internalaudit
Internal Audit
When to Activate This Skill
- "Plan internal audit programme"
- "Create audit checklist for [process/area]"
- "Conduct process/product/QMS audit"
- "Document audit findings"
- "Write nonconformance report"
- "Plan layered process audit (LPA)"
- "Prepare for IATF 16949 certification audit"
IATF 16949 Audit Requirements
Clause 9.2.2.1 - Internal Audit Programme
The organization shall:
- Maintain documented internal audit programme
- Cover all QMS processes over audit cycle (typically 3 years)
- Include customer-specific requirements (CSRs)
- Consider process risk and previous audit results
- Define audit criteria, scope, frequency, methods
Types of Internal Audits
| Audit Type | Focus | Frequency | Reference |
|---|---|---|---|
| QMS Audit | Management system conformance | Annual minimum per clause | 9.2.2.2 |
| Process Audit | Manufacturing process effectiveness | Based on risk, min annual | 9.2.2.3 |
| Product Audit | Product conformance | Per control plan, min annual | 9.2.2.4 |
| LPA | Layered process audit | Daily/weekly/monthly | Customer CSR |
QMS Audit (9.2.2.2)
Purpose
Verify conformance to IATF 16949/ISO 9001 requirements and organization's QMS.
Scope
All clauses of IATF 16949 over the audit cycle:
- Context of organization (4)
- Leadership (5)
- Planning (6)
- Support (7)
- Operation (8)
- Performance evaluation (9)
- Improvement (10)
Approach
- Clause-based checklist
- Interview management and staff
- Review documented information
- Verify implementation and effectiveness
Output
- Completed checklist
- Finding report (NCRs, OFIs)
- Audit report
Process Audit (9.2.2.3)
Purpose
Evaluate effectiveness of manufacturing processes using process approach.
Scope
Each manufacturing process including:
- Inputs and outputs
- Process controls
- Operator competence
- Equipment capability
- Work instructions compliance
Approach - Turtle Diagram Method
INPUTS OUTPUTS
↓ ↑
Materials, specs Products, data
↓ ↑
┌─────────────────────────────┐
│ │
WITH → │ PROCESS BEING │ → METRICS
WHAT? │ AUDITED │ KPIs met?
│ │
└─────────────────────────────┘
↑ ↑
WHO? HOW?
Competent? Per procedure?
Key Questions
- Are inputs conforming?
- Are process parameters controlled?
- Are operators competent and trained?
- Is equipment maintained and capable?
- Are work instructions followed?
- Are outputs conforming?
- Are KPIs being met?
Product Audit (9.2.2.4)
Purpose
Verify product conformance at appropriate stages of production and delivery.
Scope
- Dimensional verification vs. drawing
- Functional testing vs. specification
- Appearance vs. standards
- Packaging and labeling
- Documentation/traceability
Approach
- Select sample per Control Plan
- Measure against all drawing requirements
- Verify special characteristics
- Check packaging and identification
- Document all measurements
Frequency
- At defined stages (per Control Plan)
- All special characteristics covered annually
- After process changes
Layered Process Audit (LPA)
Purpose
Standardized process verification at multiple organizational levels.
Structure
| Level | Auditor | Frequency | Scope |
|---|---|---|---|
| Level 1 | Team Leader | Daily | Key process steps |
| Level 2 | Supervisor | Weekly | Process area |
| Level 3 | Manager | Monthly | Department |
| Level 4 | Plant Manager | Monthly | Multiple areas |
Key Characteristics
- Same checklist at all levels
- Focus on standardized work
- Quick (10-15 minutes)
- Immediate corrective action
- Trend tracking
Audit Planning
Annual Audit Schedule
Consider:
- All QMS processes over cycle (max 3 years)
- All manufacturing processes annually
- Risk-based frequency (high risk = more frequent)
- Previous audit results
- Customer complaints
- Internal quality performance
- Changes to processes
Audit Plan Elements
| Element | Description |
|---|---|
| Audit number | Unique identifier |
| Date | Scheduled date |
| Scope | What will be audited |
| Criteria | Requirements to audit against |
| Auditor(s) | Qualified auditor assignment |
| Auditee | Process owner/department |
| Duration | Expected time |
Auditor Qualification
Requirements (per 9.2.2.2)
- Understanding of automotive process approach
- Customer-specific requirements knowledge
- ISO 19011 audit principles
- Core tools knowledge (FMEA, SPC, MSA)
- IATF 16949 requirements knowledge
Independence
- Auditors shall not audit their own work
- Cross-functional audit teams encouraged
- External auditor for sensitive areas
Training Path
- Internal training on QMS and IATF 16949
- Core tools training
- Audit technique training
- Shadow audits (observe experienced auditor)
- Supervised audits
- Independent auditor status
Conducting the Audit
Opening Meeting
- Confirm scope and schedule
- Explain audit method
- Confirm resources and access
- Answer questions
Evidence Collection
- Interview personnel
- Review documents and records
- Observe processes
- Take notes with objective evidence
Audit Techniques
- Open-ended questions (How? What? Why?)
- Request evidence for claims
- Follow the trail (traceability)
- Verify vs. specification
- Compare to procedure
Closing Meeting
- Present findings
- Confirm accuracy with auditee
- Agree on corrective action timelines
- Thank participants
Finding Classification
Major Nonconformance
Definition: Absence or complete breakdown of system to meet requirement, or situation likely to result in shipping nonconforming product.
Examples:
- No documented procedure when required
- Consistent failure to follow procedure
- Pattern of nonconforming product
- Missing required records
Action: Requires root cause analysis, corrective action, and verification before certification.
Minor Nonconformance
Definition: Single lapse in meeting a requirement; does not affect product quality or system integrity.
Examples:
- Isolated instance of missing signature
- Minor record-keeping gap
- Single deviation from procedure
- Incomplete training record
Action: Requires correction, may require root cause and corrective action.
Opportunity for Improvement (OFI)
Definition: Not a nonconformance, but improvement recommendation.
Examples:
- Better organization possible
- More efficient method available
- Good practice from other areas
- Proactive enhancement
Action: Optional implementation, tracked for consideration.
Corrective Action Process
Timeline Requirements
| Finding | Initial Response | Corrective Action | Verification |
|---|---|---|---|
| Major | 24-48 hours | 30 days max | Within 90 days |
| Minor | 5 business days | 60 days max | Within 90 days |
| OFI | 30 days | As appropriate | As appropriate |
Corrective Action Elements
- Containment: Immediate action to contain impact
- Root Cause: Analysis to determine true cause (5-Why, Fishbone)
- Corrective Action: Action to eliminate root cause
- Implementation: Execute corrective action
- Verification: Confirm effectiveness
- Prevent Recurrence: Systemic changes
Output Format
Audit Report Structure
# Internal Audit Report
## Audit Information
| Field | Value |
|-------|-------|
| Audit Number | IA-[YYYY]-[SEQ] |
| Type | QMS / Process / Product |
| Date | [YYYY-MM-DD] |
| Auditor(s) | [Names] |
| Auditee | [Name/Department] |
| Scope | [Description] |
## Executive Summary
[Brief summary of audit results]
## Findings Summary
| Major NC | Minor NC | OFI | Positive Findings |
|----------|----------|-----|-------------------|
| [count] | [count] | [count] | [count] |
## Detailed Findings
### Finding 1: [Title]
**Classification:** Major / Minor / OFI
**Requirement:** [Reference]
**Evidence:** [Objective evidence]
**Finding:** [Description]
**Response Due:** [Date]
[Repeat for each finding]
## Positive Observations
[Good practices observed]
## Conclusions
[Overall assessment]
## Approvals
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Lead Auditor | | | |
| Quality Manager | | | |
Integration with Related Skills
AutomotiveManufacturing
Process audits verify work instruction compliance:
- Are documented procedures being followed?
- Are quality checkpoints being executed?
- Are records being maintained?
Load: read ~/.claude/skills/Automotivemanufacturing/SKILL.md
A3criticalthinking
For audit finding root cause analysis:
- Use 5-Why methodology
- Fishbone diagram for complex issues
- A3 format for corrective action plans
Load: read ~/.claude/skills/A3criticalthinking/SKILL.md
Supplementary Resources
For detailed guidance:
read ~/.claude/skills/Internalaudit/CLAUDE.md
For checklists:
ls ~/.claude/skills/Internalaudit/templates/
For IATF clause questions:
read ~/.claude/skills/Internalaudit/reference/iatf-clause-questions.md