Sync template from atomicqms-style deployment

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*