Purpose: To clarify the responsibilities of the Production Department.
Scope: Management responsibilities of the Production Department.
Responsibility: All personnel in the Production Department shall implement their respective responsibilities, and the head of the Production Department shall be responsible for supervising the implementation of these responsibilities.
- Complete the production tasks assigned by the factory, timely develop production plans, and complete production tasks on time with quality and quantity guaranteed.
- According to the requirements of GMP, compile production process regulations, standard operating procedures, cleaning and hygiene systems, and other production management systems, supervise and inspect the implementation of management systems.
- Timely handle abnormal problems in the production process. In case of major quality accidents, safety accidents, etc., report to the supervisor of the factory leadership in a timely manner and notify relevant departments
- Check the work situation of process technicians and team leaders, as well as the quality of process discipline, labor discipline, intermediate products, and finished products.
- Prepare monthly production statistics, including output, consumption, yield (or finished product rate), first-pass yield, and internal control compliance rate, report to the factory leadership as well as quality management department.
- Maintain good workshop environmental hygiene, process hygiene, and supervise and inspect personal hygiene to create a production environment that meets GMP requirements.
- Assist the engineering department and quality management department in completing process certification, equipment certification, clean room management, finished product inspection, etc.
- Provide quality education and technical training to all employees in the workshop, including legal education, labor discipline, safety education, hygiene education, GMP document education, job skills training and assessment, etc.
- Organize safety inspections every week, fill out the “Safety Inspection Record”, record the code, inspection date, serial number, the rectification situation of the previously discovered problems, newly discovered safety problems, the department where the problems are located, the department responsible for rectification, the completion date of rectification, the recorder, and the production department leader.
- Strictly control the materials, equipment, facilities, and factory buildings used in the production process to meet regulatory requirements. Strictly control the production process to minimize potential hazards that may affect product quality.
- Accurately and timely submit relevant reports. Collect and organize batch production records and submit them to the quality management department in a timely manner.
- Collect and organize consumption data of materials and consumables used in the production process, and cooperate with the supply department, engineering department, and finance department to determine various consumption indicators.