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National Environmental Monitoring Conference
San Antonio, TX
Thursday, August 8, 2013
Gary P. Yakub
Environmental Standards, Inc.
Laboratory Ethics:
An Auditor’s Perspective
“Let’s begin with an interesting little story…”
2
Questions
What does an auditor look for to identify
potential ethics violation?
What could have helped
the QA Manager
recognize potential
ethics violation?
Can we develop a list of tools that can help us
evaluate our laboratories?
3
Data Surveillance
Internal Surveillance
External Surveillance
4
What Does an Auditor Look for?
Evaluation Starts in the Pre-Audit Meeting
Strong Ethics Program
Does the Laboratory have:
Ethics Policy – Written Program?
Ethics Agreement – Signed by Everyone?
Ethics Support – Upper Management?
Ethics Training – Employee Understanding?
Ethics Audits – Specifically Target Ethics?
Corrective Actions – Ethics Violations?
5
What Does an Auditor Look for? (Cont.)
Uniformity
Perfection
Following Written Procedures & SOPs
Gaps in Continuity
Trained, Knowledgeable Personnel
Adequate Equipment, Glassware
Adequate Amount of Consumables
Preparation of Standards and Reagents
6
What Does an Auditor Look for? (Cont.)
Raw Data Evaluations
Timelines, Sample Through-Put
Calibration Records and Responses
Instrument Output
Manual Data Management
Related Analytical Results
7
What Can Management Do?
Assign Someone to Perform Surveillance
Someone separate from laboratory operations
Develop an Internal Audit Schedule
Specifically Target Data
Integrity/Ethics
Think Like an Auditor
Develop and Utilize Tools to
Detect Issues
Practice What You Preach
8
Data Surveillance Tools
Data Audit
Records Audit
Purchase Order Audit
Double-Blind Studies
Split Samples
Confidential Reporting Mechanism
Frequent Training and Discussions
Knowing Right from Wrong
9
“The rest of the story…”
10
Positive Factors
Strong Ethics Program
Dedicated, Educated Analysts & Managers
Strong Performance
Isolated Incident
Acceptable, Prompt Corrective Action Discipline
Re-training
Sample Qualification & Client Notification
11
BONUS SLIDES!
Don’t tell anyone that you heard it from me, but
here are some things I commonly see when I audit
a laboratory…
12
“Guess We Weren’t Paying Attention…”
Expired Standards and
Reagents
Solids Oven Temperatures
Thermometer Calibrations
Application of Correction
Factors
BOD – Chlorine Removal
& Sample Pretreatment
13
“Close, But No Cigar”
QC Tests Analyzed, Results Ignored
Balance Calibration Verifications
Incomplete Records
Indirect Traceability vs. Direct Traceability
Incomplete or Ineffective Corrective Actions
14
“That’s Just Wrong”
Metals PE Study Samples
Assorted Ethics Violations
Undertrained/Inexperienced Analysts
Incomplete Demonstrations of Capability
15
Contact
16
Gary Yakub
[email protected] | 610.935.5577
Environmental Standards, Inc. “Setting the Standards for Innovative Environmental Solutions”
Headquarters 1140 Valley Forge Road | PO Box 810 | Valley Forge, PA 19482 | 610.935.5577
Virginia 1208 East Market Street | Charlottesville, VA 22902 | 434.293.4039
Tennessee 8331 East Walker Springs Lane, Suite 402 | Knoxville, TN 37923 | 865.376.7590
Texas 11200 Richmond Avenue, Suite 350 | Houston, TX 77082 | 281.752.9782
Web www.envstd.com | E-mail [email protected]
