What are the key points of quality control and management for medical machinery parts?

Quality control and management of medical device components are crucial, directly impacting the safety and effectiveness of medical devices. Key aspects include raw material control, production process supervision, and quality inspection, detailed as follows:
Raw Material Quality Control
Strict Supplier Screening: Establish a supplier evaluation system to comprehensively audit the qualifications, production capacity, and quality assurance system of raw material suppliers. Prioritize suppliers with good reputations and stable quality. For example, for suppliers of special metal materials needed for medical sensors, their smelting processes and quality certifications should be examined.
Raw Material Inspection: Upon arrival, raw materials should be strictly inspected according to relevant standards and technical requirements. This includes visual inspection, dimensional measurement, and physicochemical property testing to ensure the materials meet production requirements. For medical plastic granules, melting point, density, and mechanical strength should be tested.
Raw Material Storage Management: Based on material properties, adopt appropriate storage conditions such as moisture-proof, mildew-proof, and oxidation prevention. For perishable materials, set reasonable storage periods and conduct regular sampling inspections to prevent quality degradation due to improper storage.
Production Process Quality Control
Formulate and Implement Process Documents: Develop detailed and standardized production process documents, clarifying operational requirements, process parameters, and quality standards for each production stage. Operators must strictly follow these documents to ensure production consistency. For example, in the welding process of medical imaging equipment components, welding temperature and time should be precisely controlled.
Equipment Maintenance and Calibration: Regularly maintain production equipment to ensure stable operation. Also, calibrate measuring and testing equipment according to the prescribed cycle to ensure the accuracy of measurement data. For example, measuring tools used to check component dimensions should be sent to a professional institution for calibration.
Personnel Training and Management: Provide professional training to production personnel so they understand production processes and quality control points, possessing the necessary operational skills and quality awareness. Establish personnel qualification certification and assessment systems to ensure that on-site personnel meet requirements.
Environmental Control: Some medical device component production has high environmental requirements, such as sterile environments and cleanliness. Monitor and control environmental parameters such as temperature, humidity, and dust particle count in the production workshop, regularly cleaning and disinfecting the workshop to meet production requirements.
Quality Inspection and Testing
First-Piece Inspection: At the start of production, conduct a comprehensive inspection of the first product. Only after confirming that the product meets quality standards can production continue. First-piece inspection can promptly identify problems with process parameter settings, preventing the production of batches of non-conforming products.
In-Process Inspection: During production, conduct sampling inspections of each process to promptly identify and correct quality deviations. For example, in the production of breathing tubes, inspect key processes such as extrusion molding and welding.
Finished Product Inspection: After completion, conduct a full inspection of the components according to relevant standards and technical requirements, including appearance, performance, and safety. Only inspected and approved products can proceed to the next stage.
Special Testing: For some critical or special medical device components, special tests may be required, such as biocompatibility testing and electromagnetic compatibility testing, to ensure the components meet medical usage requirements and relevant regulatory standards.