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).
Field
Details
EEG Net Type/Model
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Serial Number / Asset ID
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Size
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Manufacturer
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Quantity Affected
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Condition at Last Use
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5. Incident Details
Describe the circumstances under which the EEG net(s) were lost or discovered missing.
Field
Details
Date of Incident
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Time of Incident
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Location (Lab/Room/Site)
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Study or Session ID
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Responsible User
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Last Known User
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Date Loss Discovered
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6. Description of Loss
Provide a clear and factual description of what occurred.
Description
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7. Immediate Actions Taken
Document actions taken upon discovery of the loss.
Action
Responsible Person
Date
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8. Quality Control Review
Assess compliance with equipment handling and tracking procedures.
QC Item
Yes
No
N/A
Comments
Equipment sign-out procedure followed
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Net labeled with asset ID
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Storage procedure followed
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Inventory log updated
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9. Root Cause Assessment
Identify the most likely cause(s) of the loss.
Potential Cause
Selected (Yes/No)
Comments
Human error
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Inadequate tracking process
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Training deficiency
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Process noncompliance
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Other
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10. Corrective and Preventive Actions (CAPA)
Define actions to prevent recurrence.
Action Description
Action Type (Corrective/Preventive)
Responsible Person
Target Completion Date
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11. Effectiveness Check
Evaluate whether implemented actions were effective.
Review Date
Method of Verification
Effective (Yes/No)
Comments
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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.
