Create form: EEG Equipment Loss and Quality Control Record Form

Forms/FRM-LAB-001-eeg-equipment-loss-and-quality-control-record-form.md

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+---
+title: "EEG Equipment Loss and Quality Control Record Form"
+author: ""
+date: 2025-12-29
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+*This form is used to document, investigate, and quality control incidents involving loss, damage, or unaccounted EEG nets. The record supports traceability, corrective actions, and compliance with FDA 21 CFR Part 11, ISO 9001, and ISO 13485.*
+
+## 2. Scope
+- Applies to all EEG nets owned, leased, or managed by the organization  
+- Covers loss, misplacement, damage, or failure to return EEG nets after use  
+- Used by clinical, research, and technical staff handling EEG equipment  
+
+## 3. Definitions
+- **EEG Net**: Reusable or disposable electrode net used for EEG data acquisition  
+- **Loss Incident**: Any situation where an EEG net cannot be located, accounted for, or returned as expected  
+- **Quality Control (QC)**: Activities ensuring EEG nets are tracked, maintained, and handled according to procedures  
+
+## 4. Equipment Identification
+*Record identifying information for the affected EEG net(s).*
+
+| Field | Details |
+|------|--------|
+| EEG Net Type/Model | "" |
+| Serial Number / Asset ID | "" |
+| Size | "" |
+| Manufacturer | "" |
+| Quantity Affected | "" |
+| Condition at Last Use | "" |
+
+## 5. Incident Details
+*Describe the circumstances under which the EEG net(s) were lost or discovered missing.*
+
+| Field | Details |
+|------|--------|
+| Date of Incident | "" |
+| Time of Incident | "" |
+| Location (Lab/Room/Site) | "" |
+| Study or Session ID | "" |
+| Responsible User | "" |
+| Last Known User | "" |
+| Date Loss Discovered | "" |
+
+## 6. Description of Loss
+*Provide a clear and factual description of what occurred.*
+
+| Description |
+|------------|
+| "" |
+
+## 7. Immediate Actions Taken
+*Document actions taken upon discovery of the loss.*
+
+| Action | Responsible Person | Date |
+|------|-------------------|------|
+| "" | "" | "" |
+| "" | "" | "" |
+
+## 8. Quality Control Review
+*Assess compliance with equipment handling and tracking procedures.*
+
+| QC Item | Yes | No | N/A | Comments |
+|-------|-----|----|-----|----------|
+| Equipment sign-out procedure followed | "" | "" | "" | "" |
+| Net labeled with asset ID | "" | "" | "" | "" |
+| Storage procedure followed | "" | "" | "" | "" |
+| Inventory log updated | "" | "" | "" | "" |
+
+## 9. Root Cause Assessment
+*Identify the most likely cause(s) of the loss.*
+
+| Potential Cause | Selected (Yes/No) | Comments |
+|----------------|------------------|----------|
+| Human error | "" | "" |
+| Inadequate tracking process | "" | "" |
+| Training deficiency | "" | "" |
+| Process noncompliance | "" | "" |
+| Other | "" | "" |
+
+## 10. Corrective and Preventive Actions (CAPA)
+*Define actions to prevent recurrence.*
+
+| Action Description | Action Type (Corrective/Preventive) | Responsible Person | Target Completion Date |
+|-------------------|------------------------------------|-------------------|-----------------------|
+| "" | "" | "" | "" |
+| "" | "" | "" | "" |
+
+## 11. Effectiveness Check
+*Evaluate whether implemented actions were effective.*
+
+| Review Date | Method of Verification | Effective (Yes/No) | Comments |
+|------------|-----------------------|--------------------|----------|
+| "" | "" | "" | "" |
+
+## 12. Record Retention and Compliance
+- This record is maintained in accordance with document control procedures  
+- Electronic records and signatures comply with FDA 21 CFR Part 11  
+- Retention period: "" years  
+
+## 13. Approval Signatures
+*Signatures confirm review, accuracy, and approval of this record.*
+
+| Role | Name | Signature | Date |
+|-----|------|----------|------|
+| Prepared By | "" | "" | "" |
+| Reviewed By | "" | "" | "" |
+| Approved By | "" | "" | "" |
+
+## 14. Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2025-12-29 | Initial draft | "" |