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# Standard Operating Procedure: Document Control
| Document ID | SOP-001 |
|-------------|---------|
| Title | Document Control |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
## 2. Scope
This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Specifications
- External documents of external origin
## 3. Responsibilities
### 3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
## 4. Procedure
### 4.1 Document Creation
1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Submit for review and approval
### 4.2 Document Review and Approval
1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Final approval by designated approver
5. Quality Assurance releases document
### 4.3 Document Numbering
Documents shall be numbered according to the following convention:
| Type | Prefix | Example |
|------|--------|---------|
| Policy | POL | POL-001 |
| SOP | SOP | SOP-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
### 4.4 Revision Control
1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer
### 4.5 Document Distribution
1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed
### 4.6 Periodic Review
1. Documents reviewed at least every 2 years
2. Review documented even if no changes made
3. Reviews may result in revision or reaffirmation
## 5. Related Documents
- FRM-001 Document Change Request Form
- FRM-002 Document Review Record
## 6. Definitions
| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
| Document ID | SOP-002 |
|-------------|---------|
| Title | Corrective and Preventive Action |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
## 2. Scope
This procedure applies to:
- Product and process nonconformities
- Customer complaints
- Audit findings
- Process deviations
- Potential nonconformities identified through risk analysis
## 3. Definitions
| Term | Definition |
|------|------------|
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
| Root Cause | Fundamental reason for a nonconformity |
| Effectiveness Check | Verification that implemented actions achieved desired results |
## 4. Responsibilities
### 4.1 CAPA Owner
- Investigates the issue
- Identifies root cause
- Develops and implements corrective/preventive actions
- Verifies effectiveness
### 4.2 Quality Assurance
- Manages CAPA system
- Assigns CAPA numbers
- Tracks CAPA status
- Reviews and approves CAPAs
- Reports CAPA metrics to management
### 4.3 Management
- Provides resources for CAPA implementation
- Reviews CAPA trends
- Ensures timely closure
## 5. Procedure
### 5.1 CAPA Initiation
1. Identify nonconformity or potential nonconformity
2. Document issue on CAPA Form (FRM-003)
3. Classify severity and priority
4. Assign CAPA owner
### 5.2 Investigation
1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Use appropriate investigation tools:
- 5 Whys
- Fishbone Diagram
- Failure Mode Analysis
### 5.3 Root Cause Analysis
1. Identify potential root causes
2. Verify root cause through evidence
3. Document root cause determination
4. Consider systemic implications
### 5.4 Action Development
1. Develop corrective/preventive actions
2. Assign responsibilities and due dates
3. Assess actions for:
- Appropriateness to problem severity
- Impact on other processes
- Resource requirements
### 5.5 Implementation
1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide training as needed
### 5.6 Effectiveness Verification
1. Define effectiveness criteria
2. Allow sufficient time for actions to take effect
3. Collect and analyze data
4. Document verification results
5. If ineffective, reopen CAPA for further action
### 5.7 Closure
1. Review all CAPA documentation
2. Verify all actions completed
3. Confirm effectiveness verified
4. Obtain approval for closure
## 6. CAPA Metrics
Quality Assurance shall track and report:
- Number of open CAPAs
- CAPA aging
- On-time closure rate
- Effectiveness rate
- CAPAs by category/source
## 7. Related Documents
- FRM-003 CAPA Form
- SOP-003 Nonconforming Product Control
- SOP-004 Customer Complaints
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Training and Competence
| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |
---
## 1. Purpose
To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
## 2. Scope
This procedure applies to:
- All employees performing quality-affecting activities
- Contractors and temporary personnel
- Personnel requiring GxP training
## 3. Responsibilities
### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure training is completed before performing tasks
- Evaluate competence of personnel
- Maintain department training records
### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Archive training records
### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for GxP activities
- Audit training compliance
### 3.4 Employees
- Complete assigned training on time
- Maintain current qualifications
- Report training needs to supervisor
## 4. Procedure
### 4.1 Training Needs Assessment
1. Identify competence requirements for each role
2. Document requirements in job descriptions
3. Assess current competence of personnel
4. Identify training gaps
### 4.2 Training Curriculum Development
1. Define learning objectives
2. Develop training materials
3. Identify delivery method:
- Classroom
- On-the-job
- Self-study
- Computer-based
4. Define assessment criteria
5. Obtain approval from Quality (for GxP training)
### 4.3 Training Delivery
1. Schedule training session
2. Document attendance
3. Deliver training per curriculum
4. Assess comprehension through:
- Written test (minimum 80% passing)
- Practical demonstration
- Supervisor observation
### 4.4 Training Documentation
Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results
- Signatures
### 4.5 Retraining Requirements
Retraining is required when:
- Significant document revisions occur
- Performance deficiencies identified
- Extended absence from job function
- Periodic requalification due
### 4.6 New Employee Orientation
All new employees shall complete:
1. Company orientation
2. Quality system overview
3. Job-specific training
4. SOP read and understand for applicable procedures
## 5. Training Records Retention
- Training records maintained for duration of employment
- Records retained 3 years after employee departure
- Records available for regulatory inspection
## 6. Related Documents
- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- Job Descriptions
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Internal Audit
| Document ID | SOP-004 |
|-------------|---------|
| Title | Internal Audit |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
## 2. Scope
This procedure covers:
- QMS process audits
- Compliance audits
- Product audits
- System audits
## 3. Definitions
| Term | Definition |
|------|------------|
| Audit | Systematic, independent examination to determine conformance |
| Auditor | Person qualified to perform audits |
| Finding | Observation of conformance or nonconformance |
| Observation | Noted item not rising to level of finding |
## 4. Responsibilities
### 4.1 Lead Auditor
- Plans and schedules audits
- Prepares audit checklists
- Conducts audit activities
- Reports audit findings
### 4.2 Quality Manager
- Maintains audit program
- Qualifies auditors
- Reviews audit reports
- Reports to management
### 4.3 Auditee
- Provides access to areas/records
- Responds to findings
- Implements corrective actions
## 5. Procedure
### 5.1 Annual Audit Schedule
1. Develop annual audit schedule considering:
- Previous audit results
- Process criticality
- Regulatory requirements
- Changes to processes
2. Ensure all QMS processes audited at least annually
3. Obtain management approval
4. Communicate schedule to affected areas
### 5.2 Auditor Qualification
Auditors shall:
- Complete auditor training course
- Conduct at least 2 audits under supervision
- Be independent of area being audited
- Maintain competence through ongoing audits
### 5.3 Audit Preparation
1. Review applicable procedures and standards
2. Review previous audit reports
3. Prepare audit checklist
4. Notify auditee of audit scope and schedule
5. Confirm auditor availability
### 5.4 Conducting the Audit
1. Hold opening meeting with auditee
2. Execute audit checklist
3. Gather objective evidence:
- Document review
- Personnel interviews
- Process observation
4. Document findings with evidence
5. Classify findings:
- Major Nonconformance
- Minor Nonconformance
- Observation
6. Hold closing meeting
### 5.5 Audit Reporting
1. Complete audit report within 5 business days
2. Report shall include:
- Audit scope and criteria
- Personnel interviewed
- Findings with evidence
- Recommendations
3. Distribute report to auditee and management
### 5.6 Finding Resolution
1. Auditee responds with corrective action plan within 10 business days
2. Quality reviews and approves plan
3. Auditee implements corrective actions
4. Auditor verifies effectiveness
5. Close finding upon verification
## 6. Audit Records
Maintain for 5 years:
- Audit schedules
- Checklists
- Reports
- Corrective action records
## 7. Related Documents
- FRM-006 Audit Checklist Template
- FRM-007 Audit Report Template
- SOP-002 CAPA
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Management Review
| Document ID | SOP-005 |
|-------------|---------|
| Title | Management Review |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
## 2. Scope
This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
## 3. Frequency
Management reviews shall be conducted:
- At least annually
- More frequently if significant changes occur
- As needed based on quality performance
## 4. Responsibilities
### 4.1 Quality Manager
- Prepares management review agenda and materials
- Facilitates the meeting
- Documents meeting minutes and action items
- Tracks completion of action items
### 4.2 Top Management
- Attends management review meetings
- Reviews QMS performance data
- Makes decisions on QMS improvements
- Allocates resources as needed
### 4.3 Department Managers
- Provides input data for their areas
- Attends management review
- Implements assigned action items
## 5. Management Review Inputs
The following shall be considered:
### 5.1 Actions from Previous Reviews
- Status of action items
- Effectiveness of implemented actions
### 5.2 Changes in Context
- Internal changes (organization, resources)
- External changes (regulations, market)
### 5.3 QMS Performance
- Customer satisfaction and feedback
- Quality objectives achievement
- Process performance metrics
- Nonconformities and corrective actions
- Audit results
- Supplier performance
### 5.4 Resource Adequacy
- Personnel
- Infrastructure
- Work environment
### 5.5 Risk and Opportunities
- Risk assessment results
- Effectiveness of risk controls
- New opportunities identified
### 5.6 Improvement Opportunities
- Process improvements
- Product improvements
- QMS enhancements
## 6. Management Review Outputs
Decisions and actions related to:
- Improvement of QMS and processes
- Product improvement
- Resource needs
- Changes to quality policy or objectives
## 7. Documentation
### 7.1 Meeting Minutes
- Date and attendees
- Items discussed
- Decisions made
- Action items with owners and due dates
### 7.2 Record Retention
- Management review records retained for 5 years
- Available for regulatory inspection
## 8. Related Documents
- FRM-008 Management Review Agenda Template
- FRM-009 Management Review Minutes Template
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Routine EEG Recording
| Document ID | SOP-EEG-001 |
|-------------|-------------|
| Title | Routine Electroencephalography (EEG) Recording |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Neurophysiology/EEG Laboratory |
---
## 1. Purpose
To establish standardized procedures for recording routine electroencephalograms (EEG) in accordance with American Clinical Neurophysiology Society (ACNS) guidelines to ensure high-quality recordings for accurate interpretation.
## 2. Scope
This procedure applies to routine EEG recordings including:
- Routine awake EEG
- Routine EEG with sleep
- Activation procedures (hyperventilation, photic stimulation)
- Portable/bedside EEG
- Ambulatory EEG
## 3. Responsibilities
### 3.1 EEG Technologist
- Prepare patient for recording
- Apply electrodes according to 10-20 system
- Perform recording per protocol
- Monitor recording quality
- Perform activation procedures
- Document relevant observations
### 3.2 Electroneurodiagnostic Technologist (R.EEG.T or CNIM)
- Supervise EEG recordings
- Perform complex studies
- Train and mentor technologists
- Ensure quality standards
### 3.3 Interpreting Physician (Neurologist/Epileptologist)
- Review and interpret recordings
- Provide clinical correlation
- Generate diagnostic report
- Recommend follow-up studies
## 4. Definitions
| Term | Definition |
|------|------------|
| 10-20 System | International electrode placement system |
| Montage | Arrangement of electrode channels for display |
| Impedance | Resistance between electrode and scalp |
| Sensitivity | Amplitude of EEG display (µV/mm) |
| Activation | Procedures to provoke abnormalities (HV, photic) |
## 5. Equipment and Materials
- Digital EEG recording system
- Electrodes (disc, cup, or disposable)
- Electrode paste/gel (conductive)
- Skin preparation materials (abrasive gel/paste)
- Measuring tape
- Electrode placement cap or headbox
- Impedance meter
- Photic stimulator
- Video recording system
- Calibration equipment
## 6. Procedure
### 6.1 Patient Preparation
#### 6.1.1 Pre-Procedure Verification
1. Confirm patient identity (two identifiers)
2. Verify physician order and indication
3. Review relevant history:
- Seizure history
- Current medications (especially AEDs)
- Sleep deprivation (if ordered)
- Recent seizure activity
4. Patient Instructions Verified:
- [ ] Hair clean, dry, no styling products
- [ ] Sleep deprivation completed (if ordered)
- [ ] Medications taken as instructed
- [ ] No caffeine morning of test (if applicable)
#### 6.1.2 Patient Education
- Explain procedure and duration
- Describe electrode application process
- Explain activation procedures
- Discuss what to expect during recording
### 6.2 Electrode Application
#### 6.2.1 Measurement and Marking
**10-20 System Measurements:**
1. Measure nasion to inion (anterior-posterior)
2. Mark Fpz at 10% from nasion
3. Mark Fz at 30%, Cz at 50%, Pz at 70%
4. Mark Oz at 10% from inion
5. Measure preauricular points (transverse)
6. Mark T3/T4 at 10% from preauricular
7. Mark C3/C4 at 30%
8. Mark Cz at 50% (should match A-P)
9. Measure head circumference
10. Mark remaining positions per 10-20 system
#### 6.2.2 Standard Electrode Positions
| Position | Location | Hemisphere |
|----------|----------|------------|
| Fp1, Fp2 | Frontopolar | Left, Right |
| F3, F4 | Frontal | Left, Right |
| C3, C4 | Central | Left, Right |
| P3, P4 | Parietal | Left, Right |
| O1, O2 | Occipital | Left, Right |
| F7, F8 | Anterior Temporal | Left, Right |
| T3, T4 | Mid-Temporal | Left, Right |
| T5, T6 | Posterior Temporal | Left, Right |
| Fz | Frontal | Midline |
| Cz | Central | Midline |
| Pz | Parietal | Midline |
| A1, A2 | Ear/Mastoid | Reference |
#### 6.2.3 Electrode Application Process
1. Part hair at electrode site
2. Clean scalp with abrasive gel
3. Apply conductive paste to electrode
4. Affix electrode to scalp
5. Secure with tape, collodion, or cap
6. Repeat for all electrodes
#### 6.2.4 Impedance Check
- Check impedance for all electrodes
- Target: <5 kΩ
- Maximum acceptable: <10 kΩ
- Document impedance values
- Reapply electrodes if impedance excessive
### 6.3 Recording Setup
#### 6.3.1 System Configuration
| Parameter | Standard Setting |
|-----------|-----------------|
| Sensitivity | 7 µV/mm |
| Low frequency filter | 1 Hz |
| High frequency filter | 70 Hz |
| Notch filter | 60 Hz (if needed) |
| Time constant | 0.16 seconds |
| Paper speed/display | 30 mm/sec |
#### 6.3.2 Standard Montages
**Longitudinal Bipolar (Double Banana):**
- Fp1-F7, F7-T3, T3-T5, T5-O1
- Fp1-F3, F3-C3, C3-P3, P3-O1
- Fz-Cz, Cz-Pz
- Fp2-F4, F4-C4, C4-P4, P4-O2
- Fp2-F8, F8-T4, T4-T6, T6-O2
**Transverse Bipolar:**
- F7-Fp1, Fp1-Fp2, Fp2-F8
- T3-C3, C3-Cz, Cz-C4, C4-T4
- T5-P3, P3-Pz, Pz-P4, P4-T6
**Referential:**
- All electrodes referenced to average or specific electrode
#### 6.3.3 Calibration
1. Perform square wave calibration
2. Document calibration signal
3. Verify all channels responding appropriately
### 6.4 Recording Procedure
#### 6.4.1 Recording Timeline
| Phase | Duration | Activity |
|-------|----------|----------|
| Initial | 5-10 min | Eyes closed, relaxed wakefulness |
| Eyes open/closed | 2-3 cycles | Assess reactivity |
| Hyperventilation | 3-5 min | Deep breathing |
| Post-HV | 2-3 min | Recovery period |
| Photic stimulation | 5-10 min | Flashing lights |
| Drowsiness/Sleep | As able | Natural or sleep-deprived |
| Total Recording | 20-40 min | Minimum per ACNS |
#### 6.4.2 Routine Recording Protocol
1. **Resting Recording**
- Eyes closed, relaxed
- Minimize movement
- Record representative sample
2. **Eyes Open/Closed**
- Command to open eyes (10 seconds)
- Command to close eyes
- Document alpha reactivity
- Repeat 2-3 times
3. **Hyperventilation (if not contraindicated)**
**Contraindications:**
- Recent stroke
- Significant cardiovascular disease
- Respiratory compromise
- Sickle cell disease
- Pregnancy
- Intracranial hemorrhage
**Procedure:**
- Explain deep, rapid breathing
- Patient breathes deeply for 3-5 minutes
- Document effort level
- Continue recording 2-3 minutes post-HV
- Document any symptoms or findings
4. **Photic Stimulation**
**Standard Frequencies:**
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 20, 25, 30 Hz
**Procedure:**
- Position photic stimulator 30 cm from face
- Eyes closed
- 10 seconds at each frequency
- 10 second pause between frequencies
- Document any clinical responses
- Stop if clinical seizure occurs
5. **Sleep Recording (if ordered)**
- Encourage natural drowsiness
- Record drowsiness transition
- Record sleep if achieved
- Document sleep stages observed
### 6.5 Documentation During Recording
Technologist must annotate:
- [ ] Patient state (awake, drowsy, asleep)
- [ ] Eye movements and blinks
- [ ] Movement artifacts and cause
- [ ] Patient activities (talking, coughing)
- [ ] Clinical events observed
- [ ] Activation procedures (start/stop times)
- [ ] Any technical problems
### 6.6 Recording Quality Checks
Throughout recording, monitor for:
| Issue | Action |
|-------|--------|
| Electrode pop/artifact | Check connection, reapply if needed |
| Movement artifact | Reposition patient, note cause |
| Sweat artifact | Cool patient, apply antiperspirant |
| Muscle artifact | Relax jaw/neck, adjust position |
| 60 Hz interference | Check grounds, move cables |
### 6.7 Post-Recording
1. **Electrode Removal**
- Remove electrodes carefully
- Clean paste from scalp
- Inspect scalp for irritation
- Provide patient aftercare instructions
2. **Equipment Care**
- Clean reusable electrodes
- Disinfect equipment per protocol
- Store equipment properly
3. **Documentation**
Complete FRM-EEG-001 including:
- Recording duration
- Montages used
- Activation procedures performed
- Patient cooperation level
- Technical quality assessment
- Technologist observations
## 7. Special Considerations
### 7.1 Pediatric Patients
- May require sedation (per physician order)
- Age-appropriate electrode sizes
- Modified activation procedures
- Parent/guardian present as appropriate
### 7.2 ICU/Portable EEG
- Increased artifact sources
- Document artifact causes
- Extended recording times may be needed
- Coordinate with bedside care
## 8. Quality Control
| Metric | Target |
|--------|--------|
| Electrode impedance <5 kΩ | >90% of electrodes |
| Recording duration meets minimum | 100% |
| Activation procedures completed | 100% (unless contraindicated) |
| Technical quality adequate for interpretation | >95% |
## 9. References
- ACNS Guideline 1: Minimum Technical Requirements for Performing Clinical EEG
- ACNS Guideline 6: Recording EEG
- ASET Standards of Practice
- ABRET Certification Requirements
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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