This regulation provides general principles for the development of quality assurance plans for ionizing radiation monitoring. It is applicable to all departments engaged in radiation protection work. GB 8999-1988 General Regulations for Quality Assurance of Ionizing Radiation Monitoring GB8999-1988 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
General rule of quality assurance forionizing radiation monitoringUDC
681.2:621
GB8999-88
This regulation provides general principles for the formulation of quality assurance plans for ionizing radiation (hereinafter referred to as radiation) monitoring. It is applicable to all departments engaged in radiation prevention and control.
1 Terminology
1.1 Radiation monitoring is the measurement of radiation or radioactive activity in order to estimate or control the exposure of radiation or radioactive materials. The term also includes the analysis of the measurement results.
1.2 Quality assurance refers to the planned and systematic actions taken to ensure that the monitoring results have an appropriate degree of confidence. 1.3 Quality control refers to those measures used to evaluate the performance of instruments and devices. All actions that determine the degree to which equipment and procedures adapt to established requirements. Quality control is part of quality assurance.
1.4 Personal monitoring refers to the use of devices worn by workers on certain parts of the body to measure and analyze the measurement results, or to measure the radioactive activity in the body, exudates or body fluids. The purpose of this measurement is to estimate the dose to human tissue or the maximum dose, or to estimate the intake of radioactive substances in the body or the content of radioactive substances in the body. 1.51 Workplace monitoring is monitoring conducted to provide workers with data on the working environment and radiation levels related to the operations they are engaged in.
1.S Operational monitoring refers to monitoring specifically related to a certain operation. 1.7 Environmental monitoring 1.1.1.1.2 Monitoring refers to monitoring conducted to estimate or control the environmental radiation level or the degree of radioactive material contamination and the maximum collective dose to the public in a certain range around a nuclear facility. 1.2.1.3 Emissions monitoring refers to monitoring conducted to estimate or control the discharge of radioactive materials from a nuclear facility into the surrounding environment. 1.3.1.4 Emissions refer to gaseous and liquid radioactive materials discharged from a nuclear facility, also known as effluents. 1.4.1.5 Routine monitoring refers to monitoring conducted when the time of monitoring is unrelated to the specific operating steps being performed at the time. Routine monitoring is usually conducted at predetermined intervals to determine whether conditions are suitable for continued operation and whether any changes have occurred that require re-evaluation of operating conditions. 1.4.1.6 Special monitoring refers to monitoring conducted to Monitoring conducted over a limited period of time to explain a particular problem or when an abnormality or suspected abnormality exists.
1.12 A quality control chart is a chart that plots the value of a certain statistic calculated from samples drawn successively from a population and has control limits. It is used to check whether a process is under control. The type of control chart is determined based on the different statistics (mean, range or standard deviation, individual value, etc.). 1.13 Sample refers to the individual sample:
a. A specific object that can be observed in a series; b. A certain amount of material that can be observed in a series; c. It can be an observation or a qualitative or quantitative observation. 1.14 Traceability refers to a characteristic of a measurement result that allows people to link the measurement result to a "suitable" standard (device) [usually a national standard (device) or an international standard (device)] through a continuous chain of comparison. 1.15 Nuclear equipment refers to the inspection of the results of radiation monitoring and the evidence provided to determine whether the monitoring results meet the quality requirements. The standards, procedures, instructions, monitoring plans, administrative management and other application documents formulated are the appropriate source of the Ministry of Nuclear Industry of the People's Republic of China on March 7, 1988, and implemented in 1988-1201. 8999—88
Whether they are effectively executed and the planned work is carried out. 2 Development of quality assurance plan
2.1 When developing any monitoring plan, a corresponding quality assurance plan must be included. The quality assurance plan should be developed specifically according to the type of monitoring and the object of monitoring.
a. Monitoring types can be divided into routine monitoring, operational monitoring and special monitoring. b. Monitoring objects can be divided into personal monitoring (including external exposure personal monitoring, internal contamination monitoring and skin contamination monitoring), workplace monitoring (including external exposure radiation field monitoring, air pollution monitoring and surface contamination monitoring), and other aspects. 2.2 The whole process of monitoring must be quality assured. The whole monitoring process refers to the organizational preparation of all information, equipment and operations related to a given measurement to the processing of measurement results. 2.3 When formulating a quality assurance plan, the following aspects should generally be considered: a sound radiation monitoring and quality assurance organization, a. Selection and training of personnel, a. The quality of instruments and devices and their maintenance and calibration frequency, standard methods. , application and maintenance of standard instruments, standard materials and reference radiation; d.
Quality assurance measures during the monitoring process:
The monitoring results must be traceable to national standards; it must be proven that the degree of conformity between the monitoring results and objective reality has reached and maintained the required quality. g.
3 Implementation of the quality assurance plan
3.1 Organizational structure
3.1.1 Each department and unit must make clear provisions for the establishment (configuration) of the quality assurance management organization or personnel, and should stipulate the organization or personnel’s role in supervising, managing and guiding the implementation of the quality assurance plan. 3.1.2 The leaders in charge of radiation safety in each unit shall be responsible for the entire quality assurance plan. 3.1.3 The quality assurance organization of each unit shall be responsible to the superior organization and have full supervision and verification rights over the monitoring organizations at the same level. 3.1.4 When setting up organizations and defining responsibilities, the following must be taken into consideration: a. Radiation monitoring quality assurance is not only the responsibility of quality assurance management personnel, but mainly depends on all personnel engaged in each link of the monitoring process.
b. The responsibilities and obligations of the monitoring organization or personnel in implementing the quality assurance plan must be clearly defined. When a monitoring task involves multiple departments or units or individuals, the responsibilities and obligations of all parties must be clearly defined and documented.
3.2 Selection and training of personnel
3.2.1 All personnel engaged in radiation monitoring and quality management should be qualified and competent in terms of education, professional knowledge, technical level and practical work experience. These personnel should remain relatively stable. 3.2.2 Regular training, examinations or assessments should be conducted to ensure that these staff members reach and maintain a level appropriate to the work they undertake. 3.3 Measuring devices and materials
3.3.1 Measuring devices and materials of qualified quality must be used. 3.3.2 According to the Metrology Law of the People's Republic of China, mandatory verification must be implemented for safety protection and environmental protection monitoring and measuring instruments. 3.3.3 The instruments used must be calibrated regularly in accordance with relevant national standards. 3.4 Metrology standards
3.4.1 Radiation metrology standards should be equipped according to the national value transfer standard level, and the scale and deployment of metrology centers or stations at all levels and metrology rooms or groups of each unit should be built in accordance with the regulations of the metrology authority. 3.4.2 The value transfer standard level requirements for standard metrology instruments must comply with the requirements of the Implementation Rules of the Metrology Law of the People's Republic of China. 438
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3.4.3 Standard sources or reference radiation should be qualified by the national metrology department or traceable to national standards.
3.4.4 Standard reference material should be a uniform, stable material with radioactive or stoichiometric properties. Its matrix should be the same or similar to the sample matrix, and its radioactive activity should be similar to the activity in the sample to be tested. Generally, the difference should not be more than several or more than ten times. 3.4.5 Inspection source, the inspection source used to inspect the working state of the instrument should have good long-term stability. 3.4.6 Various measurement standards must be carefully maintained to keep their metrological properties within the specified limits. 3.5 Quality assurance measures during monitoring
3.5.1 Specific provisions must be made for the management of documents and information related to the quality assurance plan. 3.5.2 The monitoring method should adopt the standard method, or the method approved by the superior competent department, or the method that has been verified by comparison.
3.5.3 The selected monitoring points or parts and the collected samples should have good temporal and spatial representativeness. 3.5.4 The error requirements should be determined based on the experience of various monitoring under normal conditions in the past and the requirements of the monitoring plan to control and inspect the quality of monitoring.
3.5.5 The sample size (sample capacity) or measurement time of the measurement in the monitoring plan should meet the statistical requirements. The statistical representation of the monitoring results includes the mean value, standard deviation and the confidence range of the mean value. The number of significant figures of the data should reflect the accuracy of the data.
3.5.6. Data processing should use appropriate statistical test methods or quality control charts for statistical tests. The elimination of abnormal data must be cautious, and the reasons should be analyzed and found, and recorded. 3.5.7. The measurement results should be traceable throughout the monitoring process. 3.5.8. The main parameters before and after the maintenance or replacement of instruments must be archived. A certain amount of each batch of important samples should be reserved and kept for a certain period of time for acceptance or inspection and tracking. 3.5.9. In order to evaluate various measurement results and link the measured quantity with the protection standard, different models can be used to express the relationship between the measured and studied quantities. This model should reflect the situation of the real system as much as possible. The basic assumptions of the model should ensure that the degree of overestimation or underestimation of the converted quantity value is acceptable. 3.6.1. The control methods must be clearly defined for various factors related to quality assurance. 3.6.2. The analysis and measurement of quality control samples provide a method to determine the precision and accuracy of monitoring results. The management of quality control samples must be strengthened. Quality control samples include: monitoring quality inspection samples (standard reference materials or samples) with known activity issued by superior departments or monitoring centers, or personal dosimeters issued by superior departments or monitoring centers and worn at the same time ("reference dosimeters" for dual-track personal dose monitoring), etc.
3.6.3 The radiation monitoring quality management department shall organize inter-laboratory measurement comparisons regularly or in a timely manner. Each laboratory shall actively participate in the comparisons, especially the comparisons between internal and external laboratories that can be traced back to national or international standards, so as to find errors or problems that are difficult to find only in the laboratory. 3.7 Quality assurance records
3.7.1 Quality assurance records suitable for quality assurance plan management must be prepared. 3.7.2 Objective evidence of quality must be given in the records. 3.7.3 All records must correspond to the projects, practical activities and results recorded. 3.7.4 Management regulations for quality assurance records must be formulated 3.7.4.1 Contents of records
a. Monitoring records: Necessary and accurate records shall be kept for each step of the monitoring process. b. Quality control records: including the inspection, calibration, verification and maintenance of all instruments and equipment, as well as the use of standard counters, inspection sources, standard sources and reference radiation, quality control samples and their analysis and measurement, inter-laboratory comparisons and the use of reference materials or comparison samples. c. Verification and inspection records: including the verification of analytical measurement and data processing methods, the verification of computer programs, and the verification of monitoring results.
3.7.4.2 Record preservation
GB8999-88
Should monitor and quality assurance plans. Proper storage period shall be stipulated for the original monitoring records and the results of the monitoring plan. Generally speaking, the monitoring results (including the original materials and data that must be attached) and the inspection report shall be kept for a long time, and important data and information shall be copied and stored in different places.
3.7.4.3 Record storage and use
The monitoring data archives and the storage, use and reporting systems should be established by category. 4 Quality Assurance Verification
4.1 A planned and documented internal and external verification system must be formulated and implemented to check whether there is a quality assurance plan, the adaptability of the plan and the implementation status. This kind of verification can be planned or random. 4.2 The unit responsible for the verification must formulate the qualification review standards for the verification personnel. The qualification review must consider the following aspects: professional knowledge, technical level and work experience in the field to be verified; a.
Knowledge of relevant laws, regulations, standards, work procedures and production processes; c. No direct relationship with the monitoring work to be verified; 4.3 When conducting internal verification, the responsible personnel directly engaged in monitoring work shall not intervene in the selection and determination of the work of the verification personnel. 4.4 The verification results must be reported in writing by the verification personnel and copied to the person in charge of the unit to be verified. The unit must take necessary corrective measures according to the problems found in the verification and implement them in time. 4.5 The unit responsible for the verification shall continue to check whether the problems found in the verification have been corrected, and the results shall be supplemented in the verification report.
GB8999-88
Appendix A
Data processing
(reference)
A1 Data processing procedures for the measurement of quality control samples and inter-laboratory measurement comparison: A1.1 Strictly round off each observed value in accordance with the digital rounding rules. A1.2 Perform consistency test on the logarithm - judgment and processing of abnormal values: A1.2.1 The inspection procedure generally includes:
8. Select appropriate inspection rules according to the parameters to be inspected and their actual conditions; b. Determine the significance level α of the statistical test for detecting outliers, referred to as the detection level, which should be 5% or 1%. Determine the critical value of the statistic based on α and the number of observations n: Substitute each observation into the test rule to obtain the statistic. If the value c
obtained exceeds the critical value, it is judged to be an outlier. Otherwise, it is judged as "no outlier". If an outlier is detected, the same detection level and test rules are used to continue testing the remaining observations after being judged as outliers until no outliers can be detected. A1.2.2 The general way to deal with outliers is: a. The outliers are retained in the sample for subsequent data analysis; the outliers are corrected when the cause is found;
the outliers are eliminated (sometimes appropriate observations can be added to the sample). C.
A1.2.3 Elimination or correction of outliers:
a. Any outlier shall not be eliminated or corrected without sufficient technical or physical reasons: b. In addition to sufficient reasons to explain its abnormality, it should also show a high degree of statistical abnormality before it can be eliminated. The test of high abnormality: determine the significance level of the statistical test of high abnormality, half α, referred to as the elimination level, which is less than the detection level.
(α*α). Test the abnormal values ​​according to the above test procedures and rules, using α* instead of α. The elimination level is generally 1% or less.
A1.2.4 The detected abnormal values, the observed values ​​that have been eliminated or corrected, and their reasons should be recorded for future reference. A1.2.5 Test rules. This regulation recommends referring to GB4883-85 "Statistical Processing and Interpretation of Data: Judgment and Processing of Normal Sample Abnormal Values".
The recommended test rules are used for the observed values ​​of the sample to be tested (or the values ​​obtained after a certain function change). Except for individual abnormal values, they all come from the same normal population or an approximately normal population. A1.3 Estimate the systematic error of the measurement result (the error whose cause can be determined). A1.4 Calculate the standard deviation or coefficient of variation of the measurement result. The sample standard deviation refers to the parameter S representing the degree of dispersion of the results of n measurements of the same measured physical quantity, and is given by the following formula:
; is the result of the ith measurement, to is the arithmetic mean of the n measurement results. The ratio of the absolute value of the standard deviation to the arithmetic mean is called the coefficient of variation, and the ratio can sometimes be expressed as a fraction. (A1)
. The sample standard deviation should not be confused with the population standard deviation. The population standard deviation iH of a population size of N and a half-mean of ur is given by the following formula:
（A2)
GB8999—88
b. The n measurement series studied is regarded as a sample of a population, and S is an estimate of the population standard deviation. The expression S/Vn gives an estimate of the standard deviation of the mean relative to the population mean μr, and the expression S/Vh is called the sample standard deviation of the mean.
A1.5 The expression of measurement results should take into account the confidence interval. If the distribution is normal and the number of measurements is sufficient, the result can be expressed as: result μr±kg
where r is the standard deviation of the population mean μr (αr=-%)
When 1-α=68.3%, K= 1, 1-α=95%, K= 2, 1-α=99.7%, K= 3. When the number of measurements is small, the t value of the "Student's" distribution is used, which can be expressed as: result=α±ts,
where S,The standard deviation of the arithmetic mean of the measurement column (S, = A2 In routine monitoring, the data processing procedure can be simplified. S
(A3)
(A4)
A3 When necessary, apply the normal hypothesis test rule to test the quality of the measurement, that is, to test whether a batch of observations (or the values ​​after the observations are transformed by a function) come from the same normal population. 442
B1 Mean control chart
GB 8999-88
Appendix B
Preparation and application of several control charts
(reference)
Draw two horizontal lines at u, ±3α/VN on the vertical axis of the coordinate paper, marked as the upper control limit (UCL) and the lower control limit (LCL), and draw a center line at μr in the middle, which is the mean control chart. Sometimes two horizontal lines are drawn at μr±2α/VN, marked as the upper warning limit (UWL) and the lower warning limit (LWL). μ is the population mean, α is the population standard deviation, and N is the population size. The half-mean control chart reflects the deviation between the sample mean and the population mean, and controls the accuracy of the measurement results. Accuracy. When the sample mean exceeds the warning limit, an abnormal situation may occur. If it exceeds the control limit, it means that an abnormal situation exists and the cause should be investigated. B2 Range Control Chart
Use a similar method to the above chart to draw a center line on the vertical axis of the coordinate paper, and draw the upper and lower control limits at R ± 3α. Similarly, sometimes the upper and lower warning limits are also drawn at μ ± 2 to form a range control chart. μ is the mean of the range, and is the standard deviation of the range.
The range control chart reflects the degree of dispersion of the internal values ​​of the sample data and controls the precision of the measurement results. When the sample range exceeds the upper control limit, it indicates that the dispersion of the sample is too large, and it is almost certain that there are abnormal values. , the reason should be checked. If it is lower than μR, it means that its precision is better than the specified precision.
Use standard deviation instead of range, and use the same method to make a standard deviation control chart. However, the method of calculating the range is simpler. B3 individual value control chart
The method of making a half-mean control chart is the same. Use μ as the center line, u±3 as the upper and lower control limits, and u±20 as the upper and lower warning limits to form an individual value control chart. bzxz.net
Applying the individual value control chart, the cause of the problem in the sample data can be discovered. For example, a laboratory measures a comparison sample, and its average value exceeds the control limit of the mean control chart. By placing each of its measured values ​​on the individual value control chart, it can be found based on the Is there a value, or is there a few values ​​that cross the control limit to analyze the cause.
In actual work, the above three control charts are often used in pairs to complement each other from different angles, reflect the control situation, and find out the cause of the problem.
These three control charts are all compiled based on the normal distribution theory, and they all assume that and are known, but in actual work, they are often unknown. The estimated values ​​of μ and can be obtained by estimation. Under normal conditions, a series of random samples with a capacity of n are randomly selected, preferably n20, and the average value of these samples is calculated as the estimated value of the overall average value, and the sample standard deviation is calculated as the estimated value of the overall standard deviation. The value can also be determined based on the experience of monitoring under normal conditions in the past and the requirements of the monitoring plan. In specific cases, such as measurement comparison, μ is the activity value, specific activity value or concentration value of the standard source, standard reference material or reference sample used. Additional notes:
This standard was reviewed by the Radiation Protection Subcommittee of the National Nuclear Energy Standardization Technical Committee. This standard was drafted by the Security Bureau of the Ministry of Nuclear Industry. The main drafter of this standard is Ren Jingxuan.
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