ML19210C790

QA Program,Revision 1

ML19210C790
Person / Time
Site:	07100121
Issue date:	10/29/1979
From:	Ransohoff J, Smedira C NEUTRON PRODUCTS, INC.
To:
Shared Package
ML19210C787	List: ML19210C786 ML19210C790
References
NUDOCS 7911200110
Download: ML19210C790 (46)

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QUALITY ASSURANCE PROGRAM FOR NEUTRON PRODUCTS, INCORPORATED REVISION 1 OCTOBER 29, 1979 1373 003 LL ML C. Smedira, Mana er Quality Assuran e

.Ransohoffg p'

President 1G50?

TABLE OF CONTENTS I.

Introduction II.

Company Organization III. Company Operations IV.

General Quality Assurance Approach V.

Specific Quality Assurance Programs VI.

Records VII. Audits 1373 JC4

-- M

. I.

Introduction Neutron Products, Inc. (NPI) was established in 1959 to commercially produce radioisotopes. Activities,f 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 possi~ ole, 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.

The Quality Assurance Program presented in this document 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 the customers of NPI.

II.

Company 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-sible for the radioprocessing and radiation testing operations c:

the company.

Mr. D. L. Repp is the Manager responsible for tae overall plant and equipment.

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. Because of the relatively small size of the company, some personnel, among them the QA Manager, have been assigned multiple responsibilities.

Personnel assignments and responsibilities are presented in more detail in each of the specific quality control programs presented in Section V.

1373 005

NEUTRON PRODUCTS, INC.

BOARD C W. RECTORS J. Ransohoff, M. Turkanis, D. Woodard PRESIDENT J. Ransohoff FINANCE AND ADMINISTRATION QUALITY ASSURANCE D. Lewis - Treasurer C. Smedira F. Kreysa - Secretary Manager SOURCES AND SYSTEMS ITTILIZATION, FACILITIES RADIATION PROCESSING AND EQUIPMENT SERVICES M. Turkanis D. Repp D. Woodard Vice President Manager Vice President RADIOTHERAPY MARKETING CONSTRUCTION IRRADIATIONS D. Baumgardner J. Demory M. Harmon Section Manager Section Manager Section Manager TELETHERAPY SERVICES DICKERSON PLANT CHEMICAL OPERATIONS J. Fogle CONDITION D. Deore c

Section bbnager R. Gerbig Section bbnager Section Manager SOURCE PRODUCTION MARKETING

~

J. Corun FREDERICK PLANT D. Woodard Section Manager CONDITION Section Manager J. Fogle LAMINAR FLOW TECHNOLOGY Section Manager J. Hale Section Manager EQUIPMENT DESIGN AND ASSEMBLY SPECIAL PROJECTS D. Repp J. Demory Section Manager C. Smedira Section Managers FIGURE.

j77 i:i<

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>UO 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.

Maintenance of Teletherapy Units The company is engaged in the business of repairing and reconditioning cobalt-60 teletherapy units currently in use.

3.

Radioprocessirg, The company uses cobalt-60 irradiators to process materials to achieve desired biological, chemical, and physical pro-perties.

Irradiators are also used for testing to determine the effect of radiation on chemical and physical properties 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 Marketing 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.

I3/3 JG7 Radiation 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 Quality 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 organization 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 iniependent 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 train-ing, monitoring, and coordination.

Because of the diverse nature of the various operations of the company, separate subplats 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 appioach is consistent with the general intention of this section.

7

,inq lN UUb Each subplan follows this outline:

Scope 1.

Organization 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 15.

Handling, Storage, Distributing, Shipping, and Installation 16.

Evaluation, Inspection, Test, and Operating Status 17.

Nonconforming Materials, Parts, and Components 18.

Corrective Action 19.

Packaging and Labeling Where a particular scetion is not appropriate to a specific subplan, it is so stated.

V.

Specific Quality Assurance Programs The specific subplans which are contained in this section are:

1.

Cobalt-60 Irrad ation Sources l

1.1 Reactor Target Assemblics 1.2 Radioactive Source Inventory Control 1.3 Radioactive Source Fabrication 1.4 Radioactive Transportation 1.5 Radioactive Source Transfer 2.

Teletherapy Unit Reconditioning 3.

Radioprocessing 3.1 Dose Control Irradiations 3.2 Physical and Chemical Properties Irradiations 3.3 Other Irradiations 4.

Laminar Flow Testing 5.

Product Marketing 13/.3 J07 1.1 Reactor Target Assemblies 1.1.1 Organization Design, fabrication, transport tion, and irradiation of cobalt-60 reactor targets is the respont bility of the Vice President for Sources and Systems. Under the Vice President, the responsible Special Project Section Manager is Mr. C. Smedira, hk. Smedira will be assisted by other company personnel as cppropriate.

A definite distribution of responsibilities between NPI, other contractors, and the reactor operator will be established for each contract and the procedures, specifications, and criteria of a contractor which shall be approved by NPI will be docu-mented in the contract agreement.

1.1.2 Definitions Reactor target assemblies - completed rods, herein called targets, ready for loading into a reactor.

Capsule - a scaled 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.

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 performed 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 inspections in their respective facili-ties. No less than two inspections per year will be performed.

The line organization shall be responsible for cleaning the buildings. Adequate sanitary facilities will be provided.

I3/3 Ji0 1.1.4 Equipment Nondisposable equipment used in the manufacturing process of target components and assemblies shall be cleanable and, if necessary, adjustable. Equipment 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 manufacturing process and not desired in the final product will be removed and such removal shall be documented.

1.1.5 Design Control Tho Special Project Section Panager shall establish and implement methods for controlling design activities to assure that applicable 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 interfacing with other organizations, contractors and the reactor operator to assure compliance with these requirements. A design review to assure that the design meets the design criteria shall be conducted. Represen-tatives 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 docu-ments which may be necessary to describe the design, materials, fabrication, installation, testing, inspection, packaging, shipping and storage requirements of the targets will be prepared at NPI and at other contractor organi::ations.

A specific definition of respon-sibilities for all documentation shall be made.

A method 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 t..e original design.

1.1.6 Procurement Documt.t Control Vei. dors supplying target material and/or capsule material shall comply with NPI Specifications, P-2, Specifications, Procedures, and Quality Control Plan for Tube Type Cobalt Targets, and P-3 Specifications, Procedures, and Quality Control Plan for Clad Wire Type Cobalt Targets.

1373 Jil 1.1.7 Instructions, Procedures, and Drawings All inst 2 actions, procedures, and drawings necessary to assure quality in the fabrication of targets r 4 capsules will be listed in NPI Specification P-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 conformance.

1.1.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Special Project Section Manager and by contractors, as appropriate. These documents shall be submitted to the Vice President for Sources and Systems for approval. Changes to any of these docurnts shall also require his appre ~al.

1.1.9 Control of Purchased Material, Equipment, and Services Independent materials testing and examination of each and every target and capsule shall be performed and the results documented.

1.1.10 Identification and Control of h!aterials, Parts, and Components The Special Project Section Manager shall establish a control 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 Specifications P-2 and P-3.

1.1.11 Special Processes Any individual performing a welding, heat treating,'or nondestruc-tive examination of target components or a forming or melting operation of the components shall be certified by the Special Project Section Manager cr by the contractor's organization.

Nondestructive examination of target components shall be in conformance to NPI Specifications Q-4, X-Ray Inspection (Hollow),

Q-5, X-Ray Inspection (Solid), Q-6, Helium Mass Spectrography Inspection, 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.

1373 012 Periodically, NPI personnel will witness these inspections.

Inspections to be performed by NPI personnel will periodi-cally be witnessed by the Quality Assurance Fhnager or his designee.

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 Measuring and Test Equipment Equipment used to examine targets and capsules shall be con-trolled, calibrated, 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 whien a calibra-tion should be performed.

1.1.1S Handling, Storage, Distributing, Shipping, and Installation largets 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, Procedure 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, Inspection, Test, and Operating Status Target operating status shall be ascertained by the reactor operator via flux level indicators, flowmeters, and thermc-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.

13/3 013

_9_

Nonconforming material shall be stored physically apar: from acceptable material and a list of nonconforming items shall be prepared by the Special Project Section Manager or by con-tractors and provided on a weekly basis to the Vice President for Sources and Systems. The Special Project Section Manager shall make recommendations for appropriate disposition for nonconforming materials. The approval of the Vice President for Sources and Systems is required for any disposition of nonconforming material. Such disposition shall be documented.

1.1.18 Corrective Action The Special Project Section Manager shall document the cause for nonconformance of any items so labeled, lie 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 all radioactive source material inventory belongs to the Vice President for Sources and Systems. Under the Vice President, the responsible individual is the Section Manager for Source Production, Mr. J. Corun.

Mr. Corun will be assisted by other company personnel as appropriate.

1.2.2 Definitions Quality inventory 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-60 sources contained in target rod assemblies.

I3/3 Ji4 Teletherapy sources - singly or doubly encapsulated cobalt-60 teletherapy slugs. Telether py sources acquired from cus-tomers or other suppliers ma? contain cobalt-60 pellets.

Teletherapy slugs - cobalt-60 sources prepared by a melting prccess.

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 raJiation monitors.

1.2.3 Buildings Inventory control facilities shall have adequate space and storage equipment to prevent mixn 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 Equipment Nondisposable equipment used in the handling and calibrating process shall be cleanable and, if necessary, adjustable.

Equipment shall be stored in such a manner to reduce contamination by dust or dirt.

Equipment will be clean when used. Equipment which requires periodic 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, chey shall be calibrated. After calibration, the target rods shall 13/3 J15 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 shall contain information as to source number, source type, date of calibration, activity, date of activity, and source holder number and position. After areas have been run on these traces and activities calculated, the traces shall be stored in notebooks by holder numbers. Changes to these traces can be nade only at the direction of the persons originating the traces. After sources have been sold, the traces for that source shall be pulled and placed in the customer's file.

1.2.9 Control of Purchased Material, Equipment, and Services Not applicable 1.2.10 Identification and Control of Materials, 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-rented. All rod and spring sources shall be calibrated by the underwater pool calibrator or by the hot cell calibrator (in both 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 a,*ivity).

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 source 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 Ass' trance Manager.

1373 Jl6 1.2.13 Test Control Not applicable 1.2.14 Control of Measuring and Test Equipment 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, Shioping, and Installation All incoming target rods shall be handled in accordance with NPI Procedures NR 2001, Procedure for Loading and Removal of Radio-active Shippica Containers from the Main Storage Pool; R 2007, Calibration by \\rea Method; R 5002, Opening Hot Cell Door After Processing Sing,;e and Double Encapsulated Cobalt-60; R 5004, Transfer of Sou :es Between Hot Cell and Canal Tanks; R 5005, Loading of Encapsulated Sources in Transfer and Shipping Con-tainers from Hot Cell; 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 Manager 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 Sourets 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.

1373 017 1.2.18 Corrective Action Each nonconforming source will be evaluated on a case-by-case basis to decide if salvage or disposal is warranted.

1.2.19 Packaging and Labeling All sources shall be uniquely labeled.

1.3 Source Fabrication 1.3.1 Organization Source design and fabrication and equipment ar3 facilities for fabrication, testing, and calibration is the overall responsi-bility of the Vice President for Sources and Systems. He has delegated 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 Prograns and in accordance with all applicable Federal and state regulations.

Teletherapy sources - sources designed specifically for use in medical teletherapy units.

Industrial sources - sources designed specifically for indus-trial use.

Other sources - scurces designed for use other than above.

Hot cell - the shielded enclosure in which the majority of source fabrication operations are performed.

Pool - a pool of diceneralized w;rar used for storage of cobalt-60 sources and for certr.in fabrication operations.

1373 Jl8 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 fo operations and storage of all sources including as received, in w>rk, and finished product. Adequate lighting, ventilation, and temperature control shall be provided to assure the safety of operations, containment of contanination, and inte-grity of the product.

1.3.4 Equipnent All equipment used in the fabrication process and unique building services shall be designed, maintained, and operated to provide safe and functional working conditions, to minimize the spread of radioactive contanination, and to provide a high degree of reli-abilit/ and reproducible accuracy as required.

1.3.S Design Control Not applicable 1.3.6 Procurement Document Control Vendors supplying source encapsulation materials shall supply nanufacturer'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 MPI Specification M-1, Specification for Seamless 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, Eauipment, and Service.s The Source Production Section Manager will initiate and approve all purchases and maintain records of the source inventory.

1373 Ji9 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 stored and identified.

1.3.11 Special Processes Fabrication of sources is a special process which will be performed in accordance with NPI <pecifications 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 bbnager.

1.3.12 Inspection Inspection of all critical operations wi. i be in accordance with NPI Specification P-1, Specifications, Procedures, and Quality Centrol for Sealed Cobalt-60 Sources.

1.3.13 Test Control All sources shall be tested for quality and integrity in accordance with NPI Specification P-1.

1.3.14 Control of Measuring and Test Equipment Equipment for calibrating and measuring shall be in accordance with NPI Procedure R 2007, 1.3.15 Handling and Storage Source handling and storage shall be in accordance with NPI Procedure R 2003.

1.3.16 Evaluation, Inspection, Test, and Operating Status Not applicable 1.3.17 Nonconforming Materials All nonconforming source 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 regarding disposal or salvage on a case-by-case basis.

I373 J20 1.3.19 Packaging and Labeling All teletherapy finished sources shall be uniquely identifiable.

Packaging for shipment shall be in accordance with Section 1.4 of this document.

1.4 Radioactive Materials Transportation 1.4.1 Organization Design, fabrication, and maintenance of radioactive material shipping containers and transportation of radioactive shipments is the respon-sibility of the Vice President of Sources and Systems.

Transportation equipment design, fabrication, and maintenance is the responsibility of the Manager of Utilization, Facilitics, and dquipment, Mr. D. L. Repp.

1.4.2 Definitions Quality packaging - the loading of radioactive materials in a NPI or other organization's shipping container for shipment in conformance with applicable regulatory requirements, and comple-tion of the documentation of this activity in accordance with the requirements of this section.

Off site location - a location other than Dickerson at which a radioactive shipment controlled by NPI may originate.

Quality transportation - the safe and efficient carrying of radio-active materials from one site to another in accordance with applicable requirements and the completion of documentation of this activity.

Radioactive materials shipping container - herein called container, is one complying with the applicable regulations of the DOT and NRC.

1.4.3 Buildings Buildings in which shipping containers are stored or handled shall have adequate space for cleaning, maintaining, and orderly handling of incoming and outgoing shipments. Airborne contamination shall be minimized and monitored in facilities which have encapsulated radioactive materials.

Inspections of the building conditions shall be performed periodically and the results recorded.

I373 J21 1.4.4 Equipment E.,aipment used in handling and vehicles used for transporting con-tainers shall be stored in such a manner as to maintain an adequate condition for use. Shipping containers, overpacks, special handling equipment, instruments, and tools will be maintained by the Tele-therapy Services Section bianager. Vehicle maintenance is the responsibility of the user.

1.4.5 Design Control The blanager of Utilization, Facilities, and Equipment is responsibic for the design of containers and handling equipment. When additional transportation equipment design is required, he shall establish pro-cedures to assure that applicable design criteria, standards, prac-tices, and regulatory requirements are defined and translated into specifications, drawings, procedures, and instructions. He shall establish and implement a method for coordinating with other organ-i:ations and contractors.

A design review to assure that the design maets the design criteria shall be conducted.

1.4.6 Procurement Document Control Vendors or contractors supplying shipping containers, handling equipment, and parts shall comply with NPI Specification E-1, Equipment Specification for a Lead Shielded Shipping Cask or other appropriate specification. Control of procurement documents shall be the responsibility of the bfanager of Utilization, Facilities, and Equipment.

1.4.7 Instructions, Procedures, and Drawings See Section 1.4.8.

Periodic audits to check for conformance to these documents will be conducted by the QA blanager er his designee.

1.4.8 Document Control Instructions, procedures, drawings, and specifications for containers, container handling, packaging and shipping are listed in and shall comply with NPI QC Procedure 1001. Responsibilities for the initia-tion and approval of these documents are specified in this procedure and no changes to these documents shall be made without the approval of the same people who initially approved these documents.

1.4.9 Control of Purchased F!aterial, Equinment, and Services The blanager for Utilization, Facilities, and Equipment shall be responsible for prc urement and control of purchased material, equipment, and services.

!3/3 J22 1.4.10 Identification and Control of b!aterials, Parts, and Components The Vice President for Sources and Systems shall be responsible for the proper identification and sontrol of materials, parts, and com-ponents associated with the fabrication of radioactive shipping con-tainers.

1.4.11 Special Processes Loading and unloading containers for radioactive shipments are special processes. These shall be performed in accordance with NPI QC Program 1003, Package Loading Procedure for Radioactive b!aterials and QC Program 1004, Package Unloading Procedure for Radioactive b!aterials.

1.4.12 Inspection See Section 1.4.16 below.

1.4.13 Test Control Not applicable 1.4.14 Control of b'easuring and Test Equipment Not applicable 1.4.1S Handling, Storage, Distribution, Shipping, and Installation All operations concerning handling, storage, and shipping shall be in accordance with NPI QC Program 1005, Handling, Storage, and Shipping Procedure for Shipment of Radioactive bfaterials.

1.4.16 Evaluation, Inspection, Test, and Operating Status The evaluation, inspection, and test requirements are listed in NPI QC Program 1006, Inspection, Testing, and Operating Status Procedure for Shipping of Radioactive bfaterials.

1.4.17 Nonconforming Parts Any nonconforming pr.rts will be so identified and segregated for disposal or removal from the container or shipping areas.

1.4.18 Corrective Action Repair or replacement of nonconforming parts or the correction of other deficiencies shall be reccamended by the Source Production 1373 023 Section Manager, the Manager for Utilization, Facilities, and Equipment, or the Health Physics Technician, and must be approved by the Vice President of Sources and Systems.

1.4.19 Packaging and Labeling All NFI radioactive shipments shall be packaged and labeled in accordance with NPI QC Program 1003.

1.5 Radioactive Scurce Transfer 1.5.1 Organi ation The Vice President for Sources and Systems has the overall respon-sibility for radioactive source transfers.

The loading and unloading of radioactive shipping containers and the preparation for shipment at NPI is the responsibility of the Source Production Section Manager.

Loading, unloading, and prepa-ration for shipnent offsite is the responsibility of the Teletherapy Services Section Manager who is also responsible for installation of sources into teletherapy units.

Design and fabrication of source adapters which are installed in a teletherapy unit is the responsibility of the Source Production Sectio 1 Manager. Design and fabrication of container insert holders and adapters which are part of the transfer operation are the respon-sibility of the Utilization, Facilities, and Equipment Manager.

1.5.2 Definitions Radioactive source transfer - the field operation inv>1ving 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 naintenance.

Teletherapy unit - a nachine using cobalt-60 at a distance for radiation therapy.

Quality radioactive source transfers - transfers made in accordance with the procedures referenced herein.

1373 024 1.5.3 Buildings Not applicable 1.5.4 Equipment Shipping containers, overpacks, 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-ment documents cssociated with equipment or services in support of any radioactive source transfer operation.

1.5.7 Instructions, Procedures, and Drawings 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, Equipment, and Services Control of purchased material, equipment, and services for source adapters installed in a teletherapy unit shall be the responsibility of the Source Production Section Manager. Control for parts used in transfer of sources shall be the responsibility of the Teletherapy Services Section Manager.

1.5.10 Identification and Control of Materials, Parts, and Components The Teletherapy Services Section Manager shall be responsible for all materials, parts, and components used in making equipment for radioactive source transfers.

I373 025 1.5.11 Special Processes Source replacement in the field is a special process and shall be performed only by trained and licensed personnel.

1.5.12 Inspection Routine inspection of containers, equipment, instruments, tools, and parts shall be conducted by the Teletherapy Services Section Manager. Transportation vehicles shall be inspected by the quality Assurance Manager or his designee.

1.5.13 Test Control Not applicable 1.5.14 Control of Measuring and Test Eauipment 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 Handling, 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 vill be segregated and identified for disposition.

1.5.18 Corrective Action In the event thet 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.

13/3 JZ6

% 1.S.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 Organization Reconditioning of teletherapy units is the overall responsibility of the Vice President for Sources and Systems. The Teletherapy Services Secticn Manager is responsible for accomplishment of this work.

2.1.2 Definitions Teletherapy unit - a machine 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 Maintaining Cobalt-60 and Cesium-137 Teletherapy Equipment," N449-1974 2.1.3 Buildings The buildings in which teletherapy units and components are reconditioned shall have adequate working space, with appropriate lighting and ventilation systens 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.

13/3 JZ7 2.1.4 Equipment Reconditioning and installation equipment and tools shall be main-tained by the Teletherapy Services Section blanager. Responsibility for the maintenance of vehicles shall be with the Teletherapy Ser-vices Section blanager.

Equipment purchased for replacement items shall be the responsi-bility of the Teletherapy Services Section b!anager.

2.1.5 Design Control Not applicable 2.1.6 Procurement Document Control Documentation of procurements for materials or componev.s for recon-ditioning teletherapy units shall be the responsibility of the Tele-therapy Services Section b!anager.

2.1.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings required for recondition-ing, shipping, and installation shall be in accordance with NPI Procedure R 5010*.

Periodically audits will be conducted to check for conformance.

2.1.8 Document Control All documents relating to reconditioning, instructions, procedures, drawings, and specifications shall be controlled by the Teletherapy Services Section b!anager and shall have the approval of the Vice President for Sources and Systems. Changes to these documents shall require his approval.

2.1.9 Control of Purchased hfaterial, Equipment, and Services The Teletherapy Services Section olanager shall be responsible for procurement of purchased materiel, equipment, and services.

2.1.10 Ident'fication and Control of b!aterials, Parts, and Components The Teletherapy Services Section blanager shall establish and main-tain a clean area in which parts for reconditioning teletherapy machines are stored and labeled.

• New procedure, not yet written kJo b Jf d

- 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 irspection 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 necessary to assure that an installed unit has not suffered damage in transport.

2.1.14 Control of Measuring 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 on which it was done, and the next date on which a calibration should be performed.

2.1.15 Handling, Storace, Distribution, Shipping, 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 Procedure R 5010.

2.1.17 Nonconforming Parts Parts from existing teletherapy units and/or purchased parts found to be 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 13/3 JZ9 the Vice President for Sources and Systems and the QA Manager.

The Vice President for Sources and Systems shall make the deter-mination of appropriate corrective action.

2.1.19 Packaging and Labeling Reconditioned teletherapy units shall be packaged for transit and transported by truck.

A reconditioned unit shall be appropriately labeled.

3.1 Dose Control Irradiations 3.1.1 Organization The Vice President for Radiation Processing Services, Mr. D. G.

Woodard, has the responsibility for all activities required to perform dose control irradiations. This responsibility has been delegated to the Irradiations 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 qualified operators are available to run these machines.

3.1.2 Definitions Quality - A quality dose control irradiation is one which was conducted in accordance with the requirements of this section and which delivered a dose (from cobalt-60) to a product in the range specified on the purchased 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.

3.1.3 Buildings For any operation or processing campaign, sufficent space shall be provided to facilitate adequate cleaning, prevent mixups, and to assure the orderly handling of incoming material, rejected material, material in the irradiation process, and testing and measuring equipment. Adequate space to perform dosimetry measure-ments will be provided as will sufficient lighting, ventilation, and temperature control. Airborne contemination (principally from o:one, as a result of radiolysis of air) shall be kept within 13/3 J30 acceptable industrial standards.

Inspections of the building condition shall be periodically performed and the results of these inspections shall be recorded. The NPI quality assurance organi-zation shall be responsible for the performance and documentatien of these inspections. No less than two inspections per year will be performed. The line organization shall be responsible for cleaning the process areas. Sanitary facilities will be provided.

3.1.4 Equipment Nondisposable equipment used for handling, irradiation, and shipping shall be cleanable and, if necessary, adjustable.

Equipment shall be stored in such a manner to reduce contamination by dust or dirt or the accummult. tion of chemicals.

Equipment will be clean when used. Equipment which requires periodic adjustment shall have allowable tolerances posted where the equipment is stored or used.

3.1.5 Design Control Not applicable 3.1.6 Procurement Document Control Not applicable 3.1.7 Instructions, Procedures, and Drawings 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 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Irradiations Section Manager. These documents shall have the approval of the Vice President for Radiation Pro-cessing Services. Changes to any of these documents shall also require his approval.

3.1.9 Control of Purchased Material, Eauipment, and Services Control of materials, equipment, and services shall be the respon-sibility of the Irradiations Section Manager.

13/3 J3!

3.1.10 Identification and Control of Materials, Parts, and Components Materials, parts, and components required for irradiation, except cobalt-60, shall be stored and identified by the Irradiations Sec-tion Manager.

3.1.11 Special Processes Not applicabic 3.1.12 Inspection Product dosimetry shall be the principal means of inspection.

Dosimetry shall be performed in accordance with Irradiator Operat-ing Instructions, Processing Dosimetry. Products determined to be nonconforming to the customer's specifications shall be tagged accordingly and stored physically separate from acceptable material.

The Irradiations Section Manager shall document all nonconformances and bring them to the attention of the Vice President of 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 />.

3.1.13 Test Control Not applicable 3.1.14 Control of Measuring and Test Equipment Dosimetry equipment will be used to ascertain uniformity and/or levels of radiation doses. This equipment will, at a minimum, consist of an optical density reader and a thickness gauge.

These items will be examined to determine if periodic calibration is required. Calibration will be performed per NPI Instruction, Calibration of Far West Dosimeters.

Periodic 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 cali-bration should be performed.

3.1.15 llandling, Storage, Distributing, and Shipping For each product handled by NPI, a specific instruction is prepared which documents the company's methods for controlling customer prod-ucts during handling, storage, and shipping.

1373 J32 3.1.16 Evaluation, Inspection, Test and Operating Status Operation of the irradiators shall be in accordance with NPI Pro-cedures NPI R 6001 and R 7003.

3.1.17 Nonconforming bbterials, Parts, and Components Not applicabic 3.1.18 Corrective Action In the event that dosimetry reveals that a product has not received the required dose, this fact shall be documented and reported to the Vice President for Radiation Processing Services and the QA Manager.

The Irradiations Section bbnager shall determine and document the cause of the problem. Upon obtaining the approval of the Vice Presi-dent for Radiation Processing Services, he shall reirradiate or return the product as appropriate.

3.1.19 Packaging and Labeling Incoming and irradiated products shall be labeled in accordance with specific instructions.

3.2 Physical and Chemical Properties Irradiations 3.2.1 Organization See Section 3.1.1.

The Operations Section Manager, Mr. D. Deore, has the 21.( onsibility for laboratory work necessary to determine required doses and to ascertain the quality of the product.

3.2.2 Definitions Quality - a quality physical or chemical property irradiation is one which was conducted in accordar.cc with the requirements of this section and which results in a product which has achieved the physical and chemical properties specified on the purchase order received from the customer.

Irradiators - See Section 3.1.2 3>-

3

)O3 3.2.3 Buildings See Section 3.1.3.

Appropriate laboratory space shall be provided for product sampling and testing.

3.2.4 Equipment See Section 3.1.4.

3.2.S Design Control Not applicable 3.2.6 Procurement Document Control Not applicable 3.2.7 Instructions, Procedures, and Drawings 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 Manager for activities associated with running the irradiators and by the Operations Section Manager for laboratory support activities. These documents shall have the approval of the Vice President fer Radiation Processing Services and by the Quality Assurance Manager.

Change to any of these documents shall also require their approval.

3.2.9 Control of Purchased Material, Equiprent, and Services See Section 3.1.9.

3.2.10 Identification and Control of Matel_als, Parts, and Components See Section 3.1.10.

3.2.11 Special Processes 1373 J34 Not applicable 3.2.12 Inspection Properties testing shall be the principal means of inspection.

Testing shall be performed in compliance with written instruc-tions.

Dosimetry shall be performed in accordance with Irradiator Operat-ing Instructions, Processing Dosimetry.

Products determined to be nonconforming to the customer's specifications shall be tagged accordingly and stored physically separate from acceptable material.

The Operations Section Manager shall document all nonconformances and bring them to the attention of the Irradiations Section Manager and the Vice President for Radiation Processing Services within 24 hoars.

3.2.13 Test Control See Section 3.2.12.

3.2.14 Control of Measuring and Test Equipment Laboratory equipment necessary for sampling and testing of products shall be available and the Operations Section Manager shall deter-nine if periodic adjustments or calibrations are required.

Labora-tory equipment 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 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.

3.2.15 Handling, Storage, Distributing, and Shipping See Section 3.1.1S.

3.2.16 Evaluation, Inspection, Test, and Operating Status See Section 3.1.16.

3.2.17 Nonconforming Materials, Parts, and Components Not applicable

/7 93/3 d))

i 3.2.18 Corrective Action The Operations Section Manager and the Irradiations Section Manager shall recomnend in writing to the Vice President for Radiation Pro-cessing Services and the QA Manager:

- an appropriate disposition for nonconforming products;

and,

- the likely cause of the nonconforniance.

The Vice President for Radiation Processing Services shall make the determination of the final disposition.

3.2.19 Packaging and Labeling Incoming and irradiated products shall be packaged and labeled in accordance with specific instructions.

3.3 Other Irradiations 3.3.1 Organization The Vice President for Radiation Processing Services has the overall responsibility for all irradiations conducted at NPI's facilities.

He has delegated the responsibility for the day-to-day operations of the irradiators to the Irradiations Section Manager, the responsibility for laboratory support activities for irradiations to the Chemical Operations Section Manager, and the responsibility for planning specialized irradiations to the Section Manager for Radiation Processing Research and Development.

3.3.2 Definitions Quality - A quality irradiation is one which was conducted in accor-dance with the requirements of this section (m.' 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.

3.3.3 Buildings See Section 3.2.3.

-f b

/

j

• New procedure, not yet written 3.3.4 Equipment See Section 3.2.4.

Equipment requirements for any special irradia-tion shall be specified in accordance with NPI Procedure R 2013, 3.3.3 Design Control The Radiation Processing Research and Development Section Manager or other designee specified per NPI Procedure R 2013, will assure that special irradiations or tests are designed in accordance with the previously specified requirements. He shall also establish and im-plement a method for coordinating and interfacing with customers or other organizations as may be necessary. A design review to assure that the proposed test or irradiation meets the established require-ments will be conducted. Representatives of other organizations (such as a customer) may participate in this review.

A method 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 measures commensurate with those applied to the original design.

3.3.6 Procurement Document Control Customer supplied material shall be in accordance with NPI Procedure R 2013.

3.3.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings necessary to specify tests and assure quality of subsequent irradiation shall be prepared in accordance with NPI Procedure R 2013. Periodically audits shall be conducted to check for conformance and the results recorded.

3.3.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Section Manager for Radiation Processing Research and Development or by another section manager specified by the Vice President for Radiation Processing Services. These documents shall have the approval of the Vice President for Radiation Processing Services. Changes to any e" these documents shall also require his approval.

3.3.9 Control of Purchased Material, Equipment, and Services Responsibility for control of material, equipment, and services shall be specified in accordance with NPI Procedure R 2013.

!3/3 J37 3.3.10 Identification and Control of Materials, Parts, and Components Materials, parts, and components re m* red for irradiation, except cobalt-60, shall bc. ored and i

.t3 4 by the section manager designated by the Vice Pres 2ent tor Ra.- ation Processing Services.

3.3.11 Special Prc. sses Since all of the processc. de.=ignated under this Section 3.3 are in essence special processes, this section is not applicabic.

3.3.12 Inspection Product dosimetry and properties testing as cppropriate 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 responsible section manager shall document all nonconformances 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 />.

3.3.13 Test Control Not applicable 3.3.14 Control of Measurint and Test Equipment See Section 3.2.14.

3.3.15 Handling, Storage, Distributing, Shipping, and Installation Additional instructions or requirements for handling, storage, and shipping may be specified in accordance with NPI Procedure R 2013.

3.3.16 Evaluation, Inspection, Test, and Operating Status Operation of irradiators shall be in accordance with NPI Procedures R 6001 and R 7003. Additional operational procedures may be required in accordance with NPI Procedure R 2013.

3.3.17 Nonconforming Materials, Parts, and Components Not applicabic 3.3.18 Corrective Action In the event that dosimetry or physical and/or chemical properties testing reveals that a product has not received the required dose i373 J38 or other specified environmental condition, this fact shall be documented and reported to the Vice President for Radiation Pro-cessing Services and the QA Manager. The responsible section manager shall recommend to them in writing:

- An appropriate disposition for nonconforming products; and,

- The likely cause of the nonconformance.

The Vice President for Radiation Processing Services shall make the dets.,ination of the final dispo=ition.

3.3.19 Packaging and Labeling Incouing and irradiated products shall be packaged and labeled in accordance with specific instructions.

4.1 Laminar Flow Testing 4.1.1 Organization The Vice President for Sources and Systems is responsible for NPI laminar flow testing activities. He has delegated this responsi-bility to the Laminar Flow Technology Section Manager, Mr. J. P.

Hale.

Mr. Hale will be assisted by other company personnel as ap-propriate.

4.1.2 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-in a confined area essentially moves with uniform velocity along parallel flow lines.

Quality laminar flow testing program - one which accurately examines laminar flow equipment for compliance with the manufacturer's specifications and the appropriate criteria of Federal Standard No. 209B.

4.1.3 Buildings Not applicable/} ]}} 4.1.4 Equionent Nondisposable equipment used in the examination and testing program shall be cleanable and, if necessary, adjustable. Equipment shall be stored in such a manner to reduce contamination by dust or dirt. Equipment will be cican when used. Equipment which requires periodic adjustment shall have allowable tolerances posted within the equip-ment storage boxes. The Laminar Flow Technology Section Manager shall prepare and keep current ca?ibration procedures for all equipment which requires periodic calibration. 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 calibration should be performed. 4.1.5 Design Control Not applicable 4.1.6 Procurement Document Control Not applicable 4.1.7 Instructions, Procedures, and Drawings NPI personnel shall conduct all laminar flow testing work in accor-dance with NPI Procedure 10001, Standard Procedure for In-Place Integrity Inspection and Testing of Horizontal and Vertical Laminar Flow Hoods. Occasionally, audits may be conducted to check for conformance. 4.1.8 Document Control All instructions, procedures, and specifications for the laminar flow testing program shall be issued by the Section Manager for Laminar Flow Technology. These documents shall have the approval of the Vice President for Sources and Systems and the Quality Assurance Manager. Changes to any of these documents shall also require their approval. 4.1.9 Control of Purchased hhterial, Equipment, and Services A qualitative and, whenever possible, a quantative evaluation of installed HEPA filter performance shall be made on the Field Ser-vice Inspection Report. The Section Manager for Laminar Flow Tech-nology shall examina these reports once every calendar quarter to determine if purchased HEPA filters have becu in compliance with NPI procurement specifications. 1373 RU 4.1.10 Identification and Control of Materials, Parts, and Comnonents Materials and parts used in the laminar flow testing program shall be stored either in the service 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 laminar flow testing program. 4.1.14 Control of Measuring and Test Equipment See Section 4.1.4. 4.1.15 Handling, Storage, Distributing, Shipping, and Installation Equipme.at and replacement parts are stored and transported by vans. Maintenance of the van is the responsibility of the Laminar Flow Technology Section Manager. 4.1.16 Evaluation, Inspection, Test, and Operating Status For each unit serviced, the NPI !ield Service Inspection Report shall be completed. The original shall be given to the customer and one copy shall be kept in NPI company files. 4.1.17 Nonconforming Parts Incoming material identified as nonconforming to any NPI specifi-cation shall be tagged accordingly. Nonconforming material shall be stored physically separate from acceptabic material and appro-priately disposed of by the Laminar Flow Technology Section Manager. 4.1.18 Corrective Action When a nonconforming item is disposed of, the Laminar Flow Technology Section Manager will document this disposition and the reasons 1373 J41 therefore in a note to the laminar flow files, with a copy to the QA Manager. 4.1.19 Packaging 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 Marketing 5.1.1 Organization The President of Neutron Products, Inc. is reponsible for marketing of all NPI products. He may be assisted by other company personnel as appropriate. 5.1.2 Definitions Quality product marketing - 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 han ' ling of NPI marketed products shall have sufficient space to facilitste adequate clean-ing, prevent mixups, and to assure the orderly handling of inconing material, rejected material, material in the fabrication process, and testing and measuring 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 inspections in their respective facilities. No less than two inspections per year will be performed. Sanitary facilities will be provided. 5.1.4 Equipment Nondisposable equipment used in the manufacturing process of NPI marketed products shall be cleanabic and, if necessary, adjustable. 1373 J42 Equipment shall be stored in such a manner to reduce contamination by dust or dirt. Equipment will be cican then used. Equipment which requires periodic adjustment shall have allowable tolerances posted where the equipment is stored or used. Material.s used in the manufacturing process and not desired in the final product will be removed and such removal documented. Mea-suring equipment will bc examined to determine if periodic calibra-tic,n 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 Design Control For any product which NPI markets there shall be a specific distri-butorship agreement written in which the specifications of the product to be marketed are clearly and completely delineated. Any changes to this specification or distribution shall require the approval of the QA Manager. 5.1.6 Procurement Document Control The manufacturer shall have definite npecificatior.s for all purchased material. The distributorship agreement between the manufacturer and NPI shall state which, if any, of these 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 marketed by NPI will be listed in the manufacturers' specifications. NPI shall have access to these specifications and shall be allowed to conduct periodic audits to check for conformance. 5.1.8 Document Control The manufacturer shall assure that all instructions, procedures, drawings, and specifications are controlled by a sufficiently high 1cvel of management and shall warrant that changes to any of these documents will not occur without the same level of management approval. l !) jl3 5.1.9 Control of Purchased Material, Eauipment, and Services The manufacturer shall inform NPI of all testing and examination activities which he corducts to ascertain the condition of pur-chased material, equipment, and services. 5.1.10 Identification and Control of Materials, Parts, and Components The manufacturer shall establish control areas in which all materials, parts, components, and completed products are stored and labeled. NPI shall have the right to inspect for conformance to this method. 5.1.11 Special Processes Special manufacturing 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 performed. 5.1.12 Inspection Manufacturer's inspection methods shall be provided to NPI. 1;PI personnel may witness these inspections. 5.1.13 Test Control The manufacturer shall specify to NPI the way in which the products are tested to assure suitability for application. NPI personnel may witness these tests. 5.1.14 Control of Measuring and Test Ecuipment 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 Handling, Storage, Distribution, Shinping, and Installation Handling, storage, distribution, shipping, and installation shall be in accordance with the distributorship agreement between the manufacturer and NPI. 5.1.16 Evaluation, Inspection, Test, and Operating Status NPI shall monitor, as appropriate, performance of all products dis-tributed by NPI. A performance record for all products marketed by 1373 J44 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 perfomance will either be dropped from further marketing or actions taken to improve the product quality. 5.1.17 Nonconfoming Parts The manufacturer shall identify and tag parts which do not confom to written specifications. Nonconfoming material shall be stored physi-cally separate from acceptable material and a list of nonconforming items shall ?3 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 detemine the cause for recurring non-conformances. He shall document actions taken to correct such pro-blems. This information shall be available to NPI 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 organizations 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 availabic to company management as evidence of the workings of the QA program. The following documents are planned to be controlled: 1. Quality Assurance Program 2. Procurement Documents 3. Procedures 4. Instructions 5. Drawings 6. Specifications 7. Design Review Reports 8. Contract Agreements 9. Inspections l)[) JQ] 10. Installations 11. Dosimetry Records 12. Health Physics Records 13. Radioactive Respiratory Protection Program 14. NPI's Program for Radiation Protection of Employee Exposures IS. NRC Cask Use Certificates 16. Road Use Certificates 17. Truck Drivers' Logs (Form b!CS-59) 18. Vehicle Inspection and b!aintenance Records 19. Annual Review of Drivers' Driving Record 20. Daily Reports of Vehicle's Condition 21. Reports cf Accidents (Forms b!CS 50-T and b!CS 50-B) 22. Radioactive Shipment Record 23. Personnel Qualification Approval and Certification Records 24. Shipping Package b!aintenance Schedule and Authorization 25. Shipping Package b!odification Authorization 26. b!edical Device Description for Reconditioned Teletherapy Units 27. Device b! aster and Hisotry Records for Sources 2S. Customer Complaint Files 29. Calibration Records 30. Component Control and Nonconformance Records These documents shall include records of the acceptante or rejection of all components used in target and source manu-facture, 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. 31. Equipment / Maintenance Records These records shall include a description of the piece of equipment used or in operation, along with any modifications or adjustments, and shall document the performance and neces-sary maintenance schedules. 32. Driver Qualification Record Records required to be maintained pursuant to Federal biotor Carrier Safety Regulation 391.51. This file shall include: - The medical examiner's certificate of the driver's physical qualification to drive a motor vehicle or a legible photographic copy of the certificate; - A letter granting waiver of a physical disqualifica-tion, if a waiver was issued. 1373 046

- The memorandum on the annual review of the driver's 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 saft'y; - 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 number, and the identification number, type, and issuing state of his motor vehicle operator's license. 33. Device Distribution Records 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. 34. QA Audit Reports The above records shall be maintained at the NPI facilities and shall be reasonably accessible, many on a proprietary basis, to government employees designated to perform inspections. All shipping package design related ecords shall be maintained for at Icast two years. VII. Audits Audits of the Quality Assurance Program will be dependent on the significance of the activity being audited. Audits shall include !3/3 J47 an evaluation of the shipping and manufacturing practices and/or procedures, and shall be concerned with the safety and effective-ness of their implementation. Audits shall be planned and include the monitoring of operations and activities, review of pertinent documents and their control and maintenance. Audit procedures will be established prior to conducting an audit and shall stress the safety aspects of the package or device. Audits shall be performed at least twice a year with spot checks as deemed 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 shal: be performed 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 shall be maintained by the QA Manager and reported to the President along with any suggestions of recom-mendations for improvement. In the event that deficient areas are located, they shall be re-audited on a timely basis to verify implementation of corrective actions. 13/3 x3 1ec? -}}