Throughout this blog series, we have addressed the benefits of paperless manufacturing by highlighting the cost effectiveness of the following:

  • Eliminating the cost of paper
  • More accurate order processing
  • Reducing Non-Conformances

Today’s final feature addresses the fourth benefit of implementing a paperless manufacturing execution system:  Improved Production Performance

Medical device manufacturing is faced with many complexities. Product lifecycles are becoming shorter, and if a company hopes to maintain a competitive edge in the industry, it must evolve the manufacturing processes quickly. As products become more complex, regulatory pressures also increase.  Due to this increased regulatory pressure, each manufacturing process change is likely to 1 – increase the number of steps involved and 2 – require that more product (and process) information be collected during those steps. Strong companies realize that automating the manufacturing process leads to more efficient production.  If a company utilizes a product lifecycle management system (PLM), the design and the development of the product change as well.  Ideally, the result is a more efficient manufacturing process.

Herein lies the advantage of utilizing a paperless manufacturing system.  Companies that use MES learn more about the production process because MES allows for the user to more actively view the activity occurring on the production floor. Utilizing this new knowledge, the user can determine what new capabilities can be added to MES to improve production performance – providing tighter control and visibility.

When working to increase production performance, it is important to look at the process for handling product change-over during production.  Analyzing how a company prioritizes orders is vital to success.   As a company transitions from an ERP System to MES, intelligent dispatching optimizes and enforces order processing. As new products are introduced, MES allows the company to build on existing workflows to establish new manufacturing processes. These copied workflows may include items such as required training, required components and equipment use; and because of MES enforcement, production rework is greatly reduced.  MES utilization allows for immediate examination of the manufacturing process, and identifies specification and component errors. 

At Seabrook, one common mistake seen with manufacturers is the lack of inclusion of the purely paper-based operations in their cycle times. Remember, medical device manufacturers produce the product as well as the Device History Record (DHR).   Seabook has assisted companies as they assess the requirements for MES, and we walk through the vendor selection process with them. As an example, we are currently working with a client using a paper-driven manufacturing process that implements a two-week DHR review process that begins once their product is ready to ship.  For two weeks, the product unnecessarily sits on the floor waiting to be shipped. With the implementation of MES, this company can eliminate this two-week waiting period, and their plan is to evolve their process and review by inspection instead.  Because of MES, they will no longer have product shipment lag time, which will increase distribution speed significantly.

The tables below represent the many benefits experienced by two actual Seabrook customers who converted to MES.  DHR time was reduced significantly, leading to a reduction in inspector headcount.   NCR disposition also significantly dropped, meaning less material is wasted in the manufacturing process.  Paper-based solutions require a significant amount of manual review, which leads to longer decision-making time and more time between production and distribution of the product.  Tear-backs (when a product passes through packaging but must be torn open for inspection) were also significantly reduced.  Although not as expensive as a product recall or field action, a tear-back is an indicator of how far a product can pass through the manufacturing process before a problem is discovered.

Consider this as well:  to discover the values in the Pre-MES column, someone had to manually gather the data.  Following MES implementation, someone merely needs to run a report.

As seen in these tables, significant savings occurred through the DHR inspection process, labor cost, training cost,paper-related cost and more.  The second client (table 2) realized a cost savings of over a half a million dollars in one year, which resulted in a complete MES return on investment in less than two years.  This is consistent with a study lead by Gartner, which found that return on investment from MES implementation varies from 6 to 24 months – with an average ROI of 12 months.

As seen by each blog in this series, there are numerous financial and organizational benefits that are experienced as companies transition to paperless MES.   At Seabrook, we believe that MES and cloud-based MES are vital to the success of manufacturers.  We have recently been recognized by CIO Review as a Top Ten Manufacturing Technology Solution Provider.  Our team of experts seek to come alongside manufacturers to provide the best solutions in the industry, and we would be honored to serve those looking to make this transition.  Simply contact us via this web page or contact us directly:  Tel: +353 21 4800 840 or [email protected]

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