L The-loading and unloading-of;rai uctive shipping' containers and-the preparation for shiprent at NPI-is the responsibility of the L
Source Production Section Manager.
Loading, unloading, and prepa-l ration for shipment offsite is_ the responsibility-of the Teletherapy Services Section Manager who is also responsibic for installation of Sources into teletherapy units.
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Design and fabrication cf source adapters which are installed in a teletherapy unit is the responsibility of the Source Production Section !!anager.
Design and fabrication of container insert holders
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and adapters which cre part of the transfer operation are the respon-sibility of the Utilization, racilities, and Equipnent l'anager.
1.5.2 Definitions Radioactive source transfer - the field operation involving the transfer of sources between shipping containers and teletherapy units, unloading units, transferring sources into and out of an operating unit and transferring sources from one operating unit to another, including teletherapy unit checkout, servicing, and maintenance.
" Teletherapy unit - a machine using cobalt-60 at a distance for-j radiation therapy.
Quality radioactive source transfers - transfers made in accordance
- 3 with the procedures referenced herein.
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. 1.5.3 Buildings Not applicable 1.5.4 Ecuipment Shipping containers, everpacks, special handling equipment, instru-ments, and tools will be maintained by the Teletherapy Services Section Manager.
Vehicle maintenance will be the responsibility of the user.
1.5.5 Design control Not applicable 1.5.6 Procurement Document Control The Teletherapy Services Section Manager shall be responsible for assuring.that necessary requirements are specified in all procure-nent documents associated with equipment or services in support of any radioactive source transfer operation.
1.5.7 Instructions, Procedures, and Drawincs These will be prepared, maintained, and listed in'NPI Specification P-9, Procedures for Source Transfer, Maintenance, and Service Asso-ciated with Teletherapy Devices, and approved by the Vice President for Sources and Systems.
1.5.8 Document Control Instructions, procedures, drawings, specifications,-and shipping and transfer documents shall be maintained by the Teletherapy Services Section Manager. These documents and changes or revisions to them shall be approved by the Vice President for Sources and Systems.
1.5.9 Control of Purchased Material. Eouipment, and Services Control of purchased caterial, equipment, and services for sourc'e adapters installed in a teletherapy unit shall be the responsibility of the Source Production Section Manager.
Centrol for parts used in transfer of sources shall be the responsibility of the Teletherapy l
Services Section Manager.
L 1.5.10 Identification and Control of Materials, Parts, and Components i
i The Teletherapy Services Section Manager shall1 be responsible for l
all materials, parts, and components used in making _ equipment for radioactive source transfers, o
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' 1.5.11 Special' Processes Source replacement in the field is a special process and shall be performed only by trained and licensed personnel.
e 1.5.12 Inspection Routine inspection of containers, equipment, instruments, tools, and parts shall be conducted by the Teletherapy Services Section i
Manager.- Transportation vehicles shall be inspected by the Quality.
Assurance Manager or his designee.
l 1.5.13 Test Control Not applicable 1.5.14 Control of Measuring and Test Eauinnent The Teletherapy Services Section Manager shall be responsible for the maintenance and calibration of radiation monitoring--instruments used in the field.
1.5.15 Handling, Storage, Distribution, Shipping, and Installation llandling, storage, and shipping of transfer. equipment is the respon-sibility of the Teletherapy Services Section Manager.
1.5.16 Evaluation, Inspection, Test, and Operating' Status Teletherapy units serviced by NPI personnel.shall;be checked for operating condition in accordance with NPI Specification P-9.
1.5.17 Nonconforming Parts Any nonconforming parts will be segregated and identified for disposition.
1.5.18 Corrective Action i
In the event that either customer or NPI personnel-have reason to believe that some corrective action associated with an NPI per-formed radiation source transfer is necessary, the Teletherapy Services Section Manager shall make appropriate -recommendations for.the approval of the Vice President for-Sources and Systems and the_QA Manager.
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-1.5.19 Packaging and labeling All. parts will be packaged and labeled for identification. The.
shipping container shall be labeled in accordance with regulatory requirements.
2.1 Teletherapy Unit Reconditioning 2.1.1 Organi ation Reconditioning of teletherapy units is the overall responsibility of the Vice President for Sources and Systems.
The Teletherapy Services Section Manager is responsible for acco:plishment' of this work.
2.1.2 Definitions Telethcrapy unit - a nachine using cobalt-60 at a distance for radiation therapy Quality teletherapy unit reconditioning - the repair, replace-ment, refurbishing, shipping, installation, and testing re-quired to produce reusable units or components, in compliance with ANSI " Guidelines for thintaining Cobalt-60 and Cesium-137 Teletherapy Equipment," N449-1974 2.1.3 Buildings-b The buildings in which teletherapy units and co:ponents 'are reconditioned shall_have adequate working space, with appropriate lighting and ventilation systems to afford good shop conditions.
Safe and proper handling equipment shall be provided. Well lighted bench space shall be provided for reconditioning'of electrical control-and other small subassemblies.
Buildings of contractors' shall also comply with the above conditions.
General building conditions shall be periodically inspected by_
the Vice-President for Sources and Systems and independently by-the QA Manager.
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'. -2.1.4 Ecuforent Reconditioning and installatien er,uiptent and tools shall be main-tained by the Teletherapy Services Section Manager. Responsibility for the enintenance of vehicles shall be with the Teletherapy Ser-vices Section Manager.
Equiprent purchased for replacetent items shall be the responsi-bility of the Teletherapy Serrices Section !!anager.
2.1.5 Desien Control Not applicable 2.1.6 Procurerent Docurent Control Documentation of-procurerents for raterials or components for recon-ditioning tcletherapy units shall be the responsibility of_the Tele-therapy Services Section Manager.
2.1.7 Instructions, Procedures, and Drawines All instructions, procedures, and drawings required for recondition-ing, shipping, and installation shall be in accordance with UPI Procedure R 5010. Periodically audits will be conducted to check for conforeance.
2.1.8 Docurent Control All doeurents relating to reconditioning, instructions, procedures, drawings, and specifications shall be controlled by the Teletherapy Services Section Manager and shall have the approval of the Vice President for Sources and Systets. Changes to these doeurents shall require his approval.
2.1.9 Control of Purchased Paterial Eculocent, Land Services The Teletherapy Services Section Manager shall be responsible for procurerent of purchased caterial, equipeent, and services.
2.1,10 Identification and control of Materials, Parts, and Coroonents The Teletherapy Services Section Manager shall establish and main-tain a clean area in which parts for reconditioning teletherapy
-eachines are stored and labeled.
1
. 2.1.11 Special Processes Installation of a source into a reconditioned teletherapy unit is a special process which is covered by Section 1.5 of this document.
2.1.12 Inspection Routine inspection of parts and components shall be done by the Teletherapy Services Section Manager or his appointee. A complete inspection of finished units or components before shipping and after installation shall be in accordance with NPI Procedure R 5010.
2.1.13 Test Control NPI Procedure R 5010 establishes the steps necessar/ to assure that an installed unit has not suffered damage in transport.
2.1.14 Control of Measurine and Test Equipment Meters used to check radiation leakage from teletherapy units shall be periodically calibrated. Calibration shall be recorded. Each calibration record shall show the name of the person who performed the calibration, the date en which it was done, and the next date on which a calibration should be performed.
2.1.15 llandling, Storage, Distribution, Shippinc, and Installation All operations concerning the handling, storage, distribution, shipping, and installation shall be in accordance with NPI Procedure R 5010.
Conformance is the responsibility of the Teletherapy Ser-vices Section Manager.
2.1.16 Evaluation, Inspection, Test, and Operating Status The evaluation, inspection, test, and operating status shall be in accordance with NPI Procodure R 5010.
2.1.17 Nonconforming Parts Parts fre-existing teletherapy units and/or purchased parts found to le nonconforming will be so identified and segregated for dis-posal or removal.
, 2.1.18 Corrective Action If a reconditioned teletherapy unit is suspected of needing correc.
tive-action by NPI or customer personnel, the Teletherapy Services Section Manager shall recommend an appropriate course of action to L
.- the Vice President f or Sources and Systens and the QA Manager.
The Vice President for Fources and Systets chall rake the deter-mination of appropriate corrective action.
2.1.19 Packagine end inheline Reconditioned teletherapy units shall be packaged for transit and transported by truck. A reconditioned unit sna11 be appropriately labeled.
3.1 Dese Control Irradiations 3.1.1 O_rranir.ation The Vice President for Radiation Processing Services Mr. D. G.
Uoodard, has the responsibility for all activities required to perform dose control irradiations. The responsibility for nasur-ing compth1nce n'Lth the custcrot's specificatlons and schedtdes I:.s been deicpated to the ".ica: biological Costtrol Produc.ts llanager,
!ls. G. Starett.
The respcs:sibiliitt f01 conductbtg the DAadiation has been delegared to the _1rradiations Section Manager, Mr. M. W.
Harmon.
Mr. Harmon is responsible for the day-to-day operations of the irradiators and is also responsible for assuring-that quali-fled operators are avatianic to run these machines.
3.1.2 perinitions Quality - A quality dose. control irradiation is one which was conducted in accordance with the requirements of this section and uhich delivered a dose (from cobalt-60) to a product in the range specified on the purchase order received from the customer.
Irradiators - There are two irradiators at the company's Dickerson facility. The first irradiator is called Dickerson I, the second is called Dickerson II.
Both use cobalt-60 as their radiation sources.
'3. '. 3
?uildines Tor any operatien or prowessing carpaign, sufficient space shall.
be provided to facilitate adequate cleaning, prevent mixups, and to assure the orderly handling of incoming raterial, rejected material, catcrial in the irradiation process, and: testing and reasuring equipeent. Adequate space to perform dosimetry measure-ments wil' be provided as vill sufficient lighting, ventilation,.
and temp;rature control.
Airborne contamination shall be kept within
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.i acceptable industrial standurds.
Inspections of the building condition shall be periodically performed and the results of these inspections shall be recorded.
The NPI quality assurance organi-ration shall be respensible for the perforracce and docutantation of these, inspections.
No less than two inspections per year vill be perforced. The line organization shall be responsible for.
cleaning the process areas.
Sanitary f acilities will be provided,-
3.1.4
.E.ou toren t
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Nondisposable equipnent used for handling, irradiation, and shipping shall be cleanabic and, if necessary, adjustable.
Equipeent shall i
be stored in such a tanner to reduce contamination by dust or dirt j
or the accuenulation of chemicals.
Eculprent vill be clean when I
used.
Equipment which requires periodic adjusteent shall have allowable tolerances posted where the equittent is stored or used.
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3.1.5 Desien Controly Not applicable 3.1.6 Procureecnt Docurent Control Not applicable t
3.1.7 Instructions, Procedures, and Drawi..gs NPI Procedures R 6001.-General Procedure for Package Irradiator-Operations, R 6002, Procedure for Package Irradiator Operator Qualifications, R 6003, Procedure for Routine Package Irradiator Maintenance, and R 7003, General Procedure for Dickerson II Irradi-ator Operations and Instructions for Specific Products shall be used-for-all irradiations.
3.1.8 Docurent Control.
Instructions, procedures, drawings, and specificatiens shall be' issued b i the !Licrobiologicd Conttol Traduct Knager or by the l
Irradiations Section Manager. These documents shall have the I
approval of the Vice President for Radiation Processing Services.
Changes to_any of these-documents shall.also require his approval..
- 3.1.9 Control of Purchased Materin1. Ecuineent, and -Services.
Control oof materials, equiptent, and services shall be the respon-sibility of the Irradiationo'Section' Manager.
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1.l 3.1.10 Identification and Contro1 of Materinis, Parts, and Components J
Materials, parts, and cempenento required for irradiation, except I
cobalt-(,0, shall be stored and identified by the Irradiations See-tion Manager.
t 3.1.11 Spreial Processes t
Not applicable l
t 3.1.12 Inspection.
q Product dosimetry shall be the principal means of inspection. -Dosi-metry shall be performed in accordance with Irradiator-operating Instructions, Processing Dosimetry. Products determined to be non-conforning to the customer's specifications shall be tagged. accord-f ingly and stored physically separate fron acceptabic material. The Microhlologic44 Coritol P,toduc.t Manager shall document all nonconfor-mances and bring them to the attention of the Vice President of Radia-tion Proccasing Services and the QA Manager within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.1.13 Test Control 1
t Not applicable i
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3.1.14 Control of Mensurine and Test Ecuinrent Dosimetry equipeent will be used to ascertain uniformity and/or levels cf radiatien doses.
This equipment vill, at a minimum, consist of an optical density reader and a thickness gauge. Those items vill be examined to determine if periodic calibration is re-quired. Calibration vill be performed _per NPI Instruction, Cali-bration of Far West Dositeters.
Periodic calibrations shall be recorded. Each calibration record shall s,hou the name of the person who performed the calibration, the date on which it vas -done, and the next date on which a enli-bration should be perforced.
3.1.15 Handline, storace, Distributine, and Shinping i
For each product handled by NPI, a specific instruction is prepared which documg,;s the corpany's methods for controlling customer -prod-ucts during handling, storage, and chipping.
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. 3.1.16 Evaluatien, intrectien. Tent and Operatinc Status Operatien of the irrtdiatorc shal' he in accordance vitt I Pro-ceduren !!?I E 0001 and R 7003.
3.1.17
- enconf errinc ?'nterial s, Par cs, and Cormenents Not applicable 3.1.18 Corrective Action In the event that dositetry reveals that a product has not received the required dose, this fact shall be docr-enied and reported to the Vice President for Radiation Processing Services and the QA tbnager.
The Irradiations Section Manager shall determine and document the cause of the probice. Upon obtaining the approval of the Vice Presi-dent for Radiation Processing Services, he shalt.cirradiate or return the product so appropriate.
3.1.19 Packarine and Labeline Incoming and irradiated products shall be labeled in accordance with specific instructions.
3.2 Physical and Checiesl Properties Irradiations 3.2.1 Orranization See Section 3.1.1.
The Pol 'mcr Modification P,toduci Manager, Mr. J. Tang, has the respon-
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sibtitty for assttting compliance tolth the custcrch's specifications and schedacca.
IIe 4apervisca the laboratory work necessary to deter-nine required doses and to ascertain the quality of the product.
3.2.2 Definitions Quality - a quality physical or chemieni property irradiation is, one which was ccnducted in accordance with the requirements of this section and which tecults in a product which has achieved the physical and chenical properties specified on the purchase order received from the customer.
Irradiators - See Cettica 3.1.2
. ' 3.2.3 Euf1 dines See Section 3.1.'.
Appropriate laboratory space shall be provided for product sarpling and testing.
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3.2.4 Equinrent 1
See Section 3.1.4.
3.2.5 Design Control Not applicable 3.2.6 iProcurerent Docueent control Not applicabic 3.2.7 Instructions, Procedures, and Drawines See Section 3.1.7.
Specific instructions shall be written for the necessary laboratory support and product testing activities.
3.2.8 Document Control Instructions, procedures, drawings,- and specifications shall be issued by the -Irradiations Section Man.ager for activities associated with -
running the irradiators and by the Polsper flodifica4Lon Product Manager for laboratory support activities.
These documents shall have the approval-of the Vice President f or. Radiation Processing Services and by the Quality Assurance Manager.
Changes to any of chese documents shall also require their approval.
3.2.0 control of Purchased Material. Ecuionent. and Services See Section 3.1.9.
3.2.10 Identification and control of Materials, Parts, and Components See Section 3.1.10.
3.2.11-Special Processes Not applicabla i
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3.2.12 Irspection Properties testing shall be the principal means of inspection.
Testing shall be perforced in compliance with written instruc-tions.
Dositetry shall be perforced :ba accordance with Irradiator Operat-ing Instructions Processing Dositetry. Products detertined to be nonconforcing to tFr custocer's specifications shall be tagged accordingly and stored physically separate fron acceptable caterial.
The Polpa llodificMien Product Manager shall document all noncon-formances and bring thee to the attention of the Irradiations Sec-tion Manager and the Vice President for Radiation Processing Services within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.2.13 Test Control See Section 3.2.12, 3.2.14 Control of Yeasurine and Test Equipment Laboratory equiptent necessary for sampling and testing of products shall be available and the Polym !JodificMien Product Manager shall deternine if periodic adjusteents or calibrations are required. Lab-oratory equiprent which requires periodic adjustment shall have allow-able tolerances posted where the equipment is used.
Periodic calibrations shall be recorded. Each calibration record shall show the nace of the person who perforned the calibration, the date on which it was done, and the next date on which a calibra-tion should be perforced.
3.2.15 Handling, Storare, Distributing, and Shioping See Section 3.1.15.
3.2.16 Evaluation, Inseection, Test, and Onerating Status See Section 3.1.16.
3.2.17 Nonconformine Materials, Parts, and Coenonents Not applicable r>
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t 3.2.18 Corrective Action The Pokyecr flodification Product Manager and the Irradiations Section Manager shall recorr.cnd in vriting to the Vice President for Radiation Procccsing Services and the QA !!anager:
- an appropriate disposition for nonconforming products;
- and,
- the likely cause of the nonconfo mance.
The Vice President for Radiation Processing Services shn11 make the determination of the final disposition.
3.2.19 Packaging and-Labeling Incoming and irradiated products shal. be packaged and labeled in accordance with specific instructions.
Tottacrytaride Produc, tion 3.3 j
3.3.1 Oraatti:ation The Vice President fo.t Radiation Processing Scruices, Ht. D. G.
Woodard, has the responsibility for ali activitics required for the production of polyacrytaride.
The responsibliitti for assurh19
. compliance with the customer's spectfications and seltedules has been delegated to.the Polymcrization Plant Section Lfanagch, FLt. D. Decre.
The responsibility for conducting the Ltradiations has been delegated
.to.the irradiations Section^ Hanagch Mt. M. W. Harnon.
Mt. Harmon is responsible for.the day to-day op,erations of.the irradiators and-is also responsibt.e for assuring _ tint qualified operators are avait-abic to run these machines.
3.3.2 Definitions A quality polyacrytaride product is one editch vus ptoduced Quality dance with the requitements of this section and u+ich.through-in acco,t out its progtcssion '{ rom a conomer to a polymcr has the phtjsical and cherical propcrtics spccifLed bi the customer, Hcrcutcs.
j Irradiators - See Section 3.1.2.
' 3.3.3 Balldinas See Section 3.1.3.
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The acrylic acid tuilding shall be malnutined in such a fashion as to preclude entty by unauthoti:cd personnet and the public.
Its explcsion rcLief and preventien fcMates shall bc rantained by appropride personnet under the direction of the ToitecAi:ation Plant Section !!anaget.
The condition of this building and the tank room and thcL% suppoMing heating and cooling systcrs, sh1LL be in-spected by the Quality Assurance !hnager or Iis designce M Least twice a year and such inspections documented.
3.3.4 Equipment See Section 3.1.4.
1kidenance of the tanks, process Lines, heating, ventitMing, and cooling systcrs, and conttol. devices for the acAyLic acid building and.the tank room is the responsibility of the Pottecni:Mion Plant Section Ihnaget.
3.3.5 Design Control Not applicable 3.3.6 Procto:crent Document ContAot Supplich ccAtifications of rake up chemicals shall be retained for at LCast AKo years.
3.3.7 1nstructions, Proccdures, and Drancings See Scetion 3.2.7.
3.3.3 Document ContAol Instructions, ptccedurcs, drawings, and,specsfications shatt be issued by the Irradiations Section Manager for activitics associ-ated teith running the Ltradiators and by the Polymeri:ation Plant
- ction Ihnager for chemical processing and laboratory suppod
.tivitics.
These docurents shall have the apptovat of the Vice Yresident for Radiation Processing Serv *ces and by the cuality Assuratnce ihnager.
Changes to any of these documents shall aLsc require.their app'toval.
3.3.9 Control of Patchaacd lia.tcrial, Ecuiement, and Service 2 Control of purchased material, equipment, and services is.the respon-s.ibillty of the Pottyerization Plant Secticn,thnager.
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AU incoming shisecuts of acrytic acid and acaytamide shan be tested fot con {crranue to Herculcs' specifications.
3.3.10 idcuttlfication and Cortttot of Pate~.lats, Parts, and Comoonents See Section 3.1.10.
3.3.11 Special Processcs Not applicabic 3.3,12 inspe;cion inspections and cuatua.tions of finished product shall be pchformed in accordance leith Herculcs' specifica.tions.
3.3.13 Test Cont 90%.
Testing and control of.tcsts of finished ptoduc.ts shaLL be performed in accordance teith Hercutc.s' specifications.
3.3.14 Control of Measurina and Test Eouicment Laborattort) equipment necessart) for sampling and testing of products shan be available and the Special 1rradiations Section Manager sha.U detettsine if periodic adjustrents or calibrations are required.
Laboratory equipment tdtich requi.tes pericdic adjustnent shalt have aftonable tolerances posted schere the equipment is used.
Periodic calibraticns shall be recorded.
Each calibration record shall shoto the name of the person tdto performed the calibra. tion,
.the date on schich it utts donc, and the next date on tehich a calibra-tion sham be performed.
- 3. '.15 Handlina, Sto?. ace, Distributing, and Shipping See Section 3.1.15.
3.3.16 Evaluation, Inspeckion, Test, and Ccerating Status See Section 3.1.16.
3.3.17 Noncondorrina Materia.ls. Parts, and Cceponents Not applicable
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3.3.18 Coucctive Action The Potymerization Ptant Section ! tanager and the irradiations Section Ihnacer shall recorrend in initina.to the l' ice President for Radiation Precessing StAvices and the OA Ikitagers
~
- an appopriate disposition for nonconforning products;
- and,
- the likcty cause of.the nonconforrance.
i The \\! Lee President for Radiation Processb19 Services shalt make the determination of the finat disposition.
3.3.19 Pachaaina and Labckh19 Not applicable 1
3.4 Other Irradiations P
1 3.4.1 Orcanization The Vice President for Radiation Processing Services has the overall-responsibility for all irradiations cc,nducted at NPI's facilities.
lie has delegated the responsibility for the day-to-day operations of '
the irradiators_to the Irradiations Section Manager and the respon-sibility for laboratory support activities and specint' irradiations to the Special Iuadiations and Laboratories -Section Manager.
3.4.2 Definitions Quality - A quality irradiation is one which vss conducted in accor-dance with the requirenents of this section and which subjects a product to the environmental or testing conditions specified-in-accordance with NPI Procedure R 2013, Special Irradiations, and whose history has been documented in accordance with this procedure.
Irradiations - See Section.3.1.2.-
3.4.3-Buildings, See Section 3.2.3.
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. 3.4.4 Ecuirrent lee Secticn 3.2.4.
Equiprent recuiretents for any special irradia-ion shall be specified in 4ccordance with NPI Procedure R 2013.
3.4.5 Penien Control The Special IV:Adnttiod Section Manager or other designee specified per UP1 Procedure R 2013, vill assure that special irradiations or tests are designed in accordance with the previously specified require-cents. lie shall also establish and icplement a r'ethod f or coordinat-ing and interfacing with custerers or other organizations as cay be nee':sary. A design review to assure that the proposed test or irrrdiation reets the established requirenents will be conducted.
Representatives of other organizations (such as a customer) may par-ticipate in this review.
]
A rethod shall be established to define and control interfaces be-tween NPI and other organizations. Design changes, including pro-cedural changes, shall be subject to control censures commensurate with those applied to the original design.
3.4.6 Procurerent Docurent Control Customer supplied raterial shall be in accordance with NPI Procedure Q
R 2013.
3.4.7 Instructions, Precedures, and Prnuines All instructions, procedures, and drawings necceenry to specify tests and assure quality of subsequent irradiation r: hall be prepared in accordance with FPI Procedure R 2013. Periodically audits shall be conducted to check for conformance and tN results recorded.
3.4.8 Docurent control Instructions, procedures, drawings, and specifications shall be issued by the Section Manager for Spccint iuadiatioM or by another sectien canager specified by the Vice President for Radiation Pro-cessing Services. These docueents shall have the approval of the Vice President for Radiation Processing Services.
Changes to any of these coeurents shall also require his approval.
3.4.9 Control of Purchased Material, Ecuintent, anci Services Responsibility for control of caterial, equipment, and services shall be specified in accordance with YPI Procedure R 2013.
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f 3.4.10 Identification and Control of Materints, Parts, and Components Materials, parts, and corponents required for irradiation, except cobalt-60, shall be stored and identified by the section ranager i
designated by the Vice President for Radiatien Processing Services.
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3.4.11 Special Freecsses Since all of the processes designated under this Sect 3on 3.3 are in essence special processes, this section is not applicable.
3.4.12 Inspection Product dosimetry and properties testing as appropriate shall be performed. Products determined to be nonconforming to the pre-viously set specifications shall be tagged accordingly and stored physically separate from the acceptable material. The responsibic section canager shall document all nonconfortances and bring them to the attention of the Vice President for Radiation Processing Services and-the QA Manager within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.4.13 Test Control Not applicable 3.4.14 Control of Measurine and Test Equipment See Section 3.2.14.
3.4.15 Handling, Storace, Distributine, Shiryinc, and Installation Additional instructions or requirements for handling, storage, and shipping may be specified in accordance.vith NPI Procedure R 2013.
3.4.16 Evaluation, Inspection, Test, and Operating Status Operation of irradiator-shall be in accordance with NPI Procedures R 6001 and R 7003.. Ad61tional operational procedures may_be required in accordance with N?I Procedure R 2013.
3.4.17 NonconforminrJL (ta*s, Parts, and Coroonents Not applicabl' 3.4.18 Corrective Actient In the event that dositetry or physical and/or chemical properties testing-reveals that a product has not received the required dose l.
or other specified environcental condition, this fact shall be docurented and reported to the Vice President for Radiation Pro-ceasing Services and the QA Panager.
The responsible section nanager shall recorrend to then in vriting:
- an appropriate di;pssition for nonconforming products; and,
- the likely causa of the nonconformance.
The Vice President for Radiation Processing Services shall make the determination of the final dispeaition.
3.4.19 Packacine and Labeling Incoming and irradiated products shall be packaged and labeled in accordance with specific instructions.
1 1
'h 4.1 Laminar Flow Testing 4.1.1 Orcanization The Corporate SecActary is responsible for KPI laminar flow testing ac tivitie s.
He will be assisted by other company personnel as appropriate.
s'.l.2 Definitions Laminar air flow - For the purpose of this document, laminar air flow is defined as air flow in which the entire body of air with-ir. a confined area essentially moves with uniform velocity along parallel flow lines.
Quality laminar flow testing program - one which accurately exaaines le.inar flew equipment for compliance with the manufacturer's specifications and the appropriate criteria of Federal Standard l1o, 209B.
(
4.
.3 Euildines Not applicable
l l
-M-
.I.4 Eculprent
';ondisposabic equip ent used in the examint icn and testing program shall be cleanable and, if necessary, adjustable.
Ecuipment shall iust or dirt.
be stered in such a ranner to reduce contatinatior
.s Equipment vill be clean when used.
viprent whir ires periodic
.'?
i the equip-adjustrent shall have allowabic tolerances posted cent storage boxes.
The CorpoaAtc Secretattf shall prepare u.J keep current calibration procedures for all equiprent which requires periodic calibration.
Each calibration record shall show the name of the person who per -
forced the calibrction, the date on which it was done, and the next date on which a calibration should be perf orced.
5 4.1.5 Desten Centrol
- ot applicable 1.1.6 Procurerent Docurent Centrol
?;ot applicable 4.1.7 Instructiens, Procedures, and Drawinns
!PI personnel shall conduct all latinar flow terting work in accor-dance wish ITI Procedure 10001, Standard Procedure for In-Place Integrity Inspection and Testing of IIoricontal and Vertical Laminar Flow Hoods.
Audits vile be conducted to check for conforrance.
4.1.8 Docurent Control All instructions, procedures, and specifications for the laminar flew testing progran and change 5 of eare shall be issued by the Cc'ipoaAtc Sccac,taty.
These docurents shall have the approval of the Quality Assurance Manager.
4.1.9 Control of Purchned Material, Ecuimnt, and Fervices A qualitative and, whenever possible, quantative evaluation of in-stalled liEPA filter perf orcance shall be made on the Field Service Iaspection Report.
The Cotparate SccAc.tAty 01 h46 dcaLgnce shall exacine these reports once every calendar quarter to determine if purchased IIEPA filters have been in compliance with ITPI procurement specifications.
t A -
4.1.10 Tdentification and Centrol of cterinir. Parts. nnd Corponents Materials and parts used in the latinar flow testing program shall be stered either in the tervice vehicles or in a reserved separate area of the facility.
4.1.11 Special Processes Not applicable 4.1.12 Inspection NPI Procedure 10001 lists all inspections required for the laminar flow testing program.
4.1.13 Test Control NPI Procedure 10001 lists all tests required for the latinar flow testing program.
4.1.14 Control of Mensurine and Test EcuSrent See Section 4.1.4 4.1.15 Handline. Storcee, Distributine, Shinnin:', and Installation Equipnent and replacetent parts are stored and transported by vans.
Maintenance of the van is the responsibility of the Corpor 't Secretzty.
4.1.16 Evaluation. Insnection., Test, and Operatine Status 1
For each unit serviced, the NPI Field Service Inspection Report shall be completed. The original shall be given to the customer and one copy shall be kept in NPI ccepany files.
4.1.17 Noncenf omine Parts inecming material identified as nonconf orr.ing to any NP1 specifi--
catien shall be tagged ac:ordingly.
Nonconforning material shall be s:cred physically separate free acceptable raterial and appro-priately dispesed of by the Ccaporata Sccacfaty.
4.1.18 r rective Action When a nonconforming iten is disposed of, the COAporate SCCAC-tzu:y vill document this disposition and the reasons
. therefore in a note to the laminar flow files, with a copy to the QA ".2 nager.
2.1.19 Packacinc and Labeling A NPI Inspection and Testing Sticker shall be placed, when appro-priate, on all units serviced by the Laminar Flow Technology Sec-tion.
Documentation of what, if any, sticker was affixed to a customer's unit shall be made on the Field Service Inspection Report.
5.1 Product "arketing 5.1.1 Dr:anization The President of Neutron Products, Inc. is responsible for narketing cf all NPI products, l!e nay be assisted by other company personnel as appropriate.
5.1.2 Definitiens Quality product rarketing - the completion of all activities neces-sary to sell and deliver a product that conforms to all stated specifications.
5.1.3 Buildings Buildings used for the fabrication and handling of NPI narketed products shall have sufficient space to facilitate adequar.a clean-ing, prevent nixups, and to assure the orderly handling of incoming material, rejected naterial, naterial in the fabrication process, and testing and reasuring equipment. Appropriate lighting, venti-lation, and temperature and humidity control shall be provided.
Inspection of the building condition shall be periodically per-formed and the results of these inspections shall be recorded.
The NPI and manufacturers' QA organizations shall be responsible for the performance and documentation of these insp~ections in their respective facilities.
No less than two inspections per year will be perforned.
Sanitary facilities will be provided.
5.1.4 Ecuipment Nondisposable equipment used in the manufacturing process of NPI marketed products shall be cleanable and, if necessary, adjustable.
t 2:.
Equipment shall be stored in such a ranner to reduce contamination by dust or dirt.
Equiptent will be clean when used.
Equipment which reouires periodic adjustrent shall have allowable tolerances posted where the equipnent is stored or used.
Materials used in the nanufacturing process and not desired in the final product will be removed and such removal documented. Mea-suring equipment will be exanined to determine if periodic calibra-tion is required.
Product calibration shall be recorded. Each calibration record shall show the name of the person who performed the calibration, the date on which it was done, and the next date on which the calibration should be performed.
5.1.5 Desien Control For any product which NPI narkets there shall be a specific distri-butorship agreement written in which the spec?fications of the product to be narketed are clearly and complett_y delineated.
Any changes to this specification or distribution shall require the approval of the QA Manager.
5.1.6 Procurement Docunent Control The manufacturer shall have definite specifications for all purchased caterial.
The distributorship agreement between the manufacturer and NPI shall state which, if any, of there specifications will require NPI's approval.
In all circumstances, NPI will have the right of inspection to check for compliance with these specifications.
5.1.7 Instructions. Procedures, and Drawings All instructions, procedures, and drawings necessary to assure quality in the fabrication of a product to be tarketed by NPI will be listed in the nanufacturers' specifications. NPI shall have access to these specifications and shall be allowed to conduct periodic audits to check for conformance.
5.1.S Document Centrol The nanufacturer shall assure that all instructions, procedures, drawings, and specificaticns are controlled by a sufficiently high level of canagenent and shall warrant that changes to any of these documents will not occur without the same level of nanagement approval.
3.1.9 Control of Purchased 5!aterial,-Eauionent, and Servicts-The manufacturer shall inform NPI of all testing and examination activities which he conducts to ascertain the condition of pur-chased m,aterial, ecuipnent, and services.
5.1.10 Identification knd Control of Materials, Parts, and Components The manufacturer shall establish control areas in which all.aaterials, parts, components, and completed products are stored and-labe.ed. NPI shall have the right to inspect for conformance to this method.
5.1.11 Special Processes Special manuf9cturing processes such as welding, heat' treating, or nondestructive examination of manufactured components or parts shall be certified by a suitably high level of manufacturer's management.
NPI shall_be given the specifications to which these special processes have been perforned.
5.1.12 Inspection ihnufacturer's inspection methods shall be provided to NPI. NPI personnel may witness these inspections.
5.1.13 rest Control The manufacturel shall specify to NPI the way in which the products are tested to assure suitability-for application. NP1 personnel may witness these tests.
5,1,14 Control of Measurine and Test Eauirment Equipment used to examine components'and products shall be controlled, calibrated, adjusted, and maintained in accordance with written pro-cedures. -NPI personnel may_ check for conformance.
5.1.15-Handline, Storage, Distribution, Shineing, and Installation Handling, storage, distribution, shipping, and installation shall be in accordance with-the distributorship agreenent between the manufacturer-and NPI.
' 5.1.16 Evaluation, Insucction, Test, and = 0uerating Status NPI shall monitor, as appropriate, performance of all products dis-tributed.by.NPl.- A performance record for all products marketed by-
,w.-
y
1.
, NPI shall be made at least once per year and appropriate corrective action Initiated.
Products which in the judgement of the President of NPI have had unacceptable performance will either be dropped from further marketing or actions taken to improve the product quality.
5.1.17 Nonconfonaine Parts The manufacturer shall identify and tag parts which do not conform to written specifications.
Nonconforming material shall be stored physi-cally separate from acceptable material and a list of nonconforming items shall be prepared. The disposition of nonconforming material shall require the approval of the manufacturer's QA organization.
5.1.18 Corrective Action The manufacturer shall try to determine the cause for recurring non-conformances. He shall document actions taken to correct such pro-blems. This information shall be available to NP1 upon request.
5.1.19 Packaging and Labeling All products shall be packaged and labeled in accordance with the distributorship agreement between NPI and the customer.
VI.
Records NPI line organications and the QA Manager shall maintain records in accordance with the specific QA subplans presented in Section V.
These records shall be retrievable, identifiable, and available to company management as evidence of the workings of the QA program.
Provisions have been established to control the distribution of the following documents and revisions thereto:
1.
The NPI Quality Assurance Program 2.
NRC Cask Use Certificates 3.
Road Use Certificates The following documents are also maintained:
l.
Procedures 3.
Instructions 4.
Drawings 5.
Specifications 6.
Design Review Reports 7.
Contract Agreements S.
Installations
j-R,
9.
Dosimetry Records 10.
Health Physics Records 11.
Radioactive Respiratory Protection Program-12.
NPI's Progran for Radiation Protection of Employee Exposures
- 13., Truck Driver's Logs (Form MCS-59) 14.
Vehicle Inspection and Maintenance Records 15.
Annual Review of Drivers' Driving Record 16.
Daily Reports of Vehicle's Condition.
17.
Reports of Accidents (Forms MCS 50-T and MCS 50-B) 18.
Radioactive Shipment Record 19.
Personnel Qualification Approval:and Certification Records-20.
Shipping Package Maintenance Schedule and Authorization 21.
Shipping Package Modification Authorization 22.
Medical Device Description for Reconditioned Teletherapy Units 23.
Device Master and History Records for Sources 24.
Customer Complaint-Files 25.
Calibration Records 26.
Inspection and Test Records These records shall contain the following where applicable:
a.
A descriution' of the type of observation.
b.
Evidence of completing and verifying a manufa'eturing, inspection, or test operation.
c.
The-date and results of the inspection or test.
d.
Information related to-conditions adverse to quality.
Inspector or data recorder identification, c.
f.
Evidence as to the acceptability of the results.
27.
Component Control and_Nonconformance Records These documents. shall include records -of the ' acceptance or rejection of all components used in target and source man-ufacture, records of the disposition of all. obsolete, rejected, or deteriorated components,-records of the removal of unwanted materials from manufacturing, and records of nondestructive examination and other test results.
28.
Equipment / Maintenance Records These records shall include a description-of the pieceiof-equipment used or in operation, along with any modifications or adjustments, and shall document the performance and neces-sary-maintenance schedules.
29.
Driver Qualification Record Records required to be maintained pursuant'to Federal Motor Carrier Safety Regulation 391.51. This file shall-include:
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, q
- The medical examiner's certificate of the driver's
~
physica1' qualification to drive a motor vehicle or a legible photographic copy of the certificate;
~
- A Ictter granting waiver of a physical ~ disqualifica-tion, if a waiver was issued;
- The memorandum on the annual review. of the driver's
'i driving record;
- The list or certificate relating to violations of motor-vehicle laws.and ordinances;
- Any other matter which relates to the driver's quali-fications or ability to drive a motor vehicle safely;
~
- The driver's application for employment;
- The responses of state agencies and past employers to-inquiries concerning the driver's driving record and-employment;
- The certificate of driver's road test issued to the driver or a copy of the license or. certificate which NPI accepted as equivalent to the driver's_ road test;--
- The questions asked, the_ answers;the driver gave, and-the certificate of written examination issued to him, or a copy of a certificate which_NPI accepted as equi-valent to a written examination; and,,
- The driver's name, his social security n'imber, and-the identification number, tyTe, and issuing state of his motor vehicle operator's license.
- 30. - Device Distribution Records
- 2 Adequate distribution records for critical devices 'shall in-clude, or make reference to, the location of: the name and address of the consignee, the name and quantity of. devices, the date shipped, and:the-control number used.
- 31. Corrcetive Action Repoht.s
- 32. QA Audit Reports The above records shall be maintained at apecific'focationa in the FPI facilities and shall be reasonably accessible, many on a proprie-tary basis, to government employees designated 'to perform inspecticas.
,.v.
- 42a -
- Ali - shipping-package design related recor_ds shall be rnaintained for '
the' life of the Ishipping packagc; irradiator operations chatts, Lstadiator Logs, and istadiation warksheets which document -dose controt 1Atadiations-'shalt be' maintained for at least five yeau;1 and ait other recods arc ma.intained at least two yeau..
VII.
Audits Audits of the 4:ality Assurance Program will be depend'ent on the
- significance of the activity being audited. Audits shall include 3
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. 43 an evaluation of the shipping and ranufacturing practices and/or procedures, and shall be concerned with the safety and effective-ness of their inplenentation.
Audits shall be planned and include the nonitoring of operations and activities, review of pertinent documents and their control and raintenance. Audit procedures will be established prior to conducting an audit and shall stress the safety aspects of the package er device.
Audits shall be perforced at least twice a year with spot checks as dected necessary by the QA Manager. Those areas having a higher safety significance, as well as those areas in which undesirable problems habitually are found, shall be audited more frequently.
Audits shall be perforned by persons who do not have responsibility for the area being audited, and who possess the ability to evaluate adequately the functions under investigation.
The results of these audits sha]1 be docunented and maintained by the QA ?!anager and reported to the President along with any sugges-tions of reconnendations for improvement. Subsequently, the Preaident shdt direct Line ranagement to take tchatever corrective actions he decide.s is neecasary.
In the event that deficient areas are located, they shall be re-audited on a tirely basis to verify inplementation of corrective actions.
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- o UNITED STATES 3'
3, NUCLEAR REGULATORY COMMISSION e
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WASHINGTON, D. C,20555
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JUL 101960 FCTC: RHO 71-0121 Neutron Products, Inc.
ATTN:
Mr. Carmine Smedira 22301 Mt. Ephraim Road Dickerson, MD 20753 Gentlemen:
Enclosed is Quality Assurance Program Approval for Radioactive Material Packages No. 0121. Revision No. O.
Sincerely, SL3 4 Char es
. PacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
As stated r
3
.- 4 x}C RRC FURM 311 -
U.S. NUCLEAR REGULATORY COMMISSION
- 1. APPROV AL NUMe t R D
0121
((
"2"8' QUALITY ASSURANCE PROGRAM APPROVAL -
REVisl0N NUMBER
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FOR RADIOACTIVE MATERIAL PACKAGES 0
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Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Title 10, ihd::
Code of Federal Regulations, Chapter 1, Part 71, and in reliance on statements and representations heretofore made in item 5
[
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t by the person named in item 2,the Quality Assurance Program identified in item 5 is hereby approved, This approval is issued to i
satisfy the requirements of Section 71.51 of 10 CF R Part 71. This approval is subject to all applicable rules, regulations, and h.
orders of the Nuclear Regulatory Commission now or hereafter in ef feet and to any conditions specified below,
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- 2. MM E
- 3. EXPIR ATION DATE (j!,.,
Neutron Products, Inc.
w sTaEET AconEss October 31, 1985 GFF 22301 Mt. Ephraim Road
- 4. oocxET nuusEa l STATE j ZIP CODE CIT Y MD.
I 20753 71-0121 Dickerson 7 ~7
- 5. QuALIT Y AsSuR ANCE PROG R AM APPLICATION CAT kis)
June 24, 1980
- 6. CO NDITIO NS
-A.
Activities conducted under applicable criteria of Appendix E of 10 CFR Part 71 to be executed with regard to transportation packages by October 1,1980.
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Charles E a d, C e tation Certification Branch' JUL 101980 Divisiin of Fuel Cycle and Material Safety, NMSS
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w-FORM N RC-341 '
FORM APPFWED !* GAO (12-79)
R 0078 4
10 CFR 150 E X P!F.' ES: 10-3140 ~
U.S. NUCLE AR REGUL ATORY COMMIS$10N
/
REPORT OF PROPOSED ACTIVITIES IN NON-AGREEMENT STATES MM.
(Please read the instructions on the cover sheet before completing this form)
- 1. N AM E OF LECENSE E (Person or brm propoung to conduct the
- 2. ADDRESS OF LICENSEE (Mathng addrest or otherlocarno. were actienties descerbed belowl leensee mcy be itxatedl sentran Prsdents, Inc.
. 12301. Hee Ephrain Reed, aos 68 A
I 3.NAME OF PERSON AUTHORIZED BY LICENSEE TO PERFORM e'
ACTIVITY Jerry L. Petle
- 4. DESCRIPTION OF ACTIVITIFS TO BE CONDUCTED IN NON. AGREEMENT STATES UNDER THE GENERAL LICENSE GivEN IN 10 CFR 150.20 Inar=11=t4=a and Eemsval of cobalt-60 teletherapy neurte under Maryland Lisemme 10-31-023-03.,
- 5. LOCATIONS AT WHICH THESE ACTivlTIES WILL BE CONDUCTED AND DATES SCHEDULED.
STREET AND NUMBER OR OTHER t.,0 CATION DATESSCHEDULED No.
CITY AND STATE (Gere as complete en address as possib/,)
Themes Jeffaroes tfmiversity Heepital
' Philadelphia e 1025 Welast Street teensylvania 10-30-80 14-31-80 2
6 LIST SE ALED SOURCES.OR DEVICESCONT AINING SEALED SOURCES,WHICH WILL BE POSSESSED, USED,1NSTALLED.SERVCED 0R TESTED 1N NON-AGR E EMENT STATES. linclude descnotion of type and avantitv of reducactive matenat contained on each seated s;urce or devoct.}
MPI source, NPI-20-7000W - containing 6980 eurias of eebalt-60
- 7. NUMBER OF SPECIFIC LICENSE AND NAME OF STATE ISSUING SUCH SPECIFIC LICENSE WHICH AUTHORIZES THE UNDERSIGMED TO CONDUCT ACTIVITIESWHICH ARE THE SAME EXCEPT FOR LOCATION OF USE, AS THOSE SPECIFIED IN ITEM 4 ABOVE. Sur copres of the specohe license must accompany this report.)
MD-31-025-03 CERTIFICATE DATE 8.1. THE UNDERSIGNED, HEREBY CERTIFY THAT:
NME No 1
- a. AH mtormation in this report is true and complete, UCENSEE*5 N AME (TYPE OR PRINTI
- b. I have read and understand the provmons of the general iconse g
8 10 CFR 150.20 reprinted on the cover sneet of this form set; and I unoerstand that I am required to comoly with tnese provisions as to all byproduct, source. or special nuclear matersal which I possess CERTIFYING OFFICI AL -
I and use m non. Agreement States unoer the general license for SIGNATURE
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wesen this report is filed with the U.S. Nuciear Regulatory Com -
hI miss.on.
T t T 1.E
- c. I understand that activities. encludmg storage, conducted m non-PhaMa{a (.h l
Agreements under general scense 10 CFR 150.20 are limited to a totai of 180 days m any calendar year.
- WARNING: 18 U.S C.,- Section 1001: Act of June 25.1948; 62 Stat. 749; memes it a criminal of fense to make a winfully fatse statement er -sore-sentation to any department or agency of the United States as to any matter withen its jurisdiction.
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- Fj DEPARTMENT OF HEALTH AND MENTAL-HYGIENE DIVISION OF RADIATION CONTROL RADIOACTIVE MATERIAL LICENSE Pa;e 1 of 1 pages Supplementary Sheet Licensa No.
Amendment No.
1:eutren Products, Inc. -
rnekerson, Earyhnd 20753 To ccrrect an errer, Radica eti.ve Ea terial I.icense D-31-025-03 is s. ended as fc1% ws:
Conditicn 11 is an. ended to read:
- 11. A. Padicacti re raterial sh:11 be used by er vr.dcr the rupervisicn r.d in the physical presence of 1'arvin Turkacis and/or Dale ?. cyp.
B. ?adicactive raterial in the Ficker and A2;L teletherapy units cnly shs11 bc ed by er under the supervisica and in the physical prescr.ca of Zarl Jenkins andi:r 1
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C. I'ransfer of radicactive scu-ces in the T ::cbaltrcn and Stzbilatren units sh:11 be perfor.ed under the direct supervisicn of and in the physical presence of Eduard Frank Finn, Rei;inald Ocrek Catlett er Jou;1as Jchn Head.
For the Maryland State Department of Healtn, -
and Mental Hygiene L& k1.
9 Date Au Ust 4.197$
_ dOA Divison of Radiation Control 1 ow+3co4 tsupo.
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DEPARTTAENT OF HEALTH AND MENTAL HYGIEiJE
[H orvis:oN OF R D!MION CONTROL stw'
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RADIOACTIVE f2ATERIAL LIC2NSE
.P Page 1 of 1 p:n Supp': ment:ry Sheet Licente i;o.
Amendment flo.
F.D 31-025-J3 05 I!eutron Fredacts, Inc.
Dickerten, Mn_f and 20733 l
In accednce with letter dated Srch 23, 1776, Endic.:ti,'e Materir.1 License MD 31-025-33 is amended as follows:
The expiration date is cr.anged to Mcy 33, 1931.
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For the Maryland State Dep/rtment or r ea:th y
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and Mental Hygiene Date April 30, 1976
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DIVISION OF RADIATION CONTROL RADIDACTIVE MATERIAL LICENSE Page 1 of 1 py; Supp?cmentary Sheet License No.
Amendment No.
d MD-31-025-03 N utron Promtets., Inc.
Dickerson, Earyland 20733 In accordance with letter dated August 6,1976, Fadioactive Paterial License No. MD-31 025-03 is anended as follevst Condition 11 B is randed to read:
11 B.
Radioactive raterial in the Picker and AIOL teletterapy units only shall be used by or under the supervision and in the physical presa::e of Je.m ~iogle.
%h, For the Maryland State Department of Hen.:n and Menta ygiene August 17, 1976
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Date Divison of Radiation Control DMM H 300 5(L,op.)
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DEPARTMENT OF HEALTH AND MENTAL HYGIENE OMS:ON CF PAD!ATION CONTROL RADIOACTIVE MATERIAL LICENSE 1
Page of ? pm Supplementary Sheet i.
License No.
10-31-025-03 Amendment No. 07 Moutron Products, Inc.
Dic).orron, E2ryland 20753 In accordance with letters dated December 10, 1975, April 23, 1976 and August 26, '.976, Radion:tive Material License Nu:foer ED-31-025-03 is ancnded as follows:
-To Add:
- 6. Radioactive caterial
- 7. Chemical and/or 8.
Maxint:n amount of (elerent and rass nurbar) physical Form radioactivity -inich licensee may ::ssess-at a:q one tine C.
Cobalt - c0 C.
Teletherapy Sealed C. No source to exceed Source (General Elec-13,000 Curies tric Drauing No.106D39h9; Neutrcn troducts Drauing Nos. 20C057, 200173A, A200036 - NPI Kodels HPI II-IIII and.?I-II-IIIIW) 9.
Authorized Use
-C.
To be loaded into, stored in and unloaded from Toshiba RCR-120 teletherapy 1mits and N?I shipping container (2,71 drawing 3-170003 ":!PI-Toshiba Teletherapy Sou :e.
Transfer Adaptor Arrangenent") incidente_1 to the instm tion and replacement Of a
sources and servicing.- The licensee is hereby authcriced to perform tha 5-year inspection and naintenance se:" ricing en the Toshiba teletherapy units in acc:rd:nes with " Detailed Precedure for the 5-year Maintenance and Inspection Program for-he Toshiba Teletherapy Unit" sub.-itted with letter dated December 21, 1976.
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DEPARTMENT OF HEAL.TH AND MENTAlf HYGIENE DivtSION OF IUDIATION CONTROL.
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RADIOACTIVE 'MATERIAt. LICENSE -
Page.l of 2, pages Supplementary Sheet -
Amendment Ns.g7 License No.
CONDITIONS Condition 11 is amended to read:
11 A.
Radioactive material in the Picker, AEC1, Keleket-Barnes and Westinghc.se teletherapv units shall be used by, or under the supervision of Marvi 3:rkanis or Dale Repp.
B.
Radioactive material in the ricker and AECL' teletherapy units'only shr*1 be used by or under the supervision and in t' e physical presence of Jerry 7:gle.c s
C.
Radioactive material in the TE2d Ecbaltron and Stabilation units shn17 te:
used under the direct supervision of and in the physical presence of Edward Fracx Finn, Reginald Derek Catlett or Dougls.s John Hoad.
D.
Radioactive material in tho Sienens Gamatron teletherapy units shall.te used by or under the supervision and in the physical presence of Dale Happ.
E.
Radioactive material in the Toshiba' teletherapy units shall be~ used by or under the supervision and in the physical presence of Darroll 0. Pcc'e. -
Condition 16-is anended to add:
- 16. Dececher 10,1975, April 23,1976, August 26,;1976 w
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Fof the Maryland State oepartment of Heb and Mental Hygiene
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Divison of Radiation Control (QMheM-300 4 (Suced
APR 2 5 E-77
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1 RADIOACTIVE MATERIAL LICENSE 1 ~ of' 1~ pages Page SupplementarV Sheet License No.
Amendment No.
Neutron Products, Inc.
Dickerson, E1ryland 207f3 In accordance with letter dated April 1,1977, Padicactive Material License No. MD-31-025-03 is ar. ended as fo11cus:
- Condition 11C is anended to read:
11 0. Radicactive aterial in the TS4 Mobaltron and Stabilatren units shall; be used under the direct supervision of-and -
in the physical presence of E6tard Frank Finn, Reginald Derek Catlett, Deu;;1as John Road, and/or Dale Repp.
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For the Maryland State Departm nt of Healn and Mental Hygien b ;(f gf,,, ;,"
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. April 20,1977-gg(jg,f 7
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Divkon of Radiation Centrol jHuM 300-6 (5v'co.3
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DEPARTMENT OF HEALTH AND MENTAL HYGIENE:
yg g78 DMstON OF RADIATION CONTROL RADIOACTIVE MATERIAL LICENSE Page of ps;es Supplement;ry Sheet License No Amendment No.
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Neutron Products, Inc.
Dickerson, Maryland 20753 T accordance with letters dated January n,1978 and March 30, 1978, Radioactive.hterial license Ntaber MD-31-025-03 is amended as follows:
Condition H is amended to read:
A.
Tae radiation prctaction progran shall be under the supervision of Harvin Turkanis.
B.
Radioactive material in the Picker, AECL, Keleket-Barnes and Westinghouse tohtherapy units shall be used by, or under the supervision of Marvin Tu-kanis or Dale Repp.
C.
Radioactive material in the Picker and AEC1 teletherapy units only shan be used by or under the supervision and in the physical presence of Jerry Fogle and/or Ioslie Forrest.
D.
Radioactive material in the TEM Mobaltron and Stabilatron units shall be : sed under the direct supervision of and in the physical presence of Edward Frank Finn, RegirW Derek Catlett, Douglas John Hoad, and/or Dale Repp.
E.
Radioactive material in the Siemens Garr.atron teletherapy units shall-be : sed by or under the supervision and in the physical presence of Dale Repp.
F.
Radioactive material in the Toshiba teletherapy units shall be used by er under the supervision and in the physical presence of Darrell 0. Poole.
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-DEPARTMENT OF HEALTH-AND MENTAL! HYGIENE =
OtVislON OF RADIATION CONTROL RADIOACTIVE MATERIAL LICENSE Page of pages '
~
Supplementary Sheet -
License No-J.3,,3,1 og,93 Amendment flo.; 09 G '. Maintenance, disassenbly, and packaging of Keleket-Dames and Westinghouse -
teletherapy units shall be perfcrmed by or under the supervisicn of Jerry T gle.
Source installation or renoval and the five year maintenan o and inspectic: of these u-its is not ant.horized.
4 Conditien 16 is amended to-add:
- 16. Iotters dated January 11, 1978, March 30, 1978' a
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For he Maryland State Department of Health,
- and Ment I)giene -
' June 6,1978 '-
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. DatQ Divison of Radiation Control
- . DCtMM-300 6 (Supo.)"
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JUL 101976
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DEPARTMENT OF HEALTH AND MENTAL HYGIENE llVISION OF RADIATION CONTROL RADIOACTIVE MATERIAL LICENSE Page 1 of 1 pages Supplementary Sheet Amendment No, 10 Liva se No.
l'D-31-025-03
.?
Neutren Products, Inc.
Dickerson, Earyland 20753 In accordance with let,ters dated Fay 1,1978, May 16,1976,
?2dicactin Esterial License U" der MD-31-025-03 ::.s anended as fellcws:
To add Condition 10 C:
10 C. Depleted uranium as shielding in teletherapy heads and colli aters may also be stored at the licensee's facility at 329 East Second Street, Frederick,
}hryland.
A V7.
For tde Mahland Sta M nt of Hea.:n and Me ',ygiene dc7fw Date
.T n-a in. Sc78 3
Divison of Radiation Control j
l OMMM 300 6 (Supp.)
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SEP '241979 DEPA8tTMENT OF Mt aLIN AND MENT AL MVGif ME Charles 94. Buck, Jr.,5c. D.
s oevanommernvat ma at.t..u m o.neiseestaatsoas 5.u.iarv
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,,,,,.o DIVISION OF RADIATION CONTROL r
" %Dl0 ACTIVE MATERIA 1. L.lCENSE 1
I Pa;e of m
Supplementary Sheet License No.
Amendment No.
11 MD.-31.-025-03 Neutron Eroducts, Inc.
Dickerson, Maryland 20753 In accordance-with letter dated September 7,1979, Radioactive Material License tmber MD-31-025-03 is-anended as follows:
To Add rea
- 1.1. S
- 11. H.
n.,Mnactive-raaterial in the Pickce and Kelekot-Barne7 teletherapy units shall ebe-usaa hy or under the supervision _and in the physical presence of Glenn Siebet N
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For the Maryland State Department of Health and Mental
- g. Se i
September 19, 1979 h
j Date Administrator, Community Itealtn Programs owun.30o4 (Supo.) (3/79)
2 pa cMugjo UNITCD STATES
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g NUCLEAR REGULATORY COMf *:SSION g g'4
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l OCT 311980 FCTC: RHO 71-0121 tieutron Products, Inc.
ATTil:
Mr. Carmine Smedira 22301 Mt. Ephraim Road Dickerson, MD 20753 Gentl emen:
Enclosed is Quality Assurance Program Approval for Radioactive Material Packages fio. 0121, Revision lio, 1.
Sincerely, LL Charles E. MacDona d. Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, 11 MSS
Enclosure:
As Stated
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UA NUCLEAR REGULATORY COMMISSION
- 1. APPROV AL Nuus t R NRC FORM 311 0121 OUALITY ASSURANCE PROGRAM APPROVAL nsaa'
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FOR RADIOACTIVE MATERIAL PACKAGES Pursuant to tb Atomic Energy Act of 1954, as amended,the Energy Reorganization Act of 1974, as amended, and Title 10.
Code of Fedeial Regulations, Chapter 1, Part 71, and in reliance on statements and representations heretofore made in item 5 f:-i by the person named in item 2,the Quahty Assurance Program identified in item 5 is hereby apptoved. TK. apptovalis issued to
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satisty the requirements of Section 71.51 of 13 CFR Part 71. This approvalis subject to all applicable rules, regulations, and i....,
orders of the Nuclear Regulatory Commission now or hereafter in etf eet and ta any conditions specified below.
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- a. E mein AT ion o AT t tNAut tieutron Products, Inc.
October 31, 1985 sTattT Acontss
- 4. oocktT Nuwst a 223D1 Mt. Ephraim Road t.:
l stave jziPcoor cerv Dickerson HD 20753 71-0121
- b. QUALITY AESUR ANet PRooR AM APPLICAlloN OAT tt$1 June 24, 1980 and October 17, 1980
- 6. Co NolT ions Activities conducted under applicable criteria of Appendix E of 10 CFR Part 71 to t, d -
is be executed with regard to transportation packages.
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/J d 7t;rn THE U,EL PFCLEAR REGULATORY COMMISSION oATe sioNATunt p/(.tcA)%
g Charles E. MacDonald, Chie,
r s ortation Certificatior. Branch, W 3 1 1930 Division of Fuci Cvele and Material Safety, f4 MSS k
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