Journal of the ICRU Vol 6 No 2 (2006) Report 76 Oxford University Press
doi:10.1093/jicru/ndl025
EXECUTIVE SUMMARY documents the actions taken to ensure quality. Some of the items this manual should address include policies and procedures of the laboratory, quality performance goals, competence and training of staff, responsibilities and authorities of staff, records management procedures, equipment specifications, identification and correction of errors, as well as procedures for reviews and audits. When a measurement result is disseminated, an evaluation of the uncertainty associated with the value must be provided. The methods for evaluating and specifying the uncertainty are discussed, and typical sources of uncertainty are given as examples. The methods of the ISO Guide to the Expression of Uncertainty in Measurement are used in the present report. MEASUREMENT ANALYSIS METHODS DEVELOPMENT OF THE QUALITY SYSTEM AND QUALITY MANUAL The management of quality requires attention to a number of areas of activity. Measurement quality is the result of planning, development of procedures, training, monitoring equipment performance, documenting results, and evaluating uncertainties. There are a number of types of institutions and facilities performing calibrations and measurements of ionizing radiation. These include primary or national standards laboratories, secondary and accredited dosimetry calibration laboratories, as well as manufacturers’ and end-users’ facilities. Each type of institution has different needs and requirements for maintaining measurement quality. The primary laboratories are expected to maintain the highest metrological quality and, therefore, will have the most extensive quality management system. However, measurement quality is also extremely important to secondary laboratories, manufacturers, and end-users whose measurements may directly affect the health and safety of workers or members of the public. MEASUREMENT QUALITY ASSURANCE Establishing and maintaining the quality of measurements involves developing a quality manual that
The quality of ionizing-radiation measurements is dependent upon the use of physical standards that remain stable for a long time. The equipment used in calibration measurements must also be shown to operate properly and to remain stable for a long time. Methods used to evaluate the stability of measurement results include control charts that are helpful in identifying unwanted trends or drifts that may indicate developing problems. Statistical analysis of data may also be necessary to identify unusual measurement results or outliers. As part of the quality-management program, measurement and calibration results must be reviewed and approved before results are disseminated. An important aspect of ensuring data quality is the use of selfaudits and reviews conducted by staff members in the laboratory. The purpose of such self-evaluations is to minimize the chance for errors in results before reports leave the laboratory. PRACTICAL APPLICATIONS AND RECOMMENDATIONS Examples of practical problems that occur in calibration and measurement laboratories are provided in order to illustrate the application of quality-management procedures. Recommendations for the control of influence quantities such as
Ó International Commission on Radiation Units and Measurements 2006
Downloaded from http://jicru.oxfordjournals.org/ at University of Oklahoma on August 24, 2014
The present report describes methods for establishing, maintaining, and evaluating the quality of ionizing-radiation calibrations and measurements. The report is directed primarily toward individuals and organizations responsible for calibrations and measurements of ionizing radiation. The goal of the report is to provide calibration and measurement laboratories with recommended procedures for quality management that are consistent with the recommendations contained in applicable national and international standards. The information and guidance provided should also be useful to personnel performing radiation measurements as well as to the users of calibration services. The present report is also expected to be of interest to agencies responsible for regulating radiological activities.
MEASUREMENT QUALITY ASSURANCE FOR IONIZING RADIATION DOSIMETRY
of the term ‘calibration factor’ is clarified. The definitions are consistent with those of ICRU, ISO, IEC, and the International Vocabulary of Basic and General Terms in Metrology.
environmental conditions are discussed along with suggested contents for recorded information and report forms. The suggestions apply to the needs of primary laboratories, secondary or accredited dosimetry calibration laboratories, dosimetry services, manufacturers of equipment and sources of radiation, and end-user facilities.
CONCLUSION
DEFINITIONS AND GLOSSARY OF TERMS In the field of ionizing-radiation measurements and calibrations, and specifically in the area of quality assurance for ionizing-radiation measurements, specialized terms and definitions are used. A glossary of definitions is provided as a resource to the practitioner responsible for quality management in a laboratory. The definitions are also useful to the laboratory staff so that a uniform vocabulary is used in daily practice as well as in report forms. The use
8
Downloaded from http://jicru.oxfordjournals.org/ at University of Oklahoma on August 24, 2014
References are provided to many international standards and guidance documents that should prove useful to personnel performing radiation measurements as well as to the users of calibration services and governmental agencies responsible for regulation of the uses of ionizing radiation. The present report should serve to provide general guidance for establishing a quality-management program in a radiation-measurement laboratory by offering information, specific terminology, examples of practical applications, and recommendations for personnel involved in such activities.
doi:10.1093/jicru/ndl025
EXECUTIVE SUMMARY documents the actions taken to ensure quality. Some of the items this manual should address include policies and procedures of the laboratory, quality performance goals, competence and training of staff, responsibilities and authorities of staff, records management procedures, equipment specifications, identification and correction of errors, as well as procedures for reviews and audits. When a measurement result is disseminated, an evaluation of the uncertainty associated with the value must be provided. The methods for evaluating and specifying the uncertainty are discussed, and typical sources of uncertainty are given as examples. The methods of the ISO Guide to the Expression of Uncertainty in Measurement are used in the present report. MEASUREMENT ANALYSIS METHODS DEVELOPMENT OF THE QUALITY SYSTEM AND QUALITY MANUAL The management of quality requires attention to a number of areas of activity. Measurement quality is the result of planning, development of procedures, training, monitoring equipment performance, documenting results, and evaluating uncertainties. There are a number of types of institutions and facilities performing calibrations and measurements of ionizing radiation. These include primary or national standards laboratories, secondary and accredited dosimetry calibration laboratories, as well as manufacturers’ and end-users’ facilities. Each type of institution has different needs and requirements for maintaining measurement quality. The primary laboratories are expected to maintain the highest metrological quality and, therefore, will have the most extensive quality management system. However, measurement quality is also extremely important to secondary laboratories, manufacturers, and end-users whose measurements may directly affect the health and safety of workers or members of the public. MEASUREMENT QUALITY ASSURANCE Establishing and maintaining the quality of measurements involves developing a quality manual that
The quality of ionizing-radiation measurements is dependent upon the use of physical standards that remain stable for a long time. The equipment used in calibration measurements must also be shown to operate properly and to remain stable for a long time. Methods used to evaluate the stability of measurement results include control charts that are helpful in identifying unwanted trends or drifts that may indicate developing problems. Statistical analysis of data may also be necessary to identify unusual measurement results or outliers. As part of the quality-management program, measurement and calibration results must be reviewed and approved before results are disseminated. An important aspect of ensuring data quality is the use of selfaudits and reviews conducted by staff members in the laboratory. The purpose of such self-evaluations is to minimize the chance for errors in results before reports leave the laboratory. PRACTICAL APPLICATIONS AND RECOMMENDATIONS Examples of practical problems that occur in calibration and measurement laboratories are provided in order to illustrate the application of quality-management procedures. Recommendations for the control of influence quantities such as
Ó International Commission on Radiation Units and Measurements 2006
Downloaded from http://jicru.oxfordjournals.org/ at University of Oklahoma on August 24, 2014
The present report describes methods for establishing, maintaining, and evaluating the quality of ionizing-radiation calibrations and measurements. The report is directed primarily toward individuals and organizations responsible for calibrations and measurements of ionizing radiation. The goal of the report is to provide calibration and measurement laboratories with recommended procedures for quality management that are consistent with the recommendations contained in applicable national and international standards. The information and guidance provided should also be useful to personnel performing radiation measurements as well as to the users of calibration services. The present report is also expected to be of interest to agencies responsible for regulating radiological activities.
MEASUREMENT QUALITY ASSURANCE FOR IONIZING RADIATION DOSIMETRY
of the term ‘calibration factor’ is clarified. The definitions are consistent with those of ICRU, ISO, IEC, and the International Vocabulary of Basic and General Terms in Metrology.
environmental conditions are discussed along with suggested contents for recorded information and report forms. The suggestions apply to the needs of primary laboratories, secondary or accredited dosimetry calibration laboratories, dosimetry services, manufacturers of equipment and sources of radiation, and end-user facilities.
CONCLUSION
DEFINITIONS AND GLOSSARY OF TERMS In the field of ionizing-radiation measurements and calibrations, and specifically in the area of quality assurance for ionizing-radiation measurements, specialized terms and definitions are used. A glossary of definitions is provided as a resource to the practitioner responsible for quality management in a laboratory. The definitions are also useful to the laboratory staff so that a uniform vocabulary is used in daily practice as well as in report forms. The use
8
Downloaded from http://jicru.oxfordjournals.org/ at University of Oklahoma on August 24, 2014
References are provided to many international standards and guidance documents that should prove useful to personnel performing radiation measurements as well as to the users of calibration services and governmental agencies responsible for regulation of the uses of ionizing radiation. The present report should serve to provide general guidance for establishing a quality-management program in a radiation-measurement laboratory by offering information, specific terminology, examples of practical applications, and recommendations for personnel involved in such activities.
