The organization shall determine, provide and maintain the infrastructure required to achieve product conformity. Where applicable, infrastructure includes:

1. Buildings, workplaces and related facilities; such as plant layout, office space, buildings, production workshops and warehouses; considering the impact on product compliance procedures once built, therefore, in the design and construction of the installation. Control the links and factors that may affect product compliance. Such as the cleanliness requirements of GMP workshops of pharmaceutical factories, and the explosion-proof requirements of electrical appliances, equipment and circuits in chemical enterprise workshops. In addition, after the building, workplace and related facilities are put into operation, in addition to routine maintenance, when production process adjustments or major repairs and other activities that have a large impact on product compliance, it is also necessary to consider the maintenance of building-related facilities. Retrofit and upgrade;

2. Process facilities (hardware and software); production equipment, tooling molds, pipes, etc.

Early management of equipment

A. Purchase requisition for equipment

B. Equipment selection and purchase

C. Acceptance and commissioning

Equipment use and maintenance

A. The equipment operators should be trained and have the ability to operate. before taking up the job. It is required to understand three (understand the principle, performance, structure) and four (understand the diagram, operate, maintain, and troubleshoot).

B. Maintenance will generally be implemented to individuals. Make arrangements, inspections, and assessments linked to income.

Equipment maintenance management

Inspection and maintenance together. In order to achieve long-term, full-load, safe and stable operation;

Maintenance is divided into minor repairs Maintenance inspection of general wearing parts or general defects

Intermediate repair Replacement or repair of the main components of the equipment

Overhaul A complete repair of equipment. Repair and improve equipment performance and improve equipment technical condition;

Scrap of equipment

3. Supporting services (transportation, communication or information systems), product development facilities, transportation facilities and ERP systems, etc.

The information system is based on computer, network technology, modern communication technology and various software technologies, providing information services, processing various input data, and solving certain aspects of the enterprise.