What are quality control plan and Implementation Rules

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1. Formulation and implementation of quality control methods and plans
Main quality control methods
1) Comparison between laboratories, capability verification, measurement review.
2) Internal quality control:
a) Different analytical methods (technologies) or different instruments of the same model are used to compare and detect the same sample.
b) More than two personnel shall conduct comparative test on the reserved samples.
c) The same operator shall conduct comparative test on the retained samples.
d) Configuration of standard solution used in daily analysis and detection.
e) Carry out quality control during instrument testing with standard solution.

Formulation and implementation of quality control plan
1) The laboratory shall establish a quality control plan for the next year at the end of each year to ensure and prove the control of the testing process and the accuracy and reliability of the testing results. The quality control plan includes capability verification, measurement audit and internal comparison of the laboratory (such as personnel comparison, method comparison and sample retest). The plan shall also include judgment criteria and measures to be taken in case of suspicious situations, And cover all testing technologies and methods that have applied for approval or have been approved.
2) The technical director shall appoint senior personnel to prepare the quality control plan, and the technical director shall review the plan and organize and supervise the implementation of the quality control plan.
3) The technical director shall count and analyze the quality control data and organize the review of the feasibility and effectiveness of the above activities.
4) The quality supervisor shall supervise the inspectors to complete the sample assessment task, comparison and capability verification test assigned by the superior, supervise and urge the implementation of internal quality control requirements, and review the results of comparison and capability verification test.
5) Testing personnel: complete the testing work that should be undertaken in quality control activities, and carefully fill in the original testing records.

2. Quality control mode and implementation procedure
Comparison between laboratories, capability verification, measurement review

A) The ability verification activities organized by the laboratory accreditation institution, or the comparison and testing tasks among testing laboratories. They should actively participate in such tasks.

B) Implementation of inter laboratory comparison
For the comparison test between the laboratory and the external laboratory, the technical director shall compare the test items with the same parameters according to the ability of the laboratory and the external laboratory, and select the same test method as far as possible.

C) Project selection
Generally, the items involved in the comparison and capability verification test plan issued by the metrological certification / laboratory accreditation institution or the competent authority must participate.

The comparison and capability verification test organized by the laboratory shall be formulated by the senior engineer and submitted to the technical director for approval, mainly including the following aspects:
-Customer complaint items;
-New test items;
-Test items of instruments and equipment that cannot be traced;
-Items using non-standard testing methods;
-Other test items with high technical level requirements or necessary.

D) Organization of test
After clarifying the tasks of comparison and capability verification test, contact the external laboratories participating in the comparison and capability verification test, arrange the time of comparison and capability verification test, and calculate the required experimental funds.

The implementation plan of comparison and capability verification test mainly includes:
-Selection of items for comparison and capability verification test: generally, laboratories that have passed metrological certification or laboratory accreditation are preferred to participate in inter laboratory comparison and capability verification;
-Schedule of comparison and capability verification test;

Inter laboratory comparison, capability verification and other procedures
1) In the comparison and capability verification test organized by metrological certification / laboratory accreditation institution or competent authority, the technology department will distribute the samples to all inspectors for testing after receiving them.
2) In the comparison test organized by the laboratory, the Engineer shall prepare several same samples according to the plan requirements, one of which shall be sent to the laboratory for analysis as a test task, and the other shall be sent to the external laboratory participating in the comparison and capability verification test for entrusted testing.
3) After the task of comparison and capability verification test is assigned, the technical director shall be responsible for organizing the implementation, and at least two inspectors shall be arranged to participate each time.
4) After receiving the testing task, the testing personnel participating in the comparison and capability verification test shall carry out the testing work with a rigorous and scientific attitude, including the confirmation of the testing environment, the preparation of instruments, equipment and relevant consumables, the control of the testing process and the recording of the testing results.
5) After completing the comparison and capability verification test tasks, the inspectors shall issue the results in the form of a written report and submit it to the technical director for summary and evaluation.

Internal quality control mode of laboratory
Quality control before developing new methods: when developing new methods, samples and standard samples without target substances need to be used to verify that the target substances will not be introduced after sample preparation and pretreatment;

Intra laboratory comparison
1) When preparing to carry out a new test project, the laboratory shall organize the testers who may participate in the project to carry out inter personnel comparison and inter test method comparison. The review of personnel comparison and method comparison shall be conducted with F-test and t-test first. It can be considered as qualified only after both tests are qualified. When the results exceed the requirements and are dissatisfied, the technical director shall organize all inspectors to find out the reasons and improve them.
2) When there is a change in the participants of a test project, or as the pre job training of new staff, the laboratory shall timely arrange the comparison experiment between personnel and make a review according to the comparison results.
3) When there is doubt about the accuracy or reliability of the test results, the laboratory shall timely arrange and make full use of the existing conditions to compare the instruments and different methods.
4) The testing process shall include blank analysis, repeated testing, labeling test and analysis of control samples.

Quality supervision and control during daily inspection
The quality supervisor shall carry out quality control on the test methods from time to time, including the standard addition and recovery of samples, test control with RM standard, and retain the reproducibility test of samples. The general recovery rate must be 80%.
120%。 If it is beyond this range, it is necessary to find out the reason and make rectification. For the data of quality monitoring, a control chart shall be established to facilitate the observation of its change trend, and the quality control chart shall be made every two months according to the actual situation.

Quality control and supervision of unconventional projects
Internal quality control measures shall be strengthened. If necessary, a comprehensive analysis system shall be carried out, including the use of reference materials or control samples with known analyte concentration, and then repeated analysis of samples or spiked samples shall be carried out to ensure the reliability and accuracy of test results.

3. Effectiveness of management review
The effectiveness of laboratory quality control management shall be reviewed once a year to confirm whether its principle and theory are correct and complete, whether there are defects, whether the operation is feasible, whether the method can be improved and supplemented, and whether the organizational process is perfect, which shall be used for the improvement of quality control work in the next year.

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