# Standard Operating Procedure: Training and Competence

| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |

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## 1. Purpose

To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.

## 2. Scope

This procedure applies to:
- All employees performing quality-affecting activities
- Contractors and temporary personnel
- Personnel requiring GxP training

## 3. Responsibilities

### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure training is completed before performing tasks
- Evaluate competence of personnel
- Maintain department training records

### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Archive training records

### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for GxP activities
- Audit training compliance

### 3.4 Employees
- Complete assigned training on time
- Maintain current qualifications
- Report training needs to supervisor

## 4. Procedure

### 4.1 Training Needs Assessment

1. Identify competence requirements for each role
2. Document requirements in job descriptions
3. Assess current competence of personnel
4. Identify training gaps

### 4.2 Training Curriculum Development

1. Define learning objectives
2. Develop training materials
3. Identify delivery method:
   - Classroom
   - On-the-job
   - Self-study
   - Computer-based
4. Define assessment criteria
5. Obtain approval from Quality (for GxP training)

### 4.3 Training Delivery

1. Schedule training session
2. Document attendance
3. Deliver training per curriculum
4. Assess comprehension through:
   - Written test (minimum 80% passing)
   - Practical demonstration
   - Supervisor observation

### 4.4 Training Documentation

Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results
- Signatures

### 4.5 Retraining Requirements

Retraining is required when:
- Significant document revisions occur
- Performance deficiencies identified
- Extended absence from job function
- Periodic requalification due

### 4.6 New Employee Orientation

All new employees shall complete:
1. Company orientation
2. Quality system overview
3. Job-specific training
4. SOP read and understand for applicable procedures

## 5. Training Records Retention

- Training records maintained for duration of employment
- Records retained 3 years after employee departure
- Records available for regulatory inspection

## 6. Related Documents

- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- Job Descriptions

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |