It is very important to implement effective quality control in all aspects of the reception, circulation, storage, disposal of test samples, and the identification of test samples. The management of test samples can ensure the representativeness, validity and completeness of test samples, thereby ensuring the accuracy of test results.
1. Management of test samples needs to do these 8 aspects
1. Sample collection:
The sample should be representative. Use the results of the samples to explain the overall situation and draw conclusions about the overall situation. Sampling follows the following principles:
1.1 Representativeness:
Special attention should be paid to overcome and eliminate the influence of various factors when sampling, so that the sample is as close to the overall situation as possible, and the sample is fully representative of the overall.
1.2 Availability:
In some cases, samples may not be representative, but determined by their availability.
1.3 Notarization:
Sampling must be fair and conducted by qualified personnel (persons who have received sampling training and passed the assessment). If necessary, sign the seal with the accompanying personnel of the inspected unit at the site, and make a record of on-site sampling. Fill in the sample collection record form, and both parties sign for confirmation.
2. Receipt of samples
2.1 Fill in the power of attorney
Regardless of whether the sample is inspected or sent for inspection, the entrusting party should first fill in the“Sample inspection power of attorney, general power of attorney As a receipt of report”.
2.2 Audit Power of Attorney
The recipient should review whether the sample inspection power of attorney is filled in standard, whether there are empty items, whether the procedures are complete, whether the information is complete, and whether the standard reference is correct and appropriate.
2.3 Check samples
The sample should be the same as the “sample inspection power of attorney”. The sample packaging should be intact, if not, there should be written records. The number of samples submitted for inspection should meet the requirements of inspection, re-inspection and arbitration. If the samples submitted for inspection are only samples for inspection, there should be a written description.
2.4 Formal acceptance
The sample receiver signs the “Sample Inspection Power of Attorney” and promises to issue the report date.
3. Sample number
In order to ensure the traceability of test samples, in principle, a sample is given a unique number (CNAS requirements are to avoid confusion, not a unique number, of course a unique number Definitely meet the requirements).
Several samples of the same event can be regarded as one sample and given a number. The sample number can be composed of year, sample category code and sample serial number (or other numbers suitable for laboratories). In order to ensure the uniqueness of the sample number, the sample receiving department is generally responsible for the unified compilation, or the laboratory with LIMS can be generated by the system.
4. Sample identification
The identification of the sample includes the unique number (sample acceptance number) and the identification of the different test status of the sample (uninspected, inspected, inspected, retained sample). The inspected samples should be marked with “inspected”, “passed”, “unqualified”. For the same sample in multiple packages, a bar and a number should be added after the sample acceptance number to subdivide the identification to ensure the uniqueness of each package. The sample manager is responsible for affixing the identification labels of the samples to the samples one by one.
5. Circulation of samples
After the sample is accepted, the undertaker will issue the “sample inspection handover form” to the testing department (personnel) according to the requirements in the customer“sample inspection power of attorney, and notify the inspection The room sample manager takes samples to be inspected. The sample manager of the testing room should check the condition of the sample during the handover and sign for approval on the "sample inspection handover form". After the samples are delivered to the testing room, they will be registered by the sample manager of the testing room. Uninspected, inspected, and inspected samples should be stored separately. When the inspector receives samples for testing, the sample identification number shall not be changed. Samples should be protected during circulation and testing to avoid non-detection damage or loss.
6. Management of subcontracted samples
For samples provided to the subcontracting laboratory externally, the integrity of the samples should be checked before delivery, and the samples delivered to the subcontracting laboratory should have the receipt certificate of the other party. The subcontracting management department shall do a good job in the registration of subcontracted samples. The subcontractor shall have measures to protect the integrity of the samples, and do a good job of marking and keeping the samples.
7. Sample storage and custody
Sample storage and custody should be equipped with special samples and equipped with appropriate facilities;
The sample room is under the responsibility of the sample manager, and access is restricted;
The sample storage environment should be safe, non-corrosive, clean, dry and well ventilated, with temperature and humidity monitoring;
For samples that require storage under special environmental conditions, environmental conditions should be strictly controlled, and environmental conditions should be recorded regularly;
The reserved samples should be executed in accordance with the specified quantity and variety for re-inspection and arbitration purposes;
Corrosive, flammable, explosive and toxic hazardous samples should be stored separately and clearly marked;
The sample manager must carefully check and register the retained samples, and store samples of different natures in categories.
8. Sample processing
After the report is issued, the sample retention period shall not be less than the report complaint feedback time. If necessary, the retention period of samples and special samples can be extended. After the inspection, the sample processing points There are several ways to deal with it:
8.1 The samples requested by the customer, after the expiration of the sample retention period, the customer can get it back. When the customer returns the sample, the sample collector needs to present the "Sample Inspection Power of Attorney" to the sample room, and the sample manager will handle the return procedure.
8.2 When customers need to retrieve samples in advance (within the sample retention period), they should sign on the sample inspection power of attorney after "no objection to this test report". Sample return procedures can be handled by the sample manager;
8.3 For customers whose sample retention period has expired, the samples should be processed according to the requirements filled in by the customer;
8.4 For samples that must be monitored and processed, the sample manager must monitor and process them in accordance with the prescribed methods to prevent environmental pollution and harm. The monitoring and processing should be recorded.
Two. Several small details that cannot be ignored in the sample management process
1. Test sample circulation:
1.1 The sample manager should keep a record of all the commissioned samples received, and deliver the samples to the relevant testing room according to the testing requirements, and complete the handover procedures;
1.2 Inspectors check and hand over the submitted samples, and prepare samples according to the requirements;
1.3 After the test sample is tested, the tester should place the test sample in the sample tested area;
2. Storage of test samples:
“Completed the test”The sample and the remaining samples that the customer has special requirements for inspection are finally handed over to the sample manager “retained” for safekeeping.
3. Disposal of test samples:
3.1 After the test, the sample retention period shall not be less than the time limit stipulated by relevant national laws and regulations.
3.2 The sample retention period for the remaining samples without special requirements shall not exceed the reporting appeal period.
3.3 The company's internal routine and routine commissioned testing of test samples without special requirements, the retention period is 1 week.
4. Confidentiality and security of test samples:
4.1 The testing, storage and disposal of test samples shall be carried out in strict accordance with the agreement signed with the customer or relevant regulations, and the confidentiality management regulations shall be strictly implemented. The test samples, technical data and Relevant information is responsible for confidentiality.
4.2 Corresponding arrangements should be made for test samples with special requirements, including test sample reception, circulation, storage, disposal and management of technical data, and safety protection measures should be taken , To ensure the integrity and confidentiality of the test samples.
Three. How to manage the sample room of the inspection agency to be standardized
1. Responsibilities of the sample manager:
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