BEST PRACTICES
FOR MARKING AND
TRACEABILITY
Gravotech, Inc.
2200 Northmont Parkway | Duluth, Georgia 30096 | USA
Tel: 1-800.843.7637 | Fax:1-800-533-7637
Marking and traceability requirements can be an intimidating process. Lack of compliance
may lead to liability issues, increased costs, steep penalties, federal prosecution, and/or
counterfeiting problems. More importantly, noncompliance could mean the loss of your
company’s reputation.
Manufacturers, for example, must adhere to strict marking standards with regards to position, size,
and contents of the mark, leaving no room for error. Additionally, marks must resist the harshest of
environments, standing up to acid cleaning, corrosion, and high temperature sterilization.
This article will review the various marking requirements and purposes for marking and
the equipment best suited to permanently mark a wide range of products.
What is marking and traceability in regards to manufacturing? Marking is the act of
identifying a product with a specific bit of information and traceability is an unbroken record
of that identified information. For example, a lot number specifying the date, time, or worker
on shift when the product was created or even when and where a piece of
fruit was picked for sale.
GOVERNMENT REGULATIONS
Companies use marking and traceability for many important reasons. The first reason is government
regulation. For example, in the US, any company that manufactures medical equipment must comply
with the FDA’s standards for UDI marking. UDI marking stands for “Unique Device Identification”.
This process, when completed, will provide doctors, nurses, patients, and the general public
with critical information about every medical device, including recalls.
Product recalls can cause very serious consequences in the healthcare industry. For example,
the maker of a surgical clip called the “Hem-o-lok” issued an urgent recall notice warning
doctors to stop using the fasteners on living kidney donors. It said the clips could dislodge in
their bodies, with “serious, even life-threatening consequences.” Unfortunately, not everyone
received this message. A surgeon in Brooklyn used one of the clips to tie off a patient’s renal
artery when he donated a kidney to his ailing wife. Twelve hours later, the clip popped off.
The patient bled to death internally in the hospital as his wife lay helplessly nearby. He was 29.
A tragedy like this could have been easily prevented with an interconnected network of
information about medical devices. To make this a reality, the FDA implemented UDI marking.
The FDA will assign a unique number to each type of medical device. This number identifies the
product and its intended use. Once this number is generated, it must be permanently encoded
into both machine and human readable form on the surface of the device itself and the packaging.
It will also include details such as the lot/batch number, product serial number, expiration date,
and more. All this information is stored on an easy to access portal called AccessGUDID.
Once complete, there will be an information source for every single medical device in the
United States. UDI implementation will improve patient safety, modernize device post-market
surveillance, and facilitate medical device innovation. This is just one example of government
regulated marking and traceability.
Another traceability regulation brought by the government deals directly with our military. The United
States Department of Defense uses unique ID (UID) method to track assets that cost over $5,000,
are mission essential, controlled inventory, serialized products, or consumable items. The UID system
utilizes DataMatrix codes ensuring the mark is readable throughout its life. It also gives them the
ability to encode large amounts of data. Direct Part Marking ensures these marks remain
on the product even if the packaging is damaged or misplaced.
GRAVOTECH.US
LIABILITY AND CORPORATE OEM COMPLIANCE
Today’s society is very litigious in nature. Liability for manufacturers is a huge consideration.
Consumers, customers, government agencies and courts expect higher quality standards and levels
of corporate responsibility. It is up to the manufacturer and supply chain to track their processes and
business information so critical safety-related decisions and operations related to warranty issues
can be properly analyzed.
Industries like automotive and aerospace carry enormous amounts of liability and need to track each
and every part back to its OEM in case of safety malfunctions. If marking and traceability is not
implemented during each part’s manufacturing process, there is no way to trace an issue back to its
origin. If companies intend on selling products in industries where strict OEM policies are in effect,
they need to have a partner knowledgeable in marking and traceability.
Companies that do not implement this process must recall weeks or months’ worth of products in the
event of a malfunction. Once these products are recalled there is no way to know if the issue has truly
been rectified because the origin of the problem was not identified. In these cases, the company’s reputation can be permanently damaged.
COUNTERFEITING
Another reason for implementing marking and traceability into a manufacturing process is to fight
counterfeiting. Companies counterfeit products to offer a less expensive option to the market.
Often times this product is manufactured using inferior materials and will fail when in use.
Any type of product can be counterfeited from bearings and spark plugs to designer handbags.
One method used to fight counterfeiting is marking and identification. By always marking products
with a particular font, style, or nuance, it allows companies to prove a part was counterfeited.
This will release the company of any liability and allow them to civilly prosecute the
counterfeiting company for damages.
COST-REDUCTION
Cost reduction is a major consideration for manufacturers to implement a marking and traceability
solutions. U.S manufacturers spend more than $25 billion ever year on product warranties.
Automotive warranty costs alone exceed $9 billion per year.
Part traceability solutions work to eliminate recalls by providing real-time reports on the machines,
components, stations, shifts and operators involved in the defective product and processes before the
product is shipped. This allows for earlier design changes to improve a parts performance and reduce
in-process costs.
There are both short term and long term benefits for implementing marking and traceability. The short
term benefit is to identify products affected by the defect after customer delivery to minimize recall costs.
This minimizes the number of products that must be recalled when a manufacturing flaw is found by
identifying only the specific serial numbers that were built with the faulty component or material or by
the faulty process. The long term benefit is to identify defects prior to customer delivery to reduce i
n-process costs and eliminate the need and costs of a recall. Traceability functionality has emerged
as a true competitive advantage for the manufacturing supply chain.
GRAVOTECH.US
HOW DO YOU IMPLEMENT MARKING INTO
YOUR MANUFACTURING PROCESS?
Deciding to implement a marking and traceability solution into the manufacturing process will be one
of the best decisions a company can make. Now that the decision has been made to find a solution,
where do you go? Any method of marking and traceability can be integrated directly into a production
line or added in a standalone workstation. To decide which implementation method is best,
answer the following questions about integrating directly onto a production line:
What is the physical area available for the marking equipment at the location required
in the production line?
How will the part be presented to the marking system and then taken to next step in production?
Also consider part handling, manipulation and holding of the part.
How will the marking system communicate from the Production line PLC or other company
databases or control system?
What is the physical positioning of the marking equipment within the production/assembly line?
Space is sometimes very limited.
Safety considerations
The variability of components, types and batches
Best practice to help answer these questions is consult with a permanent marking
specialist at Gravotech.
If integration does not work with your current process, you can always add a separate stand-alone
marking station. These are typically manual load and unload stations with marking occurring automati
cally upon completion of the process or a test at the station. These stand-alone stations can be
completely customized depending on the application and marking technology used.
Again, the best practice is to have an experienced permanent marking specialist
design a solution for you.
Integrated into a production line
Standalone work station
GRAVOTECH.US
WHAT IS THE BEST PRACTICE FOR MARKING?
From government regulations to competitive advantages, there is still an important
piece of information, how do you physically mark a part?
Gravotech specializes in a particular method of marking called Direct Part Marking (DPM).
Direct Part Marking permanently marks a product directly on the surface of the part during or after
the manufacturing process. Not all methods of marking are permanent and may need to be remarked
later, costing time & money. For over 78 years Gravotech has tested lots of methods and we
recommend 4 technologies… Laser, rotary, dot-peen and scribing.
So how do you choose which technology works best for your manufacturing process?
Let’s explore lasers first.
LASER stands for Light Amplification by Stimulated Emission of Radiation. The only contact made
to the part is via the laser light wave. This makes laser marking ideal for sensitive materials damaged
by other technologies. Lasers are compatible with a wide variety of materials including glass, wood,
ceramic, metal, plastic, and many, many more. 4 different types of lasers are manufactured by
Gravotech, CO2, Fiber, Green and Hybrid. Each laser type has specific qualities that can work with any
industry and marking requirement.
For more information about these laser types visit www.gravotech.us.
Watch a laser machine in action: http://bit.ly/2ad6edG
Fiber lasers are ideal for marking on uncoated metals giving a highly contrasted mark
A Green laser uses “cold marking” to minimize the amount of heat being applied to parts and reducing
mechanical stress & distortion. Great for precious metals.
Our Hybrid laser is not sensitive to shiny materials which makes it a great choice for reflective metals
Finally, a CO2 laser is great for marking organic materials such as wood, plastic and more.
watch video
Standalone work station
GRAVOTECH.US
Rotary engraving and cutting is another very popular form of marking. Rotary engraving is the term
used to describe engraving done with a rotating cutting tool in a motorized spindle. The tool, or cutter,
cuts into the surface of the material to a predetermined depth and produces a groove of the same
shape and dimension of the cutter. Rotary engraving can be performed on a wide variety of materials
with plastic, brass, aluminum and more. Rotary engraving can be found in the awards industry,
industrial manufacturing, signage manufacturing and more.
Watch a rotary machine in action: http://bit.ly/2aHWsjv
Dot-Peen and Scribing are the remaining two direct part marking methods Gravotech recommends.
Dot-peen marking is a technique used for traceability on almost any material. Dot-peen leaves a series
of dot indentations without removing any of the component material. Scribing produces a continuous
carved mark and is much quieter than Dot-Peen machines. The common materials used with these
technologies are typically metal and other hard materials. Since this machine requires a hard strike
to the surface of a part, it is not recommended for sensitive and delicate parts. You may have seen this
technology commonly used for automobile VIN numbers.
Watch a Dot-Peen machine in action: http://bit.ly/2aMwz0g
GRAVOTECH.US
Even though we recommend 4 specific marking technologies, that doesn’t mean they
are the only methods available. A few others include Hand Marking which is easy to implement,
but slow and inconsistent. It’s also labor intensive and when a hammer smashes a thumb it can be
expensive. Ink Jet application is fast and programmable, but it is not permanent and can be removed.
The ink is not cheap and the solvent is an environmental liability. Presses can make fast permanent
marks, but they are not very flexible and set up is time consuming. They can’t be used on hard or fragile
parts and they can be dangerous. Chemical Etching is inexpensive, but slow and inconsistent.
Plus, it also has environmental waste as well. For all the reasons mentioned above, we do not
feel these marking methods are considered best practices in marking.
Marking and traceability is a best practice in manufacturing for a multitude of reasons especially
for government regulations, liability, corporate OEM compliance, counterfeiting and cost-reduction.
Implementing this practice will take time and resources, but the results can save a company
millions of dollars and their reputation. Let the marking and traceability experts at Gravotech
guide you through this process and select the most efficient technology for
your manufacturing process.
Gravotech offers a FREE service to all potential clients. We will take your product and apply a
permanent mark to the surface so you can see, first-hand, the quality and precision.
Send your part to: 2200 Northmont Parkway, Duluth, GA 30096 and we will return your part
with a mark from the technology of your choice and discuss the needs of your business.
For more information or to speak with a traceability expert, email: [email protected];
call: 1-800-843-7637; or visit: www.gravotech.us
1-800-843-7637 | [email protected] | www.gravotech.us
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