Sync template from atomicqms-style deployment

.gitea/workflows/atomicai.yml

@@ -0,0 +1,79 @@
+name: AtomicAI Pathology 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 Pathology 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 Pathology and Anatomic Pathology Quality Management.
+
+            ## Your Expertise
+            - CAP (College of American Pathologists) accreditation
+            - CLIA laboratory standards
+            - Surgical pathology specimen handling
+            - Histology and tissue processing
+            - Immunohistochemistry protocols
+            - Cytology and FNA procedures
+            - Autopsy protocols and procedures
+            - Frozen section procedures
+            - Specimen identification and tracking
+            - Quality assurance and peer review
+            - Critical diagnosis communication
+            - Digital pathology and whole slide imaging
+
+            ## Document Creation Guidelines
+            - Place Surgical Path SOPs in SOPs/Surgical-Pathology/
+            - Place Histology SOPs in SOPs/Histology/
+            - Place Cytology SOPs in SOPs/Cytology/
+            - Place QA Forms in Forms/Quality-Assurance/
+            - Place Specimen Forms in Forms/Specimen/
+            - Place Policies in Policies/
+
+            ## Numbering Convention
+            - SOP-SP-XXX for Surgical Pathology SOPs
+            - SOP-HIS-XXX for Histology SOPs
+            - SOP-CYT-XXX for Cytology SOPs
+            - SOP-AUT-XXX for Autopsy SOPs
+            - POL-XXX for Policies
+            - FRM-XXX for Forms
+
+            Always create branches and submit changes as Pull Requests for review.
+            Prioritize specimen integrity, diagnostic accuracy, and turnaround time.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'

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

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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*

Forms/FRM-003-CAPA-Form.md

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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*

Forms/FRM-006-Audit-Checklist.md

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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*

Forms/Specimen-Tracking/FRM-PATH-001-Specimen-Receipt-Log.md

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+# Specimen Receipt Log
+
+| Form ID | FRM-PATH-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Log Information
+
+| Field | Entry |
+|-------|-------|
+| Date | |
+| Shift | ☐ Day ☐ Evening ☐ Night |
+| Accessioning Technician | |
+| Technician ID | |
+
+---
+
+## Specimen Receipt Record
+
+### Specimen 1
+
+| Field | Entry |
+|-------|-------|
+| Time Received | |
+| Received From | ☐ OR ☐ Clinic ☐ Courier ☐ Transport ☐ Other: |
+| Accession Number | |
+| Patient Name | |
+| MRN | |
+| DOB | |
+| Specimen Type | |
+| Specimen Site | |
+| Number of Containers | |
+| Fixative | ☐ Formalin ☐ Fresh ☐ Other: |
+| Collection Date/Time | |
+| Container Labeled Correctly? | ☐ Yes ☐ No |
+| Requisition Complete? | ☐ Yes ☐ No |
+| Specimen Condition | ☐ Acceptable ☐ Compromised (see notes) |
+| Priority | ☐ Routine ☐ Rush ☐ STAT |
+| Discrepancy? | ☐ No ☐ Yes (Resolution: _______) |
+| Received By (Initials) | |
+
+### Specimen 2
+
+| Field | Entry |
+|-------|-------|
+| Time Received | |
+| Received From | ☐ OR ☐ Clinic ☐ Courier ☐ Transport ☐ Other: |
+| Accession Number | |
+| Patient Name | |
+| MRN | |
+| DOB | |
+| Specimen Type | |
+| Specimen Site | |
+| Number of Containers | |
+| Fixative | ☐ Formalin ☐ Fresh ☐ Other: |
+| Collection Date/Time | |
+| Container Labeled Correctly? | ☐ Yes ☐ No |
+| Requisition Complete? | ☐ Yes ☐ No |
+| Specimen Condition | ☐ Acceptable ☐ Compromised (see notes) |
+| Priority | ☐ Routine ☐ Rush ☐ STAT |
+| Discrepancy? | ☐ No ☐ Yes (Resolution: _______) |
+| Received By (Initials) | |
+
+### Specimen 3
+
+| Field | Entry |
+|-------|-------|
+| Time Received | |
+| Received From | ☐ OR ☐ Clinic ☐ Courier ☐ Transport ☐ Other: |
+| Accession Number | |
+| Patient Name | |
+| MRN | |
+| DOB | |
+| Specimen Type | |
+| Specimen Site | |
+| Number of Containers | |
+| Fixative | ☐ Formalin ☐ Fresh ☐ Other: |
+| Collection Date/Time | |
+| Container Labeled Correctly? | ☐ Yes ☐ No |
+| Requisition Complete? | ☐ Yes ☐ No |
+| Specimen Condition | ☐ Acceptable ☐ Compromised (see notes) |
+| Priority | ☐ Routine ☐ Rush ☐ STAT |
+| Discrepancy? | ☐ No ☐ Yes (Resolution: _______) |
+| Received By (Initials) | |
+
+### Specimen 4
+
+| Field | Entry |
+|-------|-------|
+| Time Received | |
+| Received From | ☐ OR ☐ Clinic ☐ Courier ☐ Transport ☐ Other: |
+| Accession Number | |
+| Patient Name | |
+| MRN | |
+| DOB | |
+| Specimen Type | |
+| Specimen Site | |
+| Number of Containers | |
+| Fixative | ☐ Formalin ☐ Fresh ☐ Other: |
+| Collection Date/Time | |
+| Container Labeled Correctly? | ☐ Yes ☐ No |
+| Requisition Complete? | ☐ Yes ☐ No |
+| Specimen Condition | ☐ Acceptable ☐ Compromised (see notes) |
+| Priority | ☐ Routine ☐ Rush ☐ STAT |
+| Discrepancy? | ☐ No ☐ Yes (Resolution: _______) |
+| Received By (Initials) | |
+
+### Specimen 5
+
+| Field | Entry |
+|-------|-------|
+| Time Received | |
+| Received From | ☐ OR ☐ Clinic ☐ Courier ☐ Transport ☐ Other: |
+| Accession Number | |
+| Patient Name | |
+| MRN | |
+| DOB | |
+| Specimen Type | |
+| Specimen Site | |
+| Number of Containers | |
+| Fixative | ☐ Formalin ☐ Fresh ☐ Other: |
+| Collection Date/Time | |
+| Container Labeled Correctly? | ☐ Yes ☐ No |
+| Requisition Complete? | ☐ Yes ☐ No |
+| Specimen Condition | ☐ Acceptable ☐ Compromised (see notes) |
+| Priority | ☐ Routine ☐ Rush ☐ STAT |
+| Discrepancy? | ☐ No ☐ Yes (Resolution: _______) |
+| Received By (Initials) | |
+
+---
+
+## Special Handling/Fresh Specimens
+
+*Document any specimens requiring immediate processing (frozen sections, special studies, etc.)*
+
+| Accession # | Specimen Type | Special Handling Required | Time to Grossing | Pathologist Notified |
+|-------------|---------------|---------------------------|------------------|---------------------|
+| | | | | ☐ Yes |
+| | | | | ☐ Yes |
+
+---
+
+## Discrepancy Log
+
+| Time | Accession # | Discrepancy Type | Description | Resolution | Resolved By |
+|------|-------------|------------------|-------------|------------|-------------|
+| | | ☐ Labeling ☐ Requisition ☐ Condition ☐ Other | | | |
+| | | ☐ Labeling ☐ Requisition ☐ Condition ☐ Other | | | |
+
+---
+
+## Shift Summary
+
+| Field | Count |
+|-------|-------|
+| Total Specimens Received | |
+| Surgical Pathology | |
+| Cytology | |
+| Frozen Sections | |
+| STAT/Rush Cases | |
+| Specimens with Discrepancies | |
+| Specimens Held/Not Accessioned | |
+
+---
+
+## Quality Notes
+
+*Document any quality issues, equipment problems, or unusual occurrences:*
+
+---
+
+## Shift Handoff
+
+| Field | Entry |
+|-------|-------|
+| Pending Issues for Next Shift | |
+| Outstanding Discrepancies | |
+| Equipment Issues | |
+| Shift Sign-Off | |
+| Date/Time | |
+
+---
+
+## Supervisor Review
+
+| Field | Entry |
+|-------|-------|
+| Reviewed By | |
+| Date | |
+| Comments | |
+| Signature | |
+
+---
+
+*Form FRM-PATH-001 Rev 1.0 - Specimen Receipt Log*

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

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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*

Policies/POL-001-Quality-Policy.md

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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] |

README.md

@@ -1,3 +1,133 @@
-# pathology
+# Pathology & Laboratory Medicine Quality Management System
 
-A comprehensive QMS template designed for anatomic pathology, clinical pathology, and laboratory medicine departments.
+A comprehensive QMS template designed for anatomic pathology, clinical pathology, and laboratory medicine departments.
+
+## 🔬 Designed For
+
+- **Anatomic Pathology** - Surgical pathology, cytopathology, autopsy
+- **Clinical Pathology** - Chemistry, hematology, microbiology, transfusion medicine
+- **Reference Laboratories** - Specialized testing services
+- **Molecular Pathology** - Genetic and molecular diagnostics
+- **Forensic Pathology** - Medical examiner and coroner services
+- **Dermatopathology** - Skin biopsy interpretation
+- **Neuropathology** - Brain and nervous system pathology
+
+## 📋 Regulatory Framework
+
+This template supports compliance with:
+
+- **CAP** - College of American Pathologists accreditation
+- **CLIA** - Clinical Laboratory Improvement Amendments
+- **The Joint Commission** - Hospital accreditation (laboratory chapter)
+- **FDA** - IVD and LDT regulations
+- **AABB** - Blood bank standards (if applicable)
+- **State Clinical Laboratory Licensing** - State-specific requirements
+- **OSHA** - Bloodborne pathogens, chemical safety
+- **HIPAA** - Patient information privacy
+- **ASCP** - Pathologist and technologist standards
+- **CAP Biorepository** - Tissue banking requirements (if applicable)
+
+## Repository Structure
+
+```
+├── SOPs/
+│   ├── Specimen-Handling/     # Accessioning, processing, storage
+│   ├── Histology/             # Tissue processing, embedding, sectioning, staining
+│   ├── Cytology/              # Cytology preparation and screening
+│   ├── Autopsy/               # Post-mortem examination procedures
+│   ├── Molecular/             # Molecular testing, NGS, PCR
+│   └── General/               # Document control, training, CAPA
+├── Forms/
+│   ├── Requisition-Forms/     # Specimen submission, clinical history
+│   ├── Grossing-Templates/    # Specimen dictation templates
+│   ├── QC-Records/            # Staining QC, reagent logs, instrument checks
+│   ├── Report-Templates/      # Synoptic and narrative report templates
+│   ├── Competency/            # Technologist and pathologist assessments
+│   └── Incident-Reports/      # Specimen quality, labeling errors
+├── Policies/                  # Department policies
+├── Work-Instructions/         # Step-by-step procedures
+└── Templates/                 # Document templates
+```
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-SP-XXX**: Specimen Handling SOPs
+- **SOP-HIS-XXX**: Histology SOPs
+- **SOP-CYT-XXX**: Cytology SOPs
+- **SOP-AUT-XXX**: Autopsy SOPs
+- **SOP-MOL-XXX**: Molecular SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+
+## 🤖 AI-Powered Assistance
+
+This repository includes **AtomicAI**, your pathology QMS assistant. Mention `@atomicai` in any issue or pull request to:
+
+- Draft specimen handling and processing SOPs
+- Create histology and staining procedures
+- Generate grossing templates for specimen types
+- Develop molecular testing protocols
+- Create quality control procedures
+- Review documents for CAP/CLIA compliance
+
+### Example Prompts
+
+- "@atomicai create an SOP for surgical specimen grossing and sampling"
+- "@atomicai draft a tissue processor validation procedure"
+- "@atomicai write an immunohistochemistry staining and QC protocol"
+- "@atomicai create a synoptic report template for breast cancer"
+- "@atomicai develop a frozen section procedure with turnaround time standards"
+- "@atomicai create a specimen labeling and identification policy"
+
+## Getting Started
+
+1. **Establish Specimen Policies** - Define accessioning and handling requirements
+2. **Standardize Processing** - Document histology and cytology procedures
+3. **Implement QC Programs** - Set up staining, reagent, and instrument QC
+4. **Define Reporting Standards** - Create synoptic and narrative templates
+5. **Train Staff** - Use competency assessment forms
+
+## Key Documents to Create First
+
+1. **Specimen Accessioning SOP** - Receiving, labeling, and logging specimens
+2. **Tissue Processing SOP** - Fixation, processing, embedding procedures
+3. **H&E Staining Protocol** - Routine hematoxylin and eosin procedure
+4. **Immunohistochemistry SOP** - IHC staining and controls
+5. **Frozen Section SOP** - Intraoperative consultation procedure
+6. **Grossing Manual** - Specimen-specific grossing guidelines
+7. **Critical Values Policy** - Urgent result communication
+
+## Special Considerations for Pathology
+
+### Specimen Integrity
+- Specimen identification and labeling
+- Fixation timing and adequacy
+- Cold ischemia documentation
+- Tissue banking considerations
+- Chain of custody (legal cases)
+
+### Quality Control
+- H&E and special stain QC
+- IHC positive and negative controls
+- Reagent expiration and storage
+- Instrument calibration and maintenance
+- Proficiency testing participation
+
+### Reporting
+- Turnaround time standards
+- Synoptic reporting (CAP protocols)
+- Critical/unexpected results
+- Amendment and addendum procedures
+- Second opinion and consultation
+
+### Safety
+- Formalin handling and exposure limits
+- Xylene substitutes and ventilation
+- Infectious specimen handling
+- Sharps safety (microtome blades)
+- Prion precautions (CJD)
+
+---
+
+*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

SOPs/General/SOP-001-Document-Control.md

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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] |

SOPs/General/SOP-002-CAPA.md

@@ -0,0 +1,134 @@
+# 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] |

SOPs/General/SOP-003-Training.md

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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] |

SOPs/General/SOP-004-Internal-Audit.md

@@ -0,0 +1,136 @@
+# 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] |

SOPs/General/SOP-005-Management-Review.md

@@ -0,0 +1,114 @@
+# 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] |

SOPs/Safety/.gitkeep

@@ -0,0 +1 @@
+# Placeholder

SOPs/Specimen-Handling/SOP-PATH-001-Specimen-Accessioning.md

@@ -0,0 +1,293 @@
+# Standard Operating Procedure: Pathology Specimen Accessioning
+
+| Document ID | SOP-PATH-001 |
+|-------------|-------------|
+| Title | Pathology Specimen Accessioning and Processing |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Anatomic Pathology |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for the receipt, accessioning, and initial processing of pathology specimens to ensure proper identification, optimal preservation, and regulatory compliance.
+
+## 2. Scope
+
+This procedure applies to all anatomic pathology specimens including:
+- Surgical pathology specimens
+- Cytology specimens
+- Skin biopsies
+- Bone marrow biopsies
+- Autopsy specimens
+
+## 3. Responsibilities
+
+### 3.1 Accessioning Staff
+- Receive and log specimens
+- Verify specimen-requisition match
+- Assign case numbers
+- Distribute to appropriate areas
+
+### 3.2 Histology Technician
+- Process tissue specimens
+- Embed and section specimens
+- Prepare slides for pathologist review
+
+### 3.3 Pathologist
+- Perform gross examination
+- Dictate gross description
+- Review slides and render diagnosis
+
+### 3.4 Laboratory Director
+- Ensure quality standards
+- Review policies and procedures
+- Oversee accreditation compliance
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Accession | Process of receiving and logging specimens |
+| Fixation | Chemical preservation of tissue |
+| Grossing | Macroscopic examination and description |
+| Cassette | Container for tissue during processing |
+| Block | Paraffin-embedded tissue section |
+
+## 5. Equipment and Materials
+
+- Specimen containers (various sizes)
+- 10% neutral buffered formalin (NBF)
+- Requisition forms
+- Barcoded labels
+- Cassettes
+- Tissue processor
+- Embedding station
+- Microtome
+- Slides and coverslips
+
+## 6. Procedure
+
+### 6.1 Specimen Receipt
+
+#### 6.1.1 Verification at Receipt
+Upon receiving each specimen:
+- [ ] Container properly labeled with patient identifiers
+- [ ] Requisition form accompanies specimen
+- [ ] Container intact without leakage
+- [ ] Specimen in appropriate fixative (if applicable)
+- [ ] Time of collection documented
+
+#### 6.1.2 Label Verification
+
+**Minimum required on container:**
+| Element | Present |
+|---------|---------|
+| Patient name | ☐ |
+| Second identifier (MRN, DOB) | ☐ |
+| Specimen type/site | ☐ |
+| Date of collection | ☐ |
+| Collector identification | ☐ |
+
+**Requisition must include:**
+| Element | Present |
+|---------|---------|
+| Patient name and identifiers | ☐ |
+| Ordering physician | ☐ |
+| Specimen source/site | ☐ |
+| Clinical history | ☐ |
+| Date/time of collection | ☐ |
+| Date/time of receipt in lab | ☐ |
+
+#### 6.1.3 Discrepancy Handling
+
+If discrepancies exist:
+1. Do NOT accessioned until resolved
+2. Contact ordering physician/collector
+3. Document resolution in LIS
+4. Complete discrepancy log
+
+| Discrepancy Type | Required Action |
+|------------------|-----------------|
+| Name mismatch | Contact collector, do not process |
+| Missing information | Request completion before accessioning |
+| Damaged container | Document, assess specimen integrity |
+| No requisition | Hold specimen, request requisition |
+| Unlabeled specimen | Do not process until properly labeled |
+
+### 6.2 Accessioning
+
+#### 6.2.1 Case Number Assignment
+1. Log specimen into Laboratory Information System (LIS)
+2. System assigns unique accession number
+3. Format: [Year]-S[Sequential#] (e.g., 2024-S12345)
+4. Generate specimen labels
+
+#### 6.2.2 Labeling
+1. Apply barcoded labels to:
+   - Specimen container
+   - Cassettes
+   - All associated paperwork
+2. Verify label matches requisition
+3. Apply orientation labels if applicable
+
+#### 6.2.3 Specimen Categorization
+
+| Category | Description | Priority |
+|----------|-------------|----------|
+| Routine | Standard turnaround | 2-3 days |
+| Rush | Expedited processing | 24-48 hours |
+| STAT | Emergency | Same day |
+| Intraoperative | Frozen section | Immediate |
+
+### 6.3 Fixation Assessment
+
+#### 6.3.1 Optimal Fixation Times
+
+| Specimen Type | Minimum | Optimal | Maximum |
+|---------------|---------|---------|---------|
+| Small biopsy (≤5mm) | 6 hours | 6-12 hours | 24 hours |
+| Medium tissue (5-15mm) | 12 hours | 12-24 hours | 48 hours |
+| Large specimen (>15mm) | 24 hours | 24-48 hours | 72 hours |
+
+#### 6.3.2 Fixative Requirements
+- Standard: 10% neutral buffered formalin (10:1 ratio)
+- Breast tissue for biomarkers: Cold ischemia <1 hour, fixed within 1 hour
+- Special fixatives per protocol (e.g., Bouin's, B5)
+
+Document:
+- Time of collection (if available)
+- Time of receipt in fixative
+- Time placed in processor
+
+### 6.4 Gross Examination (Grossing)
+
+#### 6.4.1 Pre-Grossing Preparation
+1. Verify specimen identity
+2. Review clinical history and prior pathology
+3. Gather appropriate supplies
+4. Photograph specimen (if indicated)
+
+#### 6.4.2 Gross Description Components
+
+**Standard elements:**
+- [ ] Specimen type and site
+- [ ] How received (container, fixative)
+- [ ] Dimensions (3 measurements)
+- [ ] Weight (if applicable)
+- [ ] External appearance
+- [ ] Cut surface appearance
+- [ ] Lesion description (size, location, margins)
+- [ ] Sections submitted summary
+
+**For resection specimens:**
+- [ ] Orientation (sutures, clips, inks)
+- [ ] Margin assessment
+- [ ] Lymph node identification
+- [ ] Relationship of lesion to margins
+
+#### 6.4.3 Inking Protocol
+
+| Color | Common Usage |
+|-------|--------------|
+| Black | Anterior/superficial |
+| Blue | Posterior/deep |
+| Green | Superior |
+| Orange | Inferior |
+| Red | Medial |
+| Yellow | Lateral |
+
+Document inking scheme in gross description.
+
+#### 6.4.4 Section Submission
+
+| Specimen Type | Standard Sections |
+|---------------|-------------------|
+| Small biopsy | Entire specimen |
+| Skin ellipse | 3mm cross-sections, all margins |
+| Breast lumpectomy | Lesion, margins (6 directions), representative |
+| Colon resection | Tumor (4 sections), margins, nodes, mucosa |
+
+### 6.5 Tissue Processing
+
+#### 6.5.1 Processing Steps
+1. Dehydration (graded alcohols)
+2. Clearing (xylene)
+3. Infiltration (paraffin)
+4. Total processing time: 8-14 hours
+
+#### 6.5.2 Processing Schedules
+
+| Schedule | Duration | Specimen Types |
+|----------|----------|----------------|
+| Routine overnight | 12-14 hours | Standard specimens |
+| Extended | 16-20 hours | Fatty tissue, large specimens |
+| Rapid | 2-4 hours | Urgent specimens |
+| Rush microwave | 1-2 hours | STAT specimens |
+
+### 6.6 Embedding
+
+1. Orient tissue in cassette per protocol
+2. Embed in paraffin at 60°C
+3. Cool on cold plate
+4. Verify block identity
+
+### 6.7 Microtomy
+
+1. Face block until full tissue visible
+2. Cut at specified thickness (typically 4-5 µm)
+3. Float sections on warm water bath
+4. Pick up on labeled slide
+5. Dry slides before staining
+
+### 6.8 Slide Preparation
+
+1. H&E staining (routine)
+2. Special stains per request/protocol
+3. Immunohistochemistry as ordered
+4. Coverslip slides
+5. Verify slide-block-patient match
+
+## 7. Quality Control
+
+### 7.1 Daily QC
+- [ ] Reagent checks
+- [ ] Processor function verification
+- [ ] Temperature monitoring
+- [ ] Staining controls
+
+### 7.2 Specimen Quality Metrics
+
+| Metric | Target |
+|--------|--------|
+| Specimen rejection rate | <2% |
+| Accessioning errors | <0.5% |
+| Lost specimens | 0 |
+| Turnaround time (routine) | ≤48 hours |
+| Block/slide discrepancies | <0.1% |
+
+## 8. Documentation
+
+- FRM-PATH-001 Specimen Receipt Log
+- FRM-PATH-002 Gross Description Template
+- FRM-PATH-003 Processing Log
+- Discrepancy reports
+- QC logs
+
+## 9. References
+
+- CAP Laboratory Accreditation Checklist
+- ASCO/CAP Guidelines for Biomarker Testing
+- CLIA regulations
+- Institutional policies
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

Templates/SOP-Template.md

@@ -0,0 +1,62 @@
+# 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] |

Work Instructions/WI-001-Template.md

@@ -0,0 +1,68 @@
+# 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] |