6 Ways Paperless Manufacturing Can Help Your Shop Floor

A paperless manufacturing system can quickly and easily deliver even more benefits than you might think.

By David Oeters, Corporate Communications with CIMx Software

Ensure an early ROI for your project by focusing on items with the greatest return. Illustration by www.colourbox.com

Ensure an early ROI for your project by focusing on items with the greatest return. Illustration by http://www.colourbox.com

Many companies begin researching paperless manufacturing to solve a single problem.  Depending on the problem, paperless manufacturing likely holds the solution.  No other shop floor investment addresses so many of the challenges manufacturing faces.  Which is why manufacturing firms spent more than $5 Billion on MES and paperless manufacturing solutions in 2013, and estimates predict the MES market will expand more than 20% annually.

But, a powerful and capable paperless manufacturing system offers more than just a single solution or capability.  With the right system, you have workflow control and complete shop floor visibility.  As you consider a system for your shop floor, take a look at the six capabilities that provide the foundation of any paperless system.

1)      Track, measure, record and dynamically manage work flow.

Every manufacturer must track and manage workflow – it’s the key to a production system.  The methods used to manage work vary between manufacturers, and can lead to vastly different results.

With paperless systems, work flow is digitized, allowing automated tracking and recording of work.  Management of the work flow is made possible with instantaneous communication and error-free work instructions.

2)      Create production plans with approved, accurate work instructions.

Operations benefit from standards, best practices, and process improvement plans such as Lean manufacturing and Six Sigma only when they are implemented in production.

Using a paperless manufacturing system, procedural enforcement ensures the productions team incorporates best practices on the shop floor.  Planners use only the most recent and approved plans.   A library of approved work plans, best practices and standards ensures your team completes planning in less time and with better work instructions.

3)      Collect data on all production operations.

Data is a valuable commodity.  Unfortunately for many manufacturers, the age and inaccuracy of collected data significantly limits its usefulness.

A successful paperless system collects real-time data at each work station.  The system automatically verifies specified quality metrics fall within acceptable ranges.  The collected data becomes a valuable tool for manufacturers.

4)      Create a complete, accurate production record for all products.

The production record includes every action taken, every specification read, every training module referred to, every log in and out on a job, and every measurement taken on a product.

Most (if not all) manufacturers monitor shop floor activity, but an effective paperless solution automatically creates a comprehensive production record used to verify all actions were completed accurately.  This unified record, compliant with all regulatory body or key customer standards, provides a rich source of accurate data for future use.

5)      Have a continuous real-time view of all open work orders.

In the past, a real-time view of production meant walking around the shop floor asking questions.

With a paperless system, manufacturers can get a comprehensive, real-time view of production.  Current work can be seen in the context of actual work flow order at each moment.  This real time view is invaluable to plant management and quality assurance, helping proactively solve problems and ensure smooth production.  It is a major component of business intelligence.

6)      Enable seamless communication across the enterprise from a single source of truth about production.

Many companies struggle with data coming from multiple locations with no coordination, and often communication focuses on building consensus rather than manufacturing.

Paperless manufacturing is built around the concept of a single source of truth about the product.  Everyone works from the same data and toward the same goal.  The solution has the flexibility to manage, record, and distribute information from multiple sources, eliminating mistakes from faulty information while managing WIP all the time.

Delivering Benefits and ROI with Paperless Manufacturing

Process Improvement graph.

No other shop floor solution addresses so many production challenges, or offers a bigger benefit. Illustration by http://www.colourbox.com

With paperless manufacturing, companies reduce quality defects, eliminate human error, minimize waste and scrap, and increase productivity.  The system delivers shop floor control and visibility like no other product on the market.

Current trends in manufacturing are pushing companies to adopt paperless solutions.  Customers demand more customization and quicker turnaround times through smaller production runs.  They expect real-time information on the status of their orders.  Paperless manufacturing offers a clear advantage over paper-driven processes in delivering these goals.

Want to learn more, or to see what paperless manufacturing can do for you, then contact CIMx today.  We’re happy to help.

Understand (and Increasing) the ROI of your MES

Many companies wonder where the inflection point will be for their paperless manufacturing project.  Let us show you how you can design a project that gives you control of your ROI.     

By Kristin McLane, President of CIMx Software

I spoke to a group of prospects about the inflection point in an ROI – the point where project costs (in licensing, services, training, support, and internal resources) equal the cost savings generated by the paperless manufacturing system.  As we talked, I realized there are many misconceptions about ROI, misconceptions that lead to more frustration than certainty.

Unraveling the ROI Conundrum

ROI is a tricky thing.  The term is so overused some believe it’s more like the accounting

Often misunderstood, the ROI is a vital component of any successful MES project. Image by www.colourbox.com

Often misunderstood, the ROI is a vital component of any successful MES project. Image by http://www.colourbox.com

Easter bunny than a data point.  Despite that, ROI is more important than ever to control project cost.

Over-engineering is prevalent in the MES industry… some vendors want you to add one more feature or capability, because it adds to their bottom line.  These vendors design fancy, flashy demos, post pretty YouTube videos, host elaborate conferences, with fancy marketing collateral, and even pay bloggers to help sell their services so they can offer module after module and entice you into buying more.  Let’s be honest, none of that will provide you the cost savings to justify the investment.  Without a clear ROI, you can’t be sure if the additional costs will offer a return.  You might be the poor customer with a bloated service bill helping to pay for the YouTube videos and marketing collateral.

With enough time and money, anyone can build anything, so vendors make promises that can’t be achieved except through costly custom services, even as they promise their system is “configurable.”  The higher the final cost, the more difficult it will be to achieve an ROI.  Don’t be fooled.  If extensive services are required – it is not configuration.  Configuration is done by the software itself – not by the expensive implementation team you are renting.

Here’s a tip for discovering how “configurable” your potential software solution really is – ask the vendor what percentage of the installation services are related to configuration.  Ask them how configuration changes are made.  Do you need the vendor to make changes?  If the configuration services are a large portion of the total service cost or an expensive line item on the itemized proposal costs (you should ask for those, too), then you shouldn’t expect an early ROI.  As you start adding up the costs, the inflection point may not even be visible.

An Honest Look at Projected Savings

Some vendors will offer “suggestions” on how to calculate the ROI, but you need to be careful.  We do not sell, nor do we recommend, customers rely on reduced headcount to calculate ROI.  It is tempting to build a business case on a reduced number of resources, as they are the most costly line item on your production P&L.  But that’s not really what happens…

You have more control over the ROI of your paperless manufacturing project.  Let us show you how.  Illustration by www.colourbox.com

You have more control over the ROI of your paperless manufacturing project. Let us show you how. Illustration by http://www.colourbox.com

Take your most experienced Quality Engineer.  In many cases, this is an employee with a hectic schedule, and yet is underutilized for their training.  Manufacturers need QEs to implement Continuous Improvement initiatives, but if your QE is running around the shop floor, fighting fires and trying to stay ahead of the next problem, then they aren’t being utilized efficiently.  A well-designed MES system will greatly improve the efficiency of the QE, allowing them to implement improvement plans and build new, more efficient processes for your shop floor operations.  The net effect is an entire production team that’s more efficient and more accurate.  You may find that you don’t hire to fill spaces as operators leave (and the least capable may leave as the system begins tracking shop floor efficiency), but it isn’t common for MES customers to see large gains from reduced headcount.

Maximize the Inflection Point

So, if reduced headcount is not a key factor in projected savings, how do you maximize the inflection point and increase your ROI?

At CIMx, we focus on generating ROI for our customers through understanding their workflows and providing value in more efficient work.  Our system is behavior-based, not template- or module-based.  The software provides value through your workflows and best practices, enhancing behavior rather than changing the shop floor to adapt to a new system. This is possible through the use of our architecture.  Unlike modular or template-based systems, workflow or behavior-based MES utilize a system architecture that gives customers the flexibility and tools they need to implement automatic and ever-increasing efficiency improvements to their workflow and processes – changes that have the greatest impact on your shop floor.  By not focusing on isolated, individual requirements, capabilities or functions, which can drastically increase the cost of the system, customers manage the inflection point and ensure an early ROI by focusing on the total workflow process and the largest gains.

The key is to manage what you spend on the project, and focus on items with the greatest ROI – your workflow.  Complete the installation in manageable phases that provide a planned and measurable return, and identify future expenses for the system that could impact the ROI.  The next time you have an improvement event in your business, will the system support the improvement, or must you purchase expensive assistance with customization?  If you can perform the necessary business improvements without an expensive services contract from the software vendor, then you can maximize the inflection point and your ROI.

This doesn’t mean it’s not tempting to create a massive requirements document that resembles a manufacturing wish list.  You should identify key capabilities, but make sure there is an expected ROI attached to each.  Then take a look at the workflow using the system, and identify improvements and benefits there.  It’s those benefits that will generate your greatest ROI.

If you want to see how we can deliver savings and increase profit through workflow efficiency, contact us or give us a call – we’re happy to help.

Care and Feeding of Your MES or Paperless Manufacturing System

Maximizing the ROI and benefit of your shop floor system isn’t hard, if you plan for regular upkeep and maintenance of the system.

By David Oeters, Corporate Communications with CIMx Software

This spring, I planted a garden in the back yard.  With the kids, I tilled the ground, added fertilizer and topsoil, put up tomato cages, and carefully planted seeds.  I’m happy to report, our efforts worked.  In just a few days we saw new growth peek out of the ground.  There are leafy green lettuce, prickly tendrils of cucumbers, and tomato vines slowly making their way up the cages.

Like any garden, your paperless manufacturing system requires a little attention to continue to operate efficiently.

Like any garden, your paperless manufacturing system requires a little attention to continue to operate efficiently.

But, here’s what I’ve come to learn… planting a (successful) garden requires some work!  We now have a “watering schedule,” and each night one of us takes the hose and waters the garden.  On the weekend, we pull weeds.  We’ve added more stakes for the wayward tomatoes that want to grow out, not up.  Keeping the belligerent cucumber in line is daily task.  But, we’ve already made our first salad from lettuce in the garden, so the diligence in our upkeep is paying off.

I see a lot of similarities between an MES or paperless manufacturing system and my garden.

Any good MES (or garden) project starts by studying your current processes and work flow, then formulating a requirement list.  Then you have to plan the project, coordinate schedules with your team, gather the tools and materials and put it all together.

But the work doesn’t stop with the installation, which I didn’t realize when the garden was planted.  You need to keep the system up and running with regular maintenance.  Change is constantly happening on the shop floor.  There are new processes, new technology, new tools and new employees.  Every change subtly alters how you might be using the system, or how the system might be supporting your shop floor processes.  This is where simple upkeep and basic maintenance can have a substantial positive impact on your investment.  Here are a few basic tips to keep in mind as you evaluate paperless manufacturing vendors or plan your own installation:

  • Is there a cost for patches?  Face it, with any complex computer system there will come a time for a patch.  It’s part of the basic maintenance of the system.  Find out if there is a cost associated with a patch.  Does the system you purchased have a patch, maintenance and upkeep plan, and who is managing it?  How will it work?  These answers will have a direct impact on the ROI.
  • Make sure your MES vendor offers value when it comes to upkeep, maintenance and upgrades.

    Make sure your MES vendor offers value when it comes to upkeep, maintenance and upgrades.

    What about upgrades?  As new technology is introduced to the market, new features and functionality will be available for the system.  Before you install a system, look at the cost (if there is one) for an upgrade.  Some systems offer upgrades free of charge (or for a minimal cost), ensuring you aren’t looking for a new MES or paperless system every few years once your current system can no longer adequately support your shop floor.

  • How much does basic service cost?  Even if you aren’t planning on making any changes or updates to the system now, there may come a time when you need a basic service.  These services could include a custom report, an integration to another system, or a data migration.  Look at the service costs when evaluating vendors.
  • Does the vendor offer a schedule or price guarantee?  If not, then keep in mind the initial project estimate may not resemble the final price you pay for the system, especially if you are charged for the basic upkeep such as patches or continuing training.
  • Can your team configure or customize the system?  Face it, some vendors will charge you less up front, knowing that you must turn to them for any configuration or customization to the system.  Ask about the administrative functions of the system, and how the configurations are handled.

Many of these questions seem simple, but the answers will have an impact on the final cost of your paperless manufacturing system and the ROI.  Even as you install the software, change is happening, affecting the overall effectiveness of the system.  Basic maintenance through patches, upgrades and further training, will help ensure the software continues to deliver positive benefits to you and your team.

Think of it like the garden… without basic upkeep, the cucumber would slowly strangle the tomatoes, weeds would overwhelm the lettuce, and a few days of no rain would turn the leaves brown.  A little bit of work ensures a healthy garden and a continuing ROI (and no one wants their MES to strangle their ERP).

Questions, or want to see how CIMx helps our customers optimize their system with a dedicated product engineer?  Give us a call or leave a message, we’re happy to help.

The Land of Paperless Manufacturing

The beginning adventures of a stranger discovering the world of paperless manufacturing.

By Lisa Kessler, Product Support with CIMx Software

Stepping into the world of paperless manufacturing can be bewildering at first, but we have the answers. Image by www.colourbox.com

Stepping into the world of paperless manufacturing can be bewildering at first, but we have the answers. Image by http://www.colourbox.com

The Wizard of Oz is one of my favorite movies.  The mystifying, bewildering, moment when Dorothy lands in Oz fascinates me – discovering the world is much larger, more amazing and more magical than you thought.  I find myself relating to that moment – not only because my short frame makes me feel like a munchkin, but because I’ve landed in the magical land of paperless manufacturing.

A short time ago I joined the team at CIMx Software, the leader in paperless manufacturing.   I packed up my desk at my previous job and made the journey (which didn’t involve a tornado) to CIMx.  When I started, I knew a little about paperless manufacturing, but the truth is – there was so much more I didn’t know.

The first few weeks I sat during meetings and listened intently.  I thought everyone was speaking a different language. KPI, ROI, servers, platform, as-builts… it was difficult to keep it all straight.  I kept thinking, if I only had a brain! There were no wicked witches in this new land, but there was plenty of wicked tricky software and manufacturing technology terms and ideas to learn!

I started writing down everything I could, so many acronyms, MES, SaaS, ERP, NDA, DBA, TCO, the list goes on.  I Googled everything, asked questions every chance I got, and slowly but surely it began to make sense.  It all sounds bewildering, but understanding what we do isn’t difficult at all.  We help manufacturers improve their business by managing their work flow – providing the right information to the right person at the right time.  We help keep track of and record all the data and processes that go into building stuff.  We do this by implementing low-risk, low-cost software solutions, delivering shop floor visibility and control, helping companies eliminate errors, improve quality, and increase profitability.  Ta-Dah!

Making Sense of MES and Paperless Manufacturing

Looking for answers?  We're happy to help.  Send us a message and let us know what we can do.  Image by www.colourbox.com

Looking for answers? We’re happy to help. Send us a message and let us know what we can do. Image by http://www.colourbox.com

There is a lot that goes into the software we install, but I’m not a software developer.  But, I do know this; CIMx is innovative, always wanting to push farther and higher in the land of paperless manufacturing.  We’re constantly looking at how people work, and what they do with our software, and how can we can help them work better, faster, and with fewer errors.  It sounds simple, but it’s what drives us (it feels good to say, “us” there).

We really aren’t satisfied with the status quo; we’re constantly looking to improve.  It starts with our customers, and their business.  We don’t just build software, we build relationships and work with them to solve problems and improve production. CIMx stands behind their products, and is proud of the work they do (and so am I).

At the end of each day I don’t feel the urgent need to click my ruby red slippers and say “there’s no place like home” because the land of paperless manufacturing isn’t so bad.  It’s exciting, and we really are making a positive impact on our customers.  I’m still learning every day, and I’m sure I will continue to learn every day in the future.  Manufacturing is always changing, and there is always something more to learn.  That’s one thing I love about my job.

The author of The Wizard of Oz, L. Frank Baum, said it best “No thief, however skillful, can rob one of knowledge, and that is why knowledge is the best and safest treasure to acquire.”  I love learning and building my knowledge, especially about an industry and company you can be passionate about.  We’re excited to utilize the latest technology, to find new ways to deliver value to our customers and manufacturing, bridge the gap between the software and technology world and the manufacturing shop floor.

It’s a cool place to be.  Questions?  Give us a call.  We’re always happy to share our knowledge.

The Future of Medical Device Manufacturing

As companies work to comply with changing regulations in the Medical Device industry, there is an opportunity to improve production and revenue for the savvy manufacturer.

By Anthony Cuilwik, CEO of CIMx Software

Change is happening across the Medical Device Manufacturing industry.

With the right tools, you can meet the new manufacturing regulations and improve production.

With the right tools, you can meet the new manufacturing regulations and improve production.

Additional standards are being implemented at an accelerated pace across the industry.  There is a push for electronic medical records to increase collaboration and improve patient care.  Hospital facilities and medical treatments are under increased scrutiny.  In addition, globalization of medical device production, the rapid development of new treatments, and a focused push to lower the cost of treatment are just a few of the reasons the industry must adapt and adjust to new regulations, standards and processes.

In fact, in a recent survey, 43.3% of medical device manufacturers reported changing regulatory environment as the biggest challenge they face in the future.  Companies are looking at cost efficient ways to, “… navigate the increased regulatory burden,” according to another industry report.   New standards require more detailed and careful labeling, dating, use-by dates, sourcing, detailed manufacturing records, and accountability, resulting in tightened production constraints and record requirements.  To comply, manufacturers must adopt new processes and utilize new tools.

At the same time, changes in the medical device industry are pushing manufacturers to lower cost and standardize production for a global market, while absorbing a new tax on medical devices.  As the population ages and the cost of healthcare increases, everyone must look at ways to make healthcare cost effective and more available.  To meet these goals, manufacturers must adjust their operations to improve production, lower cost and increase quality, while accommodating new regulations.

Market Pressure Driving Solutions

Outdated paper-driven shop floor processes don't offer the solution medical device manufacturers need.  Image by www.colourbox.com

Outdated paper-driven shop floor processes don’t offer the solution medical device manufacturers need. Image by http://www.colourbox.com

The current paper-driven manufacturing shop floors in the medical device industry simply cannot efficiently comply with the new regulations while increasing production, improving quality, and lowering cost.  Research has shown paper-driven processes increase costs, introduce errors, and create compliance issues.  In fact, 75.9% of companies reported significant business risks due to inefficient document-driven processes, including paper-based processes.

More than increasing risk, paper-driven processes significantly increase costs for businesses.  As reported by Oracle, a study by the Association for Information and Image Management (AIIM) found businesses, “spend $20 in labor to file a document, $120 in labor to find a misfiled document, and $220 in labor to reproduce a lost document,” (www.aiim.org).

Paperless Manufacturing or MES (Manufacturing Execution System) is a software solution used to manage, control, and document manufacturing operations.  A successful MES project improves productivity and profit by managing all the information needed during the manufacturing process, collecting and documenting all production data and ensuring real-time access to the production information.  No other manufacturing solution can have the profound and beneficial impact of paperless manufacturing.

MES systems have been used (successfully) in aerospace and other regulated manufacturing industries for many years, helping manage and collect the information necessary to comply with standards and regulations, while helping make production more efficient, less costly and faster to market with higher quality product.  Paperless solutions are delivering the same results and benefits to the Medical Device Manufacturing industry.  For example, these solutions offer electronic sign off, automatic data collection, process control, parts traceability, and use electronic record management, among other tools, to alleviate the regulatory constraints challenging the medical device manufacturing industry.

Adding Value to the Medical Device Manufacturing Industry

The 21 CFR Part 11 regulations from the FDA specify how to create and manage quality production records in an electronic system, providing clearly documented accountability for quality checks and production methods that meet all specifications for a product.  Similar regulations exist in the aerospace industry where MES and paperless manufacturing systems ensure regulation compliance.  The ability to complete work more efficiently and accurately, and provide continual process improvement through monitoring and analysis of collected data adds to the value of the software solution.  In aerospace companies it has been proven that a paperless solution provides regulation compliance, process improvement and quality improvement at significantly lower cost than using a paper-driven process.

Paperless manufacturing offers a holistic solution for manufacturing, addressing many of the challenges facing the shop floor.  Image by www.colourbox.com

Paperless manufacturing offers a holistic solution for manufacturing, addressing many of the challenges facing the shop floor. Image by http://www.colourbox.com

The current Universal Device Identification (UDI) regulation provides standards for the barcode labeling and dating of medical devices and products in general.  Because barcoding standards are different worldwide, any system that provides labels must be flexible enough to meet requirements in each country the product is shipped.  In a paper-driven shop, meeting these requirements can be costly, resulting in a number of potentially disastrous errors since there are small differences in standards that are easy to miss through quick visual inspection.  A paperless system will help ensure compliance with these regulations by managing data in production and eliminating these errors.

Global competition and a push to lower medical and healthcare costs are also pushing change in the industry.  Medical device manufacturers are increasingly looking toward platform manufacturing to reduce cost and speed time to market.  Platform-based manufacturing uses the same base frame or core parts in a variety of products to meet different requirements or price points in different countries.  Precise control of parts used in production can be accomplished more accurately and consistently using a paperless solution that validates all parts and verifies processes throughout the production process.

Value of Paperless Manufacturing

While each manufacturing operation is different, paperless manufacturing has been delivering increasing value to aerospace production for years by ensuring all production records are accurate, complete and available for analysis in real time.  Quality issues can be identified and fixed immediately.  Specification deviations are recorded and repaired or replaced immediately.  Shop floor management uses the system to monitor and control work processes, and enforces and promotes process improvement.  On the other hand a paper-driven shop floor is restrictive, error-prone and an increasingly costly way to deliver products.  Paper records or PDFs hinder the ability of a company to analyze shop floor work flow data for continuous improvement, making it almost impossible to fully implement modern process improvement programs.

When looking at shop floor solutions to ensure compliance with regulations, take the opportunity to find solutions that do more than simply meet immediate needs.  See it as an opportunity to significantly improve your current production and position your business for future growth.  Ask yourself, can you afford to continue manufacturing in a paper-driven environment, or is it time to examine paperless solutions?

What Can You Learn About Your MES and Paperless Manufacturing Vendor?

With 5 simple tips, you can learn a lot about a manufacturing software solution before you ever sign a contract.

By Kristin McLane, President of CIMx Software

With the wrong MES or paperless manufacturing vendor, your project could resemble a giant pile of dirt hindering production efficiency.

With the wrong MES or paperless manufacturing vendor, your project could resemble a giant pile of dirt hindering production efficiency.

I have called a dozen landscapers to move a large pile of dirt in my backyard.  I still can’t get a return call or sales appointment.  I don’t have the tools or the expertise to move the dirt.  I’m at the mercy of the vendors.  How is it that I can’t find a single company to call me back?  I’m realistic – I know there are times you can’t take on new work, but a simple phone call is all I want.

What message are these companies sending to potential customers?  I don’t want to sign a contract without knowing they will deliver on their promise.  What confidence do I have in their work if they can’t even be bothered to give me a call?

I’m constantly amazed at this same lack of follow-through in the software industry.  Too many prospects tell us we were one of the few (or the only) vendors to call them back.  How is that possible?  We’re never too busy to help, and we’d love to grow our business while helping you grow yours.  It’s not that we don’t have a full calendar – we are blessed with a full pipeline of work and high standards for our product.  We want to build the system features that continue to make our products more robust, user-friendly and dynamic, and that takes time and effort.

But, we also know how frustrating a problem you can’t solve alone can be.  When you’re talking manufacturing software like MES or paperless manufacturing, build-it-yourself solutions often become disasters that spiral out-of-control, consume resources and build frustration.  So if you know that you can’t, won’t or shouldn’t DIY, then you rely on the vendors (just like me).   This can lead to frustration.  You have a problem, but the potential solution-providers ignore you.  What can you do?  Here are a few pointers I’ve learned in software and manufacturing solution industry (and I’m considering for the mud dump in my backyard):

  • It’s safe to assume if sales won’t return your calls, delivery won’t be any more reliable. 
Look for a vendor that's responsive to your needs and works with you as a partner. Illustration from www.colourbox.com

Look for a vendor that’s responsive to your needs and works with you as a partner. Illustration from http://www.colourbox.com

True, there are times when a single company resource (who should call you back) is giving the whole organization a bad name, but company culture is either built for exceptional service or not.  Sloppy calling habits will mean sloppy delivery habits.  Don’t expect a company that can’t call you back to deliver exceptional service.

  •  Ask the vendor about their guarantees (if they even HAVE any). 

Just like everyone else, we make mistakes.  I know no one is perfect, but when mistakes happen, we admit our error and make it right.  You have my personal guarantee for any work we do, and we put it in writing.  Problems will happen during any software project, so it pays to ask about a guarantee.

  • Question the vendor on promise-based language on the website.

Do you see paragraphs of “we are the world’s leading…,”  “fastest to…” or “guaranteed to…” on the vendor website?  What makes someone a global leader?  Who is handing out “global leadership badges” and how is that going to help your shop floor?  What benefit are you going to get from the accolades they heap on themselves?  Is that global leader also a company that outsources their help desk so you never get service when you need it?  I even came across a company that calls themselves a, “cool vendor.”  Really?  How will that help you?

  • Focus on what you need.

As a subject matter expert in manufacturing systems and workflows, CIMx consults with its customers throughout the sales process.  We often see customer teams get hungry, and create a laundry list of requirements so long the project loses steam and profitability before you ever get to production.  Determine the “top” challenges and focus on the solution to those problems to ensure project success.

I’ll be honest, the dirt is STILL sitting in my backyard as I write this blog, and I’m getting ready to call a few more companies today.  I know I need to find someone to move the dirt (or build a mud pit or hilltop fort in my backyard), but I also know that choosing the wrong solution will lead to more frustration.

Take a few moments before you call a software vendor.  Ask the right questions, and have a focused plan of action, will help ensure you’ve found the right solution, and not created an even bigger pile of problems leaving a muddy mess on your shop floor.

A Simple Solution to the FDA’s UDI Requirement

New FDA regulations regarding UDI (Unique Device Identification) are causing worry among medical device manufacturers.  We show how you can fulfill the new requirements in a few simple steps.

By David Oeters, Corporate Communications with CIMx Software

There are times when a potential solution may cause more trouble than the problem itself.  A good example… the day I decided to use a hammer to open a jar of peanut butter.  It was a disaster we still call the “great peanut butter explosion.”  Another example – my neighbor tried to use a chainsaw to tear out weeds on his back fence.  The only thing left standing among the carnage was the weed.

The problem is the solution isn’t scaled to the problem.  In the end, you aren’t even solving the original problem, just creating a new problem.

Manufacturers working to meet the imminent deadline for UDI regulations set by the FDA are running into the same struggle – they are offered solutions that aren’t scaled to the problem.

Understanding the FDA’s UDI Requirements

The US FDA (Food and Drug Administration) is rolling out a UDI (Unique Device Identification) for medical devices.  The system will help identify product problems more quickly, target product recalls, and improve patient and user safety.  The UDI is a unique numeric or alphanumeric code consisting of two parts – the Device Identifier (DI), which identifies the specific model of the device, and the Production Identifier (PI) that identifies specific details related to the manufacturing of a device, which could include (among other things) the lot or batch number, the serial number, the date a device was manufactured and the expiration date.

When combined with the Global Unique Device Identification Database (GUDID), the FDA will be able to identify problems with a device and track defects to more effectively issue recalls.  The FDA has created an aggressive schedule for compliance – the first phase of compliance begins on September 24, 2014.  An extension of the compliance date must be submitted by June 23, 2014.

These regulations require medical device companies accurately collect manufacturing data.  Fulfilling the UDI requirements means real-time data collection, accurate archiving of manufacturing data, and shop floor control – all benefits of MES and Paperless Manufacturing.

A Solution Scaled to Your Shop Floor Needs – Phased Implementation

Why struggle with a solution that doesn't work for you?  Phased Implementation puts you in control of the project.  Illustration by www.colourbox.com

Why struggle with a solution that doesn’t work for you? Phased Implementation puts you in control of the project. Illustration by http://www.colourbox.com

Unfortunately, some manufacturers are struggling to meet the new requirements.  Faced with the imminent deadline, they look for MES solutions, and end up with a custom or highly-configured system that takes months (or even years) to build.   Add in the time necessary to install the system and train the shop floor in its usage and the exorbitant cost, and the solution begins to resemble the hammer to a glass jar of peanut butter.

Other times, a manufacturer will select a “module” for bar codes and labeling to meet the FDA requirements.  The vendor will offer them a data collection module or two (or three), and then a reporting module, a work instruction module, and then an integration module to put it all together.  Soon the single-module solution has become a massive MES project much more complex than anyone thought.  It’s a chain saw waiting to pull up a weed.

With paperless manufacturing and a phased implementation, you control the scope of the project and ensure the solution is scaled to your manufacturing needs.

With a phased implementation, the entire system is quickly installed straight out-of-the-box (or you use it as a cloud application).   You begin benefitting from the software in less than 30 days with UDI labeling built in from the start.  There’s no need to separately install each module or application.  There is no reason for multiple integrations or additional complexity.  Once installed, you decide what functions to turn on and pay for.  Your team is trained only on what you need.  Select the parts of the system you need to meet the UDI requirements, and focus on the functions that deliver the greatest result and ROI, resulting in a controlled transition to a more effective shop floor that easily incorporates the new FDA requirements for UDI.

Even better – you aren’t trapped by your solution.  When you and your team are ready, roll out new functionality and enhanced capabilities.  Since you are supported by the full software package, you have access to the latest software updates, releases and upgrades.  The solution will never become obsolete or another piece of legacy software.

A Different, better solution to the FDA UDI Regulations

Make your project a success with paperless manufacturing. Illustration by www.colourbox.com

Make your project a success with paperless manufacturing. Illustration by http://www.colourbox.com

The truth is, paperless manufacturing was designed as an alternative to traditional MES.  Utilizing the latest technology and building on CIMx’s experience as a best-in-class MES provider, paperless manufacturing delivers innovative MES functionality, including all the tools and functionality you need to meet the new UDI requirements, at less than 10% of the cost traditional MES.  Paperless manufacturing applications are easy to adapt, configure, add features and evolve without increasing the cost or creating custom software.

The UDI requirement deadline is fast approaching (if it hasn’t already passed) but you can still meet the requirements with minimal cost and complexity using a solution scaled to your shop floor needs.  You can improve your shop floor, improve quality and production, and deliver an ROI in months, not years.  Want to know more?  Give us a call or leave a message – we’re happy to help.