developmental-pediatrics/Forms/FRM-006-Audit-Checklist.md

# Internal Audit Checklist

| Form ID | FRM-006 | Revision | 1.0 |
|---------|---------|----------|-----|

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## Section 1: Audit Information

| Field | Entry |
|-------|-------|
| Audit Date | |
| Auditor Name(s) | |
| Auditee (Department/Area) | |
| Audit Scope | |
| Audit Criteria (SOPs, Standards) | |

## Section 2: Audit Criteria and Findings

### Instructions
- **C** = Conformity (requirement met)
- **NC** = Nonconformity (requirement not met)
- **OBS** = Observation (potential issue or improvement opportunity)
- **N/A** = Not Applicable

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## Section 3: Document Control (SOP-001)

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Documents have proper identification (ID, rev, date) | ☐C ☐NC ☐OBS ☐N/A | | |
| Current versions are available and accessible | ☐C ☐NC ☐OBS ☐N/A | | |
| Obsolete documents are removed from use | ☐C ☐NC ☐OBS ☐N/A | | |
| Revision history is maintained | ☐C ☐NC ☐OBS ☐N/A | | |
| Document reviews conducted per schedule | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 4: Training and Competency (SOP-003)

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Training records maintained for all staff | ☐C ☐NC ☐OBS ☐N/A | | |
| New employee onboarding completed | ☐C ☐NC ☐OBS ☐N/A | | |
| Competency assessments documented | ☐C ☐NC ☐OBS ☐N/A | | |
| Assessment tool certifications current | ☐C ☐NC ☐OBS ☐N/A | | |
| Annual training requirements met | ☐C ☐NC ☐OBS ☐N/A | | |
| Inter-rater reliability checks conducted | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 5: Clinical Assessment Procedures

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Assessment protocols followed correctly | ☐C ☐NC ☐OBS ☐N/A | | |
| Standardized administration maintained | ☐C ☐NC ☐OBS ☐N/A | | |
| Scoring accuracy verified | ☐C ☐NC ☐OBS ☐N/A | | |
| DSM-5-TR criteria applied appropriately | ☐C ☐NC ☐OBS ☐N/A | | |
| Assessment materials properly maintained | ☐C ☐NC ☐OBS ☐N/A | | |
| ADOS-2/ADI-R fidelity maintained (if applicable) | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 6: Documentation and Records

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Clinical records complete and accurate | ☐C ☐NC ☐OBS ☐N/A | | |
| Informed consent documented | ☐C ☐NC ☐OBS ☐N/A | | |
| Reports completed within timeframes | ☐C ☐NC ☐OBS ☐N/A | | |
| Required elements included in reports | ☐C ☐NC ☐OBS ☐N/A | | |
| Records stored securely (HIPAA) | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 7: Screening Programs (if applicable)

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Screening tools administered correctly | ☐C ☐NC ☐OBS ☐N/A | | |
| Follow-up protocols followed | ☐C ☐NC ☐OBS ☐N/A | | |
| Parent communication documented | ☐C ☐NC ☐OBS ☐N/A | | |
| Referral pathways established | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 8: School Liaison (if applicable)

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| IEP documentation complete | ☐C ☐NC ☐OBS ☐N/A | | |
| 504 plans properly documented | ☐C ☐NC ☐OBS ☐N/A | | |
| IDEA requirements met | ☐C ☐NC ☐OBS ☐N/A | | |
| School communication timely | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 9: CAPA Process (SOP-002)

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Nonconformities documented | ☐C ☐NC ☐OBS ☐N/A | | |
| Root cause analysis performed | ☐C ☐NC ☐OBS ☐N/A | | |
| Corrective actions implemented | ☐C ☐NC ☐OBS ☐N/A | | |
| Effectiveness verified | ☐C ☐NC ☐OBS ☐N/A | | |
| CAPA records maintained | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 10: Safety and Incidents

| Requirement | Status | Evidence Reviewed | Findings/Comments |
|-------------|--------|-------------------|-------------------|
| Safety procedures followed | ☐C ☐NC ☐OBS ☐N/A | | |
| Incidents documented and investigated | ☐C ☐NC ☐OBS ☐N/A | | |
| Staff aware of emergency procedures | ☐C ☐NC ☐OBS ☐N/A | | |

## Section 11: Summary of Findings

### Conformities (Positive Findings)




### Nonconformities

| NC # | Type | Description | Objective Evidence |
|------|------|-------------|-------------------|
| | ☐Major ☐Minor | | |
| | ☐Major ☐Minor | | |
| | ☐Major ☐Minor | | |

### Observations/Opportunities for Improvement




## Section 12: Audit Conclusion

### Overall Assessment
- [ ] Satisfactory - minor or no issues identified
- [ ] Needs improvement - nonconformities require corrective action
- [ ] Unsatisfactory - major nonconformities requiring immediate action

### Recommended Follow-Up Actions




## Section 13: Closing Meeting

| Attendees | |
|-----------|---|
| Date | |
| Audit findings presented | ☐ Yes |
| Questions addressed | ☐ Yes |

## Section 14: Signatures

| Auditor Signature | | Date | |
|------------------|---|------|---|
| Auditee Signature | | Date | |

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*Form FRM-006 Rev 1.0*