1 Quality control methods and planning and implementation
Main quality control method
1) Comparison between laboratories, proficiency testing, and measurement review.
2) Internal quality control:
a) Compare the same sample using different analytical methods (technologies) or different instruments of the same model.
b) Comparative testing of retained samples by more than two persons.
c) Contrast testing of retained samples by the same operator.
d) Configuration of standard solutions used in routine analytical testing.
e) Quality control during instrument testing with the standard solution.
Quality control plan development and implementation
1) The laboratory shall establish the next year's quality control plan at the end of each year to ensure and demonstrate the control process and the accuracy and reliability of the test results. The quality control plan includes capability verification, measurement review and internal laboratory comparison ( Such as: personnel comparison, method comparison, sample retesting, the plan should also include the criteria and the measures to be taken when suspicious circumstances occur, and cover all testing techniques and methods that have been approved or approved.
2) The technical person in charge designates senior personnel to be responsible for writing quality control
Planning, the technical leader reviews the plan and is responsible for organizing the implementation of the quality control plan.
3) The technical person in charge carries out statistics and analysis on the quality control data, and organizes the feasibility and effectiveness evaluation of the above activities.
4) The quality supervisor supervises the inspectors to complete the sample assessment tasks and comparisons and capability verification tests issued by the superiors, supervise the implementation of internal quality control requirements, and review the results of the comparison and proficiency testing.
5) Inspectors: Complete the inspection work that should be undertaken in the quality control activities, and carefully fill in the original records.
2 quality control methods and implementation procedures
Interlaboratory comparison, proficiency testing, measurement review
A) A proficiency testing activity organized by a laboratory accreditation body, or a comparison test task between each testing laboratory. Active participation in such tasks.
B) Execution of interlaboratory comparisons
The comparison test between the laboratory and the external laboratory organized by the laboratory is performed by the technical person in charge according to the capabilities of the laboratory and the test items of the same parameters performed by the external laboratory, and the same detection method is selected as much as possible.
C) Project selection
The items involved in the comparison and proficiency testing pilot program issued by the metrology accreditation/laboratory accreditation body or the competent authority must generally participate.
The laboratory self-organized comparison and proficiency testing, the project is developed by senior engineers and reported to the technical supervisor for approval, mainly including the following aspects:
- customer complaints;
- new testing projects;
- items that are not traceable to instrumentation;
- projects using non-standard testing methods;
- Other testing items that require higher or necessary technical levels.
D) Organization of the trial
After clearing the tasks of the comparison and proficiency testing, contact the external laboratories participating in the comparison and proficiency testing, schedule the comparison and proficiency testing, and calculate the experimental funding required.
The content of the comparison and proficiency test implementation plan mainly includes:
- Project selection for comparison and proficiency testing: generally preferred to participate in interlaboratory comparisons and proficiency testing by accredited or laboratory accredited laboratories;
- the timing of the comparison and proficiency testing trials;
Interlaboratory comparison, proficiency testing, measurement review implementation procedures
1) In the comparison and proficiency testing conducted by the metrology accreditation/laboratory accreditation body or the competent authority, the technical department will collect the samples and distribute them to the inspectors for testing.
2) In the laboratory self-organized comparison test, the engineer prepares several identical samples according to the plan requirements, one is sent to the laboratory for analysis as a test task, and the other is distributed to the external experiment for the comparison and proficiency test. The room commissioned the test.
3) After the comparison and capability verification test tasks are issued, the technical person in charge is responsible for organizing and implementing, and at least two testers are arranged to participate each time.
4) After receiving the testing task, the testing personnel participating in the comparison and proficiency testing should conduct the testing with a rigorous scientific attitude, including the confirmation of the testing environment, the preparation of the equipment and related consumables, and the control and detection of the testing process. Record of results, etc.
5) After the test personnel complete the comparison and ability verification test tasks, the results are reported in the form of a written report, and the technical person in charge is summed up.
Laboratory internal quality control method
Quality control before the development of new methods: When developing new methods, samples and standard samples containing no target substances are required to verify that the target substances are not introduced after sample preparation and pretreatment;
Laboratory internal comparison
1) When preparing for a new test project, the laboratory organization is likely to participate in the comparison of the inter-personal comparison and test methods. The comparison of personnel comparison and method comparison is subject to F test, t test, and both tests are qualified before they can be considered qualified. When the result exceeds the requirement and there is dissatisfaction, the technical person in charge organizes each tester to find the cause and improve it.
2) When there is a change in the participants of a test project, or as a pre-employment training for new participants, the laboratory shall arrange inter-personal comparison experiments in a timely manner and make a review based on the results of the comparison.
3) When there is doubt about the accuracy or reliability of the test results, the laboratory should arrange and make full use of the existing conditions to compare the instruments and compare the different methods.
4) Blank analysis, repeated testing, spiked testing and analysis of controlled samples should be included in the testing process.
Quality supervision and control during daily inspection
The quality supervisors do not regularly control the quality of the test methods. The methods include the standard addition and recovery of the samples, the test control by the RM standard, and the reproducibility test of the samples are retained. The general recovery rate must be 80% -
120%. If you exceed this range, you need to find the reason and make corrections. For the quality monitoring data, a control chart needs to be established to observe the trend of the change, and the quality control chart is produced every two months according to the actual situation.
Unconventional project quality control supervision
Internal quality control measures should be strengthened and, if necessary, a comprehensive analysis system, including the use of standard materials or controlled samples of known analyte concentrations, followed by repeated analysis of samples or spiked samples to ensure reliable and accurate results.
3 Validity review of quality control management
The effectiveness of laboratory quality control management is reviewed once a year to confirm whether its principles and theories are correct, complete, defective, operationally feasible, whether the method can be improved and supplemented, whether the organizational process is perfect, and used in the next Improvement of annual quality control work.