GB 11216-1989 General requirements for quality assurance plans for nuclear facility effluent and environmental radioactivity monitoring
Some standard content:
National Standards of the People's Republic of China
General requirements of quality assurance program for effluent and environmental radioactivity monitoring at nuclear facilities1 Subject content and scope of application||tt ||GB11216—89
This standard specifies the general requirements for the development and implementation of quality assurance plans for nuclear facility effluent and environmental radioactivity monitoring. The principles of using this standard can also be referred to when formulating a quality assurance plan for environmental non-radioactive monitoring. 2 Glossary
2.1 Quality assurance
are all planned, systematic and necessary measures taken to provide sufficient credibility to ensure that the monitoring results meet the specified requirements. 2.2 Quality control
is part of quality assurance. It is the methods and measures prescribed to control and monitor the performance of processes and measuring devices to meet predetermined quality requirements.
2.3 Effluents
are airborne or liquid wastes released into the environment. 2.4 Monitoring
Measurement of radiation or radioactive activity for the purpose of estimating or controlling exposure to radiation or radioactive material. The term also includes the analysis of measurement results.
2.5 Documentation
is any written or graphical information that describes, defines, explains, reports or demonstrates relevant quality assurance activities, requirements, procedures or results. 2.6 Uncertainty
indicates the degree of uncertainty about the measured value due to errors or variability in monitoring. Uncertainty can be divided into systematic uncertainty and random uncertainty according to the nature of the error. Or according to the estimation method of its value, it can be divided into: Type A component - the standard deviation calculated by statistical methods for multiple repeated measurements; Type B component - the approximate "standard deviation" estimated by other methods. Type A components and Type B components can usually be synthesized into synthetic uncertainties using the method of synthetic variance. 2.7 Accuracy
refers to the degree of consistency between the measurement results and the agreed true value or correct value of the measured quantity. 2.8 Precision
refers to the degree of dispersion of the measurement results around the average value when performing multiple analysis measurements under certain conditions. 2.9 Quality control samples
are samples specially prepared to determine and control the uncertainty in analytical measurements. They mainly refer to parallel samples, spiked samples and blank samples.
National Environmental Protection Administration approved 1990-01-01 implementation on 1989-03-16
2.10 parallel samples
GB11216-89
refers to collection at the same place at the same time, A group of samples prepared with the same composition and physical and chemical properties. 2.11 Blank samplebZxz.net
is a sample that is exactly the same as the sample to be tested except that it does not contain the components to be measured. 2.12 Spiked samples
refer to samples in which a known amount of the radioactive substance to be measured is added to the blank sample. 2.13 Instrument background
is the response of the instrument when there is no sample to be measured. 2.14 Measurement standards
are measuring instruments or substances used as the basis for verification according to the accuracy level specified by the country. 2.15 Standard source
is a radioactive source whose radioactive core content, radioactive decay rate or photon emission rate is accurately known. 2.16 Test source
is a radioactive source with high nuclide purity, but whose activity does not need to be accurately known, and is used to determine whether the measuring instrument is working properly. 2.17 Standard reference material
is a substance or material that has highly stable physical, chemical or metrological properties under specified conditions and has been verified and officially approved for use as a standard.
2.18 scale
determines the numerical relationship between the observed output value of a base measurement system and the corresponding standard characteristics. 2.19 Calibration
is the entire work of determining the indication error of the measuring instrument (including determining other measurement performance if necessary) and performing correction. 2.20 Verification
is all the work performed to evaluate the performance of measuring instruments (accuracy, stability, sensitivity, detection efficiency, instrument background, etc.) and determine whether it is qualified.
2.21 Test
is to use an instrument to measure the response generated by a test source to determine whether the instrument is working properly. 2.22 Energy scale source
is a source containing one radionuclide or several radionuclides that emit two or more α or rays of accurate known energy. 2.23 Quality control chart
is a chart depicting the measurement results of the performance parameters of a measuring instrument or sample to determine whether the performance of the instrument or sample is in a normal state under statistical control.
2.24 Verification
refers to the investigation, inspection and evaluation of objective evidence to determine whether the established procedures, instructions, instructions, specifications, standards, administrative and operational programs, and other application documents are appropriate and complete, and to determine the effectiveness of its implementation.
3 Quality control in sample collection, transportation and storage 3.1 Sampling plans and procedures are mainly to ensure that representative samples are collected and to maintain the original concentration of radionuclides before analysis. 3.1.1 A scientific sampling plan must be formulated, including selecting appropriate sampling sites and locations, avoiding some disturbing and poorly representative locations, and selecting reasonable sampling time, sampling rate, and sampling methods. 3.1.2 Detailed operating procedures for sampling, packaging, transportation and storage of various types of samples must be formulated and strictly followed. In addition to stipulating technical methods and requirements, this procedure should also include specific operating steps, record content, format, and label settings. Preventive measures to avoid the loss of radionuclides in samples through chemical, physical or biological effects and accidental contamination generally require the adoption of national or international standard procedures. GB11216-89
3.1.3 For effluent samples, in addition to having the same physical and chemical characteristics as the discharged effluent, the quantity must also be proportional to the radioactive content in the effluent. Under release conditions, the representativeness of the sample must also be ensured. 3.2 The mass, volume or flow rate of the sample should be measured accurately, and the error should generally be controlled within 10%. Flow meters for air and water sampling devices should be calibrated at least annually. For effluent sampling systems, the actual flow rate of the sampler should be determined and the flow rate calibrated at the temperature and pressure at which the system is operating.
3.3 The radionuclide collection efficiency of the sampling device should be documented. Generally, the collection efficiency should be measured experimentally according to the actual conditions of use. If the use conditions are the same or similar to the measurement conditions of the manufacturer of the sampling device, the data given by the manufacturer can also be used. 3.4 In order to determine the uncertainty of sampling, parallel instantaneous samples should be collected regularly. The number of parallel samples collected accounts for about 5% to 20% of the total number of conventional samples.
3.5 Original samples or pre-processed samples should be kept for future reference. Samples from environmental background surveys before the operation of nuclear facilities should be kept for ten years after the facility is decommissioned. Percent of the number of conventional samples that can be stored should be stored for ten years; strongly contaminated samples and samples with special circumstances should be stored until a conclusion is made after processing.
4 Quality Control in Analytical Measurements
4.1 Sample pretreatment and analytical measurement methods must have complete written procedures. Sample pretreatment and analytical measurement methods should use standard methods, or methods that have been identified and validated. No operating personnel may modify routinely used methods or procedures without authorization. 4.2 During the operation of analysis and measurement, care should be taken to prevent cross-contamination between samples. Analysis and measurement experiment rates and instruments and equipment should be graded according to the type of radionuclides in the sample and its concentration. 4.3 In order to determine the uncertainty generated during the analytical measurement process so that appropriate correction measures can be taken, measurement quality control samples (parallel samples, spiked samples and blank samples) should be analyzed. 4.3.1 To determine the precision of analytical measurements, parallel samples should be analyzed and measured, prepared from samples that are as homogeneous as possible. 4.3.2 In order to determine the accuracy of analytical measurements, the corresponding standard reference material or spiked sample should be analyzed and measured using the same operating procedures as the sample to be measured, and it is generally hoped that the spiked sample to be analyzed and measured will not be known to the analyst. The determined systematic errors in analytical measurements must be corrected.
4.3.3 In order to detect and measure sample contamination during pretreatment and analysis and provide appropriate background subtraction data, the measurement blank sample should be analyzed . Blank samples should be pretreated and chemically analyzed at the same time as the samples to be tested. 4.3.4 The number of each type of quality control samples analyzed and measured accounts for approximately 5% to 10% of the total number of samples analyzed and measured. And should be evenly distributed among each batch of samples.
4.4. Carriers and standard solutions should be accurately prepared, and the use period or recalibration period should be determined based on their stability. When purchasing and receiving reagents, pay attention to checking the quality. Those who fail to meet the standards will not be used. 4.5 In order to discover and determine the system uncertainty generated by the analytical measurements of this laboratory, it is necessary to participate in the comparison of analytical measurements between laboratories organized by the country and the competent department of this system and the international comparison arranged by the competent department. If the analysis is performed without a formal comparison sample, samples can be exchanged regularly with other laboratories for interchangeable analytical measurements. Results with systematic errors should be analyzed to identify the causes and take corrective measures.
4.6 The performance of analytical measuring devices should be verified, calibrated and inspected. 4.6.1 All analytical and measuring devices should have performance and detailed operating instructions. 4.6.2 New analytical measuring devices or repaired analytical measuring devices must undergo performance debugging, verification and calibration before regular use. The frequency of subsequent regular calibrations depends on the type and stability of the instrument. When replacing an old measuring instrument, the old and new instruments should be compared and measured, and there should be enough representative overlapping measurement data to make the measurement data of the old and new instruments comparable. 4.6.3 The standard source, standard reference material or standard measuring instrument used for verification or calibration should be used correctly according to the accuracy level specified by the country.
4.6.4 Routine inspections should be carried out on routinely used analytical measuring devices. 4.6.4.1 The main performance of regularly used measuring devices should be routinely inspected. For automatic and manual fixed counting and measuring devices, the background and detection efficiency or counting rate of the inspection source should be measured once when measuring each batch of samples. The plateau characteristics of the measuring device should be inspected every six months.
4.6.4.2 For a, energy spectrum measurement device. Energy calibration verification should be performed regularly with an energy calibration source. The frequency depends on the stability of the spectrometer system. Usually, the energy calibration verification is performed and the count rate of the characteristic peak of the verification source is measured when each batch of samples is measured. Energy resolution should be verified monthly. If the segment counting method is used, the stability of the spectrometer should be tested once a week. 4.6.4.3 For portable measuring instruments, a verification source should be used to check whether the operating parameters are normal before each use. 4.6.4.4 The minimum detectable limit of analytical measuring instruments should be verified annually. 4.6.5 Effective quality control must be carried out on the continuous effluent measurement system. 4.6.5.1 All effluent monitoring devices should have detailed performance, operation and maintenance instructions. 4.6.5.2 The measurement standards for verification and calibration of the effluent continuous measurement system should be traceable to national standards. 4.6.5.3 The measurement standard for calibrating the effluent continuous measurement system should be able to establish a calibration relationship for the entire range and energy range or nuclide measured by the instrument.
4.6.5.4 As long as practicable. Periodic inspections of direct continuous measurement systems for effluents should use remote inspection sources. 4.6.5.5 The frequency of verification and calibration should be determined according to the type, stability and complexity of verification and calibration of the continuous measurement system. Calibration is usually carried out every six months and checked with a verification source once a week. 4.6.5.6 The measurement results of the effluent continuous measurement system should be checked and calibrated by regularly sampling the effluent and conducting analytical measurements in the laboratory.
4.6.5.7 The equipment of the effluent continuous measurement system must be repaired and maintained regularly. Important equipment that is easily damaged must be backed up and recalibrated after maintenance.
4.6.6 If a test source is used to check the performance of the measuring device, it is found that its performance has changed or after the measuring device has changed that affects the working parameters (for example: replacing the gas of the flow counting tube, replacing, After repairing important parts of the detector or measuring instrument) the measuring device should be recalibrated or calibrated. If the instrument is shipped to an outside unit for calibration, verification or repair, the instrument should be inspected after being shipped back to the laboratory.
4.6.7 Special written procedures should be prepared for the methods and operating procedures for verification, calibration and inspection of the performance of analytical measuring devices and should be strictly followed.
4.6.8 The results of the performance inspection of the analytical measuring device should be recorded in the quality control record book and drawn on the quality control chart. The upper and lower warning limits and control limits of the quality control chart can generally be taken as plus or minus two and three times the standard deviation of the single measurement value of the parameter. When the measured value falls outside the control limit of three times the standard deviation or falls outside the warning limit of two standard deviations for two consecutive times, research should be conducted, the cause should be identified and corrective measures should be taken. Although a series of measurement results are within the control limits, but show a tendency to deviate from the control limits, it is also necessary to study to determine the cause of this tendency and correct it. 4.7 Each sample must be measured with sufficient precision. Generally, the relative standard deviation of measurements should be controlled at around 5% to 10%. 5 Requirements for data recording, processing and management
5.1 Every step of the entire process from sampling, preprocessing to analysis and measurement, and result calculation for each sample must have clear, detailed and accurate records. The record content and format of each operation step should be clear and specific, and each sample should be affixed with a corresponding label or mark that is not easy to fall off and be damaged. In order to track and control the flow of each sample, there should also be a sample record sheet that is transferred with the sample to record the relevant conditions of each operation step. The relevant staff member should sign the record sheet. 5.2 Quality control during the monitoring process, including performance verification, calibration, inspection, maintenance of sampling and analytical measuring instruments, analysis of quality control samples; comparison of analysis and measurements between laboratories; standard measuring instruments, standard sources, and standard references The use of substances, spiked samples, preparation of carriers and standard solutions should be recorded in detail and accurately. 5.3 Detailed records should also be kept of the computer program’s verification certificate and supporting documents, the qualifications of the monitoring personnel and the results of the quality assurance plan verification.
5.4 All monitoring records and quality assurance documents should be properly preserved, and their retention period should be stipulated. Generally, GB11216-89
should be preserved for ten to ten days after the facility stops operating. For ten years, the results of environmental monitoring should be permanently preserved. 5.5 Data processing should use standard methods as much as possible to reduce errors generated during the processing. The assumptions and calculation methods in data processing and calculation results, the rationality, consistency and accuracy of the original data and calculation results must be reviewed. The review of the calculation results can be done by two people independently or by a person who did not participate in the calculation. If computer calculations are used, computer methods and procedures should be reviewed and operationally verified. The original procedures for formal review and approval must be documented, and each input data should be independently checked. The auditor must sign the audit report. 5.6 Abnormal results that deviate from normal values ??should be reported to the technical leader in a timely manner and verified within the scope of one's own responsibilities. 5.7 The quantities, units and symbols used in the environmental monitoring report should comply with the standards promulgated by the state. 5.8 The formal reporting or use of monitoring data must be signed by the technical person in charge of monitoring. 6 Personnel Qualifications and Training
6.1 Since the precision and accuracy of monitoring results are also related to the experience, knowledge and technical level of the operator, it is necessary for the personnel engaged in monitoring to have sufficient education, professional knowledge, technical level and work experience. Qualifications in terms of abilities and other aspects should be stipulated for the child. They should obtain corresponding technical certificates through examinations or assessments.
6.2 In order to maintain the technical proficiency of monitoring personnel and adapt them to the evolving technical level, they should be subject to repeated technical training, assessment, identification and regular skills review according to the corresponding circumstances. 7 Verification
7.1 In order to check the implementation of the quality assurance plan and determine whether it is appropriate and complete and the effectiveness of its execution. Planned and regular verification must be carried out, generally once every quarter. 7.2 Verifications should be carried out by qualified personnel who have no direct role in the area being verified. 7.3 The verifier shall write a written report on the verification results, which shall be reviewed by the management unit responsible for the verification work. Further measures should be taken to address existing problems, including re-verification. 8 Organization and Management
8.1 Proper organization and management are an important factor in effluent and environmental monitoring quality assurance activities. The organizational structure, personnel settings, responsibilities, and authority levels for managing and implementing the quality assurance plan should be clearly defined. 8.2 The organization and personnel implementing the quality assurance plan should have sufficient power and talent to discover and identify quality problems, recommend and provide solutions, and verify the implementation of the solutions. Additional notes:
This standard is proposed by the National Environmental Protection Administration and the Ministry of Nuclear Industry. This standard is drafted by the China Institute of Atomic Energy. The main drafters of this standard are Song Shaoyi, Guo Mingqiang, Li Ruixiang, Wang Huamin and Ban Ying. The National Environmental Protection Administration is responsible for interpreting this standard.2 The organization and personnel implementing the quality assurance plan should have sufficient power and talent to discover and identify quality problems, recommend and provide solutions, and verify the implementation of the solutions. Additional notes:
This standard is proposed by the National Environmental Protection Administration and the Ministry of Nuclear Industry. This standard is drafted by the China Institute of Atomic Energy. The main drafters of this standard are Song Shaoyi, Guo Mingqiang, Li Ruixiang, Wang Huamin and Ban Ying. The National Environmental Protection Administration is responsible for interpreting this standard.
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