Republic of Turkey Prime Ministry Atomic Energy Commission
T. C. BAŞBAKANLIK A TO M ENERJİSİ K O M İS YO N U
GQDE OF P R A C T IC E
ON
QUALITY ASSURANCE
FOR SAFETY IN
NUCLEAR
POWER PLANTS
GÜVENLİK YÖNETMELİSİ
NÜKLEER GÜÇ SANTRALLARINDA
GÜVENLİK İÇİN
KALİTE TEMİNİ
NGY 6
A R A L IK 1978Republic of Turkey Prime Ministry Atomic Energy Commission
T. C BAŞBAKANLIK ATO M ENERJİSİ K O M İS YO N U
COD E OF P R A C T IC E
ON
QUALITY ASSURANCE
FOR SAFETY IN
NUCLEAR POWER PLANTS
GÜVENLİK YÖNETMELİĞİ
NÜKLEER GÜÇ SANTRALLARINDA
GÜVENLİK İÇİN
KALİTE TEMİNİ
NGY 6
A R A L I K 1978i
-Bu g ü v e n lik y ö n e tm e liğ i'n d e k u lla n ıla n ''R egu la tory Body" t e r im i i l e Atom ^ h e r j i s i Komisyonu, "R esp on sible O rg a n iz a tio n " i l e de T ü rk iye E le k t r ik Kurumu tanım lanm aktadır.
YORUM
İ n g i l i z c e m e tin *in yorumunda h e rh in g i b i r f i k i r a y r ı l ı ğ ı olm a sı durumunda, AEK ta ra fın d a n y a p ıla n ^orum g e ç e r l i o la c a k t ır .
i i
1 . INTRODUCTION 1 .1 GENERAL
1 .2 . SCOPE
1 . 3 . R E S P O N S IB IL IT Y
2. QUALITY ASSURANCE PROGRAMMES 2 .1 . GENERAL
2 .2 . PROCEDURES, INSTRUCTIONS AND DRAWINGS 2 .3 . MANAGEMENT REVIEW
3. ORGANIZATION
3 .1 . RESPONSIBILITY, AUTHORITY AND COMMUNICATIONS 3 .2 . ORGANIZATIONAL INTERFACES
3 .3 . STAFFING AND TRAINING
4. DOCUMENT CONTROL
4 .1 . DOCUMENT PREPARATION, REVIEW AND APPROVAL 4 .2 . DOCUMENT RELEASE AND DISTRIBUTION
4 .3 . DOCUMENT CHANGE CONTROL
5. DESIGN CONTROL 5 .1 . GENERAL
5 .2 . DESIGN INTERFACE CONTROL 5 .3 . DESIGN VERIFICATION 5 .4 . DESIGN CHANGES 6. PROCUREMENT CONTROL 6 .1 . GENERAL
6 . a . SU PPLIER EVALUATION AND SELECTION
MATERIAL CONTROL 7.
7 . 1 . . IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS
7 .2 . HANDLING, STORAGE AND SHIPPING
8 . PROCESS CONTROL
9. INSPECTION AND TEST CONTROL 9 .1 . PROGRAMME OF INSPECTION 9 .2 . TEST PROGRAMME
9 .3 . CALIBRATION AND CONTROL OF MEASURING AND TEST EQUIPMENT 9 . ^ . INDICATION OF INSTALLATION, TEST AND OPERATING STATUS
10. NON-CONFORMANCE CONTROL 1 0.1. GENERAL
1 0 .2 . NON-CONFORMANCE REVIEW AND DISPOSITION
11. CORRECTIVE ACTIONS
22. RECORDS
1 2 .1 . QUALITY ASSURANCE RECORDS PREPARATION
1 2 .2 . QUALITY ASSURANCE RECORDS COLLECTION, STOBAGI AND PRESERVATION
13. AUDITS 1 3 .1 . GENERAL 1 3 .2 . SCHEDULING
1 . IMTBPPOCTIOM 1.1* OSTiSAL
This document provides the p rin cip les and object Ives to he adopted as regards s a fe ty when esta b lish in g both a s a tis fa c to ry o v e r a ll quality assurance programme fo r a nuclear power plant, and also separate qu ality assurance programmes fo r each o f the constituent areas o f a c t iv it y
(e*g* design , manufacturing, construction, commissioning, o p e ra tio n ). The principles to be follow ed in each case, fo r each type of'programme, are the same*
The establishm ent and istplassentation o f & q u a lity assurance
progra&ae fo r a nuclear power plant i s ess en tia l * Be .ever, i t s h a ll always ha recognised th at th e b asic re s p o n s ib ility fo r achieving q u a lity in p « N form ing * p a rtic u la r task (e *g * in design, in manufacturing, in o om U slon in gf in o p e ra tio n ), belongs with those assigned th e task sad so t w ith those seeking to assure by means o f v e r ific a t io n th at i t has been achieved*
Quality assurance i s an essen tia l aspect o f '’’ good management" * Good management contributes to the achievement o f q u a lity through thorough analysis o f the teaks to be performed, id e n t ific a t io n o f th e s k ills required, the selection and train in g o f appropriate personnel, th e us a o f appropriate equipsent, the creation o f a s a tis fa c to ry environment in which a ctiv ity can be performed and, as already noted, a recogn ition o f the re s p o n s ib ility o f the individual who i s to perform tn e task* B r ie fly sta ted , then, a quality assurance programa ah ali provid e fo r a d is c ip lin e d approach to a ll activ i t ie s a ffectin g qu ality, in clu d in g, where appropriate, v e r ific a t io n that each task has been sa tis fa c to rily performed and th at necessary corrective actions have been ispleaented* I t s h a ll also provide fo r production o f documentary evidence to demonstrate th at the requ ired q u a lity has been achieved*
The manner in which th e p rin c ip le s described in th is document are implemented both at th e o v e ra ll plant le v e l, and at the constituent ac tiv ity le v e ls , w ill va ry from country to country and organ isation to organisation* These v a ria tio n s w ill ba due to such considerations as
regu la tory requirem ents, the general organ ization o f indu stry, and the degree o f so p h istica tio n and experience o f the tech n ical organ izations in volved in p rovid in g and op eratin g the nuclear power plan t* In any event, the b a sic in ten t o f th e p rin c ip le s s h a ll be kept in mind at a ll tim es and the d e ta ile d implem entations! procedures s h a ll be arranged accordin gly* 1 .2 . SCOPE
This document provides the p rin cip les and o b je c tiv e s fo r the establishment and implementation o f a q u a lity assurance programme during design, manufacture, constru ction , commissioning and operation o f
structures, systems and components important to sa fety * They apply to a c t i v i t i e s a ffe c tin g q u a lity o f item s, such as designing, purchasing, fa b ric a tin g , manufacturing, handling, shipping, s to rin g , cleaning,
erectin g , in s ta llin g , te s tin g , commissioning, operatin g, in sp ectin g, main ta in in g , re p a irin g , r e fu e llin g , m odifying and decommissioning. They are applicable by a l l those responsible fo r the power p la n t, by plant
designers, su p p liers, a rc h ite c t—engineers, plant constructors, plant oper atöre and oth er organ izations p a rtic ip a tin g in a c t iv it ie s a ffe c tin g q u a lity * 1*3* HESFONSIBILITT
la i t s re s p o n s ib ility to assure the health and s a fe ty o f the p u b lic, the Government o f the IAEA Member State should have establish ed a gen eral, le g a l framework (see Code o f P ra c tic e on Governmental O rganization fo r th e R egulation o f Nuclear Power P la n ts )* W ithin th is framework should be the requirement th at an e ffe c t iv e , o v e ra ll q u a lity assurance programme be estab lish ed *
The organ ization having o v e ra ll re s p o n s ib ility fo r a nuclear power plant s h a ll also be responsible fo r the establishment and implemen ta tio n o f th e o v e r a ll q u a lity assurance programme fo r the complete plant* This orga n ization may d elega te to oth er organ izations the work o f
esta b lish in g and implementing a l l , o r a p a rt, o f the programme but sh a ll re ta in re s p o n s ib ility fo r the e ffe c tiv e n e s s o f the o v e ra ll programme, without p reju d ice to the contractors* o b liga tio n s and/or le g a l responsi b i l i t i e s *
~ 3
-2» QUALITY ASSORAKCB PBQSRAMK^S
2 *1» CH3HERAL
An o verall quality assurance programs sh a ll be established con sistent with the requirement o contained in tid e Coda o f Practice as an in tegral part o f the nuclear power plant project» The overall programe s h a ll provide fo r oontrol o f the constituent a c t iv it ie s associated with a nuclear power plantt such as design, construction and op eration » The control o f each constituent activity sh all also be consistent with th is Cods o f Practioe#
Management in the o verall and constituent arm s o f activ ity sh all provide fo r effective implementation o f the q u a lity assurance programmes consistent with the time achedules fo r accomplishing project a c t iv it ie s , including the procurement o f materials £or long-delivery items*
A ll programmes sh a ll define the organ! sa&ionil structure within iMcsh the qu ality assurance a c tiv itie s are to bo plesasâ a»sd implemented and sh a ll d e a r ly delineate the respon sibility and authority o f the various personnel and organisations involved»
The establishment o f the programmes a h d i include consideration ©? the technical aspects o f the a c tiv itie s to bs perfomed» The pro grammas s h a ll contain provisions to assure iden tification o f, oo»pliaaoe with, rmsuirements o f appropria te reoognized engineering codes, standards, speci fic a tio n * and practices»
Items, ssrvioss and processes to which the quality assuranos programmes w ill apply sh all be id en tified * Appropriate methods or le v d s o f oontrol and v e rific a tio n sh all be assigned to those items, services and processes* A ll programmes sh a ll provide control anâ v e rific a tio n over a c tiv itie s a ffectin g the qu ality o f the id en tified lie s * to an extent con sistent with th e ir importance to safety»
A ll pro greases sh e ll provide suitably co n trolled conditions fo r the accomplishment o f a c tiv itie s affectin g quality* This includes
appropriate environmental conditions, appropriate equipmant and s k ills to attain the required quality*
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-A ll programmes sh a ll provide fo r tra in in g o f personnel perform ing a c t iv it ie s a ffe c tin g qu ality#
A ll programmes s h a ll he subject to regu lar evaluation and updating# A ll programmes sh a ll s ta te the languages used fo r documentation# Measures s h a ll be estab lish ed to assure that persons performing the q u a lity
assurance fu nction have adequate knowledge o f th e language in which th e documentation is w ritten# Translations o f the documentation sh a ll be
reviewed by competent persons# V e r ific a tio n o f conformance to the o rig in a l is necessary#
2#2« PROCEDURES, INSTRUCTIONS AND DRAWINGS
A ll programmes s h a ll provide th at th e a c t iv it ie s a ffe c tin g q u a lity are accomplished in accordance with w ritten procedures* in stru ction s o r drawings o f a type appropriate to the circumstances# Instru ctions, pro cedures and drawings sh a ll include appropriate q u an titative and/or q u a li t a t iv e acceptance c r it e r ia fo r determ ining that important a c t iv it ie s have been s a t is fa c t o r ily accomplished#
Procedures fo r implementing the q u a lity assurance programmes on a planned and system atic basis fo r d iffe re n t phases o f the nuclear power p ro je c t s h a ll be developed and documented by th e organ !ration perform ing th e constitu ent a c tiv itie s # The procedures s h a ll be p e r io d ic a lly reviewed and updated as necessary to assure adequate coverage o f those a c tiv itie s # 2# 3# MANAGEMENT REVIEW
A ll programmes s h a ll provide fo r the review at appropriate in te rv a ls by management o f organ izations p a rtic ip a tin g in the programme, o f the status and adequacy o f th e part o f the q u a lity assurance programme fo r vdtich they have designated re sp o n sib ility # C orrective a ction sh a ll be taken «hen the programme d e fic ie n c ie s are discovered#
3# ORGANIZATION
3#1. RESPONSIBILITY, AUTHORITY AND COMMUNICATIONS
A documented orga n ization a l stru ctu re, with c lo - r ly defin ed fu n ction al r e s p o n s ib ilitie s , le v e ls o f au th ority and lin e s o f in te rn a l and extern al communication fo r management, d ire c tio n , and execution o f th e
5
-q u a lity assurance programae s h a ll be established* Tb© organ isation al stru ctu re and fu n ction al assignments ah ali rsoogrd se that execution o f a q u a lity assurance program s im o lv e a both perform ers and v e r ifie r s and i s not th e s o le domain o f a s in g le group* The orga n isa tion 's stru ctu re end th e fu n ction al assignments s h a ll he such th a t:
(a ) attainment o f q u a lity o b je c tiv e s is accomplished hy those who have been assigned re s p o n s ib ility fo r perform ing th s work; th is may include examination, cheohs and in spections o f tho work by th e in d ivid u a ls performing the work
(b ) when v e r ific a t io n o f conformance to estab lish ed requ irements i s necessary i t is ca rried out by those who do not have d ire c t re s p o n s ib ility fo r perform ing the work*
fh e a u th ority and duties o f persons and organ isation s responsib le fo r q u a lity assurance performance and v e r ific a t io n sh a ll be d elin ea ted in w ritin g * fh e persons and organisations perforating the q u a lity assurance functions o f
(a ) assuring th at an appropriate q u a lity assurance progresses is estab lish ed and e ffe c t iv e ly executed, and
(b , v e r ify in g th at a c t iv il ie s have been corn c t ly performed s h a ll have s u ffic ie n t au th ority and organ isation al freedom to id e n tify q u a lity problems; to in it ia t e , recommend o r provide solutions and, where necessary, to in it ia t e action s to con trol fu rth er processing, d e liv e ry o r in s ta lla tio n o f an item which i s non>ooxiforsdBg, deficien t o r u n satisfacto ry, u n til proper d is p o s itio n has been achieved*
Such persons and organ isation s perform ing q u a lity assurance functions s h a ll rep ort to a management le v e l such th at th is requ ired
a u th ority and organ isation al freedom, in clu ding s u ffic ie n t independence from cost and schedule consideration s, are provided* Because o f th e many
v a ria b le s in vo lv ed , ouch as th e number o f personnel, th e typ e o f a c t iv it y b ein g performed, and th e lo c a tio n o r lo ca tio n s where a c t iv it ie s are per formed, the o rga n ization a l stru ctu re fo r executing the q u a lity assurance
programa© say take various forms, provided that the persons and organi sations assigned the q u a lity assurance functions have th is required
a u th o rity and o rga n ization a l freedom# Ir r e s p e c tiv e o f the o rga n izatio n a l stru ctu re, th e in d ivid u a l o r in d ivid u a ls assigned the r e s p o n s ib ility fo r assuring e f f e c t i v e execution o f any portion o f the q u a lity assurance programme at any lo c a tio n where a c t i v i t i e s a ffe c t in g q u a lity are bein g performed s h a ll have d ir e c t access to such le v e ls o f management as may be necessary to achieve e ff e c t i v e implementation o f the q u a lity assurance programme®
3*2# OEGMfXSATIGNAL INTERFACES
Where m u ltip le o rga n izatio n a l arrangements e x is t , the responsi b i l i t y o f each orga n ization sh a ll be c le a r ly establish ed and in te rfa c e s end co-ord in ation among organ izations ensured by appropriate measures* P ro v is io n s h a ll be made fo r communication among organ izations and organi za tio n a l groups p a r tic ip a tin g in a c t i v i t i e s a ffe c t in g q u a lity * The communi ca tio n o f e s s e n tia l inform ation sh a ll be by means o f appropriate doctaasn- ta tio n * The typ e o f documents s h a ll be id e n t ifie d and a d is tr ib u tio n l i s t should be provided*
3*3* STAFFING AND TRAINING
Plans s h a ll be developed fo r s e le c tin g s t a f f end tr a in in g
personnel to perform a c t i v i t i e s a ffe c t in g q u a lity * Plans sh a ll r e f l e c t the schedule o f a c t i v i t y so as to a llow adequate time f o r assignment o r selection and t r a in in g requ ired personnel*
A l l personnel responsible fo r performing a c t i v i t i e s a ffe c t in g q u a lity s h a ll be q u a lifie d on the basis o f general education, experience and p r o fic ie n c y required fo r performing the s p e c ific assigned tasks* T rain in g programmes and procedures s h a ll be establish ed to assure that su ita b le p r o fic ie n c y i s achieved and maintained# As appropriate, th e accomplishment and maintenance o f p ro fic ie n c y s h a ll be marked bv the issue o f a w ritte n statement, such as a c e r t if ic a t e *
BOCSSBIf OOBTBOL
4
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® p a s p M m o s , a eeviem aub » y m.S © preparation, review , approval ©ad issue off docmeots ess en tia l to the perfornanoe and v e r ific a t io n o f the tsork, such as in stru ction s, pro— cs&urss mad drawings, sh all ha subject to con trol. The control ocas urea sh a ll include the i d e n t i f i cation off a ll individu als o r organisations
rosporsih lo fo r preparing, rerviewing, approving and iesn3.Bg docments rela ta d
to a c t i v i t i e s a ffe c tin g q u s lity , fh® review ing and approving organ isation o r in d ivid u a ls sh a ll have access to pertinent background information upon uhieh
to h&se the rev£$v o r approval,
4#2# 300ÜIE3Î E S M 5 âSB SXgEtlSUTXXR
A iocm o si roles»© and distribution system shall he establish *!, u tilis in g ujv4 o»dato distribution l i s t s » ü e a r n s shel l ho provided fo r
•astslng that those participatin g in as a c tiv ity arc aware off and m e
appropriate ard correct doeureuta fo r perforsdrg the activity#
4»3s 33Ç12S-5SÎ CB4533 003HS9L
Cb'îsccs to docusents shall 1® subject to
T&fim
approval Inaccordance t d t l dootsetstod proee&m*# The ravleistLag organisations sh a ll have ©CC233 to pertinent background iiaffbrsustion upon tMch to base th e ir
approval, rad shall have an adequate taıierstaadirg off the requirements and
In test off the o rigin a l doounort# Changes to doetsasssts shall he review ed
m â approved eith er by the sane organisations that performed the o r ig in a l
review ®rel approval or other ©rgeaiEatieaa that have be®» s p e c ific a lly designated# Timely information on doomest revision and i t s actual states
sh ell he promptly relayed to a l l affected pereons and organisations to preclude the m e off outdated and inappropr i ate doeunsnts#
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Control aeasures sh a ll he ©stablishod and doomeated to assure th at applicable s p e c ifie d design requirsnents, such as regu latory
reqt&renrafcs, design bases, codes m i standard®, ®ra c o rr e c tly tra n sla ted in to s p e c ific a tio n s , drawings, procedures o r instructions# They s h a ll
p, _
İncilide provisions to assure that applicable q u a lity et<' udards are s p e c ifie d and stated in design documents* Changes and deviations from s p e c ifie d
design requirements and q u a lity standards sh a ll be con trolled * Measures s h a ll also be established fo r the s e le c tio n and review fo r s u it a b ilit y o f applications o f any m aterials, parts, equipment, and processes that are essen tia l to the function o f the structure, system o r component*
Design control measures sh a ll be applied to items such as the fo llo w in g : ra d ia tio n p rotection , physics, stress, thermal, hydraulic,
seismic and accident analysis; com patibility o f m aterials; a c c e s s ib ilit y fo r in -s e rv ic e in spection, maintenance, and re p a ir; and d elin ea tion o f acceptance c r i t e r i a fo r in spection and te s ts *
Design a c t iv it ie s sh a ll be documented to permit adequate evalu a tion by tech n ical personnel other than those performing the o r ig in a l design* 5*2* DESIGN INTERFACE CONTROL
External and in tern al in te rfa ces between organizations and organi sation al units performing the designs sh a ll he id e n t ifie d in w ritin g*
R es p o n sib ility f o r each organization and organizational unit sh all be defined i n s u ffic ie n t d e t a il to cover the preparation, review, approval, re lea se, d is trib u tio n and re v is io n o f documents in vo lv in g in te rfa c e s . Methods sh a ll be established f o r communicating design information, including changes, across the design in te rfa c e s * The information communication sh a ll be docu mented and con trolled *
5.3* DESIGN VERIFICATION
Design control measures sh a ll provide fo r v e r ify in g the adequacy o f design, such as by the performance o f design reviews, by the use o f a lte rn a tiv e ca lcu la tion a l methods, o r by the performance o f a su ita b le t e s t in g programme* Design v e r ific a t io n sh a ll be performed by in dividu als or groups other than those who performed the o rig in a l design* V e r ific a tio n methods to be applied sh a ll be id e n t ifie d by a responsible organ ization and design v e r ific a t io n resu lts sh a ll be documented to the extent s p e c ifie d *
Where a t e s t programme i s used to v e r ify the adequacy o f a s p e c ific design featu re in l i e u o f other v e r ify in g o r checking processes, i t sh a ll include su ita b le q u a lific a tio n te s tin g o f a prototype unit under
the Boat adverse conditions fo r the s p e c ific design features being verified# Where testin g oaanot be carried out under the «©at adverse design conditions* testin g ie perm issible under other conditions i f th e re su lts can be extrapo lated to the »c a t adverse design conditions end I f they can v e r i f y th e adequacy o f a sp ecific design featu re*
5*4* SE SE » CBUK3ES
Soom ented procedure sh all be provided fo r e ffe c tin g design
ohaagee* in clu d in g f ie ld changes* the tedhxdoal iapact o f changes s h a ll be c a refu lly considered and requ ired action s doeusented* fh e changes
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be subject to th e ease design con trol Erasures as those applied to the o r ig in a l design* Change documents s h a ll be reviewed sad approved by th e ease groupso r organ isation s resp on sib le fo r r e e l
m
nd approval o f th e o rig in a l design a docm entSf unless o th er organ isation s are © p osifically designated* Shisdesignation o f a lte rn a tiv e organ! a s lio s s s h e ll be conditional os t h e ir having seoess to p ertin en t background in fbrs& tion * on ta c ir demonstrating oenpeteaoe in the s p e c ific design area o f eonoers* and on th e ir fcavisg ®a adequate
understanding o f th e o r ig in a l design resu lressct® eisl in ts n t* Zsfbsnation eonosraing th e du nces s h a ll be tr a ra a ltte d to
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affcoted persons s d organisations*6 .
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Beasures s h a ll be estab lish ed i©om*a
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to »«su re th at appli— oable regu la to ry requ ireoeats* design bases* standards* s p e e ifie a tio n s sad other r egutreaents necessary toassure
adequate q u a lityare
in elw ied o r referen ced in th e documents f o r p ro c e s s e s * o f itccrs and services#Proourcneat requirements f a r assuring q u a lity sh a ll include but
seed sot be U n it e d to the fb llo s ln f'* mepplio«M.®§ (a ) a statement o f th e scope o f the uori: to fe® performed by the
supplier
(b ) tecim i ca l requirement® s p e c ifie d b y r e fe r e n c e to d eo ta esi» such, as codes* standards* regulation®* procedures* in stru ction s and s p e c ific a tio n s * In clu din g re v is io n s th e reto th a t describe the itens o r services, to be porfoasod
( c ) t e s t , in sp ection , and. acceptance requirements, and any sp e cia l in stru ction s and requirements rela ted to these (d ) provision s fo r access to plant f a c i l i t i e s and records fo r
th e purpose o f source* inspection and audit when the need fo r such in sp ection and audit has been determined
( e ) id e n tific a tio n o f q u a lity assurance requirements and the elements o f the programme applicable to the items o r services procured. Hot a l l suppliers need
to
have a q u a lity assurance programme which complies with a l lthe
elements o f th is Code. To the extent necessary, theprocurement requirements
sh a ll requ ire contractors o rsubcontractors to provide a
q u a lity assurance programme consistentwith the pertinent
provision s o f th is Code o f P ra c tic e< f) id e n tific a tio n o f documentation
required,
such as in stru ction s, procedures, s p e c ific a tio n s , inspection end t e s t records, and oth er q u a lity assurance records tohe prepared and
submitted fo r review o r approval by thepurchaser
( * ) p rovision s fo r c o n tro lled d istrib u tio n , reten tion , maintenance and d is p o s itio n o f q u a lity assurance records
(h ) requirements fo r rep ortin g and approving d isp ositio n o f non conformances
( i ) p rovision s fo r extending applicable requirements o f procurement documents to lo w e r -tie r sub-contractors and suppliers, in clu d in g purchaser*s access to f a c i l i t i e s and
record®
( j ) p rovision s fo r s p e c ify in g the tim ing o f the subadssion o f documents.
6*2* SUPPLIER EVALUATION AND SELECTION
A basic consideration in the s e le c tio n o f n-upili&oa sh all be the supplier*s evaluated c a p a b ility to provide items o r services in accordance with the requirements o f th e procurement documents.
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11
Supplier evaluation includes as appropriate:
(a ) the nee o f historical, quality performance data o f sim ilar procurement actions
(b ) the use o f supplier’ s current quality assurance records sup ported by documented quantitative o r qu alitative information which can be objectively evaluated
(c ) souroe evaluation o f supplier’ s technical, capability and quality system
(& ) evaluation by selective product samples*
6
*3
* OONTROL OF PURCHASED ITSUS AND SERVICESPurchased items and services sh all be subject to oontrol to assure the oonformance to procurement documents* The control consists o f measures such as objective evidence o f quality furnished by the contractors»
inspection and audit at the source» and examination o f the product upon delivery*
I f necessary samples o f material aa specified sh all be retained fb r a sp ec ific time at an agreed location and controlled to provide means fo r further examination*
Documentary evidence that purchased items conform to procurement documents sh a ll be available at the nuclear plant s ite p rio r to in sta lla tio n o r use* This evidence sh all be su fficien t to iden tify a ll requirements met by the purchased items* This documentary evidence may take the form o f a written c e rtific a te o f oonformance which id e n tifie s the requirements met by the item» providing the v a lid ity o f such certificatio n s can be v e rifie d *
7
* MATERIAL CONTROL7
.1
* IDENTI FI CATION AND CONTROL OF MATERIALS» FARTS AMD OOMPOH9
T3
Measures sh all be established fo r the iden tification and oontrol o f items» including p a rtia lly fabricated assemblies» as required throughout fabrication » erection» in sta lla tio n and use* These measures assure that Id en tificatio n o f the item is maintained by batch number» part number»
İ P
s e r ia l number, o r oth er appropriate means, e ith e r on the item or records tra cea b le to th e item , as
required
throughout fa b ric a tio n , e rectio n ,in s t a lla t io n , and case* Required documentation sh a ll be a v a ila b le f o r items as they proceed through the construction process*
Physical id e n t ific a t io n s h a ll be used to th e maximum extent p o ssib le* Where ph ysical id e n t ific a t io n is e ith e r im practical o r in su f f i c i e n t , ph ysical separation, procedural co n tro l, o r other appropriate means should be employed to maintain id e n t ific a t io n . These id e n t ific a t io n and co n trol measures s h a ll be designed to prevent th e use anywhere o f in c o rre c t o r d e fe c t iv e m a teria l, parts and components*
Where id e n t ific a t io n marking i s employed, the marking s h a ll be c le a r , unambiguous and in d e lib le , and s h a ll be applied in each a 'menaer as not to a ffe c t th e fu nction o f the item* Marking sh a ll not be hidden by su rface treatment o r coatin gs, unless other means o f id e n t ific a t io n are su b stitu ted *
7*2» HANDLING, STORAGE AND SHIPPING
Measures s h a ll be establish ed and documented to con trol handling, sto ra ge and shipping* These s h a ll include cleaning, packing end p reserva tio n o f m a teria l and equipment in accordance with established in s tru c tio n s , pro cedure® o r drawings to prevent damage, d e te rio ra tio n o r lo s s . When necessary f o r p a r tic u la r item s, sp e cia l coverings, sp e cia l handling equipment and
s p e c ia l p r o te c tiv e environments s h a ll be s p e c ifie d , provided and t h e ir existen ce v e r i f i e d *
8* PROCESS CONTROL
Processes a ffe c t in g q u a lity such as used in design, construction, fa b r ic a tio n , t e s t in g , commissioning and operation o f a power plant s h a ll be c o n tro lle d in accordance with s p e c ifie d requirements* Where requ ired by a p p lica b le codes, standards, s p e c ific a tio n s , c r i t e r i a o r oth er sp ecia l requirements, measures s h a ll be establish ed and documented to ensure that th ese processes are accomplished by q u a lifie d personnel, using q u a lifie d procedures and equipment* For processes not covered by a v a ila b le standards, o r where the q u a lity requirements exceed th e requirements o f th e e x is tin g standards, the necessary q u a lific a tio n o f personnel, procedures o r equipment s h a ll be defined*
9* INSPECTION ABU TEST CONTROL 9.1* PROGRAMME OP INSPECTION
In order to v e r ify conformance to the documented in stru ctio n s, pro cedures and drawings a programme fo r in sp ection o f items and services and th e a c t iv it ie s a ffe c tin g th e ir q u a lity sh a ll he establish ed and executed by o r fo r th e organ ization perform ing these a c t iv it ie s * Such in sp ection s h a ll be performed by in d ivid u a ls other than those perform ing the a c t iv it ie s being inspected* In spections s h a ll be performed fo r each work operation where necessary to assure q u a lity *
The programme s h a ll provide in d ire c t control by m onitoring o f the processing methods, equipment and personnel i f , fo r example, in sp ection o f processed items is im possible o r i f ad d ition al process m onitoring is required* Both in sp ection and process m onitoring sh a ll be provided tfoen con trol is
inadequate without both*
H old-points beyond which work sh all not proceed without th e approval o f a designated organ isation , i f such inspection o r witnessing o f the
in sp ection is requ ired , s h a ll be in d ica ted in appropriate documents* Such approval s h a ll be documented p rio r to the continuation o f work beyond th e designated h old-p oin t*
A programme fo r requ ired in -s e rv ic e inspection o f completed systems, stru ctu res and components s h a ll be planned, executed and the resu lts sh a ll be evaluated against b a se-lin e data*
9*2. TEST PROGRAMME
A te s t programme sh a ll be established t o ensure the id e n t ific a t io n , performance and documentation o f a l l te s tin g required to demonstrate th at the stru ctu res, systems and components w i l l perform s a t is fa c t o r ily in s e rvice* The t e s t programme sh a ll cover a l l required te s t s , and include, as appropriate, procedure and equipment q u a lific a tio n te s ts , prototype q u a lific a tio n t e s t s , p ro o f te s ts p r io r to in s ta lla tio n , pro-operational and s ta rt—up te s ts and op era tion a l te s ts *
T e s tin g s h a ll he performed in accordance with w ritten te a t pro cedures w him in corp ora te th e requ iraaects and accept at. se lim its s p e c ifie d in design documents , and in clu de p rovision s fo r as sirring that p re re q u is ite s f o r a giv en te s t have been met and th a t th e t e s t i s performed under su ita b le environmental con d ition s by a p p rop ria tely tra in ed personnel using p rop erly c a lib r a te d instrum entation* T est re s u lts s h a ll be documented and evaluated t o assure th a t t e s t requirem ents have been s a t is fie d .
9.3® CALIBRATIONMD CXJWEHOI* OP MSâSUKIHG ABD TEST E ^ 3 IR I® r Measures s h a ll be esta b lish ed to assure that t o o ls , gauges,
instnsBsnfcs, and o th er in sp ectio n , measuring and t e s t «squipseut and d evices used in determ ining conformance to acceptance c r i t e r i a are o f th e proper range, ty p e , accuracy and p re c is io n .
T e s tin g and measuring d evices used in a c t i v i t i e s a ffe c tin g q u a lity s h a ll be c o n tr o lle d , c a lib ra te d and adjusted a t s p e c ifie d in te rv a ls o r p r io r t o ® a to m aintain accuracy w ith in necessary lim it s . When d evia tio n s beyond p rescrib ed lim it s are d etected , an evalu ation s h a ll be mad® o f th e v a lid it y o f previous measurements and t e s t s , and acceptance
o f
te s te d items reassessed. C ontrols s h a ll be esta b lish ed to assure proper handling, s to rin g and use o f c a lib r a te d equlpaent*9*4® H M C m O N OP IH3PPCTÎ0K, TEST AHD OPHtAOTS STATUS
T est and in sp ectio n statu s o f in d iv id u a l items o f the nuclear
power p la n t s h a ll be id e n t ifie d by th e use o f marking®, atasps, ta g s , la b el® , ro u tin g cards, in sp ectio n record s, p h ysical lo c a tio n or oth er su ita b le means, which can in d ic a te th e a c c e p ta b ility o r m n-confoxm nc® o f items w ith regard to te s ts and in sp ection s performed# The id e n tific a tio n o f th e in sp ectio n and t e s t statu s s h a ll be maintained as necessary throughout manufacturing, in s t a lla t io n and o p era tion o f th e item to assure th a t only items th a t have passed th e req u ired in sp ectio n and t e s t are used, in s t a lle d o r op erated .
Measures s h a ll a ls o be esta b lish ed fo r in d ic a tin g th e o p era tin g sta tu s o f systems and components o f th e nuclear power p la n t, such as by ta g g in g v a lv e s and sw itches to prevent in ad verten t operation®
1 0 , KOH-CQIK)KKAHCB CONTROL
10*1« GENERAL
Measures s h a ll also be establish ed to con trol items which do not conform to requirem ents, in order to prevent th e ir inadvertent use o r in s ta lla tio n * To ensure control , these noo~oonforndng items s h a ll be id e n t ifie d by marking) ta ggin g and/or by physical segregation ) where p ra c tic a l* Measures which con trol fu rth er processing) d e liv e ry o r in s ta l la tio n o f non-conforming o r d e fe c tiv e items sh a ll be esta b lish ed ) doctmented and implemented*
10*2. T O - CONÎOEMANCE REVIEW AND EISFOSITIOf
Kon-confonaing item s bh all be reviewed and accepted without modi fic a tio n .) re je c te d ) rep aired o r reworked in accordance with documented pro cedures* The re s p o n s ib ility fo r review and au th ority fo r d is p o s itio n o f non-oonfoxmances s h a ll be defined* Accepted non-conforming items in v o lv in g a d e v ia tio n from procurement requirements s h a ll be reported to th e purchaser and) when necessary) to the designated au th ority* The d escrip tio n o f
changes) waiver o r d evia tio n th at has been accepted s h a ll be documented to denote th e "a s b u ilt " condition*
11. QOBHTOIVE ACTIONS
The programme s h a ll provide that appropriate action be taken to assure th a t conditions adverse to q u a lity , such as fa ilu r e s , m alfunctions, d e fic ie n c ie s , d evia tio n s, d e fe c tiv e o r in oorrebt m aterial
md
equipment,and a iy oth er non-conformances, are id e n tifie d and oorrectnd* For s ig n ific a n t conditions adverse to q u a lity , th e programme s h a ll provide th at th e cause o f such con d ition be determined) and c o rre c tiv e a ction taken to prevent repe t it io n * The id e n tific a tio n o f th e s ig n ific a n t conditions adverse to q u a lity , th e cause o f th e con d ition and th e c o rre c tiv e action s taken s h a ll be docu mented and rep orted to appropriate le v e ls o f management*
1.2. RECORDS
12*1* QUALITY ASSURANCE RECORDS PREPARATION
Q u ality assurance records adequate fo r use in management o f th e q u a lity assurance programme s h a ll be prepared* Records s h a ll represent o b je c tiv e evidence o f q u a lity and should inolude the re su lts o f review s, in sp ection s, te s ts , au d its, m onitoring o f work performance, m aterials analyses
and power plant operation lo g s , as w ell as c lo s e ly r e la te d data, such as
q u a lific a tio n s o f personnel, procedures and equipment, rep a irs required and
other appropriate documents# A ll q u a lity assurance records sh a ll be le g ib le ,
complete and id e n t ifia b le with respect to the item in volved ,
12*2# QUALITY ASSURANCE RECORDS COLLECTION, STORAGE AND PRESERVATION A q u a lity assurance record system s h a ll be establish ed and
executed in accordance with w ritten procedures and in s tru c tio n s . The system
sh all require that s u ffic ie n t records be maintained to furnish evidence o f
a c t iv it ie s a ffe c tin g q u a lity and to describe baseline pro-operation al
conditions. The system s h a ll provide fo r id e n tific a tio n , c o lle c t io n , indexing,
f i l i n g , storin g, maintenance and disposal o f records® Records s h a ll be stored
in such a way that they are re a d ily retrieva b le and maintained in a su itable
environment to minimize d e te r io r a tio n o r damage and to prevent lo s s .
R eto rtio n times o f q u a lity assurance records and associated test
m aterial end specimens s h a ll b© establish ed in writing® In gen eral, records
which c o rre ctly id e n t ify th e "as built** condition o f items in the plan t s h a ll
be maintained by o r fo r th e responsible organisation fo r the useful l i f e o f
the item from manufacture through storage, in s t a lla t io n and operation#
Periods o f re te n tio n f o r records oth er than life t im e records s h a ll be assigned
reten tion times consistent with the type o f record involved® Disposal o f
records sh all be in accordance with w ritten procedures*
13* AUDITS
13*1* GENERAL
Measures sh a ll be undertaken to v e r i f y the implementation and e ffe c tiv e n e s s o f th e q u a lity assurance programme. As necessary, a system o f planned and documented in te rn a l and extern al audits sh a ll be ca rried out to v e r i f y compliance with a l l aspects o f the q u a lity assurance programme and to determine th e e ffe c tiv e n e s s o f th e programme. The audits s h a ll be performed in accordance with w ritten procedures o r check l i s t s . The responsible
auditing organisations sh a ll select and assign q u a lifie d auditors. They s h a ll be independent o f any d ir e c t r e s p o n s ib ility f o r the a c t i v i t i e s which
I f
-they au dit* In the case o f in te rn a l audits, the persons having th e d ire c t re s p o n s ib ility fo r performance o f the a c t iv it ie s being audited sh a ll not be in volved in th e s e le c tio n o f th e audit team# The resu lts o f audits s h a ll be documented by the auditors and review ed by organisations having responsi b i l i t y in th e area audited* Follow-up a ction sh a ll be taken to v e r it y th at d e fic ie n c ie s noted in the audit have been corrected*
13*2* SCHEDULING
Audits sh a ll be scheduled on the basis o f the status and importance
o f th e a c t iv it y , and sh a ll be conducted t&en one o r more o f the fo llo w in g conditions e x is t :
(a ) when a system atic, independent assessment o f programme effe c tiv e n e s s i s considered necessary
(b ) when i t is necessary to determine the c a p a b ility o f a con t r a c t o r 's q u a lity assurance programme p r io r to awarding a contract o r purchase order
(c ) a ft e r award o f a contract, when s u ffic ie n t time has elapsed fo r implementing the q u a lity assurance programme and i t is appropriate to determine that the organisation is adequately performing the functions as defined in the q u a lity assurance programsa, applicable codes and standards and other contract do assents
(d ) when s ig n ific a n t changes are made in functional areas o f th e q u a lity assurance programme, suteh as s ig n ific a n t reorgani
sa tion o r revisio n s o f procedure
( e ) when i t is suspected that the q u a lity o f an item o r a s e rv ic e is in jeopardy due to a d eficien cy in the q u a lity assurance programme
( f ) vdien i t i s necessary to v e r ify implementation o f requ ired c o rre c tiv e actions*
