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

title, author, date, version, status

title	author	date	version	status
Standard Operating Procedure for Handling Broken EEG Nets		2026-01-05	1.0	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
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