At a Glance:
- Learn how to build or strengthen food safety plans.
- Understand the components of technology-driven plans, and how to use them for efficient compliance.
- Verify that steps in your plans are being followed.
- Use plans to meet the specific requirements of new FSMA preventive control rules.
- Maintain documentation efficiently and effectively.
My name is Jon Cowan, and I’m the Senior Account Executive for the Food Solutions specifically here at Plex Systems. I will be presenting today along with my colleague, Tom Nessen, who serves as the Senior Solution Engineer of Food Solutions at Plex Systems. By way of background, our organization provides these thought leadership webinars as an extension of our mission to really help food companies implement best practices.
Today’s webinar is the second one in this series focused on improving food safety and planning. While the specific impacts of the FSMA or Food Safety Modernization Act haven’t fully been announced, there are some things that manufacturers and food processors and companies like you could do now to establish a foundation for what the act will likely require.
I will be presenting on some background of the Food Safety Modernization Act, and then I will turn things over to Tom, who will talk about cloud technology can really help you meet some of the challenges we expect the Act to present. After that, we will have plenty of time for some Q&A and we encourage you to use the Q&A panel to present your questions throughout the webinar so that we can address those at Q&A session.With that, I will go ahead and kick it off with an introduction. If you were lucky enough to sit through the previous webinar, Dr. David Acheson of Leavitt Partners discussed in a lot of detail what a food safety plan entails. My goal is just to highlight some of those things that he covered, and then we will get into some more detail.
The Food Safety Modernization Act, as most of us on this call know, was signed into law on January 4th, 2011 and really truly was the most sweeping overhaul of the food safety system since 1938 and it’s really there to reflect risk-based integration and a global systems approach, so it is not just about how do we react to an issue, it is about how do we prevent an issue from happening.
Quickly, who is covered, it’s anybody who has to register with the FDA under Section 415 of the Food, Drug, and Cosmetic Act. If you manufacture, process, pack or hold human food, this most likely applies to you. This is for both domestic and if you import foods, so there are various exemptions from folks who must adhere to juice or seafood HACCP programs, certain farm exemptions, dietary supplements, and some other things relative to the size of business. Dr. Acheson covered all those in some good detail on the previous webinar. If you weren’t lucky enough to join during the previous webinar, we do have a recording of it at our website where you can go back and get a lot of detail on the specifics of what he covered.
The guts of what Dr. Acheson was talking about was really around this graphic, and that is what is a food safety plan? What is it likely to look like? What is the FDA likely to require out of this? We know that everyone is going to be required to have one, but what is it? What is it going to entail?
So I wanted to highlight some of the things that Dr. Acheson covered and go through those slides in some detail. The first is hazard analysis. I think we all have a HACCP plan in some way. For most folks, that is a paper-based, three-ring binder type plan. We have been through this, but having the HACCP plan Dr. Acheson talked about is not enough. There are some resources on the Leavitt Partners website about is a HACCP plan enough. I would encourage you to read those documents about where the delta between a HACCP plan and a food safety plan. The Leavitt Partners team and Dr. Acheson do a great job of spelling that out. You can find those links through our resource center as well.
He laid out a plan, and really it’s about a ten-step plan, and the first three apply to the hazard analysis piece. The first thing to do is create a team. You need to create a team to focus on food safety. Then enable that team to brainstorm what hazards exist in my facility and combine a list of these hazards and score them by severity. Those are three things you want to do as it relates specifically to hazard analysis.
The fourth thing we want to do is assign preventative control to each hazard. When we talk about preventative control, we are talking about whether it’s a process control, whether it’s a food allergen control, whether it’s sanitation control, and we are talking about recall plans. You must consider biological, chemical, physical, and radiological adulteration. If a hazard is reasonably likely to occur, then it is imperative that you identify and implement preventative controls, again, around the process control, the allergen control, the environmental control. That’s number four.
Moving on to number five is to validate those controls and implement control and monitoring. We have to make sure that we establish and implement actual written procedures to monitor each preventative control. There is something very important here. That is that we must actually keep written records of the monitoring activity. It is not good enough to just make observations. We actually have to write those down, record specific measurements, and it has to be more than just a checklist as Dr. Acheson advised.
We have to make sure that we are actually monitoring and writing down what we are observing as part of this process. If the process starts trending out of control or there is something that goes awry, we must have a corrective action identified for that.
Again, you must establish and implement a written corrective action. It is not good enough to just think about what has to happen. You have to write it down and adhere to it. We will talk about this in more detail in a moment, but this is where technology can really help by helping you monitor activity in the plant, see how things are trending, whether they are trending in control or out of control, and then immediately go on through a documented corrective action process to rectify any situations that come up.
The next step at number eight of the list of ten things that Dr. Acheson talked about as putting together a food safety plan is to verify. We need to make sure that we are verifying the entire plan through the hazard analysis, preventative control, monitoring, corrective action, we need to go back, reanalyze, and verify that the plan is working. As new products are introduced, as new processes are introduced, we have to go back and re-verify our food safety plan.
Finally, the last thing that Dr. Acheson really talked about–and we hit it a couple times here–is that we really need to document everything along the way. It doesn’t necessarily matter whether it is electronic or on paper, but the documentation of this is critical. It’s all about controlling and taking measurement, writing things down, and understanding exactly what is going on. You must document, document, document.
Along with this, recordkeeping is of utmost importance. The records may be paper, they may be electronic, but they must be maintained for at least a period of two years and when the FDA comes knocking at the door, you better be able to present them the records that they are asking for upon request. You are not going to have a lot of time to turn around these records like in the past.
So recordkeeping, that is really a lot of what we are going to talk about here today, is how we help you with that recordkeeping. That recordkeeping and record retention is a huge part of this food safety plan.
The last thing that Dr. Acheson talked about as part of his summary was how much the technology can really help. We spend every day of our careers in and out of food plants, looking at the ways that they are processing food. We see a lot of these plans, and HACCP plans in three-ring binders and part of what we are trying to bring to the food manufacturing and processing world is that technology can really help.
There are much more efficient ways of capturing all of this information, recording all of this documentation, and the activities that are going on in the organization so that pulling that information back out when required is much easier. You don’t have to necessarily go to a three ring binder or a huge file cabinet or an offsite storage location to try and find a lot of these old records. We can help you manage day-to-day transactions and records in an immediate fashion, or a real-time way. Technology can certainly help.
There is a major shift in the market toward documenting. What the FDA is mandating is more documentation and record retention and control. It is about being preventative. Let technology do the heavy lifting. That is what Tom Nessen is going to talk to you about now. So with that I will hand it over to Tom Nessen and let him take you into more detail.
Thanks Jon, I appreciate the lead in there and the recap of the previous webinar that we did involving Food Safety Modernization Act. Today I am going to take you down a different route, and it’s going to focus on the main point of the previous slides which is documentation within a manufacturing process to ensure that your process is complying with all FDA regulations, all industry regulations, your customers’ expectations, and you are doing everything to protect your brand, your consumers, your customers, and comply with their requirements.
Before we dive into that, I want to start with a quick story that I think illustrates this point really well. That is the story of Burch Farms. I have the article up on the screen here detailing what happened with them, but this is a story of lack of record retention and what happens when there is a public health issue.In the wake of the Jensen Farms outbreak last May or June which resulted unfortunately with the deaths of many people, everyone was acutely aware of the potential of Listeria appearing on fresh melons. Burch Farms, unfortunately, was detected to have Listeria on one of their products. That started the public health officials down the road of trying to trace back to the source of the outbreak. It was easily tracked to Burch Farms and it initially started at about a 5,200 cantaloupe recall back in July, but it quickly expanded to having to recall every cantaloupe that was shipped by Burch Farms during that harvest season.
The main driver for that, was that Burch Farms had no electronic, nor paper records at all about where that product, processed during a particular day of production, shipped to. If you look at the picture on the screen of the yellow and orange box, that is essentially all they did to track the product to the retail store. It was just a box. They had no markings, no labelings.
Now, Burch Farms was in complete compliance with all FDA requirements that were in place back in July, and they are in complete compliance with the new Food Safety Modernization Act requirements that are currently on the books today. The fact of the matter is they are no longer in business shipping melons to retail stores because they failed to have the proper records in place to be able to effectively help the public health officials quarantine an outbreak directed from their products. It is a story about the importance to protect the brand, to protect your consumers. It starts with either electronic, as we prefer, or documentation in general.
Let us go a little deeper here and just talk about the legacy of recordkeeping requirements as they relate to food and beverage processes. The bottom line here is we are still regulated, from a recordkeeping requirement, not by Food Safety Modernization Act, but by the 2002 bioterrorism act and the 2005 FDA regulation on recordkeeping that mandates you need to keep records about where you received the product from, where you sent it to, and while you had it, what you did to it, how it was transformed and other types of things.
An important point to note is there is currently no format specified. If the public health officials come knocking at your door, and they want records related to what you produced, you could hand it to them in a shoe box and that would cover you from an FDA regulation standpoint. Lot number is only required for manufacturers if it is available. If it is not available, it is not a requirement.
There are exemptions for each part of the supply chain. Burch Farms being a great example of that. The agricultural producer small farm is completely exempt from these recordkeeping requirements. Likewise, the retail end of the supply chain is exempt as well.
That really brings into focus the idea or the question of why we need to comply? My argument is that compliance should never be the driver. It should be paid attention to, but the main driver should be the protection of your brand and the protection of the people that are consuming your products.
With that as a driver, it really brings into focus when you should start undertaking these projects. My argument is now, immediately. The FDA has proposed additional requirements, but they haven’t been released yet. There are industry initiatives that are underway. Some are more fully formed than others. The most important thing that you can keep in mind as you are examining these projects for electronic recordkeeping for advanced manufacturing systems is that you do not want your company to be the weakest link the supply chain.
In the example we gave of a public health outbreak, if that product or outbreak is traced back to you, and you may know that it is an ingredient in your product, that it’s not your product directly, but you cannot produce the records to determine what batch, what day of production, or what quality measurements were taken, then you run the risk of recalling or quarantining your entire production of that particular product. You do not want to be the weakest link. There is dramatic impact to your businesses that could occur if that is the case.
When we are talking about the supply chain in recordkeeping requirements and documenting what you are doing, there are two components that are very important when it comes to either recall or trace back. There is a big distinction here.
Trace forward, or recall, is the simpler question to answer. The where did it go? I made a product, I shipped it to customer X, it was on purchase order number 123, I shipped it on March the 5th, 2013. Those are pretty easy records to keep. Those are pretty easy records to recall, and you can get those records pretty quickly to somebody and call your customers if there is a recall issue.
The more complicated question involves the trace back. If there is an outbreak and it is traced to you, or it is traced to your distributor, they are going to want to know what is causing this illness. Since you produced this food, what was the source of the ingredients? That is where you do not want to become the weakest link, is during that trace back.
Right now, the box around federal regulations relating to trace back really fits around the processor, the manufacturer, and in some cases the distributor, but it is pretty tightly focused on the processor and manufacturer. That kind of frames up the discussion.
What I am going to do now is turn a little bit more toward the technology side. Plex Online is a cloud-based ERP system. It is helping food companies every day to lockdown and establish best practices for electronic recordkeeping throughout the manufacturing process. It’s a new way of doing business that is different from the old way of purchasing license software, installing it in the data center at your facility and operating it that way. There are some distinct advantages to what we do.
What I am going to do is set up here an image of existing ERP systems as they have been over the last 20 years, and in typical fashion, if you install a system like this 10, 15, 20 years ago, it started with a core accounting and finance package and then it might have had limited manufacturing capabilities that would slowly add it on to over a period of time. You added on quality control, human resources, time and attendance, document control potentially. All of these things live in their own silos and do their own thing and the result is fragmented data sources.
A lot of food companies that we start working with that are looking at new business systems- this is what they are wrestling with today. A system that inherently doesn’t work for the business. Companies have written expensive workarounds around this kind of model. They use Excel. They use Microsoft Access. Most importantly, they use tons of paper to keep track of the production process.
Naturally, there are problems with this model. It is limited in visibility, it is costly to maintain. It restricts the overall growth of the business and really acts like a boat anchor to where you want to go. It is not very collaborative. It doesn’t allow you to talk to your suppliers, to talk to your customers, to give them access to certain things that they may need to see in the system.
Most importantly, it is very static. It is not something that is going to change dynamically with a market and a regulatory framework that is changing very quickly. That is what we are seeing today. A lot of food companies that are in this boat and are trying to change. What we are offering as a different solution is Flex Online and it is a cloud ERP for food and beverage manufacturers and processors. It really covers the whole continuum of important documentation that needs to occur during the production process.
What we are going to do today, is we are going to look at that model and we are going to talk about each piece in detail and at the end I am going to show you a brief example of how Plex actually works to be able to respond in a situation where a customer is having a problem. This is really going to set up our next webinar which we are going to do a few weeks from now. We are actually going to go into a deep dive demo into the Plex Online software. Today I want to set up these concepts and talk about them in detail and then we will move to the system briefly in a few minutes.
Let us talk about receiving. It all starts with receiving. Receiving is the most important piece of the chain. If you have a very tight relationship with your suppliers, and your supply chain, they may be able to access your system and provide information about what you are going to be receiving on the next shipment. They may be able to pre-label the inventory before it even hits your receiving dock.
Regardless of how tight your relationship is with your trading partner, at a very basic level, everything needs to be labeled, barcoded, and identified uniquely with lot numbers, suppliers, where it came from, what transportation provider was involved. These are all critical things that can really set up the basis to be able to trace back effectively through this supply chain.
The next thing is involved with inventory moves. Once the inventory is within your four walls, are you documenting when that inventory moves from raw material or QC into work in process, or moves into reserved inventory. How is that move being monitored? How is it being tracked? Who is involved in taking those moves’ recordings? Most importantly, where is it located?
In an event where inventory is important and inventory is moving rapidly, what is the program that we are putting in place to cycle count that inventory and understand its disposition on a day to day basis. Inventory is very important to track and monitor.
During the manufacturing process, a lot is occurring. You are using raw materials. You are using different inputs. They are moving into intermediate stages. They are going from work center to work center. How is a system helping you track the activity, track the unique lot numbers, track the ingredient composition, or prevent you from doing things that adulterate the food, and track that all the way through the process?
In conjunction with that, food companies have very detailed inspection programs from start to finish that may include one or many different critical control points. As your people are inspecting those critical control points, or inspecting quality related to the characteristics of your food product, how are you tracking that in real time along with the production process? A system like Plex Online can play a big role in collecting that data throughout the manufacturing process.
As we know also, in today’s world, outside processing is a big part of food production. Whether it is co-packing, or co-manufacturing, a lot of times food companies are sending product out for service, receiving it back, drop shipping it to multiple locations. We need to have a system that is flexible enough to allow other people to provide documentation into your core system, because no matter if they are co-packing or co-manufacturer, you as the food producer, are ultimately responsible for those recordkeeping requirements.
The last link in the chain here is around shipping. Not only do we want to make sure we are shipping the right product to the right customers, but if we are using an advanced system, we should expect some benefits such as reduced shipping costs, consolidation of loads out to the customer. Doing some things in advance that makes our business work in a smarter fashion.
Let us take each of those in turn now and discuss those in detail. When we talk about receiving, within an electronic system, this is what typically comes to mind for most folks. There are some food companies that are doing some really advanced work with RFID, and those types of things, but at a basic level, the bar code is still the cornerstone of most inventory tracking activities. You need a license plate number. You need to barcode the item number potentially. In this case, our bar codes on Plex Online provide images of the product. It is a lot easier for operators to understand what they are supposed to be doing with what product. The system should be able to generate these bar codes natively [inaudible 26:15].
The next thing is the move part of it. Moving and relocating of inventory. There is a paper trail generated there typically, or there can be. In the case of Plex Online, the barcode is the key part of the inventory move and inventory count process. It works hand in hand with the mobile device and the mobile device is on the right part of the screen. It is a typical RF scanning device asking for location and license plate number. When those two details are provided and the move is made, the electronic system tracks who made the move, when it was made, and potentially the reason code for that move. The very inventory control is the use of multiple devices.
This is an example of one of our customers who uses very small amounts of certain ingredients. They still bar code everything when they take a measurement out of a raw material ingredient container. The decrement it, and they take that small portion, segregate it into a cart, move it line side, and everything that they move, whether it is the smallest pinch of salt up to the 50-pound bag of cayenne pepper, they always bar code, they always track, and they always verify. That occurs with the bar coding within the system.
The next thing is around manufacturing and inspection. Electronic records are important at this stage of the game as you go through production. This is what Plex provides. We separate ourselves from this old type of environment where everything is controlled within a single work center.
I am sure most of you have seen this kind of environment where there are whiteboards, bulletin boards, clip boards, and there is a lot of paper and a lot of pencil. Everything is being controlled by somebody writing down a record and taking that record to a central control point, where eventually it is aggregated, analyzed, and people can take action.
We believe in today’s modern world, that this information should be collected more at the point of occurrence and that the analysis should be done in real time to be able to take real concrete action against some sort of a non-conformance in the business. What we do at Plex is that we provide that central point of control through what we call a control panel. A control panel is nothing more than a simple human-machine interface that allows our system to reach down into the production floor where the work is actually happening.
The image you are looking at here is one of our customer [inaudible 28:54]. This person may be involved in QA. They may be involved with production recording, but this screen is literally right down at the line side and accessible for this person to record those measurements. In most Plex installations, this is a cornerstone of how that works.
If we take a look at the control panel that they are using, you can see there are some key features here. The control panel allows us to record production, produce bar code labels, allows the operator to look at the production schedule, is instrumental in quality recording and HACCP recording. It is also a key part in alerting plant employees of quality issues with a product, with announcements in general about the plant. It acts as a universal communication tool between the supervisor and the plant level employees. Gauge control calibration, maintenance is at play, document control is accessible through the control panel. If you have detailed work instructions, or a HACCP plan, or corrective actions and preventative actions, those can be brought up line side with the control panel.
Most importantly, there is an aspect here of human resources that comes into play with the control panel. We want to make sure that the right person is doing the right job on the plant floor. By incorporating human resources skills maker, we can make sure that those people are trained before they are allowed to log in to the system. This is an important component for food safety.
Lastly, on the outside services piece, Plex Online has extensive functionality on sub-contract and sub-contract operations, which allows the trading partners or suppliers in these contract activities to provide their quality information, provide their output of work, and allows them to ship to your customers if drop-shipping is part of the deal.
That is a quick look of all of the different phases of the production process, all the different opportunities for a system to be involved in capturing and collecting data on the plant floor and the importance of collecting data at each of those situations. I want you to keep in mind that we are moving away from this model, and we are moving more toward a unified model where a central database is controlling electronically all of the records in the system.
What I am going to do is switch over now and do a brief demo of a typical scenario within Plex Online. What you are looking at on this screen is the Plex Online system. I am going to go through a brief scenario here. It is kind of a real life scenario of the impact of collecting electronic records at each stage.
So let us go over to ship history. We can imagine that a customer might call us with a lot number and they may be having issues with what they received from our manufacturing operation. By putting in the lot number, I can quickly see that, based on that lot number of inventory, I shipped something to Meijer Grocery store through a distributor called Dot Foods, and it was shipped recently. If I want to find out more information, I can click into the shipper, find out who they shipped to, who the sold to was, the date it shipped. It was February 8th, 2013. I can move to the bottom of the screen here, and I can see exactly what inventory, exactly what lot numbers, constituted that shipment to that customer.
In the case of this shipment, we were interested in the lot number 2013 206999. You can see there were other lot numbers associated with that shipment. If I click on this inventory number now, I am going to be presented with a lot more information about exactly what shipped to that customer. You can see it was gummy bears that went through final packaging. It was related to a specific job or work order number. We assigned it a lot number. It had a shelf life on it that expired back on January the 29th. You can see who the last person was to update the inventory record back on February the 12th, 2013.
Now there is a lot of other information that we stored related to the production of this product. We can bring a couple of those up.
The first thing I am going to do is take a look at the traceability tree. That really goes to the core of recordkeeping that we have been talking about today. If we look at this screen here, we can see a few different things. This screen tells us a story about the genealogy of production for this particular product. I am bringing it down so it is a little easier to see.
What we have here is a product that started out with minor ingredients and major ingredients. Minor ingredients being things you have to measure out in a scale house. Major ingredients being those things that may be piped in through a tank or a silo or those types of things. They came into a mixing process, they were mixed, and then they next went to a filling station. During the filling station, we brought in a bottle, we brought in a label, and we brought in a cap. Each of those have a traceability requirement because they do come into contact with the food; therefore, they are a part of our traceability matrix.
The last thing that happened here is we went into final packaging. At final packaging, we brought in a 24 pack retail box, and some plastic wrapping. Again, both come into contact with food, so we have to trace these accordingly.
From this screen, I have an immediate picture from the finished stages of the product all the way back to the very source of the ingredients of the products that were manufactured. Since I have a problem with this particular shipment that went to Meijer [SP], by looking at the color code, you can see the yellow box indicates that there was some sort of a non-conforming issue that occurred with one of my minor ingredients.
By clicking on the link here, I can go a level deeper to see what the issue was with this inventory. I am going to click on the bottom part of this box. The system is going to launch another section, and it is going to take me right into the inventory screen for that minor ingredient. From this stage, I can look at the same information I looked at before, or I can choose to go to the inventory check screen to find out what were the non-conforming occurrences that were recorded during the receipt or during the use of this ingredient.
By bringing up check sheet number 962, I can see that the inspector, Tom Nessen, at a specific work center, recorded a failure during the continuous microbial analysis stage. We failed some sort of swab test that occurred. If I want to pull up the record of the actual signed document that was electronically signed by Tom Nessen. I can click that document, and you can see we have time stamped electronically the name, the date, the time, a signature note, and where it failed.
Now this electronic document is completely compliant with 21 CFR part 11 and it is stored electronically within the Plex System as a record of this failure. From this failure, I now can go back and do a little more interrogation work, pull up the traceability tree and I can see that this ingredient was instrumental in the production of not only the one I sent to Meijer [SP], but it was also involved in the production of another product that maybe went to another customer. I have a quarantine issue going on here right now. If I bring up this final packaging information about this product, I should see if there was another issue that is being pursued by potentially somebody else in the business.
So I am looking at this inventory container. It currently looks like it is still within the four walls of the building, but there is a problem control record associated with it now. It is a contamination issue that we are pursuing related to this lot number. If I bring up this problem control information, I quickly can see the details of what is occurring. We have a supplier problem from SM products. The supplier has been assigned. The description can be updated. we have a category of a supplier issue. It is in the baked good plants. It is a contamination defect. We can actually upload images of the issue as we track them through the system. This acts like my filing cabinet for all activity related to a non-conformance report that is occurring within my business.
Along with this, we can assign ownership statuses. We can define a full cost recovery plan, so if you want to track the financial impact of recovering from a quality defect, we can track that here, which allows us to assign accountability out to our supplier community. We can also implement containment details and we can institute structured problem control methodology like 5Y analysis or 8D analysis.
Lastly, the system is instrumental in collecting and containing inventory information related to the issue that we are pursuing. From a systematic standpoint, Plex Online acts as a central point of control for all activity related to the non-conforming issues that have been reported by our customer.
That is a quick demonstration of Plex Online. Also a quick overview of electronic recordkeeping best practices. I think at this point in the presentation, I am going to turn it back over to Jon, and he is going to moderate the question and answer part of this presentation today. So Jon, back to you.
Alright, thanks, Tom. As Tom said, we are going to go ahead and move to the Q&A portion of today’s session. We have already had a few questions come in. If you have any others, please don’t hesitate to ask them. We will get to the ones we can and answer the ones we can. If there is something we need to get back with you on, we will certainly do that as well.
The first one, which is very easy to answer, is are we going to get PowerPoint slides as well as recordings sent to the attendees? We will absolutely send you a copy of the recording. You have access to go up and view the slides as part of the recording at any point in time that you wish. It will be an on-demand webinar recording at that point, so we will send that out to all attendees and you can also go up through the Plex.com, through the resource center website and get that information as well and view past recordings. That is the first one.
The next one is kind of specific to BRC. If we are currently audited under BRC, please explain where to draw the line between a nonconformity and an in-process variance that is caught that may not directly impact either food safety and/or quality of the finished product. This is one that we will probably have to go back and do a little bit of research with some of the experts that we pull in to support us. I am not an expert on BRC specifically. I think this is just another way to get to the same level of safety whereas a nonconformity might mean that you are in default, but we need to do a little bit more digging. We will do that and get back to you on that one.
The next question–on slide three, we referred to human food. Does this apply to animal food as well? The answer to that is that food per the statute is for human and animals, so the preventative control doesn’t differentiate, but the FDA themselves decided to write two rules. The first one that has come out, there was a preventative control rule, and the produce rules that have been release that are out for comment. That one is specific to human food. The FDA is going to release one of the rules that is specific to animal food, but that has not been released yet.
The next question was, do you recognize the difference between ERP and MRP only MRP has been referenced thus far? I am going to defer to my colleague Tom Nessen on that one.
Yes, we recognize the distinction between ERP and MRP. ERP is the umbrella topic for enterprise resource planning which typically includes material resource planning, which is what MRP is. On the procurement side of the house, a system that is in place to determine the requirements for the ingredients or raw materials, and then likewise on the other side of the house, doing production planning and scheduling based on the demand inputs and the available raw materials.A system like Plex Online, which is an ERP system, also has those key components of MRP. We did not get into them today because the MRP conversation will probably be more appropriate for our demonstration that we do in the coming weeks for the next segment of our webinar series. Definitely Plex Online as an ERP system has full, functional MRP capabilities.
Okay. Tom, I will let you take the first answer at this one, and then I can elaborate. The topic for the webinar was FSMA compliance. Can you advise on what FSMA requirements are in effect as of today?
I think you mentioned it. The produce requirements and . . .
The preventative control.
. . . and the preventative controls are the two pieces that have been released for public comment.
Exactly. Like I said, there are I think three more rules due out in the near future. When we talk about the food safety plan, there are still many specifics to be defined, but what the FDA is telling us is that we must document and we must be able to manage those documents and verify what our control plan is. What our safety plan is.
The next question was do we need to track and do traceability exercise for non-food contact packaging materials regarding a food manufacturer? Tom do you want to take that one?
Sure. The answer is no. If it is not coming into contact with a food product, like cardboard boxes that contain retail ready store packing for a product, those do not need to be tracked and traced. Only the materials that are coming in direct contact with the food product.
That at the moment will conclude the Q&A that we have received at this point. Again, we thank you for attending. We hope you found the session today to be worthwhile.As you know that the food plans and the rules coming out from the FDA are constantly evolving. We continue to bring thought leaders in, not only from Plex, but outside of Plex as well such as Dr. David Acheson from Leavitt Partners and others to talk about these new rules as they are introduced. We will help you try to stay on top of those as well as help you understand some of the technology that can help you meet these rules and laws as they go into effect.Our next session will deal directly with that. We think there is a lot inside of a fully encompassing ERP and food safety management system that Plex can really help food manufacturers with in meeting these standards as well as becoming more efficient. We hope you join us for that next webinar that helps you understand how the cloud technology and ERP can help ease FSMA compliance and drive efficiencies.
On a final note, as we conclude here, you will see a brief survey pop up with a few questions about the presentation today. We do encourage your feedback on those to find out what you found valuable, what you would like to see in the future. This is an evolving series that we are producing out there. It is really for you all. We just want to help be part of that conversation. The responses to those surveys are extremely important to us and we are greatly appreciative if you would answer those.
Thanks again to Tom for being a presenter today and we look forward to talking with you again at future events. Thank you all.