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Contents of laboratory test report review

2021-09-23View Original

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The products of a laboratory are reports or certificates that contain data or conclusions; the verification of these reports or certificates is very important for the laboratory, and high standards are also required of the authorized signatories. Below, I will explain in detail the key points that should be checked when reviewing and issuing reports or certificates. 1. Whether the version of the report or certificate is current and valid. The report or certificate should have a control number and a version number, and laboratories that prepare reports manually need to verify whether the version is current and valid. 2 Are the basic information details correct? This includes sample information, the standards applied, equipment information, environmental conditions, customer information (including contact details), etc. The description of the sample should match the description on the order form as well as the actual condition of the sample. The standard referenced should be currently valid, the year should be correct, and there should be no spelling errors. If there are multiple methods in the standard, and only one is to be used, this should be clearly stated. 3 When the commissioning unit and the reporting unit are not the same, an explanation is required. In such cases, the laboratory may receive samples commissioned by Client A, who requests that the unit indicated on the test report be B. The laboratory should state in the report that the name B was provided by A, and the laboratory is not responsible for verifying its accuracy. 4. Are all the items listed in the report along with their corresponding standards included in the annex of the certificate? For CMA reports, it is required that qualified and unqualified items be presented separately. According to the CNAS report, qualified and unqualified items can be included in the same report, but unqualified items must be clearly identified. 5. All items listed in the report and the corresponding standards must be those for which the individual has given authorization to sign; it is prohibited to issue reports beyond the authorized scope. If the customer requests tests that cover multiple areas or for other reasons, and the laboratory does not have an authorized signatory to issue reports for all of the tests, the situation should be explained to the customer during contract review, and written consent from the customer must be obtained regarding whether reports can be issued separately. Generally, a report should have only one approver. 6 Is there any situation where reports are separated? Reports for qualified and unqualified items should not be issued separately. If the customer tests multiple items, only the qualified items should not be reported. 7 If there is data provided by customers or external sources, are there clear identifiers and disclaimers? The data originating from customers or external sources must be clearly identified. Whether two or more sets of data are correlated – such as the levels of calcium and magnesium in tap water along with its total hardness – these two sets of data are correlated. 9 Check whether the test values of routine test samples fall within the acceptable range. 10 Pay special attention to the failed test results and review their original records. 11 Examine the original records to ensure that the information recorded is complete, clear, and valid; verify that the personnel conducting the testing/calibration and those performing the reviews are properly authorized to do so, and that the tasks fall within the scope of their authorized responsibilities. It is necessary to perform rounding of the experimental values in the original records to check whether there are any abnormalities in these values, as well as to ensure that the correct units are used. 13 Is the method detection limit correct? For quantitative analysis, the method detection limit should be reported when required by the client or when nothing is detected. 14 Review the uncertainty assessment: If uncertainty is reported, it is necessary to check whether the uncertainty assessment is correct. 15 Review the basis for judgment and the judgment results: If a compliance statement is included in the report, it is necessary to verify whether the basis for judgment and the judgment results are accurate. 16 Check whether the equipment used is within its valid period, including instruments, reagents, reference materials, etc. 17 If the calibration report includes recommendations regarding an appropriate calibration interval, check whether there is an agreement with the customer; if no such agreement exists, no recommendation regarding a calibration interval should be given. 18 Verify whether the dates of pre-review processing, instrument testing, report issuance, etc., follow logical chronological order to prevent fraud. 19 The subcontract report should clearly indicate which data results were provided by the subcontractor.

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