quality system

Process control
Laboratory

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Address: Building 41,Wanyang Zhongchuang City,Qianku,Cangnan,Zhejiang Province

Tel: 0577-68523555

Email: [email protected]
Fax:0577-68520555

In modern soft packaging enterprises, the role of the laboratory can not be ignored. The most fundamental function of the laboratory is product quality inspection and control. At the same time, it is also an important technical institution that provides technical basis for improving and improving product quality, developing new products, etc., with great responsibility.

Work content of the laboratory

(1) implement the quality policy and quality objectives of the enterprise, and complete the quality inspection and testing work quickly and accurately.
(2) be responsible for the quality acceptance inspection of purchased raw materials, supporting products and other articles according to the provisions of technical standards, purchase contracts or relevant technical documents.
(3) be responsible for the quality control of semi-finished products suitable for inspection and test in the laboratory and the quality control inspection of finished products before delivery.
(4) be responsible for routine test, reliability test and durability test of products.
(5) undertake or participate in the cause analysis and technical verification of product quality problems
(6) responsible for the inspection and test work in product quality improvement and new product development.
(7) participate in the review of the supplier's product quality assurance capability and the product quality audit of the enterprise.
(8) feedback and report product quality information in time, and put forward suggestions for correcting and preventing quality problems.

Basic working principles of laboratory

The laboratory shall ensure to provide correct and reliable test results for each test task, and draw correct judgments and conclusions based on the test results. If the test results provided are wrong, it will inevitably lead to the wrong judgment and conclusion of the relevant personnel, and as a result, quality out of control, decision-making errors and other problems will occur, causing significant harm to the enterprise. Therefore, the most basic working principle of the laboratory should be to insist on impartiality, scientificity and timeliness, and do well in the inspection and testing work.

(1) fairness. The laboratory staff are required to act in strict accordance with the inspection procedures and relevant regulations, free from interference and influence from all aspects in the process of testing, be able to make independent and fair judgments, and always speak with scientific test data.
(2) scientific. It is required that the laboratory should have the technical ability and perfect quality assurance system suitable for the testing task, the quality and staffing of the personnel can meet the needs of the testing task, the instruments, equipment and environmental conditions meet the technical requirements of the testing, the effective control and management of various factors that may affect the testing quality in the testing process, and the accuracy and reliability can be provided continuously and stably Test results of.
(3) timeliness. It is required that the laboratory test work should be fast and timely. Therefore, it is necessary to strictly implement the test plan and do a good job in the preparation of the test.

Management of technical documents

Technical documents are the basis of laboratory management and guidance of testing work. Out of control management of technical documents will cause great harm to testing work. In order to ensure the applicability and current effectiveness of technical documents, and to be implemented in the work of the laboratory, strict management and control should be carried out for technical documents.

The laboratory shall formulate working procedures for the preparation, approval, release, distribution, modification, filing, storage, use and handling of technical documents, clarify the management responsibilities of technical documents, and ensure the orderly progress of testing.
(1) all kinds of technical documents quoted and prepared to strengthen laboratory management and guide testing work shall be identified, reviewed, and issued and implemented after formal approval.
(2) the technical documents in use in all workplaces shall be officially approved and the current effective version.
(3) the expired or obsolete technical documents shall be recovered from the place of use in time to prevent misuse; the obsolete documents that need to be retained shall be approved and approved, and the obsolete documents shall be marked with obvious obsolete marks to show the difference with the effective version.
(4) technical documents are important files of the laboratory, which should be clearly defined and properly kept. The damaged archives shall be repaired and sorted out in time. The distribution, use and return of technical documents shall have clear accounts and orderly management. When it needs to be modified, it can be recovered from the place of use.

(5) there shall be specific provisions for the change and change procedure of technical documents. Generally, the examination and approval of the change shall be carried out by the original examination and approval unit of the technical document. When other units examine and approve, they shall obtain the relevant data on which the original examination and approval unit is based.

Detection process control

1. Detection process

(1) before the test, check whether the sample or test piece is in good condition, whether the function and accuracy of the instrument and equipment meet the requirements, and whether the environmental technical conditions meet the technical requirements of the test.

(2) start the testing, and require the testing personnel to carry out the testing in accordance with the specified testing procedures and procedures.

(3) the inspection personnel shall make inspection records and ensure the accuracy of the recorded data.

(4) in case of edge data close to the qualified limit in detection, necessary repeated detection shall be carried out to verify the accuracy of detection data.

(5) at the end of the test, the technical status and environmental technical conditions of the instrument and equipment shall be checked. In case of any abnormality, the cause shall be found out and the reliability of the test results shall be verified.

2. Handling of abnormal conditions during detection

(1) in case of abnormal distribution of test data, the cause shall be found out and the test can be continued only after correction.

(2) when the detection results are affected by external interference (such as power failure, water outage, etc.), the detection personnel shall stop the detection and re detect after eliminating the interference. The original test data is invalid and the interference is recorded.

(3) if the detection is interrupted due to the failure of the instrument and equipment, the original detection data will be invalid. After troubleshooting, retest can be conducted only after the calibration is qualified.

(4) in the process of testing, if it is found that the sample or test piece is damaged or contaminated, and the correct test data cannot be obtained, the standby sample shall be used or the test sample shall be re sampled, and the test data of the later shall prevail.

3. Quality control by computer

When using computer to collect, process, calculate, record, report and store test data, necessary quality control shall be carried out to ensure the reliability and integrity of test data. The specific requirements are as follows.

(1) the operation of computers shall be carried out under the special responsibility system, and shall not be cross used without approval.

(2) an account shall be established for the storage medium of test data, and special personnel shall be responsible for proper management. It is not allowed to randomly place or contact unauthorized persons, so as to prevent artificial modification of test data.

(3) the first test and data processing results of the product shall be compared by other methods such as manual calculation to verify the correctness of the computer test.

(4) if necessary, the computer shall be equipped with uninterruptible power supply of appropriate capacity to prevent the loss of detection data in case of power interruption.

(5) to prevent computer virus infection, do not use unknown floppy disk, U disk or other storage media.

(6) the inspector shall sign on the original record, and the original record with multiple pages shall be stamped with the seal on the perforation for preservation.

Basic requirements for inspection records

The test record is the objective evidence of the test results, the basis of analyzing the problems and tracing the history, and the important basis of taking corrective and preventive measures, so the test record is a very important basic work. There shall be specific regulations on the format, identification, filling, check, change and filing of inspection records.

(1) the test records shall be true, accurate, complete and clear, and the blank items shall be marked with a slash.

(2) the format and content of test record shall be reasonably prepared according to different requirements of different test objects, generally including the following contents.

① sample name, specification and model, quantity, sample number and technical basis of the test.

② main instruments and equipment, environmental technical conditions (such as temperature, humidity, etc.).

③ technical reference value and actual measurement value specified in the test item.

④ necessary calculation formula and results.

⑤ the abnormal situation occurred in the detection and the countermeasures.

⑥ inspection time, and signatures of inspectors and verifiers.

⑦ the number and number of pages of the test record.

(3) in case of wrong value recorded in the test record, it shall be corrected in time. The method of correction is to draw a horizontal line on the wrong value, fill in the correct value above or below it, and affix the seal of the person who made the change. The change can only be made by the testing recorder, and no other person can replace the change. It is not allowed to record with pencil or change with correction fluid.

(4) the test record shall be signed by the tester and the checker to show that they are responsible for the record.

(5) data records shall conform to the provisions of error analysis and relevant technical standards.

Basic requirements of test report

Test report is the result of laboratory work, and the quality of test report is the comprehensive reflection of test work quality. The test report shall be complete, accurate and clear, and the conclusion shall be correct and easy to understand. The specific requirements are as follows.
(1) the format of test report shall be unified. The content of the test report includes all the necessary information related to the test results, such as the identification, number, sample status, test basis, test date and place, various test items and test data, test environmental conditions, determination of test results, preparation, approval and approval personnel of the report, etc.
(2) preparation and approval of test report. The test report is usually prepared by the testing personnel and approved by the technical director of the laboratory after being reviewed by the auditor.
① according to the relevant provisions of inspection record and inspection report, the preparation personnel shall complete and accurately fill in the items and make the judgment conclusion correct.
② the auditor shall check whether the content filled in the test report is correct, whether the test basis is applicable, whether the environmental conditions meet the requirements, and whether the judgment conclusion is correct.
③ the approver shall approve the correctness of test report basis and judgment conclusion after verification.
④ if the reviewer and approver find any error in the report, they shall inform the report preparation personnel to review and change it. After the change, they shall go through the approval procedures again.
(3) if there are test items subcontracted to external laboratories in the test report, the name of the subcontracted laboratory shall be indicated or explained when recording the test results.
(4) if the issued test report needs to be modified or corrected for some reason, the personnel who prepared the original report shall put forward the change report, perform the examination and approval procedures of the test report according to the regulations, distribute the corrected report to the distribution scope of the original report upon approval, and withdraw and void the original report at the same time.

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