Page 73 - 2013 ISPAM Mid-Year Mtg Book

1. Documentation: method version, verification plan, training documents, work sheets,
SOPs, etc.
2. Environment: bio-containment, compatibility, environmental monitoring, etc.
3. Equipment: as stated in the method; properly calibrated and maintained as stated in the
method.
4. Materials: supplies as stated in the method.
5. Analyst / personnel competency: training plans, training records, PT samples, etc.
6. Laboratory performance: method, food category and food type , verification sheet with the
determined performance characteristics, verification protocol, description of the
repeatability and reproducibility conditions
7. Final approval: lab manager, supervisor.
In case of methods that are reinstated after a period of disuse, the following items must be re-verified:
 Documents
 Equipment
 Analyst / personnel competency
This document addresses the laboratory performance element of the verification process. All other
elements of verification listed above are an integral part of a laboratory quality management system
and are not elaborated in this document.
Summary table of relevant performance characteristics of micro methods validation and verification.
Performance
characteristic
Qualitative methods Quantitative methods
Validation Verification Validation Verification
Trueness + +
Detection limit + + +
Limit of
quantification
+
Linearity +
Repeatability + +
Reproducibility + +
Inclusivity + +
Exclusivity + +
Robustness + +
Measurement
uncertainty
+
4.1 Laboratory performance of qualitative methods:
In order to verify laboratory performance, analyze a minimum of 15 samples by the method
as written. It is recommended to include a wide range of matrices that are routinely analyzed
in the laboratory.
Artificially inoculate 10 samples at 3 to 5 times the Limit of detection (LOD) or at around 10-
25 CFU per analytical unit if the LOD is not available. The samples may be inoculated with
un-stressed cells without any equilibration period. The inoculum must be quantified using a
direct plating method on non-selective agar to confirm the targeted concentration has been
reached. The remaining 5 samples will be the negative controls for the sample set.
Blind code all 15 samples before analysis.
Comment [L8]: TBD: to keep or remove?
Comment [L9]: Insert table “relevant perf.
Characteristics – valid vs. verification; and spectrum
of repeatability to reproducibility
Comment [ii10R9]: Table included after the
November meeting_ ACTION : DISCUSS STILL
NEEDED- if still need have a disclaimer
indicating that only partial list of characteristic
are evaluate.
Comment [ii11]: Should we have here a list of
the mmc parameter and indicate that for published
method this should be the parameters. ACTION
question to discuss