Sync template from atomicqms-style deployment

.gitea/workflows/atomicai.yml

@@ -0,0 +1,80 @@
+name: AtomicAI IT Infrastructure 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 IT Infrastructure 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 Healthcare IT Infrastructure and Cybersecurity Quality Management.
+
+            ## Your Expertise
+            - HIPAA Security Rule technical safeguards
+            - NIST Cybersecurity Framework
+            - SOC 2 compliance
+            - Network security and segmentation
+            - Access control and identity management
+            - Incident response and disaster recovery
+            - Vulnerability management and patching
+            - Medical device network security
+            - Cloud security (AWS, Azure, GCP)
+            - Data backup and recovery procedures
+            - Change management for IT systems
+            - Security awareness training
+            - Audit logging and monitoring
+
+            ## Document Creation Guidelines
+            - Place Security SOPs in SOPs/Security/
+            - Place Infrastructure SOPs in SOPs/Infrastructure/
+            - Place Incident Response in Protocols/Incident-Response/
+            - Place Change Management in Forms/Change-Management/
+            - Place Audit Forms in Forms/Audit/
+            - Place Policies in Policies/
+
+            ## Numbering Convention
+            - SOP-SEC-XXX for Security SOPs
+            - SOP-INF-XXX for Infrastructure SOPs
+            - SOP-NET-XXX for Network SOPs
+            - IRP-XXX for Incident Response Procedures
+            - POL-XXX for Policies
+            - FRM-XXX for Forms
+
+            Always create branches and submit changes as Pull Requests for review.
+            Prioritize security, compliance, and system availability.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'

Forms/Change-Requests/FRM-CHG-001-Request-For-Change.md

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+# Request for Change (RFC)
+
+| Form ID | FRM-CHG-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Change Request Information
+
+| Field | Entry |
+|-------|-------|
+| RFC Number | RFC-[YYYY]-[####] |
+| Date Submitted | |
+| Requester Name | |
+| Requester Department | |
+| Requester Email | |
+| Requester Phone | |
+
+## Change Classification
+
+**Change Type:**
+- [ ] Standard (Pre-approved, routine)
+- [ ] Normal (Requires CAB approval)
+- [ ] Emergency (Critical, time-sensitive)
+
+**Change Category:**
+- [ ] Hardware
+- [ ] Software/Application
+- [ ] Network
+- [ ] Database
+- [ ] Security
+- [ ] Cloud Infrastructure
+- [ ] Other: _______________
+
+**Priority:**
+- [ ] Critical (Must be completed ASAP)
+- [ ] High (Within 1 week)
+- [ ] Medium (Within 2 weeks)
+- [ ] Low (Within 30 days)
+
+## Change Description
+
+### Summary
+*Provide a brief description of the proposed change (1-2 sentences)*
+
+
+
+### Detailed Description
+*Describe the change in detail, including what will be modified*
+
+
+
+### Reason/Business Justification
+*Why is this change necessary? What business need does it address?*
+
+
+
+## Impact Assessment
+
+### Affected Systems
+| System/Application | Environment | Impact Level |
+|-------------------|-------------|--------------|
+| | ☐ Prod ☐ Test ☐ Dev | ☐ High ☐ Med ☐ Low |
+| | ☐ Prod ☐ Test ☐ Dev | ☐ High ☐ Med ☐ Low |
+| | ☐ Prod ☐ Test ☐ Dev | ☐ High ☐ Med ☐ Low |
+
+### Affected Users/Groups
+
+
+### Dependencies
+*List any dependencies on other systems, changes, or external parties*
+
+
+
+## Risk Assessment
+
+**What could go wrong?**
+
+
+**Likelihood of failure:**
+- [ ] Low
+- [ ] Medium
+- [ ] High
+
+**Impact if failure occurs:**
+- [ ] Low - Minor inconvenience
+- [ ] Medium - Degraded service
+- [ ] High - Service outage
+- [ ] Critical - Data loss or security breach
+
+**Overall Risk Level:**
+- [ ] Low
+- [ ] Medium
+- [ ] High
+
+## Implementation Plan
+
+### Proposed Change Window
+| Field | Entry |
+|-------|-------|
+| Start Date/Time | |
+| End Date/Time | |
+| Estimated Duration | |
+| Maintenance Window Required? | ☐ Yes ☐ No |
+
+### Implementation Steps
+| Step | Action | Responsible | Est. Time |
+|------|--------|-------------|-----------|
+| 1 | | | |
+| 2 | | | |
+| 3 | | | |
+| 4 | | | |
+| 5 | | | |
+
+### Pre-Implementation Checklist
+- [ ] Backup completed
+- [ ] Stakeholders notified
+- [ ] Test plan documented
+- [ ] Rollback plan documented
+- [ ] Required access/permissions confirmed
+
+## Rollback Plan
+
+**Rollback Trigger Criteria:**
+*Under what conditions will rollback be initiated?*
+
+
+
+**Rollback Steps:**
+| Step | Action | Responsible | Est. Time |
+|------|--------|-------------|-----------|
+| 1 | | | |
+| 2 | | | |
+| 3 | | | |
+
+**Estimated Rollback Time:**
+
+## Testing Plan
+
+**Test Environment:**
+- [ ] Already tested in Dev
+- [ ] Already tested in Test/Stage
+- [ ] Production verification only
+
+**Test Cases:**
+| Test | Expected Result | Pass/Fail |
+|------|-----------------|-----------|
+| | | ☐ |
+| | | ☐ |
+| | | ☐ |
+
+## Communication Plan
+
+### Notifications Required
+- [ ] End users
+- [ ] Help desk
+- [ ] Management
+- [ ] External parties
+- [ ] None required
+
+### Notification Details
+| Audience | Method | Timing | Responsible |
+|----------|--------|--------|-------------|
+| | | | |
+| | | | |
+
+## Approvals
+
+### Technical Review
+| Field | Entry |
+|-------|-------|
+| Reviewer Name | |
+| Date | |
+| Decision | ☐ Approved ☐ Rejected ☐ More Info Needed |
+| Comments | |
+| Signature | |
+
+### CAB Review
+| Field | Entry |
+|-------|-------|
+| CAB Meeting Date | |
+| Decision | ☐ Approved ☐ Approved w/Conditions ☐ Deferred ☐ Rejected |
+| Conditions (if any) | |
+| CAB Chair Signature | |
+
+### Management Approval (if required)
+| Field | Entry |
+|-------|-------|
+| Approver Name | |
+| Date | |
+| Signature | |
+
+## Post-Implementation
+
+### Results
+| Field | Entry |
+|-------|-------|
+| Implementation Date | |
+| Actual Start Time | |
+| Actual End Time | |
+| Status | ☐ Successful ☐ Partial ☐ Failed ☐ Rolled Back |
+
+### Issues Encountered
+
+
+### Lessons Learned
+
+
+### PIR Required?
+- [ ] Yes (Schedule date: _________)
+- [ ] No
+
+### Closure
+| Field | Entry |
+|-------|-------|
+| Closed By | |
+| Date Closed | |
+| Final Status | ☐ Successful ☐ Failed |
+
+---
+
+*Form FRM-CHG-001 Rev 1.0 - Request for Change*

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/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 @@
-# it-infrastructure
+# IT Infrastructure Quality Management System
 
 A comprehensive QMS template designed for IT departments, managed service providers, and technology infrastructure teams in regulated industries.
+
+## 💻 Designed For
+
+- **Healthcare IT Departments** - Hospital and clinic technology teams
+- **Managed Service Providers (MSPs)** - IT service organizations
+- **Data Centers** - Colocation and hosting facilities
+- **Cloud Operations Teams** - AWS, Azure, GCP management
+- **Cybersecurity Teams** - Security operations centers
+- **Research Computing** - HPC and scientific computing
+- **Compliance-Focused IT** - HIPAA, SOC 2, PCI environments
+
+## 📋 Regulatory Framework
+
+This template supports compliance with:
+
+- **ISO 27001** - Information Security Management Systems
+- **SOC 2** - Service Organization Control (Trust Services Criteria)
+- **HIPAA Security Rule** - Healthcare information security
+- **NIST Cybersecurity Framework** - Security controls and practices
+- **PCI DSS** - Payment Card Industry Data Security Standard
+- **GDPR** - Data protection requirements (if applicable)
+- **FISMA** - Federal information security (government)
+- **CIS Controls** - Center for Internet Security benchmarks
+- **ITIL** - IT Service Management best practices
+- **COBIT** - Governance and management of IT
+
+## Repository Structure
+
+```
+├── SOPs/
+│   ├── Change-Management/     # Change requests, approvals, implementation
+│   ├── Incident-Response/     # Security incidents, outages, escalation
+│   ├── Access-Control/        # User provisioning, authentication, authorization
+│   ├── Backup-Recovery/       # Backups, disaster recovery, business continuity
+│   ├── Security-Operations/   # Vulnerability management, patching, monitoring
+│   └── General/               # Document control, training, CAPA
+├── Forms/
+│   ├── Change-Requests/       # RFC forms, CAB meeting records
+│   ├── Incident-Reports/      # Incident tickets, post-mortems, RCA
+│   ├── Access-Requests/       # User access, privilege escalation forms
+│   ├── Audit-Checklists/      # Security audits, compliance assessments
+│   ├── Asset-Inventory/       # Hardware, software, license tracking
+│   └── Training/              # Security awareness, competency assessments
+├── Policies/                  # IT and security policies
+├── Work-Instructions/         # Step-by-step procedures
+└── Templates/                 # Document templates
+```
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-CHG-XXX**: Change Management SOPs
+- **SOP-INC-XXX**: Incident Response SOPs
+- **SOP-ACC-XXX**: Access Control SOPs
+- **SOP-BAK-XXX**: Backup and Recovery SOPs
+- **SOP-SEC-XXX**: Security Operations SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+
+## 🤖 AI-Powered Assistance
+
+This repository includes **AtomicAI**, your IT infrastructure QMS assistant. Mention `@atomicai` in any issue or pull request to:
+
+- Draft change management and incident response procedures
+- Create access control and user provisioning SOPs
+- Generate backup and disaster recovery plans
+- Develop security policies and procedures
+- Create audit checklists and compliance documentation
+- Review documents for ISO 27001/SOC 2 compliance
+
+### Example Prompts
+
+- "@atomicai create an SOP for change management with CAB approval workflow"
+- "@atomicai draft a security incident response procedure"
+- "@atomicai write a user access provisioning and deprovisioning SOP"
+- "@atomicai create a disaster recovery plan template"
+- "@atomicai develop a vulnerability management procedure"
+- "@atomicai create a patch management SOP with testing requirements"
+
+## Getting Started
+
+1. **Establish Governance** - Define IT policies and approval authorities
+2. **Implement Change Management** - Configure RFC and CAB processes
+3. **Set Up Incident Response** - Create escalation procedures and playbooks
+4. **Define Access Controls** - Establish user provisioning workflows
+5. **Train Staff** - Security awareness and procedure training
+
+## Key Documents to Create First
+
+1. **Change Management SOP** - RFC, approval, and implementation workflow
+2. **Incident Response Procedure** - Detection, containment, recovery, post-mortem
+3. **Access Control Policy** - Least privilege, authentication, authorization
+4. **Backup and Recovery SOP** - Backup schedules, retention, testing
+5. **Vulnerability Management SOP** - Scanning, prioritization, remediation
+6. **Patch Management SOP** - Testing, deployment, rollback procedures
+7. **Business Continuity Plan** - DR procedures and RTO/RPO targets
+
+## Special Considerations for IT Infrastructure
+
+### Change Management
+- Request for Change (RFC) documentation
+- Change Advisory Board (CAB) process
+- Risk assessment and testing requirements
+- Rollback procedures
+- Post-implementation review
+
+### Security Operations
+- Vulnerability scanning and assessment
+- Penetration testing programs
+- Security monitoring and SIEM
+- Threat intelligence integration
+- Incident detection and response
+
+### Access Control
+- Identity and access management
+- Privileged access management
+- Multi-factor authentication
+- Access reviews and recertification
+- Termination and offboarding
+
+### Business Continuity
+- Disaster recovery planning
+- RTO/RPO definitions
+- Backup verification and testing
+- Failover procedures
+- Communication plans
+
+---
+
+*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

SOPs/Change-Management/SOP-CHG-001-Change-Management.md

@@ -0,0 +1,193 @@
+# Standard Operating Procedure: Change Management
+
+| Document ID | SOP-CHG-001 |
+|-------------|-------------|
+| Title | IT Change Management Process |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | IT Operations |
+
+---
+
+## 1. Purpose
+
+To establish a controlled process for managing changes to IT infrastructure, applications, and services to minimize risk and ensure stability while enabling business agility.
+
+## 2. Scope
+
+This procedure applies to all changes to:
+- Production servers and network infrastructure
+- Databases and storage systems
+- Applications and software
+- Security configurations
+- Cloud infrastructure and services
+- Network and firewall rules
+
+## 3. Responsibilities
+
+### 3.1 Change Requester
+- Submit complete RFC with business justification
+- Coordinate with stakeholders
+- Verify change success post-implementation
+
+### 3.2 Change Manager
+- Review and classify changes
+- Schedule CAB meetings
+- Track change metrics
+
+### 3.3 Change Advisory Board (CAB)
+- Review and approve/reject changes
+- Assess risk and impact
+- Prioritize conflicting changes
+
+### 3.4 Technical Implementer
+- Develop implementation plan
+- Execute approved changes
+- Document results
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| RFC | Request for Change - formal change proposal |
+| CAB | Change Advisory Board - approval committee |
+| ECAB | Emergency CAB - expedited approval for urgent changes |
+| PIR | Post-Implementation Review |
+
+## 5. Change Categories
+
+### 5.1 Standard Changes
+Pre-approved, low-risk, routine changes:
+- Password resets
+- User account creation
+- Approved software installations
+- Scheduled maintenance activities
+
+### 5.2 Normal Changes
+Require CAB review and approval:
+- Application deployments
+- Server configuration changes
+- Network modifications
+- Database changes
+
+### 5.3 Emergency Changes
+Require ECAB approval, used only for:
+- Security incidents requiring immediate response
+- Critical system failures
+- Regulatory compliance issues
+
+## 6. Procedure
+
+### 6.1 Change Request Submission
+
+1. **Complete RFC Form** (FRM-CHG-001)
+   - Description of change
+   - Business justification
+   - Risk assessment
+   - Implementation plan
+   - Rollback plan
+   - Testing plan
+   - Affected systems/users
+
+2. **Submit RFC**
+   - Submit via ticketing system
+   - Attach all supporting documentation
+   - Identify change window preference
+
+### 6.2 Change Assessment
+
+| Risk Level | Criteria | Approval Required |
+|------------|----------|-------------------|
+| Low | Single system, no downtime, easy rollback | Change Manager |
+| Medium | Multiple systems, planned downtime, tested rollback | CAB |
+| High | Critical systems, extended downtime, complex rollback | CAB + Management |
+
+### 6.3 CAB Review Process
+
+1. **Pre-CAB Preparation**
+   - Review all pending RFCs
+   - Verify completeness
+   - Identify conflicts with other changes
+
+2. **CAB Meeting Agenda**
+   - Review of failed/problematic changes
+   - Assessment of new RFCs
+   - Scheduling of approved changes
+   - Review of change calendar
+
+3. **Decision Outcomes**
+   - **Approved**: Proceed as planned
+   - **Approved with conditions**: Requires modifications
+   - **Deferred**: Reschedule for later review
+   - **Rejected**: Not approved, requires rework
+
+### 6.4 Change Implementation
+
+1. **Pre-Implementation**
+   - [ ] Approval documented in ticket
+   - [ ] Stakeholders notified
+   - [ ] Backup completed
+   - [ ] Rollback plan ready
+   - [ ] Monitoring in place
+
+2. **During Implementation**
+   - [ ] Follow implementation plan exactly
+   - [ ] Document each step
+   - [ ] Test at defined checkpoints
+   - [ ] Communicate status updates
+
+3. **Post-Implementation**
+   - [ ] Verify change success
+   - [ ] Update documentation
+   - [ ] Close RFC with results
+   - [ ] Schedule PIR if required
+
+### 6.5 Rollback Criteria
+
+Initiate rollback if:
+- Change causes unplanned outage
+- Functionality fails verification
+- Security vulnerability introduced
+- Performance degradation exceeds threshold
+- Change window expiring with incomplete work
+
+### 6.6 Emergency Change Process
+
+1. Obtain verbal ECAB approval (minimum 2 members)
+2. Document decision and justification
+3. Implement with minimal viable scope
+4. Complete formal RFC within 24 hours
+5. Conduct PIR for all emergency changes
+
+## 7. Change Freeze Periods
+
+No non-emergency changes permitted during:
+- Month-end/quarter-end processing
+- Major business events
+- Holiday periods (as defined)
+- Audit periods
+
+## 8. Metrics and Reporting
+
+| Metric | Target |
+|--------|--------|
+| Change success rate | >95% |
+| Emergency change ratio | <5% |
+| Unauthorized changes | 0 |
+| Average approval time | <3 business days |
+
+## 9. Related Documents
+
+- FRM-CHG-001 Request for Change Form
+- FRM-CHG-002 CAB Meeting Minutes
+- SOP-INC-001 Incident Response Procedure
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

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

@@ -0,0 +1,123 @@
+# 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/Incident-Response/SOP-INC-001-Incident-Response.md

@@ -0,0 +1,182 @@
+# Standard Operating Procedure: Security Incident Response
+
+| Document ID | SOP-INC-001 |
+|-------------|-------------|
+| Title | Security Incident Response Procedure |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | IT Security |
+
+---
+
+## 1. Purpose
+
+To establish a structured approach for detecting, responding to, containing, and recovering from security incidents to minimize impact and prevent recurrence.
+
+## 2. Scope
+
+This procedure applies to all security incidents including:
+- Unauthorized access attempts
+- Malware infections
+- Data breaches
+- Denial of service attacks
+- Phishing attacks
+- Lost or stolen devices
+- Insider threats
+- System compromises
+
+## 3. Responsibilities
+
+### 3.1 All Staff
+- Report suspected incidents immediately
+- Preserve evidence (do not turn off systems unless directed)
+- Follow instructions from incident response team
+
+### 3.2 IT Security Team
+- Triage and classify incidents
+- Lead response efforts
+- Coordinate with stakeholders
+
+### 3.3 Incident Response Manager
+- Authorize containment actions
+- Escalate to management as needed
+- Coordinate external communications
+
+## 4. Incident Classification
+
+| Severity | Criteria | Response Time |
+|----------|----------|---------------|
+| Critical | Active breach, data exfiltration, ransomware | Immediate |
+| High | Confirmed compromise, malware spreading | < 1 hour |
+| Medium | Attempted intrusion, isolated malware | < 4 hours |
+| Low | Policy violation, suspicious activity | < 24 hours |
+
+## 5. Incident Response Phases
+
+### 5.1 Phase 1: Detection and Reporting
+
+**Detection Sources:**
+- Security monitoring tools (SIEM, IDS/IPS)
+- User reports
+- Vendor notifications
+- Audit findings
+- Automated alerts
+
+**Reporting:**
+1. Document initial observations
+2. Report via security hotline or email
+3. Complete FRM-INC-001 Incident Report
+4. Do NOT attempt remediation without guidance
+
+### 5.2 Phase 2: Triage and Analysis
+
+1. **Initial Assessment**
+   - Confirm incident is genuine (vs. false positive)
+   - Classify severity level
+   - Identify affected systems/data
+   - Determine initial scope
+
+2. **Evidence Collection**
+   - System logs
+   - Network traffic captures
+   - Memory dumps (if warranted)
+   - Screenshots
+   - Preserve chain of custody
+
+3. **Escalation Decision**
+   - Critical/High: Immediate escalation to management
+   - Notify legal/compliance if data breach suspected
+   - Engage external forensics if needed
+
+### 5.3 Phase 3: Containment
+
+**Short-term Containment:**
+- Isolate affected systems from network
+- Block malicious IPs/domains
+- Disable compromised accounts
+- Preserve evidence before changes
+
+**Long-term Containment:**
+- Apply temporary fixes
+- Increase monitoring
+- Implement additional controls
+- Prepare for eradication
+
+**Containment Decision Matrix:**
+| Action | Authority Required |
+|--------|-------------------|
+| Isolate single workstation | Security Team |
+| Disable user account | Security Manager |
+| Block network segment | IT Director |
+| Shut down production system | Executive approval |
+
+### 5.4 Phase 4: Eradication
+
+1. Identify root cause
+2. Remove malware/backdoors
+3. Patch vulnerabilities exploited
+4. Reset compromised credentials
+5. Verify removal is complete
+
+### 5.5 Phase 5: Recovery
+
+1. Restore systems from clean backups
+2. Rebuild if necessary
+3. Verify integrity before reconnecting
+4. Monitor closely post-recovery
+5. Confirm normal operations
+
+### 5.6 Phase 6: Post-Incident Review
+
+**Conduct within 5 business days:**
+- Timeline reconstruction
+- Root cause analysis
+- Response effectiveness review
+- Lessons learned
+- Improvement recommendations
+
+**Documentation:**
+- Complete FRM-INC-002 Post-Incident Report
+- Update procedures as needed
+- Brief stakeholders
+
+## 6. Communication Guidelines
+
+### Internal Communication
+| Audience | Information | Method |
+|----------|-------------|--------|
+| Executive Team | Status, business impact, decisions needed | Phone/meeting |
+| IT Staff | Technical details, actions required | Secure channel |
+| All Staff | General awareness (if warranted) | Email |
+
+### External Communication
+- All external communications through designated spokesperson
+- Coordinate with Legal and PR
+- Regulatory notifications per compliance requirements
+- Customer notifications per contract/law
+
+## 7. Regulatory Notification Requirements
+
+| Regulation | Notification Timeframe | Authority |
+|------------|----------------------|-----------|
+| HIPAA | 60 days (breach of >500) | HHS OCR |
+| GDPR | 72 hours | Supervisory Authority |
+| PCI DSS | Immediately | Card brands, acquirer |
+| State Laws | Varies | State AG |
+
+## 8. Related Documents
+
+- FRM-INC-001 Incident Report Form
+- FRM-INC-002 Post-Incident Report
+- Contact list for incident response team
+- Vendor/partner contact list
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Safety/.gitkeep

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

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] |