ML20148F508
| ML20148F508 | |
| Person / Time | |
|---|---|
| Site: | Vermont Yankee, Yankee Rowe, Maine Yankee |
| Issue date: | 07/02/1976 |
| From: | Stello V Office of Nuclear Reactor Regulation |
| To: | Sidebotham D NEW ENGLAND COALITION ON NUCLEAR POLLUTION |
| Shared Package | |
| ML20148F512 | List: |
| References | |
| NUDOCS 8011050679 | |
| Download: ML20148F508 (13) | |
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3 DISTRIBUTION Dockets Files (3)
ORB #1 Reading RRRXXXRudiMg
/ 'i1 c?'i NRC PDR (3) m Dockets Nos. 50-29/271/309 Local PDR(3) v ASchwencer KRGoller Ms. Diana P. Sidebotham, President TJCarter New England Coalition on N.2 clear VSTello Pollution, Inc.
E KH Box 637 ORB #4 Reading Brsttleboso, Vermont 05301 W01mstead, OELD EGCase.
Dear Ms. Sidebothan:
KRG011er xRReid In our telephone conversat.4on today, July 2, 1976, you, requested a
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copy of the list of 89 QA items the NRR staff discussed with the Yankee Atomic Electric Company on August 21, 1975, which was refarred to in my April 9.,
1976 letter. A copy of that list is ' enclosed.
I an also enclosing a copy of my May 6,1976 letter to that company.
Sincerely, THIS DOCUMEtlT CONTAlt1S a
POOR QUAUTY PAGES vietor Stello, Jr., Director Division of Operating Reactors Office of Nuclear Reactor Regulation-9 Enclosures.
1.
List of 89 QA Items ASEXHMH1 2.
May 6, 1976 letter VRooney FBurger cc w/ enc.i:
PDiBenedetto Anthony Z. Roisman, Esquire Berlin, Roisman and Kessler 1712 N. Street, NW.
Washington, D.C.
20036 Mr.'D. E. Vandenburgh, Vice Presi nt
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Vermont Yankee Nuclear Power C tion 20 Turnoike Road j
Westboro, Massachusetts b
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QUALITY ASr!.ANCI L
410.0 l
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i 410.1 The respc ibilities of get-e "Vice Presic'
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' page 2 of Section I, but Figure 1 on page 21 of Section. I.
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shows - two "Vice Presidents".
Clarify this discrepancy.
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41'O.2 Describe the provisions which assure that clear and effective (I) lines of ce==unication between the QA organizations of Yankee Atomic and his principal contractors are established to assure proper direction of the QA program and rcsolution of QA proble a.
410.3 Describe the qualification require =ents for the principal-(I)
QA/QC canage=ent' positions to demonstrate competence'co==ensurata with the responsibilities of these positions.
j 410.4 Describe the provisions which assure that verification.of-(J) conformance. to established require ='ents is accceplished by
' individuals or groups uho do.not have direct' responsibility
. for perfor=ing the work being verified.
410.5 Describe the provisions which assure that personnel performing (I)
QA/QC functions have sufficient authority and organizational freedom to perform their QA/QC functions effectively and '
without reservation.
They can:
a.
Identify quality problems; Initiate,reco==end,orprogfdesolutionsthroughdesignatedg b.
c channels, and; Verifyimpff=entation'ofsolutions, es---
c.
410.6 Describe the provisions which assure that designated QA (I) individuals have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further-processing, delivery, or installation of nonconforming material.
410.7 Give a brief su==ary of the corporate QA policies, goals, and (II) objectives and describe how these policies, goals, and objectives are transmitted down through the levels of =anagement.
410.8 Describe the provisions which assure that the QA program (II) procedures are derived frem QA policies, goals, and objectives.
410.9 Describe the provisions which assure that QA/QC responsibilitics *
(II) are designated for the implementation of the major activitics contained in the QA manual.
410.10 Describe the provisions for controling the distribution of (II) the QA manuals and revisions thereto.
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410.11 Descrit' ' :he provisions for communicat' 'pto all responsible
,(II) organicacions and individuals that qual _cy policies, QA manuals, and procedures are mandatory requirements which
.must be imple= anted and enforced.-
410.12 Give-a listing of QA procedures plus a matrix of these procedures (II) cross referenced. to each criterion of Appendix B to 10 CFR Part 50 to demonstrate that Appendix B provisions are-fully implemented by documented procedures.
I 410.13 Identify the safety-re' lated structures, syste=s, and ccuponents (II) contro'lled by the QA program.
410.14 Describe the provisions which assure that Yankee Atomic (II) reviews and formally concurs with:the QA program provisions of his suppliers to the extent that he can be assured that Appendix B will be implemented.
410.15 Describetheprovision[resolvingdisputesinvolving
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(II) quality, arising from a difference of opinion between QA/QC personnel.and other department (engineering, procur" ment, manufacturing-, etc.) personnel.
410.16 Clarify that the indoctrination and training program (II) assures that:
i a.
Personnel responsible for performing quality affecting activities are instructed as to the purpose, scope, i
and implementation of the quality-related manuals,
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instructions, and procedures.
b.
Personnel performing quality-affecting activitics are trained and qualified in the principles and techniques i
of the activity being performed.
c.;
The scope, the objective, and the method of implementing the indoctrination and training program are documented.
d.
Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
c.
Methods are provided for documenting training sessions describing content; who attended; when attended; and the results of the training session.
l 410.17 Describe the provisions which arsure that quality-related (II) activitics are performed with specified equipment under suitable environmental conditions and prcrcquisites have been satisfied prior to inspection and test.
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<C 410.18 Describe
.e provisions provided for des ibing how changes (II) to the SAR QA program are identified and incorporated into the FSAR.
I410.19 Describe the provisions for correciby translating the applicable e-(III) regulatory requirements and design # bases.into specifications, 1
drawings, written procedures, and instructions.
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410.20-Describe the provisions which assure that suitable design (III) controls are applied to'such activities as reactor physics; j
seismic; stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, caintenance, and repair.
.j 410.21 Describe the provisions which assure that designs are reviewed (III) to assure that design characteristics can be controlled, inspected and tested.
410.22 Describe the provisions which assure that proper selection (III) and accomplishment of design verification or checking j
process 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 the most adverse design conditions shall be used.
410.23 Describe the provisions which assure that design and specification (III) changes, including those originating "onsite", ere subject to the same design controls and approvals that were applicable to the original design unless Yankee Atomic designates another responsible organization.
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410.24 Describe the provisione which assure that errors and deficiencies (III) thatadverselyaffectsafety-relatedstructures,syst$s,and d--
components in the design process are documented, and corrective action is taken to preclude repetition.
410.25 Describe the provisions which assure that standard "off the (III) shelf" comnercial or previously approved materials, parts, and equipment that are essential to the safety-related functions of structuras, systems, and components are reviewed
.for suitability of application prior to selection.
410.26 Describe the provisions for selecting suitable materials, (III) parts, u;uipment, and processes for safety-related structures systems, and components.
410.27 Describe the provisions which assure that the review and (IV) approval of procurement documents are documented prior to release and are availabic for verification.
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~410.28 Describe the provisions which assure that procurecent (IV) documents identify the applicabic 10 CFR Part 50, Appendix 3 requirements which cust be complied with and described in the supplier's-QA program.
This QA program or portions thereof should be reviewed and concurred with by qualified. personnel in QA prior to initiation of activities affected by the. program.
410.29 Describetheprovisions$whichassurethatprocurement (IV) docu=ents identify the documentation (e.g., drawings, specifications, procedures, inspc: tion and fa,brication plans, inspectica and test records, personnel and procedure qualifications, and chc=ical and physical test results of material) to be prepared, =aintainep, and submitted to Yankee Atomic for review and approval.
410.30-Describe the provisions which a.4sure that procure =en* documents (IV) identify those records which shall be retained, controlled, and maintained by the supplier and those delivered to Yankee Atomic prior to use or installation of the hardware.
410.31 Describe the provisions,which assure that procurement documents (IV) contain Yankee Atomic's right of access to supplier's facilities and records for source inspection and audits.
410.32 Describe the provisions which assure that changes and revisions (IV) to procurement documents are subject to at least the saac review and approval as the original document.
410.33' Describe the' provisions.which assure that procurc=ent (IV) documents for sparc or replacement parts of safety-related structures, systems, and components are subject to controls
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at least equivalent to these used for the original equipmant.
1 410.34 Describe the provisions for clearly delineating the sequence of j
(V) actions to be accompidshed in the preparation, review, approval, and control of instructions, procedures, and drawings.
410.35 Describe the provisions uhich assure that methods for complying (V) with each of the 13 criteria of 10 CFR Part 50, Appendix 3 are specified in instructions., procedures, and drawings.
410.36 Describe the provision; which assure that the "offsite" (V) or. "onsite" QA organization reviews and concurs with inspection plans; test, calibration, special process, maintenance,
. modification and repair procedurcs; drmings and specifications; and changes thereto or acceptable alternatives are described.
410.37 Describe the provisions uhich assure that changes to dccuments (VI) are reviewed and approved by the anne organinations that performad the origiani review and approval or by oth:r qualified reuponsible:organir.ations delegated by Yankee Atomic.
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.410.38 Describe -ae provisions which assure tha. approved changes (VI) are included in instructions, procedures, drawings, and other docu=ents prior to implementation of the change.
410.391 Describe the provisions which assure that documents are (VI) available at the location where the activity will be perfor=ed prior to co: encin;.the work.
410.40 Describe *.he provisions which assure that a master list CVI) or equiv*.lcr.* is established to identify the current revision.nu Ler of instructions, procedures, specifications, drawings, and procurement docunents.
This list.is updated and distributed to predetermined, responsible personnel to
. preclude use of superceded documents.
410.41 Identify the documents thatJare controlled under this J
(71) subsection,h,samini=unthisshould include:
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D: sign specifications.
b.
Design, manufacturing, construction, and installation drawings.
c.
Procurc=ent documents.
d.
QA manual and maintenance, modification, and operating i
procedures.
e.
Final safety analysis. report (FSAR),
f.
Manufacturing, inspection, a' d testing instructions.
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Test procedures.
h.
Design change requests.
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Nonconformance reports.
.i 410.42 Clarify that the evaluation of suppliers is based on one (VII) or tore of the follouing:
a.
The supplier's capability to com. ply with the elements of 10 CFR Part 50,.\\ppendix B"that are applicable to che type of material, equipment, or service being procured.
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Areviewofpreviousrecordsandperforn/nceofsuppliers
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who have provided similar articles of the type being procured.
c.
A survey of the supplier's facilities and QA program to determine his capability td supply a product which meets the design, nanufacturing, anJ quality requirements.
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410.43:
Describt..he provisions which assure th' results of supplier (VII)
. evaluations are documented and filed.
.410.44.
Describe'the provisions'which assure that' surveillance L
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'(VII)=
'of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and compcnents is planned; i
and performed in accordance with writtan procedures to assure.
conformance to the. purchase order requirements.
These
. procedures provide.for:'
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Ins,tructions that specify the characteristics or processes-to be witnessed, inspected or. verified, a,nd accepted; the method of surveillance and the extent of documentation j
required; and those. responsible for implementing these instructions.
.b.
Audits and surveillance which assure that~the supplier complied with the quality requirements.
Surveillance,is performed on those items where verification of procurement requirements cannot be determined upon receipt..
410.45-Describe the provisions which assure that the supplier furnishes
.(VII) the following records, as a minimus, to Yankee Atomic:
a.
Certifications that identify the. purchased. material or equipment and te specific procurement requirements i
(e.g., codes, standards, specifications) ret by the items.
b.
Certifications that identify any procurement requirements which have not been met together with a description of those nonconformances dispositioned " accept as is" or y
" repair".
The review and' acceptance of these documents shall be described in Yankee Atomic's QA program and, as a ndnimum, shall be undertaken by 'a responsibl,e QA individual.
410.46 Describe the provisions which assure that rocciving inspection (VII) of the supplier furnished material, equipment, and services is performed to assure:
i a.
The material, component, or equipment is properly identified und corresponds with the identification on.the receiving documentation.
b.
Material, components, or equipment, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
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c.
Inspection records or certifica'ces of conformance attesting i
to the t.cceptance of material, compenears, and equircent arc available at 5 he nucicar pcuer plant prior to ins:allation t
or use.
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410-7 d.
Itet. accepted and released are idt ified as to their inspection status prior to forwarding then to a controlled storage area.or releasing them for installation or further
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Describe the proviciens which assure that the effectiveness (VII) of the control of quality by suppliers is assessed by
- Yankee Ato ic at intervals consistent with.the importance, compicxity, and qual'.ty of the item, i
410.43 Describe the provisions which assure that-identification (VIII) of materiala and parts important to the function of safety-related structures, syste=s, and co=penents can be traced to the appropriate documentacion such-as drawings, specifications, j
purchase orders, manufacturing
'"nspection docu ents, ^
i deviation reports, and physical and chemical mill test raports.
410.4?
Describe the provisions which assure'that the location and (VIII) the =cchod'of identification do not affect the fit, function,.
or quality of the item being identified.
410.50 Describ'e the provisions which assure that correct identification
-(VIII) of materials, parts, and components is verified and documented prior to release for fabrication, asse=bling, shipping, or installation.
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C 410.51 Describe the provisions which assure that qualification (IX) records of procedures, equip cat, and personnel associated l
with special processes are established, filed, and kept cur.ent.
410.52 Dcscribe the provisions which assure that inspection personnel (X) are independent from the individuals performing the activity being inspected.
410.53 Describe the provisions which assure that inspection procedures, (X) instructions, and check lists provide for the following:
a.
Identification of characteristics and activitics to be inspected, b.
Identification of the individuals or groups responsible for performing the inspection operation.
I c.
Acceptance and rej ection criteria.
d.
A description of the cethod of inspection.
c.
Recording evidence of completing and verifying a manuf acturing, inspection, or test operation.
f.
Recording, the inspector or data recorder and the results of the inspection operation.
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-410.54 Describc Se provisions which assure th
' inspection procedures.
(X)
.or instrue: ions are used:with necessary urawings and specifications when performing irgpection operations.
410.55 Describe the prcrisiens which assure that modifications, G:)
repairs, and replacements are inqpected'in accordance "th the original' design and inspection requirc=ents or 5
acceptable alternatives.
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processing =cthods, equipcent,.and personr.el if direct l
inspect'icn is not possible.
410.57
. Describe the provisions which assure that inspectors are (X) qualified in accordance with applic[able codes, standards, and cocpany training programs, and their qualifications and certifications are kept current.
410.58 Describe the provisions which assura that maintenance and (X) modification procedures are reviewed by qualified personnel knowledgeable in QA to determine the need for a) inspection, b) identification of inspection personnel, and c) documenting inspection results.
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410.59 Describe the provisions which assure that modif(ations, (KI) repairs, and replacements are tested in accordance with the original des.ign and testing requirements or acceptabic alternatives.
410.60 Describe the provisions which assure that written test (XI) procedures incorporate or reference:
a.
The requirements and acceptauco limits contained in applicable design and procurc=ent documents, b.
Instructions for performing the test.
c.
Test prerequisites such c--
s Calibrated instrumentation.
Adequate and appropriate equipnent.
. 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 *itness by cwner, contractor, or idspector.
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Acce ' 'ance and rej ection criteria.
f.
Methods of documenting-or recording test data and results.
'410.61 Describe the provisions which assure that ceasuring and (XII)'
test equip =ent is identified and traceabic _ to the calibration test cata.
410.62 Describe the provisions which assure that =casuring and test (XII).
equipmentris labelled et agged to indicate the date of the next calibration.
410.63~
Describe the provisions which assure that cea'suring and (211) test instruments are calibrated at specificd intervals based on the required accuracy, pur,'pese, degree of usage,
' stability characteristics, and other conditions affecting,the measurc=ent.
410.64 Describe the provisions for determining the validity of (XII) previous inspections perfor ca when measuring and test equipment is found to be out of calibration.
410.65 Describe t Q provisions which assure that calibrating standards (XII) have an uncTrtainty (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."
410.66 Describe the provisions which assure that the 'omplete c
(XII) status of ull items under the calibration system is recorded and maintained.
410.67 Describe the provisions which assure that reference and transfer (XII) standards are traccable to nationally recognized standards; 4
or, where national standards do not exist, provisions are established to document the basis for calibration.
410.68 Describe the provisions which assure that identification (XIV) of the inspection, tast, and operating status of structures, systems, and components is known by affected organizations.
410.69 Describe the provisions which assure that bypassing of required (XIV) inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organizatic.
410.70 Describe the provisions which assure that documentativ (XV) identifies the nonconforaing item: describes the nonconformance,
'l the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
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410-10 Describe the provisions for identifying those individuals or
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410.71
()W) groups delegated the responsibili.-f and authority for the J
disposition end approval of nonconforming items.
Describetheprovisionswhichassurekhatnonconfor=in; 410.72 (ZV)-
items are segregated from acceptabla items and identified as' disc cpant unt11 properly dispositioned.
410.73 Describe the provisicas which assure that accertability of (XV) rework or repair of =at'erials, parts, compenents, systems, and structuras is verified by reinspecting and retesting the item as originally inspectcd and tested or by a cethod which is equivalent to the original inspection and testing method; and inspection, testing, rework, and repair procedurcs 3
are documented.
P 410.74-Dese-ibe the provisions which assure that nonconformance (KV) reports dispositioned " accept as.is" or " repair" are made part of the inspection records and forwarded with the hardwarc to Yankee Atomic for review and assessment.
. 410.75 Describe the provisions which assure that nonconformance (XV) reports are periodically analy:cd to show quality trends, and the results are reported to management for revieu and assessment.
410.76 Describe the provisions which assure that corrective action (XVI) is initiated following the determination of a condition adverse.to quality to preclude recurrence.
i 410.77 Describe the provisions which assure that follow-up reviews (XVI) are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
410.78 Describe the provisions which assure that significant (XVI) conditions adverse to quality, the cause of the conditione, and the corrective action taken are reported to cognizant icvels of both "offsite" and "onsite" nanagement for review and assessment.
410.79 Describe the provisions which assure that QA records include (XVII) plant history; operating logs; principal maintenance and modification activitics; abnormal occurrences; results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurenent documents, calibration procedures and reports; nonconformance reports, and corrective action reports, t
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410.80-Describi
.h t. provisions which assure tl require =ents (XVII)_
and responsibilities for record transmittals, retention (such as duratio'n, location, fir. protection, and assigned
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responsibilities), and caintenance subsequent to completion of work are consistent vlth applicable costs, standards, t
-and procurcrent docu: nts.
410.81 Describe the provisions which assure that inspection and (XVII) test records centain the following where applicable:
a.
A deceription of th'c type of observation.
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- b.
Evidence of completing and. verifying a cinufacturing,
. incpection, or test operation.
c.
The date and results of the inspecti:n or test.
d.
Information reiched to conditions adverce to qu:.lity.'
Inspector or data recorder identification.
e.
f.
Evidence as to the acceptability of the results.
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J410.82 Describe the provisions which assure that record storage (XVII) facilitics are constructed, located, and secured to prevent i
destruction of the records by fire, flooding, theft, and j
deterioration by environ = ental conditions such as te=perature or humidity.
410.83 Describe the provisions which assure that audit results (XVIII) are documented and then reviewed with management having responsibility in the area audited.
410.84 Describe the provisions which assure that responsible (XVIII) management takes the necessary action to correct the deficiencies revealed by the audit.
410.85 Describe the provisions which assure that deficient areas (XVIII) are reaudited until corrections have been accomplished to preclude recurrence of the deficiencies.
410.86 Describe the provisions which assure that audits include (XVIII) an objective evaluation of quality-related practices, procedurcs, and instructions and the effectiveness of impicmentation.
410.87 Describe the provisions which assure that audits include the (XVIII) objective evaluation of work arecs, activities, processes, and items and the review of documents and records.
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. i Describe ne previsions for rcquiring t-
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. 410.88 (XVIII)L in those areas where the require =2nts of Appendix B'to 10 CFR Part 50 are being implenented.
These areas shall include those safety-related activitics associated with:
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Operation, maintenance,.and codification.
a.
b.. The pre'paration, review, approval, and. control'of designs,
. specifications, procurement.docucents, instructions,.
' procedures, and draaings.
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- c. LReceiving and plant inspections.
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- d..Indoctrinatien and training-progra s'.
The 1mplementation of operating'cnd test proceduras..
c.
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Calibration of measuring and test equip =cnt..
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' 410.89 Describe-the provisions which assure that audits are regularly
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(XVIII) scheduled on the basis of the status and safety importance-of the a..ivities.being perforced.
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