ML19344A369
| ML19344A369 | |
| Person / Time | |
|---|---|
| Site: | 07100164 |
| Issue date: | 08/05/1980 |
| From: | Lisa Clark MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 17023, NUDOCS 8008200027 | |
| Download: ML19344A369 (8) | |
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August 5, 1980 U. S. Nuclear Regulatory Commission ATTN: Charles E. MacDonald, Chief j
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Transportation Certification Branch 3
Division of Fuel Cycle and Material 9
Safety, 'DiSS
'd Washington, D. C.
20555 E
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Subject:
Quality Assurance Program under 10CFR71.51 E.,
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Dear Mri MacDonald:
This letter is in response to your request of June 12, 1980 for additonal f nformation concerning MIT's quality assurance program for radioactive material ehipping packages.
Additional information was requested for 35 items. After a careful study of the items, it is my belief that they fall into three categories:
a) activities and procedures not specifically addressed in the SAR (Safety Analysis Report for the MIT Research Reactor (MITR-II),
Document MITNE-ll5, October 22, 1970, as amended);
b) intua:ation already provided, principally in SAR Chapter 11, Quality Assurance, and; c) information not relevant to activities involving the procurement and use of shipping p:ckages by MIT.
For category (1), SAR Chapter 11, which was revised in June 1978 to cover shipping packages, has been further revised to provide the infor=ation specified in ite=s # 7, 10, 12, 19, 20, 29 and 32-35 of your letter. The following table lists the sections of Chapter 11 in which the requested information is provided:
Item No.
SAR Section Item No.
SAR Section 7
11.17 20 11.6 10 11.5 29 11.6 12 11.4 32-35 11.7 19 11.6 1'7023 e
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0 U. S. Nuclecr Reguletory Co==ission f
ATTN: Cantles E. MacDonald, Chief i
_2-The affected pages are 11. 4-1, 11. 6-1, 11. 7-1 and 11.17-1.
The revised pages are enclosed herewith and should be substi:uted for si=ilarly ne=bered pages in our submission on June 30, 1978.
Revisions are indicated by vertical lines in the righthand margin. Page 11.7-1 has no changes but was retyped to acccc=cdate the changes on p. 11.6-1.
For ite=s in category (2), I have lis:ed each ite= below and given a reference to that part of the SAR or the Technical Specifica:icas where the infor=stion has been provided.
So=e explanatory ec==ents have also been added.
'Je are cogninan: of and have applied the " graded approach" noted in 10CFR71.51(a) and the five "considera:icus" spelled out in 10CFR71, Appendix E, Section 2.
It should be observed that the shipping of materials subject to 10CFR71 will. be done only under the generaLIicenses of 10CFR71.11.and 71.11 and pursuan: 'to anyrequire=ents that =ay be'i= posed by amend =en to the MIT Reactor Operating License No. R-37 for the ship =ent of spent fuel in a leased container.
Ite: No.
SAR Section Ce==ent 1.
11.1 and The supervisors referred to in 11.1 are shown in Fig. 13.1.1-1 Fig. 13.1.1-1 as Asst. Director for Engineering and Design, Supt. of Operations and Maintenance, and Supervisor of Electronics Engineering and Maintenance. Sc=e of the titles are out of date but the structure and functions of the Reactor Division re=ain the same.
2.
11.1 Please see under Director and Supervisors 3.
11.1 Reactor Director (new title Director of Reactor Operations). Also, the MIT Reactor Safeguards Co=nittee reviews and approves all parts of the SAR, including Chapter 11.
Please see License R-17 Technical Specification 4
7.3.l(a).
5.
11.1 These sections cover responsibilities of group 11.7 and shift supervisors. Technical Specifications l
11.10 7.5.1.f(ii) and 7.1.6 assure that conservative courses of action will be followed, whether initiated by QA individuals or by others.
6.
11.18 8.
- 11. 7 This is covered by Technical Specification 11.10
- 7. 5.1. f (ii).
9.
11.1 Provide for use of outside expertise when it is 11.9 not available in-house.
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c U. S. Nucisar Rsguistory Commission ATTN: Charles E. MacDonald, Chief Item, No.
SAR Section_
Coc=ent 11 11.1 The program as written does not preclude 11.3 design verification by an immediate supervisor or subordinate due to the size of the organization. However, the principle is recognized, and it will be applied wherever the " considerations" of Appendix E, Section 2, warrant complete independence.
12 11.4 Also 11.4 is slightly revised.
11.17 17.
11.6 13, 11,p-
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II.9 21.
11.1 11.7 26.
11.5 The tests and inspections specified in 10CFR71.53 and 71.54 are performed by qualified individuals using written procedures and instructions. The statement in 11.5 addresses this point.
27.
11.5 11.5 specifies 10CFR71.54, which states
" Prior to each use...".
30.
11.15 s
We question the relevance of several of the information items listed (Category (3)). We do not expect to purchase special shipping containers, only Department of Transportation specification containers listed in '+9CFR178, which will carry other fabricator's marking in accordance with 178.0-2.
This in turn may be accepted by the shipper (49CFR173.22(a)). We do not fore-see circumstances under which items #13-16 would apply.
Also, it is not apparent how items # 22-25 apply to the routine packing and shipping of radioactive materials in DOT specification containers, other than possibly to weighing of the loaded package, if necessary, to assure compliance with gross weight limitations. We also plan shipm nts of solid waste and spent fuel, for which the relevance of the statement again is not understood.
U. S. Nuclear Regulatory Commission ATTN: Charles E. MacDonald, Chief s Item #28 does not appear necessary since 49CFR173.22(b) already makes this a shipper'aresponsibility. 10CFR73.67(g)(3) requires it for certain fissile shipments. Procedures for leased casks for spent fuel and large waste shipments also include it.
The occasions when packaging materials, parts, components, or services will be found to be nonconforming (item #31) are expected to be so infrequent that they probably should be handled on a case-by-case basis. Information on nonconformance vill appear in the documentation of the preliminary and routine determinations required by 10CFR71.53 and 71.54, referred to in 11.5, and a statement regarding identification, repair, transfer, and disposal appears in.
11.15., we do not understand the benefit to be derived frem the addition of still another statement'such as #31.
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If you have any questions regarding the revisions to the QA program as submitted herewith, please feel free to contact the writer.
Sincerely, m'
Lincoln Clark, Jr.
LC/cre cc: MIT Reactor Safeguards Committee enc 1:
7 copies of pp. 11.4-1, 11.6-1, 11.7-1, 11.17-1 4P4q+3 5*
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11.4-1 11.4 Procurement Document Control In docu ents for procurement of materials, equipment and services, assurance that applicable regulatory requirements, design bases and other requirements which are necessary to assure adequate quality are suitably included or referenced in such documents shall be accomplished by requiring that the appropriate group supervisor or his designee and either the Reactor Director or Co-Director, as appropriate, or his designee, must both review and approve prior to their release the specifications, drawings, procedures, instructions or other docu=ents which are parts of purchase orders and contracts subject to the quality assurance program. The Director or Co-Director shall specify for which caterials, equipment and services the procurement documents shall be reviewed. These shall include, but not be limited to, the core housing, core tank and D 0 reflector tank, for the MITR-II, the containment penetra-tions, the pressure relief systen filters, safety channel instrumentation, effluent and area radiation monitors, emergency power supply, fuel elements, and shipping packages.
11.5 Instructions, Procedures and Drawines Activities affecting quality shall be prescribed where appropriate, by documented instructions, procedures, or drawings.
These docu=ents shall specify the equip =ent to be used and the necessary environ-cental conditions, where appropriate, and shall state the required prerequisites, if any, for QA activities, inspections and tests. For modifications or additions to structures, systems or components within the scope of the program, such documents shall be prepared, approved as provided in Subsection 11.3 (Design Control), and re-tained on file. For the MITR-II modification, for example, engineering drawings of every assembly and subasse=bly, with detail of every fabricated item, shall be pre-pared; specifications shall be written governing the f abrications of non-standard items; detailed instructions, with acceptance standards, shall be prepared for the conduct of fabrication tests such as leak tightness, hydro-static pressure tests, and 1.,..~ s SR # O-80-26 AUG 51980 1
11.6-1
=:chanical opera:ing perfor=ance. For fuel procure::nt as a second exa:ple, engineer-ing drawings shall be prepared; detailed specifications for fabrication, testing, and inspectics methods ahall be prepared by MIT or, if sub=itted by the vendor, shall re-quire approval in writing by MIT; standards for horogeneity of the fuel alloy and tolerances on core and clad thickness and en fin dirensiens shall reflect the uncer-tainties used in the core hydraulic and ther=al analyses, as described in Subsection 11.3.
For shipping packages, as a third example, docu=entation of the tests and inspections specified in 10 CTR 71.53 and 71.54 for the initial se and subsequen:
use of packaging subject to :he QA rec;2irenents shall be prepared and retained on file.
11.6 Docu=ent Cont rol Docu=ents relating to a particular type of activity are, in general, prepared under the direction of the supervisor having responsibility for that activity. That supervisor is delegated the responsibility for maintaining a file of such documents, revising thes to reflect approved design changes and as-buil: conditions, and clearly identifying all drafts, the document as originally approved, and all revisions. He assures that necessary documents are available at the location where the activity will be perfor=ed prior to coerencing the work. Other distribution of docu=ents is subject to the approval of the Reactor Director or Co-Director or other designated individual.
See Subsection 11.17 for a list of :Se files containing docu=ents of the type described above.
Changes to docu=ents shall be reviewed and approved, prior to i=plementation of the change, by the sa=e Reactor Division group or the sane organisation that per-for=ed the original revies and approval, unless the Reactor Director or Co-Director, as appropriate, specifically designates another responsible group or organizatien.
Changes to written procedures for inspec:icas, tests and other critical operations are
=ade in accordance with established procedures for te=porary changes and under the cognizance of the responsible supervisor.
SR# O-80 26 AUG 51980
11.7-1 11.7 Control of Purchased Material, Equipment, and Services In general, all materials, equipeent and services arc subject to inspection and approval of both the quality and quantity prior to acceptance. Responsibility for these functions rests with the group supervisor initiating the procurement, or his designee, unless responsibility is otherwise assigned by the Director or Co-Director as appropriate.
Inspection generally is performed af ter receipt of the material, equipment or servica at the reactor site.
For sane items, including the fuel housing, core tank and D 0 reflector tank of 3
the MITR-II, and for fuel elements, in-process inspection and/or final inspection are specified at the vendor's plant prior to delivery. Further inspection requirements for these itens are given belcw in this subsection and in Subsection 11.10.
When considered necessary to assure quality, and particularly for non-standard items, only vendors deemed qualified and acceptable to MIT are invited to bid. Con-tractors and suppliers arc selected on the basis of references, past performance at HIT, reputation and other investigation. Appropriate credentials, and licenses when required by law, code or regulation, will be furnished and retained on file.
No deviations from procurement documents are allowed without written request by the vendor and written approval by MIT.
Materials specifications for the f abrication of fuel elements and for the MITR-II core housing, core tank and D 0 reficctor tank require the furnishing of certified 2
chemical analyses and =sy require, prior to fabrication, representative samples of stock materials used. Other special materials are specified by MIT and cust be certi-fied by the supplier for compliance to material specifications prior to fabrication.
Responsibility for acceptance in all cases is with MIT.
If vendor and MIT do not agree on the quality of naterial or fabrication as de-fined in the specifications, the vendor may consult an independent expert acceptable to MIT. This expert opinion will then be used to determine the issue.
SR # O-80.26 AUG 51980
11.17-1 Failures adverse to safety which occurred or could have occurred during opera-tion are reported in " Unusual Occurrence Reports" which describe the failure and recommend corrective action. These are reviewed by the Director and are also sub-mitted annually to the MITR Safeguards Committee.
Incidents which are " Abnormal Occurrences" as defined in the Technical Specifications are submitted to the Safe-guards Committee for review at the time of submittal to the AEC.
Decisions as to corrective action are made on a case by case basis, depending upon the nature, severity and frequency of the deficiency.
11.17 Quality Assurance Records Procedures that implement the QA program are incorporated in the MIT Reactor Pro-cedure Manual, for which thero is a controlled circulation, including revisions, to appropriate personnel. Activities within the scope of the quality assurance program are documented in the records listed in the attached Table 11.17-1.
The table also shows the normal location of the records, the person assigned responsibility for their maintenance, and the required period of retention.
11.18 Audits An audit of the quality assurance progran shall be performed at least annually in accordance with a preestablished written procedure. The audit will be performed by the Reactor Director, or a designated, qualified individual, except that activities related to the design, installation and startup of the MITR-II will be audited by the Co-Director for the MITR-II. Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
The audit will cover all aspects of the quality assurance program including shipping. Documentation of the audit will include, as a minimum, a report of any changes in the program made since the previous audit, a report of random or complete reviews of all the records listed in Table 11.17-1, and an evaluati.on of the effect-iveness of the program. The audit, along with necessary actions initiated by the Director for Reactor Operations and/or Superintendent of Reactor Operation and Main-tenance to correct dificiencies revealed by the audit, are reviewed by all supervisors and operators.
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AUG 51980 SR # O-80-2 6