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]