Quality Auditing

Understanding the auditing landscape:

Types of Audits:

First Party (Internal):
- Organization audits itself
- Foundation for quality system
- Identifies issues before external audits
- Drives continuous improvement

Second Party (Supplier/Customer):
- Customer audits supplier
- Verify supplier capability
- Assess specific requirements
- Risk management tool

Third Party (Certification):
- Independent registrar audits organization
- For certification/registration
- ISO 9001, IATF 16949, AS9100
- Formal findings and decisions

Audit Scope:

System Audit:
- Overall quality management system
- Policies, procedures, effectiveness
- Organization-wide assessment
- Certification audits

Process Audit:
- Specific process examination
- Inputs, activities, outputs
- Conformance and effectiveness
- Often used for problem areas

Product Audit:
- Finished product assessment
- Conformance to specifications
- Customer perspective
- Sampling based

Key Standards:

ISO 19011:
Guidelines for auditing management systems:
- Audit principles
- Managing audit programs
- Auditor competence
- Applies to all management systems

ISO 9001:
Quality management system requirements:
- Customer focus
- Process approach
- Continuous improvement
- Most common QMS standard

Industry Standards:
- IATF 16949 (Automotive)
- AS9100 (Aerospace)
- ISO 13485 (Medical devices)
- GMP regulations (Pharmaceutical, Food)

Conducting effective audits:

Audit Planning:

Preparation:
- Review previous audit results
- Understand process/area scope
- Review relevant documentation
- Prepare audit checklist
- Notify auditees

Checklist Development:
- Based on standard requirements
- Include process-specific elements
- Allow for observations beyond checklist
- Balance structure with flexibility

Audit Execution:

Opening Meeting:
- Introduce audit team
- Confirm scope and schedule
- Explain process
- Address questions

Evidence Gathering:

Document Review:
- Procedures and instructions
- Records and data
- Training records
- Previous audit findings

Interviews:
- Process owners and operators
- Open-ended questions
- Verify understanding of procedures
- "Show me" approach

Observation:
- Watch activities performed
- Compare to documented procedures
- Note conditions and practices
- Objective evidence

Sampling:
- Select representative samples
- Trace through process
- Verify records match activities

Audit Techniques:
- Follow the process flow
- Trace from input to output
- Verify objective evidence
- Ask "why" to understand
- Look for consistency

Closing Meeting:
- Summarize findings
- Clarify misunderstandings
- Explain next steps
- Thank participants

Documenting and communicating audit results:

Types of Findings:

Nonconformity:
Failure to meet requirement:
- Major: Significant system failure, risk to product/customer
- Minor: Isolated instance, contained impact

Observation:
- Potential for nonconformity
- Improvement opportunity
- Not yet a requirement failure
- May become finding if unaddressed

Positive Finding:
- Good practice noted
- Effective implementation
- Often overlooked but valuable

Writing Effective Findings:

Elements:
- What requirement was not met (reference)
- What objective evidence showed the gap
- Where the issue was observed
- Clear, factual statement

Example:
"ISO 9001:2015, Clause 8.5.1(d) requires identification and traceability. Audit of Assembly Line 3 on [date] found three units (SN 12345, 12346, 12347) without required lot traceability labels."

Avoid:
- Vague statements
- Opinion without evidence
- Solutions in the finding
- Multiple issues in one finding

Audit Report:

Contents:
- Scope and objectives
- Team and dates
- Summary of results
- Detailed findings
- Positive observations
- Conclusions

Corrective Action:
- Required response to findings
- Root cause analysis
- Corrective action plan
- Verification of effectiveness
- Timeline for completion

Follow-Up:
- Verify corrective actions implemented
- Assess effectiveness
- Close findings when resolved
- Trend analysis across audits

Developing auditing expertise:

Auditor Skills:

Technical:
- Knowledge of standards
- Process understanding
- Industry/domain knowledge
- Analytical ability

Interpersonal:
- Communication (listening, questioning)
- Objectivity and fairness
- Diplomacy and tact
- Ethical conduct

Professional:
- Attention to detail
- Time management
- Report writing
- Continuous learning

Auditor Qualifications:

Internal Auditor:
- Training course (typically 2-3 days)
- Understanding of ISO 19011
- Knowledge of company QMS
- Mentored audits for experience

Lead Auditor:
- Formal lead auditor training (5 days)
- Experience requirements (varies)
- Manage audit teams
- Required for certification body roles

Certifications:

ASQ Certifications:
- CQA (Certified Quality Auditor)
- Recognized credential
- Requires experience and exam

Registrar Qualifications:
- Specific to certification body
- IATF, IAQG requirements
- Ongoing development required

Career Paths:

Internal Quality:
Quality Inspector -> Auditor -> Lead Auditor -> Quality Manager
$45,000 -> $55,000 -> $70,000 -> $90,000+

Certification Body:
Auditor -> Lead Auditor -> Technical Manager
$60,000 -> $85,000 -> $100,000+
Travel-intensive

Consulting:
- Independent auditor
- System implementation support
- Training delivery
- $75-200/hour

Industries:
All industries using quality management systems benefit from auditors. Automotive, aerospace, and medical devices have highest demand due to regulatory requirements.