| 1. Introduction Importance of internal audits in laboratory quality systems Objectives of auditing: Ensure compliance with ISO/IEC 17025 Improve effectiveness of the management system Relationship between audits, nonconformities, and improvement 2. Internal Auditing Fundamentals Definition of internal audit Types of audits: System audit Process audit Technical audit Audit principles: Integrity Objectivity Confidentiality Evidence-based approach 3. Audit Planning Establishing an audit program Frequency and scheduling Risk-based audit planning Selecting qualified auditors Preparing audit checklists 4. Audit Process ✔️ Audit Stages Preparation Review documents and procedures Opening Meeting Define scope and objectives Conducting Audit Interviews, observation, record review Collecting Evidence Objective evidence vs opinion Closing Meeting Present findings 5. Audit Techniques Interviewing skills Sampling methods Traceability checks Process approach auditing 6. Audit Findings Types of findings: Conformity Nonconformity Observation Opportunity for improvement (OFI) 7. Non-Conformance Reporting (NCR) Definition of nonconformity Types: Major Minor Writing effective NCRs: Clear statement of issue Reference to standard or procedure Objective evidence 8. Root Cause Analysis Importance of identifying true cause Methods: 5 Whys technique Fishbone (Ishikawa) diagram Fault tree analysis 9. Corrective Actions Definition and purpose Steps: Identify nonconformity Analyze root cause Plan corrective action Implement action Verify effectiveness 10. Preventive Actions & Risk-Based Thinking Difference between corrective and preventive actions Identifying risks and opportunities Proactive improvement approach 11. Follow-Up and Closure Verification of corrective actions Effectiveness review Closing nonconformities Maintaining records 12. Documentation & Records Audit reports NCR forms Corrective action reports (CAR) Audit schedules and checklists 13. Common Audit Mistakes Poor planning Lack of objective evidence Weak root cause analysis Ineffective corrective actions 14. Roles and Responsibilities Internal auditor Technical manager Quality manager Top management 15. Practical Exercises Mock audits Writing NCRs Root cause analysis case studies Evaluating corrective actions ✔️Key Takeaways Internal audits are a tool for improvement, not fault-finding Strong root cause analysis is critical Corrective actions must be effective and verified Documentation is essential for compliance and traceability |
Specialized Training Program Internal Auditing, Non-Conformance Reporting & Corrective Actions (ISO/IEC 17025:2017:)
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