Category Archives: FDA UDI Regulations

Turning Manufacturing Audits into Profit

Ed Deaton | CIMx Software

Audits can either cost you money or make you money. The choice is yours.

In the manufacturing industry, audits are the key factor in determining a company’s continued growth or imminent decline. Audits quantify the success of your team’s efforts by ensuring your shop is up to snuff in every stage of production.

However, the stress and time invested into filing frequent audits can weigh on your team, slowing down production and negatively impacting your bottom line.

Save Resources and Increase Value

The simple solution is to implement a system that reduces auditing time while impressing potential customers into delivering more contracts. Manufacturing Execution Systems (MES) are designed to optimize production while automatically collecting the essential data required to complete audits in a fraction of the time of manual audits.

But as you know, it’s not enough to just be compliant in a global market; you need to “wow” your way into new work and onto Preferred Supplier lists. Your shop needs to be the number your customers’ dial when a run absolutely must be completed on time. Audits are about one thing, mitigating risk. Show your prospective customers exactly why they should trust your shop by implementing an MES into your existing workflow.

Reduce your average audit time by 50% when you connect, correct and control every asset, operator and order in an MES designed specifically for your industry.

“We’ve already had eight separate audits in 2018 and every one has been completed in half the time. An audit that should take a full day only takes half a day in Quantum. From an ISO standpoint it’s been great. Every document we make becomes a permanent record and every revision is automatically stored in one system.”
– Ray Swanson, President of Tornik, LLC

MES systems like Quantum track and control production from Engineering through Delivery with Digital Planning, Real-Time Scheduling, Asset Management and Quality Control built into one complete platform. Give accurate timelines and enforce best practices on every job regardless of the unique specifications or complexity of an operation. Your Operators will complete their work faster with fewer non-conformances while automatically collecting the data required for future audits.

Give your best customers a tour of your shop floor to see your competitive advantage in action. The more Preferred Supplier lists you land your company on, the more readily your customers will bring you work and recommend your team to colleagues. It’s time you connected production with the complete MES designed for real world manufacturing, Quantum.

Next Steps
Connect with a CIMx Application Expert to discuss your workflow and determine if the Quantum MES/MOM is the right solution for your shop. Request a quote or schedule your live demo today!


Manufacturing Software Experience | CIMx Software
For more than 20 years, CIMx has developed software solutions that connect, correct and control production for U.S. manufacturers of all sizes. Build it right with Quantum®.

Schedule your live Quantum demo with a CIMx Application Expert today!

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Creating a Culture of Compliance

Ed Deaton | CIMx Software

Catch and resolve these common audit issues before the regulators do.

If you’re in the manufacturing industry you understand how essential auditing is to your company’s success. The amount of resources required to report multiple times a year may be frustrating, but their value cannot be overstated.

That said; you hate everything about them.

Here are three tips for getting ahead of your inspection and receiving the most value out of every audit.

 


1. Risk Avoidance

Audits are all about mitigating risk. Whether it’s risk to your employees, your customers or your bottom line; audits exist to keep your shop on schedule, compliant and safe. Inconsistencies in processes, Operator error and record keeping are among the most common issues reported during internal reviews.

To mitigate these risks you need to both control how work is executed and collect the right data as consistently as possible.

Leverage the digital work packets and data collections in your Manufacturing Execution System (MES) to guarantee every order is built to spec. By utilizing clear work instructions with automatic Quality checks your Operators will have everything they need at their fingertips.

Modern MES platforms also generate permanent as-built records (eDHR) to ensure you have a complete history of every material, tool and process used on an order. With the asset traceability and revision control tools (included in your MES) your data will be reliably stored for easy access when requested by auditors.

2. Know Your Weaknesses

This isn’t your first rodeo. Audit preparation 101 is addressing and reporting on the results of your previous review. You need to show that, not only have past issues been addressed, but that the processes set in place to prevent their reoccurrence have been enforced and well documented. Being docked for a new infraction is bad, but being docked for reoccurring infractions is much worse.

Remember, no two audits/auditors are the same. To assure yourself that processes are being followed, visit the areas most likely to commit an error. This could be anywhere from a highly complex workstation to an area with an above average number of new hires. Regardless, visit your areas where failure is at his highest probability and don’t leave until you’re confident in their success.

3. Stop Cutting Corners

The truth is most manufacturers will only do the bare minimum to pass their audits. Management has other priorities and often sees these check-ins as intrusive and unnecessary. This leads to a culture of sweeping the dirt under the rug twice a year without making any real changes to support the growth of the business.

However, this line of thinking is dangerously flawed. The reality is that there are few greater risks to a manufacturer’s success than losing their certifications. How many customers would your company lose if its ISO 9001, AS 9100 or FDA certifications were revoked?

Implement a long-term solution designed to grow with your business. Do your research and select a vendor with the experience and dedication you need to succeed. Enforce quality, control production and track every order from engineering through delivery with an MES designed for your industry. 


 

Next Steps

If your company needs a plan leading into your next audit, connect with a CIMx Application Expert today to learn more about complete MES functionality. Our experienced team understands your industry and can provide the insight you need to succeed. Learn more about what the right Manufacturing Execution System can do for your shop today!

The Quantum® MES/MOM delivers the order traceability, audit control and production efficiency your shop needs to compete in a global market. Complete orders ahead of schedule and under budget with the manufacturing system designed for your industry. Build it right with Quantum.


Manufacturing Software Experience | CIMx Software

For more than 20 years, CIMx has developed complete solutions for manufacturers. The experience and innovation behind CIMx systems have delivered decades of increased production and cost savings. Quantum® is designed to deliver the production control your team needs to build it right™, ahead of schedule and under budget.

Schedule your live Quantum demo with a CIMx Application Expert today!

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?

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.