Sync template from atomicqms-style deployment

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/Testing-Logs/FRM-BB-001-Compatibility-Testing-Log.md

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+# Compatibility Testing Log
+
+| Form ID | FRM-BB-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Patient Information
+
+| Field | Entry |
+|-------|-------|
+| Patient Name | |
+| MRN | |
+| Date of Birth | |
+| Sex | ☐ Male ☐ Female |
+| Location/Unit | |
+| Ordering Physician | |
+| Date of Request | |
+| Time of Request | |
+
+---
+
+## Specimen Information
+
+| Field | Entry |
+|-------|-------|
+| Date Collected | |
+| Time Collected | |
+| Collected By | |
+| Phlebotomist ID | |
+| Tube Type | ☐ EDTA ☐ Clot ☐ Both |
+| Specimen Acceptable? | ☐ Yes ☐ No (reason: _______) |
+| Previous Records Available? | ☐ Yes ☐ No ☐ N/A |
+
+---
+
+## ABO/Rh Typing
+
+### Current Sample
+
+| Test | Result | Interpretation |
+|------|--------|----------------|
+| Anti-A | ☐ Pos ☐ Neg | |
+| Anti-B | ☐ Pos ☐ Neg | |
+| Anti-D | ☐ Pos ☐ Neg | |
+| A1 Cells | ☐ Pos ☐ Neg | |
+| B Cells | ☐ Pos ☐ Neg | |
+
+**ABO Type:** ☐ A ☐ B ☐ AB ☐ O
+
+**Rh Type:** ☐ Positive ☐ Negative
+
+**Weak D Testing (if applicable):**
+☐ Not performed ☐ Positive ☐ Negative
+
+### Historical Results (if available)
+
+| Date | ABO | Rh | Source |
+|------|-----|----|--------|
+| | | | |
+| | | | |
+
+**Results Consistent?** ☐ Yes ☐ No (see discrepancy resolution)
+
+---
+
+## Antibody Screening
+
+| Field | Entry |
+|-------|-------|
+| Method | ☐ Tube ☐ Gel ☐ Solid Phase |
+| Enhancement | ☐ LISS ☐ PEG ☐ None |
+| Screen Cell Lot # | |
+| Expiration Date | |
+
+### Screen Cell Results
+
+| Cell | Immediate Spin | 37°C | AHG | CC |
+|------|----------------|------|-----|-----|
+| I | | | | |
+| II | | | | |
+| III | | | | |
+
+**Antibody Screen Result:** ☐ Negative ☐ Positive
+
+**If Positive, Antibody Identified:**
+
+---
+
+## Antibody Identification (if screening positive)
+
+| Field | Entry |
+|-------|-------|
+| Panel Lot # | |
+| Method | |
+| Antibody(ies) Identified | |
+| Clinical Significance | ☐ Yes ☐ No |
+| Phenotyped Units Required? | ☐ Yes ☐ No |
+| Phenotype Requirements | |
+
+| Panel Cell | Results | Antigen Correlation |
+|------------|---------|---------------------|
+| 1 | | |
+| 2 | | |
+| 3 | | |
+| 4 | | |
+| 5 | | |
+| 6 | | |
+| 7 | | |
+| 8 | | |
+| 9 | | |
+| 10 | | |
+| 11 | | |
+
+---
+
+## Crossmatch
+
+### Unit 1
+
+| Field | Entry |
+|-------|-------|
+| Unit Number | |
+| ABO/Rh | |
+| Expiration Date | |
+| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
+
+| Phase | Result | Interpretation |
+|-------|--------|----------------|
+| Immediate Spin | ☐ Compatible ☐ Incompatible | |
+| 37°C | ☐ Compatible ☐ Incompatible | |
+| AHG | ☐ Compatible ☐ Incompatible | |
+| Coombs Control | ☐ Valid ☐ Invalid | |
+
+**Final Result:** ☐ Compatible ☐ Incompatible
+
+### Unit 2
+
+| Field | Entry |
+|-------|-------|
+| Unit Number | |
+| ABO/Rh | |
+| Expiration Date | |
+| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
+
+| Phase | Result | Interpretation |
+|-------|--------|----------------|
+| Immediate Spin | ☐ Compatible ☐ Incompatible | |
+| 37°C | ☐ Compatible ☐ Incompatible | |
+| AHG | ☐ Compatible ☐ Incompatible | |
+| Coombs Control | ☐ Valid ☐ Invalid | |
+
+**Final Result:** ☐ Compatible ☐ Incompatible
+
+### Unit 3
+
+| Field | Entry |
+|-------|-------|
+| Unit Number | |
+| ABO/Rh | |
+| Expiration Date | |
+| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
+
+| Phase | Result | Interpretation |
+|-------|--------|----------------|
+| Immediate Spin | ☐ Compatible ☐ Incompatible | |
+| 37°C | ☐ Compatible ☐ Incompatible | |
+| AHG | ☐ Compatible ☐ Incompatible | |
+| Coombs Control | ☐ Valid ☐ Invalid | |
+
+**Final Result:** ☐ Compatible ☐ Incompatible
+
+---
+
+## Electronic Crossmatch (if applicable)
+
+| Field | Entry |
+|-------|-------|
+| Two ABO/Rh on file? | ☐ Yes ☐ No |
+| Results consistent? | ☐ Yes ☐ No |
+| Antibody screen negative? | ☐ Yes ☐ No |
+| Computer system validated? | ☐ Yes |
+
+---
+
+## Special Requirements
+
+| Requirement | Ordered? | Provided? |
+|-------------|----------|-----------|
+| CMV Negative | ☐ | ☐ |
+| Irradiated | ☐ | ☐ |
+| Leukoreduced | ☐ | ☐ |
+| Washed | ☐ | ☐ |
+| Volume Reduced | ☐ | ☐ |
+| HbS Negative | ☐ | ☐ |
+| Antigen Negative: _______ | ☐ | ☐ |
+
+---
+
+## Results Summary
+
+| Field | Entry |
+|-------|-------|
+| ABO/Rh | |
+| Antibody Screen | ☐ Negative ☐ Positive |
+| Antibodies Identified | |
+| Units Crossmatched | |
+| Units Compatible | |
+| Units Available for Issue | |
+
+---
+
+## Verification
+
+### Performed By
+
+| Field | Entry |
+|-------|-------|
+| Technologist Name | |
+| Tech ID | |
+| Date | |
+| Time | |
+| Signature | |
+
+### Reviewed By (if required)
+
+| Field | Entry |
+|-------|-------|
+| Reviewer Name | |
+| Date | |
+| Signature | |
+
+---
+
+## Discrepancy Resolution (if applicable)
+
+| Field | Entry |
+|-------|-------|
+| Type of Discrepancy | |
+| Investigation Performed | |
+| Resolution | |
+| Resolved By | |
+| Date | |
+| Supervisor Review | |
+
+---
+
+*Form FRM-BB-001 Rev 1.0 - Compatibility Testing 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*