Sync template from atomicqms-style deployment

Forms/FRM-006-Audit-Checklist.md

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+# 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*