Category Archives: mid-size manufacturing

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!

Fix Your Shop Floor Processes Now

Don’t fall into the “If it ain’t broke…” trap.  Sometimes your biggest mistake is in not doing anything.

By David Oeters, Corporate Communications with CIMx Software

I don’t know where I first heard the phrase, “If it ain’t broke, don’t fix it?” but it’s become the rallying cry of procrastinators everywhere.  Unfortunately, it’s a rallying cry that ends up a funeral dirge or death knell…

Case in point… my neighbor had a rattle in the car engine.  It sounded like an engine wheeze – metal on metal.  “No big deal,” my neighbor said. “It’s just something loose and the car’s working fine.  I’ll get to it before vacation.”

Does your shop floor run like a well-oiled machine, or a wheezing engine?  Photo by www.colourbox.com

Does your shop floor run like a well-oiled machine, or a wheezing engine? Photo by http://www.colourbox.com

Vacation passed and the rattle continued.  Other priorities and expenses came up, so why bother with a rattle that wasn’t hurting anything?  That is, until he destroyed the engine on his way to a business meeting.   The car overheated, the head gasket blew and it completely ruined the engine.  My neighbor missed his meeting, spent more than $4,000 fixing his car, enjoyed a night on the side of the highway waiting for a tow truck, and was forced to coordinate rides to work and trips to the grocery store while the car was fixed.

Lesson of the story… a simple belt replacement ended up costing him thousands in repairs, plus lost time, missed meetings, and endless aggravation.

Choices and options.

How will you handle broken and inefficient processes on your shop floor? Photo from http://www.colourbox.com.

It’s a lesson not all manufacturers understand.  Software Advice recently released a survey (found here) detailing manufacturing software buyer trends. The report, by Software Advice’s analyst Derek Singleton, identifies paper and spreadsheets as the primary method of tracking manufacturing processes for many of the manufacturers taking the survey.  Research by Oracle has shown paper-driven processes increase costs, introduce errors, add complexity and create compliance issues.  In fact, 75.9% of companies reported significant business risks due to inefficient document-driven processes, including paper-based processes.  So why do so many companies continue to use paper-driven processes to control the shop floor (the heart of manufacturing)?

Because if it ain’t broke, why fix it?  If all your shop floor knows is inefficiency and is comfortable with it, then why change?

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).  The money has to come from somewhere, so these costs are either eaten by the manufacturer or passed along to the customers.  So why are companies throwing away money on paper?

I go back to my neighbor and the months he spent with a rattle in his engine.  He knew he should do something, but other priorities came up and the engine never seemed that bad.  “It’s more work to fix than deal with it”, he told me once.

What steps can you take to increase shop floor efficiency?  What steps are your competition taking?  Photo by www.colourbox.com

What steps can you take to increase shop floor efficiency? What steps are your competition taking? Photo by http://www.colourbox.com

For manufacturers operating in a paper-driven environment, going paperless would mean buying and installing a new system (which takes valuable IT resources), integrating a new process, and training the shop floor.  It feels like a lot of work for some nebulous, paperless return.  If the decision-maker isn’t a shop floor employee, it is even more difficult to justify the cost since you don’t feel the paper-based shop floor pain on a daily basis… and so, life under, “if it ain’t broke, don’t fix it?” goes on.

But there is a danger to the, “if it ain’t broke, don’t fix it?” mentality, and the grinding noise in my neighbor’s engine perfectly illustrates it…  We recently worked with a manufacturer that repeatedly failed audits due to paper-based record-keeping.  In less than a month, we were able to install a system on the shop floor and begin collecting audit-worthy as-built records.  Another manufacturer lost a major client because they couldn’t guarantee timely change orders – a simple function in paperless manufacturing and MES.  Waiting to fix shop floor challenges isn’t a solution, it means disaster hasn’t struck yet.  Worse yet is failing to recognize there is a problem and it needs fixing.

So what does this mean for you and your shop floor?

Another section of the Software Advice study identifies improving or automating processes as the top reason manufacturers purchase new manufacturing software.  Other reasons include updating or modernizing their software, additional features and functionality, and company growth.  Another part of the study identified improving efficiency as the primary reason companies seek to replace existing manufacturing software.  We are seeing a consistent drive to improve the shop floor, and the beginning of a movement away from the “If it ain’t broke…” mentality because people are starting to realize “It is broke”.

Companies are beginning to take control of their own destiny and take action proactively, rather than reactively.  The manufacturing marketplace is tightening, and proactive process and efficiency improvements are a competitive advantage for many companies.   More and more companies are turning every day to paperless manufacturing and manufacturing software for an advantage.

“If it ain’t broke…” isn’t a recipe for success in modern manufacturing.  Take a lesson from my neighbor – if you hear a grinding engine wheeze in your shop floor, get it fixed or you might be stuck waiting while your competition moves ahead.  Are there problems you are waiting to solve on your shop floor?  Are there problems you don’t even recognize on your shop floor?  Are your work processes a victim of the, “it ain’t broke…” mentality?  If so, let us know.  The solution may be much closer, easier to solve, and less expensive, than you might think.

Is Paperless Manufacturing Right for You?

No matter your company size or industry, paperless manufacturing delivers shop floor benefits (if you have the right system).

By David Oeters, Corporate Communications at CIMx Software

A while back, I had a leak in my basement- water from the shower came pouring out of the ceiling in a torrent, splashing across boxes of Christmas decorations.  I called a plumber, who gave me an estimate that included major construction, a replacement pipe, and a team of plumbers.  The estimate made me dizzy, but what could I do- shower in the basement below the leak?

Choices and options.

You have a shop floor challenge and you’re not sure what to do. Have you considered all the solutions available? Photo from http://www.colourbox.com.

I called another plumber who offered to take a look.  He studied the waterfall, and then cut a small hole in the closet outside the bathroom.  With a little wire and a wrench, he fixed the leak in 10 minutes.  “No worries,” he said. “The pipes are fine, but the fitting came loose.  I changed the seal, so it shouldn’t happen again.”  Total cost of the repair was less than $100.

The moral of the story… sometimes a solution is much easier, much cheaper and much closer than you might think.

It’s a scenario I’ve seen played out time and again in manufacturing.  A business will struggle with out of control shop floor processes, inefficient operations, significant loss from scrap and rework, or even failed audits because they believe a solution like paperless manufacturing or an MES is out of reach, too costly, and too complex.  They know the solution exists, but they think it won’t work for them.

Some try to build a software solution in-house, thinking this will get them a “personalized” solution under their control for less money, not realizing how much time and cost is involved in writing computer code from scratch.  An effective in-house solution can take YEARS of effort, with no guarantee of success.

Have you considered paperless manufacturing for your company?

Have you considered paperless manufacturing for your company?

Other companies limp along with patchwork solutions, legacy systems, or increasingly larger stacks of spreadsheets and documents traveling the highways and byways of their shop floor.  These companies believe software solutions are designed for multi-national companies with sales in the billions and the resources to pay for a team of programmers.  This belief leads many smaller companies to continue to use paper build books and excel spreadsheets.

You’ll be happy to know, the solution IS much closer than you imagine.  CIMx offers paperless manufacturing solutions for any size company, large or small, in any industry.  It is the right system for many manufacturers.  Here’s why:

  • CIMx offers scalable solutions.  CIMx designed a paperless manufacturing solution that scales to your operations.  You never have to take on more complexity or functionality than you want or need.  If all you need is improved quality, or as-built records, or a real-time view of production for improved customer service, paperless manufacturing offers a solution.  With CIMx, you can focus on the solution you need, then integrate additional capabilities when you are ready.  The solution scales to your needs, your operation doesn’t struggle to scale to the solution.
  • Phased implementation gives you control of the process.  The entire system can be completely installed in weeks.  At that point, you select the features and functions you want, turning them on in phases and using them when you are ready.  You and your team never take on more cost, risk, or change than you are prepared to manage.
  • Use your current processes and work instructions. With CIMx, there is no need to change your work instructions or adapt your current processes.  The system doesn’t require you to squish or adapt your current processes or instructions into new forms or tables.  The CIMx solution works as a tool for you.  This minimizes change and shop floor disruption, and ensures an even quicker ROI.
Paperless manufacturing is now a scalable solution, offering benefits to manufacturers in all industries and of all sizes. Photo by www.colourbox.com.

Paperless manufacturing is now a scalable solution, offering benefits to manufacturers in all industries and of all sizes. Photo by http://www.colourbox.com.

On top of that, CIMx offers one of the most effective support systems in the industry.  Rather than an impersonal help desk or support line, you have an applications engineer assigned to your account who is available for training, questions, and product support.  They know you, your business and your system.   They offer solutions instead of questions, and ensure the software is really benefitting your shop floor.  You never have to worry that once the system is installed, you are left on your own.

Ever since the waterfall in my basement, I’ve quit assuming the easiest, most practical solution isn’t for me.  I won’t take a reactive approach to problem solving, instead I try to use the BEST solution with the RIGHT answer (yeah, I’m looking at you broken air conditioner).  This approach has saved me money, minimized frustration and made me happier.

So what challenges does your shop floor face?  Have you thought about what paperless manufacturing can do for you?  Contact CIMx Software today to learn how we can help you overcome shop floor challenges with solutions that include workflow control, shop floor and production visibility, mobile manufacturing, and visual multi-media work instructions.  We have a number of solutions ready to tackle your biggest problems.