How to check the original data writing format and content record of the sample, how to meet the measurement certification and laboratory accreditation standards? -Huaqiang Electronics

Ensuring the accuracy, reliability, and scientific validity of test results is crucial under metrological certification and laboratory accreditation requirements. It is essential to accurately record all relevant data during testing, including sufficient information to identify factors affecting measurement uncertainty. This ensures that tests can be replicated as closely as possible to original conditions and that measurements are traceable. Therefore, it is necessary to discuss the format and content requirements of original records, standardize them for primary laboratories, and lay a solid foundation for future participation in laboratory accreditation.

1

Main Content and Requirements of the Original Record

a. Basic Information

A.1 Title of the testing organization and type of original record.

A.2 Sample name: For product property samples, use the trade name; for non-product property samples, specify the exact name (e.g., gas, water, catering, or suspected poisoning samples collected at the site).

A.3 Sample number: Assigned by the sample acceptance or quality control department. Write the full code of the sample number, which serves as its unique identifier.

A.4 Test item: The specific name of the item being tested.

A.5 Testing method: Prefer international, regional, or national standards. Specify the exact method used, including the book title and method name.

A.6 Start and end date of the test: The dates when the test was conducted, critical for result validity.

A.7 Instrument name and usage conditions: Include model, name, factory number (unique instrument identifier), and operating conditions (e.g., temperature, wavelength, etc.).

A.8 Environmental conditions: Indicate environmental factors directly influencing the test results, such as temperature and humidity.

A.9 Reference material: Describe the source, grade, validity period, and expiration date of the reference material used for quality control.

A.10 Standard solution: For spectrophotometry, include the name, source, concentration, set value, and expiration date. For titration, indicate the name, calibrated concentration, and calibration date.

A.11 Calculation formula: The final calculation formula for each analytical method.

A.12 Tester's signature: After recording all test data, the tester must sign their name. They must be a professional or long-term contractor with proper training.

A.13 Reviewer’s signature: The reviewer checks and signs off on all data and processing steps.

A.14 Page count: Record the page number and total number of pages to ensure completeness of the original record.

b. Test Data

B.1 Relevant data: Include the actual sample amount, dilution factor, air sampling volume, and conversion factor. Also list the main components of the instrument (e.g., column, detector) and reagents (mobile phase, carrier gas), along with experimental conditions.

B.2 Measured data:

(1) Spectrophotometry: Concentration range of the standard curve, corresponding absorbance values, and key parameters like a, b, r. Blank and sample absorbance, and the calculated concentration or mass from the standard curve.

(2) Titration: Initial and final titrant readings for blank and sample, along with the total consumption.

(3) Gravimetric method: Record the constant weight of the vessel and the sample after baking or burning.

(4) Instrument method: In addition to quantitative curves, blank and sample instrument responses, and qualitative data (e.g., retention time) must be recorded.

(5) Sensory test: Document observed phenomena like color, smell, taste, and draw conclusions.

(6) Visual limit test: Record observations and the limit standard's concentration or mass.

(7) Toxicity test: Record all phenomena and confirm positive samples using additional methods.

(8) Calculated results based on formulas.

(9) Final test results.

B.3 Original record writing requirements: Always filled out with pen or carbon pen. Avoid pencils or ballpoint pens. If errors occur, cross out the incorrect text with a double line, write the correct entry above, and sign the correction.

2

Key Elements to Reflect in the Original Record

2.1 Measurement Traceability

2.1a Use legal units of measurement.

2.1b For reference materials, record purchase date, level, and traceability to SI units or certified reference materials. Self-prepared solutions should trace back to sources or use certified ones.

2.1c For equipment, include unique identifiers to verify calibration and verification by authorized departments.

2.2 Quality Control

Include quality control measures and data throughout the testing process.

2.2a Select appropriate analytical methods based on national standards or authoritative recommendations.

2.2b Include blank data (sample blank if needed). Blank values affect accuracy and reproducibility, especially for low concentrations.

2.2c Calibration curve data: Draw calibration curves for each batch. Obtain regression equation Y = a + bx and correlation coefficient r. Ensure sample data falls within the curve range.

2.2d Parallel sample data: Reduce random error by measuring samples in parallel. At least 10–20% of batch samples should be measured in parallel.

2.2e Internal quality control: Periodically use certified reference materials for quality checks.

2.2f Recovery test data: Include spike recovery data in each batch. Ensure measured values do not exceed the method’s upper limit.

2.2g Critical data handling: When values are near critical limits, increase measurements to observe trends before making judgments.

2.3 Unqualified Samples

For unqualified samples, treat the remaining samples using the same or different methods. Perform repeated testing or corroborate data.

3

Reporting of Analysis Results

3.1 Significant Figures in Reported Results

Determine significant figures based on data precision, sample size, standard solution concentration, instrument accuracy, and measurement sensitivity. Do not arbitrarily increase or decrease digits. Follow GB/T8170 or specific method guidelines for calculations and rounding.

3.2 Parallel Sample Results

Report the average of parallel measurements. The number of significant figures should meet hygiene standard requirements.

3.3 Selection of Suspicious Data

Record suspicious data truthfully. If not due to systematic error, apply statistical tests per standard or method to decide whether to exclude it.

3.4 Reporting Results

If the result is below the detection limit, report it as “not detected” and state the detection limit. Note:

(1) The method’s sensitivity must meet hygiene standards; otherwise, the result is invalid.

(2) If the unit differs from the standard, follow the standard. If no quantification is specified, use terms like “not detected,” “negative,” or “qualified.” If the background contains the target, report the minimum detectable concentration instead of simply stating “not detected.”

3.5 Uncertainty Report

If the test method or customer request involves critical values, the original record must include uncertainty data. If the recognized method specifies uncertainty limits and reporting, no further action is needed.

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