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Internal Auditing for Small Laboratories

Internal Auditing for Small Laboratories. Matthew Sica Principal Scientist (207) 624-1532. Goal of this Session. Understand different types of audits Understand: How to perform a process audit H ow to make it meaningful. Nelac 5.4.13.1. Internal Audit (annual)

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Internal Auditing for Small Laboratories

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  1. Internal Auditing for Small Laboratories Matthew Sica Principal Scientist (207) 624-1532 Matthew Sica Consulting "Assisting Laboratory Compliance“

  2. Goal of this Session • Understand different types of audits • Understand: • How to perform a process audit • How to make it meaningful Matthew Sica Consulting "Assisting Laboratory Compliance“

  3. Nelac 5.4.13.1 • Internal Audit (annual) • Predetermined schedule • Procedure • Verifying lab continues to comply • Quality system • Standard Matthew Sica Consulting "Assisting Laboratory Compliance“

  4. Nelac 5.4.13.1 • Internal audit program to address • all elements of the quality system • environmental testing activities Matthew Sica Consulting "Assisting Laboratory Compliance“

  5. Audits • Ameans of verification which involves: • Monitoring and measurement • Purpose of quality audits • Establish factual information on quality performance Matthew Sica Consulting "Assisting Laboratory Compliance“

  6. Process Monitoring Approach • Process Monitoring • Traditional tool for internal audit • Results Oriented (Review reports) • Measures what is being processed • Not if the rules are followed • Internal Audits • Miss opportunities to make process more efficient Matthew Sica Consulting "Assisting Laboratory Compliance“

  7. Process Approach • Includes: • Process monitoring, plus • Reviews • the activities are performed as planned • the resources are being effectively utilized Matthew Sica Consulting "Assisting Laboratory Compliance“

  8. Types of audits • Auditing for conformance • Auditing for compliance • Auditing for effective implementation or maintenance system Matthew Sica Consulting "Assisting Laboratory Compliance“

  9. Need to make a choice What do you want to get out of your audit? How are you going to do it? Matthew Sica Consulting "Assisting Laboratory Compliance“

  10. Labs new to accreditation • Auditing: • Compliance • Accreditation Body requirements • Regulatory requirements • Effective Implementation of system Matthew Sica Consulting "Assisting Laboratory Compliance“

  11. Labs w/Mature Systems • Auditing • Conformance • to system requirements • Maintenance of system • Compliance if change occurred Matthew Sica Consulting "Assisting Laboratory Compliance“

  12. Process Approach Matthew Sica Consulting "Assisting Laboratory Compliance“

  13. Laboratory Workflow Matthew Sica Consulting "Assisting Laboratory Compliance“

  14. Pre-Analytical Matthew Sica Consulting "Assisting Laboratory Compliance“

  15. Sample Management Matthew Sica Consulting "Assisting Laboratory Compliance“

  16. During Review Matthew Sica Consulting "Assisting Laboratory Compliance“

  17. Analytical Matthew Sica Consulting "Assisting Laboratory Compliance“

  18. During Review Matthew Sica Consulting "Assisting Laboratory Compliance“

  19. Post-Analytical Matthew Sica Consulting "Assisting Laboratory Compliance“

  20. During Review Matthew Sica Consulting "Assisting Laboratory Compliance“

  21. When things go wrong Matthew Sica Consulting "Assisting Laboratory Compliance“

  22. During Review Matthew Sica Consulting "Assisting Laboratory Compliance“

  23. Nelac 5.4.13.2 • When audit findings cast doubt • on the effectiveness of the operations or • on the correctness or validity of results, • Laboratory • CA • Notify clients Matthew Sica Consulting "Assisting Laboratory Compliance“

  24. Nelac 5.4.13.3 • Document • area of activity audited • findings and • corrective actions • Laboratory management shall ensure that these actions are discharged within the agreed time frame Matthew Sica Consulting "Assisting Laboratory Compliance“

  25. Nelac 5.4.13.4 • Follow-up audit activities • Verify • Record • Implementation of CA • Effectiveness of CA Matthew Sica Consulting "Assisting Laboratory Compliance“

  26. References • 2003 NELAC Standard • ISO/IEC 17025:2005 • David Hoyle • ISO 9000 Quality Systems Handbook, 6th Ed. • Clinical and Laboratory Standards Institute • GP26A4 QMS Model for Lab Services, 4th Ed. Matthew Sica Consulting "Assisting Laboratory Compliance“

  27. Thank You! Matthew Sica Consulting "Assisting Laboratory Compliance“

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