Sync template from atomicqms-style deployment
This commit is contained in:
0
Forms/Competency/.gitkeep
Normal file
0
Forms/Competency/.gitkeep
Normal file
64
Forms/FRM-001-Document-Change-Request.md
Normal file
64
Forms/FRM-001-Document-Change-Request.md
Normal file
@@ -0,0 +1,64 @@
|
||||
# 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*
|
||||
91
Forms/FRM-003-CAPA-Form.md
Normal file
91
Forms/FRM-003-CAPA-Form.md
Normal file
@@ -0,0 +1,91 @@
|
||||
# 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*
|
||||
56
Forms/FRM-006-Audit-Checklist.md
Normal file
56
Forms/FRM-006-Audit-Checklist.md
Normal file
@@ -0,0 +1,56 @@
|
||||
# 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*
|
||||
0
Forms/Grossing-Templates/.gitkeep
Normal file
0
Forms/Grossing-Templates/.gitkeep
Normal file
0
Forms/Incident-Reports/.gitkeep
Normal file
0
Forms/Incident-Reports/.gitkeep
Normal file
0
Forms/QC-Records/.gitkeep
Normal file
0
Forms/QC-Records/.gitkeep
Normal file
0
Forms/Report-Templates/.gitkeep
Normal file
0
Forms/Report-Templates/.gitkeep
Normal file
0
Forms/Requisition-Forms/.gitkeep
Normal file
0
Forms/Requisition-Forms/.gitkeep
Normal file
196
Forms/Specimen-Tracking/FRM-PATH-001-Specimen-Receipt-Log.md
Normal file
196
Forms/Specimen-Tracking/FRM-PATH-001-Specimen-Receipt-Log.md
Normal file
@@ -0,0 +1,196 @@
|
||||
# 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*
|
||||
72
Forms/Training/FRM-004-Training-Record.md
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
@@ -0,0 +1,72 @@
|
||||
# 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*
|
||||
Reference in New Lab Ticket
Block a user