MES – Challenges of Implementing a Business Transformational Tool

HGP MES ServiceOver the past 3 years, I’ve had the privilege of traveling and meeting with customers all over Asia to promote our services in Manufacturing Execution Systems (MES) implementation.

These customers were all large successful manufacturers in Singapore, China, Taiwan and India, and all were already implementing MES or were very interested in having one.

To put it simply, MES is an information system that acts to execute the plants manufacturing processes and enables paperless batch records and management. At its optimum, the system serves to reduce processing cycle times, improve equipment OEE and promote best practice and compliance.

The adoption of MES has been picking up speed in Singapore with many plants successfully implementing MES over the past 2-3 years, up north in China and Taiwan, MES is a hot topic, with dozens of manufacturers from biologics, pharma to even traditional medicines companies requesting for proposals and exploring road maps to go paperless. These endeavours have been anything but a smooth ride.
These projects have been fraught with issues, some of the common and prominent issues include:

  • Users advocating process changes during PQ phase, resulting in system change and repeat of OQs
  • Hundreds of deviations as the systems was not properly unit tested prior to functional testing, resulting in a repeat of the entire FAT/SAT endeavour
  • Failure to go-live following the pilot implementation as users refused to support two system – manual paper-based system and MES paperless system; this resulted in the system becoming a white elephant with implementation costs of over USD$1M and ongoing licensing fees
  • Failure to launch due to resource issues during the implementation phase even though the project was initiated and a system was selected
  • No efficiency gains as the system completely mimics the paper-based process prior; the vendor’s consultants did not provide any value adding to the plant’s manufacturing process
  • Multiple delays due to unrealistic timelines and lack of support from various stakeholders
  • MES viewed as an IT project, hence lack of ownership by other stakeholders
  • URS was not followed during implementation  resulting in a system that does not meet its intended requirements
  • Lack of configurability – System cannot be used without substantial customisation, otherwise the manufacturer would have to modify their workflow to suit the system

These and many more issues have resulted in many MES projects being delayed at substantial time and cost or completely left dead in the water.

I see the issues are a result of a failure to take a People, Process and Technology approach.

Many organisations do not realise that implementing MES is not purely an IT project, it is a business transformational change and affects the entire organisation. Taking a functional approach, without substantial efforts in organisational change management and buy-in from key stakeholders top to bottom in a manufacturing organisation, a project is doomed to fail. Top management needs to back the project completely, and require all stakeholders to participate fully and provide adequate and competent resources. Evangelism of the merits of MES and the efficiencies it will realise need to be substantiated with analysis and profound thought to convince stakeholders of the merits of MES. Without stakeholder buy in, the best technology is useless.

Process optimisation studies need to take place to improve processes and workflows before implementing a project, eliminating redundancies and wastage of resources. The process should be looking for efficiency and quality gains in adopting the system and align to the MES’ structure. Policies, procedures and controls need to already be in place to ensure that there is a resilient and robust management system already in place, adopting best practices and actively steering stakeholders to towards manufacturing excellence.

People and processes first! Technology is the tangible aspect of the people, process and technology approach, and tends to be sole focus area of many MES implementation project. As we enter an age of digitised manufacturing, and our generation becoming over reliant on technology being a magic pill, we need to remember that every good solution and idea starts with a person or a group of people. Without integrity and robust management procedures in place, the best and brightest technology cannot shine. People and process are the foundations for any successful technology to stand on, without a shift of mindsets towards these foundational pieces, I fear we will continue to see MES projects falter, stuttering to find direction, and worst of all executed but left in purgatory as manufacturers find themselves with a system they do not want to adopt.

Author

HGP Senior Consultant & Director HGP ASIA Wee Ming Chua, Pharma Consultant, Quality, Risk & Compliance, Computer System Validation, MESMing Chua

Wee Ming CHUA is the Director of HGP Asia and heads a team of 20 consultants across all of HGP’s service offerings in Asia. Ming has over 15 years of experience as a business and functional consultant for GMP manufacturing processes, facilities and information management systems.

2 Comments

  1. David Adeola on 27. September 2016 at 14:46

    Are the MES process specific to the Healthcare industry or can it be used in any manufacturing environment?

    • Ming Chua on 27. September 2016 at 16:26

      Any manufacturing environment; it’s very common in the automotive and semi-con industries! For process industries, specifically Pharma, production is done in batches and has to comply with industry regulations.

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