MES Consultant Selection

July 28th, 2009

Executive Summary

This white paper discusses the MES Consultant selection process, one that often is made difficult when unnecessary limitations are imposed.  When searching for qualified MES Consultants, several other critical factors that must also be taken into account to ensure project success.

 

Introduction

Currently, one of the most popular topics in the manufacturing sector, across virtually all industries, is Manufacturing Execution Systems (MES).  Executives from pharmaceutical, bio-tech, gas & oil, process and other industries have discussed and studied these systems in one form or another, evaluating whether or not the investment in an MES system is wise, beneficial and/or appropriate for their specific business needs.

 

Such evaluation discussions can be lengthy and time-consuming, and rightly so, given that an investment in an MES system implementation typically runs into millions of dollars, particularly when integration with new or legacy systems is considered. After the business case has been presented, analyzed and evaluated and the decision has been made by management to proceed with an MES implementation project, evaluating and selecting an MES vendor is the next, extremely important step in the process.  Performing a preliminary ‘gap analysis’ between current manufacturing processes and the features and functions of various MES products can help determine the extent of changes that are required (e.g. product customizations or revised SOPs) as well as the level of integration effort that will ultimately be necessary.  The significance of this ‘gap’ may be what separates one MES vendor from another and ultimately decides which system is selected. 

 

When pursuing a project of this size and cost, having all the right pieces in place to ensure success is of vital importance.  Perhaps the most important of all these pieces is experience – and more often than not, that experience comes in the form of seasoned, qualified MES consultants.

 

Key to Successful Selection

 However, independent of which MES vendor is selected, the most vital factor in ensuring MES project success is the project implementation team.  Furthermore, the extent to which this team is leaned upon for direction, development and support (both during and after go-live) could make this decision even more crucial.

 

Manufacturing customers that don’t have access to a large, internal resource pool for a long-term project must often look outside their company to staff such an effort.  That search typically leads them in one of three directions:  (1) the Services group of the selected MES vendor, (2) independent MES consultants or (3) a combination of both.  For reasons of cost and objectivity, the practical choice in most cases is the combination option (3).

 

Consultants who are experienced in MES projects can provide invaluable insight, having gone through the entire project life cycle with many other customers and MES vendors.  This widespread exposure inherently results in a treasure-trove of ‘lessons learned’ (e.g. you absolutely must do this, avoid doing that at all costs).  Knowing where the typical pitfalls lie in the often-times long, winding, bumpy MES project road allows the project to be structured and guided in such a way as to minimize ‘go-live pains’ and maximize the likelihood of overall project success.  Additionally, those consulting firms that have had exposure to multiple MES vendors can provide the unique perspective of objectivity, something that, of course, isn’t possible when using an MES vendor’s own Services group.

 

With all that being said, the question then becomes:  How do I find the best MES consultants to lead/supplement my project team and what criteria should be used to decide who gets hired?

 

The answer to that very fundamental question presents the #1 Project Pitfall to avoid:

 

When hiring MES contractors, don’t tie your own hands by limiting your choices to only those contractors that have extensive experience with one MES vendor – the one that has been selected for your project.

 

The ability to apply past lessons-learned when navigating through most MES projects has absolutely no dependency on one MES vendor vs. another.  Project-critical issues typically occur in the areas of accurately defining user requirements, getting buy-in from Subject Matter Experts (SMEs) and operations personnel, controlling project scope creep, managing the project schedule and ensuring the validation effort is organized and effectively challenges all requirements.  Every one of these success factors is completely independent of the MES vendor that has been selected. If your MES consultant search process has narrowed the field of qualified candidates down to two or three who all appear to be similarly qualified, perhaps then vendor-specific experience can potentially be used as a ‘tie-breaker’.  But as a cardinal rule, overall MES experience should be the #1 consideration.

 

MES solutions typically possess the functionality to provide a ‘dock-to-dock’ solution:  from purchase order receiving to raw material inventory management, from dispensing to recipe execution and in-process statistical controls, from packaging to shipping.  However, for any number of reasons, customers may choose to initially implement a subset of these functions, with the intent of expanding the MES umbrella further down the road, when the schedule and funding permit.

 

Likewise, experienced and qualified MES consultants can provide all services required as part of an MES project, or just a subset, as required by the customer.  In those cases where the scope of hired MES consultants is in a fairly limited role, the extent and value of their knowledge is often discovered as the project progresses and their role expands as the customer is able to lean more heavily on them and their expertise.  For this very reason, making the correct selection up-front can reap significant dividends throughout the project life cycle.  And, once again, this value being independent of any specific MES vendor provides more than ample justification for not limiting the initial MES consultant search.

 

Conclusion

MES consulting is still a niche market in which the pool of experienced, qualified consultants is fairly limited.  When evaluating the best consulting firm for a specific project, extensive MES project exposure and experience should be considered vastly more important than a firm’s intimate knowledge of a specific MES vendor.

Introduction to a MES-centered system integration

January 29th, 2009

Many companies have numerous, complex and critical IT systems within their business enterprise to manage financial, scheduling, production, inventory and quality data. Over the course of time, business needs change and technology advances, so it is common for companies to implement and/or upgrade systems in various areas of their business processes.

When the data owned by these various systems is synchronized between areas and visible throughout the enterprise, companies avoid duplication, maximize their IT investments and stay ahead of the competition.

Benefits of System Integration
There are numerous reasons for linking various systems together to share data:

  • Visibility of plant-floor data in real-time or near real-time at a global level
  • Standardization of processes
  • Increased operational excellence
  • Lower operating costs
  • Provides accurate manufacturing costs based on productivity
  • Manufacturing Execution Systems (MES)
    With an emphasis on MES systems, the professional consultants at EIS have extensive experience integrating these systems to share relevant information.

    ERP: While MES directs operator activity on the production floor, it may not be the owner of the database. When an ERP system, such as SAP or JDE, is that owner, on-the-floor material consumptions must be reported in real-time to ERP to keep the inventory levels accurate. These material lot consumptions establish product genealogy, providing complete history information to ERP. Batch start & stop times assist with finite scheduling. Additionally, lot changes in QC status and/or expiration dates must be reported in real-time to ensure product quality.

    LIMS: The use of Laboratory Information Management Systems is widely used within the pharmaceutical and biotech industries. Automatically registering samples to the laboratory system and receiving sample results on the production floor in real-time expedites production activities, minimizing any delays due to product sampling. MES can use and record this data to help ensure the quality of materials and products that are consumed or produced by production-related activities. Stored in a single database, this data supports efforts to track genealogy for a specific batch or lot.

    CAPA: MES systems are often the first to detect out of specification conditions. When these situations occur, interfacing to a Corrective and Preventive Action system provides a single place where all process deviations are logged and the appropriate corrective action is maintained.

    DMS: Document Management Systems may be used to create and track Standard Operating Procedures (SOPs) and other production & quality related documents. When properly interfaced, MES systems are able to retrieve documents directly from a DMS and display them on-screen for the operator at the time and point of use. Keeping electronic copies at the production operator’s fingertips eliminates the need for hard-copies throughout the facility, and minimizes the chances of referencing out-of-date revisions.

    Reports: When an MES system directs operator activity and records operator data entry, all information is stored in a centralized database. From this single storehouse of data, reporting software can be used to pull and display any type of data for any specific event/task. For example, genealogy for a given production batch can be determined in seconds, savings thousands of dollars, and hours/days/weeks of time. Available electronically from anywhere within a company’s secure network, these reports can help save time, money, lost product, and help ensure the quality of the output product.

    Extensive experience in numerous MES-related projects has cultivated a deep skill set within our consultant team, in all phases of a given integration project. From assistance with problem identification, project scoping and user requirements to developing and implementing technical solutions, EIS professionals help ensure successful synchronization and optimal operation of the systems that are the business lifelines of our valued customers.

    System Integration

    Flexible MES in a Global Pharma World

    January 28th, 2009

    With the increase in Global manufacturing in which Pharmaceutical corporations are researching, developing, piloting, and manufacturing products in multiple sites domestically and internationally, MES vendors are taking notice and providing functionality to make a single enterprise MES solution a reality.

     

    While MES solutions in the Life Science market have existed for over 20 years, it hasn’t been until recently that those solutions have started reaching across a single plant into a single enterprise solution.  Through enhancements in the integration with ERP and Controls systems, as well as the flexibility to handle plants of all types and purposes, MES vendors have reached out to satisfy the needs of their Global Pharmaceutical customers.

     

    Research and Development

    R&D manufacturing has always been a significant challenge for Manufacturing Execution Systems (MES) as the flexibility of the research process makes it difficult for many software vendors that are typically focused on “controlling” the manufacturing floor.  To overcome this challenge, MES software companies have added flexible steps to their product suites.  These steps allow for special cases such as allowing any material or equipment to be added without being “planned” as part of a bill of materials or a bill of equipment.   This functionality allows for R&D operations to properly document each activity, thereby ensuring valid lots and equipment are recorded in the electronic record.  By simply changing a few configurable options within the product, R&D users can change materials, equipment and instructions while in production and the system will record each activity in an electronic batch record as well as in enormously useful databases that can be used to easily capture and query production data.  This capability provides companies with the ability to maintain some level of control of the R&D process – such as:

    ·         verifying that the material, lot and quality statuses of each ingredient are valid before consumption

    ·         verifying that equipment statuses are valid before continuing processing

    ·         capturing all deviations from the expected process

    ·         real-time updates of inventory and financial systems

     

     

    Pilot Plants

    As the possibility of a new product progresses closer to become a reality, pilot plants are used to determine how small or large the production process can be to make the product economically feasible.   Many MES vendors allow for this flexibility by defining batch material and equipment scaling easily within their process recipes.  The system performs all required calculations to make sure that all materials and equipment are sized appropriately, without asking operators to manually perform these calculations on paper.   By making MES recipes highly scalable, pilot plants can focus on determining the correct equipment and product constraints without the added cost or trouble of manually updating paperwork systems. Again the reportable database becomes extremely useful, as the results of multiple batches can be analyzed to determine the best production environment and parameters for each product.

     

     

    Multi-Product Manufacturing Facilities

    Manufacturing multiple products within a single facility can be difficult for some MES systems.   While the processes and equipment may be similar between products, the materials and their parameters are potentially quite different.   But the latest version of many MES software packages provides for the capability to ‘parameterize’ almost every aspect of a recipe, thus making the recipe more flexible right up to the point of production execution.  Recipe authors can create process operations which utilize placeholders for parameters such as instruction text, timers, process limits, materials, and equipment classes.  Since populating these recipe placeholders with run-time values can be deferred until later in the process when the actual values are known, an MES system can now be used to standardize the manufacturing floor across multiple products.  Additionally, MES systems provide tools to make authoring recipes as simple as cutting and pasting reusable operations and filling in the deferred parameter values.  This activity allows for planned, predictable manufacturing throughout the facility and provides for cost improvements in training, fewer operator errors, SOP maintenance and product consistency.

     

     

    Global Manufacturing

    As manufacturing specialization and tax laws make it more beneficial for companies to begin production at one facility and complete production at a second facility – sometimes in a different country – genealogy, material and equipment management, and recipe consistency across sites becomes an even greater challenge.  MES vendors are addressing this challenge by creating enterprise solutions.  Web Farm systems that can maintain specification data for all worldwide sites can be implemented to allow for:

     

    • easily transferring recipes from one facility to another
    • sharing operation templates to create process improvement and commonality across facilities
    • globalization capabilities which display on-screen text in the primary language of each logged on user
    • a single repository for genealogy and inventory information across facilities

    Control System Integration

     To achieve a more fully-automated and tightly-controlled production environment, integrating the Manufacturing Execution System with the process control system is a growing trend throughout the pharmaceutical and biotech industries.  Many MES vendors are teaming up with control system vendors to provide seamless links between electronic batch record instructions and process equipment controls within a single suite.  For those pharmaceutical and biotech companies with existing process control systems already in place, MES offerings also have the capability to communicate using cross-platform interfaces.  Whether the solution is a single-suite or across platforms, the MES-to-control system links provide for significant benefits in the following areas:

     

    • Inclusion of appropriate control system data directly within the electronic batch record
    • Verification of material and equipment statuses prior to control system recipe start
    • Ability to call up manual process phases in MES from within the control system recipes
    • A single-screen user interface to simplify operator involvement

     

    Global MES benefits 

    While the implementation of an MES system is always challenging, the rewards and return on investment is higher than it has ever been.  Some of these benefits include:

     

    • Reducing inventory
    • Shorter time to market
    • Quality review by exception (automatic lot release)
    • Reduction in Compliance costs
    • Reduction in indirect labor
    • Ability to move products to multiple plants
    • Planned, predictable performance

     

    Now might be a great time to check out what the MES vendors have to offer to put your enterprise on the road to flexibility and predictability!

     

      

    Mike Eiselt

    President - Enhanced Information Solutions, Inc.

    Stillwater, MN USA

    Tel: (651) 351 9227 x201

    Fax: (651) 351 2762

    meiselt@eisincorporated.com

    www.eisincorporated.com

    What is MES?

    January 27th, 2009

    According to the Manufacturing Enterprise Solutions Association MESA International,

    “A Manufacturing Execution System (MES) is a dynamic information system that drives effective execution of manufacturing operations. Using current and accurate data, MES guides, triggers and reports on plant activities as events occur. The MES set of functions manages production operations from point of order release into manufacturing to point of product delivery into finished goods. MES provides mission critical information about production activities to others across the organization and supply chain via bi-directional communication.”

    A visual presentation of where MES fits in an enterprise system is illustrated as the follows (*1),

    MES Diagram

     

    *1:  This diagram is found at techeng Web site.


      Copyright © 2009 Enhanced Information Solutions, Inc. All Right Reserved.

    MES Insights is proudly powered by WordPress