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name: AtomicAI Radiology Assistant
on:
issue_comment:
types: [created]
issues:
types: [opened, assigned]
pull_request:
types: [opened, synchronize, assigned]
pull_request_review_comment:
types: [created]
jobs:
claude-assistant:
runs-on: ubuntu-latest
if: |
github.actor != 'atomicqms-service' &&
(
(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
)
permissions:
contents: write
issues: write
pull-requests: write
steps:
- uses: actions/checkout@v4
with:
fetch-depth: 0
- name: Run AtomicAI Radiology Assistant
uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
with:
trigger_phrase: '@atomicai'
assignee_trigger: 'atomicai'
claude_git_name: 'AtomicAI'
claude_git_email: 'atomicai@atomicqms.local'
custom_instructions: |
You are AtomicAI, an AI assistant specialized in Radiology and Medical Imaging Quality Management.
## Your Expertise
- ACR (American College of Radiology) accreditation
- Radiation safety and ALARA principles
- Mammography Quality Standards Act (MQSA)
- CT, MRI, Ultrasound, Nuclear Medicine protocols
- Image quality assurance and phantom testing
- PACS administration and DICOM standards
- Radiologist workflow optimization
- Contrast media safety protocols
- Pediatric imaging dose optimization
- Equipment quality control and calibration
- Critical results communication (ACR guidelines)
- Radiation dose monitoring and reporting
## Document Creation Guidelines
- Place Imaging SOPs in SOPs/Imaging/
- Place Safety SOPs in SOPs/Radiation-Safety/
- Place QC Protocols in Protocols/Quality-Control/
- Place Equipment Forms in Forms/Equipment/
- Place Patient Forms in Forms/Patient/
- Place Policies in Policies/
## Numbering Convention
- SOP-RAD-XXX for Radiology SOPs
- SOP-RSF-XXX for Radiation Safety SOPs
- SOP-QC-XXX for Quality Control SOPs
- PRO-XXX for Protocols
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize radiation safety, image quality, and patient care.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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# 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*

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# 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*

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# 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*

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# CT Procedure Log
| Form ID | FRM-RAD-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Age | |
| Sex | ☐ Male ☐ Female |
| Weight | kg / lbs |
| Height | cm / in |
---
## Exam Information
| Field | Entry |
|-------|-------|
| Date of Exam | |
| Time Start | |
| Time End | |
| Ordering Physician | |
| Exam Type | |
| Accession Number | |
| Scanner ID | |
---
## Clinical Information
| Field | Entry |
|-------|-------|
| Indication | |
| Relevant History | |
| Prior CT exams? | ☐ Yes (Date: _______) ☐ No |
---
## Pre-Procedure Screening
### General Safety
| Question | Response |
|----------|----------|
| Patient identity verified (2 identifiers)? | ☐ Yes |
| Order verified? | ☐ Yes |
| Procedure explained to patient? | ☐ Yes |
| Pregnancy status (if applicable) | ☐ Not pregnant ☐ Pregnant ☐ Unknown ☐ N/A |
| Metallic implants in scan area? | ☐ Yes (describe: _______) ☐ No |
### Contrast Screening (if contrast study)
| Question | Response |
|----------|----------|
| Contrast study? | ☐ Yes ☐ No → Skip to Technical Parameters |
| Previous contrast reaction? | ☐ Yes (describe: _______) ☐ No |
| Premedication given? | ☐ Yes ☐ No ☐ N/A |
| Allergies? | ☐ Yes (list: _______) ☐ NKDA |
| Kidney disease? | ☐ Yes ☐ No |
| Diabetes? | ☐ Yes ☐ No |
| Metformin use? | ☐ Yes ☐ No |
| eGFR/Creatinine | Value: _______ Date: _______ |
| Adequate renal function? | ☐ Yes ☐ No (radiologist notified) |
### Consent
| Field | Entry |
|-------|-------|
| Consent obtained? | ☐ Yes ☐ Waived (emergency) |
| Consent signed by | |
| Witnessed by | |
---
## IV Access (for contrast studies)
| Field | Entry |
|-------|-------|
| IV Access | ☐ Existing ☐ New |
| Gauge | ☐ 18G ☐ 20G ☐ 22G ☐ Other: |
| Location | ☐ Right AC ☐ Left AC ☐ Right Hand ☐ Left Hand ☐ Other: |
| Patency verified | ☐ Yes |
| Inserted by | |
---
## Technical Parameters
### Protocol Used
| Field | Entry |
|-------|-------|
| Protocol Name | |
| Body Region | ☐ Head ☐ Neck ☐ Chest ☐ Abdomen ☐ Pelvis ☐ Spine ☐ Extremity ☐ Other |
| kVp | |
| mAs (or reference) | |
| Slice Thickness | mm |
| Pitch | |
| Gantry Rotation Time | sec |
| Scan Mode | ☐ Axial ☐ Helical |
| Coverage | |
### Multi-Phase Studies
| Phase | Delay (sec) | Acquired? |
|-------|-------------|-----------|
| Non-contrast | - | ☐ |
| Arterial | | ☐ |
| Portal Venous | | ☐ |
| Delayed | | ☐ |
| Other: | | ☐ |
---
## Contrast Administration
| Field | Entry |
|-------|-------|
| Contrast Agent | |
| Manufacturer | |
| Lot Number | |
| Expiration Date | |
| Concentration | mgI/mL |
| Volume Administered | mL |
| Injection Rate | mL/sec |
| Injection Method | ☐ Power Injector ☐ Hand Injection |
| Saline Flush | ☐ Yes Volume: ___mL ☐ No |
| Warming Used? | ☐ Yes ☐ No |
### Contrast Timing
| Field | Entry |
|-------|-------|
| Timing Method | ☐ Fixed Delay ☐ Bolus Tracking ☐ Test Bolus |
| Trigger Location (if tracking) | |
| Threshold (HU) | |
| Delay after trigger | sec |
---
## Dose Information
| Metric | Value |
|--------|-------|
| CTDIvol | mGy |
| DLP | mGy·cm |
| Scan Length | cm |
| Number of Series | |
**Dose within reference level?** ☐ Yes ☐ No (explain: _______)
---
## Image Quality Assessment
| Criterion | Satisfactory? |
|-----------|---------------|
| Positioning correct | ☐ Yes ☐ No |
| Coverage adequate | ☐ Yes ☐ No |
| No significant motion artifact | ☐ Yes ☐ No |
| Contrast enhancement adequate (if applicable) | ☐ Yes ☐ No ☐ N/A |
| Noise level acceptable | ☐ Yes ☐ No |
**Overall Technical Quality:** ☐ Diagnostic ☐ Limited ☐ Non-diagnostic
**If limited/non-diagnostic, explain:**
**Repeat acquisition required?** ☐ Yes ☐ No
---
## Patient Monitoring (Contrast Studies)
### During Injection
| Time | BP | HR | SpO2 | Symptoms |
|------|----|----|------|----------|
| Pre-injection | | | | |
| Post-injection | | | | |
### Post-Procedure Observation
| Field | Entry |
|-------|-------|
| Observation time | minutes |
| Any adverse reactions? | ☐ Yes (complete Reaction section) ☐ No |
| IV site condition at removal | ☐ Normal ☐ Swelling ☐ Erythema ☐ Extravasation |
---
## Adverse Reaction (if occurred)
| Field | Entry |
|-------|-------|
| Time of onset | |
| Type of reaction | ☐ Mild ☐ Moderate ☐ Severe |
| Symptoms | |
| Treatment given | |
| Outcome | ☐ Resolved ☐ Transferred for care |
| Radiologist notified | ☐ Yes Time: |
| Adverse Event Report filed | ☐ Yes Report #: |
---
## Extravasation (if occurred)
| Field | Entry |
|-------|-------|
| Estimated volume extravasated | mL |
| Location | |
| Symptoms | ☐ Pain ☐ Swelling ☐ Erythema ☐ Blistering |
| Treatment | ☐ Elevation ☐ Ice ☐ Warm compress ☐ Other |
| Follow-up instructions given | ☐ Yes |
| Incident report filed | ☐ Yes |
---
## Post-Procedure
| Field | Entry |
|-------|-------|
| Patient condition at discharge | ☐ Stable ☐ Other: |
| Instructions provided | ☐ Hydration ☐ Metformin hold ☐ Reaction warning signs ☐ Other |
| Images sent to PACS | ☐ Yes |
| Priority | ☐ Routine ☐ Urgent ☐ STAT |
---
## Special Circumstances/Notes
---
## Technologist Attestation
| Field | Entry |
|-------|-------|
| Technologist Name | |
| RT(R)(CT) # | |
| Signature | |
| Date | |
| Time | |
---
## Radiologist Review (if applicable at time of exam)
| Field | Entry |
|-------|-------|
| Radiologist Name | |
| Preliminary Findings | |
| Signature | |
---
*Form FRM-RAD-001 Rev 1.0 - CT Procedure Log*

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# 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*

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# Quality Policy
| Document ID | POL-001 |
|-------------|---------|
| Title | Quality Policy |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
---
## 1. Policy Statement
[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction.
## 2. Quality Objectives
Our organization commits to:
1. **Customer Focus**: Understanding and meeting customer needs and expectations
2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards
3. **Continuous Improvement**: Continually improving the effectiveness of our QMS
4. **Employee Engagement**: Ensuring all employees understand their role in quality
5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities
## 3. Management Commitment
Top management demonstrates commitment to the QMS by:
- Ensuring the quality policy is appropriate to the organization's purpose
- Ensuring quality objectives are established and compatible with strategic direction
- Ensuring integration of QMS requirements into business processes
- Promoting the use of the process approach and risk-based thinking
- Ensuring resources needed for the QMS are available
- Communicating the importance of effective quality management
- Ensuring the QMS achieves its intended results
- Engaging, directing, and supporting persons to contribute to QMS effectiveness
## 4. Scope
This policy applies to all employees, contractors, and processes within the scope of our Quality Management System.
## 5. Communication
This policy shall be:
- Communicated and understood within the organization
- Available to relevant interested parties as appropriate
- Reviewed for continuing suitability
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# radiology # Radiology & Medical Imaging Quality Management System
A comprehensive QMS template designed for radiology departments, imaging centers, and diagnostic imaging services. A comprehensive QMS template designed for radiology departments, imaging centers, and diagnostic imaging services.
## 🩻 Designed For
- **Hospital Radiology Departments** - Full-service diagnostic imaging
- **Outpatient Imaging Centers** - Freestanding radiology facilities
- **Interventional Radiology** - Image-guided procedures
- **Breast Imaging Centers** - Mammography and breast MRI
- **Nuclear Medicine** - PET, SPECT, and nuclear imaging
- **Radiation Oncology** - Therapeutic radiology services
- **Teleradiology Services** - Remote interpretation services
## 📋 Regulatory Framework
This template supports compliance with:
- **ACR** - American College of Radiology accreditation
- **The Joint Commission** - Hospital accreditation (diagnostic imaging)
- **FDA** - Medical device regulations, MQSA (mammography)
- **CMS** - Medicare imaging requirements
- **State Radiation Control** - State licensing and inspection
- **NRC** - Nuclear Regulatory Commission (if radioactive materials)
- **HIPAA** - Patient privacy and image security
- **OSHA** - Radiation worker safety
- **AAPM** - Medical physics standards
- **ACR Appropriateness Criteria** - Clinical decision support
## Repository Structure
```
├── SOPs/
│ ├── General-Radiography/ # X-ray, fluoroscopy, portable imaging
│ ├── CT-Imaging/ # CT protocols, contrast administration
│ ├── MRI-Operations/ # MRI safety, protocols, contrast
│ ├── Ultrasound/ # US protocols, transducer care
│ ├── Nuclear-Medicine/ # Radiopharmaceutical handling, imaging
│ ├── Equipment/ # QC, maintenance, calibration
│ └── General/ # Document control, training, CAPA
├── Forms/
│ ├── Patient-Screening/ # MRI safety, contrast allergy, pregnancy
│ ├── Protocol-Sheets/ # Imaging protocol documentation
│ ├── QC-Records/ # Daily QC, equipment logs
│ ├── Contrast-Records/ # Contrast administration, reactions
│ ├── Dose-Logs/ # Radiation dose tracking
│ └── Training/ # Competency assessments
├── Policies/ # Department policies
├── Work-Instructions/ # Step-by-step procedures
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-RAD-XXX**: General Radiography SOPs
- **SOP-CT-XXX**: CT Imaging SOPs
- **SOP-MRI-XXX**: MRI Operations SOPs
- **SOP-US-XXX**: Ultrasound SOPs
- **SOP-NM-XXX**: Nuclear Medicine SOPs
- **SOP-EQ-XXX**: Equipment SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## 🤖 AI-Powered Assistance
This repository includes **AtomicAI**, your radiology QMS assistant. Mention `@atomicai` in any issue or pull request to:
- Draft imaging protocol SOPs
- Create patient screening and safety procedures
- Generate equipment QC protocols
- Develop contrast administration procedures
- Create radiation dose tracking systems
- Review documents for ACR compliance
### Example Prompts
- "@atomicai create an SOP for MRI patient screening and safety"
- "@atomicai draft a CT contrast administration and reaction protocol"
- "@atomicai write a mammography quality control procedure per MQSA"
- "@atomicai create an equipment QC log for digital radiography"
- "@atomicai develop a radiation dose optimization protocol"
- "@atomicai create a portable X-ray infection control procedure"
## Getting Started
1. **Establish Safety Programs** - Implement MRI, radiation, and contrast safety
2. **Define Imaging Protocols** - Standardize protocols by exam type
3. **Set Up Equipment QC** - Daily, weekly, and monthly QC schedules
4. **Implement Dose Monitoring** - Track and optimize radiation dose
5. **Train Technologists** - Use competency assessment forms
## Key Documents to Create First
1. **MRI Safety Screening SOP** - Patient and personnel safety
2. **CT Contrast Administration SOP** - IV contrast protocols and reactions
3. **Equipment QC Procedures** - Daily QC for each modality
4. **Radiation Dose Tracking Policy** - DRL monitoring and optimization
5. **Mammography QC Program** - MQSA-required procedures
6. **Image Quality Review SOP** - Technologist quality feedback
7. **Critical Results Communication** - Urgent finding notification
## Special Considerations for Radiology
### Patient Safety
- MRI screening (implants, devices, pregnancy)
- Contrast allergy and reaction management
- Radiation dose optimization (ALARA)
- Pregnancy screening and shielding
- Pediatric dose reduction
### Equipment Quality Control
- Daily QC phantoms and tests
- Annual physics surveys
- Preventive maintenance schedules
- Calibration verification
- Service documentation
### Imaging Protocols
- Standardized protocol libraries
- Indication-based protocol selection
- Dose optimization techniques
- Image quality standards
- Protocol deviation documentation
### Regulatory Compliance
- ACR accreditation maintenance
- MQSA requirements (mammography)
- State radiation inspection preparation
- Credentialing and privileging
- Peer review programs
---
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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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: CT Imaging Protocol
| Document ID | SOP-RAD-001 |
|-------------|-------------|
| Title | Computed Tomography (CT) Imaging Protocol |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Radiology/Diagnostic Imaging |
---
## 1. Purpose
To establish standardized procedures for performing computed tomography (CT) examinations to ensure patient safety, optimal image quality, and regulatory compliance with ACR, state, and federal requirements.
## 2. Scope
This procedure applies to all CT examinations including:
- Non-contrast CT studies
- Contrast-enhanced CT studies
- CT angiography (CTA)
- CT-guided procedures
- Emergency/trauma CT
## 3. Responsibilities
### 3.1 CT Technologist
- Screen patients for contraindications
- Position patient properly
- Select and execute protocols
- Assess image quality
- Monitor patient during examination
### 3.2 Radiologist
- Approve protocols
- Supervise contrast administration
- Interpret studies and generate reports
- Manage contrast reactions
### 3.3 Radiology Nurse (if applicable)
- Assess IV access
- Administer contrast
- Monitor for reactions
- Provide patient care
### 3.4 Medical Physicist
- Establish dose optimization protocols
- Perform quality control
- Monitor radiation exposure
## 4. Definitions
| Term | Definition |
|------|------------|
| CTDI | CT Dose Index - measure of radiation output |
| DLP | Dose Length Product - total dose metric |
| HU | Hounsfield Units - density measurement |
| kVp | Kilovoltage peak |
| mAs | Milliampere-seconds |
| MPR | Multiplanar reconstruction |
## 5. Equipment and Materials
- CT scanner (accredited)
- Power injector
- Contrast media (iodinated)
- IV supplies
- Emergency equipment and medications
- Shielding devices
- Patient monitoring equipment
## 6. Procedure
### 6.1 Pre-Examination
#### 6.1.1 Order Verification
- [ ] Valid physician order present
- [ ] Appropriate indication documented
- [ ] Protocol selection appropriate for indication
- [ ] Prior imaging reviewed (if available)
#### 6.1.2 Patient Identification
- Verify using two identifiers
- Confirm exam matches order
- Review clinical history
#### 6.1.3 Safety Screening
**For all patients:**
- [ ] Pregnancy status (women of childbearing age)
- [ ] Previous CT studies (cumulative dose awareness)
- [ ] Ability to cooperate with positioning
- [ ] Metal implants/devices in scan field
**For contrast studies - additional screening:**
| Risk Factor | Check |
|-------------|-------|
| Previous contrast reaction | ☐ Yes ☐ No |
| Allergies (iodine, shellfish) | ☐ Yes ☐ No |
| Kidney disease/elevated creatinine | ☐ Yes ☐ No |
| Diabetes (metformin use) | ☐ Yes ☐ No |
| Thyroid disease | ☐ Yes ☐ No |
| Multiple myeloma | ☐ Yes ☐ No |
| Age >70 years | ☐ Yes ☐ No |
| Dehydration | ☐ Yes ☐ No |
**Renal Function Assessment:**
| eGFR Level | Risk | Action |
|------------|------|--------|
| ≥60 | Low risk | Proceed |
| 45-59 | Moderate risk | Hydration, consider alternatives |
| 30-44 | High risk | Alternative imaging preferred, radiologist approval |
| <30 | Very high risk | Avoid unless emergent, nephrology consult |
#### 6.1.4 Consent
- Explain procedure and risks
- Obtain informed consent for contrast (if applicable)
- Document consent
### 6.2 Patient Preparation
#### 6.2.1 Preparation by Exam Type
| Exam Type | Preparation Required |
|-----------|---------------------|
| Head CT | Remove metallic objects from head/neck |
| Chest CT | Breathing instructions, arms above head |
| Abdomen/Pelvis CT | Oral contrast (if ordered), full bladder (pelvic) |
| CT Angiography | IV access, contrast protocol |
| CT Colonography | Bowel preparation |
#### 6.2.2 IV Access for Contrast
- Assess vein suitability
- 20-gauge or larger preferred for power injection
- Verify patency with saline flush
- Secure catheter properly
### 6.3 Patient Positioning
#### 6.3.1 Standard Positions
| Body Part | Position | Gantry Entry |
|-----------|----------|--------------|
| Head | Supine, neutral | Head first |
| Neck | Supine, neck extended | Head first |
| Chest | Supine, arms up | Head or feet first |
| Abdomen | Supine, arms up | Head first |
| Pelvis | Supine, arms up | Feet first |
| Extremity | Per protocol | Varies |
#### 6.3.2 Positioning Considerations
- Center patient in gantry
- Use positioning aids as needed
- Apply shielding where appropriate
- Ensure patient comfort
- Remove all artifacts from scan field
### 6.4 Protocol Selection and Parameters
#### 6.4.1 Dose Optimization Principles
- ALARA (As Low As Reasonably Achievable)
- Use automatic exposure control (AEC)
- Size-appropriate protocols
- Limit scan range to clinical question
#### 6.4.2 Standard Protocol Parameters
| Protocol | kVp | mAs | Slice Thickness | Pitch |
|----------|-----|-----|-----------------|-------|
| Head routine | 120 | Auto | 5mm | N/A (axial) |
| Chest routine | 120 | Auto | 5mm/1.25mm | 1.0-1.5 |
| Abdomen routine | 120 | Auto | 5mm/2.5mm | 1.0-1.5 |
| CT Angiography | 100-120 | Auto | 0.625-1.25mm | 0.8-1.0 |
| Low-dose chest | 100-120 | Reduced | 1.25mm | 1.0-1.5 |
#### 6.4.3 Pediatric Considerations
- Reduce kVp and mAs based on weight/age
- Use pediatric-specific protocols
- Apply "Image Gently" principles
- Minimize number of phases
### 6.5 Contrast Administration
#### 6.5.1 Contrast Selection
| Indication | Contrast Type | Concentration |
|------------|---------------|---------------|
| Routine enhanced | Low-osmolar | 300-350 mgI/mL |
| CT Angiography | Low-osmolar | 350-370 mgI/mL |
| High-risk patients | Iso-osmolar | 270-320 mgI/mL |
#### 6.5.2 Contrast Volume and Rate
| Exam Type | Volume | Rate |
|-----------|--------|------|
| Head with contrast | 100 mL | 1-2 mL/sec |
| Chest with contrast | 100-125 mL | 2-3 mL/sec |
| Abdomen with contrast | 100-150 mL | 2-3 mL/sec |
| CT Angiography | 75-125 mL | 4-5 mL/sec |
#### 6.5.3 Timing Methods
- Fixed delay (empiric)
- Bolus tracking (threshold trigger)
- Test bolus (timing determination)
### 6.6 Image Acquisition
1. **Scout/Topogram**
- Acquire scout images
- Verify positioning and coverage
- Set scan range
2. **Pre-Contrast (if applicable)**
- Acquire non-contrast images
- Assess for baseline findings
3. **Contrast Injection (if applicable)**
- Verify IV patency
- Program injector parameters
- Monitor injection
4. **Post-Contrast Acquisition**
- Acquire at appropriate phase(s)
- Arterial: 25-35 seconds
- Portal venous: 60-70 seconds
- Delayed: 3-5 minutes (as needed)
5. **Image Review**
- Review images for quality
- Assess for artifacts
- Repeat if technically inadequate
### 6.7 Post-Examination
#### 6.7.1 Patient Care After Contrast
- Monitor for 15-30 minutes
- Assess IV site
- Provide hydration instructions
- Advise on potential delayed reactions
- Metformin patients: follow institutional protocol
#### 6.7.2 Documentation
- Complete FRM-RAD-001 CT Procedure Log
- Document dose metrics (CTDIvol, DLP)
- Record contrast details
- Note any adverse events
- Submit images to PACS
### 6.8 Image Post-Processing
| Reconstruction | Application |
|----------------|-------------|
| Soft tissue | Routine interpretation |
| Bone | Skeletal evaluation |
| Lung | Pulmonary parenchyma |
| 3D/MPR | Vascular, complex anatomy |
| MIP | Angiography |
## 7. Contrast Reaction Management
### 7.1 Reaction Classification
| Severity | Symptoms | Action |
|----------|----------|--------|
| Mild | Nausea, urticaria (limited), warmth | Observe, treat symptoms |
| Moderate | Extensive urticaria, bronchospasm, hypotension | Medical treatment, monitor |
| Severe | Anaphylaxis, cardiac arrest, seizure | Emergency response, call code |
### 7.2 Emergency Equipment
Available in CT suite:
- Oxygen and suction
- Emergency medications (epinephrine, diphenhydramine, etc.)
- IV fluids
- Defibrillator/AED
- Crash cart
## 8. Radiation Safety
### 8.1 Dose Monitoring
- Record CTDIvol and DLP for each exam
- Compare to diagnostic reference levels
- Investigate outliers
### 8.2 Diagnostic Reference Levels
| Exam | CTDIvol (mGy) | DLP (mGy·cm) |
|------|---------------|--------------|
| Head | 60 | 1000 |
| Chest | 15 | 400 |
| Abdomen | 20 | 700 |
| Abdomen/Pelvis | 20 | 900 |
## 9. Quality Control
| Activity | Frequency |
|----------|-----------|
| Daily warm-up and calibration | Daily |
| Water phantom QC | Daily/Weekly |
| CT number accuracy | Weekly |
| Spatial resolution | Monthly |
| Physicist review | Annually |
## 10. Documentation
- FRM-RAD-001 CT Procedure Log
- FRM-RAD-002 Contrast Administration Record
- FRM-RAD-003 Adverse Reaction Report
- Dose reports
- QC logs
## 11. References
- ACR Practice Parameter for CT
- ACR Manual on Contrast Media
- Image Gently Campaign
- AAPM CT Protocols
- State radiation regulations
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: [Title]
| Document ID | SOP-XXX |
|-------------|---------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[State the purpose of this procedure]
## 2. Scope
[Define the scope and applicability]
## 3. Responsibilities
### 3.1 [Role 1]
- [Responsibility]
- [Responsibility]
### 3.2 [Role 2]
- [Responsibility]
- [Responsibility]
## 4. Definitions
| Term | Definition |
|------|------------|
| | |
## 5. Procedure
### 5.1 [Section Title]
[Procedure steps]
### 5.2 [Section Title]
[Procedure steps]
## 6. Related Documents
- [List related procedures, forms, etc.]
## 7. References
- [External standards, regulations, etc.]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Work Instruction: [Title]
| Document ID | WI-001 |
|-------------|--------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[Describe the purpose of this work instruction]
## 2. Scope
[Define what activities this instruction covers]
## 3. Safety Precautions
- [List any safety requirements]
- [Personal protective equipment needed]
- [Hazards to be aware of]
## 4. Equipment/Materials Required
| Item | Specification |
|------|---------------|
| | |
| | |
## 5. Procedure
### Step 1: [Title]
[Detailed instructions]
### Step 2: [Title]
[Detailed instructions]
### Step 3: [Title]
[Detailed instructions]
## 6. Acceptance Criteria
[Define what constitutes successful completion]
## 7. Records
| Record | Location | Retention |
|--------|----------|-----------|
| | | |
## 8. References
- [Related SOPs]
- [Specifications]
- [Standards]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |