ML19321A431
| ML19321A431 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 06/24/1980 |
| From: | Ransohoff J, Smedira C NEUTRON PRODUCTS, INC. |
| To: | |
| Shared Package | |
| ML19321A426 | List: |
| References | |
| 16678, NUDOCS 8007230354 | |
| Download: ML19321A431 (100) | |
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C QUALITY ASSURANCE PROGRAM FOR NEUTRON PRODUCTS, INCORPORATED REVISION 3 JUNE 24, 1980 d'. %W Ghylav C. Smedira,f-nager Quality Assu.mco s
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Introduction Neutron Products, Inc. (NPI) was established in 1959 to commercially produce radioisotopes. Activities of the company have grown to in-clude the production of radioactive sources for medical and industrial applications, the sterilization of hospital supplies and the radiation processing of chemicals to change their chemical and physical proper-ties.
NPI has, and will continue, to provide quality products and services to its customers. Efforts to improve the safety of company personnel, the public, the local environment, and when possible, the users of NPI products will continue and are closely coupled to the company's Quality Assurance Program.
NPI operates under the regulatory scope of the Nuclear Regulatory Commission (NRC), the Food and Drug Administration (FDA), the Depart-ment of Transportation (DOT), and the State of Maryland.
In the interest of public and occupational health and safety, regulations have been established with respect to quality assurance.
Execution of the Quality Assurance Program presented in this document, which has been written to comply with all appropriate regulations and is part of a continuing effort to provide high quality services at reasonable costs to 011 customers, is the sole responsibility of NPl.
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II.
Company Organization A company organization chart is indicated in Figure 1.
Mr. J. A.
Ransohoff, President of the company, is responsibic for overall management and operation.
Mr. M. M. Turkanis is the Vice President directly responsible for cobalt-60 production, marketing, and dis-tribution.
Mr. D. G. Woodard is the Vice President directly respon-sible for the radiation processing and radiation testing operations of the company.
Mr. C. Smedira is the Quality Assurance Manager.
As such, he will be responsible for the company's QA program. The QA Manager has the authority to stop any company operation which he has reason to believe is proceeding in an unsatisfactory fashion. The QA Manager reports. directly to the President and has.the catharity to identify problems, to initiate, recomend, or provide solutions, and to veri-fy.the implemerhttion of solutions.
The Quality Assurance.%1 nager must have a sufficientty broad educa-tion and experience.to be able to interpret the requirements of att reguia. tory agencies to att aspects of the company's operations.
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The QA organization reviews and concurs with inspection plans, test, calibration, and special process procedures; drawings and specifica-tions; and changes thereto.
i 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 tchicIt are.to be performed by.the NPI QA organization are listed in Section V of.this document.
Corporate fbtance and adninisttation occur under the ' direction of.the Corporate Treastuter and Secretary, respectively. The Corporate Secre-tary also manages the company's Laminar Flow Technology activities.
From time.to time, special ptofeets are undertaken under the direct supervision of the President of.the company. When this happens, a senior
. technical manager, as opposed to one of.the corporate of ficers or the QA ffanager, teill be given the responsibility.to execute.the project.
The President and.the QA !fanager shall confer a.t.the htitia. tion of any such ptofeet.to deternine an approptiate QA apptoach for.the project.
Personnel assignments and responsibilities are presented in more detail in each of the specific quality control programs presented in Section V.
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The Presidestt of NPI teilt, at least once each year, communicate.to all-reptesentative organizations and hidividuals.that.the requirements of
.the QA ptogram and ptocedures are mandatory and that he has charged
.the QA Hanager taith the responsibility.to implemeest and enforce these requirements. The President of the company shall be responsible for the resolution of att disputes involving qualittj arising from a dif-ference of ophtion beticeen. tite QA Manager and oBier Line management in the company.
Lbte management at NPI sitall be responsible for estab-lishing an htdoctrination and trahting ptogram such.that:
1.
Personnel responsible for performbig quality related activities are insttucted as to.the purpose, scope, and implementation of.the QA ptogram, insttuctions, and ptocedures.
2.
Personnet performing qua.lity affecting activities are ZAabted and qualificd in.the pthiciple and. techniques of the activity being pc:tfonned.
3.
The scope,.the objective, and the method of implement-ing the indochtination and training program are docu-mented.
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Proficieney of personnet perforning quality affecting activities is mabttained by retrahting, reexaminbtg, and/or recertifging.
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Company Operations This section presents a listing and brief description of the present and anticipated products and services of NPI.
1.
Cobalt-60 Irradiation Sources The company is engaged in the business of selling cobalt-60 sources for teletherapy, intercavity, and industrial appli-cations. Toward this end, company activities include cobalt-59 target design, procurement, transportation, and irradiation, as well as cobalt-60 transportation, process-ing, encapsulation, delivery, installation, maintenance, and replacement.
2.
Maintenance of Teletherapy Units The company is engaged in the business of repairing and reconditioning cobalt-60 teletherapy units currently in use.
3.
Radiation Processing The company uses cobalt-60 irradiators to process materials to achieve desired biological, chemical, and physical pro-perties and in conjwtetion with a chemical mix pEant, to produce a group of polymeric products largely based on acrijtanide.
Irradiators are also used for testing to deter-mine the effect of radiation on chemical and physical pro-perties of substances and to determine the performance of equipment used in radiation environments during normal and off-normal conditions.
4.
Laminar Flow Testing The company provides inspection, testing, and routine main-tenance services for horizontal and vertical laminar flow hoods used in hospitals, pharmacies, and in other cican 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.
NEUTRON PRODUCTS, INC.
-E0ARD OF DIRECTORS J. Ransohoff, M. Turkanis, D. Woodard Office of the President Special Projects J. Ransohoff, President R. Demory D. Culler D. Repp Laminar Flow Techn21ogy F. Kreysa Acting Manager
' Finance and Administration Quality Assurance F. Kreysa, Secretary g gg1 PNeds D. Lewis, Treasurer C. Srmdira, Manager L
Sources and Systems Radiation Processing H. Turkanis D. Woodard Vice President Vice President Ffgure 1
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k Radiation Detectors - The company sells the Primalert-10 Radiation Level Monitor and the optional Primalarm remote signal unit.
Simulators - The company plans to market a new radiation therapy simulator, a device used in the localization of tumors and for planning radiation treatments.
IV.
General Quality Assurance Approach 10 CFR 50, Appendix B, and 10 CFR 71, Appendix E, provides 18 guidelines for establishing and implementing a quality assurance program for some types of nuclear activities. 21 CFR 5 provides nine guidelines for the establishment of " Good Manufacturing Practices" for medical devices.
The NPI Quality Assurance Program is committed to complying with these 27 guidelines (not all of which are different). This QA plan represents NPI's application of these guidelines to company activities. The formal QA approach presented in this document consists of the following key elements:
Planning - what to do to provide quality Judgement - to determine what should be verified and/or documented
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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, ju 4ement, execution, and documentation activities. The QA Manager participates and concurs in these activities and has the responsibility for auditing tasks.
In view of NPI's size, maximum use of line indi-viduals has been made. Line individuals will be qualified to check, verify, test, and inspect independent actions of other line individuals.
The QA Manager will continue to assess the effectiveness of the overall program and be responsible for program change, indoctrination and, 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 from Section II, and the basic approach is consistent with the general intention of this section.
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HPI management sciEL assess the scope, status,.implemesttation, and ef fec-tiveness of the QA ytogram to assure tlat the program is adequate and complies icith all applicable regulations, at least.bco times a tjear.
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.
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, Each subplan follows this cutline:
Scope 1.
Organization 2.
Quality Assurance Definitions 3.
Buildings 4.
Equipment 5.
Design Control 6.
Procurement Document Control 7.
Instructions, Procedures, and Drawings 8.
Document Control 9.
Control of Purchased Material, Equipment, and Services 10.
Identification and Control of Materials, Parts, and Components 11.
Special Processes 12.
Inspection 13.
Test Control 14.
Control of Measuring and Test En at 15.
Handling, Storage, Distributing, Snipping, and Installation 16.
Evaluation, Inspection, Test, and Operating Status 17.
Nonconforming Materials, Parts, and Components 18.
Corrective Action 19.
Packaging and Labeling Where a particular 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 Materials Transportation 1.5 Ra:Licactive Source Transfer 2.
Teletherapy Unit Reconditioning 3.
' Radiation Processing n
3.1 Dose Control Irradiations 3.2 Physical and Chemical Properties Irradiations 3.3 Pofyacrytamide Production 3.4 other Irradiations
- 4. -Laminar Flow Testing 5.
Product Marketing
1.1 Reactor Target Assemblies 1.1.1 Organization Design, fabrication, transportation, and irradiation of cobalt-60 reactor targets is the responsibility of the Vice President for Sources and Systems. He will be assisted by other company person-nel as appropriate.
A definite distribution of responsibilities between NPI, other contractors, and the reactor operator will be established for each 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 assemblics - completed rods, herein called targets, ready for loading into a reactor.
Capsule - a scaled stainless steel tube containing cobalt-59 material. This tube is contained inside the target assembly.
Quality - a quality target is one which has the purity and integrity of composition to withstand the necessary handling, irradiation, and transportation without the release of cobalt to any reactor system or the environment and perform its in-tended neutron absorbing function within the reactor.
1.1.3 Buildings Targets and target components will be fabricated and handled in NPI existing buildings and in other facilities.
Adequate space shall be provided to facilitate cicaning, prevent mixups, and asure the orderly handling of incoming material, rejected material, material in the fabrication process, and testing and measuring equipment.
Adequate lighting, ventilation, and tem-perature and humidity control shall be provided. Airborne con-tamination shall be monitored and kept within appropriate limits.
Inspections of the building condition shall be periodically per-
- formed and the results of these inspections shall be recorded.
The NPI and contractor quality assurance crganizations shall be responsibic for the performance and documentation of these inspec-tions in their respective facilities. No less than two inspec-tions per year will be performed. The line organization shall be responsibic for cleaning the buildings. Adequate sanitary facilities will be provided.
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1.1.4 Equinrent Nondisposable equiptent used in the manufacturing process of target components and assecblies shall be cleanable and, if necessary, adjus tabic. Equiptent shall be stored in such a manner to reduce contamination by dust or dirt or radioactivity.
Equipment will be clean uhen used.
Equipment which requires periodic adjustment shall have allowable tolerances posted where the equipment is stored or used.
Materials used in the canufacturing 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 rethod for coordinating and interfacing with other organ-izations, contractors and the reactor operator to assure compliance with these requirecents. A design review to assure that the design meets the design criteria shall be conducted. Representatives of
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other organizations (such as the reactor operator) may participate in this review. Only parts, materials, and processes which have been proven to be acceptable for targets will be used.
Specifications, drawings, instructions, and other engineering documents which may be necessary to describe the design, materials, fabrication, instal-lation, testing, inspection, packaging, shipping and storage require-ments of the targets will be prepared at NPI and at other contractor organizations. A specific definition of responsibilities for.all documentation shall be cade.
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.
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1.1.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings 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 Assenbly and in the approved specifications of a contractor as appropriate. Periodi-cally, audits shall be conducted to check for conformance.
1.1.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Vice President for Source 6 and Systerto and by con-tractors, as appropriate. These documents shall be submitted to the QA Hanaget for approval. Changes to any of these documents shall also require his approval.
1.1.9 Control of Purchased Material, Equipment, and Services Independent materials testing and examination of each and every target and capsule shall be performed and the results documented.
1.1.10 Identification and Control of Materials, Parts, and Components
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The Vice Pac 4ident for Sourcea and Systema shall establish a con-trol area in which all targets and capsules are stored and labeled.
Access to this area shall be limited. Vendors supplying target and/or capsule materials shall comply with NPI 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 appropriate dcaignee of the Vice Pacaident for Sourcca and Systema or by the contractor's organization. Nondestructive examination of target compenents shall be in conformance to NPI 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 nrproved 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.
Per;odically, 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 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.
1.1.1S 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 2008, Procedure for Placing and Unloading Casks in Main Storage Pool.
Target installation in a reactor shall be in accordance with the appropriate technical specifications of the reactor opera-tor.
1.1.16 Evaluation, Inspection, Test, and Operating Status Target operating status shall be ascertained by the reactor operator via flux level indicators, flowmeters, and thermo-couples. Acceptable flux and comperature 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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i i Nonconforming material shall be stored physically apart from acceptable material and a list of nonconforming items shall be prepared by the Vice President for Sources and Systems or by contractors and provided on a weekly basis to the 0 atity Assumtnce Manager. The Vice President for Sources and Systems shall make recommendations for appropriate disposition for nonconforming materials. The approval of the QA Manager is required for any disposition of nonconforming material. Such disposition shall be documented.
1.1.18 Corrective Action The Vice President for Sources and Systems shall document the cause for nonconformance of any items so labeled. lie shall also document recommendations for suggested corrective actions.
1.1.19 Packaging and Labeling All targets and capsules shall be uniquely labeled.
1.2 Radioactive Source Inventory Control 1.2.1 Organization The responsibility for the characterization and maintenance of all radioactive source material inventoryfhas been delegated to the Vice President for Sources and Systems. Under the Vice President, the responsible individual is the Section Manager for Source Production, Mr. J. Corun.
Mr. Corun will be assisted by other company personnel as appropriate.
1.2.2 De'finitions
~ Inventory quality control program - one which (1) continually
~ and accurately records the identity, location, and activity of all individual source material; (2) is conducted in com-pliance with the NPI Radiation Protection Program; end, (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.
1.2.5 Design Control Not applicable 1.2.6 Procurement Document Control Not applicable 1.2.7
' Instructions, Procedures, and Drawings After target rod sources have been removed from an incoming shipping l
' cask and' documented as to their position in the pool storage tank, j
they shall be calibrated. After calibration, the target rods shall l
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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 target number, 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 removed from the inventory file, identified as to encapsu-lated source number, and placed in the customer's file.
1.2.9 Control of Purchased Material, Equipment, and Services Not applicable 1.2.10 ' Identification and Control of Materials, Parts, and Components As each rod'is remove'd from the shipping cask, its identifying number shall be documented and the position in the pool storage tank noted.
1.2.11 Special Processes Each individual source shall be calibrated and the results docu-mented. All rod and spring sources shall be calibrated by the underwater pool calibrator or by the hot cell calibrator (in both of these the source is passed under a shicided collimated detector and the output reading plotted; the readings are compared to a known standard to determine curie activity). Teletherapy
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sources shall be rated by direct output dose rate by measurement in the hot. cell.
1.2.12 Inspection Periodic inspections shall be conducted to assure that the pool operator can locate a particular source. The source shall be pulled from the holder and calibrated and the resulting trace shall be compared with the trace already existing for that source.
A record of such inspections shall be maintained by the Quality 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 measurt.nent of standard industrial sources. The dose rate meter shall be periodically tested by measurement of a standard teletherapy source. The calibrator and planimeter shall be tested periodically.
Records of such testing and the results shall be kept.
1.2.15 Handling, Storage, Distributing, Shipping, and Installation All incoming target rods shall be handled in accordance with NPI Procedures NR 2001, Procedure for Loading and Removal of Radio-active Shipping Containers from the Main Storage Pool; R 2007, Calibration by Area Method; R 5002, Opening Hot Cell Door After Processing Single and Double Encapsulated Cobalt-60; R 5004, Transfer of Sources Between Hot Cell and Canal Tanks; R 5005, Loading of Encapsulated Sources in Transfer and Shipping Con-tainers from Hot 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 tie Source Production Manager or appointee at least once a day a<d a graph of pool temperature as a function of time shall be p ovided 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 Presidcnt 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 applicabic 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.
Ilot cell - the shielded enclosure in which the majority of source fabrication operations are perforced.
Pool - a pool of dimenerali:ed 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, coatainment of contamination, and inte-grity of the product.
1.3.4 Equipment 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 minimi::e the spread of radioactive contamination, and to provide a high degree of reli-ability and reproducible accuracy as required.
1.3.S 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 materials.
This control shall be the responsibility of the Source Production Section blanager and periodically checked by the Quality Assurance i
bianager or appointee _in accordance with NPI Specification P-4, i
Procedure for Encapsulation of Teletherapy Sources.
1.3.7 Instructions, Procedures, and Drawings All instructions, procedures, and drawings required to fabricate sources will be provided in NPI Specification 51-1, 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 j
the Source Production Section bianager. These shall have the approval of the Vice President of Sources. and Systems.
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1.3.9 Control of Purchased bfaterial, Equipment, and Services The Source Production Section b!anager will initiate and approve all purchases and maintain records of the source inventory.
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1.3.10 Identification and Control of Materials, Parts, and Components The Source Production Section !!anager 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 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 c11 critical operations will be in accordance with NPI Specification P-1, Specifications, Procedures, and Quality Control for Sealed Cobalt-60 Sources.
1.3.13 Test Control All sources shall be tested for quality and integrity in accordance with NPI Specification P-1.
1.3.14 Control of Measuring and Test Equipment
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Equipment for calibrating and measuring shall be in accordance with NPI Procedure R 2007.
1.3.15 llandling 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 r
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.
. 1.3.19 Packaging and Labeling All finished teletherapy sources shall be uniquely identifiable.
Packaging for shipment shall be in accordance with Section 1.4 of this document.
1.4 Radioactive Matetials Transportation 1.4.1 Organization Design, fabrication, and maintenance of radioactive material shipping containers and transportation of radioactive shipmentts is the respon-sibility of the Vice President for Sources 'and Systems.
He shall be assisted by o.ther company personnel as appropriate.
1.L2 Definitions Quality packaging - the loading of radioactive ma.terials in an NPI or odier organtization's sitipping container for sitipment in con-formance with applicable regulatory requirematts, and completion of the documentation of Biis activity in accordance teith the requirements of.this section.
Off site tocation - a location other tJian Dickerson at which a radioactive shipment controlled by NPI may origina,te.
Qualiti transportation - 6te safe and efficiatt carrging af radio-active ma.terials from one site to another in accordance taith applicable requiremotts and the completion of documentation of B11s activity.
Radioactive ma,terlats shipping container - herein cailed container, is one complying with Bie applicable regulations of the DOT and NRC.
1.4.3 Buildings Buildings in which shipping con. tainers are stored or handled shall have adequa.te space for cicaning, maintaining, and orderly handling of-inconing and outgoing shipments. Airborne contamination shail be minimized and monitored in facilities whicit have a1 capsula.ted radioactive materiais.
Inspections of 6te buliding conditions shall be performed periodically and ute results recorded.
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1.4.4 Equipment Equipment used in handling and vehicles used for ZAansporting con-tainers shalt be Mored in such a manner as to maintain an adequate condition for use. Shipping con. tainers, overpacks, special handling equipmott, inMruments, and tools teilt be mairttained by.the Tele-
. therapy Services Section Manager.
Equipment needed.to perform quality related activities shall be specified ptier to use, as shall.the en-vironmental conditions under tehich the equipment is.to be operated.
1.4.5 Design Contnot The V. ice President for Sources and SyMems is responsible for.the design of containeAs and handling equipment. u' hen additional trans-portation equipment design is required, he shalt establish procedures to assure.that applicable design criteria, standards, ptactices, and regulatory requitements are defined and LAanslated into specifica-tions, draicings, procedures, and instructions.
He shall establish and impicmait a method for coordina. ting v:ith other organiza.tions and con-tractors. A dc. sign revieu: shall be conducted to assure that i1).the design meets the design criteria; (2) design charac.teristics can be controtted, inspected, and. tested; and, (3) inspeclion and. test cri-
.teria are identified. The individual responsible for.the design re-victe shall be othcA than,the original designer and the designer's
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inmediate supervisor.
Design and specification changes shall be subject to.the same design contAots and approvals.tha.t tecre appli-cable to.the o.tiginal design.
For cach design activity for a trans-portation package, specific organizational responsibilities shall be established.
1.4.6 Procurement Document Control Vendors or contractors supplying shipping containeAs, handling equip-ment, and parts shall comply teith HPI Specification E-1, Equipmott Specification for a Lead Shielded Shipping Cash or other appropriate specification.
Control of procurerent documents shall be.the respon-sibility of.the Vice President for Sources and SyMems. He shall be responsible to (1) ptepare as appropriate, procedures or instruckions
.tlutt clearly delincate the sequence of actions to be accomplished,in
.the preparation, reviete, apptovat, and control of permanent documents; (2) identify in aCL appropriate procurementt documents, the applicable 10 CTR Pa.tt 71, Appendix E requiremotts tdtich must be compiled toith and described in the supplicr's CA ptogram; (3) require tha.t ptoctttematt documents contain or refenence the design bas.is teclutical requirements 1
. including.the applicable regttlatory requincments, ma.terial and com-ponent identificaticn requirevents, drateings, specifications, codes
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and industrial standards, test and inspection requirements, and special ptocess b structions; and that they specify.the documen-tation (e.g., drateings, specifications, ptocedwtes, inspection and fabrication plans, htspection and test reco.1ds, personnel and procedures qualifications, and chenical and physical test results of matcriat) to be prepared, maintained, and submitted to NPI for revietc and approval; (4) specify those records to be retained, con-traded, and ma.intained by the supplier, and those delivered.to NPI prior to use or instaliation of.the hardaure; and, (5) reqttire HPI's right of access.to supplier's facilities and records for htspection and audit.
Changes and revisions to procurement docume tts shalt have at least the same revicic and approvat as the original document.
1.4.7 Instructions, Procedures, and Drateings See Section 1.4.8.
Periodic audits.to check for conformance to
.these documeitts teilt be conducted bi.the QA l'anager or his designee.
j 1.4.8 Documen.t Conttot Insttuctions, procedures, drateings, and specifications for containers, container imidling, packaging and shipping are lis.ted in and shall
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comply taith NPI QC Procedure 1001.
Responsibilities for the initla-tion, revietc, approval, and issuance of these documents are specified in.this procedure and no changes to.these documents shall be made leithout.the approval of the same people teho htitially approved these documents. Approved changes in instructions, procedures, drateings, and other documents shall be made prior to.the implementation of such changes.
The QA Manager shall be responsible for assuring
.that the sequence of actions required by Procedure 1001 for the ytepa-nation and revicio of required documentation is fottoteed.
Apptopriate documents shall be available at att teork Locations ptior to commencement af teork. The Vice President for Sources and Systems shall have and mahttain a mas.ter list tdtich identifies.the curren.t.
revision niunber of instructions, procedures, specifications, drate -
ings, and procurement documents.
1.4.9 Corttal of Purchased Iktterial, Equipment, and Services The Vice President for Sources and Systems shall have an evaluation done of ait suppliers.to assess.their capability.to provide acceptable C
a.
quality services and products.
Thls evaluation shalt be based on a survey of.the supplier's facilities and QA program.to determine his capability to supply a product tdtich meets.the design, manu-facturing, and quality requiremeris. AfL supplich evaluations shalt be documented and filed.
When required, HP1 surveittance of suppliers during fabrication, inspection,. testing, and shipment of materials, equipment, and componer2s shalt be performed.to assure conformance.to the purchase order regtdrements.
Att suppliers shall be requi'ted.to furnish the folloteing records as a mirdmum.to the purchase:
1.
Documentelion t!at ida:tifies.the purchased materlat or equipmen,t and.the specific procuremott requirements (e.g., codes, standards, and specifications) met by
.the itens.
2.
Documentation tha.t identifies any procurement require-ments edich have not been met together icith a descrip-tion of.those nonconformances dispositioned " accept as is" or " repair."
Receiving inspection of the supplier-furnished material, equipment, and scruices shall be perfarmed to assure:
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1.
The ma.terlat, components, or equipmatt is property idattified and corresponds teith.the idattification on receiving docurattation.
2.
Material, componatts, equipment, and acceptance records are inspec,ted and judged acceptable in accordance teith predc.termined inspection instruc-tions prior.to installedian or use.
3.
Inspection records or certifica.tes of conformance attesting to.the acceptance of materlat and com-ponents are available prior to installation or use.
4.
Itens accepted and retcased are idattified as to
.their inspection status ptior.to forvurding them to a controlled s.torage area or retcasing them for further teork.
1.4.10 identification and Conttot of Materlats, Parts, and Components The Vice President for Sources and Systems shall be responsible for the proper idertification and control of materials, parts, and com-ponents associated teith the fabrication of radicactive shipping containers.
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1.4.11 Special Processes Loading and w: Loading coriainers for radioactive siipmeris are special processes.
These shalt be performed in accordance scith HPI QC P.togran 1003, Packaae Loading Procedure for Radioactive Materials and QC Prograr 1004, Package Untoading Procedure for Radioactive Ma.terials.
1.4.12 Inspection Inspection of all quality conformance activities shall be performed wider the responsibility of the QA Manager in accordance taith QC Procedure QC 1006.
InspecAion personnet teill be independent from
.those performing.these activities. These inspec. tors shall be qualified ht accordance tcith.the company's.trairing program and tchen other qualifications and certifications are required they shall be kept currert.
Ifodifications, repairs, and replacements for shipping casks sludt be inspec.ted in accordance teith the original design and inspecklon requirements, or acceptable alternatives.
Operating and QC procedures teilt identify, tchere applicable, mandatory htspection hold points for teltness by an inspector.
C-1.4.13 Test Control The l' ice President of Sources and Systems shall be responsible for shipping cask test corirol.
A. test procedure for demonstrat-ing tha.t shipping casks tcitt perform satisfac.tority in service is established and documented. This procedure is a checklist performed in accordance teith QC Procedure 1006. Any moclifications, repairs, or replacements.to shipping ca.sks shaLL be tested in accordance telth.the original design and. test requirements or acceptable alternatives.
Test results are documeried, evalua.ted, arid their acceptability deternined by.the Secklon l'anager responsible fc.:.the radiation shipment.
i 1.4.14 Control of Measuring and Test Equipment Alt measuring and. test htstruments shall be calibrated at specific httervais to assure accuracy for intended purposes.
Calibration
. test data for.these histrtwents shall be identifiable and.traceabic.
Wheneven +"st equipment is found.to be out of calibration, previous tests tew. be investigated for validity and so documented.
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Where applicable, as in the case of radiaticn measuring instruments, t1e basis for calibration sciU be traceable to natiorally recognized 1
Mandards.
1.4.15 Handling, Storage, and Shipphtg AU operations concerning handling, storage, and si'ipping of radio-active shipping casks shall be ht accordance v:ith NPT QC Procedure 1005, Handling, Storage, and Shipping Procedurz for Radioactive Haterials.
Special handling, preservation, Morage, cleaning, packaging, and shipping requiremeris are eMablished in this pro-cedure.
These are accomplished by trahted, specifically designated qualified individuals ht accordance teith tite above procedure.
All conditions of HRC package approval and U. S. DOT shipping re-quiremertts shall be satisfied prior.to any shipment. Att necessary shipping papers shan be property prepared. Departure and arrivat time and destination of each package shaLL be established and moni-
.tored to a degree consistent scith safe transportation of the package.
1.4.16 Eva.Euation, inspection, TcM, and Operating Status Inspection,. testing, and operating Matus of att sitipping packages and components shall be ht accordance tcith NPI QC Procedure 1006, C,
Inspection, Ted, and Operating Status Procedure for Radioactive Materials.
Identification,. test, and operating Matus of att packages and components shall be knotat by all affec.ted sections.
Application and removat of hispection tag markings, and shipping or other labels shan be controlled ht accordance leith QC Procedure St -passing of required inspections, tests, and other critical 1006.
j operations, requires the prior approval of.the tiice President for Sources and.the QA Manager.
The status of nonconforming, htoperative, or malfunetioning packages or components sha.lt be clearti identified to prevent inadvertent j
use.
1 1.4.17 Nonconforning Parts Any nonconforming parts teilt be so identified and segregated for disposal or removat from the container or shipping arcas.
Honcon-farming ma.terlats, parts, componeris, and scruices shatt be con-
. trolled in accordetce telth NPI QC Procedures 1005 and 1006 tehich require.the identification, documentation, segregation of noncon-forming itcms and the natification of affec.ted individuals.
Desig-nations of individuals responsibte for the review and disposttion
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of the materials are made in these procedures.
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Documentation shali identify.the nonconforming itan, state its inspection requirerents, describe the nonconfowance, and iden-
.tify final disposition.
Signa.ture approvat of.the Vice President for Sources and Systens is required for final disposition.
Acceptability of.ter:ork or repair shalt be verified by reinspec-tion and re. testing, a.s required, and as originally inspec.ted or by an equal method.
1.4.18 Cou ec.tive Action The QA Hanager shall conduc an evaluation, in conjunction teith
.the Vice Presiden.t for Sources and Sys.tems, of any conditions determined.to be adverse to quality (such as nonconformances, faliares, matfunctions, deficiencies, deviations, auid defective ma.terials and equiptrent) to determine.the need for corrective action.
Repair or replacement of nonconforming parts or the correction of 0.ther deficiencies shall be recommended by.the Source Produc-tion Section Ifanagcr,.the !!anager for Utilization, Facilities, and Equipment, or.the Health Physics Technician, and must be approved by the Vice Presiden.t for Sources and Systems.
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To.the cztent possiblz, corrective ac.tions shall attempt.to preciude recurrence of the adverse condition.
Foltoaup revicies shall be conducted by the QA Manager to verify
.the proper implementation of correclive actions and.to close out.the corrective action docwnentclion.
1.4.19 Packaging and Labeiing Ali NPI radioactive shipments shall be packaged and labeled in accordance leith WI QC Program 1003.
1.5 Radioactive Source Transfer 1.S.1 Organization The Vice President for Sources and Systens has the overall respon-sibility for radioactive source transfers.
The loading and unloading of radioactive shipping containers and the preparation for shipment at NPI is the responsibility of the Source Production Section Manager.
Loading, unloading, and prepa-ration for shipment offsite is the responsibility of the Teletherapy
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Services Section Manager teho is also responsible for installation of sources into teletherapy units.
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Design and fabrication of source adapters which are installed in a teletherapy unit is the responsibility of the Source Production Section Manager.
Design and fabrication of container insert holders and adapters which are part of the transfer operation are the respon-sibility of the Utilization, Facilities, and Equipnent Manager.
1.5.2 Definitions Radioactive source transfer - the field operation involving the transfer of sources between shipping centainers and teletherapy units, unloading units, transferring, sources into and out of en operating unit and transferrhg sources from one operating unit to another, including teletherapy unit checkout, servicing, and maintenance.
~ Teletherapy unit - a machine using cobalt-60 at a distance for 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-mer.;s, and tools will be maintained by the Teletherapy Services Section Manager. Vehicle maintenance will be the responsibility of the user.
1.5.5 Design Control Not applicable 1.S.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
(,
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 Cor.irol 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 sourc'e adapters installed in a teletherapy unit shall be the responsibility of the Source Production Section Manager. Centrol for parts used in transfer of sources shall be the responsibility of the Teletherapy Services Section Manager, 1.5.10 Identification and Control of Materials, Parts, and Components The Teletherapy Services Section Manager shall be responsible for all materials, parts, and components used in making equipment for radioactive source transfers.
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1.5.11 Special Processes Source replacecent in the field is a special process and shall be i
performed only by trained and licensed personnel.
1.5.12 Inspection Routine inspection of containers, equipment, instruments, tools, and parts shall be conducted by the Teletherapy Services Section Manager. Transportation vehicles shall be inspected by the Quality Assurance Manager or his designee.
1.5.13 Test Control Not applicable 1.5.14 Control of Measuring and Test Equipment The Teletherapy Services Section Manager shall be responsible 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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IIandling, 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 Nonconforning 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 t
)
believe that sone corrective action associated with an NPI per-formed radiation source transfer is necessary, the Teletherapy Services Section Manager shall take appropriate recommendations for the approval of the Vice President for Sources and Systems and the QA Manager, i
. 1.S.19 Packaging and Labeling All parts will be packaged and labeled for identification. The shipping container shall be labeled in accordance with regulatory requirements.
2.1 Teletherapy Unit Reconditioning 2.1.1 Organi::ation Reconditioning of teletherapy units is the overall responsibility of the Vice President for Sources and Systems. The Teletherapy Services Section Manager is responsible for accomplishment of this work.
2.1.2 Definitions Teletherapy unit - a machine using cobalt-60 at a distance for radiation therapy Quality teletherapy unit reconditioning - the repair, replace-ment, refurbishing, shipping, installation, and testing re-(.
quired to produce reusable units or components, in compliance wii.h ANSI " Guidelines for Maintaining Cobalt-60 and Cesium-137 Teletheracy Equipmat," N449-1974.
2.1.3 Buildings The buildirrs 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 comply with the above conditions.
General building conditions shall be periodically inspected by the Vice President for Sources and Systems and independently by the QA Manager.
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2.1.4 Equipment Reconditioning and installation equipment and tools shall be main-tained by the Teletherapy Services Section Manager. Responsibility for the maintenance of vehicles shall be with the Teletherapy Ser-vices Section Manager.
Equipment 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 Document 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 Drawings All instructions, procedures, and drawings required for recondition-ing, shipping, and installation shall be in accordance with NPI
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Procedure R 5010. Periodically audits will be conducted to check for conformance.
2.1.8 Document Control All documents relating to reconditioning, instructions, procedures, drawings, and specifications shall be controlled by the Teletherapy Services Section 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 which is covered by Section 1.5 of this document.
2.1.12 Inspection Routine inspection of parts and components shall be done by the Teletherapy Services Section Manager or his appointee. A complete inspection of finished units or components before shipping and after installation shall be in accordance with NPI Procedure R 5010.
2.1.13 Test Control NPI Procedure R 5010 establishes the steps necessary to assure that an installed unit has not suffered damage in transport.
2.1.14 Control of Measuring and Test Equipment Meters used to check radiation leakage from teletherapy units shall be periodically calibrated. Calibration shall be recorded. Each calibration record shall show the name of the person who performed the calibration, the date on which it was done, and the next date on which a calibration should be performed.
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2.1.15 Handling, 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 Manager.
2.1.16 Evaluation, Inspection, Test, and Operating Status The evaluation, inspection, test, and operating status shall be in accordance with NPI Procedure R 5010.
2.1.17 Nonconforming Parts Parts from existing teletherapy units and/or purchased parts found to be nonconforming will be so identified and segregated for dis-posal or removal.
2.1.18 Corrective Action If a reconditioned teletherapy unit is suspected of needing correc-tive action by NPI or customer personnel, the Teletherapy Services Section Manager shall recommend an appropriate course of action to (L
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. the Vice President for Sources and Systems aad the QA Manager.
The Vice President for Sources and Systems shall make the deter-mination of appropriate corrective action.
2.1.19 Packaging and Labeling Reconditioned teletherapy units shall be packaged for transit and transported by truck. A reconditioned unit shall be appropriately labeled.
3.1 Dose Control Irradiations 3.1.1 Organization The Vice President for Radiation Processing Services, Mr. D. G.
Woodard, has the responsibility for all activities required to perform dose control irradiations. The responsibility for assur-ing compliance teith the customer's specifications and schedules has been delegated to the f.Licrobiological Control Products Manager, Ms. G. Barrekt.
The responsibility for conducting the irratdiation 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-(
fled 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.
3.1.3 Buildings For any operation or processing campaign, sufficient spcce shall be provided to facilitate adequate cleaning, prevent mixups, and to assure the orderly handling of incoming material, rejected material, material in the irradiation process, and testing and measuring equipment. Adequate space to perform dosimetry measure-ments will be provided as will sufficient lighting, ventilation, and temperature control. Airborne contamination shall be kept within C
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acceptable industrial standards.
Inspections of the building condition shall be periodically performed and the results of these inspections shall be recorded. The NPI quality assurance organi-zation shall be responsible for the performance and doeurentation of these inspections. No less than two inspections per year will be perforced. The line organization shall be responsible for cleaning the process areas.
Sanitary facilities will be provided.
3.1.4 Equipment Nondisposable equipment used for handling, irradiation, and shipping shall be cleanable and, if necessary, adjustable.
Equipment shall be stored in such a manner tu reduce contamination by dust or dirt or the accumnulation of chemicals. Equiprent will be clean when used. Equipment which requires periodic adjustment shall have allowable tolerances posted where the equiptent is stored or used.
3.1.5 Design Control Not applicable 3.1.6 Procurement Docurent Control Not applicable
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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 Docurent Control Instructions, procedures, drawings, and specifications shall be issued by.the Microbiological Control Product %:ager 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 Material, Equipment, and Services Control of materials, equipment, and services shall be the respon-
.sibility of the Irradiations Section Manager.
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3.1.10 Identification and Control of Materials, Parts, and Components bbterials, parts, and components required for irradiation, except cobalt-60, shall be stored and identified by the Irradiations Sec-tion Manager.
3.1.11 Special Processes Not applicable 3.1.12 Inspection Product dosimetry shall be the principal means of inspection. Dosi-metry shall be performed in accordance with Irradiator Operating Instructions, Processing Dosimetry. Products determined to be non-conforming to the customer's specifications shall be tagged accord-ingly and stored physically separate from acceptable material. The Picrobiological ContAof Produc,t Manager shall document 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 Equipment Dosimetry equipment will be used to ascertain uniformity and/or levels of radiation doses. This equipment will, at a minimum, consist of an optical density reader and a thickness gauge. These items will be examined to determine if periodic calibration is 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 perforned the calibration, the date on which it was done, and the next date on which a cali-bration should be perfort '.
3.1.15 Handling, storage, Distributing, and shipping For each product handled by NPI, a specific instructi u is prepared which documents the company's methods for controlling customer prod-ucts during handling, storage, and shipping.
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3.1.16 Evaluation, Inspection, Test and Operating Status Operation of the irradiators shall be in accordance with NPI Pro-cedures !!PI R 6001 and R 7003.
3.1.17 Nonconforming Materials, Parts, and Components Not applicable 3.1.18 Corrective Action In the event that dosinetry reveals that a product has not received the required dose, this fact shall be documented and reported to the Vice President for Radiation Processing Services and the QA Manager.
The Irradiations Section 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.
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3.2 Physical and Chemical Properties Irradiations 3.2.1 Organization See Section 3.1.1.
The Polt mer Modification Product Manager, Mr. J. Tang, has the respon-j sibility for assuring compliance with the customer'4 4pecifications and achedulca.
He aupervisca the laboratory work necessary to deter-nine required doses and to ascertain the quality of the product.
3.2.2 Definitions Quality - a quality physical or 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
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3.2.3 3uildings See Section 3.1.3.
4 Appropriate laboratory space shall be provided for product saepling i
and testing.
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3.2.4 Equinrent See Section 3.1.4.
3.2.5 Design control Not applicabic 3.2.6 iProcurement Document Control Not applicabic 3.2.7 Instructions, Procedures, and Drawings See Sect *.an 3.1.7.
Specific instructions shall be written for the necessary laboratory
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support and product testing activities.
3.2.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Irradiations Section Manager for activities associated _vith running the irradiators and by the Poltper f.fodification Produc,t Manager for laboratory support activities. These documents shall have the approval cf 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, Eauipeert, and Services See Section 3.1.9.
3.2.10 Identification and control of Materials, Parts, and Components See Section 3.1.10.
3.2.11 Special Processen Not applicable k
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3.2.12 Inspection Preperties testing shalt be the principal reans of inspection.
Testing shall be performed in compliance with written instruc-tions.
Dosiretry shall be perforced in accordance with Irradiator Operat-ing Instructions, Processing Dosimetry. Products determined to be nonconforcing to the custorer's specifications shall be tagged accordingly and stored physically separate frc: acceptable material.
The Polymer ucaigicazten Produe2 Manager sha11 accueene all noncon-formances and bring them to tha attention of the Irradiations Sec-tion ibnager and the Vice President for Radiation Processing Services within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.2.13 Test Control See Section 3.2.12.
3.2.14 control of Veasuring and Test Equipment Laboratory equipeent necessary for saepling and testing of products shall be available and the Polymer Modif.icAtien Produci Manager shall determine if periodic adjustments or calibratiens are required. Lab-(
oratory equiprent which requires periodic adjusteent shall have allow-able tolerances posted where the equipment is used.
Periodic calibrations shall be recorded.
Each calibration record shall show the name of the person who perforced the calibration, the date on which it was done, and the next date on which a calibra-tion should be performed.
3.2.15 liandling, Storage, Distributing, and Shipping See Section 3.1.15.
3.2.16 Evaluation, Inspection, Test, and Onerating Status See Section 3.1.16.
3.2.17 Nonconforming Materials, Parts, and Components Not applicable
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t 3.2.18 Corrective Action The Pott mcr Hodification Produci Manager and the Irradiations Section j
Manager shall recorr.end in writing to the Vice President for Radiation 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 shall make the determination of the final disposition.
3.2.19 Packaging and Labeling i
Inconing and irradiated products shall be packaged and labeled in accordance with specific instructions.
3.3 Polyachtjtanide Production T
3.3.1 Organization l(*
The Vice President for Radiation Proce* r 'ng Services, lit. D. G.
Woodard, has the responsibilittj for att act.ivitics required for the production of poitacrtjtamide. The responsibility for assuring j
compliance scith the caste.ver's specifications and schedules has been delegated to the Poit merization Plant Section Manager, llt. D. Deore.
j The responsibillttj for conductbig.the irradiations has been delegated to the Irradiations Section Manager, lh. M. W. Harmon. Ilt. Harmon is responsible for.the day-to-dat) operations of the irradiators and is also responsible for assuring tha.t qualified operators are avait-able to run these machines.
3.3.2 Definitions Qualltj - A quali.ttj polt acrytanide product is one tdtich vus produced j
in accordance Leith the requLtements of.this section and tehich through-out its progression from a monomer to a pott mcr has.the phtjsical j
and chemical properties specified bi the customer, Hercules.
j Ernadiators - See Section 3.1.c.
3.3.3 Buildinas See Section 3.1.3.
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The acrylic acid building shall be raintained in such a fashion as to preclude entry by unauthorized personnet and the public.
Its explosion retief and prevention fcattutes slall be maintained bij apptopria.te personnel undeA the direction of the PolymeA.ization Plant Section !!anager.
The condition of this buliding and.the tank room and theit supporting heating and cooling systems, shall be in-spec.ted bi.the Quality Assurance ifanager or h,is designee at teast j
twice a t ear and such inspections documented.
j 3.3.4 Equipment See Section 3.1.4.
bfaintenance of the tanks, process Lines, heating, ventitating, and cooling systcms, and conthat devices for.the achglic acid building and the tank room is the responsibilitt) of.the Polymerization Plant Secticn ifanager.
3.3.5 Design Control Not applicable 3.3.6 Procurement Document Control
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Supplier certifications of make up chericato shall be retained for a.t least tuo yeau.
3.3.7 instructions, Procedurcs, and Dratcings See Section 3.2.7.
3.3.8 Documen.t Control instructions, procedures, drawings, and specifications shall be issued bij.the irradiations Section !3anager for activitics associ-ated with running the irradiators and bi.the Polymerization Plant j
Section ifanagcr for chemical processing and labora. tory suppor.t i
activities.
These documents shall have the approval of the V. ice President for Radiation Processing Scruices and by the Qualitj Assurance Ifanager.
l Chanoes to any af.these documen.ts shall also require thelt approvat.
I 3.3.9 Control of Plutchased fla.terial, Equipment, and Services Control of purchased ma.terlat, equipment, and services is the respon-sibilitt) of the Polymerization Plant Section Managcr.
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Att incoming shipments of acrylic acid and acrylamide shall be
. tested for conformance.to Hercules' specifications.
3.3.10 identification and Control of Paterials, Parts, and Components See Section 3.1.10.
3.3.11 Special Processes Not applicable 3.3.12 inspection inspections and evaluatlons af finished product shall be performed l
in accordance seith Hercules' specifications.
3.3.13 Test Control Testing and control of tests of finished products shall be performed in accordance teith Hercules' specifications.
3.3.14 Control of Heasuring and Test Eculpment Laboratory equipment necessary for sampling and testing of products
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shaEL be available and the Speclat Irradiations Seetion Yanager shatt deterwine if perloclic adjustrents or calibraticns are nequired.
Labora. tory equipment tdzich requires periodic adjtakent shall have allouable totcunces posted schere.the equipment is used.
Periodic calibrations shall be recorded.
Each calibration record shalt shote.the name of.the persen edio performed.the calibration,
.the da.te on tchich it t>us done, and.the next date on tehich a calibra-tion shall be perforred.
3.3.15 Handling, Storage, Distributing, and Shipping See Section 3.1.15.
3.3.16 Evaluation, inspection, Test, and Operating Statta See Section 3.1.16.
3.3.17 Nonconforming Wa.terials, Parts, and Components Not applicable
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3.3.18 Corsective Action The Pol.tmerization Plant Section !!anager and the Irradiatiens Section llanager shdt recorrend in wtiting to the Vice Etesider.t fer. Radiation Processing Services and.the QA !.fanagst:
- an apptopriate disposition for nonconfcrning products;
-and,
- the likely cause of.the nonconformance.
The Vice President for Radiation Processing Services slu:lt rake the determine. tion of.the fine.l disposition.
3.3.19 Packaging and Labeling Not applicable 3.4 Other Irradiations 3.4.1 Organization The Vice President for Radiation Processing Services has the overall
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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 Irradiat. ions Section Manager and the respon-sibility for laboratory support activities and specid. irradiations to the Special Irradiations and Laboratories 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 docueented In accordance with this procedure.
Irradiations - See Section 3.1.2.
3.4.3 Euildings See Section 3.2.3.
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3.4.4 Eaulpment 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 Irradiah",oM 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. He 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-i 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 Docurent control
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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 specify tests and assure quality of subsequent irradiation shall be prepared in accordance with NPI Procedure R 2013. Periodically audits shall be conducted to check for conformance and the results recorded.
3.4.8 Document Control Instructions, procedures, drawings, and specifications shall be issued by the Section Manager for Special 74AndiatioM or by another section manager specified by the Vice President for Radiation Prb-cessing Services.
These documents shall have the approval of the Vice President for Radiation Processing Services.
Changes to any of these docurents shall also require his approval.
3.4.9 Control of Purchased Material. Eauipment, and Services Responsibility for control of material, equipment, and services shall be specified in accordance with NPI Procedure R 2013.
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3.4.10 Identification and Control of Materials, Parts, and Components Materials, parts, and corponents required for irradiation, except cobalt-60, shall be stored and identified by the section manager designated by the Vice President for Radiatien 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 nonconforning to the pre-viously set specifications shall be tagged accordingly and stored physically separate from the acceptable material. The responsible section manager shall document all nonconformances and bring them to the attention of the Vic6 President for Radiation Processing Services and the QA Manager within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
3.4.13 Test Control Not applicable 3.4.14 Control of Measurine and Test Equipment See Section 3.2.14.
3.4.15 Handling, 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 Nonconforming Fbterials, Parts, and Components Not applicable 3.4.18 Corrective Action In the event that dosimetry or physical and/or chemical properties testing reveals that a product has not received the required dose
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or other specified environmental condition, this fact shall be documented and reported to the Vice President for Radiation Pro-cessing Services and the QA Ifanager. The responsible section manager shall recommend to then 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 It'oming and irradiated products shall be packaged and labeled in accordance with specific instructions.
4.1 Laminar Flow Testing 4.1.1 Organization The. Corporate Secretattj is responsible for NPI Icminar flow testing
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activities. He 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.
N 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.
i 4.1.3 Buildings Mat applicabic I
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4.1.4 Equipeent Nondisposable equiprent used in the examination and testing program shall be cleanabic and, if necessary, adjustable.
Equipeen ; shall be stored in such a tanner to reduce contamination by dust or dirt.
Equipment will be clean when used.
Equipment which requires periodic adjusteent shall have allowable tolerances posted within the equip-ment storage boxes.
The Corporaic Secretaty shall prepare and keep current calibration procedures for all equiptent 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 performed.
4.1.5 Design Control Not applicable 4.1.6 Procurement Docurent Control Not applicable 4.1.7 Instructions, Procedures, and Drawings
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NPI personnel chall conduct all laminar flow testing work in accor-dance with NPI Procedure 10001, Standard Procedure for In-Place Integrity Inspection and Testing of Horizontal and Vertical Laminar Flow Hoods.
Audits will be conducted to check for conformance.
4.1.8 Document Control All instructions, procedures, and specifications for the laminar flou testing program and changed of 4ame shall be issued by the Corporaic Secretaty. These documents shall have the approval of the Quality Assurance E1 nager.
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 Corporaft SecAclary or h46 dc4ignce 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 lacinar flow testing program shall be stored either in the service vehicles or in a reserved separate area of the facility.
4.1.11 Specfal Processes Not applicable 4.1.12 Inspection NPI Procedure 10001 lists all inspections required for the laminar flow testing program.
4.1.13 Test Control NPI Procedure 10001 lists all tests required for the laminar flow testing program.
4.1.14 Control of Measuring and Test Eculpment See Section 4.1.4.
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4.1.15 Handling, 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 Secretart.J 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.
4.1.17 Nonconforming Parti 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 Corporate Sectetart. J 4.1.18 Corrective Action When a nonconforming item is disposed of, the Corporate Secre-tartj will document this disposition and the reasons e
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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 Drganization 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-latian, and temperature and humidity control shall be provided.
Inspection of the building condition shall be periodically per-formed and the results of these inspections shall be recorded.
The NPI and manufacturers' QA organizations shall be responsible fo'r 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 Eguipment Nondisposable equipment used in the manufacturing process of NPI marketed products shall be cleanable and, if necessary, adjustable.
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Equipment shall be stored in such a manner to reduce contamination by dust or dirt. Equipment will be cican when used. Equipment which requires periodic adjustment shall have allowable tolerances posted 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. Nea-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 Contr61 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 c1carly 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 material. The distributorship agri 3 ment between the manufacturer and
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NPI shall state which, if any, of these specifications will require NPI's approval.
In all circumstances, MPI will have the right of inspection to check for complianca with hese specifications.
5.1.7 Instructions, Procedures, and Di..ings All instructions, procedures, and drawing.: 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, and Components The manufacturer shall establish control areas in which all materials, parts, components, and comple
- d products are stored and labeled. NPI shall have the right to insp for conformance to this method.
5.1.11 Special Processes Special manufacturing processes such as welding, heat treating, or nondestructive examination of manufactured components or parts shall be certified by a suitably high level of manufacturer's management.
NPI shall be given the specifications to which these special processes have been performed.
5.1.12 Inspection Manufacturer's inspection methods shall be provided to NPI. NPI personnel may witness these inspections.
5.1.13 Test Control The manufacturer shall specify to NPI the way in which the products are tested to assure suitability for application. NPI personnel may witness these tests.
5.1.14 Costrol of Measuring and Test Equipment Equ pment used to examine components and procucts shall be controlled, calibrated, adjusted, and maintained in accordance with written pro-cedures. NPI personnel may check for conformance.
5.1.15 llandling, Storage, Distribution, Shipping, and Installation llandling, storage, distribution, shipping, and installation shal1 be in accordance with the distributorship agreement betveen the manufacturer and !!PI.
5.1.16 Evaluation, Inspection, Test, and Operating Status NPI shall monitor, as appropriate, performance of all products dis-tributed by NPI. A performance record for all products marketed by
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NPI shall be made at 1 cast once per year and appropriate corrective action initiated. Products which in the judgement of the President of NPI have had unacceptable performance will either be dropped from further marketing or actions taken to improve the product quality.
5.1.17 Nonconforming Parts The manufacturer shall identify and tag parts which do not conform to written specifications. Nonconforming material shall be stored physi-cally separate from acceptable material and a list of 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. IIe shall document actions taken to correct such pro-blems. This information shall be availabic 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 NP1 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, identifiabic, and availabic to company management as evidence of the workings of the QA program.
Provisions have been established to control the distribution of the following documents and revisions thereto:
1.
The NPI Quality Assurance Program 2.
NRC Cask Use Certificates 3.
Road Use Certificates The following documents.*e also
'inta axl:
1.
Procedures 3.
Instructions 4.
Drawings 5.
Specifications 6.
Design Review Reports 7.
Contract Agreements 8.
Installations
s 9.
Dosimetry Records 10.
Health Physics Records 11.
Radioactive Respiratory Protection Program
- 12. NPI's Program for Radiation Protection of Employeo Exposures
- 13. Truck Driver's Logs (Form MCS-59) 14.
Vehicle Inspection and Maintenance Records 15.
Annual Review of Drivers' Driving Record 16.
Daily Reports of Vehicle's Condition 17.
Reports of Accidents (Forms MCS 50-T and MCS 50-B) 18.
Radioactive Shipment Record 19.
Personnel Qualification Approval and Certification Records 20.
Shipping Package Maintenance Schedule and Authorization 21.
Shipping Package Modification Authorization
- 22. Medical Device Description for Reconditioned Teletherapy Units 23.
Device Master and History Records for Sources 24.
Customer Complaint Files 25.
Calibrttion Records 26.
Inspec tion and Test Records These records shall contain the following where applicable:
1 a.
A description of the type of observation.
b.
Evidence of completing and verifying a manufseturing, inspection, or test operation.
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c.
The date and results of the inspection or test.
d_.
Informatior related to conditions adverse to quality.
c.
Inspector or fata recorder identification.
f.
Evidence as to the acceptability of the results.
27.
Component Control and Nonconformance Records These documents shall include records of the acceptance or rejection of all components used in target and source man-ufacture, records of the disposition of all obsolete, rejected, or deteriorated components, records of the removal of unwanted materials from manufacturing, and records of nondestructive examination and other test results.
28.
Equipment / Maintenance Records These records shall i.:cIn'c a description of the piece of equipment used or in operation, along with any modifications or adjustments, and shall document the performance and neces-sary maintenance schedules.
29.
Driver Qualification Record i
Records required to be maintained pursuant to Federal Motor Carrier Safety Regulation 391.51. This file shall include:
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- The medical examiner's certificate of the driver's physical qualification to drive a motor vehicle or a 1cgible photographic copy of the certificate;
- A letter granting waiver of a physical disqualifica-tion, if a waiver was issued;
- 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
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NPI accepted as equivalent to the driver's road test;
- The questions asked, the answers the driver gave, and the certificate of written examination issued to him, or a copy of a certificate which NPI accepted as equi-valent to a written examination; and,
- The driver's name, his social security number, and the identification number, type, and issuing state of his motor vehicle operator's license.
30.
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.
- 31. Conective Action Reports
- 32. QA Audit Reports The above records shall be maintained at 4pecific locations in the NPI facilities and shall be reasonably accessible, many on a proprie-tary basis, to government employees designated to perform inspections.
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All shipping package design related records shall be maintained for tite life of the sltipping pacfzage; inadia. tor operations cliarts, irradiator Logs, and istadiation teorksitee,ts telticIt document dose conttol iMadiations sliatt be maintained for a,t lea.st five t cass; j
and att otlier records are maintained 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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an evaluation of the shipping and manufacturing practices and/or procedures, and shall be concerned with the safety and effective-ness of their inpler.entation.
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 decced 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 mere frequently.
Audits shall be perforned by persons who do not have responsibility for the area being audited, and who possess the ability to evaluate adequately the functions under investigation.
The results of these audits shall te documented and maintained by the QA Manager and reported to the President along with any sugges-tions of reconcendations for improvement. Subsequently,.the Preoident shall. direc.t line managemert to take whatever corrective action 4 he decides is necesacry.
In the event that deficient areas are located, they shall be re-
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audited on a timely basis to verify implercntation of corrective N
actions.
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