clinical-inpatient/SOPs/General/SOP-003-Training.md

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]