ML20079N763
| ML20079N763 | |
| Person / Time | |
|---|---|
| Site: | Beaver Valley |
| Issue date: | 01/24/1984 |
| From: | Woolever E DUQUESNE LIGHT CO. |
| To: | Knighton G Office of Nuclear Reactor Regulation |
| References | |
| 2NRC-4-007, 2NRC-4-7, NUDOCS 8401300329 | |
| Download: ML20079N763 (57) | |
Text
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2NRC-4-007 (412)iTI-5141 Telecopy Nuclear Construction Division January 24, 1984 Robinson Plaza. Building 2, Suite 210 Pittsburgh.PA 15205 United States Nuclear Regulatory Commission Washirgton, DC 20555 ATTENTION:
Mr. George W. Knighton, Chie f Lice ns irg Bra nch 3 Of fice of Nuclear Reactor Regulat io m
SUBJECT:
BEAVER VALLEY POWER STATION - UNIT NO. 2 Docket No. 50-412 Revised Res po nses to QA Bra nch Ques t io m Ge nt leme n-At t achme nt I to this le t t e r prov ides revised res po ns es to QA b ra nch que s t io ns.
Thes e que s t io m were originally forwarded to Duquesne Light Company (DLC) in your letter dated August 31, 1983.
Res po mes were provided in an FSAR Ame ndme nt in Oc t obe r, 1983, a rti sub seque nt ly discussed in a meetirg with the reviewers on Jaruary 4,1984.
As a result of that meet irg, the attached revis io m are provided to more clearly describe those as pect s of the QA program of concern to the reviewers.
These res po ns es are scheduled to be subm i t t ed as pa rt of Ame rrlme rt 6 to the BVPS-2 FSAR.
Also provided is the DLC Quality Assurance Policy (Attachment 2) which was reques ted in response to Questio n 260.10 at the same meet irg.
DUQUESNE LIGHT COMPANY' SUB CRIBED AND WORN TO BEFORE ME TilIS j _ DAY ecus /
, 1984.
W
/
b BY g
E. J. Woolever 4 Notary Public
.t LVA G. LESCflDAK, NOTARY PdBUC Vice President RCBINS0i1 TOWNSHIP. ALLEGHEis'Y COUNTY GLB/w], s f.1Y COMMISS!ON EXPlRES OCTOBER 20,1986 At t achme nt s cc:
Mr. H. R. De nto n, Di rector NRR (w/att achme nt s)
Mr. G. Walto n, NRC Res ide rt Ins pecto r (w/ nt tachme nt s)
Ms. L. Lazo, Project Manager (w/attachme rt s)
Mr. D. Eiserhut, Director Divisio n of Lice m irg (w/ attachment s) 8401300329 840124 00l PDR ADOCK 05000412 A
PDR g
l
i United Ststsa Nuclear Fagulatory Comission Mr.-. George W. Knighton Page 2 COMMONWEALTH OF PENNSYLVANIA )
) SS:
COUNTY OF ALLEGHENY
)
, /((h before me, a Notary On this j d day of 4 4A.</
Public in and for said Commonweilth and Cdhnty, ~ personally appeared R. J.
Washabaugh who being duly sworn deposed and said that (1) he is duly authorized to execute and file the foregoing Submittal on behalf of E. J.
Woolever, Vice President of Duquesne Light, (2) he is duly authorized to execute and file the foregoing Submittal on behalf of said Company, and (3)
-the statements set forth in the Submittal are true and correct to the best of his knowledge.
t d
f
_.a2 Notary'Public /
cLVA G, LESONDAK, NOTARY FUBUC I
ROBINSON TC7/NSHIP, ALLEGHENY COUNTT MY COMMISS:0N EXPlRES OCTOBER 20,1986 v--r-o-
-,myy
ATTACHMENT I l '
Question 260,1 (SRP 17.1.l A4)
Describe clear management controls ani ef fect ive li nes of communicatio n between the Qtr a rd QC organizat iors to as sure prope r direct ion ani impleme rc ation of the QA program.
Response
The Quality Assurance Department (QA) Audits Ope rations Quality Cortrol (0QC) ani performs reviews of their administrative procedures.
The Operations Quality Control organization is divided irto three sect io ns for the purpose of impleme nt i ng the Quality Co nt rol Program.
Each sect io n wi thi n the Operations Quality Control organization is supervised by a OQC Engineer.
OQC E ng i nee r (Ma i nt e na nce ) i s res po ns ib le for implement irg the quality requiranent s of. pla nt ma i nt e na nce, surveilla nce act ivi t ies, mai nt e nance rela t ed no rdes truct ive examinations (NDE) and Operations Quality Control Inspector training programs.
OQC Engi nee r (Inservice Ins pect io n) is r es po ns ib le fo r impleme nt i ng the quality requiremerts of inservice inspect ion, collect io n of inservice rec o rd s, ard cortrol of Nondestructive Examination Procedures.
OQC Engi neer (Ref ueli rg/ Modi ficat io n) is res po rs ib le fo r impleme tt i rg the quali ty requirements of refueling, new fuel receipt ard modification activities.
The res po ns ibili ty fo r no n-c o nfo rma nce c o nt ro l, quality co nt rol do cume nt at io n retert ion for Quality Assurance record s s to rage, as well as review of procureme rt d ocume nt s, mai nt e na nce work proced ures, ma i rt e na nce work req ues t s ard materi al receiving is unilaterally shared by all three groups.
The Duquesne Light Company Project Ma nageme rt Committee is chaired by the Duquesne Light Compa ny Vice Pres ide rt, Nuc le ar Co ns truct io n Divi s io n.
Membe rs of the committee i nclude appropriate departmert he ad s from those departmert s i rwo lved in nuclear safety related act ivit ies.
The Quality Assurance Manager is a membe r of the committee ard by charter is further designated as the secretary.
Through this mechanism Duquesne Light Compa ny ma nageme nt is cogniza nt of all Quality Aseura nce ma t t e rs.
The committee is also ch art ered to reso lve impas ses which may occur in quality matters.
Meet i ngs are corducted bi-mo nthly or at the specific request of a ny membe r, as nec es s a ry.
Minutes of the meetirgs are recorded ard distributed to all members.
Question 260.2 (SRP 17.1.lAS)
Describe the criteria for determinirg the size of the QA organization includirg the i ns pect io n staf f, ard prese rt the project ed number of profes sional QA/QC perso nnel to be on board during the operation phase recognizirg this rumber will vary some-wh at throughout the operations ph as e.
Ide nt ify in more det ail the orga nizatio nal positions within theQC organizations on Figure 17.2-1.
Respo nse :
The size of the QA and QC organizatiom is depe rde nt on the various tasks they will perform when BVPS-2 becomes operational.
It is presertly ant icipated that the QAD will have approximately 40 profes sio nal QA pe rso nnel ard OQC will have ap pr oxi-mately 41 professional QC personnel when BVPS-2 becomes operational.
The Quality Control positiom identified on Figure 17.2-1 (Revised) are the Direc-tor, Operations Quality Cortrol ani the Operat ions Quality Cottrol Ergi neers.
The Director estab lishes, impleme nt s ard direct s the perioruance of the DLCo.
Nuc le ar Power Station Quality Cottrol Program.
Refer to oues t io n 260.1, Revised Res po me,
for functional responsibilities of Quality Control Engineers.
The Quality Control Engineer (Mairtenance) impleme nt s the quality requirement s of pla rt mai rt e na nce ; however, the review fo r comple t e nes s of ma i nt e na nce work requests is pe rfo rmed by the Maintenance Foreman.
He in tur n forwards the Main-t enance Work Request (MWR) a ni its as so ci at ed do cume nt s to the Ma i nt e na nce S upe r-visor or his designee for review to de t ermi ne that al l requi reme rt s have been s at is fied a n1 that al l non-co nfo rma nces have been properly resolved.
The MWR a rd associated document s are transmitted to the records retert io n ce rt er.
A serialized OQC Ge ne ral Ins pect io n Repo rt (GIR), wh ich is also tr a nsmi t t ed to the record s ret e rt io n ce nt er, is complet ed whe n 0QC c aerage is requi r ed fo r mai rt e na nce relat ed ac t ivi t ies.
Informat io n cont ained on the GIR i nc ludes ide rt i ty of the i ns pecto r, the type of obse rvat io n, the res ult s, the ac cept abi li ty, a ny act io rs taken in connection with any deficiencies not ed ard the rumber of the MWR used to perform the work activities.
The Quality Assurance Depa rt me rt is res po ns ib le fo r review ard co ncur re nce with Operations Quality Control Program procedures.
Question 260.3 (SRP 17.1.lA5)
Ide rt ify those org a niza t io nal pos itio m repo rt i rg "o ns i t e" a rd those repo rt i rg "of fsite" on Figures 17.2-1 and 2.
Res po nse :
All managers ani their respect ive staf fs that report to the Vice Pres ide nt, Nuc le ar Divisio n ard P.he Vice Preside nt, Nuc lear Cons truct ion Division are com idered to be r epo rt i rg "o ns i t e."
Figure 17.2-1 is marked to ide nt ify those orga nizat io nal positions reporting "of fsite."
All organizational positions noted on Figure 17.2-2 report "o ns i t e".
Question 260.4 (SRP 17.1.l A6)
Describe in more detail the responsibilities of those QC positiors ani QA pos it io m ide nt ified on Figures 17.2-1 a ni
-2, res pect ivel y.
Ide nt ify the QA ard QC pos i-t io ns that have dual responsibilities for Beaver Valley Units 1 ani 2, describe the responsibilities and clearly explain why the QA ard QC ef fort on Beaver Valley Unit 2 will not suffer should Beaver Valley - Unit I demard the full attert ion from the QA ani QC staff with dual responsibilities.
Respo nse :
Responsibilities of Quality Assurance pe rso nnel ide nt ified on Figure 17.2-2 are as follows:
The Ma nage r of Quality As sur a nce is res po ns ib le fo r es t ab li sh i rg, m a nag i rg, a ni measuring the ef fectiveness of the Operations Quality Assurance Program.
The Quality As sura nce Di recto r, Ope ra t io ns is res po ns ib le fo r as sur i rg that the ope rat io n, t es t i rg, mai nt e na nce, a ni fab rica t io n ard i m t al la t io n of f uel in Nuclear Power Statiom is pe rfo rmed in accordance with the Duquesne Light Company Quality Assurance Program ard that the program compli es with regulato ry requi re-me nt s for those activities.
The Senior Quality Assurance Engineer, Administration is res po m ib le fo r the QA admi ni s tr a t ive rev i ew o f proced ur es, QA Tr a i ni rg, a ni u pda t i rg a rd rev i s i rg (a) the DLC QA Program, (b) QA Internal Ins truct io ns, a ni (c) QA sect iom of the DLC Safety Analysis Reports.
The Se nio r Quality As sura nce E ng i nee r, Mai nt e na nce is res po m ib le fo r a s ses s i rg the implementation of the Duquesne Light Compa ny Quality Assurance Program anl other applicable requirement s as they apply to maintenance act ivi-ties of BVPS ard when appropriate, maki rg recommerdstio m which will assist in more ef fectively implemencirs these requirements.
The Senior Quality Assurance Engineer, Operatio rs is res po ns ib le for as ses si rg the implementation of the Duquesna Light Company Quality Assurance Program ard other regulatory requi reme nt s as they ap ply to ope rat io m, fab rica t io n a rd imtallation of fuel, a ni testirg act ivi t ies of N uc le ar Powe r S t at io rs ard whe n ap propr i at e, maki rg rec omme rd a t io m wh ich wil l as s i s t in more ef fect ively implementing these requirements.
The Quality Assura nce Director, Des ign, Com truct io n ard Procureme nt is res po ns ib le for as sur i rg that desien, e rgi neeri rg, procur eme nt, com truct io n ard modificatio n act ivit ies duri rg both the cons t ruct io n a ni ope ra t io n phases of Nuc le ar Power Stations are performed in accordance with the Duquesne Light Company Quality Assur-ance Program ard that the program compu es with regulatory requireme nt s for those activities.
The Se nio r Quality As sur a nce E rg i nee r, Data Analysis is res po rs ib le fo r providits irdicators of performance aga i m t the es t ab li shed Quali ty As sura nce Program.
This res po ns ibility is ca rried out through the deve lopme nt a n!
impleme nt ation of computer programs to track ard analyze data, the evaluat io n of data ard the ge ne ra t io n of informat io n report s to ma nageme nt to i nlica t e group or project improvement or slippage.
The Senior Quality Assurance Ergi neer, Engi neeri rg an! Com truct ion is res po n-s ib le fo r as ses s i rg the implemert ation of the Duquesne Light Compa ny Quali ty as they apply to design Assurance Program and other regulatory requirement s a rd e rgi neeri ng ac t ivi t i es of Nucicar Power S t at io ns ard whe n ap propri at e,
makirg reccanme rdat io ns wh ich will assist in more ef fect ively impleme nt i rg these requirements.
The Se nic r Quality As sur a nce E ngi neer, Procur eme nt is res po m ib le fo r a s ses s i rg the implement atio n of the Duque me Light Company Quality Assurance Program ani other regulatory requirements as they apply to procurement act ivi-t ies of Nuclear Power St atio ns and when appropri ate, maki rg recomme rd a t io m which will assist in more ef fect ively implement irg these requireme nt s.
Evalu-a t io n of ve ndo rs ani maintenance of a Qualified Suppliers List is included in these procurement res po ns ibilit ies.
The Quality As sura nce Record s Supe rviso r is res po m ib le fo r the record ke epi rg systems a pi procedures i ncludi rg the filirg, ret e rt io n, r etri eval, ma i rt e na nce,
prot ect ion ani disposition of all Quality Assurance rec ord s a rti docume rt s requi red for the operation of the Quality Assurance Program.
Question 260.5 (SRP 17.1.lB5)
Describe those provisiom for the resolut ion of disputes i rwo lvi rg quali ty, a ri s i rg from a dif fe re nce of opi nio n between QA a ni QC pe rso nnel a ni ot he r de pa rtme nt (engineering, procurement manufacturi ng, etc.) personnel.
Res po nse :
The Ope rat io ns Quality Assurance Program al lows di f ferences of opi nion regardi rg quality to escalate up the chain of commani as high as the Pres ide nt if neces sary.
The Of fsite Review Committee (ORC) can be ut ilized to reso lve di f fe re nces of opi nio n.
OQC uses the Nonconforma nce Correct ive Act ion Report (NCAR) for resolvi rs no nco nfo rmi rg items, pa rt s, procedures ani work.
Both the Director of Operatiom Quality Control anl the Quality Assurance Manager have "Stop Work Authority".
Question 260.6 (SRP 17.1.lB6)
Describe those provisio ns wh ich as sure that des ignated QA/QC i rtlividuals are i rwo lved in day-to-day pla nt ac t ivi t ies (i.e.
the QA/QC organizatio m rout i nely atterti ard part icipate in daily plant work schedule ard status meet irgs to as sur e they are kept abreast of day-to-day work as signme nt s throughout the plant ani that there is adequate QA/QC coverage relative to procedural a rti i ns pect io n cont rols,
acceptance criteria, arri QA/QC staf firg ard qualification of personnel to carry out QA assignnents).
Res po nse :
Repres e nt at ives of the O pe ra t io m Quality Co nt r ol Sect io n atterti da ily pla nt scheduli ng meet i rgs a nd review mai nt e na nce work req ues t s fo r ap plicabili ty of Quality Control coverage.
Question 260.7 (SRP 17.1.1C2)
Describe tho se provis io ns wh ich assure the quali fica t io n req ui reme nt s of the QC Director of Operations and QA Manager include the following prerequisites:
a.
Ma nageme nt experience through assignments to responsible positions.
b.
Knowledge of QA regulations, policies, practices, an! standards.
m c.
Experience workin;; in QA or related act ivity in reactor design, cons truct tion, or operation or in a similar high technological industry.
Respo nse:
DLC job descriptions identify the necessary attribt.tes fo r the Director of Opera-t io ns QC a ni the QA Manager.
These at t rib ut es i nclude as a minimum the followi rg requirement s:
a.
Ma nageme nt experience through assignnents to responsible positions.
b.
Knowledge of QA regulations, policies, practices ani standards, c.
Experience workits in QA or related ac t iv i ty in reactor des ign, cos truc-tion, or operation in a similar high technological industry.
d.
Must have a degree from an accredited college or university, preferab ly in e ngi neeri ng.
Question 260.8 (SRP 17.1.2Alc)
Describe those provis io ns wh ich assure that the developme nt, control arti use of computer code programs associated with safety-r ela t ed items will be conduct ed in accorda nce with the QA program a rti a descript ion of how the QA program wilI be applied.
Res po nse :
Nuc lear Engi neeri ng Manageme nt Procedures (Nuclear Engi neeri rg Departmert) cont ain cont rols wh ich assure that the developme nt, c.o nt r o l a ni use of comput er code programs associ ated with safety-related items will be-conducted in accorda nce with the QA program.
The QA program will be appli ed in the control areas of res po rw i-bili t ies, i ns truct io ns, reviews a nl approv als, the prope r impleme nt ation of which are subject to QA program audits.
Question 260.9 (SRP 17.1 lC2e)
Describe or refere nce the QA program that will apply to the fire prot ect io n pro-gram.
Respo nse:
Sect io n 9.5.1.5 of the Unit 2 FSAR references the Duquesne Light Company Quality Assurance Fire Protection procedure, which is Appendix C to the DLC QA program.
Question 260.10 (SRP 17.1.2A2)
Provide a'brief summary of the com pa ny's corporate policy relative to the imple-mentation of the QA program.
Res po nse :
This informatio n is co nt ai ned in the " Int roduct io n a ni Let t ers of Promulgatio rf' contained in the QA Program.
. Question 260.11 (SRP 17.1.2B2)
Describe those provisions which assure that the NRC Region I Of fice will be not i-fied of changes to the QA program in accordance with 10 CFR Part 50, 50.54a.
Respo nse :
DLC QA program description charges will be submitted to the NRC in accordance with 10CFR Part 50.54( a).
Question 260.12 (SRP 17.2-2, Item 2)
Describe those provis io ns wh ich assure that the QA Program for operation will be implemented at least 90 days prior to fuel loading.
Res po nse '
The Operations Quality Assurance Program will be implemented at BVPS-2 ninety days prior to fuel loadi rig. for those systems which have been completed. Any systems nct comple t ed ni nety days prior to fuel loadirg will be tur ned ove r to the Nuc lear Division upon completion by the Startup Croup on a system by system basis.
Question 260.13 (SRP 17.1.2B3)
Describe those QA program provisions which assure compliance with 10 CFR Part 50, 50.55a.
Response
Compliance with the applicab le codes a rd s tarda rd s required in ac corda nce with 10CFR50, Paragraph 50.55a is as sured through impleme nt at io n of the O pe ra t io ns Quality Assurance Prograa.
Administrative controls are first pr epa red a ni imple-mented through internal procedures.
These administrative documert s are written to co nfo rm to the applicab le regulatory requireme nt s other admi nistrative procedures shall es t ab li sh the speci fic i ns truct io rs for is sua nce of d:: cume nt s, inc ludi rg charges that prescribe activities af fect irg safety-related items includi rg adequate review, approval, ani distribut ion res ponsibilities. The administrative procedures are reviewed by the DLC Quality Assurance Department to assure compliance with the DLC Ope ratio ns Quality As sura nce Program.
The DLC QA Departme rt also has the res po ns ibility for conluct i rg a comprehensive pla nned system of audi t s to ve ri fy compliance with all aspects of the Operations QA Program.
In addition to the Quality Assurance Department Audits, the Onsite Safety Committee a nl the Of f aite Review Committee have be e n fo rmed to perform the review ani audit program to assure that ope ra t io ns are pe rfo rmed in a safe ma nner ard co ns is t e nt with the license provisions.
The purpose of the OFC in specifically to advise the Station Superinterdent on matters associated with ruclear safety.
The ORC corduct s reviews and audits of all matters that i nvolve s a fe ty co ns iderat io ns.
Through the use of the administrative controls ard QA Department Audits, compliance with the required codes and standards is assured.
_.,-._c._
_m._
.y
Question 260,14 (SRP 17.1.2B4)
Ide nt ify those existirg or proposed QA pr oced ur es that requi r e that Regulatory Guides listed in Section 1.8 of the SAR will be met by documented prodecures.
Res po nse :
This is accomplished through the QA instructiom which describe the audit pr oces s and administrative procedure review process.
Question 260.15 (SRP 17.1.2B5)
Provide a desc ript io n that emph as izes how the docke t ed QA program de sc rip t io n, part icularly the Regulatory Guides listed in Sect io n 1.8 of the SAR, will be properly carried out.
Res po nse :
The admi ni s tr at ive cont rols are written to co nf o rm to admi ni s tr at ive po licies of Duques ne Light Compa ny (DLC), FS AR a ni Tech nical S peci f icat io n req ui reme nt s, a nl the appropriate ANSI Stardards ani Regulatory Guides,
the DLC review ani QA audit program will also as sur e cortpli ance with the Regulatory GuHes to the ext e rt presented in Section 1.8 of the FSAR.
Question 260.16 (SRP 17.1.2C3)
Describe how res po ns ibili t ies a ni control of safety-related act ivit ies are tr a m-ferred fr om the pri ncipal cont r acto rs to the applic a nt dur i rg the phasecut of design ar'd construction and duri ts preoperational testirg turnover.
Res po nse :
Duri ty the phaseout of design a ni cons truct io n ani duri rg pr eope rat io nal t es t i rg a n! pla nt tur nov e r, the res po ns ibilities aid control of safety-related act ivities are tr a ns fe rred from the pri ncipal co nt racto r to the ap plica nt (DIE) by a fo rmal walkdown anl tur nover process in accordance with the mirutes of a meet irg held to est ab li sh tr a m i t io n from the design & construction QA progr am to operation QA program.
These agr eeme nt s are tra m la ted i nto impleme nt i rg proced ur es fo r each group i nvolved in the tr a m i t io n.
In this tra m it io n ph as e, the Co m truct io n Startup Group is res po ns ib le for proof t es t i rg.
The Operatiom Startup Group is res po ns ib le for preope ra t io nal tes t i rg a ni O pe ra t io m is res po m ib le fo r fi nal acc ept a nc e.
Question 260.17 (SRP 17.1.2D)
Describe those provisio n wh ich as sur e that the inlo ct ri nat io n, t r a i ni ng, ard qualification programs are established such that:
a.
For fo rmal traini rg ard quali ficatio n pr ogr ams, docume nt at io n i nc ludes the objective, content of the program, at t e ndee s, ard date of attendance.
4-
b.
Proficiency tests are given to those perso nnel performi rs and veri fyi rs act iv-it ies af fectirg quality, ani acceptarv:e criteria are developed to det ermi ne if individuals are properly trained ard qualified.
c.
Ce rt ificate of quali fica tio ns cle arly de li neat es (a) the speci fic funct io m personnel are qualified to pe rfom a rd (b) t he c ri t e ri a used to quali fy pe rso re nel in each function, d.
Proficiency of personnel performi rg ard veri fyi rg act ivit ies af fect irg quality is maintained by retrainirg, r eexami ni rg, ani/or recert ifyirg as determined by management or program commitment.
Res po nse :
a.
Procedures are provided for formal trainirg ard qualification of operatiom, QA ard QC personnel which require a documented surmaary of materiti covered at each training session and written documentation of attendees including date.
b.
Groups that require a demonstratio n of proficiency have procedures in place to address the appropriate criteria, c.
Admi nistrat ive procedures are availab le wh ich describe the ce rt i f ica t io n method.
d.
Pe rfo rma nce, r et ra i ni rg, reexami ni rg a rd/or rece rt ific a t io n req ui reme nt s as specified by the Nuclear Division are described in the appropriate procedures.
Question 260.18 SRP 17.1.3B)
Describe those organizational respons ibilities fo r prepa ri rg, revi ewi rg, approv i rg,
a ni verifyirg de s ign do cume nt s such as system desc ript io ns, design i rput, des ign drawings, design analyses, computer programs, specificat ions, and procedures.
Res po nse :
The Nuclear Engi neeri rg Department has the orga nizat io nal res po ns ibi1i t ies ard the admi nis trative controls fo r pr epa ri rg, reviewi ng, ap prov i rg, ard veri fyi rg des ign document s such as system descript io m, design input, design drawirgs, design analy-ses, computer programs, specifications, ard procedures.
Question 260.19 (SRP 17.1.3Cl)
Describe in more detail those prov i s io ns sh ich as sure that errors ani deficiencies i n approved de s ig n docume nt s, i nc ludi rg des ign methods (such as comput e r codes),
that could adversely af fect safety-r ela t ed structures, systems, a rd c cinpo ne rt s are docume nt ed ; a rd act io n is t ake n to assure that all errors a ni de fici e nci es are corrected.
Respo nse :
Nuclear Engineeri rg Manageme rt Procedures (Nuclear Ergineeri rg Department) cont ai n co nt rols wh ich as sure that erro rs a rd de fici e nci es in approved des ign docume nt s,
t' includi ng design methods (such as com put e r codes) that could adve rs ely af fect s afe t y-rela t ed structures. systems, a rd co npo ne rt s, a r e do cume nt ed : ani act io n is taken to assure that all errors ard deficiencies are corrected Question 260.20 (SRP 17.1.3EI)
Describe those provis io ns wh ich assure proced ures are es t ab li shed requi ri rg a
docume nt ed check to verify the dime m io nal accuracy a n! comple t e nes s of design drawings ani specifications.
Res po nse :
The Nuc lear E ngi neeri ng Depa rt me nt has es t ab li shed pr oced ural co nt rols wh ich require a documented check to verify the dime ns io nal accuracy an! completenes s of design drawings ard specifications.
Question 260.21 (SRP 17.1.3E2)
In addi t io n to the des ign cont r ols s peci fied in Sect ion 17.2.3, desc ribe those prov is io ns wh ich as sure procedures are es t ab lished requi ri rg that design drawirgs a n! speci ficat io ns be reviewed by the QA orga nizatio n to det enni ne that the docu-me nt s are prepared, reviewed, a ni ap proved in ac cord a nce with compa nf proced ures ani that the documents cont ain the necessary QA requirement s such as i m pe ct io n a ni t es t requi reme nt s, accept ance requireme nt s, a nd the ext ert of do cume nt i rg i m pe c-tion crxl test result s.
Res po nse :
The Nuclear Engi neeri rs Department has the o rga niza t io nal res po m ibili ty a rd the procedural ani administrative controls for assurirg that design drawi rgs ani s pe ci-f ica t io ns are i rxlepe nle nt l y reviewed by quali fied Nuc le ar E ng i neeri rg Depa rt e nt perso nnel to de t ermi ne that the docume nt s are prepared, r ev i ewed, a ni ap proved in accordance with es tab lished Nuc lear Engi neeri ng Manageme nt Proced ur es, a nl that the documerts co nt ai n the nec es sa ry QA r equi reme nt s such as i m pe ct io n ard t es t requi r eme nt s, ac cept a nce req ui reme rt s, a nl the ext e rt of docume rt irg i m pect io n ard test res u lt s.
Question 260.22 (SRP 17.1.3E3)
Describe those provis io ns wh ich as sure guideli nes or cri teria are es tab lished fo r det ermi ni ng the met hod of design ve ri fic a t io n (design review, alternate calcula-t ions, or test).
Res po nse :
Nuc lear Engi neeri rg Manageme rt Procedures (Nuc le ar Ergi neeri rg Departme nt ) cont ai n controls which assure that the method of design verification (design reviaw. alt e r-nate calculations, or test) i s de t ermi ned in accordance with procedural guideli nes or criteria.
Question 260.23 Desc ribe those provisio ns wh ich assure procedures are es t ab li shed fo r des ign verification activities which assure the following:
(3E4)
a.
We verifier is qualified ard is not directly res pons ib le fo r the des ign (i.e.
neither the pe rfo rme r nor his immediate su pe rvi so r).
In exceptional ci rcum-s t a nces, the designer's immed i at e su pe rv iso r ca n pe rfo rm the veri fica tio n provided:
(1) The supervisor is the only technically qualified individual.
(2) The need is iniividually documented ani approved i n advance by the supe r-visor's management.
(3) QA audits cove r freq ue ncy a nl ef fect ive nes s of use of supe rviso rs as design verifiers to guard against abuse.
b.
Design verificat ion, if other than by qualification testirg of a prototype or lead product io n unit, is comple t ed prior to rele ase for procureme nt, maru fac-t uri rg, c o rs truct io n or to another organizat io n for use in other des ign act ivi-t ies. In those cases where this t irii rg ca nnot be met, the design verification may be deferred, providing that the justificat ion for this act io n is document ed a ni the unverified port ion of the design output docume nt ani all design output d ocume nt s, based on the unve ri fied data, are ap propri ately ide nt ified a ni c ont rolled.
Cmtruct io'n site act iv i t ies as so ci at ed with a design or design charge should c proceed without verification past the point wh e re the i ns t al-lat io n would become irrevers ib le (i.e.,
req ui re ext e rs ive demo li t io n a n!
rework). In all cases, the design verification should be comple t e prio r to fuel load for a plant under construction, or in the case of an operatirg niant, prior to relyi ng upo n the compo ne nt, system, or structure to pe rfo rm its funct io n.
c.
Procedural control is established for design documents that reflect the commit-mer2s of the SAR; this control dif ferert iates between docume rt s that rece ive formal design verification by irterdieciplinary or multi-organizational t eans a nl those which ca n be reviewed by a sirgle inlividual (a signature ard date are ac cep t ab le docume rt at io n for pe rso nnel ce rt ifica t io n).
Des ign docume nt s subject to procedural control include, but are not limited to, specifications,
calculatior.s, computer programs, system descript io ns, SAR when used as a design docume nt,
a ni. dr awi rg s i ncludi rs flow diagrams, electrical s i rg le-li ne di agr ams, structural systems fo r major facili t ies, site arra rgeme nt s, a ni equi pme nt loca t io ns.
Speci alized reviews should be used whe n unique nes s or special design considerations warrant.
d.
We res po nsibilit ies of the verifier, the areas ard fe atures to be ve ri f ied,
the pe rt i ne rt co ns ide ra t io ns to be ve ri fi ed, ard the ext e rt of docume rt at io n are identified in procedures.
Respo nse :
Nuclear Engi neeri rg Manageme nt Procedures (Nuc lear Engi neeri ng Departmert) cont ain controls for design verification activities which assure the following:
a.
We verifier is qualified ard is not directly res;nns ible for the des ign (i.e.
neither the pe rfo rme r nor his immediate supe rv iso r).
In exceptio nal circum-s t a nces, the des igne r's immediate supe rv i so r ca n pe rfo rm the ve ri fica t io n provided:
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(1) The supervisor is the only technically qualified indi/idual.
(2) The need is irriividually documented a rti ap proved i n ad va nce by the su pe r-visor's management.
(3) QA audits cove r freque ncy ani ef fect ive nes s of use of su pe rv i so'rs as design verifiers to guard agairst abuse.
'I h.
Design verification, if other than by qualification' testirg of, a prototype or~
lead product io n unit, is completed prior to release Ifor procureme rt, ma m fac-t uri rg, c ons truct io n or to a nothe r orga nizat io n fo r use i n ot he r de s ign act ivi-N t ies. In those cases whe re this t imi rs ca nnot be met, Jhe des ign veri fica't io n may be de fe rred, prov id i ts t hat the j ust ific a t io n fo r t his act io n is do cume ne c<'
arul the unverified portion of the design output do cume rt a ni all des ign ou'tput d ocume nt s, based on the unveri fied data, are appropri ately ide rt ified Jn!
co nt rolled.
Construct ion site act ivit ies aseociated with a des ign or des'rgn charge should. not proceed without verification past the poi nt where the i rs t al-lat io n would become ir revers ib le (i.e.
requi re ext e rs ive demoli t io n a ni 5
rework). In all cases, the design verification should be comple t e prior to k
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fuel load for a plant under construct ion, or in the case of an operatirg plant,
prior to relyirg utan the com po ne rt, system, or structure to pe rfo rm its funct io n.
a c.-
Procedural control is es tablished for design docuaent s that reflect the commit-me nt s of the SAR: this cont rol di f ferett iates be tween mcume nt s that rece ive formal design verification by i nterdiscipli nary or mult i-organizatio nal teams a rti those wh ich ca n be reviewed by a sirgle inlividual. (a signature arti. date are ac cept ab le do cume nt at io n fo r pe rso nnel ce rt i f ica t Io n).
Des ign docume nt s s ubj ect to procedural control include, but are rot limited to, s peci f ica t io rn,
c alcula t io ns, c omput e r programs, sys t em desc ript io ra SAR wh e n used as a des ign d ocume rt,
a rvi drawirgs i ncludi rs flow di agr rian, / ettet rical s i rg le-li ne
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diagrams, structural sy s tems fo r majo r faci li t ies, site arra rgeme rt s, a ni equi pme rt locat io ns.
Spe ci alized reviews should b? ' used ; whe n unique nes s or special design considerations warrant.
d.
The res po ns ibilities of the verifier, the areas ani features; to be ve rified,
the pe rt i ne rt co ns ide ra t io ns to ve ri f ied, a ni the ext e rt of docume rt at io n are identified in procedures.
Question 260.24 (SRP 17.1.3B3)
Describe those prov isio ns which as sure that the fo 1lowi rg are i neluded ii the verification method is only by test:
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a.
Procedures provide criteria that specify when verification shonM be by test, b.
Prototype, component or feature testirg is performed as early as possib le prior to installation of platt equipoent, or prior to the poi rt wh e n t he i rs t al la t io n would become irreversible.
c.
Veri ficatio n by test is pe rformed unde r corrii t io rs that simulate-the nras t adverse design conditions as determined by analysis.
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Respo nse:
Nuc lear Engi neeri rg Manageme nt Procedures (Nuc lear Engi neeri rg Departme nt) cont ain controls which assure that the following are included if the verification method is
. only by test:
1 Procedures provide criteria that specify when verification should be by test,
- a.
b.
Prototype, component or feature testirg is performed as early as possible prior to imtallation of plant equipme rt, or prior to the poi nt wh e n the i rs t al la t io n would become irreversible.
'c. Veri ficat io n by test is pe rfo rmed unde r co rsli t io ns that simulate the most adverse design conditions as determined by analysis.
Question 260.25 (SRP 17.1.3E4)
Describe those provisio ns wh ich assure that proced ures are es t i li shed to as sur e that verifed computer codes are certified for use and that their use is specified.
yp
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Nuclear Engi neerirg Management Procedures (Nuclear Engi neeri rE Departme nt ) cont ain controls which as sur e that verified computer codes are cert ificd for use anl that 4
their use is specified.
- z Question 260.26 (SRP 17.2.3, Item 2) s
. Describe those provis io ns wh ich as sure that res po ns ib le pla nt pe rso nnel are made aware of design ch arges / modi ficat io ns wh ich may af fect the pe rfo rma nce of their duties.
Respo nse:
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Administrative controls are provided to ensure that responsible plant pe rso nnel are made aware of design ch a rged/ modi ficat io ns wh ich may af fect the pe rfo rma nce of their dut ies prior to final acceptance of the modification.
Question 260.27 (SRP 17.1.4B1)
Ide nt ify in more det ail the orga ni zat io nal res po m ibili t ies fo r (1) procuremcot pla nni rg; (2) the pr eparat io n, review, ap pr ov al, ard control of procuremert do cu-3 me nt s ; (3) aupplier selection; (4) bid evaluatiom; a rti (5) review ani concurrence of supplier QA programs prior to initiatio n of act ivities af fect ed by the program.
Particular emphasis should be devo t ed to the QA ard QC organizational i rwo lveme nt
^
in the area of procurement document control.
Re s po nse :
The ope ra t io ns QA program ide nt ifies the o rga nizat io nal res po m ibili t ies fo r c o nt rol of procureme nt of ma t e ri al, eq ui pme nt, a ni se rv ic es.
The O pe rat io rs Quality Co nt rol grou p rev iews purch ase requi s i t io ns as so ci at ed wi th Category I
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s afe ty-r elat ed com po ne rt s, pa rt s a ni co ns umab les.
If sour ce i m pect io n is ide nt ified on the procureme nt quali ty docume nt atio n fo rm, OQC rev iews the so ur ce v
t
ins pect io n requir eme nt s ard not ifies the QAD that source i rs pect io n is. requi red.
The Quality Assurance Department evaluates ve rdors, mairt ains a Qualified _ Suppliers List ard.arrarge' fer source ins pect io ns when required.
The Purchasirg Department places ~ orders with approved suppliers.
5 Question 260.28 (SRP 17.1.6Al)
Describe those provis io ns wh ich as sure the ~docume rt co nt rol program controls the 4
followirs documents.
- a.
Design do cume nt s (e.g.,
calcula t io ns, dr awi rg s,
speci ficat io ns,,. analyses) including documents related to computer codes.
b.
c.
Ins truct io ns ard. procedures for such act ivities as f abrica t io n, cons truct io n, j
modificat io n,. i nst allat io n, test, a rd i nspect io n.
- d.
As-built document s.
-e.
Quality assurance ard quality control marmals ard quality-af fect irg procedures.
f.
Topical ~ reports.
_g' SAR.
h.
Nonconformance reports.
' Respo nse :
a.
Detailed Des ign Docume rt s such as caIculat io ns,' drawi rgs, speci fica t io rs, ard analysis associated with Design Charges are reviewed ard approved in accordance with existirs administrative procedures. Th is. type of - de t ailed information is
- ma i rt ai ned as pa rt of the Design Charge Package by the ergi neers ard does not require distribution in a controlled manner, b.
Speci fic documert cortrol requireme nts for these pr ocedur es are ide rt ified lin the associated group's administrative procedures.
c.
Refer to ' item b above.
-~d.
Control of as built dr awi rg s is delineated in the Nuclear Division Administra-tive Procedures.
~
e.
Quality Assurance. and Quality Co nt rol procedures ard maruals are di s tribut ed a rd co rt rolled usirg requi reme rt s in each i rd ividual 's Admi nis trat ive procedures.
f.
Topical repo rt s are not normally used; however, these would be ha rd led in a controlled manner should the situation arise.
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BVPS-2 FSAR
.g.
The FS AR a rd Ame rrime nt s to the FSAR are issued usirg a controlled distribution method.
h.
Refer to item b above.
Question 260.29 (SRP 17.1.6A2)
Describe those provis io ns which as sure procedures fo r the review, ap proval, a rd issua nce of docume nt s ard ch a rges thereto are es t ab lished to assure t ech nical adequacy arrl inclusion of appropriate quality requirement s prior to impleme rc at io n.
The QA organization, or an irrlividual other than the person who generated the docu-me nt but quali fied in quality as sura nce, reviews ard concurs with these docume rt s with regard to QA-related aspects.
Res po nse :
The Operations. Quality Assurance Program requires that each Site organization be res po ns ib le for es t ab lishirg a ni impleme nt i rg docume nt control measures fo r its res pect ive i ns truct io ns, proced ures, a rd dr awi rg s.
To assure that al1 irrlividual groups prepare their procedures in a consistert ma nner, ard that these procedures incorporate. all the necessary Quality Assurance Co nt r o ls, each group es tablishes their..res pect ive de t ailed format s fo r proced ures which ef fect ively impleme nt its
. group's funct io ns.
These irdividual group procedures are based on the Quality As sura nce reviewed Nucle ar Divis io n's almi nis trat ive proced ur es.
Pe rso nnel who prepare the i ndividual-procedures are required to follow the i nfo rma t io n pr es e rt ed in these administrative procedures.
Question 260.30 Describe those provisions which as sure that a master li s t or equivale rt do cume nt c o nt rol system is es t ab li shed to ide nt ify the cur re tt revision of i ns truc t io ns,
procedures, specifications, drawings, azul procurement documents.
Res po nse :
The Nuclear Division Administrative Procedures ide nt ify the requireme rt s neces sa ry to assure that i ns t ruct io ns, procedures, speci fica t io ns, drawi rgs, a ni procur eme rt docueert s are distributed in a controlled manner to assure recipiert s are provided with the la t es t revisio n in a timelv ma nne r.
Individual grou p proced ur es are
- prov id ed which specify the co ntrol req ui reme rt s aid res po ns ibili t ies as so ci at ed with that group's document ' control funct io ns, a.
Controlled manuals are namally distributed with a current t ab le of co nt e rt s wh'ich irdicates the latest revision applicable to each procedure.
The distri-bution process utilizes transmittals which provide i ns truct io ns for the removal ard return or destruction of superseded document s.
These transmittals i nc lude provis io ns fo r the recipi e rt to acknowled ge rece ip t of the procedur e or revision ard the resulting procedure update.
r.
b.
Procedures for the pe rfo rma nce of ma i nt e na nce ard calibrat io n act ivit ies are di s tribut ed by irdividuals specified in the administrative procedures who also maintain a current irdex or log identifyirs the la t es t revis io n of each docu-me nt.
These docume rt s are sui t ab ly ide nt if i ed. as beirs approved for use a ni assigned expiration dates after which they may no longer be used, c.
Co nt rolled drawirgs are included in an i sdex aystem wh ich su ppli es drawirg title, identifying number, latest revision, ani any Design Charge Package (DCP) wh ich af fect s the dr awi rg.
Full size pr i nt s ard ape rt ur e ca rd pr i nt s are issued in a controlled manner usirg an issuara.-c log.
A similar irdex system is used for procurement documents.
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The irdividual irdex systems may take the form of a comput er report, i rdex ca rd s,
logs, or other equivalent record keepirg systems which are reviewed a rd u pda t ed as prescribed in the administrative procedures.
Question 260.31 (SRP 17.1.6C1)
Describe those provisio ns wh ich as sure that procedures are es t ab li shed to prov ide for the prepa rat io n of as-built drawirgs ard related docume nt at io n in a timely manner to accurately reflect the actual plant design.
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Nuclear Engineerirg Management Proced ur es (Nuclear Engineeri rg Department) cont ain
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cont rols which provide for the prepa rat io n of as-bui lt dr awi rg s a rd rela t ed documentation in a timely manner to accurately reflect the actual plant de s ign.
Question 260.32 (SRP 17.2.6, Item 2)
Describe those prov is io ns wh ich as sure that mai nt e na nce, modi fic a t io n a ni i rs pe c-tion procedures are reviewed by qualified personnel knowledgeable in QA discipli nes (normally the QA organization) to determine:
a.
The need fo r i ns pect io n, ide nt if ic at io n of i ns pect io n pe rso nnel, a ni do cume nt a-tion of inspection results, b.
That the necessary i ns pe ct io n requi r eme nt s, methods, a rd ac cep t a nce cri teri a have been identified.
Res po nse :
Ope ra t io ns Quality Control perso nnel knowledgeable in QA discipli nes are requiral to review maintenance, modificatio n ard inspect ion procedures in order to de t e r-mine:
a.
The need fo r i ns pect io n, ide nt ificat io n of ins pect ion perso nnel, ani docume nt a-tion of inspection results.
b.
That the neces sary i ns pect io n requi reme nt s, methods, a rd ac cept ance cri t eri a have been identified.
Question'. 260.33 (SRP 17.1 7A4)
Describe those provis io ns wh ich as sure that ' procureme nt of spare or replaceme rt part s for safety-related structures, systems, a ni compor.stt s is subject to pr ese nt
.QA program controls, to codes anl stanlards, arsi to technical requirement s equal to
- or better than the original technical requirements.
Response
. The Operatio ns. Quality As sura nce Program requi res that rep laceme rt mat eri als ani
~equipme nt (or - additio nal materi al an! equipme nt for s to ck) be purch ased to the original material or equipment speci ficatio ns arul the. pr ese nt QA program controls.
Where this is not - possible, charges to the original specificatio n that af fect the s afety of the. equipme nt or materi al. must. be evalua t ed before the items are pr o-cured.
Individual group administrative procedures speci fy the de t ailed req ui re-ments for spare parts procurement.
. Question 260.34 (SRP '17.1.7B3)-
Describe those. provisions which as sure that the supplier fur nishes the fo llowi rg records to the purchaser:
a.
Documentation identifyirg any procurement requirements that have not been met,
- b. TA description of those no nco nfo rma nces from the procureme rt requi reme nt s dispositioned " accept as is" or " epair".
, The review ani acceptance of.these documert s should be described in the purch aser's
'QA program.
Respo nse :
The Duques ne Light Company Ope rat io ns Quali ty. Assurance Program requires that suppliers shall obt ain the Duquense Light Company's approval of all dispositions of nonconformances, when the ef fect of the dis pos itio n is to waive or modi fy (i.e.
" accept as is" or " repair") a requi reme nt which was specified or approved by the Duque nse ' Light Compa ny (DLC).
The DLC impleme rt i ng procedures wh ich co rt ai n i ns truct io ns for the preparation ard issuance of procurement do cume rt s fo r s pa re or replaceme rt ' part s.. fo r BVPS-2 addres s in det ail the docume rc at io n requireme rt s a ssoci at ed with the procuremert. of eafety-related items.
The suppli ers rece ive instruct ions l which state that. they must idert ify any procureme.t requi rer.he rt e that h' ave not been met.
Questio n 260.35 (SRP 17.1.7B4)
Describe those. provis io ns wh ich as sure that for commercial "o f f-t he-shelf" items where specific quality as sur a nce co rt rols appropriate for ruc le ar ap plic a t io ns c a nnot be imposed in a pr act icab le ma nner, special quality verificatio n require-merts shall be established to provide the necessary assurance of an acceptab le item by the purchaser.
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. Res po nse :
Nuclear Ergineeri rg Managemert Procedures (Nuclear Engi neerirg Departme rt) cort ain cortrols which as sure that, -- for. commerci al "of f-the-shelf" itens wh e re speci fic i
quality assurance : controls appropri at e for _ nuclear applicatio ns ca nnot be impos ed.
i n a 1 pract icab le ma nner, cons ide ra t io n wil l be give n to the impos itio n of special 4
providirs the necessary as sura nce of. an
. quali ty ;.verificatio n requiremerts i n acceptable purchased item.
. Question 260'.36 -(SRP 17.1.7B3)-
Describe those provisions which assure that suppli ers ' certificates.of conformance
- are periodically - evaluated by audits', -iniepe nde nt-i rs pect io ns, o r t es t s to assure they are valid armi the results documented.
Response
The Quality Assurance Departmert evaluates vendors periodically to ensure cort.,ued
. quality, performa nce.
Problem veniors may be audited-if deemed. necessary.
Rece ip t inspection provides additional assurance of validity.
P The Quality Assurance l~partmerts evaluation of a suppliers capability to provide a i
quality item or service includes any or all of the following:
a.
Evaluatirg the supplier's history of providirg a quality product which performs s atis facto rily in act ual use.
Information which should be evaluated - should include:
(1). Expe ri ence of users of ide rt ical or similar product s of the pros pect ive.
supplier.
- (2). Purchaser's records that have beeo accumulated in connect ion with previous procureme nt actions and product operatirg experience.
The success of ' quality - perforrra nce is highly. depe nde nt upo n the suppli ers '
'pe rso nnel capabilities, phys ical condi t io ns of the 'maru facturi rg. facility. ani equipme rt ani managemert 'r attitude towards quality. Historical data should'be represe rt at ive of the supplier's cur re rt capability.
If there has be e n no
' rece rt experience with the supplier, or if he is' a new supplier, t he pros pe c-
' t ive. supplier shall be reques t ed to submit i nfo rmat io n ' o n a s imilar item or
. service' (such as applicable drawirgs or data) for evidence of his capabilities.
.b.
The supplier's currett quality records supported by documerted qualitative ani quart itative~ information which ca n be ' objectively evaluated.
This would i nelude rev i ew. a rd evalua t io n of the ' supplier's Quality As sura nce P r ogr am, Manual and Procedures, ' as. appropriate.
cc.
The supplier's technical arti quality capability as de t ermi ned by a source evaluat io n.
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Question 260.37 (SRP 17.1.8B3)
Describe how correct ident ificat io n of material, part s, a rd compo ne rt s is verified a rri ' docume nt ed. prio r to release fo r fab ric a t io n, as semb li rg, ship pi rg, a rti i m t al-Lat io n.
Respo nse :
Depa rtme rt al procedures describe ide nt ificatio n requi reme nt s fo r mai nt ai ni rg
-msterial traceability.
Ide ntification of materials is verified through receipt a ni quality control receivirs inspection.
A status i rtlica t i rg system ut ilized duri rg receivirg i ns pect io n incorpo ra tes the use of Hold Tags, Accept Tags a rd Reject Tags.
Material found to be accept 41e through receivirg inspect ion is tagged with
- an Accept Tag prior to Issuance for installation.
Question 260.38 (SRP 17.1.9A2 and SRP 17.1.9B1)
Describe the res po ns ibilities of the QA/QC organization for the qualificatio n of s peci al proces ses, equipme nt, a nd pe rso nnel a rri in assuri rg that these qua li fica-tions have been satisfactorily performed.
Respo nse :
Quality Control i ns pect io ns ersure that properly qualified pr oced ur es, eq ui pme nt,
a rti pe rso nnel are utilized for speci al proces ses through their review of special process procedures. QA audits verify compliance.
Question 260.39 (SRP 17.1.9B1)
Describe those provisio ns wh ich as sur e that equipme rt as soci at ed with speci al processes are qualified arti are in conformance with applicab le codes, stardards, QA procedures, arti s peci ficat io ns.
Respo nse :
These provisioru are included in the Operatiom Quality Assurance Program.
Det ails are included in various implementing procedures.
Question 260.40 (SRP 17.1.9B2)
Describe in more detail those measures which as sure that procedures are es tab lished for recordirg evide nce of ac cept ab le ac compli shme nt of speci al pr oces ses us i rg qualified procedures, equipment, arxl personnel.
Respo nse :
The Beaver Valley Power Station Weldirg Marual arti OQC Procedures desc ribe these measures.
Question 260.41 (SRP 17.1.10A)
Describe those prov i s io ns which assure that an ef fect ive i rs pect io n progt am has been estab lished which provides cri teria for determinirg the accuracy require nt s
of inspect io n equipment a ni provides clearer cri teria for det ermi ni rg whe n i ns pec-t io ns' are requi red.
Desc ribe the res po ns ibilit ies of the QA/QC organizations in the above functions.
Response
' The Maintenance Marual provides cri teri a fo r ac curacy requi reme rt s.
OCQ reviews precedures that speci fy i rs pect io n req ui reme nt s.
QA r eviews admi nis tr at ive pro-cedures and audits these activities.
Questio n 260.42 ISRP 17.1.10BL)
Describe i n more detail those prov i s io ns wh ich assure that irdividuals pe rfo rmi rg i ns pect io ns are other than those who performed or directly supervised the act ivity beirg i ns pect ed ad do not repo rt directly to the iramed i ate su pe rv iso rs dio are res po ns ib le fo r the act ivi ty be i rg i rs pe ct ed.
If the i nlivid uals pe rfo rmi rg i ns pect io ns are not pa rt of the QA orga nizatio n, the inspect ion procedures, pe rso n-nel qualification criteria, ani i rdepe rde nce from undue pr es sur e such as cos t ard schedule shall be reviewed ard found acceptable by the QA organization prior to the initiation of the activity.
Respo nse:
The organization chart of the Nuclear Divisio n ide nt ifies the i rdepe rde nce of the OQC organization.
The Quality Assurance Departmert audits DCQ to as sure i rdepe n-dence ' from cost and scheduling is maintained.
Question 260.43 (SRP 17.1.10B2)
Describe in more de t ail the quali fica t io n program fo r i ns pect o rs (i ncludi rg NDT personnel).
Res po nse :
OQC procedures provide fo r the ' qualificatio n ard ce rt ifica t io n req ui r ane rt s of pe rso nnel - who pe rfo rm i rs pect io n act ivi t ies.
These pr oced ur es also spe ci fy the levels of qualification of OQC personnel who perform liquid penetrart exami nat io rs.
Question 260.44 (SRP _17.1.10Cl)
Describe these provisio ns which as sure that i ns pect io n procedures, i rs truct io rs, or checklists provide for the following:
Identification of characteristics ard activities to be inspected.
a.
b.
A description of the method of inspection.
c.
Ide nt ificatio n of the irdividuals or gr ou ps res po ns ib le fo r pe rfo rmi rg the inspection operation in accordance with the provisions of Item 10Bl.
d.
Acceptance ard rejection criteria.
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Ide ntificatio n of req ui red procedur es, dr awi rg s,
aid s peci fic a t io rs,
a nd revis io ns.
f.
Recordirg i ns pect o r or data recorde r and the result s of the i rs pect io n operatio n.
g.
Specifyirs necessary measuri rg a nd test equipme nt includi rg accuracy require-me nt s.
Res po nse :
Operations Quality Control procedures ard the Maintenance procedures include provi-sio ns which as sure that i ns pect io n procedures, i ns truct io ns or checklists provide for the following:
a.
Ideritification of characteristics and activities to be inspected.
b.
A description of the nethod of inspection.
4 c.
Ide nt ificat io n of the irdividuals or grou ps res po re ib le fo r pe rfo rmi rg the inspection operation in accordance with the provisions of Item 10Bl.
d.
Acceptance and rejection criteria.
c.
Ide nt if
. io n of requi red pr oced ur es, dr awi rg s,
ard speci fic a t io m,
ard revi s io ns.
f.
Recordi rg i ns pect o r or data recorde r ard the result s of the i rs pect io n ope rat io n, g.
Specifyi rg necessary measuri rg ard test equipme nt includi rg accuracy require-me nt s.
Question 260.45 (SRP 17.1.10C2)
Dacribe those provisiors which as sure that procedures _ are es tablished to ide nt ify,
i n pe rt i ne nt docume rt s, mardatory irs pect io n hold poi nt s beyo rd which work may not proceed until inspected by a designated inspector.
Respo nse :
Requirement s for mardatory irs pect io n hold point s are contained within Dif internal
-procedures.
Ope rat io ns Quality Control Holdpoi nt verification may be waived prov ided prope r autho rizat io n fo r the wa ive r is obt a i ned from the Director O pe ra t io rs Quality Co nt rol or his de s ignee.
All safe ty-related proced ur es are se rt to Ope ra t io ns Quality Cortrol for review so that Ho ldpoi rt s fo r wi t nes s i rg may be i rs e rt ed.
Any revis io ns necessary will follow the same review ard approval cycle as the origi nal.
Question 260.46 -(SRP 17.1.10C3)
Decribe' in more detail those provisions ~ which assure that i rs pect io n result s docu-me nt ed, evalua ted, a nd their acceptability _ determined by a respons ib le irdividual or group.
Response
L Operations Quality-Control Procedures cont ain controls which assure that ins pect io n r es u lt s are docume nt ed, evalua t ed, a ni t he ir ac cep t ab i l i ty de t ermi ned by a res po n-
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sib le individtal or group.
' Question 260.47 (SRP.17.2.10, Item 2)
. Describ'e. the-. provisio ns which assure.that whe n ins pect io ns as sociated with normal operatio ns - of L the plant - (such as~ rout ine mairt enance, surve il la nce, ard tes ts) are
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performed by individuals other than those who performed or directly supervised the work, but are within the same group, the following controls are met:
a.
The quality. of the work can be demo ns tra ted through p funct io nal. tes t wh e n the activity involves breaching a pressure retainirg item.
- b.. The. qualification criteria for inspect ion perso nnel are reviewed ard found
. acceptable by.the QA organization prior to initiating the inspection.
Response
Operations' Quality Control performs all inspect io ns' as sociated with normal opera-t io ns of the pla nt (such as rout ine mairtenance, an! surveilla nce) a rd is i rd epe n-dent of those who performed or directly supervised the work.
Quest ion.260.48 (SRP 17.1.12.2)
Describe in more detail the role of the 'QA arx! other organizations res po ns ib le fo r e s t ab li shi rg,. impleme nt i ng, a ni as sar i rg ef fect ive nes s ard co ns is t e ncy of the calibration program.
Response
The: Operatio ns Quality Assurance. Program i ncludes requi reme nt s fo r the es t ab li sh-me nt, : impleme rt at io n, ard control of the calibration program. This 'is accomplished
.by the issuance ' of ' suit able admi nis trat ive procedures - wh ich de t ail the speci fic program requirement s.
The Senior Instrume nt ard Control (I&C) Calibration Ergineer i s res po ns ib le. fo r impleme nt i rg the I&C calibration program.
The admi ni s trat ive
-procedures control the ' preparat io n, review, ard ap proval cyc le fo r the req ui red calibrat io ns proceduree i nc ludi rg revis io ns.
These procedures are reviewed by the q
onsite safety committee ard approved by the station superi ntenient.
The I&C group ia respons ib le for the performance ' of the calibrations in accordance with approved procedures.
The calibration result s are summarized fo r ' e ach pr ocedure pe r fo rmed ard are reviewed as directed-by the I&C Supervisor to assure that each calibration h as L bee n prope rly completed, ard that al l ope n i t ems h ave be e n di s pos i t io ned. The Pla nni rg ard Scheduli rg group ide nt ifies the I&C group when calibrations are due usirg frequency information specified in the administrat ive procedures.
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- audits - on - these calibratio n act ivities to assure that all provisions of the Oper-a t io ns Quality As sura nce Program are be i rg ef fect ively impleme nt ed.
Ope ra t io ns Quali ty -- Co nt rol verifies i ns trume nt calibrat io n pe r - proced ur e ho ldpoi rt s a ni general surveillance of the program activities.
Question 260.49 (SRP 17.1.12.3)
Describe.in more det ail the review ani do cume nt ed co ncur re nce of calibratio n control precedures and ' identify the organization responsible for these functions.
Res po nse :
-~ Calibration control. procedures as requi red. fo r impleme nt at io n of the Operatio ns initially prepared by the Architect Ergi neer ani/or
. Quality Assurance Program are DLC.
All calibration procedures receive an internal review ani concurrence by the Duquesne Light Ins trume nt an! Control (I&C) group.
After resolut io n of comment s
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ge nerated by this I&C group review, the fi nal proced ur es are submi t ted to the Onsite Safety Committee (OSC) for their review.
Procedur es found acceptable by the OSC are forwarded to the Station Superi ntenient for his subsequent ap pr ov al.
Rev i-sio ns to these procedures follow the same review ani approval cycle as de sc ribed for the original calibration procedures.
Question 260.50 (SRP 17.1.12.6)
Describe those provisio ns which as sure that the basis of ac cep t i rg calib ratio n equipme nt with an accuracy greater than one-fouth the to le ra nce of the equi pme nt beirg calibrated is docume nt ed ard autho rized by res po ns ib le manageme rt.
Ide nt ify the organization with this authorizat io n.
Res po nse :
Measurity ard test eq uipme nt is normal ly calibrated aga i ns t workirg s t ard a rds havity to lerances not greater than.one-fourth the tolerance of the equipment being c alib rated.
The Nuclear Division has res po ns ibility fo r this act ivity.
When the
- calibration of an item of measurirg ard t es t equipme nt must be pe rfo rmed usi ty a
s taniard whose accuracy is greater than one-fourth the to le ra nce of the equipme nt be irg ca lib rated, the do cume rt at io n as so ci ated with each such calib rat io n is reviewed ard approved by designated personnel from the Nuclear Division knowledge-able in ' ins trument atio n ani control act ivities includi rg ~docume nt i rg the bas is fo r de t ermi ni rg : this pos i t io n.
Question 260.51 (SRP 17.1.12.9)
Describe those prov is io ns which as sure that fo r those items under suspect because they may have be e r. c.11b r a t ed by out of calibratio n devices that they will be r ei ns pec t ed o r ret es t ed as de t e rmi ned by pe rso nnel knowled ge ab le i n e rg i neeri rg a ni calibrating practices.
L Res po nse :
The Ope rat io ns Quality As sura nce Program i nc lude s req ui reme nt s that ap ply to me asuri rg a ni test equipme nt found out of calibration.
Speci fic al ly, the validity
of previous ins pect io ns pe rfo rmed ard the ac cept ab i li ty of items i m pect ed or tested. si nce the last calibration is inves t igat ed a nd evalua t ed by pe rso nnel knowledge ab le in engineeri rg a rd calibratio n pract ices to de t ermi ne the need fo r rei ns pect io n.
Question 260.52 (SRP 17.2.13, Item 2)
Describe those provi s io ns fo r the co nt rol and s to rage of chemicals, reage nt s (including control of shelf life), lubrica nt s, ard other consumable materials.
Respo nse:
Duquesne Light Company (DLC) Stores Department Procedures cont ain the req ui reme nt s fo r s to rage i ns pect io ns, exami nat io ns a rd mat eri al h is to ry records. Ma ru fact ur er's i ns truct io ns or ma nuals,
e rgi neeri rg s peci fic a t io ns and gove r ni ng pr oced ur es establish the frequency and extent of storage checks.
Question 260.53 (SRP 17.1.14.3)
Describe those provis io ns wh ich as sure that proced ures are es t ab li shed to control alt eri rg the seque nce of requi r ed t es t s ard i ns pect io ns.
Such act io ns should be subject to the same controls as the original review and approval.
Res po nse :
Durirg normal pla nt ope ratio ns, the test orga niz a t io n is requi r ed to revi ew ard approve test procedures and changes there to.
Question 260.54 (SRP 17.1.15.1 and 17.1.15.2)
Describe those provis io ns which as sure thet QA ard other orga nizatio nal res po ns-ibilities are described for the definition ard implement ation of act ivities rela t ed to no nco nfo rua nce co nt rol.
This inc ludes ide nt ifyi rg those irdividuals or groups with aut ho ri ty fo r i rdepe nde nt review ard fo r the di s pos i t io n of no nco nfo rmi rg items.
Res po nse :
Operations Quality Control (OQC) procedures cont ain the controls for processing of No nconfo rma nce Corrective Act io n Report s (NC ARs).
OQC is res po rs ib le fo r ma i n-t aini rg the of ficial file of NCARs.
The Supe ri nt e rde nt or Sect io n Supe rviso r res po ns ib ic fo r the area in wh ich a non-c o nfo rma nce exists is res po ns ib le for comple t io n of the Co rrect ive Act io n Sect io t' of the repo rt ard fo r i ni t ist i rg disposition of the correct ive ac t io n.
The correct ive act io n is revi ewed by the Director of OQC fo r accept abi 1i ty ard ide nt ifi(d as either unique or ge neric in nature. When correct ive action is found to be acceptable by OQC the NCAR is closed and signed of f.
If correct ive actio n is not acceptab le the NCAR is resubmitted.
The Of f-Site Review Committee reviews OQC NCARs in the capacity of an irdeperdent
. reviewer.
Question 260.55- (SRP 17.1.15.5)
Describe those provisiors which assure that nonconformance report s are periodically nalyzed by the QA organization to show quality trenis, and the significant res ult s a
- are report ed to uppe r ma nageme nt fo r revi ew a ni as ses sme et.
Briefly describe the-quality trend program.
~
Respo nse :
Operations-Quality Cortrol (0QC) procedures contain the co nt rols fo r tr e rrii rg of Nonconformance Correct ive Act ion Report s (NCARs) a nd the report irg of these trenis to upper management on a periodic basis.
The procedure eleme nt s cors is t of NCAR review, measure of correct ive act io n ef feet ive nes s, r ecomme nia t io rs fo r ch a rge a rd ide nt ificatio n of any trenis' in nonco nfo rmi'rg co ndi t io ns.
The QA Depa rtme nt
-. performs ~ audits nonconformances ard corrective actions.
Question 260.56 (SRP 17.1.16.1 and 17.1.16.2)
Describe the QA organizatio n res po ns ibili ties in the review a ni co ncur re nce of procedures contro11i rg the correct ive act io n program arri. the ext e rt they are involved in concurring with the adequacy of documented corrective actions.
Respo nse :
The QA Department review Operations Quality Cortrol (OQC) Administrative Procedures armi audits the Nonconformance and Corrective Action Program.
Refer : to. Ques t io n 260.54, Revised Res po ns e, fo r sys t emat ic proces s i rg of No ncon-formance Corrective Action Reports (NCARs).
. Question 260.57 (SRP 17.1.16.3)
Describe -' those provisio ns which as sure that fo llowu p act io n is take n by the QA organization. to verify proper implement atio n of correct ive act io n arti to close out the corrective action in a timely manner.
Resp <
t The area of nonconformances a rti correct ive act io rs are audited to ensure close out in a timely manner.
Refe r to Questio n 260.54, Revised REspo nse, fo r sys temat ic pr oces s i rg of No ncon-formance Corrective Action Reports (NCARs).
If the nature of' the Nonconfomance Report warrant s an inspect io n, OQC perfonns the i rs pect io n to de t enni ne ef fect ive nes s - of the correct ive act io n.
In situatiors requiring rework or repair of a nonconforming item, the inspect io n metMd employed
'shall be the same - as that empi syed at the time the origi nal no nco nfo nna nce was ide rt if ied.
If it is impractical to employ the origi nal i ns pect io n method, a suitable alternate method is selected.
Question 260.58 (SRP 17.1.16.4)
Describe those pr ov is io ns which assure that signi f ica nt co rd i t io m ad ve rs e to q ua li ty, the cause of the co rdi t io m, a nd the correct ive act io n t ake n to pr ec lude r epet it io n are do cume nt ed a ni report ed to immediate manageme nt ani uppe r levels of ma nageme nt for review and assessment.
Respo nse :
The Quality As sur a nce Depa rt me nt ide nt ifies signi f ica nt co rdi t io m ad ve rs e to quality through audits, report s, ard Correct ive act ion Report s.
These report s are s e nt to the i rdividual res po ns ib le fo r the area in Aich the coniition adverse to q uali ty was ide nt if ied.
The reci pi e nt of the repo rt is requi red te state the act io n(s) t ake n to correct the de ficiency and the correct ive act io n t ake n to Quality Assurance as sesses the ef fect ive nes s of the correct ive pr eve nt recur re nce.
act io n t ake n.
The Of f-Site Review Committee reviews and as ses ses the significa nce of findings on a periodic basis.
Question 260.59 (SRP 17.1.17.2)
Ide nt ify the QA ard other organizat io ns ani describe their res po ns ibilities fo r the definition ard implementation of activities related to QA records.
Res po nse :
Both the QA Department ard the Nuclear Support Services Departme rt have res po m-are ide nt i fi ed in the Nuc lear Support ibilit ies for QA records.
Res po ns ibili t ies Service Department Administrative Procedures and QA Department Procedures.
Question 260.60 (SRP 17.1.17.3)
Describe those prov is io ns wh ich as sur e that the date of i m pe ct io n or t es t is recorded on the inspection ard test record.
Res po nse :
The Operation Quality Assurance Program requires that i ns pect io n ard t es t record s identify the date of inspection or test.
Question 260.61 (SRP 17.1.18A2)
Describe those pr ov i s io ns wh ich as sur e that an audit plan is pr epa red id e nt ifyi rg audits to be performed, their frequencies ard schedules.
Respo nse :
QA i ns truct io ns describe the sch eduli rg a nd pla nni rg of audits.
The i m truct io m include requirements for the review, approval, ard updati rg of audit schedules.
Question 260.62 Relative to structural modificatio m or repairs to Beaver Valley -Unit 2 duri rg the operations phase provide a clearer commitment to comply with Regulatory Guide 1.94, Itevision 1 in Table 1.8-1 of Chapter 1.8 of the FSAR.
' Respo nse :
Nuclear Engineerirs Management Procedures require incorporation ard verification of FSAR 'a ni Regulatory commitme nt s i nto design modification document s thus e ns uri rg compliance to any Regulatory Guide commitments.
Question 260.63 In Tab le 1.8-1. under Regulatory Guide 1.144 it-is stated than an evaluation of suppliers will be pe rfo rmed at le as t o nce eve ry 18 mo nt hs i ns t ead of 'every 12 justif ica t io'n fo r this alt er nat ive or revise the stat eme nt to mo nt hs.
Provide a meet the 12 month requirement.
Res ponse :
QA will evaluate suppliers once every 12 months.
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ATTACHMENT 2 i
DUQUESNE LIGilT COMPANY QUALITY ASSURANCE POLICY a
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I Duquanne Light Company Quality Asstrance Policy
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TABLE OF. CONTENTS Introduction and Letter of Promulgation Page I Organization Section 1 Quality Assurance Program Section 2 Design Control Section 3 Procurement Document Control Section 4 Instructions, Procedure. and Drawings Section 5 Document Control Section 6 Control of Purchased Material, Equipment and Services Section 7 Identification and Control of Materials, Parts, and Components Section 8 Control of Special Processes Section 9 Inspection Section 10 Test Control Section 11 Control o'f Measuring and Test Equipment Section 12 Handling, Storage, and Shipping Section 13 Inspection, Test, and Operating Status Section 14 Nonconforming Materials, Parts, or Components Section 15 Corrective Action Section 16 Quality Assurance Records Section 17 Audits Section 18 i
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- t INTRODUCTION AND LETTCR OF' PROMULGATION
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s Duquesne Light Company shall institute a corporate quality assurance program that establishes the quality criteria to be followed by the Company and its architect-engineers,
-contractors, and vendors during the design, procurement, cons truction, testing, and operation of Company nuclear power plants.
This program, to be known as the Duquesne Light Company Quality Ascurance Program, shall meet the requirements of Appendix B to 10 CFR Part 50, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," and shall conform to other applicabic requirements deemed appro-priate by the Company Quality Assurance Manager such as kj' Regulatory Guide 1.28, " Quality Assurance Program Requirements (Design'and Construction)," and Regulatory Guide 1.33,'" Quality Assurance Program Requirements (Operation). "
The Company Quality Assurance Manager is responsible for instituting and managing this Quality Assurance Program.
In this capacity, he is authorized to repo'rt quality problems directly to any level of Company management necessary to ensure corrective action.
Company management shall give full support to main-taining the effectiveness of the Quality Assurance Program and Company personnel shall act in strict accordance with the
, applicable requirements of the Program.
And, compliance with O
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applicable requirements of the Program shall be made a condition of contract for supporting' companies..
The attached'Duquesne Light company Quality Assurance Policy, hereby approved for implementation, states the Company position on the various aspects of quality assurance and thereby establishes the governing principles and framework for the Duquesne Light Company Quality Assurance Program.
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,6tanleyjG. Schaffe Presid nt
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Section 1 ORGANIZATION
1.0 INTRODUCTION
l.0.1 Duquesne Light Company management shall establish an -
organization to develop and implement a corporate quality assurance program for nuclear power plants.
Activities relating to the establishment and execution of the program may be delegated to other organizations.
However, Duquesne Light-Company shall retain the ultimate responsibility for compliance to 10CFP50, Appendix B.
-1.1 POLICY 1.1.1 Quality Assurance 5 unctions shall be performed by persons and organizations with clearly defined authority and responsibilities.
The authority and duties of persons and organizations ~ performing quality assurance functions shall be established and delineated in writing.
Where multiple organizational arrangements exits, the dutics of each organization shall be clearly established.
1.1.2 Persons and organizations performing quality' assurance functions shall have sufficient authority and organiza-tional freedom to idenLify quality problems; to initiate, recommend, or provide solutions.through designated channels and to verify implementation of solutions; and to control further processing, delivery, installation, or operation of a nonconforming item, deficiency or unsatis-factory condition until a proper disposition has been made.
1.1.3 The individual or group assigned the respo,nsibility for checking, auditing, inspecting, or other wise verifying that any activity has been correctly performed shall be independent of the individual or group directly responsible for the performance of that specific activity.
1.1.4 Activities affecting quality shall be defined and docu-mented in applicable procedures, instructions, drawings specifications, directives, policies, and similar documents.
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4 Section 2' QUALITY ASSURANCE-PROGRAM d
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2.0 INTRODUCTION
2.0.1 The Duquesne. Light Company Quality Assurance Program shall provide assurance.that quality programs of Duquesne Light Company, its architect engineer, constructor, vendors /
subvendors, and contractors / subcontractors are implemented to produce specified_ quality and reliability.
The pro-gram shall also be responsive to the applicable AEC quality assurance and regulatory requirements for nuclear power plants.- All activities pertaining to the progr'am i
shall be documented by written policies, procedures, and/or instructions which shall be in effect throughout the life of the plant.
2.1 POLICY 2.1.1 The Duqueste Light Company shall require for its nuclear power plants, a corporate Quality Assurance Program to ensure that the nuclear power plants are designed, erected, operated, and maintained utilizing quality practices to a degree proportionate with each component's contribution to safety, reliability, and economic value.
The program'shall be applied to the design, procurement, manufacturing, construction, installation, preoperational testing, operation and maintenance of structures, systems, and components to the' extent necessary to prevent undue
.' risk to the health and safety of the public.
Th'e application of the program shall be identified in the l2'1.2 safety analysis reports and in the Duquesne Light Company Quality Assurance Program.
2.1.3 The program may be additionally applied to structures, systems, and components not specifically related to safety.
The application of the program to these items will be to an extent consistent with their importance to unit availability, reliability, and maintainability.
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2.1.~ 4 The major organizations participating in the Duquesne Light Company Quality Assurance Program, together with the division of functional responsibility for structures, systems, and components, covered by the program shall be delineated in the appropriate documents.
.2.1.5 Activities affecting quality shall be accomplished under suitably controlled conditions which include, as necessary, the use of appropriate equipment, environmental conditions for accomplishing activities, and assurance that all re-quirements for the given activity have been satisfied.
The requirements for special controls, processes, equip-ment, and skills as well as the verification of quality by inspections and tests shall be identified in detailed procedures and/or instructions.
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'2.1.6-Education and training shall be provided for personnel performitig activities affecting quality.
The objective of the training program shall be to assure that a suitable level of proficiency is achieved and maintained by participating personnel.
2.1.7 Periodically, Duquesne Light Company management shall thoroughly review the status and adequacy of the Duquesne Light Company Quality Assurance Program.
The results of these reviews shall be analyzed to determine the effectiveness of the program.
In a similar manner, the management of, participating organizations shall regularly review the status and adequacy of that part of the Duquesne Light Company Quality Assurance Program which they are executing.
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Section 3 DESIGN CONTROL
3.0 INTRODUCTION
3.0.1 In order to assure that structures, systems, and com-ponents are provided in accordance with design intent, measures shall be established to assure that the applicable specified design requirements such as design bases, regulatory requirements, codes, and standards are correct-ly translated into design documents.
These documents in-clude specifications, drawings, procedures, instructions, and other documents as required.
4 3.1 POLICY 3.1.1 Design control measures shall provide for design analyses involving reactor physics, stress, thermal, hydraulic, and accident considerations; compatibility of materials; accessibility for inservice inspection, maintenance and repair; and the delineation of acceptance criteria for inspections and tests.
Procedures shall also be established for the selection and review of appropriate processes, equipment, parts, and materials that are escential to the safety-related functions of the structures, systems, and components.
3.1.2 Design criteria shall be responsive to the applicable regulatory requirements of the AEC.
Applicable standards and codes including ASME, ANSI, ASTM, etc., shall be specified and included in appropriate design documents.
Where such recognized standards do not exist, practices may be developed which establish necessary controls to assure that design, materials, parts, equipment, and pro-cesses are adequate.
Deviations from specified quality standards or design requirements shall be identified, documented, and controlled.
3.1.3 Design control measures shall be applied as necessary to identify and control design. interfaces.
They shall also be utilized for coordination among participating design organizations for review, approval, issuance, and revision of documents involving design interfaces.
3.1.4 Design control measures shall be applied to verify or check i
the adequacy of the design.
This may be accomplished by the performance of design reviews, use of alternate or simplified calculational methods, or performance of a suitable testing program.
Design reviews shall be con-ducted according to clearly documented procedures.
The verification or checking process shall be performed by technically qualified personnel or groups who did not perform the original design.
Where a design adequacy is to be verified by testing, the testing shall demonstrate the acceptable performance of a prototype unit under the most adverse conditions for which it was designed.
Although 4
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design verification may be assigned td other organizations jin procurement documents, the organization which originated jthe procurement document must retain responsibility for the design.
3.1.5 Procedures shall be established which assure that design changes, including field changes, are' governed by control measures commensurate with those applied to the original design.
Whenever possible, design changes shall be reviewed and approved by organizations that perform the original design review and approval.
When this is not possible, other design organizations may be designated to review and approve the design, provided the designated organizations have demonstrated sufficient competence in the specific design area,.and have a thorough understanding of the t,
requirements and intent of the original design.
Design changes.and their justification shall be documented.
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Section 4 PROCUREMENT DOCUMENT CONTROL
4.0 INTRODUCTION
4.0.1 Controls shall be established to assure that procurement documents include appropriate quality assurance requirements, basic technical requirements, documentation requirements, and control of lower tier subcontractors or supplies.
Procurement documents include the purchase contract and all references and supporting documents.
4.1 POLICY 4.1.1 The procurement documents and subsequent changes shall include, as applicable, references to the appropriate revisions of codes and standards, design drawings, specifications, and regulatory requirements.
All such specific requirements shall be referenced in the pro-curement documents.
4.1.2 The procurement documents shall include provisions for access to the contractor's plant facilities and records for inspection, tests, and audit as required by the Duquesne Light Company Quality Assurance Program.
4.1.3 Quality assurance / control requirements applicable to the items or service to be procured shall be clearly stated in the procurement documents.
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4. 1. 4 The purchase contracts shall require the contractor to impose on subcontractors, quality requirements consistent with the item being procured.
4.1.5 Procurement documents shall identify the r'ecords and documents necessary to provide assurance that quality is achieved and maintained.
These documents may include drawings, specifications, procedures, qualifications, inspection and test records, and material, chemical, and physical test results.
Instructions on record retention and disposition shall be provided.
4.1.6 The requisitioning organization shall review procurement documents to assure that requirements are complete and appropriate.
4.1.7 The procurement documents shall state the control which must exist between the purchaser and vendor in requesting and accepting changes in any of the procurement documents.
Changes in procurement documents, including field modi-fications, shall be subject to the same degree of control as utilized in the preparation of the original documents.
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Section 5 INSTRUCTIONS, PROCEDURES AND DRAWINGS
5.0 INTRODUCTION
5.0.1 Instructions, procedures, and drawings shall be provided as appropriate to prescribe those activities affecting quality.
Among those activities for which instructions, procedures, and drawings may be required are design, procurement, construction, fabrications, testing, operation, and maintenance, 5.1 POLICY-5.1.1 Instructions and procedures shall be established in writing.
These instructions and procedures shall ade-quately describe the scope of the work to be covered by such instructions.
Instructions, procedures, and drawings shall include appropriate quantitative and qualitative criteria for determining satisfactory work performance and quality compliance.
5.1.2 Instructions, procedures, and drawings are considered controlled documents and shall be handled and treated in accordance with appropriate document control measures.-
5.1.3 Work instructions for activities up to final installation or erection shall provide for verification of sequential events.
This includes routing cards, shop travellers, and erection instructions among others.
5.1.4 Instructions for testing shall include identification of the system under test and the sequence in which the test is to be accomplished.
The instructions shall clearly define characteristics to be tested and provide for evidence of acceptability.
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5.1.5 Mandatory hold points, as required, shall be clearly identified in the instructions.
Space shall be provided for entering evidence of acceptability of activity up to that point.
5.1.6 Records maintained shall include as a minimum, identity to material / component / system to allow traceability to the instructions; signature of responsible person (s); date; criteria for acceptance; evidence of satisfactory com-pletion of the event.
5.1.7 Operation and maintenance procedures shall be prepared in accordance with commitments contained in the license, applicable regulatory requirements, and manufacturer's recommendations.
These procedures shall provide a sequen-tial order for accomplishment of events and include re-quirements as necessary for special equipment, acceptance criteria, limits, etc.
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_Section 6 DOCUMENT CONTFOL.
60 INTRODUCTION 6.0.1 Measures'shall be established to control the release, distribution, receipt, utilization, and storage of documents and changes to the documents which affect quality.
Included.in such documents are drawings, speci-
'fications, instructions, and' procedures utilized in the design, manufacturing, installation, testing, inspection, and operation.
6.1 POLICY u6.1.1 Each organication issuing documents which affect quality shall identify a responsible party or parties controlling the release of the documents.
The documents shall be re-viewed for adequacy and appropriate approval for release.
Measures shall be taken to assure that documents are distributed to the' prescribed location where the activity is performed.
6.1.2 Organizations receiving documents which affect quality shall control the receipt and distribution of the current revisions of the documents.
This control chall alsc be applied to the disposition of the obsolete documents.
6.1.3 Measures shall be taken to assure that the current revision of documents are available at the location where the activities prescribed by such documents are performed.
Those persons responsible for an activity shall be made aware of and must use the proper instructions, procedures, and drawings necessary for the performance of that activity.
Measures shall be established to assure that incorrect or superseded documents are identified and removed from the areas of use.
6.1.4 Those documents which are identified as quality assurance records shall be handled in such a manner as to minimize damage and preserve the clarity.
Documents which have been revised shall be stored in a manner which allows easy and positive identification.
The filing technique shall provide ready retrievability of the document.
.6.1.5 Document changes shall be subject to controls equivalent to those applied to the original documents.
Changes shall be reviewed and approved by the same organization that performed the original review and approval unless other responsible organizations are specifically designated.
The reviewing organization shall have an adequate understanding of the requirements and intent of the original documents.
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I.
'Section 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES
7.0 INTRODUCTION
7.0.1 Measures shall be established and documented to assure that purchased material, equipment, and services, whether, purchased directly or through contractors, conform to the-procurement documents. -As appropriate, the measures shall include-provisions for contractor / subcontractor evaluation and selections, objective evidence of quality,
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inspection and/or audit at the source, and receiving in-spection when delivered.
s at 7.1 POLICY 7.1.1 Vendors / contractors shall be chosen on the basis'of.
demonstrated ability to provide a service, material, or equipment required by the procurement' document.
In the absence of records or other valid information pertaining to a' vendor / contractor's quality performance; a survey of the vendor / contractor's qualifications is made.
Surveys performed for this purpose shall'be recorded and mcintained.
7.1.2 Prior to the awar'd of the order, the_ bidder's quality
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performance or program shall be analyzed in' relation to the
'S" product, process, or service being procured.
i 7.1.,3 The vendor / contractor shall have an appropriate quality program which includes measures for assuring conforman'ce with the requirements of the proccrement documents and any special instructions.
Such programs shall also pro-vide necessary documentation to render objective evidence that quality requirements imposed by the procurement s
documents have been satisfied.
7.1.4 Source inspections and/or audits shall be performed as required, to assure the specified quality of the item..
The need and type of inspections or audits shall be deternined by the importance and the complexity of the
. item and its contribution to the safety'a,spects.
7.1.5 Material or equipment procured from vendors shall be in-spected upon delivery.
The characteristics which shall be assessed at such inspections include, damage during shipment, correctness of the material or equipment, and traceability and conformance to the requirements of the procurement documents.
7.1'. 6 Applicable requirements of this Policy shall be similarly imposed by the vendors / contractors on any of their sub-vendors / subcontractors.
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f 7.1.7-Documents containing objective. evidence furnished-in compliance with procurement documents for certain
.r materials and equipment shall be classified as permanent i,..
0A records, and as such shall be filed at the plant cite.
Temporary storage off site may be provided for by writt'en authorization during the construction stages of the plant.
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S ction 8 IDENTIFICAT. ION OF MATERIALS, PARTS, AND COMPONENTS
8.0 INTRODUCTION
8.0.1 Measures for the identification and control of materials, parts, and components including partial fabrications shall be established.
They shall be designed to prevent use of incorrect or defective material, parts, or components and to assure traceability of items at any stage from initial receipt through and including final.
8.1 POLICY 8.1.1 Materials, parts, and components shall be adequately identified to assure traceability to pertinent quality documents.
Permanent physical identification shall be used wherever practicable.
Physical separation, ad-ministsttive controls, or other appropriate measures may
_g be employed when necessary, as an alternate means of control.
8.1.2 Identification shall be maintaf.ned on the item or on re-cords traceable to the item or both as appropriate.
Markings must be clear and indelible and applied in such a manner as not to affect the function of the item.
8.1.3 Identity of materials, parts, and components shall be maintained during manufacturing, fabrication, installation, operation, and maintenance.
Partial fabrications in-corperated into an assembly shall have their identifications recorded to provide for traceability.
8.1.4 Items which have inadequate or incomplete quality control documentation or which cannot be acceptable repaired shall be uniquely identified.
Those items lacking documentation shall be identified and controlled in a manner which prevents their inadvertent When items are determined to be beyond repair, identi-use.
fication and when possible physical segregation shall be provided to assure their separation from acceptable items.
8.1.5 The program shall provide traceability of material, parts, and components to specific inspection and/or test records, as required by applicable codes, standards or specifications.
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S:ction 9 CONTROL OF SPECIAL PROCESSES 9.0' INTRODUCTION 9.0.1 Formal procedures and instructions shall be established for the performance and control of special processes.
Personnel, procedures, and equipment involved in special' processes shall be qualified and certified as necessary
.to applicable codes, standards, specifications, or other special requirements.
9.1 POLICY 9.1.1 Controll.ed written procedures and instructions shall govern special processes utilized in the fabrication and erection of materials and components.
The controls shall apply to processes perforned at the plant site as well as in vendor shops.
The procedures shall identify equipment, preparation, operating parameters, processing details, and other information required for the process.
9.1.2 Included as special processes are the nondestructive examination techniques.
These are radiography, ultrasonic, liquid penetrant, magnetic particle, and eddy current examinations when such are required by procurement documents.
9.1.3 Personnel responsible for the performance of special processes shall be trained, tested, and certified as de-fined in the applicable codes, standards, specifications, or procurement documents.
9.1.4 Records shall be maintained for qualified personnel, pro-cesses, and equipment on a current basis.
The parameters and results of procedure and personnel qualification tests shall be recorded and maintained.
Objective evidence that special processes were performed by qualified personnel to qualified procedures shall be maintained in the documentation file.
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Ssetion 10 INSPECTION 1 0. 0 INTRODUCTION 10.0.1 A program for the inspection of activities affecting quality shall be es, tab 11shed.
The program shall provide for inspections during manufacturing, receiving, storing, handling, installing, preparing for operations, opera-tions, repair, maintenance, and modification.
10.1 POLICY 10.'l.1 Persons responsible for inspection shall be independent of those persons performing the activity or those ner-sons having the responsibility for the accomplishment of the activity.
10.1.2 Examinations, measurements, or tests of itema shall be performed for each work operation where it is necessary to assure quality.
Characteristics for inspection and criteria for acceptance shall be defined in procedures, specifications, manufacturer's special instructions, codes, standards, and drawings.
10.1.3 Appropriate mandatory hcid points required by speci-fication or other instructions shall be clearly identified in the appropriate documents.
Activity may not proceed beyond mandatory hold points without Duquesne Light Company (or agent) participation or documented approval.
10.1.4 In-service inspection of completed system, structures, and components shall be performed by or for Duquesne Light Company in accordance with applicable Technical Specification and ASME Code requirements.
Inspection of repairs and routine inspections during operation and maintenance of the plant shall be performed in accord-ance with approved procedures and instructions.
10.1.5 Inspection procedures shall specify, as appropriate, the method by which an inspection shall be performed, the characteristics to be inspected, and acceptance criteria, as a minimum.
10.1.6 Records shall be maintained describing the results of inspections and verifying that inspections were per-formed in compliance with approved procedures.
10.1.7 Inspection and process monitoring both shall be provided when control is inadequate without both.
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Section 11 TEST CONTROL
11.0 INTRODUCTION
11.0.1 A suitable testing program shall be established to assure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and documented.
The program shall assure that the testing is performed in accordance with written test procedures incorpor-ating or referencing requirements and acceptance limits contained in the applicable design documents.
11.1 POLICY 11.1.1 The test program shall encompass all required testing, such as prototype testing, proof and acceptance up to final installation, preoperational testing, and operational tests.
11.1.2 Test procedures shall. include specific instructions establishing all prerequisites for a given test.
11.1.3 All testing shall be performed by competent personnel using calibrated instrumentation and appropriate equip-l ment and tools, in accordance with the requirements of the test procedure.
11.1.4 'The test procedures shall identify and clearly describe testing techniques or the method by which the test must be performed.
They shall also include the speci-fication or reference of test criteria which must be satisfied, acceptance criteria, and requirements for documentation.
11.1.5 Prerequisites to the tests, results of the tests, and other supporting data shall be documented and main-tained in the plant files.
Review and evaluation of test results shall assure satisfaction of test re-quirements.
The records shall provide evidence that testing was performed in accordance with approved procedures.
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eL-L%9AM'2Rs CONTROL OF MEASURING AND TEST EOUIPMENT
12.0 INTRODUCTION
12.0.1 Controls shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are pro-perly controlled, calibrated, and adjusted with a schedule frequency adequate to assure'that accuracy is maintained within necessary limits.
These measures shall apply to measuring and testing devices used in vendor shops as well as those used at the nuclear power plant site.
12.1 POLICY 12.1.1 Measurement and test equipment shall be adjusted and caliorated at established intervals against certified standards which have known valid relationships to national standards.
If, in some cases, no national standards exist, the basis for calibration shall be defined and documentede 12.1.2 The method and interval of calibration for each item shall,be defined.
Factors affecting the method and
-interval of calibration include; type of equipment, required accuracy, frequency of utilization, conditions under which equipment is used, and other circumstances affecting the required accuracy.
12.1.3 Special calibration outside the normal intervals shall be performed if the accuracy of an item is suspect.
-When measuring and testing equipment is found to be out of calibration, an evaluation shall be made and documented of the validity of previous inspections, test results, and acceptability of items previously inspected or tested with such equ-pment.
Measuring or testing equipment found consistently to be out of calibration shall be repaired or replaced.
~12.1.4 Measuring and testing equipment shall_be identified to allow traceability to the appropriate records.
In addition, tags, decals, or other suitable identification shall be affixed to such equipment indicating, as a minimum,-date of calibration and date next calibratica is due.-
This traceability shall provide a basis for recall for the purpose of recalibration or adjustment.
12.1.5 Records shall be maintained of measurement and testing devices which require calibration and recalibration.
The records shall identify the piece of equipment and show the dates of calibration, maintenance, and repairs.
12.1.6 Measuring and testing equipment used in implementation of test procedures shall be identified to provide 15
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0 12.1.6 (Continued) traceability in the event of questions regarding the validity of equipment calibration.
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S ction 13 HANDLING, STORAGE, AND SilIPPING 13.0 INTRODUC' ION 13.0.1 Measures shall be established to control the handling, storage, and shipping of material and equipment ir.
accordance with work and inspection instructions to prevent damage, deterioration, or loss.
These measures shall include the control of cleaning, packaging, and preservation of material and equipment.
13.1 POLICY 13.1.1 Adequate handling devices shall be utilized during the fabrication, construction, and installation of materials, parts components, or assemblies.
13.1.2 The handling of critical items or items of unusual size or shape shall be acccmplished according to specific written procedures.
Srecial handling tools, equipment, and instructions shall be provided and controlled as necessary to ensure safe and adequate handling.
Special handling tools and equipment shall be inspected and tested at specified times in accordance with written procedures.
13.1.3 The storage of equipment and material shall be con-trolled to prevent deterioration.
Storage instructions shall provide for protective measures, preventive maintenance, periodic inspection, and future handling,.
13.1.4 Written instructions shall 1:e provided for the pre-servation of items which may be subject.to deterior-ation or damage through exposure to the environment during storage or shipping.
When necessary for parti-cular items, special protective environments such as inert gas atmosphere, desiccants and controlled temper-ature IcVels shall be specified and provided.
E>.is tence and adequacy of such protective environments shall be periodically verified.
13.1.5 Special provisions shall be made to control the trans-portation of items which are susceptible to shipping damage or items which might cause risk to the general public if such damage should occur.
The shipping of such items shall be controlled by written procedures and all such items shall be clearly marked to denote special handling.
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Section 14 INSPECTIOU, TEST, AND OPERATING STATUS
14.0 INTRODUCTION
14.0.1 Measures shall be established to indicate the in-spection and test status of material, parts, components, and assemblics throughout manufacturing, installation, testing, and operation.
The measures sl.all include provision for identification of those items which have satisfactorily passed required inspections and tests.
Measures shall also be established for indicating the oeprating status of structures, systems, and components, to prevent inadvertent operation.
34.1 POLICY 14.1.1 Inspection and test status shall be indicated by the use of stickers, tags, labels, equipment record cards, check-off lists, records traceable to the item, or other appropriate means.
Status indicators which are attached to the item, such as tags or labels, shall be securely fastened.
14.1.2 The operating status of plant equipment shall be indi-cated by records, checklists, and/or tags, including the use of Duquesne Light Company tagging and clearance procedures.
14.1.3 Controlled stamps may be used to identify status.
The organization utilizing such stamps shall be responsible for maintenance of records involving their issuance and use.
14.1.4 Identification of a permanent nature (etching, low-stress stamps, etc.), shall be applied in accordance with applicable standards, or other requirements.
14.1.5 Status of materi=1s, parts, or components may be identified on records not attached to the item.
- However, the item shall be marked to provide traceability to the records.
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3 S:ction 15 NONCONFORMING MATERIALS, PARTS OR COMPONENTS
15.0 INTRODUCTION
15.0.1 Measures shall be establishad for the control of materials, parts, or components which do not conform to the requirements of applicable drawings, codes, standards, specifications, or other contractual do-cuments, to prevent their inadvertent use or installa-tion.
These measures shall require that identification, documentation, segregation, disposition, and notifica-tion requirements be detailed in written procedures.
15.1 POLICY 15.1.1 Nonconforming items shall be reviewed in order to determine their disposition.
The disposition of a non-conforming item shall be one of the following: accept as is, rework to drawing and/or specification require-ments, repair to an acceptable condition, or reject.
Repaired / reworked items shall be reinspected for com-pliance to requirements in accordance with applicable procedures.
15.1.2 The procedures shall identify the person (s) or group (s) responsible for assigning dispositions to nonconforming items.
15.1.3 Nonconforming items shall be clearly identified by the use of tags, labels, stickers, markings, or other appropriate means.
Nonconforming items shall be physically segregated or controlled in a manner to pre-vent the inadvertent use or installation.
15.1.4. The acceptability of nonconforming items following dis-position and as applicable, repair rework and rein-spection shall be documented.
A description of the change, waiver, or deviat' ion that has been accepted shall be documented to re.ord the change and denote the as-built condition.
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Scction 16 CORRECTIVE ACTION
16.0 INTRODUCTION
16.0.1 Measures shall be establisr.ed to assure that conditions adverse to quality are promptly identified and corrected.
16.1 POLICY 16.1.1 Conditions adverse to quality, such as failures, mal-functions, deficiencies, nonconformances, defective material and equipment, and deviations from specific-ations, drawings, instructions, or procedures shall be identified by means of audits and inspections.
Results of such audits and inspections shall be reported to appropriate management levels.
16.1.2 When necessary, analyses shall be made to determine the causes of conditions adverse to quality and to prevent repetition of such conditions.
Corrective action shall be recommended to the appropriate management.
16.1.3.The effectiveness of the corrective action shall be checked by a follow-up audit.
The report of the follow-up audit and the acceptability of the corrective measures shall be directed to the appropriate levels of management.
16.1.4 Documents shall be maintained which provide objective evidence that conditions adverse to quality have been identified and corrective action has been taken.
The corrective measures recommended, and the results of the implementation of the corrective measures, shall be documented.
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S cticn 17 QUALITY ASSURANCE RECORDS
17.0 INTRODUCTION
17.0.1 Sufficient records shall bn maintained to furnish documentary evidence of the quality of items and activities affecting quality.
17.1 POLICY 17.1.1 Quality Assurance records required by applicable codes, standards, specifications, and contracts, shall be re-tained and maintained in accordance with documented procedures.
The records shall be compiled, handled, and retained in such a manner as to facilitate identi-fication and retrievability.
17.1.2 Quality Assurance records shall include but are not limited to: the results of reviews, inspections, tests, audits, monitoring of work performance; materials analyses; operating logs; documented qualification of personnel, procedures, and equipment; and other do-cumentation required by the quality assurance program.
17.1.3 Inspection and test records shall identify the date of the inspection or test, the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted.
1.7.1.4 Records shall be accumulated, transmitted, retained and maintained in accordance with applicable codes, standards, procurement documents, and regulatcry requirements.
17.1.5 Records which identify the "as-built" items in the plant shall be maintained for the life of the plant.
These records include material certification for traceability, and test data for quality verification; reports of inspections, examinations, and tost results which verify conformance of the material, part, or component; specifications, procedures, and instructions applicable to the material, part or component; and re-cords of nonconformances and their resolution.
17.1.6 Quality Assurance records maintained by others shall be transferred to Duquesne Light Company at the conclusion of their efforts.
Where retention periods are stipu-lated by contracts, codes, or standards for those or-ganizations involved, it is that organization's re-sponsibility to maintain such records until the ex-piration of the retention period, at which time Duquesne Light Company shall provide instructions for disposition of the records.
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S:ction 18 AUDITS
18.0 INTRODUCTION
18.0.1 A comprehensive system of planned and documented audits shall be carried out to verify that all aspects of the quality assurance program are implemented and complied with, and to determine the effectiveness of the program.
18.1 POLICY 18.1.1 Audits shall be performed:
18.1.1.1 To determine the adequacy of the quality assurance program of a potential contractor /
subcontract prior to the awarding of a contract or urchase order; 18.1.1.2 To determine the adequacy of its implementation by a contractor / subcontractor; 18.1.1.3 To provide an objective evaluation of com-pliance with established requirements, methods, and procedures; 18.1.1.4 To assess progress in assigned tasks; 18.1.1.5 To verify the implementation of recommended corrective action.
18.1.2 Audits shall be conducted periodically or on a random basis, or both.
The frequency of audits shall be based upon the importance, quantity, and complexity of the work being performed by the organization; the schedule of work accomplishment; the results of previous audits; and the severity of reported nonconformances.
Each audit shall be scheduled in cooperation with the or-ganization being audited.
18.1.3 Audits shall be performed in accordance with written procedures or checklists by appropriately trained per-sonnel who do not have direct responsibilities in the areas being audited.
The written procedures or check-lists shall identify the characteristics to be verified and provide a minimum basis for performing the audit.
18.1.4 The results of the audit shall be documented and re-ported formally to management.
The documented audit results shall be reviewed by management having re-sponsibility in the area audited.
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ganization, and the general areas dr items audited.
The reports shall detail specific deficiencies that have been observed, with reconmendations for corrective action to be taken.
When necessary, the audit report shall establish a date by which written response is required from the appropriate managerial level.
This response shall contain a scheduled commitment for corrective action or justification of why corrective action is not to be taken.
18.1.6 When recommendations and corrective actions have been assigned following an audit, a follow-up audit shall be performed to ascertain that these corrective measures have been implemented, and to determine their effect-iveness.
The results of such follow-up action shall also be reported to management, including thoce having responsibility in the area auditef.
18.1.7 Records of all audits chall be maintained, including the checklists used and the resulting audit re orts.
These records shall be utilized by management to provide a means for analyzing and evaluating the effectiveness of the quality assurance program.
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