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By Kenny Pravitz | May 3, 2018
Value-added assembly is a process where the value of an article is increased at each stage of manufacturing.

There are typically a variety of pieces and processes involved in making a complete part. As a result, customers sometimes require several different suppliers to make each specific component of the assembly. Even smaller products can have a long list of components and suppliers. During the manufacturing process, costs can vary greatly and the time it takes for products to be completed depends on a range of factors, one of them being how long the supply chain is. In general, a shorter supply channel means your products will get to market quicker, with fewer costs. A great way to shorten your supply chain can be to partner with suppliers that offer value-added processes, or can provide multiple different services or aspects of production.

Value-add can be defined as a process where the value of an article is increased at each stage of its manufacturing, bringing an enhanced benefit and cost savings to the customer.

As a value-added supplier, GM Nameplate’s (GMN) plastics division in Beaverton, OR created a video that demonstrates the value-added assembly process of a medical part. In this video, you can see the stages that these molded parts go through to reach the completed subassembly. Similar to most projects at GMN’s plastics division, the process begins with injection molding. Once that part is molded, it can be decorated, depending on what the customer wants. Offering different decorating options, such as screen printing or hot stamping, after a part is formed is an example of a value-added benefit.

In the video, an operator can be seen placing 17 brass inserts in different bosses of the molded part. To make sure the inserts are properly installed every time, the operator places the molded part in a poka-yoke (Japanese term for “mistake-proofing”) fixture. The molded part will only fit in the fixture one way, so the operator installs the inserts into the correct bosses. These inserts are then heat staked, where a heating element makes contact with each brass insert. The insert then transfers heat to the boss, melting the plastic around the screw. This enables the screw to be removed without stripping the plastic.

Next, the video shows the part being placed in another fixture where a three-camera vision system verifies all the inserts were properly installed. This vision system also has a poka-yoke fixture to ensure consistent verification. Once the vision system notifies the operator that all inserts were properly installed, the part moves to the next value-add station. We see the molded part moved to an assembly fixture where a blue latch-spring component (which is also injection molded by GMN) is assembled to the main plastic enclosure. After this, an operator installs gasketing to the perimeter of the part. Finally, the part is inspected and then packaged for shipment.

From beginning to end, multiple different components and processes were used to make this part, all under one roof. This added value allows customers a cost savings as well as a streamlined supply chain, as several components were completed by one manufacturer, instead of multiple vendors for each individual operation. GMN takes a holistic approach to building your device, and the breadth and depth of our internal capabilities bring increased control, predictability, and reduced costs to your supply chain.

To watch this process in action, click play on the video below. 

By Gerry Gallagher | Dec 5, 2017
GMN is an early adopter of robotic innovation in our industry

Custom manufacturing companies like GM Nameplate (GMN) face the challenge of producing high-quality parts, with short lead times at the tightest tolerances. There are many steps involved from receiving an order to delivering the required parts to the customer in a timely manner. A number of the tasks in the production phase are tedious, and by improving the efficiency of output with these tasks, we can ensure customers receive cost-effective and quick-turn solutions for their projects.

To increase the value we deliver to our customers, we work every day to deliver our services quickly and cost-effectively, while maintaining the same standard of high quality, tested parts. GMN continuously drives to eliminate unexpected results and cultivate seamless production. We have always had a high-caliber skilled labor force, however using this labor as effectively as possible is an ongoing goal we strive for. One way we have achieved this objective is through the use of robotics. Robots are becoming great partners in the manufacturing process by working side-by-side with our employees.

Most recently, GMN has started to employ multi-jointed robots that are registered using coordinates to operate with distinct movements that are precise and repeatable. These are most typically used for a compilation of several small tasks for a specific function. Once a robot is set up with its coordinates and materials, it can reiterate the task for a set number of times, with speed and accuracy. Thus allowing our employees to spend their time programming the robots and focusing on setting up more jobs. GMN has been using robots with loading and unloading laser cutters, clam shell die-cutting presses and other repetitive processes. This allows for a more interesting and rewarding role for the employee as well as more value to our customer.

Safety is our top priority for our employees at GMN, and these robots were made with employee’s safety in mind. They have “smart-technology” to sense if they bump into someone or something, so they do not need to be in a cage. For example, if a robot’s arm swings into an employee, the robot will stop at the point of contact. Robots without this technology will swing with force into objects (or people).

Robotic automation is being implemented more and more among manufacturing companies, and GMN is an early adopter of this innovation in our industry. This allows employees of GMN to focus on skilled tasks that robots can’t perform, so labor is better applied during production. Robotic automation is one of the many ways GMN brings value to customers, by improving efficiencies, reducing costs, and seeking continuous improvement.

To see our robots in action, watch the short video below. 

Todd Boedecker, GMN
By Todd Boedecker | Jul 15, 2016
GMN’s laser capabilities

Upon hearing the word “lasers” many people think of an action-packed scene from Star Wars. The lasers used in manufacturing may not be of the lightsaber variety, but they do play an important role in production today. 

While there are many applications for lasers in the fields of research, law enforcement, and medical practices to name a few, we are going to focus on manufacturing in this article. GM Nameplate (GMN) is equipped with laser machines that are used for both cutting and etching. The first process is used to cut parts from sheets or rolls of material while the second typically provides a decorative function by engraving a piece or removing ink from a part.

Laser cutting is best used for applications including prototypes, program development, low volume production, parts with small or intricate features (such as interconnected holes for two-sided circuits), and materials that cannot be cut with a tool. The lead time for laser cutting is faster compared to die cutting and changes can be made quickly with programming instead of tool modifications. In contrast, cutting time is typically longer than punching time so piece price is normally higher with laser cutting. 

In addition to cutting, lasers are also used for etching. Through this technology, parts can be engraved or marked. One way etching is used is to remove paint or ink from the surface of a part to allow the material underneath to show through. For example, GMN has utilized laser etching capabilities for various automotive gear shift indicator parts by removing a top layer of paint to reveal various colors underneath. One of these programs can be seen in our case study. Laser etching can be done on a variety of materials including plastic, rubber, and metal. Laser etching is often chosen for its ability to achieve fine detail. It is an extremely accurate process and is repeatable to support high volume cycles.

GMN has decades of experience using lasers to fabricate a variety of products including overlays, nameplates, and circuits. Our understanding of laser cutting and etching along with the wide range of materials used in our production allows us to react quickly to our customers’ needs.  We are able output parts using lasers with visual aesthetics and tolerances that meet or exceed other fabrication methods.   

With world-class laser capabilities located at facilities around the globe, GMN is equipped with the technologies needed to meet customer needs wherever and whenever they arise.

Link to PRNDL case study

Dean Karousos, GMN
By Dean Karousos | Sep 8, 2015
Medical custom manufactured overlay

During a recent conversation discussing problem solving capabilities at GMN, a project worked on a few years ago with Sotera Wireless was brought up. This project was unique because a standard polycarbonate, typically used for overlays, didn’t meet Sotera’s requirements. To overcome this challenge, our team needed to think outside of the box to create a solution.

Sotera Wireless, a leader in mobile patient monitoring medical devices, was looking for an overlay for one of their medical devices. Along with DD Studio, an industrial design studio hired to design the device overlay, GMN needed to find an overlay solution with optical clarity, impact resistance, and chemical resistance.

One of the greatest challenges with this project was finding the right material for the overlay. Originally, the plan was to use an injection molding process, but this was found to have problems when the material flowed around the small holes. Next, a laser was chosen to cut parts from sheet-stock, but this process introduced its own challenges. First of all, the chemical resistance was a concern on the cut edges. In addition, while an acrylic laser cuts cleaner and better than a polycarbonate, it isn’t as durable and is prone to chip or shatter on impact.

To solve these problems, a unique material was used, Eastman’s Tritan MP 100, a proprietary impact resistant co-polyester. The Eastman co-polyester material provides a cleaner laser cut edge than polycarbonate, and is available in 0.060” sheets, the desired overlay thickness. Lastly, an Exxene hard coat, the Flexform 200, was applied to the overlay.

One more challenge was faced during the project: identifying a metallic ink without metallic flakes. The ink could not contain any metal because it would interfere with IR scanner readings. GMN spearheaded the research and development needed to find a solution that satisfied both Sotera’s functional and cosmetic requirements.

Sotera Wireless was overwhelmingly pleased with the product. GMN’s cost effective solution not only provided design solutions but technological innovations as well. This overlay is a good example of the benefits of vendor consolidation, innovative processed and a solution-based approach.

Cynthia Schulte, GMN
By Cynthia Schulte | Jan 3, 2014

GM Nameplate's Seattle division recently met the quality standard for ISO 13485: 2003.  Following the exciting milestone, I took the opportunity to sit down with the division's director of quality, Michael Wodrich. 

Congratulations on achieving ISO 13485:2003.  For those that don’t know, can you explain what it is?

ISO 13485:2003 is the international quality management system standard for the design and manufacturing of medical devices, subassemblies and their components.  Many aspects of the 13485 standard align very well to requirements of the Quality System Regulations (QSRs per 21CFR820) for FDA-regulated products, often referred to as current Good Manufacturing Practices (“cGMPs”).  Companies certified to the 13485 standard can ensure their medical device market and customers that they have a strong business system with procedures in place to demonstrate consistent controls exist to consistently meet applicable specifications and quality requirements.

It is important to recognize that while GM Nameplate is prepared to manage a quality system that maps closely to those QSRs, we deliver only subassemblies and components to FDA-regulated customers. GM Nameplate is not currently producing regulated medical device products and therefore we’re exempt from those federal QSRs, but we still use them as guidance.

Why did GM Nameplate pursue ISO 13485? 

We sought ISO 13485 to pursue even better alignment with our customers and their quality systems, which are driven by federal requirements.  The 13485 standard is generally harmonized with ISO 9001 but promotes greater awareness and emphasis on cGMPs to ensure there is a system in place to consistently produce safe and consistently reliable products for the medical devices market.

As a supplier to the medical industry, we are exempt from the QSR requirements which drive many of our customers.  However, it is important to us that we support our customers, understand their requirements, and align with their needs.  By meeting the standards set for ISO 13485 we are better positioned to serve our customers across the medical device industry. 

This also sets us apart from our peers in the industry.  Few competitors have the same level of quality systems in place.      

How is it different from other quality standards that GM Nameplate already meets? 

ISO 13485 is specific to the quality management system requirements for medical device manufacturers (sub-assembly and component manufacturing, as far as GM Nameplate is concerned).  ISO 13485 builds upon the ISO 9001 framework with higher expectations for risk management and design control activities when we develop sub-assemblies and product components together with our customers.  There is no margin for error in any regulated industry, and this ISO 13485 standard promotes the effectiveness of meeting a comprehensive set of requirements.  Achieving certification to the ISO 13485 standards helps ensure that the medical device components and parts we produce meet or exceed thoroughly planned quality specifications every time, without exception.   

All GM Nameplate facilities already meet ISO 9001, a quality management standard that applies to general quality and management oversight principals, regardless of the industry.   In general, ISO 13485 compliments ISO 9001 and can be seen as broadening our quality system to better align to cGMPs.  

In addition to ISO 9001 and 13485, two GMN divisions are also certified to AS 9100C, an aerospace quality system standard.  All are examples of GMN’s commitment to stringent quality management systems.  GM Nameplate’s pursuit of so many stringent quality systems is a testament to the company’s commitment to quality.  

To learn more on the difference between our quality systems, visit my blog Quality Systems 101.

What was the greatest challenge in achieving this milestone? 

The first step was to revise our procedures to better align procedure language with our intent.  In the end, we developed a stand-alone quality manual to meet ISO 13485.

Once that step was completed, our biggest challenge was transition and education to the additional requirements and supporting procedures.  Our staff needed to understand the new procedures – what they mean, what they don’t, how they apply to core business functions, and how to comply.  With quality, compliance is paramount.

What’s next on the horizon for GM Nameplate’s quality group?

A lot of hard work went into achieving this milestone and an equal amount of work will go into maintaining it.  It is important to keep staff trained and vigilant about protocols through education and development efforts.  Quality is always an ongoing process.

In addition, we will be looking to align our quality systems across our facilities.  Quality standard are applied on a facility by facility basis.  We will be taking what we have learned while rolling out ISO 13485 in Seattle to further improve our processes at other locations.