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

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