1. Internal Auditing for Small Laboratories
Matthew Sica
Principal Scientist
(207)
Matthew Sica Consulting "Assisting Laboratory Compliance“
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 A means of verification which involves:
Monitoring and measurement
Purpose of quality audits
Establish factual information on quality performance
Matthew Sica Consulting "Assisting Laboratory Compliance“
Matthew Sica Consulting "Assisting Laboratory Compliance“

6. Process Monitoring Approach
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
Conformance to your management system requirements
Compliance to AB and regulatory requirements
Implementation and maintenance
Matthew Sica Consulting "Assisting Laboratory Compliance“
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 Maintenance of system
to system requirements
Maintenance of system
Compliance if change occurred
Matthew Sica Consulting "Assisting Laboratory Compliance“
Matthew Sica Consulting "Assisting Laboratory Compliance“

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

13. Laboratory Workflow Pre-Analytical Analytical Post-Analytical
Matthew Sica Consulting "Assisting Laboratory Compliance“

14. Sampling and Sample Transport
Pre-Analytical
Contract Review
Sampling and Sample Transport
Sample Management
Matthew Sica Consulting "Assisting Laboratory Compliance“

15. Subcontracting of Tests
Sample Management
Sample Receipt
Subcontracting of Tests
Sample Storage
Matthew Sica Consulting "Assisting Laboratory Compliance“

16. During Review Documents and Records Personnel
Matthew Sica Consulting "Assisting Laboratory Compliance“

17. Assuring Quality of Test
Analytical
Environment
Equipment
Method
Assuring Quality of Test
Matthew Sica Consulting "Assisting Laboratory Compliance“

18. During Review Documents and Records Personnel
Purchasing of Services and Supplies
Traceability
Handling of Test Item
Matthew Sica Consulting "Assisting Laboratory Compliance“

19. Post-Analytical Service to Customer Control of Data
Reporting of Results
Matthew Sica Consulting "Assisting Laboratory Compliance“

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

21. When things go wrong Corrective Action Complaints Improvement
Nonconforming Work
Improvement
Matthew Sica Consulting "Assisting Laboratory Compliance“

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

23. Nelac 5.4.13.2 When audit findings cast doubt Laboratory
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
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“