ML19257C307
| ML19257C307 | |
| Person / Time | |
|---|---|
| Site: | 07100249 |
| Issue date: | 01/16/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Michel C NUCLEAR FUEL SERVICES, INC. |
| References | |
| NUDOCS 8001250590 | |
| Download: ML19257C307 (11) | |
Text
(W p.m Rio ug'o, UNITED STATES NUCLEAR REGULATORY COMMISSION n
h WASHINGTON, D. C. 20555
%.....+
JAN 161980 FCTC: RHO 71-0249 Huclear Fuel Services, Inc.
ATTN: Mr. C. J. Michel P.O. Box 218 Erwin, TN 37650 Gentlemen:
We have evaluated your Quality Assurance Program submitted with your December 14, 1979 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 1810 020 8 0012 50 M O
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NUCLEAR FUEL SERVICES (71-0249)
Request for Additional Information r
1.
Provide a statement that verification of conformance to established requirements is accomplished by individuals or groups who do not have direct responsibility for perfonning the work being verified.
2.
Provide a statement that designated QA individuals have the responsi-bility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconfonning material.
3.
Clarify if the " Quality Control Manager" noted on page 6 and the " Quality Control Supervisor" shown in Figure 1 are one.and the same.
If not,show the QC Manager on the organizational chart.
4.
Provide a list of the QA procedures plus a matrix of these procedures i.
cross referenced to each criterion of Appendix E to 10 CFR Part 71.
L 5.
Provide a statement that quality-related activities are perfonned with specified equipment and under suitable environmental conditions, and t
prerequisites have been satisfied prior to inspection and test.
6.
Provide a statement that measures are established to correctly translate the applicable regulatory requirements and design bases into specifica-tions, drcwings, written procedures, and instructions.
7.
Provide a statement that quality standards are specified in the design docu-ments and deviations and changes from these quality standards are controlled.
8.
Provide a statement that suitable design controls are applied to such activities as stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and act essibility for inservice inspection, maintenance, and repair.
9.
Provide a statement that designs are reviewed to assure that (1) design characteristics can be controlled, inspected, and tested and (2) inspec-tion and test criteria are identified.
- 10. Provide 'a statement that proper selection and accomplishment of design
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verification or checking processes such as by design reviews, alternate calculations, or qualificatron testing are performed. When a test pro-t gram is used to verify the adequacf of a design, a qualification test of a prototype unit under adverse design conditions shall be used.
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- 11. Provide a statement that individuals or grdups responsible.for design' verification are other than the original designer and the designer's-immediate supervisor.
1810 02b E
- 12. Provide a statement that design and specification changes, inc.luding field changes, are subject to the same design controls and approvals that were applicable to the original design unless the applicant designates another qualified responsible organization.
13.
Provide a statement that errors and deficiencies in the design, including the design process, that could adversely affect safety-related structures, systems, and componcats are documented; and corrective action is taken to preclude repetitivn.
14.
Provide a statement that materials, parts, and equipment which are standard, conmercial (off the snelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
15.
Identify the positions or groups responsible for design reviews and other design verification activities.
- 16. Provide a statement that measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and ccmponents which include the use of valid industry standards and specifications.
17.
Clarify that procedures are established to clearly delineate the sequence of actions to be accomplished in the prepa ation, review, approval, and control of procurement documents.
18.
Clarify that the review of procurement documents detennines that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement docu-ment has been prepared, reviewed, and approved in accordance with QA pro-gram requirements.
- 19. Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
20.
Provide a statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program. 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.
21.
Provide a statement that procurement documents contain or reference the design basis technical requirements. including the applicable regulatory requirements, material and component identification requirements, draw-
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ings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
22.
Provide a statement that procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test reco-ds, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, main-tained, and submitted to NFS for review and approval.
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23.
Provide a stai.ement that procure.nent documents identify those records to be retained, controlled, and maintained by the supplier, and those i
delivered to NFS prior to use or installation of the hardware.
- 24. ' Provide a statement that procurement documents contain NFS's right of access to supplier's facilities and records for source inspection and r
audit.
25.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original docu-ment.
26.
Provide a statement that procurement documents for spare or replacement parts of safety-related structures, systems, and components are subject to controls at least equivalent to those used for the original equipment.
27.
Provide a statement that provisions are established which clearly delineate
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the sequence of actions to be accomplished in the preparation, review,
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approval, and control of instructions, procedures, and drawings.
I 28.
Provide a statement that methods for complying with each of the 18 cri-
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teria of 10 CFR Part 71, Appendix E are specified in instructions, proce-E dures, and drawings.
29.
Provide a statement that instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria to verify
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that important activities have been satisfactorily accomplished.
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- 30. Provide a statement that the review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
31.
Identify those individuals or groups responsible for reviewing, approving, and issuing documents and revisions thereto.
- 32. Provide a statement that changes to documents are reviewed and approved r
by the same organizations that performed the original review and approval F
or by other qualified responsible organizations delegated by the applicant.
- 33. Provide a statement that approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.
34.
Provide a statement that absolete or superseded docunents are controlled to prevent inadvertent use.
35.
Provide a statement that docunents are available at the location where the activity will be performed prior to commencing the work.
- 36. Provide a statement that a master list or equivalent is established to e
identify the current revision number of instructions, procedures, speci-1810 023
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fications, drawings, and procurement documents. This list is updated and distributed to predetermined, responsible personnel to preclude use of superseded documents.
- 37. Provide a statement that the documents that are controlled under this subsection include as a minimum:
f a.
Design specifications.
i b.
Design, manufacturing, construction, and installation drawings..
c.
d.
Design criteria documents.
e.
Manufacturing, inspection, and testing instructions.
f.
Design change requests.
g.
Nonconformance reports.
38.
Provide a statement that qualified personnel evaluate the 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 avaluation of those suppliers providing criti-cal components.
- 39. Provide a statement that the evaluation of suppliers is based on one or more of the following:
a.
The su, plier's capability to comply with the elements of 10 CFR Part 71, Appendix E that are applicable to the type of material, equipment, or service being procured, b.
A review of previous records aqu performance of suppliers who have pro-vided similar articles of the type being procured.
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c.
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
- 40. Provide a statemera that the results of supplier evaluations are documented and filed.
- 41. Provide a statement that surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components
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is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements. These procedures provide for:
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a.
Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveil-lance and the extent of documentation required; and those responsible for implement'ing 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 procurement requirements cannot be' determined upon receipt.
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- 42. Provide a statement that the supplier furnishes the following records as a miniman to NFS:
a.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, 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 NFS's QA program and as a minimun shall be undertaken by a responsible QA individual.
43.
Provide a statement that supplier's certificates of conformance are periodi-cally evaluated by audits, independent inspections, or tests to assure they are valid.
44.
Provide a statement that receiving inspection of the supplier-furnished 1
material, 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.
thterial, components, equipments, and acceptance records are inspec-ted and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
c.
Inspection records or certificates of conformance attestirq to the acceptance of material, components, and equipment are available at NFS 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.
45.
Provide a statement that the effectiveness of the control of quality by suppliers is assessed by NFS at intervals consistent with the impor-tance, complexity, and quantity of the item.
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- 46. Provide la statement that procedures are established to identify and control materials, parts, and components including partially fabricated subassembH es.
- 47. Provide a statement that identification requirements are determined during generation of specifications and design drawings.
l 48.
Provide a statement that the identification and control procedures assure that identification is maintained either on the item or on records traceable t
to the item to preclude use of incorrect or defective items.,
49.
Provide a statement that identification of materials and parts important to the function of safety-related structures, systems,-and components l
1810 025
. can be traced to the appropriate documentation such as drawings, specifi-cations, purchase orders, manufacturing and inspection documents, devia-tion reports, and physical and chemical mill test reports.
- 50. Provide a statement thct the location and the method of identification do not affect the fit, function, or quality of the item being identified.
51.
Provide a statement that correct identification of material, parts, and components is verified and doctanented prior to release for fabrication, assembling, shipping, and installation.
- 52. Provide a statement that special processes such as welding, heat treating, nondestructi - testing, and cleaning are procedurally controlled.
53.
Provide a statement that procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
- 54. Provide a statement that special processes are perfonned by qualified personnel and accomplished in accordance with written process sheets or equivalent with recorded evidence of verification.
55.
Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes are established, filed, l
and kept current.
- 56. Provide a statement that an inspection program which verifies conformance of quality-affecting activities with requirements is established, docu-mented, and accomplished in accordance with written controlled procedures.
- 57. Provide a statement that inspection personnel are independent from the individuals perfonning the activity being inspected.
58.
Provide a statement that inspection procedures, instructions, and check lists provide for the following:
Identification of characteristics and activities to be inspected.
a.
b.
Identification of the individuals or groups responsible for perform-ing the inspection operation.
c.
Acceptance and rejection criteria.
d.
A description of the method' of inspection.
Recording evidence of completing.and verifying a manufacturing, e.
inspection, or test operation.-
s, f.
Recording inspector or data recorder and the results of the inspec-tion operation.
- 59. Provide a statement that inspection procedures or instructions are used with necessary drawings and specifications when performing inspection operations.
- 60. Provide a statement that inspectors are qualified in accordance.with applicable codes, standards, and company training programs; and their qualifications and certifications are kept current.
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61.
Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original design end inspection require-ments or acceptable alternatives.
- 62. ' Provide a statement that provisions are established that identify manda-tory inspection hold points for witness by an inspector.
63.
Provide a statement that provisions are established for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible.
64.
Provide a statement that modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
- 65. Provide a statement that written test procedures incorporate or reference:
a.
The requirements and acceptance limits contained in applicable design and procurement documents.
b.
Instructions for performing the test.
c.
Test prerequisites such as:
Calibrated instrumentation Adequate and appropriate equipment Trained, qualified, and licensed or certified personnel.
Completeness of item to be tested.
Suitable and controlled environmental conditions.
Provisions for data collection and storage.
d.
Mandatory inspection hold points for witness by owner, contractor, or inspector, e.
Acceptance and rejection criteria.
f.
Methods of documenting or recording test data and results.
- 66. Provide a statement that measuring and test equipment is identified and traceable to the calibration test data.
- 67. Provide a statement that measuring and test equipment is labeled or i
tagged to indicate date of the next calibration.
- 68. Provide a statement that measuring and test instruments are calibrated t
at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and otMr conditions affecting the measurement.
- 69. Provide a statement that measures are taken )nd documented to detennine the validity of previous inspections performed when measuring and test
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equipment is found to be out of calibratiori.
- 70. Provide a statement that calibrating standards have an uncertainty (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 -
j
" s tate-of-the-a rt."
i.
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. 71.
Provide a statement that the complete status of all items under the cali-bration system is recorded and maintained.
- 72. Provide a statement that reference and transfer standards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
73.
Provide a statement that procedures are prepared which control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and spect-fication requirements to preclude damage, loss, or deterioration by environ-mental conditions such as temperature or humidity.
74.
Provide a statement that identification of the inspecMon, test, and operating status of structures, systems, and components is known throughout manufacturing and installation.
75.
Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
76.
Provide a statement that the status of nonconforming, inoperative, or malfunctioning structures, systems, or components is identified to prevent inadvertent use.
77.
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 disposi tion.
78.
Identify those individuals or croups delegated the responsibility and authority for the disposition and approval of nonconforming items.
- 79. Provide a statement that no.nc_onforming items are segregated from acceptable items and identifiud as discrepaht until properly dispositioned.
- 80. 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 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.
Provide 'a statement that nonconformance reports dispositioned " accept as 81.
is" or " repair" are made part of the inspection records and forwarded with the hardware to NFS for review and assessment.
82.
Provide a stntement that nonconformance reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
83.
Provide a statement that evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, devia-tions, and defective material and equipment) is conducted to detennine 1810 028
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the need for corrective action in accordance with established procedures.
- 84. Provide a statement that corrective action is initiated following the determination of a condition advarse to quality to preclude recurrence.
- 85. Provide a statement that follow-up reviews are conducted to verify proper implementation of corrective actions and tr. close out the corrective action documentation.
- 86. Provide a statement that significant conditions adverse to quality, the cause of the conditions, and the corrective action taken are rcported to cognizant levels of management for retiew and assessment.
- 87. Provide a statement that QA records include operating logs; results of reviews, audits, and material analyses; monitoring of work performance; qualification of personnel procedures, and equipment and other documen-tation such as drawings, specifications, procurement documents, calibra-tion procedures and reports; nonconformance reports; and corrective action r.eports.
- 88. Provide a statement that records are identifiable and retrievable.
- 89. Provide a statement that requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent witl. applicable codes, standards, and procurement docu-ments.
- 90. Provide a statement that inspection and test records contain the following where applicable:
a.
A description of the type of observation.
b.
Evidence of completing and verifying a manufacturing, inspection, or test operation.
c.
The date and results af the inspection or test.
d.
Infonnation related to conditions adverse to quality.
e.
Inspector or data recorder identification.
f.
Evidence as to the acceptability of the results.
- 91. Providela statement that record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deter (oration by envirorrnental conditions such as temperature or humidity.
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- 92. Provide a statement that audits are perform d in accordance with preestablished written procedures or check lists and conductri by trained personnel not having direct responsibilities in the area's oefng audited.
93.
Provide a statement that audit results are documented and then reviewed with management having responsibility in the area audited.
- 94. Provide a statement that responsible management takes the neceesary action.
to correct the deficiencies revealed by the audit.
- 95. Provide a statement that deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
- 96. Provide a statement that audits include an objective evaluation of quality-related practices, procedures, and instructions and the effectiveness of implementation.
97.
Provide a statement that audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
- 98. Provide a statement that audits to assure that p,..;js s 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 th quality-related procedures and activities.
b.
NFS and its principal contractors, to verify and evaluate their suppliers' QA programs, procedures, and activities.
- 99. 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 design, procurement, and contracting activities.
100. Provide a statement that audit data are analyzed and the reports, which indicate quality trends and the effectiveness of the QA program are reported to management for review and assessmnt.
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