Standard Operating Procedure for Maintenance Training and Qualification

1) Purpose

The purpose of this SOP is to establish guidelines for training and qualifying maintenance personnel in pharmaceutical manufacturing facilities to ensure competency and compliance with maintenance procedures.

2) Scope

This SOP applies to all maintenance personnel involved in equipment and facility maintenance within the facility premises.

3) Responsibilities

The Human Resources Department, Facilities Management Department, and department supervisors are responsible for implementing and adhering to this SOP.

4) Procedure

1. Training Needs Assessment
   1. Conduct a training needs assessment to identify skills and knowledge gaps among maintenance personnel.
   2. Document training requirements based on job roles, tasks, and regulatory compliance.
2. Training Program Development
   1. Develop training programs and materials tailored to the specific needs of maintenance personnel.
   2. Include training modules on equipment operation, maintenance procedures, safety protocols, and regulatory requirements.
3. Training Delivery
   1. Deliver training sessions through classroom instruction, hands-on demonstrations, online courses, or workshops.
   2. Ensure trainers are qualified and competent to deliver training content effectively.
4. Competency Evaluation
   1. Assess maintenance personnel competency through written tests, practical demonstrations, or evaluations.
   2. Provide feedback to individuals and identify opportunities for further development.
5. Training Records and Documentation
   1. Maintain records of training sessions attended, competency assessments, and certifications obtained by maintenance personnel.
   2. Document training effectiveness and revise programs as necessary to address feedback and changes in procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Training Needs Assessment Report, Training Program Modules, Training Attendance Records, Competency Assessment Records

7) Reference, if any

Regulatory requirements for personnel training in pharmaceutical manufacturing, industry standards for maintenance training, and equipment-specific training materials.

8) SOP Version

Version 1.0