How are original records “original””

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This post was last edited by Majestic Ultraman. Edited on 2021-4-16 at 08:01. 1. Pay attention to the signatures in the original records. Generally, the original records are signed by testing personnel and verification personnel. Signing signifies that the signer has carried out the necessary verification or review of the original record, serving as a final check to detect any errors made by the inspectors as early as possible. Any discrepancies in the original records must be resolved before entering the test report; if necessary, retests should be conducted to ensure the accuracy of the data. 2 Select the appropriate testing method: CNAS requires that laboratories use suitable methods and procedures for all tests. The laboratory deals with products, and different products have different standards to be followed as well as different testing methods to be used. For products with clearly defined execution standards, one can simply select the testing methods specified in the standards. In actual work, we encounter a large number of non-standard products; especially when conducting commissioned inspections, it is necessary to communicate with the client and adopt methods that meet the client’s requirements and are suitable for the tests to be performed. When the customer does not specify the method to be used, the laboratory shall select an appropriate testing method from those published in international, regional, or ** industry standards, or those published by renowned technical organizations or relevant scientific books and journals, or those specified by the equipment manufacturer. Testing methods developed or adopted by the laboratory can also be used if they meet the intended purpose and have been validated. Such communications must be documented for future reference. Any discrepancies between the client’s requirements and the samples submitted for testing should be resolved prior to the commencement of testing, and must be accepted by both the laboratory and the client. If the customer’s requirements cannot be met due to the laboratory’s capabilities and resources, the customer should be informed accordingly. 3. Standardize the recording of sample information: After receiving the samples, do not rush to conduct tests; first check whether the samples have any defects that could affect the accuracy of the tests. For some packaged samples where defects cannot be observed directly, if defects are found upon opening the packaging, the inspection should be terminated immediately, the sample should be handled properly, and the customer should be informed promptly. Even if there are no defects, the condition of the sample should be described appropriately in the original records. 4. The standards must be understood accurately. Standards serve as the basis for inspection work; it goes without saying that one must select the correct and currently valid standards for inspections. Understanding standards accurately is not a simple task. Laboratories conduct tests in accordance with standards, and it is essential to understand those standards accurately. 5. Sufficient amount of information: CNAS requires that observations, data, and calculations be recorded at the time they are generated. It also stipulates that the records for each test must contain sufficient information to identify the factors influencing uncertainty, where possible, and to ensure that the test can be repeated under conditions as close as possible to the original ones. Inspectors must record each individual raw measurement data; they shall not only write down final results such as averages. The text must contain specific details; it is not acceptable to simply write “compliant”/“non-compliant” or “qualified”/“unqualified”. The original records must not be altered arbitrarily; if modification is indeed necessary, the error should first be crossed out with a horizontal line (so that the altered content remains clearly visible), and then the correct value should be entered next to it. All changes made to the record should be accompanied by the signer’s name or stamp at the place of alteration. 6. Proper data processing: Under normal circumstances, product standards specify the number of decimal places or significant figures that should be retained for test data. It is necessary to read the data strictly in accordance with these standards during testing, and the data should also be recorded in the original records in line with these standards. For the data that requires calculation after testing, if there are relevant provisions in the product standards, the calculations should be carried out in accordance with those standards ； If there are no relevant provisions in the product standards, the calculations shall be carried out in accordance with the requirements of GB8170 \"Rules for Rounding of Numerical Values\". The result determination is done by comparing the measured values or calculated values obtained from the testing with the limit values specified in the standards. For the evaluation of test results, if the product standards contain relevant provisions, the evaluation shall be carried out in accordance with those requirements ； If not specified in the standards, determination may be carried out in accordance with GB1250 \"Methods for Expressing and Determining Limit Values\". 7 Do not ignore the calibration certificates. General standards specify exact accuracy requirements for testing equipment; when selecting such equipment, it is essential to ensure that it meets these standards, and the instruments must be used in strict accordance with the operating procedures. The original records should not only indicate the name of the instruments and equipment used, but also include their unique identification numbers to prevent confusion among identical devices. CANS requires that equipment be calibrated or verified before it is put into use, and also requires that it be verified and/or calibrated prior to use. Periodic verification involves using appropriate verification methods and relevant standards to conduct inspections during the time between two calibrations or tests, in order to ensure that the equipment in use remains in good condition throughout its operational life, maintains optimal measurement capabilities, confirms the reliability of the test results, and enhances the laboratory’s confidence in keeping its testing equipment in good condition. 8 Control of subcontractor data: Subcontracting refers to the practice whereby a laboratory, under certain circumstances, entrusts another laboratory to provide it with testing data. The laboratory shall be responsible to the client for the work of subcontractors, except for those subcontractors designated by the client or a statutory authority. For tests carried out by subcontractors, this shall be indicated in the original records; the data provided by the subcontractor shall be archived together with the original records, and this shall be demonstrated in the test report issued. 10 The testing personnel must be qualified. According to CNAS CL01:2018, laboratory managers shall ensure that all personnel who operate specialized equipment, conduct tests, evaluate results, and sign test reports possess the necessary competence. For those engaged in specific jobs, qualification verification shall be carried out as required, based on corresponding education, training, experience, and/or proven skills. First, the laboratory should determine the skill requirements for different personnel based on the nature of the testing work it carries out. Then, in accordance with these requirements, it shall assess each testing employee in terms of their educational background, training received, practical work experience, and evidence of their skills. Those who meet the criteria will be issued qualification certificates appropriate to their positions. Only personnel holding the appropriate qualification certificates may carry out inspection work within the scope of those certificates, including the preparation of original records.