Course Details
Course Outline
5 days course
Auditing Fundamentals
- Types of Quality Audits
- - Method
- - Auditor-auditee relationship
- - Purpose
- - Common elements with other audits
- Purpose and Scope of Audits
- - Elements of purpose and scope
- - Benefits of audits
- Criteria to Audit Against
- Roles and Responsibilities
- Professional Conduct and Consequences of Auditors
- - Professional conduct and responsibilities
- - Legal consequences
- - Audit credibility
Audit Process
Audit Preparation and Planning
- Elements of the audit planning process
- Auditor selection
- Audit-related documentation and considerations Logistics
- Auditing tools and working papers
- Auditing strategies
- Auditing plan
Audit performance
- On-site audit management for the auditor
- On-site audit management for the auditee
- Opening meeting
- Audit data collection and analysis
- Establishment of objective evidence
- Organization of objective evidence
- Exit and closing meetings
Audit Reporting
- Report development and content
- Effective reports
- Final audit report steps
Audit Follow-Up and Closure
- Elements of the corrective and preventive action (CAPA) process
- Review of corrective and preventive action (CAPA) plan
- Verification of corrective and preventive action (CAPA)
- Follow-up of ineffective corrective and preventive action (CAPA)
- Audit closure
Auditor Competencies
- Auditor Characteristics
- On-Site Audit Resource Management
- Conflict Resolution
- Communication and Presentation Techniques
- Interviewing Techniques
- Use open-ended or closed question types
- Use active listening, paraphrasing, and empathy
- Recognize and respond to non-verbal cues
- Determine when and how to prompt a response
- Team Dynamics
- Team-building
- Team facilitation
- Stages of team development
Program Management and Business Applications
Audit Program Management
- Senior management support
- Staffing and resource management
- Auditor training and development
- Audit program evaluation
- Internal audit program management
- External audit program management
- Best practices
- Organizational risk management
- Management review input
- Electronic records and computerized system considerations
Business and Financial Impact
- Auditing as a management tool
- Interrelationship of business processes
- Cost of quality (COQ) principles
Quality Tools and Techniques
- Basic Quality and Problem-solving Tools
- Process Improvement Techniques
- Six Sigma
- Lean
Basic Statistics
- Measures of central tendency
- Measures of dispersion
- Qualitative and quantitative analysis
Process Variation
- Common and special cause
- Process performance metrics
- Outliers
Sampling Methods
- Acceptance sampling plans
- Types of sampling
- Sampling terms
- Change Control and Configuration Management
- Verification and Validation
- Risk Management Tools
