RER8010RER8010Quality Control Methods Quality Control Methods

and Procedures for and Procedures for Radiation TechnologyRadiation Technology

Mikiko SAWANISHIMikiko SAWANISHIProgramme Management Officer (PMO)Programme Management Officer (PMO)

Division for Europe Division for Europe Department of Technical Cooperation IAEA Department of Technical Cooperation IAEA

12 June, 2007, Bran, Romania 12 June, 2007, Bran, Romania

PMO Goals PMO Goals Get to know members/experts in Get to know members/experts in

participating countries participating countries Understand the outline of the subject Understand the outline of the subject Understand the results of the project 05-Understand the results of the project 05-

06 and the latest status of each country 06 and the latest status of each country Seek guidance on 07-08 Work Plan and Seek guidance on 07-08 Work Plan and

activities activities Explore possible synergy w/ other Explore possible synergy w/ other

projects in industrial application (e.g. projects in industrial application (e.g. RER8011) RER8011)

2007-2008 Cycle 2007-2008 Cycle (www.pcmf.iaea.org)(www.pcmf.iaea.org)

Objective: To enhance MS’s Objective: To enhance MS’s capabilities in applying harmonized capabilities in applying harmonized quality control methods and quality control methods and procedures in the radiation processing procedures in the radiation processing of human health related products as of human health related products as well as advanced materials. Promotion well as advanced materials. Promotion of nuclear technology’s contribution to of nuclear technology’s contribution to the health, environment and the health, environment and technological progress related areas. technological progress related areas.

Total BudgetTotal Budget

Total 2 Years ($148.440)Total 2 Years ($148.440)11stst Year $76.820 Year $76.82022ndnd Year $71.620 Year $71.620

Extra-budgetary resources are Extra-budgetary resources are necessary and welcomenecessary and welcome

2005-2006 Cycle2005-2006 CycleOutcome achieved through outputs Outcome achieved through outputs

produced (development impact !) produced (development impact !) Coordination Meeting in Poland (21-25 Coordination Meeting in Poland (21-25

February 2005)February 2005) Expert Missions (e.g. Poland to Expert Missions (e.g. Poland to

Slovakia)Slovakia) Comparison Trial (05-06) Comparison Trial (05-06) Training courses Training courses ------------------------

What is the difference between What is the difference between 05-06 and 07-08, and future ?05-06 and 07-08, and future ?

05-06 – development/improvement 05-06 – development/improvement of radiation processing techniques of radiation processing techniques

07-08 – enhance MS’s capabilities in 07-08 – enhance MS’s capabilities in applying harmonized QA/QC methods applying harmonized QA/QC methods and procedures in the radiation and procedures in the radiation processingprocessing

09-11 (3 years) ? 09-11 (3 years) ?

Improvement in 07-08 Improvement in 07-08 ProjectProject

(Phase I) Introduction and extension of (Phase I) Introduction and extension of radiation technologies to process health radiation technologies to process health care products & advanced materials. care products & advanced materials.

(Phase II) Harmonization of: testing (Phase II) Harmonization of: testing methods and new technologies adapting methods and new technologies adapting the QA/QC and Safety Standards. the QA/QC and Safety Standards.

Improved inter-comparison Exercise Improved inter-comparison Exercise (PART2)(PART2)

Assistance for the accreditation Assistance for the accreditation

Expected outcome/outputs 07-Expected outcome/outputs 07-08 08

Quality management system establishedQuality management system established (tangible results) (tangible results) At least 2 labs ready for accreditationsAt least 2 labs ready for accreditations 10 dosimetry certificates given10 dosimetry certificates given 18 people trained in Dosimetry 18 people trained in Dosimetry 15 people trained in Monte Carlo 15 people trained in Monte Carlo

MethodsMethods

Synergy with other Synergy with other programmesprogrammes

IAEA TC Regional(RER8011 (EBFGT), IAEA TC Regional(RER8011 (EBFGT), RER0023 (Sustainability), RER5013 RER0023 (Sustainability), RER5013 (Mutant Cereals) etc.), National (Mutant Cereals) etc.), National Projects Projects

IAEA CRP and Other Technical IAEA CRP and Other Technical Activities Activities

EU and other regional programmes EU and other regional programmes Bilateral cooperation Bilateral cooperation

Work Plan 2007Work Plan 2007Activity Activity Budget Budget Timing Timing

Workshop on Workshop on harmonization on QA/QC harmonization on QA/QC methods methods

$27.5K$27.5K June 07June 07

Training Course on EB Training Course on EB Dosimetry (Riso Lab) 9 Dosimetry (Riso Lab) 9 traineestrainees

$25.5K$25.5K 22 -26 22 -26 Oct. 07 Oct. 07

SV for radiation facilities & SV for radiation facilities & technologies familiarizationtechnologies familiarization

$7.32K$7.32K 1 wk1 wk

0707

EM to audit QC procedures EM to audit QC procedures (2-3)(2-3)

$6.6K$6.6K 1 wk1 wk

Oct. 07Oct. 07

EM to provide dosimetory EM to provide dosimetory intercomparison exercise intercomparison exercise

$9.9K$9.9K 2 wks2 wks

Sept. 07Sept. 07

Work Plan 2008Work Plan 2008Activity Activity Budget Budget Timing Timing SV for radiation facilities & SV for radiation facilities & technologies familiarization (AC)technologies familiarization (AC)

$7.725K$7.725K 0808

Training Course on Gamma Training Course on Gamma Dosimetry (Riso Lab) 9 traineesDosimetry (Riso Lab) 9 trainees

$28K$28K Oct. 08Oct. 08

Training course on Training course on computational methods in computational methods in gamma & X-ray irradiation gamma & X-ray irradiation processing processing

$25.5K$25.5K Feb.08 or Feb.08 or July 08 July 08 TBDTBD

(Ukraine)(Ukraine)

EM on voluntary audit at EM on voluntary audit at irradiation facilities irradiation facilities (accreditation preparation)(accreditation preparation)

$10.395K$10.395K 0808

2 wks2 wks

Riso Training on EB Dosimetry Riso Training on EB Dosimetry (2007)(2007)

Objectives of the training Objectives of the training Content of the training Content of the training Qualifications of Participants Qualifications of Participants

(countries w/ running facilities, (countries w/ running facilities, experience w/ dosimetry) experience w/ dosimetry)

Costs (training fee plus costs) – Costs (training fee plus costs) – provided a hotel residenceprovided a hotel residence

Inter-comparison exercise Inter-comparison exercise (07)(07)

Objectives Objectives Differences/improvement from the Differences/improvement from the

previous trial previous trial Costs for the exercise Costs for the exercise Expert Expert

Familiarization SV (2007)Familiarization SV (2007)

Objective of the SVObjective of the SV Which country to which county ?Which country to which county ? When (1 week)When (1 week)

EM to QA/QC audit (2007)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 When (1 week in one country, or 2

days to 3 countries?)days to 3 countries?)

Training course on computational Training course on computational methods in gamma & X-ray irradiation methods in gamma & X-ray irradiation

processing (2008)processing (2008)

Venue (Ukraine)Venue (Ukraine) Timing-1 week, February 2008Timing-1 week, February 2008 Number of Trainees (15-20 people) Number of Trainees (15-20 people) Objectives Objectives Training content and methodologyTraining content and methodology Computer Program ($9,000, open-Computer Program ($9,000, open-

license) license)

7 Criteria 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

New Concept Ideas 09-11New Concept Ideas 09-11

Radiation Technology in Nano and Radiation Technology in Nano and advanced materials based on natural advanced materials based on natural Polymers. (New Concept will be Polymers. (New Concept will be formulated by a group, Poland, formulated by a group, Poland, Romania, Kazakhstan?, Hungary, and Romania, Kazakhstan?, Hungary, and others.) others.)

Tissue banking? (may be a separate Tissue banking? (may be a separate concept) Romania will prepare a concept) Romania will prepare a concept (Poland, Romania, Portugal, concept (Poland, Romania, Portugal, Hungary and others) Hungary and others)

RER8010 Phase III RER8010 Phase III ObjectivesObjectives

Validation of the Process and Testing Validation of the Process and Testing Methods (including dosimetry, Methods (including dosimetry, microbiology, and materials) microbiology, and materials)

Further improvement in quality and Further improvement in quality and implementation of GMP in order to be implementation of GMP in order to be viable/competitive in European market. viable/competitive in European market.

Maintain effectiveness and improve quality Maintain effectiveness and improve quality management system demonstrated by management system demonstrated by appropriate appropriate certification/license/accreditation. certification/license/accreditation.

(Computerization of methodology – to be (Computerization of methodology – to be included as a tool) included as a tool)

Follow-up itemsFollow-up items Conference papers should be submitted to the TO Conference papers should be submitted to the TO

by 19 June 07.by 19 June 07. Conference report should be finalized by the host Conference report should be finalized by the host

and TO by 31 August 07. and TO by 31 August 07. All CPs need to contact TO on their intension to All CPs need to contact TO on their intension to

participate in Inter-comparison study by 15 July 07.participate in Inter-comparison study by 15 July 07. IAEA will formulate training prospectus and IAEA will formulate training prospectus and

invitations in appropriate timing.invitations in appropriate timing. CPs (WG) will formulate the concept of RER8010 CPs (WG) will formulate the concept of RER8010

Phase III and the two new concepts by 28 Phase III and the two new concepts by 28 September 07. September 07.

CPs should submit national project proposals by CPs should submit national project proposals by July 07 if they wish. July 07 if they wish.

Conclusions 1 Conclusions 1 QA/QC is essential for radiation technology QA/QC is essential for radiation technology

and its development. and its development. RER8010 plays a key role in improvement in RER8010 plays a key role in improvement in

QA/QC management in participating QA/QC management in participating laboratories. This project also contributes to laboratories. This project also contributes to sustainability & self-reliance of R&D institutes. sustainability & self-reliance of R&D institutes.

Implementation of the project will support the Implementation of the project will support the technology transfer to countries in need. technology transfer to countries in need.

Participants were informed of the recent Participants were informed of the recent development of dosimetry, QA/QC standards , development of dosimetry, QA/QC standards , microbiology and product qualification applied microbiology and product qualification applied in radiation sterilization. in radiation sterilization.

Conclusions 2 Conclusions 2 Participants were also informed a variety of Participants were also informed a variety of

technology applications , i.e. food technology applications , i.e. food irradiation, tissue banking, environment, irradiation, tissue banking, environment, and cultural heritage conservation.and cultural heritage conservation.

Inter-comparison exercise results on Inter-comparison exercise results on dosimetry were presented and discussed. dosimetry were presented and discussed. Certificates were distributed to participated Certificates were distributed to participated countries.countries.

Participants agreed to participate in the Participants agreed to participate in the improved inter-comparison study widely in improved inter-comparison study widely in order to be prepared for accreditation. order to be prepared for accreditation.

Conclusions 3Conclusions 3

Detailed design of Activities in 07-08 Detailed design of Activities in 07-08 were agreed.were agreed.

Future projects were also discussed: Future projects were also discussed: Phase III of RER8010 and two new Phase III of RER8010 and two new concepts (advanced materials, tissue concepts (advanced materials, tissue banking). banking).

Recommendations 1Recommendations 11.Partipants are interested in the inter-1.Partipants are interested in the inter-

comparison trials because it is crucial for comparison trials because it is crucial for proving their competence in performing proving their competence in performing accurate dosimerty measurement required accurate dosimerty measurement required for validation and process control. (to for validation and process control. (to participants) participants)

2.The IAEA/IDAS Programme should be 2.The IAEA/IDAS Programme should be considered to be replaced by the inter-considered to be replaced by the inter-comparison trials. (to IAEA)comparison trials. (to IAEA)

3. Computer codes are becoming more 3. Computer codes are becoming more important in this field. Thus IAEA should important in this field. Thus IAEA should offer a training and a possibility of offer a training and a possibility of software distribution. (to IAEA) software distribution. (to IAEA)

Recommendations 2Recommendations 2

4. IAEA Safety Standard Series No.107/92 4. IAEA Safety Standard Series No.107/92 should be revised and updated. (to IAEA)should be revised and updated. (to IAEA)

5.Bilateral activities (TCDC framework) 5.Bilateral activities (TCDC framework) should be promoted. Knowledge in should be promoted. Knowledge in promoting specific applications should also promoting specific applications should also be shared among participating countries. be shared among participating countries. (to participants)(to participants)

6.New Concepts on regional project 09-11 6.New Concepts on regional project 09-11 should be formulated and submitted by should be formulated and submitted by Sept. 07. (to participants) Sept. 07. (to participants)

Recommendations 3Recommendations 3