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How to check the original records

2021-05-24View Original

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1. Personnel signatures: After each experiment, all individuals involved in the experimental research must sign the original records, both the researchers and the person in charge of the experiment. Signatures are required in many places within the original records; it is important to understand the seriousness of signing. All signatures must be made by the respective individuals themselves, and no one else may sign on their behalf. 2. Testing methods: CNAS requires laboratories to use appropriate methods and procedures for all tests. Laboratories work with products, and different products require different standards as well as different testing methods. For products with clear execution standards, simply select the testing methods specified in those 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 use methods that meet the client’s requirements and are suitable for the tests to be carried out. 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. 3. Sample information: After receiving the sample, do not rush to conduct testing; first check whether the sample has any defects that could affect proper testing. For some packaged samples where defects cannot be observed directly, if defects are found upon opening the package, testing should be stopped immediately, the sample should be handled properly, and the customer should be informed promptly. Even if there are no defects, the sample condition should be appropriately described in the original records. 4. Record modification: The original records shall not be deleted, modified, or have their data altered arbitrarily. If a modification is necessary, a diagonal line should be drawn over the modified portion; the text should not be completely shaded black so that the original record remains readable. The person making the modification must sign their name, along with indicating the date and reason for the change. 5. Standard solution: The original records must not be altered arbitrarily, and no data may be added or removed. If a modification is necessary, a diagonal line should be drawn over the modified portion; the text should not be completely shaded black so that the original record remains readable. The person making the modification must sign their name, along with indicating the date and reason for the change. 6. Usage and issuance records: Commonly used standard solutions include titrant solutions, standard pH buffers, standard colorimetric solutions, standard lead solutions, standard arsenic solutions, and so on. When using these standard solutions, the processes of their preparation and calibration must be recorded in the original documentation, or their source must be indicated; furthermore, records of preparation and calibration should be kept in a separate notebook. 7. Photos from the experiment: During the experiment, it is necessary to keep records of the use of instruments; the original records should correspond to these usage logs. Records of the receipt of special reagents (toxic, narcotic, psychotropic, radioactive substances) should also be kept and matched with the original experiment records. Similarly, records of the receipt of reference standards and control herbs should correspond to the original experiment records. 8. Writing of records: The original records should be written in neat handwriting using standard characters; pencils or ballpoint pens must not be used for any records (except for microscopic drawings). Common foreign language abbreviations (including those for experimental reagents) should comply with the relevant regulations. When it appears for the first time, annotate it in Chinese. Uncertain quantities (such as 1–2 drops, 5–10 ul) should not be included in the experimental records. Standard professional terminology should be used, measurement units must be specified and recorded in accordance with international standards, and the selection of significant figures should meet the requirements of the experiment. Selection of significant figures: Rounding principles: Round up, round down, and keep five when it’s five; select significant figures appropriately. The number of significant figures is determined based on the magnitude of the value; for example, if the area of a liquid chromatography peak is in the tens of thousands or hundreds of thousands, simply use the integer part of that value ; When indicating measurement accuracy, the standard deviation should have at most two significant digits. 9. Sample weighing requirements: When determining the content, the weighing of the reference substance must meet the requirements regarding weighing accuracy. A balance with a precision of one in 100,000 should be used, and the amount weighed should be no less than 10 mg. Do not use a balance with a sensitivity of one ten-thousandth; some even measure only 1 or 2 mg, which results in large measurement errors. 10. Originality: Original records should be kept as experiments are conducted; no retroactive entries or copying is allowed. The original records must not only include the ideal experimental results that are part of the standard text, but also any additional experimental results that were not included in the standard text. 11. Printing of the spectrum: A spectrum is a graph that is generated by software, which captures the electrical signals produced by instruments, converts them into digital signals, and then prints out the resulting graph after analysis and processing. As the functions of the data acquisition and processing software become more advanced, the system records a great deal of information with each sample insertion. Generally, only some of the information we need is selected for printing, but none of the information that is essential must be omitted. The experiment information section includes: collection time, storage path, printing time, name of the experimental method, operator’s name, injection volume, etc. 12. Experimental conclusion: Before starting each experimental project, it is necessary to first record what the purpose of that experiment is. After the experiment, the results should also be analyzed to draw clear conclusions. 13. Quality control data: Many experiments require quality control data, such as blanks, replicates, spiked samples, standard samples, etc ; For example, the standard requires ash to be used as a parallel sample; two samples should be prepared in parallel to test the consistency of the results obtained from both tests. 14: Subcontracting 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 evidenced in the test report issued.
Reply #22021-05-24
It’s already quite good if a regular corporate laboratory can have some basic records. Of course, higher requirements are imposed on qualified laboratories. However, experts can also create fake records that are flawless; P
Reply #32021-05-24
Our analysis center has basically gone paperless, using the LIMS system to record data. There are cameras in the analysis room; the data written on draft paper is clearly visible, and the chromatograms can be viewed. However, there are also \"experts\" who can control the injection volume using the external standard method.

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