【Weekly Topic】(35) July 11, 2015: How to fill out original records and reports correctly?

Accurate description and recording of the observed facts； Records must be made promptly and completely; retroactive entry or transcription is strictly prohibited. •The test data is accurate, with no errors in transmission or recording ； •The written expression or entries must be accurate, including the use of standard terminology, terms, formulas, etc ； Clear and concise • Presented in table format ； •Pay attention to keeping the original records clean and neat; • Items that have not been inspected should be marked ； The test results, whether successful or not, including those from retests, should be carefully recorded and preserved ； For discarded data and failed experiments, the reasons should be analyzed promptly and noted in the test records. •Change the specification. If an error is found in the record, it should be crossed out with a single line while ensuring that the original handwriting remains legible; erasing or altering the text is not allowed. A stamp should be placed on the corrected area to indicate responsibility.

In my opinion, the most important thing is that the data is accurate and reliable

The original test records should completely and in detail document all the test results, data, and conclusions that are relevant to or affect the test report, so that other professionals who were not involved in the testing can obtain from these records all the information needed to verify the test report.

Fill in records and reports in a timely, accurate, correct, complete manner, at one time, and with signatures.

How to fill out original records and reports correctly? Original records and various quality inspection reports serve as the basis for tracing quality management back to its origins, and are important documents that the laboratory needs to retain. There are strict requirements for its filling out and management. 1) The original records must ensure their authenticity, completeness, and integrity. It is required to record in a notebook using a pen or ballpoint pen while conducting the experiment; no copying or recalling after the fact is allowed. A reasonable format can be set in advance. 2) The measurement conditions, instruments, reagents, data, operators, and measurement time must be recorded in detail, clearly, and accurately. It is required to use the Fangsong font. 3) Use legal measurement units. Data should be recorded with the effective number of digits of the measuring instrument, and any observation errors should be indicated. 4) The method for correcting incorrect data is the cross-out method. That is, a horizontal line is drawn over the original data to indicate its deletion, the correct data is written beside it, and the person making the change signs it. 5) The normal modification rate of original records shall not exceed 0.2%. It must not be altered arbitrarily; alterations are prohibited. Ensure that the original records are neat. All types of quality inspection reports are prohibited from being modified.

Record the original information first, right or wrong, before making any decisions

First, it is necessary to understand the various requirements regarding the original records and reports; then, one must act objectively, fairly, and in accordance with the facts; finally, the forms should be filled out carefully and in a proper manner.

How to fill out original records and reports correctly? 1. Detection data record management 1.1 Quality records must be filled out carefully and promptly. All original records must be filled out in dedicated forms, in a neat, clear, truthful, accurate, and complete manner. Pencils are not allowed for taking notes; making arbitrary alterations, scribbling, drawing, or folding is prohibited. When a typo occurs, use “——” to cross it out and make the correction above the “——” by yourself. Draw a slash over the blank fields that are not filled in ； 1.2 Quality records are divided into original inspection records, inspection report forms, inspection reports, etc ； 1.3 The test data should be entered into the original records immediately; the analytical results that require calculation should be recorded only after they have been verified to be correct. The original test records must be filled out by the person who conducted the tests, and once they are confirmed to be accurate, they should be submitted to the laboratory supervisor for review/verification. The examiner is responsible for the authenticity of the original records and the accuracy of the test results, while the laboratory director is responsible for the accuracy of the calculation formulas and results, as well as for the timeliness, accuracy, and completeness of the data reports, and is accountable for the quality of the reports ； 1.4 Quality records shall be compiled into volumes on a monthly, quarterly, or annual basis, properly labeled, and archived for storage. The storage of quality records is carried out in accordance with the relevant regulations on quality record and archive management ； 1.5 Strictly implement the relevant regulations on quality record and document management, and properly store quality records. Original inspection records, inspection reports, and inspection sheets for raw materials and products are generally retained for 42 months ； 1.6 During storage, quality records should be protected from moisture, mold, and insect damage ； Be careful of loss and theft; pay attention to fire prevention and ventilation. The use and management of quality records must comply with the provisions of the quality system procedure documents.

Make original records in all aspects such as experimental conditions, experimental procedures, observations, and data analysis. The report is mainly meant to be standardized, and it usually has a fixed format and tables.