1. RER8010 Quality Control Methods and Procedures for Radiation Technology Mikiko SAWANISHI Programme Management Officer (PMO) Division for Europe Department of Technical Cooperation IAEA 12 June, 2007, Bran, Romania

2. PMO Goals Get to know members/experts in participating countries Get to know members/experts in participating countries Understand the outline of the subject Understand the outline of the subject Understand the results of the project 05- 06 and the latest status of each country Understand the results of the project 05- 06 and the latest status of each country Seek guidance on 07-08 Work Plan and activities Seek guidance on 07-08 Work Plan and activities Explore possible synergy w/ other projects in industrial application (e.g. RER8011) Explore possible synergy w/ other projects in industrial application (e.g. RER8011)

3. 2007-2008 Cycle (www.pcmf.iaea.org) Objective: To enhance MS ’ s capabilities in applying harmonized quality control methods and procedures in the radiation processing of human health related products as well as advanced materials. Promotion of nuclear technology ’ s contribution to the health, environment and technological progress related areas. Objective: To enhance MS ’ s capabilities in applying harmonized quality control methods and procedures in the radiation processing of human health related products as well as advanced materials. Promotion of nuclear technology ’ s contribution to the health, environment and technological progress related areas.

4. Total Budget Total 2 Years ($148.440) Total 2 Years ($148.440) 1 st Year $76.820 1 st Year $76.820 2 nd Year $71.620 2 nd Year $71.620 Extra-budgetary resources are necessary and welcome

5. 2005-2006 Cycle Outcome achieved through outputs produced (development impact !) Coordination Meeting in Poland (21-25 February 2005) Coordination Meeting in Poland (21-25 February 2005) Expert Missions (e.g. Poland to Slovakia) Expert Missions (e.g. Poland to Slovakia) Comparison Trial (05-06) Comparison Trial (05-06) Training courses Training courses ------------ ------------

6. What is the difference between 05- 06 and 07-08, and future ? 05-06 – development/improvement of radiation processing techniques 05-06 – development/improvement of radiation processing techniques 07-08 – enhance MS ’ s capabilities in applying harmonized QA/QC methods and procedures in the radiation processing 07-08 – enhance MS ’ s capabilities in applying harmonized QA/QC methods and procedures in the radiation processing 09-11 (3 years) ? 09-11 (3 years) ?

7. Improvement in 07-08 Project (Phase I) Introduction and extension of radiation technologies to process health care products & advanced materials. (Phase I) Introduction and extension of radiation technologies to process health care products & advanced materials. (Phase II) Harmonization of: testing methods and new technologies adapting the QA/QC and Safety Standards. (Phase II) Harmonization of: testing methods and new technologies adapting the QA/QC and Safety Standards. Improved inter-comparison Exercise (PART2) Improved inter-comparison Exercise (PART2) Assistance for the accreditation Assistance for the accreditation

8. Expected outcome/outputs 07-08 Quality management system established Quality management system established (tangible results) At least 2 labs ready for accreditations At least 2 labs ready for accreditations 10 dosimetry certificates given 10 dosimetry certificates given 18 people trained in Dosimetry 18 people trained in Dosimetry 15 people trained in Monte Carlo Methods 15 people trained in Monte Carlo Methods

9. Synergy with other programmes IAEA TC Regional(RER8011 (EBFGT), RER0023 (Sustainability), RER5013 (Mutant Cereals) etc.), National Projects IAEA TC Regional(RER8011 (EBFGT), RER0023 (Sustainability), RER5013 (Mutant Cereals) etc.), National Projects IAEA CRP and Other Technical Activities IAEA CRP and Other Technical Activities EU and other regional programmes EU and other regional programmes Bilateral cooperation Bilateral cooperation

10. Work Plan 2007 ActivityBudgetTiming Workshop on harmonization on QA/QC methods $27.5K June 07 Training Course on EB Dosimetry (Riso Lab) 9 trainees $25.5K 22 -26 Oct. 07 SV for radiation facilities & technologies familiarization $7.32K 1 wk 07 EM to audit QC procedures (2- 3) $6.6K 1 wk Oct. 07 EM to provide dosimetory intercomparison exercise $9.9K 2 wks Sept. 07

11. Work Plan 2008 ActivityBudgetTiming SV for radiation facilities & technologies familiarization (AC) $7.725K08 Training Course on Gamma Dosimetry (Riso Lab) 9 trainees $28K Oct. 08 Training course on computational methods in gamma & X-ray irradiation processing $25.5K Feb.08 or July 08 TBD (Ukraine) EM on voluntary audit at irradiation facilities (accreditation preparation) $10.395K08 2 wks

12. Riso Training on EB Dosimetry (2007) Objectives of the training Objectives of the training Content of the training Content of the training Qualifications of Participants (countries w/ running facilities, experience w/ dosimetry) Qualifications of Participants (countries w/ running facilities, experience w/ dosimetry) Costs (training fee plus costs) – provided a hotel residence Costs (training fee plus costs) – provided a hotel residence

13. Inter-comparison exercise (07) Objectives Objectives Differences/improvement from the previous trial Differences/improvement from the previous trial Costs for the exercise Costs for the exercise Expert Expert

14. Familiarization SV (2007) Objective of the SV Objective of the SV Which country to which county ? Which country to which county ? When (1 week) When (1 week)

15. EM to QA/QC audit (2007) Objectives Objectives Procedures Procedures Who should go to where Who should go to where When (1 week in one country, or 2 days to 3 countries?) When (1 week in one country, or 2 days to 3 countries?)

16. Training course on computational methods in gamma & X-ray irradiation processing (2008) Venue (Ukraine) Venue (Ukraine) Timing-1 week, February 2008 Timing-1 week, February 2008 Number of Trainees (15-20 people) Number of Trainees (15-20 people) Objectives Objectives Training content and methodology Training content and methodology Computer Program ($9,000, open-license) Computer Program ($9,000, open-license)

17. 7 Criteria Networking and information sharing Networking and information sharing Self-reliance and sustainability Self-reliance and sustainability TCDC Framework, helping each other TCDC Framework, helping each other Cross-boarder problem Cross-boarder problem Regional Norm Setting Regional Norm Setting

18. New Concept Ideas 09-11 Radiation Technology in Nano and advanced materials based on natural Polymers. (New Concept will be formulated by a group, Poland, Romania, Kazakhstan?, Hungary, and others.) Radiation Technology in Nano and advanced materials based on natural Polymers. (New Concept will be formulated by a group, Poland, Romania, Kazakhstan?, Hungary, and others.) Tissue banking? (may be a separate concept) Romania will prepare a concept (Poland, Romania, Portugal, Hungary and others) Tissue banking? (may be a separate concept) Romania will prepare a concept (Poland, Romania, Portugal, Hungary and others)

19. RER8010 Phase III Objectives Validation of the Process and Testing Methods (including dosimetry, microbiology, and materials) Validation of the Process and Testing Methods (including dosimetry, microbiology, and materials) Further improvement in quality and implementation of GMP in order to be viable/competitive in European market. Further improvement in quality and implementation of GMP in order to be viable/competitive in European market. Maintain effectiveness and improve quality management system demonstrated by appropriate certification/license/accreditation. Maintain effectiveness and improve quality management system demonstrated by appropriate certification/license/accreditation. (Computerization of methodology – to be included as a tool)

20. Follow-up items Conference papers should be submitted to the TO by 19 June 07. Conference papers should be submitted to the TO by 19 June 07. Conference report should be finalized by the host and TO by 31 August 07. Conference report should be finalized by the host and TO by 31 August 07. All CPs need to contact TO on their intension to participate in Inter-comparison study by 15 July 07. All CPs need to contact TO on their intension to participate in Inter-comparison study by 15 July 07. IAEA will formulate training prospectus and invitations in appropriate timing. IAEA will formulate training prospectus and invitations in appropriate timing. CPs (WG) will formulate the concept of RER8010 Phase III and the two new concepts by 28 September 07. CPs (WG) will formulate the concept of RER8010 Phase III and the two new concepts by 28 September 07. CPs should submit national project proposals by July 07 if they wish. CPs should submit national project proposals by July 07 if they wish.

21. Conclusions 1 QA/QC is essential for radiation technology and its development. QA/QC is essential for radiation technology and its development. RER8010 plays a key role in improvement in QA/QC management in participating laboratories. This project also contributes to sustainability & self-reliance of R&D institutes. RER8010 plays a key role in improvement in QA/QC management in participating laboratories. This project also contributes to sustainability & self-reliance of R&D institutes. Implementation of the project will support the technology transfer to countries in need. Implementation of the project will support the technology transfer to countries in need. Participants were informed of the recent development of dosimetry, QA/QC standards, microbiology and product qualification applied in radiation sterilization. Participants were informed of the recent development of dosimetry, QA/QC standards, microbiology and product qualification applied in radiation sterilization.

22. Conclusions 2 Participants were also informed a variety of technology applications, i.e. food irradiation, tissue banking, environment, and cultural heritage conservation. Participants were also informed a variety of technology applications, i.e. food irradiation, tissue banking, environment, and cultural heritage conservation. Inter-comparison exercise results on dosimetry were presented and discussed. Certificates were distributed to participated countries. Inter-comparison exercise results on dosimetry were presented and discussed. Certificates were distributed to participated countries. Participants agreed to participate in the improved inter-comparison study widely in order to be prepared for accreditation. Participants agreed to participate in the improved inter-comparison study widely in order to be prepared for accreditation.

23. Conclusions 3 Detailed design of Activities in 07-08 were agreed. Detailed design of Activities in 07-08 were agreed. Future projects were also discussed: Phase III of RER8010 and two new concepts (advanced materials, tissue banking). Future projects were also discussed: Phase III of RER8010 and two new concepts (advanced materials, tissue banking).

24. Recommendations 1 1.Partipants are interested in the inter-comparison trials because it is crucial for proving their competence in performing accurate dosimerty measurement required for validation and process control. (to participants) 2.The IAEA/IDAS Programme should be considered to be replaced by the inter- comparison trials. (to IAEA) 3. Computer codes are becoming more important in this field. Thus IAEA should offer a training and a possibility of software distribution. (to IAEA)

25. Recommendations 2 4. IAEA Safety Standard Series No.107/92 should be revised and updated. (to IAEA) 5.Bilateral activities (TCDC framework) should be promoted. Knowledge in promoting specific applications should also be shared among participating countries. (to participants) 6.New Concepts on regional project 09-11 should be formulated and submitted by Sept. 07. (to participants)

26. Recommendations 3