Circular No. 10/2007/TT-BTNMT guiding the assurance and control of quality in environmental monitoring

CIRCULAR

Guidelines for Ensuring Quality and Quality Control in Environmental Monitoring

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The Prime Minister issues this Decision amending and supplementing certain provisions of the Regulation on Response Activities to Oil Spill Incidents issued together with Decision No. 02/2013/QĐ-TTg dated January 14, 2013 of the Prime Minister.

||| Based on Decree No. 80/2006/NĐ-CP dated August 9, 2006 of the Government detailing and guiding the implementation of certain provisions of the Law on Environmental Protection;

||| Based on Decree No. 91/2002/NĐ-CP dated November 11, 2002 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Natural Resources and Environment;

||| Based on Decision No. 16/2007/QĐ-TTg dated January 29, 2007 of the Prime Minister approving the Overall Network Planning for National Resource and Environmental Monitoring until 2020;

||| The Ministry of Natural Resources and Environment guides the ensuring of quality and quality control in environmental monitoring as follows:

||| Part 1:

GENERAL PROVISIONS

I. SCOPE OF REGULATION AND APPLICABLE OBJECTS

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

||| This Circular guides the ensuring of quality and quality control in environmental monitoring activities, including: designing monitoring programs, field monitoring, laboratory analysis, data processing, and reporting monitoring results.

Thông tư này áp dụng đối với tổ chức, cá nhân có liên quan đến hoạt động kinh doanh đối tượng thủy sản nuôi chủ lực trên lãnh thổ Việt Nam.

||| This Circular applies to central and local state management agencies for the environment; environmental monitoring stations and organizations and individuals participating in environmental monitoring activities to report monitoring result data to central and local state management agencies for the environment.

||| This Circular does not apply to automatic continuous environmental monitoring stations.

II. DEFINITIONS

In this Circular, the following terms shall be understood as follows:

||| 1. Quality Assurance (QA) in environmental monitoring is an integrated system of management and technical activities within an organization aimed at ensuring that environmental monitoring activities meet the prescribed quality standards.

||| 2. Quality Control (QC) in environmental monitoring involves implementing measures to assess, monitor, and promptly adjust to achieve the accuracy and precision of measurements according to the requirements of quality standards to ensure that environmental monitoring activities meet the prescribed quality standards.

||| 3. Vietnamese Technical Standards (TCVN) in this Circular are used in accordance with the Law on Environmental Protection and are understood as environmental technical regulations under the Law on Standards and Technical Regulations.

||| III. PRINCIPLES FOR ENSURING QUALITY AND QUALITY CONTROL IN ENVIRONMENTAL MONITORING

||| Ensuring quality and quality control must be implemented throughout all environmental monitoring activities and comply with the following principles:

||| 1. Honesty, accuracy, timeliness.

||| 2. Scientific, modern.

||| Part 2:

||| ENSURING QUALITY IN THE DESIGN OF ENVIRONMENTAL MONITORING PROGRAMS

||| I. DETERMINATION OF THE OBJECTIVES OF THE MONITORING PROGRAM

||| Based on the requirements of state management agencies for environmental protection, environmental monitoring stations, organizations, and individuals participating in environmental monitoring determine specific objectives for the monitoring program. Determining the objectives must be based on current environmental protection policies and laws and information needs to be collected.

||| II. DESIGN OF ENVIRONMENTAL MONITORING PROGRAMS

||| 1. Basic requirements for a monitoring program

||| a. Consistent with national environmental protection programs and strategies;

||| b. Meeting monitoring objectives, ensuring quality, timeframes, and feasibility;

||| c. Adhering to technical guidelines, procedures, and norms for each environmental component to be monitored;

||| d. Implementing all steps in the design of the environmental monitoring program.

||| 2. Steps in designing an environmental monitoring program

||| a. Clearly define the type and kind of monitoring;

||| b. Identify the environmental components to be monitored;

||| c. Establish a list of monitoring parameters according to environmental components: parameters measured in the field, parameters analyzed in the laboratory;

||| d. Select monitoring options, identify sources of impact, major pollutants in the monitoring area; identify issues, potential risks in the monitoring area; determine the boundaries of the monitoring area and forecast possible impacts or changes in the monitoring area;

||| đ. Design sampling plans: determine sampling lines, points, and mark them on maps or diagrams; describe the location, geography, coordinates (longitude, latitude) of monitoring points and symbols for monitoring points;

||| e. Determine sampling frequency, timing, sampling methods, monitoring methods, and analysis methods;

||| g. Determine sampling procedures, sample volume required, container types, preservative chemicals, storage time, sample types, and quantity of quality control samples (QC samples);

||| h. Establish a list and plan for maintaining and calibrating field equipment and laboratory equipment, including safety equipment;

||| i. Develop a human resource plan for monitoring, where specific tasks for each staff member must be clearly assigned;

||| k. Prepare a budget for implementing the monitoring program, including costs for ensuring quality and quality control in monitoring and environmental analysis;

||| l. Identify organizations and individuals participating in the implementation of the program.

Part 3:

ENSURING QUALITY AND QUALITY CONTROL IN FIELD MONITORING

I. FIELD MONITORING

1. Ensuring Quality

To ensure quality in field monitoring, the following requirements must be met:

a. Determining parameters to be monitored, including parameter name, unit of measurement, and required accuracy. Information on parameters to be monitored is presented in Table 1, Appendix I attached hereto;

b. Analytical methods: using appropriate analytical methods suitable for the set objectives. Analytical methods according to TCVN on the environment or other international standards recognized and applied by competent Vietnamese authorities. Information on analytical methods is presented in Table 2, Appendix I attached hereto;

c. Environmental monitoring equipment: using equipment suitable for the determined measurement and testing methods, meeting technical and measurement requirements of the methods. Equipment must be equivalent among monitoring points within the same monitoring program. Equipment must have user instructions, detailed information on maintenance date, calibration, and equipment users. Information on equipment is presented in Table 3, Appendix I attached hereto;

d. Chemicals and standard samples: having all chemicals and standard samples as prescribed by each analytical method. Chemicals and standard samples must be stored in appropriate containers labeled with information such as chemical name or type, supplier, storage concentration guidance, preparation date, preparer, usage period, and other relevant information;

đ. Personnel: individuals conducting monitoring and analysis must have appropriate professional qualifications. Assignment of tasks to each individual must be specific and clearly documented in the sample form at Table 4, Appendix I attached hereto;

e. Data processing and reporting results: the field monitoring team leader is responsible for processing measured and tested data, compiling, evaluating results, and preparing reports according to the model at Table 5, Appendix I attached hereto.

2. Quality Control

When conducting field monitoring and analysis, quality control samples (QC) must be used, including: blank equipment samples, standard check samples, method blank samples, replicate samples, and standard comparison samples.

II. SAMPLING, PROCESSING, AND PRESERVATION OF SAMPLES AT THE FIELD SITE

1. Ensuring Quality

To ensure quality during sampling, processing, and preservation of samples at the field site, the following requirements must be met:

a. Correctly identifying sampling locations;

b. Ensuring monitoring parameters: according to the parameters identified in point a, Clause 1, Section I of this Part;

c. Ensuring correct sampling frequency and time;

d. Sampling, processing, and preservation methods: using appropriate methods according to TCVN on the environment or other international standards recognized and applied by competent Vietnamese authorities. Information on methods is presented in Table 6, Appendix I attached hereto;

đ. Equipment: using equipment suitable for the technical requirements of the methods. Equipment must have operating instructions and must be checked and calibrated before being taken to the field site. Equipment must be equivalent among monitoring points within the same monitoring program. Information on equipment is presented in Table 3, Appendix I attached hereto;

e. Personnel: individuals taking samples, processing, and preserving samples must have appropriate qualifications and expertise. Assignment of tasks to each individual must be specific and clearly documented in writing according to the model at Table 4, Appendix I attached hereto;

g. Sample containers: must be suitable for each monitoring parameter and labeled. Labels on samples must remain affixed to the sample containers throughout their existence, including information on analytical parameters, sample code, sampling time, sample preservation technique used, sampler, and other relevant information;

h. Chemicals: using appropriate chemicals for the sampling method and substances to be analyzed;

i. Sampling reports must be completed during the sampling process. Report contents follow Table 7, Appendix I attached hereto.

2. Quality Control

To control quality during sampling, processing, and preservation of samples at the field site, the following types of QC samples must be used: blank sample containers, field blank samples, field replicate samples, and field duplicate samples.

III. TRANSPORTING SAMPLES TO THE LABORATORY

1. Ensuring Quality

To ensure quality during transportation of samples to the laboratory, the following requirements must be met:

a. Transporting samples: sample transportation must ensure stability in quantity and quality. Transportation time and temperature must comply with TCVN for each monitoring parameter and sample preservation method. Information on sample transportation must be recorded according to Table 8, Appendix I attached hereto;

b. Handover and receipt of samples: handover and receipt of samples must be conducted at the field site (field team handing over to transporter) or at the laboratory (field team or transporter handing over to laboratory) and must be documented in a handover record (with signatures of all relevant parties) containing contents as per Table 9, Appendix I attached hereto.

2. Quality Control

To control quality during transportation of samples to the laboratory, blank transport samples and standard transport samples must be used to monitor contamination and sample changes during transportation.

Part 4:

ENSURING QUALITY AND QUALITY CONTROL IN THE LABORATORY

To ensure quality and quality control, the laboratory must comply with the following basic requirements:

I. MANAGEMENT REQUIREMENTS

1. Clearly define the organizational structure of the laboratory; assign tasks and responsibilities to each staff member, technical management personnel, and quality management personnel.

2. A system of documents and materials, including: quality manuals, operational procedures, forms, and specific job guidance documents.

3. The laboratory conducts internal assessments periodically to check compliance with the quality system requirements. Quality management personnel are responsible for planning and organizing evaluations according to the program while promptly conducting corrective actions and reporting in writing to relevant agencies and units.

4. Laboratory leadership regularly reviews the quality management system and laboratory activities to ensure continuous suitability and effectiveness.

II. TECHNICAL REQUIREMENTS

1. Ensuring Quality

a. Analytical methods

- Method selection: use standardized methods, appropriate methods that have been published, or internal methods (developed by the laboratory) that meet regulatory requirements and have been approved. Prioritize using the latest standardized methods. For methods not published in standards or procedures, written approval from the monitoring program management authority is required.

- Method validation: use standard solutions or reference materials, compare results with other methods, evaluate factors affecting the results to verify the suitability of the selected method. Method validation aims to re-evaluate information on repeatability, reproducibility, typical characteristics of the analytical, measurement, and testing methods, and related factors. The process and results of method validation must be documented in writing.

- Estimate measurement uncertainty: use appropriate methods such as ISO/TAG4/WG3 (guidance on estimating measurement uncertainty) and ISO 5725 standards (accuracy, precision, and trueness of measurement methods and results) to estimate the uncertainty of analytical, measurement, and testing methods through error-causing factors.

b. Equipment

- Laboratory equipment must be calibrated before use. Operation and maintenance of equipment must be assigned to competent personnel.

- Equipment must be marked and labeled for easy identification and differentiation, reflecting calibration status, verification status, and the next calibration and verification due date. Records of each type of equipment must be kept.

- Equipment must be maintained regularly and periodically. Defective equipment must be labeled to distinguish it from normal equipment and stopped from use until repaired and recalibrated.

- Equipment must ensure traceability to the laboratory's measurement standards:

+ The laboratory must develop and implement a calibration program for all equipment to ensure the accuracy of analytical, measurement, and testing results. The calibration program applies to auxiliary measuring devices (such as meteorological parameter measuring devices).

+ For equipment that cannot undergo the above calibration, the laboratory may apply the following measures: participate in inter-laboratory comparison programs or proficiency testing to demonstrate the suitability of related equipment; use certified reference materials or substances with known concentrations from reputable chemical standard suppliers to test equipment; use standard methods or methods chosen and agreed upon by relevant parties.

c. Laboratory conditions and environment: must meet the requirements specified in the analytical method.

d. Sample management

- Apply appropriate sample management procedures for each specific parameter.

- Identification and differentiation marks for samples must be maintained throughout their existence, during analysis, transfer, and when filing records and documents.

- Follow sample instructions; prevent influences that could alter sample quality during storage, handling, preparation, and analysis.

- When receiving samples, record any unusual or deviating points compared to descriptions in the analytical, measurement, and testing methods used.

- After analysis, samples must be stored and preserved for a specified period for possible retesting.

đ. Ensuring data quality

- Check data quality using statistical methods;

- Participate in inter-laboratory comparisons and annual proficiency testing of analytical processes as required by the Ministry of Natural Resources and Environment's Environmental Protection Department;

- Regularly use certified reference materials;

- Repeat analyses using similar or different methods;

- Re-analyze retained samples;

- Consider the correlation between analytical results and sample sensory characteristics.

2. Quality Control

a. To control quality in the laboratory, quality control samples (QC), including: blank equipment samples, blank method samples, replicate samples, additional samples, reference standard samples, and check standard samples, must be used.

b. Acceptance criteria for quality control: analytical, measurement, and testing results of QC samples are only valid when limits for comparison and acceptable errors are established as stipulated in Appendix II attached to this Circular.

Part 5:

ENSURING QUALITY AND QUALITY CONTROL IN DATA PROCESSING AND REPORTING

I. MANAGEMENT AND DATA PROCESSING OF ENVIRONMENTAL MONITORING

1. Documents and records related to the monitoring process at the site and laboratory analysis must be completed fully, truthfully, and promptly.

2. All original documents and records of monitoring activities established under Clause 1 of this Section must be retained and managed in accordance with regulations.

3. Data measured and tested on-site and analyzed in the laboratory must be verified, calculated, and processed. In case of discovering errors in environmental monitoring activities, such data must be reported for a decision to invalidate them. However, original documents as mentioned in Clause 2 of this Section must still be retained and not destroyed.

4. Absolute honesty must be maintained with the results, both on-site testing and laboratory analysis results; no speculation, alteration, or arbitrary supplementation of data. When encountering suspicious phenomena or data, re-monitoring and re-analysis must be conducted and noted in the monitoring documents and records.

II. REPORT PREPARATION

1. Environmental monitoring stations, organizations, and individuals conducting national environmental monitoring must prepare Monitoring Result Reports after each monitoring period and compile annual monitoring result reports based on the monitoring and analysis results of the monitoring periods within the year.

2. Each periodic and annual Monitoring Result Report must ensure truthfulness, timeliness, accuracy, and objectivity. These reports must be reviewed and signed and stamped with confirmation by the leaders of the monitoring organizations before submission to the Department of Environment under the Ministry of Natural Resources and Environment.

Part 6:

IMPLEMENTING PROVISIONS

1. Based on procedures, norms, economic-technical standards, and current expenditure regulations relevant to the monitoring activities, organizations and individuals participating in environmental monitoring must establish budgets ensuring quality and quality control during the preparation of cost estimates for implementation.

2. This Circular takes effect fifteen days from the date of publication in the Official Gazette; all previous provisions contrary to this Circular are abolished.

3. During the implementation of this Circular, if there are difficulties or obstacles, they should be reflected to the Ministry of Natural Resources and Environment (through the Department of Environment) for prompt resolution./.