Experiences and Lessons Learned from the Application of Different Management System Standards in the Nuclear Industry Lukman Hakim Nuclear Energy Regulatory Agency IAEA VIC M Building, Room M2 Vienna, Austria 15 19 December 2014
Content Nuclear Regulatory Hierarchy Current Status of Reference Continouse Improvement BCD 04/2010 BCD 15/2014 Case : Ir-192 Sources Conclusion 2
NUCLEAR REGULATORY HIERARCHY System Management IMPLEMENTING REGULATION ACT GR ACT No.10/1997 Nuclear Energy 26/2002; 33/2007; 29/2008; 54/2012 ; 61/2013; 02/2014 Pres.Reg 49/1986; 80/1993; 81/1993; 82/1993; 106/2001; 46/2009 Chairman Decree 04/2010 Nuclear Management System 15/2014 BAPETEN Management System GUIDELINES / Work Instructions Management System 3
REFERENCE Employees Req t Management Responsibility Stakeholder Req t Customer Req t Monitoring, Measurement, Assessment, and Improvement Safety Culture Resources Management Supplier Req t Regulator Req t Process Implementation Society Req tt INTEGRATES REQUIREMENTS OF ALL FACTORS AFFECTING THE ACTIVITIES 4
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Continuous Improvement BCD No. 10 / 2011 BMS BC No. 15 / 2014 SIJAMUPATEN BC No. 2 /2006 ISO 9001 ISO 9004 ISO 9001 ISO 9004 GS-R-3 IRRT 1999 & 2003 GS-R-3 ISO 9001 ISO 9004 Team RB 2011 IAEA Review 2012 # IAEA International Regulatory Review Teams (IRRT) 6
BCD 04/2010 (user) Operators basis for their Management Systems to discharge their prime responsibility for safety basis for the interaction with the other parties Suppliers basis for additional safety requirements in contracts basis for introduction of additional requirements into their management systems 7
BCD 04/2010 To manage : Nuclear Installation; Activities that use ionizing radiation sources; Radioactive waste management; Radioactive transportation; Radiation protection activities and / or Any other practice or circumstances in which people may be exposed to radiation from naturally occuring or artificial sources (Article 3 (2)) Applies to all activities (Normal, Transient, and emergency) Article 3- (3) 8
Ch 3 : Management System 1- Safety Culture 3 Documentation a. characteristics and activities of the organization; and b. complexity and interaction of processes 2 - Grading Application SM Req t complexity and level of importance of each product or activities easy to read, easy to understand, can be identified immediately, and available at the time of use. adjust resources appropriately; products or activities of each process. potential hazards and impacts associated with aspects of safety, combined with other aspects The result that can be caused by a failure of a product or errors in the conduct of activities 9
Ch 4 : Management Responsibility 1. Commitment 2. Stakeholder Satisfaction 3. Organizational Policy 4. Planning 5. Responsibilities and Authority for Systems Management must take into consideration the expectations of stakeholders in activities and interactions in the process management system to improve the satisfaction of interested parties and at the same time ensuring there is no compromise on safety implementation of the plan reviewed regularly against performance targets at least 1 (one) years; and actions taken to correct any deviations from the plan. 10
Ch 5 : Resources Management Licensee must ensure every personnel are competent to carry out the work assigned and understand the influence of his work on safety. licensee must ensure that all personnel have obtained the proper education and training, and have acquired the skills, knowledge, and experience to achieve the necessary competence. Licensee must ensure education and training to foster awareness of the importance of the effect of any personnel on safety activities in achieving the organization's objectives. Licensee shall establish, provide, maintain, and re-evaluate the infrastructure and working environment necessary for the work carried out in accordance with the safety requirements 11
General Process Ch 6 : Process Implementation Control of Document s Control of Product s Control of Record s Purchasing Communication Managing Organizational Change Developing Process Process Management 12
Ch 7 : Monitoring, Measurement, Assessment, and Improvement Monitoring and Measurement Assessment Self Assessment Independent Assessment Management Review (bianually) Nonconformity, Corrective Action, and Prevention Improvement to ensure the suitability and effectiveness of sustainable management system and its ability to achieve the target organization a. output of all forms of assessment; b. given the results and goals achieved by the organization and its processes; c. nonconformity, corrective and preventive actions repetition mismatch; d. lessons from the experience of other organizations as appropriate; and e. opportunities for improvement. submit the results of the review to BAPETEN as Information 13
Continuous Improvement BCD No. 10 / 2011 BMS BC No. 15 / 2014 SIJAMUPATEN BC No. 2 /2006 ISO 9001 ISO 9004 ISO 9001 ISO 9004 GS-R-3 IRRT 1999 & 2003 GS-R-3 ISO 9001 ISO 9004 Team RB 2011 IAEA Review 2012 # IAEA International Regulatory Review Teams (IRRT) 14
WHAT'S EXPECTED? To ensure performance accountability BAPETEN; To ensure adherence to specified requirements and in accordance with laws and regulations relating to generate output control; standardize every process BAPETEN comprehensively and clearly; To assign responsibility and authority limits and output performance of each unit and work unit; standardize documentation and record control system; and realize institutional strengthening, and human resource management BAPETEN. Fulfilling regulations and requirements Stakeholder satisfication 15
Documenta tion Measurement, Analysis and Improvement 8.1. general 8.2. Monitoring and Measurement 8.3. control discrepancy Output compliance BAPETEN 8.4. Data analysis 8.5. Improvement 1. Introduction 2. Purpose 3. Vision, Mission & Values 4. Organization 5. Scope 6. Definition II I Management Responsibilities 5.1. Commitment 5.2. Stakeholder Satisfication 5.3. Organizational Policy 5.4. Planning 5.5. Responsibilities and Authority for Systems Management 5.6. Management Review Process Implementation 7.1. Overview 7.2. Process Planning (including stakeholders relevant). 7.3. Innovation 7.4. Activities Implementation Requirements. Safety & Security Culture to produce output for BAPETEN III Grading Resources Management 6.1. Provision of Resources 6.2. Human Resources 6.3. Infrastructures 6.4. Procurement 6.5. Equipment control Monitoring, Measurement, Assessment, and Improvement 6.6. Environmental 6.7. Finance 6.8. Knowledge, Information and Technology Stakeholder Satisfication IV 16
BAPETEN MANAGEMENT SYSTEM BMS 15/2014 VISION MISION VALUES To carry out nuclear Supervision - Safety, Security and safeguardwith international standards Developing and strengthening the Nuclear Security Infrastructure and National Nuclear preparedness Become The World Class of Nuclear Regulatory Body independence Integrity Profesional Transparent Service Excellent 17
Licensing Assessment 18
TENORM Tin-Slag from Tin Mines BAPETEN (NERA) Nuclear Power Plants!? Nuclear Research Reactors (BATAN) RSG-GAS (30 MW) TRIGA-2000 (2 MW) KARTINI (100 kw) Nuclear Installations BATAN Nuclear Installations Non-BATAN / INUKI RR Fuel Element Prod. Inst. RadioIsotopes and Radiopharmachy Prod Inst. 30/12/2014 19 19
Map of The Distribution Industrial Permits in 20
Case : Ir-192 Sources Ir-192 sources of Gamma Camera was broken in the remote area of Oil and Gas Area. NERA investigation and founding : Welding capsules is not good (in field); Speed up production to meet demand so that the effect on the quality; Management is not commitment in safety ; Enforcement : License Suspended Action : Licensee should be improved management system 21
Process for Control of Work (Inspection on Production Radioisotopes Installation) Activities must be checked and verified by competent persons Before being distributed, documents and data production must be verified by a competent person, other than the person who prepared them. All documentation relating to particular products must be unambiguously linked to the products. All inspection activities of quality related products shall be conducted by competent persons different from those who conducted the activity. All controls and verifications must be documented. 22
Capsules Welding (1) (Applied by facilities) Welding under ASME is recognized as being so important that the requirements are incorporated in to the dedicated Section IX of the code. This section includes code specific requirements for the qualification of welders and welding procedures, together with guidance on-weld joint design, base metal and filler material properties. The Welding Requirements specified in the Licensee code covers both general provisions and specific requirements such as the required Welding Data Pack Information and weld filler material qualification. The required weld qualification procedures and welder qualification is covered by the appropriate ISO standards, but with additional requirements. 23
Capsules Welding (2) Iridium-192 (IR-192) sources are constructed using iridium metal discs or pellets of uniform size in a welded stainless steel capsule. The source cores prepared were encapsulated in titanium or stainless steel capsules and welded. The welding was mostly carried out by TIG welding for stainless steel ones. Quality control tests examining various parts of the capsule before welding, leak tests to check welding wipe tests for radioactive contamination, accurate activity measurements and source uniformity of the welded capsule. Safety must always be the prime consideration. Standards for sealed radioactive source testing have been specified by : ISO.2918 : Wipe Test Passed at 120 Psi ISO/TR4816(E) 1994 Passed at < 5 nci (<185 Bq) ISO.9978 'Sealed radioactive sources leak test methods passed vacum pressure at 20 in Hg 24
Measurements Each source or batch of sources is checked to ensure that the strengths of the sources supplied are within the limits specified. Wherever possible, the results of these checks are indicated on the rest report. Test Reports A test report is supplied with each source or batch of sources. The following information is supplied where applicable: Product code Product description Capsule type ISO classification Special form certificate Serial number of source Measurement check Leakage check Contamination check 25
Conclusion Commitment management is very important in management system to achieve safety culture; The management systems of licensee or organizations that provide nuclear items or products and services must comply with safety requirements; BCD 04/2010 (adopted from GSR-3 ) need to be complemented by industry standards to address specific technical and regulatory requirements; The standards developed by the ISO are complementary technical documents that emphasize industrial application and contractual aspects. 26
Thank You 27