internalaudit（internalaudit 搜索）

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

IATF 16949 requires three types of internal audit (clauses 9.2.2.2–9.2.2.4):

Note: Layered Process Audits (LPA) are not a standalone IATF 16949 requirement. They are a customer-specific requirement (CSR) from certain OEMs (e.g., GM, Ford, Stellantis). They must be implemented when required by customer CSRs but are separate from the three IATF-mandated audit types above.

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

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

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

1. Internal training on QMS and IATF 16949
2. Core tools training
3. Audit technique training
4. Shadow audits (observe experienced auditor)
5. Supervised audits
6. 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

Corrective Action Elements

1. Containment: Immediate action to contain impact
2. Root Cause: Analysis to determine true cause (5-Why, Fishbone)
3. Corrective Action: Action to eliminate root cause
4. Implementation: Execute corrective action
5. Verification: Confirm effectiveness
6. 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