ML19209C776
| ML19209C776 | |
| Person / Time | |
|---|---|
| Site: | 07100250 |
| Issue date: | 10/09/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Goldmann K TRANSNUCLEAR, INC. |
| References | |
| NUDOCS 7910180282 | |
| Download: ML19209C776 (7) | |
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UNITED STATES S 'Y)%w'j NUCLEAR REGULATORY COMMISSION
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- 00T 0 91979 FCTC: RHO 71-0250 Transnuclear, Inc.
ATTN: Mr. Kurt Goldmann One North 9 roadway White P1ains, NY 10601 Gentlemen:
We have evaluated your Quality Assurance Program for Design, Manufacture, Test, Use, Maintenance, and Repair of Packages for Transport of Radioactive Materials submitted with your December 29, 1978 letter to satisfy the require-ments of 10 CFR 571.51.
Our review indicates ti..c additional information is required to satisfy the appliedble 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, 8
Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information 1178 183 701016 0 2 S' t
TRANSNUCLEAR, INC. (71-0250)
Recuest for Additional Infomation 1.
In Figure 1, "TNY Organization Chart," clarify the meaning of the " dotted (1) line" between Project Manager and Quality Assurance.
2.
When the Chief Engineer is assigned the "QA function for that Project,"
(1) explain how he is independent of undue influences and responsibilities for costs and schedules.
3.
Describe the qualificatior, requirements for the position of Chief Engineer (1) and also the position "who has responsibility for the QA function for that Project."
4.
Provide a statement that verification of confomance to established require-(1) ments is accomplished by individuals or groups who do not have direct responsibility for perfoming the work being verified.
5.
Give a brief summary of TNY's corporate QA policies, goals, and objectives (2) and describe how these policies, goals, and objectives are transmitted down through the levels of management.
6.
Provide a statement that provisions are established for communicating to (2) all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requirements.
7.
List the QA procedures plus a matrix of these procedures cross referenced (2) to each criterion of Appendix E to 10 CFR Part 71.
8.
Provide a statement that an indoctrination and training program is established (2) such that:
a.
Personnel responsible for perfoming quality-affecting activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and precedures.
b.
Proficien;y of personnel perfoming quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
9.
Provide o statement that designs are reviewed to assure that (1) design (3) characteistics can be controlled, inspected, and tested and (2) inaection and test criteria are identified.
- 10. Provide a statement that errors and deficienci - in the design, including the (3) design process, that could adversely affect safety-related structures, systems, and ccmoonents are documented, and corrective action is take, to preclude repetition.
1l78 J84 11.
Provide a statement that materials, parts, and equipment which are standard, (3) com.ercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
12.
Provide a statement that measures are established for the selection of suit-(3) able materials, parts, equipment, and processes for safety-related structures, systems, and components which include the use of valid industry standards and specifications.
13.
Provide a statement that a review and concurrence of the adequacy of quality (4) requirements stated in procurement documents is performed by qualified personnel. This review should deternine that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.
14.
Provide a statement that the review and approval of procurement documents are (4) documented prior to release and available for verification.
15.
Provide a statement that procurement documents identify the documentation (4)
(e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to TNY for review and approval.
- 16. Provide a statement that procurement documents identify those records to be (4) retained, controlled, and maintained by the supplier, and those delivered to TNY prior to use or installation of the hardware.
- 17. Provide a statement that procurement documents contain the TNY's right of (4) access to supplier..acilities and records for source inspection and audit.
- 18. Provide a statement that changes and revisions to procurement documents are (4) subject to at least the same review and approval as the original document.
- 19. Provide a statement that methods for complying with each of the 18 criteria (5) of 10 CFR Part 71, Appendix E are specified in instructions, procedures, and drawings.
20.
Identify those individuals or groups responsible for reviewing and approving (6) documents and revisions thereto.
- 21. Provide a statement that approved changes are included in instructions, (6) procedures, drawings, and other documents prior to implementation of the change.
22.
Provide a statement that documents are.vailable at the location where the (6) activity sill be performed prior to commencing the work.
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. 23.
Identify the organizations or groups who perfonn source evaluations prior (7) to the award of the procurement order or contract.
- 24. Provide a statement that the evaluation of suppliers is based on one or more (7) of the follcwing:
a.
The supplier's capability to comply with the elements of 10 CFR Part 50, Appendix B that are applicable to the type of material, equipment, or service being procured.
b.
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
c.
A survey of the supplier's facilities and QA program to detemine his capability to supply a product which meets the design, manufacturing, and quality requirements.
25.
Provide a statement that the results of supplier evaluations are documented (7) and filed.
26.
Provide a statement that the supplier furnishes the folicwing records as a (7) minimum to TNY:
Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances dispositioned
" accept as is" or " repair." The review and acceptance of these documents shall be described in TNY's QA program and as a minimum shall be undertaken by a responsible QA individual.
- 27. Provide a statement that supplier's certificates of conformance are periodically (7) evaluated by audits, independent inspections, or tests to assure they are valid.
- 28. Provide a statement that receiving inspection of the supplier-furnished material, (7) equipment, and services is performed to assure:
a.
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
b.
Material, components, equipment, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
c.
Inspection records or certificates of conformance attesting to the acceptance of material, components,and equipment are available at the nuclear power plant prior to installation or use, d.
Items accepted and released are identified as to their inspection status prior to forsarding them to a controlled storage area or releasing them for installation or further work.
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. 29. Provide a t, itement that identification requirements are datennined during (8) generation of specifications and design drawings.
30.
Provide a statement that the location and the method of identification do (8) not affect the fit, function, or quality of the item being identified.
31.
Provide a statement that correct identification of material, parts, and (8) components is verified and documented prior to release for fabrication, assembling, shipping, and installation.
- 32. Provide a statement that inspection procedures, instructions, and check lists (10) provide for the following:
a.
Identification of characteristics and activities to be inspected, b.
Identification of the individuals or groups responsible for performing the inspection operation.
c.
A description of the method of inspection.
d.
Recording evidence of completing and verifying a manufacturing, inspection, or test operation.
e.
Recording inspector or data recorder and the results of the inspection operation.
33.
Provide a statement that inspectors are qualified in accordance with applicable (10) codes, standards, and company training programs; and their qualifications and certifications are kept current.
34.
Provice a statement that modifications, repairs, and replacements are (10) inspected in accordance with the original design and inspection requirements or acceptable alternatives.
35.
Provide a statemenu that provisions are established for indirect control by (10) monitoring processing methods, equipment, and personnel if direct inspection is not possible.
36.
Provide a statement that modifications, repairs, and replacements are tested (11) in accordance with the original design and testing requiren.ents or acceptable al ternatives.
37.
Provide a statement that written test procedures incorporate or reference:
(11)
The requirements and acceptance limits contained in applicable design and a.
procurement documJnts.
b.
Instructions for perforning the test.
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. c.
Test prerequisites such as:
Adequate and appropriate equipment.
Trained, qualified, and licensed or certified personnel.
Completeness of item to be tested.
Provisions for data collection and storage.
d.
Mandatory inspection hold points for witness by owner, contractor, or inspector.
- 38. Provide a statement that measuring and test equipment is identified and trace-(12) able to the calibration test data.
39.
Provide a statement that measuring and test equipment is labeled or tagged to (12) indicate date of the next calibration.
40.
Provide a statement that measures are taken and documented to determine the (12) validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
- 41. Provide a statement that calibrating standards have an uncertainty (error)
(12) requirement of no more than hth of the tolerance of the equipment being calibrated. A greater uncertainty may be acceptable when limited by the
" state-of-the-art."
42.
Provide a statement that the complete status of all items under the calibration (12) system is recorded and maintained.
43.
Provide a statement that bypassing of required inspections, tests, and other (14) critical operations is procedurally controlled under the cognizance of the QA organization.
44.
Provide a statement that nonconformance reports include inspection requirements (15) and signature approval of the disposition.
45.
Provide a statement that acceptability of rework or repair of materials, parts, (15) components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
Inspection, testing, rework, and repair procedures are documented.
46.
Provide a statement that requirements and responsibilities for record transmittals, (17) retention (such as duration, location, fire protection, and assigned responsibilities),
and maintenence subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.
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. 47.
Provide a statement that inspection and test records contain the following (17) where applicable:
a.
A description of the type of observation.
b.
Evidence c' completing and verifying a manufacturing, inspection, or test operation.
c.
The date and results of the inspection or test.
d.
Information related to conditions adverse to quality.
e.
Inspector or data recorder identification.
f.
Evidence as to the acceptability of the results.
48.
Provide a statement that record storage facilities are constructed, located, (17) and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
49.
Provide a statement that audits include an objective evaluation of qui.lity-(18) related practices, procedures, and instructions and the effectiveness of implementation.
50.
Provide a statement that audits to assure that procedures and activities are (18) meaningful and comply with the overall QA program are performed by TNY to verify and evaluate their suppliers' QA programs, procedures, and activities.
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