124 lines
3.0 KiB
Markdown
124 lines
3.0 KiB
Markdown
# 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 |
|
|
|
|
---
|
|
|
|
## 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
|
|
|
|
---
|
|
|
|
## Revision History
|
|
|
|
| Rev | Date | Description | Author |
|
|
|-----|------|-------------|--------|
|
|
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|