Full transcript below:
Welcome. This is Ann McGuire with Arena Solutions Product Marketing. Today, we’re going to discuss how 1factory empowers quality control professionals. Next, we’ll talk about how 1factory and Arena, together, simplify quality processes from development through production, especially for companies using complex and distributed manufacturing processes. Nipun Girota, founder and CEO of 1factory, is joining us today. Welcome.
Hi, Ann. Thank you for having me.
Glad to have you. Nipun, I wanted to get started with why you founded 1factory.
Yeah, thanks Ann. That’s a very, very good question. As you can see, on this first slide up here, you can see there’s an image of a part. Any part of product is typically made up of many different features or parameters. You can see on there, there’s some diameters, some radiuses, some flatness, and so on. So a few years ago, I was running a manufacturing plant where we were buying over 100,000 unique parts and each part had anywhere from 10 to 1,000 features that needed to be controlled. What I discovered was that it was very difficult for both me as the product manufacturer and my suppliers who made my parts for me, it was very difficult for both of us to control quality at the feature level. The picky part is that quality control is always at the feature level. Any one of these features that are built incorrectly or not to specification can make the machine that we’re building not operate correctly, or fail early, or cause other types of issues, including safety issues for our customers. So I looked at that problem and I thought maybe there’s a better way to solve this problem and work through this problem. I decided to kind of go off a sketch for what eventually became 1factory.
And yeah. Do you want me to tell you a little bit more about what we do at 1factory?
Yeah. Yeah. I was interested to know some of the challenges that you face with quality control that you solve.
Yeah. Yeah. As I was describing, that we were buying almost 100,000 unique parts. So every part has its own drawing, its own specifications that need to be met. So now you have 100,000 parts and let’s say you have 10 features per part. Well, that’s a million features for which you need to control quality. And if you’re in a, what you’d call a high mix manufacturing environment, in that environment, the product configuration changes frequently, and therefore the parts that you buy are different every day. Now all your suppliers, what that means is they have to build in small batches, they have frequent changeovers, and that makes quality control very, very challenging.
If I were to kind of boil down the problem to a few lines, it’s how do you control quality for hundreds, even thousands of parts with tens to thousands of features per part. How do you do this within your own factory? How do you do this across the extended supply chain? So, we had at the time nearly 600 Tier 1 suppliers that we have to work with and every part that we bought went through at least one tier, in most cases, they actually went through two tiers of supplier before they got to us. So we had to figure out how to do this, not just within our factory, but across, also, an extended supply chain.
You won’t believe, but the standard around the world is still Excel and paper. Data is being collected either on paper or in Excel, because on paper it’s transcribed to Excel. And as a buyer, if you want the data, your suppliers are sending it to you via email. So the [inaudible] is very reactive. If you have a problem, you have to call up your supplier. The data is not available on demand. Then they have to go look for the data, send it to you. So there’s a lot of time lost in just trying to find the right data to then solve the problem.
Yeah. And the consequences are very expensive. So there’s, of course, what I noticed in my factory was that we were losing productivity. We were wasting time and I’d say, in some cases, as high as 50% of labor time was lost in resolving quality control problems. A part that comes in, but it doesn’t fit an assembly. Or a part that actually fits, but then the machine gets to final tests and fails in final tests and now you have to troubleshoot, figure out where the defect is. In some cases, have to disassemble the machine, get a replacement part, reassemble, retest. That’s how you lose productivity. Actually, you end up wasting a lot of capacity, which is impossible to recover.
Then, of course, there’s the cost of defects. Bad quality has many obvious costs, including scrap, rework, but also there’s the impact to your customer of those defects. Machine might not operate as well as it should, so your customers see performance. Or it may not be as reliable and then it fails sooner than it should. Those kinds of things then drive up your warranty costs. So it’s all of these things that kind of start off deep down in your supply chain, but end up with an impact all the way to your customer.
What I thought I’d do is walk you through a little bit more about the problem and why it is such a hard problem to solve. If you look at the modern supply chain, there’s increasing complexity in the supply chain. I think up until the 1980s, maybe, some people making things mostly in-house. Over time, a lot of manufacturing started getting outsourced, in some cases for cost reasons, but in many cases for just technical capability reasons. So, you started to end up with an extended supply chain. So, to bring any product to market, you need a supply chain and that supply chain is now increasingly complex. You have multiple tiers of suppliers and now you have a globally distributed supply chain. You also have increasing product and process complexity. On the product complexity side, customers are more demanding, they want more features, which results in more parts, more variance, and so on. Everybody is demanding more and that drives a lot of complexity. Finally, there is one additional level of complexity, which is regulatory and customer compliance requirements. If I’m in a regulated industry like medical devices, I have a lot of compliance requirements that I have to meet. Similarly, if I worked with customers in the automotive industry or the semiconductor industry, I have customer compliance requirements to meet also.
Like I described, it’s a two-sided problem. I can’t get to market successfully without my suppliers. And what I found when I was starting up 1factory was that it’s actually a two-sided problem in the sense that if the suppliers cannot do quality control effectively and efficiency, then the buyer will not be successful. So, the first thing we need to do is help the suppliers, and if the suppliers can do things efficiently and effectively, and if you can layer onto that visibility so the buyer can see the suppliers’ quality control processes and data, then we can solve this problem.
If we go a little bit deeper into what the suppliers’ problems are, it’s kind of what I discovered in my last job, was my suppliers were struggling with data. They were struggling with capturing data, managing the data, with the analysis of the data, and the reporting of the data. All of these things were being done in inefficient ways and quality control, like I described before, has been in paper and spreadsheet based.
On the buyer side, as the buyer in my last role, my challenges were: How do I communicate the requirements to my supplier? And how do I make sure I have the right controls? How do I make sure that those controls are actually being followed, data is actually being collected and analyzed? And how do I provide them with the analytics so they can start solving these problems? Or how can we work together to solve these problems? So, if we can create this shared understanding of and shared visibility into the quality control data, then we are more likely to solve problems earlier in the product development lifecycle or in the manufacturing process.
Like I described, in 1factory what we do is we help both the supplier and the buyer. In other words, we help you do quality control both within your factory and across your supply chain. And if you use 1factory inside your factory, we help you simplify and speed up your quality control tasks and if you’re a buyer buying parts from across the supply chain, we give you the real-time visibility into your suppliers’ data. And again, the goal is to help you discover these problems early in either the product development lifecycle or in the manufacturing process, and also allow you to collaboratively solve problems. Our overriding goal, our mission, is that we want to help you ensure quality at source, which may be deep down within your supply chain or somewhere within your own factory.
Ann, I’m going to give it back to you, but before I do that, let me actually talk a little bit about how I view the Arena to 1factory integration. We partnered with Arena because Arena, as you know, provides product lifecycle management tools, and there’s a very important linkage between the product lifecycle management tool and the quality control software. When a part’s design has changed and the engineering change order goes through a PLM system, that change order has some associated tasks with it. One of those tasks typically is to update the quality control documentation. With 1factory, your inspection documentation and your quality control plans will always be in sync with the Arena engineering change orders. If you have a change order on Arena, it’s going to sync up really well with the quality control plan in 1factory.
As the change order will drive a change to the plan in 1factory, and similarly, if you have your quality nonconformance processes or your corrective action processes built up in Arena, 1factory will populate those processes with data from inspections, so you can continue to run your nonconformance process and your corrective action process through Arena. Our goal is to link the product lifecycle management solutions like Arena with 1factory’s quality control solution, so that your product lifecycle data is always in sync with your quality control data and it’s tied back in real time.
With that, I’m going to hand it back to you, Ann, to give an overview of Arena, please.
Let me introduce Arena. Since inventing Cloud PLM, Arena’s offering has grown to a product realization platform that over 900 high tech and medical device companies use around the world. What Arena does is it eliminates infrastructure barriers for sharing product information and it also manages changes to that information. This is the most comprehensive approach for teams to introduce new products to market with fewer errors, through better visibility and enhanced collaboration, especially collaboration with supply chain partners and external design partners. This leads to better business decisions as you design and release new products. The diagram you see here is how we fit into your organization. Arena manages the complete product record, which includes all the information you need to build, test, and improve your product. And today, the elements we’re going to really talk about are the engineering change processes and the quality processes like 8D, CAPA, and nonconformance.
We work with other solutions in your organization to speed accurate information throughout the development process. From the left, we integrate with the tools used to design and describe your product. On the right, we integrate with the products that use the information that we manage. So, for instance, the ERP, when we release a new design, the bill of material, item master, all gets electronically uploaded to the ERP so they can plan and purchase with the latest designs.
In the upper right-hand corner is 1factory, where you see our integration points are the inspection plans and quality control processes, which are managed in Arena. When I say managed in Arena, as a design revises, these documents have to revise too. When the product changes, the inspection plan, for instance, has to change. So when we have a new inspection plan, that is used by 1factory. Going in the other direction, when 1factory detects a quality issue on the factory floor, that can be escalated to Arena where it can be reviewed by quality assurance and engineering, if necessary, and all that information becomes part of the product record.
This slide is a quick show of why so many companies use Arena. This is what happens if you don’t have Arena. The product record is distributed over many disconnected silos and different roles in the organization have access to only some of that information and it’s really hard to pull together a complete picture of the product record.
Overall, the impact of the disconnected silos: it impacts the people; it impacts the data itself; it causes slower and more error prone processes, which would all result in lower than optimal products. Maybe the quality might be impacted, or maybe you don’t get all the features that you want to market on time. All these problems impact the business with increased costs, reduced profits. If one of those poor-quality products makes it to market you’ll have customer issues, which will eventually lead to lost market share.
This slide lists the top EMS and component distributors that are using Arena around the world to collaborate with their customers and also their supply chain partners. There are other suppliers and EMS providers using Arena around the world, but this is just to focus on the top ones. So, let’s take a look at 1factory and then the integration with Arena and as we do that, you’ll see how products together simplify quality processes. Okay. Nipun?
Yes. Thanks, Ann. Thank you. Okay. Imagine that a quality control person has five or six things that they have to do on a daily or weekly basis in their jobs. Their work typically begins with what’s called quality planning and in quality planning they define what is it that they are going to measure, so in this case it could be a counterbore, a diameter or depth of flatness callout, a torque, or some sort of force measurement. So, what they’re going to measure, the specifications for that [inaudible] or parameter they’re going to measure, then how they’re going to measure it. What’s the inspection method, what are the work instructions? What are the rules? What, for example, are the sampling rules of inspection frequency they will follow? All of that defines what’s called the quality control plan, and on the screen here you can see that in 1factory we begin our work also with the quality control plan.
With the quality control plan, you can start by defining the controls and, also, you can share those controls with or share that plan with your suppliers. Or there are suppliers that we are going to plan, they can share their plan with you. That way you always have visibility into how your parts are being made, how they’re being tested, and so that there’s no dispute after the fact.
To get to that quality control plan historically has been kind of tedious, and one of the things we’ve done is we’ve helped our customers create these quality control plans in a number of ways. One of the ways is up here on the screen, which is we help by reading the drawing and then you can point and click the dimensions you want to pull into your plan. But if, let’s say, your plan was not created from a drawing, it was created from sort of Word or Excel document, we could import the documents also to get you started into a quality control plan.
Once the quality control person has created that quality control plan, whether they come to the quality control plan from a drawing or from an Excel spreadsheet or Word document or any other source, typically the next step in terms of product development process is what’s called a first article or first batch. So 1factory supports the creation of this first article inspection package and that package includes all your dimensional measurements, all your raw material certificates, any outside processing certificates. So maybe it’s a heat treatment, an anodization. And also, it includes the ballooned drawing if that’s needed.
The output package that 1factory generates can be shared from within 1factory with the customers. The way 1factory is built, is it’s built in a collaborative manner, so you as the buyer get your account, your suppliers get their accounts. But any work they do, they can make visible to you by just clicking on “share” so they can share with you the quality control plans and they can also, in this case, share with you the first article inspection reports.
Now, if your supplier does not have 1factory, does not use 1factory, or your customer doesn’t use 1factory, you can always download that first article package and then email them the zip package.
The next thing we do … you can imagine that once the quality control person has finished up the current development tasks, which includes the quality planning, the first article, and now we’re into the ongoing inspection process. We want to do some incoming inspections, some in-process inspections, and some finished goods inspections. What’s common in all of these is we have to collect data. The data may come from a digital gauge, may just be keyed in, or may be read from some sort of automated device like CMM. We support all of these various types of data entry. If I go back to what made the suppliers’ life difficult, data management was probably the most difficult thing. We work really hard to simplify that by making sure you can easily and systematically collect the data and manage the data and always checking against the quality control plan to make sure that it’s in spec in real time.
Here’s an example of data collection. The data coming from any source, whether it’s coming directly from a gauge or it’s keyed in from a barcode reader or from a CMM. You’ve entered it into the screen here and in real time we’re giving you a run chart and we’re giving you histograms and some statistics. So, the factory technician has simple, easy-to-interpret tools with which he can ensure that what he’s making, the process he’s monitoring, is in control and products are free of defects.
Next what we do is … first, like I said, we equip the technician with useful information for their job and then we roll it up. Once I’m done with one feature … this is a view of all features for that part or for that batch of parts. Now I get my process capability calculation, my Cp, CPPM, PcPCm, with one important addition, and that is we’re kind of color coded to highlight risk. So if Cpk or Ppk are less than one, we flag it as red or high risk of defect. If it’s between 1.0 and 1.33, we flag it as yellow or medium risk of defect. If it’s greater than 1.33, we flag it as green or low risk of defect. Now very quickly, without having to look through a thousand features, without having to look through data of a thousand features, I can very easily identify which features I’m having trouble with.
This of course, one, helps me prevent defects, but, also, in many industries where they’re sensitive to variation between parts—so think semiconductor equipment industry or even the automotive industry—their part-to-part variability impacts the functioning of the product. This provides you the data so you can focus in on the ones where you need to reduce the variation.
Once you’ve identified the high-risk features, you can solve those problems quicker. But now imagine for a minute that you’re the factory manager, you’re shipping out tens of hundreds of batches per day of different things. How do you as a factory manager know where to look? So, what we do is we roll up that feature-level defect risk and do a batch-level defect risk. We point out for you, or highlight for you, which batches need your attention. And then you can drill back down to the feature-level risk and into that run chart and histogram to see where the problems are. From this screen chart you can see that the first 10 don’t need your attention. There are two that need your attention. The next three, again, don’t need your attention. This makes the factory manager’s job very easy. Or if you’re a supply quality engineer receiving all the data from a number of suppliers, you can very quickly identify which batches that are coming in need your attention.
Then we roll it up one level higher, of course, at the factory level, but then you also need to do this across suppliers. So here’s an example. This is a dashboard of suppliers: Acme, Baker, Chatsworth, and so on. For each supplier, we give you kind of a pie chart that shows you what fraction of the inspection lots are lowest of detect, medium risk and high risk of defect. As the supply quality engineer, we can now work with the supplier to resolve the ones that are medium or high risk of defect.
As part of our product, we also help with traceability. What I mean by that is, let’s say you’ve made a batch of products and you want to know which technician worked on that batch of products or which tools were used, which machines were used, which gauges were used. 1factory records all of that information. Here’s an example: We’ve recorded not just the batch number or the lot number in the top left-hand corner, but you’ve also recorded serial numbers. And similarly, we have recorded against each measurement, the data ID and the operator ID, and the time of measurement. If you have a problem in the future, and you want to understand where the problem originated, and let’s say you narrow it down to a particular operator or a particular gauge, this information will help you bracket the problem. You can define very clearly which batches could be impacted and this will help you with things like managing recalls and minimizing the scope of recalls.
Now, we also have in the 1factory system, once you’re done with your inspections and reporting, we also have nonconformance management. We’ve built in processes, CAPA processes, and SCAR processes. As you can see on here is an example of a CAPA process in the 8D format, team member, assignment to problem definition, containment planning, root-cause analysis, and so on. But what we also do, and this is where 1factory and Arena solutions play very well together, is instead of managing this process separately in 1factory, we can create the CAPA directly from an inspection, but created in the Arena system. So it can follow your standard, nonconformance, or CAPA process.
I’ll hand it back to Ann to walk you through how the Arena solution works.
Sure. This would be the view for the Arena user, which would typically be quality assurance, engineering people there. What we have here is this is a view of the product record. We have a part number, a description. This is a shippable product. Also, the indented bill of materials with all the subassemblies and components used to make the product. It’s things that you’d expect to see on the bill of material, so there’s the item, the part number, the description, what lifecycle status it’s at, the quantity, of course. But there’s a few other icons here on our bill of material, including working mods. That means there’s a proposed change against that part. “Where used” shows wherever other places that part’s used. But this is the most important for today, which is it shows the open quality processes against, in this case, the packaging subassembly. Right now, we have two quality processes against the packaging. They noticed that the unit was arriving damaged, so we have 8D process launched in here. Also, there’s a corrective action on the LCD screen cracking when it was shipped.
Also here in Arena, you can see we have a NCMR that was created by 1factory when they were measuring on the floor and it went out of spec. This NCMR has its own workflow and right now we’re at the point where we’re filling out the description. It will get linked with the part itself and become part of the product record.
This is the inspection where it went out of spec, so it’s red here to indicate. Then the operator pressed on the new NCMR button to successfully create one in Arena.
This quality assurance now decided to put together a corrective action on this issue and they pull all the information together in one view. They took a picture of the problem part, they listed the parts that were involved with the problem, and they also include that NCMR that was automatically generated from 1factory. In this case, too, there’s other systems that can update Arena, including in this case, there was probably a product that made it out to the field and the customer called in with a complaint and that customer support person wrote up a case that we can link to, again, all from this one view. See how this corrective action process, by the way, has their own workflow.
This is the sign-off page of the corrective action. These are the actions that need to be done, including an action by a supplier. And these are the signatures that they collected. We have some employees who signed off, but also, and this is real typical, is we have our suppliers also involved. Not only they have the action, but they can electronically sign off that they did do the action.
That is a summary of our integration. It does improve all the quality processes. It simplifies the quality processes from every lifecycle phase of a product. We think this is a very powerful solution.
Nipun, you want to add anything?
Yeah. I think this is a great slide to end on, in the sense that if I look at the slide, between Arena and 1factory, we’re covering the entire product lifecycle process, as you said, from engineering change order release through the actual creation of the inspection plan, the collection of the inspection data. In the event you have some nonconformances or some resulting corrective actions, that entire process can be managed in these two systems, and, more importantly, the data can be tied back so that the engineers that are designing the new parts actually now have this ability to order nonconformances, CAPAs, and SCARs. So, it helps not only speed up the process, but also inform the engineers working on the new design. So this is building a very good or very tight link between the quality and the manufacturing processes.
Right. I should say, not only the engineer, but the compliance officers. So if you’re a medical device company and you have to maintain a device master record, this is all the information that the FDA inspectors would expect to find in the device master record. Yeah. So it’s all in one place. Useful to the company but also useful to the regulating agencies.
Yeah. I think that’s very, very important. I think from my observation about 40% of the time in the QC team is spent on compliance, just creating reports or making sure data can be found or retrieved at the right time, or preparing for orders and so on. So, this integration really simplifies all of the data management associated with compliance. I think that’s a very good point.
Yeah. Good. All right. Well, thank you so much. Thank you for listening to our audience. And yeah, I think we have one more slide here with some information on how to contact either company—if you have any questions that you want to see some more detail about the offerings. So, thank you very much.