LIMS Laboratory Management System - Sample Management
The final product of the laboratory is the test report, and the test report is based on the test sample. If the sample management does not form effective document guidelines , laboratory personnel do not clearly define their job responsibilities and implement them, and the reception, identification, circulation, storage and retention of test samples become chaotic, which brings risks to the test. Therefore, the management of test samples is very important.
SHLIMS sample management is as follows:
1. Sample reception
Provide the necessary test samples and fill in the "Entrusted Test Form". The sample manager will receive the samples when receiving the samples. , you should check whether the sample status and description are consistent with the content on the test application form, and whether they meet the requirements of the test standards.
Whether the sample size meets the test requirements, if any non-compliance is found, or the sample is not suitable for testing standards, or insufficient sample size, etc.
Non-conformities should be recorded, and the applicant should be inquired and confirmed before the testing work is carried out. The LIMS sample administrator should check the samples and the commissioned testing after checking that they are correct. Sign the order and confirm the sample collection date and hand it to the technical person in charge (or laboratory supervisor, etc.) for final confirmation, indicating that the testing project has been accepted. The test samples will be identified, managed and photographed. If there are any discrepancies between the sample and the test application form, you need to contact the customer in time to modify/amend the test application form or return the sample. The contact method can be face-to-face verbal communication, telephone or email communication, etc. According to the procedure document "Customer Requirements and "Contract Review Procedure" and "Inspection Work Management Procedure" are implemented.
2. Identification of test items
After completing the handover of test samples with the customer, the sample administrator registers the sample information in the LIMS system and uniquely identifies the samples submitted for inspection. And affix the sample identification card to the test sample. For chemical testing, check the sample identification card to ensure that the sample is intact and signed electronically.
3. Processing of test items and preparation of test samples
3.1. Sample removal personnel will split the received samples that need to be split, and will provide samples if necessary Split sheet (the technical person in charge of finished products/new products will provide the sample split sheet, and the data administrator will print the split sheet for old parts). The separated test samples should be marked and transferred to the testing personnel, and the sample identification card should be checked and signed. For metals, rubber raw materials, liquids that do not need to be dried, etc. that do not need to be split, they should be directly Give it to the testing personnel, who will check and sign on the sample identification card. The preparation of all chemical samples should follow the regulations and requirements of testing standards or work instructions.
3.2. After the sample is prepared, place it in the designated sample area to be tested and complete the handover. Before starting the testing work, if the testing personnel find that the sample is abnormal, or does not meet the requirements provided, or has doubts about whether the sample is suitable for testing, they should promptly feedback it to the applicant, obtain further explanation, and keep records.
3.3. When all samples are stored, handled, tested, and transferred, the sample numbers and identifications must not be changed. For samples with different testing status, the relevant personnel should handle them carefully and strictly abide by the relevant sample safety regulations. Protection and disposal regulations to prevent abnormal failure, damage or loss of samples
3.4. The inspected items should be returned to the storage area of ??the inspected items by the inspection personnel, and the relevant information should be properly archived.
4. Storage and disposal of samples
4.1. Samples should be stored in designated areas or sample racks in the warehouse and managed by sample administrators; cross-contaminated samples should be Store separately to ensure no contamination. The sample room environment should meet the storage conditions of the samples (such as temperature and humidity requirements, etc.), and should be equipped with corresponding facilities to maintain, monitor and record the environmental conditions. Sample storage conditions should meet customer requirements. During storage, care should be taken to prevent moisture, overheating, fire and mechanical damage to ensure that the storage environment meets the requirements for sample storage. This is to confirm that the storage of test items always meets customer requirements to protect the status and integrity of the samples.
4.2. If the customer has no special requirements, after testing, uncounted or doubtful samples will be kept in the laboratory for more than one week, and if there are doubts or counted samples, they will be kept in the laboratory for more than one month. Samples that need to be removed can be removed by sample management personnel as required if there is no data or doubt after the test is completed. Samples that do not need to be removed will be processed by sample management personnel after the storage period has expired. For samples taken back by customers or retained according to customer requirements, the customer should sign for confirmation, and the laboratory will record and record the preservation, return and random inspection information.
4.3. The scrapping and splitting of samples need to be in a specific area of ??the laboratory, classified according to different materials, and labeled to effectively distinguish them.
4.4. Sample retention and backup
4.4.1. When it is necessary to separate and retain backup samples of test samples, the sample administrator should arrange to retain and seal the backup samples at the same time as the customer. And mark the item with the "Backup" mark. The sealed prepared samples shall be stored by the laboratory in accordance with the storage conditions agreed upon by both parties.
4.4.2. When the sealed sample needs to be unsealed for testing, it should be agreed by both the customer and the laboratory. If necessary, it should be unsealed simultaneously when both parties are present. Samples should be tested as soon as possible after unsealing to avoid sample deterioration.
5. Confidentiality of samples
5.1. During the circulation process of testing samples, testing personnel at each stage of testing should be responsible for the confidentiality of testing items;
LIMS is responsible for Responsible for the preservation, safety, confidentiality and integrity of test items, and the laboratory supervisor shall supervise the management of test samples during the inspection period.
5.2. When the sample sent by the customer for inspection is a confidential product, when receiving the sample, the sample manager should ensure the status of the sample, whether the confidentiality seal, etc. are intact and take photos, and record the unique number of each sample. Check the sample transfer order provided by the customer. Products marked as confidential shall be handed over to inspectors for testing. After the test is completed, the testing personnel must return the inspected samples and accessories to the sample administrator for safekeeping. The sample manager checks the sample information after inspection, and after confirming that it is correct, fills out the sample transfer form and returns it to the customer or his designated person.
5.3. No unrelated persons are allowed to visit the test items while they are being inspected. Relevant technical information is not allowed to be read by unrelated personnel or taken away from the testing site.
5.4. This laboratory will not retain samples for testing samples involving patented products and patented technologies, and the information and tested samples will be completely returned to the customer.
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