Is Now the Time to Modernize Your MES?

    March 10, 2025
    As manufacturers move toward Industry 4.0, manufacturing execution systems can be foundational to these efforts because the technology’s analytics provided in moving data from the plant floor to the enterprise is a key requirement.
    Related To:
    Scott Woodward, Huffman Engineering Inc.

    Modernization in global manufacturing is drawing major focus these days with an  estimated 74% of manufacturers in the U.S. reporting they plan to implement or upgrade  their MES (manufacturing execution system) technology within the next 5 years. These manufacturers tell the Manufacturing Enterprise Solutions Association International (MESA) they are planning to do this to improve production efficiency,  reduce downtime and enhance quality control.

    And those of us who work in industrial manufacturing every day shouldn’t be surprised  that MES is the next logical step for manufacturers to take in moving toward Industry 4.0.  To answer why this is such a logical step, consider that MES software expands on the  requirements identified in ANSI/ISA-95 Enterprise Control System Integration to  bridge the gap between ERP (enterprise resource planning) systems and the plant floor. 

    Industrial activities at the intersection of MES and ERP

    Real-time message flows that occur at the MES/ERP interface can include data related to:  materials, handling units (location, quantity and quality status), process orders and batch  information. At the plant floor level, MES integration can include ISA-88 batch control  systems, SCADA systems and process devices.  

    At the heart of MES are work instructions and electronic batch records (the electronic  instructions and record of the process to transform raw material into intermediate or  finished goods). Not surprisingly, global pharmaceutical and life science manufacturers, as  well as bio science facilities, have latched on to this technology for six reasons:

    • MES eliminates paper process required in life science manufacturing. 
    • Master batch records are updated and qualified through an electronic workflow. 
    • The electronic batch record is executed electronically — no more hand cramps  writing signatures and initials. 
    • MES improves data integrity and eliminates the verified-by-review process by  capturing values — no more guessing if the written number was 4 or 9. 
    • Deviations are handled in real time with remote review and approval. 
    • Finished quality reviews are streamlined using review by exception. 

    MES software provides real-time state information on all production requirements, such as:

    • Equipment — correct setup, recipes, cleaning, quality status, calibration and  maintenance.
    • Parts — correct part, cleaning, quality status, maintenance and location. 
    • Materials — quality status, expiration/retest date, quantity, substitutions and  location. 
    • Personnel — training, roles and availability. 

    Furthermore, MES tech uses electronic logbooks for complete records of usage and events.  These logbooks cannot be lost and can be reviewed at any time or location.

    When an MES system can rapidly calculate, verify, prove and archive stringent and ever-changing qualification and validation standards in a fraction of the time it takes a team of people in the document team to do the same job, efficiency alone is a standout measure of improvement.

    Weighing the high cost of an MES Implementation

    There is no question that there is a high initial cost to implementing MES technology, which  can give any manufacturer pause. However, carefully weighing the cost of not making the  change to a digital format can also be costly. 

    At a global pharmaceutical facility Huffman Engineering has worked with, the upfront costs of  time and money associated with an MES upgrade included building out three system  environments to allow for continued production, as well as a development system and a  quality system on the front end to allow for quality approval. 

    This example is, of course, specific to industries that need to meet the requirements of the  Food and Drug Administration (FDA). Current MES technology commonly used in the  pharmaceuticals, life sciences and food and beverage industries meet the requirements of  GxP (good practice guidelines) and are recognized by ISPE’s GAMP. 

    This pharmaceutical manufacturer saw the advantages of implementing MES, as the quality  standards that need to be met with every batch of medicine are ensured by the compliance  and data integrity of MES technology. Other benefits provided by MES include reduced  human error, a reduction of personnel to manage paper trails, and an elimination of checks  and balances by two verified operators. 

    And this doesn’t even take into account the loss that could be incurred if a two-inch-wide  binder of paper is lost, and an entire batch of medication has to be thrown out because the  paper batch record cannot be found. The cost of that product alone could be enough  incentive to start tracking and archiving records for audit purposes to free up your  personnel to do higher level strategic work rather than pushing paper. 

    When an MES system can rapidly calculate, verify, prove and archive stringent and ever- changing qualification and validation standards in a fraction of the time it takes a team of  people in the document team to do the same job, efficiency alone is a standout measure of  improvement.

    The value of MES across industry

    The good news is: MES can be used across all industrial and utility sectors — and often  without such high barriers to entry as are commonly experienced in highly regulated  industries like pharmaceuticals. Plus, MES can be implemented initially as a stand-alone  system. While you won’t experience the full capabilities and functionality of a fully  integrated MES system in this scenario, some organizations choose to start small and build  to full integration.

    And with the growing consumer demand for more customized products, 72% of  manufacturers are investing in flexible manufacturing systems and MES to handle product  variations in real time, according to Deloitte.

    Over the next decade, the digital transformation of manufacturing will continue to advance  with the explosion of artificial intelligence, predictive analytics and robotics. Simultaneously, the necessity of staying ahead of the curve and cataloging the data from  your plant floor systems to make wise business decisions will only increase. 

    Scott Woodward is engineering technical specialist at Huffman Engineering Inc., certified members of the Control System Integrators  Association (CSIA). For more information about Huffman Engineering, visit its profile on the Industrial Automation Exchange.

    More insights on MES from Automation World:

    Continued Reading