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

---
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

VersionDateDescription of ChangeAuthor1.02026-01-05Initial draft""

## 14. Approval Signatures

NameTitleSignatureDate""""""""""""""""""""""""