Regulation of Quality Assurance

1、This guideline adheres to the regulations in the air pollution prevention law and was written in accordance to the fourth article item three.

2、Definition of terms in this guideline are below:

(1) Air quality monitoring facility: automatic or manual controlled air pollution monitoring instruments and related supplementary meteorological monitoring instruments.

(2) Automatic monitoring facility: a monitoring facility using continuous automatic analysis methods to assess the density of pollutants.

(3) Manually operated monitoring facility: a monitoring facility using manual operation to retrieve samples, conduct testing and analysis.

(4) Precision: This refers to the identical level of a repeated analysis. Precision can be obtained by repeatedly analyzing one sample to calculate the measured value with the standard deviation.

(5) Accuracy: This refers to the a test value or the average of a set of test values and how close they are to the actual value. Accuracy can be obtained by comparing to the density value of a standard sample.

(6) Integrity: This refers to the ratio of collected data to the data that should be collected in a set time period.

(7) Representation: This refers to the degree to which the monitored data can reflect the monitored environment.

(8) Comparative: This refers to the degree in which different sets of monitored data can be compared.

(9) Correction: Under specified conditions in order to confirm a measuring instrument or system's detection value, taking comparative known recorded values to make corrections.

(10) Zero offset: When a monitoring instrument is in stable condition and has not been calibrated or operated, using 12 or 24 hour intervals to use zero standard gas to repeatedly test the instrument's fluctuations in detection.

(11) Whole offset: When a monitoring instrument is in stable condition and has not been calibrated or operated, using 12 or 24 hour intervals to use whole density standard gas to repeatedly test the instrument's fluctuations in detection.

(12) Zero point standard gas: A gas that does not contain any elements that can register a reading on measuring instruments.

(13) Whole density standard gas: Standard gas substance that registers at a maximum of 80% density of the measuring instrument's capacity.

(14) Systems audit: Assess and confirm the execution of quality assurance procedures by the management system, operations, analysis system, and data management system.

(15) Performance audit: Using national or approved standards to conduct the auditing of monitoring equipment.

(16) Retrospective: Using the precision or credibility of the highest standards (such as national or international standards as a reference) and transferring them on-site to usable standards or measurement results.

(17) Standard Operating Procedure (SOP): The execution of “operation, maintenance, sampling, analysis, correction, auditing” according to the regulated procedure given for these actions.

(18) Single point automatic monitoring facility: An automatic facility which uses specified sampling of atmospheric air samples to gauge pollution density.

(19) Open automatic monitoring facility: A monitoring facility that uses single or multiple monitoring paths to gauge the average density of pollutants in atmospheric air.

3、Air quality monitoring facilities of each level must follow the specified guidelines written in accordance with article 13 of the air pollution prevention law.

4、Air quality monitoring requires the establishment of a quality assurance operation standard along with a quality assurance project plan to ensure the quality of monitored data. The quality assurance project plan, aside from having signatures on the title, index, and documents, aside from the mailing list and document management, the contents below should be included:

(1) Organization and Responsibilities

(2) Project goals and goals in data quality (includes monitoring and data quality assurance goals)

(3) Monitoring facility establishment (includes choice of monitoring station site, sampling device, monitoring methods and instrument choice)

(4) Establishment of standard operating procedure

(5) Routine preventive maintenance and repair program

(6) Method and frequency of correction and quality control examination (includes samples and retrospectives)

(7) Assessment procedure for precision and accuracy

(8) Data collection, validity confirmation, saving and transport

(9) Method and frequency of auditing system performance

(10) Record of documents

(11) Production and submission of quality assurance reports

(12) Other items specified by central governing facilities (Former quality assurance plans should be approved by all levels of governing authorities)

5、In accordance to this guideline all air quality monitoring stations are required to establish monitoring data quality goals according to their monitoring goals and need for data use, as regulated by appendix I.

6、Choosing the type of station, station principles, and determination of project when establishing an air quality monitoring station requires the following of the regulations in this guideline. The basic elements are the following:

(1)、The site of the station must be chosen with a year or more of representative meteorological data and suitable air quality dispersion simulations or other means of assessment.

(2)、The method of choosing the station and sampling instrument for different monitoring goals and types of station should adhere to the principles regulated in appendix II.

(3)、The detection methods of the air quality monitoring facility must adhere to methods approved by the central governing facility, as regulated in appendix III.

7、Standard operating procedure of air quality monitoring stations are as below:

(1)、Operation of automatic detection facilities

(2)、Manual sampling and analysis

(3)、Equipment maintenance and correction

(4)、Data processing, documentation, and transfer

(5)、Performance and system auditing

8、Routine quality assurance operation of air quality monitoring are below:

(1)、Air pollutant detection:

1.Gaseous pollutants:

  1. (1) Single point automatic monitoring facilities need to conduct a zero and whole offset daily for examination and record; a precision examination and documentation should be conducted every two weeks; a multiple point correction should be conducted at least once per season for documentation.
  2. (2) Open automatic monitoring facilities should conduct a single point precision examination every two weeks for documentation.
  3. (3) Equipment should be re-calibrated with three to five standard samples of various densities in the following situations: new facility, moved facility, completion of repair, more than three consecutive days of in-operation, when the zero and whole offset values are more than standards.
  4. (4) Managing authorities of the detection facilities should set preventative maintenance measures and frequency, repair maintenance measures in accordance to actual operating conditions and types of instruments.

2.Particulate pollutants:

  1. (1)、Automatic monitoring facilities should conduct a flow correction once every season. If it is a new facility, has been moved, has just been repaired, or has not been in operation for more than three days, execution and documentation of flow correction should be conducted.
  2. (2)、Manual monitoring stations should conduct single point calibrations monthly and multiple point corrections seasonally, with documentation.

(2)、Meteorological Monitoring:Management units of monitoring facilities should set quality assurance goals and execution frequency in accordance to the types of measuring instruments at the facility; furthermore, they should set preventative maintenance goals and frequency and repair maintenance goals according to actual operating conditions.

9、 Governing facilities of all levels should assess the precision and accuracy of all monitored data, as stated in appendix IV.

10、The retrospective use of gases and standard items follow the standards below:

(1)、Gases and items used for correction and audit should follow the regulations stated in appendix V.

(2)、Correction and audit gases and items should be used retrospectively in accordance to the standards below.

  1. 1.Retrospective to national standards.
  2. 2.Retrospective to departments approved by the central governing facility.
  3. 3.Retrospective to international standards of departments approved by international accreditation facilities.
  4. 4.Retrospective approved by governing facilities.

(3)、Gases and standard items used in audit should differ from gases and standard items used in correction.

11、Processing, documentation, and transfer of monitored data as below:

(1)、Automatic monitoring facilities should use hours as the average value when recording data.

(2)、Correct data regulations as below:

  1. 1.If more than 45 minutes are spent sampling per hour, that hour is an effective value.
  2. 2.If there are more than 16 effective hours in a day, that day's average is an effective average.
  3. 3.If there are more than 20 effective days in a month, that month's average is an effective monthly average.
  4. 4.If there are more than three quarters effective days in a season, that year's average is an effective annual average.

(3)、Once the monitored data has been confirmed to adhere to the rules stated above, these values are deemed to be effective values. The viability confirmation operations should follow the regulations stated in appendix VI.
  1. 1.Automatic monitoring facilities should be flow corrected once every season. If the equipment is new, has been moved, has just been repaired or has not been in operation for three days, it should be flow corrected and documented.
  2. 2.Manual monitoring facilities should conduct single point correction monthly, and multiple point correction seasonally, and document both.

(4)、Data submission should follow the format in appendix VII.

12、Performance auditing of monitoring facilities are conducted as below:

(1)、Auditing should be conducted at least once a year, and should be conducted by personnel not related to the operation and maintenance of the equipment.

(2)、 Auditing operations, standards, categories, and standard operating procedure should adhere to the regulations stated in appendix VIII.

(3)、If the auditing results do not hold up to the auditing standards, the time period between the the current audit and previous audit should be noted with auditing results with the data user given the decision for the use of the data.

(4)、National and regional monitoring stations will be irregularly given performance audits by the central governing facility, and management units at these monitoring facilities should assist in auditing operations.

13、Systems audit operations

(1)、Monitoring networks in their first year need to undergo one systems audit, subsequently they will require one system audit every 3 to 5 years.

(2)、The auditing categories of monitoring facilities and systems are below, operations description are as stated in appendix IX.

  1. 1.Management of monitoring station network
  2. 2.On site monitoring operation
  3. 3.Laboratory analysis operation
  4. 4.Data management
  5. 5.Quality assurance and quality control

(3)、National and regional monitoring stations will be irregularly given system audits by central governing facilities, and management units at these monitoring facilities should assist in auditing operations.

14、Documented categories of monitoring facility operations are below:

(1) Monitoring categories and measurement values of density

(2) Zero and whole offset examination and adjustment records

(3) Routine preventative maintenance and repair maintenance records

(4) Standard item records

(5) Correction and audit records

(6) Data viability confirmation records

(7) Other categories requested by the central governing facility (the records above should be saved for three years or more for the perusal of management facilities at all levels.)

15、Management facilities at all levels should write annual reports on the quality assurance of monitoring facilities, and they should include the following items:

(1) Project goals

(2) Planned audit range

(3) Audit personnel

(4) Auditing equipment

(5) Auditing methods

(6) Auditing records, including preparations and confirmed results

(7) Auditing result assessment

(8) Discussion and suggestions

(9) Reference material (such as standard quality assurance documents, etc.)

16、This guideline will go into effect after approval by the administration head, and will stay in effect after amendments.