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