How should a laboratory keep proper original records? It’s a difficult problem, but it can be solved……

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Requirements of CNAS guidelines for original records [4.13.1.2]: All records shall be clear and legible, and stored in facilities with an appropriate environment to prevent damage, deterioration, or loss, in a manner that facilitates access to them. A retention period for the records should be specified. 【4.13.1.3】 All records shall be securely protected and kept confidential. 【4.13.2.1】The record for each test or calibration shall contain sufficient information to identify the factors affecting uncertainty where possible, and to ensure that the test or calibration can be repeated under conditions as close as possible to the original ones. The record should include the identity of the person responsible for sampling, the operator for each test and/or calibration, and the person who verified the results. 【4.13.2.2】 Observation results, data, and calculations should be recorded at the time they are generated, and be able to be identified and classified according to specific tasks. 【4.13.2.3】 When an error occurs in the record, each error should be crossed out; it must not be erased to avoid blurring or disappearance of the writing, and the correct value should be written next to it. All changes made to the record should be signed or initialled by the person who made the change. Specifically, we need to take action in the following areas: 1. Standards for the preparation and revision of blank original records. The original records should be comprehensive in terms of the types included, complete in information, convenient to use, and well-designed. First, the laboratory’s technical supervisor and quality manager should establish uniform guidelines for the format of test records. Then, personnel with extensive practical experience should be tasked with preparing various draft versions of these test records in accordance with relevant standards, specifications, methods, and the actual conditions of the testing work. On this basis, the quality management department, together with the heads of the relevant departments, conducts a thorough review of the completeness, effectiveness, and coherence of the draft blank test records; after making the necessary revisions based on the feedback from this review, they submit them to the technical supervisor for approval. If it is necessary to modify the blank detection records during use, the department or individual responsible shall submit an application. After preparing a draft of the modifications, it should be submitted to the quality management department, which will then organize the heads of the relevant departments to review it again. Once approved, it will be submitted to the technical manager for approval before implementation. The approved revised version is given a new unique identifier by the quality management department (the number remains the same as that of the original record, but the version number should differ from that of the original record); the original record is replaced and printing is arranged. A notice is sent to the departments or personnel using the record stating that the original record is no longer valid, the original record is collected, and the revised test record is provided for use by the relevant personnel. 2 Writing and modification of original records: The handwriting on original records should be neat, clear, and accurate, with appropriate line spacing to allow for modifications ； For fields with no content to fill in, enter “None” or “/”, and there should be no empty fields ； The original records should use standard professional terminology; try to avoid using uncertain quantities (such as 1–2 drops, 5–10 ml). International standard units of measurement should be used, and the selection of significant figures should comply with the requirements of the experiment ； Common foreign language abbreviations (including those for experimental reagents) should comply with relevant standards, and they must be accompanied by a Chinese explanation when used for the first time ； All records must be written in blue or black ink using a pen or fountain pen. Pencils or other writing tools that cause ink to fade must not be used. Additionally, the original records should be signed by the laboratory personnel, and all signatures must be made personally; proxy signing is not allowed. The original records shall not be arbitrarily deleted, modified, or have their data altered. If modifications are necessary, they should be made in accordance with the requirements of the system documents; any alterations must be made in such a way that the original records remain readable, and the person making the changes must sign them (changes can only be made by the personnel responsible for testing or data compilation; reviewers and auditors shall not alter the information or data in the original test records on their own). Test records that become invalid due to certain reasons during the testing process should also be retained, to ensure that the test records remain original, true, complete, accurate, and well-organized, with all relevant data and information available for reference and allowing for accurate tracing. 3 The authenticity of original records: Inspectors must fill out the original inspection records in accordance with the general requirements of leaving traces, enabling tracking, and providing evidence. Inspection records should be filled out as experiments are conducted; there should be no omissions, copying, retroactive entries, or transcription. The original record should not only document the experimental results as described in the standard text, but also fully record the phenomena observed during the experiment, the handling of any abnormalities, as well as the analysis of the possible causes and influencing factors behind those abnormalities ； At the same time, the experimental purpose of each testing item should be recorded first before it begins. After the experiment, the results should also be analyzed to draw clear conclusions. 4 Traceability of original records: The contents of detection original records include solutions, instruments, reagents, controls, spectra, tables, and other elements; each record of such content must be traceable. (1) Solutions: Commonly used solutions include standard titrant solutions, standard pH buffers, standard colorimetric solutions, standard lead solutions, standard arsenic solutions, and so on. When using these solutions, their source must be indicated in the original records, and it should be possible to trace back to the records of preparation, calibration, etc. in another notebook ； (2) Instruments: Records of instrument usage should be kept throughout the experiment, and the original records must correspond to the instrument usage logs. (3) Reagents: The registration of the issuance of certain special reagents (toxic, narcotic, psychotropic, radioactive) should correspond to the original experiment records. (4) Control substance: Its source, batch number, and pre-use treatment should be recorded ； For use in determining content (or potency), its content (or potency) and loss on drying (or moisture content) should be indicated. (5) Charts and tables: With the advancement of analytical instruments, the functions of data acquisition and processing software have become increasingly powerful. With each test, the system records a great deal of information; typically, this includes details such as the sample number, collection time, storage path, printing time, method used, and operator name. This information is printed out, and when necessary, it is attached to record sheets. For information that cannot be attached in this way, it can be compiled into separate volumes and numbered, with corresponding notes made in the record book. 5 Accuracy of original records: Original records undergo three levels of review to ensure that the relevant information and data are accurate. Any original record must be signed by the tester, reviewed by the relevant testing personnel, and approved by a higher-level tester or the head of the department. The first-level review is the responsibility of the testing personnel themselves. After completing the filling out of the original test records, the tester shall conduct a preliminary review to verify that the records are complete, that there are no errors in the numbers or symbols, that the relevant calculations are correct, and that the sample labels and test numbers are accurate. Once everything is confirmed to be correct, the tester signs the records. If any incorrect entries are found, they should be corrected; if there are doubts, reinspection should be carried out. Secondary review is carried out by personnel who are involved in the testing as well or by other testers in the same position. The review mainly checks whether the testing process (steps) meet the standard requirements, whether digital rounding is appropriate, whether the calculation results are correct, and whether test results that are unqualified or at the threshold value have been rechecked; once no errors are found, the reviewer signs their name to confirm it. If any errors are found or if there are doubts, it should be returned to the original tester for correction or retesting. The third-level review is carried out by higher-level relevant inspectors or the head of the department. The review mainly focuses on whether the first-level and second-level reviewers have signed, whether the testing was conducted within the valid period of the samples, whether all required testing items were carried out, whether the values derived from other original records, standard curves, and technical drawings are accurate, and whether the testing criteria meet the requirements of the client or the higher-level supervisory department. Once everything is confirmed to be correct, the reviewer signs off. If any errors are found or if there are doubts, it should be returned to the original tester for correction or retesting. 6 Confidentiality of original records: The original records from the testing process are kept by the testers. After the testing is completed, the relevant departments must, within the specified time frame, collect all the various original testing records that have undergone three levels of review and hand them over to the quality management department for sorting and archiving. To prevent the archived original test records from being modified or to avoid the leakage of client confidential information, such archived records are generally available only for review by relevant personnel within the organization. Those who wish to view them must go through the necessary procedures and obtain approval from the department head, and at least two people must be present during the review. The reader may only excerpt or copy its contents, and shall not modify or annotate them ； The original records of tests must not be lent out under any circumstances; no one is allowed to take them away from the facility. If borrowing is truly necessary, the borrower must go through the appropriate borrowing procedures, and after approval by the laboratory supervisor, the archives manager will provide copies. The retention period for original test records should generally be no less than 6 years (one accreditation cycle); for those tests that are of particular importance, or for which there are relevant industry regulations, the retention period can be extended appropriately or such records can be kept on a long-term basis. For the original test records that have reached their retention period, the archives manager may submit an application for their destruction. Once approved by the relevant person in charge of the organization, the archives manager, together with the relevant departments, will carry out the destruction process and keep proper records of it. - End -