Professional Documents
Culture Documents
Method Validation
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Sources
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Purpose of presentation
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My Background
◼ ISO
– Anyone participates, through TAG or
“mirror committee”
– One vote per country
– CD, DIS, FDIS, Approved stages
◼ CLSI
– Anyone participates
– Balance Industry, Profession, Government
– SC Draft, Proposed, Approved stages 8
TC 69 Scope
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SC 1: Terminology
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SC 5: Acceptance
Sampling
◼ Inspection by variables
◼ Inspection by attributes
◼ Assessment of declared quality levels
◼ Double sampling
◼ Sequential sampling
◼ Accept-zero sampling plans
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SC 6: Measurement
Methods and Results
◼ ISO 5725: Accuracy (trueness and precision)
of measurement methods and results
– Part 1: General principles
– Part 2: Repeatability and reproducibility
– Part 3: Intermediate precision
– Part 4: Trueness
– Part 5: Alternative methods for precision
– Part 6: Use of accuracy values
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ISO 5725 Procedures
◼ Part 2 (precision)
– Selection of laboratories
– Selection of materials (levels)
– Statistical analysis
◼ Outliers (labs, samples, replicates)
◼ Graphics (h and k statistics)
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ISO 5725 Procedures
◼ Equipment
◼ Conditions
◼ Part 4 (Trueness)
– Comparison to reference method
◼ By level
◼ Across levels
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SC 6: Limit of Detection
◼ “Currie” model
– Considers Type 1 and Type 2 error
(consistent with new VIM)
– Assumes normal distribution
– Assumes repeatability conditions
– No “less than” values allowed
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SC 6: Other Documents
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CLSI Evaluation Protocols
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EP 9 Procedures
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EP 21 Procedures
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EP Process Capability
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EP 6 Procedures
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EP 17 Procedures
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EP Method Verification
◼ EP7: Interference Testing
◼ EP10: Preliminary Evaluation of Quantitative
Methods
◼ EP14: Evaluation of Matrix Effects
◼ EP15: User Verification of Precision and
Trueness
◼ EP18: Quality Management for Unit-Use
Testing
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EP Risk Management
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Contact Information
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Thank you!
(Questions?)
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