ML19309C649
| ML19309C649 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 03/13/1980 |
| From: | Ransohoff J, Smedira C NEUTRON PRODUCTS, INC. |
| To: | |
| Shared Package | |
| ML19309C648 | List: |
| References | |
| 15762, NUDOCS 8004090121 | |
| Download: ML19309C649 (45) | |
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QUALITY ASSURANCE PROGRAM FOR.
NEUTRON PRODUCTS, INCORPORATED REVISION 2 MARCH 14,1980 fC5.I NG
$ 3fEt C. Smedira, M ger Quality Assu aice.
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/Presidentf. fA. Kanfohoff y
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l 15762 800.4090121
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Introduction i
Neutron Products, Inc. (NPI) was established in 1959 to commercially produce radioi<atopes. Activities of the company have grown to in-clude the production of radioactive sources for medical and industrial applications, the sterilization of hospital supplies and the radiation processing of chemicals to change their chemical and physical proper-ties.
NpI has, and will continue, to provide quality products and services to its customers.
Efforts to improve the safety of company personnel, the public, the local environment, and when possibic, 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 Reguintory 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.
Execettion of the Quality Assurance Program presented in this document, (dticlt has been written to comply with all appropriate regulations and is part of a continuing effort to provide high quality services at reasonabic costs to otut customers, is tlte sole Acsuonsibility 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 dio-tribution.
Mr. D. G. Woodard is the Vice President directly respon-afble for the radioprocessing and radiation testing operations of the company.
Mr. C. Smedira is the Quality Assurance Manager. As such, he will be responsible for the company's QA program. The QA Manager has the authority to stop cny company operation which he has reason to believe is proceeding in on unsatisfactory fashion. The QA Manager reports directly to the President and has.the authorittj to identift) probicins, to initiate, recommend, or provide sottttlons, and to veri-ft) the imptenentation of sollttions.
The Opatitt) Assurance Manager must have a sufficicottky broad educa-tion and expeAicnce to be able to inteAptet.the reqttinescorts of all regttlatort) agencies to att aspec.ts of the company's opeActions.
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Because of the relatively small size of the company, some personnel, among them the QA Manager, have been assigned multiple responsibilities.
The specific QA/QC functions ultich are to be performed by the NPI QA organization are lis.ted in Section V of.this document.
Corporate finance and administration occur under.the direction of.the Corporate Treasurer and Secretary, respectivelt.
The Corpora.te Secre-
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tar)t also manages.the companfts Laminar Floto Technology activities.
From time to time, special projects are under.taken under.the direct supervision of.the President of.the compant. When.this happens, a senior
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technical manager, as opposed.to one of Bie corporate officers or ute QA Manager, sciti be given.the responsibility.to execu.te the project.
The President and.the QA Manager shall confer at Die initiation of any such ptoject to determine an appropriate QA approach for the project.
Personnel assignments and responsibilities are presented in more detail in each of the specific quality control programs presented in Section V.
The President of HPI teilt, at least once cach year, communicate to all reptesentative orgastizaticns and individual.s that the require-ments of the QA program and ptocedurcs ai e mandatort) and that he has charged the QA Manager teith the responsibility.to implement and en-force.these requirements. The President of.the company shall be responsible for the resolution of ali disputes involving quality arising from a difference of opinion betteeen the QA Manager and other line management in the company.
Line managemen.t a.t NPI shall be responsible for establishing an indoctrination and training program such that:
1.
Personnet responsible for performing quality related activities are instructed as to the purpose, scope, and implementation of.the QA ptogram, instructions, and procedurcs.
2.
Personnet performing quality affccting activities are trained and qualifled in.the principle and. techniques of.the activitt) being performed.
3.
The scope, Die objective, and.the method of implement-ing Die indoctrination and. training program are docu-mented.
4.
Proficiencer of personnel perforning qtuttittj affecting activitics is maintained bi rettaining, reexanining, j
and/or rccertifging.
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. 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 cobsit-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.
Radioprocessing The company uses cobalt-60 irradiators to process caterials to achieve desired biological, chemical, and physical pro-perties and.in conjunction u'ith a chemical ptoduction plant, to produce a product kncan as pctyacrylamide.
Trradiators are also used for testing to determine the effect of radiation on chemical and physical properties of substances and to deter-mine the performance of equipment used in radiation environ-cents 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, pharracies, 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 co111mation of the radiation beams during therapy.
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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 medicci 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
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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 organization has the responsibility for the planning, judgement, execution, and documentation activities. The QA Manager participates and concurs in these activitics and has the' responsibility for auditing tasks.
In view of NPI's size, maximum use of line indi-viduals has been made.
Line individuals will be qualified to check, verify, test, and inspect independent actions of other line individuals.
The QA Manager will continue to assess the effectiveness of the overall program and be responsible for program change, indoctrination and train-ing, monitoring, and coordination.
Because of the diverse nature of the various operations of the company, separate subplans for quality assurance have been generated for each operation. The intent of each of these subplans follows from Section I of this document, the organization in each of these subplans follows fro:a Section II, and the basic approach is consistent with the general intention of this section.
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HPi management nill assess tite scope, stattus, implementation, and effee-tiveness of tite QA progran to assure titat tite program is adequate and -
cariptics vitit all applicable regulations, at least hw times a year.
The QA Manager will continue to asse:,s the effectiveness of the overall progran and be responsibic for progran change, indoctrination and train-ing, monitoring, and coordina*. ion.
Because of the diverse nature of the various operations of the company, separate subplans for quality assurance have been generated for each operation.
The intent of each of these subplans follows from Section I of this document, the organization in each of these subplans follows -
from Section II, and the basic approach is consistent with the general intention of this section.
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, Each subplan follows this outline:
Scope 1.
Organization 2.
Quality Assurance Definitions 3.
Buildings 4.
Equipment 5.
Design Control 6.
Procurement Docueent Control 7.
Instructions, Procedures, and Drawings 8.
Docuttent Control 9.
Control of Purchased Material, Equipment, and Services 10.
Identification and Control of Materials, Parts, and Components 11.
Special Processes l
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 l
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Nonconforming Materials, Parts, and Components 18.
Corrective Action 19.
Packaging and Labeling Where a particular section is not appropriate to a specific subplan, it is so stated.
V.
Special Quality Assurance Programs The specific subplans which are contained in this section are:
1.
Cobalt-60 Irradiation Sources 1.1 Reactor Target Assemblies 1.2 Radioactive Source Inventory Control 1.3 Radioactive Source Fabrication 1.4 Radioactive Scurce Transfer 2.
Teletherapy Unit Reconditioning 3.
Radioprocessing 3.1 Dose control Irradiations 3.2 Physical and Chemical Properties Irradiations 3.3 Potyachytamide Production 3.4 other Irradiations 4.
Laminar Flow Testing 5.
Product Marketing 4
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~ 1.1 Reactor Target Assemblies 1.1.1 Organization Design,. fabrication, transportation, and irradiation of cobalt-60 f
reactor targets is the responsibility of the Vice President for Sources and Systems. He will be assisted by other company person-nel as oppropriate.
A definite distribution of responsibilities between ITI, 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 documented in the contract agreement, 1.1.2 Definitions Reactor target assemblies - completed rods, herein called targets, ready for loading into a reactor.
Capsule - a sealed stainicss 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 c1 caning, 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-parature and humidity control shall be provided. Airborne con-tamination shall be monitored and kept within appropriate limits.
Inspections of the building condition shall be periodically per-formed and the results of these inspections shall be recorded.
The NPI and contractor quality assurance organizations shall be responsibic for the perfornance and documentation of these inspec-tions in their respective facilitics. No less than two inspec-tions per year will be performed. The line organization shall be responsible for cleaning the buildings. Adequate sanitary facilities will be provided.
. 1.1.4 Equiprent Nondisposable equipment used in the manuf acturing process of target components and assemblies shall be cleanable' and, if necessary, adjustabic.i 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 recoved and such removal shall be documented.
1.1.5 Design Control The Vice President for Sources and Systems shall establish and imple-ment methods for controlling design activities to assure that appli-cable design criteria, codes, standards, practices, and requirements for targets are defined and correctly translated into specifications, drawings, procedures, and instructions. He shall also establish and implement a method for coordinating and interf acing with other organ-izations, 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. Representatives of other organizations (such as the reactor operator) may participate in this review. Only parts, materials, and processes which have been proven to be acceptabic for targets will be used.
Specifications, drawings, instructions, and other engineering documents which may be necessary to describe the design, materials, fabrication, instal-lation, testing, inspection, packaging, shipping and storage require-cents of the targets will be prepared at NPI and at other contractor organizations. A specific definition of responsibilities for all documentation shall be made.
4 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 the original design.
1.1.6 Procurement Document Control Vendors 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.
. 1.1.7 Inntructions, Procedures, and Drawings All instructions, procedures, and drawingo necessary to assure quality in the fabrication of targets and 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 shsll be issued by the Vice President for Sourcc4 and Systems and by con-tractors, as appropriate. These documents shall be submitted to the QA 1bnager for approval. Changes to any of these documents i
shall also require his approval.
1.1.9 Control of Purchased Material, Equipment, and Services l
Independent materials testing and examination of each and every j
target and capsule shall be performed and the results documented.
l 1.1.10 Identification and control of Materials, Parts, and Components The Vice President for Sourcca and Systems shall establish a con-trol area in which all targets and capsules are stored and labeled, i
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 opera-tion of the components shall be certified by the apptopriate dchignce of the Vice President for Sourcc4 and Systems or by the contractor's organization. Nondestructive examination of target-components shall be in conformance to NPT Specifications Q-4, X-Ray Inspection (Hollow),
Q-5, X-Ray Inspection (Solid), Q-6, Helium Mass Spectrography In-spection, and Q-7, Dypenetrant Inspection, or those of a contractor approved by NPI.
1.1.12 Inspection Contractor inspection requirements for targets and capsules shall be in accordance with NPI Specifications P-2 and P-3.
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Periodically, NPI personnel will witness these inspections.
Inspections to be performed by NPI personnel will periodi-cally be witnessed by the Quality Assurance 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 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 t
name of the person who performed the calibration, the date on which it was done, and the next date on which a calibra-tion should be performed.
1.1.15 Handling, Storage, Distributing, Shipping, and Installation Targets and component materials shall be handled and stored in accordance with NPI Procedures R 2003, General Procedure for
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In-Pool Source Operations, NR 2005, Procedure for Decanning Cobalt-60 Sources from Zircaloy Tubes, and NR 2003, Procedure for Placing and Unloading Casks in Main Storage Pool.
Target installation in a reactor shall be in accordance with i
the appropriate technical specifications of the reactor opera-tor.
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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 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.
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Nonconforning material shall be stored physically apart.from acceptable material and a list of nonconforming' items shall be prepared by the Vice Pacaident for Source 4 and Sy4ter.4 or by contractors and provided on a weekly basis to the Qgality Assurance Ifanager. The Vice Prealdent for Source 4 and Sy4tema shall make recorrendations 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 Prc4ident for Sourcea and Sy4tcm4 shall document the 4
cause for nonconformance of any items so labeled. He shall i
also document recommendations for suggested corrective actions, i
l 1.1.19 Packaging and Labeling All targets and capsules shall be uniquely labeled.
i 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 4
President for Sources and Systems. Under the Vice President, the responsibic individual is the Section Manager for Source 1
Production, Mr. J. Corun.
Mr. Corun will be assisted by other j
company personnel as appropriate.
i 1.2.2 Definitions i
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.
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Teletherapy sources - singly or doubly encapsulated cobalt-60 teletherapy slugs. Teletherapy sources acquired from,cus-tomers or other suppliers may contain cobalt-60 pellets.
Teletherapy slugs - cobalt-60 sources prepared by a melting process.
Industrial sources - doubly encapsulated rods and/or springs of solid cobalt-60.
Rod sources - singly encapsulated cobalt-60 rods.
Spring sources - singly encapsulated cobalt-60 springs.
Check sources - cobalt-60 or cesium-137 sources used for cali-bration or checking of radiation monitors.
1.2.3 Buildings Inventory control facilities shall have adequate space and storage equipment to prevent mixups and to assure the accurate handling of all incoming cobalt-60 sources, regardless of form, and to enabic 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 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.E Design Control Not applicable 1.2.6 Procurement Document Control Not applicable 1.2.7 Instructions, Procedures, and Drawings After target rod sources have been removed from an incoming shipping cask and documented as to their position in the pool storage tank, they shall be calibrated. After calibration, the target rods shall
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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 made 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
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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 d
Each individual source shall be calibrated and the results docu-mented. All rod and spring sources shall be calibrated by the underwater pool calibrator or by the hot cell calibrator (in
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both of these the source is passed under a shielded co111 mated detector and the output reading plotted; the readings are compared to a known standard to determine curie activity). Teletherapy sources shall be rated by direct output dose rate by measurement in the hot cell.
1.2.12 Inspection Periodic inspections shall be conducted to assure that the pool operator can locate a particuinr source. The source shall be pulled from the holder and calibrat:5 and the resulting trace shall be compared with the trace already existing for that source.
A record of such inspections shall be maintained by the Quality Assurance Manager.
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1.2.13 Test Control Not applicable 1.2.14 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 Ilandling, Storage, Distributing, Shipping, and Installation All incoming target rods shall be handled in accordance with NPI Procedures NR 2001, Procedure for Loading and Removal of Radio-active Shipping Containers from the Main Storage Pool; R 2007, Calibration by Area Method; R 5002, Opening Ilot Cell Door After Processing Single and Double Encapsulated Cobalt-60; R 5004, Transfer of Sources Between llot Cell and Canal Tanks; R 5005, Loading of Encapsulated Sources in Transfer and Shipping Con-tainers from llot Cell; and, NR 5007, Processing Exposed Cobalt-60.
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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 Sources and Systems.
1.2.17 Nonconforming Parts Encapsulated sources which fail leak tests or are damaged or otherwise defective shall be stored separately from all others and held for disposal.
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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 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 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 Quality source fabrication - the process of transforming
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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 designed specifically for use in medical teletherapy units.
Industrial sources - sources designed specifically for indus-trial use.
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 dimeneralized water used for storage of cobalt-60 sources and for certain fabrication operations.
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1.3.3 Buildings Sources are fabricated and handled in a hot cell and pool until transferred to a shipping cask.
Both cell and pool shall have adequate space for operations and storage of all sources including as received, in work, and finished product. Adequate lighting, ventilation, and temperature control shall be provided to assure the safety of operations, containment of contamination, and inte-grity of the product.
1.3.4 Equipment 4
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 contamination, and to provide a high degree of reli-ability and reproducible accuracy as required.
1.3.5 Design Control Not applicable 1.3.6 Procurement Document Control
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Vendors supplying source encapsulation materials shall supply manufacturer's test reports and certifications for these macerials.
This control shall be the responsibility of the Source PrcJuction Section Manager and periodically checked by the Quality Assurance Fhnager or appointee in accordance with NPI Specificat$ an P-4, Procedure for Encapsulation of Teletherapy Sources.
1.3.7 Instructions, Procedures, and Drawings 4
All instructions, procedures, and drawings required to fabricate sources will be provided in NPI 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
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approval of the Vice President of Sources. and Systems.
1.3.9 Control of Purchased Material, Eouipment, and Services The Source Production Section Manager will iniciate and approve-all purchases and maintain records of the source inventory, e
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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 Specifications P-2, P-3, and P-4.
Changes
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to these specifications require the approval of the Vice President for Sources and Systems and the Quality Assurance Manager.
1.3.12 Inspection Inspection of all critical operations will be in accordance with.
NPI Specification P-1, Specifications, Procedures, and Quality Control ~for Scaled Cobalt-60 Sources.
1.3.13 Test Control All sources shall be tested for quality and integrity in accordance with NPI Specification P-1, 1.3.14 Control of Measuring and Test Equipment
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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.
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. 1.3.19 Packaning and Labeling All teletherapy finished sources shall be uniquely identifiable.
Packaging for shiprent shall be in accordance with Section 1.4 of this docurent.
1.4 Redicactive Haterials Transportation 1.4.1 Organiza.tlon Design, fabrication, and maintenance of radioactive materlat shipping containers and transportation of radicactive shipments is.the respon-sibility of the l' ice Presidestt for Sources and Systers.
He shall be assis.ted by other company personnet as appropria.te.
1.4.2 Definitions Quallty packaging
.the toading of radioactive materials in an NPI o'r other organization's shipping container for shipment in con-formance teith applicable regula. tory requirenents, and completion of.the documentation of.this activity in accordance seith.the requirenents of.this scction.
nff site location - a location other than Dickerson at tdtich a radioactive shipment contratied by HP1 may originate.
Quality transportation
.the safe and cfficient carrting of radio-j active materlats from one site to another in accordance telth applicable requirerents and the completion of documentation of.this activitt).
Radioactive nzterials shipping container - herein catted container, is one compfting teith the applicable regtdaiions of the DOT and j
HRC.
1.4.3 Buildings Buitilings in tehich shipping containers are stored or handled shalt have adequate space for etcaning, maintaining, and orderttj handling of incoming and outgoing shipments. Airborne costtanination shati be minimized and monitored in facilitics idach have encapsulated radioactive materials.
Inspections of the building conditions shall be performed periodically and.the results recorded.
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- 1.4.4 Equipment Equipmatt tacd in handling and vehicles used for JAansporting con-tainers shall be stored in such a mannch as to maisttain an adequate condition for use.
Shipping containers, oveApacks, special handling equipment, instAumatts, and tools teilt be maintained by.the Tele-therapi Scruices Section !1anager.
Equipment needed to peAform qualitt j
related activttles shall be specified prior to use, as shall the en j vironmental conditions under u'hich the equipmast is.to be operated.
1.4.5 Desian Control The Vice Presidott for Sources and Ststems is responsible for the j
design of containers and handling equipment. When additional LAans-poMation equipment design is requ.uted, he shalt establish procedures
.to assure tlutt applicable design cAlteria, standards, practices, and regulatory requirements are defined and translated into specifica-tions, drawings, procedurcs, and instructions, lie shalt estab!1sh and ixptement a method for coordinating teith o.ther organizations and con-tractors. A design revice shall be conducted to assure that (1) the design meets the design criteria; I2) design characteristics can be controlled, inspected, and tested; and, (3) inspection and. test cri-teAla are identified.
The individual responsible for the design re-view shall be other than the original designer and.the designer's immediate supctvisor.
Design and specification clutnges slutti be subject to the same design controts and approvals that weAe appli-cable to the original design.
For cach design activittj for a trans-por.tation package, specific organizational responsibilities shall be established.
1.4.6 Procurcmcnt Documertt Control Vendou or contractou supplying shipping containers, handling equip-ment, and parts shall comply with NPI Specification E-1, Equipment Specification for a lead Shielded Shipping Cash or other appropriate specification.
Control of procurementt documents shall be the respon-sibilittj of the Vice President for Sources and St stems.
lit. shall be j
responsible.to (1) prepa.te as appropriate, ptocedurcs or instAuctions tIutt etcarli delincate the sequence of acklons to be accomplished in j
the preparation, review, approvat, and control of permanent documents; (2) identiftj in att apptopria.te ptocurement documents, the applicable 10 CTP Part 71, Appendix E requirements tchich must be complied with and described in the supplicr's QA ptogram; (3) require that procuremott documents contain or reference the design basis technical requirements including the applicable reputatort) requirements, materlat and com-ponent identification requiAcments, drawings, specifications, codes l
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and industrial standards, test and inspection requiremersts, and special ptocess instructions; and that thet) speciftj the documen-tation (c.g., drateings, specifications, procedures, inspection and fabricaticn plans, inspection and test records, personnet and procedures qualifications, and chemical and phtjsical test results of matcrlat) to be preparcd, maitttained, and subt:titted.to NP1 for revicte and approval; (4) spccif tj those records to be retained, con-
. trotted, and maintained bij the supplich, and those delivered to NPT ptior to use or instaliation of the harduure; and, (5) require NPI's riglut of access to supplicr's facilitics and records for inspection and andet.
Changes and revisions.to procurement documents shall have at least the same revicte and approval as the original document.
1.4.7 Instructions, Procedures, and Drateings See Section 1.4.8.
Periodic audi,ts.to check for conformance to these dccurents teill be conducted bt) the QA Manager or his designce.
1.4.8 Document Cont ^ol Instructions, procedures, drateings, and specifications for containers, container kndling, packaging and shipping are Elsted in and shati compiti taith NPT QC Procedurc 1001.
Responsihttitics for the initia-tion, revicte, apptovat, and issuance of these documents are specified in this ptocedure and no changes to.these documents shati be ude uti.thout -the approval of the same pcopic v'ho initiatttj approved these documents. Approved changes in instructions, ptocedures, drautings, and ather documents shatt be madc prior to the imptencntation of such changes.
The QA Manager shalt be responsible for assuring
.that the sequence of actions required bij Procedure 1001 for the prepa-nation and revicte of required documentation is forloteed.
Appropriate documents shall be available at all unrk locations ptior to commencement of teork.
The Vice President for Sources and Stjstens shatt have and traintain a mastet list idtich identifics the current revision number of instructions, procedurcs, specifications, draw-ings, and procurcrent documents.
1.4.9 Control of Purchased Matetial, Equipment, and Services The Vicc President for Sources and Stjstems shatt have an evaluatlon done of att supplichs to assess their carnbilittj to ptovide acceptable U
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. qualitij services and prcducts. This evaluation shalt be based on a survey of the supplier's facilities and QA program to determine his capability to suppli a ptoduct tdtich meets the design, manu-j factwting, and qualitij requirements. Att supplier evaluations shall be docureded and filed. 0: hen requiAed, HPI suruclitance of suppliers during fabrication, inspection, testing, and sitipment of mateAials, equipment, and componestts shall be performed to assure conformance to.the purchase order requircrents. Att suppliers shall be required to furnish.the foltouring records as a minimum to the purchase:
1.
Documenttalion tha.t identifies the purchased ma.terlat or equipment and.the specific procurement requiremertts (e.g., codes, standards, and specifications) met bij
.the items.
2.
Documentation that idatifLes any procurement require-ments idtich have not bete met together vith a descrip-tion of those nonconformances d.ispositioned " accept as is" or "repain."
Receiving inspection of.the supplicr-furnished ma.terial, equipment, and services shall be perforned to assure:
1.
The mateAlat, ccmponents, or equiprestt is ptoperty identifled and corresponds vi' th the identification on receiving documentation.
2.
htterial, componeutts, equipmentt, and acceptance records are inspected and judged acceptable in accordance teith prede.termined inspection instruc-tions prior to instaliation or use.
3.
Inspection records or certifica.tes of conformance attesting to.the acceptance of materlat and com-ponents are available prior to installittion or use.
4.
Items accepted and released are identificd as to their inspection status ptior to foruurding them to a controtted storage arca or releasing.them for fuk.thcx tecrk.
1.4.10 identification and Conttet af htterials, Parts, and Components The Vice President for Sources and Systems shall be responsible for the ptopcr identification and conttot af materlats, parts, and com-poncuts associated teith the fabrication of radicactive shipping containers.
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1.4.I1 Special Processes Loading and witoading codainers for radioactive sMpments are special processes.
These shalt be performed in accordance vlth HP1 QC Progran 1003, Package loading Procedure for Radioactive Materlats and QC Prograr: 1C04, Package Untoading Procedure for Radioactive !fateriais.
1.4.12 Inspection inspection of all quality conformance activities shall be wider.the responsibill.ty of.the QA Manager in accordance vperformed ith QC Procedure QC 1006.
Inspection personnet teilt be independent from
.those performing these activities.
These inspectors shall be qualifled in accordance v:Lth the compantfs. training program and tchen other qualificatices and certifications are required.they shall be hep.t curred.
ifodifications, repairs, and replacements for shipping casks shall be inspected in accordance teith.the original design and inspection requirements, or acceptable afternatives.
Operating and QC procedures teilt identify, tchere applicable, mandatory inspection hold points for teitness by an inspector.
1.4.13 Test Control The l' ice President of Scurces and Sys.tems shalt be responsible for sMpping cask test cor1Aol. A test procedure for demonstrat-ing tha.t sMpping casks tcili perform satisfac.tority in service is established and documented. TMs prccedure is a checklist performed in accordance leith QC Procedure 1006.
Any modifications, repairs, or replaccrents to sMpping casks shall be. tested in accordance telth.the original design and. test requirements or acceptable allcrnativcs.
Test results are documerled, evaluated, arid..their accep.tabilitjt de.tchnined by.the Section l'anager responsible ;for.the radiation sMpmeri.
1.4.14 Control of Measuring and Tc.st Equipment Att measuring and test instrument.s shalt be. calibrated at specific intervals.to assure accuracy for intended purposes.
Calibration test data for these insttunents shalt be identifiabic and traceable.
Whenever. test equipment is found.to be out of calibration, previous tests teilt be investigated for validity and so documen.ted.
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Where applicable, as in the case of radiatica reasuring instruments, the basis for calibration teill be traccatte to r.dionalltj recognized standards.
1.4.15 Handling, Storage, and Shipping All operations concerning handling, storage, and shipping of radio-active slapping casks shall be in accordance v:ith NPI QC Procedure 1005, Handling, Storage, and Shipping Procede.c fc.: Radioactive Itaterials. Special handling, preservation, storage, cleaning, packaging, and shipping requirements are c.stablished in this pro-cedure. These are accomplished by trained, speci!ically desi qualified individuals in accordance teith.the above procedure.gnated All conditions of HRC package apptovat and U. S. DOT shipping re-qtarements shall be satisfied ptior to any sidyced. All necessary shipping papers shall be property prepared. Depadure and ar.rivat time and destination of each package shall be e.stablished and moni-tored to a degree consistent teith safe transpoddion of the package.
1.4.16 Evaluation, inspeellon, Test, and Operating Stk Inspection, testing, and operating status e! clt shipping packages and components shall be in accordance tei.th HPI QC Procedure 1006, Inspection, Test, and Operating Status Procedure for Radioactive ifa.teriats.
Identification,. test, and operating status of att package.s and components sha.lt be knotat by att affccted sections.
Application and renovat of inspecklon tag mar! drgs, and shipping or o.ther labeis shall be controlled in accordance viith QC Procedure 1006.
By-passing of required inspections,. tests, and other critical operations, requires.the prior approvat of the Vice President for Sources and the QA tianager.
The status of nonconforming, inoperative, or malfunctioning peekages or components shall be clearly identified to prevent inadout. tent us e.
1.4.17 Nonconforming Parts Any nonconforming parts scitt be so.identifled and. segregated for disposal or renoval from the container or shipping areas.
Hancon-forming ntterials, parts, components, and services shall be con-trolled in accordance Leith NPT QC Procedures 1005 and 1006 seldch require.the identification, documentation, segregation of noncon-forming items and.the notification of affected individucts. Desig-nations of individuals responsible for.the revie:e and disposition of.the materials are made in.these ytocedures.
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Documentation shall identify the nonconfonming item, state its inspection requirements, describe the nonconformtnce, and iden-
.tify final disposition. Signature approval of the Vice President for Sources and Systems is required for final disposition.
Acceptability of rerwrk or repair shall be verified by reinspec-tion and retesting, as required, and as originalty inspected or by an equal nc.thod.
1.4.18 Corrective. Action The QA Manager shall conduc.t an evaluation, in conjunction teith
.the Vice President for Sources and Systems, of any conditions determined.to be adverse to quati.ty (such as nonconformances, faliares, malfunettons, deficiencies, deviations, and defective ma.terlats and equipwit) to determine.the need for corrective action.
Repair or replacement of nonconforming parts or.the correction of o.ther deficiencies shall be recommended by.the Source Produc-7 tion Section Manaser,.the Manager for Utilization, Facilities, and Equipmen.t, or.the Health Physics Technician, and must be approved by the Vice Presidatt for Solvtces and Systems.
To.the extent possible, corrective actions shall attempt.to preclude recurrence of.the adethse condition.
Tolecuup revicies shall be conducted by.the QA Manager to verify
.the proper implementation of corrective actions and.to close out the corrective action documentation.
1.4.19 Packaging and Labeling Att NPI radioactive shipments shall be packaged and labcLed in accordance teith NPI QC Program 1003.
1.5 Radioactive Source Transfer 1.5.1 Organization 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, nnd prepa-ration for shipment offsite is the responsibility of the Teletherapy Services Section Manager who is also responsibic for installation of sources into teletherapy units.
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Design and fabrication of source adapters which are installed in I
a teletherapy unit is the responsibility of the Source production Section ihnager.
Design and fabrication of centainer insert holders and adapters which are part of the transfer operation are the respon-sibility of the Utilization, Facilities, and Equipnent ?!anager.
1.3.2 Definitions
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Radioactive source transfer - the field operation involving the transfer of sources between shipping containers and teletherapy units, unloading units, transferring, sources into and out of an operating unit and transferring sources from one operating unit to another, inc1uding teletherapy unit checkout, servicing, and maintenance.
' Teletherapy unit - a machine using cobalt-60 at a distance for
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radiation therapy.
Quality radioactive source transfers - transfers made in accordance with the procedures referenced herein.
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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 Fhnager. Vehicle maintenance will be the responsibility of the user.
1.5.5 Design Control i
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 associated with equipment or services in support of any radioactive source transfer operation.
1.5.7 Instructions, Procedures, and Drawings
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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 hbnager. 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 responsibic for all materials, parts, and components used in making equipment for radioactive source transfers.
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1.5.11 Special Processes Source replacener.t 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.S.13 Test Control Not applicable 1.5.14 Control of Measuring and Test Equipment The Teletherapy Services Section Manager shall be responsibic for the maintenance and calibration of radiation monitoring instruments used in the field.
1.5.15 llandling, Storage, Distribution, Shipping, and Installation
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11andling, storage, and shipping of transfer equipment is the respon-sibility of the Teletherapy Services Section Manager.
1.5.16 Evaluation, Inspection, Test, and Operating Status Teletherapy units serviced by NPI personnel shall be checked for operating condition in accordance with NPI Specification P-9.
1.5.17 Nonconforming Parts Any nonconforming parts will be segregated and identified for disposition.
1.5.18 Corrective Action In the event that either customer or NPI personnel have reason to believe that some corrective action associated with an_NPI per-formed radiation source transfer is necessary, the Teletherapy Services Section Manager shall make appropriate recommendations for the approval of the Vice President for Sources and Systems and the QA Manager.
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1.5.19 Packaging and Labeling All parts will be packaged and labeled for identification. The shipping container shall be labeled in accordance with regulatory requirements.
2.1 Teletherapy Unit Reconditioning 2.1.1 Organization Reconditioning of teletherapy units is the overall responsibility of the Vice President for Sources and Systems. The Teletherapy Services Section 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 reusabic 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 systems to afford good shop conditions.
Safe and proper handling equipment shall be provided. Well lighted bench space shall be provided for reconditioning of electrical control and other small subassemblies.
Buildings of contractors' shall also s. ply with the above conditions.
General building conditions shall be periodically inspected by the Vice President for Sources and Systems and independently by the QA Manager.
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2.1.4 Equipment Reconditioning and installation equipment and tools shall be main-tained by the Teletherapy Services Section Manager. Reaponsibility for the maintenance of vehicles shall be with the Teletherapy Ser-vices Section Manager.
Equiprent purchased for replacement items shall be the responsi-bility of the Teletherapy Services Section Manager.
2.1.5 Design control Not applicable 2.1.6 Procurement Docueent Control Documentation of procurements for materials or components for recon-ditioning teletherapy units shall be the responsibility of the Tele-therapy Services Section Manager.
2.1.7 Instructions, Procedures, and DrawinPs 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 confornance.
2.1.8 Docurent Control j
All documents relnting to reconditioning, instructions, procedures, drawings, and specifications shall be controlled by the Teletherapy Services Section Manager and shall have the approval of the Vice President for Sources and Systems. Changes to these docurents shall require his approval.
2.1.9 Control of Purchased Material, Equipment, and Services The Teletherapy Services Section Manager shall be responsible for procurement of purchased material, equipment, and services.
2.1.10 Identification and Control of Materials, Parts, and Components The Teletherapy Services Section Manager shall establish and main-tain a cican area in which parts for reconditioning teletherapy machines are' stored and labeled.
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2.1.11 Special Processes Installation of a source into a reconditioned teletherapy unit is a special process whi:h 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 b!anager or his appointee. A complete inspec'.: ion 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 bicasuring and Test Equipment b!eters 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.
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2.1.15 !!andling, Storage, 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 blanager.
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 Flanager shall recommend an appropriate course of action to
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the Vice President for Sources and Systens and the QA Manager.
The Vice President for Sources and Systems shall make the deter-mination of arPropriate 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 i
labeled.
3.1 Dose Control Irradiations 3.1.1 Organization The Vice President for Radiation Processing Services, Ifr. D. C.
Woodard, has the responsibility for all activities required to perform dose control irradiations. The responsibility for assar-ing compliance u'ith the customer's specifications and schedules has been detegated to the Microbiological Control Products Manager, Ms. G. Barrett.
The responsibility for conduc. ting the irradiation 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 quali-fied 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 purchase order received from the customer.
Irradiators - There are two irradiators at the company's Dickerson facility. The first irradiator is called Dickerson I, the second is called Dickerson II.
Both use cobalt-60 as their radiation sources.
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3.1.3 Buildings For any operation or processing campaign, sufficient space shall be provided to facilitate adequate cicaning, 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 contamination shall' bc kept within
. acceptabic industrial standards.
Inspections of the building condition shall be periodically perforned and the results of these inspections shall be recorded. The NPI quality assurance organi-zation shall be responsible for the perforrance and docurentation 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 Ecuipment Nondisposable equipment used for handling, irradiation, and shipping shall be cicanable and, if necessary, adjustable.
Equiptent shall be stored in such a tanner to reduce contamination by dust or dirt or the accummulation of chemicals.
Equiprent will be clean when used. Equipment which requires periodic adjustment shall have allowabic tolerances posted where the equiptent 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 Docueent Control Instructions, procedures, drawings, and specifications shall be issued by the Microbiological Control Product.*!anager or by the Irradiations Section Manager. These documents shall have the approval of the Vice President for Radiation Processing Services.
Changes to any of these documents shall also require his approval.
3.1.9 Control of Purchased Materfal, Ecufprent, and services Control of materials, equipment, and services shall be the respon-sibility of the Irradiations Section Manager.
I
, 3.1.10 3dentification 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 Fbnager.
3.1.11 Special Processes Not applicabic 3.1.12 Inspection Product dosimetry shall be the principal means of inspection. Dosi-netry shall be performed in accordance with Irradiator Operating Instructions, Processing Dosir.etry. Products determined to be non-conforming to the custorer's specifications shall be tagged accord-ingly and stored physically separate from acceptabic material. The i
Microbiological ConfAof Product Manager shall docueent all nonconfor-mances and bring them to the attention of the Vice President of Radia-tion 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 applicabic 3.1.14 Control of Measuring and Test Equiprent 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 re-quired. Calibration will be performed per NPI Instruction, Cali-bration of Far West Dositeters.
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 perforced.
3.1.15 liandling, Storage, Distributine, and Shipping For each product handled by NPI, a specific instruction is prepared which documents the company's cethods for controlling customer prod-ucts during handling, storage, and shipping..
. 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 Materials Parts, and Components Not applicable 3.1.18 Corrective Action In the event that dosimetry reveals that a product has not received the required dose, this fact shall be docutented and reported to the Vice President for Radiation Processing Services and the QA Manager.
The Irradiations Section Manager 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 Chemien1 Properties Irradiations 3.2.1 Organization See Section 3.1.1.
The Pofffmcr IJodification Produci Manager, Mr. J. Tang, has the respon-sibility for assuring compliance with the custorer's specifications and 4chedales.
He supcavisc4 the laboratory work necessary to deter-mine 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 accordance 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
3.2.3 Buildings See Section 3.1.3.
Appropriate laboratory space shall be provided for product sarpling and testing.
3.2.4 Equipnent See Section 3.1.4.
3.2.5 Design Contrel Not applicable 3.2.6 Procurement Docur.ent 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 specirications shall be issued by the Irradiations Section Manager for activities associated with running the irradiators and by the Poltper i.rodificat2on Produe.c ManaSer for laboratory support activities. These docurents shall have the approval of the Vice President for Radiation Processing Services and by the Quality Assurance Manager.
Changes to any of these documents shall also require their approval.
3.2.9 Control of Purchased Material. Equineent, and Services See Section 3.1.9.
3.2.10 Identification and Control of Materials, Parts, and Comoonents See Section 3.1.10.
3.2.11 Special Processes Not applicable
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, 3.2.12 Inspection Properties testing shall be the principal means of inspection.
Testing shall be performed in compliance with written instruc-tions.
Dositetry shall be perf,, reed in accordance with Irradiator Operat-ing Instructions, Processing Dositetry. Products determined to be nonconforming to the custorer's specifications shall be tagged accordingly and stored physically separate from acceptable caterial.
The Polper f.fodifice. tion Produc.t Manager shall document all noncon-formances and bring them to the attention of the Irradiations Sec-tion 1bnager and the Vice President for Radiation Processing Services within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.2.12 Test Control See Section 3.2.12.
3.2.14 Control of Feasuring and Test Equiprent Laboratory equipment necessary for sarpling and testing of products shall be available and the Pofper !.!cdification Produc.t Manager shall determine if periodic adjustments or calibrations are required. Lab-oratory equipment which requires periodic adjustrent shall have allow-able tolerances posted where the equiptent 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 I!andling, Storage, Distributing, and Shipping See Section 3.1.15.
3.2.16 Evaluation Inspection. Test, and coerating Status See Section 3.1.16.
3.2.17 Nonconforming Materials, Parts, and Components Not applicable
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3.2.18 Corrective Action The Pott mer IJodification Produc.t Manager and the Irradiations section j
Manager shall recotrrend in writing to the Vice President for Radiation Processing Services and the QA Manager:
- an appropriate disposition for nonconforcing products;
- and,
- the likely cause of the nonconformance.
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.
Polyachtlamide Production 3.3 j
3.3.1 Organization The l! ice President for Radiation Processing Scruices, lit. D. G.
Woodard, has the responsibili.ty for att activities required for
.the production of polyacrylamide. The responsibLlitt) for assuring compliance leith the customer's specifications and schedules has been delegitted.to the Polymerization Plant Section."anager, llt. D. Deore.
The responsibility for conducting.the irradiations has been delegated
.to.the Irradiations Section llanager, I.lt.14. W. Harmon. Ilt. Harmon is responsible for.the day-to-day operittions of the irradiators and is also responsible for assuring that qualified operators are avali-able to run these machines.
3.3.2 Definitions Qualitt) - A qualittj polyacrylanide produc.t is one tdtich vus produced in accordance leith the requirements of this section-and uhich through-out its progression from a monomer to a poltper luts.the physical and chemical properties specified bi the customer, HeAcules.
j Thradiators - See Section 3.1.2.
3.3.3 Buildings See Section 3.1.3.
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D The acrylic acid building shall be maintained in such a fashion as to prectade edry by unauthorized personnel and the public.
Its explosion relief and prevention features shall be maintained by apptopriate peuonnel under the direction of the Poti erization p
Plant Section Manager.
The condition of this betilding and the tank room and their suppor. ting heating and cooling sys.tems, shaLL be in-spec.ted bi.the Quality Assurance Manager or his designee at least j
ticice a t ear and such inspections documented.
j 3.3.4 Equipment See Section 3.1.4.
Maintenance of.the tanks, proccss lines, heating, ventitating, and cooling systens, and control devices for the acrylic acid building and.the. tank room is.the responsibilitt) of.the Pottperization Plant Section Manager.
3.3.5 Desinn Control Not applicable 3.3.6 Procurement Document Conttot Supplier certifications of mke up chemicals shall be retained for at least.two t ears.
j 3.3.7 Instructions, Procedures, and Dratcings See Section 3.2.7.
3.3.8 Documen.t Conttot Instructions, procedures, drateings, and specifications shall be issued by.the Irradiations Section Manager for ac.tivities associ-a.ted teith running the Ltraduttors and bi.the Polymerization Plant j
Section Manager for chemical proccssing and labora. tort) support activities. These documents shall have.the apptovat of the Vice President for Radiation Processing Schvices and by the Quality Assurance JLinager.
Changes to any of.these documents shalt also require their approvat.
3.3.9 Control of Purchased Ma.tchiat, Equipment, and Services Conttot of purchased na,terial, equipment, and services is.the respon-sibility of.the Pattyerization Plant Section Manager.
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Att incoming sitipments of acrtjtic acid and acrylamide shall be tested for conformance to Hercules' specifications.
3.3.10 identification and Control of Haterlats, Parts, and Components See Section 3.1.10.
3.3.11 Special Processes Not applicable 3.3.12 inspection inspections and evaluations of finished produc.t shall be performed in accordance seith Hercules' specifications.
3.3.13 Test Control Testing and control of tests of finished products shall be performed in accordance Leith IIcreates' specifications.
3.3.14 Contitot of Measuring and Test Equipmestt Labo:tatort) equipment necessary for sampling and. testing of products shall be avaliable and the Special irradiations Section ifanager.
shall determine if periodic adjustneutts or calibrations are required.
Labotatory equipment tdtich requires periodic adjusteent shall have attomble tolerances posted v:hcre the equipment is used.
rcriodic calibrations shall be recorded.
Each calibration record shalt shoto the name of the person tdto performed the calibration, the date on tchich it tats done, and.the next date on tehich a calibra-tion shall be performed.
3.3.15 llandling, Storage, Disttibating, and Shipping See Section 3.1.15.
3.3.16 Evaluation, inspection, Test, and Opera, ting Status See Section 3.1.16.
3.3.17 Nonconforning ifa.tchlitts, Parts, and Components Hot applicable f
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g-O 3.3.18 Cornective Action The Polymerization Plant Section Hanager and the Irradiations Section Manager shalt recommend in wtiking to the Vice President for Padiation Processing Services and the QA Manager:
- an appropriate disposition for nonconforming products;
- and,
- the likely cause of the nonconformance.
The Vice President for Radiation Processing Services shalt make the determination of the final disposition.
3.3.19 Packaging and Labeling Not applicable 3.4 Other Irradiations 3.4.1 Orranization The Vice President for Radiation Processing Services has the overall responsibility for all irradiations conducted at NPI's facilities.
lie has delegated the responsibility for the day-to-day operations of the irradiators to the Irradiations Section Manager and the respon-sibility for laboratory support activities and special irradiations to the Special IAradiations and laborat042cs Section Manager.
3.4.2 Definitions Quality - A quality irradiation is one which was conducted in accor-dance with the requirements of this section and which subjects a product to the environrental or testing conditions specified in accordance with NPI Procedure R 2013, Special Irradiations, and whose history has been docur.ented in accordance with this procedure.
Irradiations - See Section 3.1.2.
3.4.3 Buildings See Section 3.2.3.
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e 6 3.4.4 Eauipment See Section 3.2.4.
Equipment requirements for any special irradia-tion shall be specified in accordance with NPI Procedure R 2013.
3.4.5 Design Control The Special Irradiation 4 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 require-ments. lie shall also establish and implement a method for coordinat-ing 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 requirements will be conducted.
Representatives of other organizations (such as a customer) may par-ticipate 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.
3.4.6 Procurement Document Control Customer supplied material shall be in accordance with NPI Procedure R 2013.
3.4.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings necessary to spectfy 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.
3.4.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Section IMnager for Special Taradiation4 or by another section manager specified by the Vice President for Radiation Pro-cessing Services. These documents shall have the approval of the Vice President for Radiation Processing Services. Changes to any of these documents shall also require his approval.
3.4.9 Control of Purchased Material, Ecuipment, and Services Responsibility for coner:1 of material, equipment, and services shall be specified in accordance with NPI Procedure R 2013.
. 3.4.10 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 section manager designated by the Vice President for Radiation Processing Services.
3.4.11 Special Processes Since all of the processes designated under this Section 3.3 are in essence special processes, this section is not applicable.
3.4.12 Inspection Product dosimetry and properties testing as appropriate shall be performed. Products determined to be nonconforming to the pre-viously set specifications shall be tagged accordingly and stored physically separate from the acceptable material. The responsible section canager 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 />.
3.4.13 Test Control Not applicable 3.4.14 Control of Measuring and Test Equipment See Section 3.2.14.
3.4.15 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.
3.4.16 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.
3.4.17 Nenconforming Materials, Parts, and Components Not applicable 3.4.18 Corrective Action l
In the event that dositetry or physical and/or chemical properties testing reveals that a product has not received the required dose l
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a 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 determination of the final disposition.
3.4.19 Packaging and Labeling Incoming and irradiated products shall be packaged and labeled in accordance with specific instructions.
4.1 Laminar Flow Testing 4.1.1 Organization The Corporate Secretartj is responsible for NP1 laminar flow testing activities. IIc will be assisted by other company personnel as appropriate.
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 l
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. 4.1.4 Equipment Nondisposable equipment used in the examination and testing program shall be cleanable and, if necessary, adjustable.
Equipment shall be stored in such a canner to reduce contamination by dust or dirt.
-Equipment will be clean when used. Equipment which requires periodic adjustment shall have allowable tolerances posted within the equip-ment storage boxes.
The Corporate Secretary shall prepare and keep current calibration procedures for all equipment which requires periodic calibration.
Each calibration record shall show the name of the person who per-formed the calibration, the date on which it was done, and the next date on which a calibration should be perforced.
4.1.5 Design Conceol Not applicabic 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 Flou Hoods.
Audits Will be conducted to check for conforrance.
4.1.8 Document Control All instructions, procedures, and specifications for the laminar flow testing program and change 4 of 4ame shall be issued by the Corporate Secretatr. These documents shall have the approval of j
i the Quality Assurance Manager.
4.1.9 Control of Purchased Material, Equipment, and Services A qualitative and, whenever possible, quantative evaluation of in-stalled HEPA filter performance shall be made on the Field Service Inspection Report. The Corpordic Sccaciary or hi4 dcaignce shall examine these reports once every calendar quarter to determine if purchased HEPA filters have been in compliance with NPI procurement specifications.
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. 4.1.10 Identification and Control of Materials, Parts, and Components 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 Inspecti on 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 roulpeent See Section 4.1.4 4.1.15 llandling, Storage, Distributing, Shipping, and Installation Equipment and replacement parts are stored and transported by vans.
Maintenance of the van is the responsibility of the Corporate Secretary.
4.1.16 Evaluation, Inspection, Test, and Operating Status For each unit serviced, the NPI Field Service Inspection Report shall be completed. The original shall be given to the customer and one copy shall be kept in NPI company files.
4 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 acceptable material and appro-priately disposed of by the Corporaic SecAclary.
4.1.18 Corrective Action When a nonconforming item is disposed of, the Corporate Secac-fary will document this disposition and the reasons 1
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. ~b 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 responsible 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 handling of NPI marketed products shall have sufficient space to facilitate adequate clean-ing, prevent mixups, and to assure the orderly handling of incoming 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 periodica11y'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 Nond3 sposable equipment used in the manufacturing process of NPI marketed product; snall be cleanable and, if necessary, adjustabic, i
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,*s 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 tolerancer 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 documented. Mea-suring equipment will be examined to determine if periodic calibra-tion is required.
Product calibration shall be recorded. Each calibration record shall show the name of the person who performed the calibration, the date on which it was done, and the next date on which the calibration should be performed.
5.1.5 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 specifications for all purchased
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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 level of management and shall warrant that changes to any of these documents will not occur without the same level of management approval.
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5.1.9 Control of Purchased Material, Equipment, and Services The manufacturer shall inform NPI of all testing and examination activities which he conducts to ascertain the' condition of pur-chased material, equipment, and services.
5.1.10 Identification and Control of Materials, Parts, cnd Components The manufacturer shall establish control areas in which all caterials, parts, components, and completed products are stored and labeled. NPI shall have the right to inspect for conformance to this cethod.
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 shs11 be provided to NPI. NPI personnel may witness these inspect'.ons.
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 Equipment 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 conforcance.
5.1.15 llandling, Storage, Distribution, Shipping, and Installation llandling, 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 m'arketed by C
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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 acceptabic material and a list of nonconforming items shall be prepared. The disposition of nonconforming material shall require the approval of the manufacturer's QA organization.
5.1.18 Corrective Action The manufacturer shall try to determine the cause for recurring non-conformances. Ile 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.
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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 retrievabic, identifiable, and available to company management as evidence of the workings of the QA program, i
The following documents are planned to be controlled:
1.
Quality Assurance Program 2.
Procedures 4.
Instructions 5.
Drawings 6.
Specifications 7.
Design Review Reports 8.
Contract Agreements 9.
Inspections 10.
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6.
Specifications 7.
Design Review Reports S.
Contract Agreements 9.
Inspections 10.
Installations
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11.
Dosimetry Records 12.
IIea'.th Physics Records 13.
Radioattive Respiratory Protection Program 14.
NPI's Program for Radiation Protection of Employee Exposures 15.
NRC Cask Use Certificates 16.
Road Use Certificates 17.
Truck Drivers' Logs (Form MCS-59) 18.
Vehicle Inspection and Maintenance Records 19.
Annual Review of Drivers' Driving Record 20.
Daily Reports of Vehicle's Condition 21.
Reports of Accidents (Forms MCS 50-T and MCS 50-B) 22.
Radioactive Shipment Record 23.
Personnel Qualification Approval and Certification Records 24.
Shipping Package Maintenance Schedule and Authorization 25.
Shipping Package Modification Authorization 26.
Medical Device Description for Reconditioned Teletherapy Units 27.
Device Master and llisotry Records for Sources 28.
Customer Complaint Files 29.
Calibration Records 30.
Component Control and Nonconformance Records These documents shall include records of the acceptance or rejection of all components used in target and source manu-facture, records of the disposition of all obsolete, rejected,
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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 perfornance and neces-sary maintenance schedules.
32.
Driver Qualification Record Records required to be maintained pursuant to Federal Motor 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.
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- 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 safely;
- The driver's application for employment;
- The responses of state agencies and past employers to inquiries concerning the driver's driving record and employment;
- The certificate of driver's road test issued to the driver or a copy of the license or certificate which NPI accepted as equivalent to the driver's road test;
- The questions asked, the answers the driver gave, and the certificate of written examination issued to him, or a copy of a certificate which NPI accepted as equi-valent to a written examination; and,
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- 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 records shall be maintained for at least two years.
VII.
Audits Audits of the Quality Assurance Program will be dependent on the significance of the activity being audited. Audits shall include
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V.
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36.
Corrective Action Reports 37.
QA Audit Reports The above records shall be maintained at specific locations in the UPI facilities and shall be reasonably accessibic, many on a proprie-tary basis, to governn:ent employees designated to perform inspections.
All shipping package design related records shall be maintained for the life of the shipping packaqe; irradiator operations charts, irradia-tor Logs, and irradiation unrk1heets which document dose control irradia-tions shall be maintained for at least five tjears; and an other records are maintained at feast.cto years.
VII. Auditn Audits of the Quality Assurance Program will be dependent on the significance of the activity being audited. Audits shall include 1
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Y an evaluation of the shipping and manufacturing practices and/or procedures, and shall be concerned with the safety and effective-ness of their inpler.cntation.
Audits shall be planned and include the nonitoring 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 shall be perforned by persons who do not have responsibility for the acca being audited, and who possess the ability to evaluate adequately the functions under investigation.
The results of these audits shall be documented and reaintained by the QA ?!anager and reported to the President along with any sugges-tions of reconmendations for improvement. Subsequentltf,.t/te Prcoident sliall direct line ranancment to take ultatever corrective actions lie decides is necessari).
In the event that deficient areas are located, they shall be re-audited on a timely basis to verify implementation of corrective
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actions.
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