Title: Effective Date: Code:

Finished Product Allergen Testing 01/31/2017 QAW 8.2.01

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PURPOSE:
To describe the process of sample collection and allergen testing in order to comply with
Allergen Program Requirement for Gluten free finished product.

SCOPE:
Apply to Gluten free tortillas

RESPONSABILITY:
QA Technician shall follow the instructions given in this document.
QA Manager and Supervisor shall verify procedure is followed and results are within
limits before releasing product.

ASSOCIATED MATERIALS:
1. QAF 8.2-01 and 8.2-02
2. Veratox kit (soy and gliadin)
3. Gluten tox kit
4. Gluten free supplies for kits (extraction and testing)
5. Gloves
6. Scale
7. Gluten free Laboratory

INSTRUCTIONS:

Gluten Free Sample Collection

1. Ensure destruction of the first 3 min of gluten free production run.
2. “Sample”: a sample is considered as one finished product package (or bag) of
gluten free tortillas collected at the lazy Susan area.
3. After the first 3 min destroyed, collect two consecutive samples from the start of
the run. Number all samples with a sample sequence number starting with #1.
4. Continue collecting samples every 10 minutes until the end of the Pallet #2.
5. For pallet #3 until the end of the run collect one sample per pallet (at the middle
of the pallet preferable).
6. Record all pallet’s information for all samples in form QAF 8.2-02. This includes
the last two digits of the production batch number, pallet sequence, time of
sample, code.
7. Place a hold tag on each pallet.
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Gluten ToxTesting:

1. Test all samples from first and second pallet for Gluten Tox at a level of 5 ppm at
the start of the run. These results are only a guide and must not be used to release
product.

2. Test other sample(s) if needed to provide feedback to production on run status.

3. Document results in QAF 8.2-02

Veratox Gliadin Testing

1. Prepare samples to test according to Veratox kit instructions

2. Perform gliadin extraction following heat treated samples instructions; follow

precautions to avoid cross-contamination such as the use of gloves to pull tortillas
samples and changing them out at every sample with frequent sanitizer use.

3. The sample to be collected from each individual package of tortilla need to be

collected from random spots from the tortilla trying to collect from at least 3
small spots and placed on sampling boat without any contamination.

4. Samples to test need to include ALL samples from first and second pallet
(including the duplicate of start of run). In addition to these for the following
pallets, need to select samples based on a 2 hours frequency from the end of 2 nd
pallet until the end of run.

5. Follow instruction in Veratox kit avoiding any cross contamination.

Rechecks

1. Retest will be conducted with the same extraction solutions if the calibration
curve fails. No testing will be acceptable unless a regression of 0.98 or higher is
obtained.
2. Gliadin failures passing limit is <10ppm. Make sure that the readings from the
veratox kit reader are multiply by 2 (to consider the two parts of protein in
gluten) before comparing to passing limit.
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3. Gliadin failures (results>10ppm) need to be confirmed by conducting a retest

with the same extraction solution. If failure is obtained on re-test, failure is
confirmed and no further test will be conducted.

4. After one sample fails testing, the samples for the pallets in between last good
check will have to be tested with veratox test. If there is any failure is for pallets #
1 and # 2 that have more than one sample under test; the whole pallet will be
considered as failure if at least one sample fails.

5. If other failures occur, retest can be performed with the same extraction solution
for a second time only.

6. The pallets with sample with confirmed failures will remain on hold for
destruction.

Results

1. Document all testing results with print out of veratox reader attached to form
QAF 8.2-02
2. Verify SAP batch numbers produced with pallets tested.
3. Release pallets that passed testing, communicate failure results with identification
of the pallets by using the batch number.
4. Pallets that failed will be disposed.

Soy test in Finished Product.

1. After each run of gluten free tortillas, line will be cleaned /sanitized and verified
for absence of soy with soy swabs.
2. The first 3 pallets from any product ran in the same line after gluten free will be
placed on hold for soy testing.
3. A sample of flour used in the line in question will be collected; identify silo
number on sample or lot number if sacs are being used.
4. Test one sample (one package) from each pallet and one sample from the flour
collected.
5. Write information for samples in form QAF 8.2-02
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6. Follow precautions to keep the flour sample and finished product preparation
outside the gluten free area except for required extraction and testing steps.
Consider that samples contain gluten to take precautions to avoid cross
contamination of equipment and area.
7. Follow instructions for Soy Veratox kit extraction and testing.

Rechecks

1. Retest will be conducted with the same extraction solutions if the calibration
curve fails. No testing will be acceptable unless a regression of 0.98 or higher is
obtained.

2. Soy failure passing limit is not defined, however the flour sample result is
considered as the reference for tortillas samples as flour contains soy residues
from grain storage comingling. The tortillas samples are expected to have a value
less than the flour reference sample to be considered as passing.

3. Soy readings from the veratox kit reader are NOT multiplied by 2

4. Veratox failures need to be confirmed by conducting a retest with the same

extraction solution. If failure is obtained on re-test, failure is confirmed and no
further test will be conducted.

Results

5. Document all testing results with print out of veratox reader attached to form
QAF 8.2-02
6. Verify SAP batch numbers produced with pallets tested.
7. Release pallets that passed testing, communicate failed pallets identification by
using the batch number.
8. Pallets that failed will be disposed.

Corrective Actions:
1. Follow up for failures will follow recommendations in Corporate Document
CQW 8.2.1