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What should laboratory equipment management pay attention?
2024-10-12
1. establishment of equipment quality management system
(1) EstablishmentLaboratory EquipmentManagement Organization
The equipment management organization consists of quality management department, technical department and support service department. According to the characteristics, scope and workload of equipment management, determine the responsibilities, powers and interrelationships of management personnel, inspectors, operators and service personnel, so that various management functions are decomposed and implemented to relevant departments and positions, and try to achieve clear responsibilities and clear division of labor.
(2) Development of equipment management procedures
Equipment management procedures are the way for testing institutions to implement equipment management. Through the establishment of corresponding program documents, the process, steps, contents and all links of equipment management activities are clearly defined, so that all work can be followed by rules.
Preparation of equipment operation instruction
The equipment operation instruction is a normative document to guide the inspection personnel to operate the equipment. General equipment can be operated in accordance with the instructions. Large and complex instruments or equipment with large mobility and unstable performance of operators need to prepare operation instructions or operating procedures.
2. improve the equipment quality management system
(1) Evaluation system
Review is a preliminary work for the purchase or disposal of equipment, mainly from the equipment adaptability, reliability, economy, safety, maintenance and other aspects of comprehensive analysis, the purpose is to reasonably allocate equipment resources, play the best benefits of equipment. For large, valuable and precise instruments, feasibility certification shall be carried out to achieve advanced technology, reliable performance, work needs and reasonable economy; for equipment leased, maintained and eliminated, as well as small or auxiliary equipment, necessary review shall be carried out.
(2) Acceptance system
Acceptance is an important means to ensure the normal operation of the equipment purchased or repaired. The unpacking and unpacking of instruments and equipment shall be carried out when the equipment manager, operator, supply personnel and other relevant personnel are present. During the acceptance process, the equipment review requirements, order contract and packing list shall be counted one by one, and records shall be made. For large-scale and precise instruments and equipment, after installation and commissioning, it shall pass a trial operation for a certain period (within the contract period), and shall be accepted after confirming that there is no quality problem according to the actual operation effect and various index test conclusions. The instruments and equipment can be handed over for use only after acceptance.
(3) Use of the system
In order to extend the service life of the equipment and give full play to its role, it is necessary to establish a system for the use of equipment, and make clear requirements for personnel, working environment, facility conditions, repair and maintenance.
Record system
Record is a basic work to establish a complete equipment file and ensure the normal distribution of equipment. It is very important for the implementation of equipment management responsibilities, system implementation and the operation and improvement of management procedures. Each equipment shall keep complete records from planned purchase to elimination. In addition to general equipment files, the contents shall also include equipment purchase, verification and maintenance plans, demonstration opinions or reports, commissioning and acceptance reports, equipment use and calibration records, instrument failure and maintenance records, operating conditions, performance changes, abnormal phenomena and rectification, etc.
(5) Verification system
Verification is an important measure to confirm that the equipment meets the technical specifications and avoid affecting the test results. Before and after using the instrument, the operator shall, in accordance with the technical regulations and instructions, take self-calibration, comparison and other methods to calibrate the main performance parameters to ensure that the accuracy and range of the instrument meet the requirements. The quality management team shall regularly check the use and records of the equipment, and shall formulate verification procedures for newly purchased or leased equipment, equipment used for on-site testing, and equipment with frequent use or large drift to keep the equipment in good working condition.
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