Create report: Standard Operating Procedure for Handling Broken EEG Nets

Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md

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+---
+title: "Standard Operating Procedure for Handling Broken EEG Nets"
+author: ""
+date: 2026-01-05
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+- Define standardized procedures for identifying, handling, documenting, repairing, or disposing of broken EEG nets.
+- Ensure compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requirements.
+- Minimize risk to subjects, staff, and data integrity.
+
+## 2. Scope
+- Applies to all EEG nets used in clinical, research, or manufacturing environments within the organization.
+- Covers detection of damage, removal from service, evaluation, repair, disposal, and documentation.
+
+## 3. Definitions
+- **EEG Net**: A multi-electrode sensor array used for electroencephalography data collection.
+- **Broken EEG Net**: Any EEG net exhibiting physical damage, electrical malfunction, missing components, or performance deviation.
+- **Nonconformance**: Failure to meet specified requirements.
+
+## 4. Regulatory and Quality References
+- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
+- ISO 9001 – Quality Management Systems
+- ISO 13485 – Medical Devices Quality Management Systems
+- Internal Quality Manual ""
+- Risk Management Procedure ""
+
+## 5. Responsibilities
+- **EEG Technician**
+  - Identify and report broken EEG nets.
+  - Remove affected nets from service immediately.
+- **Quality Assurance (QA)**
+  - Review documentation and assess compliance.
+  - Approve repair or disposal decisions.
+- **Engineering / Maintenance**
+  - Evaluate damage and perform authorized repairs.
+- **Document Control**
+  - Maintain records in accordance with Part 11 requirements.
+
+## 6. Required Materials and Records
+- Nonconformance Report (NCR) Form ""
+- Equipment Log ""
+- Repair and Maintenance Record ""
+- Labeling materials for status identification
+
+## 7. Procedure
+### 7.1 Identification of Broken EEG Nets
+- Inspect EEG nets before and after each use.
+- Indicators of breakage include:
+  - Visible tears or frayed wiring
+  - Missing or damaged electrodes
+  - Signal noise or failure during testing
+- *Document findings immediately upon detection.*
+
+### 7.2 Removal from Service
+- Tag the EEG net as "Out of Service".
+- Remove from clinical or research area.
+- Update the Equipment Log with date and reason.
+
+### 7.3 Documentation
+- Complete a Nonconformance Report with:
+  - Net identification number ""
+  - Description of damage ""
+  - Date identified ""
+  - Reporter name ""
+- Ensure electronic records comply with 21 CFR Part 11 controls.
+
+### 7.4 Evaluation and Disposition
+- QA and Engineering assess:
+  - Severity of damage
+  - Impact on data integrity and safety
+- Determine disposition:
+  - Repair
+  - Return to vendor
+  - Disposal
+- *Record justification for the decision.*
+
+### 7.5 Repair Process
+- Perform repairs only by trained and authorized personnel.
+- Verify functionality post-repair using approved testing methods.
+- Document all repair activities and results.
+
+### 7.6 Disposal
+- Dispose of irreparable EEG nets according to waste management and environmental procedures.
+- Remove asset from inventory records.
+
+### 7.7 Return to Service
+- QA approval required prior to reuse.
+- Update status label to "Approved for Use".
+- Archive all related records.
+
+## 8. Training Requirements
+- Personnel must be trained on this SOP prior to handling EEG nets.
+- Training records shall be maintained and reviewed periodically.
+
+## 9. Risk Management
+- Identify risks associated with use of damaged EEG nets.
+- Implement controls to prevent recurrence.
+- Link nonconformance data to corrective and preventive action processes.
+
+## 10. Deviations and Corrective Actions
+- Document any deviations from this SOP.
+- Initiate CAPA when trends or repeated failures are identified.
+
+## 11. Records Retention
+- Retain records according to Records Retention Policy "".
+- Ensure secure storage and controlled access.
+
+## 12. Change Management
+- Changes to this SOP require review and approval per Document Control procedures.
+- Maintain revision history.
+
+## 13. Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|-----------------------|--------|
+| 1.0 | 2026-01-05 | Initial draft | "" |
+
+## 14. Approval Signatures
+| Name | Title | Signature | Date |
+|------|-------|-----------|------|
+| "" | "" | "" | "" |
+| "" | "" | "" | "" |
+| "" | "" | "" | "" |