At a Glance:
- Meets requirements for preventive controls and food plan documentation.
- Securely manages recipes and ingredients.
- Tracks complete genealogies and traceability.
- Enable real-time recall management.
- Provides easy access to documentation needed for FSMA compliance, mock recalls and third-party audits.
Good afternoon, everyone, or good morning, depending on where you’re joining us from. Welcome to today’s demo highlighting how Plex Online Cloud ERP helps to ease industry mandates and FSMA compliance. My name is Jon Cowan, and I’m the Senior Account Manager for Food Solutions at Plex Systems. Plex Systems provides demos like this to show food companies how Cloud ERP can meet your business needs. Today’s demo follows two webinars that have focused on how to establish and strengthen food plans and get ready for compliance with the Food Safety Modernization Act. Those are hosted by Dr. David Acheson and Tom Nessen and myself.
While the specific impacts of FSMA, as we’ve discussed, have not yet been announced, there are some things that companies can do now [to establish a] foundation for what the Act will likely require. Today’s great presenters are, again, Tom Nessen and myself. And with that, I’ll get things started. Just to briefly recap what we discussed on the last webinar, and Dr. Acheson went through this in some great detail, but it was putting together a food safety plan and what’s involved with creating a food safety plan. All of you on today’s call, I’m assuming anyway, are likely to have a HAACP plan. And the first thing that Dr. Acheson talked about that that’s HAACP plans are great and required, but they’re not enough.
So, it starts with a HAACP plan for hazard analysis. Then we moved to a series of things that he suggested that we do in terms of creating teams, brainstorming what hazards need to be evaluated, combining this list of hazards and scoring them by severity, and then assigning preventive controls to each one. These need to be validated and implemented and monitored, and corrective actions need to be put in place in case something does go awry. But it’s not good enough just to monitor and do the corrective actions, but periodically, you have to verify, figure control plans are working. You have to consistently go back and reanalyze anytime you introduce a new product, a new ingredient, a new process. You need to reanalyze your food safety plan and ensure that it is working properly.
The key that Dr. Acheson really talked about was documentation, and that’s something that you need to do throughout all these different steps is document, document, document. It’s really truly all about record-keeping. On the next slide, Dr. Acheson really dove into record-keeping requirements and what you need to do in order to meet the mandates that the FDA is like going to require.
The recordkeeping really needs to happen in conjunction with the activity that’s going on, whether it’s some sort of transaction, a quality measurement, something of the like, then you need to make sure that you’re recording that information when it’s happening. You need to record the actual values and the observations when happening as well. You can do this on paper, that’s just fine. The FDA doesn’t mandates that you do something in an electronic system versus doing it on paper. And quite a lot of organizations out there still do things on paper, but when you do things electronically it is subject to 21 CFR Part 11, say need to make sure that your electronic systems can manage that e-signature aspect to the record-keeping requirements. You got to maintain these records were a couple of years, and that you always must have at least six months worth of these records available upon request when the FDA comes knocking at the door.
So, recordkeeping is hugely, hugely important. Dr. Acheson also talked about how technology can help, and that’s really the intent of today’s slide. We start doing everything on paper–and I see this all the time, I’m in and out of food plants weekly, you know, a lot of these records are being kept on paper. It becomes fairly cumbersome to go back and research certain data. For instance, if there were a recall, a mock recall, somebody inquiring about something specific, where certain raw material has gone, or whose touched the certain finished product, all those kinds of things that the FDA’s going to want you to track. And it’s not just the FDA, we look at things, like, TFSI compliance as well, so whether you’re BRC, SQF or any of those.
And this paper-based record-keeping can really just be over-burdensome, where you look like the picture on the right here, where you’re just buried in a mound of paper, and you’re really looking for a way to help. And we believe that Plex Online, that having a unified system really built in a unified system that covers all aspects of the business, recording all these transactions that are going on in the business. Where material came from, where finished product went to, who touched it, right? Who took the quality measurement, what was the quality measurement? All those kinds of things can be recorded and be recorded in a real-time fashion inside of a single system.
Plex happens to do all that via the cloud, we’ll talk about that more in a minute. But we really feel like this is how companies can really help ease these mandates and really become operationally efficient as well, by implementing a system, like a Plex Online, the has a core food safety management system and full ERP, all-in-one. And that’s the intent of today’s webinar. And Tom Nessen’s now going to go into more specifics about exactly how Plex can help you manage that. Tom?
Great, thank you, Jon, appreciate the introduction to the demonstration today. Like Jon talked about, we’re discussing, today, how a food safety management system can address a lot of the concerns everyone has in relation to food safety compliance and adhering to the new mandates that are rolling out. So today we’re going to cover that topic in context of a system that can help you manage that environment. And the title of today’s demo is The Four Elements of a Food Safety Management System. So what does that mean? And from a larger perspective, what is the context of the food safety environments that we all have to work within.
The numbers I have on the screen really illustrates the complexity that most food processors and food manufacturers find themselves in today. The fact is that a lot of processed foods, most processed foods, can contain upwards of 50 ingredients. The product itself is very complicated. Once you start incorporating the supply chain aspects into this, you can see that those ingredients, those raw materials, use subcontractors for instance, or co-packers, or co-manufacturers, that product may exchange hands through many, many different business entities. Within your four walls, you may have hundreds of unique suppliers of ingredients.
And in today’s extended supply chain with multiple suppliers it makes it increasingly complex to manage all aspects of your business on paper. The result here is that, and the fact of the matter is, it only takes one incident through your supply chain to harm your customer and destroy brand. So that’s why these things are very important and as complexity increases, forcing more and more people addressing this with electronic record-keeping within an ERP system like Plex. So the question becomes then, how do we do it? There’s a lot of moving pieces and parts, there’s a lot of compliance requirements, you still have to run your business, your business is hopefully growing as the economy recovers.
So how do you deal with all of those issues simultaneously? And there’s really two sides to the coin. One side is how legacy systems or old ERP systems used to address this problem, and that typically started buying finding accounting and finance package that acted as kind of the core platform of your back-office systems. And then, inevitably, what most companies found out years ago was you have to start bolting on other solutions to make this all work. And the bolt-ons usually started at quality–if you’re fortunate to do electronic HAACP that might be an aspect of it. Once quality is implemented then another system might have to come into play to do statistical process control, understanding your control charts and certain process capabilities.
The next common area that people bolted on systems came in with plant maintenance, those are typically separate systems. And then if you want to do some advanced analysis of your plant floor uptime and downtime, and do things, like Overall Equipment Effectiveness, or OEE, that was a separate system, that was a [shop floor], or a plant floor system where people can record production near the work center where they’re operating. Manufacturing operations, again, that’s another area where it typically resulted in a bolt-on system. HR systems have become important recently, but a lot of times companies have to address this separately as well.
So if you want things like a skills matrix or some sort of training database, that’s another system that lives outside of your ERP and has little interaction with the core business. Document control and traceability have been add-ons to most ERP systems as well as compliance management. The thing that stitches them all together, usually, something called Custom Application Logic, which is, basically, the band-aid that you have to put on between these systems to make them try to communicate with one another through different databases, and through different interface structures, and different application layers.
The end result in most places that Jon and I visit, like he said, a weekly basis, is that people who implemented this strategy are suffering with fragmented data that’s not easily accessible and forces those people into writing further workarounds, like your Microsoft Access or using Excel. And it creates a real bottleneck to the business activity and business growth.
So we want to do with Plex is, obviously, limit the pain point that people are suffering from this type of an implementation. And the pain points that we see are limited visibility, costly to maintain, which restricts the growth of the business, prevents collaboration with not only folks within your business, but also collaboration with your supply chain, your customers, and it’s very static. We all know that businesses are growing and changing, responding to different needs, whether it be the federal government or your customers, and this model is very stagnant and static and prevents that flexibility. So the alternative we’re providing, the other side of that coin, is Plex Online, that’s what I’ll be demonstrating today.
Plex Online is a modern system, it’s based in the cloud, it’s a single database of all the information that we’ve just talked about, is a single application, [bed of] source code that never needs to be upgraded. Now, in the world of business systems, and enterprise system, those are revolutionary concepts. There’s things that we see every day consumer applications, like Jon highlighted, but they’re rarely within the world enterprise software.
And Plex is a leader in providing a different approach to ERP, and we’ll be talking about the details of that today as I break down this diagram that you see here. So what is Plex Online? Well, for our discussion today, Plex Online centers on a few key features and functions. I’ve divide them up into three key categories, and then there’s a box here we’ll talk about in detail.
And the three key categories of today’s discussion revolver around Manufacturing Operations Management, and that’s simply the concept of manufacturing execution, but with an eye on optimization, using the data to streamline and drive efficiencies within the plant floor. The next area we’re going to focus on today is Quality, Logistical Process Control, and things like electronic HAACP. How do we take data is coming from your QC department, make it real-time, and have your business be able to respond immediately if things are moving out of control?
And then another key, key part of this is once a system like Plex is implemented them is the ability to do instant traceability and recall fast and efficient. So if there’s an issue with your product, with a system like Plex, you can understand exactly what customers it was sent to immediately. And likewise, if there’s some sort of a public health crisis and the FDA comes knocking at your door, you’ll have the ability to do the much harder part of that, which is the instant trace back through your [agree-in], through your supply chain, to understand who might be the cause from supply chain of the issue that’s occurring.
Now the last piece here is a very, very important one, but I grade it out because it really doesn’t focus on food safety which is what we’re talking today. Everything we deliver at Plex is delivered in context of the manufacturing ERP. And the ERP is really covers every aspect of what we’re talking today. So whether it’s accounts payable, accounts receivable, supplier quality, human resources, those fall into the category of the larger ERP system. And we have a couple of examples that will show today of that, but today’s focus mainly food safety, quality, and production. Let’s talk a little bit about the first box, which is manufacturing operations management. What does that mean in detail?
Well, to most folks and to the Plex system, that means efficient plants for data collection through a very easy to use human machine interface or HMI. The ability to go down through the SCADA server, directly to the PLC, capture uptime/downtime information, understand that the root cause of issues happening with production lines. Those are all the types of things that Plex Online is able to collect in our database and help you analyze, and become better from a manufacturing standpoint.
So specifically, let’s take a look at Manufacturing Operations Management through the eyes of a Plex operator. So what you’re looking at here is one of our customers Cuisine Solutions, they have an operator, to have these touch screens actually working in every key functional area of their business. Where production is being recorded, quality is being recorded, inventories being moved, we’ll find these touch screens.
It allows the operator to quickly and easily provide information directly to the system so people can take effective action immediately if there needs to be an action taken. So we take a snapshot of what that person’s looking at. This is the actual control panel she might be seeing. So the control panel has a lot of key features and functions, and I’ll go around them real quick.
The control panel allows the operator to view the production schedule, to print barcode labels if there’s work in process, or an immediate food product that needs to be tracked. You can also record quality and if it’s a HAACP, I’m sorry, a Critical Control Point, then we can record that as well to the control panel. A plant-wide bulletin. So, are there issues with food quality? Are there issues with changes in formulations where the operator needs to be aware that there may be something special they need to look at? Or simply is there a new time clock at the east entrance of the building? Those are the types of things that we can alert the operator to through the control panel.
So, forget the whiteboard, the bulletin board, and all the paper that used to occupy most production work centers, it’s now able to be delivered virtually through the control panel. Operators who use Plex Online can also launch maintenance work orders, do gauged calibration and do gauge control. They can look at quality history if it’s been occurring at the work center. There’s a key point of access for document control through the control panel. So, we know that there’s many instructions around GMPs, around preventative controls, around corrective actions–you want that information to be in the hands of the operators right where they’re performing their work.
And the document control button on the control panel allows the operator to bring up any type of file, whether it’s a word document, a PDF, or potentially, even a movie, showing how you do a clean and place on a piece of equipment. That’s important for the operator to do their job properly, and we provide that through the control panel. Another important part of this is leveraging the Plex Human Resources system to provide verification the right employee, with the right training, is actually recording production within your plans. We don’t want people who have expired certifications, or an expired training records, to be able to log into a control panel and record quality or any kind of production, because that would be a violation.
So our HR system is integral in making sure the right people are doing the right work within your operation. So let’s actually go over to Plex Online now take a look at an actual control panel and we’ll actually click on some of the touch screen areas to show you how it works.
So I’m in Plex Online right now at the main menu, I have a series of shortcuts on my cover menu that I can quickly navigate to different key features of the system. One of the things I’m going to do is navigate over to the control panel. Now that I’m at the control panel, I have some really timely information about what’s occurring at Mixer 01. First of all, I’m working on job number 379, my work center status is currently in production, it’s okay.
I have a few work center bulletins that have been posted, mostly about maintenance that’s occurred at this work center–somebody did something that we need to pay attention if there’s further issues. And then there’s a quality bulletin here about problems with the consistency of the mixture–so, there’s been a formula change and I need to start paying attention to that.
Over on the right, or left-hand part of the screen here, you can see that I’m currently logged in as an operator, and the two yellow blocks on the middle of my control panel tell me that I’m late in performing my two in-process checks that I need to perform on my products. So, in-process every 15 minutes, I need to do a certain check, and every one hour I have another in-process check. So I’ll come back to those in just a second, but what I want to do, is actually take and put my work center into a downtime status.
So let’s assume that we have some sort of a problem, it’s a motor problem. What this does now is this turns my work center effectively off, it stops me from being able to record production. And from an efficiency standpoint, it starts the stopwatch on recording the actual downtime that’s occurring from this motor problem. So some key features that are occurring, so if I come back in here and try to turn my control panel back on and say that the mode problem has been fixed, the system’s going to alerts me to tell me that, “Hey, you haven’t completed your startup check sheet that needs to be completed before you can go back into production.” So with that warning, I’m going to go back to the control panel and I’m going to record my quality checks. So my first one is I have to check the color and the packaging quality, I’m going to go ahead and pass those.
And you’ll see here a key feature of Plex Online is the ability to not only take quality measurements, but also to digitally sign the documents and store it in our document control systems. So you don’t have to print the paperwork, put in a filing cabinet, and like Jon’s slide showed earlier, end up drowning in a mound of paperwork. So just by clicking the Sign button, I can come in here and say it’s accepted, provide a note, and then provide a separate electronic signature password that allows me to stamp this document and store it away.
Now, if you’re familiar with 21 CFR Part 11, Plex is compliant with that standard in the method that we’ve implemented to sign electronic documents. So let’s close this down and let’s go sign–or take good quality measurements for the second one.
This is a pH measurement, so check the pH of the mix, and we need to be between eight and six. Now I can record seven, or, as is sometimes common, I can fat-finger a larger number. And what’s going to happen? Well, first thing is, Plex it’s going to recognize that that value is out of spec and it’s going to give me a chance to change the value. So by clicking ‘Okay’, and coming back in here and taking the right reading, I now can move forward with my quality operation.
Now the nice part about this is that if somebody overrides that message, we can send an alert to the quality manager so they can proactively go out to the line in just make sure everything’s going okay with the production of this job. So, I’m going to go ahead and add this check sheet. I’m going to close down that electronic signature box, and then both boxes of green which tells me all the quality measurements have been taken for Job 379 before we can start things back up.
So now I’m going to go back to production, and everything is running again, so we’re in good shape. So that’s a quick example of the power of the control panel, the ability for us to take [inaudible 00:22:51] information as it’s happening, and to represent the real-time conditions that are on your plant floor and allow your managers to take action before things get too far out of control. So that’s a good example of the control panel.
Let’s go back to the presentation, and I want to talk about a couple other things as they relate to Manufacturing Operations Management. And the first thing is, that at Plex, we believe that the system should be used as most effectively as possible by the people who are down on the floor.
And sometimes that means making things available through mobile devices, whether it’s an iPad, or a symbol device, like you’re saying here, or some sort of a truck mounted RF device–we enable that natively through Plex, there is no third-party bolt-on to provide this. And what you’re looking at on your screen is an actual screen that’s delivered on the mobile device, so that comes with Plex.
The other thing I want to point out here is the concept of OEE. If you’re measuring that today, you may be doing it through a spreadsheet or some sort of a system outside of your core manufacturing system or planning system. This gives you an example of how we’re leveraging that information that’s coming out of the machine, potentially, from the PLC, and we’re making sense of it for the supervisors in the operation. So this is showing Mixer 03 and the current OEE rating for a certain time period within the plant. So I want to make sure that was out there in front of you guys as well.
So let’s move forward and talk a little bit about quality how quality relates to the larger ERP [system.] So for folks that use Plex Online, embedded document control is one of the hallmarks of our system, the ability to manage your compliance program within our system, and use our framework for compliance is important. The ability to take your HAACP system out of your three-ring binder and put it into an electronic system is something that our customer finds a tremendous benefit too. And also, working on corrective actions, preventative actions, using SPC charting, to electronic signature–those are the key things that are happening in our quality system.
And the key part of it is that Plex is built with quality and quality data collection in mind, so you’ll find it, really, in all aspects of [our systems.] So I wanted to point out a couple key things that relate to quality, and as we’ve talked about earlier in the presentation, but I’m going to highlight it right now, which is the idea that document control should be seamlessly part of your enterprise system.
And this little icon on the screen, the yellow piece of paper, or torn off quarter of a piece of paper with paperclip, indicates to Plex Online users that there is a document attached to the record in the database. It’s a very, very important thing, and it’s a very important concept in our system. The other icon to the right is what we call the green book, and the green book is instrumental in providing a comprehensive audit trail for all master data records within [the system.]
So, gone are the days where somebody makes a change to some key configuration, everyone’s scratching their head where the change was made, and who made it, and why they made it–we keep track of that. So if you have to roll something back because someone make a change that they weren’t supposed to, then we can easily see who made the change, when they made it, and assist you in a rollback procedure. So, audit trails are very, very important.
So let’s go back over to the system, I’m going to pull up the Compliance Module because the Compliance Module is a great place to see document control in action. Within my demo system I’ve created a framework for three different compliance schemes that are used for, in this case, FSSC 22000, and SQF 2000 are both approved standards for GFSI, for instance.
And then we obviously have the FDA Food Safety Plan. If I click on the SQF 2000 plan, you’ll see that we’ve got a partial recording here of the compliance manual for SQF 2000. Now, at each of these levels, we’ve recorded the actual text of the standard. We’re showing, here, how we’re supporting that part of the standard through Plex functions. The paperclip with the yellow piece of paper indicates I have potentially supporting evidence documents to how we perform this procedure in the plant. And then I have a signoff, and last, review status which indicates to me when we last reviewed it, are we conforming, and when is the next signoff [date.] So I’m going to do now is just pick apart a couple of these and show you how they work.
So if I click on to 110.8, that would take me down to a section of the document where he actually records the text. We record how it’s being fulfilled, who is the champion, we can color-code it if need be. And then we have all the information here about how we audit this, what kind of checklist supports the audit procedures, who requires signoff, who requires action, and all of that is stored under Requirement 110.8.
Likewise, if I go over a couple columns over here, I can click on this hyperlink which will show me the chosen modules within Plex that are currently supporting section 110.8. So, for instance, to support the production in process controls, we use the check sheet, we use control plans, and we use the electronic HAACP system. If I want to go quickly to the control plan and show my auditor that we have control plans in place, then I can immediately see all the control plans from a quality standpoint, for every item within the system.
And if I want to drill down a little further and take a look at the specific control plan itself and how it’s applied, and the type of check sheet that the operator’s going to see, this is the information that’s easily accessible within Plex within about four clicks. And I’m going to navigate back up the chain and go back through the control plan and back to my evidence that supports section 110.8. All this is managed from a single location within the ERP system. As I move over to the right, here, you’ll see this is our Document Control System, there’s also a link for the entire SQF 2000 Level 3 Compliance System. If I click on the link, you’ll see I have a PDF that’s been loaded, 221 CFR Part 820, I have the ability to check this out and check it in.
I click the little pencil here, you’ll see the document will open, and here’s a copy of the document. And I have the ability, now, to edit this document, and then when I’m finished, go ahead and check it in. Now while I’m checking this out, everyone else who tries to view or modify the document is obviously going to be alerted that this has been checked out and it’s been edited. So, a great document control, functions right within the ERP system. If I click on the details tab for document control, you can see the level of control that Plex allows our users to take over either documents or groups of documents. So you can assign an owner, and you can tell the system whether your suppliers can have access to this document for supplier quality.
You can set up version control, you can track the versions, and you can set up annual review process through the workflow–so very important features. So what I want to do now is show you an example of how that to green book is applied in the system, so I’m going to go over to the item list, I’m going to do a quick search for the product that you are using today, and I’m going to bring up this product.
And one of the key parts of any system is establishing a process and a formulation for every product. So, let me go into the formulation for a second. This is a basic formulation that’s been developed for this product, it has a minor ingredients, it has major ingredients. In this case, a bottle, a cap, and a label, and a corrugated box, which all come together to make one pallet of this product off the end of the production line.
If I go into the quantity field here, you’ll notice that I have the green book at the top of the Formulation page. So any change that’s being made to a formulation is being tracked through this audit trail. So if I click on the green book, you’ll see all the changes that have been made since this product was created back January 16th, 2013. So the record was added, and then most recently on February 13th, we added a [position] to it here that says you have to make [inaudible 31:48].
So just a great way to quickly and easily see the entire change history, in this case, for a formulation. And this change history applies to inventory, so anytime inventory moves, we track that within the audit trail as well. Let’s go back over here and then pick up a couple other screenshots that I wanted to highlight.
The first is doing process flow charting. Obviously, that’s a critical first step in any HAACP program, is charting out the actual process and then moving into a phase where you actually analyze and look for hazards for potential risks in the process. So Plex can help you facilitate that process flow charting part of the HAACP process.
We also have great functionality that allows you to take, like I said before, the HAACP program out of the three-ring binder, and put into an electronic system. And what you’re looking at here is a snapshot of a HAACP program that was developed for cold deli potato salad. So on the left-hand side you can see the steps that are involved in production, you can see the potential failure that could occur in each step in the process.
Plex provides the ability to rate a severity and an occurrence level, which allows you to quantify the risk in a way that a lot of HAACP programs don’t take into account. So all this is electronic, all this is being maintained in Plex Online right along with the rest of our quality system. This is just an example of the check sheet that’s being recorded–you guys are the earlier when I looked at the control panel.
This is an example of our SPC charting capabilities, so every data point that’s been taken from a quality data collection standpoint, has the option to be stored in our SPC database, and has the ability to be charted on a variety of different control chart. And we’ll actually take a look at that one.
I’m going to go back into the [box], and I’m going to go straight to our inventory system, and I’m going to bring up an item, the gummy bear that we were looking at. When I do a search on that you’re going to see inventory for that product across all this in production steps. So the first step in the production of that product is scaling out the minor ingredients–you can see we have a lot of minor ingredients being scaled.
As I scroll down here, you can see I got some that is in Batch Mix & Blend, I’ve got some of the product does gone through Filling, and then I have some that’s gone into Final Package. The rainbow colors as you see on the right-hand side indicate to me the status of that inventory throughout production. So you can see there’s been some nonconforming product that’s been held; that’s a very serious function within Plex–it doesn’t allow anyone to handle that material or use it in downstream operation. We’ve got some that’s okay, we’ve expired some based on shelf life attribute.
But what I want to do is narrow this down a little bit to something very specific. So we’re going to look for, here’s a LPN within the production process because I want to look at the quality information that’s being recorded. So here’s my LPN, 9538–this might be pallet, it might be a case. If I click on it, the system takes me down a level deeper where I can see the current location, I can see the shelf life that’s currently on product if there is any left, the country of origin, potentially, if it was shipped in. and, in this case, the product shipped out to a customer so I can easily see the shipper that was on, and what container it originally came from. Now, what I want to look at more specifically, is the quality information around this product.
So I’m going to click the link on the right-hand side of it shows me container history, and this is the quality information that’s been taken for this product. So, let’s take a look at a couple of these. I’m going to bring up check sheet number 911. This is a great example of a check sheet that’s been stored, and I’ve got a link at the top the control chart that we’re choosing to use to control this process.
So, it’s an in process individuals chart. I have statistics related to capability and prediction, I have my upper and lower control limits so when we’re charting this information. And then at the bottom, I have the ability to alert, in situations where we would go above or below the control limits, or if we’re getting a trend as occurring over a certain period of time that appears to be running out of control. This is where you can get really proactive and preventative, from a quality standpoint, is by leveraging the Plex Online statistical process control capability. Going to go back out for a second and take a look at the other check sheet, so let’s click on this check, and let’s bring up check number 960.
So 960 is more of a cosmetic check that was done–we check the color, we check the packaging quality, I’ve got a date and time stamp, I know who the inspector was, I know where the inspection occurred, and specifically, at what work center or on what machinery. Now, at the top of this one, I have my green book, which is my audit trail somebody changes this check sheet and then I have a link to my document control. Now since this is yellow, it tells me that I have a digitally signed check sheet attached to this. So if I click that, you’ll see that this was electronic signed by Tom Nessen, and if I bring up the image itself, will see the actual check sheet data, and then at the top you’ll see the staff that says electronic signature, Tom Nessen, the date of March 26th, 2013, the signature type, and it was a good check.
So all the information’s available–if you need to download it, you know it, printed, fax it, all that can be done directly from Plex [as well.] So that’s a quick look at quality. The next thing I want to talk about and provide an example of one is, all the great things can happen if you’re using a system directly down on the plan for recording inventory, or recording manufacturing, recording raw material usage–it makes the process of traceability either backwards, or forwards, so much easier.
And a system like Plex Online provides information that through a graphical product genealogy. It shows, potentially, the extended supply chain from your suppliers all the way to your customers, it does advanced lot tracing, allergen tracking. And most importantly, it potentially can reduce the scope of an overall recall if you have that information available to pull up quickly.
Let’s take a look [inaudible 00:38:35]. I’m going to go over to shipping history, and this is usually a good access point for starting the process of understanding customer complaints. So if I have a customer who’s called me, they may call me with a lot number and say, “You know, Tom, I’ve got an issue with the shipment you sent to me and I’m looking at the box right now, and I have a lot number available.” So what I can do in Plex is put that lot number in . . . This 20130206-999, do a quick search with an open date range, and lo and behold, here is that shipment that we made to Walgreens, we went through a distribution channel called Dot Foods.
Here’s my ship date, any notes from the shipment, what was on the pallet, whether the customer call it so we could look up, in the case of Walgreens, they have WIC numbers are very specific to them, we can track as well. And then over on the right-hand side I’ve got my Document Control System as well, so if there were something I scanned before I ship the product out, I can see what that was as well. In this case, it was a JPEG image. But now I want to start the process of figuring out what inventory was affected in the shipment, so by clicking on the shipper I can see the information about the status, the shipped to, the build to, all the shipment information around the freight and the carrier. the truck that was used, the arrival time–everything that was collected at the time of shipment.
And then most importantly at the bottom, is all the information about what inventory was collected, picked, packed and shipped for this customer. And we were interested in a very specific lots number, in this case 20130206-999, it was attached to this LPN, number 9538, and because this has a hyperlink, I can click on it and view that inventory in a very detailed way. I know who it was last touched by, I know the quantity that was on the case, I know all the information about manufacturing. And the most importantly, I have the ability to access what we call the Traceability Tree. So by clicking Traceability Tree, I now can see the genealogy of this product as it made its way through production within Plex.
So I’m going to move these out and allow these to be seen a little easier, and this tells a story about this product. So the story that’s being told starts on the right-hand side of the screen with the finished product that the customer called about–it’s blue because it shipped out. But if I start going back into the left, you can see that’s this product contained 24 pack retail case, it included some plastic wrapping that we had to track because it touched the food, and then I go back to the filling operation. At the filling operation we brought in a bottle, we brought in a label, and we brought in a cap. All of those are important, all of them need to be traced, and they all came together at the filling station. The filling station also brought together some of the mixture that we mixed and blended further upstream.
So at this stage I’ve got minor ingredients, major ingredients, and low and behold, one of them is yellow with tells me there was a quality issue at some point with this product. So, from this stage of the game I have the ability, now, to use two different links that are available from the Traceability Tree. The top link will allow me to do a quick downstream trace from the ingredient all the way down to all the finished products that have shipped out to the customer.
So here’s the one that shipped to Walgreens, but over here I’ve got one that looks like somebody has already taken action and quarantined this product because it’s red, so it’s now a [non-conformant], so I don’t need to take any action. But if I wanted to, one of the things I could do is start the process of doing an [even] [inaudible 00:42:32] for the lot number that’s [been] [inaudible 00:42:34].
So on the Inventory screen, 2000130206-999, hit return, and I want to bring everything within the system that applies to that lot number. And I can start the process of doing a mass update and initiating a quarantine on this product or any other product that shipped to the customer. So I’ve got the ability to initiate a non-conformance report, issue a customer problem, or a structured proper methodology called 8D, and then I can put that product in a nonconforming status. And then to our problem control system . . . I have the ability to bring up all the problem record that I’m currently tracing for nonconformance reasons, and let’s bring up number 41 here. Actually, I’m going to bring up number 40. Number 40, the good example of the types of things that we’re collecting and our problem control system related to customer complaints.
So we know that there’s an issue with the supplier, we know who the supplier is, we’ve taken pictures of the root cause, we can store those right along with the Problem Control System. We can define problem teams, recovery teams, we can contain raw materials, we can track the cost of containment, and potentially charge back our suppliers. And then we have the ability to generate approvals and track the detailed root cause analysis and develop corrective actions right from the screen. So it’s a great tool for collecting all that information to make things available to everyone in your company.
Let’s go back over here, and I’m going to skip through the slides here–we’ve already covered traceability. This is an example of one of our customers and how they achieved, really, world-class traceability, and even down to their smallest ingredients, and that’s, in this case, spices that are used in very small amounts. This customer barcodes everything, and when they go to their scaling operation, they’re required to scale out a certain amount of product and scan it out of the container, and then scan it into the container that goes to the mixer, or to the line.
Each of these bags are able to be identified, it’s made up ahead of time. If an auditor was to walk through the building, they can easily walk up to any of these containers, look at the information that’s on the container, and understand exactly what it is and do a similar trace that I just did, if need be, within the system. It’s great control for inventory control, and really adds another level to preventative controls within food safety system.
So that’s traceability and recall management. The last thing I want to talk about what the larger ERP functions that are found with Plex, so Plex does have an HR skills matrix, we do have visitor logs, we do have complete accounting and finance package, AP, AR, GL.
Extensive financial reporting capability, advanced product costing, so if you’re doing standard cost or actual cost, is so my place to help you narrow down the cost, or product costs, very, very quickly and easily. Maintenance management, we mentioned earlier, Plex also does have a full CRM system to manage customer interactions, as well as purchasing, MRP, and those types of functions. I’m going to use this as an example to bring up one last piece within Plex, and that’s the idea of supplier quality management. So we know that in that extended supply chain we talked about earlier, it’s sometimes difficult to maintain and monitor the activities around certain suppliers, and to also stack them up against one another, so you know where they stand in relation to one another. And more importantly, they know where they stand in your eyes.
So our supplier quality management system helps us, or helps our customers achieve that. So what we’re looking at here is a supplier code, supplier name, what type of supplier they are, and then these are all certifications that they’re required to maintain on hand with us in Plex. If any of these expire, they’re notified through email to upload a new piece of evidence to show that they’re still complying with the standards. So if I go into the supplier, for instance, we’ll see a little bit more detail about their certification, the sign off, who’s required to approve them. We can see a snapshot of their overall rating in terms of the metrics that we’re measuring them against.
And then we’ve got these key supplier contact information and who are the users in the system. A key part of Plex is it’s encouraging the extended use of our system by your suppliers and your customers, giving a supplier a login, letting them update the information, letting them provide quality information to your operation, and potentially, even printing barcode labels for inventory. Those are all functions that we facilitate within Plex. And the last thing I want to hit on is the ability to support [inaudible 00:47:50] against certain metrics within Plex.
So let’s bring up a supplier performance review, let’s look at SM Products, our key supplier, and we’ll see if we’ve done a scorecard for them. Our current one is from March 2013, so I can actually bring up, actually, let’s close that down. And here’s the scorecard, and the scorecard can be accessed by the supplier online, this can be printed or emailed to them automatically.
But it gives you a good snapshot on certain metric sets, in this case, quality parts per million, problem reports, and on-time delivery, where that supplier scores. And the color coding gives a really quick easy way to understand the supplier’s performance. So in the case of quality parts per million shipped, the max score that they can get before there’s an issue is 20, I’m sorry, their max they need to get is 20, in this case, zero parts per million, and they’ve achieved it. And the same thing applies for the other metrics down the line.
So this is great feature function capability for [by logging in.] I’m going to head back over to the presentation now, and I want to wrap up by just briefly highlighting the areas we went to today. It was manufacturing operations management, plant floor data collection, and all the great OEE mobile device stuff that we talked about.
We looked at quality in detail, how your data collects the quality, how you can chart it from a statistical standpoint, how you can go completely paperless with an electronic signature, 21 CFR Part 11 compliant system like Plex. We saw the idea of instant traceability throughout your extended supply chain, so the ability to really quickly pull up a forward and backward trace no matter where you are in the production process.
The last piece around the ERP system is all the other functions that we bring to the table that allow you not to run in multiple systems with but a single unified system called Plex Online. I want to revisit the image here real quick, remind you that this is not the approach that you need to take if you’re looking for a business system, if you’re looking for a quality system, if you’re looking for a compliant system.
This does nothing but just act as a boat anchor to the business and will prevent future growth. What we encourage you to do is look at a system like Plex Online–it’s a single database for all the records we talked about today. They all work together, talk together, and it runs on the cloud, so there’s no infrastructure that’s needed to be maintained on your end. And with that, I’m going to turn things back over to Jon Cowan, and I thank you very much for your attention today.
Okay, thanks, Tom. Thanks for the great presentation and demonstration. So, today’s webinar was titled Cloud ERP Eases FSMA Compliance, right? So, we’ve talked about ERP and how it potentially eases FSMA compliance or regulatory compliance.
And it’s, again, to touch on what Tom just went through, right? And what we touched on at the beginning, was it’s about record-keeping and documenting everything per Dr. Acheson, you know, former FDA second in charge, right? You know, his advice was record everything, document everything, and do it in real time. Hopefully, you’ll see how our ERP system, a fully integrated system, actually does apply to the regulatory environment and how we can help you meet compliance, how we can help you improve control and reduce risk.
And if we think about what the FDA is telling us now with the new Food Safety Modernization Act, it’s not about being able to react if something goes wrong. That’s important, right, and we showed you how you could react. But it’s about prevention–prevention is key. And from our perspective, a real-time business system is key to driving, helping with the preventative nature that the FDA is asking you for.
So imagine an auditor coming in and you being able to log into the system right there without printing a bunch of reports, right. Just log into the system and show them what you’re doing, show them who’s touched what, where inventory came from, where it went to, who took the quality records, what the quality records were. If you were in control or out of control, how you went back, and if there was an issue, how you documented what the issue was and went to your correct preventative action process.
Have all that documented in real-time in the system living forever inside the Document Control System. To us, that’s what it’s all about. So that’s the ERP side of it, but let’s talk about the cloud side of it, right? Get back to what the point of the webinar was, Cloud ERP Eases FSMA Compliance. So, why the cloud? Well, let’s look at this technology shift that’s happening in the last ten years or so represented by the red line down the middle. There was an old way of doing things and a new way of doing things which was really the cloud. This cloud terminology really came into play in the last couple of years, before that, it was On Demand, or SaaS or Internet Delivered–those were the other terms.
This is what Plex is. Tom, go ahead. If you look at the way things used to be, right? We used to look for information in encyclopedias. Not anymore, right, we go to the cloud, we go to Wikipedia look for information. Same thing with mapping–I don’t know that any of us on the phone probably use a road atlas anymore today or maps. We go to Google maps on a mobile device, we look to the cloud to something that’s always up-to-date with that we can get directions in real time, right? Well, the same things happening with business systems and that’s what each of these bars represent on this chart. As our business system and technologies too, is moving to the cloud. And that’s, indeed, what Plex Online is.
So, if you look at Plex, we’re really on the forefront of this technology shift, and the biggest names in enterprise software are right there with us. So you probably recognize a lot of the names on this chart. Well, this is the way that Plex delivers our softwares, through a true cloud technology. And here’s why that’s important, right, Tom, you can go ahead and shift it. Tom represented the, you know, the old way of doing things, right? And that’s a thing of the past, and think about block, the center block with the bolt-on, I mean, that’s how people, that’s how companies, that’s how [organizations] attempted to solve this problem in the past, of getting all this information in one place, but it doesn’t work. We think this unified system from the cloud from [Plex Online] really is the answer.
But why is cloud, what are the real benefits of doing it this way? Why are all these big time technology companies transitioning their infrastructure to a cloud-based system? Well here’s a few key points of why it’s better and why we think it matters, right? First and foremost, you can access all this great information that comes just showed you, access anytime, anywhere, from any device, right? Do it right on your mobile phone, right from your iPad, wherever you are in the world, login and see what’s going on in real-time in your organization. Very powerful.
You know, you’re always on a single unified system; with the cloud, with a true cloud system like Plex, you don’t have to worry about upgrading your infrastructure–it’s always up-to-date. We’re constantly updating it, you just opt in to enhancements inside the single unified system that we’re rolling out all the time, just opt into them when they make sense for your business, but there are no upgrades to manage and maintain.
If you customize a system, like in the old legacy way, it becomes very hard to take an upgrade. That goes away with the true cloud system like Plex. Don’t worry about bolt-ons and integrations, those kinds of things–do it all in one unified system. Ultimately, you can implement a system like this faster, it’s more scalable, as Tom mentioned, business requirements, businesses are constantly changing new, you know, federal and industry mandates are constantly being pushed down on you as a manufacturer. How do you adapt and change to those? The old way was very difficult to do that, the Cloud ERP system much more nimble because we’re constantly evolving and updating it.
And then finally, you get all this great functionality without having to implement any infrastructure to manage or support it–you just log in. You just need Internet access and you just pay a monthly subscription for it. So, forget the huge upfront costs, and having the infrastructure, and the personnel to manage and maintain this type of environment, to pull all this stuff together like the cinder block side represented–forget all that. Come to the clouds, right? One unified system, just login, it’s at your fingertips.
So, really, this is how we ease regulatory compliance, and increase and improve operational efficiency. So, that’s our presentation today. We ran a little bit long, but we are willing to take some questions here, so please feel free to enter those in the Q&A panel.
I do see that we have one that I’m going to direct towards Tom Nessen now, and that is, “How does your HMI connect with the PLC network, OBC, or some other means? And does your HMI provide similar shop [floor] visualization and process results?”
Yeah, great question. And if we’re talking HMI and PLC integration, you know, the minimum requirements is, you know, those PLCs need to be IP addressable, number one. And then the next challenge is, you know, there’s a whole host of PLC communication protocols depending on which PLC it is that you’ve installed, Allen-Bradley, Siemens, you name it.
What we’ve done through a partner of Plex is created something called [Plex ML] which acts as a message broker between our system and the PLC or the SCADA server. And it’s a great device that really cuts a lot of the time outs of the integration process between us and the PLC. So, it’s a very detailed topic and we’re happy to follow up with more detail if you needed, but those are the basics of how we do things.
Now, as far as providing similar shop floor visualization to process results, yes, we do do that. There’s a corresponding control panel session or settings that allow the operator to see those process results in a visual environment. So that’s the answer to that question, Jon.
All right, great, thank you. Here’s another question that came in and we actually see this quite a bit, is, “That we currently use a different accounting package, like a QuickBooks, for a lot of our tracking transaction stuff. Does Plex have the ability to work with QuickBooks for accounting purposes?” I’ll go ahead and take that one, Tom.
And that, you know, we talked about having a unified system. It’s something we really believe in here at Plex; it’s really in our DNA–the heart and soul of what we believe in is having one system of record for everything. So, while it is, I guess, physically possible for us to tie in to another accounting package, and sometimes that’s necessary, right? Very large customers have made huge investments into ERP systems to tens of millions of dollars or more. Sometimes we may have to tie into something like that, where we are in a two-tier system running the plant.
But for other organizations that are smaller than that, that have maybe outgrown a QuickBooks-like environment, we would suggest putting it all on one system. In fact, it’d probably cost you less money to have it all together instead of trying to bolt-on systems much like our cinder block slide represented. So our recommendation would be to replace QuickBooks with our accounting system which is part of our unified system that you just saw Tom demonstrate today.
So, I think that’s the end the questions that I see. We really want to thank you all for your time, I appreciate you giving us a couple extra minutes, here. If you want to contact us please go to, send us an email at info@Plex.com. You can go to our website at www.plex.com/industries/food, or there’s another URL you can go to plex.com/FSMA, and we do have a FSMA [inaudible 01:01:04] leadership micro site up there where folks like Dr. Acheson and others are constantly participating, answering questions, and doing some things for us there. So there’s a lot of resources that can be found up at plex.com.
We hope you enjoyed today’s presentation, we hope you see the real advantages that our Cloud ERP system can really help a food processors, food manufacturers. So, please reach out to us with any questions, thanks, and have a great day.