Program Overview
This comprehensive program offers an immersive deep-dive into managing non-conformities through effective CAPA and audit readiness practices. Delivered by a seasoned expert, the course unpacks globally accepted standards (like ISO 9001, IATF 16949, ISO 13485), tools for root cause analysis, documentation best practices, and real-time simulations. From conceptual grounding to solving real audit failures, participants will learn to close NCs systematically and prepare for both internal and external audits with confidence.
Features
- Understand types and lifecycles of non-conformities
- Apply structured CAPA methodologies for long-term resolution
- Evaluate audit readiness and improve documentation trails
- Use real-life tools and frameworks for proactive compliance
Target audiences
- Quality Managers
- Compliance Heads
- Functional Leaders
- Internal Auditors
Curriculum
- 4 Sections
- 21 Lessons
- 1 Day
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- Foundations of Non-Conformity Management6
- 1.1Key definitions: Non-conformity, Deviation, Observation, Finding
- 1.2Types of non-conformities (Major, Minor, Critical, Repeat)
- 1.3Regulatory and standard frameworks (ISO 9001, IATF 16949, ISO 13485)
- 1.4Risk-based thinking in non-conformity identification
- 1.5Concept of ‘Audit Readiness’ and Quality Culture
- 1.6Key Terms: Corrective Action, Preventive Action (CAPA), QMS, Root Cause, Risk Matrix
- Situational Awareness & NC Lifecycle6
- 2.1Lifecycle of a non-conformity from detection to closure
- 2.2NC documentation best practices and audit expectations
- 2.3Stakeholder alignment during NC handling
- 2.4Escalation matrix and deviation impact analysis
- 2.5Case Based Examples: Failed audits due to poor NC closure
- 2.6Situational Drill: Review of a poorly documented NC report and discuss gaps
- CAPA Frameworks (Real-world Examples)6
- 3.1The 7 Steps of Effective CAPA
- 3.2Root Cause Analysis Techniques: 5 Why, Fishbone, FMEA
- 3.3SMART CAPA Plans: How to ensure accountability and timelines
- 3.4KPIs for CAPA effectiveness – leading vs lagging indicators
- 3.5Linking CAPA to continuous improvement
- 3.6Case Study Analysis: CAPA failure in a high-risk domain – What Went Wrong?
- Simulations & Interactive Activity3
Instructor
