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SOPs/SOP-004-Internal-Audit.md

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+# Standard Operating Procedure: Internal Audit
+
+| Document ID | SOP-004 |
+|-------------|---------|
+| Title | Internal Audit |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for conducting internal audits of the Developmental Pediatrics Quality Management System to verify compliance with established procedures and identify opportunities for improvement.
+
+## 2. Scope
+
+This procedure applies to all processes, departments, and activities within the QMS including:
+- Clinical assessment procedures
+- Diagnostic evaluations
+- Screening programs
+- School liaison activities
+- Documentation and record keeping
+- Training and competency
+- Safety and incident management
+- Administrative processes
+
+## 3. Responsibilities
+
+### 3.1 Quality Assurance Manager
+- Develops annual audit schedule
+- Selects and trains auditors
+- Reviews audit findings
+- Tracks corrective actions
+- Reports audit results to management
+
+### 3.2 Internal Auditors
+- Conduct audits according to schedule
+- Document findings objectively
+- Maintain independence and objectivity
+- Follow audit procedures
+- Complete audit reports
+
+### 3.3 Auditee (Area Being Audited)
+- Provide access to records and personnel
+- Respond to audit findings
+- Implement corrective actions
+- Verify effectiveness of corrections
+
+### 3.4 Management
+- Review audit results
+- Allocate resources for corrective actions
+- Support audit process
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Audit | Systematic, independent examination of activities and results |
+| Auditor | Person qualified to conduct audits |
+| Auditee | Person or department being audited |
+| Nonconformity | Failure to meet a specified requirement |
+| Observation | Potential issue or opportunity for improvement |
+| Objective Evidence | Data supporting existence or truth of something |
+
+## 5. Procedure
+
+### 5.1 Audit Planning
+
+1. **Annual Audit Schedule**:
+   - QA Manager develops schedule covering all QMS areas
+   - High-risk areas audited more frequently
+   - Clinical assessment procedures audited semi-annually
+   - Schedule reviewed and approved by management
+
+2. **Audit Frequency**:
+   - Core QMS processes: Annually minimum
+   - Clinical assessment protocols: Semi-annually
+   - High-risk areas: Quarterly
+   - New procedures: Within 3 months of implementation
+
+3. **Auditor Selection**:
+   - Auditors independent of area being audited
+   - Clinical audits conducted by qualified clinical personnel
+   - External auditors may be used for objectivity
+
+### 5.2 Audit Preparation
+
+1. **Define Audit Scope**:
+   - Identify processes/areas to audit
+   - Specify audit criteria (SOPs, regulations, standards)
+   - Determine audit timeframe
+
+2. **Review Documentation**:
+   - Current SOPs and protocols
+   - Previous audit reports
+   - Recent CAPA records
+   - Relevant regulations (HIPAA, IDEA, AAP guidelines)
+
+3. **Develop Audit Checklist**:
+   - Use FRM-006 Audit Checklist template
+   - Include key requirements to verify
+   - Prepare interview questions
+   - Plan document sampling strategy
+
+4. **Notify Auditee**:
+   - Provide 2-week advance notice
+   - Communicate audit scope and schedule
+   - Request access to records and personnel
+
+### 5.3 Audit Execution
+
+1. **Opening Meeting**:
+   - Confirm audit scope and schedule
+   - Explain audit process
+   - Answer questions
+
+2. **Evidence Gathering**:
+   - **Document Review**: Sample clinical records, assessment reports, training records
+   - **Interviews**: Discuss procedures with staff
+   - **Observations**: Observe assessment administration, clinical processes
+   - **Data Analysis**: Review metrics, completion rates, accuracy data
+
+3. **Clinical Audit Focus Areas**:
+   - Assessment tool administration fidelity
+   - Diagnostic criteria application (DSM-5-TR)
+   - Report completeness and accuracy
+   - Standardization of protocols
+   - Family communication documentation
+   - School liaison documentation (IEP/504)
+   - Screening program adherence
+   - Multidisciplinary coordination
+
+4. **Document Findings**:
+   - Record objective evidence
+   - Note conformities and nonconformities
+   - Identify opportunities for improvement
+   - Document findings on audit checklist
+
+5. **Closing Meeting**:
+   - Present findings to auditee
+   - Discuss nonconformities
+   - Answer questions
+   - Explain follow-up process
+
+### 5.4 Audit Reporting
+
+1. **Audit Report Contents**:
+   - Audit scope and criteria
+   - Audit date and participants
+   - Summary of findings
+   - Nonconformities identified
+   - Observations and recommendations
+   - Positive findings (conformities)
+
+2. **Classification of Findings**:
+   - **Major Nonconformity**: Significant failure affecting patient safety, diagnostic accuracy, or regulatory compliance
+   - **Minor Nonconformity**: Isolated failure with limited impact
+   - **Observation**: Potential issue or improvement opportunity
+
+3. **Report Distribution**:
+   - Auditee
+   - Department manager
+   - Clinical Director (for clinical audits)
+   - Quality Assurance Manager
+   - Senior management
+
+### 5.5 Corrective Action
+
+1. Auditee develops corrective action plan for nonconformities
+2. Actions documented using FRM-003 CAPA Form
+3. Target completion dates established
+4. QA Manager tracks action completion
+5. Follow-up audit conducted to verify effectiveness
+
+### 5.6 Audit Records
+
+Maintain audit records including:
+- Audit schedule
+- Audit checklists
+- Audit reports
+- Evidence reviewed
+- Corrective action documentation
+- Follow-up verification
+
+Records retained for minimum 7 years.
+
+## 6. Special Audit Types
+
+### 6.1 Clinical Assessment Audits
+
+Focus on:
+- ADOS-2/ADI-R administration fidelity
+- Cognitive assessment standardization
+- Scoring accuracy
+- Diagnostic criteria application
+- Report quality and timeliness
+- Informed consent documentation
+
+### 6.2 School Liaison Audits
+
+Focus on:
+- IEP documentation completeness
+- 504 plan adherence
+- IDEA compliance
+- School communication timeliness
+- Educational records management
+
+### 6.3 Screening Program Audits
+
+Focus on:
+- Screening tool administration
+- Follow-up protocols
+- Referral pathways
+- Parent communication
+- Data tracking and outcomes
+
+## 7. Auditor Qualifications
+
+Internal auditors shall:
+- Complete internal auditor training
+- Understand QMS requirements
+- Maintain objectivity
+- Clinical auditors: Hold appropriate clinical credentials
+- Demonstrate knowledge of audit techniques
+
+## 8. Related Documents
+
+- FRM-006 Audit Checklist
+- FRM-003 CAPA Form
+- SOP-002 Corrective and Preventive Action
+- Annual Audit Schedule
+
+## 9. References
+
+- ISO 19011:2018 Guidelines for Auditing Management Systems
+- Clinical quality audit methodologies
+- HIPAA audit protocols
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |