The quality control and management of medical machinery parts is crucial, directly related to the safety and effectiveness of medical devices. The main points mainly include raw material control, production process supervision, quality inspection and other aspects, as follows:
Raw material quality control
Strict supplier screening: establish a supplier evaluation system, conduct a comprehensive audit of the qualification, production capacity, quality assurance system of raw material suppliers, and prioritize the selection of suppliers with good reputation and stable quality. For example, for the production of medical sensors required for the special metal material suppliers, need to examine its smelting process, quality certification.
Raw material inspection: raw materials arrive, should be based on relevant standards and technical requirements for strict inspection. Including appearance inspection, size measurement, physical and chemical performance tests, etc., to ensure that the raw materials meet the production requirements. Such as medical plastic granules, to detect its melting point, density, mechanical strength and other indicators.
Raw material storage management: According to the characteristics of raw materials, take appropriate storage conditions, such as moisture, mold, oxidation and so on. For perishable raw materials, a reasonable storage period should be set, and regular sampling inspection should be carried out to prevent quality degradation due to improper storage.
Production process quality control
Formulation and implementation of process documents: Formulate detailed and standardized production process documents to clarify the operational requirements, process parameters and quality standards of each production link. Operators need to strictly follow the process documents to ensure the consistency of the production process. For example, in the welding process of medical imaging equipment parts, the welding temperature, time and other parameters should be precisely controlled.
Equipment maintenance and calibration: Regular maintenance of production equipment to ensure stable equipment operation. At the same time, in accordance with the prescribed cycle of measuring equipment, testing equipment and other calibration to ensure the accuracy of the measurement data. For example, the gauges used to test the dimensions of accessories need to be sent to professional organizations for calibration.
Personnel training and management: professional training for production personnel, so that they master the production process and quality control points, with the appropriate operating skills and quality awareness. At the same time, the establishment of personnel qualification certification and assessment system to ensure that the personnel on duty to meet the requirements.
Environmental control: some medical machinery parts production has high environmental requirements, such as sterile environment, cleanliness, etc.. It is necessary to monitor and control the environmental parameters such as temperature, humidity, dust particle count and so on in the production workshop, and clean and sterilize the workshop regularly to meet the production requirements.
Quality inspection and testing
First piece inspection: At the beginning of production, the first piece of product for a comprehensive inspection to confirm that the product meets the quality standards before continuing production. The first piece of inspection can find out the problems of process parameter setting in time to avoid the generation of batch unqualified products.
Process inspection: In the production process, the product of each process for sampling inspection, timely detection and correction of quality deviations in the production process. Such as in the production of respiratory tubes, extrusion molding, welding and other key processes for inspection.
Finished product inspection: after the completion of the finished product, according to the relevant standards and technical requirements, the fittings for the whole project inspection, including appearance, performance, safety and other aspects. Only products that have passed the inspection can enter the next stage.
Special testing: For some critical or special medical machinery parts, special testing may be required, such as biocompatibility testing, electromagnetic compatibility testing, etc., to ensure that the parts meet the requirements of medical use and relevant regulations and standards.