method verification part ii tdlm workshop · tdlm symposia on importing a method – degrees of...
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Method Verification Part IITDLM Workshop
John Szpylka, Ph.D.Technical Manager
Medallion Laboratories
AOAC Int’l Annual MeetingDallas, TX
September 2008
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Last Year Started It All . . .
TDLM Symposia on Importing a Method– Degrees of importing– Using available data– Depth of verification– Ongoing competency tracking
Kicked off ALACC Guidance Document– Free on AOAC Website
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Why Import A Method?
All the method development work has been done.Method performance understood.
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Why Import A Method?
“Official” methods used to settle disputes.Inter-laboratory proficiency testing may already be in place.
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Once Imported . . .
Must show you can do the method correctly at your site!
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Degrees of Importing Methods
Performing the method exactly as written“Slightly” modifying the methodModifying the Method
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Matrix Application
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J. AOAC, 83 (2), 413 (2000)“The Referee”, AOAC Int’l, July 1993
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Ready To Use Methods
Slightly modified– It’s always wise to have supporting data
You Never Know!
– Prove or state that modifications have no or understood effect
– Must have supporting documentation– May use validation data
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Ready To Use Methods
Modified– Supporting data is a must!– Examples
different column,different detector,change of sample weights, dilutions or other sample preparation steps,solvent switch.
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Verification is a “Mini-Validation”
Pull method performance during original validations (SLV and MLV)– See if you can repeat performance
To evaluate matrix effects
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Analyst CompetencyTraining– Establish a written list of steps to document the training
procedure.
Our labs require– 7 replicates of a known NIST or Internal Reference Material, or– 7 side-by-side with expert.– Optional spike/recovery and/or matrix challenge.
Compare average, st. dev., and statistical analyses (ANOVA or t-Test).
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Ongoing Demonstration ofMethod Performance
Participate in Proficiency testing ProgramDuplicate analysesControl Chart
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Ongoing Demonstration ofMethod Control
Date/Time
Mea
sure
men
t
Average
+ 1 std dev
+ 2 std dev
+ 3 std dev
- 1 std dev
- 2 std dev
- 3 std dev
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Takeaways
Importing a method is truly an adoption– Be prepared to adopt– Welcome it to your home– Take care of it– Keep it healthy– Be prepared for it to grow
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This Year Goes tothe Next Level
Take what I learned last yearTake the ALACC Guidance documentShow Me How!
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Thank You!Let’s Get Started!!