ML19253B793
| ML19253B793 | |
| Person / Time | |
|---|---|
| Site: | 07100251, 07100259 |
| Issue date: | 10/09/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Dipiazza R WESTINGHOUSE ELECTRIC COMPANY, DIV OF CBS CORP. |
| References | |
| NUDOCS 7910220247 | |
| Download: ML19253B793 (12) | |
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UNITED STATES
! } w ~,,g NUCLEAR REGULATORY COMMISSION WASHINGTC,N, D. C. 20555 j
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CCT 0 31979 FCTC: RHO 71-0251/
71-0259 Westinghouse Electric Corporation ATTN: Mr. Ronald P. DiPiazza P.O. Box 355 Pittsburgh, PA 15230 Gentlemen:
We have reviewed Revision 1 to the Quality Assurance Plan submitted by the Water Reactor Disisions of Westinghouse Electric Corporation on September 21, 1979 (WRD-LS&S-832). To keep the activities of the Nuclear Fuel Division separate and distinct from the other divisions, we have assigned our docket number 71-0259 to the Nuclear Fuel Division and 71-0251 to the other Water Reactor Divisions.
Regarding the QA program for the Nuclear Fuel Division, we believe the appropriate revision of WCAP-7800 which should be used to satisfy Appendix E to 10 CFR Part 71 is Revision 5A which was found :cceptable by the NRC on September 10, 1979.
Please provide a commitment to Revision SA.
Regarding the QA program for the other Water Reactor Divisions, the submittals of December 28,1978 and September 21, 1979 describe an acceptable QA program for the procurement, maintenance, repair, and use of Special Form material. However, if you want our ac'ceptance to extend to Normal Fom material, a more detailed descrip-tion of your QA program is required. Please identify to what your QA program applies.
If it does apply to Nomal Fom material, the enclosed " Acceptance Criteria" should assist you in revising your QA program description.
Please respond to this letter within 30 days of receipt.
If you have any questions, call Jack Spraul on (301) 492-7741.
Sincerely, L
Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety,PfiSS
Enclosure:
Acceptance Criteria
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s 10 CFR 71 - APPENDIX E ACCEPTANCE CRITERIA - TPANSPORTATION PACKAGES FOR NORMAL /SPECIAL FORM PADI0 ACTIVE MATERIAL I.
Orcaniza tion
- l '.
Provide a statement that the responsibility for the QA pr: gram is retained and exercised by the applicant.
- 2.
Identify and describe the QA/QC functions performed by the applicant's CA organization or delegated to other organizations providing controls to assure appropriate elements of Appendix E will be implemented.
-* 3.
Provide a current organizational chart that identifies the organizational elements which function under the control of the QA program.
- 4 Identify and describe the responsibilities of each job function shown on the organization chart.
5.
Describe the duties and qualifications of t.5e individual who retains overall authority and responsibility for the CA program.
' 6.. Provide a statement that designated QA individuals have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material.
II. Cuality Assurance Procram
- 1.
Provide a statement that management (i.e., above or outside the QA organization) regularly assesses the scope, status, implementation, and effectiveness of the QA program to assure that the program is adequate and ccmplies with 10 CFR Part 71, Appendix E criteria.
2.
Provide a statement that provisions are established to control the distribution of the CA manuals and revisions thereto.
Cnly asterisked items must be addressed unless activities include the design, fabrication, assemoly, testing, or modification of transportation packages.
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s 3.
Frovide a statement that provisions are established for ccc..unicating to all responsible organizations and individuals that quality policies, CA manuals, and procedures are mandatory requirements which must be implemented and enforced.
- 4.
Identify the safety-related systems, structures and components controlled by the QA program.
- 5.
Provide a statement that provisions are established for the resolution of disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.) personnel.
- 6.
Provide a statement that an indoctriaation and training program is est:blished such that:
(1) Personnel responsible for perfoming quality-related activities are instructed as to the purpose, scope, and implementation of the QA maouals, instructions, and procedures.
(2)
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
(3)
The scope, the objective, and the method of implementing the indoctrination and training program are documented.
(4) Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recerti fying.
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- 7.
Pr0 vide a sta tement that quality-related activities are performed with s ecified equipment under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
III.
Desian Co'ntrol 1.
Provide a statement that measures are established to carry out design activities in a planned, controlled, and orderly manner.
2.
Provide a statement that measures are established to correctly translate the a;plicable regulatory requirements and desicn bases into specifica-tiens, drawings, written procedures, and instructions.
3.
Provide a statement that quality standards are s:ecified in the design coc ents, and deviations and changes fr:m these cuality standards are con: rolled.
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- 4 Provide a statement that designs are reviewed to assure that (1) design characteristics can be controlled, inscected and tested and (2) inspection and test criteria are identified.
5.
Provide a statement that proper selection and acccmplishment of design verification 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 design cen:itions should be used.
6.
Provide a statement that individuals or grcups respcnsible for design verification are other than the origir.al designer and the designer's immediate supervisor.
7.
Provide a statement that design and specificaticn changes are subject to the same design controls and approvals that were applicable to the original design unles's the licensee designates another qualified responsible organization.
8.
Provide a statement that the positions or groups res;cnsible for design reviews and other design verification activities and their authority and responsibility are identified and controlled by written procedures.
IV.
Procurement Document Control
- 1.
Provide a statement that procedures are established that clearly
. delineate the sequence of actions to be acccmplished in the prepara-tion, review, approval, and control of procurement documents.
- 2.
Provide a statement that procurement documents identify the applicable 10 CPR Part 71, Appendix E requirements which must be c0mplied with and described in the supplier's QA program.
- 3.
Provi.de a statement that procurenent documents contain or reference the design basis technical requirements including the applicable regulatcry requirements, material and cenponent. identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, ard special process instructions.
- 4 Provide a statement that procurement documents identify the documen-tation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inscection and test records, perser.nel and procedures cualifications, and chemical and physical test results of material) to be prepared, maintained, and subr:itted tc P.e purchaser for review and approval.
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5.
Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the hardware.
6.
Provide a statement that procurement documents contain the procuring agency's right of access to supplicr's facilities and records for source inspection and audit.
7.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
V.
Instructions, Procedures, and Crawines 1.
Provide a statement that. activities affecting quality are prescribed and accomplished in accorda-ce with documented instructions, procedures, or drawings.
2.
Provide a statement that provisions are established which clearly.
delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of instructions, procedures, and drawings.
3.
Provide a statement that the QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI.
Document Control 1.
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.
2.
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 the applicant.
3.
Provide a statement that approved changes are included in instructions, procedures drawings, and other documents prior to implementation of the change.
'2 Provide a statement that documents are available at tne location where the activity will be parformed prior to commencing :ne.ork.
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- 5.
Provide a statement that a master lif t, or equivalent, is established to identify the :urrent revision number of instructions, procedures, specifications, drawings, and procure: Jt documents.
VII.
Control of Purchased Materials, Parts and Comconents 1.
Provide a st'tement that qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
2.
Provide a statement that the evaluation of suppliers is based on one or more of the folicwing:
(1). The supplier's capability to cceply with the elements of Appendix E to 10 CFR Part 71 that are applicable to the type of material, equipment, or service being procured.
(2) A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
(3) A survey of the supplier's facilities and QA program to determine his ca. ability to supply a product which meets the design, manuf cturing, and quality requirements.
3.
Provide a statement that the results of supplier evaluations are documented and filed.
,4.
Provide a statement that surveillance, if required, 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 crder requirements.
5.
Provide a statement that the supplier furnishes the folicwing records as a minimum to the purchaser:
(.1 )
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items.
(2) Cocumentation that identifies any procurement requirements which have not been met togetner with a description of those nonconfor ances dispositioned " accept as is" or " repair."
6.
Frovide a sta%nent that receiving inspecticn o' the supplier-furnished material, equipment, and services is perfcrmed :: assure:
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The material, component, or equi;=ent is properly identified and corresponds with the identification on receiving documentation.
(2) Material, ccaponents, equipments, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
(3)
Inspection records or certificates of conformance attesting to the acceptance of material and com:onents are available prior to installation or use.
(4)
Items accepted and released are identified as to their inspection status prior to foraarding them to a controlled storage area or releasing them for further work.
VIII.
Iden+.ification and Contral of Materials, Parts, and Comconents
- 1.
Provide a statement that procedures ara estat hed to identify and control materials, parts, and components including partially fabricated subassemblies.
2.
Provide a statement that the identification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
- 3.
Provide a statement that identification of mater 'als and parts imoortant to the ' unction of safety-related systems and ccmconents can be traced to the aporopriate documentation such as drawings.
specifications, purchase orders, manufacturing and inspection docurents, deviation reports, and physical and chemica' mill test reports.
4.
Provide a statement that the location and the method of identification do not affect the fit, function, or quality of the item being identified.
- 5.
Provide a statement that correct identification of materials, parts, and components is verified and documented prior to release for fabricaticn, assembling and installation.
IX.
Control cf Soecial Professes
- 1.
Prov'de a state..: that special processes such as welding, heat treating, nonde.,tructive testing, and cleaning are procedurally controlled.
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. 2.
Provide a statement that procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and speci'fications.
3.
Provide a statement that qualification records of procedures, equipment, and personnel associated with special processes ara established, filed, and kept current.
X.
Insoection
- 1.
Provide a statement that an inspection program which verifies ccnfor ance of quality-affecting activities with recuirements is established, documented, and acc:mplished in accordance with written and controlled procedures.
- 2.
Provide a statement that inspection personnel are independent from the individuals performing the activity being inspected.
3.
Provide a statement that inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualificatio.ns and certifications are kept current.
4 Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original des'gn and inspection requirements or acceptable alternatives.
5.
Prcvide a statement that provisions are established that identify
-mandatory inspection hold points f'or uitness by an inspector.
i XI.
Test Control 1.
Provide a statement that a test program to demonstrate that the item or component will perform satisfactorily in service is established, documented, and accomplished in accordance with written controlled p roce'dures.
2.
Provide a statement that modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptabla alternatives.
3.
Provide a statement that th results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
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- XII.
Control of Measuring and Test Ecuicment
- 1.
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.
2.
Provide a statement that measuring and test equipment is identified and traceable to the calibration test data.
3.
Provide a statement that measures are taken and documented to determine the validity of previous inspections perfccmed when measuring and test equipment is found to be out of calibration.
- 4 Provide a statement that reference and transfer star.dards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis far calibration:
XIII. Handlinc, Storage, and Shiccinc
- 1.
Provide a statement that special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and acccmolished by qualified individuals in acccrdance with predetermined work and inspection instructions.
- 2.
Provide a statement that all conditions (operati:ns, tests, inspections, specifications, etc.) of the NRC package aporoval and the U.S.
Department of Transportation shipping requirements are satisfied prior to shipment.
-* 3.
Provide a statement that all necessary shipping ; apers will be prepared, as required.
- t.
Provide a statement that departure, arrival ti.ne and destination of a package will be established and monitored to a degree consist:nt with the safe transportation of the package.
XIV.
Inscection Test and Oceratina Status
- 1.
Provide a statement that identification of the inspection, test, and operating status of packages and c:mponents is krev.n by affected crganira? ons.
- 2.
Provide a statement that the application and remcval of inspection anc welding stamps and status indicators sucn as tags, mar' ings, labels, and stamps are procedurally cortrolled.
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- 3.
Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled.
- 4.
Provide a statement that the status of nonconforming, inoperative, or malfunctioning packages or components is identified to prevent inadvertent use.
?N. f,'onconformino Material, Parts, or Ccmoonents
- 1.
Provide a statement that the identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming materials, parts, comoonents, or services are procedurally con trol l ed.
2.
Provide a statement that documentation identifies the nonconforming item; describes the ncnconformance, the disposition of the nonconformance, and the inspection requir'ements; and includes signature approval of the disposition.
3.
Provide a statement that nonconforming items are segregated from acceptable items and identifiec as discrepant until properly dispositioned.
4.
Provide a statement that acceptability of rework or repair of materials, parts, comoonents and systems 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.
DI.
Correctiv6 Action 1
Provide a statement that evaluation of conditions adverse to quality (such as nonconfomances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedur?s.
2.
Provide a statement that corrective action is initiated folicwing the determination of a condition adverse to quality to preclude recurrence.
3.
Provide a statement that follow-up reviews are conducted to verify proper implementation of corrective tctions and to close out the corrective action documentation.
r/I Cuality Assurance Records
- 1.
Provide a statement that sufficient records are maintained to provide documentary evidence of the quality and safety of itsms and the activities 1149 320
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affecting quality and safety.
- 2.
Provide a statement that CA records inclufe' ocerating legs; results of reviews, inspections, tests, audits, a - material analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, pro:urement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
- 3.
Provide a statement that records are identifiable and retrievable.
- 4.
Provide a statement that a list of the required recceds and the'ir storage locations will be maintained.
' 5.
Provide a statement that design related records (e.g., crawings, calculations, etc.) are maintained for the life of the shipping package and all other records are maintained for a minirum of two yea rs.
- G.
Provide a statamant that inspection and test records contain the folicwing where applicable:
(1) A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, inspection, or test operation.
(3)
The date and results of the inspection or test.
4(4)
Information related to conditions adverse to cuality.
(5)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the results.
DIII. Audits
- 1.
Provide a statement that audits are performed in accordance with preestablished written procedures or check lists and corducted by personnel not having direct responsibilities in the areas being audited.
- 2.
Provide a statement that audit results are docu ented a d thu. reviewed with management having responsibility in the area audited.
- 3.
P-ovide a statement that responsible management takes the necessary ac; ion to correct the deficiencies revealed by the audi:.
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- 4.
Provide a statement that deficient areas are reauditad en a timely basis to verify implementation of corrective actions. hich minimize recurrence of deficiencies.
- 5.
Provide a statement that audits of the QA program are performed at least annually based on safety significance of the activity being audited.
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