aigroup-workflow 1.0.1 → 1.1.0

package/skills/jarvis/engineering-team/ra-qm-team/qms-audit-expert/SKILL.md

@@ -1,323 +0,0 @@
----
-name: "qms-audit-expert"
-description: ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.
-triggers:
-  - ISO 13485 audit
-  - internal audit
-  - QMS audit
-  - audit planning
-  - nonconformity classification
-  - CAPA verification
-  - audit checklist
-  - audit finding
-  - external audit prep
-  - audit schedule
----
-
-# QMS Audit Expert
-
-ISO 13485 internal audit methodology for medical device quality management systems.
-
----
-
-## Table of Contents
-
-- [Audit Planning Workflow](#audit-planning-workflow)
-- [Audit Execution](#audit-execution)
-- [Nonconformity Management](#nonconformity-management)
-- [External Audit Preparation](#external-audit-preparation)
-- [Reference Documentation](#reference-documentation)
-- [Tools](#tools)
-
----
-
-## Audit Planning Workflow
-
-Plan risk-based internal audit program:
-
-1. List all QMS processes requiring audit
-2. Assign risk level to each process (High/Medium/Low)
-3. Review previous audit findings and trends
-4. Determine audit frequency by risk level
-5. Assign qualified auditors (verify independence)
-6. Create annual audit schedule
-7. Communicate schedule to process owners
-8. **Validation:** All ISO 13485 clauses covered within cycle
-
-### Risk-Based Audit Frequency
-
-| Risk Level | Frequency | Criteria |
-|------------|-----------|----------|
-| High | Quarterly | Design control, CAPA, production validation |
-| Medium | Semi-annual | Purchasing, training, document control |
-| Low | Annual | Infrastructure, management review (if stable) |
-
-### Audit Scope by Clause
-
-| Clause | Process | Focus Areas |
-|--------|---------|-------------|
-| 4.2 | Document Control | Document approval, distribution, obsolete control |
-| 5.6 | Management Review | Inputs complete, decisions documented, actions tracked |
-| 6.2 | Training | Competency defined, records complete, effectiveness verified |
-| 7.3 | Design Control | Inputs, reviews, V&V, transfer, changes |
-| 7.4 | Purchasing | Supplier evaluation, incoming inspection |
-| 7.5 | Production | Work instructions, process validation, DHR |
-| 7.6 | Calibration | Equipment list, calibration status, out-of-tolerance |
-| 8.2.2 | Internal Audit | Schedule compliance, auditor independence |
-| 8.3 | NC Product | Identification, segregation, disposition |
-| 8.5 | CAPA | Root cause, implementation, effectiveness |
-
-### Auditor Independence
-
-Verify auditor independence before assignment:
-
-- [ ] Auditor not responsible for area being audited
-- [ ] No direct reporting relationship to auditee
-- [ ] Not involved in recent activities under audit
-- [ ] Documented qualification for audit scope
-
----
-
-## Audit Execution
-
-Conduct systematic internal audit:
-
-1. Prepare audit plan (scope, criteria, schedule)
-2. Review relevant documentation before audit
-3. Conduct opening meeting with auditee
-4. Collect evidence (records, interviews, observation)
-5. Classify findings (Major/Minor/Observation)
-6. Conduct closing meeting with preliminary findings
-7. Prepare audit report within 5 business days
-8. **Validation:** All scope items covered, findings supported by evidence
-
-### Evidence Collection
-
-| Method | Use For | Documentation |
-|--------|---------|---------------|
-| Document review | Procedures, records | Document number, version, date |
-| Interview | Process understanding | Interviewee name, role, summary |
-| Observation | Actual practice | What, where, when observed |
-| Record trace | Process flow | Record IDs, dates, linkage |
-
-### Audit Questions by Clause
-
-**Document Control (4.2):**
-- Show me the document master list
-- How do you control obsolete documents?
-- Show me evidence of document change approval
-
-**Design Control (7.3):**
-- Show me the Design History File for [product]
-- Who participates in design reviews?
-- Show me design input to output traceability
-
-**CAPA (8.5):**
-- Show me the CAPA log with open items
-- How do you determine root cause?
-- Show me effectiveness verification records
-
-See `references/iso13485-audit-guide.md` for complete question sets.
-
-### Finding Documentation
-
-Document each finding with:
-
-```
-Requirement: [Specific ISO 13485 clause or procedure]
-Evidence: [What was observed, reviewed, or heard]
-Gap: [How evidence fails to meet requirement]
-```
-
-**Example:**
-```
-Requirement: ISO 13485:2016 Clause 7.6 requires calibration
-at specified intervals.
-
-Evidence: Calibration records for pH meter (EQ-042) show
-last calibration 2024-01-15. Calibration interval is
-12 months. Today is 2025-03-20.
-
-Gap: Equipment is 2 months overdue for calibration,
-representing a gap in calibration program execution.
-```
-
----
-
-## Nonconformity Management
-
-Classify and manage audit findings:
-
-1. Evaluate finding against classification criteria
-2. Assign severity (Major/Minor/Observation)
-3. Document finding with objective evidence
-4. Communicate to process owner
-5. Initiate CAPA for Major/Minor findings
-6. Track to closure
-7. Verify effectiveness at follow-up
-8. **Validation:** Finding closed only after effective CAPA
-
-### Classification Criteria
-
-| Category | Definition | CAPA Required | Timeline |
-|----------|------------|---------------|----------|
-| Major | Systematic failure or absence of element | Yes | 30 days |
-| Minor | Isolated lapse or partial implementation | Recommended | 60 days |
-| Observation | Improvement opportunity | Optional | As appropriate |
-
-### Classification Decision
-
-```
-Is required element absent or failed?
-├── Yes → Systematic (multiple instances)? → MAJOR
-│   └── No → Could affect product safety? → MAJOR
-│       └── No → MINOR
-└── No → Deviation from procedure?
-    ├── Yes → Recurring? → MAJOR
-    │   └── No → MINOR
-    └── No → Improvement opportunity? → OBSERVATION
-```
-
-### CAPA Integration
-
-| Finding Severity | CAPA Depth | Verification |
-|------------------|------------|--------------|
-| Major | Full root cause analysis (5-Why, Fishbone) | Next audit or within 6 months |
-| Minor | Immediate cause identification | Next scheduled audit |
-| Observation | Not required | Noted at next audit |
-
-See `references/nonconformity-classification.md` for detailed guidance.
-
----
-
-## External Audit Preparation
-
-Prepare for certification body or regulatory audit:
-
-1. Complete all scheduled internal audits
-2. Verify all findings closed with effective CAPA
-3. Review documentation for currency and accuracy
-4. Conduct management review with audit as input
-5. Prepare facility and personnel
-6. Conduct mock audit (full scope)
-7. Brief personnel on audit protocol
-8. **Validation:** Mock audit findings addressed before external audit
-
-### Pre-Audit Readiness Checklist
-
-**Documentation:**
-- [ ] Quality Manual current
-- [ ] Procedures reflect actual practice
-- [ ] Records complete and retrievable
-- [ ] Previous audit findings closed
-
-**Personnel:**
-- [ ] Key personnel available during audit
-- [ ] Subject matter experts identified
-- [ ] Personnel briefed on audit protocol
-- [ ] Escorts assigned
-
-**Facility:**
-- [ ] Work areas organized
-- [ ] Documents at point of use current
-- [ ] Equipment calibration status visible
-- [ ] Nonconforming product segregated
-
-### Mock Audit Protocol
-
-1. Use external auditor or qualified internal auditor
-2. Cover full scope of upcoming external audit
-3. Simulate actual audit conditions (timing, formality)
-4. Document findings as for real audit
-5. Address all Major and Minor findings before external audit
-6. Brief management on readiness status
-
----
-
-## Reference Documentation
-
-### ISO 13485 Audit Guide
-
-`references/iso13485-audit-guide.md` contains:
-
-- Clause-by-clause audit methodology
-- Sample audit questions for each clause
-- Evidence collection requirements
-- Common nonconformities by clause
-- Finding severity classification
-
-### Nonconformity Classification
-
-`references/nonconformity-classification.md` contains:
-
-- Severity classification criteria and decision tree
-- Impact vs. occurrence matrix
-- CAPA integration requirements
-- Finding documentation templates
-- Closure requirements by severity
-
----
-
-## Tools
-
-### Audit Schedule Optimizer
-
-```bash
-# Generate optimized audit schedule
-python scripts/audit_schedule_optimizer.py --processes processes.json
-
-# Interactive mode
-python scripts/audit_schedule_optimizer.py --interactive
-
-# JSON output for integration
-python scripts/audit_schedule_optimizer.py --processes processes.json --output json
-```
-
-Generates risk-based audit schedule considering:
-- Process risk level
-- Previous findings
-- Days since last audit
-- Criticality scores
-
-**Output includes:**
-- Prioritized audit schedule
-- Quarterly distribution
-- Overdue audit alerts
-- Resource recommendations
-
-### Sample Process Input
-
-```json
-{
-  "processes": [
-    {
-      "name": "Design Control",
-      "iso_clause": "7.3",
-      "risk_level": "HIGH",
-      "last_audit_date": "2024-06-15",
-      "previous_findings": 2
-    },
-    {
-      "name": "Document Control",
-      "iso_clause": "4.2",
-      "risk_level": "MEDIUM",
-      "last_audit_date": "2024-09-01",
-      "previous_findings": 0
-    }
-  ]
-}
-```
-
----
-
-## Audit Program Metrics
-
-Track audit program effectiveness:
-
-| Metric | Target | Measurement |
-|--------|--------|-------------|
-| Schedule compliance | >90% | Audits completed on time |
-| Finding closure rate | >95% | Findings closed by due date |
-| Repeat findings | <10% | Same finding in consecutive audits |
-| CAPA effectiveness | >90% | Verified effective at follow-up |
-| Auditor utilization | 4 days/month | Audit days per qualified auditor |

package/skills/jarvis/engineering-team/ra-qm-team/qms-audit-expert/references/iso13485-audit-guide.md

@@ -1,388 +0,0 @@
-# ISO 13485 Audit Guide
-
-Clause-by-clause audit methodology with sample questions and common findings.
-
----
-
-## Table of Contents
-
-- [Audit Approach](#audit-approach)
-- [Clause 4: Quality Management System](#clause-4-quality-management-system)
-- [Clause 5: Management Responsibility](#clause-5-management-responsibility)
-- [Clause 6: Resource Management](#clause-6-resource-management)
-- [Clause 7: Product Realization](#clause-7-product-realization)
-- [Clause 8: Measurement and Improvement](#clause-8-measurement-and-improvement)
-- [Common Nonconformities](#common-nonconformities)
-
----
-
-## Audit Approach
-
-### Risk-Based Audit Planning
-
-Prioritize audit focus based on:
-
-| Risk Level | Audit Frequency | Scope Depth |
-|------------|-----------------|-------------|
-| High | Quarterly | Full clause review |
-| Medium | Semi-annual | Targeted review |
-| Low | Annual | Sampling-based |
-
-### Evidence Collection Methods
-
-| Method | Best For | Examples |
-|--------|----------|----------|
-| Document review | Procedures, records | SOPs, DHF, batch records |
-| Interview | Process understanding | Operators, supervisors |
-| Observation | Actual practice | Production, calibration |
-| Tracing | Process flow | Order to delivery |
-
----
-
-## Clause 4: Quality Management System
-
-### 4.1 General Requirements
-
-**Audit Questions:**
-- Show me documentation of your QMS scope and exclusions
-- How do you identify processes needed for the QMS?
-- Show me evidence of outsourced process control
-
-**Evidence to Review:**
-- [ ] Quality Manual or QMS description
-- [ ] Process interaction diagram
-- [ ] Outsourced process agreements
-
-**Common Findings:**
-- Scope exclusions not justified
-- Outsourced processes not controlled
-- Process interactions not defined
-
-### 4.2 Documentation Requirements
-
-**4.2.1-4.2.2 Quality Manual and Documents**
-
-**Audit Questions:**
-- Where is your documented quality policy?
-- Show me the procedure for document control
-- How do you ensure documents are current at point of use?
-
-**Evidence to Review:**
-- [ ] Quality Manual
-- [ ] Document master list
-- [ ] Sample of controlled documents
-
-**4.2.4 Control of Records**
-
-**Audit Questions:**
-- What is your record retention policy?
-- Show me the procedure for record storage and protection
-- How do you ensure record legibility and retrievability?
-
-**Evidence to Review:**
-- [ ] Record control procedure
-- [ ] Retention schedule
-- [ ] Sample record retrieval test
-
-**Common Findings:**
-- Obsolete documents in use
-- Records not legible or retrievable
-- Retention periods not defined for all record types
-
----
-
-## Clause 5: Management Responsibility
-
-### 5.1-5.2 Management Commitment and Customer Focus
-
-**Audit Questions:**
-- How does top management demonstrate commitment to QMS?
-- Show me evidence of customer requirement determination
-- How are regulatory requirements communicated?
-
-**Evidence to Review:**
-- [ ] Quality policy communication
-- [ ] Management review minutes
-- [ ] Customer feedback records
-
-### 5.4 Planning
-
-**Audit Questions:**
-- Where are your quality objectives documented?
-- Show me the plan for achieving quality objectives
-- How do you maintain QMS integrity during changes?
-
-**Evidence to Review:**
-- [ ] Quality objectives (measurable, time-bound)
-- [ ] Quality planning documentation
-- [ ] Change management records
-
-### 5.5 Responsibility and Authority
-
-**Audit Questions:**
-- Where are responsibilities and authorities defined?
-- Who is the management representative?
-- How is QMS performance communicated to top management?
-
-**Evidence to Review:**
-- [ ] Organization chart
-- [ ] Job descriptions with QMS responsibilities
-- [ ] Management representative appointment
-
-### 5.6 Management Review
-
-**Audit Questions:**
-- Show me management review records from last 12 months
-- What inputs are included in management review?
-- What decisions and actions resulted?
-
-**Required Review Inputs:**
-- [ ] Audit results
-- [ ] Customer feedback (including complaints)
-- [ ] Process performance and product conformity
-- [ ] CAPA status
-- [ ] Changes affecting QMS
-- [ ] Recommendations for improvement
-- [ ] New/revised regulatory requirements
-
-**Common Findings:**
-- Management review not conducted at planned intervals
-- Required inputs missing
-- Action items not tracked to completion
-
----
-
-## Clause 6: Resource Management
-
-### 6.1-6.2 Human Resources
-
-**Audit Questions:**
-- How do you determine competency requirements?
-- Show me training records for personnel affecting quality
-- How do you evaluate training effectiveness?
-
-**Evidence to Review:**
-- [ ] Competency requirements by role
-- [ ] Training records
-- [ ] Effectiveness evaluations
-
-### 6.3-6.4 Infrastructure and Work Environment
-
-**Audit Questions:**
-- How do you determine infrastructure requirements?
-- Show me maintenance records for critical equipment
-- How is work environment controlled for product conformity?
-
-**Evidence to Review:**
-- [ ] Equipment list with maintenance schedules
-- [ ] Environmental monitoring records
-- [ ] Contamination control procedures (if applicable)
-
-**Common Findings:**
-- Training effectiveness not evaluated
-- Preventive maintenance not performed on schedule
-- Environmental conditions not monitored
-
----
-
-## Clause 7: Product Realization
-
-### 7.1 Planning of Product Realization
-
-**Audit Questions:**
-- Show me the quality plan for a recent product
-- How do you determine verification and validation activities?
-- What records are required to demonstrate conformity?
-
-**Evidence to Review:**
-- [ ] Quality plan or project plan
-- [ ] Risk management integration
-- [ ] Required records defined
-
-### 7.2 Customer-Related Processes
-
-**Audit Questions:**
-- How do you determine customer requirements?
-- Show me the contract review process
-- How do you handle customer communications?
-
-**Evidence to Review:**
-- [ ] Contract/order review records
-- [ ] Customer requirement documentation
-- [ ] Communication records
-
-### 7.3 Design and Development
-
-**Audit Questions (per phase):**
-
-| Phase | Key Questions |
-|-------|---------------|
-| Planning | Show me design plan with stages, reviews, responsibilities |
-| Inputs | How are regulatory requirements identified? |
-| Outputs | Show me design outputs addressing inputs |
-| Review | Who participated in design reviews? |
-| Verification | Show me verification activities and results |
-| Validation | Show me validation under actual use conditions |
-| Transfer | How was design transferred to production? |
-| Changes | Show me design change control records |
-
-**Evidence to Review:**
-- [ ] Design History File (DHF)
-- [ ] Design review records with participants
-- [ ] Verification/validation protocols and reports
-- [ ] Design change requests
-
-### 7.4 Purchasing
-
-**Audit Questions:**
-- How do you evaluate and select suppliers?
-- Show me approved supplier list with evaluation criteria
-- How do you verify purchased product?
-
-**Evidence to Review:**
-- [ ] Supplier evaluation procedure
-- [ ] Approved supplier list
-- [ ] Incoming inspection records
-- [ ] Supplier audit records
-
-### 7.5 Production and Service Provision
-
-**Audit Questions:**
-- Show me work instructions for production
-- How are special processes validated?
-- Show me traceability records for a product lot
-
-**Evidence to Review:**
-- [ ] Production work instructions
-- [ ] Process validation records
-- [ ] Device history records (DHR)
-- [ ] Traceability records
-
-### 7.6 Control of Monitoring and Measuring Equipment
-
-**Audit Questions:**
-- Show me calibration records for measuring equipment
-- How do you handle out-of-tolerance conditions?
-- How is software used for monitoring validated?
-
-**Evidence to Review:**
-- [ ] Equipment calibration records
-- [ ] Calibration procedure
-- [ ] Out-of-tolerance investigation records
-
-**Common Findings:**
-- Design inputs not completely addressed in outputs
-- Supplier evaluations not performed or documented
-- Process validation not maintained after changes
-- Calibration overdue
-
----
-
-## Clause 8: Measurement and Improvement
-
-### 8.2.1 Feedback
-
-**Audit Questions:**
-- How do you collect customer feedback?
-- Show me complaint handling records
-- How is feedback data used for improvement?
-
-**Evidence to Review:**
-- [ ] Complaint procedure
-- [ ] Complaint log with trending
-- [ ] Feedback to design/production
-
-### 8.2.2 Internal Audit
-
-**Audit Questions:**
-- Show me the internal audit schedule
-- How do you ensure auditor independence?
-- Show me audit records and follow-up actions
-
-**Evidence to Review:**
-- [ ] Audit program/schedule
-- [ ] Auditor qualification records
-- [ ] Audit reports and findings
-- [ ] CAPA records from audits
-
-### 8.2.3-8.2.4 Monitoring and Measurement
-
-**Audit Questions:**
-- How do you monitor process performance?
-- Show me product acceptance records
-- What happens when acceptance criteria not met?
-
-**Evidence to Review:**
-- [ ] Process monitoring data
-- [ ] Inspection records
-- [ ] Nonconforming product records
-
-### 8.3 Control of Nonconforming Product
-
-**Audit Questions:**
-- Show me the procedure for nonconforming product
-- How do you prevent unintended use of nonconforming product?
-- Who authorizes concessions/deviations?
-
-**Evidence to Review:**
-- [ ] NC product procedure
-- [ ] NC product records
-- [ ] Concession authorizations
-
-### 8.4 Analysis of Data
-
-**Audit Questions:**
-- What data do you analyze for QMS effectiveness?
-- Show me trend analysis for complaints, NC, CAPA
-- How does data drive improvement?
-
-**Evidence to Review:**
-- [ ] Data analysis reports
-- [ ] Trend charts
-- [ ] Management review inputs
-
-### 8.5 CAPA
-
-**Audit Questions:**
-- Show me the CAPA procedure
-- How do you determine root cause?
-- Show me CAPA effectiveness verification
-
-**Evidence to Review:**
-- [ ] CAPA procedure
-- [ ] Open/closed CAPA log
-- [ ] Root cause analysis records
-- [ ] Effectiveness verification records
-
-**Common Findings:**
-- Complaint trending not performed
-- CAPA not initiated for recurring issues
-- Root cause analysis superficial
-- Effectiveness verification not documented
-
----
-
-## Common Nonconformities
-
-### Top 10 ISO 13485 Audit Findings
-
-| Rank | Clause | Finding |
-|------|--------|---------|
-| 1 | 7.3 | Design inputs not traceable to outputs |
-| 2 | 8.5 | CAPA effectiveness not verified |
-| 3 | 4.2.4 | Records not retrievable or legible |
-| 4 | 7.4 | Supplier evaluation not documented |
-| 5 | 6.2 | Training effectiveness not evaluated |
-| 6 | 7.5.2 | Process validation not maintained |
-| 7 | 8.2.2 | Internal audits not covering all clauses |
-| 8 | 5.6 | Management review inputs incomplete |
-| 9 | 7.6 | Calibration records incomplete |
-| 10 | 8.3 | NC product control inadequate |
-
-### Finding Severity Classification
-
-| Severity | Definition | Response Required |
-|----------|------------|-------------------|
-| Major | Systematic failure, absence of element | CAPA within 30 days |
-| Minor | Isolated lapse, partial implementation | Correction within 60 days |
-| Observation | Improvement opportunity | Optional action |