Avoid Labeling Related Recalls

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Tips and techniques to get labels right the first time,


every time.

By Wayne Labs, Senior Technical Editor[1]

February 4, 2015

No Comments

Continuous inkjet printing is ideal for high speed coding on


bottling lines. Date codes, lot numbers and other tracking data
can be applied on the fly as bottles proceed through high-speed
printing equipment. Source: Videojet.

More than 60 percent of FDA recalls are due to labeling issues.


Most of these errors relate to allergens. Processors inadvertently

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put the wrong label on products, a change in the ingredients


(undeclared allergens) doesn’t show up on the label, or the label
doesn’t include a complete list of allergens. But the label
includes more than just allergens.

FDA requires five basic pieces of information on a food label:


product identity, net contents, nutrition facts,
ingredients/allergens and a signature line with the
processor’s/distributor’s/importer’s contact information.

A labeling-related recall may be initiated for a number of reasons


that have nothing to do with allergens. “Wrong ingredient deck,
expiration declaration and labels not being current,” offers
Warren Gilbert, owner of FSS Corp.-Food Safety[2] Specialists.

“Improper or missing date, lot, ‘best by,’ machine code, etc.,”


adds Mark Breunig, Videojet regional product manager. “Virtually
every food product requires a code at the time of manufacture.
While the specific code contents may change, the requirement for
the code to be on the product and for it to be correct does not.
Any improper or missing code can result in returned, rejected or
recalled product.”

Carole Besnard, Luceo Inspection marketing manager, lists some


other problems from an inspection viewpoint that often pop up:

Missing or incorrect information including quantity, price and


promotional stickers
Improper position (e.g., bad position and orientation of
information or products within the package or misalignment of
the top film)
A poor-quality barcode that can’t be read by retailer scanners
Food spoilage due to inadequate package sealing.

“Sealing is a critical control point in food security that can be


difficult to master,” says Besnard. “Rigid or flexible packaging[3]
conditioned in a modified atmosphere is becoming widespread in
our daily life in response to our requirements for freshness,
extended shelf life or simply practical considerations.”

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Modified atmosphere packaging guarantees it is hermetically


sealed from the outside environment, irrespective of the
technology used to create it. It is not only an essential safeguard
against health risks, the sealing is the first line of defense to
stresses that occur throughout the product’s lifecycle (crating,
transportation and shelving). The slightest sealing defect can
compromise an entire package, allowing the product to develop
anaerobes (mold, bacteria, etc.) that can contaminate food, says
Besnard.

According to FDA, most allergen-related recalls are for bakery


products, followed by snacks, candies, dairy and dressing, while
the most common allergen recalls are for milk, wheat and soy (in
descending order). Typically, these recalls are caused by the use
of the wrong package or an incorrect label. How can processors
and their employees avoid these mix-ups?

“First-off inspection is a simple check and signoff for all


changeovers or startups,” says Gilbert. “It all goes back to the
verification and validation process. Labeling inventories also can
be a big problem, if it is not managed correctly.”

When rolls of film with printed ingredient statements are used,


processors must confirm the labeling is correct at the beginning
and end of each roll. “Film manufactured at the packaging
manufacturing site often involves splicing multiple rolls together,”
explains Stephanie Lopez, president, AIB International -
certification services. “And when those rolls get spliced, there is
the opportunity for incorrect rolls to get spliced together.”1[4]

Internal operational changes can wreak havoc, too. “Each time


the coding requirements change, there is an opportunity for an
error,” adds Breunig. “Manufacturers should choose a coding
solution that reduces operator interaction to minimize errors.
They also should employ automated[5] strategies such as

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barcodes and networked job input to further reduce the


opportunity for input errors.”

A machine vision system can catch many mistakes before they get
to the loading dock. For example, Luceo’s solutions inspect,
identify, trace and reject products that display contaminated
seals or do not conform to visual appearance specifications, says
Besnard. Luceo’s ThermoSecure software/hardware system checks
for the presence, position and orientation of the label; coherence
of information; required product information (use-by date,
barcode, weight/price, etc.); and correlates the top, bottom and
side labels.

The ThermoSecure software also inspects and tracks all


packaging, and archives important production data and images to
prevent the reworking of defective packaging, complaints or
product recalls due to packaging integrity problems. The system
prevents risk of a product mix-up at the start of every new batch
by matching the product to information on the label. Usually, the
system is placed at the end of a line after the weighing and metal
detection stations.

The second-most common cause for allergen recalls is incorrect


terminology in the ingredient list. For example, “contains butter”
is not an appropriate allergen listing, whereas “contains milk” is.
“One way to mitigate the inaccurate terminology is to create and
manage print jobs centrally,” suggests Videojet’s Breunig.
“Rather than creating codes and messages for each production
run, line operators can select from a menu of print jobs. This
enables a one-time creation and review process to assure the
correct terminology is used.”

Incorrect, outdated or damaged data files in computerized onsite


printing systems also can be a source of labeling errors. How can
these issues be remedied? “Certain marking and coding solutions
are available with ‘code assurance’ software designed to ensure
the right code is applied in the right location on the right
product,” adds Breunig.

These solutions begin with centralized message management and

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printing control. Code accuracy issues can be detected with


scanners positioned throughout the production line. Whether the
code is printed directly on the product/package or label, the
technology that drives the data to the printers should allow the
automatic setup of multiple printers with the correct code, says
Breunig.

According to Jean-Christophe Calmejane, vice president North


America, Lascom Solutions, another relevant issue that seems to
come up frequently is the lack of a standard format for ingredient
specification sheets.

Australian and European processors often have specification


sheets geared to national standards with a clear recommendation
on the way data should be presented. This makes including the
specification sheet within PLM (product lifecycle management) and
batch systems much easier, and if an ingredient change adds an
allergen, it’s much faster and easier to pick up on the change.

“But in the US, this is usually not the case,” says Calmejane.
“Each company has its own template, and that makes it difficult
to find the allergen and microbiological information related to the
raw material specification from the supplier.”

With a lack of continuity and/or connectivity between raw


materials specifications, the final formula may not accurately
reflect all its ingredients, making mistakes on the label a distinct
possibility. For example, if a processor creates a new formula by
dragging and dropping a strawberry purée into a dairy product,
milk should appear on the final product label as an allergen,
according to Calmejane.

Plus, if a formula change includes an allergen, the old,


non-allergen labels should be destroyed, says AIB’s Lopez.

PLM software can help processors organize their products and

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manufacturing worldwide. For instance, when Monin, a worldwide


premium syrup manufacturer with R&D centers in the US, France
and Malaysia, needed some help with global product management
and development, it chose Lascom Solutions PLM.

“Monin is the brand of choice for creative beverage professionals.


Our strong, proactive innovation[6] strategy, covering 140
countries, is one of the key factors in our continued success,”
says Gislene Da Silva Razavet, R&D group director of Monin.
“But our global product development and management operations
expose us to complex regulatory [liabilities]. Lascom PLM helps
us manage these operations quickly and effectively.”

“Labeling is normally one of the last activities in the packaging


operation, but it reflects the status and condition [and
genealogy] of the products,” says Maryanne Steidinger, director,
software and product marketing, Schneider Electric. “At a
minimum, the label should identify the lot, location/plant and
date of the product’s production. By tracking and documenting
labels, manufacturers can add an extra measure of quality control
to their production.”

In the past, barcode readers were used to verify the correct label
was applied to the correct lot; custom- or purpose-built software
did the real-time (or off-line) comparison of lots to packaged
products. Newer systems use MES (management execution
system) software to verify the correct label is associated with
each lot. If a split or quarantine occurs, the software chronicles
which lots were affected and which products were split into a
separate lot. This information then becomes part of the
“as-built” record of the work order (or batch record) the
software tracks.

For serialized lots, MES software tracks not only the applied
barcode, but also the actual serial numbers applied to the lots.
The collective serial numbers/sequences become part of the
record showing which products are within a single lot or batch.

Today’s vision systems are capable of 100 percent inspection in

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real time and can provide control and/or tie into the MES.
Continuous inspection allows the immediate detection and
withdrawal of defective packaging, explains Luceo’s Besnard.
Data-driven inspection systems also can indicate printing or
labeling problems. Once these trends have been identified, the
volume of rejects tends to decrease and, in some cases, disappear
altogether.

With a real-time vision system, each packaging item is individually


controlled, and defective products are removed one by one from
the production line. In addition, the system can identify any drift
in production so it can be corrected immediately.

“Manufacturing intelligence [MI] platforms can be configured to


require in-process traceability checks and label verification,” says
Eric Weisbrod, InfinityQS technical services manager. “The
software application is connected to a database that stores all
the information related to products, such as container type, size,
color and material; closure type and color; front and back label;
ingredient statement; and any other item critical to traceability.”

When an operator sets up a line to run a specific product, the


container and packaging information can be retrieved to ensure
the correct packaging and labeling are being used. At various
stages of production, the operator addresses a number of
questions related to various characteristics of the product,
including the traceability or identification number of the labels
being used. After the operator enters this number—manually or
with a barcode scanner—the software compares the entry to the
number associated with the product in the database and provides
immediate feedback with either a green “Passed” screen or a red
“Failed” screen. These messages can be further customized to
specify results such as “Passed Front Label Inspection” and
“Failed Back Label Inspection,” says Weisbrod.

If the red failure screen appears, a number of other automated


actions occur, continues Weisbrod. First, the failure is recorded
into the manufacturer’s database to ensure accurate records for
audits and continuous improvement efforts. Second, an email can
be sent immediately to supervisors and quality managers to make

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them aware of nonconformances across operations. The operator


also can be required to enter assignable cause information to
explain why the product is nonconforming, such as noting if the
label is for a different size of container or the wrong promotion is
displayed. Then, the operator would also enter which corrective
actions were taken to fix the issue, such as changing the label
reel and removing all mislabeled products.

MI software can also address allergen concerns from two


different perspectives. For example, the database for a cookie
manufacturer would note which cookies contained allergens in
their ingredient lists and ensure the proper labels were used
during packaging. These verifications can use a single traceability
number identifying the label/package and/or can request specific
verbiage, such as “contains dairy,” to be utilized. In addition, the
software can ask operators to confirm specific, regulated cleaning
and sanitization steps were completed to ensure all allergens
were removed when a line is converted from allergen-containing
to non-allergen products.

Labeling is an important part of any track-and-trace effort. In


fact, FDA commissioned the Institute of Food Technologists (IFT)
to coordinate and conduct the product tracing pilots required by
Section 204 of FDA’s FSMA 2, including an evaluation of the
costs and benefits to industry and consumers. The pilots for three
ingredients (chicken, peanuts and crushed red pepper) were used
to demonstrate the effectiveness of track-and-trace with
electronic recordkeeping and labeling practices.3

1
[E-Book] Co-produced by TraceGains, Inc and AIB International:
http://www.tracegains.com/top-6-best-practices-for-your-
allergen-control-program-e-book[7]

FDA website (Information available related


to Product Tracing under the FDA Food Safety Modernization

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Act (FSMA))www.fda.gov/Food/GuidanceRegulation
/FSMA/ucm270851.htm[8]

www.fda.gov/downloads
/Food/GuidanceRegulation/UCM341810.pdf[9]

[10] [11]

[12]
[13]

[14] [15]

[16]

[17]
[18]

[19] [20]

1. http://www.foodengineeringmag.com/authors/1812-wayne-labs-senior-
technical-editor/articles

2. http://www.foodengineeringmag.com/topics/2628-food-safety

3. http://www.foodengineeringmag.com/topics/2632-packaging

4. http://www.tracegains.com/top-6-best-practices-for-your-allergen-
control-program-e-book

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5. http://www.foodengineeringmag.com/topics/2630-automation

6. http://www.foodengineeringmag.com/topics/2631-innovation

7. http://www.tracegains.com/top-6-best-practices-for-your-allergen-
control-program-e-book

8. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htm

9. http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM341810.pdf

10. mailto:warreng175@idcnet.com

11. http://www.foodsafetyspecialists.com/

12. mailto:mark.breunig@videojet.com

13. http://www.videojet.com/

14. mailto:c.besnard@luceo-inspection.com

15. http://www.luceo-inspection.com/

16. mailto:slopez@aibonline.org

17. mailto:maryanne.steidinger@schneider-electric.com

18. http://www.schneider-electric.com/

19. mailto:jc.calmejane@lascomsolutions.com

20. http://www.lascom.com/en

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