developmental-pediatrics/SOPs/SOP-004-Internal-Audit.md

# 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 |

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## 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

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |