1. IAEA International Atomic Energy Agency Lecture 8 – Quality management system Postgraduate Educational Course in radiation protection and the Safety of Radiation sources PART V: ASSESSMENT OF EXTERNAL AND INTERNAL EXPOSURES (OTHER THAN MEDICAL) Module V.1 - Assessment of occupational exposure due to external sources of radiation

2. IAEA Quality Management System - lecture objectives The objectives of this lecture is to outline the principles of quality management system as they relate to the occupational exposure assessment program, and to stress the importance of effective quality management to external and internal dosimetry. At the completion of this lecture, the student should understand the basic concepts of quality management, and how to apply them in the workplace. Module V.1 Lecture 8 - Quality management system2

3. IAEA What is Quality ?  To know not only customer‘s needs  but also his expectations  and to fulfil both to his satisfaction  at reasonable cost Module V.1 Lecture 8 - Quality management system3

4. IAEA 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 expectations are produced correctly at acceptable costs. Module V.1 Lecture 8 - Quality management system4

5. IAEA Main components of 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. Module V.1 Lecture 8 - Quality management system5

6. IAEA 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 extent of human error) that the results are correct. Module V.1 Lecture 8 - Quality management system6

7. IAEA International Standards for Quality Management  The ISO9000 standards series: u Present a concept ISO9000 u Present requirementsISO9001 u Present guidelinesISO9004 l ISO 17025 General requirements for the competence of testing and calibration laboratories l ISO10012 Quality assurance requirements for measuring systems Module V.1 Lecture 8 - Quality management system7

8. IAEA Concepts for implementing a quality management system (QMS) Module V.1 Lecture 8 - Quality management system8

9. IAEA 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. Module V.1 Lecture 8 - Quality management system9

10. IAEA 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 Module V.1 Lecture 8 - Quality management system10

11. IAEA Documentation Module V.1 Lecture 8 - Quality management system11

12. IAEA Documentation  Documentation in quality management is the sum of  documents = instructions that lead to an action and  records = notation of the results of an action  Documents are changeable and the development history (revisions), the period of validity and the extent of distribution has to be shown.  Records primarily should not be altered and have to be kept legible, identifiable and retrievable. Module V.1 Lecture 8 - Quality management system12

13. IAEA ISO 17025 Management Requirements Module V.1 Lecture 8 - Quality management system13

14. IAEA ISO 17025  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. Module V.1 Lecture 8 - Quality management system14

15. IAEA ISO 17025 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 Module V.1 Lecture 8 - Quality management system15

16. IAEA ISO 17025 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 Module V.1 Lecture 8 - Quality management system16

17. IAEA 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. Module V.1 Lecture 8 - Quality management system17

18. IAEA Procedures A procedure shall be written, defining the process to be followed for: l writing l reviewing l approving and l revising procedures Module V.1 Lecture 8 - Quality management system18

19. IAEA Quality Improvement Module V.1 Lecture 8 - Quality management system19

20. IAEA 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: Module V.1 Lecture 8 - Quality management system20

21. IAEA Internal Audit ISO 17025:  The internal audit program 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. Module V.1 Lecture 8 - Quality management system21

22. IAEA Control of Measurement Instruments Module V.1 Lecture 8 - Quality management system22

23. IAEA 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. Module V.1 Lecture 8 - Quality management system23

24. IAEA Selection  Selection of measurement instruments should be governed by quality needed for the applied methods and operational value:  accuracy  sensitivity  selectivity  operability  maintenance  price Module V.1 Lecture 8 - Quality management system24

25. IAEA 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. Module V.1 Lecture 8 - Quality management system25

26. IAEA 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. Module V.1 Lecture 8 - Quality management system26

27. IAEA 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. Module V.1 Lecture 8 - Quality management system27

28. IAEA Calibration  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. Module V.1 Lecture 8 - Quality management system28

29. IAEA Calibration  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. Module V.1 Lecture 8 - Quality management system29

30. IAEA Instrument operation ISO 17025 (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 major changes in operation instructions (software changes, instrument adaptations) Module V.1 Lecture 8 - Quality management system30

31. IAEA 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. Module V.1 Lecture 8 - Quality management system31

32. IAEA Traceability of Measurements Module V.1 Lecture 8 - Quality management system32

33. IAEA 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 Module V.1 Lecture 8 - Quality management system33

34. IAEA Dosimetry Applications - Examples  External dosimetry (thermoluminescent dosimeters)  Internal dosimetry (whole body counter) Module V.1 Lecture 8 - Quality management system34

35. IAEA 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). Module V.1 Lecture 8 - Quality management system35

36. IAEA 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 Module V.1 Lecture 8 - Quality management system36

37. IAEA 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 Module V.1 Lecture 8 - Quality management system37

38. IAEA 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 Module V.1 Lecture 8 - Quality management system38

39. IAEA 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, …) Module V.1 Lecture 8 - Quality management system39

40. IAEA Validation of a Measurement Method Module V.1 Lecture 8 - Quality management system40

41. IAEA 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. Module V.1 Lecture 8 - Quality management system41

42. IAEA Measurement Uncertainty Module V.1 Lecture 8 - Quality management system42

43. IAEA 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 Module V.1 Lecture 8 - Quality management system43

44. IAEA 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). Module V.1 Lecture 8 - Quality management system44

45. IAEA 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: Module V.1 Lecture 8 - Quality management system45

46. IAEA Thermoluminescent Dosimeter (II) Reasonable estimate of the combined (total) measurement uncertainty for thermoluminescent dosimeters: Up to + 30% Module V.1 Lecture 8 - Quality management system46

47. IAEA 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: Module V.1 Lecture 8 - Quality management system47

48. IAEA Whole Body Counter (II) Reasonable estimate of the combined (total) measurement uncertainty for whole body counting: Up to + 50 %; - 25 % Module V.1 Lecture 8 - Quality management system48

49. IAEA References GSR 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). Module V.1 Lecture 8 - Quality management system49

50. IAEA References INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION, Quality management systems – Requirements, ISO 9001:2008 (incorporated ISO 9002 and 9003) INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANIZATION /INTERNATIONAL ELECTROTECHNICAL COMMISSION, General Requirements For The Competence Of Testing And Calibration Laboratories, ISO/IEC 17025 (2005). UNITED STATES DEPARTMENT OF ENERGY, The Department of Energy Laboratory Accreditation Program for Radiobioassay, DOE-STD-1112-98 (1998). Module V.1 Lecture 8 - Quality management system50