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

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Ernie Pedapati
2025-12-29 09:45:49 -05:00
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Forms/FRM-LAB-001-eeg-equipment-loss-and-quality-control-record-form.md
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@@ -5,111 +5,82 @@ 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
- 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
- **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 | "" |
FieldDetailsEEG 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 | "" |
FieldDetailsDate 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 |
|------------|
| "" |
Description""
## 7. Immediate Actions Taken
*Document actions taken upon discovery of the loss.*
| Action | Responsible Person | Date |
|------|-------------------|------|
| "" | "" | "" |
| "" | "" | "" |
ActionResponsible PersonDate""""""""""""
## 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 | "" | "" | "" | "" |
QC ItemYesNoN/ACommentsEquipment 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 | "" | "" |
Potential CauseSelected (Yes/No)CommentsHuman 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 |
|-------------------|------------------------------------|-------------------|-----------------------|
| "" | "" | "" | "" |
| "" | "" | "" | "" |
Action DescriptionAction Type (Corrective/Preventive)Responsible PersonTarget Completion Date""""""""""""""""
## 11. Effectiveness Check
*Evaluate whether implemented actions were effective.*
| Review Date | Method of Verification | Effective (Yes/No) | Comments |
|------------|-----------------------|--------------------|----------|
| "" | "" | "" | "" |
Review DateMethod of VerificationEffective (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
- 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 | "" | "" | "" |
RoleNameSignatureDatePrepared By""""""Reviewed By""""""Approved By""""""
## 14. Version Control
| Version | Date | Description of Change | Author |
|--------|------|----------------------|--------|
| 1.0 | 2025-12-29 | Initial draft | "" |
VersionDateDescription of ChangeAuthor1.02025-12-29Initial draft""