# Work Instruction: [Title]

| Document ID | WI-001 |
|-------------|--------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |

---

## 1. Purpose

[Describe the purpose of this work instruction. If pediatric-specific, indicate applicable age ranges.]

## 2. Scope

[Define what activities this instruction covers and any age-specific or population-specific limitations.]

## 3. Safety Precautions

[List safety requirements, especially important for procedures involving children:]
- [Personal protective equipment needed]
- [Hazards to be aware of]
- [Child safety considerations]
- [Parent/guardian presence requirements]
- [Emergency procedures]

## 4. Equipment/Materials Required

| Item | Specification |
|------|---------------|
| | |
| | |

[For pediatric procedures, specify age-appropriate sizes, child-friendly materials, etc.]

## 5. Prerequisites

[List required training, certifications, or competencies needed to perform this work instruction]
- [GCP certification]
- [Pediatric-specific training]
- [Procedure-specific competency]

## 6. Procedure

### Step 1: [Title]
[Detailed instructions including child-specific considerations]

**Materials needed:** [List]
**Personnel:** [Who performs this step]
**Documentation:** [What to record]

### Step 2: [Title]
[Detailed instructions]

**Age-specific modifications:**
- **Neonates/Infants:** [Specific approach]
- **Children:** [Specific approach]
- **Adolescents:** [Specific approach]

### Step 3: [Title]
[Detailed instructions]

### Step 4: [Additional steps as needed]
[Continue with detailed step-by-step instructions]

## 7. Pediatric-Specific Considerations

### 7.1 Age-Appropriate Communication
- [How to explain procedure to child]
- [Language to use]
- [Visual aids or demonstrations]

### 7.2 Family Involvement
- [Parent/guardian role during procedure]
- [When to request family step out]
- [Family support and reassurance]

### 7.3 Child Comfort and Cooperation
- [Strategies to reduce anxiety]
- [Distraction techniques]
- [Rewards or positive reinforcement]
- [When to pause or reschedule]

### 7.4 Developmental Considerations
- [Positioning for different ages]
- [Expected cooperation levels by age]
- [Restraint considerations (if absolutely necessary)]

## 8. Acceptance Criteria

[Define what constitutes successful completion]
- [Quality standards]
- [Completeness requirements]
- [Child tolerance/comfort]

## 9. Troubleshooting

| Issue | Solution |
|-------|----------|
| Child refuses procedure | [Steps to take] |
| Parent anxious | [Approach] |
| Technical difficulty | [Resolution] |

## 10. Records

| Record | Location | Retention |
|--------|----------|-----------|
| | | |
| | | |

## 11. Related Documents

- [Related SOPs]
- [Study protocols]
- [Specifications]
- [Forms]

## 12. References

[Include relevant pediatric references:]
- [Clinical guidelines]
- [Pediatric standards]
- [Regulatory requirements]

---

## Revision History

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