TLP Bring Your Children to Work Day 2016

Tailored Label Products (TLP) employees brought their children to work this week to get a hands on opportunity in a manufacturing environment. They were able to see what their parents do, find out about the science that goes into making a label, and learn about what it takes to be a great team member at work.

New FDA Standards for Unique Device Identifier Labels


Most industries around the world have strict labeling standards and regulations, but almost nowhere are the specifics of labels more scrutinized than in the medical industry. Each and every piece of equipment that is used to facilitate the treatment and care of a patient needs to carry a label. And the slightest deviation from stipulated standards can result in strict penalties.

To improve patient safety, modernize device postmarket surveillance and encourage medical device innovation, the FDA’s Unique Device Identifier labels policy was created. This policy requires a unique device identifier (UDI) to be included on device labels and packages by device labelers.

The table below outlines key compliance dates in the UDI final rule.

Compliance Date Requirement
1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016) Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class II medical devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
5 years after publication of the final rule (September 24, 2018) A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020) Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
Source: http://www.fda.gov

Anatomy of a UDI Label

A UDI is a unique numeric or alphanumeric code that consists of a device identifier (DI) and a production identifier (PI) and all UDIs are to be issued under a system operated by an FDA-accredited issuing agency.

Anatomy of an UDI Label

The Unique Device Identifier (UDI) Rules & Regulations 

  • The DI is mandatory and identifies the labeler and the specific version of a model of a device
  • The PI is a variable portion of the UDI which can include the lot or batch number when a device was manufactured, the devices’ serial number, the devices expiration date and the date the device was manufactured.
  • The UDI labels should be readable – both by humans and by computers
  • The device manufacturers will be in charge of marking their equipment with UDI labels and it is the duty of the label creators or facilitators to upload device information to the Global Unique Device Identification Database (GUDID) for unrestricted access by healthcare stakeholders.
  • The GUDID which is supported by the UDI labels will allow doctors to be able to download instructions and guidelines of device use and make the most of features and functionalities for optimum patient care.

How Does Tailored Label Products Play Its Part in the UDI Revolution?

Tailored Label Products has been the gold standard in the world of labeling for years. Accurate, capable of withstanding harsh environmental conditions and always legible, vibrant and durable. Our products have been used on vials, devices and containers for the medical industry.  Our capabilities and technical expertise allow us to meet UDI rules and regulations by printing labels with the right construction for the application and required information for UDI correctly included.

Also to help maintain the integrity of the unique IDs in the supply chain, TLP offers advanced features such as a dual label verification system that allows a technician to remove the first layer of the label for documentation, while a duplicate label will remains on the product.  With variable data capabilities, specific, unique information regarding each device can also be printed onto each label.

Have a UDI Label Question? TLP can help!

 

TLP Employee Receives Global Recognition for Label Academy Achivement

TLP Label Application Engineer Recognized by Labels & Labeling Magazine for “Leading the Label Academy”

TLP-Label-Academy-ArticleMonday, May 2th, 2016 – Menomonee Falls, Wis. – Tailored Label Products, Inc. (TLP) Regional Application Engineer Lindsey Muchka was highlighted in a feature article by Labels & Labeling magazine for having”taken – and passed – more Label Academy exams than anyone globally.

“Continuing education and technical competency are core elements of TLP culture, so we are very proud to have our team members recognized by our industry for this kind of achievement, not only at a national level, but globally.” said Tracy Tenpenny, V.P. of Sales and Marketing at Tailored Label Products.

This article in Labels & Labeling can be found online in its entirety on page 80 of the Labels and Labeling | Volume 38 | Issue #2 | April 2016 – May 2016.

About Label Academy

Label Academy is a global training and certification program for the label and package printing industry. It consists of a series of self-study modules, and once a student has completed a module, they take a timed,  50-question online test. Those who pass earn a Label Academy certificate. It is expected that a Label Academy qualification will become a standard in the industry, and has been supported by label associations including TLMI, Finat and LMAI. For more information on Label Academy, visit www.label-academy.com.

About Tailored Label Products, Inc.

Tailored Label Products, Inc. (TLP) is a custom manufacturer of high-performance labels, tags, and die-cut adhesives. TLP provides custom engineered adhesive and label solutions for the electronics, automotive, aerospace, industrial, biomedical, medical equipment, hydraulic fluid and power industries. For more information, contact TLP at 800.727.1344 or visit www.tailoredlabel.com.

Media Contact:  Larry Harvey  |  (262) 345-6404  |  lharvey@tailoredlabel.com

3D CAD model of a TLP Gasket Die Cut Adhesive

Using SolidWorks Software to Provide TLP Customers with Accurate Label & Die Cut Adhesive Prototype Models

SolidWorks is a 3-D modeling CAD software system that TLP frequently uses us make things easier for our engineering customers. Many of our more technical custom adhesive and labeling projects benefit from sophisticated modeling techniques.

3D CAD model of a TLP Gasket Die Cut AdhesiveAs an example, TLP may be preparing a product to be placed on a gasket that has a layer of adhesive, a layer of foam as a protectant, another layer of adhesive, an under-liner and then a release layer. That can be difficult to show in 2-D, but Solidworks allows us to accurately show and model each layer.

In addition, SolidWorks software allows TLP engineers to be more creative and innovative during the design process, trying different design concepts before they are produced, which can significantly accelerate the design process and reduce costs.

The CAD models let the engineers that we supply part to, to test those parts in simulated real-world conditions to be sure the design is correct before the product is built.

“Since many of our items are auto applied, having precise measurements is crucial to ensure that the production line flows smoothly and there are no jams or mis-feeds. Each layer is clearly seen and modeled, as well as the thickness of each layer, so specific items can be adjusted before being manufactured,” says Jim Brown, a Senior Manufacturing Engineer at TLP.

“The 3D modeling & prototyping capability enhances the relationship we have with many customers as they can view their projects in a new way,” says Jim. “We see this as the future in many manufacturing applications, so we are working to stay ahead of the curve.”

Click here to request more information on how TLP’s engineering and CAD services for labels and die cut adhesives can benefit your company.

6 Things You Can Do to Retain High-Performing Team Members

As the economy continues to improve, and their top talent has been established, what can companies do to keep their best workers engaged and producing at a high level for customers? With leading industry talent in high demand, retention rates become exceedingly important. At TLP we work hard on cultivating longer-term loyalty with our high performance team members. Here are some tips to help keep your best performers:

  1. Demonstrate Passion
    To retain the best employees, you should demonstrate a passion for the business. This seems inherent, but by projecting your passion for the work you do, and working to inspire others with your energy, the likelihood of your employees picking up on and absorbing that passion is high.
  2. Show Positive Recognition
    Sincere and routine recognition can go a long way with employees. Keep your eye out for exemplary work and be sure to acknowledge their efforts while showing appreciation of extra effort and smarts on your team. Others on the team will recognize that, and follow suit.
  3. Identify Weak Spots
    Being responsible for the performance of other employees, you may eventually have to deal with a person who isn’t living up to the high standards that have been set. While it’s an uncomfortable position, you’re much better off giving the employee feedback on his/her performance, and identifying areas of improvement, rather than letting the company suffer with weak performance. The best like working with the best.
  4. Listen Often, Listen Well
    Leaders who listen are able to create trustworthy relationships that are transparent and breed loyalty. Every insight is worth hearing in order to more effectively inspire professional development and overall performance.
  5. Demonstrate Clear Communication
    Clearly communicating expectations is a key factor in any business environment. Being able to articulate exactly what needs to be done, when it needs to be done and by whom will give your employees the resources they need to complete any given task.
  6. Coach the Best
    Be an advisor to your employees, let them know that your time with them is valuable, and mentor them in a way that helps build and maintain their personal culture of innovation. By giving them your time and knowledge, you’re helping them facilitate opportunities for professional development.

2 of 10 – TLP’s STRENGTH Focused Employee Development Program

 

 

According to research, only 2 out of every 10 people “play to their strengths” at work and in their personal lives. In other words, only 20% of us take advantage of our core personal attributes to enhance our work, play and attitude. “Everyone has core strengths,” says Nicole Richard, PHR, TLP’s Human Resource Manager. “To be as productive and happy as possible, you need to identify your strengths and tap into them because that’s what you’ll be most successful at and the happiest doing.” That’s the philosophy behind TLP’s 2 of 10 Employee Development Program. Nicole and Joe Phelan, TLP’s Continuous Improvement Administrator, head-up the program. “Our 2 of 10 program is a means of tapping into employees’ strengths so that TLP can be as efficient as possible in using those skills and our employees can identify and take advantage of opportunities to maximize those abilities,” Joe explains. As a result, our team members are able to get the most satisfaction possible from the work they do on behalf of our customers. “The program impacts how we operate as a business, how we manufacture products and how we provide customer service. The entire process has a positive bottom-line impact for our customers,” he adds.

Broadening the Impact throughout Our Organization

The program was introduced to TLP by Jeff Kerlin, President & COO. Initially, it encompassed a select group of managers. The results were so inspiring that a formal curriculum was created and expanded to include everyone at TLP. The course is composed of four, one-hour sessions. The first step in the process is filling out Strengths Finder® questionnaires to identify each team member’s top five strengths. Then everyone in the group learns what their specific strengths really mean. “Virtually 100% of the time, individuals agree with the findings,” says Nicole. The next step is to explore how team members are using their strengths at TLP and in their personal lives. “We want our team members to feel that they are achieving to the highest level of their abilities so that they are happier on the job,” Joe says. “We want them to have opportunities to know what it means to be really good at something. At the same time, TLP and our customers gain an advantage because we are utilizing people to their fullest potential.” Follow-up sessions are held between team members and their supervisors to make sure each individual is getting opportunities to use their strengths. If team members want to enhance an identified strength, TLP will help them through additional education, involvement in challenging projects or learning new skills at TLP. “One of our designers wanted to learn how to operate a press, for example, so he would be able to better understand things from the entire production process from artistic to manufacturing and assembly. We gave him that opportunity,” says Joe. The program also encourages employees to share their strengths in new ways. “We chart the strengths of all of our employees. So when we’re putting together a team that may need a good organizer or a creative person or a good communicator, we use that information to select individuals who will be a good fit for those challenges,” says Joe.

Scoring a Big Hit with Happier, More Productive Employees

Feedback from employees has been extraordinarily positive, according to Nicole and Joe. “Our team members really appreciate the chance to build relationships with other employees whom they otherwise would not have an opportunity to interact with,” says Nicole. “They value the chance to learn about the duties and skills of other team members.” Joe adds, “Those who have gone through the program are more engaged and happy. They take more pride in their work. And they know a lot more about one another and about one another’s jobs, responsibilities and challenges. That strengthens our team environment, which strengthens our entire company and, ultimately, provides major benefits for our customers.”