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:

Comment [L8]: TBD: to keep or remove?

 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.

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.

Performance characteristic

Qualitative methods

Quantitative methods

Validation

Verification

Validation

Verification

+ + + + + + + + +

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Trueness

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Detection limit Limit of quantification Repeatability Reproducibility Linearity

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Inclusivity Exclusivity Robustness

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Measurement uncertainty

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

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.