Sync template from atomicqms-style deployment

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name: AtomicAI Mental Health Inpatient 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_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.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 Mental Health Inpatient 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 Mental Health Inpatient Quality Management.
## Your Expertise
- Psychiatric hospital accreditation (Joint Commission, CMS)
- Involuntary commitment and patient rights
- Seclusion and restraint policies and documentation
- Acute psychiatric stabilization protocols
- Suicide precautions and observation levels
- Medication administration in psychiatric settings
- Milieu therapy and unit safety
- Discharge planning and aftercare coordination
- Behavioral emergency response (Code Green)
- 42 CFR Part 2 and HIPAA compliance
## Document Creation Guidelines
- Place Clinical SOPs in SOPs/Clinical/
- Place Safety SOPs in SOPs/Safety/
- Place Emergency Protocols in Protocols/Emergency/
- Place Nursing SOPs in SOPs/Nursing/
- Place Patient Rights in Policies/Patient-Rights/
- Place Assessment Forms in Forms/Assessment/
## Numbering Convention
- SOP-PSY-XXX for Psychiatric SOPs
- SOP-SAF-XXX for Safety SOPs
- SOP-NUR-XXX for Nursing SOPs
- PRO-EMR-XXX for Emergency Protocols
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize patient safety, dignity, and least restrictive interventions.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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# Inpatient Safety Assessment
| Form ID | FRM-MHI-002 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Unit/Room | |
| Admission Date | |
| Date of Assessment | |
| Time of Assessment | |
| Assessor Name | |
| Assessor Credentials | |
---
## Suicide Risk Assessment
### Current Suicidal Ideation
| Question | Response |
|----------|----------|
| Are you having thoughts of suicide or self-harm? | ☐ Yes ☐ No |
| If yes, how often? | ☐ Fleeting ☐ Intermittent ☐ Persistent |
| How strong is the urge to act on these thoughts? | ☐ None ☐ Mild ☐ Moderate ☐ Strong ☐ Overwhelming |
| Do you have a plan? | ☐ Yes ☐ No |
| If yes, describe plan: | |
| Do you have access to means? | ☐ Yes ☐ No |
| Do you intend to act on these thoughts? | ☐ Yes ☐ No ☐ Ambivalent |
### Suicidal Behaviors
| Behavior | Present |
|----------|---------|
| Recent suicide attempt (within 30 days) | ☐ Yes ☐ No |
| If yes, date and method: | |
| Interrupted or aborted attempt | ☐ Yes ☐ No |
| Preparatory behaviors (writing note, giving away possessions, etc.) | ☐ Yes ☐ No |
### Historical Risk Factors
| Factor | Present |
|--------|---------|
| Previous suicide attempt(s) | ☐ Yes ☐ No |
| If yes, number and methods: | |
| Self-harm without suicidal intent | ☐ Yes ☐ No |
| Family history of suicide | ☐ Yes ☐ No |
| Previous psychiatric hospitalization | ☐ Yes ☐ No |
### Clinical Risk Factors
| Factor | Present |
|--------|---------|
| Depression | ☐ Yes ☐ No |
| Hopelessness | ☐ Yes ☐ No |
| Anxiety/agitation | ☐ Yes ☐ No |
| Psychosis | ☐ Yes ☐ No |
| Command hallucinations (self-harm) | ☐ Yes ☐ No |
| Intoxication/withdrawal | ☐ Yes ☐ No |
| Chronic pain/medical illness | ☐ Yes ☐ No |
| Recent discharge from psychiatric hospital | ☐ Yes ☐ No |
| Insomnia | ☐ Yes ☐ No |
### Precipitating Factors
| Factor | Present |
|--------|---------|
| Recent loss (relationship, job, housing) | ☐ Yes ☐ No |
| Recent humiliation/shame | ☐ Yes ☐ No |
| Legal problems | ☐ Yes ☐ No |
| Financial problems | ☐ Yes ☐ No |
| Anniversary of loss | ☐ Yes ☐ No |
| Other: | ☐ Yes ☐ No |
### Protective Factors
| Factor | Present |
|--------|---------|
| Reasons for living | ☐ Yes ☐ No |
| Future orientation | ☐ Yes ☐ No |
| Social support | ☐ Yes ☐ No |
| Religious/spiritual beliefs against suicide | ☐ Yes ☐ No |
| Responsibility for children/pets | ☐ Yes ☐ No |
| Fear of death/pain | ☐ Yes ☐ No |
| Engaged in treatment | ☐ Yes ☐ No |
| Therapeutic alliance | ☐ Yes ☐ No |
### Suicide Risk Level
**Low Risk** - No current ideation, few risk factors, strong protective factors
**Moderate Risk** - Ideation without plan/intent, some risk factors, some protective factors
**High Risk** - Ideation with plan, intent, access to means; multiple risk factors; few protective factors
**Imminent Risk** - Immediate danger, requires 1:1 observation
---
## Violence/Homicide Risk Assessment
### Current Homicidal/Violent Ideation
| Question | Response |
|----------|----------|
| Are you having thoughts of hurting someone else? | ☐ Yes ☐ No |
| Is there a specific person? | ☐ Yes ☐ No |
| If yes, identify: | |
| Do you have a plan to harm this person? | ☐ Yes ☐ No |
| Do you have access to weapons? | ☐ Yes ☐ No |
| Do you intend to act on these thoughts? | ☐ Yes ☐ No |
### Historical Risk Factors
| Factor | Present |
|--------|---------|
| History of violence | ☐ Yes ☐ No |
| History of weapons use | ☐ Yes ☐ No |
| Criminal history | ☐ Yes ☐ No |
| History of impulsive behavior | ☐ Yes ☐ No |
| Childhood conduct disorder | ☐ Yes ☐ No |
| Victim of abuse/violence | ☐ Yes ☐ No |
### Clinical Risk Factors
| Factor | Present |
|--------|---------|
| Command hallucinations (violence) | ☐ Yes ☐ No |
| Paranoid delusions | ☐ Yes ☐ No |
| Manic symptoms | ☐ Yes ☐ No |
| Active substance use | ☐ Yes ☐ No |
| Medication non-adherence | ☐ Yes ☐ No |
| Lack of insight | ☐ Yes ☐ No |
### Situational Factors
| Factor | Present |
|--------|---------|
| Active interpersonal conflict | ☐ Yes ☐ No |
| Perceived threats | ☐ Yes ☐ No |
| Access to potential victims | ☐ Yes ☐ No |
| History with identified target | ☐ Yes ☐ No |
### Violence Risk Level
**Low Risk** - No ideation, few risk factors
**Moderate Risk** - General ideation, some risk factors
**High Risk** - Specific ideation, identified target, plan, multiple risk factors
### Duty to Warn/Protect
| Field | Entry |
|-------|-------|
| Is there an identifiable potential victim? | ☐ Yes ☐ No |
| Has duty to warn been triggered? | ☐ Yes ☐ No |
| If yes, actions taken: | |
| Notification date/time: | |
| Law enforcement notified? | ☐ Yes ☐ No |
| Potential victim notified? | ☐ Yes ☐ No |
---
## Self-Harm Risk Assessment
| Question | Response |
|----------|----------|
| Are you having urges to hurt yourself (without suicidal intent)? | ☐ Yes ☐ No |
| Method typically used: | |
| When did you last engage in self-harm? | |
| What triggers self-harm urges? | |
| How do you typically cope with these urges? | |
---
## Elopement/AWOL Risk
| Factor | Present |
|--------|---------|
| Expressed desire to leave AMA | ☐ Yes ☐ No |
| Involuntary admission status | ☐ Yes ☐ No |
| History of elopement | ☐ Yes ☐ No |
| Agitation or restlessness | ☐ Yes ☐ No |
| External pressures to leave | ☐ Yes ☐ No |
| Poor insight into need for treatment | ☐ Yes ☐ No |
### Elopement Risk Level
☐ Low ☐ Moderate ☐ High
---
## Fall Risk Assessment
| Factor | Points | Present |
|--------|--------|---------|
| Age 65+ | 2 | ☐ |
| History of falls | 3 | ☐ |
| Impaired gait/balance | 2 | ☐ |
| Psychotropic medications | 2 | ☐ |
| Sedation | 2 | ☐ |
| Confusion/disorientation | 2 | ☐ |
| Sensory impairment | 1 | ☐ |
| Toileting frequency | 1 | ☐ |
| **Total Score** | | |
**Risk Level:** ☐ Low (0-4) ☐ Moderate (5-9) ☐ High (10+)
---
## Assigned Precautions
### Observation Level
☐ 1:1 Continuous (within arm's reach)
☐ 1:1 Visual (constant visual)
☐ Close observation (q5-15 min)
☐ Routine observation (q15-30 min)
☐ Open
### Additional Precautions
| Precaution | Ordered |
|------------|---------|
| Suicide precautions | ☐ |
| Self-harm precautions | ☐ |
| Violence precautions | ☐ |
| Elopement precautions | ☐ |
| Fall precautions | ☐ |
| Seizure precautions | ☐ |
| Aspiration precautions | ☐ |
| Assault precautions | ☐ |
### Environmental Modifications
☐ Safety room (ligature-resistant)
☐ Remove sharps from access
☐ Remove potential ligature materials
☐ Supervised shaving
☐ Supervised meals (plastic utensils)
☐ Other: _____________
---
## Plan
**Immediate Safety Interventions:**
**Recommended Observation Level:**
**Rationale for Level:**
**Reassessment Schedule:**
☐ Every shift
☐ Daily
☐ Other: _____________
---
## Physician Review
| Field | Entry |
|-------|-------|
| Physician Name | |
| Date/Time Reviewed | |
| Agrees with Assessment | ☐ Yes ☐ No |
| Orders Modified? | ☐ Yes ☐ No |
| Modifications: | |
| Signature | |
---
## Reassessment Log
| Date/Time | Assessor | Risk Level Change | New Observation Level | Signature |
|-----------|----------|-------------------|----------------------|-----------|
| | | ☐ Yes ☐ No | | |
| | | ☐ Yes ☐ No | | |
| | | ☐ Yes ☐ No | | |
| | | ☐ Yes ☐ No | | |
---
*Form FRM-MHI-002 Rev 1.0 - Inpatient Safety Assessment*

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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*

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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*

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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*

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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*

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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] |

134
README.md
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# mental-health-inpatient # Mental Health Inpatient Services Quality Management System
A comprehensive QMS template designed for psychiatric hospitals, inpatient behavioral health units, and acute psychiatric care facilities. A comprehensive QMS template designed for psychiatric hospitals, inpatient behavioral health units, and acute psychiatric care facilities.
## 🏥 Designed For
- **Psychiatric Hospitals** - Freestanding behavioral health facilities
- **Hospital Psychiatric Units** - Inpatient psych units within general hospitals
- **Crisis Stabilization Units** - Short-term acute psychiatric care
- **Child/Adolescent Psychiatric Units** - Pediatric behavioral health
- **Geriatric Psychiatric Units** - Older adult mental health care
- **Forensic Psychiatric Facilities** - Court-ordered treatment settings
- **Residential Treatment Centers** - Extended care facilities
## 📋 Regulatory Framework
This template supports compliance with:
- **The Joint Commission** - Behavioral Health Care accreditation
- **CMS Conditions of Participation** - Psychiatric hospital requirements
- **State Mental Health Authority** - State licensing regulations
- **42 CFR Part 482** - Hospital Conditions of Participation
- **HIPAA** - Patient privacy requirements
- **EMTALA** - Emergency psychiatric presentations
- **State Commitment Laws** - Involuntary treatment regulations
- **APA Practice Guidelines** - Psychiatric treatment standards
- **NPSG** - National Patient Safety Goals (behavioral health)
- **Nurse Practice Act** - Psychiatric nursing regulations
## Repository Structure
```
├── SOPs/
│ ├── Admission-Discharge/ # Voluntary/involuntary admission, discharge planning
│ ├── Assessment/ # Psychiatric evaluation, risk assessment, treatment planning
│ ├── Safety/ # Suicide prevention, elopement, environmental safety
│ ├── Restraint-Seclusion/ # Use, monitoring, debriefing, documentation
│ ├── Medication/ # Psychotropic meds, PRN protocols, monitoring
│ └── General/ # Document control, training, CAPA
├── Forms/
│ ├── Admission-Forms/ # Consent, legal status, voluntary/involuntary
│ ├── Assessment-Tools/ # PHQ-9, GAD-7, Columbia, mental status
│ ├── Safety-Plans/ # Suicide safety plans, precaution levels
│ ├── Restraint-Records/ # Restraint/seclusion orders, monitoring logs
│ ├── Treatment-Plans/ # Individualized treatment plans, goals
│ └── Training/ # Competency assessments
├── Policies/ # Institutional policies
├── Work-Instructions/ # Step-by-step procedures
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-ADM-XXX**: Admission/Discharge SOPs
- **SOP-ASM-XXX**: Assessment SOPs
- **SOP-SAF-XXX**: Safety SOPs
- **SOP-RS-XXX**: Restraint/Seclusion SOPs
- **SOP-MED-XXX**: Medication SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## 🤖 AI-Powered Assistance
This repository includes **AtomicAI**, your mental health QMS assistant. Mention `@atomicai` in any issue or pull request to:
- Draft admission and assessment procedures
- Create suicide risk assessment protocols
- Generate restraint/seclusion procedures
- Develop medication management SOPs
- Create safety and elopement prevention plans
- Review documents for Joint Commission compliance
### Example Prompts
- "@atomicai create an SOP for suicide risk assessment using Columbia-Suicide Severity Rating Scale"
- "@atomicai draft an involuntary admission procedure per state requirements"
- "@atomicai write a restraint/seclusion policy meeting CMS requirements"
- "@atomicai create a psychiatric medication monitoring protocol"
- "@atomicai develop an elopement prevention and response procedure"
- "@atomicai create a therapeutic milieu safety checklist"
## Getting Started
1. **Align with State Laws** - Review involuntary commitment and patient rights laws
2. **Establish Safety Protocols** - Implement suicide prevention and environmental safety
3. **Define Assessment Standards** - Standardize psychiatric evaluation tools
4. **Set Up Medication Monitoring** - Configure psychotropic medication protocols
5. **Train Staff** - Crisis intervention and de-escalation training
## Key Documents to Create First
1. **Suicide Risk Assessment SOP** - Standardized screening and intervention
2. **Involuntary Admission Procedure** - Legal holds and commitment process
3. **Restraint and Seclusion Policy** - CMS-compliant R/S procedures
4. **Environmental Safety Checklist** - Ligature risk and contraband
5. **Elopement Prevention SOP** - Risk assessment and precautions
6. **Treatment Planning SOP** - Individualized treatment plan development
7. **Discharge Planning Procedure** - Safe transitions and aftercare
## Special Considerations for Psychiatric Inpatient Care
### Patient Safety
- Suicide risk screening and assessment
- Environmental safety (ligature points, sharps)
- Contraband prevention and searches
- Elopement risk and prevention
- Patient supervision levels
### Legal and Rights
- Voluntary vs. involuntary status
- Informed consent for treatment
- Patient rights notification
- Grievance procedures
- Advance directives and healthcare proxies
### Restraint and Seclusion
- Least restrictive interventions
- Physician orders and time limits
- Continuous monitoring requirements
- Debriefing and documentation
- Reduction initiatives
### Treatment
- Psychiatric evaluation and diagnosis
- Treatment plan development
- Medication management and monitoring
- Group and individual therapy
- Discharge planning and aftercare
---
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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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] |

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# 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] |

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# 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] |

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# 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] |

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# 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] |

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# Standard Operating Procedure: Psychiatric Inpatient Admission and Assessment
| Document ID | SOP-MHI-001 |
|-------------|-------------|
| Title | Psychiatric Inpatient Admission and Comprehensive Assessment |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Inpatient Psychiatry |
---
## 1. Purpose
To establish standardized procedures for the admission and comprehensive psychiatric assessment of patients to the inpatient psychiatric unit, ensuring safety, regulatory compliance, and appropriate treatment planning.
## 2. Scope
This procedure applies to all psychiatric inpatient admissions including:
- Voluntary admissions
- Involuntary/emergency detentions
- Transfers from other facilities
- Forensic admissions
- Medical clearance requirements
## 3. Responsibilities
### 3.1 Admitting Psychiatrist
- Conduct psychiatric evaluation
- Determine admission criteria met
- Establish initial treatment plan
- Complete admission documentation
### 3.2 Nursing Staff
- Conduct nursing admission assessment
- Complete safety assessment and precautions
- Inventory personal belongings
- Orient patient to unit
### 3.3 Social Worker
- Conduct psychosocial assessment
- Contact family/supports
- Begin discharge planning
- Assess resource needs
### 3.4 Mental Health Technicians
- Assist with admission process
- Implement observation levels
- Secure patient belongings
## 4. Definitions
| Term | Definition |
|------|------------|
| Voluntary Admission | Patient consents to hospitalization |
| Involuntary Hold | Legal detention for evaluation/treatment without consent |
| 1:1 Observation | Continuous direct observation by staff member |
| Elopement Precautions | Measures to prevent unauthorized departure |
| Medical Clearance | Confirmation patient is medically stable for psychiatric unit |
## 5. Procedure
### 5.1 Pre-Admission Requirements
#### 5.1.1 Medical Clearance
Before admission to psychiatric unit, patient must have:
- [ ] Medical history and physical examination
- [ ] Vital signs within acceptable parameters
- [ ] Laboratory studies per protocol
- [ ] Medical conditions stabilized or treatment plan in place
- [ ] Clearance from ED physician or medicine consultant
**Minimum Laboratory Studies:**
| Test | Required |
|------|----------|
| Complete Blood Count | ☐ |
| Comprehensive Metabolic Panel | ☐ |
| Urinalysis | ☐ |
| Urine Drug Screen | ☐ |
| Blood Alcohol Level | ☐ |
| Pregnancy Test (if applicable) | ☐ |
| Additional (as indicated) | |
#### 5.1.2 Legal Status Determination
| Status | Documentation Required |
|--------|------------------------|
| Voluntary | Signed voluntary admission form |
| Involuntary | Completed legal detention documents, physician certification |
| Court-Ordered | Court order, sheriff documentation |
| Minor | Parent/guardian consent OR court order |
### 5.2 Admission Process
#### 5.2.1 Patient Arrival
1. Greet patient and escort to admission area
2. Verify identity with two identifiers
3. Confirm legal status and documentation
4. Apply identification band
#### 5.2.2 Safety Search and Contraband Removal
**Required for all admissions:**
- [ ] Wand metal detector screening
- [ ] Personal search (same-gender staff)
- [ ] Belongings search
- [ ] Remove and secure contraband
**Contraband List:**
| Always Remove | Document Securely |
|--------------|-------------------|
| Sharps, blades | Medications |
| Ligature materials (belts, cords, laces) | Valuables |
| Drugs/alcohol | Electronics (per policy) |
| Weapons | Lighters/matches |
| Glass items | |
Document all items on FRM-MHI-001 Belongings Inventory.
#### 5.2.3 Observation Level Assignment
| Level | Criteria | Monitoring |
|-------|----------|------------|
| 1:1 Continuous | Active suicidal/homicidal, severe agitation | Within arm's reach |
| Close Observation | Recent attempt, high risk | Every 5-15 minutes |
| Routine | Low/moderate risk | Every 15-30 minutes |
| Open | No safety concerns | Per unit routine |
### 5.3 Psychiatric Evaluation
#### 5.3.1 Comprehensive Psychiatric Assessment
**Required within 24 hours of admission:**
1. **Chief Complaint and History of Present Illness**
- Current symptoms and duration
- Precipitating events
- Previous episodes
- Current stressors
2. **Psychiatric History**
- Previous diagnoses
- Hospitalizations
- Outpatient treatment
- Medication trials
- ECT or other treatments
3. **Suicide/Violence Risk Assessment**
**Suicide Risk:**
| Factor | Present |
|--------|---------|
| Current ideation | ☐ Yes ☐ No |
| Plan | ☐ Yes ☐ No |
| Intent | ☐ Yes ☐ No |
| Access to means | ☐ Yes ☐ No |
| Previous attempts | ☐ Yes ☐ No |
| Protective factors | |
**Violence Risk:**
| Factor | Present |
|--------|---------|
| Homicidal ideation | ☐ Yes ☐ No |
| Identified target | ☐ Yes ☐ No |
| History of violence | ☐ Yes ☐ No |
| Command hallucinations | ☐ Yes ☐ No |
| Access to weapons | ☐ Yes ☐ No |
4. **Substance Use History**
- Substances used
- Quantity, frequency, route
- Last use
- Withdrawal history
- Treatment history
5. **Medical History**
- Chronic conditions
- Current medications
- Allergies
- Recent medical issues
6. **Family History**
- Psychiatric disorders
- Substance use disorders
- Suicide history
7. **Social/Developmental History**
- Education
- Employment
- Living situation
- Relationships
- Legal history
- Trauma history
8. **Mental Status Examination**
| Domain | Findings |
|--------|----------|
| Appearance | |
| Behavior | |
| Speech | |
| Mood | |
| Affect | |
| Thought Process | |
| Thought Content | |
| Perceptions | |
| Cognition | |
| Insight | |
| Judgment | |
9. **Diagnosis (DSM-5)**
- Primary diagnosis
- Secondary diagnoses
- Medical conditions
- Psychosocial stressors
### 5.4 Nursing Admission Assessment
Complete within **8 hours** of admission:
- [ ] Vital signs
- [ ] Pain assessment
- [ ] Fall risk assessment
- [ ] Skin assessment
- [ ] Nutritional screen
- [ ] Medication reconciliation
- [ ] Allergies verified
- [ ] Current symptoms
- [ ] Functional status
- [ ] Sleep patterns
- [ ] Safety precautions implemented
### 5.5 Treatment Planning
#### 5.5.1 Initial Treatment Plan (within 24 hours)
- Provisional diagnoses
- Initial medication orders
- Observation level
- Activity level
- Diet
- Laboratory/diagnostic orders
- Consultation requests
- Initial goals
#### 5.5.2 Comprehensive Treatment Plan (within 72 hours)
- Multidisciplinary input
- Patient participation
- Measurable goals
- Interventions by discipline
- Discharge criteria
- Estimated length of stay
### 5.6 Patient Rights and Orientation
#### 5.6.1 Rights Information
Provide and document receipt of:
- [ ] Patient rights document
- [ ] Grievance procedure
- [ ] Privacy practices
- [ ] Voluntary/involuntary rights specific to status
- [ ] Right to refuse treatment (voluntary)
- [ ] Advance directive information
#### 5.6.2 Unit Orientation
- [ ] Room assignment
- [ ] Unit layout (exits, bathroom, common areas)
- [ ] Schedule (meals, groups, visiting)
- [ ] Rules and expectations
- [ ] How to contact staff
- [ ] Telephone use
- [ ] Personal belongings policy
### 5.7 Special Populations
#### 5.7.1 Minors
- Parental/guardian involvement
- Age-appropriate assessments
- Educational needs assessment
- Child protective services notification if indicated
#### 5.7.2 Geriatric Patients
- Enhanced medical monitoring
- Cognitive assessment
- Fall precautions
- Medication review for appropriateness
#### 5.7.3 Forensic Patients
- Legal hold documentation
- Notification requirements
- Security considerations
- Court date tracking
## 6. Documentation
- FRM-MHI-001 Belongings Inventory
- FRM-MHI-002 Admission Safety Assessment
- FRM-MHI-003 Suicide Risk Assessment
- Psychiatric Evaluation
- Nursing Admission Assessment
- Social Work Assessment
- Treatment Plan
- Patient Rights Acknowledgment
## 7. Regulatory Compliance
| Regulation | Requirement |
|------------|-------------|
| The Joint Commission | Assessment within 24 hours |
| CMS | Treatment plan within 72 hours |
| State Mental Health Code | Involuntary hold procedures |
| EMTALA | Medical screening examination |
## 8. References
- State mental health statutes
- The Joint Commission standards
- CMS Conditions of Participation
- Institutional policies
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Placeholder

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# 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] |

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# 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] |