According to the requirements of metrological certification and laboratory accreditation, it is very important to ensure the accuracy, reliability and scientificity of the test results. It is necessary to truly record the various data at the time of detection, including sufficient information to identify the influencing factors of the uncertainty, to ensure that the detection can be reproduced as close as possible to the original conditions, and to ensure traceability of the measurement, so It is necessary to discuss the writing format and content requirements of the original records, and also standardize the original records of the majority of the primary laboratories, and apply for participation in laboratory accreditation in the future to lay the foundation for this link.
1
Main content and requirements of the original record
a Basic information
A.1 Title detection organization and original record of detection category.
A.2 Sample name Product property sample refers to the trade name; non-product property sample refers to the specific name of gas, water, catering, suspected poisoning sample collected by the tested site.
A.3 Sample number (unified by the sample acceptance or quality control department) Write the full code of the full sample number, which is the unique identification of the sample.
A.4 The test item detects the specific name of an item.
A.5 The test is based on the standard of the test method (the international, regional or national standard should be preferred) or the name of the book and the name of the test method, specifically to the entry. This is the identification of the method used.
A.6 The start and end date of the test refers to the start date and end date of the test of an item, which is the date that is crucial to the validity of the result.
A.7 Instrument name and conditions of use refers to the instrument model, name, and factory number (this is the unique identifier of the instrument) used for the detection of an item, and the conditions for the use of the instrument (eg, high temperature furnace temperature, spectrometry) Photometer wavelength, etc.).
A.8 Environmental conditions indicate environmental conditions (such as temperature and humidity) that directly affect the test results.
A.9 Reference material (or reference material) Refers to the reference material (or reference material) used for quality control, indicating the source, grade, period of validity and expiration date of the standard.
A.10 Standard solution used in standard solution experiments. Example: For the standard solution used in the spectrophotometry, the name, source, concentration, set value and expiration date of the standard should be indicated; the standard solution used for titration should be marked with the name, the concentration after calibration, and the date of calibration.
A.11 Calculation formula The final calculation formula for each project analysis method.
A.12 After all the test data of the tester is recorded, the signature of the person of the project is detected. This person must be a professional or a long-term contractor with professional training.
A.13 The entire process of data and data processing by the reviewer is checked and signed by a responsible professional.
The a.14 page count detects the page number and total number of pages of the original record to ensure that the page is part of the original record.
b Test data
B.1 The actual sample amount, dilution factor, air sampling volume and conversion factor required for the relevant data detection; main components of the instrument (eg, column, identifier, etc.) and reagents (mobile phase, carrier gas, etc.) and each Kind of experimental conditions.
B.2 measured data(1)
Spectrophotometry:
The concentration or mass point of the standard curve range, and the corresponding absorbance value and the three important parameters of the curve, a, b, r values; blank, absorbance of the sample; the concentration of the sample corresponding to the standard curve Or quality.(2)
titration:
The starting and ending values ​​of the titrant when titrating the blank and the sample, and the final consumption of the titrant.(3)
Gravimetric method:
The constant weight record of the vessel and the constant weight record after the sample is baked or burned.(4)
Instrument method:
In addition to the quantitative standard curve, blank and sample instrument response data and maps, all data (retention time, etc.) need to be qualitative.(5)
Sensory test:
Record the description of the phenomenon observed by color, smell, taste, etc. and draw conclusions.(6)
Visual limited test:
It is necessary to record the observed phenomenon and the concentration or quality data of the limit standard.(7)
Toxic qualitative test:
In addition to recording the various phenomena that occur during the test, there are other methods for confirming the test for positive samples.
(8) Sample test results obtained by calculation formula.(9) Determine the final test results.
B.3 original record writing requirements
The original records are always filled in with a pen or carbon pen. It is forbidden to fill in with a pencil or a ballpoint pen. Data modification: The original record should be filled in time and truthfully, and it is not allowed to change it at will. When an error occurs in the record that must be corrected, it should be changed and cannot be altered. Draw a "=" double line on the wrong text or number to clear it, write it correctly in the upper right corner, and change the person's signature (or signature). Abbreviation).
2
Several elements to be reflected in the original record
2.1 Measurement traceability
2.1a The data unit of measurement should use a legal unit of measure.
2.1b For the reference material (or reference material), reference, transfer standard or working standard used, the unit of purchase, date and level should be recorded in the standard basic information to check whether it is traceable to the SI unit or certified reference material. Self-matching standard solutions are traced back to the source if necessary, or purchased with certified standard solutions.
2.1c For the equipment used, including measuring instruments, the unique identification shall be recorded in the basic information to check whether the calibration and period verification are carried out by a special metrology department.
2.2 Quality Control
In the original record, measures and test data with quality control guarantees throughout the inspection process should be reflected.
2.2a Selecting the appropriate analytical method should be based on the standard method promulgated by the state, or by selecting the method recommended by the authoritative organization at home and abroad or the international standard method, and then selecting the method of publication at home and abroad (but subject to verification).
2.2b blank data need to be reagent blank (sample blank if necessary). Because the size of the blank value directly affects the accuracy and reproducibility of the determination results, especially for the low concentration determination.2.2c Calibration Curve Data The calibration curve must be drawn at the same time for each batch of samples. The regression equation is obtained: Y = a + bx and correlation coefficient r. | r| should meet the requirements of each method of measurement. When using the calibration curve to determine the sample concentration, the data of the sample concentration should be within the standard curve, and the line should not be arbitrarily extended.
2.2d parallel sample data reduces the random error in the measurement, and increasing the number of measurements of the same sample is a very effective measure. In order to ensure the accuracy and reliability of the data, a single sample should be measured in parallel, and batch samples should be guaranteed to randomly select 10% to 20% of the samples for parallel determination. The relative error of the parallel sample determination should follow the provisions of each analytical method, otherwise it will be re-measured.
2.2e Internal quality control data Periodic quality control is performed periodically using certified reference materials (reference materials) and/or secondary reference materials (reference materials).
2.2f Recovery test data There should be spiked recovery data in each batch of samples. The measured value after the spike must not exceed the upper limit of the method. The recovery rate varies depending on the method of measurement.
2.2g Critical Data Processing When the measured value is close to the critical control value, there should be data to increase the number of consecutive measurements to observe that the trend tends to be stable or divergent, and then the sample is judged.
2.3 Unqualified samples
For unqualified samples, the remaining samples should be treated by the same or different methods.
Repeated testing or corroborating data.
3
Expression of analysis results
3.1 Valid number of digits of the reported results
It should be determined by the number of significant digits of the data, such as the sample size, the concentration of the standard solution, the accuracy of the gauge and the instrument, and the sensitivity of the measurement method. The number of digits cannot be increased or decreased arbitrarily. The calculation of the measured value and the determination of the effective number shall be in accordance with the provisions of GB/T8170 or the provisions of various standard methods or books.
3.2 Parallel sample results
Report the arithmetic mean of the parallel sample measurements, and the number of significant digits of the assay results should meet the requirements of the hygienic standard.
3.3 Choice of suspicious data
Outliers or suspicious data should be recorded truthfully, and should not be arbitrarily chosen. If it is not the cause of system error, it should be statistically tested according to the standard or method, and then decide the trade-off.
3.4 Results report
The standard stipulates that if the analysis result is below the detection limit of the method, the analysis result can be expressed as “undetectedâ€, but the detection limit value of the analytical method used should be indicated, or the value of the detection limit is less than ( < ).have to be aware of is:
(1) The sensitivity of the analytical method used must meet the requirements of the sanitary standard, otherwise the analysis results are meaningless.
(2) When the unit of measurement expressed by the analytical method is inconsistent with the sanitary standard, the indicator of the sanitary standard shall prevail. When the national and health standards stipulate that there are no quantitative indicators, the examples are “not detectableâ€, “negative†and “qualifiedâ€, that is, according to the background of the sample. If the background does not contain the object to be tested, it can be reported according to the qualitative concept. "Detection", etc., if the background contains the object to be tested, that is, the analysis result cannot be simply expressed as "undetected", and the minimum detection concentration of the method must be indicated.
3.5 Report of uncertainty
If the test method and the customer's request or test result are at the critical value, the original record shall contain data information about the uncertainty. For example, the recognized test method specifies the limit of the main source value of the measurement uncertainty and specifies the representation of the calculation result. Way, you don't need to do this.
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