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

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“

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“

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“

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“

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“

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“

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“

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“

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

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“

Process Approach Matthew Sica Consulting "Assisting Laboratory Compliance“

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

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

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

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

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

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

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

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

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

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

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“

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“

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

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“

Thank You! Matthew Sica Consulting "Assisting Laboratory Compliance“