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6 basic requirements for original records

2023-02-28View Original

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Originality requirement: The original records should reflect the originality of the testing process. Observations and data should be recorded at the time they are generated; no retroactive recall, reorganization, transcription, or irrelevant modifications are permitted. However, specific calculation steps can be carried out later as needed. 2 Operability requirements: When establishing original records, full consideration should be given to the operability of those records. The operability of the original records is ensured by using standardized language, proper descriptive statements for the testing criteria, easy-to-use/data tables with appropriate sizes, and providing sufficient space for entering each piece of testing data. Based on the characteristics of the testing items, the order in which these items appear in the original records can be arranged according to the sequence of the testing process or the order of the standard provisions, thereby improving the usability of the original records. 3. Truthfulness requirement: The data recorded in the original records must be accurate; the representation of the data should faithfully reflect the output of the measuring instruments, including values, significant figures, and units. Where necessary, the error of the measuring instruments should also be recorded. 4 Validity requirements: The laboratory shall ensure that the format of the original records used is a valid controlled version. 5 Traceability requirements: The original records should fully document all the method conditions used in the testing, and they must contain sufficient information, including but not limited to: information on the testing environment, testing conditions, instruments used, instrument settings, the date and person responsible for each test, as well as the date and person responsible for reviewing the data results. This is done so that the factors affecting uncertainty can be identified whenever possible, and to ensure that the testing can be repeated under conditions as close as possible to those originally used. For test items that have become qualified after rectification, the original unqualified data as well as the methods used for rectification must still be retained in the records. 6 Integrity requirement: The content of the original records is an important source for the test report. To facilitate the generation of test reports, the original records should fully reflect the testing basis, test items, testing methods, test data, and necessary process data.

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