diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..23dec6c --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,78 @@ +name: AtomicAI Animal Facility 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 Animal Facility 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 Animal Research Facility Quality Management. + + ## Your Expertise + - IACUC (Institutional Animal Care and Use Committee) protocols + - AAALAC International accreditation standards + - USDA Animal Welfare Act and regulations + - PHS Policy on Humane Care and Use of Laboratory Animals + - Animal housing and husbandry standards + - Veterinary care and monitoring protocols + - Pain and distress assessment and management + - Euthanasia methods and documentation + - Occupational health and safety for animal workers + - Breeding colony management + - Quarantine and biosecurity procedures + + ## Document Creation Guidelines + - Place Animal Care SOPs in SOPs/Animal-Care/ + - Place Veterinary Protocols in Protocols/Veterinary/ + - Place IACUC Forms in Forms/IACUC/ + - Place Training Records in Forms/Training/ + - Place Safety SOPs in SOPs/Safety/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-AC-XXX for Animal Care SOPs + - SOP-VET-XXX for Veterinary SOPs + - SOP-BIO-XXX for Biosecurity SOPs + - PRO-XXX for Protocols + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Prioritize animal welfare, regulatory compliance, and scientific validity. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Census-Tracking/.gitkeep b/Forms/Census-Tracking/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Environmental/.gitkeep b/Forms/Environmental/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..55c718a --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -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* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..6790a8f --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -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* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..45bf0b6 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -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* diff --git a/Forms/Health-Records/.gitkeep b/Forms/Health-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Health-Records/FRM-VET-001-Daily-Health-Check.md b/Forms/Health-Records/FRM-VET-001-Daily-Health-Check.md new file mode 100644 index 0000000..711fef3 --- /dev/null +++ b/Forms/Health-Records/FRM-VET-001-Daily-Health-Check.md @@ -0,0 +1,136 @@ +# Daily Animal Health Check + +| Form ID | FRM-VET-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Room/Area Information + +| Field | Entry | +|-------|-------| +| Room Number | | +| Species | | +| Date | | +| Observer Name | | +| Observer Initials | | + +## Health Observation Checklist + +For each cage/pen, check off normal observations. Circle and note any abnormalities. + +### General Colony Status + +- [ ] All animals present and accounted for +- [ ] No mortalities observed +- [ ] HVAC functioning (temp/humidity in range) +- [ ] Lighting on appropriate cycle +- [ ] No unusual odors + +### Individual Cage Assessment + +| Cage # | Animals OK | Food OK | Water OK | Abnormalities Noted | +|--------|------------|---------|----------|---------------------| +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | +| | ☐ | ☐ | ☐ | | + +## Abnormality Details + +If any abnormalities noted above, provide details: + +### Animal 1 +| Field | Entry | +|-------|-------| +| Cage # | | +| Animal ID | | +| Protocol # | | +| PI Name | | +| Clinical Signs Observed | | +| Action Taken | | +| Vet Notified? | ☐ Yes ☐ No | +| Vet Name/Time | | + +### Animal 2 +| Field | Entry | +|-------|-------| +| Cage # | | +| Animal ID | | +| Protocol # | | +| PI Name | | +| Clinical Signs Observed | | +| Action Taken | | +| Vet Notified? | ☐ Yes ☐ No | +| Vet Name/Time | | + +## Clinical Signs Reference + +Check all that apply for abnormal animals: + +**Appearance** +- [ ] Rough/unkempt coat +- [ ] Hunched posture +- [ ] Piloerection +- [ ] Lethargy +- [ ] Weight loss visible + +**Respiratory** +- [ ] Labored breathing +- [ ] Nasal discharge +- [ ] Open-mouth breathing + +**GI/Elimination** +- [ ] Diarrhea +- [ ] Blood in stool +- [ ] Bloated abdomen + +**Neurological** +- [ ] Circling +- [ ] Head tilt +- [ ] Seizures +- [ ] Ataxia + +**Other** +- [ ] Wounds/lesions +- [ ] Eye abnormalities +- [ ] Tumor growth +- [ ] Other: _______________ + +## Environmental Observations + +| Parameter | Reading | Normal Range | OK? | +|-----------|---------|--------------|-----| +| Temperature | °F/°C | Species-specific | ☐ | +| Humidity | % | 30-70% | ☐ | +| Light Cycle | :00 - :00 | Per protocol | ☐ | + +Environmental concerns noted: + +_______________________________________________ + +## Completion Verification + +| Field | Entry | +|-------|-------| +| All cages checked? | ☐ Yes | +| All abnormalities documented? | ☐ Yes ☐ N/A | +| Vet notified of concerns? | ☐ Yes ☐ N/A | +| Observer Signature | | +| Time Completed | | + +## Supervisor Review (if abnormalities noted) + +| Field | Entry | +|-------|-------| +| Reviewed By | | +| Date | | +| Comments | | + +--- + +*Form FRM-VET-001 Rev 1.0 - Daily Animal Health Check* diff --git a/Forms/IACUC-Protocols/.gitkeep b/Forms/IACUC-Protocols/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Incident-Reports/.gitkeep b/Forms/Incident-Reports/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/FRM-004-Training-Record.md b/Forms/Training/FRM-004-Training-Record.md new file mode 100644 index 0000000..b66164d --- /dev/null +++ b/Forms/Training/FRM-004-Training-Record.md @@ -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* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..ebd85dd --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,57 @@ +# 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] | diff --git a/README.md b/README.md index f8b79ff..d0a50b4 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,134 @@ -# animal-facility +# Animal Research Facility Quality Management System -A comprehensive QMS template designed for animal research facilities, vivaria, and laboratory animal care programs supporting biomedical research. \ No newline at end of file +A comprehensive QMS template designed for animal research facilities, vivaria, and laboratory animal care programs supporting biomedical research. + +## 🐭 Designed For + +- **Academic Vivaria** - University and medical center animal facilities +- **Pharmaceutical Research** - Drug discovery and preclinical testing facilities +- **Contract Research Organizations (CROs)** - Animal study service providers +- **Biotechnology Companies** - Research and development animal programs +- **Government Research Facilities** - NIH, CDC, and agency research programs +- **Veterinary Schools** - Teaching and research animal programs +- **Breeding Colonies** - Specialized genetic model production facilities + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **PHS Policy** - Public Health Service Policy on Humane Care and Use of Laboratory Animals +- **USDA/AWA** - Animal Welfare Act and Regulations (9 CFR Parts 1-4) +- **AAALAC** - Association for Assessment and Accreditation of Laboratory Animal Care International +- **IACUC** - Institutional Animal Care and Use Committee requirements +- **Guide for the Care and Use of Laboratory Animals** (8th Edition) +- **AVMA Guidelines** - Euthanasia and veterinary care standards +- **OLAW** - Office of Laboratory Animal Welfare requirements +- **GLP** - Good Laboratory Practice for regulated studies (21 CFR Part 58) +- **OSHA** - Occupational safety for animal handlers +- **CDC/NIH BMBL** - Biosafety in Microbiological and Biomedical Laboratories + +## Repository Structure + +``` +├── SOPs/ +│ ├── Animal-Care/ # Daily care, feeding, environmental enrichment +│ ├── Veterinary-Services/ # Health monitoring, treatments, euthanasia +│ ├── Colony-Management/ # Breeding, genetics, census tracking +│ ├── Facility-Operations/ # Sanitation, cage wash, environmental controls +│ ├── Safety/ # Zoonosis, allergens, occupational health +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── IACUC-Protocols/ # Protocol submission and amendment forms +│ ├── Health-Records/ # Veterinary treatment and observation logs +│ ├── Census-Tracking/ # Animal inventory and disposition records +│ ├── Environmental/ # Temperature, humidity, light cycle logs +│ ├── Training/ # Competency assessments, certifications +│ └── Incident-Reports/ # Adverse events, protocol deviations +├── Policies/ # Institutional policies and IACUC guidelines +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-AC-XXX**: Animal Care SOPs +- **SOP-VET-XXX**: Veterinary Services SOPs +- **SOP-COL-XXX**: Colony Management SOPs +- **SOP-FAC-XXX**: Facility Operations SOPs +- **SOP-SAF-XXX**: Safety SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records +- **PRO-XXX**: IACUC Protocol Templates + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your animal facility QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft species-specific SOPs for animal care and handling +- Create IACUC protocol templates and amendments +- Generate veterinary treatment and monitoring procedures +- Develop environmental enrichment programs +- Create biosafety and occupational health procedures +- Review documents for regulatory compliance + +### Example Prompts + +- "@atomicai create an SOP for rodent health monitoring per the Guide" +- "@atomicai draft a post-operative care procedure for surgical models" +- "@atomicai write an environmental enrichment policy for NHPs" +- "@atomicai create an IACUC annual review checklist" +- "@atomicai develop a quarantine procedure for incoming animals" +- "@atomicai create a controlled substance log for veterinary use" + +## Getting Started + +1. **Review IACUC Requirements** - Align policies with your institutional IACUC +2. **Customize Species SOPs** - Adapt procedures for your animal models +3. **Set Up Health Monitoring** - Configure veterinary observation forms +4. **Establish Environmental Controls** - Implement monitoring logs +5. **Train Personnel** - Use competency assessment forms + +## Key Documents to Create First + +1. **Animal Health Monitoring SOP** - Foundation for veterinary oversight +2. **Euthanasia Policy** - AVMA-compliant methods by species +3. **Environmental Enrichment Program** - Species-specific enrichment plans +4. **IACUC Protocol Template** - Standardized protocol submission format +5. **Post-Procedure Monitoring Form** - Observation and scoring records +6. **Occupational Health Program** - Staff safety and zoonosis prevention +7. **Sanitation and Cage Wash SOP** - Facility hygiene procedures + +## Special Considerations for Animal Research + +### Species-Specific Requirements +- Housing density and cage dimensions +- Environmental parameters (temp, humidity, lighting) +- Dietary requirements and feeding schedules +- Social housing and compatibility +- Enrichment appropriate to natural behaviors + +### Veterinary Care +- Regular health monitoring schedules +- Pain and distress assessment scales +- Anesthesia and analgesia protocols +- Humane endpoints and euthanasia criteria +- Emergency veterinary coverage + +### Regulatory Compliance +- IACUC protocol approval and amendments +- Annual protocol reviews and renewals +- Semi-annual facility inspections +- USDA annual reports (covered species) +- Personnel training documentation + +### Biosafety and Occupational Health +- Zoonotic disease prevention +- Allergen exposure monitoring +- Personal protective equipment +- Hazardous agent handling (if applicable) +- Medical surveillance program + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Animal-Care/.gitkeep b/SOPs/Animal-Care/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Colony-Management/.gitkeep b/SOPs/Colony-Management/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Facility-Operations/.gitkeep b/SOPs/Facility-Operations/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/SOP-001-Document-Control.md b/SOPs/General/SOP-001-Document-Control.md new file mode 100644 index 0000000..b64ef52 --- /dev/null +++ b/SOPs/General/SOP-001-Document-Control.md @@ -0,0 +1,112 @@ +# 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] | diff --git a/SOPs/General/SOP-002-CAPA.md b/SOPs/General/SOP-002-CAPA.md new file mode 100644 index 0000000..8dace85 --- /dev/null +++ b/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] | diff --git a/SOPs/General/SOP-003-Training.md b/SOPs/General/SOP-003-Training.md new file mode 100644 index 0000000..22538c1 --- /dev/null +++ b/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] | diff --git a/SOPs/General/SOP-004-Internal-Audit.md b/SOPs/General/SOP-004-Internal-Audit.md new file mode 100644 index 0000000..749d6a5 --- /dev/null +++ b/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] | diff --git a/SOPs/General/SOP-005-Management-Review.md b/SOPs/General/SOP-005-Management-Review.md new file mode 100644 index 0000000..dd82006 --- /dev/null +++ b/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] | diff --git a/SOPs/Safety/.gitkeep b/SOPs/Safety/.gitkeep new file mode 100644 index 0000000..dcf2c80 --- /dev/null +++ b/SOPs/Safety/.gitkeep @@ -0,0 +1 @@ +# Placeholder diff --git a/SOPs/Veterinary-Services/.gitkeep b/SOPs/Veterinary-Services/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Veterinary-Services/SOP-VET-001-Health-Monitoring.md b/SOPs/Veterinary-Services/SOP-VET-001-Health-Monitoring.md new file mode 100644 index 0000000..c6ba7b5 --- /dev/null +++ b/SOPs/Veterinary-Services/SOP-VET-001-Health-Monitoring.md @@ -0,0 +1,157 @@ +# Standard Operating Procedure: Animal Health Monitoring + +| Document ID | SOP-VET-001 | +|-------------|-------------| +| Title | Daily and Weekly Animal Health Monitoring | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Veterinary Services | + +--- + +## 1. Purpose + +To establish standardized procedures for monitoring the health and welfare of laboratory animals in accordance with the Guide for the Care and Use of Laboratory Animals and IACUC requirements. + +## 2. Scope + +This procedure applies to all laboratory animals housed in the facility, including: +- Rodents (mice, rats, hamsters, guinea pigs) +- Rabbits +- Large animals (as applicable) +- All other species maintained under approved protocols + +## 3. Responsibilities + +### 3.1 Animal Care Staff +- Perform daily health observations +- Document abnormal findings +- Report concerns to veterinary staff immediately + +### 3.2 Veterinary Technician +- Conduct weekly detailed health assessments +- Provide treatments as directed +- Maintain health records + +### 3.3 Attending Veterinarian +- Review health reports +- Prescribe treatments +- Make euthanasia decisions when necessary +- Report to IACUC as required + +## 4. Definitions + +| Term | Definition | +|------|------------| +| BCS | Body Condition Score - assessment of nutritional status | +| Clinical Sign | Observable indication of disease or abnormality | +| Humane Endpoint | Predetermined point at which animal is euthanized to prevent suffering | + +## 5. Equipment and Materials + +- Health observation forms +- Weighing scale (appropriate for species) +- Flashlight for cage inspection +- PPE (gloves, gown, mask as required) +- Body condition score reference charts + +## 6. Procedure + +### 6.1 Daily Health Observations + +Performed by animal care staff during routine husbandry: + +1. **General Appearance** + - [ ] Coat condition (smooth, groomed, no lesions) + - [ ] Posture (normal stance, no hunching) + - [ ] Activity level (appropriate for species/time of day) + - [ ] Respiration (no labored breathing) + +2. **Food and Water** + - [ ] Food consumption (evidence of eating) + - [ ] Water consumption (bottle/sipper functioning) + - [ ] No evidence of dehydration + +3. **Cage Environment** + - [ ] Normal fecal output + - [ ] No evidence of diarrhea + - [ ] No blood in cage + - [ ] Bedding condition adequate + +4. **Documentation** + - Record any abnormalities on Daily Health Check form + - Notify veterinary staff of concerns immediately + - Do not wait until end of shift for urgent findings + +### 6.2 Weekly Health Assessments + +Performed by veterinary technician: + +1. **Individual Animal Examination** + - Body weight (compare to baseline) + - Body condition score (1-5 scale) + - Eyes, ears, nose examination + - Skin and coat assessment + - Palpation as appropriate + +2. **Colony Health Review** + - Mortality/morbidity trends + - Sentinel animal results (if applicable) + - Environmental monitoring review + - Protocol-specific assessments + +### 6.3 Body Condition Scoring + +| Score | Description | Action | +|-------|-------------|--------| +| 1 | Emaciated - Bones prominent | Immediate vet consult | +| 2 | Underconditioned | Increase monitoring, consider intervention | +| 3 | Well-conditioned (ideal) | Continue routine care | +| 4 | Overconditioned | Dietary review | +| 5 | Obese | Dietary intervention required | + +### 6.4 Clinical Signs Requiring Immediate Veterinary Notification + +- Respiratory distress +- Severe lethargy or non-responsiveness +- Bleeding or open wounds +- Seizures +- Prolapsed organs +- Severe weight loss (>20% of baseline) +- Tumor burden exceeding protocol limits +- Signs of pain not controlled by protocol analgesia + +### 6.5 Humane Endpoint Assessment + +When clinical signs indicate potential endpoint: + +1. Assess against protocol-specific humane endpoints +2. Calculate combined clinical score if applicable +3. Consult veterinarian immediately +4. Document assessment and decision +5. Proceed with euthanasia if criteria met + +## 7. Documentation + +All health observations must be documented: +- **Daily observations**: FRM-VET-001 Daily Health Check +- **Weekly assessments**: FRM-VET-002 Weekly Health Assessment +- **Abnormal findings**: FRM-VET-003 Veterinary Treatment Record +- **Euthanasia**: FRM-VET-004 Euthanasia Record + +## 8. References + +- Guide for the Care and Use of Laboratory Animals (8th Edition) +- AVMA Guidelines for the Euthanasia of Animals +- Institutional IACUC policies +- Species-specific husbandry guides + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..2e9f35e --- /dev/null +++ b/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] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..68167f1 --- /dev/null +++ b/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] |