purpose
The representativeness, validity and completeness of samples will directly affect the accuracy and reliability of verification/calibration/testing/inspection. This procedure is formulated in order to effectively control all aspects of the sample and do a good job in the confidentiality and safety of the sample at the request of customers.
2. Scope of application
It is suitable for the management of sample receiving, circulation, storage, disposal, distribution and identification in the verification/calibration/testing/inspection process of our hospital.
3. Responsibility
3. 1 The business department is responsible for effectively controlling the sampling, receiving, circulation, storage, handover and distribution of samples. Responsible for sample identification and status management.
3.2 Professional laboratories are responsible for the effective control of samples during verification/calibration/testing/inspection, as well as the state management of samples.
4. Procedures
4. 1 sample reception
4. 1. 1 inspection: the customer goes to the instrument receiving room to go through the entrusted registration formalities for inspection (including quality inspection and quantitative packaging), and the customer fills in the entrustment form for verification/calibration of measuring instruments (or the entrustment form for measuring production, commodity inspection/testing or the entrustment form for measuring commodity quantity), and the sample collector checks the sample status according to the filling form (. Carefully check the integrity of the sample and its accessories, check whether the nature and state of the sample are suitable for the required verification/calibration/testing/inspection, and assist the customer to fill in all the information of the entrustment form. If there are special circumstances (such as the lack of an end button, etc.). ), whether there are standards, specifications, power cord, certificate of last cycle, etc. ; Fill in the special requirements and emergency requirements for the use of measuring instruments. ) need to be indicated in the entrustment form.
The first copy of the order is kept by the bill collector, the second copy is handed over to the client, and the third copy is handed over to the personnel entering the site.
4. 1.2 entrusted inspection: when the customer leaves the factory for service, the customer entrusts the inspection on behalf of the customer, and the customer shall assist the customer to fill in the entrustment form for verification/calibration of measuring instruments (pay attention to filling in all information), and keep the second copy of the entrustment form for the customer as a sampling certificate. After returning to the hospital, the trustee shall immediately handle the instrument receiving and dispatching procedures on behalf of the customer. The instrument receiver shall check the completeness of the entrustment sheet and its consistency with the actual measuring instruments submitted for inspection according to the requirements of 4. 1. 1. After the client has filled in all the information, the receiver and the client should sign the entrustment form respectively and indicate the date of receipt.
The customer entrusts our staff to conduct inspection through other channels (e.g. mail), and the entrusted person goes to the instrument receiving room to handle the receiving procedures on behalf of the customer according to the clause 4. 1. 1, and the entrusted person is responsible for contacting the customer and handing over the entrusted inspection form of measuring instruments to the customer.
Sampling for quality inspection and quantitative packaging shall be handled by the sampler in the instrument mailroom according to Article 4. 1. 1. The sampler is responsible for contacting the customer and handing over the entrustment form to the customer.
4. 1.3 On-site verification/calibration/testing/inspection: the inspector is responsible for filling in the Verification/Calibration/Testing/Inspection Entrustment Sheet for Measuring Instruments (please fill in all information), and ask the representative of the entrusting unit to sign it. The second copy of the Entrustment Sheet will be kept with the customer as payment voucher and withdrawal certificate.
4.2 Input of samples
Establish a sample account through the sample receiving and dispatching network for internal circulation.
4.2. 1 After the sample collector completes the sample collection work, the third delivery sample collector of the entrustment form will enter it into the microcomputer.
4.2.2 Factory personnel shall go to the instrument mailroom to go through the computer entry formalities with the third copy of the entrustment form.
4.2.3 The sample entry clerk shall check the filling situation of the entrustment form, and those with irregular or incomplete filling shall be returned for re-filling.
4.2.4 The sample entry clerk should pay attention to the completeness and standardization of the input information (especially the input of attachments and remarks), supplement the information in the established database, and fill in the unique identification number on the entrustment form.
4.2.5 After the entry is completed, the entry clerk prints out the unique identification of the sample and pastes it on the sample or the sample packaging box (box), and the sample receiver prints out the sample circulation form (in triplicate) and turns it into the sample circulation stage.
4.3 Circulation of samples
After the input work is completed, enter the sample circulation stage.
4.3. 1 sample sending: the receiver sends the sample to the laboratory with the Sample Flow Sheet. The laboratory receiver shall explain the sample status, accessories and remarks according to the sample circulation list. If the situation is inconsistent, it may not be accepted. If there is no attachment or instruction manual, it should be indicated on the received sample circulation form, and the sample receiver is responsible for collecting it from the customer and deducting the waiting time. After the handover is completed, the receiver shall sign the sample circulation form. The first copy of the sample circulation form is kept by the sample receiver, and the second copy and the third copy are left to the laboratory.
4.3.2 Sample return: For the verification/calibration/testing/inspection samples found to be unacceptable after being received by the laboratory, the return formalities can be handled with the approval of the director of the laboratory. The returned samples shall be applied to the instrument mailroom, and the person in charge of the instrument mailroom shall put forward the handling opinions and report them to the Minister of Commerce for approval before implementation.
4.3.3 Fill in the fees: After the laboratory completes the verification/calibration/testing/inspection process, it shall fill in the fees according to the metrological verification standards of Jilin Province.
4.3.4 Sample return: The laboratory is responsible for returning samples, sample circulation forms, certificates and copies of certificates to the sample warehouse in the instrument receiving room, and handling handover procedures with the sample distributor. The sample distributor enters the "receiving and reactivating" interface, confirms the return of samples, and carefully checks whether the samples, sample circulation sheets, certificates and copies of certificates meet the requirements. After the sample dispatcher confirms, he shall sign and seal the sample circulation form, one of which shall be kept in the instrument mailroom for filing and the other in the laboratory.
4.4 Sample Distribution
4.4. 1 collection note: after the sample is returned, the sample teller shall send a collection note to the customer on the same day. The dunning notice can take different forms such as telephone, fax, e-mail and letter, but it must be filed in the sample receiving and dispatching network.
4.4.2 Payment: When customers receive the samples, they should pay first. The customer should contact the sample teller with the entrustment form for payment or settlement (transfer or remittance in advance). The sample teller enters the "Settlement and Collection" interface, inquires about the fees payable and informs the customer. After the customer pays the fee, the sample teller will settle the account in the "Settlement and Collection" interface, print the accounting voucher, issue an invoice for the customer, and ask the customer to sign the invoice. After the charge is completed, the sample teller shall sign and seal the second consignment form.
4.4.3 Sample distribution: After the customer pays the fee, the customer sends the entrustment form to the sample distributor to collect the sample. The sample distributor will check whether the consignment note is signed and sealed by the cashier, enter the "Delivery Takeaway" interface, perform the delivery procedures against the consignment note, and then deliver the samples. When distributing samples, carefully check the entrustment sheet, samples, certificates or reports, send them to customers after confirmation, and go through the handover and signature procedures.
4.5 Storage of samples
4.5. 1 The sample library in the instrument mailroom is divided into the area to be inspected and the area to be inspected. Samples that cannot be sent to the laboratory in time are placed in the waiting area and managed by the sample collector; The returned samples are placed in the inspection area and managed by the sample distributor. Samples should be stored in categories, clearly marked and consistent with the accounts.
4.5.2 Samples with special requirements shall be stored as required.
4.5.3 For the samples that have been urged for many times and have not been collected for more than half a year, the instrument mailroom can clean up and register them, which will be put on record by the Quality Assurance Department, submitted to the Quality Supervisor for approval, and then evacuated from the sample warehouse.
4.6 Management of subcontracted samples
The subcontracted samples are provided by professional laboratories to the subcontracted laboratories. When delivered to the subcontractor, the integrity of the samples shall be checked. After the samples are delivered to the subcontracting laboratory, the receiving certificate of the other party shall be provided, and the return method of the samples shall be clearly stated. Implement CX/JLY 28—200 1 Subcontracting Management Procedure.
4.7 Management of on-site testing samples
Samples that go to the site for verification/calibration/testing according to work needs shall be marked with samples to ensure that the samples are in environmental conditions that meet the requirements of verification/calibration/testing specifications. According to CX/JLY 16-200 1 Management Procedure for Field Calibration and Inspection.
4.8 confidentiality and safety of samples
If customers have confidentiality and protection requirements for sample ownership, our institute strictly implements all confidentiality and protection procedures (patents) of CX/JLY 25-200/KLOC-0. Responsible for the confidentiality of users' samples, accessories and related information to ensure the integrity and confidentiality of samples.
4.9 When the sample is damaged or fails, the relevant parties shall protect the site and ask the quality director to organize an investigation. The handling opinions need to be approved by the sample sending customer. According to CX/JLY 36-2001accident handling procedure.
4. Unique identification of10 sample
The unique identification of the sample is not only the number of the sample entrustment or work order, but also the registration number of the sample, as well as the number of the original records and certificate reports of sample verification/calibration and testing.
The unique identification label of the sample should also indicate the experimental status of the sample, which is indicated by "pending inspection", "being inspected", "finished inspection" and "sample preparation" respectively. After receiving the sample, the instrument mailroom shall tick "√" in the box after "to be inspected"; Verification/calibration/testing/inspection personnel shall mark "√" after the label "Verification/calibration/testing/inspection", and verification/calibration/inspection/inspection personnel shall mark "√" after the verification/calibration/inspection/inspection. If the sample is a substitute sample for inspection/inspection,
5. Quality records:
A. Verification/calibration entrustment sheet for measuring instruments
B. Sample flow chart