1、 Organization and personnel

1. Have medical mask production management personnel, personnel with practical operation skills and inspectors.

2. Ensure that the personnel meet the health requirements, and prohibit the personnel with infectious diseases from directly contacting the product.

2、 Plant and facilities

1. There should be a buffer zone for washing hands, changing shoes, changing clothes and cleaning and disinfection when entering and leaving the workshop.

2. The production environment shall be kept clean and tidy, with appropriate lighting, temperature, humidity and ventilation control conditions.

3. It shall have corresponding production equipment for medical masks.

4. Testing equipment released from the factory shall be equipped& nbsp;

5. A sufficient number of disinfection facilities (such as ultraviolet lamps) shall be equipped to disinfect and sterilize the production environment every day.

3、 Raw material requirements

1. Be able to control the microbiological indexes of raw materials such as non-woven fabrics, melt blown filter materials and gauze used in the production of medical masks, and meet the quality requirements of medical masks.

2. A quality agreement shall be signed with raw material suppliers to clarify the procurement quality and supply assurance requirements. The quality assurance certificate or inspection report issued by the raw material supplier shall be provided.

4、 Quality control

Be able to assign special personnel to be responsible for production and release management.

5、 Production management

In specific production management, medical mask manufacturers also need to:

1. Prepare production process procedures and operation instructions;

2. Identify the inspection status of products in the production process;

3. Control the production process of key processes;

4. Test the finished products according to the mandatory standards and product technical requirements;

5. Make production records and inspection records to meet traceability requirements.

In the production process after being approved, the enterprise shall also make rectification and improvement while producing according to the relevant requirements of the medical device production quality management specification, national standards and industrial standards, so as to gradually meet the requirements of the medical device production quality management specification and ensure the product quality and safety.