EPA \ TAQMN \ Quality Assurance \ Work Flow

Work Flow

This can be separated to preparation operations, on site audit operations, and post audit operations:

1. Preparations for system audit operations The preparations for systems auditing include:

Check the system before the preparatory work will include:

    (1) Creating a survey before systems audit
    (2) Creating an on site check list of items to audit
    (3) Data processing method of data obtained at audit
    (4) Format of systems audit report

The auditing team must first create a survey whose contents include the management of the monitoring network, on site monitor and operation conditions, laboratory operating conditions, data management conditions, and the conditions of execution in regards to quality assurance and quality control. In order to achieve the goals of the systems audit, prior to the systems audit the team will pass out the survey to the responsible units of the air quality monitoring network. After retrieving the surveys, the audit team will organize and analyze the contents of the survey to gain a general knowledge of the possible errors of the operation personnel and the operating conditions of the station. The audit team will then use this information to formulate items they should pay special attention to during the audit to more swiftly find errors in the operation and management of the monitoring station when they perform the audit. Furthermore, the audit team will use the results of the survey to analyze results and create an on site check list, including the monitoring station and center's check list focusing on the below:

The on site check list for the monitoring station should include

  1. Is the location of the station up to standards
  2. Is the placement of the sampling tube up to standards
  3. Are monitoring methods and instruments up to standards
  4. Operation documents and contents
  5. Data records
  6. Condition of station
  7. Protection of station
  8. Safety of station
  9. Execution personnel
  10. The processing procedure of data
    (1) Monitoring center (data processing center) on site check list includes:
    • The operating conditions and data flow of data processing
    • Data type
    • Data input
    • Validity of data and correction measures
    • Data report
    • Saving of data and records
    • Operation documents and content
    • Condition of equipment
    • Protection of data
    • Execution personnel
    • The flow of data processing to completion

    (2) On site check list of the laboratory includes:
    • Conditions of safety precautions measures in the laboratory
    • Condition of laboratory equipment
    • Operations document and contents in the laboratory
    • QA and QC operation documents and contents
    • Analyze the operation condition and data flow of data processing
    • Validity of data and correction measures
    • Analyze data reports
    • Analyze the data and storage of records
    • Preparation and training of laboratory personnel

2. On site systems audit tasks

On-site systems to check the contents of the work will include:

  1. Communication, description, and planned schedule prior to the audit
  2. On site auditing tasks
  3. Organization and analysis of auditing data

The communications tasks before the audit include checking the scheduled time and station, and notifying management and personnel of the station for their cooperation with auditing tasks. The manager of the monitoring network will be invited to accompany the audit team with their tasks to facilitate deep discussions during the auditing process to on one hand support the systems audit task while also giving them a clear understanding of the conditions in the monitoring network. The on site audit tasks should follow the scheduled audit procedure to fill in the prepared check list, with audit contents as below:

  1. Monitoring network management
  2. On site monitor operations
  3. Data management
  4. Quality assurance and quality control
  5. Analysis of laboratory operations

When all on site auditing tasks are completed, immediate preliminary data organization and analysis should be conducted to prevent the forgetting or confusion of details due to time and delay.

3. Follow up and correction operations

If the audit personnel finds serious faults on site then a follow up correction application should be filed and given to the manager of the audited facility or quality assurance personnel for discussion before both parties sign the form. The manager of the facility should conduct correction operations within the allotted time specified after discussion.

4. Audit result report and method of presentation

When executing quality assurance audits, on site work record tables should be used and when auditing tasks are completed at each station, immediately begin preliminary data organization and analysis. Afterwards, enter the results into the audit results table and systems audit ratings table to prevent confusion of the recorded data. Aside from the items listed above, the categories below should be included in the performance and system audit report to form a complete quality assurance audit report.

  1. Standard operating procedure of auditing should be substituted with other methods if the existing conditions do not follow regulations, and should be explained in detail for a correct interpretation of the auditing results.
  2. Audit the certification documents of the standard items: for instance the certification documents of the standard gas cylinders.
  3. Analyze audit results to ascertain what has caused monitoring instruments to not meet standards.
  4. Propose follow up correction operations to suggest measures to improve or correct conditions. If the problem discovered is severe, a follow up correction application should be filed and given to management or quality assurance personnel to setup a specified time to complete corrections.

last update : 2019/11/27