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name: AtomicAI Mental Health Outpatient 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 Outpatient 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 Outpatient Quality Management.
## Your Expertise
- Behavioral health accreditation (Joint Commission BHC, CARF)
- Outpatient mental health treatment protocols
- Crisis intervention and safety planning
- Suicide risk assessment procedures
- Psychiatric medication management
- Therapy documentation standards
- HIPAA and 42 CFR Part 2 (substance abuse confidentiality)
- Telehealth/telepsychiatry protocols
- Group therapy and intensive outpatient programs
## Document Creation Guidelines
- Place Clinical SOPs in SOPs/Clinical/
- Place Crisis Protocols in Protocols/Crisis/
- Place Therapy SOPs in SOPs/Therapy/
- Place Safety Plans in Forms/Safety/
- Place Assessment Forms in Forms/Assessment/
- Place Policies in Policies/
## Numbering Convention
- SOP-MH-XXX for Mental Health SOPs
- SOP-CRS-XXX for Crisis SOPs
- PRO-XXX for Treatment Protocols
- ASM-XXX for Assessment Tools
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize patient safety, confidentiality, and evidence-based practices.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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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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# Mental Health New Patient Intake Form
| Form ID | FRM-MHO-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Last Name | |
| First Name | |
| Preferred Name | |
| Date of Birth | |
| Age | |
| Sex | ☐ Male ☐ Female ☐ Other |
| Gender Identity | |
| Pronouns | |
### Contact Information
| Field | Entry |
|-------|-------|
| Address | |
| City, State, ZIP | |
| Home Phone | |
| Cell Phone | |
| Email | |
| Preferred Contact Method | ☐ Home ☐ Cell ☐ Email |
| OK to Leave Detailed Message? | ☐ Yes ☐ No |
---
## Emergency Contact
| Field | Entry |
|-------|-------|
| Name | |
| Relationship | |
| Phone | |
| Address | |
---
## Referral Information
| Field | Entry |
|-------|-------|
| Referred By | |
| Referring Provider Phone | |
| Primary Care Physician | |
| PCP Phone/Fax | |
| Current Therapist (if any) | |
| Current Prescriber (if any) | |
---
## Reason for Seeking Treatment
**What brings you in for treatment today?**
**What are your main symptoms or concerns?**
**When did these symptoms start?**
**What do you hope to get out of treatment?**
---
## Symptom Checklist
*Check all symptoms you are currently experiencing:*
### Mood Symptoms
☐ Depressed mood
☐ Loss of interest/pleasure
☐ Hopelessness
☐ Guilt
☐ Irritability
☐ Mood swings
☐ Elevated/euphoric mood
☐ Decreased need for sleep
☐ Racing thoughts
☐ Increased energy
### Anxiety Symptoms
☐ Excessive worry
☐ Restlessness
☐ Difficulty concentrating
☐ Muscle tension
☐ Sleep problems
☐ Panic attacks
☐ Fear of social situations
☐ Specific phobias
☐ Obsessive thoughts
☐ Compulsive behaviors
### Trauma Symptoms
☐ Flashbacks/intrusive memories
☐ Nightmares
☐ Avoiding reminders of trauma
☐ Emotional numbness
☐ Hypervigilance
☐ Easily startled
### Psychotic Symptoms
☐ Hearing voices
☐ Seeing things others don't see
☐ Paranoid thoughts
☐ Unusual beliefs
☐ Confused thinking
### Other Symptoms
☐ Difficulty concentrating
☐ Memory problems
☐ Impulsivity
☐ Anger problems
☐ Relationship difficulties
☐ Work/school problems
☐ Appetite changes
☐ Weight changes
☐ Fatigue/low energy
☐ Chronic pain
---
## Suicidal/Self-Harm History
| Question | Response |
|----------|----------|
| Are you currently having thoughts of suicide? | ☐ Yes ☐ No |
| Are you currently having thoughts of harming yourself? | ☐ Yes ☐ No |
| Have you ever attempted suicide? | ☐ Yes ☐ No |
| If yes, when and how? | |
| Have you ever engaged in self-harm (cutting, burning, etc.)? | ☐ Yes ☐ No |
| If yes, describe: | |
---
## Psychiatric History
### Previous Treatment
| Treatment Type | Yes/No | Where | When | Helpful? |
|----------------|--------|-------|------|----------|
| Outpatient therapy | ☐ | | | ☐ Yes ☐ No |
| Outpatient psychiatry | ☐ | | | ☐ Yes ☐ No |
| Intensive outpatient (IOP) | ☐ | | | ☐ Yes ☐ No |
| Partial hospitalization (PHP) | ☐ | | | ☐ Yes ☐ No |
| Psychiatric hospitalization | ☐ | | | ☐ Yes ☐ No |
| Residential treatment | ☐ | | | ☐ Yes ☐ No |
| ECT | ☐ | | | ☐ Yes ☐ No |
| TMS | ☐ | | | ☐ Yes ☐ No |
### Previous Diagnoses
*Check all that you have been diagnosed with:*
☐ Depression
☐ Bipolar Disorder
☐ Anxiety Disorder
☐ Panic Disorder
☐ PTSD
☐ OCD
☐ ADHD
☐ Schizophrenia/Schizoaffective
☐ Personality Disorder (type: _______)
☐ Eating Disorder
☐ Substance Use Disorder
☐ Autism Spectrum Disorder
☐ Other: _______________
---
## Current Medications
| Medication | Dose | Frequency | Prescriber |
|------------|------|-----------|------------|
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
### Past Psychiatric Medications
*List medications you have tried in the past:*
| Medication | Helpful? | Side Effects? | Reason Stopped |
|------------|----------|---------------|----------------|
| | ☐ Yes ☐ No | | |
| | ☐ Yes ☐ No | | |
| | ☐ Yes ☐ No | | |
| | ☐ Yes ☐ No | | |
---
## Allergies
☐ No Known Allergies
| Medication/Substance | Reaction |
|---------------------|----------|
| | |
| | |
---
## Substance Use History
| Substance | Ever Used | Age First Used | Current Use | Amount/Frequency | Last Used |
|-----------|-----------|----------------|-------------|------------------|-----------|
| Alcohol | ☐ | | ☐ | | |
| Marijuana/Cannabis | ☐ | | ☐ | | |
| Cocaine/Crack | ☐ | | ☐ | | |
| Heroin/Opioids | ☐ | | ☐ | | |
| Methamphetamine | ☐ | | ☐ | | |
| Benzodiazepines (non-Rx) | ☐ | | ☐ | | |
| Tobacco/Nicotine | ☐ | | ☐ | | |
| Other: | ☐ | | ☐ | | |
**Have you ever had treatment for substance use?** ☐ Yes ☐ No
If yes, describe:
---
## Medical History
### Current Medical Conditions
☐ None
| Condition | Notes |
|-----------|-------|
| | |
| | |
| | |
### Past Surgeries/Hospitalizations
| Surgery/Hospitalization | Year |
|------------------------|------|
| | |
| | |
### For Women
| Field | Entry |
|-------|-------|
| Are you pregnant? | ☐ Yes ☐ No ☐ Maybe |
| Are you breastfeeding? | ☐ Yes ☐ No |
| Last menstrual period | |
| Using contraception? | ☐ Yes ☐ No |
---
## Family Psychiatric History
*Check all that apply to biological relatives:*
| Condition | Mother | Father | Sibling | Grandparent | Other |
|-----------|--------|--------|---------|-------------|-------|
| Depression | ☐ | ☐ | ☐ | ☐ | ☐ |
| Bipolar Disorder | ☐ | ☐ | ☐ | ☐ | ☐ |
| Anxiety | ☐ | ☐ | ☐ | ☐ | ☐ |
| Schizophrenia | ☐ | ☐ | ☐ | ☐ | ☐ |
| Substance Abuse | ☐ | ☐ | ☐ | ☐ | ☐ |
| Suicide/Attempt | ☐ | ☐ | ☐ | ☐ | ☐ |
| ADHD | ☐ | ☐ | ☐ | ☐ | ☐ |
| Other: | ☐ | ☐ | ☐ | ☐ | ☐ |
---
## Social History
### Living Situation
| Field | Entry |
|-------|-------|
| Who do you live with? | |
| Type of housing | ☐ Own ☐ Rent ☐ With family ☐ Homeless ☐ Other |
| Housing stability | ☐ Stable ☐ At risk ☐ Unstable |
### Relationships
| Field | Entry |
|-------|-------|
| Marital/Relationship status | ☐ Single ☐ Married ☐ Partnered ☐ Divorced ☐ Widowed |
| Children (ages) | |
| Quality of relationships | ☐ Good ☐ Fair ☐ Poor |
| Social support | ☐ Strong ☐ Some ☐ Limited ☐ None |
### Education/Employment
| Field | Entry |
|-------|-------|
| Highest education | |
| Current employment | ☐ Full-time ☐ Part-time ☐ Unemployed ☐ Disabled ☐ Retired ☐ Student |
| Occupation | |
| Work/school problems? | ☐ Yes ☐ No |
### Legal
| Field | Entry |
|-------|-------|
| Current legal issues? | ☐ Yes ☐ No |
| If yes, describe: | |
| History of incarceration? | ☐ Yes ☐ No |
### Trauma History
*Have you experienced any of the following?*
☐ Physical abuse
☐ Sexual abuse
☐ Emotional/verbal abuse
☐ Neglect
☐ Domestic violence
☐ Witnessed violence
☐ Military combat
☐ Serious accident
☐ Natural disaster
☐ Other trauma: _______________
---
## Current Stressors
*Rate your current stress level (1-10):* _____
*What are your main stressors right now?*
---
## Strengths and Supports
*What are your strengths?*
*Who are your supports (family, friends, community)?*
*What coping strategies do you currently use?*
---
## Goals for Treatment
*What would you like to accomplish through treatment?*
1.
2.
3.
---
## Signature
| Field | Entry |
|-------|-------|
| Patient Signature | |
| Date | |
| Guardian Signature (if minor) | |
| Relationship to Patient | |
---
## For Office Use
| Field | Entry |
|-------|-------|
| Date Received | |
| Entered By | |
| Appointment Date | |
| Assigned Provider | |
| Notes | |
---
*Form FRM-MHO-001 Rev 1.0 - Mental Health New Patient Intake Form*

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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] |

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# mental-health-outpatient
# Mental Health Outpatient Services Quality Management System
A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices.
A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices.
## 🧠 Designed For
- **Community Mental Health Centers** - Publicly funded outpatient services
- **Private Psychiatric Practices** - Outpatient psychiatry and medication management
- **Counseling and Therapy Centers** - Individual, group, and family therapy
- **Child/Adolescent Mental Health** - Pediatric outpatient behavioral health
- **Substance Abuse Treatment** - Outpatient addiction services
- **Intensive Outpatient Programs (IOP)** - Structured day treatment
- **Partial Hospitalization Programs (PHP)** - Day hospital services
## 📋 Regulatory Framework
This template supports compliance with:
- **The Joint Commission** - Behavioral Health Care accreditation
- **CARF** - Commission on Accreditation of Rehabilitation Facilities
- **State Mental Health Authority** - State licensing and certification
- **HIPAA** - Mental health information privacy
- **42 CFR Part 2** - Substance abuse treatment confidentiality
- **State Licensing Boards** - Psychologist, social worker, counselor regulations
- **Medicare/Medicaid** - Outpatient mental health billing requirements
- **APA Practice Guidelines** - Evidence-based treatment standards
- **SAMHSA** - Substance abuse treatment guidelines
## Repository Structure
```
├── SOPs/
│ ├── Intake-Assessment/ # Referral, intake, diagnostic evaluation
│ ├── Treatment/ # Therapy protocols, medication management
│ ├── Crisis-Management/ # Crisis response, safety planning, hospitalization
│ ├── Documentation/ # Progress notes, treatment plans, outcomes
│ ├── Compliance/ # Consent, confidentiality, records
│ └── General/ # Document control, training, CAPA
├── Forms/
│ ├── Intake-Forms/ # Registration, consent, authorization, history
│ ├── Assessment-Tools/ # PHQ-9, GAD-7, AUDIT, depression/anxiety scales
│ ├── Treatment-Plans/ # Initial and updated treatment plan templates
│ ├── Safety-Plans/ # Crisis plans, safety contracts
│ ├── Progress-Notes/ # Session documentation templates
│ └── Training/ # Competency assessments
├── Policies/ # Practice policies
├── Work-Instructions/ # Step-by-step procedures
└── Templates/ # Document templates
```
## Document Numbering Convention
- **POL-XXX**: Policies
- **SOP-INT-XXX**: Intake/Assessment SOPs
- **SOP-TX-XXX**: Treatment SOPs
- **SOP-CRS-XXX**: Crisis Management SOPs
- **SOP-DOC-XXX**: Documentation SOPs
- **SOP-CMP-XXX**: Compliance SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
## 🤖 AI-Powered Assistance
This repository includes **AtomicAI**, your outpatient mental health QMS assistant. Mention `@atomicai` in any issue or pull request to:
- Draft intake and assessment procedures
- Create treatment protocols for specific conditions
- Generate crisis intervention and safety planning SOPs
- Develop progress note documentation standards
- Create consent and confidentiality procedures
- Review documents for accreditation compliance
### Example Prompts
- "@atomicai create an SOP for psychiatric intake evaluation"
- "@atomicai draft a crisis intervention and safety planning protocol"
- "@atomicai write a progress note documentation standard per billing requirements"
- "@atomicai create a treatment plan template for depression"
- "@atomicai develop a no-show and missed appointment policy"
- "@atomicai create a telehealth informed consent procedure"
## Getting Started
1. **Establish Consent Procedures** - Configure informed consent and authorization forms
2. **Standardize Assessments** - Implement validated screening tools
3. **Define Documentation Standards** - Set up progress note and treatment plan templates
4. **Create Crisis Protocols** - Establish safety planning and escalation procedures
5. **Train Clinicians** - Use competency assessment forms
## Key Documents to Create First
1. **Intake Assessment SOP** - Standardized evaluation process
2. **Treatment Planning Policy** - Individualized treatment plan requirements
3. **Crisis Response Procedure** - Suicidal/homicidal ideation management
4. **Safety Plan Template** - Client crisis planning tool
5. **Progress Note Standards** - Documentation requirements for sessions
6. **Informed Consent Forms** - Treatment consent, HIPAA, 42 CFR Part 2
7. **Telehealth Policy** - Virtual care protocols and consent
## Special Considerations for Outpatient Mental Health
### Intake and Assessment
- Referral management and triage
- Comprehensive diagnostic evaluation
- Validated screening instruments
- Treatment matching and level of care
- Insurance authorization
### Treatment Services
- Evidence-based therapy protocols
- Medication evaluation and management
- Group therapy programming
- Family and couples therapy
- Care coordination with other providers
### Crisis Management
- Suicide risk assessment
- Safety planning
- Crisis hotline resources
- Hospitalization criteria and procedures
- Post-crisis follow-up
### Documentation and Compliance
- HIPAA and 42 CFR Part 2 requirements
- Progress note medical necessity
- Treatment plan updates
- Outcome measurement
- Supervision and peer review
---
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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# Standard Operating Procedure: Outpatient Mental Health Initial Evaluation
| Document ID | SOP-MHO-001 |
|-------------|-------------|
| Title | Outpatient Mental Health Initial Evaluation |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Outpatient Mental Health |
---
## 1. Purpose
To establish standardized procedures for conducting comprehensive initial mental health evaluations for new outpatient patients to ensure accurate diagnosis, appropriate treatment planning, and regulatory compliance.
## 2. Scope
This procedure applies to all initial evaluations for outpatient mental health services including:
- Adult psychiatric evaluation
- Child/adolescent psychiatric evaluation
- Psychological evaluation
- Intake assessment for therapy
- Medication management evaluation
- Telehealth evaluations
## 3. Responsibilities
### 3.1 Psychiatrist/Psychiatric NP/PA
- Conduct psychiatric diagnostic evaluation
- Establish diagnoses
- Initiate medication treatment
- Refer for therapy as indicated
### 3.2 Therapist/Counselor
- Conduct therapy intake assessment
- Establish treatment goals
- Initiate therapy services
- Coordinate care with prescriber
### 3.3 Psychologist
- Conduct psychological evaluations
- Administer psychological testing
- Provide diagnostic clarification
- Treatment recommendations
### 3.4 Support Staff
- Schedule evaluations appropriately
- Collect intake paperwork
- Verify insurance and authorizations
- Facilitate check-in process
## 4. Definitions
| Term | Definition |
|------|------------|
| Chief Complaint | Primary reason for seeking treatment |
| Mental Status Examination | Structured assessment of current mental functioning |
| DSM-5 | Diagnostic and Statistical Manual of Mental Disorders, 5th Edition |
| PHQ-9 | Patient Health Questionnaire (depression screen) |
| GAD-7 | Generalized Anxiety Disorder scale |
## 5. Procedure
### 5.1 Pre-Evaluation Preparation
#### 5.1.1 Intake Paperwork
Complete prior to evaluation:
- [ ] Demographic information
- [ ] Insurance information
- [ ] Consent for treatment
- [ ] HIPAA acknowledgment
- [ ] Release of information (prior providers)
- [ ] Symptom questionnaires
- [ ] Medical history form
- [ ] Medication list
#### 5.1.2 Records Review
If available, review:
- Prior mental health records
- Recent medical records
- Hospitalization summaries
- Previous psychological testing
- Current medication list
### 5.2 Initial Evaluation Components
#### 5.2.1 Psychiatric Diagnostic Evaluation
**Chief Complaint and Present Illness**
- Current symptoms in patient's words
- Onset and duration
- Severity and frequency
- Impact on functioning
- Precipitating factors
- What has helped/not helped
**Psychiatric History**
| Element | Detail |
|---------|--------|
| Previous diagnoses | |
| Previous hospitalizations | Dates, location, reason |
| Previous outpatient treatment | Providers, duration, helpfulness |
| Previous medications | Name, dose, response, side effects |
| ECT/TMS/other treatments | |
| Suicide attempts | Method, intent, lethality, medical treatment |
| Self-harm history | |
| Violent behavior | |
**Substance Use History**
| Substance | Ever Used | Current Use | Last Use | Quantity/Frequency |
|-----------|-----------|-------------|----------|---------------------|
| Alcohol | ☐ | ☐ | | |
| Cannabis | ☐ | ☐ | | |
| Opioids | ☐ | ☐ | | |
| Stimulants | ☐ | ☐ | | |
| Benzodiazepines | ☐ | ☐ | | |
| Tobacco/Nicotine | ☐ | ☐ | | |
| Other | ☐ | ☐ | | |
- Substance use treatment history
- Withdrawal history
- Periods of sobriety
**Medical History**
- Chronic conditions
- Current medications
- Allergies (medications, environmental, food)
- Recent labs (if available)
- Primary care provider
**Family History**
- Psychiatric disorders
- Substance use disorders
- Suicide
- Response to medications (if known)
**Social History**
| Domain | Information |
|--------|-------------|
| Education | Highest level, any difficulties |
| Employment | Current status, history |
| Living situation | With whom, stability |
| Relationships | Marital status, support system |
| Legal | Current or pending legal issues |
| Trauma history | Abuse, neglect, other trauma |
| Military | Branch, combat exposure, discharge status |
| Cultural/spiritual | Relevant beliefs/practices |
**Developmental History** (especially for children/adolescents)
- Pregnancy/birth complications
- Developmental milestones
- School performance
- Peer relationships
- Behavioral issues
**Mental Status Examination**
| Domain | Findings |
|--------|----------|
| Appearance | Dress, grooming, hygiene, apparent age |
| Psychomotor | Activity level, retardation, agitation |
| Attitude | Cooperative, guarded, hostile |
| Eye contact | Good, poor, variable |
| Speech | Rate, rhythm, volume, coherence |
| Mood | Patient's stated mood |
| Affect | Range, congruence, appropriateness |
| Thought process | Linear, tangential, circumstantial, loose |
| Thought content | Delusions, obsessions, preoccupations |
| Perceptions | Hallucinations (type), illusions |
| Cognition | Orientation, attention, memory |
| Insight | Good, fair, poor |
| Judgment | Good, fair, poor |
**Risk Assessment**
| Risk | Assessment |
|------|------------|
| Suicide | Ideation, plan, intent, means, attempts |
| Violence | Ideation, target, plan, history |
| Self-harm | Current urges, methods, history |
| Risk level | Low / Moderate / High |
**Diagnosis (DSM-5)**
| Priority | Diagnosis | ICD-10 Code |
|----------|-----------|-------------|
| Primary | | |
| Secondary | | |
| Additional | | |
| Substance | | |
| Medical | | |
**Treatment Plan**
- Medication recommendations
- Therapy recommendations
- Frequency of follow-up
- Laboratory monitoring
- Referrals
- Patient goals
### 5.3 Standardized Assessments
Administer as indicated:
| Assessment | Population | Purpose |
|------------|------------|---------|
| PHQ-9 | Adults | Depression severity |
| GAD-7 | Adults | Anxiety severity |
| C-SSRS | All | Suicide risk |
| MDQ | Mood disorders | Bipolar screening |
| ASRS | Adults | ADHD screening |
| PCL-5 | Trauma history | PTSD screening |
| AUDIT | Alcohol use | Alcohol use disorder |
| DAST-10 | Drug use | Drug use disorder |
### 5.4 Informed Consent
Discuss and document:
- Nature of recommended treatment
- Expected benefits
- Potential risks and side effects
- Alternatives (including no treatment)
- Right to refuse or withdraw
- Confidentiality and limits
- Emergency procedures
### 5.5 Safety Planning
For patients with elevated risk:
- [ ] Complete safety plan (FRM-MHO-002)
- [ ] Provide crisis resources
- [ ] Establish emergency contact
- [ ] Reduce access to means
- [ ] Schedule appropriate follow-up
### 5.6 Care Coordination
- [ ] Request records from prior providers
- [ ] Communicate with PCP as indicated
- [ ] Coordinate with other treaters
- [ ] Referral to appropriate level of care if needed
## 6. Special Considerations
### 6.1 Telehealth Evaluations
- Verify patient location and identity
- Confirm emergency contact and local resources
- Assess appropriateness for telehealth
- Document telehealth consent
### 6.2 Child/Adolescent Evaluations
- Include parent/guardian interview
- School information as relevant
- Developmentally appropriate assessment
- Assent/consent as appropriate
### 6.3 Geriatric Evaluations
- Cognitive screening
- Capacity assessment if concerns
- Medical complexity consideration
- Caregiver involvement
## 7. Documentation
- Initial evaluation note (complete within 72 hours of visit)
- Consent forms
- Standardized assessment scores
- Safety plan (if applicable)
- Release of information forms
## 8. Quality Metrics
| Metric | Target |
|--------|--------|
| Evaluation completed within scheduled time | >90% |
| Documentation complete within 72 hours | 100% |
| Suicide risk assessment documented | 100% |
| Treatment plan documented | 100% |
| Follow-up scheduled | 100% |
## 9. References
- American Psychiatric Association Practice Guidelines
- DSM-5 Diagnostic Criteria
- State mental health regulations
- Payer documentation requirements
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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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: [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] |