developmental-pediatrics/SOPs/SOP-001-Document-Control.md

# Standard Operating Procedure: Document Control

| Document ID | SOP-001 |
|-------------|---------|
| Title | Document Control |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |

---

## 1. Purpose

To establish a procedure for the creation, review, approval, distribution, and control of documents within the Developmental Pediatrics Quality Management System.

## 2. Scope

This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Assessment protocols
- Forms and Templates
- Clinical protocols
- External documents of external origin

## 3. Responsibilities

### 3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
- Maintains clinical accuracy of assessment protocols

### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
- Ensures version control

### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
- Verify clinical protocols align with professional standards

### 3.4 Clinical Director
- Reviews and approves clinical assessment protocols
- Ensures alignment with evidence-based practice
- Verifies standardized assessment procedures

## 4. Procedure

### 4.1 Document Creation

1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Reference applicable professional standards (AAP, DSM-5-TR, IDEA, etc.)
6. Submit for review and approval

### 4.2 Document Review and Approval

1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Clinical protocols reviewed by Clinical Director
5. Final approval by designated approver
6. Quality Assurance releases document

### 4.3 Document Numbering

Documents shall be numbered according to the following convention:

| Type | Prefix | Example |
|------|--------|---------|
| Policy | POL | POL-001 |
| Diagnostic Evaluation SOP | SOP-DE | SOP-DE-001 |
| Screening SOP | SOP-SCR | SOP-SCR-001 |
| School Liaison SOP | SOP-SCH | SOP-SCH-001 |
| Clinical SOP | SOP-CLI | SOP-CLI-001 |
| Administrative SOP | SOP-ADM | SOP-ADM-001 |
| Safety SOP | SOP-SAF | SOP-SAF-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |

### 4.4 Revision Control

1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer
5. Clinical protocol changes reviewed for impact on assessment standardization

### 4.5 Document Distribution

1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed
4. Clinical staff notified of assessment protocol updates

### 4.6 Periodic Review

1. Documents reviewed at least every 2 years
2. Clinical protocols reviewed annually to ensure alignment with current professional standards
3. Review documented even if no changes made
4. Reviews may result in revision or reaffirmation

### 4.7 External Documents

1. External standards (DSM-5-TR, ADOS-2 manual, AAP guidelines) maintained as reference
2. Latest versions obtained and archived
3. Changes to external standards trigger review of related internal documents

## 5. Related Documents

- FRM-001 Document Change Request Form
- FRM-002 Document Review Record

## 6. Definitions

| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
| Clinical Protocol | Procedure for standardized assessment administration or clinical decision-making |

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## Revision History

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