Standard Operating Procedure for Training and Competency Assessment

1) Purpose

This SOP outlines the procedures for identifying training needs, conducting training programs, assessing competency, and maintaining records to ensure that all personnel are adequately trained and competent to perform their assigned tasks in compliance with regulatory requirements.

2) Scope

This SOP applies to all departments and personnel within the company, including manufacturing, quality control, quality assurance, regulatory affairs, and support functions, where training and competency assessment are essential for job performance.

3) Responsibilities

The Human Resources (HR) department is responsible for coordinating training activities and maintaining training records. Department heads and supervisors are responsible for identifying training needs, ensuring training effectiveness, and assessing competency.

4) Procedure

4.1 Training Needs Identification

1. Identify job roles and tasks requiring training based on job descriptions, performance evaluations, new hires, changes in procedures, or regulatory updates.
2. Assess competency gaps and prioritize training needs.

4.2 Training Program Development

1. Develop training programs or modules based on identified training needs and objectives.
2. Ensure training content includes relevant regulatory requirements, procedures, and best practices.

4.3 Training Delivery

1. Schedule training sessions and notify participants in advance.
2. Deliver training using qualified trainers or subject matter experts.
3. Provide training materials, manuals, or electronic resources as necessary.

4.4 Competency Assessment

1. Assess competency through written tests, practical demonstrations, simulations, or on-the-job assessments.
2. Document assessment results and provide feedback to employees.
3. Address identified competency gaps through additional training or corrective actions as needed.

4.5 Training Records

1. Maintain accurate and up-to-date training records for each employee, including training attended, assessment results, and competency status.
2. Ensure training records are accessible for audits, inspections, and performance evaluations.

4.6 Training Effectiveness Review

1. Periodically review training effectiveness through feedback from participants, supervisors, and performance evaluations.
2. Revise training programs as necessary to improve effectiveness and address changing needs.

5) Abbreviations, if any

SOP: Standard Operating Procedure
HR: Human Resources

6) Documents, if any

Training Needs Assessment Forms, Training Program Modules, Training Records, Competency Assessment Reports

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ISO 13485 (Medical Devices – Quality Management Systems)

8) SOP Version

Version 1.0