155 lines
5.4 KiB
Markdown
155 lines
5.4 KiB
Markdown
# Internal Audit Checklist
|
|
|
|
| Form ID | FRM-006 | Revision | 1.0 |
|
|
|---------|---------|----------|-----|
|
|
|
|
---
|
|
|
|
## 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
|
|
|
|
---
|
|
|
|
## 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 | |
|
|
|
|
---
|
|
|
|
*Form FRM-006 Rev 1.0*
|