Laboratory Accreditation for power .pptx

Laboratory Accreditation for power using nuclear technique

1. THE IAEA QUALITY POLICY AND OBJECTIVES Past and current activities Ales Fajgelj Quality Systems Manager Office of the Deputy Director General Department of Nuclear Sciences and Application Training Workshop on Quality Assurance for Nuclear Spectrometry F1-TR-52968, 19-23 June 2017 Vienna, Austria

2. Within the NA Department

3. Mutual Recognition Arrangement (MRA) signed by the IAEA in 1999 ‘Measured once, accepted everywhere’ Within the NA Department IAEA DMRP Section, Division of Human Health Dosimetry Laboratory, IAEA Laboratories Operational Quality System according to the ISO 17025:2005 standard, as essential component of measurement and calibration capabilities, demonstrated to and accepted by the Joint Committee of Regional Metrology Organizations and BIPM (JCRB) on 6 October 2006.

4. Formal Laboratory Accreditation

5. Quality Management within the IAEA SEC/NOT/1900 Director General CCA Quality Management active since 2004 Agency medium term strategy 2006-2011: Agency medium term strategy 2012-2017 Enhancement of Agency Responsiveness and Quality Management for quality performance to be sustained, a quality management culture needs to be created and sustained within the Secretariat along with the implementation of a quality management system . The Secretariat will continue to vigorously pursue opportunities to improve its efficiency, both in its programme activities, as well as in its management practices. The Secretariat will use best practice tools, including a comprehensive application of quality management , and benchmarking, and it will continue its commitment to a more systematic approach to identifying, quantifying and reporting on efficiency gains.

6. Quality - the IAEA cross cutting activity Director General in SEC/NOT/1900; 2002-03-19 Cross Cutting Activity Quality Assurance Chairman: Mr. J. Patten (SG) Secretary: Mr. P. Vincze (NE) NA representatives: A. Fajgelj and J. Izewska WGs: General, Inventory, Accreditation, Revision of Safety Standards on Management System, Liaison with ISO 176 Currently ongoing interaction with DGO regarding IAEA Quality Policy Statement and Quality Policy. Clear responsibilities and roles related to the IAEA QM are still to be defined, including future of the CCA-QM Committee.

7. Current NA Quality Policy Statement The International Atomic Energy Agency is seeking to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world. Within this context, the mission of the Department of Nuclear Sciences and Applications is to contribute to sustainable development in Member States through the use of nuclear sciences and their applications in food and agriculture, human health, industry, water resource management, and environmental monitoring, research and protection, with due regard to safety. The Department is committed to meet the Member States priority needs in an efficient and effective way. To support this commitment and in recognition of the need for the continuous quality improvement necessary to meet programmatic challenges, the Department of Nuclear Sciences and Applications will follow quality management principles as described in the ISO Standard 9001:2000, ISO Standard 17025:2005 and other international standards and guides relevant for Departmental activities. This quality policy statement represents the commitment of the Departmental top management and its support for the implementation of quality systems for specific Departmental activities. While the Deputy Director General–NA carries the ultimate responsibility for the effectiveness and quality of the work of the Department of Nuclear Sciences and Applications, it is expected from the NA Directors, Section and Unit Heads to provide the leadership, support and necessary resources for the implantation of quality management principles at all operational levels. Where relevant, a formal quality system should be established. All NA staff members should be fully aware of this policy and should contribute to its implementation when carrying out their assigned duties and responsibilities.

8. View in the future: Department of Safeguard  ISO 9001/GS-R-3 Department of Nuclear Energy  Department of Nuclear Sciences and Applications  ISO 17025, ISO ISO17034 and ISO 17043, GS-R-3 Department of Technical Cooperation  Department of Management  Department of Nuclear Safety and Security  ISO 17025, GS-R-3

9. Within the NA Department Reference materials and proficiency tests (P & B 2008/2009: Realignment 2010, P & B Subprogramme 2.4.1) Testing (chemical & physical) Training and Services Instrumentation, etc. Provision of data (nuclear data bases) .................... Networks (ALMERA, etc.)

10. Prerequisites Top Management decision/commitment required Scope and target time to be clearly defined Necessary resources to be assured Staff involved (responsibilities and authorities) Each RM to be run as a projects Collaborators to be incorporated properly Team work and communication RMP accreditation

11. 11 of 19 Managing Successful Projects Pr ojects in C ontrolled E nvironment (PRINCE) PRINCE 2 Project: A finite and defined life cycle A defined and measurable business products A corresponding set of activities to achieve the business products A defined amount of resources An organizational structure, with defined responsibilities, to manage the project

12. PRINCE 2 cont. PRINCE2 relationship with projects and business

13. PRINCE 2 cont. PRINCE2 processes and components

14. Project processes and components Business Case (Project aim) Organization (Project team) Plans (Project plan) Controls (Milestones) Management of Risks (Constrains) Quality in a Project Environment (Product quality) Configuration Management (Products) Change Control (Changes)

15. Business Case (Project aim) Accreditation according to ISO 17034 and ISO 17025 in 3 rd quarter 2017 ( 2 nd quarter 2014) , with the following scope: Production of reference materials of environmental origin characterized for radionuclides (Bq/kg  activity concentration ≈ massic activity ≈ specific activity of gamma emitting radionuclides) Determination of activity concentration of gamma emitting radionuclides by high resolution gamma spectrometry in the energy range between 45 keV and 2.5 MeV - In-house method (or selected radionuclides) Determination of moisture content by Karl Fischer method - s tandard or modified standard methods. Particle size analysis using laser light scattering

16. Organization Project Board (= Project Executive) : DDG-NA, DIR-NAEL Project Managers: M. Groening, I. Osvath, M. Angelidis Team Managers: M. Rozmaric, A. Harms, S. Tarjan A. Pitois (QM Seibersdorf), A. Mauring E. Vasileva-Veleva , S. Asonov Team Members: Seibersdorf: T. Benesch, A. Trinkl, RM Specialist, Monaco: M. Pham, L. Lliong Wee Kwong, J. Bartocci, I. Levy, O. Blinova, S. Azemard,, J. F. Comanducci Project Management Team Project Facilitator A. Fajgelj

17. Plans (Project plan)

18. Plans (Project plan) cont.

19. Controls (Checks, Milestones) Regular meetings List of actions (continued) Reports to Project Board ( on a two month basis) Internal audits (at least two) (Pre-audit ?)

20. Management of Risks (Constrains) Time Cost Quality Scope Benefit People/Resources

21. Management of Risks (Constrains) People/Resources Rotation of P Staff Members ... Time 3 rd quarter 2017 has to be met, certificate to be obtained before the GC 2017, Cost (~ 30000 €, exact numbers to be obtained) Scope (potential to be expanded) Benefit Added value to the IAEA reference materials, opening the door for other formal quality management set-ups, integral part of laboratory modernization,...

22. Quality in Project Environment Quality requirements directly imply on measurement results: gamma spectrometry, Karl Fischer method Regarding RMP quality requirements should be more generic; they will be defined for each RM separately in the RM project Quality system covers this area

23. Configuration Management Quality documentation Quality records Equipment RMs (= products) Storage an post delivery services and activities Quality system covers this area

24. Change Control Response to changes Project Issue Management (Project issue might be raised at any time during the project, by anyone with an interest in the project outcome!) Risks Cost Time Advantage Saving Promotion Change

25. Some points of consideration Quality Policy : Review required , leadership , resources , etc. Links of QM with other NA groups: e.g. Knowledge Management Links of QM with NA Strategic Plan Integration of QM into laboratory modernization plans