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How is the quality of food microbiology laboratories managed?
Hello poster: The quality of food microbiology testing is related to food safety. This article will briefly discuss the quality management of food microbiology laboratories from several aspects such as quality management system, personnel organization, laboratory equipment, utensils and materials, internal quality control and external quality assessment. With the development of the economy and the improvement of living standards, the public's attention has shifted from food supply security to food safety and nutrition. Pathogenic microorganisms are the most harmful among the factors affecting food safety. Food microbial contamination is the type of contamination with the widest coverage, greatest impact, and most problems. Therefore, the improvement of quality management in food microbiology laboratories is one of the important measures to ensure the accuracy and reliability of inspection results, thus ensuring the food safety of the public. The author will discuss the quality management of food microbiology laboratories from the following aspects. Quality Management System A quality management system is the organizational structure, procedures, processes and resources necessary to implement quality management. Whether the quality management system is complete or not is a key factor that determines the accuracy and reliability of test results. Food microbiology laboratories should establish, implement and maintain a quality management system that is suitable for the scope of their activities; their policies, systems, plans, procedures and instructions should be made into quality system documents and meet the requirements to ensure the quality of laboratory test results. extent. Quality system documents must be communicated to relevant personnel and must be understood, obtained and implemented by them. Through careful implementation of quality system documents, the laboratory's quality policy can be realized and expected quality goals can be achieved. Quality system documents are also evidence of the existence of the laboratory management system and a written expression of quality assurance capabilities. Quality system documents are also the basis for internal laboratory audits and the guarantee for continuous quality improvement. The laboratory should establish a quality management system in accordance with the requirements and form system documents. Through regular internal audits and daily quality supervision and other activities, the laboratory should identify non-conforming items or potential non-conforming items, and take corrective and preventive measures to ensure the effectiveness of the quality management system. run on ground. The quality management system must be scientific and reasonable, and must be continuously modified and improved based on specific implementation conditions. Personnel and Organization Food laboratory personnel must have a good understanding of quality system documents and be able to implement them conscientiously. The personnel of a food microbiology laboratory usually include laboratory managers, laboratory inspectors and inspection assistants. Laboratory managers are fully responsible for the work of the laboratory and usually also serve as the quality manager. They also have good moral character, have sufficient knowledge and experience in microbial testing projects, and are familiar with laboratory accreditation and management. Have good laboratory management and comprehensive coordination skills. Laboratory inspectors are mainly responsible for laboratory inspection and the research and development of new testing technologies, including microbial testing of laboratory samples, solving technical problems encountered in the work, and assisting the quality manager to solve related problems in testing work. Participate in the development and verification of laboratory testing methods or procedures. Laboratory testing assistants should abide by laboratory management regulations and assist laboratory technicians in their work. Laboratory testing assistants should also have a serious and responsible work attitude and be familiar with the laboratory's quality manual and corresponding work procedures. Although laboratory staff have relevant professional knowledge, they must continue to receive corresponding training in management or technical updates to improve their comprehensive abilities and meet the requirements of laboratory positions when engaging in laboratory testing. Therefore, personnel training has become an important link in ensuring laboratory capabilities and is closely related to the quality level of the laboratory. Only through regular and targeted education and training of laboratory staff and continuous improvement of work skills and understanding levels can laboratory personnel be ensured to have the professional knowledge, abilities and experience required for their jobs and meet the current and expected requirements of the laboratory. Detection task requirements. Laboratory equipment, instruments and materials The equipment, instruments and materials of the microbiological testing laboratory are the material basis and guarantee for carrying out microbial testing work. A quality management system that meets standard requirements should be established for laboratory equipment, utensils and materials, and comprehensive quality management should be implemented to keep the equipment, utensils and materials in good working condition and meet testing requirements. All instruments and equipment must have a sound quality management system to ensure the effective implementation of the review system, acceptance system, usage system, recording system, and verification system. Standard operating procedures must be established for all instruments and equipment to ensure that users can use them correctly. Instruments and equipment should be equipped with corresponding facilities and environment to ensure normal operation of instruments and equipment and avoid damage or contamination of instruments and equipment.
With the development of testing disciplines, many automated instruments and trace biochemical reaction systems have entered microbiology laboratories, bringing fast and accurate results to the culture and identification of bacteria and fungi. Laboratory equipment and materials must have a sound procurement and verification system, as well as a management system for use, to ensure that these equipment and materials can meet the requirements for use. The procurement of culture media should be provided by the manufacturer with corresponding detailed necessary documents: such as technical data list, quality control certificate, necessary safety (hazard) data, all performance evaluations and all test strains, etc. For more technical information related to quality testing, analytical testing, chemical measurement, and reference materials, please refer to the National Standard Materials China Institute of Food and Drug Control. For imported standards, please refer to /plist_5/plist_5_0_0_1.html. All routine performance test data of culture media should be based on quality. The requirements of the system are documented and stored in appropriate methods during the validity period, and the test results are evaluated. The storage, preparation, and use of culture media and the storage and use of reference materials should be managed in accordance with requirements and management systems to ensure the accuracy of testing. Internal quality control and external quality assessment Laboratory quality control is an important means to ensure that test data meets quality target requirements. Laboratory quality control can generally be divided into two aspects: internal quality control (IQC) and external quality assessment (EQC). Internal quality control in the laboratory refers to the technical operations and activities carried out in the laboratory to meet quality requirements. Its purpose is to monitor the laboratory's testing process, to evaluate whether the test results are reliable, and to find and eliminate problems that cause dissatisfaction in the quality process. reason. Laboratory internal quality control generally includes: personnel comparison, regular use of standard materials (reference materials) for monitoring and/or use of secondary reference materials (reference materials) for internal quality control, repeated testing using the same or different methods, and Store items for re-testing, etc. In addition, long-term monitoring of the testing projects that have been carried out can be carried out through parallel sample experiments and regular blind sample testing. Food microbiology laboratories should make plans for regular internal quality control, carry out work according to the plan, evaluate the results of internal quality control, propose improvement measures for problems that arise, and track and evaluate the implementation effects of improvement measures, so as to achieve the goal of Continuous promotion of laboratory work. Laboratory external quality assessment is a third-party organization that uses a series of methods to continuously and objectively evaluate the test results of each laboratory, and discovers inaccuracies that are not easy to find in the laboratory itself; understand the differences in results between laboratories, and help It is calibrated to make the results comparable. External quality assessment can be carried out in two ways. First, the accreditation body sends assessors to conduct on-site assessment of the laboratory in accordance with the requirements of ISO/IEC 17025; second, the experiment is evaluated through proficiency testing activities and comparison experiments between laboratories. room operations.
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