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Answers to 7 Questions About Digitization and Configurability

MasterControl Product Manager, Katie Farley, is a key figure in defining and developing Manufacturing Excellence™. A defining feature of the solution is configurable templates. In this Q&A, she discusses the importance of digitization to achieve configurability and how it streamlines the manufacturing process.

Q. What is one of the reasons manufacturers hesitate to move from a paper-based process to a digital process?

In many cases people continue with paper because it’s comfortable – it’s what people are familiar with. In some cases, it’s what they’ve been using for decades. They worry a digital interface will be completely different and have a new, complicated format that isn’t intuitive to them. In reality, a good digital system allows for full configuration, which means the digital templates can resemble what’s already being used. People on the manufacturing floor will see a configuration they’re familiar with, and it will just be on a laptop or tablet instead of paper.

Q. Where is a good place for a manufacturer to begin when they transition from a paper-based process to a digital one?

When you start thinking about taking an entire paper-based manufacturing process and transferring it to a digital system, a good jumping off point is looking at processes and breaking them into smaller pieces that make sense. Some of those processes include quality control inspections, staging of materials, and packaging of the end item.

In a paper-based system, these sections are often broken up and handed out to different groups on the floor. This results in significant problems because paper gets lost, communication breaks down, and nobody is aware of what’s happening within other groups.

One way we have addressed this problem in the MasterControl interface is following the ISA 88 design philosophy. We organize information into a hierarchy with units, operations and phases. Structuring it this way allows us to configure the different processing a way that makes sense. For example, staging needs to happen before kitting. The processes that happen during staging need to be completed before another one can begin.

One of the primary benefits of this type of workflow is everything occurs in the right order, and it ensures no steps are missed.

Q. You mentioned that a configurable solution is easy to adopt. Can you elaborate on why that is?

In addition to the configurability allowing for digital templates to have a familiar look, they’re also easy to maintain. You don’t need a computer programmer to design a system from the ground up and come in every time a change needs to be made. This is costly and time consuming.

With a configurable solution like the one offered by MasterControl, no coding is necessary. There is a minimal amount of training, and anyone can quickly and seamlessly create records. An added benefit is that every desired configuration that is unique to your process can be created. For example, if you want to be able to reject a numerical entry that falls outside certain data limits, that can be done very easily.

Once an initial master template is built, these can be reused or repurposed. This not only makes a configurable system faster to set up, but it helps maintain consistency for all products throughout the organization.

A great example of this is line clearance forms. If you can manufacture 100 different products on the same line, they will likely need the same line clearance form. In the paper world, this is handled a couple of different ways. Sometimes the form is embedded into each individual master template, but in this scenario change control is a nightmare. The other common scenario is keeping the line clearance form as a separate document, and then it’s printed and attached each time a product is run. This brings its own set of problems.

In a digital environment, the line clearance form is created and any needed changes can be made, then it is digitally connected each time the product is run. This optimizes the process and saves a considerable amount of time.

Q. How does digitization streamline steps like QC inspections and viable counts that have to be performed multiple number of times?

With digital tables, you can configure a set of steps and then those steps can be repeated as many times as necessary. This can happen at the phase level or repeat these operations at a higher level. This means that you don’t have to account for one off scenarios where more rows might be required, which end up resulting in a record full of n/as.

Q. If there are steps that need to be added or removed for a customer work order, how is that accomplished?

It’s easy to create conditional paths within a template. This could be what is or is not included in a customer work order such as additional steps after testing. In a digital system, you can automatically configure certain steps as being not applicable or n/a based on another outcome like numeric limits or pass/fail. This greatly reduces the number of errors on the execution side and helps on the configuration side. It can also help reduce the number of master templates to be managed because conditional paths can help you combine those templates and n/a sections that aren’t needed.

Q. How can a digital system handle Master Templates for product families or products within a line with small variations?

Templates can be created for similar products that have small variations like a different color, size, or country of shipment. These variations are configured within one master template interface, and when operators go to execute, they only see the steps that are relevant to them. This reduces the number of mistakes that can happen on the shop floor and is really an excellent example of the advantages a digital system can offer that a paper one cannot.

Q. What’s next after adopting digital production records?

Ideally, the digital production records can be integrated with business systems like work instructions, operator training, equipment calibration and more. Additionally, after the digitization of your production records, you now have access to data in a way that you never have before. There are a lot of benefits to having this type of connectivity, and we’ll touch on that next time, but for now, a great step in the right direction is digitizing production records to take advantage of configurability.

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Dale Thompson is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. Her areas of expertise are pharmaceuticals and manufacturing. Thompson’s varied career includes extensive work in grant writing and journalism as well as crafting content to highlight the work of biology professors and paleontologists. She has a bachelor’s degree from Evergreen State College and a master’s degree in professional communication from Westminster College.

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