ML19339B839
| ML19339B839 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 10/16/1980 |
| From: | Ransohoff J, Smedira C NEUTRON PRODUCTS, INC. |
| To: | |
| Shared Package | |
| ML19339B838 | List: |
| References | |
| 17647, NUDOCS 8011100249 | |
| Download: ML19339B839 (15) | |
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l QUALITY ASSURANCE PROGRAM FOR NEUTRON PRODUCTS, INCORPORATED
- J REVISION 4 OCTOBER 16, 1980 C-Carmine Smedira, Manager Quality Assurance Ot/WhY \\M J. h. Ransohoff 11 N
President V
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4 III. Company Oomations 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 replacemer.t.
2.
Maintenance of Teletherapy Units The company is engaged in the business of repairing and reconditioning cobalt-60 telath-rapy units currently in use.
3.
Radiation Processing The company uses cobalt-60 irradiators to process materials C..
perties and.in conjunction with a chemical mix plant, to to achieve desired biological, chemical, and physical pro-p,toduce a grouo of polymeric products largelv based on ac,tulanide.
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, terting, and rotitine 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 - TMs attachment to teletherapy units allows finer co111mation of the radiation beams during therapy.
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PRM 80 - Radiation' Therapy Computer and treatment verification system.
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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. Repp Laminar Flow Technology J. Adkinson Manager l
Finance and Administration Quality Assurance and F. Kreysa, Secretary Special Projects D. Lewis, Treasurer C. Smedira, Manager Sources and Systems Radiation Processing M. Turkanis D. Woodard i
Vice President Vice President Figure 1 l
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Radiation Detectors - The company sells the Primalert-10 Radiation Level Monitor and the optional Primalarm remote signal unit.
Biotest Air Sampler - An air sampler which measures bacteria content in the air in a specific location.
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 S 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 applicat on of these guidelines to company activities. The formal QA approach presented in this document consists of the following key elements:
Planning - what to de to provide quality Judgement - to determine what should be verified and/or documented f:
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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 organizatien has the responsibility for the planning, -
judgement, execution, and acumentation activities. The QA Manager participates and concurs in these activities and has the responsibility for auditing tasks.
In view of NPI's si:e, 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 train-ing, monitoring, and coordination.
Because,of the diverse nature of the various operations of the ecmpany, separate subplans for quality assurance have been genersted 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 general intention of this section
. Each subplan follows this outline:
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.
"ocument Control S.
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 IS.
Corrective Action 19.
Packaging and Labeling Where a particular section is not appropriate to a specific subplan, L
it is so stated.
V.
Specific 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 Radicactive Source Fabrication 1.4 Radioactive Materials Transportation 1.5 t
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Teletherapy Unit Reconditioning 3.
Radiation Processing 3.1 Dose Control Irradiations 3.2 Physical and Chemical Properties Irradiations l
3.3 Polyac,1f amide Ptodaction 3.4 Other Irradiations 4.
Laminar Flow Testing 5.
Product Marketing
-S-Periodically, NPI persennel will witness these inspections.
Inspections to be performed by NPI personnel will periodi-cally be witnessed by the Quality Assurance Manager 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 Eauipment 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 of which a calibra-tion should be performed.
1.1.lS Handling, Storage, Distributing, Shinping, and Installation 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 thermo-couples. Acceptable flux and temperature levels for each target shall be specified prior to irradiation.
Upon receipt of the irradiated target, NPI personnel shal'1 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 sp6cification shall be tagged acccrdingly.
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Nonconforming material shall be stored physically apart from acceptable material and a list of nonconforming items shall be prepared by the Vice Pruidertt for Scu,1ces and Sys.tems or by contractors and provided on a weekly basis to the QuaEty Assutance Managet. The Vice P.tesident for Sowtce.s and Systems shall make recoi::mendations for appropriate disposition for nonconforming materials. The approval of the QA Manager is required for any disposition of nonconforming material. Such disposition shall be documented.
1.1.18 Corrective Action The Vice President for Scwtces and Sys.tems 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 I.abeling All targets and capsules shall be uniquely identifiable.
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1.2 Radioactive Source Inventory Control l
1.2.1 Organization The responsibility for the characterization and maintenance of all radioactive source material inventory has been delegated 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 Inventory quality control program - one which (1) c'ontinually and accurately records the identity, location, and activity of_ all individual source material; (2) is conducted in eco-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.
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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 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
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source activity calibrations.
1.2.4 Ecuipment 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 Desien Control Not applicable l
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
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! 1.2.13 Test Control Not Applicable.
1.2.14 Control of Measuring and Test Eouipment The industrial source calibrations 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.
1.2.1S 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 2003, General Procedure for In Pool Scurce Operations; NR 2005, Pro-cedure for Decanning Cobalt-60 Sources from Zircaloy Tubes; R 2007, Calibration by Area Method; NR 2008, Procedure for Placing and Unloading Casks in the Main Storage Pool; 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 S005, Loading of Encapsulated Sources in Transfer and Shipping Containers from Hot Cell; and, NR 5007, Processing Exposed Cobalt-60.
Target rods shall be stored in the main storage pool.
1.2.16 Evaluation, Insuection, 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 Sources and Systems.
f 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 disposition.
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. 1.2.18 Corrective Action Each nonconforming source will be evaluated on a case-by-case basis to decide if salvage or disposal is warran+-d.
1.2.19 Packaging and Labeling All sources shall be uniquely identifiable.
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-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
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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 with all applicable Federal and state regulations.
Teletherapy sources - sources designad specifically for use in medical teletherapy units.
Industrial sources - sources designed specifically for indus-trial use.
e Other sources - sources 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 'di=enerali:ed water used for storage of cobalt-60 sources and for certain fabrication operations.
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. 1.3.10 Identification and Centrol of Materials, Parts, and Cocoonents The Source Production Section Manager shall establish a control area where all encapsulation =aterials are stored and identified.
1.3.11 Special Processes Fabrication of sources is a special process which will be performed in accordance with NPI Specifications P-1, P-3 and P-4.
Changes to these specificaticus 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 NPI Specification F-1, Specifications, Procedures, and Quality Control for Sealed Cobalt-60 Sources or P-4, Procedure for Encapsu-lation of Teletherapy Sources.
i 1.3.13 Test Centrol All sources shall be tested for quality and integrity in accordance with NPI Specification F-1, Specifications, Procedures, and Quality Control for Sealed Cobalt-60 Sources, or P-4, Procedure for Encapsu-lation of. Teletherapy Sources.
1.3.14 control of Measuring and Test Ecuienent Equipnent for calibrating activity in industrial sources shall be in accordance with NPI Procedure R 2007, Calibration of Effective Activity by Area Method.
- l. 3. 15 Handling and Storage Source handling and storage shall be in accordance with NPI Procedures NR 2002, Procedure for Dry Transfer of Sources from Pool to Hot Cell, R 2003, General Procedure for In-Pool Source Operations, NR 2005, Procedure for Decanning Cobalt-60 Sources from Zircaloy Tubes, R 2006,-
leak Testing in the Pool, R 2007, Calibration of Effective Activity by Area Method, R 4000, Procedure for Canal Operations, R 5001, General Procedure for' Hot Cell Operations, NR 5002, Opening Hot Cell Door Af ter Processing Single and Double Encapsulated Cobalt-60, NR 5003, Opening Hot Cell Door Af ter Processing Exposed Cobalt-60, R 5004, Transfer of Sources Between Hot Call and Canal Tanks, R 5006, Processing Single and Double Encapsulated Cobalt-60 Sources, and NR 5007, Procedure for
. Processing Exposed Cobalt-60.
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1.3.16 Evaluation, Inscection, Test, and coerating 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 disposition and so documented.
1.3.18 Corrective Action Nonconforming encapsulated sources will be reviewed by the Vice President of Sources and Systems for a determfnntion regarding disposal or salvage on a case-by-case basis.
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. the Vice President for Sources and Syste=s and the OA Manager.
The Vice President for Sources and Syste=s shall make the deter-l 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 Organi:etion The Vice President for Radiation Processin, Services, Mr. D. G.
Woodard, has the responsibility for all activities required to perfor::2 dose control irradiations. The responsibility for assur-ing cogliance enth the customer's specificaticns and schedules has been delegated to the Microbiclogical Control Products Mamger, Ms. G. Barrett. The responsibility for conducting the irradiation has been delegated to the Irradiations Section Manager, Mr. M. W.
Har=en.
Mr. Har=cn is responsible for the day-to-day operations of the irradiators and is also responsible for assuring that quali-fled operators are available to run these cachines.
3.1.2 Definitions Quality - i quality dose control irradiatica is one which was conducted under appropriate environmental conditions and 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 purchase order received from the customer.
Irradiators - There are two irradiators at the company's Dickerson facility. The first irradiator is called Dickerson I, 0 second is called Dickerson II.
Both use cobalt-60 as 'their radiation sources.
3.1.3 Buildings For any operation or processing campaign, sufficient space shall be provided to facilitate adequate cleaning, prevent miraps, and to assure the orderly handling of incoming material, rejected material, material in the irradiation process, and testing and 4
measuring equipment. Adequate space to perform dosimetry meas re-ments with proper ultraviolet light control will be provided at will I
sufficient lighting, ventilation, and temperature control. Air -
borne contambation shall be kept within M
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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 Nonconforming 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 ncnconforming items snall be prepared. The disposition of nonconforming material shall require the approval of the manufacturer's QA organi:ation.
5.1.18 ~ Corrective Action
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The manufacturer shall try to determine the cause for recurring non-conformances. He shall document actions taken to correct such pro-blems. This information shal: be available to NPI upon request.
J 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 organi:ations 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.stablished 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 NPI Quality Assurance Program (this document) will be revised as the need is determined. Changes (revisions) to this document must be approved by both the QA Manager and the President of the company. Any employee may prop,ose a change by submitting his suggested revision to either the QA Manager or-the company President.
The following documents are also maintained:
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Procedures
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Drawings 5.
Specifications
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Design Review Reports
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Contract Agreements
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Installations
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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 cuntrol 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 dee=ed necessary by the QA Manager. Those areas having a higher safety significance, as well as those areas in which undesirable problems habitually arr. 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 shall be documented and maintained by the QA Manager and reported to the President along with any sugges-tions of recocmendations for improvement. Subsequently,,the President sitall dIJtect Line manage. Tent to tche idtateve)L eorrective actions he decide.s is necessaty.
In the event that deficient areas are located, they shall be re-
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audited on a timely basis to verify implementation of corrective t
actions.
r Inspections and audits may be performed on aspects of the company's i
operations by regulatory authorities or customer representatives.
Whenever this occurs, the President of the company and/or the Quality Assurance Manager shall have an exit interview with the auditor and the QA Manager shall make sure a written record of the auditor's findings is made. Appropriate corrective actions shall be determined and documented.
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17647
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