Perdix Software Blog

Additive Manufacturing? What A.M. I talking about?

What is additive manufacturing?

Definition - a process of making a three-dimensional solid object of virtually any shape from a digital model. Additive manufacturing is achieved using an additive process, where successive layers of material are laid down in different shapes. Additive manufacturing is also considered distinct from traditional machining techniques, which mostly rely on the removal of material by methods such as cutting or drilling (subtractive processes). -- SME

The image that comes to mind when most of us think of manufacturing is not one of additive manufacturing but rather subtractive manufacturing. This is the traditional method of making things that we are all very familiar with, which involves taking away material to make a part or product.

Think of a chair: you have pieces of wood that you cut and whittle down into legs and maybe arms, there’s a large roll of fabric and a chunk of foam that you cut the upholstery and padding out of and then you put it all together. You subtract the chair shaped pattern out of the materials and assemble it.

Now, there’s a whole new way of doing things. Additive manufacturing is the opposite of subtractive manufacturing because instead of cutting parts out of a larger whole, the material is created in the shape you need it in, right from the beginning.

We chatted with our partner Vetted Tech, located in Syracuse, NY, to learn more about additive manufacturing, and now we’re sharing our knowledge with you! To learn more about Vetted Tech check out our video: Meet Vetted Tech.

How it works:

Additive manufacturing relies on CAD, or computer aided design. This is a type of computer program that allows engineers to create their design digitally and then the program slices that design into thin layers. Next, a machine, such as a 3D printer, is able to build the design up, forming it layer by layer, allowing for more flexibility in the design.

3D printing is the classic example of additive manufacturing. You can see how the material is added during the 3D printing process, since the nozzle squeezes the material out like a toothpaste tube only where the material is meant to be.

Some methods of additive manufacturing don’t squeeze material out of a tube but rather use heat to solidify or cure powdered materials such as plastic, metal, or other polymers. This process starts with a thin layer of powdered [insert material here] - additive manufacturing technologies are compatible with a very large variety of materials.

Next, a laser heats the powder, melting it together and creating the first layer of the design. Then, another layer is spread over the first as that first layer descends into the machine so that the top, working layer is always on the same plane for the laser. The laser does its thang again, and so on and so forth until the whole design has been crafted. At the very end, the object is raised back up and the powder falls away, revealing the product.

If you’re more of a visual learner, and this description just isn’t doing it for you, check out this video from GE.

What are the implications for the manufacturing industry?

These additive manufacturing techniques can eliminate some of the obstacles of traditional, subtractive manufacturing.

For example, additive manufacturing allows for much more intricate shapes, and stronger ones too. Think of a simple metal chain: each link needs to be fused at some juncture in order to connect them together and that juncture then becomes a point of weakness. With additive manufacturing, however, the whole link can be made already intertwined with the others. This is because of the layer-by-layer nature of additive manufacturing.

Additionally, additive manufacturing allows for flexibility while working with a lot of materials that traditionally are not very easy to work with. With metallic powders, metal objects can be created without having to bend or mold metal into tricky shapes.

Types of Additive Manufacturing

Laying out the alphabet soup of all the different types of additive manufacturing.

Powder Bed Fusion (PBF) –

This is the name for processes like the powder and laser process described above and other techniques like it including:

DMLM	Direct Metal Laser Melting
DMLS	Direct Metal Laser Sintering
EBM	Electron Beam Melting
SHS	Selective Heat Sintering
SLS	Selective Laser Sintering

Material Extrusion –

This process is like the 3D printing process described above; material quite literally extrudes from a nozzle as the 3D printer lays it down. Like the PBF method, the design is slowly lowered so that the laser, moving on a horizontal plane can stay in the same vertical positioning as it lays down each successive layer.

Other Types of Additive Manufacturing –

Directed Energy Deposition (DED)	The process of directed energy deposition (DED) is similar to material extrusion, although it can be used with a wider variety of materials, including polymers, ceramics and metals. An electron beam gun or laser mounted on a four- or five-axis arm melts either wire or filament feedstock or powder.
Material Jetting	With material jetting, a print head moves back and forth, much like the head on a 2D inkjet printer. However, it typically moves on x-, y- and z-axes to create 3D objects. Layers harden as they cool or are cured by ultraviolet light.
Binder Jetting	The binder jetting process is similar to material jetting, except that the print head lays down alternate layers of powdered material and a liquid binder.
Sheet Lamination	Laminated object manufacturing (LOM) and ultrasonic additive manufacturing (UAM) are two sheet lamination methods. LOM uses alternate layers of paper and adhesive, while UAM employs thin metal sheets conjoined through ultrasonic welding. LOM excels at creating objects ideal for visual or aesthetic modeling. UAM is a relatively low-temperature, low-energy process used with various metals, including titanium, stainless steel and aluminum.
Vat Polymerization	With vat photopolymerization, an object is created in a vat of a liquid resin photopolymer. A process called photopolymerization cures each microfine resin layer using ultraviolet (UV) light precisely directed by mirrors.

Source: GE

How is this technology being applied?

Because of the flexible nature of additive manufacturing, it is often used to prototype parts and products. For Vetted Tech and companies like it, this rapid prototyping is one of the most common uses for their additive manufacturing capabilities.

This is because, generally, additive manufacturing is not currently a mass production method, though there is a lot of potential for those applications in the future. Right now, it is used to create small batches with high variation between each lot.

This allows product developers to design a product, manufacture it quickly, test it for design flaws, and edit their design to start the process again. Once they have the prototype worked out, they can invest in the tooling and infrastructure needed to mass produce it using traditional, subtractive manufacturing.

Similarly, in the defense industry, additive manufacturing is often used to produce spare or obsolete parts for maintenance. This cuts down on the inventory expenses of having spare parts constantly on hand, as well as the logistics expenses of procuring and shipping those parts around the globe.

Even when parts are shipped around the globe, additive manufacturing greatly reduces the weights of the material which would cut down on logistics costs. One reason for the reduction in weight is that, like the metal chain example, parts can be made already connected thereby reducing the number of parts used in the final product and, consequentially, its weight. There is much less need to weld or bolt parts together.

This is a major benefit in the aerospace industry as well, where the approximately 30 3D printed parts that were certified for flight in 2020 replaced over 50 traditionally manufactured parts (TCT). Additionally, the wide array of materials available with 3D printing make it especially good at manufacturing parts for heat and fluid management on aircraft.

Much of what makes additive manufacturing so good at rapid prototyping also makes it a great method for producing highly customized products. In defense and aerospace, this may mean developing casings for drones or other flying objects that are customized to a specific mission or environment.

This customization is a major reason additive manufacturing has taken off in the medical field. CAD has made it possible to use patient scans to design highly personalized devices. Again, the small batch sizes with high variation between each patient’s specifications makes additive manufacturing ideal for the medical industry.

Additive manufacturing is allowing manufacturers to make stronger, more intricate, and more specialized parts. As the technology becomes more widely available, these techniques will continue to grow in popularity and their use for mass production will become more feasible. Additive manufacturing continues to be an excellent solution for product development and customized products especially in the early-adopting defense, aerospace, and medical fields.

Perdix Software’s Audit Survival Guide

Spoiler Alert:

Röchling Medical Rochester went digital with MOLI, the information processing machine built for manufacturers. This update eliminated compliance errors that arose with physical paperwork, saved time during audits (which makes auditors happier – and therefore nicer), and allowed for documents to be easily stored without filing cabinets taking up half of the quality department’s floor space!

Audits!

What do you think of then you hear the word audit? If you’re a big Wolf of Wallstreet fan you may be thinking “oh sh*t,” but they aren’t always that dramatic. Really, it depends on the type of audit – for this piece, we’re focusing on manufacturing audits through the lens of a medical device manufacturer, though many of the takeaways can be applied across multiple industries. An external audit, especially an unexpected one, might spike your heart rate (though they don’t have to) – but internal audits are usually just a necessary, if somewhat tedious, part of any company’s operations.

What are audits all about?

“Audits are not the most pleasant thing we have to go through or do. However, they are a necessity that helps all of us, and drives improvement.”

We sat down with quality engineer Peter Bierre from Röchling Medical Rochester, an international medical device manufacturer, who put it superbly when he said “the first thing that comes to mind when I think of the word audit is continuous improvement.” That is what audits are really about. Bierre continued, “Audits are not the most pleasant thing we have to go through or do. However, they are a necessity that help all of us, and drive improvement.” You get there with lots of time and paperwork but the point is to make sure that your company is doing the best job of doing… well, whatever it is you’re auditing.

How do you go about performing an audit?

That documentation will vary depending, again, on what it is that you’re auditing, because audits vary widely. A company can audit a process, a product, or even a whole department. Auditing a process might look something like checking that the entire assembly process is up to your company’s standards, whether those are set by the company itself or a regulation. Auditing a product consists of following the material trail from start to finish as a specific part or product is produced. Auditing a department, on the other hand, is more about checking that the employees of that department are following the procedures they are supposed to be following.

While talking to Steven Smith, co-founder of Perdix Software, Bierre describes auditing departmental procedures saying, “think about this, you have done auditing of us and not even known it. When you came to us and you asked us ‘how do you do this process?’ essentially, that is a question an auditor would ask. Except, the only difference would be [that] they would actually have the procedure in one hand and then ask you, ‘how do you do this process?’ and then see if your answers match the paper.”

If all these parts, procedures, and departments sounds like a lot to audit and a lot to keep up with it’s because they are. That is why today some companies are changing the way they audit by instead auditing to the standards with which they comply. To do this, companies may audit across “multiple areas or multiple processes simultaneously” according to Bierre. This ensures that when performing internal audits companies are covering the whole standard as if they were being audited by external auditors.

“we’ve taken it from 64 audits to seven”

Bierre shared with us how auditing to the standards has changed and simplified Röchling Medical Rochester’s auditing process: “originally, before we switched to this, our audit system was by department and we were doing 64 audits a year because each area was being audited twice. It was brutal. We have probably a pool of sixteen auditors…. trying to perform 64 audits in one year, how effective do you think those audits would be? So, we’ve taken it from 64 audits to seven.”

Wow.

Clearly, auditing to the standards can simplify the audit process and ease the strain on limited resources such as internal auditors themselves.

Sidebar: what are these standards everyone is talking about?

Missing some background? Check out our Introduction to ISO standards and other national compliance standards.

So, what do you even look for when you do an audit?

"We audit to prove that you comply, not that you don’t comply.”

The reason audits have this reputation of being “oh [insert expletive]” moments is because everyone seems to think that auditing is about auditors going through everything they can get their hands on with a fine-tooth comb to look for infractions. That is actually not the case. Bierre described the process saying, “The most important thing to look for is – and this is a saying that auditors often say to us – we don’t audit to find things. We audit to prove that you comply, not that you don’t comply. So, technically, I’d say the most important thing we look for is compliance. During an audit you’re bound to find some level of non-compliance.” The severity of that non-compliance depends on what it is.

In the medical manufacturing industry, Bierre explained, the severity of non-compliance is based on risk to the end-user, the patient. It is about protecting someone on the operating table (or wherever they interact with the product) and making sure the devices are safe and deliver on their promises.

On a scale of 1-3 with one being a small issue and three being a major infraction, anything that might compromise a company’s data, failing to record data during a specific time frame for instance, would be a three. Something small like a mistake in how changes to documents are noted would be a one as the data is okay but you are still not following the established procedure correctly.

How can I prevent non-compliance?

“So that’s why we went digital, because if you’re digital you don’t have any of that documentation error”

Though low severity issues like those with documentation don’t seem like a huge deal, they start to add up fast and, because they seem minor, are often overlooked. Bierre highlighted this when explaining how Röchling Medical Rochester addressed this concern in their own facilities: “so that’s why we went digital, because if you’re digital you don’t have any of that documentation error. We don’t eliminate [all] error but we eliminate the errors that we were getting, like not initialing and dating when they make a correction, we completely eliminated that.”

The future is digitalization, honestly the present is digitalization, it’s already here. At least for companies with the resources to implement it. But as technology improves it becomes more accessible and an increasing number of companies are able to implement digitalization into their operations.

What are the other benefits of digitalization?

"an angry auditor is not a nice auditor.”

Using digitalization to make data driven decisions is the big draw for digitalization but even simple digitization (wondering what the difference is? Check out our blog on digitalization) can have huge benefits. When asked what the biggest hurdle in the audit process is, Bierre says “time… that is literally the biggest hurdle.” He discussed how internal auditors often are not strictly dedicated to auditing but do it in addition to their other responsibilities so finding time for both is a challenge.

He also discussed the time constraints for external auditors and the importance of having everything ready and available when an auditor asks for it. Shuffling through papers in a filing cabinet is a hassle that is completely unnecessary, and it eats up that limited time for both internal and external auditors.

Bierre emphasized the importance of time to external auditors saying digitization “took away that whole shuffle. That was a very common problem and it would annoy the auditors because it’s just eating time. Audits usually operate under a predetermined amount of time and they hate when you waste time. There’s a saying,” he chuckled, “an angry auditor is not a nice auditor.”

While digitization of records allows for ease of access, it also allows for ease of storage, very important for ensuring compliance, especially in the medical device manufacturing industry. Product records often need to be stored for long periods of time so that, in the event of something going wrong, products can be traced back through the value chain to see where the problem arose. “We have some customers that require 20 years. We have some customers that, as long as we use this part in the field, you’re required to maintain your records.” That can be a very long time to keep track of physical paperwork, so I hope you have a good filing system. Bierre added, “[that] is another great thing that digitalization has helped us with, it helped us get better use of the space.”

Bierre described how document storage worked before digitalization talking about the quality office: “originally half the quality office was filled with nothing but filing cabinets…. filing cabinets back-to-back…. then, on top of the filing cabinets we had boxes.” Digitalizing with MOLI has freed up all that space to be used for employee desks.

Introducing ISO

Standards: some people’s are high, some people’s are questionable, and some people are that one college roommate who never – ever – cleaned (read also: VERY low standards). Roommates are one thing, but when it comes to the quality of products you use every day, you expect a certain minimum threshold. In manufacturing ISO (International Organization for Standardization) is the international authority on quality standards. There are general standards as well as industry specific standards, this blog focuses on the medical device manufacturing industry, but there is plenty of information about the general standards as well if the medical scene isn’t for you.

The ISO standards exist to ensure a variety of things from consistency to safety. Some of the most common standards in the medical manufacturing field are ISO standards and FDA (Food and Drug Administration) standards. The two most common ISO standards are ISO 9001 (general manufacturing) and ISO 13485 (medical device manufacturing).

ISO 9001 is mostly about consistency and leaves a lot of room for companies to create their own standards that they then have to keep. Individual companies are responsible for determining their relevant inputs and outputs, the sequence and interaction of their processes, the application of critical methods, the resources needed and their availability, and who is responsible for what. The goal throughout should be to address risks and opportunities as well as evaluate processes and decide what needs to be changed in order to improve them and your quality management system (QMS) overall. Companies also need to keep documentation regarding their plans for maintaining that QMS.

Some of this documentation includes the scope of the QMS, the quality objectives, the fitness of resources for monitoring and measuring the conformity of products and services to requirements, the reasoning behind internal standards when no national or international standards exist, and competence among employees to uphold these standards.

That’s a lot to document, but wait there’s more! – more requirements for how you store and maintain controlled documents. To be considered a controlled document, a document needs an ID like a title, date, author, and reference number. Then, the documents need to be protected and preserved from unauthorized changes or changes that aren’t documented properly but must also be available to relevant employees. However, when the documents need to be changed or updated you need version control to see what changes were made when, and by who. Finally, you need to be able to retain that documentation for whatever length of time is required.

Those are the basics for ISO 9001, which is essentially the basic ISO standard. It can be applied to any industry. Some industries, such as medical device manufacturing, have their own standards, ISO 13485, for example, which is much more focused on finding and eliminating risks, and requires more specific documentation about the medical devices being made.

One difference to note is that for ISO 13485 manufacturers are required to keep a medical device file for “each medical device or medical device family” that they produce. This file should include a description of the device and its intended use, any labels or instructions, product specifications, production specifications from manufacturing to distribution, measurement and monitoring procedures, and, when needed, installation and servicing information.

Find the full ISO 9001 standards here, find the full ISO 13485 standards here.

The ISO standards are, as mentioned before, international standards. Based on what countries you produce in or sell to you will encounter additional, national standards. For the United States medical manufacturing industry these are the FDA 21 CFR part 820 standards. The European Union equivalent to this FDA standard is the European Medical Device Directive or 93/42/EEC which stipulates which medical devices may be sold in that market. In Canada you would be looking to comply with CMDR and GD207.

Whatever standards you comply with, you will experience both internal and external auditing. Internal auditing is how you check yourself to make sure your QMS is up to par. External audits are how regulatory and certification-granting bodies check your QMS.

To learn more about audits checkout our Audit Survival Guide.

Meet Our Interns

Meet Catherine McConnell and Jenna Schlick, both from the SUNY Brockport School of Business — the inaugural interns at Perdix Software!

This video was produced by Jenna Schlick during her internship at Perdix Software.

Automation and Computerization and Digitalization, Oh My!

Breaking down these buzzwords and busting the myths of digitalization

Digitalization. Oh no. The future is upon us.

Technology, like digitalization, has changed our world for good, but has it been changed for the better? People love to debate it, but at Perdix we, unsurprisingly, think yes, and if you’re up to date on the Industry 4.0 revolution we’re sure you’ll agree.

Well, what even is digitalization?

Di-gi-ta-li-za-tion. Awkward, isn’t it?

But we better get used to it because digitalization, not to be confused with digitization (no al), is the future of business – any business. Digitalization affects us al (see what we did there?) It is a new method of doing things, a more efficient, informed method. It will disrupt industries and forever change the way business decisions are made. It’s the latest band wagon and it’s here to stay, so hop on.

We hear the word digitalization all the time but it’s usually used interchangeably with automation or computerization so what’s the difference? We’ll break it down:

Word	Definition
Automation	n. automatically controlled operation of an apparatus, process, or system by mechanical or electronic devices that take the place of human labor.
Digitization	n. the conversion of text, pictures, or sound into a digital form that can be processed by a computer.
Computerization	n. the process of starting to use a computer to do something that was done by people or other machines before.
Digitalization	n. the use of digital technologies to change a business model and provide new revenue and value-producing opportunities; it is the process of moving to a digital business.
Bonus: Digital Technology	n. electronic tools, systems, devices and resources that generate, store or process data.

Sources: Mirriam-Webster, Oxford Language, Cambridge Dictionary, Gartner, Victoria State Government

Let’s sum it up

You can, in fact, automate without digitizing and computerizing, like the Evans flour mill here in Rochester or the automaton in Hugo. Today, though, most automation is done with computers, making it both automation and computerization – computerized automation if you will.

Technically, you could digitize without computerizing, though we don’t know why you’d want to. You do, however, need to digitize to computerize, since digitization is just getting data and information into a format that computers can process.

Computerization, then, is similar to automation, but it uses computers (shocker). Computerization is essentially modern automation and oftentimes replaces non-computerized automation.

Finally, we have digitalization. Digitalization takes all of these building blocks and combines them to harness the full potential of computerization and digital technologies.

Digitalization further leverages digital technology to help you make data-backed business decisions. This technology allows you to gather, link, and analyze large amounts of precisely-collected data which enables these informed decisions.

What do you mean?

We can all think of decisions we’ve had to make without as much information as we would have liked, introducing more risk and uncertainty into the situation at hand.

Digitalization has the power to change this. Of course, no business will ever be 100% risk-free but, today, we can eliminate a lot of unnecessary risks.

Digital technologies make it a lot easier to monitor relevant indicators and collect data. That data can then be analyzed to find trends and gain meaningful insight as to how each aspect of an operation impacts the others, as well as to predict the impacts of future changes.

This is what everyone is talking about when they throw around the term “data driven decision making”. Technology allows us all to analyze a lot more information and better predict how operational changes will affect the bottom line.

In manufacturing, digitalization not only allows you to get rid of error-prone physical paperwork throughout your facility, but also export and analyze data that was once trapped – trapped on paperwork or trapped in software that couldn’t communicate with any of your other software, rendering it useless. When you can actually access your data, you can use it to find and correct inefficiencies in your operation.

For example, you can find out what costs more – a long wait time or a high error rate – and then focus your efforts on implementing changes that will have the biggest impact. Digitalization’s main benefit is that it allows us to take full advantage of information that may not have been available to us in the pre-digitalization era.

So, this is the job stealer everyone has been talking about?

Eh, not really. Studies have shown that, on average, advances in technology actually create more occupations than they eliminate, so why should digitalization be any different?

What will be different is the nature of the work we humans do, because we won’t have to do repetitive, non-cognitive, robot-y jobs like inputting data from physical spreadsheets into the computer. We’ll do creative, complex jobs that require uniquely human intellect, dexterity and sensory skills.

We see this first hand while consulting on digitalization projects. Sometimes entire departments are renamed and job duties change to move employees from doing tasks that computers are now capable of completing, to doing tasks that support and supplement the new technology and the business as a whole.

Oftentimes, though, digitalization is just employees doing what they’re already doing but on a computer, instead of paper, and better.

By “better” we mean in a way that makes sense for the medium. Computers are capable of doing a lot more than paper, so we shouldn’t just use them as virtual paper but rather as information processing machines that can augment and support our own personal information processing capabilities. Once you start working like this, you process information faster and can move on to processing other information – making the whole operation faster.

This will be a bit of a disruption to the industry norms we’ve grown accustomed to but it will add value and keep manufacturing efficient and, therefore, competitive in a world that increasingly looks for inexpensive consumer goods.

I’m sure we can all see the benefit in that, but let’s be real – your favorite benefit is probably not having to read that one coworker’s hand-writing anymore, and if you can’t think of that co-worker, it’s you. It’s okay though, the world is going digital now so you can just type!

In all honesty though, the process of digitalization isn’t fast enough to be the big job stealer everyone makes it out to be. Maybe someday but not today. Digitalization is a very gradual process, not free from the friction of any other major operational change.

Getting all of your data from paper to computers – the digitization step of digitalization – takes time, and successful digitalization projects require strategy.

How are we supposed to make this transition?

Digitalizing all those records? Possible restructuring of departments? Sounds like a lot, we know. No need to worry though, there are lots of companies that offer consulting services to guide businesses through their digital transition.

When evaluating these companies and choosing your consultant, there are some important things to look for, such as:

Customization from start to finish -

You want a company that will come in and evaluate your operation to see how digitalization can best benefit your operation so that right from the start your strategy is tailored to your needs.

In addition to customizing your software and features, a big part of this step is determining the best hardware setup for you and your employees / coworkers to interface with your digitalization technology. This will change depending on the size, scope, and layout of your operation.

Information fluency -

When selecting a new system and getting it set up, make sure that it can integrate your existing systems. As we said earlier, paper isn’t the only place information gets trapped, it’s just as annoying when you have all of the information on your computer but the different software, etc. don’t communicate with each other, creating a lot more friction in your tracking and analysis of data.

Personalized training -

Finally, it is important that your consultant takes the time to stick around and train you and your employees after setting everything up. There’s nothing worse than paying a lot of money for a new system and not being able to use its full functionality so make sure you understand how to use each feature to get the most out of your digitalization efforts.

As intimidating as digitalization and Industry 4.0 may sound, soon it will be a normal part of day-to-day operations. These are valuable tools to supplement your information processing capabilities and keep your processes lean. Regardless of the size of your company, organization, or operation, you can find a great digitalization system for you when you ask the right questions and find the right consultant.

For more information visit MeetMOLI.com

Meet Vetted Tech

Vetted Tech is an additive manufacturing startup based in Syracuse, NY designing and developing advanced solutions for the aerospace, defense, and medical markets.

This video was directed and edited by Jenna Schlick during her internship at Perdix Software.

MOLI MedTech Walkthrough

Feature-level demo relevant to manufacturers in the medical device supply chain.

NYS Manufacturing Now Podcast: Talking Training and Factory Automation with Steven Smith of Perdix Software

Improving Your Manufacturing Process: Ways, Tools, and Methods

As the CEO of Perdix Software, I'm frequently called upon by our customers, to make recommendations about how they can improve their processes.

After all, the worst thing you can do, when you implement a new software package, is to automate a bad process.

So, working with a few members of our implementation team, I've come up with a list of simple places to look for bad processes: a place to start — whether you're working with us, or another firm.

Setting Up - For Failure?
Look in your shop for processes requiring "setup". If you're a plastics company, I'm talking about mold setups. If you're an embroidery shop, I'm talking about loading files onto your machines, and bobbin changes. It's different for every industry. Once you've identified your setup steps, document them. And then read your document. Does it make sense? Are there opportunities to share setup time between jobs? Are there opportunities to move the tools used for setup, to a more logical place, and thus save time in the setup process?
Training - Or "Baptism by Fire"?
How do your employees train? Is it standard? Is it auditable? How do you know if an Operator is trained? What about when the instructions change? How are the changes conveyed?

Even if you're not looking at ISO 9001 certification, wrapping your head around training is a crucial step towards improving quality. Software with a focus on Electronic Work Instructions, such as MOLI, can help with this.

And when someone's out sick, having a program in place to cross-train employees — can save the day.
Fixing what's actually broken
One of your injection molding machines isn't cycling. Why?
The machine is low on oil. Why?
There is a leak in one of the lines. Why?
The tubing cracked. Why?
The preventative maintenance schedule isn't being followed.

As you can see, if you stop asking "Why?", you'll end up just putting oil in a leaky machine, and won't address the root cause of the problem. Often referred to as the "5 Whys", this technique of root-cause analysis was pioneered by Sakichi Toyoda and was used within the Toyota Motor Corporation during the evolution of its manufacturing methodologies. The specific number of "Whys" isn't important: only that you don't stop asking "Why" until you get the *real* answer.
Get Help from Tim Wood
Many people get mired in the details of Lean / Six Sigma, and forget the whole point of the exercise: minimizing waste without minimizing productivity. No matter how much you dress it up, the core thrust of Lean Manufacturing is TIMWOOD:
- Transport
- Inventory
- Motion
- Waiting
- Overproduction
- Over Processing
- Defects

Each of these 7 Wastes represent opportunities to improve quality and cut costs. The specifics are, of course, unique to every company. Take a look at your process and discover which apply to you. Then, pick one per quarter to focus on improving.
Good Software
What software do you use to run your business? Excel? Quickbooks? Enterprise software like Microsoft Dynamics, Infor SyteLine, or Netsuite?

If you're like most companies, the answer is complicated. The typical firm uses dozens of pieces of software -- most of which don't really talk to each other.

Working with a technology partner, such as Perdix Software, to help you identify opportunities for integration and streamlining of your disparate systems, is the essential first step in making your software work for you -- rather than the other way around.

Jumping Out of an Airplane... 4,100 Times

That's once a day for about 11.25 years. Even if you had 72 years to do it, like my new friend on the ski lift, it's still a jaw-dropping figure.

We were on the high speed quad at Bristol Mountain, so our ride was short. I didn't inquire about his name or occupation, nor how long he'd been married to his wife (God bless her soul!). I didn't really care. I wasn't going to waste our brief time together talking about his favorite brand of ski pants. This was a man after my own heart — willing to risk it all, over and over again... 4,100 times.

I leaned over and candidly asked, "What on earth drives a person to jump out of a plane 4,100 times?"

He looked back and cracked a smile. "Life is precious," he said to me. "And damn short!"

His face turned more serious as he continued, "Our only guarantee is this brief moment between the day we exist [birth] and the day we cease existing [death]. You have to decide whether you make your decisions to avoid failure, or to achieve something else... something greater."

I suppose those words have been on the tip of my tongue for a long time. For some of us, it's in our blood to push the boundaries — to avoid "content" and eradicate "apathy" — and in doing so, we learn that risk isn't a statistic to be bound by. Risk should be delicately managed and outcomes are for our choosing.

In sky diving, as in business, preparation, competence, and, most importantly, GRIT are our survival tools. They help us achieve something greater, 4,100 times and counting. And that is key: achievement isn't one big-game win, one new business idea, or the right team that'll be together forever. It's 4,100 continuous, persistent acts. Each one requires us to take a leap of faith in its own way... and if we truly want to build something greater — something that's never been done before — we have to leap.

Jump now. Jump often.

Originally published at https://www.linkedin.com/pulse/jumping-out-airplanes-4100x-jake-weidert

Perdix Software to Present at HTR LaunchPad Demo Day

Perdix Software will be among 11 Rochester-based companies to present at High Tech Rochester's 2015 HTR LaunchPad Demo Day at Geva Theatre Center in downtown Rochester.

"We're thrilled to have this opportunity to share our story with an audience of prospective clients, employees, and investors," said Steven Smith, CEO of Perdix Software. "HTR LaunchPad has been fundamental in clarifying the direction of our company."

HTR LaunchPad Demo Day 2015
Tuesday, June 9, 2015 from 4:00 PM to 7:30 PM
Geva Theatre Center
75 Woodbury Boulevard
Rochester, NY 14607

Registration is requested, and can be done through EventBrite.

About Perdix Software

Perdix Software, LLC, established 2014 by Steven L Smith and Jacob R Weidert, is a Rochester, NY-based software company that is creating subscription-based, cloud-hosted business process automation software, and value-added services surrounding the implementation and customization of this software.

Perdix’s flagship product is the Multi-Operation Lean Intelligence System, or MoLi Sys. MoLi can be thought of best as an expert system. By collecting all data about your business in one place, MoLi can help you understand it better, and ultimately make better decisions.

More information about Perdix is available at www.perdixsw.com

About High Tech Rochester

High Tech Rochester is a nonprofit whose mission is to be a catalyst for entrepreneurship and innovation-based economic development. We do this by applying business expertise and network connections to aid in the formation and profitable growth of companies in the Rochester area and the Finger Lakes Region of Upstate New York.

HTR provides a suite of services, including technology commercialization for very-early-stage opportunities, business incubation for high-growth-potential startups, and growth services for existing manufacturing companies seeking to improve their top- and bottom-line performance.

More information about HTR is available at www.htr.org

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UPDATE 7/14/15: VIDEO NOW AVAILABLE.

Perdix Software Selected for HTR LaunchPad

Perdix Software has been selected by High Tech Rochester to participate in the 2015 HTR LaunchPad program. The program, modeled after the highly-acclaimed Lean LaunchPad program developed at Stanford University, is funded locally by a grant from the Max and Marian Farash Charitable Foundation. HTR LaunchPad is for software and web-based startups and entrepreneurs developing new software applications.

"We're thrilled to be a part of High Tech Rochester's LaunchPad program," said Steven L Smith, CEO of Perdix Software. "Their program will help us with our mission to create the next generation of business process automation software, and provide us with the resources we need to be successful."

About Perdix Software

More information about Perdix is available at www.perdixsw.com

About High Tech Rochester

More information about HTR is available at www.htr.org

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