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By Steve Baker | Sep 21, 2017
Technical printing projects must face strict qualification procedures before moving into full-scale production.

In the final blog of our three-part series on technical printing, we will discuss the qualification procedures that technical printing projects endure.

In the last blog, we described the five phases of development for technical printing projects. Once that process is complete and stable, the project goes through qualification procedures as it moves on to production. GM Nameplate (GMN) carefully applies these procedures with technical printing projects, especially those belonging to highly regulated industries such as aerospace and medical.

There are three qualifications that projects must pass during production to be validated as parts ready to sell:

Installation qualification (IQ)

Correct installation of machinery is vital, because if the equipment isn’t properly installed, the parts it produces won’t be viable. IQ is typically conducted for new pieces of equipment purchased for a particular job. This involves testing the equipment and understanding the ins and outs of how it works. One of the most important factors when conducting IQ is learning the equipment’s variability when being used so we know the accuracy of the machine. With technical printing projects, only so much variability is allowed, and the variance of the equipment used must be carefully considered during production. If the piece of equipment has been used before, past qualification tests can be referenced.

Operation qualification (OQ)

This process is to ensure that variables and critical operational parameters are held constant throughout production. In the previous blog, we described the initial development process that technical printing projects go through when moving from concept to production. OQ is all about understanding variability in our operation processes and how to maintain consistency during large-scale production. This is essentially development on the production level, requiring testing of many variables to gain a better understanding.

Since technically printed parts belong to pieces of equipment like medical devices, many variables must be controlled strictly, such as drying temperature, ink dispensing, ink thickness, and substrate materials. During OQ, the parameter windows are set with a minimum and maximum level of variances allowed, and it is critical to stay within these throughout production. For example, once we know the optimal temperature at which the ink will cure, the optimal thickness of the ink, and which substrate material is best for the ink to adhere to, we can move forward with production knowing the variables will be held constant at the appropriate level.

Production qualification (PQ)

Production qualification is testing our production processes and the materials used when we manufacture parts (our suppliers’ control parameters). Since technically printed parts belong to highly regulated industries, we must make sure the substrates, dielectrics, carbons, silvers, and other materials are without defect and that our production processes are keeping the many variables in the middle of their parameter window. This process is done by doing three different runs/setups with different lots of materials during initial production. Once the parts are produced, each lot is examined to make sure it falls within the tight parameter windows. If it doesn’t, a root-cause analysis is conducted to determine whether the failure was due to poor materials, an issue with production setup, or another factor. This process is a final review which ensures that by the time the part is completed, it will be ready for the customer.

Since technically printed parts belong to highly regulated industries, they often go through this process when initially setting up for production. GMN employs an expert team of quality control inspectors and quality engineers and utilizes IQ, OQ, PQ processes to ensure quality and repeatability throughout production.

To learn more about technical printing, check out the other blogs from this series:

By Steve Baker | Sep 11, 2017
Technical printing projects are common in highly regulated industries

This blog is the second in our series on technical printing. In our first blog we gave an in-depth description of what technical printing is. In this blog, we will talk about how technical printing projects go from development to production.

How are technical printing projects started? At GM Nameplate (GMN), technical printing projects start in our development department. Here the design is scrutinized, reviewed, and tested. The goal is to produce development part designs and find out quickly whether the part is manufacturable or not. This department will provide design considerations and test reports until a conclusion is drawn. Once a batch of parts has a high yield per volume and a high success rate, the project can move onto full production.

There are five phases that technical printing projects go through during development before it can move on to full-scale production, each one with specific operations. These phases are particular to technical printing projects only because of the high level of scrutiny required in development.

Phase 1: Ideation

Ideation is an ongoing conversation between the customer and GMN to identify the areas of highest design risk. This allows both parties to define steps to test design assumptions and evaluate potential design and material solutions to help build confidence about the known challenges.

Phase 2: Risk mitigation

This phase is used to validate material stability and printability, explore material handling and registration options, review curing processes, and establish a planned production approach. Defining the risks and challenges that are likely to occur allows for a plan to be made accordingly. All challenges must be addressed with extreme scrutiny because technical printed parts require much tighter tolerances.

Phase 3: Low volume functional prototyping

Low-volume prototyping is used to create functional printed parts using the materials and preliminary product design planned for use during full volume production. This could take several rounds of prototype layouts and testing, and repeating this process until a high yield success rate is achieved. With technical printing, projects in this phase become more device-specific and are outside of typical production, development, and industry standards.

Phase 4: Production development prototyping

With a suitable design identified, GMN will work on transitioning into production manufacturing development. Larger quantities of parts will be printed and evaluated, with the goal of meeting customer specifications. The parameter window for meeting the customer’s specifications is very small in technical printing, and is why technically printed parts are evaluated so thoroughly.

Phase 5: Production validation

Once the parts have passed the previous phase, the project is handed to a production team and design engineer to apply to production volume quantities.

GMN’s expertise and strict quality systems allow us to work in these highly regulated spaces and gives our clients confidence in the parts we produce for them.

For an overview of technical printing, read our previous blog in this series.