Collect laboratory test reports. System or procedure for the archiving of documents such as original records.

This post was last edited by zbx on 2011-7-1 19:44. 1. Detection data record management 1.1 Quality records must be filled out carefully and in a timely manner. 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; no arbitrary alterations, scribbling, drawing, or folding is permitted. 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 after verification, 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 statements for raw materials and products are generally kept 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.

Inspection reports can be provided in electronic format, which makes them easy to search for. But it’s necessary to carefully compare it with the hard copy version

1 Only inspection personnel who have passed the technical training examination are permitted to issue analysis reports. 2. The items on the original records and quality report forms should be filled in completely, with clear and neat handwriting in the Fangsong font. 3 The original records shall be entered directly; they must not be altered or redrafted. There must be signatures from the inspector and the reviewer. In case of errors, they shall be corrected using the prescribed methods, with the correction rate remaining below 1% (as calculated based on reviews). 4. The quality report shall have accurate error and conclusion statements; it must be signed by the inspector, reviewer, and approver, along with an official seal. 5 The original records and quality reports are bound into volumes at the end of each month as required, and organized for archiving on a monthly and annual basis. The laboratory keeps them on its own; the workshop laboratory designates a specific person to be responsible for their storage. The original records and quality reports shall be retained for three years. 6 Provisions for amending the original records and quality reports: 6.1 In the original records, if errors such as numerical calculation mistakes or incorrect symbols are found, the analyst shall cross out the erroneous parts with a “–”. In the incorrect upper-right corner, indicate the number or symbol and affix the corrector’s stamp. No unauthorized alterations are permitted, nor is it allowed to arbitrarily remove the cover page records. 6.2 For any issued quality reports that need to be supplemented or amended, the analyst shall prepare a supplementary (or corrected) quality report. In the remarks section, it should be indicated that this is a “correction” to the report issued on a certain date and for a particular batch. The original quality report must be retrieved by the analyst and filed for record-keeping purposes.