Course Highlights
  • Successfully pass the Certified Quality Auditor in the first attempt
  • Understand the roles and responsibilities of the auditor
  • Confidently conduct internal/external quality management system audit
  • This course is fully aligned with the Certified Quality Auditor Body of Knowledge provided by most internationally recognized certification bodies.
Curriculum

17 Topics
1A1 Methods - Introduction and three defintions
1A1 Quality Auditing - Standards
1A1 Auditing Methods - Product Process and System Audits
1A1 Auditing Methods - Combined and Joint Audits
1A2 Auditor-auditee Relationship (First Second and Third Party Audits)
1A3 Purpose - Registration/Certification and Accreditation
1A3 Purpose - For cause Risk based Compliance Surveillance and CAPA
1A4 Common Elements with other Audits
1B1 Elements of purpose and scope
1B2 Benefits of audits
1C Criteria to audit against
1D Roles and responsibilities of audit participants
1E1 Professional conduct and responsibilities
1E2 Legal consequences
1E3 Audit credibility
Section 1 Slides: Download pdf file
Section 1 Quiz - Auditing Fundamentals

25 Topics
2A Audit Preparation and Planning
2A1 Elements of the audit planning process
2A2 Auditor selection
2A3 Audit-related documentation and considerations
2A4 Logistics
2A5 Auditing tools and working papers
2A6 Auditing strategies
2A7 Auditing plan
2B1 On-site audit management for the auditor
2B2 On-site audit management for the auditee
2B3 Opening meeting
2B4 Audit data collection and analysis
2B5 Establishment of objective evidence
2B6 Organization of objective evidence
2B7 Exit and closing meeting
2C1 Audit report development and content
2C2 Effective reports
2C3 Final audit report steps
2D1 Elements of the corrective and preventive action (CAPA) process
2D2 Review of corrective and preventive action (CAPA) plan
2D3 Verification of corrective and preventive action (CAPA)
2D4 Follow-up on ineffective corrective and preventive action (CAPA)
2D5 Audit closure
Section 2 Slides: Download pdf file
Section II Quiz - Audit Process

12 Topics
3 Auditor Competencies
3A Auditor Characteristics
3B On-site Audit Resource Management
3C Conflict Resolution - Part 1
3C Conflict Resolution - Part 2
3D Communication and Presentation Techniques
3E Interviewing Techniques
3F1 Team Building
3F2 Team Facilitation
3F3 Stages of Team Development
Section 3 Slides: Download pdf file
Section III Quiz - Auditor Competencies

15 Topics
4A1 Senior Management Support
4A2 Staffing and Resource Management
4A3 Auditor Training and Development
4A4 Audit Program Evaluation
4A5 Internal Audit Program Management
4A6 External Audit Program Management
4A7 Best Practices
4A8 Organizational Risk Management
4A9 Management Review Input
4A10 Electronic Records and Computerized System Considerations
4B1 Auditing as a Management Tool
4B2 Interrelationship of Business Processes
4B3 Cost of Quality (COQ) Principles
Section 4 Slides: Download pdf file
Section IV Quiz - Audit Program Management and Business Applications

49 Topics
5A Basic Quality and Problem Solving Tools - Introduction
5A1 Pareto Chart
5A2 Cause and Effect Diagrams
5A3 Flowcharts
5A4 Statistical Process Control (SPC) Charts
5A5 Check Sheets
5A6 Scatter Diagrams
5A7 Histograms
5A8 Root Cause Analysis (RCA)
5A9 Plan-Do-Check-Act (PDCA) Cycle
Section V Quiz 1 - Basic Quality Tools
5B1 Six Sigma
5B2 Lean - Introduction and Benefits
5B2 Lean Philosophy
5B2 Lean - Value Stream Mapping (VSM)
5B2 Lean - Types of Wastes - Muda Mura and Muri
5B2 Lean - Eight Types of Wastes
5B2 Waste Elimination - Pull System
5B2 Waste Elimination - Kanban Card
5B2 Waste Elimination - 5S
5B2 Waste Elimination - Standard Work and Poka-Yoke
Section V Quiz 2 - Six Sigma and Lean
5C Basic Statistics
5C1 Measures of Central Tendency
5C2 Measures of Dispersion
5C3 Qualitative and Quantitative Analysis
Section V Quiz 3 - Basic Statistics
5D1 Common and Special Cause
5D2 Process Performance Metrics
5D3 Outliers
Section V Quiz 4 - Process Variation
5E2 Types of Sampling
5E1 Acceptance Sampling Plans
5E3 Sampling Terms
Section V Quiz 5 - Sampling Methods
5F Change Control
5F Configuration Management
Section V Quiz 6 - Change Control and Configuration Management
5G Verification and Validation
Section V Quiz 7 - Verification and Validation
5H Risk Management Tools
5H Plan Risk Management and Identify Risks
5H Analyze Risks
5H Plan Risk Response and Monitor/Control Risks
5H Failure Mode and Effects Analysis
5H Hazard Analysis and Critical Control Points (HACCP)
5H Critical to Quality (CTQ) Analysis
Section V Quiz 8 - Risk Management
Section 5 Slides - Download pdf file

1 Topic
Bonus Lecture

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