2.9 KiB
title, author, date, version, status
| title | author | date | version | status |
|---|---|---|---|---|
| EEG Equipment Loss and Quality Control Record Form | 2025-12-29 | 1.0 | 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).
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.
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""
7. Immediate Actions Taken
Document actions taken upon discovery of the loss.
ActionResponsible PersonDate""""""""""""
8. Quality Control Review
Assess compliance with equipment handling and tracking procedures.
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 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 DescriptionAction Type (Corrective/Preventive)Responsible PersonTarget Completion Date""""""""""""""""
11. Effectiveness Check
Evaluate whether implemented actions were effective.
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
13. Approval Signatures
Signatures confirm review, accuracy, and approval of this record.
RoleNameSignatureDatePrepared By""""""Reviewed By""""""Approved By""""""
14. Version Control
VersionDateDescription of ChangeAuthor1.02025-12-29Initial draft""