ML19260E083
| ML19260E083 | |
| Person / Time | |
|---|---|
| Site: | 07100170 |
| Issue date: | 02/01/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cunningham G GENERAL ELECTRIC CO. |
| References | |
| NUDOCS 8002130319 | |
| Download: ML19260E083 (10) | |
Text
/
'o, UNITED STATES y
g NUCLEAR REGULATORY COMMIS$10N g
C WASHINGTON, D. C. 20555 o-5
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FEB 011980 FCTC: RHO 71-0170 General Electric Company Vallecitos Nucletr Center ATTN:
Mr. G. E. Cunningham P.O. Box 460 Pleasanton, CA 94566 Gentlemen:
We have evaluated your Quality Assurance Program submitted with your June 29,1978 letter to satisfy the requirements of 10 CFR 371.51.
Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71. Please address the enclosed request for additional information and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Si ncerely,
fb[$
=
Charles E. MacDonald. Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information 3/
800e13 0
GENERAL ELECTRIC - VALLECITOS (71-0170)
Request for Additional Information 1.
Describe how GE's QA organization ' interfaces with his contractors to assure proper direction of the QA program and resolution of QA problems.
2.
Identify the level of management responsible for establishing GE's QA policies, goals, and objectives.
3.
Identify the position wno retains overall authority and responsibility for the QA program.
4.
Describe the qualification requirements for the principal QA/QC management positions.
5.
Provide a statement that designated QA individuals have the responsibi-lity and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconform-ing material.
6.
Identify the management level (i.e., above or outside the QA organization) that regularly assesses the scope, status, implementation, and effective-ness of the QA program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E criteria.
7.
Provide a statement that measures are provided by GE to assure that trained, qualified personnel within the GE organization are assigned to determine that_
functions delegated to contractors are being properly accomplished.
8.
Give a brief summary of GE's QA policies, goals, and objectives.
9.
Provide a statement that provisions are established to control the distri-bution of the QA manuals and revisions thereto.
- 10. Provide a statement that provisions are established for comunicating to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory requircments.
- 11. Provide a listing of the QA procedures plus a matrix of these procedures cross referenced to each criterion of Appendix E to 10 CFR Part 71.
- 12. Provide a statement that GE reviews and documents agreement with the QA program provisions of his contractors to the extent that he can be assured that Appendix E will be implemented.
- 13. Describe how disputes involving quality, arising frmi a difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.) personnel are resolved.
- 14. Provide a statement that an indoctrination and training program is estab-lished such that:
a.
Personnel responsible for performirg quality-affecting activities 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 performed.
c.
The scope, the objective, and the method of implementing the indoctri-nation and training program are documented.
d.
Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
- 15. Provide a statement that quality standards are specified in the design documents,.and deviations and changes from these quality standards are controlled.
- 16. Clarify that when a test program is used to verify the adequacy cf a design, a qualification test of a prototype unit under adverse dasign conditions shall be used.
- 17. Provide a statement that' individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor.
- 18. Provide a statement that design and specification changes, including field changes, are subject to the same design controls and approvals that were applicable to the original design unless GE designates another qualified responsible organization.
- 19. Provide a statement that errors,and deficiencies la the der.ign, including the design process, that could adversely affect safety-related structures,
systems, and components are documented; and corrective action is taken to preclude repetition.
- 20. Provide a statement that materials, parts, and equipment which are standard, commercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.
s 21.
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 specifications.
- 22. Clarify that the review of procurement documents determines 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.
23.
Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
- 24. Provide a statement that procurement documents identify the opplicable 10 CFR Part 71, Appendix E requirements wMch must be complied with and described in the supplier's QA program. This QA program or portions thereof shall 6e reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program.
- 25. Provide a statement that procurement documents contain or reference the design bas-is technical requirements including the applicable regulatory requirunents, material and component identification requirements, draw-ings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
26.
Provide a statement that procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and f abrication plans, inspection test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, main-tained, and submitted to GE for review and approval.
- 27. Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to GE prior to use or installation of the hardware.
- 28. Provide a statement that' procurement dccuments contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
'9.
Provide a statement that procurement incuments 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.
- 30. Provide a statement that provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings.
- 31. Provide a statement that methods for complying with each r" the 18 criteria of 10 CFR Part 71. Appendix E are specified in instructions; procedures, and drawings.
- 32. Provide a statement that the QA organization reviews and concurs with inspec-tion plans; test, calibration, and special process procedures; drawings, and specifications; and changes thereto or acceptable alternatives are described.
33.
Identify tnose individuals or groups responsible for reviewing, approving, and issuing documents and revisions thereto.
- 34. Provide a statement that changes to documents are reviewed and approved by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by GE.
- 35. Provide a statement that approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the chang e.
- 36. Provide a statement tisat :focuments are available at the location where the activity will be perfarmed prior to commencing the work.
- 37. Provide a statement that a master list or equivalent is established to identify the current revision number of instructions, procedures, speci-fications, drawings, anu procurement documents. This list is updated and distributed to predetermined, responsible personnel to preclude use of su';erseded documents.
38.
Identify the documents that are controlled under this program.
As a minimum this should include; a.
Design specifications.
b.
Design, manufacturing, construction, and installa+1on drawings.
c.
d.
QA manuals.
e.
Design criteria documents, f.
Manufacturing, inspection, and testing instructions.
g.
Test procedures.
h.
Design change reque'sts.
- i. Nonconformance reports.
- 39. Provide a statement that qualified personnel evaluate the supplier's capa-bility to provide acceptable quality serviws and products before the r/4ard of the procurement order or contract. The QA and engineering groups participate in the evaluation of those suppliers providing critical com-ponents.
- 40. Provide a statement that the evaluation of suppliers is based on one or more of the following:
The supplier's capability to comply with the elements of 10 CFR Part 71, a.
Appendix E 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 pro-vided similar articles of the type being procured.
A survey of the supplier's facilities and QA program to determine his c.
capability to supply a product which meets the design, manufacturing, and quality requirements.
41.
Provide a statement that the results of supplier evaluations are documented and filed.
- 42. Provide a statement that surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements. These procedures provide for:
a.
Instructions that specify the characteristics or processes to be wit-nessed, inspected or verified, and accepted; the method of surveil-lance 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 procurement requirements cannot be determined upon receipt.
- 43. Provide a statement that the supplier furnishes the following records as a minimum to GE:
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.
Doc'umentation 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 GE's QA program and 'as a minimum shall be undertaken by a responsible QA indivi-dual.
44.
Provide a statement that supplier's certificates of conformance are periodi-cally evaluated by audits, independent inspections, or tests to assure they are valid.
- 45. Provide a statemet that receiving inspection of the supplier-furnished material, equipment, and services is performed to assure:
a.
The material, component, or equipment is properly identified and s
corresponds with the identification on receiving documentation.
b.
Inspection records or certificates of conformance attesting to the acceptance of material, components, and equipment are available at Vallecitos prior to installation or use.
Item, accepted and releas'ed are identified as to their inspection c.
status prior to forwarding them to a controlled storage area or releasing them for installation or further work.
- 46. Provide a statement that the effectiveness of the control of quality by suppliers is assessed by GE at intervals consistent with the importance, complexity, and quantity or the item.
- 47. Provide a statement that identification of materials and parts important to the function of safety-related structures, systems, and components can be traced to the appropriate documentation such as drawings, speciffi.ations, purchase orders, manufactu:ing and inspection documents, deviation reports, and physical and chemical mill test reports.
- 48. Provide a statement that the location and the method of identificaticn do not affect the fit., function, or quality of the item being identified.
- 49. Provide a statement that correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping and installation.
50.
Provide a statement that inspection personnel are independent from the individuals performing the activity being inspected.
51.
Provide a statement that inspection procedures, instructions, and cheuk lists provide for the following:
a.
Identification of characteristics and activities to be inspected,
- b.. Identification of the individuals or groups rest.onsible for performing the inspection operation.
c.
A description of the method of inspection.
d.
Reccrding evidence of completing and verifying a manufacturing, inspection, or test operation, Recording inspector or data recorder and the results of the inspection e.
operation.
- 52. Provide a statement that inspectors are qualified in accordance with appli-cable codes, standards, and company training programs; and their qualifica-tions and certifications are kept current.
53.
Provide a statement that modifications, repairs, and replacements are inspe~cted in accordance with the original design and inspection requirements or acceptable al ternatives.
~
54.
Provide a statement that provisions are established for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible.
55.
Provide a statement that modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
- 56. Provide a statement that written test procedures incorporate or reference:
The requirements and acceptance limits contained in applicable design and a.
. b.
Instructions for perfoming the test.
c.
Test prerequisites such as:
9 Calibrated instrumentation.
8 Adequate and appropriate equipment.
8 Trained, qua'lified, and licensed or certified personnel.
O Completeness of item to be tested.
O 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.
57.
Identify the individual or group who detemines the acceptability of test results.
- 58. Provide a statement that procedures describe the calibration technique and frequency, maintenance, and control of the measuring and test equipment (instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment) which is used in the measurement, inspection, and monitoring of safety-related components, systems, and structures.
59.
Provide a statement that measuring and test equipment is identified and trace-able to the calibration test data.
- 60. Provide a statement that measuring and test equipment is labeled or tagged to indicate date of the next calibration.
s
- 61. Provide a statement that measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
- 62. Provide a statement that measures are taken and documented to determine the validity of previous inspectibns performad when measuring and test equipment is found to be out of calibration.
- 63. 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 " state-of-the-art."
64.
Provide a statement that the complete status of all items under the calibra-tion system is recorded and maintained.
. 65. Provide a statement that procedures are prephred which control the cleaning, handling, storage, packaging, shi' ping, and preservation of materials, p
compcnents, and systems in accordance with' design and specification require-ments to greclude damage, loss, or deterioration by environmental conditions such as temperature or humidity.
- 66. Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
- 67. Provide a statement that 'he identification, documcatation, segregation, review, disposition, and notification to affected organizations of noncon-fonning materials, parts, components, or services are procedurally controlled.
- 68. Provide a statement that documentation identifies the nonconforming item; describes the nonconformance, the disposition of the nonconform:nce, and the inspection requirements; and includes signature approval of the disposi-ti on.
- 69. Provide a statement that nonconforming items are segregated from acceptable items and identified as discrepant until pr7erly dispositioned.
- 70. 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.
- 71. 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 G.E. for review and assessment.
- 72. Provide a statement that nonconformance reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
- 73. Provide a statement that evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
- 74. Provide a statement that follow-up reviews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
- 75. Provide a statement that QA records include qualification of personnel, procedures, and equipment; and other documentation such as drawings, speci-fications, procurement documents, calibration procedures and reports; non-conformance reports; ard corrective action reports.
. I 76.
Provide a stet ment 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 with applicable codes, standards, and procurement documents.
- 77. Provide a statement that record storage. facilities are constructed, located, and secured to prevent destruction of ine records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
- 78. Provide a statement that audits are performed in accordance with preestablished written procedures or check lists and conducted by trained personnel not having direct responsibilities in the areas being audited.
- 79. Provide a statement that responsible management takes the necessary action to correct the daficiencies revealed by the audit.
- 80. Provide a statement that deficient areas are reauditL on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
81.
Provide a statement that audits include an objective evaluation of quality-related practices, procedures, and instructions and the effectiveness of implementation.
- 82. Provide a statement that audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
- 83. Provide a statement that audits to assure that procedures and activities are meaningful and comply with the overall QA program are performed by:
The QA organization, to provide a comprehensive independent verification a.
and evaluation of quality-related procedures and activities.
b.
G.E. and its contractors, to verify and evaluate their suppliers' QA programs, procedures, and activities.
- 84. 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 manage-ment for review and assessment.