ML19294C944
| ML19294C944 | |
| Person / Time | |
|---|---|
| Site: | 07100244 |
| Issue date: | 09/02/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Dixon G NL CHEMICALS (USA), INC. |
| References | |
| NUDOCS 8009190692 | |
| Download: ML19294C944 (6) | |
Text
' ['(pa arog
,y
'o UNITED STATES 4
8 NUCLEAR REGULATORY COMMISSION
) e, g
^
E W ASHING TON, D. C. 20555
- %..... /
SE? 0 21980 FCTC: RHO 71-0244 NL Industries, Inc.
ATTN: Mr. George N. Dixon, Jr.
P.O. Box 2046 Wilmington, DE 19899 Gentlemen:
We have evaluated your quality assurance program (NLQ-63, Rev.1) submitted with your February 14, 1980 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, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information 8009190 f2
s NL INDUSTRIES (71-0244)
Recuest for Ad 4 tional Infomation 9A.
Describe how all responsible organizations and individuals are made aware that quality policies, QA manuals, and procedures are mandatory requirements.
10A.
Describe how disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manu-facturing, etc.) personnel are resolved.
IlA.
Clarify that the proficiency of personnel perfoming quality-affecting activities is maintained by retraining, reexamining, and/or recertify,ing.
12A.
Provide a statement that quality standards are specified in the design docum'ents, and deviations and changes from these
- ality standards are controlled.
13A.
Provide a statement that suitable design controls are applied to such activities as stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
14A.
Provide a statement that designs are reviewed to assure that '(1) design character-istics can be controlled, inspected, and tested and (2) inspection and test cri-teria are identified.
15A.
Provide a statement that proper selection and accomplishment of design verifica-tion or checking processes such as by design reviews, alternate calculations, or qualification testing are performed.
When a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under adverse design conditions shall be used.
17A.
Provide a statement that errors and deficiencies in the design, including the design process, that could adversely affect safety-related structures, systems, and c roonents m 2 documented; and corrective action is taken to preclude repetition.
18A.
Provide a statement that materials, parts, and equipment which are standard, commercial (off the shelf) or which have been previously approved for a dif-ferent application are reviewed for suitability prior to selection.
19A.
Identify the positions or groups responsible for design reviews and other design verification activities.
20A.
Provide a statement that measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and components which include the use of valid industry standards and specifica-tions.
22A.
Provide a statement that a review and concurrence of the adequacy of quality requirements stated in procurement documents is perfomed by qualified personnel.
This review should deteanine 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 ap in accordance with QA program requirements.
23A.
documented prior to release and available for verification. P 29A.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
30A.
of safety-related structures, systems, and components at least equivalent to those used for the original equipment.
- 32A, Provide a statement that methods for complying with each of the 18 criteria of 10 CFR Part 71, Appendix E are specified in instructions, procedures, and drawings.
34A.
Clarify that the QA organization reviews and concurs with calibration procedure 39A.
Provide a statement that a master list or equivalent is established to identi the current revision number of instructions, procedures, specifications and procurement documents.
, drawings, responsible personnel to preclude use of superseded documents.This lis 45A.
minimum to NL Industries: Provide a statement that the supplier furnishes the fo Documentation that identifies the purchased material or equipment and the a.
tions) met by the items, specific procurement requirements (e.g., codes, stand b.
Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances dispositioned
" accept as is" or " repair. "
45A.
evaluated by audits, independent inspections, or tests 49A.
Provide a statement that identification requirements are detennined during generation of specifications and design drawings.
5 2A.
affect the fit, function, or quality of the item being identified.
53A.
nents is verified and documented prior to release for f shipping, and installation.
56A.
Clarify that special processes are accomplished in accordance with written process sheets or equivalent with recorded evidence of verification.
. 60A.
Provide a statement that inspection procedures, instructions, and check lists 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.
Acceptance and rejection criteria.
d.
A description of the method of inspection.
e.
Recording evidence of completing and verifying a manufacturing inspec-tion, or test operation.
f.
Recording inspector ce data recorder and the results of the inspection operation.
61A.
Provide a statement that inspection procedures or instructions are used with-necessary drawings and specifications when performing inspection operations.
62A.
Provide a statement that inspectors are qualified in accordance with applicable codes, standards, and ccmpany training programs; and their qualifications and certifications are kept current.
70A.
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.
- lA.
Provide a statement that calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being cali-b ra ted. A greater uncertainty may be acceptable when limited by the " state-of-the-art."
72A.
Provide a statement that the complete status of all items under the calibration system is recorded and maintained.
74A.
Provide a statement that special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
78A.
Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
80A.
Provide a statement that documentation identifies the nonconforming item; describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
SlA.
Identify those individuals or groups delegated the responsibility and authority for the disposition and approval of nonconforming items.
83A.
Provide a statement that acceptability of rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as original.ly 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.
84A. Provide a statement that nonconformance reports dispositioned " accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to NL Industries for review and assessment.
86A.
Provide a statement that follow-up re fews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
88A.
Provide a statement that QA records include results of reviews, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifica-tions, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
89A.
Provide a statement that records are identifiable and retrievable.
91A.
Clarify that inspection and test records contain the following where applicable:
a.
Infonnation related to conditions adverse to quality, b.
Inspector or data recorder identification.
c.
Evidence as to the acceptability of the results.
95A.
Provide a statement that deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
95A.
Provide a statement that audits include an objective evaluation of quality-related practices, procedures, and instructions and the effectiveness of implementation.
97A.
Provide a statement that audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
98A.
Provide a statement that audits to assure that procedures and activities are meaningful and comply with the overall QA program are performed by:
a.
The QA organization, to provide a comprehensive independent verifica-tion and evaluation of quality-related procedures and activities.
b.
NL Industries, to verify and evaluate their suppliers' QA programs, procedures, and activities.
99A.
Provide a statement that audits are regularly scheduled on the basis of the status and safety importance of the activities being performed and are initiated early enough to assure effective quality assurance during the desiga, procure-ment, and contracting activities.
5-100A. Provide a statement that audit data are analyzed and the reports, which indi-cate quality trends and the effectiveness of the QA program, are reported to management for review and assessment.
.