ML091540079
| ML091540079 | |
| Person / Time | |
|---|---|
| Site: | Oregon State University |
| Issue date: | 05/29/2009 |
| From: | Reese S Oregon State University |
| To: | Gee F NRC/NMSS/SFST |
| Frank Gee 492-3329 | |
| References | |
| Download: ML091540079 (19) | |
Text
osu Radiation Center Oregon Slate University, 100 RadiatiQn Center, CorvaUis, Oregon 97331-5903 T 541-737-2341 I F 541-737-0480 I http://ne.oregonstate.edulfacilitiesiradiatlon_center May 29, 2009 Director Attn: Frank Gee Spent Fuel Project Office Office of NucIear Material Safety and Safeguards U, S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852-2738
Reference:
Oregon State University TRIGA Reactor (OSTR)
Docket No. 50-243, License No. R-I 06
Subject:
Submission of Transportation Quality Assurance Plan Rev 1 Mr. Schuster:
Per a conversation with a Mr. Jim Pierson (NRC) on May 28, 2009, we are hereby submitting a revision to the Quality Assurance plan submitted to you on March 23, 2009. Attachment 1 to this letter contains the Revision 1. Attachment 2 to this letter iJlustrates the changes made to Revision O.
I declare under penalty of perjury that the foregoing is true and correct.
Executed on: s.il'tl()~
Sincerely,
~
Director Attachment cc: Document Control, NRC Al Adams, NRC Craig Bassett, NRC John Cassady, OSU Rich Holdren, OSU Todd Palmer, OSU Todd Keller, OSU
Attachment 1 Oregon State University Quality Assurance Program Rev 1
Date Approved Appendix V: Quality Assurance Number: ntle: Revision: Pace: ~ate:
QAP Quality Assurance Program 1 Page 1 of8 OS/28/09 Oregon State University QUALITY ASSURANCE PROGRAM 1 INTRODUCTION The Quality Assurance Program submitted here is to assist in the handling of shipments of irradiated TRIOAOil type reactor fuel.
The Quality Assurance Program will be the responsibility of the Senior Health Physicist at Oregon State University. The transport of all radioactive material will be conducted by a licensed carrier. The shipping container will be Type B containers with an approved Certificate of Compliance (CoC). The containers will usually be on lease or loan from entities such as the Department of Energy or prime contractor.
Oregon State University does not design, fabricate, assemble, or test Type B containers, and does not intend to procure any Type B container for ownership or lease to others. Oregon State University does not intend to rework, repair, maintain or modify the Type B container.
Oregon State University is responsible for ensuring that all aspects of this Quality Assurance Program meet all applicable requirements, including but not limited to the requirements found in 10 CFR Part 71. Where this Quality Assurance Program identifies other organizations to perfonn a function under contract, it is still the responsibility of Oregon State University to ensure that the work perfonned is in full compliance with all applicable regulations. To ensure compliance, activities perfonned under this Quality Assurance Program will be audited as described in Section 19.
The QA Program is submitted pursuant to 10 CFR Part 71.
2 ORGANIZATION Figure 1 shows the organization chart for the operation of the reactor facility. The Quality Assurance Program will be perfonned by this organization. Approval of procedures is covered under OSTROP 6, Administrative Procedures. The Senior Health Physicist will have primary responsibility for monitoring all packaging, shipping and receiving activities.
Date Approved Appendix V: Quality Assurance Nllmber: l1tIe; Revision: Pele: Dete:
QAP Quality Assurance Program 1 Page 2of8 OS/28/09 Vice President for f----
Research (Levell)
Reactor Operations Committee I
I I
I I
Radiation Center Director ,
I
.--- (Level 2) f-- I I
I I
I I
I I
J I
I Reactor Administrator Senior Health Physicist (Level 3) (Level 3)
Reactor Supervisor Health Physics Staff (Level 3)
Reactor Operators (Level 4)
Normal administrative reporting channel Communication lines Figure 1 3 QUALITY ASSURANCE PROGRAM The scope of the program includes handling, loading and delivering to a carrier an approved package for the transport of lRIGA fuel or other radioactive material. The shipments will be periodic in nature and will occur at a maximum frequency of up to several shipments per year.
Quality assurance will be exercised primarily through the use of written procedures constructed from regulatory requirements, applicable Oregon State TRIGA Reactor Operation Procedures
Date Approved Appendix V: Quality Assurance Number: TItle; Revi$lon: Pace: Date:
QAP Quality Assurance Program 1 Page 3 of8 OS/28/09 (OSTROP), Radiation Center Health Physics Procedures (RCHPP), specific procedures developed by the manufacturer of the package, and other procedures or safeguards developed during review of packaging and transportation planning. Quality Assurance will be affected by formatting these procedures as check-lists (or equivalent) to be used by the individuals or their designates who are responsible for quality assurance.
4 PACKAGE DESIGN CONTROL Design activities related to packages will not be perfonned by the Oregon State University.
5 PROCUREMENT DOCUMENT CONTROL Procurement activities related to packages will not be perfonned by Oregon State University.
The proper procurement document control shall be the responsibility of the supplier of the designated package.
6 INSTRUCTIONS, PROCEDURES, AND DRAWINGS Activities important to safety will be ensured by following all manufacturer's instructions, procedures, and limitations as they relate to the safe use of the packages.
7 DOCUMENT CONTROL Control shall be exercised over the documents that are used in this shipping activity. The documents include a master document check-list, inspection procedures, loading and unloading procedures, package certification documents, radiation survey records, and shipping papers.
Changes shall be implemented by the procedures outlined in OSTROP 6, Administrative Procedures.
8 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES No materials or equipment are to be purchased for this activity. Any required services such as container off-loading and carrier transport will be procured via nonna! University procedures.
9 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS No materials, part or components are to be identified or controlled for this activity. Replacement parts will be obtained from the manufacturer or certificate holder.
Date Approved Appendix V: Quality Assurance Number:
Title:
Revision: hie: Date:
QAP Quality Assurance Program 1 Page 40f8 OS/28/09 10 CONTROL OF SPECIAL PROCESSES No special processes are to be undertaken for this activity.
11 INTERNAL INSPECTION The following inspection activities will be implemented for each package procured for shipping purposes:
11.1 Receiving Inspections Inspections will be performed to ensure the integrity of containers that are used for transportation purposes. Visual inspection will include surface conditions, structural integrity, gaskets and flanges, tie-downs, labeling and marking, and other features as specified by the certificate holder.
11.2 Final Inspections Checklists will be established to ensure inspections are performed to verify:
- 1. Proper package assembly
- 2. Moderators and neutron absorbers are present (if applicable)
- 3. Valves are set to specification and to prevent tampering
- 4. Shipping papers are properly completed
- 5. Packages are conspicuously and durably marked in compliance with USDOT regulations
- 6. Measures are established to ensure that appropriate personnel designated by the package user sign shipping tags or indicators prior to the authorization for shipping 11.3 Maintenance Inspections These inspections will not be performed under this activity unless specifically designated by the package standard operating procedures.
11.4 Inspection Documentation Inspection records will be maintained to document performance of inspection activities.
12 TEST CONTROL 12.1 Procedures Measures will be established to ensure that applicable tests, surveys, or other measurements be perfonned according to manufacturer's instructions. Properly calibrated equipment will be used and methods for documenting tests will be established.
Date Approved Appendix V: Quality Assurance Nllmber; TItle; Revision: Pase: Date:
QAP Quality Assurance Progr;;tm 1 Page 5 of8 OS/28/09 12.2 Acceptance Tests Measures will be established to ensure that acceptance tests (as applicable) are performed prior to offering a package for transport. Tests may include structural integrity, leak tightness, component performance, and shielding and thermal integrity.
12.3 Results Measures will be established to ensure that test results are documented, evaluated, and maintained as QA records. The Senior Health Physicist will determine acceptability of the records.
13 CONTROL OF MEASURING AND TEST EQUIPMENT 13.1 Calibration Control Gauges, reference standards, etc are not expected to be used for this activity. The exception to this is the use of radiation measuring equipment. This equipment will be properly calibrated with traceable standards according to existing standard operating procedures.
13.2 Out of Calibration Equipment Radiation measuring equipment that is out of calibration will not be used. If it is discovered that out of calibration instrumentation was utilized, a review by the Senior Health Physicist shall be performed of all work involving the use of the out of calibration instrument to detennine appropriate corrective actions.
14 HANDLING, STORAGE, AND SHIPPING CONTROL 14.1 Preservation Measures will be established to ensure that cleaning, handling, storage, and shipping are accomplished in accordance with the package design requirements to prevent damage or deterioration by environmental conditions. Provisions for use of special equipment such as cranes or lifting devices will be established to adequately identify and protect package components. Conditions identified in the CoCwill be adhered to when unloading packaging.
14.2 Preparation, Release and Delivery to Purchaser Measures will be established to ensure that the following requirements are completed prior to shipping:
Date Approved Appendix V: Quality Assurance N\lmber: TItfe: Revision; Pa,e; Date:
QAP Quality Assurance Program 1 Page 6 of8 OS/28/09
- 1. Cavities have been adequately dried.
- 2. All conditions have been completed prior to offering for transport.
- 3. All USNRC and USDOT requirements have been satisfied prior to offering for transport.
- 4. All shipping papers have been completed and reviewed by qualified personnel for accuracy and completeness.
15 INSPECTION, TEST, AND OPERATING STATUS A master check-list will be established to track the status of inspections, test, and operating conditions.
16 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS This section does not apply to this activity.
17 CORRECTIVE ACTION 17.1 Reporting Causes of conditions that are detrimental to quality will be promptly identified and reported to the Senior Health Phy~icist. Measures will be established to identify any corrective action from suppliers are obtained and that corrective actions were implemented and effective.
18 QUALITY ASSURANCE RECORDS 18.1 General QA records will be generated for each activity that is perfonned during the receipt, unloading, opening and closing, loading, preparation of shipping papers, and adherence to conditions specified by the manufacturer. The records will demonstrate delivery to a carrier and have evidence to show that USNRC and USnoT requirements have been satisfied.
Inspection and test records will identify the test or observation, show that the tests or inspections were complete, .r ecord test or survey data, identify any conditions that are non-conforming or are detrimental to quality, names of individuals performing the tests or inspections, and whether the results were acceptable.
18.2 Generating Records Measures will be established to generate and store records. Paper copies of records generated will be stored in secure files. Additionally documents will be scanned in a pdf format for electronic storage.
Date Approved Appendix V: Quality Assurance Nl,lmber:
Title:
Revision: Pale: Date:
QAP Quality Assurance Program 1 Page 7 of8 OS/28/09 18.3 Indexing and Classification Records Records generated for these activities will be designated as non-pennanent and will be retained for a period of at least 3 years after the associated shipment.
18.4 Receipt, Retrieval, and Disposition of Records The records generated by these activities will be maintained by the Senior Health Physicist.
Procedures are in place for storage of records that relate to transportation and health physics activities that relate to the use of licensed material at the University.
18.5 Storage, Preservation, and Safekeeping Measures will be established to maintain records for the required period. Measures to be established include:
- 1. Prevention of damage from fire, flood, or other environmental damage
- 2. Record will be filed in folders in steel storage cabinets
- 3. Electronic records will be stored on a server which is backed up daily in a remote location
- 4. Unauthorized pe.rsonnel willl'lot have access to records 5.. Electronic infonnation is accessible to authorized users with password only access
- 6. Data will be electronically stored as read only pdf files
- 7. Damaged records wiJI be promptly replaced 19 AUDITS 19.1 Elements of an Audit Program Due to the small number of uses of any Type B package an audit will be conducted after each use of a package. In addition to this audit, the procedures associated with this Quality Assurance Program have requirements for both primary (i.e., the person perfonning the identified task) and secondary (i.e., a reviewer) confmnation of completion of an indentified task. The conditions of Regulatory Guide 7.10 Section 18.1 will be met in establishing an audit program.
19.2 Scheduling of Audits An audit will be perfonned both during and after each Type B shipment to ensure that elements of the program are in place and that appropriate documentation was generated and maintained.
Date Approved Appendix V: Quality Assurance Number: TItle; Revision: Page: Date:
O,AP Quality Assurance Program 1 Page 8 of8 OS/28/09 19.3 Team Selection An auditor will be appointed by the Senior Health Physicist. Due to the small scope of this activity an independent individual will be chosen that has an understanding of the program and the requirements for compliance. The independent individual chosen shall have a minimum of five (5) years experience in radiation protection and shall be an approved shipper of radioactive material.
19.4 Various Audit Actions The auditor will meet prior to the audit to discuss scope and objectives and after the audit to discuss findings. clarify facts,and to ensure all appropriate infonnation has been gathered. A report will be generated to identify deficiencies and a response is required to address deficiencies. The auditor will ensure that a schedule for resolving the items identified is presented and that corrective action is implemented.
Attachment 1 Oregon State University Changes Made to Quality Assurance Program Rev 0
Date Approved Appendix V: Quality Assurance Number:
Title:
Reylslon: P~8e : Date:
QAP Quality Assurance Program 91 Page 10f8 930~{BW09 Oregon State University QUALITY ASSURANCE PROGRAM 1 INTRODUCTION The Quality Assurance Program submitted here is to assist in the handling of shipments of irradiated TRIGA type reactor fuel. '
The Quality Assurance Program will be the responsibility of the Senior Health Physicist at
- I Oregon State University. The transport of all radioactive material will be defle-conducted by a licensed carrier. The shipping container will be Type B containers with an approved Certificate of Compliance (CoC). The containers will usually be on lease or loan from entities such as the Department of Energy or prime contractor.
Oregon State University does not design, fabricate, assemble, or test type-~B containers, and does not intend to procure any type-~B container for ownership or lease to others. Oregon State University does not intend to rework, repair, maintain or modify the ~~B container.
Oregon State University is responsible for ensuring that all aspects of this Quality Assurance Program meet all applicable requirements, including but not limited to the requirements found in 10 CFR Part 71. Where this Quality Assurance Program identifies other organizations to perform a function under contract, it is still the responsibility of Oregon State University to ensure that the work performed is in full compliance with aU applicable regulations. To ensure compliance, activities performed under this Ouality Assurance Program will be audited a described in Section 19.
The QA Program is submitted pursuant to 10 CPR Part 71.
2 ORGANIZATION Figure 1 shows the organization chart for the operation of the reactor facility. The Quality Assurance Program will be performed by this organization. Approval of procedures is covered under OSTROP 6, Administrative Procedures. The Senior Health Physicist will have primary responsibility for monitoring all packaging, shipping and receiving activities.
Date Approved Appendix V: Quality Assurance Number: TItle: Revision: P_,e: o.te:
QAP Quality Assurance Program 91 Page 2 of8 G30..M~W09 Vice President for I--
Research (level 1)
. Reactor Operations Committee I
I I
I I
Radiation Center Director I
.-- f-t t
(level 2) t I
't t
t t -------------------------- 1 t
t I Reactor Administrator Senior Health Physicist (level 3) (level 3)
Reactor Supervisor Health Physics Staff (level 3)
Reactor Operators (leveI4)
Normal administrative reporting channel Communication lines Figure 1 3 QUALITY ASSURANCE PROGRAM The scope of the program includes handling, loading and delivering to a carrier an approved package for the transport of TRIGA<<l fuel or other radioactive material. The shipments will be periodic in nature and will occur at a maximum frequency of up to several shipments per year.
Quality assurance will be exercised primarily through the use of written procedures constructed from regulatory requirements, applicable Oregon State TRIGA Reactor Operation Procedures
Date Approved Appendix V: Quality Assurance Number: TItle: Revision: Pace: Date:
QAP Quality Assurance Program gl Page 3 of8 G302IG3W09 (OSTROP), Radiation Center Health Physics Procedures (RCHPP), specific procedures developed by the manufacturer of the package, and other procedures or safeguards developed during review of packaging and transportation planning. Quality Assurance will be affected by formatting these procedures as check-lists (or equivalent) to be used by the individuals or their designates who are responsible for quality assurance.
4 PACKAGE DESIGN CONTROL Design activities related to packages will not be performed by the Oregon State University.
5 PROCUREMENT DOCUMENT CONTROL Procurement activities related to packages will not be performed by Oregon State University.
The proper procurement document control shall be the responsibility of the supplier of the designated package.
6 INSTRUCTIONS, PROCEDURES, AND DRAWINGS Activities important to safety will be ensured by following all manufacturer's instructions, procedures, and limitations as they relate to the safe use of the packages.
7 DOCUMENTCONTROL Control shall be exercised over the documents that are used in this shipping activity. The documents include a master document check-list, inspection procedures, loading and unloading procedures, package certification documents, radiation survey records, and shipping papers.
Changes shall be implemented by the procedures outlined in OSTROP_ 6, Administrative Procedures.
8 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES No materials or equipment are to be purchased for this activity. Any required services such as container off-loading and carrier transport will be procured via normal University procedures.
9 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS No materials, part or components are to be identified or controlled for this activity. Replacement parts will be obtained from the manufacturer or certificate holder.
Date Approved Appendix V: Quality Assurance Number: ntle: Revision: Pace: Date; QAP Quality Assurance Program Ql Page 4 of8 Q30~~W09 10 CONTROL OF SPECIAL PROCESSES No special processes are to be undertaken for this activity.
11 INTERNAL INSPECTION The following inspection activities will be implemented for each packaged procured for shipping purposes:
11.1 Receiving Inspections Inspections will be performed to ensure the integrity of containers that are used for transportation purposes. Visual inspection will include surface conditions, structural integrity, gaskets and flanges, tie-downs, labeling and marking, and other features as specified by the certificate holder.
11.2 Final Inspections Checklists will be established to ensure inspections are performed to verify:
I. Proper package assembly
- 2. Moderators and neutron absorbers are present (if applicable)
- 3. Valves are set to specification and to prevent tampering
- 4. Shipping papers are properly completed
- 5. Packages are conspicuously and durably marked in compliance with USDOT regulations
- 6. Measures are established to ensure that appropriate personnel designated by the package user sign shipping tags or indicators prior to the authorization for shipping 11.3 Maintenance Inspections These inspections wiJI not be perfonned under this activity unless specifically designated by the package standard operating procedures.
11.4 Inspection Documentation Inspection records will be maintained to document perfonnance of inspection activities.
12 TEST CONTROL 12.1 Procedures Measures will be estabHshed to ensure that applicable tests, surveys, or other measurements be performed according to manufacturer's instructions. Properly calibrated equipment will be used and methods for documenting tests will be established.
Date Approved Appendix V: Quality Assurance Number:
Title:
Revision: Pace: Date:
QAP Quality Assurance Program 91 Page 5 of8 G30~~W09 12.2 Acceptance Tests Measures will be established to ensure that acceptance tests (as applicable) are performed prior to offering a package for transport. Tests may include structural integrity, leak tightness, component performance, and shielding and thermal integrity.
12.3 Results Measures will be established to ensure that test results are documented, evaluated, and maintained as QA records. The Senior Health Physicist will determine acceptability of the records.
13 CONTROL OF MEASURING AND TEST EQUIPMENT 13.1 Calibration Control Gauges, reference standards, etc are not expected to be used for this activity. The exception to this is the use of radiation measuring equipment. This equipment will be properly calibrated with traceable standards according to existing standard operating procedures.
13.2 Out of Calibration Equipment Radiation measuring equipment that is out of calibration will not be used. If it is discovered that out of calibration instrumentation was utilized. a review by the Senior Health Physicist shall be pertormed of all work involving the use of the out of calibration instrument to determine appropriate corrective actions.
14 HANDLING, STORAGE, AND SHIPPING CONTROL 14.1 Preservation Measures will be established to ensure that cleaning, handling, storage, and shipping are accomplished in accordance with the package design requirements to prevent damage or deterioration by environmental conditions. Provisions for use of special equipment such as cranes or lifting devices will be established to te-adequately identify and protect package components. Conditions identified in the CoC will be adhered to when unloading packaging.
14.2 Preparation, Release and Delivery to Purchaser Measures will be e.stablished to ensure that the following requirements are completed prior to shipping:
Date Approved Appendix V: Quality Assurance N\lmber:
Title:
Revl$lon: Pa,e: Date:
QAP Quality Assurance Program 91 Page 6 of8 Q30~~lW09
- 1. Cavities have been adequately dried.
- 2. All conditions have been completed prior to offering for transport.
- 3. All USNRC and USDOT requirements have been satisfied prior to offering for transport.
- 4. All shipping papers have been completed and reviewed by qualified persoIUlel for accuracy and completeness.
15 INSPECTION, TEST, AND OPERATING STATUS A master check-list will be established to track the status of inspections, test, and operating conditions.
16 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS This section does not apply to this activity.
17 CORRECTIVE ACTION 17.1 Reporting Causes of conditions that are detrimental to quality will be promptly identified and reported to the Senior Health Physicist. Measures will be established to identify any corrective action from suppliers are obtained and that corrective actions were implemented and effective.
18 QUALITY ASSURANCE RECORDS 18.1 General QA records will be generated for each activity that is performed during the receipt, unloading, opening and closing, loading, preparation of shipping papers, and adherence to conditions specified by the manufacturer. The records will demonstrate delivery to a carrier and have evidence to show that USNRC and USDOT requirements have been satisfied.
Inspection and test records will identify the test or observation, show that the tests or inspections were complete, record test or survey data, identify any conditions that are non-conforming or are detrimental to quality, names of individuals perfonning the tests or inspections, and whether the results were acceptable.
18.2 Generating Records Measures will be established to generate and store records. Paper copies of records generated will be stored in secure files. Additionally documents will be scaIU1ed in a pdf format for electronic storage.
Date Approved Appendix V: Quality Assurance Number: ntle: Revision: Pale: Date:
OAP Quality Assurance Program 91 Page 70f8 ~G3W09 18.3 Indexing and Classification Records Records generated for these activities will be designated as non-pennanent and will be retained for a period of at least 3 years after the associated shipment.
18.4 Receipt, Retrieval, and Disposition of Records The records generated by these activities will be maintained by the Senior Health Physicist.
Procedures are in place for storage of records that relate to transportation and health physics activities that relate to the use of licensed material at the University.
18.5 Storage, Preservation, and Safekeeping Measures will be established to maintain records for the required period. Measures to be established include:
- 1. Prevention of damage from fIre, flood, or other environmental damage
- 2. Record will be filed in folders in steel storage cabinets
- 3. Electronic records will be stored on a server which is backed up daily in a remote location
- 4. Unauthorized personnel will not have access to records
- 5. Electronic infonnation is accessible to authorized users with password only access
- 6. Data will be electronically stored as read only pdf fIles
- 7. Damaged records will be promptly replaced 19 AUDITS 19.1 Elements of an Audit Program Due to the small number of uses of any Type B package an audit will be conducted after each use of a package. In addition to this audit, the procedures associated with this Quality Assurance Program have requirements for both primary (i.e., the person performing the identified 1a k) and secondary (Le., a reviewer) confinnation of completion of an indentified task. fidi tUIElitor will be appointed by the Sefl:ior Health Physieist. The conditions of Regulatory Guide 7.10 Section 18.1 will be met in establishing an audit program.
19.2 Scheduling of Audits An audit will be perfonned both during and after each Type B shipment to ensure that elements of the program are in place and that appropriate documentation was generated and maintained.
Date Approved Appendix V: Quality Assurance Number; Title; Revision: Pase: D<lte:
QAP Quality Assurance Program 91 Page 8 of8 930.2/G3W09 19.3 Team Selection An auditor will be appointed by the Senior Health Physicist. Due to the small scope of this activity an independent individual will be chosen that has an understanding of the program and the requirements for compliance. The independent individual cho en shall have a minimum of five (5) years experience in radiation protection and shall be an approved shipper of radioactive material.
19.4 Various Audit Actions The auditor will meet prior to the audit to discuss scope and objectives and after the audit to discuss fmdings, clarify facts, and to ensure all appropriate information has been gathered. A report will be generated to identify deficiencies and a response is required to address deficiencies. The auditor will ensure that a schedule for resolving the items identified is presented and that corrective action is implemented.