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

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Ernie Pedapati
2026-01-05 10:49:33 -05:00
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Reports/SOP-LAB-001-Broken-EEG-Net-Handling.md
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@@ -5,22 +5,25 @@ date: 2026-01-05
version: "1.0" version: "1.0"
status: "Draft" status: "Draft"
--- ---
## 1. Purpose ## 1. Purpose
- Define standardized procedures for identifying, handling, documenting, repairing, or disposing of broken EEG nets. - 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. - Ensure compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485 requirements.
- Minimize risk to subjects, staff, and data integrity. - Minimize risk to subjects, staff, and data integrity.
## 2. Scope ## 2. Scope
- Applies to all EEG nets used in clinical, research, or manufacturing environments within the organization. - 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. - Covers detection of damage, removal from service, evaluation, repair, disposal, and documentation.
## 3. Definitions ## 3. Definitions
- **EEG Net**: A multi-electrode sensor array used for electroencephalography data collection. - **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. - **Broken EEG Net**: Any EEG net exhibiting physical damage, electrical malfunction, missing components, or performance deviation.
- **Nonconformance**: Failure to meet specified requirements. - **Nonconformance**: Failure to meet specified requirements.
## 4. Regulatory and Quality References ## 4. Regulatory and Quality References
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures - FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- ISO 9001 – Quality Management Systems - ISO 9001 – Quality Management Systems
- ISO 13485 – Medical Devices Quality Management Systems - ISO 13485 – Medical Devices Quality Management Systems
@@ -28,6 +31,7 @@ status: "Draft"
- Risk Management Procedure "" - Risk Management Procedure ""
## 5. Responsibilities ## 5. Responsibilities
- **EEG Technician** - **EEG Technician**
- Identify and report broken EEG nets. - Identify and report broken EEG nets.
- Remove affected nets from service immediately. - Remove affected nets from service immediately.
@@ -40,13 +44,16 @@ status: "Draft"
- Maintain records in accordance with Part 11 requirements. - Maintain records in accordance with Part 11 requirements.
## 6. Required Materials and Records ## 6. Required Materials and Records
- Nonconformance Report (NCR) Form "" - Nonconformance Report (NCR) Form ""
- Equipment Log "" - Equipment Log ""
- Repair and Maintenance Record "" - Repair and Maintenance Record ""
- Labeling materials for status identification - Labeling materials for status identification
## 7. Procedure ## 7. Procedure
### 7.1 Identification of Broken EEG Nets ### 7.1 Identification of Broken EEG Nets
- Inspect EEG nets before and after each use. - Inspect EEG nets before and after each use.
- Indicators of breakage include: - Indicators of breakage include:
- Visible tears or frayed wiring - Visible tears or frayed wiring
@@ -55,11 +62,13 @@ status: "Draft"
- *Document findings immediately upon detection.* - *Document findings immediately upon detection.*
### 7.2 Removal from Service ### 7.2 Removal from Service
- Tag the EEG net as "Out of Service". - Tag the EEG net as "Out of Service".
- Remove from clinical or research area. - Remove from clinical or research area.
- Update the Equipment Log with date and reason. - Update the Equipment Log with date and reason.
### 7.3 Documentation ### 7.3 Documentation
- Complete a Nonconformance Report with: - Complete a Nonconformance Report with:
- Net identification number "" - Net identification number ""
- Description of damage "" - Description of damage ""
@@ -68,6 +77,7 @@ status: "Draft"
- Ensure electronic records comply with 21 CFR Part 11 controls. - Ensure electronic records comply with 21 CFR Part 11 controls.
### 7.4 Evaluation and Disposition ### 7.4 Evaluation and Disposition
- QA and Engineering assess: - QA and Engineering assess:
- Severity of damage - Severity of damage
- Impact on data integrity and safety - Impact on data integrity and safety
@@ -78,48 +88,52 @@ status: "Draft"
- *Record justification for the decision.* - *Record justification for the decision.*
### 7.5 Repair Process ### 7.5 Repair Process
- Perform repairs only by trained and authorized personnel. - Perform repairs only by trained and authorized personnel.
- Verify functionality post-repair using approved testing methods. - Verify functionality post-repair using approved testing methods.
- Document all repair activities and results. - Document all repair activities and results.
### 7.6 Disposal ### 7.6 Disposal
- Dispose of irreparable EEG nets according to waste management and environmental procedures. - Dispose of irreparable EEG nets according to waste management and environmental procedures.
- Remove asset from inventory records. - Remove asset from inventory records.
### 7.7 Return to Service ### 7.7 Return to Service
- QA approval required prior to reuse. - QA approval required prior to reuse.
- Update status label to "Approved for Use". - Update status label to "Approved for Use".
- Archive all related records. - Archive all related records.
## 8. Training Requirements ## 8. Training Requirements
- Personnel must be trained on this SOP prior to handling EEG nets. - Personnel must be trained on this SOP prior to handling EEG nets.
- Training records shall be maintained and reviewed periodically. - Training records shall be maintained and reviewed periodically.
## 9. Risk Management ## 9. Risk Management
- Identify risks associated with use of damaged EEG nets. - Identify risks associated with use of damaged EEG nets.
- Implement controls to prevent recurrence. - Implement controls to prevent recurrence.
- Link nonconformance data to corrective and preventive action processes. - Link nonconformance data to corrective and preventive action processes.
## 10. Deviations and Corrective Actions ## 10. Deviations and Corrective Actions
- Document any deviations from this SOP. - Document any deviations from this SOP.
- Initiate CAPA when trends or repeated failures are identified. - Initiate CAPA when trends or repeated failures are identified.
## 11. Records Retention ## 11. Records Retention
- Retain records according to Records Retention Policy "". - Retain records according to Records Retention Policy "".
- Ensure secure storage and controlled access. - Ensure secure storage and controlled access.
## 12. Change Management ## 12. Change Management
- Changes to this SOP require review and approval per Document Control procedures. - Changes to this SOP require review and approval per Document Control procedures.
- Maintain revision history. - Maintain revision history.
## 13. Version Control ## 13. Version Control
| Version | Date | Description of Change | Author |
|--------|------|-----------------------|--------| VersionDateDescription of ChangeAuthor1.02026-01-05Initial draft""
| 1.0 | 2026-01-05 | Initial draft | "" |
## 14. Approval Signatures ## 14. Approval Signatures
| Name | Title | Signature | Date |
|------|-------|-----------|------| NameTitleSignatureDate""""""""""""""""""""""""
| "" | "" | "" | "" |
| "" | "" | "" | "" |
| "" | "" | "" | "" |