ML19318B566
| ML19318B566 | |
| Person / Time | |
|---|---|
| Site: | 07100164 |
| Issue date: | 06/12/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lisa Clark MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE |
| References | |
| NUDOCS 8006270055 | |
| Download: ML19318B566 (4) | |
Text
-- -
. p' **c uq[o
,-T UNITED STATES
~g J I, e.
g NUCLEAR REGULATORY COMMISSION t
._ 4 j
WASHINGTON, D. C. 20555
..h. ',$. "f JUN 121980 FCTC: RHO 71-0164 Massachusetts Institute of Technology ATTN: Mr. Lincoln Clark, Jr.
135 Albany Street Canbridge, MA 02139 Gentlemen:
We have evaluated your quality assurance program submitted with your June 30, 1978 letter to satisfy the requirements of 10 CFR 571~.51.
Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71.
Please address the enclosed request for additional information and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Sincerely,
=Y Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Recuest for Additional Infomation THIS DOCUMENT CONTAINS P00R QUALITY PAGES i
8006270055 l
i.
f MASSACHUSETTS INSTITUTE OF TECHNOLOGY (71-0164)
Request for Additional Information l
- 1. Provide ar. organizational chart (s) which identifies the organizational elements cict function under the control of the QA program.
2.
Describe the QA responsibilities of each organizational element identified in the respocse to question 1.
3.
Icentify the level of managment that is responsible for establishing MIT's QA pcGicies, goals, and objectives.
4.
Describe the qualification requirements for the position of Reactor Director.
5.
provide a statenent that designated QA individuals have the responsibility and ac.therity, delineated in writing, to:stop. unsatisfactory work and control further processine, delivery, or installation of nonconforming material.
6.
Icen:ify the management level who regularly assesses the scope, status, implemen-taticn, ard effectiveness of the QA program to assure that the program is adequate and :amplies with 10 CFR Part 71, Appendix E criteria.
- 7. Provide a statement that provisions are established to control the distribution of' tre QA :nanual and revisions thereto.
B.
Describe row disputes involving quality, arising from a difference of opinion between designated QA/QC personnel and other department personnel, are resolved.
S. provide a statement that training and experience for all QA functions will be required and accomplished in accordance with established procedures.
3 D.
Provide a statement that quality-related activities are performed with specified ecui: ment and under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
- 71. Provide a statement that individuals or groups responsible for design verifica-tf on are cther than the original designer and the designer's immediate supervisor.
- 22. Provide a statement that the review and approval of procurement documents are do:unentec pricr to release and available for verification.
- 33. Provide a statenent that procurement documents identify the applicable 10 CFR Fr.rt 71, bpen:iix E requirements which must be complied with and described in me ra:ol'er 's QA program. This QA program or portions thereof shall be reviewed and =::ured with by qualified personnel prior to initiation of activities affe::ed :y the program.
' 4.
- ov'de a statement that procurement documents identify the documentation (e.g.,
- ar ;s, specifications, procedures, inspection and fabrication plans, inspection
. and test records, personnel and procedure qualifications, and chemical and pFysical test results of material) to be prepared, maintained, and submitted tc the purchaser for review and approval.
lE.
Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to MIT prior to use or installation of the hardware.
l E.
Provide a statement that procurement documents contain MIT's right of access to suaplier's facilities and records for source inspection and audit.
17.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
l E.
Provide a statement that a designated QA individual (s) reviews and concurs with inspection plans, test, calibration, and special process procedures, drawings and specifications; and changes thereto or acceptable alternatives are described.
15.
Provide a statement that approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.
2C.
Provide a statement that documents are available at the location where the activity will be performed prior to commencing the work.
21.
Provide a statement that inspection personnel are independent from the individuals perforcing the activity being inspected.
22.
Provide a statement that measuring and test equipment is identified and traceable tc the calibration test data.
23.
Provide a statement that measuring and test instruments are calibrated at spt i-fied ir.tervals based on the required accuracy, purpose, degree of usage, stabinty characteristics, and other conditions affecting the measurement.
24 Provide a statement that measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
25.
Provide a statement that reference and transfer standards are traceable to nation-ally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
2f.
Provide a statement that handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by qualified individuals ir. acccrdance with predetermined work and inspection instructions.
27.
Provide a statement that shipments will not be made unless all tests, certifica-ti:ns, acceptances, and final inspections have been completed.
Previce a statement that departure, arrival time, and destination of a package 21.
adil be established and monitored to a degree consistent with the safe transpor-tici:n of the package.
. 29. Prosice a statement that bypassing of required inspections, tests, and other cridcal a;;erations is procedurally controlled under the cognizance of the QA ommization.
- 30. Proside a statement that the status of nonconforming, inoperative, or malfunc-tioring structures, systems, or components is identified to prevent inadvertent use.
- 31. Proside a statement that the identification, documentation, segregation, review, disp 3sition, and notification to affected organizations of nonconforming materials, par:s, conponents, or services are procedurally controlled.
- 32. Provide a statement that audits are perfonned in accordance with preestablished written p-ocedures or check lists and conducted by trained personnel not having dire:t responsibilities in the areas-being audited.
- 33. Pnvide a statement that audit results are documented and then reviewed with imanagesnent having responsibility in the area audited.
- 34. Provide a statement that responsible management takes thc necessary action to correct tne deficiencies revealed by the audit.
- 35. Frovide a statement that deficient areas are reaudited on a timely basis to verify inplementation of corrective actions which minimize recurrence of 6efi:iencies.
r
,-- ---