Auditee: Properly handling and documenting employee training records is essential to ensure that personnel are adequately trained, competent, and compliant with FDA regulations. Here’s a walkthrough of our process for handling and documenting employee training records:
Step 1: Training Needs Assessment
- Training Matrix: A training matrix is developed, outlining the roles, responsibilities, and required training for each job position.
- Job Descriptions: Job descriptions include the required skills and competencies for each role, helping identify the appropriate training.
- Regulatory Requirements: FDA regulations and industry standards are reviewed to ensure that all mandatory training is identified and included in the matrix.
Step 2: Training Program Development
- Training Plans:
Training plans are created for each role, detailing the specific courses, sessions, and on-the-job training required.
Course Content: Training materials, including presentations, handouts, and quizzes, are developed or sourced to cover the required topics.
Step 3: Training Execution
- Training Sessions: Scheduled training sessions, whether in-person or virtual, are conducted by qualified trainers.
- Documentation: Attendance records are maintained for each training session, indicating the date, time, attendees, and trainer.
- Skills Assessment: Skills and competencies are assessed through practical evaluations or tests to ensure comprehension and competency.
Step 4: Training Record Management
- Individual Training Records: Each employee has an individual training record that tracks their completed training, certifications, and competence assessments.
- Electronic System: A secure electronic system is used to store and manage training records, providing easy access and retrieval.
Step 5: Record Maintenance and Review
- Documentation: Training records include information such as the employee’s name, training type, date of completion, and the signature of the trainer.
- Document Retention: Training records are retained for a defined period as required by regulatory guidelines.
Step 6: Auditing and Compliance
- Internal Audits: Training records are subject to internal audits to ensure accuracy, completeness, and compliance with established procedures.
- Regulatory Inspections: During FDA inspections, training records are provided for review to demonstrate the competence and compliance of the workforce.
Through this comprehensive process, we ensure that employee training records are maintained accurately, accessible, and compliant with FDA regulations. This approach helps us uphold a highly trained and competent workforce to support the quality and safety of our products.