Packing Leader Company clean workshop personnel entry and exit management regulations
Step 1: Purpose
In order to ensure that the clean workshop of the company maintains a high degree of cleanliness and asepsis, effectively manage personnel in and out, and ensure that the medical device production environment meets high standards, this procedure is formulated.
2. Scope of application
This procedure applies to the management of personnel entry and exit activities in all clean workshops involved in workshop production.
3. Assignment of responsibilities
Production Technology Department: responsible for determining the number of operators in the clean workshop, supervising the implementation of personnel entry and exit management, organizing regular assessment and training.
Quality Control Department: review the personnel entry and exit applications, supervise the personnel behavior in the clean workshop to meet the standard requirements, and ensure that the production environment meets the quality standards.
4. Content
4.1 Number of personnel and access control
1. Strictly control the number of operators in the clean workshop, which shall be jointly determined by the production technology department and the quality Control Department according to the production demand, and strictly implement the quantity limit.
2. Maintenance and testing personnel and other non-operators (such as visitors) who temporarily enter the clean workshop must implement strict application and approval procedures, and require them to wear special entry and exit identifiers to distinguish their identities. 
4.2 Personnel health and behavior requirements
The staff in the clean workshop shall maintain good personal hygiene and receive regular health checks to ensure that they do not carry any pathogens that may pollute the production environment.
4.3 Training and assessment
Conduct regular training and assessment for the staff of the clean workshop, covering the operation specifications of the clean room, personal hygiene requirements, product protection knowledge, etc., to ensure that each employee can master and strictly implement it.
