1. International Atomic Energy Agency Quality Management System ASSESSMENT OF OCCUPATIONAL EXPOSURE DUE TO EXTERNAL RADIATION SOURCES AND INTAKES OF RADIONUCLIDES

2. International Atomic Energy Agency Quality Management System - Unit Objectives The objectives of this unit is to outline the principles of quality management system as they relate to the occupational exposure assessment programme, and to stress the importance of effective quality management to external and internal dosimetry. At the completion of this unit, the student should understand the basic concepts of quality management, and how to apply them in the workplace.

3. International Atomic Energy Agency What is Quality ? To know not only customer‘s needs but also his expectations and to fulfil both to his satisfaction at reasonable cost

4. International Atomic Energy Agency What is Quality Management ? Quality Management is a set of rules, which an organization uses internally to assure that the products and services, which it delivers to it’s customers satisfy customers needs and also his expectation and are produced correctly at acceptable costs.

5. International Atomic Energy Agency Main components of the Quality Management l Two main components of the quality management (ISO9000:2000)  quality assurance (QA) and  quality control (QC) l QA is an interdisciplinary management tool that provides a means for ensuring that all work is adequately planned, correctly performed and assessed; l QC is a means of applying controls to the process to ensure that the product or service consistently meets specifications.

6. International Atomic Energy Agency Difference Certification - Accreditation Certification only states that an organisation is operating according to a set of rules complying to relevant (international) standards. A certificate does not guarantee that the products are of top quality. Accreditation not only confirms that a QM- system according to relevant standards is in operation, but also that the organisation is competent in performing measurements, tests, inspections or calibrations. It guarantees (to the extend of human error) that the results are correct.

7. International Atomic Energy Agency International Standards for Quality Management The ISO9000 standards series: u Present a concept ISO9000 u Present requirementsISO9001 u Present guidelinesISO9004 l ISO17025 General requirements for the competence of testing and calibration laboratories l ISO10012 Quality assurance requirements for measuring systems

8. International Atomic Energy Agency Concepts for implementing a quality management system (QMS)

9. International Atomic Energy Agency QMS Implementation Basics identify the processes needed for the QMS; determine the sequence and interaction of these processes; determine criteria and methods required to ensure the effective operation and control of these processes; ensure the availability of information necessary to support the operation and monitoring of these processes and measure, monitor and analyze these processes, and implement action necessary to achieve planned results and continual improvement.

10. International Atomic Energy Agency 7. Write procedures 8. Initial Training of personnel 9. Implementation 7. Internal Audit 8. Management Review 7. Improve system 1. Decision taking 2. Management commitment 3. Implementation team 4. Plan the implementation 5. Identify existing processes 6. Define document structure QMS Implementation process

11. International Atomic Energy Agency Documentation

12. International Atomic Energy Agency Documentation Documentation in quality management is the sum of  documents = instructions that lead to an action and  records = annotation of the results of an action Documents are changeable and have to be shown the development history (revisions), the period of validity and the extend of distribution. Records primarily should not be altered and have to be kept legible, identifiable and retrievable.

13. International Atomic Energy Agency ISO17025 Management Requirements

14. International Atomic Energy AgencyISO17025 This standard contains all the requirements to demonstrate that companies operate a quality management system and are technically competent and able to generate technically valid results.

15. International Atomic Energy Agency ISO17025 Management requirements 1. Organization 2. Quality system 3. Document control 4. Review of requests, tenders and contracts 5. Subcontracting 6. Purchasing 7. Service to the client 8. Complaints 9. Control of nonconforming testing/calibrations 10. Corrective action 11. Preventive action 12. Control of records 13. Internal audits 14. Management reviews

16. International Atomic Energy Agency ISO17025 Technical requirements 1. General 2. Personnel 3. Accommodation and environmental conditions 4. Test and calibration methods and method validation 5. Equipment 6. Measurement traceability 7. Sampling 8. Handling of test and calibration items 9. Assuring the quality of test and calibration results 10. Reporting the results

17. International Atomic Energy Agency Quality Manual The quality manual, which contains the total documentation, may be organized in different ways : l one large manual containing all procedures and working instructions or l a centralized quality management document, which contains the basic information with l annexes containing the technical information.

18. International Atomic Energy AgencyProcedures A procedure shall be written, defining the process to be followed for : l writing l reviewing l approving and l revising procedures

19. International Atomic Energy Agency Quality Improvement

20. International Atomic Energy Agency Internal Audit structured processes, planned work schedules and motivated persons. The only instrument of control in a quality management system, which otherwise is based on:

21. International Atomic Energy Agency Internal Audit ISO17025: The internal audit programme shall address all elements of the quality system, including the testing and/or calibration activities. The cycle for internal auditing should normally be completed in one year.

22. International Atomic Energy Agency Control of Measurement Instruments

23. International Atomic Energy Agency Control The objective of the control of monitoring and measuring devices is to establish an effective means for ensuring, with a high degree of confidence, that data generated by these devices used as the basis for reported results, conclusions and interpretations is of suitable quality.

24. International Atomic Energy AgencySelection Selection of measurement instruments should be governed by quality needed for the applied methods and operational value:  accuracy  sensitivity  selectivity  operability  maintenance  price

25. International Atomic Energy Agency Selection Selection criteria should be derived from the necessities of the customer, governmental requirements and the possibilities of the measurement method, keeping future development potential in mind.

26. International Atomic Energy Agency Acceptance tests After delivery and before the measurement instruments are put into regular operation, the quality criteria have to be verified by test measurements, validation of the instrument. Software used to collect data and to perform calculations on collected data needs to be validated before being put into use. This can be done by: u test runs on verified data, u test runs on certified standards or u parallel evaluation of data by hand.

27. International Atomic Energy Agency Control of Instruments and Software All measurement instruments, measurement or evaluations software has to be protected against unauthorized modification. For software this is mostly done by the operating software of the computer through access-rights and passwords.

28. International Atomic Energy AgencyCalibration Before being put into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory’s specification requirements and complies with the relevant standard specifications. Calibration procedures have to be established and followed strictly.

29. International Atomic Energy AgencyCalibration Calibration results have to be documented and should be monitored to have an early indication for deterioration of instrument quality. These documents should be kept at least during the entire lifetime of the instrument. Whenever the calibration results do not reach necessary acceptance criteria, the instrument has to be treated similar to a damaged instrument. Correction (adjustment, repair, etc.) has to be applied and the instrument has to be recalibrated before returning to duty.

30. International Atomic Energy Agency Instrument operation ISO17025 (Part 5.5.3) Equipment shall be operated by authorized personnel. Up-to-date instructions on the use and maintenance of equipment (incl. any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use. Operator authorization has to be documented to perform any measurement method. Reassessment could be necessary after mayor changes in operation instructions (software changes, instrument adaptations)

31. International Atomic Energy Agency Instrument maintenance For every measurement instrument there should be a maintenance plan in place. This plan can be derived from the operation manual of the producer or developed according to experience of the organization with similar instruments. Maintenance operations shall be documented.

32. International Atomic Energy Agency Traceability of Measurements

33. International Atomic Energy Agency Definition Measurement traceability: Each measurement device with influence on the result to be calibrated before being put into service and in defined intervals afterwards standards used for calibrations must be traceable to the SI

34. International Atomic Energy Agency Dosimetry Applications - Examples External dosimetry (thermoluminescent dosimeters) Internal dosimetry (whole body counter)

35. International Atomic Energy Agency Thermoluminescent Dosimeter Primary standards laboratory: Establishes instrumentation to measure physical quantities (air kerma) by use of reference radiation fields. Uses established conversion factors to relate physical quantities to operational radiation protection quantities (dose).

36. International Atomic Energy Agency Thermoluminescent Dosimeter (II) Measurement Laboratory: Sends sample dosimeters to reference laboratory for irradiation under standard conditions (reference dose rate and dose, reference field parameters, ICRU slab phantom) Uses irradiated dosimeters for direct comparison with measurements

37. International Atomic Energy Agency Whole Body Counter Primary standard laboratory: Production of reference material (acidic solution) with well defined activity of certain nuclides (units in Bq or Bq/ml) Possibly: production of a “physical phantom”, simulating the human body, with well defined activity and activity distribution

38. International Atomic Energy Agency Whole Body Counter (II) Calibration laboratory: Production of “physical phantom” simulating the human body by distributing reference material in phantom material (plastic water-filled bottles, tissue equivalent material, …) Possibly: direct comparison of produced phantom to primary standard laboratory phantom

39. International Atomic Energy Agency Whole Body Counter (III) Measurement laboratory: Calibration of whole body counter by physical phantom Whole body measurements Possibly: removal of bias contributions by correction factors obtained by numerical methods (e.g., computer simulation, …)

40. International Atomic Energy Agency Validation of a Measurement Method

41. International Atomic Energy Agency Validation of a Measurement Method A measurement method must be well known: accuracy, correctness, repeatability, reproducibility, robustness, …). The range of measurement uncertainty must be known. This can be achieved by validation of the method: u Testing of all newly developed methods by using different parameters u All validation results need to be documented and interpreted.

42. International Atomic Energy Agency Measurement Uncertainty

43. International Atomic Energy Agency Measurement Uncertainty Measurement result should be the best estimate of measurand Type A uncertainty: estimated from statistical considerations Type B uncertainty: obtained from other sources or references

44. International Atomic Energy Agency Uncertainty Budget Investigation of all factors (uncertainty contributions) influencing the combined (total) uncertainty. Depending on uncertainty distribution of individual uncertainty contributions, correlations. Biases to be removed through correction factors (uncertainty on correction factors are uncertainty contributions).

45. International Atomic Energy Agency Thermoluminescent Dosimeter Uncertainty in TLD calibration Energy dependence of the dosimeter response Nature and direction of the radiation field Environmental conditions, background radiation Backscattering material Dosimeter readout devices Counting statistics, glow curves Possible contributions to the combined uncertainty:

46. International Atomic Energy Agency Thermoluminescent Dosimeter (II) Common size of the combined (total) measurement uncertainty for thermoluminescent dosimeters: Up to + 30%

47. International Atomic Energy Agency Whole Body Counter Uncertainty in reference standard Uncertainties in construction of a “physical phantom”, homogeneity of the phantom Detector calibration (efficiency, …) Environmental conditions, background Individual parameters (size, weight, distribution of the radionuclides, …) Detector readout, electronics Counting statistics Possible contributions to the combined uncertainty:

48. International Atomic Energy Agency Whole Body Counter (II) Common size of the combined (total) measurement uncertainty for whole body counting: Up to + 50 %; - 25 %

49. International Atomic Energy Agency References FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS, INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR ORGANISATION, OECD NUCLEAR ENERGY AGENCY, PAN AMERICAN HEALTH ORGANIZATION, WORLD HEALTH ORGANIZATION, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, Safety Series No. 115, IAEA, Vienna (1996). INTERNATIONAL ATOMIC ENERGY AGENCY, INTERNATIONAL LABOUR OFFICE, Occupational Radiation Protection, Safety Standards Series No. RS-G-1.1, IAEA, Vienna (1999). INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENTS, Direct Determination of the Body Content of Radionuclides, ICRU Report 69, Journal of the ICRU, 3, No1 (2003). INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION, Quality management and quality assurance standards — Part 1: Guidelines for selection and use. ISO 9000-1 (1994). INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION, Quality systems - Model for Quality assurance in production, installation and servicing. ISO 9002 (1994). INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION, Quality systems - Model for Quality assurance in final inspection and test. ISO 9003 (1994).

50. International Atomic Energy Agency References INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION, Quality systems - Model for Quality assurance in design, development, production, installation and servicing. ISO 9001 (1994). INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION /INTERNATIONAL ELECTROTECHNICAL COMMISSION, General Requirements For The Competence Of Testing And Calibration Laboratories, ISO/IEC 17025. UNITED STATES DEPARTMENT OF ENERGY, The Department of Energy Laboratory Accreditation Program for Radiobioassay, DOE-STD-1112-98 (1998).