From 06af3540db87cc5458a681b78617a97f31eb8ce8 Mon Sep 17 00:00:00 2001
From: Ernie Pedapati <ernest.pedapati@cchmc.org>
Date: Mon, 5 Jan 2026 10:49:33 -0500
Subject: [PATCH] Update Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md

---
 .../SOP-LAB-001-Broken-EEG-Net-Handling.md    | 32 +++++++++++++------
 1 file changed, 23 insertions(+), 9 deletions(-)

diff --git a/Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md b/Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md
index a7af182..39559c4 100644
--- a/Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md
+++ b/Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md
@@ -5,22 +5,25 @@ 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
@@ -28,6 +31,7 @@ status: "Draft"
 - Risk Management Procedure ""
 
 ## 5. Responsibilities
+
 - **EEG Technician**
   - Identify and report broken EEG nets.
   - Remove affected nets from service immediately.
@@ -40,13 +44,16 @@ status: "Draft"
   - 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
@@ -55,11 +62,13 @@ status: "Draft"
 - *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 ""
@@ -68,6 +77,7 @@ status: "Draft"
 - 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
@@ -78,48 +88,52 @@ status: "Draft"
 - *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 | "" |
+
+VersionDateDescription of ChangeAuthor1.02026-01-05Initial draft""
 
 ## 14. Approval Signatures
-| Name | Title | Signature | Date |
-|------|-------|-----------|------|
-| "" | "" | "" | "" |
-| "" | "" | "" | "" |
-| "" | "" | "" | "" |
\ No newline at end of file
+
+NameTitleSignatureDate""""""""""""""""""""""""
\ No newline at end of file