ML20126C980

Forwards Detailed Review of Section 11 (QA Program) of Topical Rept for Nutech Horizontal Modular Storage Sys for Irradiated Nuclear Fuel. Requests Rev to QA Program Description Responsive to Encl Acceptance Positions

ML20126C980
Person / Time
Issue date:	06/07/1985
From:	Rouse L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Massey J NUTECH ENGINEERS, INC.
References
REF-PROJ-M-39 NUDOCS 8506140595
Download: ML20126C980 (15)

Text

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, Distribution: Original concurrence copy to be returned to FBrown SS 396 Proj ect M-39 PDR TAnkrum Jtm 0 7 B85 R/F JRoberts JSpraul Project M-39 FCAF R/F FSturz FBrown LA File LCRouse JSchneider NUTECH, Inc.

ATTN: Dr. John V. Massey NUHOMS Project Manager 145 Hartinvale Lane San Jose, California 95119 Gentlemen:

In response to your submittal, docketed December 19, 1984, under Project No. H-39, we have reviewed your quality assurance (QA) program detailed in your submitted " Topical Report for the NUTECH Horizontal Modular Storage System for Irradiated f3uclear Fuel" (NUH-001), Revision 0, November 1984 Other safety review comments on this Topical Report, not associated with your 0A program, were enclosed with our letter of May 29,1985, to you.

Section 1.4 of the topical report indicates that NUTECH is the prime contractor for the system design and analysis and that NUTECH will subcontract the fabrication and construction. Section 11 addresses OA.

Section 11 does not address 10 CFR 50, Appendix B criteria IV, VII, VIII, IX, X, XI, XII, XIII, and XIV. If indeed, NUTECH is to subcontract the fabrication and construction of the Robinson 2 independent spent fuel storage installation (ISFSI) (or any other ISFSI), Section 11 of t'he topical report

, should be expanded to address each of the criteria of 10 CFR 50, Appendix B

'ses referenced in 10 CFR Part 72, Subpart G. Our detailed review of Section

- 11 resulted in Enclosure 1 to this letter. Enclosure 1 details our acceptance criteria for a OA program description for an ISFSI. We have lined out the acceptance positions which are adequately addressed in Section 11 of the topical report. NUTECH should revise its OA program description in Section 11 of the topical report such that it is responsive to each of the acceptance positions enclosed herein. When preparing your response to the enclosure, f10 TECH should read "the applicant" as "NUTECH." Simila rly, "its contractors" should be read by NUTECH as NUTECH's subcontractors for fabrication and construction (and any other activities which are MTHECH's responsibility but are not performed by NUTECH personnel).

If in revisire this report you have any questions, please contact us. He will, as we noted in our Fay 29, 1985, letter, be happy to discuss this matter with you or to arrange a meeting to accommodate such discussion.

Si ncerely, Ordaimel signed b'/

8506140595 850607 PDR PROJ Leland C. Rouse, Chief M-39 PDR Advanced Fuel and Spent Fuel Licensing Branch Disc W rd nivision of Fuel Cycle

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4 Enclosure Acceptance Criteria I.

The Organization elements responsible for the QA program are acceptable if:

1. The responsibility for the QA program is retained and exercised by the applicant. The assignment responsibility for the overall QA program in no degree relieves line management of their responsibility for the achievement of quality.

- 2. The Qf functi:n:, perfer. icd by th: Oppl i cent:

id:ntift d Of.crg:ni :ti c ;r nd d::cribed, 4stegated te ether erg:ri::ti:n:, Or: 44eeb4: :1 ::nt: ;f the ;A th: app providing centr:10 t: :::ur sriteri: "4 ' -b: ' ;1:::nt d.

3.

Clear management controls and lines of communication between the QA organizations of the applicant and his suppliers are established to assure proper direction of the QA program and resolution of QA problems. ,

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4. Organization charts identify:

a. "onsite" and "offsite" organizational elements which function under the cognizance of the QA program.

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b. lines of responsibility.

5. 'A high level of management is responsible for documenting and promulgating the corporate or company QA policies, goals, and objectives and this management level maintains a continuing involvement in QA matters. Communication lines between any intermediate levels of management and between this position and the Manager (or Director) of QA must be described.

c The app 14r=n+ der 4;neter e per tica that -etri- cfer:1' ruthe-ity i

2nd re:pencibity f r th: Of pr:gr::

7. The authority and independence of the individual responsible for managing the QA program are such that he can direct and control the organization's QA program, can effectively assure the conformance to quality requirements, and is sufficiently independent of undue influences and responsibilities for schedules and costs. An acceptable organizational structure would have this individual report to at le'ast the same organizational level as the highest line manager directly responsible for performing activities affecting quality.

S. oc 4 tion: c grcup r^:p:n:ible f:r d:#' 'n; :nd centrei'#ng th:

20ntent c' the Of progr:r 2rd r:1:t:d ::nuc1: :nd th; ::n ;; :nt Jeve' e pc-tib'e for #4 21 reviet 2nd :ppr:v;1 5 : :ppr:p-i;t:

ac;2a':stic- ' per tie- -d authe-ity.

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9. The qualification requirements for the principal QA management positions demonstrate management and technical competence I

commensurate with the responsibilities of these positions.

10. Verification of conformance to established requirements is accomplished by individuals or groups who do not have direct  ;

responsibility for performing the work being verified. 1

- 11. .cr :n: nd CIgeni :Ii:n perf;r,mir,; Qb fun:Ii:n 5: dir;;I :::C: f te :n:ger:nt 1:v:1: *i:P 'i :::cre :::::plich::nt ;f qu;iity-Offecting ::ti.iti::. Th::: per: nnel ch ll 5:v: :uffici:nt cuth;rity

' ead e graizet4e-21 #reede- te perfer- thei- QF function: Offecti;:ly t

nd eith: t r:::rv: tier Th:3 ::n-

2. Id^"ti#7 Qu lity ph:Il^":. l

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nd : therita, del'n :t:d '- 'riting, t: :tep un::tisf::t:ry _;rt :nd l

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acaconic + g eeteriet ^ descriptier of--hor? the: ::ti:n: :r: t: 5:-

ee wied out ie g e ided.

13. The extent of QA controls is determined by .the QA staff in-combination with the line staff and is dependent upon the specific activity, item complexity, and its importance to safety.

II. The Quality Assurance Program description is acceptable if:

1. Measures are provided by the applicant that describe how the QA program meets the QA criteria.-

2. Management commits to regularly assess the' effec'tiveness of the QA program. A description is provided for how management (above and outside the QA organization) will regularly assess the scope, status, adequacy, and compliance of the QA program to 10 CFR 72. These measures should include:

a. Frequent contact with program status through reports, meetings, and/or audits.

b. Performance of a periodic assessment which is preplanned and documented with corrective action identified and tracked.

3. Measures are provided by the applicant to assure that trained, quali-fied personnel within his organization are assigned to determine that functions delegated to his contractors are being properly accomplished.

4. A brief summary of the Company's corporate QA policies, goals, and i objectives is given and a meaningful channel for transmittal of these policies, goals, and objectives down through the levels of management is established.

5. QA responsibilities are designated for the implementation of the major activities contained in the QA manuals.

4.  % i+ ion; :r: ::t:blithed t: 09 trol the distribution :f tt: @

eaC: :nd r:;i:i: : th:r:t .

l l 7. Provisions are established for communicating to all responsible i

organizations and individuals that quality policies, QA manuals, and procedures are mandatory requirements.

8. A listing of the QA procedures plus a matrix of these procedures cross referenced to each of the QA criteria demonstrates that provisions will be fully implemented by documented procedures. .

9. The important to safety structures, systems, and components controlled by the QA program are identified.

10. The applicant reviews and documents agreement with the QA program provisions of-his suppliers to the extent that he can be assured that a program meeting the QA criteria will be implemented.

11. Provisions are established for the resol'ution of disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.)

personnel. '

' 12. Indoctrination, training, and qualification programs are established such that:

a. Personnel responsible for performing activities affecting quality are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.

b. Personnel performing activities affecting quality are trained and qualified in the principles and techniques of the activity being performed.

c. Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.

d. Specific documentation of completed training and qualification should be described in general terms.

e. Qua'lified personnel are certified in accordance with applicable codes and standards.

III. Activities related to Design Centrol are acceptable if:

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centrolled, 2nd 0 d:rly :r. r.

2. "ca:ur : Or: :t:bli:hed t: :Orrect1; tr:n:1:t: th: :pplic ble segulatory-requir:::nt: Ond d: ign t;;;; int: :p::ific:ti:n:,

d-re ngr, "-itter pr::^ dure:, :nd '.:tr.cti:n:.

i Q"?'4ty etenderds 2-e speci'ied 4- t'e d::ig- decu ent:, 2-d 3.

devist c-: 2-d c"r g:: #-e- t"c:: qu:' # t; :t:-d:rd: :: : rtr:11:".

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4. Designs are reviewed to assure that:

Design characteristics can be controlled, inspected, and tested.

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i b. Inspection and test criteria are identified.

5. Int r.21 ;n d external d::ign #nterf::: ::ntr:1: cr:0,::t:bli:h:d. di:tributi n, Ther e crat-c's .ir.-lede the-r.ev.iewr -app-ev:! , M4ee: 'th and reviticref dece ent: 4,,+:--, 4-"c1"#ng d::igr #.tcrf::::

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E. Design-:nd speci'ic: tie- ch: ;::  : : :ebject te th: :: : d::i;r sonter's ?*d the re-e c' eTr ve!cnt pprev:': th:t e : :ppli::51: ::

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9. Errors and deficiencies in the design, including the design process, that could adversely affect structures, systems, and components important to safety are documented; and corrective action, includin; root cause evaluation of significant errors and deficiencies, is taken to preclude repetition.

10. 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 tc selection.

II. The positions or groups responsible for design reviews and other design verification activities and their authority and responsibility are identified and controlled by written procedures.

. 12. Measures that include the use of valid indust'ry standards and specific 3tions are estaDlished for the selection.of suitable materials, parts, equipment, anc processes for structures, systems, and compenents important to safety.

IV. Acticities related to Procurement Documen. Control are acceptable if:

1. Procedures are established that clea-ly delineate the secuence of actions to be accomplished in the preparation, review, approval, anc i

cor.troi of procurement documents.

2. A review and concurrence of the adequacy of quality requiremerts stated in procurement documents is performed by qualified personnel.I Inis review should determine that quality requirements are correctly stated. inspectable, and controllacle; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.

i l 3. The revies and-approval of procurement documents are documented prier ,

i to . release and available for verification. '

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4. Procurement documents identify the applicable QA requirements which l

must be compiled with and described in the supplier's QA program.

j This QA program or portions thereof shall be reviewed and concurred with by the applicant. .

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5.

Procurement documents contain or reference the regulatory requirements, the design basis, and other technical requirements.

6.

Procurement documents identify the document.ation (e.g., drawings, specifications, procedures, inspection and fabricatio and chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.

7. Procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those to be delivered to the purchaser prior to use or installation of the hardware.

8. Procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.

9. Changes and revisions to procurement documents are subject to the same or equivalent review and approval as the original document.

V.

Activities related to Instructions, Procedures, and Drawinos are acceptable if:

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-1, Activities af fecting quality are-pr+scribec :nd :ccomp'i:5:e accordanc-e-witA-documented instructionsr-procedor :, er dr;_' p 2.

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.

3.

Methods for complying with each of the applicable QA criteria cre specified in instructions, procedures, and drawings.

4. Instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria to verify that activities important to safety have been satisfactorily accomplished.

5. The QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and

' specifications; and changes thereto.

VI. Activities related to Document Control are acceptable if

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- 1.  % re.ics, approvalr and-issee-of-document +-fsuch-as 'i:t:d S tel: 4 : d changes theeet<h -peior-t+-i elen::, are p:::f c:y e

sentrcl %d-to-a s s u re- they- are- adequate-and- the-quaMty-regeir c e nt 5 at: :::::d. *

2. Provisions are established which identify those' individuals or groups responsible for reviewing, approving, and issuing documents and revisions thereto.

-2. Changes--to documents- are. reviewed--and spproved-by-the a s ,

, enganizations--that- performed -the-origina4- re b

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4. Approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.

- E----Obsolete-or.. superseded documents-are-controHed-to-pre .:nt in:f;:-t:nt ;; .

i ^^ruments~are. avai.1able- at the--location--where-the-act-ivi-ty u.i'1 be-

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.peeformed-prioe--tMc :nci .; th:

7. A. master. list or- equivalent 46--establ4shed-to--identi fy t50 cur r: ni eeviSioAnumber of instructions,--procedure +r-spec 444ceti;;;, . d -

drawings,-and- procurement documents. - . This-14s-t-i+-aspd te d ;;;

4.istributeCto..predeteradaedy .re pentib!e-pcr::m:1 te -preclud:

.et--supe.r+eded 6c cr:-i: .

8. The documents that are controlled under this subsection are identified. As a minimum this should include:

a. Design specifications.

b. Design and fabrication drawings.

c. Procurement documents.

d. QA manuals.

e. Design criteria documents.

f.

Fabrication, inspection, and testing instructions.

g. Test procedures.

VII. Activities related toControl of Purchased Material, Eouipment, and Services are

1. Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products before the award of the The QA and engineering groups procurement order or contract. participate in the evaluation of th items and services important to safety and the responsibilities <ue each group's participation are provided.

2.

The evaluation of suppliers is based on one or more of the folicwing:

a.

The supplier's capability to comply with tne elements of the QA

[ criteria that are applicable to the type of material, equipment,

or service being procured.

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b. A review of previous records and performance of suppliers who have provided similar articles of the type being procured.

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c. A survey .o.f the s'upplier's facilities and QA program to -

determi'ne the capability to supply a product that meets the design, manufacturing, and quality requirements.

d. IE' confirming letter.

e. CASE - Nuclear survey. .

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f. ASME "N '-stamp survey.

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The results of supplier evaluations are documented and filed.

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4. Surveill.ance 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 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 procurement requirements cannot be determined upon receipt. ,

5. The supplier furnishes the following records as a minimum to the purchaser:

a. Documentation that identifies the purchased material or equipment and the specific procurement recuirements (e.g.,

codes, standards, and specifications) met by the items ~.

b. Documentation that identifies any procurement requirements which hav'e not been met together with a description of those nonconformances dispositioned " accept as is" or " repair."

4 The review and acceptance of th'ese documents shall be described in the purchaser's QA program and as a minimum shall be undertaken by a responsible QA inofvidual.

6. Supplier's certificates of conformance are periodically evaluated by audits, inoependent inspections, or tests.to assure they are valid.

7. Receiving inspection of the supplier-furnished material, eouipment,.

and services is performed to assure:

a. The material, component, or eouipment is properly identified and corresponds with the identification on the purchasing and receiving documentation.

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 equipment are available"at the nuclear power plant 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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8. The effectiveness of the control of quality by suppliers is assessed by the applicant at intervals consistent with the importance, complexity, and quantity of the item.

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' Vill. Activities related to Identification and Control of Materials, Parts, and Components are acceptable if i Procedures are established to identify and c.ontrol materials, pa'rts, l 1.

and components including partially fabricated subassemblies.

2. Identification requirements are determined during generation of specifications and design drawings.

3. 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..

4. Identification of materials and parts of important to safety structures, systems, and components are traceable to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.

5. The location and the method of identification do not affect the fit, function, or quality of the item being identified.

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6. Correct identification of material, parts, and components is verified and documented prior to release for fabrication, assembling. shipping, and installation.

IX. Activities related to Control of Special processes '(17.1.9) are acceptable if:

1. Special processes such as welding, heat treating, nondestructive A complete as testing, and cleaning are procedurally controlled.

possible listing of special processes, which are generally those processes where direct inspection is impossible or disadvantages, is provided.

2. Procedures, equipment, and personnel connected with special processes are qualified in accordance with a:alicable coces, standarcs, and

- specifications.

3. Special processes are performed by qualified personne with recorded evidence of verification.

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4. Qualification records of procedures, equipment, and personnel associated.with special processes are established, filed, and kept

- current. ,,._

X. Activities related to Inspection are acceptable if:

1. An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in.accordance with written controlled procedures..

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Inspection personnel are sufficiently independent from the I individuals performing the activity being inspected.

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3. Inspection procedures, instructions, and check lists provide for the following:

a. Identification of characteristics and activities to be inspected.

Identification of the individuals or groups responsible for b.

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, inspection, or test operation.

f. Recording inspector or data recorder and the re'sults of the

. inspection operation.

4. Inspection procedures or instructions are used with necessary drawings and specifications when performing inspection operations.

5. Inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualifications and certifications are kept current.

6. Modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable alternatives.

7. Provisions are established that identify mandatory inspection hold points for witness by a designated inspector.-

8. The individuals or groups who perform receiving and process ver1-fication inspections are identified and shown to have sufficient independence and qualifications.

9. Provisions are established for indirect control by monitoring processing methods, equipment, and personnel if direct inspection is not possible.

XI. Activities related to Test Control are acceptable if:

1. A test program to demonstrate that the item will perform satisfactorily in service is established, documented, and accomplished in acco-dance with written controlled procedures.

1

2. Written test procedures incorporate or reference:

a. The requirements and acceptance limits contained in applicable

'desig~n and procurement documents. .

b.- Instructions for performing the test.

c. Test prerequisites.

d. Mandatory inspection hold points.

e. Acceptance and rejection criteria.

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Methods of documenting or recording test data and results.

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Testresultsaredocumented, evaluated,andtheiracceptability[

determined by a qualified, responsible indi.vidual or group.

XII. Activities related to Control of Measurino and Test Equipment are acceptable if:

1.

Provisions, contained in 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 measurements, inspection, and monitoring of important to safety structures, systems, and components.

2. Measuring and test equipment is identified and traceable to the calibration test data.

3. Measuring and test equipment is labeled or tagged or otherwise documented to indicate the due date of the next calibration and provide traceability to calibration test data.

4. Measuring and test instrumen's t are calibrated at specified intervals based on the required accuracy, precision, purpose, degree of usage, stability characteristics, and other conditions which could affect the measurement.

5.

Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipmen found to be out of calibration.

6.

Calibrating standards have an uncertainty (error) requirement of no A more than hth of the tolerance of the equipment being calibrated.

greater uncertainty may be acceptable when limited by the

" state-of-the-art."

7. The complete status of all items under the calibration system is documented and maintained.

8.

Reference and transfer standards'are traceable to nationally k recognized standards, or, where national standards do not exist, provisions are established to document the basis for calibration.

Activities related to Handlino, Storace, and Shipping are acceptable XIII.

if: -

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1. Specialhandli3g, preservation, storage, cleanin individuals in accordance with predetermined work and inspection

- instructions.

2.

Procedu'res 'are prepared which control the cleaning, handling, storage, packaging, shipping, and preservation of materials, i

components, and systems in accordance with design and specific O

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requirements to preclude damage, loss, or deterioration by environmental conditions such as temperature or humidity.

XIV. Activities related to Inspection, Test, and Operatino Status are acceptable if:

1. Identification of the inspection and test status of structures, '

systems, and components is known throughout fabrication.

2. The appl.ication and removal of inspection and welding stamps and operating status indicators such as tags, markings, labels, and stamps are procedurally controlled.

3. Bypassing of required inspections, tests, and other organization.

4. The status of nonconforming, inoperative, or malfunctioning structures, systems, or components is documented and identified to The organization responsible for this prevent inadvertent use.

function is identified.

XV.

Activities rel,ated to Nonconformino Materials, Parts, or Components are acceptable if:

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. L.--- The-identiLicationr-dosumentati n,- trasking, :i-i :ti:n; : C disp :iti:n, end-not4f4e tier to ef f::t:d : gnonconferaing-mater 4

.are-pre::darelly ::ntr:71;d.

O 2.

Documentation identifies the nonconforming item; describes the non-conformance, the disposition of the nonconformance, and the inspec-tion requirements; and includes signature approval of the disposition.

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- Provi s ions -are- e stabki s hed4 dent-i-fying--the; 4ndi"id :': - ; ::::

3. di;p::iti;r ;nt delegated t"; -responsibility-and-authority for-4h:

the-olose-oet--of-sent:rf:r ;n::;.

Nonconforming items are ::; :g:ted ' - ::::pt:b':

't: : :nf identi-4.

fied as discrepant until properly dispositioned and closed out.

t

-5 a.:::pt:ti'it; Of r:, Ork Or Nmair of-matedah,-pacts, ::m;::n:n :,

sy:t:r:, :nd :t-wctures-4swerified-by reinspec-ting-end-ret : tin;-ee it:- :: -iginally inspec-ted -and-tested-oe-by e mett;d aH:h i; :t h::t equal-to,the-originab inspection.and-test 4ng ;;th;d.are decu eated.

i .

end--repai-r-precedure:

Inspectionr testingr-rewed 6.

Nonconformance reports dispositioned " accept as is" or " repair" are made part of the' inspection records and forwarded with the hardware to the utility for review and assessment.

7. Nonconformance reports are periodically analyzed to show quality trends and to help identify root causes of nonconformances and the 4

e

? - - . , . , . , , -.n . , . . . - . . , , - . ~ , , -, a. - ,- , - - , - - . -- , -,, . - , , , , , - , - - - , - , , - - - ,_,..---n.-

e .

I significant results are reported to responsible management for review and assessment. -

XVI. Activities related to Corrective Action are acceptable if:

1. 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.

2.

Correction action is initiated'following the determination of a condition adverse to quality to preclude recurrence.

_L Felb-cactions- are. conducted to.-veri-fy.prgh;kq:ntet :t::F m Of correctire actient and -to close eut--the--cerr :11/

d::cr:nt: tier ir ti;;l; 207 .0 7.

t: :;u lit 3, th;  ::t On;; Of th,

' Sign 4 f-icant- ceMit-ions-adve r;

_ccad.it eme, and ths. corrective-4c-tion-taker i

4 it -: ed, 15:::" : d i t:-

adverse conditiant and in. prec.luds_re?st

• 4 r- c ' t'e e r ;

esdi-t-ions-are-documented and--repo=teo-4.0 00g- f : ni h.;l; ;f manager:nt--for- reviewaM-;;;;;; :- t.

Activities related to Quality Assurance Records are acceptable if:

XVII.

1. The scope of the records program is defined such th of items and the cctivities affecting quality.

2. QA records include Oper t"; ' ;et results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and eouipme calibration procedures and reports; design review and peer review reports; nonconformance reports; anc corrective action reports.

t" : :t':.

.3.-_.' Records.-ar4-identi#ied :nd

4. Requirements and responsibilities for record cre responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.

5. Inspection and test records contain the following where applicable: -

a., A description of the type of observation.

b. The date and results of the inspection or test.

c. Information related to conditions adverse to quality.

! d. Inspector or data recorder identification.

i

e. Evidence as to the acceptability of the results.

4. *

[) - --

3

f. Action taken to resolve any discrepancies noted.

6. Record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity. The facilities are to be maintained by or under the control of the licensee throughout the life of the ISFSI or the individual product.

XVIII. Activities related to Audits are acceptable if:

_1. Audits -e perfe ed 4a accord:nt: "ith pr:::t;bli:h:d -itt:r pr:-

cede-er 0- chec' 'irt: :nd cenducted by tr:i :d pe ::rn:1 n:t hr.'n; di-ect -esponsibi'ities_.for.-the--achice:m:nt c' qc lity " th: :r:::

t:ing :udited.

2. Audit etult: tre docum:nt:d and ther re.i:,::d ith m:n:;;m:nt tr.in; ec:peariMlitp k th: :r:: tudit:d.

3. Provisions exist such that appropriate follow-up corrective action to audit reports is undertaken by responsible management. Auditing organizations schedule and conduct appropriate follow-up to assure that the. corrective action is effectively accomplished.

4. Audits are performed by the QA organization to:

a. Provide a comprehensive independent verification and evaluation of quality-related procedures and activities.

b. Verify and evaluate suppliers' QA programs, procedures, and activities.

5.  ;,udit:-are-regtrier+y-scheduled on-the-basis ef-the : au ; .d the 4mpe-t:n0 te-::fet3 cf th: ::ti.iti:: 5:in; ;;rf;cc..d ;nd ;;;

icitiated ;;rl; :ncu;' t: :::ur; c'f::ti;; ^' d r' ; th; d:::;n, p* curcrent, :nd centr : tin; ::ti 't'::.

6. Audit deficiency data are analyzed and trended. Resultant reports, which indicate quality trends and the effectiveness of the QA program, are given to management for review, assessment, corrective action, and follow-up.

7. Audits objectively assess the effectiveness and proper implementation of the QA program and address the technical adequacy of the activities being conducted.

8. P.rovisions are provided such that audits are required to be performed in all areas where the requirements of the QA program are applicable.

9. Audits are led by appropriately qualified and certified audit personnel. The audit team membership includes personnel (not necessarily QA organizatio~n personnel) having technical ex,pertise in the areas being audited.

. ._,