Learning Objectives

Upon successful completion of this course, participants will be able to:

1. Fundamentals of Operational Reviews and Audits

• Understand the purpose and scope of operational reviews and audits.
• Differentiate between internal audits, compliance audits, and operational performance reviews.
• Learn the principles of auditing (independence, objectivity, and systematic evaluation).

2. Planning and Conducting Operational Audits

• Define audit objectives, scope, and key performance indicators (KPIs).
• Identify audit stakeholders and key operational processes.
• Develop audit checklists and data collection tools.
• Use risk-based auditing approaches to focus on critical areas.

3. Identifying and Assessing Non-Conformances

• Understand non-conformance categories (process, quality, safety, regulatory, environmental).
• Identify root causes of operational inefficiencies and deviations from standards.
• Use risk assessment techniques to prioritize non-conformances.

4. Documentation and Reporting of Audit Findings

• Develop structured and actionable audit reports.
• Communicate audit findings effectively to management and stakeholders.
• Use corrective and preventive action (CAPA) frameworks.

5. Managing Non-Conformances and Corrective Actions

• Implement root cause analysis techniques (5 Whys, Fishbone Diagram, FMEA).
• Develop effective corrective action plans and timelines.
• Ensure compliance with ISO, OSHA, EPA, and other industry-specific regulations.

6. Continuous Improvement and Operational Excellence

• Utilize Lean Six Sigma methodologies to prevent recurring issues.
• Implement audit tracking systems and performance dashboards.
• Foster a culture of compliance and accountability in operations.

7. Best Practices for Audit Readiness and Compliance

• Prepare for regulatory and external audits (ISO 9001, ISO 14001, API, GMP, etc.).
• Ensure effective document control and record-keeping.
• Conduct training programs to improve audit preparedness.

8. Case Studies and Practical Applications

• Analyze real-world operational audit case studies and non-conformance issues.
• Participate in mock audit exercises and root cause analysis workshops.
• Develop a customized audit checklist and corrective action plan for a real-world scenario.

Target Audience

• Operations managers and supervisors
• Internal auditors and compliance officers
• Quality assurance and risk management professionals
• Supply chain and logistics personnel
• Corporate governance and regulatory affairs teams