Internal Auditing for Small Laboratories Matthew Sica Principal Scientist (207) 624-1532 Matthew...

Internal Auditing for

Small Laboratories

Matthew SicaPrincipal Scientist

(207) 624-1532

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


Nelac 5.4.13.1

Internal Audit (annual) Predetermined schedule Procedure Verifying lab continues to comply

Quality system Standard


Nelac 5.4.13.1

Internal audit program to address all elements of the quality system environmental testing activities


Audits

A means of verification which involves: Monitoring and measurement

Purpose of quality audits Establish factual information on quality

performance


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

Process Monitoring Approach


Includes: Process monitoring, plus Reviews

the activities are performed as planned the resources are being effectively utilized

Process Approach


Types of audits

Auditing for conformance Auditing for compliance Auditing for effective implementation

or maintenance system


Need to make a choice

What do you want to get out of your audit?

How are you going to do it?


Labs new to accreditation

Auditing: Compliance

Accreditation Body requirements Regulatory requirements

Effective Implementation of system


Labs w/Mature Systems

Auditing Conformance

to system requirements Maintenance of system Compliance if change occurred


Process Approach


Laboratory Workflow


Pre-Analytic

al

Analytical

Post-Analytic

al

Pre-Analytical


Contract Review

Sampling and

Sample Transport

Sample Manageme

nt

Sample Management


Sample Receipt Subcontracting of Tests

Sample Storage

During Review


Documents and Records

Personnel

Analytical


Environment Equipment Method

Assuring Quality

of Test

During Review



Personnel

Purchasing of Services and Supplies

Traceability

Handling of Test Item

Post-Analytical


Service to Customer

Control of

Data

Reporting of

Results

During Review



When things go wrong


Complaints Corrective Action

Nonconforming Work

Improvement

During Review



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


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


Nelac 5.4.13.4

Follow-up audit activities Verify Record

Implementation of CA Effectiveness of CA


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.


Thank You!


Internal Auditing for Small Laboratories Matthew Sica Principal Scientist (207) 624-1532 Matthew...

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