Quality Systems in Radiation Metrology: The Quality System Review of SIM NMIs and DIs in the scope of CIPM MRA

Transcription

1 IONIZING RADIATION METROLOGY NATIONAL LABORATORY Radioprotection and Dosimetry Institute Designated Institution by INMETRO Nuclear Energy National Commission Quality Systems in Radiation Metrology: The Quality System Review of SIM NMIs and DIs in the scope of CIPM MRA SIM Week, 2011 Radiation Metrology: An Ionizing Radiation Awareness Event Buenos Aires, Argentina - November 10, 2011 M. Elizabeth ACAR IRD Quality Manager acar@ird.gov.br

2 Applications of ionizing radiation Some applications 1. Medical diagnosis and treatment X rays in diagnostic radiology: conventional X ray examination, computed tomography (CT) Radiation beams used to treat patients in radiotherapy: high energy X rays; gamma rays electrons used to cure cancer or at least to alleviate the distressing symptoms; Pharmaceutical labeled with radionuclide for diagnosis or therapy in nuclear medicine : gamma rays emitters and short half-life - Tc-99m; I-131;

3 Applications of ionizing radiation Other applications Nuclear Industry: to provide electricity; 3. Conventional industry: industrial radiography, sterilization of medical products, food irradiation; 4. Scientific and medical research. The Context Balance between benefits x risks : Enjoy the benefits and minimize harmful radiation effects; Under straight regulation: Compliance with legal requirements; Globalization of trade, competitiveness, technical barriers; Wrong or inaccurate measurements can lead to wrong decisions, which can have serious consequences, which cost money and even live

4 Quality and Metrology It is essential that measurements, which are the basis for decision-making process are comparable, reliable and globally recognized, based on traceability to the same standards of measurement. These are the attributes of the QUALITY required for the measurements! How to do that?

5 Building the Current Worldwide Metrology 1. Development of the International System of Units; 2. Meter Convention signed in 1875 : treaty that created the International Bureau of Weights and Measures (BIPM) ; established a permanent organizational structure for member governments to act in common agreement on all matters relating to units of measurement; 3. Creation of the International Organization for Standardization (1947): a network of the national standards institutes of 162 countries - coordination of international standardization 4. Mutual Recognition Arrangement (CIPM MRA -1999)

6 What is the CIPM MRA? Paris, 14 October 1999; 38 member states of Meter Convention and 2 international organizations, now 86 institutes (plus 138 Designated Institutes); CIPM-MRA: Arrangement draw up by International Committee of Weights and Measures (CIPM); Objectives: 1. To establish the degree of equivalence between national standards maintained by National Metrology Institutes (NMI); 2. To enable the mutual recognition of calibration certificates an measurements issued by the INM, for quantities and ranges specified at the CIPM MRA appendix C. (

7 How to support mutual confidence? 1. international comparisons of measurements: The key comparisons; 2. supplementary international comparisons of measurements; successful participation of the NMI 3. quality systems and demonstrations of competence by NMIs. It is understood that a quality management system (QMS) is required to ensure that an NMI is able to provide reliable services consistent with their stated CMCs. Reference: SIM 05 and SIM 09

8 Approaches for the establishment of the NMI quality management system in SIM region The QMS operated by the NMI or DI should be: accredited or self declared to ISO/IEC or equivalent for an NMI or DI; or accredited or self declared to the requirements of ISO Guide 34 pertaining to NMI or DI providing certified reference materials. It is the responsibility of SIM to review the QMS operated by its member NMIs and DIs and to report on their acceptance or otherwise to the Joint Committee of the Regional Metrology Organizations and the BIPM (JCRB). Reference: SIM 09

9 Overview of QSTF

10 Quality System Task Force Created by SIM Council 2002 Task Force is composed of one voting delegate from each SIM NMI, which is a signatory to the CIPM MRA Meetings are open to all SIM members, including Designated Institutes Quality System Task Force CARICOM is also a voting member Reference: SIM09

11 QSTF Composition Argentina Bolivia Brazil Canada CARICOM Chile Costa Rica Ecuador Jamaica Mexico Panama Paraguay Peru Uruguay USA Fernando Kornblit Juan Carlos Castillo Silvio dos Santos Katalin Deczky Anthea Ishmael Francisco Garcia Liz Leiva María Altamiro Mairy Sanz Ruben Lazos Gabriela De la Guardia Ruben Ricardo Ramirez Jose Dajes Elizabeth Ferreir Sally Bruce Chair William Anderson (USA) Designated by SIM Council. Responsible for the operation of the QSTF Non-voting member Each delegate represents its NMI as well as any Designated Institutes associated with the NMI* * QMS of DIs must be presented to the QSTF by the designated institute.

12 QSTF Role Responsible to review the quality management system of each NMI and DI. The SIM QSTF must satisfy itself that, through its review process, the quality management system operated by the NMI or DI is effective and complies with the applicable requirements of ISO/IEC Standard and ISO Guide 34 when it applies. Reference: SIM 09

13 SIM QSTF Review Process

14 SIM Review Process - Overview Technical Aspects Review Quality System Review All activities must be covered by the Quality Management System NMI or DI sends CMCs to Technical Committees On-site peer review NMIs/DIs Approach Self-declaration Assessment Accreditation Intra-RMO (NMIs/DIs) SIM Technical Committees SIM QSTF Review Process Our object CMCs Approved QMS Approved Peer reviews Inter-RMO AFRIMETS APMP COOMET EUROMET SIM JCRB Representative JCRB sends the CMCs to Inter-RMO review QMS and CMCs approved

15 QSTF Review Process (SIM 09) - Rules 1. Any SIM Member NMI can request the review of its QMS, even if it is not yet a signatory of the MRA; 2. Meetings are open to all SIM members and observers from other RMOs; 3. QSTF assess whether or not the QMS of each NMI complies with the requirements of the CIPM MRA; 4. The documentation is presented by a representative of the NMI or DI. 5. All declared CMCs must be covered by a QMS 6. The QMS of each NMI/DI is reviewed at least once every 5 years;

16 QSTF Review Process (SIM 09) - Characteristics 7. On-going monitoring of the QMS of INM: NMI and DI shall promptly notify any major changes in the QMS; An annual report is required from each NMI and DI having declared CMCs to document whether significant changes have occurred. 8. SIM 09 also applies to Designated Institutes (who must make the request for a review through their SIM Member NMI);

17 QSTF Review Process Document Review Quality manual and a description of the QMS, including: 1. Organizational structure of the NMI or DI; 2. QMS policies and responsibilities; 3. List of administrative and technical procedures; 4. Cross-reference table; 5. List covered CMCs; 6. Statistics on complaints, nonconforming work and corrective actions; 7. Summary of internal audit reports; 8. Summary of management reviews; 9. Summary of on-site peer reviews; 10 General information on the vitality of the CMCs.

18 QSTF Review Process Meeting QSTF meetings: Presentation of the QMS and evidences of its implementation In addition, the review process take into account: - knowledge of the NMIs or DIs capabilities through active participation in SIM projects and activities and scientific publications; - participation in scientific and training activities, visits and consultation with technical experts from other RMOs. * Source: QSTF Minutes

19 Summary of the QSTF Review Process Quality Management System Structure Quality Manual/CMCs Quality Management System Implementation Assessments Links to additional documents such as action plans and reports. Documents remain available on QSTF Website for all voting members. NMI or DI oral presentation. Q&A Decision based on motions QSTF decisions, questions and answers are published in minutes. In case of conditional approval, additional information is requested and it can be sent by . The approval can be done by voting. In case of not approval the NMI/DI can appeal in two instances (QSTF-Chair and JCRB Representative) Invitation for QSTF Meeting NMIs and DIs submit QS description QSTF Template Approved 8 weeks prior to the meeting 4 weeks prior to the meeting Analysis of the documents is done within this period QSTF meeting Conditionally Approved Not Approved

20 Results

21 SIM Ionizing Radiation Laboratories CMCs on KCDB Country Institute Field/CMC Argentina CNEA Radioactivity (Primary methods) Number of CMCs 38 Brazil LNMRI/IRD Dosimetry, Radioactivity Neutron measurements Canada NRC-INMS Radioactivity Neutron measurements USA NIST Dosimetry Radioactivity Neutron measurements SIM: 796 Total: 3909 about 20% Ref: KCDB ; 07/11/2011

22 The Brazilian Case LNMRI Designated Institute Self-declaration based on on-site peer review; Quality Management policies and procedures ensure that calibration and measurement services complies with the applicable requirements of ISO/IEC Standard. Signature of the CIPM MRA The LNMRI-IRD quality system for the measurement services was implemented in response to the requirements of CIPM MRA. Submission of QMS covering Dosimetry, Radioactivity and neutrons activities/cmcs Submission of the LNMRI QMS covering Dosimetry, Radioactivity and neutrons activities for Re-approval Oct 1999 Mar 2004 Nov 2004 July 2009 Oct Venezuela Peru On-site peer review on LNMRI -QMS involving the three areas of ionizing radiation (17025 requirements) On-site peer review on LNMRI-IRD QMS. Management on-site peer review and Technical on-site peer review (ISO 17025)

23 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Working for re-approval (cycle 2) in 2014 Performing internal audits; Improving processes and methods; Training our staff; Performing regular management review; Listening our customer to collaborate improving their processes and to eliminate/reduce complaints; Monitoring indicators; Promoting continuous improvements

24 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Radioactivity ( ) 1. Direct Standardization System Coincidence counting 177 Lu, 123 I, 111 In, 18 F Radionuclide Sum-peak counting 123 I, 111 In, 18 F, 65 Zn, 22 Na Anticoincidence Counting MTR Lu, 123 I, 111 In, 18 F, 243 Am/ 239 Np, 166m Ho Liquid scintillation counting CIEMAT/NIST method (2 nd ) 14 C, 32 P, 3 H, 242 Pu

25 abr/91 abr/92 abr/93 abr/94 abr/95 abr/96 abr/97 abr/98 abr/99 abr/00 abr/01 abr/02 abr/03 abr/04 abr/05 abr/06 abr/07 ago/08 ago/09 ago/10 Relative frequency (%). LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Radioactivity ( ) 2. Quality control in radionuclide analises in environmental samples- 24 labs,15 radionuclides and 461 analyses (2010) Good + Acceptable Not Acceptable Intercomparison run

26 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Radioactivity ( ) 3. Quality Assurance Program applied to Nuclear Medicin Services: Radionuclides: Tc-99m, I-131, I-123, Ga-67 e Tl Carlos Lecture *

27 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Radioactivity ( ) 4. Nuclear decay data measurements Half-life determination 177Lu, 57Co, 111In, 123In g-ray emission probabilities determination 177Lu 5. Traceability Program International Level CCRI Key Comparisons: 177Lu

28 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Dosimetry ( ) 1. Comparison - coordenation Latin American and Caribbean Comparison* of Surface Contamination Monitoring Equipment; Comparison of Second Standards Air Kerma in Brasil (2010). * Brasil, IAEA, Argentina, Colombia, Chile, México, Venezuela, Cuba, Peru, Costa Rica, Nicarágua, El Salvador, Paraguai

29 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Activities of Dosimetry ( ) 2. Participation in comparisons IAEA Comparison IAEA : air kerma and Absorbed dose to water (2009); IAEA/WHO: TLD Postal Dose Quality Audit (2009, 2010 e 2011).

30 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Neutron field studies in neighborhood of clinical accelerators; Manganese Sulphate Bath quality control measurements; Rebuilding the low scattering room; Activities of Neutron Laboratory ( ) Determination of new parameters to low scattering room; Preparation of personnel dosimeter intercomparison protocol Brasil 2012; SIM comparison (NIST, LNMRI/IRD): Neutron fluence (two possible comparisons) Planned by 2012

31 References [1] BIPM Available at < [2] BIPM. The Key Comparison Database (KCDB) Available at: < [3] SIM. Sistema Interamericano de Metrologia Available at < [4] SIM. Statute, September, Available at < [5] QSTF Minutes

32 LABORATÓRIO NACIONAL DE METROLOGIA DAS RADIAÇÕES IONIZANTES Thank you