KELPO Development of the licensing and qualification processes for the systems and equipment of nuclear facilities in Finland

Transkriptio

1 1(37) Prepared by Maria Pal, ÅF Juk Tuminen, Fennvima Kirsi Hassinen, TVO Lauri Pajunen, Frtum Henrik Jkineva, Frtum Jnas Pöytäniemi, Frtum KELPO Develpment f the licensing and qualificatin prcesses fr the systems and equipment f nuclear facilities in Finland Final reprt

2 2(37) Revisin Date Changes Prepared Inspected Apprved 0 29 January 2019 First publicatin Nte: Due t the crss-rganisatinal nature f the prject, the nrmal inspectin and apprval markings are nt presented herein. The reprt has been prepared by the members f the prject team, and the cntents f the published reprt have been reviewed and apprved by the steering grup and prject team.

3 3(37) Tiivistelmä Ydinalan timijat niin Sumessa kuin ulkmailla vat havainneet timinnassaan yhä enemmän haasteita: Raskaaksi ketut luvitus- ja kelpistusprsessit tekevät ikääntyvien laitteiden ja järjestelmien mdernisinneista haasteellisia. Timittajaverkst harvenee ja kiinnstus timittaa laitteita ydinlaitksille n laskenut. Muilla tellisuudenalilla n viime vusikymmeninä tapahtunut humattavaa laatukehitystä, jta ei tällä hetkellä ydinalalla riittävästi hyödynnetä. Ydinviman kilpailukyky muuttuvassa timintaympäristössä n varmistettava. Muutstöiden ja mdernisintien kannattava tekeminen sekä kattava timittajaverkst ja laitteiden saatavuus vat edellytyksiä ydinalan timintaedellytysten varmistamiselle ja kknaisturvallisuuden takaamiselle. Vunna 2018 tteutetun KELPO-prjektin tarkitus li löytää keinja luvitus- ja kelpistusprsessien kehittämiseksi Sumessa. Tähän luvanhaltijiden yhteiseen prjektiin sallistui myös STUK. Prjektin tulksena n ehdtettu luvitus- ja kelpistusmenettelyihin muutksia, jilla menettelyistä tehtäisiin tarkituksenmukaisempia. Prjektissa keskityttiin erityisesti alempien turvallisuuslukkien mekaanisiin laitteisiin. Tarkastelun khteena li sumalainen luvitusympäristö, mutta tavitteena n jatkssa hyödyntää tulksia EU-taslla vastaavissa selvityksissä. KELPO-prjektin tavitteeksi määriteltiin graded apprach -periaatteen laajentaminen, standardilaitteiden hyödyntäminen sekä kattavan timittaja-/valmistajaverkstn varmistaminen ja luvanhaltijiden yhteistyön lisääminen. Prjektin tulksena n esitetty vaihtehtisia kehitysehdtuksia, jtka krstavat luvanhaltijiden yhteistyötä ja luvanhaltijan vastuuta sekä khdentavat STUK:n valvntaa sinne, missä ydinturvallisuuteen vidaan eniten vaikuttaa: Ehdtettu ylätasn muuts tarkastuslaajuuteen khdentaa viranmaisvalvntaa krkeampiin turvallisuuslukkiin ja laits- ja järjestelmätasille ja tisaalta krstaa luvanhaltijan maa valvntavastuuta erityisesti laitetaslla. Tisena kehitysehdtuksena esitetty menettely pyrkii pistamaan luvanhaltijiden päällekkäistä työtä ja lisäämään luvanhaltijiden yhteistyötä sekä tumaan ydinalalle käyttöön kansalliset hyväksynnät. Tämä menettely lisi tteutettavissa verrattain helpsti ja pienin muutksin nykykäytäntöön nähden. Klmas kehitysehdtus n uusi menettelytapa, jka pikkeaa nykymallista enemmän ja pyrkii viemään laitehankinnissa käytettäviä menettelyjä khti muiden tellisuudenaljen timintatapja. Tavitteena n selkeyttää vaatimuksia timittajan suuntaan ja hyödyntää muilla tellisuudenalilla käytössä levia standardeja ja menettelyjä. Ehdtetun uuden menettelyn testaamiseksi ja edelleen kehittämiseksi n suunniteltu pilttiprjektia tteutettavaksi yhteistyössä luvanhaltijiden ja STUK:n kesken. Yllä mainittujen kehitysehdtusten lisäksi prjektissa n tarkasteltu standardi-/sarjavalmisteisten laitteiden käyttöä eri tekniikanalilla sekä näiden laitteiden mahdllisia lutettavuusdatan lähteitä. Esitetyt kehitysehdtukset krstavat luvanhaltijiden yhteistyötä sekä luvanhaltijan maa vastuuta nnistuneesta ja vaatimustenmukaisesta laitehankinnasta. STUK:n valvntaa khdennetaan sinne, missä perusteet ydinturvallisuudelle ludaan ja missä siihen eniten vidaan vaikuttaa. Vaatimuksia ja menettelyjä laitetimittajien/-valmistajien suuntaan pyritään selkiyttämään ja hyödyntämään laitehankinnissa muilla tellisuudenalilla käytössä levia menettelyjä ja standardeja, jihin timittajat ja valmistajat vat tttuneet. Näillä keinin pyritään helpttamaan muutsprjektien tekemistä ja laitetimittajien/-valmistajien sallistumista prjekteihin. KELPO-prjektin jälkeen tteutettavan piltinnin tulksena saadaan selville ehdtetun menettelyn heikkudet, vahvuudet ja muutstarpeet. Ehdtettuja kehitysehdtuksia työstetään prjektin jälkeen yhteistyössä luvanhaltijiden ja STUK:n kesken niiden edelleen kehittämiseksi ja viemiseksi käytäntöön. Luvanhaltijiden yhteistyö ja sen kehittäminen sekä yhteistyö myös STUK:n kanssa vat avainasemassa tulevaisuuden kehitystyössä. Yhteistyötä n tulevaisuudessa tarkasteltava myös laajemmin, mm. Rutsin kanssa ja EUtaslla. Menettelyjen ja timintatapjen kehittäminen n välttämätöntä ydinalan timintaedellytysten varmistamiseksi ja kknaisturvallisuuden takaamiseksi muuttuvassa timintaympäristössä myös tulevaisuudessa.

4 4(37) Summary The nuclear industry in Finland and abrad is facing an increasing amunt f challenges. The licensing and qualificatin prcedures are cnsidered heavy which creates challenges in mdernisatin f equipment and systems. The equipment suppliers and manufacturers shw declining interest in participating in nuclear prjects. In ther fields f industry there has in the past decades been a significant increase in quality requirements and thus imprvement in quality f equipment. This develpment is at present nt sufficiently utilized by the nuclear industry. The cmpetitiveness f nuclear energy in the changing market has t be secured. The viability f mdificatin and mdernisatin prjects as well as a cmprehensive supplier netwrk and availability f equipment are prerequisites t enable feasible peratin f the nuclear industry in a changing envirnment and t guarantee the verall nuclear safety in the future. The purpse f the KELPO-prject carried ut in 2018 was t suggest ways t develp the licensing and qualificatin practices in Finland. The Prject was a c-peratin f the Finnish license hlders/licensees, t which als the Finnish nuclear authrity STUK participated. As a result, changes t make the licensing and qualificatin practices mre functinal are prpsed. The Prject fcused n mechanical equipment in lwer safety classes as well as n the Finnish licensing framewrk. Hwever, the gal is t utilize the results in EU-level develpment wrk later. The bjectives f the Prject were set as: widening the use f the graded apprach principle, utilizing standard equipment and securing a cmprehensive supplier netwrk as well as increasing c-peratin between license hlders. As a result, alternative ways t develp the licensing and qualificatin practices are prpsed. The suggested measures increase the c-peratin between license hlders, emphasize the license hlders wn respnsibility and fcus authrity surveillance n areas where nuclear safety can be affected the mst. Firstly, a high-level change t scpe f supervisin is prpsed: authrity supervisin is fcused n higher safety classes and n plant- and system-level, while the license hlder s wn respnsibility is emphasized especially n equipment-level. The secnd suggestin is a prcess, which cuts the verlapping wrk f licence hlders and increases c-peratin as well as intrduces natinal apprvals in Finnish nuclear industry. This prcess wuld be relatively easy t adpt, as it requires nly small changes cmpared t the existing practices. The third prpsed change is a new methd which suggests mre changes cmpared t the existing practices and aims t change the practices clser t thse used in ther industries. This methd aims t clarify the requirements fr equipment suppliers and manufacturers as well as t utilize methds and standards similar t ther fields f industry. T test the suggested methd, a pilt prject has been planned t be carried ut by the licence hlders in c-peratin with STUK. In additin t the abve-mentined suggestins the use f standard/serially manufactured equipment and the ptential surces f reliability data f such equipment has been studied. The prpsed develpment suggestins emphasize c-peratin between license-hlders as well as the license-hlder s wn respnsibility fr successful prcurement f equipment which fulfil the requirements. Authrity supervisin is fcused n areas where nuclear safety can be affected the mst. Frm the equipment suppliers and manufacturers pint f view the requirements are clarified and practices and standards familiar frm ther industries utilized. At the end, these means aim t facilitate implementing mdernizatin prjects at nuclear facilities as well as t make it easier and mre interesting fr suppliers and manufacturers t take part in these prjects. A pilt prject will be carried ut t identify the strengths, weaknesses and mdificatin needs f the prpsed new methd. The suggestins made in this Prject will be further prcessed in c-peratin between the license-hlders and STUK t develp them and bring them t practice. C-peratin amng the license hlders and with STUK is essential fr further develpment wrk. Als wider c-peratin e.g. with Sweden and n EU-level shall be cnsidered. It is essential t develp the prcedures in the nuclear industry t secure the feasibility f perating nuclear installatins and t guarantee high level f verall nuclear safety als in the future.

5 5(37) Cntents Tiivistelmä... 3 Summary... 4 Appendices... 6 Abbreviatins and definitins Intrductin Prject descriptin Other prjects n the tpic Develpment fcuses and limitatins f the prject Results Scpe f inspectin at the upper level Mdificatin prjects: phases, prcedures and dcumentatin Descriptin f the principle Current status Prcedure fr eliminating licence hlders verlapping wrk Prpsal fr the new prcedure Dcumentatin cnnected t the new prcedure Relatinship between the prpsed prcedure and draft YVL Guides Use f standard/serially-manufactured equipment Use f standard/serially-manufactured equipment and its impact Mechanical equipment I&C equipment and sftware Electrical equipment Other equipment and equipment assemblies Assessment and mnitring f equipment reliability Prbabilistic risk assessment (PRA) Pilt Purpse and gals Descriptin f the pilt prject Organisatin and implementatin methd Pilt phases, schedule and csts End results The licence hlders /applicants cperatin mdel Implementatin methd and financing f the cperatin Future develpment ptential Summary, further actins and the future References... 36

6 6(37) Appendices 1. Appendix 1 Phases f the mdificatin prject and ensuring the cnfrmity t requirements f a safety-classified prduct. Current mdel. 2. Appendix 2 Phases f the mdificatin prject and ensuring the cnfrmity t requirements f a safety-classified prduct, prpsed prcedure t eliminate verlapping wrk. A Outging/undesirable phases presented. B Prpsed prcedure, with verlapping phases and wrk eliminated. 3. Appendix 3 Phases f the mdificatin prject and ensuring cnfrmity t requirements, serially-manufactured equipment. Prpsed new prcedure. 4. Appendix 4 Cmparisn f the current practice and the prpsed new prcedure. 5. Appendix 5 Structure and cntents f the equipment requirement specificatin.

7 7(37) Abbreviatins and definitins AIO EN EYT HP IEC ISO KOT LH NDT STUK PED PG PRA E/I&C SIL SC TP YVL Authrised inspectin rganisatin Eurpean Standard N nuclear safety classificatin Hld pint Internatinal Electrtechnical Cmmissin Internatinal Organisatin fr Standardisatin Cmmissining inspectin Licence hlder/applicant Nn-Destructive Testing Radiatin and Nuclear Safety Authrity Pressure Equipment Directive Part Grup Prbabilistic Risk Assessment Electrical/Instrumentatin and cntrl Safety Integrity Level Safety Class Third Party YVL Guide Authrised inspectin rganisatin Authrised inspectin rganisatin shall refer t an independent inspectin rganisatin apprved by the Radiatin and Nuclear Safety Authrity under Sectin 60 a f the Nuclear Energy Act t carry ut inspectins f the pressure equipment, steel and cncrete structures and mechanical equipment f nuclear facilities in the capacity f an agency perfrming public administrative duties. Graded apprach A principle accrding t which safety requirements and measures must be cmmensurate with and allcated t the level f risk and safety significance. Hld pint A pint beynd which wrk cannt prceed withut an apprved fficial inspectin. Ntified bdy Ntified bdy shall refer t a ntified bdy as referred t in Article 12 f the Pressure Equipment Directive (97/23/EC). Licence hlder Licence hlder shall refer t the hlder f a licence entitling t the use f nuclear energy. In this reprt, licence hlder als refers t licence applicant, where applicable. Licensing and qualificatin Prcedures fr having a system r prduct apprved fr use at the nuclear facility.

8 8(37) Lw-energy In safety class 2, lw-energy refers t equipment with a design pressure f up t 20 bar(g) and a design temperature f up t 120 C and t which the design, dimensining and quality-cntrl requirements f crrespnding equipment frm safety class 3 can be applied withut causing a risk f the equipment lsing perability. Cnstructin inspectin An inspectin carried ut when accepting equipment t ensure that the equipment and its manufacture, testing, inspectin and dcumentatin have been carried ut as laid dwn in the specified requirements. Serially-manufactured equipment Serially-manufactured equipment shall refer t equipment that is nt designed r manufactured fr the lcatin f use specially accrding t the client s requirements. Typically, the equipment is manufactured in large batches and is als suited t ther applicatins. The structure, dimensins and materials f the equipment and the methds and quality f manufacture des nt essentially differ within r acrss manufacturing batches. Standard equipment The manufacture, testing, inspectin and dcumentatin f standard equipment is based n the standards and prcedures nrmally used by the manufacturer. Type apprval Type apprval shall refer t a natinally r internatinally recgnised prcedure whereby the accredited certificatin bdy granting the apprval verifies that the prduct and its implementatin meet the applicable technical requirements.

9 9(37) 1 Intrductin Pwer cmpanies and ther nuclear industry rganisatins have nted in their daily wrk that there is a great deal f develpment ptential in prcedures cnnected t licensing and qualificatin. By develping these prcedures t make them mre apprpriate, we can better facilitate mdificatins and lwer the threshld fr rganisatins t participate in nuclear prjects and thereby imprve the verall safety f facilities as well as prmte the cmprehensiveness f the supplier netwrk, fr example. At present, carrying ut mdificatins t imprve verall safety and plant usability is cnsidered difficult, expensive and labrius, particularly due t the large amunt f dcumentatin and the high number f time-cnsuming licensing phases required. The deviatins frm manufacturers nrmal practices and prcesses due t the special requirements in the nuclear sectr als lead t difficulties. The heavy licensing prcess cmplicates the maintenance and mdernisatin f ageing equipment and systems and des nt sufficiently supprt the implementatin f safety-imprving actins using mdern, reliable and cmmnly available technlgy. In the nuclear sectr, it must be pssible t als leverage quality develpments achieved in ther fields f industry which imprve the usability and reliability f equipment. Accrding t Sectin 7 a f the Nuclear Energy Act, fr the further develpment f safety, measures shall be implemented that can be cnsidered justified cnsidering... advances in science and technlgy, and licensing and qualificatin prcedures must supprt this principle [1]. Carrying ut mdificatins is als cnsidered difficult fr individual pieces f equipment replaced fr maintenance purpses. If the riginal manufacturer has left the market, the equipment must be replaced with an equivalent equipment frm anther manufacturer, and the cumbersme manufacturer apprval prcess must start again. This can lead t a situatin where, instead f prcuring new equipment, it is mre cst-effective t wear ut the existing equipment, which in turn leads t additinal shutdwns and lnger repair utages. On the ther hand, the large amunt f apprval dcumentatin needed has reduced the interest f equipment suppliers and manufacturers t supply nuclear facilities. The dwindling supplier netwrk hikes up prices further, makes it mre difficult t carry ut mdificatins and limits the availability f equipment fr nuclear facilities. Nuclear facilities are unable t select the best pssible equipment because the best suppliers are nt willing t participate in prjects that they find cumbersme. Cst-effective mdificatins and mdernisatins, the availability and utilisatin f highquality equipment and the best technlgy as well as ensuring a cmprehensive supplier netwrk are all vital fr ensuring the peratinal feasibility f the nuclear sectr and guaranteeing the verall safety f nuclear facilities. The nuclear sectr must cntinue t be able t perate cst-effectively in the changing perating envirnment. Based n this need, the KELPO Prject was launched with the purpse f develping the licensing and qualificatin prcesses fr the systems and equipment f nuclear facilities by prpsing mre practical prcesses and cncrete imprvements t prcedures and requirements withut the prpsed changes having a negative impact n nuclear safety. In this cntext, licensing and qualificatin prcesses refer t the prcedures fr having a system r prduct apprved fr use at a nuclear facility. The need fr the prject was als recgnised in a preliminary study cmmissined by STUK, Ydinlaitsten luvitusmallien kehittäminen (Luvike) ( Develpment f licensing mdels fr nuclear facilities ) [2]. The prpsals fr prcedure imprvements develped in this prject can be utilised in mdificatin prjects f perating nuclear facilities and in the cnstructin prjects f new facilities. The prject has als investigated and sught t prmte cperatin between licence applicants and licence hlders in licensing and qualificatin prcesses. This reprt presents the prpsals fr imprving licensing and qualificatin prcesses develped as a result f the KELPO Prject. The plan is t further imprve and advance the develpment prpsals after the prject in cllabratin between the licence hlders/applicants and STUK. Thus, the develpment wrk will cntinue after the prject.

10 10(37) 2 Prject descriptin This sectin prvides a brief descriptin f the KELPO Prject. The prject team cnsisted f representatives f licence hlders and licence applicants as well as the prject manager: Prject team members included representatives frm Frtum (Lauri Pajunen, Henrik Jkineva, Jnas Pöytäniemi), TVO (Kirsi Hassinen) and Fennvima (Juk Tuminen) as well as a prject manager frm ÅF-Cnsult (Maria Pal). In additin, STUK (Petri Vuri) participated in the wrk f the prject team s that the regulatry authrity s viewpint culd als be cnsidered in the prpsals. Furthermre, ther persns frm the afrementined rganisatins cntributed t the wrk as needed. The develpment wrk was mainly carried ut frm the perspectives and starting pints f licence hlders/applicants, and STUK participated in the wrk at a later stage by cmmenting n prpsals. The develpment prpsals f the prject are based n the experience and insight f the prject team as well as the ptential develpment needs they have bserved in their practical wrk. In the prject, equipment prcurement and the assciated prcedures in ther industries were analysed based n the experience f the prject team members, knwledge gathered frm the cmpanies represented in the prject team and interviews f individual cmpanies and equipment suppliers. Hwever, the prject did nt feature cmprehensive interviews f rganisatins frm ther industries r equipment suppliers/manufacturers. In the main, the prject fcused n mechanical equipment and equipment assemblies in safety class 3 and 2. The system level was als analysed because pieces f equipment are parts f a system and, fr example, requirements fr equipment derive frm systems. In sme respects, ther fields f engineering were als examined. Gals set fr the prject: Expansin f the graded apprach principle Develping the licensing prcedures s that the requirements and prcedures are truly lighter in case f, fr example, standard equipment, parts f equipment r equipment assemblies which are less significant fr nuclear safety, r smething in the lwer safety classes. Utilisatin f standard equipment Analysing the feasibility f nuclear facilities utilising equipment that has nt been manufactured in accrdance with nuclear-pwer specific standards and requirements, and the availability f reliability data n the equipment in questin Ensuring a cmprehensive supplier/manufacturer netwrk Finding ways t make the nuclear sectr mre attractive t suppliers Finding ways t further imprve the cperatin between licence applicants/hlders. The purpse f the prject was t present alternative prpsals fr imprving the licensing and qualificatin prcedures such that these prpsals will be prcessed further in cllabratin between the licence hlders and STUK after the prject. The current regulatins and perating principles were analysed cnstructively in the prject, striving t find ways t lighten and simplify the prcedures in a way that wuld result in imprved nuclear safety. The aim is t imprve verall safety, fr example by facilitating easier mdernisatin and a cmprehensive supplier netwrk as well as by managing t persuade the best and mst experienced suppliers t als supply nuclear facilities. The prject fcused n the Finnish licensing envirnment, thugh the aim is t utilise the results in similar analyses at the EU level in future.

11 11(37) 3 Other prjects n the tpic Sme f the challenges described in this reprt have als been bserved in the nuclear sectr utside Finland, and many in Finland and abrad have awakened t the develpments needed in rder t ensure the peratinal feasibility f the nuclear sectr. At the EU level, there is an nging prject titled Mdernisatin & Optimisatin f Eurpean Nuclear Supply Chain, which deals with the same tpic as the KELPO Prject described in this reprt. Nuclear peratrs frm several EU cuntries are participating in the prject. In Sweden, the tpic was discussed at a natinal level and a reprt n the use f standard equipment at nuclear facilities was published [3]. In additin, theses have been and are currently being written n the use f standard equipment at nuclear facilities. In 2017, TVO cmmissined a diplma thesis cnnected t the tpic, examining the use f standard equipment at nuclear facilities and cmparing the requirements and prcedures f the nuclear sectr with the il and gas industry in safety class 3 using case studies [4]. Frtum has an nging thesis examining the use f standard equipment and its qualificatin fr nuclear pwer plants, including hw the use f standard equipment imprves nuclear safety and the cst savings it can bring [5]. 4 Develpment fcuses and limitatins f the prject In accrdance with the prject plan, the prject fcused n the key develpment areas recgnised based n the experiences f the prject team, which are briefly utlined in this sectin. These develpment areas are nt separate frm ne anther; n the cntrary, they are clsely cnnected. The leading idea behind the develpment prpsals is that the safety f nuclear facilities is created thrugh, fr example, plant-level and system-level design bases, defence-in-depth levels, diverse and redundant systems as well as cmmn-cause and single-failure tlerance, and thus the equipment level culd, in sme cases, be prcessed with lighter prcedures than is the current practice, especially in safety class 3, but als in safety class 2. Fcus areas f the prject as specified in the prject plan: Change at the upper level f the scpe f inspectin: Shared apprvals: A new perspective t the scpe f inspectin, where cntrl is targeted differently frm the current practice, is prpsed fr the upper level. This is described in mre detail in Sectin 5.1. The prject reviewed hw t als utilise apprvals fr ther rganisatins and avid verlapping wrk when a cmpany has btained apprval fr a manufacturer r equipment, fr example. Shared apprvals as well as cperatin between licence hlders and suggestins in cnnectin t them are discussed in mre detail in sectins and 7. Use f alternative standards: The prject lked int intrducing alternative standards, which are used in ther industries, alngside nuclear-pwer specific standards as well as the effects and advantages f this and the availability f reliability data n standard equipment. On the whle, the prcedures and develpment prpsals presented in the prject serve the use f standard equipment, and the tpic is discussed in mre detail in Sectin 5.3. Reliability data is dealt with in Sectin 5.4 Mdificatin prject analysis:

12 12(37) Pilt: 5 Results The prject examined the life cycle f a mdificatin prject f safetyclassified equipment, described the current state f licensing and presented a visin fr the future (thrugh prcedures and dcumentatin). The current status and develpment prpsals are described in Sectin 5.2. A mdernisatin prject was selected which is prpsed t be pilted tgether with STUK, and the implementatin f the pilr prject was planned. The pilt is described in Sectin 6. The prcedures presented in this reprt are applicable t new nuclear facilities as well as replacement spare parts and mdificatin prjects at perating nuclear facilities. 5.1 Scpe f inspectin at the upper level This sectin intrduces and gives reasns fr the prpsed change in the scpe f inspectin at the upper level and discusses the changes and advantages it brings cmpared t the current situatin. Requirements cnnected t the safety design f nuclear facilities are based n the defencein-depth principle: plant design must be carried ut with several successive, independent and redundant structures and systems. The redundancy, diversity and separatin principles are als applied in design t ensure the perability f the safety functins even in the event f a failure. The verall safety f a nuclear facility is created thrugh plant- and system-level design bases, defence-in-depth levels, diverse and redundant systems as well as cmmncause and single-failure tlerance. Systems are designed such as t ensure that the failure f any single piece f safety-classified equipment cannt result in the lss f a safety functin. The regulatry cntrl and inspectins f nuclear facilities shuld fcus n areas that are essential t nuclear safety. Accrding t the principle presented and apprved in the prject plan (see Table 1), STUK s regulatry cntrl shuld fcus n the plant level and system level, in particular, frm which the specified requirements and design bases fr the lwer levels riginate. On the ther hand, the higher the safety class, the mre regulatry cntrl shuld fcus n the system level and equipment level. In the prpsal, STUK s regulatry cntrl is allcated accrding t the graded apprach principle by shifting cntrl activities in the lwer safety classes t authrised inspectin rganisatins (AIO) and t the licence hlder s independent persn/rganisatin r in-huse inspectin (licence hlder) r ther independent assessment. In safety class 3, prcedures cmmnly used in industry must, as a rule, be cnsidered sufficient t ensure equipment quality and cnfrmity t requirements. Back when the prcedures used in the nuclear sectr were drawn up, the requirements in ther industries, and thereby the quality and reliability f the nrmal prducts f manufacturers, were much lwer than tday. At the time, the prcedures t btain highquality equipment fr nuclear facilities were necessary and justified. Tday, custmers in ther industries demand that equipment be reliable, due t which the prcedures f equipment manufacturers and quality f prducts have imprved significantly in recent decades. The applicatin f the prcurement and quality assurance prcedures nrmally used in ther industries as well as the manufacture, inspectin and testing practices leads t a high-quality end prduct that cnfrms t requirements.

13 13(37) Table 1. Upper-level prpsal fr a new scpe f inspectin and allcatin f cntrl activities. SC1 SC2 SC3 Plant level STUK STUK STUK System level STUK STUK/Licence hlder* STUK/Licence hlder* Plant level ** STUK AIO/Licence hlder *** Licence hlder/ Third party Ntified bdy **** *) STUK apprves the final safety analysis reprt. After that, changes are assessed against it: small changes are prcessed by the licence hlder, while larger changes are submitted t STUK fr apprval. **) At equipment level, STUK apprves the general requirement specificatins fr equipment and materials alng with inspectin plans. ***) Lw-energy serially-manufactured equipment in SC2: Third party/ntified bdy. ****) Prcedures cmmnly used in industry equipment prcurement. Ntified bdy when PED is applied. As presented in Annex A t Guide YVL E.1, STUK currently plays a key rle at equipmentlevel in safety classes 2 and 3, and nly sme f the regulatry cntrl falls within an authrised inspectin rganisatin s purview [7]. The prpsed change in the scpe f inspectin prmtes the implementatin f the graded apprach principle. At present, the wrklad is largely fcused n the bttm right crner f the table, at the equipment level f lwer safety classes, even thugh cntrl shuld fcus where the fundatin fr safety is created, meaning the upper levels and higher safety classes. Mdificatins are the mst numerus in the lwer safety classes, which cntain a large number f systems and equipment, due t which their cntrl and inspectin cnsumes a cnsiderable amunt f time and resurces. Fr verall safety and t ptimise the activities f the licence hlder/applicant and the authrity, it makes sense t allcate the wrk accrding t the table hereinabve. It must be nted that the ther parties that carry ut regulatry cntrl (AIO, licence hlder) will cntinue t carry ut the wrk and cntrl in accrdance with the prcedures specified fr each area even after the change. The new apprach des nt mean decreased cntrl, but rather its allcatin t different phases and a different bdy than currently. The prpsed change als supprts STUK s new strategy, which states that the philsphy f STUK s regulatry cntrl will change and, in the future, STUK will steer regulatry cntrl based n safety benefits. In cnjunctin with its strategy refrm, STUK als emphasises that safety is nt created thrugh regulatry cntrl but rather as the result f the gd wrk f a respnsible peratr, emphasising the peratr s respnsibility [8]. When planning a change, the licence hlder must ensure that any equipment change r system change essentially cmplies with the safety requirements and design bases specified fr the riginal system. If a system change in safety class 2/3 is significant, the change must be submitted t STUK fr apprval. Minr changes that d nt affect the system-level design bases are prcessed thrugh the licence hlder s in-huse cntrl. The licence hlder must als assess the risks assciated with cmmn-cause failures and the necessity f the

14 14(37) equipment s cmmn-cause failure tlerance as well as ensure cmmn-cause failure tlerance. The reliable and safe peratin f a nuclear facility is f primary imprtance frm the perspective f the licence hlder/applicant. It can be partly guaranteed by ensuring that the equipment acquired fr nuclear facilities is high-quality and reliable. When lw-quality and unreliable equipment fails, it may cause extra utages and thereby affect the facility s prductin and prfitability. Therefre, the prcurement f high-quality and reliable equipment fr nuclear facilities is t the licence hlder s/applicant s advantage. That aim is als prmted by ther factrs, nt nly by the fficial requirements and apprvals required. The refrm and clarificatin f the prcedures in the lwer safety classes will als increase the inclinatin f equipment suppliers and manufacturers t supply nuclear facilities, especially if prcedures cmmnly used in industry can, in brad utline, be applied in safety class 3. At present, the heavy dcumentatin, inspectin and testing requirements that differ frm ther industries make the nuclear sectr cnfusing and uninteresting fr equipment suppliers and manufacturers. The best suppliers prefer t chse custmers that d nt require prcedures and dcuments that deviate frm its nrmal peratin. On the ther hand, the best end prduct is ften achieved when the manufacturer fllws its established practices and prcedures. Changes t these prcedures mean sme deviatin frm the nrmal manufacture and supply prcess, which may reduce the quality f the end prduct. This viewpint als recmmends adjustment f the prcedures cnnected t nuclear-sectr equipment prcurements in the lwer safety classes t be clser t the prcedures used in ther industries. The prpsed change in the scpe f inspectin will change the rle f STUK, the AIO and the licence hlder. Any change must be carried ut and fllwed thrugh between all interested parties, and the rles f all peratrs and the assciated perating principles must be cnsidered and develped tgether. With the prpsed change, STUK inspectins will fcus n the upper level and the higher safety classes, and in ther areas STUK will ccupy a mre distant regulatry cntrl rle. Hwever, it must be nted that, even thugh regulatry cntrl will underg a change, dcuments will be sent t STUK fr infrmatin in the apprpriate scpe, enabling STUK t supervise matters mre clsely t the extent it cnsiders necessary. The rle f the AIO will als change. At present, the AIO des nt have creative authrity in its regulatry cntrl r the pssibility t apply requirements at its discretin. In the future, this must be develped s that the use f an AIO des nt lead t stricter and mre inflexible requirements and prcedures than wuld be the case with STUK s prcessing. The develpment wrk must be dne in cperatin between STUK, the AIOs and licence hlders. With the change, the rle and respnsibility f the licence hlder will be emphasised, and licence hlders must imprve their prcedures t crrespnd with this rle in cperatin with the ther rganisatins. In rder t change the scpe f inspectin as prpsed, it must be reviewed what changes t existing legislatin are required (e.g. Nuclear Energy Act, Sectin 60a [1]). The necessary changes culd be carried ut in cnjunctin with the upcming ttal refrm f nuclear energy legislatin. 5.2 Mdificatin prjects: phases, prcedures and dcumentatin Descriptin f the principle The prject analysed the mdificatin prject f a safety-classified piece f equipment and the assciated licensing and qualificatin phases. Ptential develpment needs were sught by analysing these phases. The analysis fcused n prcedures cnnected t standard and serially-manufactured equipment. This sectin presents, fr cmparisn, the current state f licensing and qualificatin prcedures (5.2.2), a prcedure fr eliminating verlapping wrk f licence hlders (5.2.3) and a future prcedure prpsing mre changes frm the current state (5.2.4). This means that there are tw develpment prpsals cnnected t the prcedures f a mdificatin

15 15(37) prject: The prcedure fr eliminating verlapping wrk f licence hlders presented in Sectin can be implemented and its advantages achieved with relatively minr changes. As the licensing and qualificatin prcedures are wrked n and develped twards mre practical future prcedures, the first phase prpses an increase in cperatin between licence hlders, eliminatin f verlapping wrk and updating requirements and regulatins t make such cperatin pssible. This wrk must be started and the results applied in practice n a quick schedule. In the future, greater changes t the prcedures will be prpsed in accrdance with the new prcedure presented in Sectin The prject team recgnised that the practical applicatin f this prcedure will require mre changes and time. In the prpsed changes, the regulatry bdy is as prpsed in Sectin 5.1, depending n the level and safety class f the subject Current status The diagram in Appendix 1 depicts the licensing and qualificatin phases and prcedures f a safety-classified piece f equipment in the current situatin. The prpsed prcedure cvers all safety classes. The diagram shws hw three licence hlders each send similar r even the same dcuments t the regulatry authrity and separately apply fr apprvals, fr the same manufacturer r inspectin rganisatin fr example, even if they are abut t acquire the exact same equipment. This requires additinal wrk frm licence hlders, which separately prduce identical dcuments, and frm the authrity, which prcesses these identical dcuments individually. The diagram als presents the hld pints, beynd which wrk cannt prceed withut an apprved inspectin f the phases. They cause delays in wrk prgress and lead t mdificatin prjects being lng and time-cnsuming. Hwever, it must be nted that sme f the hld pints presented in the diagram can be cmbined and can thus be carried ut cncurrently. Sme f the phases presented, such as the general equipment requirement specificatin and manufacturer apprval, are nt carried ut separately fr each mdificatin prject; ften, they already exist. Hwever, this must always be separately cnfirmed Prcedure fr eliminating licence hlders verlapping wrk Appendix 2 (A and B) presents hw, by utilising shared apprvals, harmnising licence hlders activities and increasing cperatin, time-cnsuming licensing phases and the assciated wrk can be reduced even if the phases themselves remain quite clse t their current frm. The subjects recgnised and the related practices and prcedures prpsed are described in this sectin. This prpsed prcedure can be utilised in all safety classes and, particularly in safety classes 2 and 3, it can help achieve significant advantages in terms f reduced wrklads, expenses and the time required fr the mdificatin prject, because these safety classes cntain a large number f applicatins where similar, standard/seriallymanufactured equipment can be used at nuclear facilities. The simplificatin f mdificatin prjects will als lead t imprved nuclear safety when equipment reaching the end f its service life can be replaced mre easily with mdern equipment. The number f hld pints, beynd which wrk cannt prceed withut an apprved inspectin f the phases, will decrease with the new prcedure; after apprval f the manufacture cnstructin plan, the next hld pint is apprval f the installatin cnstructin plan. The phases during manufacture and during the acceptance f the prduct can be carried ut smthly, and the result dcumentatin can be reviewed during the installatin cnstructin plan review, at the latest. The perability analysis f E/I&C equipment will be dne at the same juncture, analysing the cmpatibility and cperativity f an E/I&C equipment and a mechanical cmpnent. Licence hlders will wrk t create shared dcuments and btain shared apprvals. On the ther hand, when licence hlders shared dcuments and apprvals are intrduced, the licence hlder must be able t refer in its dcuments t materials submitted previusly by

16 16(37) anther licence hlder and existing apprvals. It must nt be required that each licence hlder separately re-submit the same dcuments t the regulatry bdy. By increasing cperatin and cmbining verlapping dcumentatin, rughly speaking slightly ver ne-third f the separate actins/dcuments cnnected t licensing and qualificatin can be avided. Furthermre, shifting hld pints frm the manufacture phase t the installatin cnstructin plan review will reduce the time cnsumed by a mdificatin prject. When the cperatin between licence hlders and the wrk already dne by ther licence hlders can be utilised efficiently, thus reducing the time and resurces required fr an individual mdificatin prject, the threshld fr prcuring new equipment and carrying ut mdernisatins will be lwer. This will result in the imprvement f verall safety as the maintenance f safety-classified systems using mdern equipment becmes easier. The cntrl f this prcedure will take place as presented in Sectin 5.1, and the party implementing cntrl activities will depend n the level and safety class f the subject. Methds fr cperatin between licence hlders are discussed in Sectin General equipment requirement specificatins and material requirement specificatins Currently, each licence hlder/applicant creates its wn dcuments fr equipment requirement specificatins and material requirement specificatins. Each licence hlder prepares and maintains its wn dcuments, which STUK must als separately apprve fr each licence hlder. T the equipment supplier/manufacturer t, these dcuments, prepared separately by each licence hlder, can easily appear unclear and cnfusing as the licence hlders present requirements based n the same requirements, each in its wn, divergent way and in a different scpe. By imprving the cperatin between licence hlders, these dcuments can be shared, which will avid verlapping wrk cnnected t preparing and maintaining dcuments, als reducing the number f separate dcuments frm the perspective f the authrity prcessing them (STUK). Furthermre, harmnised requirement specificatins where the requirements are presented clearly will make it easier fr equipment suppliers/manufacturers t participate in nuclear prjects. Shared equipment requirement specificatins and material requirement specificatins f licence hlders/applicants are already pssible in light f the current regulatins. During the prject, STUK als expressed that such dcuments culd be cmmn t all licence hlders. In future, it must als be pssible t prcess them nly nce at STUK, and fr STUK t apprve them simultaneusly fr the use f all licence hlders. On the ther hand, if STUK has already nce apprved the dcuments submitted by ne licence hlder, it will nt be necessary fr anther licence hlder t submit the same dcuments t STUK fr apprval. Instead, the licence hlder can refer t the decisin with which the dcuments were previusly apprved in the dcumentatin it sends t STUK. The cntents and frmat f requirement specificatins need t be develped s that the cntents are clear and directly usable during the prcurement phase when requirements are presented t the equipment supplier. Jint requirement specificatins and a clear and apprpriate frmat fr their cntents are discussed in mre detail in Sectin Apprval f manufacturers, inspectin rganisatins and testing rganisatins At present, the apprval f a new manufacturer is a heavy and time-cnsuming prcess, causing wrk fr the licence hlder/applicant as well as fr the manufacturer being apprved. Fr this reasn, nuclear facilities prefer t use prducts frm manufacturers wh have already been apprved nce in rder t avid the heavy and time-cnsuming apprval prcess fr a new manufacturer. In sme cases, the riginal manufacturer f the equipment t be replaced has left the market, and the riginal equipment is n lnger available and the manufacturer n lnger exists. In such cases, the mdificatin may even be left undne due t the massive amunt f wrk needed t have a new manufacturer apprved. Frm the licence hlder s perspective, it is mre cst-effective t wear ut the existing equipment than t replace it with new equipment when the need arises.

17 17(37) Currently, each licence hlder/applicant applies fr apprvals f equipment suppliers separately, as needed. This means that, in rder t have a manufacturer apprved, each licence hlder separately submits dcuments n the same supplier. This creates unnecessary, verlapping wrk fr manufacturers, licence hlders and the regulatry authrity. In rder t avid verlapping wrk, licence hlders/applicants must cperate by applying fr apprval fr manufacturers jintly all at nce. Licence hlders must als be able t utilise existing manufacturer apprvals applied fr by anther licence hlder. Once a manufacturer has been apprved t supply a certain type f prduct t a Finnish nuclear facility, the manufacturer must be able t als supply these prducts t ther nuclear facilities based n the same apprval. Frm the perspective f the authrity, it must be sufficient that the manufacturer has already been apprved t supply prducts t nuclear facilities, regardless f which licence hlder applied fr the apprval. Other licence hlders can, in their dcumentatin, refer t a manufacturer apprval that has already been prcessed nce, thus aviding verlapping wrk. Crrespndingly, the apprvals f inspectin rganisatins and testing rganisatins must be prcessed as shared and such that anther licence hlder des nt need t separately apply fr the apprval f an rganisatin that has already been apprved nce. Instead, the rganisatin can be cnsidered apprved based n an apprval applied fr by ne licence hlder. The apprval f manufacturers and qualificatin f special prcesses must als be dne with jint apprvals. In the future, requirements cnnected t these must be based n standards, where applicable, with n ther apprvals r qualificatins required Manufacture cnstructin plan At present, a manufacture cnstructin plan has a great deal f cntent that can be created jintly by licence hlders when acquiring the same equipment frm the same supplier. In the future, the cnstructin plan must be shared, where applicable. The jint manufacture cnstructin plan will be supplemented with plant-unit specific requirements and design values such that plant-unit specific requirements are presented separately and lcatinspecific data is nt presented in the manufacture cnstructin plan but rather with the installatin cnstructin plan, where the suitability f the equipment and its design values fr the lcatin will be reviewed Preliminary and final suitability assessment f E/I&C equipment The preliminary and final suitability assessments f E/I&C equipment can be carried ut jintly by licence hlders such that they may share the same general sectin. Lcatinspecific data and cperativity with a mechanical cmpnent will be discussed in the perability analysis. In ther respects, an E/I&C equipment will be dimensined fr the lcatin during nrmal mdificatin planning Analyses and tests Licence hlders may jintly carry ut the necessary analyses, r have them carried ut, fr example t ensure the seismic resistance f equipment r equipment assemblies. Once analyses and tests have been cnducted fr a specific piece f equipment, it will be unnecessary fr anther licence hlder t have them carried ut separately (presuming that the requirements and design values used as the basis f the analyses match) Natinal apprvals f safety-classified equipment Once standard/serially-manufactured equipment has been apprved fr use at a nuclear facility in Finland, the same equipment can, based n this apprval, als be used at anther Finnish nuclear facility in a similar peratinal lcatin. In its dcumentatin, a licence hlder may refer t existing apprvals and the wrk carried ut by anther licence hlder. Lcatinspecific suitability will be analysed befre installatin.

18 18(37) Prpsal fr the new prcedure Mdificatin prject phases and prcedures under the prpsed new prcedure are utlined in the diagram in Appendix 3 which, in additin t the mdificatin prject phases, als presents the dcumentatin t be submitted t the party implementing cntrl activities during each phase and the apprvals required frm the party implementing cntrl activities. This prpsed prcedure is suitable fr standard/serially-manufactured mechanical equipment in safety classes 2 and 3. The prpsal fr the new prcedure emphasises the licence hlder s wn respnsibility fr changes and the apprval f their acceptability as well as the licence hlder s respnsibility fr successful equipment prcurement that cnfrms t requirements. Sme f the regulatry cntrl measures required frm the authrity in the current practice will transfer fr the licence hlder t perfrm, and the fcus f regulatry cntrl will shift t installatin and inspectins that prepare fr cmmissining. In the final phases f a mdificatin prject, the cntrl measures during inspectins cnnected t cmmissining will remain unchanged, and an perating licence issued by the regulatry bdy will be a precnditin fr adpting the mdificatin int peratin. The licence hlder s failure in its wn peratins will reflect directly in delays in cmmissining, but it will nt affect nuclear safety. The cncentratin f regulatry cntrl and inspectins in the final stretch f the prject will make it pssible t carry ut the earlier phases efficiently and smthly withut delays caused by the cnsecutive prcessing f several dcuments. This will make it easier t intrduce changes as the ttal time required fr the prcess becmes shrter. A change can be carried ut at the right time in terms f the plant s peratin and availability as well as with full utilisatin f data received frm cnditin mnitring. In the best-case scenari, this will prevent an unplanned shutdwn f the plant due t failure, which will further imprve the plant s verall safety cmpared t the current practice. Phases cnnected t actual equipment prcurement, which are described in Sectin (shwn n green backgrund in the diagram in Appendix 3), can be carried ut separately frm the mdificatin prject, and the necessary equipment can be prcured in advance and placed in strage. This way, when the time cmes fr the mdificatin, the ther steps can be fllwed in accrdance with the diagram, except that the equipment purchased in advance is taken frm strage and its suitability fr the intended lcatin is verified. Phases cnnected t equipment prcurement culd als have ptential fr further imprvement f the prcedures and methds twards unifrm and jint prcurement by licence hlders. Clarificatin f the prcurement prcess, especially fr the equipment supplier/manufacturer, and bringing it clser t the prcedures used in ther industries will make the prcess clearer fr suppliers and will make it easier fr them t participate in nuclear prjects. It will help demnstrate t equipment suppliers and manufacturers that supplying equipment t nuclear facilities can be sensible business, making it pssible t chse the best suppliers fr nuclear prjects t, frm a wide range f suppliers instead f being frced t buy frm a small and increasingly smaller grup f suppliers that currently agree t supply nuclear facilities. It must be nted that the times prpsed fr dcumentatin submissin in the prcedure are the submissin deadlines. If the dcumentatin is available earlier, it is naturally sensible and advantageus fr all parties t prvide and prcess the dcumentatin as sn as pssible. Appendix 4 presents a cmparisn between the current prcedure and the prpsed new prcedure in safety class 3. The cntrl measures under the current prcedure during different phases are presented based n the currently valid versins f the E series f YVL Guides (E.3, E.8 and E.9). The requirements f E.1 and E.12 regarding inspectin and testing rganisatins are als tuched n. [9] The cntrl f this prcedure will take place as presented in Sectin 5.1, and the party implementing cntrl activities will depend n the level and safety class f the subject.