Quality Assurance and Quality Control – Unit Outline

1. Quality Assurance and Quality Control – Unit Outline • Quality Assurance • Quality Control • Quality Assessment

2. Quality Assurance

3. The BSS require, inter alia, the establishment and implementation of quality assurance programmes to ensure that protection and safety requirements are met. Requirement for Quality Assurance

4. Appropriate management support. • Development, implementation and management of QA/QC system. • Clear documentation of quality methods, procedures and test results. • Quality awareness and training of personnel. • Proof or certification of QA from equipment suppliers. Quality System includes several elements

5. Acceptance and testing of new materials. • Appropriate maintenance and testing of equipment, materials and processes. • Calibration, and verification of the calibration facilities. • Reliable testing of the system performance. • Periodic performance testing of the system. Quality System includes several elements

6. Quality Assurance - planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. • Examples of QA: • type testing, performance testing, and quality audits required by a regulatory body. • blind testing and quality audits of the dosimetry service provider performed by the user of the service. Quality Assurance

7. Technical specifications may not in themselves guarantee that a customer's requirements will be consistently met, if there happen to be any deficiencies in the specifications or in the organizational system to design and produce the service. Why Quality Assurance?

8. Registrants and licensees should be responsible for establishing the quality assurance programme required by the principal requirements of the applicable standards. • The quality assurance programme should be designed in relation to the magnitude and the likelihood of potential workplace exposures. Quality assurance requirements

9. ISO 9000 Series of Quality Assurance standards • First published in 1987. • Brought international harmonization. • Supported quality as a factor of international trade. • Embodies comprehensive quality management concepts and guidance.

11. QA programme should be consistent with; • Number of workers monitored • Magnitude and likelihood of exposures • Number of individuals monitored • Type of monitoring provided • Direct measurements • Indirect measurements • Choice of monitoring periods

12. QA for indirect measurements includes: • Unique labelling which identifies the sample and the person concerned throughout the process from sampling to the recording of the measurement results • Chain of custody of all samples to preclude loss, contamination or incorrect analysis • Empty and full sample containers should be sealed and transfer of containers should be documented at each stage of the operation • Regularly scheduled calibration of all chemical procedures and detection systems, and frequent background monitoring

13. Direct measurement issues • Assurance that a direct measurement program achieves the required level of quality requires attention to practical operational issues • Example • Control of contamination and other extraneous sources of radiation, and

14. A complete QA program needs: • Compliance with operational requirements stated in accepted written criteria, • Clear and complete documentation of the in-house QA program, • Periodic performance evaluations, • Documented procedures and Q.A. program for services provided to customers, • Adequate training program for the staff.

15. A Quality Assurance programme should provide for: Planned and systematic actions to provide adequate confidence that requirements for monitoring occupational exposure are satisfied, including requirements for feedback of operational experience;

16. A Quality Assurance programme should provide for: A framework for the structuring and analysis of tasks, development of methods, establishment of norms and identification of necessary skills for the execution of the monitoring program; and

17. A Quality Assurance programme should provide for: Validation of designs, manufacturing and supply of equipment and materials, as well as operating, maintenance, inspection and testing procedures.

18. Quality Control

19. Quality Control • Quality Control - The operational techniques and activities that are used to fulfil requirements for quality. • Examples of QC: • routine (i.e. daily) use of irradiated control dosimeters, • various statistical analyses used to verify continued system performance.

20. Quality Control demands, • Procedures and practices for proper management of the program. • System calibration. • Routine verification of proper instrument performance. • Detailed documentation of all measurement, evaluation and reporting procedures. • Data recording.

21. Quality Control procedures • Should be carried out at appropriate intervals • Should cover the following: • Documentation of the required performance criteria • Identification of the person responsible for operation and maintenance of equipment • Use of traceable reference standards • Performance checks of measurement systems

22. Quality Control procedures • Quality Control procedures should also cover: • Instrument calibration, • Participation in interlaboratory-comparison programs, • Computational checks, • Periodic review of procedures, specifications and operating records, • Observation of operations and evaluation of quality control data,

23. Quality Control procedures • Finally, Q.C. procedures should cover: • Evaluation of compliance with the performance criteria of appropriate standards • Evaluation of quality control data to ensure the long‑term consistency of analytical results • Verification of determinations of minimum detectable activities

24. Quality Assessment

25. Quality Assessment includes: • Accreditation • Audits • Intercomparisons

26. Accreditation – Independent assessment • It is important to establish independent methods to assess the quality of programmes • Accreditation is a formal recognition that an organization is competent to carry out specific activities • Accreditation is conducted through on-site audits, as well as use of standardized sources, samples and phantoms for comparison

27. Accreditation – Independent assessment Accreditation programmes address the full range of laboratory quality assurance components, including; • Procedures • Documentation • Training • Calibration • Maintenance • Corrective actions, and • Measurement accuracy and precision

28. Audits • The objective of audits is to enhance the effectiveness and efficiency of the programme • Audits should be conducted by: • People who are technically competent, but • Do not have any direct responsibility for those activities

29. Audits • Auditors may be staff from other work areas within the organization, or as an independent assessment by experts from other organizations • Audits and reviews should be performed in accordance with written procedures and checklists

30. Intercomparisons contribute to QA • Evaluate services abilities • Provide access unique calibration resources and facilities • Help participants identify problem areas • Compare the performance and methods for assessment

31. Intercomparisons contribute to QA • Provide a forum for information exchange • Provide training for service staff • Provide information to justify obtaining resources for upgrading counting systems. • Obtain information to regulatory authorities to demonstrate compliance with regulations