1、 Quality Management Organizational Structure
The Affinity Column Department has established a comprehensive quality management organizational structure, which is divided into three parts:
Technical Department: Responsible for optimizing and improving production processes and product quality.
Production Department: Responsible for inspecting the production process to ensure production quality.
Quality Control Department: Responsible for quality supervision and testing of the entire production process of affinity columns, including incoming material control, production process control, and finished product quality control.
2、 Quality Management System
Under the guidance of ISO 13485 system certification experts, VNYA has established a full process quality management system including the research and manufacturing of immunoaffinity columns in accordance with relevant standards and requirements of medical device quality management systems, and has obtained ISO 9001 quality management system certification.
3、 Quality Control Policy
VNYA adheres to the quality control policy of quality first, high quality and efficiency, customer satisfaction, honesty and practicality, and continuous improvement.
- In quality management, we conscientiously follow the requirements of the quality management system for quality management, strictly produce according to customer requirements and product standards during operation, be honest and customer-oriented, and provide customers with satisfactory high value-added products.
- We will take a very responsible attitude and solve any human or product defects found by customers during the use of our products in a satisfactory manner.
4、 Quality objectives
VNYA has established a quality objective based on the framework provided by the quality policy, which is to ensure that products sold to customers are 100% qualified.
- VNYA’s product circulation is carried out under controlled conditions, strictly following procedures to control the flow of non-conforming products into the next stage, in order to achieve 100% qualified delivery of customer products.
- Abide by contracts, maintain credibility, conscientiously fulfill each contract, promptly handle any changes in performance, and achieve a 100% contract performance rate.
5、 Quality control measures
VNYA has established comprehensive quality management measures and processes to ensure 100% product quality. The quality management measures are divided into three parts: process quality management, feed quality management, and process quality management.
（1） Process quality management
Process is the fundamental link in product manufacturing, and process quality management directly affects the quality of the product. VNYA takes corresponding measures to control the six elements of human, machine, material, method, environment, and measurement according to different processes.
- Personnel control
The dual measures of pre job training and continuous training during on-the-job work ensure that production personnel can proficiently master relevant quality regulations and business operations.
- Equipment control
(1) Perform regular maintenance on all equipment every month.
(2) Key production equipment will undergo equipment calibration before use, followed by trial production of small samples and inspection before production.
(3) The equipment will be cleaned after use to ensure that it remains in a clean state.
(4) Equipment users must receive training before operating the instrument, strictly follow the instrument operating procedures, and promptly fill in equipment usage, maintenance, and calibration records.
- Material control
(1) Materials refer to the raw materials, accessories, and other materials used in the production process.
(2) Weiaiya Company has established clear and strict material quality standards, and strictly inspects materials according to the quality standards.
(3) Clearly stipulate quality requirements in the raw material procurement contract and sign a quality agreement;
(4) Raw materials enter the factory, undergo batch inspection, and provide feedback data to suppliers to urge and assist them in continuously optimizing their products and ensuring a stable supply of qualified materials;
(5) For example, sieve plate controls intra batch and inter batch differences, column tube controls appearance, gel controls appearance and performance, etc.
- Quality control related documents
(1) VNYA has established rigorous and clear production processes, testing methods, and other operational procedures, as well as strict quality standard documents.
(2) There are corresponding operating procedures and quality standards for the use, maintenance, calibration, etc. of equipment.
(3) Strictly abide by process discipline and personnel document training, set corresponding records, conduct inspections and supervision of the implementation of SOP. The records corresponding to each process must be signed and confirmed before proceeding to the next process.
- Environmental control
(1) VNYA has established strict and clear environmental hygiene standards.
(2) Daily minor cleaning and weekly major cleaning at the production site; The production environment should be kept clean, tidy, and orderly, without any unrelated debris.
(3) Control the entry and exit of personnel and items on the production site;
(4) Strictly control the temperature of semi-finished refrigerators during production; Real time temperature monitoring.
（2） Incoming quality management
Raw material quality management is the first level of enterprise quality management. VNYA has developed comprehensive measures for raw material quality management and strictly monitors the quality of each incoming material.
- Incoming materials must be inspected first and can only be stored after passing the inspection. Establish a feed ledger to ensure consistent quantities.
- After entering the warehouse, there is a registration form for material requisition, and any batch of products’ materials can be traced.
- During production, the materials are inspected first, and after passing the inspection, small sample production is carried out first. After the production personnel check and confirm that there are no problems with the sample, please go to the quality laboratory for testing by specialized quality inspectors. Only after passing the test can we proceed to the next process for mass production.
- During the mass production process, random inspections are conducted. If the product passes the inspection, production will continue. If it fails, the entire batch will be inspected, and any non-conforming products will be invalidated.
- After the completion of the entire batch production, please go to the quality laboratory for quality control personnel to conduct a full batch sampling inspection. Only after passing the inspection can it be stored and shipped.
（3） Process Quality Management
Process quality refers to the control and management of various aspects that affect product quality during the production process
Ensure that the product meets the specified quality standards. It covers the entire production process from raw material procurement to finished product delivery, including process inspection, process control, and quality improvement. VNYA Company has established strict quality management measures around process inspection, process control, and quality improvement.
- Process inspection: A three-level inspection system of first article inspection, patrol inspection, and final inspection has been established to ensure strict quality management control for each production process.
First article inspection: Ensure that the product meets the standards before proceeding with bulk production.
Patrol inspection: Quantitative sampling inspection is conducted by quality control personnel.
Final inspection: QC conducts finished product quality control inspection.
- Process control: Established a three inspection system (self inspection, mutual inspection, and special inspection), and focused on controlling key processes,
Ensure timely handling of unstable factors
- Quality improvement: Emphasize supplier guidance to ensure that incoming materials meet quality standards. Track and verify abnormal issues to ensure effective resolution.