ML19270G896
| ML19270G896 | |
| Person / Time | |
|---|---|
| Site: | 07100018 |
| Issue date: | 05/30/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Jesse Rollins NAC INTERNATIONAL INC. (FORMERLY NUCLEAR ASSURANCE |
| References | |
| NUDOCS 7906210087 | |
| Download: ML19270G896 (7) | |
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UNITED STATES y
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MAY 3 01979 FCTR: RHO 71-0018 Nuclear Assurance Corporation ATTN:
Mr. Jack D. Rollins 24 Executive Park West Atlanta, GA 30329 Gentlemen:
This refers to your application dated June 16, 1978 requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 571.51.
In connection with oJr review, we need the infonnation identified in the enclosure to this letter.
Please submit seven copies of your response to the enclosed request for additional information within 30 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 Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information 2240 245 79062100M
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NUCLEAR ASSURANCE CORPORATI0f1 (71-0018)
Request for Additional Infonnation 1.
Describe the qualification requirements for the position of (I)
Quality Assurance Administrator.
2.
Provide a statement that provisions are established to control (II) the distribution of the QA manual and revisions thereto.
3.
Provide a statement that provisions are established for (II) communicating to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requirements.
4.
Provide a matrix of the QA procedures cross-referenced to (II) each criterion of Appendix E to 10 CFR Part 71.
5.
Identify the safety-related structures, systems, and components (II) controlled by the QA program.
6.
Describe how disputes involving quality, arising from a (II) difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.)
personnel, are resolved.
7.
Provide a
_.ement that an indoctrination and training program (II) is established such tha t:
a.
Personnel responsible for performing quality-affecting activiti'es are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
b.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being perfonned.
c.
The scope, the objective, and the method of implementing the indoctrination and training program are documented.
d.
Proficiency of personnel perfonning quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
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. t 8.
Provide a statement that suitable design controls are applied (III) to such activities as stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
9.
Provide a statement that designs are reviewed to assure that (III)
(1) design characteristics can be controlled, inspected, and tested and (2) inspection and test criteria are identified.
10.
Provide a statement that, when a test program is used to verify (III) the adequacy of a design, a qualification test of a prototype unit u.nder adverse design conditions shall be used.
11.
Provide a statement that errors and deficiencies in the design, (III) including the design process, that could adversely affect safety-related structures, systems, and components are documented; and corrective action is taken to preclude repetition.
12.
Provide a statement that materials, parts, and equipment which (III) are standard, commercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
13.
Identify the positions or groups responsible for design (III) reviews and other design verification activities.
14.
Provide a statement that. measures are established for the (III) selection of suitable materials, parts, equipment, and processes for' safety-related structures, systems, and components which include the use of valid industry standards and specifications.
15.
Provide a statement that t% review and approval of procurement (IV) documents are documer1
- rior to release and available for verification.
16.
Provide a statement that procurement documents identify the (IV) applicable 10 CFR Part 71, Appendix E requirenents which must be complied with and described in the supplier's QA prog ram.
This QA program or portions thereof shall be reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program.
17.
Provide a statement that procurement documents contain or (IV) reference the design basis technical requirements, including the applicable regulatory requirenents, material and component 2240 247
identification requirements, drawings, specifications, codes
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and industrial standards, test and inspection requirements, and special-process instructions.
18.
Provide a statement that procurement documents identify those (IV) records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the hardware.
19.
Provide a statement that procurement documents contain the (IV) procuring agency's right of access to supplier's facilities and records for source inspection and audit.
20.
Provide a statement that changes and revisions to procurement (IV) docinents are subject to at least the same review and approval as the original document.
21.
Provide a statement that methods for complying with each of (V) the 18 criteria of 10 CFR Part 71, Appendix E are specified in instructions, procedures, and drawings.
22.
Provide a statement that the QA organization reviews and (VI) concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto.
23.
Provide a statement that a master list or equivalent is (VI) established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
This list is updated and distributed to predetemin.ed, responsible personnel to preclude use of superseded documents.
24.
Identify the types of documents that are controlled by the (VI)
QA program.
25.
Provide a statement that qualified personnel evaluate the (VII) supplier's capability to provide acceptable quality services and products before the award of the procurement order or contract.
The QA and engineering groups participate in the evaluation of those suppliers providing critical components.
26.
Provide a statement that the results of supplier evaluations (VII) are documented and filed.
27.
Provide a statement that surveillance of suppliers during (VII) fabrication, inspecticn, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure confomance to the purchase order requirements. These procedures provide for:
2240 248 a.
Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation required; and those responsible for implementing these instructions.
b.
Audits and surveillance which assure that the supplier complies with the quality requirements.
Surveillance is performed on those items where verification of procurenent requirements cannot be determined upon receipt.
28.
Provide a statement that the supplier furnishes the following (VII) records as a minimum to the purchaser:
a.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, sta_ndards, and specifications) met by the items.
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."
The review and acceptance of these documents shall be described in the purchaser's QA program and as a minimum shall be under-taken by a responsible QA individual.
29.
Provide a statement that receiving inspection of the supplier-(VII) furnished material, equipment, and services is performed to assure:
a.
The material, component, or equipment is properly identified and corresponds with the identification on receiving documen-tation.
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 equipnent are available at the facility prior to installation or use.
d.
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
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a 30.
Provide a statement that identification requirements are (VIII) detemined during generation of specifications and design drawing s.
31.
Provide a statement that the location and the method of (VIII) identification do not affect the fit, function, or quality of the item being identified.
32.
Provide a statement that inspection procedures, instructions, (X) and checklists provide for the following:
a.
Identification of characteristics and activities to be inspected.
b.
Identification of the individuals or groups responsible for perfonning 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, inspection, or test operation.
I f.
Recording inspector or data recorder and the results l
of the inspection operation.
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Provide a statement that inspection procedures or instructions (X) are used with necessary drawings and specifications when perfonning inspection operations.
34.
Provide a statement that inspectors are qualified in accordance (X) with applicable codes, standards, and company training programs; and their qualifications and certifications are kept current.
35.
Provide a statement that modifications, repairs, and replacements (X) are inspected in accordance with the original design and inspection requirements or acceptable alternatives.
36.
Provide a statement that measuring and test equipment is labeled (XII) or tagged to indicate date of the next calibration.
37.
Provide a statement that measures are taken and documented to (XII) determine the validity of previous inspections perfonned when measuring and test equipment is found to be out of calibration.
38.
Provide a statement that calibrating standards have an uncertcinty (XII)
(error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated.
A greater uncertainty may be acceptable when limited by the " state-of-the-art."
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39.
Provide a statement that bypasskng of required inspections, (XIV) tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
40.
Provide a statement that acceptability of rework or repair (XV) of materials, parts, 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.
41.
Provide a statement that nonconfomance reports dispositioned (XV)
" accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to the purchaser for review and assessment.
42.
Provide a statement that nonconfomance reports are periodically (XV) analyzed to show quality trends, and the results are reported to management for review and assessment.
43.
Provide a statement that follow-up reviews are conducted to (XVI) verify proper implementation of corrective actions and to close out the corrective action documentation.
44.
Provide a statement that requirements and responsibilities for (XVII) record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.
45.
Provide a statement that record storage facilities are constructed, (XVII)
(located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
46.
Provide a statement that audits include the objective evaluation (XVIII) of work areas, activities, processes, and items, and the review of documents and records.
47.
Provide a statement that audits to assure that procedures and (XVIII) activities are meaningful and comply with NAC's overall QA program are perfomed by the QA organization, to provide a comprehensive independent verification and evaluation of quality-related procedures and activities.
48.
Provide a statement that audit data are analyzed and the reports, t
(XVIII) which indicate quality trends and the effectiveness of the QA program, are reported to management for review and assessment.
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