Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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3;para 5.14 and audit reports, regulatory documents, licences, certificates of approval and authorizations, etc.) defined in accordance with established standards and incorporate the applicable requirements? STUK has used ISO9000 standard series and IAEA requirement documents as a basis when developing its Management System and regulatory guides. In the development of regulatory guides also other established standards have been used, such as IEE, ASME etc. If ‘Yes’ go to: SQID 18.1 If ‘No’ go to: SQID 18.6 Otherwise go to: QID SQID QTYPE References True Subsidiary Question Next Question 18 18.1 Text Safety Standards Series No. GS-R- 3;para 5.14 Describe how products of regulatory activities that interface or interact with each other are identified and controlled. SQID 18.2 Main products of regulatory activities are all documented in document management and achieving systems and they are always available when relating issues are handled. The activities of records management and archive are described in details in Guides HAE 3.5 and guidance for document management is presented in Guides STUK 4.7, STUK 4.9, STUK 4.10 and STUK 4.12. In addition STUK has internal guidance (Guide YTV 6.1) for inspectors that the preparer examines the documents submitted and clarifies the background to the case using SAHA (document management system) for example. QID SQID QTYPE References True Subsidiary Question Next Question 18 18.2 Text Safety Standards Series No. GS-R- 3;para 5.15-17 Describe the extent of arrangements in place that ensure all the products of regulatory activities and processes are verified in accordance with specified requirements. SQID 18.3 STUK has well defined processes for documents submitted by authorized organizations (Guides STUK 4.7, STUK 4.9, STUK 4.10, STUK 4.12, SKV 3.4, SKV 11.1, YTV 6.1 and YTV 6.5). All these guides include also verification. In most regulatory decisions at least two people are connected to the work. For inspections at nuclear facilities STUK uses electronic inspection protocol system (TARKKA) which also required verification. In addition STUK monitors, measures and evaluates its activities by many means ( for example Guides STUK 6.1 , STUK 6.3 and STUK 6.5 ) QID SQID QTYPE References True Subsidiary Question Next
18 18.3 Text Safety Standards Series No. GS-R- 3;para 5.18 How is it ensured that products do not bypass the required verification activities? Question SQID 18.4 STUK’s decisions are usually signed by two staff member, presenting officer and decision maker. This ensures that products of regulatory processes are not bypassing verification activities. In addition the products of regulatory activities (review and assessment reports, inspection and audit reports) are followed by management surveys (Guide STUK 6.4). QID SQID QTYPE References True Subsidiary Question Next Question 18 18.4 Text Safety Standards Series No. GS-R- 3;para 5.19 What are the arrangements in place to ensure the identification of the products for their proper use and ensure their traceability? SQID 18.5 STUK’s Management System includes clear guidance to ensure the traceability of products (Guide STUK 4.7). The proper use in STUK is also included in the same Guide. QID SQID QTYPE References True Subsidiary Question Next Question 18 18.5 Text Safety Standards Series No. GS-R- 3;para 5.20 What are the arrangements in place to ensure prevent loss, deterioration or inadvertent use of products? PQ 19 STUK’s Management System includes clear guidance to ensure prevent of loss, deterioration and inadvertent use of products (Guide STUK 4.7). In addition STUK’s document management System SAHA has procedures for user management and IT unit is responsible for taking back-ups of all data in STUK’s systems. QID SQID QTYPE References Primary Question Answer PA 19 Primary Safety Standards Has the regulatory body ensured that records are Yes No B Series No. GS-R- 3;para 5.21 specified in the process documentation and that they are controlled? X Select ‘Yes’ or ‘No’ above and if desired, enter notes or comments here If ‘Yes’ go to: SQID 19.1 If ‘No’ go to: SQID 19.4 Otherwise go to: QID SQID QTYPE References True Subsidiary Question Next Question 19 19.1 Text Safety Standards What are the arrangements to ensure that all records SQID 19.2
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Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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