Food Protection Trends - September/October 2019 - 418

Given the complexity resulting from such factors, it
is more important than ever to ask, "How do we assure
that test results are reliable and methods are fit for their
intended purpose?"
RELIABILITY OF TESTING
Sampling
The focus of this article is on laboratory test methods;
however we would be remiss if we failed to emphasize that
a test can yield information about only the portion tested.
Hence, it is crucial to ensure that sampling is representative
of the material under study, and to understand the power of
the sampling plan in making decisions based on test results.
There are many excellent sources of information on sampling
plans; thus they will not be addressed further here (5).
Validation and verification
A key component of laboratory accreditation in line with
ISO 17025 (updated in 2017) is that laboratories must show
that the test methods used are both validated and verified (7).
Validation is the process of demonstrating that the method
reliably detects the analyte, and verification demonstrates
that the laboratory can effectively perform the method.
Validation involves a formal process of rigorous testing to
ensure the method performs as expected and has acceptable
inclusivity, exclusivity, sensitivity and robustness (1). For
third-party certified validation, there is also some element of
inter-laboratory comparison. Third-party certification bodies
include AOAC (Performance Tested MethodSM or Official Methods of AnalysisSM), AFNOR, MicroVal, NordVal, and Health
Canada. These organizations address the abundance of forms
of matrix diversity already discussed by grouping foods
and environmental samples into categories, and perhaps
sub-categories, based on properties believed to influence
their microbiological character. Validation certification can
then be sought for a narrow or broad range of categories. For
example, AOAC has over 100 subcategories of food (2), and
only 15 matrices are required for the broadest level of AOAC
validation (2). With the ever-expanding diversity of our food
products, this leaves a great deal of room for incongruence
between the food categories in the validated scope of a method and the range of food products in the market. To ensure
food safety, we need to look beyond official validations.
Verification demonstrates that the validated method
functions in the user's hands according to the method
specifications determined during the validation activity
(6). Method verification studies have a more limited scope
than validation studies and may include evaluation of only a
small subset of performance characteristics (e.g., sensitivity
verification for identification and qualitative methods;
relative accuracy and precision verification for quantitative
methods). A method can be verified for only those matrices
or categories (including test portion size) that were included
in the validation study. However, what should be done when

418

Food Protection Trends September/October

a user wants to deviate from the intended use of a method
by testing a different matrix or a different test portion size?
Should a new, full-scale validation study be conducted on
each new matrix addition? This process would be very timeconsuming, costly, and, arguably, not necessary. Thus, a gap
exists in guidance for the method validation and verification
processes, which does not consider these types of situations
and thus creates a need for alternative approaches.
Alternative approaches
One alternative approach mirrors the FDA internal guidelines
on emergency testing, when samples must be analyzed immediately. These guidelines indicate that when a method will be used
to test a food from the same category as in the validated method,
laboratories can analyze the new matrix concurrently with a
matrix spike. When the matrix has yielded at least seven positive
and no negative results using matrix spikes, or a > 95% confidence level (19 of 20 positives) is achieved, the method
will be considered verified for that food product (13).
Another alternative approach draws on the suitability
test approach of the United States Pharmacopeia (USP).
This approach spikes every different formulation with the
organism(s) of concern to demonstrate recovery and has
some defined additional preparatory steps in the event that
recovery is not achieved initially (9).
It must be noted, however, that although abbreviated
alternative methods may save time and money, they do come
with added limitations as a result of the reduced scope of the
data obtained.
WHAT DOES A RESPONSIBLE LABORATORY
DO NEXT?
Responsible laboratories already recognize the complexity of the matrices analyzed and diligently strive to use appropriate methods. This objective is complicated by the relative dearth of guidance for independent and food industry
laboratories. In working toward a sound scientific approach,
food safety professionals in both laboratories and the food
industry should take the following into consideration:
* Are alternative method verifications using an abbreviated approach acceptable? How is "acceptable" defined?
* Are food matrices appropriately grouped? What are the
key criteria for grouping?
* What constitutes a significant difference in formulation
if intrinsic parameters match?
* Should processes used in food manufacture be considered when grouping (e.g., fermentation byproducts,
compounds produced during thermal processes)?
* How can historical data be used to substantiate
fit-for-purpose?
* What is the applicability of shared matrix
validation studies?



Food Protection Trends - September/October 2019

Table of Contents for the Digital Edition of Food Protection Trends - September/October 2019

Self-reported Food Safety Practices Among Adult Consumers in Sibu, Malaysia: A Cross-sectional Study
Adherence of Food Blog Salsa Recipes to Home Canning Guidelines
Developing a Citizen Science Method to Collect Whole Turkey Thermometer Usage Behaviors
Beyond the Bio Gary Acuff
PDG Highlight Viral and Parasitic Foodborne Disease PDG
General Interest Paper Evaluating the Applicability of a Risk-based Approach (Decision Tree) to Mycotoxins Mitigation
General Interest Paper Microbiological Detection Methods — Assuring the Right Fit
General Interest Paper Turning Research into Innovation: A Systems Approach to Innovation in Food Safety
Industry Products
Coming Events
Food Protection Trends - September/October 2019 - Cover1
Food Protection Trends - September/October 2019 - Cover2
Food Protection Trends - September/October 2019 - 359
Food Protection Trends - September/October 2019 - 360
Food Protection Trends - September/October 2019 - 361
Food Protection Trends - September/October 2019 - 362
Food Protection Trends - September/October 2019 - 363
Food Protection Trends - September/October 2019 - 364
Food Protection Trends - September/October 2019 - 365
Food Protection Trends - September/October 2019 - Self-reported Food Safety Practices Among Adult Consumers in Sibu, Malaysia: A Cross-sectional Study
Food Protection Trends - September/October 2019 - 367
Food Protection Trends - September/October 2019 - 368
Food Protection Trends - September/October 2019 - 369
Food Protection Trends - September/October 2019 - 370
Food Protection Trends - September/October 2019 - 371
Food Protection Trends - September/October 2019 - 372
Food Protection Trends - September/October 2019 - 373
Food Protection Trends - September/October 2019 - 374
Food Protection Trends - September/October 2019 - 375
Food Protection Trends - September/October 2019 - 376
Food Protection Trends - September/October 2019 - Adherence of Food Blog Salsa Recipes to Home Canning Guidelines
Food Protection Trends - September/October 2019 - 378
Food Protection Trends - September/October 2019 - 379
Food Protection Trends - September/October 2019 - 380
Food Protection Trends - September/October 2019 - 381
Food Protection Trends - September/October 2019 - 382
Food Protection Trends - September/October 2019 - 383
Food Protection Trends - September/October 2019 - 384
Food Protection Trends - September/October 2019 - 385
Food Protection Trends - September/October 2019 - 386
Food Protection Trends - September/October 2019 - Developing a Citizen Science Method to Collect Whole Turkey Thermometer Usage Behaviors
Food Protection Trends - September/October 2019 - 388
Food Protection Trends - September/October 2019 - 389
Food Protection Trends - September/October 2019 - 390
Food Protection Trends - September/October 2019 - 391
Food Protection Trends - September/October 2019 - 392
Food Protection Trends - September/October 2019 - 393
Food Protection Trends - September/October 2019 - 394
Food Protection Trends - September/October 2019 - 395
Food Protection Trends - September/October 2019 - 396
Food Protection Trends - September/October 2019 - 397
Food Protection Trends - September/October 2019 - 398
Food Protection Trends - September/October 2019 - 399
Food Protection Trends - September/October 2019 - Beyond the Bio Gary Acuff
Food Protection Trends - September/October 2019 - 401
Food Protection Trends - September/October 2019 - 402
Food Protection Trends - September/October 2019 - PDG Highlight Viral and Parasitic Foodborne Disease PDG
Food Protection Trends - September/October 2019 - 404
Food Protection Trends - September/October 2019 - 405
Food Protection Trends - September/October 2019 - General Interest Paper Evaluating the Applicability of a Risk-based Approach (Decision Tree) to Mycotoxins Mitigation
Food Protection Trends - September/October 2019 - 407
Food Protection Trends - September/October 2019 - 408
Food Protection Trends - September/October 2019 - 409
Food Protection Trends - September/October 2019 - 410
Food Protection Trends - September/October 2019 - 411
Food Protection Trends - September/October 2019 - 412
Food Protection Trends - September/October 2019 - 413
Food Protection Trends - September/October 2019 - 414
Food Protection Trends - September/October 2019 - 415
Food Protection Trends - September/October 2019 - 416
Food Protection Trends - September/October 2019 - General Interest Paper Microbiological Detection Methods — Assuring the Right Fit
Food Protection Trends - September/October 2019 - 418
Food Protection Trends - September/October 2019 - 419
Food Protection Trends - September/October 2019 - General Interest Paper Turning Research into Innovation: A Systems Approach to Innovation in Food Safety
Food Protection Trends - September/October 2019 - 421
Food Protection Trends - September/October 2019 - 422
Food Protection Trends - September/October 2019 - 423
Food Protection Trends - September/October 2019 - 424
Food Protection Trends - September/October 2019 - 425
Food Protection Trends - September/October 2019 - 426
Food Protection Trends - September/October 2019 - 427
Food Protection Trends - September/October 2019 - 428
Food Protection Trends - September/October 2019 - 429
Food Protection Trends - September/October 2019 - Industry Products
Food Protection Trends - September/October 2019 - 431
Food Protection Trends - September/October 2019 - 432
Food Protection Trends - September/October 2019 - 433
Food Protection Trends - September/October 2019 - Coming Events
Food Protection Trends - September/October 2019 - Cover3
Food Protection Trends - September/October 2019 - Cover4
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