At a Glance:
See how the Plex integrated, comprehensive system enables companies to meet the broad scope of changes coming with AS9100 Rev. C, while serving as a transformational force to drive business and operational processes across the entire enterprise. The online demo highlights the following features and benefits that Cloud ERP provides to aerospace and defense manufacturers:
- Effective, integrated QMS
- Electronic document management with revision and approval controls
- Real-time interaction with documented business processes
- Easy tracking of deficiencies, non-conformance trends, investigations and corrective actions
- Project management capabilities highly integrated with first article of inspection (FAI), advanced quality planning (AQP), and workflow functions
Thank you, everybody, for joining today. We really appreciate your participation. Along with myself today we have Bill McGee, and Bill is my partner in arms here. He will be doing the demo after my short introduction. So thank you, Bill, for participating as well.
This is the third in a series of our webinars related to the AS9100 C version of the ISO new standards for aerospace and defense.
The past two sessions were focused on the changes from B to C with our affiliated consultant, Francis Charbonneau. He mainly spoke about the changes that organizations need to go through and what they need to look at to become compliant with the new C level.
What we wanted to do here today is to show you some tools that will make that more efficient and productive. As we know, anytime you have more regulation and more requirements and procedures to follow, that puts a burden on your organization. What we want to give you a glimpse into today is how you can leverage some tools that will limit and minimize the actual effort but give you more robust information to deal with the changes, deal with the requirements, deal with audits and so on. So what we want to do is, again, show you the processes, solutions and tools to actually do that.
One thing I just want to let you know is that we’re not going to be able to show you the entire system. We’re going to be focusing on some key areas related to Rev. C. If what you see today interests you, we can definitely show you more of the system. Please contact us through the survey at the end of the presentation, or you can send us an email directly.
One of the things that Bill will be showing you is how we can move you to more of a paperless environment. So if you like what you see here today, again, please feel free to go ahead and give us a call.
So with that, I’d just like to kind of kick off today’s session with some brief visual associations in terms of what you’re probably going through.
Typically you have visits from inspectors. Anytime you deal with any kind of an ISO or an organization or even your customers themselves, you know, Pratt & Whitney, Boeing, United Technologies, all those different groups, they’re going to want to come in and make sure you’re going to be following their requirements and their processes and procedures.
Typically, they’re coming in asking for information, and you need to go to the files and manuals and so on to pull that information out to represent what you’ve done and how you conform to their requirements.
What you don’t want when they’re onsite is to have to fish through and dig through documents and show them how you actually control this all on paper, because the actual act and responsiveness that you can show them either will reduce their confidence or can increase their confidence in terms of how expeditiously you can pull the information that they’re requesting and present it to them.
So in a real world, what you’d love to be able to do is sit in a conference room with your auditor and bring up a system that can present all the information immediately when they’re asking for it. It creates a very comfortable environment in which everyone can show them – your entire team can show them how together and how accurately you process all the information and how you store it in a very logical manner.
This picture is actually a representation of one of our customers, and they’re really using the system to have their audits in a real-time basis. Yes, they do require some documentation, but you can just print that off and send it with them. But as you can imagine, if you’re sitting in a conference room with the auditor and pulling up information after information that they’re asking for, it gives them confidence that you know what you’re doing.
Very often what we find is that our customers over the years have tried to respond to these new regulations and requirements by bolting-on different systems, using spreadsheets, different tools, in a kind of hodgepodge way to address all these different requirements. And over time, it’s become very cumbersome because not all of these systems interact with each other and feed each other information in a seamless environment. So what they’ve ended up with is a very custom environment with fragmented data sources.
What we’d like to propose you take and consider for the future is one integrated system where everything that comes into your organization is tracked and traced. Any time it moves through the organization, it’s tracked and traced and you know exactly where it is within locations.
In the manufacturing process, you know exactly where it is, what step it is, what job it is, what production step it’s in. You have inspection points all along the way, even from when it’s first received all the way through the manufacturing points, and you can define those inspection processes based on your customer’s requirements or your requirements related to quality.
Many customers have outside services. You need to be able to track those outside services and show the continuity from when it left your building and when it came back, or if it was shipped on to the end customer at that point.
And then, again, shipping as well, being able to track and trace all the shipping activity, what was sent where, and have traceability through the whole process.
So that’s pretty much what Bill’s going to try to show you here today. Again, we have a very limited time. We can cover this entire universe and spectrum for your organization, so again, if what you see today is very interesting to you, please let us know and we can go deeper with you.
So, with that, Bill, I’ll turn it over to you.
Sounds good. Thanks, John, I appreciate it. Again, welcome, everybody. My name is Bill McGee.
I think as a segue to the presentation, as John had said, in review of some of our prior webinars, a quick review of just the general scope of AS9100 Rev. C and just 9100 in general is that the standard specifies requirements for a quality management system where an organization needs to do a couple of things.
One, demonstrate the ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements; and secondly, the regulation aims to enhance customer satisfaction through the effective application of the standard and the systems around it, including processes for continual improvement of the system and the assurance of conformity to customer and other requirements.
And that’s really where we and our customers key-in on is that second – kind of second order objective of requirements and standards like AS9100. You could look at them as simply regulations that you need to adhere to and provide objective evidence to that adherence, but it’s our position that if you’re going to go through the effort of having standard best practice procedures in place that you maximize the return on that effort by systematizing and really looking at the purpose of the requirements to have a system in place for best practices.
We’ll be covering three areas of AS9100 Rev. C that differ from the previous versions, and again, as John had said, how an integrated system can facilitate achieving the effective application of the standard.
We’ll start out with customer focus and satisfaction; talk a little bit about document control and the control of documents and records; and then also touch on the monitoring and measurement of processes. So these are just three key areas that had some significant or notable changes in Rev. C.
I’m going to share my desktop with you, so we’re switching over from the PowerPoint to our application live. Today what I’m going to be using is a couple of different environments to demonstrate the topics that we just discussed.
So we’re live in Plex in a company called Acme Manufacturing. Plex is a software-as-a-service based ERP system that provides access to the system to all users, both internal and those that you externally want to provide access to through a web browser, and externally meaning – this can be suppliers, customers, auditors, consultants, subcontract manufacturers. Through the unique security rules and access to Plex, it really opens up the access to the system and allows the participation in all of your business processes to anyone that you’d like to have join in in the process.
If we start out with the first topic we talked about, the customer satisfaction, some of the notes in Rev. C that discuss some changes to customer satisfaction really revolve around the monitoring of trends and activities.
Plex has an integrated customer relationship management system as part of our sales module. You’ll notice that there are a number of features that can be supportive in that area, managing the customers, managing opportunities, and a number activities that are really customer-facing, if you will.
But given that Plex is an integrated system, you’ll also notice that if I were to go into our quality operational area within the system, the quality modules, you’ll see that the customer returns function is embedded within the quality system.
So again, this is the position of taking that the activities that people within the organization are performing on a daily basis are the things that are going to result in the data that’s needed to be provided for the objective evidence to an auditor as well as to requests by the customer for, if not evidence during an audit, just simply day-to-day procedures in requests for information to monitor how things are going.
We’re going to use this one as an example. If we look at the customer return system within Plex, I’ve pre-filtered to the month of March, or at least that’s what I’ve defaulted to when I log in. We can see that in this case, we currently have a return authorization or a return record that’s been entered in the system. Most likely, this was done by a customer support person, a sales person, depending on the organization and where that responsibility lies, perhaps someone in shipping and receiving. The idea being that within Plex, given the unlimited access that users have and the security, we can give that responsibility to anyone in the organization and then based on permissions and workflow, make sure that the appropriate subsequent steps are followed.
If you notice that by filtering on the current month, we have one return that’s in play. We have some basic information around this return such as who the customer is, some types, reasons and categories. So given that these are database fields and not just information on a form, these are all candidates for being able to query and sort and filter in the future on that data.
So as we’re going through the course of registering a return, we’re logging that in the systems to make future reporting and collection of objective evidence that much more easy by simply being able to filter on say all returns from a particular customer of a certain type or category. It makes it very easy to summarize that data.
Also, there’s a series of reports that are available within Plex. If we look at the return reports, we’ve activated one within the Acme Company, a customer returns report, just to give an example of how quick you can get to that evidence of data.
Similarly, if we narrowed it down to that particular customer, for example, for that same period of time, we can have a report that not only pulls in that summary data that we saw in the previous screen, but also include things like sales price values, PPM quantities, and rolled-up PPM data as we’re trying to collect that over the course of time.
So the single activity can produce a number of data results in the system.
If we were to look at the details of a return, this would be simply an example of the form that was originally filled out by the person processing the return. Again, there’s a lot of data that can be used to categorize that return.
And then as per the point of the system, we’re trying to tie this into some of the 9100 C key additions. And within the 8.2.1 customer satisfaction section, it’s stating that the information monitored and used for the evaluation of customer satisfaction should include, but not be limited to, things like product conformity, on-time delivery, customer complaints and corrective action requests.
So to that end within Plex, our view is that if we can condense all of those or link them into a single system as much as possible, we will do that by joining those business processes together in the system.
As part of the return, you’ll see that there’s a link at the top to our document control system, which we’ll be talking about in a little bit, so if we need to attach any evidence documents from the customer as part of the return, that can be done.
We can categorize that return’s details as we have them and then also link it to the other activities that are going to take place, such as the actual receipt of the material when it comes back in from the customer. So we can register the return and then track it until such time as the actual product has been returned to us, tie it to the accounting processes in the company so that we’re deciding whether we’re going to create a credit to the customer or return the material to them, give them a replacement, and then furthermore, per some of the changes in 8.2.1, the corrective action request can be tied directly to the return.
There’s a mistake-proofing method within Plex that says when a customer return is created, we automatically create what we call a ‘problem number’ or a nonconformance within the system.
Here’s an example of a form that can be initiated at the time of return and then through the course of the proper workflow and problem-solving methodologies that your organization employs, you have a system of records that’s tied directly to that or an evidence document of corrective action.
It’s not in a separate quality system, it’s in one single system that will allow access not only by the person entering it, categorizing the return, the ability to attach documents and images along the way, but as you scroll down the screen further, you’ll see the link, again, back to the customer return, links to then ongoing problem solving, like team definitions – so these are all users of this system – as well as due dates and then whatever. In this case, this example form is kind of a standard problem-solving methodology of an A/P which goes through and allows you to add containment actions, certainly the very important root cause process and corrective action and the tie-in with preventive measures like FMEAs and ongoing control plans.
This is a great example of how the system within Plex looks at the process of customer satisfaction not just simply as a series of documents or independent activities, but an all fully-integrated process in the system.
The forms themselves within Plex are very flexible. Customers can design their own forms. Again, this is just one example of the problem-solving methodology. There’s a number of reporting activities that can be done against this as well, like we saw with the return itself.
There’s also the ability, as I mentioned, to have links to documents. This link up at the top links to our document control system. Some of these other icons give some indication to the workflow and processes that are involved, including the ability to communicate very rapidly from the system. So if a customer is looking for an update, if they don’t directly have access to Plex, which is possible, you can email them a portion of the information that they’re looking for, in this case, a specific corrective action that’s taken place.
So if we wanted to attach all the documents included, we can submit that and an email will be prompted to go out to the customer with all of those appropriate documents attached. And then it’s saved in the communication log for the customer relationship management system within Plex automatically.
Again, those that are not involved directly in this process would have access in the CRM system to see a centralized location of all communication activity with this customer.
If we look at the document control system, you’ll see this image that’s been attached, but there could be certainly many more documents attached. This is a nice segue into our second topic, which is around the control of documents and records.
Hopefully this gives you a good sense of how within Plex finding objective evidence to support the audit or for customer requests and to support the customer satisfaction effort is extremely efficient.
What I’m going to do is move over to another company, a sister company in this case. Within Plex, you have the ability, depending on the size and setup of the organization, to have multi-plant or multi-divisional capabilities. They can have visibility to each other, interplant transfers, consolidated financials.
I’ve moved over to another company to give you a sense for that flexibility as well as to show how the system can be configured differently based on how different divisions may operate independently.
Within our second bullet that we talked about in terms of control of documents and records, one of the key changes within Rev. C is the emphasis on the increased accessibility of documents.
What I’d like to discuss are really two main things. If we look within this organization, again, we have a quality management module. You may notice a few things different here than what we saw in our prior company, or our sister company, and that’s that one of the things that can change quite a bit are terminology. There’s a lot of different configurations that can take place for specific terminology used, not only division by division, but also within different languages. So Plex can be displayed in multiple languages, and our customers have control over the terminology used in each of those languages for their organization and the industries that they serve.
If we look at the quality management system in general, there are a number of supported functional areas, of course one being the document control system. If we look at the document control system, at first glance, it’s a pretty straightforward document control system with the standard requirements that you might expect, the ability to set up folders to group documents; very unique within Plex given that we’re a software-as-a-service delivered model.
These documents that are stored within our data center are very secure and have an extremely high level of backup and redundancy. So the safety and security of those documents, not only from a general security standpoint, but also from a data security standpoint is very world-class.
And for those organizations also, given that AS9100 Rev. C expands the scope to defense contractors, there’s an element of security around things like ITAR compliance that is also supported within Plex to ensure access to documents is appropriate.
If we look in the example of a folder such as this one called ‘Phoenix Documents’, you’ll see some pretty typical documents that you might store, some spreadsheets, some images, CAD drawings, videos, work instructions, standard operating procedures, really any type of document can be stored within Plex.
Then given the appropriate security by a user, some may have the ability to edit, as you’ll see if I go into edit mode up above, which expands the details of the documents in this summary table.
So for these top two documents, we can see we have a couple of PDFs, we have revision dates, which revision we’re on. Down below, you’ll see there’s a revision pending. So it has the full ability to track revisions of documents themselves, the checking in and checking out of those documents. You can see that this one was checked out be me and it’s still checked out, so anyone else going into the system to look at this document would see the prior version, if that’s how we set up the system, but not what I’m currently working on.
Then there’s a full approval and workflow around checking that document back in. So I may be the ultimate approver when I check that document in or it could go through a series of workflow steps to ensure that the appropriate approval is being taken place.
Similarly, there’s an administrative mode around the document control system that gives even more detail to show for those appropriate security and secure users the ability to look at all those documents that are checked out, by whom, at what point in time, and all documents that are currently pending approval. This gives you a glimpse to the approval system. There can be one or many approvers on a document or through a series of workflow steps that once one approves, it would go on to the next person for approval in the system.
Documents can be added to Plex in a number of ways. When we click the Add button, you have the ability to upload documents directly from a remote location as well as pointing to other servers and having things like documents scanned directly in off of a scanner. That’s very helpful for things like tracking material certifications from suppliers or other evidence documents that have been supplied to you on paper that you want to have electronically stored in the system.
So that’s a basic view of the document control system in general, just to give you a good sense of the robustness of the application.
But the real key, again, relative to Rev. C and what companies are trying to do in terms of improving processes and making the system as lean and efficient as possible is to increase that accessibility of those documents.
If I was looking for a document like a CAD drawing or an image of a product or a part that was very specific in the system, I could hunt through these different areas to find where were it may have been stored. So you may come up with a hierarchy to say, under the Phoenix Program, we have all our products and then our bill of materials, and then you could have a bunch of subfolders and whatnot which would logically organize those documents.
Plex has a very unique feature called ‘universal attachments’. We have a universal attachment system that would say that if I’m an everyday user that’s really not quite sure about what that hierarchy is and how those folders are structured, we have the ability to automatically create a folder called ‘universal attachment system’ around the various business areas of an organization; customer information, supplier information, product information. These universal attachment documents are accessed not necessarily through the foldering system.
Let’s go back to our main menu and look at the actual application and the use of the system.
We’d be looking at the engineering system, for example, and say I may be looking for that drawing associated with a part. So if I go into my engineering part list, I’ve pre-filtered on part types of gear, and when I do my search, I have a list of those parts. So I can look for documents associated directly with products and how they’re attached to those products.
So that accessibility can be just a couple clicks away. I know the part that I’m looking for, I filter on it, I find it in my system, and to the right, you’ll see the document control system. I click on that, and there’s my 3D model drawing of this document.
Within a couple clicks, I can get to that controlled document that’s tracked in the document control system, the revision that it’s at, a quick glance to the approvals and see if there’s any current edits going on with that document.
That accessibility to everyday users who may not be familiar with the folder hierarchy is very key. So that applies not only to parts and products and engineering, but throughout the entire system whether it’s human resource data, customer order information, return detail, supplier score cards, those kinds of things can be very quickly found through the joining of these documents to comprehensive database elements that users are more likely to be familiar with like their parts, processes and routings and those types of things.
If we look at this part in detail in the engineering system, this gives you another perspective of the integrated nature of Plex. So as we’re identifying products through the development process, we’re going to begin managing the product information, the current revision of that particular part, the status of it. It’s starting to collect the detail as this product gets closer and closer to first article and eventual product launch. So we’re developing the engineering data, but right alongside that, we’re building upon that data as a foundation for all the other operational areas that are affected by that product.
One of the themes in Plex is to have a single source of the truth, a database that contains all the detail information of a product, and then to not have that data replicated or redundant in other systems. That’s an inefficient process that can lead to inaccuracies and conflicts in data.
Within Plex, if we look at this particular part, we have a process routing of how this product is particularly made and as it goes through its operations that are defined by engineering, through the production process that can include subcontract operations and internal operations. Those are all defined as part of the core process along with the bill of material of a particular product.
As we go through that step, we’re building upon that effort that was done to offer quality documents. Some of the quality document authoring that’s done in Plex is done directly in the database as opposed to, again, having traditional documents or forms that are filled out and then stored in the system.
If we look at things like control plans and product flowcharts, those are kind of built along the way as you’re constructing the data in the system. So part specifications along with the process routing can help define control plans for the document, the inspection steps as defined in the system are made and we’re automatically authoring documents like check sheets that are rendered to operators in a paperless fashion, electronically, directly on the shop floor.
So that’s, again, a review of the document control system, the increased accessibility to those documents, but also a segue to our final topic today, and that’s the monitoring and measurement of these processes that are built around the product and leveraging the effort that’s been put into that to have a mistake-proof system around that.
If we go back to our sister company and we look again at a similar view of the world, we go into the engineering system of this organization, look at the part list, perhaps filter on a particular product in the system, you see we have a very similar view of a product. We have its process routing, bills of materials, the submenu that we just looked at, and all of the quality information associated with this specific part.
If we look at the quality menu and module as a whole within Plex, you’ll see that we can access all of those independently, not only the part lists, but part specifications, process flowcharts, FMEAs, control plans, all those core quality documents can be accessed and authored directly in the system.
It’s that effort that goes underway to tie all those together that allows us to then in real time communicate that to the operational organization where that activity takes place.
The way we do that in Plex is that like we have an integrated CRM system, an integrated customer returns and problem control system, we have an integrated manufacturing execution system within Plex. So as this engineering data and quality data is built and modified through continuous improvement and engineering change types of activities, we’re communicating that directly to operators on the shop floor in a production environment through what we call a ‘control panel’. The control panel in Plex is, again, a touchscreen enabled paperless environment that presents to the operator all the information they need to know to perform their operations and communicate in real-time with the system.
From a quality standpoint, segueing from those documents that we looked at when we authored the control plans and process sheets for a particular document, since it’s in a database, you can see that the operator, as they’re producing this product, can be notified through stoplight-type exception notifications like yellow colors that they need to perform an inspection.
In fact, there can be mistake-proofing put in place to say that the operator, if they don’t perform a particular inspection or work instruction step, that they would be unable to actually record the production of the product in the system, and that builds into the integrity of the data.
If we look at the in-process inspection for this particular product, you see it renders the check sheet in real-time that came from the authoring of this quality document. There are a number of features that can be activated within Plex depending upon the level of rigor that you would want to put into this process.
One example here is you’ll see a red alert – there’s a quality alert on a particular product. We would highlight deviations in the same manner with the deviation control integration within Plex. That’s all done programmatically in the database.
By having this in a database-driven system, this is a great example of how the effort that you put into documenting the objective documents around required procedures can be leveraged and gain a huge return on that effort by simply putting that into an electronic integrated system like Plex.
If an operator is measuring around those specifications and something is measured out of spec, they’ll immediately be notified during the process that something they’re measuring is above or below a particular control limit that’s been identified by the quality engineer.
So this real-time feedback to the operator, whether they’re manually taking measurements or rather they have an integrated system like a CMM or other calipers that might be electronically integrated into the system, can immediately alert them of a potential product that’s out of spec.
Directly accessed to the right is a link to the reaction plan, which can be in the document control system, more details around that. We can go even a step further to completely lock the operator out of their work center where an email could be directly sent to a quality supervisor at this point in time for assistance in dispositioning the issue.
If we went through the process, we could take the measurements, fill out the full check sheet, that gets added into the system and becomes part of the system of record for that particular process.
Those are tracked and then added to the SPC system within Plex for further analysis of that data. Again, as specification changes and product definition changes take place, they’re immediately communicated down to the operator on the shop floor so that that paper shuffle and a potential for people to be operating on old information is eliminated quite a bit.
We won’t spend a lot of time on all of the features of the control panel, but as a quick review, the operator not only has access to that inspection information directly related to the authoring of quality documents, but also to the scheduling side of the organization so we can see what job is being run right now. If they click or touch in this area on a touch screen, they’re taken to the scheduling screen. This is just one example of a job-driven scheduling screen within Plex. We have a number of these depending on how scheduling operations are managed, including a Kanban-driven work center, for example.
This is very flexible, but it’s again accessible by the operator to quickly see that once this operation is complete, they’ll move on to the setup or process of the next scheduled job and operation at their particular work center.
Each of these areas of the control panel allows access to a particular functional area, whether it’s to get instructions or to give feedback back into the process.
One of those is the ability to change what’s called the ‘work center status’. The operator can either touch this area and say, I’m going to take my work center into another status, like, I have a failure, an issue, a problem, a setup operation is taking place. What that allows us to do is very accurately track the efficiency of work centers. If we know what the status of a work center is and what job, part, and time of day it was, we can very specifically track not only operator efficiency but work center efficiency and have some standards around productivity and OEE types of reports.
This work center status can even be integrated into PLC types of controls so that the equipment that’s in play at this particular work center has an integrated intelligence that can communicate what its status is, will automatically change the work center status from production, to down, to idle, or whatever the appropriate status might be for an even more accurate and dependable view of the data.
All of that information is tracked in a work center log, so you can go back at any point in time and report on all of the activity around a work center, including the production that takes place. The operators are able to then record the production. There are many different ways, depending on the product and the process of recording production, but one is actually having the operator indicate that they’ve filled a container, they’ve completed a process. You’ll see in this particular case, we have a large job that is partially complete and it still has an open balance of that. Each time the operators complete the activity of reporting production, we have a recorded history of that production.
Within Plex, we have a very rigorous method of tracking inventory in real-time. There’s a high degree of visibility of the work-in-process inventory as well as raw material, purchased components, and finished goods. So from door-to-door, we have a very rigorous process of tracking material and the operations that it goes through.
In this case, we can see that at this particular work center, there was some production that was produced of 20 pieces at a specific time, at 10:17 A.M., and some cursory data around that product, including in this case what’s called a serial number. This terminology is often changed to something like a lot number or a case number or whatever the appropriate term would be. But in this case, we have a container of 20 pieces that we can link into and get even more detail about that particular inventory; where it came from, where it’s going to, who produced it, at what point in time, integrated bar coding so that this can be scanned to move it through its process, and a full history on that product into things like the quality checks that were done against that product, what the history of this material was as it went through its processes, and even a link to the genealogy of this product through what we call a ‘traceability tree’.
This particular container of 20 pieces is sitting here at the hot form operation and it was comprised of two other components that came together, whether this is a simple assembly or an overmolding type of a process where we’re taking material and joining it with another. You’ll notice that each of those source components or source materials have their own unique identifier of serial numbers.
If we click on those, we’re able to do a backwards and forwards genealogy and traceability in the system to see that we may be working on this particular product here, but some of the others that have been produced, whether it’s been today or in the past, have different statuses. So if we have something that is nonconforming, we can very quickly trace it back to the source material, and if necessary, quarantine all of the rest of the product that came from that batch or lot or click into the details of these and understand that this is material that’s gone into the field, it’s at a customer site, and we need to notify them in advance of getting that customer return that we started the demonstration with. We can be proactive potentially and let customers know that we may have discovered an error in some material or a process or a nonconformance in the system.
That kind of brings us full circle to where we started, that the collection of this data really is a fully integrated process. These activities like monitoring customer trends and activity, tracking documents and measuring the processes and products that go out the door are not things that happen independently and on separate islands, and really to leverage the full intent of continuous improvement and best practices that are set forth in standards like AS9100 can really only be achieved when you have a robust integrated system like Plex.
So with that, I think that covers the main topics we wanted to discuss today. John, I’ll turn control back to you and we can either field any questions …
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