Procedure for the Development and Management of Food Microbiological Methods

Development of Methods
Part 2, Section A, Quantitative Methods
May 2008

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Part 2. Data Requirements and Submission Templates for Methods

Microbiological Methods Committee
Evaluation Division,
Bureau of Microbial Hazards,
Food Directorate,
Health Products and Food Branch (HPFB),
Sir Frederick G. Banting Research Centre [PL 2204E]
Ottawa, Ontario, K1A 0K9
e-mail: Don_Warburton@hc-sc.gc.ca

1. Purpose

To define the data requirements and provide the templates needed for submissions of data created in the development or validation of food microbiological methods for inclusion in The Compendium of Analytical Methods.

This document is divided into two Sections:

Section A: Data requirements, submission templates, and examples for Quantitative Methods.

Section B: Data requirements, submission templates, and examples for Qualitative Methods.

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Section A: Data Requirements, Submission Templates, and Examples for Quantitative Methods.

1.1 Template for Review of Quantitative Methods by the Microbiological Methods Committee Technical Group

Note: Technical group (TG) members should consult the appropriate section of the Development of Methods found in Part-3, Guidelines for the Evaluation of Quantitative Food Microbiological Methods, for specific validation requirements for a new method.

The following must be provided in each submission:

Method or Procedure (full title of method including target species):

Originator (Identify all data sources):

Technical Group Name:

Members of Technical Group: names, titles and affiliations of all members

 

Documents provided for review
Documents, data, reports, letters, articles, methods etc. which were provided by the MMC to conduct the review. These documents must include at a minimum the validation protocol used, detailed raw data and summary data in the format specified in Procedures for the Development and Management of Food Microbiological Methods.

Additional documents consulted
References for additional material consulted or used during the course of the review (e.g., ISO 16140:2003, Health Canada documents, previous decisions, the Compendium of Analytical Methods, journals, books, other reviews of the method, etc.). Perform a search to determine if other reviews are available and if the method holds status from other international organizations.

Component	Observations, comments, questions
1. SUBMISSION INFORMATION
Title of method or procedure
Aim of the review (to obtain MFLP or MFHPB status or?)
Reviewed by
Date submitted
Date evaluation completed
2. GENERAL INFORMATION
Data generating lab is ISO accredited?
Does method have potential for meeting the standards of a regulation?
3. PRE-COLLABORATIVE STUDIES or METHOD COMPARISON STUDIES
Note: This section is not applicable for the evaluation of total enumeration methods (SPC, APC, total Yeast & Molds, etc.)
3.1 Determination of Critical Limit (CL) , Limit of Detection (LOD) and Limit of Quantification (LOQ)
3.1.1 Food Categories Number of food categories tested (5 for multiple foods or one or two for specific categories)
3.1.2 Selection of microorganisms Strains chosen or group of strains chosen
3.1.3 Critical Level Determination (CL)Indirect Quantitative Methods (If Applicable) Number of determination used for he baseline study (six to ten) Values of standard deviation and bias obtained CL value obtained  OR Direct Quantitative Methods (If Applicable) Levels of contamination (three levels required with six replicates at each levels) CL obtained (50% recovery)
3.1.4 LOD computed from CL
3.1.5 LOQ computed from CL
3.2 Linearity Studies	(See Section 4 below)
3.3 Inclusivity & Exclusivity Studies
3.3.1 Inclusivity studies Using at least 30 target organisms Group Genera Species Specific Type (Serotype, serovar, etc.)
3.3.2 Exclusivity studies Using at least 20 target organisms
4. ESTABLISHMENT OF THE ORIGINAL CALIBRATION CURVE
4.1 Sources of Contaminated Samples Naturally contaminated  OR Artificially contaminated
4.2 Number and Type of Samples Number of food categories tested (five for multiple foods or one or two for specific categories) Number of contamination levels (at least five) Number of replicates at each level (two, but preferably five to ten) Claim for environmental samples?
Note: In the following section (4.3) please choose the applicable range (Small or Wide)
4.3 Level of Contamination Small Range: Level 1 - no organisms spiked (negative control) or not detected if naturally contaminated. Level 2 - 0 < LOD Level 3 - LOD Level 4 - LOQ Level 5 - Regulatory level Level 6 - Regulatory level + 1 Log10  OR Wide Range: Level 1 - no organism spiked (negative control) Level 2 - LOD < LOQ Level 3 - LOQ Level 4 - Regulatory level -1 log10 Level 5 - Regulatory level Level 6 - Regulatory level + 1 log10
4.4 Selection of Strains Group Genera Species Specific Type (Serotype, serovar, etc.)
4.5 Treatment of Strains used for Spiking Strains acclimatized Stressing procedure
4.6 Preparation of Samples Replicate testing at the second stage, using the same primary enrichment for both methods?
4.7 Data Analysis Graph provided? Separate linear analysis for each food category? The points at each level form a discrete cluster? Linearity visually checked for and unacceptable situations identified? If outliers are detected, sample retested? Global assessment of the linear regression performed? Intercept confidence intervals include the value of zero? Slope confidence interval includes the value one?
5. TRANSFER STUDY (INTER-LABORATORY STUDY)
5.1 General Sections 3 and 4 (above) must be completed. Criteria have been met? Procedure written and available
5.2 Recommendations / Requirements Recommended : CL achieved LOD achieved LOQ achieved Linearity verified Required: Number of samples tested in parallel. Variance analysis performed showing methods are not statistically different (95%)? Statistical analysis showing no statistical differences between means of alternative and reference method (95%)?
6. COLLABORATIVE / COMPARATIVE STUDIES ( HPB Status)
Method successfully evaluated by a pre-collaborative study?
Published for one year in the CAM.
Routinely used in a diagnostic laboratory?
Original performance characteristics retained
6.1 Collaborative study
Data generating lab is ISO accredited?
6.1.1 Number of participating laboratories (minimum of eight)
6.1.2 Number of food categories
6.1.3 Number of spiking levels Minimum of 3 levels Regulatory level included? (see Interpretative Summary) Description of the levels
6.1.4 Number of Samples Duplicate determination per level per method? 96 data points minimum (48 alternative + 48 reference)
6.1.5 Homogeneity of the spiked samples Artificial contamination procedure provided?
6.1.6 Data analysis Relative accuracy (Bias) D value obtained = Repeatability SD and repeatability limits obtained and evaluated using the F-Test Sr= (95%) reproducibility SD and reproducibility limits obtained SR=(95%) and evaluated using the F-Test Comparison between laboratory vs within laboratory variance performed
6.1.7 Additional comments on data analysis
6.2 Comparative Study
Data generating lab is ISO accredited?
6.2.1 Number of participating laboratories (Minimum of five)
6.2.2 Number of Samples (at least 30 samples per lab in duplicate)
6.2.3 Food Types Number Types
6.2.4 Spiked samples? If yes, three levels as per 6.1.3
6.2.5 Data Analysis Evaluation of linearity Intercept confidence intervals include the value zero? Slope Confidence interval includes the value one? Evaluation of variance Variance analysis performed showing methods are not statistically different (95%)? Statistical analysis showing no statistical differences between means of alternative and reference method (95%)?

 

1.2 Microbiological Methods Committee Technical Group
Review of Quantitative Methods - Summary Report

Concerns
Number and title concerns and explain them thoroughly, e.g., missing information, identification of authors and labs, thoroughness of data.

Recommendations
Overall summary of what the data and documents presented can justify and a final recommendation of the next course of action including recommendation for HPB Method (MFHPB), or Laboratory Procedure (MFLP) status or the requirement for more information or study.

Final decision may be made on the balance of evidence rather than the existence of each and every factor outlined.
Be specific about any data that is being requested to resolve deficiencies or differences.

As a member of the technical group designated by the Microbiological Methods Committee (MMC), I have reviewed the presented data and material and agree with the recommendations presented.

_______________	Accept method for publication as a MFLP method
_______________	Accept method for publication as a MFHPB method
_______________	Accept method for publication as a MFLP or MFHPB method with the following modifications or stipulations:
_______________	Reject method for publication for the following reasons (please cite what information/data is missing or needed for reconsideration):
_______________	Other recommendation:

Signature
Signature of each of the technical group members. Approval can be done electronically, so actual signatures are not necessary. (initial beside each factor above to indicate that consideration has been given to each point as applicable). If there is not total consensus to the report; those not agreeing will have to provide sound scientific reasoning.

1. Name ____________	Title ____________	Signature ____________	Date ____________
2. Name ____________	Title ____________	Signature ____________	Date ____________
3. Name ____________	Title ____________	Signature ____________	Date ____________
4. Name ____________	Title ____________	Signature ____________	Date ____________
5. Name ____________	Title ____________	Signature ____________	Date ____________

1.3 Table for Quantitative Method - Comparative / Collaborative Study Data