Sync template from atomicqms-style deployment

Forms/FRM-001-Document-Change-Request.md

@@ -0,0 +1,64 @@
+# Document Change Request Form
+
+| Form ID | FRM-001 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Request Information
+
+| Field | Entry |
+|-------|-------|
+| Request Date | |
+| Requested By | |
+| Department | |
+
+## Section 2: Document Information
+
+| Field | Entry |
+|-------|-------|
+| Document Number | |
+| Document Title | |
+| Current Revision | |
+
+## Section 3: Change Description
+
+### Type of Change
+- [ ] New Document
+- [ ] Revision to Existing Document
+- [ ] Document Obsolescence
+
+### Description of Change
+*(Describe the proposed change in detail)*
+
+
+
+
+### Reason for Change
+*(Explain why this change is needed)*
+
+
+
+
+## Section 4: Impact Assessment
+
+### Affected Areas
+- [ ] Training Required
+- [ ] Other Documents Affected
+- [ ] Process Changes Required
+- [ ] Validation Impact
+
+### List Affected Documents
+
+
+## Section 5: Approvals
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Requester | | | |
+| Document Owner | | | |
+| Quality Assurance | | | |
+
+---
+
+*Form FRM-001 Rev 1.0*

Forms/FRM-003-CAPA-Form.md

@@ -0,0 +1,91 @@
+# Corrective and Preventive Action (CAPA) Form
+
+| Form ID | FRM-003 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: CAPA Identification
+
+| Field | Entry |
+|-------|-------|
+| CAPA Number | |
+| Date Initiated | |
+| Initiated By | |
+| CAPA Owner | |
+| Target Closure Date | |
+
+## Section 2: Classification
+
+### Type
+- [ ] Corrective Action
+- [ ] Preventive Action
+
+### Source
+- [ ] Customer Complaint
+- [ ] Internal Audit
+- [ ] External Audit
+- [ ] Process Deviation
+- [ ] Nonconforming Product
+- [ ] Management Review
+- [ ] Other: ____________
+
+### Priority
+- [ ] Critical (5 business days)
+- [ ] Major (15 business days)
+- [ ] Minor (30 business days)
+
+## Section 3: Problem Description
+
+*(Describe the nonconformity or potential nonconformity)*
+
+
+
+
+## Section 4: Immediate Containment
+
+*(Actions taken to contain the immediate impact)*
+
+
+
+
+## Section 5: Root Cause Investigation
+
+### Investigation Method Used
+- [ ] 5 Whys
+- [ ] Fishbone Diagram
+- [ ] Fault Tree Analysis
+- [ ] Other: ____________
+
+### Root Cause Determination
+
+
+
+
+## Section 6: Corrective/Preventive Actions
+
+| Action | Responsible | Due Date | Status |
+|--------|-------------|----------|--------|
+| | | | |
+| | | | |
+| | | | |
+
+## Section 7: Effectiveness Verification
+
+| Criteria | Method | Result |
+|----------|--------|--------|
+| | | |
+
+Verification Date: ____________
+Verified By: ____________
+
+## Section 8: Closure
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| CAPA Owner | | | |
+| Quality Approval | | | |
+
+---
+
+*Form FRM-003 Rev 1.0*

Forms/FRM-006-Audit-Checklist.md

@@ -0,0 +1,56 @@
+# Internal Audit Checklist
+
+| Form ID | FRM-006 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Audit Information
+
+| Field | Entry |
+|-------|-------|
+| Audit Number | |
+| Audit Date | |
+| Area/Process Audited | |
+| Lead Auditor | |
+| Auditee(s) | |
+
+---
+
+## Checklist Items
+
+| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
+|---|---------------------|-----------|---------|----------------|
+| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
+| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
+| 3 | Are training records current and complete? | SOP-003 | | |
+| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
+| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
+| 6 | Are CAPAs being completed on time? | SOP-002 | | |
+| 7 | Is equipment calibrated and maintained? | | | |
+| 8 | Are process controls being followed? | | | |
+| 9 | Are quality objectives being monitored? | | | |
+| 10 | | | | |
+
+**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
+
+---
+
+## Findings Summary
+
+| Finding # | Type | Description | Clause Reference |
+|-----------|------|-------------|------------------|
+| | | | |
+| | | | |
+
+---
+
+## Auditor Signature
+
+| Auditor | Signature | Date |
+|---------|-----------|------|
+| | | |
+
+---
+
+*Form FRM-006 Rev 1.0*

Forms/Recording-Logs/FRM-EEG-001-Recording-Log.md

@@ -0,0 +1,316 @@
+# EEG Recording Log
+
+| Form ID | FRM-EEG-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Patient Information
+
+| Field | Entry |
+|-------|-------|
+| Patient Name | |
+| MRN | |
+| Date of Birth | |
+| Age | |
+| Sex | ☐ Male ☐ Female |
+| Study Date | |
+| Study Time Start | |
+| Study Time End | |
+| Study Duration | minutes |
+
+---
+
+## Ordering Information
+
+| Field | Entry |
+|-------|-------|
+| Ordering Physician | |
+| Study Type | ☐ Routine EEG ☐ Sleep-Deprived EEG ☐ Ambulatory EEG ☐ Portable/Bedside ☐ Other: _______ |
+| Clinical Indication | |
+| Patient Location | ☐ Outpatient Lab ☐ Inpatient Unit: _______ ☐ ICU ☐ ED ☐ OR |
+
+---
+
+## Clinical History
+
+| Field | Entry |
+|-------|-------|
+| Seizure History | ☐ Yes ☐ No ☐ Unknown |
+| Last Seizure Date | |
+| Seizure Type | ☐ Generalized ☐ Focal ☐ Unknown |
+| Seizure Description | |
+
+### Current Medications (especially AEDs)
+
+| Medication | Dose | Last Taken |
+|------------|------|------------|
+| | | |
+| | | |
+| | | |
+| | | |
+
+### Other Relevant History
+
+| Field | Entry |
+|-------|-------|
+| Brain surgery/lesions | ☐ Yes ☐ No Details: |
+| Recent head injury | ☐ Yes ☐ No |
+| Developmental delay | ☐ Yes ☐ No |
+| Psychiatric history | ☐ Yes ☐ No |
+| Previous EEG | ☐ Yes (Date: _______) ☐ No |
+
+---
+
+## Pre-Recording Checklist
+
+| Item | Completed |
+|------|-----------|
+| Patient identity verified (two identifiers) | ☐ |
+| Order verified | ☐ |
+| Contraindications reviewed | ☐ |
+| Patient/family educated on procedure | ☐ |
+| Hair clean, no products | ☐ Yes ☐ No (document): |
+| Sleep deprivation completed (if ordered) | ☐ Yes ☐ No ☐ N/A |
+| Hours of sleep prior to EEG | hours |
+
+---
+
+## Technical Information
+
+### Equipment
+
+| Field | Entry |
+|-------|-------|
+| EEG System | |
+| Software Version | |
+| Amplifier Serial # | |
+| Electrode Type | ☐ Disc ☐ Cup ☐ Disposable ☐ Cap |
+
+### Electrode Placement
+
+| Field | Entry |
+|-------|-------|
+| Placement System | ☐ International 10-20 ☐ 10-10 ☐ Modified (describe) |
+| Reference Electrode | |
+| Ground Electrode | |
+| Additional Electrodes | |
+
+### Impedance Check
+
+| Electrode | Pre (kΩ) | Post (kΩ) |
+|-----------|----------|-----------|
+| Fp1 | | |
+| Fp2 | | |
+| F7 | | |
+| F3 | | |
+| Fz | | |
+| F4 | | |
+| F8 | | |
+| T3/T7 | | |
+| C3 | | |
+| Cz | | |
+| C4 | | |
+| T4/T8 | | |
+| T5/P7 | | |
+| P3 | | |
+| Pz | | |
+| P4 | | |
+| T6/P8 | | |
+| O1 | | |
+| O2 | | |
+| A1/M1 | | |
+| A2/M2 | | |
+| ECG | | |
+| Other: | | |
+
+**All impedances <5 kΩ?** ☐ Yes ☐ No (document exceptions)
+
+---
+
+## Recording Parameters
+
+| Parameter | Setting |
+|-----------|---------|
+| Sensitivity | µV/mm |
+| Low Frequency Filter | Hz |
+| High Frequency Filter | Hz |
+| Notch Filter | ☐ On (___Hz) ☐ Off |
+| Display Speed | mm/sec |
+| Sampling Rate | Hz |
+
+### Montages Used
+
+☐ Longitudinal bipolar (double banana)
+☐ Transverse bipolar
+☐ Referential (average)
+☐ Referential (ear)
+☐ Other: _______
+
+---
+
+## Activation Procedures
+
+### Hyperventilation
+
+| Field | Entry |
+|-------|-------|
+| Performed? | ☐ Yes ☐ No |
+| If No, reason: | ☐ Medical contraindication ☐ Patient unable ☐ Not ordered |
+| Duration | minutes |
+| Patient effort | ☐ Good ☐ Fair ☐ Poor |
+| Start time | |
+| Stop time | |
+| EEG changes during HV? | ☐ Yes (describe) ☐ No |
+| Clinical symptoms during HV? | ☐ Yes (describe) ☐ No |
+| Build-up present? | ☐ Yes ☐ No |
+| Resolution after HV? | ☐ Normal ☐ Prolonged |
+
+### Photic Stimulation
+
+| Field | Entry |
+|-------|-------|
+| Performed? | ☐ Yes ☐ No |
+| If No, reason: | |
+| Start time | |
+| Stop time | |
+| Lamp distance | cm |
+| Eyes condition | ☐ Closed ☐ Open ☐ Both |
+
+**Frequencies tested and response:**
+
+| Frequency (Hz) | Photic driving? | Photoparoxysmal response? |
+|----------------|-----------------|---------------------------|
+| 1 | ☐ | ☐ |
+| 3 | ☐ | ☐ |
+| 5 | ☐ | ☐ |
+| 7 | ☐ | ☐ |
+| 10 | ☐ | ☐ |
+| 13 | ☐ | ☐ |
+| 15 | ☐ | ☐ |
+| 18 | ☐ | ☐ |
+| 20 | ☐ | ☐ |
+| 25 | ☐ | ☐ |
+| 30 | ☐ | ☐ |
+
+**Photomyoclonic response?** ☐ Yes ☐ No
+
+### Sleep
+
+| Field | Entry |
+|-------|-------|
+| Sleep achieved? | ☐ Yes ☐ No |
+| Sleep stage achieved | ☐ Drowsy ☐ Stage I ☐ Stage II ☐ Deeper |
+| Method | ☐ Natural ☐ Sleep-deprived ☐ Sedation (medication: _______) |
+| Sleep spindles present? | ☐ Yes ☐ No |
+| Vertex waves present? | ☐ Yes ☐ No |
+| K-complexes present? | ☐ Yes ☐ No |
+
+---
+
+## Patient State/Behavior During Recording
+
+| State | Time (approximate) |
+|-------|-------------------|
+| Awake, eyes open | |
+| Awake, eyes closed | |
+| Drowsy | |
+| Asleep | |
+
+### Patient Cooperation
+
+☐ Excellent - fully cooperative
+☐ Good - generally cooperative
+☐ Fair - some difficulty
+☐ Poor - unable to cooperate (describe): _______
+
+---
+
+## Technologist Observations
+
+### Clinical Events During Recording
+
+☐ No clinical events observed
+
+| Time | Event Description | EEG Correlation Noted? |
+|------|------------------|------------------------|
+| | | ☐ Yes ☐ No |
+| | | ☐ Yes ☐ No |
+| | | ☐ Yes ☐ No |
+
+### Artifacts Noted
+
+☐ Muscle/EMG
+☐ Eye movement/blink
+☐ Movement
+☐ Electrode/technical
+☐ 60 Hz/electrical
+☐ ECG
+☐ Respiration
+☐ Sweat
+☐ Other: _______
+
+### Preliminary Observations (not interpretation)
+
+☐ Symmetric background
+☐ Asymmetric background
+☐ Slowing noted
+☐ Sharp waveforms noted
+☐ Seizure activity observed
+☐ Other findings: _______
+
+---
+
+## Technical Quality Assessment
+
+| Criterion | Met? |
+|-----------|------|
+| Adequate duration (≥20 min) | ☐ Yes ☐ No |
+| Acceptable impedances | ☐ Yes ☐ No |
+| Multiple montages recorded | ☐ Yes ☐ No |
+| Activation procedures completed | ☐ Yes ☐ N/A |
+| Sleep recorded (if ordered) | ☐ Yes ☐ N/A |
+| Minimal artifact | ☐ Yes ☐ No |
+| Calibration documented | ☐ Yes ☐ No |
+
+**Overall Technical Quality:** ☐ Excellent ☐ Good ☐ Fair ☐ Poor
+
+---
+
+## Post-Recording
+
+| Field | Entry |
+|-------|-------|
+| Electrodes removed | ☐ Yes |
+| Scalp inspected | ☐ Normal ☐ Irritation noted: |
+| Patient discharged from lab | Time: |
+| Patient condition at discharge | ☐ Baseline ☐ Changed (describe): |
+| Study uploaded to reading system | ☐ Yes |
+| Priority | ☐ Routine ☐ Urgent ☐ STAT |
+
+---
+
+## Technologist Attestation
+
+| Field | Entry |
+|-------|-------|
+| Technologist Name | |
+| Credentials | |
+| Signature | |
+| Date | |
+| Time | |
+
+---
+
+## Physician Review (if immediate review)
+
+| Field | Entry |
+|-------|-------|
+| Reviewed By | |
+| Date/Time | |
+| Preliminary Impression | |
+| Signature | |
+
+---
+
+*Form FRM-EEG-001 Rev 1.0 - EEG Recording Log*

Forms/Training/FRM-004-Training-Record.md

@@ -0,0 +1,72 @@
+# Training Record Form
+
+| Form ID | FRM-004 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Employee Information
+
+| Field | Entry |
+|-------|-------|
+| Employee Name | |
+| Employee ID | |
+| Department | |
+| Job Title | |
+
+## Section 2: Training Information
+
+| Field | Entry |
+|-------|-------|
+| Training Title | |
+| Training Date | |
+| Training Duration | |
+| Trainer Name | |
+| Trainer Qualification | |
+
+### Training Type
+- [ ] Initial Training
+- [ ] Retraining
+- [ ] Refresher
+- [ ] Procedure Update
+
+### Delivery Method
+- [ ] Classroom
+- [ ] On-the-Job
+- [ ] Self-Study
+- [ ] Computer-Based
+- [ ] Other: ____________
+
+## Section 3: Training Content
+
+*(List topics covered or attach training materials)*
+
+
+
+
+## Section 4: Assessment
+
+### Assessment Method
+- [ ] Written Test
+- [ ] Practical Demonstration
+- [ ] Verbal Assessment
+- [ ] Observation
+
+### Assessment Results
+
+| Metric | Result |
+|--------|--------|
+| Score (if applicable) | |
+| Pass/Fail | |
+
+## Section 5: Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Trainee | | | |
+| Trainer | | | |
+| Supervisor | | | |
+
+---
+
+*Form FRM-004 Rev 1.0*