Research Reactor (MURR)
CURRENT GOOD MANUFACTURING PRACTICE (cGMP) PRODUCTION, PACKING AND LABELING DOCUMENTS FOR APIS AND FINISH DRUG PRODUCTS, GOOD LABORATORY PRACTICE (GLP/ISO/IEC 17025) PRODUCTION AND QUALITY DOCUMENTS
- Includes records listed below, only where other sections of this retention are not applicable, does not include any training records or records of radioactive materials handling or transfer.
- A. Batch-related and Study-related records:
- Raw data, training, equipment, information protocols, QA documents, 1 year after approval of the application to which they are related 21 CFR 211.180
- Production, control or distribution, 1 year after expiry date of the batch 21 CFR 211.180
- Components, drug product containers, closures and labeling, including records relating to examination, inventory, and disposition of rejected materials 21 CFR 211.180 and 21 CFR 211.182
- B. Program-related records:
- Data derived from tests performed to ensure compliance with specifications and standards, including testing and standardization of laboratory reference standards, reagents, and standard solutions 21 CFR 211.194
- Modifications of an established test method, including the reason(s) for the modification and data to verify the accuracy and reliability are acceptable 21 CFR 211.194
- Calibration and maintenance of laboratory instruments, gauges, and recording devices 21 CFR 211.194
- Stability testing 21 CFR 211.194
- Inspection or audit reports and associated documentation
- Records relating to purchasing, examination, and inventory of materials and disposition of rejected materials
- Records of nonconforming work, complaints, and corrective actions
- A. Batch-related and Study-related records:
ENGINEERING DRAWINGS, FACILITY DESIGN PRINTS, CONSTRUCTION DOCUMENTS AND PRIMARY LICENSING DOCUMENTS
- Includes documentation related to the design and building, or later modification of the research reactor itself, any primary or secondary support systems for the reactor, buildings associated with the facility, and any reactor instrumentation or integrated equipment such as sample handlers.
- May include correspondence with architects, engineers, or designers, the Atomic Energy Commission/Nuclear Regulatory Commission, university officials, and vendors, designs, reports of progress or design research, including investigative studies, and vendor contracts.
- Original licensing bases or licensing documents and amendments.
- Includes preparation documents of the types listed above for the 10-Megawatt upgrade in 1973
- Includes re-licensing documents
- Decommissioning file, which includes any decommissioning correspondence or information, including:
- Spills where contamination remains after cleanup
- Drawings of areas with inaccessible contamination
- Records of cost estimates and funding availability
ENVIRONMENTAL AND EFFLUENT MEASUREMENTS
- Annual Reports of Environmental Monitoring and Effluent Monitoring (required by TS 6.6.e). These reports include all annually required effluent measurement data
- Preoperational environmental monitoring surveys and reports
- Meteorological data (wind roses)
EXPERIMENT AUTHORIZATIONS
- Reactor license (RL), materials license (ML), state registration (SR) project files, and Reactor Utilization Requests (RURs).
INFORMATION USED IN PREPARING NRC FORM 4, RADIOLOGICAL AUDITS, ACCESS AUTHORIZATION INFORMATION, RECORDS OF SPECIAL NUCLEAR MATERIAL AND SPENT NUCLEAR FUEL IN TRANSIT
- Information used in preparing NRC Form 4 (Determination of prior occupational dose).
- Radiological Audits (Non-Technical Specification Required)
- List of individuals approved for unescorted access
- Information used in preparing the MURR Form 4 (MURR Access Request Form)
- Information used in determining access to 10 CFR 37 and 10 CFR 73 limited information, locations, or materials (Including fingerprinting and background checks)
- Physical security procedures, access and alarm logs, and program documents for the physical security of materials
- Logs, preplanning and coordination activities, advance notifications, revisions, cancellations and procedures for irradiated fuel and special nuclear material transfers
IRRADIATED SAMPLES, BYPRODUCT MATERIAL TRANSFERS AND SERVICE REPORTS
- Applies to materials irradiated or held under the Reactor License, the following records are used to document irradiation and, if applicable, processing of samples. They may also include records of transfer of such material to another NRC licensee (FM-013). Such records may contain any or all of the following:
- Description of service requested. Currently this may take the form of a MURR Online Ordering System (MOOS) printout.
- Customer requests for irradiation
- Sample certification or pre-encapsulation approval
- Company data sheet (gray sheet)
- Target Material Control Check Sheet (original)
- Irradiation history (original)
- Processing history
- If the sample was shipped to an external customer, additional information may include:
- Opening instructions and shipment request (original)
- Shipment packaging/release control check sheet (original)
- Transportation documentation (shipping declaration and/or straight bill of lading) (one of several originals)
- Release spectrum (one of several originals)
- material transfer form (one of several originals)
- sample shipment information sheet
- also required, verification of quality of packaging, including results of 10 CFR 71.85 determinations
- Service Reports - Applies only to records outside the scopes of the MURR cGMP and GLP programs and records which do NOT contain documentation of radioactive material handling or transfer. May originate in any MURR department. May contain:
- Preliminary service request,
- Records indicating procedures used to perform service,
- Service summary, indicating name of requester, departmental affiliation, nature of service performed,
- Reports on laboratory finding if analysis services were requested,
- Forms itemizing charges to be made for service, if any.
MATERIALS LICENSE RADIOACTIVE MATERIAL
- Applies to radioactive material licensed under the MURR Broad Scope Materials License (24-00518-39), or any related or preceding license. May contain several types of records associated with receipt, control, usage and disposition of radioactive material produced outside the MURR. Includes:
- Incoming and outgoing Records of Transfer of Radioactive Materials, including Receipt of Radioactive Material Forms (FM-013)
- Materials License Inventories
- Processing and shipping records for products generated from externally sourced radioactive materials
- Verification of quality of packaging, including results of 10 CFR 71.85 determinations, may be included with shipping records
- Release of uncontaminated materials
OPERATOR LOGS, STRIP CHARTS, NON-HEALTH PHYSICS WORK CONTROL PACKAGES, TECHNICAL SPECIFICATION REQUIRED AUDITS, HEALTH PHYSICS (HP) SURVEYS AND CALIBRATIONS (NON-DOSE RELATED)
- Logs and forms completed by reactor operators to document reactor related activities performed. They may include:
- Console watch logs, listing each activity performed by the operators
- Weekly reactor startup and shutdown check sheets
- Records of maintenance and repair, including compliance checks, special maintenance and preventive maintenance
- Reactor routine patrol logs
- Nuclear data daily logs, documenting readings taken from control room instrumentation panels
- Strip Chart (stack effluent, reactor, pool, and demineralizer flow charts, reactor and pool temperature charts, channel 5 and 6 power range charts, source, intermediate and wide range charts, and Area Radiation Monitor System (ARMS) Charts.
- Work control packages for work performed outside the scope
- of the Radiation Work Permit and Modification Record programs. Such packages are not otherwise listed in the Records Retention Authorization.
- Technical Specification required audits
- HP Survey Records (non-dose related)
- Instrumentation Calibration records (non-dose related)
PROCEDURES, POLICIES, DIRECTIVES, STRATEGIC PLANS, CAP ENTRIES, DEVELOPMENT WORK AND LICENSE COMMITTEE MINUTES
- These records capture management’s direction on how to perform work and conduct of operations/business:
- Procedures describing the handling of radioactive materials
- Strategic plans include reports, correspondence, studies and background materials related to the development of strategic or long-range plans prepared at all levels of the University
- cGMP and GLP Quality Manuals and Validation Master Plans
- CAP entries for Root Cause Analysis and related Corrective Actions
- Papers, correspondence, articles, etc. that document a developing method or study method
- Lab notebooks, etc. adding facts leading toward idea fruition
- Drawings, plans, photos, and other visualizations of potential programs or studies
- Minutes from the License Required Committees and their subcommittees
REGULATORY CORRESPONDENCE, CRITICAL CLIENT CORRESPONDENCE, CUSTOMER AGREEMENTS
- Includes NRC, ANI, FDA, DOE and any other correspondence with agencies regulating the University of Missouri Research Reactor.
- Includes License Event Reports (LERs)
- Critical correspondence with companies, institutions and other departments of the university that have utilized, or are considering the use of, the facilities of the reactor for experimental research or commercial purposes. They may include:
- Copies of contracts with non-university organizations (official record is retained by the Office of Procurement)
- Originals of contract development correspondence
- Purchase order from non-University organizations
- Customer agreements
RESEARCH & TECHNICAL PROJECT FILES, COMPLIANCE AUDITS AND QUALITY RECORDS
- May include any research or technical project undertaken at MURR which does not have an overriding regulatory classification as a radiological material transfer, a reactor-related design or fabrication project, or an FDA or NRC regulated project.
- Correspondence regarding objectives and methodology of project
- Resultant papers, publications, posters, presentations, or data packages
- Final report on project
- These include student work, graduate and undergraduate, as well as MURR staff produced work. Included are theses, supporting projects, experiments, and facility and component design
- Audit Reports
- QA or other internal audits not FDA regulated
- Customer/supplier audits not FDA regulated
- Tracking and trending records
SPECIAL NUCLEAR MATERIAL TRANSFERS, WASTE DISPOSAL, TRAINING, OPERATOR LICENSING
- Records of transfer of special nuclear material to and from the MURR. Includes forms 741 (Nuclear Material Transaction Report) and 742 (Material Status Report).
- Any records pertinent to the disposal of waste (release into sanitary sewerage, incineration, land disposal/burial, low-activity H-3 and C-14 disposal), unless covered in another item of this Records Retention Authorization (e.g., transfer/shipping, liquid effluent). (FM-013)
- Records of any personnel training, including radioactive material handling, occupational safety, operator training, radiation worker training (indoctrination), procedure training, Facility Emergency Organization training and drills, and any other training.
- Includes all documentation of MURR Reactor Operator Requalification Program, as well as initial licensing:
- Operator requalification exams
- Medical qualifications, test results, medical history documents
- Documents for the design, procurement or construction, testing, and modification of major equipment associated with the research reactor center.
- Commercially purchased large or unique instrumentation or equipment purchased commercially and utilized in daily activities, laboratory work or special maintenance.
- Health Physics records involving dose or contamination:
- Surveys and calibrations used to determine dose
- Health Physics Work Control (Radiation Worker Permits and controlled special exposures, minutes of ALARA and pre-job briefings)
- Planned special exposures
- Personnel Exposure Records (including individual dose equivalents and surveys to determine dose from external sources)
- Occupational dose (includes Beam Port Floor visitor’s logs and NRC form 4), records of cumulative occupational radiation dose
- Records of dose to members of the public