Quality Watch by TIP Technologies

Managing Compliance in Highly Regulated Industries

Episode Notes

At TIP Technologies, we focus on serving the needs of companies in regulated discrete manufacturing industries and serve companies up and down the supply chain. In today's episode, we learn from Ron Dolan, President of TIP Technologies, about some examples of the regulatory standards TIPQA is designed to manage.  As well, we learn how TIPQA can:

 

- Manage regulatory compliance

- Help customers meet critical cybersecurity needs, with the recent introduction of the new CMMC requirements

-Track employee skills for compliance

-Mitigate the risk associated with suppliers’ products

 

And finally, why a best-in-class quality management solution is so important for companies who manufacture emerging technologies.

Episode Transcription

Erin Keating:

Welcome to Quality Watch, a podcast series presented by TIP Technologies. Join us as we share our perspectives on how to reduce the cost of quality, improve operations, maintain compliance, and reduce risks. Our experts stay on top of the issues and regulations that are critical to today's manufacturing leaders and ensure that those needs are met so quality can be used as a competitive advantage. Let's get started and learn more.

Erin Keating:

Hello everybody. I'm your host Erin Keating. In this episode, we speak with Ron Dolan, president of TIP Technologies about how to manage compliance in highly regulated industries, using the TIPQA Quality Management Solution. We will review just a few of the regulatory standards TIPQA is designed to manage, the new cybersecurity maturity model certification requirements, employee skills tracking, emerging technologies, and much more.

Erin Keating:

Hello everyone. Welcome to today's episode for TIP Technology's podcast. Today is actually our very first episode and I'm very excited to be joined by President Ron Dolan. Hi, Ron, welcome to the show.

Ron Dolan:

Thank you. Good afternoon. Good to be with you.

Erin Keating:

Great. Well, we're going to kick off this series talking about compliance, and I know that TIP Technologies has been focusing on serving the needs of companies in regulated discreet manufacturing industries, and of course then servicing any of the companies up and down that supply chain. I think it's pretty important for us to bring some news to our customers and our audience on how, in fact, the TIPQA Quality Management Solution helps customers manage that type of compliance.

Ron Dolan:

Thank you, Erin. It's good to be with you today. We're very fortunate that over the past 30 years, that TIP Technologies has been able to garner extensive experience within the industries that we focus on, such as aviation, space and defense, medical device manufacturing, and complex manufacturing. We're committed to being a leader in these sectors and are actively engaged with relevant legislatures, as well as associations, such as the AIA and others, to ensure that we are able to meet the latest regulatory standards.

Ron Dolan:

When you look at what we do, our product TIPQA automates the tracking of defects and quality related tasks so that we're able to alert manufacturers when something is out of spec. It could be the wrong revision; it could be the wrong subcomponent. It could be a number of factors. The same concept applies when a product or a component does not meet the intended regulatory standard. Our software helps companies to employ processes to ensure conformity throughout the entire product life cycle, from the conception all the way through to the delivery of the end product to the buyer.

Erin Keating:

Great. Well, you certainly mentioned quite a few industries there that I know to be very heavily regulated. Could you maybe help us understand what are a few of the regulatory standards that TIPQA is designed to manage?

Ron Dolan:

Sure. When you look at the complex manufacturers we work with, especially within the department of defense and the suppliers to them, there are a number of standards. There are ITAR standards, there's DFAR standards, as well as the industry standards such as ISO AS9100, and the other FAA type articles. What we work on and what we try to manage is quality documentation that's stored in the central repository so that anybody can have access to the information in case of an audit. When you look at the documentation that we provide, it's around the entire manufacturing, but it includes the genealogy of all components and assemblies in the final product.

Erin Keating:

When you speak about the genealogy... before we got on to recording, we were talking a little bit about things like executive orders and other compliance and regulatory conditions where you aren't able to purchase products that have been manufactured by, for instance, foreign adversaries. Is this what you're speaking of when you're referencing genealogy of a product?

Ron Dolan:

Absolutely. What I'm referring to is the ability to track the origin of that component or that raw material or mineral. Whether it comes out of the mine or it comes out of a manufacturing process, we can tell you who the manufacturer was, who was on the line at the time of the manufacturing, when it was built and delivered, and what were the elements of that sub-assembly or component that was delivered.

Erin Keating:

That's great. Given that I was reading a little bit of information around this and seeing that, for instance, one occurrence of violating ITAR could result in a $500,000 fine, this seems very, very important to make sure that your software systems and your quality management solutions are up to par in your regulatory compliance. Recently there's been the introduction of the CMMC, the Cybersecurity Maturity Model Certification requirements. How has your solution helped customers meet critical cybersecurity needs?

Ron Dolan:

When you look at the opportunities and the current customers that we have, as well as opportunities that are still in the market for us, we've designed a way to work with our customers and prospects to help them to map the processes to achieve at least a Level 3 CMMC standard. There's about 95 elements that are defined. We have a plan that's been put together to assist our customers to build out their project and then to help them in the execution, and finally, delivering them the end result so that they can go to the audit, have the audit completed and be certified at a Level 3. In addition to that, in our environment, we have the opportunity to provide a hosted solution, which sits on what's called a certified FedRAMP environment.

Erin Keating:

An important aspect of quality compliance is, of course, tracking employee skills. Can you explain how your solution can help manage these qualifications?

Ron Dolan:

Sure. From the point of time of onboarding an individual, you look at the resume and they have certain skills that they've identified that they've reported that they've achieved. Our software gives you the ability to use that as the starting point, record that information, and then look at what are the things that are required for that individual to continue to maintain their certification in that arena, whether it's welding or running a CNC machine or whatever the event might be, people have training and certification that goes along with that. We provide notice as to when those certifications are going to expire. We also provide notice so that they can schedule training. Keeping track of the certifications, it drives on automatic email notification to alert employees as well as to alert the supervisor or the manager of that group so they can make sure that they get them scheduled for that re-certification. In doing that, the benefit of having that kind of tracking is that it gives you the ability to support a higher quality product and meet compliance requirements on the first time.

Erin Keating:

That's fantastic. I mean, given how many things people are managing these days, to have that type of automated response is really superior and wonderful to hear. Many of the prime manufacturers you work with do have huge supply chains, as we talked about. How are you able to help mitigate the risk associated with suppliers’ products?

Ron Dolan:

I think the pillar of that is the accountability and tracking the information that's being provided into the solution. Our accountability gives the ability for the organization to streamline a significant number of their processes, and they can extend it from internal view all the way through an external view. To be able to collaborate in a real-time environment versus an email or a letter, they'd be able to do it sub-second based on our technology, provides a way to further reduce the risk within the supply chain. Specifically, our solution addresses industry requirements such as we talked about earlier around ITAR, the DFARs, managing acquisition regulations for counterfeit parts, ISO audits and certifications. Especially with the change that's coming through with the DCMA with more leaning on the prime contractor to maintain any of the deviations or nonconformances of the sub-tier, our solution is providing significant advantage to help minimize audits by DCMA for the government.

Erin Keating:

Well, I have to be honest, I'm almost overwhelmed at knowing how much work your team needs to do. Not only just to stay on top of all these regulatory compliance measures, but then to be able to have this really robustly put into a software solution, is just fantastic. Before we got on the show here today, we were talking a little bit about some cool emerging technologies, which I think we can go off on, in several different episodes here. For purposes of this episode, why is best in class quality management solutions so important for companies who do manufacture emerging technologies?

Ron Dolan:

I think a couple of elements to that. [inaudible 00:09:05] is what continues to drive defense department, commercial airlines, drone manufacturing, and other things that are in the markets that we serve. I think that being able to use advanced tools like APQP, and using temperature controlled materials and manufacturing, which are resins and carbon fiber, et cetera, to be able to have a tool that you can make sure that you are meeting the compliancy requirements on day one, because you set your manufacturing plan, you set the specifications, you know what barriers are, if you will, is what the limitations are. When you look at what organizations are doing to have a tool that gives them the ability to look at what their risk would be associated with that product, bringing it to market, looking at what the risks are around manufacturing, and then being able to build it out in a way that they know that the data that they're putting in is easily substantiated when they go for a review.

Ron Dolan:

Drones that are being manufactured today, they're in test, but you can bet your bottom dollar that the FAA is not going to allow drones to go one foot off the ground, unless they meet the FAA certification. That's what we're here to help with, is to make sure that the manufacturing that is taking place provides them a way to deliver a new product and innovations to the marketplace at the right price, the right investment, and at the right time.

Erin Keating:

Just to be clear on how I'm interpreting that, this means that even if you are a company that has just started to design a prototype, just started to be thinking when you're even at that stage of thinking about building something and manufacturing something, it's the right time to engage a quality management system like yours, solution like yours, so that from the very get-go, you're making sure that you're not only documenting the genealogy of the product, but that you're able to comply with any regulations that might be coming down the pipe for your particular technology. Is that right?

Ron Dolan:

That's absolutely correct. We have... A lot of our customers have our product that's used in production, but it's also used in their labs. That's where they're developing prototypes. They make the first article, and then they improve that, and then they go to a general manufacturing process as they go into production. We have companies, for example, obviously we can't talk about them in detail, but there's stuff that people are working on that we won't see in the marketplace for 20 years.

Erin Keating:

Wow. That's really great. I would not have thought of that to be honest with you. I think this is something that needs to be thought of at the word go, at the word dream, of a product that you want to bring to market. Well, I'm so glad that we took the cover off on compliance and regulation today. Really, hopefully our customers out there understand better the TIPQA Quality Management Solution and how it can help you manage all of these compliance requirements. We look forward to diving into plenty of other topics, even ones that I'm starting to create for you on my own with all my own questions around this industry. Thank you, Ron, as always, for so informative and articulate and letting us know what the product does.

Ron Dolan:

Well, we appreciate your time and your interest, and I look forward to speaking to you again very shortly.

Erin Keating:

If you enjoyed today's episode, please share this podcast with a colleague. For over 30 years, TIP Technologies has been helping companies define the difference between surviving and thriving. The TIP Technologies team takes a personal approach towards helping its customers achieve their most important business goals to ensure delivery of a quality product that meets stringent standards. Our quality management solutions from quality assurance to shop floor execution, supplier quality collaboration tools, and business information systems, reduce costs and increase productivity. To learn more, check us out at www.tiptech.com. That's www.tiptech.com. Quality awaits.